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MS2800	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: 33 patients with refractory irritable bowel syndrome were treated with four 40-minute sessions of hypnotherapy over 7 weeks . 20 improved , 11 of whom lost almost all their symptoms . Short-term improvement was maintained for 3 months without further formal treatment . Hypnotherapy in groups of up to 8 patients was as effective as individual therapy OBJECTIVES : Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome ( IBS ) . However , r and omized , controlled studies are rare and few have been performed outside highly specialized research centers . The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical setting s outside the traditional research units . METHODS : The study population included IBS patients refractory to st and ard management . In study 1 , patients were r and omized to receive gut-directed hypnotherapy ( 12 sessions , 1 h/week ) in psychology private practice s or supportive therapy , whereas patients were r and omized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2 . Gastrointestinal symptom severity and quality of life were evaluated at baseline , at 3 months follow-up and after 1 year . RESULTS : We r and omized 138 IBS patients refractory to st and ard management , 90 in study 1 and 48 in study 2 . In both the studies , IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups ( P<0.05 ) , but not in the control groups ( ns ) . In study 1 , a significantly greater improvement of IBS-related symptom severity could be detected in the gut-directed hypnotherapy group than in the control group ( P<0.05 ) , and a trend in the same direction was seen in study 2 ( P=0.17 ) . The results seen at 3 months were sustained up to 1 year . CONCLUSIONS : Gut-directed hypnotherapy is an effective treatment alternative for patients with refractory IBS , but the effectiveness is lower when the therapy is given outside the highly specialized research centers 30 patients with severe refractory irritable-bowel syndrome were r and omly allocated to treatment with either hypnotherapy or psychotherapy and placebo . The psychotherapy patients showed a small but significant improvement in abdominal pain , abdominal distension , and general well-being but not in bowel habit . The hypnotherapy patients showed a dramatic improvement in all features , the difference between the two groups being highly significant . In the hypnotherapy group no relapses were recorded during the 3-month follow-up period , and no substitution symptoms were observed Background / Aims Irritable bowel syndrome ( IBS ) is one of the most common functional gastrointestinal disorders and when compared to the vast knowledge pertaining to adults with IBS , very little is known about IBS in children and adolescents . We aim ed to explore the prevalence of IBS , identify symptoms and contributing factors and also to examine the efficacy of trimebutine maleate in children and adolescents . Methods The study involved 345 children and adolescents ( 4 - 18 years ) and parents were requested to fill in a question naire , Rome III criteria was used to diagnose IBS . To exclude organic disease , all patients underwent medical investigations . Half of the r and omly selected IBS patients were treated with trimebutine maleate while the rest of IBS patients were not . The IBS patients were reevaluated at the end of 3 weeks . Results The prevalence of IBS according to Rome III criteria in children and adolescents was 22.6 % and IBS with constipation was the predominant subtype . Back pain ( OR , 6.68 ) , headache ( OR , 4.72 ) and chronic fatigue ( OR , 3.74 ) were significantly higher in IBS group . The prevalence of IBS in both parents and depression in mothers was greater for the patient group than the healthy controls ( P < 0.0001 ) . The prevalence of functional dyspepsia in IBS group was 80.8 % and was significantly higher than control group . Clinical recovery was seen in 94.9 % of the trimebutine maleate group versus spontaneous recovery in 20.5 % of the non-medicated group . The difference was significant ( P < 0.0001 ) . Conclusions IBS is a common disorder in children and adolescents . IBS is closely associated with somatic and familial factors . Trimebutine maleate is effective for pediatric IBS patients Previous research from the United Kingdom has shown hypnotherapy to be effective in the treatment of irritable bowel syndrome ( IBS ) . The current study provides a systematic replication of this work in the United States . Six matched pairs of IBS patients were r and omly assigned to either a gut-directed hypnotherapy ( n=6 ) or to a symptom monitoring wait-list control condition ( n=6 ) in a multiple baseline across subjects design . Those assigned to the control condition were later crossed over to the treatment condition . Subjects were matched on concurrent psychiatric diagnoses , susceptibility to hypnosis , and various demographic features . On a composite measure of primary IBS symptoms , treatment was superior ( p=.016 ) to symptom monitoring . Results from the entire treated sample ( n=11 ; one subject was removed from analysis ) indicate that the individual symptoms of abdominal pain , constipation , and flatulence improved significantly . State and trait anxiety scores were also seen to decrease significantly . Results at the 2-month follow-up point indicated good maintenance of treatment gains . No significant correlation was found between initial susceptibility to hypnosis and treatment gain . A positive relationship was found between the incidence of psychiatric diagnosis and overall level of improvement BACKGROUND & AIMS Functional abdominal pain ( FAP ) and irritable bowel syndrome ( IBS ) are highly prevalent in childhood . A substantial proportion of patients continues to experience long-lasting symptoms . Gut-directed hypnotherapy ( HT ) has been shown to be highly effective in the treatment of adult IBS patients . We undertook a r and omized controlled trial and compared clinical effectiveness of HT with st and ard medical therapy ( SMT ) in children with FAP or IBS . METHODS Fifty-three pediatric patients , age 8 - 18 years , with FAP ( n = 31 ) or IBS ( n = 22 ) , were r and omized to either HT or SMT . Hypnotherapy consisted of 6 sessions over a 3-month period . Patients in the SMT group received st and ard medical care and 6 sessions of supportive therapy . Pain intensity , pain frequency , and associated symptoms were scored in weekly st and ardized abdominal pain diaries at baseline , during therapy , and 6 and 12 months after therapy . RESULTS Pain scores decreased significantly in both groups : from baseline to 1 year follow-up , pain intensity scores decreased in the HT group from 13.5 to 1.3 and in the SMT group from 14.1 to 8.0 . Pain frequency scores decreased from 13.5 to 1.1 in the HT group and from 14.4 to 9.3 in the SMT group . Hypnotherapy was highly superior , with a significantly greater reduction in pain scores compared with SMT ( P < .001 ) . At 1 year follow-up , successful treatment was accomplished in 85 % of the HT group and 25 % of the SMT group ( P < .001 ) . CONCLUSIONS Gut-directed HT is highly effective in the treatment of children with longst and ing FAP or IBS OBJECTIVES : Gut-directed hypnotherapy ( GHT ) in individual sessions is highly effective in the treatment of irritable bowel syndrome ( IBS ) . This study aim ed to assess the long-term effect of GHT in group sessions for refractory IBS . METHODS : A total of 164 patients with IBS ( Rome-III- criteria ) were screened , and 100 refractory to usual treatment were r and omized 1:1 either to supportive talks with medical treatment ( SMT ) or to SMT with GHT ( 10 weekly sessions within 12 weeks ) . The primary end point was a clinical ly important improvement on several dimensions of daily life ( assessed by IBS impact scale ) after treatment and 12-month follow-up . The secondary end point was improvement in general quality of life ( QOL ; Medical Outcome Study Short-Form-36 ) , psychological status ( Hospital Anxiety Depression Scale ) and reduction of single IBS symptoms . Analysis was by intention to treat . RESULTS : A total of 90 patients received allocated intervention . After treatment , 28 ( 60.8 % ) out of 46 GHT patients and 18 ( 40.9 % ) out of 44 SMTs improved ( absolute difference 20.0 % ; 95 % confidence interval ( CI ) : 0–40.2 % ; P=0.046 ) ; over 15 months , 54.3 % of GHT patients and 25.0 % of controls improved ( absolute difference 29.4 % ; 95 % CI 10.1–48.6 % ; P=0.004 ) . GHT with SMT improved physical and psychological well being significantly more than SMT alone ( P<0.001 ) . Gender , age , disease duration and IBS type did not have an influence on the long-term success of GHT . CONCLUSIONS : GHT improves IBS-related QOL , is superior to SMT alone , and shows a long-term effect even in refractory IBS Hypnosis improves irritable bowel syndrome ( IBS ) , but the mechanism is unknown . Possible physiological and psychological mechanisms were investigated in two studies . Patients with severe irritable bowel syndrome received seven biweekly hypnosis sessions and used hypnosis audiotapes at home . Rectal pain thresholds and smooth muscle tone were measured with a barostat before and after treatment in 18 patients ( study I ) , and treatment changes in heart rate , blood pressure , skin conductance , finger temperature , and forehead electromyographic activity were assessed in 24 patients ( study II ) . Somatization , anxiety , and depression were also measured . All central IBS symptoms improved substantially from treatment in both studies . Rectal pain thresholds , rectal smooth muscle tone , and autonomic functioning ( except sweat gl and reactivity ) were unaffected by hypnosis treatment . However , somatization and psychological distress showed large decreases . In conclusion , hypnosis improves IBS symptoms through reductions in psychological distress and somatization . Improvements were unrelated to changes in the physiological parameters measured BACKGROUND In western population s irritable bowel syndrome ( IBS ) affects between 10 % and 30 % of the population and has a significant effect on quality of life . It generates a substantial workload in both primary and secondary care and has significant cost implication s. Gut-directed hypnotherapy has been demonstrated to alleviate symptoms and improve quality of life but has not been assessed outside of secondary and tertiary referral centres . AIM To assess the effectiveness of gut-directed hypnotherapy as a complementary therapy in the management of IBS . DESIGN OF STUDY R and omised controlled trial . SETTING Primary care patients aged 18 - 65 years inclusive , with a diagnosis of IBS of greater than 6 weeks ' duration and having failed conventional management , located in South Staffordshire and North Birmingham , UK . METHOD Intervention patients received five sessions of hypnotherapy in addition to their usual management . Control patients received usual management alone . Data regarding symptoms and quality of life were collected at baseline and again 3 , 6 , and 12 months post-r and omisation . RESULTS Both groups demonstrated a significant improvement in all symptom dimensions and quality of life over 12 months . At 3 months the intervention group had significantly greater improvements in pain , diarrhoea and overall symptom scores ( P<0.05 ) . No significant differences between groups in quality of life were identified . No differences were maintained over time . Intervention patients , however , were significantly less likely to require medication , and the majority described an improvement in their condition . CONCLUSIONS Gut-directed hypnotherapy benefits patients via symptom reduction and reduced medication usage , although the lack of significant difference between groups beyond 3 months prohibits its general introduction without additional evidence . A large trial incorporating robust economic analysis is , therefore , urgently recommended Assessment of the physiological effects of physical and emotional stress has been hampered by a lack of suitable laboratory techniques . Since hypnosis can be used safely to induce specific emotional states of considerable intensity , we studied the effect on distal colonic motility of three hypnotically induced emotions ( excitement , anger , and happiness ) in 18 patients aged 20 - 48 years with irritable bowel syndrome . Colonic motility index was reduced by hypnosis on its own ( mean change 19.1 ; 95 % CI 0.8 , 37.3 ; p less than 0.05 ) and this change was accompanied by decreases in both pulse ( 12 ; 8 , 15 ) and respiration ( 6 ; 4 , 8) rates ( p less than 0.001 for both ) . Anger and excitement increased the colonic motility index ( 50.8 ; 29.4 , 72.2 ; and 30.4 ; 8.9 , 51.9 , respectively ; p less than 0.01 for both ) , pulse rate ( 26 ; 22 , 30 ; and 28 ; 24 , 32 ; p less than 0.001 for both ) , and respiration rate ( 14 ; 12 , 16 ; and 12 ; 10 , 14 ; p less than 0.001 for both ) . Happiness further reduced colonic motility although not significantly from that observed during hypnosis alone . Changes in motility were mainly due to alterations in rate than in amplitude of contractions . Our results indicate that hypnosis may help in the investigation of the effects of emotion on physiological functions ; this approach could be useful outside the gastrointestinal system . Our observation Output:	This study provides clearer evidence that hypnotherapy has beneficial short-term effects in improving gastrointestinal symptoms of patients with IBS
MS2801	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In this prospect i ve r and omised study two treatments after non-traumatic medial meniscal tear diagnosed with radiological examination and magnetic resonance imaging were compared ; arthroscopic partial meniscectomy followed by supervised exercise or supervised exercise alone . The aim was to evaluate knee function and physical activity . Ninety patients ( mean age 56 years ) were evaluated using the Knee Injury and Osteoarthritis Outcome Score , the Lysholm Knee Scoring Scale , the Tegner Activity Scale and a Visual Analogue Scale for knee pain prior to the intervention , after 8 weeks of exercise and after 6 months . According to the outcome scores arthroscopic partial medial meniscectomy combined with exercise did not lead to greater improvement than exercise alone . After the intervention both groups reported decreased knee pain , improved knee function and a high satisfaction ( P < 0.0001 ) . Forty-one per cent of the patients returned to their pre-injury activity level after 6 months . In conclusion , when evaluated with outcome scores , arthroscopic partial medial meniscectomy followed by supervised exercise was not superior to supervised exercise alone in terms of reduced knee pain , improved knee function and improved quality of life We report the results of a prospect i ve longitudinal study of 147 athletes who had had a meniscectomy for an isolated meniscus injury . The patients were review ed in detail after median periods of 4.5 years and 14.5 years and the results analysed . The frequency of complaints related to the operation increased from 53 % at 4.5 years to 67 % at 14.5 years , while demonstrable knee instability increased from 10 % to 36 % . The incidence of radiographic changes of degeneration rose from 40 % to 89 % and at late review 8 % of patients had definite osteoarthritis by the criteria of Ahlbäck ( 1968 ) . In consequence 46 % had given up or reduced their sporting activity , and 6.5 % had changed their occupation . Radiographic deterioration started after the 4.5-year review in 49 % of the patients and was more frequent after lateral than medial meniscectomy Summary Two hundred patients were r and omly selected for either a partial or a total meniscectomy for a meniscal tear during open operation . They were followed for a median of 7.8 years after operation . After partial meniscectomy , posterior horn tears had the worst outcome , but this was only apparent when more than two-thirds of the meniscus had been removed . The amount of meniscal tissue excised was inversely related to the function of the knee , except with bucket-h and le tears treated by partial meniscectomy . Patients with bucket-h and le , anterior and posterior horn tears had similar functional results after total meniscectomy . Preservation of the peripheral rim of the meniscus following partial meniscectomy produces the best functional results .RésuméDeux cents patients atteints de lésion méniscale ont été répartis en cours d'opération , de façon r and omisée , entre méniscectomie partielle et méniscectomie totale . Ces patients ont été revus , au dernier examen , de 6.3 à 9.8 ans après l'intervention ( à 7.8 ans en moyenne ) . Après méniscectomie partielle c'étaient les lésions de la corne postérieure qui avaient les moins bons résultats fonctionnels , mais les différences de résultat selon les types de lésion n'étaient observées que lorsque plus d'un tiers de la surface méniscale avait été réséquée . La quantité de tissu méniscal enlevé était inversement proportionnelle à la qualité de la fonction du genou , sauf dans les déchirures en anse de seau traitées par méniscectomie partielle . Ces lésions étaient celles où la plus forte proportion de tissu méniscal avait été réséquée , mais do nt les résultats fonctionnels étaient meilleurs que ceux des lésions de la corne postérieure . Les patients présentant des anses de seau , des lésions de la corne antérieure ou de la corne postérieure , avaient des résultats fonctionnels similaires après méniscectomie totale . La conservation de la périphérie du ménisque après méniscectomie partielle est le facteur essentiel d'un bon résultat fonctionnel post-opératoire Two hundred patients with a meniscus lesion were peroperatively allocated to partial or total meniscectomy . The results were compared at one year and at 6.3 - 9.8 years ( median 7.8 ) . After one year , more patients with partial meniscectomy ( 90 % ) than with total meniscectomy ( 80 % ) had no complaints ( p = 0.029 ) . At the late review these figures were 62 % and 52 % respectively ( p = 0.18 ) . However , patients with partial meniscectomy had the highest functional scores . In five percent knee joint function had improved and in 35 % deteriorated , in the latter group without detectable difference between partial and total meniscectomy . The incidence of lateral laxity rose from eight to 47 % , most frequently seen after total meniscectomy . During the observation period radiological signs of knee joint degeneration changed from solely joint line narrowing into additional ridge formation and flattening of the femoral condyle , but unrelated to whether partial or total meniscectomy had been performed . Following partial meniscectomy posterior horn lesions had the poorest functional outcome , but only if more than one third of the meniscal surface had been removed . The amount of meniscal tissue excised was inversely correlated to the level of knee joint function except in bucket h and le lesions treated with partial meniscectomy . These lesions had the largest areas of meniscal tissue removed , but higher functional scores than posterior horn lesions . Preservation of the peripheral rim of the meniscus following partial meniscectomy was essential for the functional outcome after surgery Background Repair of meniscal tears is generally preferred over meniscectomy . Hypothesis Repair of unstable bucket-h and le tears of the medial meniscus leads to better outcomes than partial meniscectomy . Study Design Retrospective review of prospect ively collected data . Methods We review ed the records of 155 patients who had isolated bucket-h and le medial meniscal tears and anterior cruciate ligament tears . Fifty-six menisci were repaired ; 99 that were degenerative and crushed beyond repair were removed . Patients were evaluated at a mean follow-up of 6 to 8 years after surgery with the International Knee Documentation Committee examination and a modified Noyes question naire . Results The mean subjective scores were similar for patients in both the repair ( N = 51 ) and meniscectomy ( N = 87 ) groups . However , in the repair group , the mean subjective score of 93.9 for nondegenerative menisci was significantly better than the 87.1 for degenerative menisci . Objective grade s for 25 patients in the repair group were normal or nearly normal in 22 patients ( 88 % ) and for 51 of 56 patients ( 91 % ) in the removal group . Radiographic subscores for the repair group were normal or nearly normal in 23 patients in the repair group and 49 in the removal group . Conclusion Outcomes from meniscal repair were not superior to those from partial removal . Patients with repaired degenerative tears had significantly lower subjective scores than those with nondegenerative tears We have carried out a prospect i ve , longitudinal 30-year review of 95 adolescents who underwent total meniscectomy in one knee , and have compared the results with those observed 13 years earlier . All the medical records were scrutinised . Of the 63 patients review ed clinical ly , 47 reported decreased sporting activity , although subjective satisfaction rose by 3 % to 71 % . The scores on the WOMAC osteoarthritis index differed significantly between patients grouped by subjective global assessment . Satisfactory function scores increased from 48 % to 60 % . In the 53 patients consenting to bilateral radiography of the knee , the incidence of narrowing of the articular cartilage in the operated knee increased significantly between the review s ( 19 % to 36 % ) . Progression of degenerative change paralleled reduction in activity . Outcome measures were best after medial , intermediate after lateral and worst after double meniscectomy In order to compare partial with total meniscectomy a prospect i ve clinical study of 200 patients was carried out . At arthrotomy 100 patients were allocated to each type of operation . The two groups did not differ in duration of symptoms , age distribution , or sex ratio . The operations were performed as conventional arthrotomies . One hundred and ninety two of the patients were seen at follow up 2 and 12 months after operation . There was no difference in the period off work between the two groups . One year after operation , 6 of the 98 patients treated with partial meniscectomy had undergone further operation . In all posterior tears were found at both procedures . Among the 94 patients undergoing total meniscectomy , 4 required further operation . In each , part of the posterior horn had been left at the primary procedure . One year after operation significantly more patients who had undergone partial meniscectomy had been relieved of symptoms . However , the two groups did not show any difference in the degree of radiological changes present BACKGROUND The efficacy of arthroscopic surgery for the treatment of osteoarthritis of the knee is unknown . METHODS We conducted a single-center , r and omized , controlled trial of arthroscopic surgery in patients with moderate-to-severe osteoarthritis of the knee . Patients were r and omly assigned to surgical lavage and arthroscopic débridement together with optimized physical and medical therapy or to treatment with physical and medical therapy alone . The primary outcome was the total Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) score ( range , 0 to 2400 ; higher scores indicate more severe symptoms ) at 2 years of follow-up . Secondary outcomes included the Short Form-36 ( SF-36 ) Physical Component Summary score ( range , 0 to 100 ; higher scores indicate better quality of life ) . RESULTS Of the 92 patients assigned to surgery , 6 did not undergo surgery . Of the 86 patients assigned to control treatment , all received only physical and medical therapy . After 2 years , the mean ( + /-SD ) WOMAC score for the surgery group was 874+/-624 , as compared with 897+/-583 for the control group ( absolute difference [ surgery-group score minus control-group score ] , -23+/-605 ; 95 % confidence interval [ CI ] , -208 to 161 ; P=0.22 after adjustment for baseline score and grade of severity ) . The SF-36 Physical Component Summary scores were 37.0+/-11.4 and 37.2+/-10.6 , respectively ( absolute difference , -0.2+/-11.1 ; 95 % CI , -3.6 to 3.2 ; P=0.93 ) . Analyses of WOMAC scores at interim visits and other secondary outcomes also failed to show superiority of surgery . CONCLUSIONS Arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and medical therapy . ( Clinical Trials.gov number , NCT00158431 . Output:	While an intact meniscus or meniscal repair was generally favorable in the ACL-reconstructed knees , meniscal repair of degenerative meniscal tissue was not favorable . Although r and omized controlled trials are considered to be the gold st and ard in medical research , a multicenter prospect i ve cohort design may be more appropriate in assessing the long-term outcome of meniscal surgery and the role that multiple preoperative and intraoperative variables may play in clinical outcomes .
MS2802	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract Three r and omised groups of 20 patients with gastro-œsophageal reflux were studied using 15-hour recordings of lower œsophageal pH , before and after two weeks ' treatment , either with an alginate/antacid compound ( ' Gaviscon ' ) , antacids alone , or a placebo tablet . Significant reduction in the number of reflux episodes and percentage time during which the lower œsophageal pH was acid was noted in the gaviscon group after treatment , whereas no significant changes occurred in the other two groups . Symptoms reported by patients during the second test were fewer after gaviscon treatment than after antacid alone The symptomatic effect of a 2-week low-dose antacid tablet regimen was assessed in a prospect i ve , double-blind , r and omized , placebo-controlled , crossover trial in 47 patients with endoscopically verified reflux oesophagitis . During treatment with antacid there were lower global symptomatic scores ( p less than 0.05 ) , less acid regurgitation ( p less than 0.05 ) , and fewer days ( p less than 0.01 ) and nights ( p less than 0.05 ) with heartburn than during placebo therapy . Also , significantly more patients preferred antacid than placebo treatment ( p less than 0.05 ) . Thus , a low-dose antacid tablet regimen relieves symptoms significantly better than placebo in patients with reflux oesophagitis Although antacids have been the mainstay of pharmacologic therapy for reflux esophagitis , their effectiveness has not been tested in a placebo-controlled double-blind trial . We report a double-blind comparison of liquid antacid vs placebo in the treatment of reflux esophagitis in 32 patients with chronic heartburn . Entry criteria included the presence of symptomatic gastroesophageal reflux confirmed by both an acid perfusion ( Bernstein ) test and by intraesophageal pH probe . Drug treatment consisted of 15 ml ( 80 mEq ) doses of antacid ( Maalox Therapeutic Concentration , William H. Rorer ) or placebo taken 7 times daily , ie , 1 and 3 hr after meals and at bedtime . Both groups showed significant improvement ( P<0.05 ) in both frequency and severity of heartburn . The time to reproduce heartburn with the timed Bernstein test was increased with both active drug and placebo therapy . The mean increase was 402 % ( 41±20 sec to 169±66 sec ) for the placebo group and 286 % ( 42±16 to 120±57 sec ) in the antacid group . Both the antacid and placebo groups showed improvement in the degree of esophagitis as assessed endoscopically . The current study asked : does regular antacid therapy have a favorable influence on the natural history of symptomatic reflux esophagitis , ie , does therapy heal or otherwise change esophagitis so that painful episodes are either less frequent , less severe , or both ? We found that the natural history of symptomatic reflux esophagitis was to improve with either antacid or placebo . There was no significant difference in antacid or placebo on the ( short-term ) natural history of the disease BACKGROUND Heartburn is frequently associated with overindulgence in food and drink , meal-stimulated gastric acid secretion , and a gastroesophageal reflux with a pH of 4 or lower . Nizatidine is a selective histamine2 receptor antagonist that effectively suppresses gastric acid secretion at lower than prescription doses and has been approved for nonprescription use in the prevention of postpr and ial heartburn . OBJECTIVE To examine the relative effectiveness of 3 dose levels of nizatidine ( 225 mg , 75 mg , and 25 mg ) in preventing postpr and ial heartburn . METHODS Four hundred thirteen subjects with documented moderate to severe heartburn following a st and ard meal that provoked heartburn were r and omized to receive a single dose of nizatidine at 225 mg ( n = 104 ) , 75 mg ( n = 101 ) , or 25 mg ( n = 105 ) , or placebo ( n = 103 ) 30 minutes before the meal , at 30 minutes ( immediately after completing the meal ) , and at 60 , 90 , 120 , 150 , 180 , and 210 minutes ( from beginning the meal ) , subjects assessed the presence or absence of heartburn ( yes or no ) and the severity of heartburn ( 100-mm visual analog scale ) . RESULTS The use of both 225 mg and 75 mg of nizatidine were significantly better than placebo in preventing heartburn in the proportion of subjects with complete prevention of heartburn ( 15 [ 14.4 % ] and 15 [ 14.9 % ] , respectively , vs 3 [ 2.9 % ] ; P < .001 ) ; the effects of nizatidine , 25 mg , in 7 subjects ( 7 % ) were not distinguishable from placebo . Similar results for nizatidine , 225 mg and 75 mg , were seen for longest duration of no heartburn , total duration of no heartburn , the average severity of heartburn , and the peak heartburn severity . All 3 doses of nizatidine were superior to placebo ( P < .001 ) in reducing average and peak heartburn severity and were well tolerated . CONCLUSIONS Single doses of 225 mg and 75 mg of nizatidine administered 30 minutes before a st and ard meal intended to provoke heartburn are significantly more effective than placebo for the prevention and /or reduction of postpr and ial heartburn A double-blind , placebo-controlled , r and omized crossover study was made of 60 patients with chronic heartburn to test the efficacy of foaming antacid in promoting symptom relief . Heartburn was induced by a meal consisting of chili , black coffee , and a spicy tomato drink mix . Of the 60 patients , 40 ( 67 % ) had relief within 15 minutes after taking foaming antacid tablets as compared to only 17 ( 28 % ) after taking a placebo . The difference in response was significant ( P < .05 ) . Foaming antacid appears to be an effective therapy for acute postpr and ial heartburn To compare the effects of ranitidine 75 mg with those of either cimetidine 200 mg or placebo given on dem and for relief of typical symptoms of gastro‐oesophageal reflux disease during a 15‐day period Summary Twenty-eight patients with hiatus hernia and severe symptoms of oesophageal reflux completed a double-blind cross-over trial in which compounds design ed to float on gastric contents were administered . Each patient received an alginate/antacid compound ( ‘ Gaviscon ’ ) , alginate without antacid and ‘ placebo ’ inr and omized order for periods of two weeks . Significant relief of both regurgitation and heartburn was achieved with the alginate I antacid compound despite its low antacid content . The mode of action of alginate is discussed and , as alginate without antacid is only marginally better than placebo , it seems probable that it facilitates placement of antacid in the upper stomach and lower oesophagus . † ‘ Gaviscon ’ is a trade mark of Reckitt and Colman Limited Output:	Over-the-counter medications are effective in treating symptomatic gastro-oesophageal reflux disease .
MS2803	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective To verify whether the combination of transcutaneous electrical neural stimulation ( TENS ) with oxybutynin in the treatment of women with overactive bladder ( OAB ) would be more effective than isolated treatments . Methods We r and omized 75 women with OAB , in three groups : GI—30 min TENS , twice a week ; GII — daily slow release 10 mg oxybutynin ; and GIII — TENS + oxybutynin ( multimodal ) ; all for 12 weeks . Patients were evaluated with vali date d question naires International Consultation on Incontinence-Short Form ( ICIQ-SF ) , International Consultation on Incontinence-OAB ( ICIQ-OAB ) , Symptom bother , and 3-day Voiding diary at weeks 0 , 12 , and 24 . Results The groups were similar before treatment . After treatment , all groups significantly improved in OAB symptoms and quality of life ( QoL ) . At week 12 , ICIQ-OAB scores were 5.9 , 4.6 , and 2.9 , in groups I , II , and III , respectively , p = 0.01 . At week 24 , GI and GIII kept the scores of the end of treatment ( week 12 ) , while GII increased ICIQ-OAB from 4.6 to 9.2 , p = 0.0001 , ICIQ-SF from 9.8 to 13.3 , p = 0.0006 , and Symptom bother score from 3.4 to 7.0 , p = 0.0001 . Conclusions The multimodal treatment was more effective and TENS alone or in association presented longer lasting results for improvement of clinical symptoms of OAB and BACKGROUND Overactive bladder ( OAB ) syndrome with urinary incontinence ( UI ) is prevalent in the population and impairs health-related quality of life ( HRQOL ) . OBJECTIVE To assess the impact on efficacy , safety , and HRQOL of onabotulinumtoxinA ( BOTOX ( ® ) , Allergan , Inc. ) treatment in patients with OAB with UI . DESIGN , SETTING , AND PARTICIPANTS This pivotal , multicentre , double-blind , r and omised , placebo-controlled , phase 3 study enrolled patients with idiopathic OAB with ≥ 3 urgency UI episodes over 3 d and ≥ 8 micturitions per day who were inadequately managed by anticholinergics . INTERVENTION OnabotulinumtoxinA at a 100U dose ( n=277 ) or placebo ( n=271 ) , administered as 20 intradetrusor injections of 0.5 ml . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Co- primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale ( TBS ) at week 12 . Additional end points included other OAB symptoms ( episodes of urinary urgency incontinence , micturition , urgency , and nocturia ) and HRQOL ( Incontinence Quality of Life [ I-QOL ] , King 's Health Question naire [ KHQ ] ) . Safety assessment s included adverse events ( AEs ) , postvoid residual ( PVR ) urine volume , and initiation of clean intermittent catheterisation ( CIC ) . RESULTS AND LIMITATIONS OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 ( -2.95 for onabotulinumtoxinA versus -1.03 for placebo ; p<0.001 ) . Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo ( p ≤ 0.01 ) . Patients perceived a significant improvement in their condition , as measured by patients with a positive treatment response on the TBS ( 62.8 % for onabotulinumtoxinA versus 26.8 % for placebo ; p<0.001 ) . Clinical ly meaningful improvements from baseline in all I-QOL and KHQ multi-item domains ( p<0.001 versus placebo ) indicated positive impact on HRQOL . AEs were mainly localised to the urinary tract . Mean PVR was higher in the onabotulinumtoxinA group ( 46.9 ml versus 10.1 ml at week 2 ; p<0.001 ) ; 6.9 % of onabotulinumtoxinA patients versus 0.7 % of placebo patients initiated CIC . CONCLUSIONS OnabotulinumtoxinA 100 U was well tolerated and demonstrated significant and clinical ly relevant improvements in all OAB symptoms , patient-reported benefit , and HRQOL in patients inadequately managed by anticholinergics . TRIAL REGISTRATION Clinical Trials.gov : NCT00910520 OBJECTIVE To determine the efficacy of intradetrusor injections of botulinum toxin A for non-neurogenic urinary urge incontinence . METHODS We conducted a six-month , r and omized , double-blind controlled trial involving women with urinary urge incontinence . Participants received intradetrusor injections of either botulinum toxin ( 100U in 10 mL ) via cystoscopy or a placebo control ( saline injection ) . The primary outcome was maximum bladder capacity at cystoscopy . Secondary outcomes included quality -of-life measures , 24-hour leakage rate , patients ' subjective assessment , and safety data . RESULTS There were 21 participants : 11 in the botulinum toxin ( treated ) group and 10 in the placebo ( control ) group . There were no significant differences between the groups at baseline . After six months the mean maximum bladder capacity at cystoscopy was 161.6 mL greater in the treated group than in the control group ( P = 0.018 ) . There were no differences in diary data or quality -of-life measures . The 24-hour pad test ( a measure of leakage ) after three months showed significant improvement in the treated group ( difference 272.12 g , P = 0.016 ) ; treated subjects also showed subjective benefit at three months ( difference 1.29 , P = 0.007 ) and at six months ( difference 1.16 , P = 0.01 ) . There was no significant difference in rates of urinary tract infection between groups . There was one serious adverse event ( a perioperative cardiac event ) in the botulinum toxin group . CONCLUSION Botulinum toxin increased bladder capacity at cystoscopy and reduced urinary incontinence on 24-hour pad testing in adult females with urinary urge incontinence . There was one adverse event in the group treated with botulinum toxin Aim : To evaluate the clinical outcomes of two different doses of BTX-A in patients with refractory idiopathic overactive bladder . Patients and Methods : Thirty nine patients with refractory idiopathic overactive bladder from 1/1/2008 till 30/3/2009 were evaluated in a tertiary care hospital . Patients were evaluated using urodynamic studies , voiding diary , UDI-6 and IIQ-7 question naires prior to being prospect ively r and omized ( alternate r and omization ) to the BTX-A applications and three months after treatment . Voiding diary and residual volume were followed two weeks later . All patients received intradetrusorial injections of BTX-A ( Botox , Allergan , Irvine , CA ) of 100u or 200u under cystoscopic control on an outpatient basis . The primary endpoint was assessed for the improvement of urodynamic parameters and adverse events at three months after the initial treatment . Secondary end points included urinary frequency , urgency and UUI episodes as assessed by voiding diary and QoL. Results : Eleven patients were enrolled to each arm of the study . There were no significant differences in demographic characteristics between the two groups . Urodynamic assessment at the end of the third month showed significant improvement in urodynamic variables in both groups . There was no statistically significant difference in urodynamic parameters and in the voiding diary between the two groups . QOL was significantly improved in both groups with no statistically significant difference between the different doses . Only three patients developed acute urinary retention . Conclusion : BTX-A at 100u and 200u appears to improve symptoms , urodynamic parameters and QoL with no statistical significance between the two groups BACKGROUND Patients with urgency urinary incontinence ( UUI ) due to overactive bladder ( OAB ) refractory to oral antimuscarinics have limited therapeutic options . OnabotulinumtoxinA appears to be an effective new treatment . OBJECTIVE Assess disease-specific quality -of-life outcomes and general health-related quality -of-life ( HRQOL ) outcomes following treatment with onabotulinumtoxinA in patients with idiopathic OAB and UUI inadequately managed with antimuscarinics . DESIGN , SETTING , AND PARTICIPANTS A phase 2 , r and omized , double-blind , placebo-controlled , dose-ranging study conducted at 40 sites from July 2005 to June 2008 with 313 patients ( 288 females ) with idiopathic OAB experiencing eight or more UUI episodes per week and eight or more micturitions per day at baseline , with follow-up of 36 wk . INTERVENTION Intradetrusor onabotulinumtoxinA ( 50 U , 100 U , 150 U , 200 U , or 300 U ) or placebo . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS HRQOL was assessed using the urinary Incontinence-Specific Quality -of-Life Instrument ( I-QOL ) , the King 's Health Question naire ( KHQ ) symptom component , and the Medical Outcomes Study 36-Item Short-Form Health Survey . Descriptive statistics were used for absolute scores/changes from baseline . Within-group changes from baseline were assessed using paired t tests . Change from baseline for each onabotulinumtoxinA group compared with placebo was analyzed using an analysis of covariance model . RESULTS AND LIMITATIONS OnabotulinumtoxinA treatment at doses≥100 U produced significantly greater improvements than placebo in the I-QOL total and subscale scores at all follow-up visits from week 2 through week 24 ( p<0.05 ) . OnabotulinumtoxinA doses≥100 U produced significantly greater improvements than placebo in the KHQ symptom score at a majority of follow-up visits . HRQOL instruments demonstrated low to moderate correlations ( Spearman correlation range : 0.01 - 0.51 ) with the symptoms of UUI recorded using daily diary data , with I-QOL demonstrating the highest correlations . A study limitation was that certain quality -of-life measures were exploratory and not vali date d. CONCLUSIONS A single onabotulinumtoxinA treatment with doses≥100 U result ed in statistically significant and clinical ly meaningful improvement in HRQOL by week 2 compared with placebo , and this improvement was sustained for ≤36 wk in patients with idiopathic OAB and UUI who were inadequately managed by oral antimuscarinics . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00168454 To compare the efficacy of tolterodine plus simplified bladder training ( BT ) with tolterodine alone in patients with an overactive bladder Introduction and hypothesisMirabegron is a potent and selective β3-adrenoceptor agonist that may represent an alternative treatment option in place of antimuscarinics for patients with overactive bladder . Methods Patients completed a single-blinded , 2-week placebo run-in period followed by 12 weeks of r and omized ( n = 928 ) double-blinded treatment with mirabegron oral controlled absorption system ( OCAS ) 25 , 50 , 100 , or 200 mg once-daily ( QD ) , placebo or tolterodine extended release ( ER ) 4 mg QD . The primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes/24 h. Secondary endpoints included changes in mean volume voided per micturition ; mean number of urinary incontinence , urgency urinary incontinence , and urgency episodes/24 h ; severity of urgency ; nocturia ; and quality of life measures . Safety parameters included vital signs , adverse events , laboratory tests , electrocardiogram measurements and post-void residual volume . Results Mirabegron 25 , 50 , 100 , and 200 mg result ed in dose-dependent reductions ( improvements ) from baseline to end-of-treatment in micturition frequency of 1.9 , 2.1 , 2.1 , and 2.2 micturitions/24 h respectively , versus 1.4 micturitions/24 h with placebo ( p ≤ 0.05 for the mirabegron 50- , 100- , and 200-mg comparisons ) . There was a statistically significant improvement with mirabegron compared with placebo for most secondary endpoints including quality of life variables . While there was a significant ( p < 0.05 ) increase from baseline in pulse rate in the mirabegron 100-mg and 200-mg groups , this was not associated with an increased incidence of cardiovascular ad Output:	New evidence -based statements and expert opinion supplement the original guideline published in 2012 , which provided guidance for the diagnosis and overall management of OAB in adults .
MS2804	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Ivacaftor has been shown to be a safe , effective treatment for cystic fibrosis in patients aged 6 years or older with a CFTR gating mutation . We aim ed to assess the safety , pharmacokinetics , and pharmacodynamics of ivacaftor in children aged 2 - 5 years . METHODS In the two-part KIWI study , we enrolled children aged 2 - 5 years weighing 8 kg or more with a confirmed diagnosis of cystic fibrosis and a CFTR gating mutation on at least one allele from 15 hospitals in the USA , UK , and Canada . Participants received oral ivacaftor 50 mg ( if bodyweight < 14 kg ) or 75 mg ( if bodyweight ≥14 kg ) every 12 h for 4 days in part A ( to establish the short-term safety of doses for subsequent assessment in part B ) , and then for 24 weeks in part B ( to assess safety and longer-term pharmacodynamics ) . Children could participate in both or just one part of the study . Primary outcomes were pharmacokinetics and safety , analysed in all patients who received at least one dose of ivacaftor . Secondary outcomes were absolute change from baseline in sweat chloride concentrations and bodyweight , body-mass index ( BMI ) , and height Z scores , and pharmacokinetic parameter estimation of ivacaftor . This study is registered with Clinical Trials.gov , number NCT01705145 . FINDINGS Between Jan 8 , 2013 , and March 1 , 2013 , nine patients were enrolled onto part A of the study , all of whom completed the 4 day treatment period , and eight of whom took part in part B. Between June 28 , 2013 , and Sept 26 , 2013 , 34 patients were enrolled in part B , 33 of whom completed the 24 week treatment period . All patients received at least one dose of ivacaftor . Results of ivacaftor pharmacokinetics suggested that exposure was similar to that reported in adults ( median Cmin were 536 ng/mL for the 50 mg dose ; 580 ng/mL for the 75 mg dose ; median ivacaftor AUC values were 9840 ng × h/mL and 10 200 ng × h/mL , respectively ) . Common adverse events in part B included cough ( in 19 [ 56 % ] of 34 patients ) and vomiting ( in ten [ 29 % ] ) . Five ( 15 % ) patients had liver function test ( LFT ) results that were more than eight times higher than the upper limit of normal , four of whom had study drug interrupted , and one of whom had study drug discontinued . Six ( 18 % ) of 34 patients had seven serious adverse events ; a raised concentration of transaminases was the only serious adverse event regarded as related to ivacaftor and the only adverse event that result ed in study treatment discontinuation . At week 24 , in patients for whom we had data , sweat chloride had changed from baseline by a mean of -46·9 mmol/L ( SD 26·2 , p<0·0001 ) , weight Z score by 0·2 ( 0·3 ; p<0·0001 ) , BMI Z score by 0·4 ( 0·4 , p<0·0001 ) , and height Z score by -0·01 ( 0·3 ; p=0·84 ) . INTERPRETATION Ivacaftor at doses of 50 mg and 75 mg seems to be safe in children aged 2 - 5 years with cystic fibrosis with a gating mutation followed up for 24 weeks , although the frequency of elevated LFTs suggests that monitoring should be frequent in young children , particularly those with a history of elevated LFTs . Results of an ongoing extension study assessing durability of these effects and longer-term safety are warranted . FUNDING Vertex Pharmaceuticals Incorporated BACKGROUND We examined data from a Phase 2 trial { NCT00457821 } of ivacaftor , a CFTR potentiator , in cystic fibrosis ( CF ) patients with aG551D mutation to evaluate st and ardized approaches to sweat chloride measurement and to explore the use of sweat chloride and nasal potential difference ( NPD ) to estimate CFTR activity . METHODS Sweat chloride and NPD were secondary endpoints in this placebo-controlled , multicenter trial . St and ardization of sweat collection , processing , and analysis was employed for the first time . Sweat chloride and chloride ion transport ( NPD ) were integrated into a model of CFTR activity . RESULTS Within-patient sweat chloride determinations showed sufficient precision to detect differences between dose-groups and assess ivacaftor treatment effects . Analysis of changes in sweat chloride and NPD demonstrated that patients treated with ivacaftor achieved CFTR activity equivalent to approximately 35%–40 % of normal . CONCLUSIONS Sweat chloride is useful in multicenter trials as a biomarker of CFTR activity and to test the effect of CFTR potentiators Background Cystic fibrosis ( CF ) is an inherited , rare autosomal recessive disease that results in chronically debilitating morbidities and high premature mortality . We evaluated how ivacaftor treatment affected CF symptoms , functioning , and well-being , as measured by the Cystic Fibrosis Question naire-Revised ( CFQ-R ) , a widely-used patient-reported outcome ( PRO ) measure . Methods STRIVE , a double-blind , placebo-controlled r and omized trial , evaluated ivacaftor ( 150 mg ) in CF patients aged 12 + with the G551D-CFTR mutation for 48 weeks . Treatment effect analysis used a mixed-effects repeated measures model . Treatment benefit analyses applied the cumulative distribution function and a categorical analysis of change scores ( “ improvement , ” “ no change , ” or “ decline ” ) . Content-based interpretation examined treatment effect on specific item responses . Results Data from 152 patients with a baseline CFQ-R assessment were analyzed . The treatment effect analysis favored treatment with ivacaftor over placebo on the Body Image , Eating , Health Perceptions , Physical Functioning , Respiratory , Social Functioning , Treatment Burden , and Vitality scales . Findings were supported by the analysis of categorical change . On all CFQ-R scales , the percentage of patients who improved was greater for ivacaftor . In the content-based analysis , the treatment benefit was characterized by better scores across a broad range of domains . Conclusions Results illustrate broad benefits of ivacaftor treatment across many domains : respiratory symptoms , physical and social functioning , health perceptions , and vitality , as measured by the CFQ-R. The breadth of improvements reflects the systemic mechanism of action of ivacaftor compared to other therapies . Findings support the patient-reported value of ivacaftor treatment in this patient population .Trial Registration Clinical Trials.gov BACKGROUND Increasing the activity of defective cystic fibrosis transmembrane conductance regulator ( CFTR ) protein is a potential treatment for cystic fibrosis . METHODS We conducted a r and omized , double-blind , placebo-controlled trial to evaluate ivacaftor ( VX-770 ) , a CFTR potentiator , in subjects 12 years of age or older with cystic fibrosis and at least one G551D-CFTR mutation . Subjects were r and omly assigned to receive 150 mg of ivacaftor every 12 hours ( 84 subjects , of whom 83 received at least one dose ) or placebo ( 83 , of whom 78 received at least one dose ) for 48 weeks . The primary end point was the estimated mean change from baseline through week 24 in the percent of predicted forced expiratory volume in 1 second ( FEV(1 ) ) . RESULTS The change from baseline through week 24 in the percent of predicted FEV(1 ) was greater by 10.6 percentage points in the ivacaftor group than in the placebo group ( P<0.001 ) . Effects on pulmonary function were noted by 2 weeks , and a significant treatment effect was maintained through week 48 . Subjects receiving ivacaftor were 55 % less likely to have a pulmonary exacerbation than were patients receiving placebo , through week 48 ( P<0.001 ) . In addition , through week 48 , subjects in the ivacaftor group scored 8.6 points higher than did subjects in the placebo group on the respiratory-symptoms domain of the Cystic Fibrosis Question naire-revised instrument ( a 100-point scale , with higher numbers indicating a lower effect of symptoms on the patient 's quality of life ) ( P<0.001 ) . By 48 weeks , patients treated with ivacaftor had gained , on average , 2.7 kg more weight than had patients receiving placebo ( P<0.001 ) . The change from baseline through week 48 in the concentration of sweat chloride , a measure of CFTR activity , with ivacaftor as compared with placebo was -48.1 mmol per liter ( P<0.001 ) . The incidence of adverse events was similar with ivacaftor and placebo , with a lower proportion of serious adverse events with ivacaftor than with placebo ( 24 % vs. 42 % ) . CONCLUSIONS Ivacaftor was associated with improvements in lung function at 2 weeks that were sustained through 48 weeks . Substantial improvements were also observed in the risk of pulmonary exacerbations , patient-reported respiratory symptoms , weight , and concentration of sweat chloride . ( Funded by Vertex Pharmaceuticals and others ; VX08 - 770 - 102 Clinical Trials.gov number , NCT00909532 . ) Background The analysis aim ed to examine the impact of pulmonary exacerbations ( PEs ) and lung function on generic measures of HRQL in patients with cystic fibrosis ( CF ) using trial-based data . Methods In a 48-week r and omized , placebo-controlled study of ivacaftor in patients ≥12 years with CF and a G551D-CFTR mutation the relationship between PEs , PE-related hospitalizations and percent predicted forced expiratory volume in one second ( ppFEV1 ) with EQ-5D measures ( index and visual analog scale [ VAS ] ) was examined in post-hoc analyses . Multivariate mixed-effects models were employed to describe the association of PEs , PE-related hospitalizations , and ppFEV1 on EQ-5D measures . Results One hundred sixty one patients ( age : mean 25.5 [ SD 9.5 ] years ; baseline ppFEV1 : 63.6 [ 16.4 ] ) contributed 1,214 observations ( ppFEV1 : no lung dysfunction [ n = 157 ] , mild [ n = 419 ] , moderate [ n = 572 ] , severe [ n = 66 ] ) . Problems were most frequently reported on pain/discomfort , anxiety/depression , and usual activities EQ-5D items . The mean ( SE ) EQ-5D index nominally decreased ( worsened ) with worsening severity of lung dysfunction ( P = 0.070 ) : 0.931 ( 0.023 ) ; mild : 0.923 ( 0.021 ) ; moderate : 0.904 ( 0.018 ) ; severe : 0.870 ( 0.020 ) . 146 PEs were experienced by 72 patients , including 52 PEs ( 35.6 % ) that required hospitalization . Mean EQ-5D index and VAS scores were lowest ( worst ) within 1 week ( before or after PE start ) for PEs requiring hospitalization . Pulmonary exacerbations , PE-related hospitalizations , and ppFEV1 were significant predictors of EQ-5D index and VAS . Conclusions In a clinical study of patients with CF ( ≥12 years of age and a G551D-CFTR mutation ) , PEs , primarily those requiring hospitalization , were associated with low EQ-5D index and VAS scores . The impact of ppFEV1 was relatively smaller . Reducing PEs , in particular those requiring hospitalization , would likely improve HRQL among these patients .Trial registration Clinical Trials.gov , NCT00909532 ; URL : clinical trials.gov , May 26 , CPX ( 8-cyclopentyl-1,3-dipropylxanthine ) is a novel compound currently under development as a potential treatment for cystic fibrosis ( CF ) . The drug has been shown to increase chloride efflux and CFTR trafficking in vitro in CF airway cells . This phase I multicenter , single-dose , placebo-controlled trial was performed at four institutions . Thirty-seven subjects homozygous for the Delta F(508 ) allele were studied in an escalating dose protocol of seven single-dose cohorts ( 1 , 3 , 10 , 30 , 100 , 300 , and 1,000 mg ) to evaluate the safety , pharmacokinetics , and efficacy of CPX . Efficacy was determined using nasal transepithelial potential difference and sweat chloride measurements prior to dosing and at 1 , 2 , and 4 hr postdose . The incidence of adverse events in the treatment group was similar to that with placebo , indicating safety of the single doses studied . One serious adverse event ( an acute pulmonary exacerbation ) occurred 13 days after dosing , and was not considered related to the study drug . The maximal plasma CPX concentration and total amount of CPX absorbed appeared to be linearly related to dose , but was highly variable throughout the Output:	Both G551D phase 3 trials ( n = 219 ) demonstrated a clinical ly relevant impact of the potentiator ivacaftor on outcomes at 24 and 48 weeks , providing evidence for the use of this treatment in adults and children ( over six years of age ) with cystic fibrosis and the G551D mutation ( class III ) .
MS2805	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results The Soteria project ( 1971–1983 ) compared residential treatment in the community and minimal use of antipsychotic medication with “ usual ” hospital treatment for patients with early episode schizophrenia spectrum psychosis . Newly diagnosed DSM-II schizophrenia subjects were assigned consecutively ( 1971 to 1976 , N = 79 ) or r and omly ( 1976 to 1979 , N = 100 ) to the hospital or Soteria and followed for 2 years . Admission diagnoses were subsequently converted to DSM-IV schizophrenia and schizophreniform disorder . Multivariate analyses evaluated hypotheses of equal or better outcomes in Soteria on eight individual outcome measures and a composite outcome scale in three ways : for endpoint subjects ( N = 160 ) , for completing subjects ( N = 129 ) , and for completing subjects corrected for differential attrition ( N = 129 ) . Endpoint subjects exhibited small to medium effect size trends favoring experimental treatment . Completing subjects had significantly better composite outcomes of a medium effect size at Soteria ( + .47 SD , p = .03 ) . Completing subjects with schizophrenia exhibited a large effect size benefit with Soteria treatment ( + .81 SD , p = .02 ) , particularly in domains of psychopathology , work , and social functioning . Soteria treatment result ed in better 2-year outcomes for patients with newly diagnosed schizophrenia spectrum psychoses , particularly for completing subjects and for those with schizophrenia . In addition , only 58 % of Soteria subjects received antipsychotic medications during the follow-up period , and only 19 % were continuously maintained on antipsychotic medications A double-blind withdrawal trial in 41 chronic schizophrenic out patients was carried out during 6 months . Depot neuroleptics ( fluphenazine decanoate or flupenthixol decanoate ) were compared with placebo to evaluate clinical and neurological effects during continued therapy and during withdrawal . The drugs were significantly more effective than placebo in preventing relapse and rehospitalization . In the placebo group 62 % relapsed compared to 27 % in the drug group . There was a weak and nonsignificant tendency to a higher relapse frequency in the flupenthixol group compared to the fluphenazine group . After withdrawal for 6 months , plasma levels for fluphenazine were detectable . Plasma levels for flupenthixol were not detectable after 9 weeks of withdrawal . The differences in the plasma levels may possibly explain the difference in relapse rate between the two depot neuroleptics . Furthermore , it was found that the patients who relapsed during fluphenazine treatment had a significantly lower plasma level of the drug than patients who did not relapse during treatment . The results from this study provide some information on the therapeutic levels of fluphenazine and flupenthixol in schizophrenic patients A six-month evaluation of penfluridol , a long-acting oral preparation , was conducted with 50 severely ill schizophrenic patients . After an initial three-month stabiization period , the patients were divided into two equal groups and a double-blind evaluation of penfluridol versus placebo was conducted . The results of this study indicate that weekly administration of penfluridol ( one oral dose ) provides relatively safe and adequate control of severely ill schizophrenic patients and displays efficacy similar to that of the shorter-acting antipsychotic agents . If these results are confirmed by other clinical investigators , this medication may prove to be of invaluable help in maintaining the schizophrenic patient in his community Out of 253 patients fulfilling criteria for a first episode of schizophrenic illness , 120 entered a r and omised placebo-controlled trial of maintenance neuroleptic medication on discharge ; they were followed to relapse or loss to follow-up , for two years or to the end of the study . Of those on active medication , 46 % relapsed , as did 62 % of those on placebo ; the most important determinant of relapse was duration of illness prior to starting neuroleptic medication . This finding might be because extended duration of symptoms before admission is more likely to be present in illnesses which in any case will have poor prognosis , or because susceptibility to relapse is reduced by early institution of treatment . The study provides no data on which a decision between these alternative explanations can be based BACKGROUND Amisulpride is a substituted benzamide with high selectivity for dopamine D2 and D3 receptors . The purpose of the study was to evaluate the effect of 100 mg amisulpride in patients with predominantly negative symptoms of schizophrenia . METHOD This was a multi-centre , r and omised , parallel-group , double-blind study . Patients received either amisulpride ( 100 mg/day ) or placebo over a six-month treatment period . RESULTS A total of 141 patients were included , 69 received amisulpride , 72 placebo . Fifty-eight patients ( 41 % ) had received neuroleptic treatment prior to inclusion . The percentage of amisulpride patients completing the study ( 55 % ) was significantly higher than that with placebo ( 32 % ) , and drop-out rates due to lack of efficacy were 27 % with amisulpride and 47 % with placebo . All efficacy assessment s were statistically in favour of amisulpride compared with placebo . The overall incidence of extrapyramidal symptoms was comparable in both groups ; only five patients started anti-Parkinsonian treatment during the study ( one in the placebo and four in the amisulpride group ) . CONCLUSION Amisulpride is effective in the medium-term treatment schizophrenic patients with predominantly negative symptoms OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate A double-blind , placebo-controlled trial was carried out to determine the value of maintenance therapy with phenothiazines in a population of out patients who had recently recovered from an acute episode of schizophrenia . The drug was shown to be significantly more effective than the placebo in preventing relapse . The relationship of the trial patients to the population from which they were selected was defined in terms of clinical , historical , and social data . Maintenance therapy seems of little value in patients with a good prognosis and in the severely ill , but it is of value in the indeterminate group between these two extremes Twenty‐seven long‐term psychiatric in patients maintained on neuroleptics with concomitant antiparkinsonian medication were entered into a study in which anticholinergic medication was gradually withdrawn in a r and omized double‐blind within‐subjects design . The extrapyramidal symptoms of each patient were compared when taking their usual anticholinergic medication , when taking placebo and when taking no antiparkinsonian drug . The relapse rate on no medication was 14 % , and if patients relapsed on no medication they also relapsed on placebo . The relapse rate was not significantly different on active medication . Nor were there significant differences in ratings of parkinsonism or dyskinesia . The lack of difference between double‐blind and overt withdrawal does not mean that studies that find a much higher relapse rate are necessarily unaffected by nonspecific factors , as significant unblinding may occur in clinical trials The plasma prolactin ( PRL ) levels of 35 chronic schizophrenic patients undergoing long‐term maintenance treatment with neuroleptic drugs were measured before and after either neuroleptic withdrawal or a switch to a fixed dose of chlorpromazine 900 mg/ day . In both men and women there tended to be a significant correlation between the initial log plasma PRL level while on neuroleptic maintenance treatment and the dosage received converted to chlorpromazine equivalents . Neuroleptic withdrawal in each of 19 cases was followed by a decline in PRL plasma levels . Switching to chlorpromazine 900 mg/day ( 16 cases ) produced either increases or decreases in PRL plasma levels that were significantly correlated with the change in neuroleptic dosage converted to chlorpromazine equivalents . Thus there was no evidence of tolerance to the PRL‐elevating effect of neuroleptics in these patients who had been treated for many years with neuroleptics An earlier study ( Study 1 : 14 months duration ) showed that the PAT ( an auditory attention task ) is sensitive to changes of clinical state in chronic schizophrenia and is able to predict hospital discharge . The newly presented study ( Study 2 : 12 months duration ) investigated the effects of increasing the dose of chlorpromazine ( CPZ ) stepwise ( double-blind ) to between 900 mg and 1800 mg per day , in 10 of the original 20 patients . Measurements were made fortnightly throughout both studies and the data were depicted continuously for each patient . Study 2 showed that a 300 % increase of CPZ dose neither improved nor impaired PAT performance . Also , the addition of orphenadrine 300 mg per day had no significant effect on performance . Four types of relapse were detected . The first was induced by placebo substitution for CPZ and recovered when the drug was reinstated . The remaining types of relapse were all resistant to CPZ and comprised : a long-period pattern with a spontaneous reversal ; unremitting deterioration ; and a short-period pattern of labile relapse and recovery The postulated deficiency of prostagl and in E1 series ( PGE1 ) in schizophrenia has been investigated in a controlled therapeutic trial . Twenty-one in patients with a schizophrenic illness resistant to neuroleptic drug treatments were r and omly assigned to one of three treatment conditions in a blind controlled trial of dihomo-gammalinolenic acid ( DHLA ) , a PGE1 precursor . Patients received depot neuroleptic medication and DHLA capsules , placebo depot medication and DHLA capsules , or placebo depot medication and placebo capsules . No marked treatment effects were noticed on ratings of the patients ' behaviour or symptomatology , though some clinical effects were noted in dyskinetic patients . Abnormalities in red blood cell lipids were observed in the patients entering the trial , suggesting that further investigation of an EFA/prostagl and in deficiency hypothesis in schizophrenia is worth pursuing The dopamine hypothesis of schizophrenia cl aims that increased dopamine activity underlies psychotic behavior . This hypothesis gets major support from the reported d-amphetamine-induced worsening of psychosis , because amphetamine increases dopamine activity in the brain . Dopamine receptor supersensitivity has been shown to be present in animals during the postneuroleptic period . In this study the postulated relationships between psychotic decompensation as observed after d-amphetamine infusion and the dopamine receptor supersensitivity expected to be present during the neuroleptic withdrawal period were examined . Tw Output:	Although this and other potential sources of bias limited the overall quality , the efficacy of antipsychotic drugs for maintenance treatment in schizophrenia was clear . The results clearly demonstrate the superiority of antipsychotic drugs compared to placebo in preventing relapse . This effect must be weighed against the side effects of antipsychotic drugs .
MS2806	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This study examined substance use among a group of 37 schizophrenia patients participating in a year-long fluphenazine decanoate ( FD ; Prolixin ) dosage reduction study ( Inderbitzin et al. ( 1994 ) Am . J. Psychiatry 151 , 1753 - 1759 ) . Ten ( 50 % ) of the 20 FD dose-reduced patients , and 6 ( 35 % ) of the 17 control group patients were identified as substance users . The dose-reduced and control groups did not differ significantly in substance use . We examine here the 37 patients regrouped by substance users ( n = 16 ) versus non-users ( n = 21 ) to determine the effects of substance use . In addition to identifying substance users and types of substances used , we hypothesize that substance users differ demographically from non-users , have worse symptomatology , worse compliance , higher rates of relapse , and therefore , can confound studies . Clinical and demographic data were obtained . At least half of the substance users were using alcohol or cocaine . The substance use group had a significantly higher severity of illness score on the BPRS at study onset . We found no significant differences between the two groups on other rating scales . The non-use group lived more independently , and the substance use group was younger . The substance use group had nearly twice as many hospitalizations in the 2 years prior to the study , a greater rate of missed appointments in the year before and during the study , and 4 times as many relapses during the year of the study than the non-use group . The key finding was that among 9 of the 37 patients who relapsed in the year of the study , 7 of the 9 had a history of substance use . Substance use was found to be a better predictor of relapse and hospitalization than gradual 50 % dosage reduction of FD in the related study . Substance use among schizophrenia patients is a major complicating factor OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate The purpose of this study is to compare the efficacy of olanzapine and risperidone for the acute treatment of first-episode schizophrenia patients with cannabis use disorders . This secondary analysis of a previously published study included 49 first-episode patients with a diagnosis of schizophrenia , schizophreniform disorder , or schizoaffective disorder and a co-occurring lifetime diagnosis of cannabis use disorders r and omly assigned to treatment with either olanzapine ( n=28 ) or risperidone ( n=21 ) for 16weeks . The olanzapine group did not differ significantly from the risperidone group for initial response rates of positive symptoms , and rates of cannabis use or alcohol use during the study . Positive symptoms and the Scale for Assessment of Negative Symptoms ( SANS ) global asociality-anhedonia scores improved over time but did not differ between study medications . In both groups , cannabis use during the study was higher in patients who used cannabis within three months of the admission . Thus , our results suggest that olanzapine and risperidone had a similar initial efficacy on psychotic symptoms and substance use in first-episode patients with co-occurring cannabis use disorders . If clinicians are choosing between olanzapine versus risperidone treatment for this population , their decision should be based upon factors other than symptom response and short-term substance misuse Psychotic disorders are characterized by significant deficits in attentional control , but the neurobiological mechanisms underlying these deficits early in the course of illness prior to extensive pharmacotherapy are not well understood . Moreover , little is known regarding the symptom and brain changes associated with amelioration of attentional impairments through antipsychotic pharmacotherapy . In this study 14 male patients experiencing a first-episode of psychosis with minimal prior antipsychotic treatment completed an attentional control task while undergoing functional magnetic resonance imaging at the onset of treatment with a second generation antipsychotic ( risperidone or aripiprazole ) in a double blind r and omized clinical trial and then again following approximately 12 weeks of treatment . In addition , 14 age- , and performance-matched healthy male volunteers who were not treated completed the same task at a baseline timepoint and then again following 12 weeks . Patients showed significantly greater activation than healthy volunteers in the right globus pallidus , left thalamus , and right thalamus at the time of the baseline scan . Among patients there was a significant reduction in right globus pallidus blood-oxygen level dependent ( BOLD ) response following antipsychotic treatment that correlated significantly with improvement in response accuracy and reductions in thought disturbance . No changes in globus pallidus activation were observed in healthy volunteers over this time period . These preliminary findings suggest that improvement in attentional control and concomitant reductions in thought disturbance in first-episode psychosis may be associated with reductions in subcortical activity following administration of second-generation antipsychotics early in the course of illness . These findings have implication s for underst and ing how changes in basal ganglia activity may be linked to improvements in attentional control through antipsychotics Background : Second-generation antipsychotics , approved for the treatment of mania , are associated with adverse effects such as weight gain and metabolic disorders . Aripiprazole , a recently introduced second-generation antipsychotic , are thought to account for its low propensity for weight gain , metabolic disturbances and sedation . The purpose of this study was to investigate the effect of risperidone versus aripiprazole in the treatment of acute mania . Material s and Methods : Fifty patients with acute episodes of mania were enrolled in this study , and they were r and omly assigned into a risperidone group of 24 cases and an aripiprazole group of 26 cases . In group A , aripiprazole with a dose of 5 - 30 mg/day and in group B , risperidone with a dose of 2 - 8 mg/day was given to patients . The average dose of aripiprazole was 27 mg/day , and the average dose of risperidone was 6 mg/day . The effects of each drug for the treatment of acute mania were assessed on the 1st day of admission and on days 2 , 4 , 6 , 8 and at weeks 2 , 4 and 6 after therapy using the young mania rating scale ( YMRS ) and at the baseline and on weeks 3 and 6 after admission using the clinical global impression ( CGI ) scale . Results : The mean age of the group of risperidone was 34 ± 8.6 years and in a group of aripiprazole it was 34 ± 9.1 years ( P = 0.83 ) . Comparison of YMRS scores over the period of 6 weeks revealed a statistically significant difference in both groups ( P < 0.0001 ) . There was also a statistically significant difference in YMRS scores between risperidone and aripiprazole at day 8 ( P = 0.026 ) and weeks 2 ( P = 0.035 ) and 4 ( P = 0.042 ) . There was also a statistically significant difference in CGI-Severity scale score at weeks 3 ( P = 0.003 ) and 6 ( P = 0.000 ) and in CGI-Improvement scale score at weeks 3 ( P = 0.005 ) and 6 ( P = 0.002 ) . The most common side-effect observed in both groups was headache ( 0%15/4 in aripiprazole vs. % 16/7 in risperidone ) Conclusion : Aripiprazole that is readily available in our market , could be considered more effective than risperidone in the treatment of acute mania BACKGROUND Many patients recovering from a first psychotic episode will discontinue medication against medical advice , even before a 1-year treatment course is completed . Factors associated with treatment adherence in patients with chronic schizophrenia include beliefs about severity of illness and need for treatment , treatment with typical versus atypical antipsychotic and medication side effects . METHOD In this 2-year prospect i ve study of 254 patients recovering from a first episode of schizophrenia , schizophreniform , or schizoaffective disorder we examined the relationship between antipsychotic medication non-adherence and patient beliefs about : need for treatment , antipsychotic medication benefits , and negative aspects of antipsychotic medication treatment . We also examined the relationship between medication non-adherence and treatment with either haloperidol or olanzapine , and objective measures of symptom response and side effects . RESULTS The likelihood of becoming medication non-adherent for 1 week or longer was greater in subjects whose belief in need for treatment was less ( HR=1.75 , 95 % CI 1.16 , 2.65 , p=0.0077 ) or who believed medications were of low benefit ( HR=2.88 , 95 CI 1.79 - 4.65 , p<0.0001 ) . Subjects r and omized to haloperidol were more likely to become medication non-adherent for > or=1 week than subjects r and omized to olanzapine ( HR-1.51 , 95 % CI 1.01 , 2.27 , p=0.045 ) . CONCLUSION Beliefs about need for treatment and the benefits of antipsychotic medication may be intervention targets to improve likelihood of long-term medication adherence in patients recovering from a first episode of schizophrenia , schizoaffective , or schizophreniform disorder OBJECTIVE This double-blind study compared a second generation ( atypical ) antipsychotic drugs compared to a representative older agent for patients with schizophrenia who use or avoid illicit substances . METHODS Schizophrenic subjects were recruited at 57 U.S. sites and r and omly assigned to olanzapine , perphenazine , quetiapine , risperidone or ziprasidone for up to 18 months . The primary aim of this analysis was to delineate differences between the overall effectiveness of these five treatments among patients who used or did not use illicit substances . RESULTS There were no significant differences between treatment groups in time to all-cause treatment discontinuation among patients who use illicit drugs ( median 3.3 to 6.8 months ) . Among non-users time to treatment discontinuation was significantly longer for patients treated with olanzapine ( median 13.0 months ) than perphenazine ( 5.9 months ) , risperidone ( 5.6 months ) , or quetiapine ( 5.0 months ) ; time to discontinuation for ziprasidone ( 4.3 months ) was even shorter , although the latter difference was not significant . The difference between risperidone and quetiapine , although small , was significant . All remaining differences were non-significant . Similar results were found for discontinuation due to inefficacy . There were no differences between illicit users and non-users in symptom reduction and global improvement , after adjustment for differential duration of treatment . Differences in discontinuation results were attenuated by non-compliance , but the trends persisted after controlling for treatment compliance . CONCLUSIONS Among patients with chronic schizophrenia who avoid use of illicit drugs , olanzapine was more effective than other antipsychotics as reflected by longer time to all-cause discontinuation , but illicit substance abuse attenuated this advantage , reinforcing the need for concurrent substance abuse treatment OBJECTIVE To compare olanzapine and risperidone in the treatment of nonpsychotic acute manic or mixed episodes . METHOD This 3-week , r and omized , controlled , double-blind , parallel multicenter study compared olanzapine ( 5 - 20 mg/day ; N = 165 ) and risperidone ( 1 - 6 mg/day ; N = 164 ) among hospital in patients who met DSM-IV criteria for bipolar I disorder , manic or mixed episode , without psychotic features . Output:	Risperidone was compared to clozapine , olanzapine , perphenazine , quetiapine and ziprasidone . AUTHORS ' CONCLUSIONS There is not sufficient good- quality evidence available to determine the effects of risperidone compared with other antipsychotics in people with a dual diagnosis .
MS2807	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES The purpose of this study was to compare the effects of N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided therapy with those of intensive clinical management and with usual care ( UC ) on clinical outcomes in chronic symptomatic heart failure . BACKGROUND Initial trial results suggest titration of therapy guided by serial plasma B-type natriuretic peptide levels improves outcomes in patients with chronic heart failure , but the concept has not received widespread acceptance . Accordingly , we conducted a longer-term study comparing the effects of NT-proBNP-guided therapy with those of intensive clinical management and with UC of patients with heart failure . METHODS Three hundred sixty-four patients admitted to a single hospital with heart failure were r and omly allocated 1:1:1 ( stratified by age ) to therapy guided by NT-proBNP levels or by intensive clinical management , or according to UC . Treatment strategies were applied for 2 years with follow-up to 3 years . RESULTS One-year mortality was less in both the hormone- ( 9.1 % ) and clinical ly-guided ( 9.1 % ) groups compared with UC ( 18.9 % ; p = 0.03 ) . Three-year mortality was selectively reduced in patients < or=75 years of age receiving hormone-guided treatment ( 15.5 % ) compared with their peers receiving either clinical ly managed treatment ( 30.9 % ; p = 0.048 ) or UC ( 31.3 % ; p = 0.021 ) . CONCLUSIONS Intensive management of chronic heart failure improves 1-year mortality compared with UC . Compared with clinical ly guided treatment and UC , hormone-guided treatment selectively improves longer-term mortality in patients < or=75 years of age . ( NT-proBNP-Assisted Treatment To Lessen Serial Cardiac Readmissions and Death [ BATTLESCARRED ] ; Australian New Zeal and Clinical Trials Registry 12605000735651 ) OBJECTIVES The aim of this multicenter study was to evaluate the prognostic impact of a therapeutic strategy using plasma brain natriuretic peptide ( BNP ) levels . BACKGROUND The prognosis of chronic heart failure ( CHF ) remains poor , even among patients treated in specialized departments . METHODS A total of 220 New York Heart Association functional class II to III patients considered optimally treated with angiotensin-converting enzyme inhibitors ( ACEIs ) , beta-blockers , and diuretics by CHF specialists were r and omized to medical treatment according to either current guidelines ( clinical group ) or a goal of decreasing BNP plasma levels < 100 pg/ml ( BNP group ) . Outpatient visits were scheduled every month for 3 months , then every 3 months . The primary combined end point was CHF-related death or hospital stay for CHF . RESULTS Both groups were similar for baseline clinical and biological characteristics . Left ventricular ejection fraction was slightly lower in the BNP group than in the clinical group ( 29.9 + /- 7.7 % vs. 31.8 + /- 8.4 % , p = 0.05 ) . At the end of the first 3 months , all types of drugs were changed more frequently in the BNP group . Mean dosages of ACEIs and beta-blockers were significantly higher in the BNP group ( p < 0.05 ) , whereas the mean increase in furosemide dosage was similar in both groups . During follow-up ( median 15 months ) , significantly fewer patients reached the combined end point in the BNP group ( 24 % vs. 52 % , p < 0.001 ) . CONCLUSIONS In optimally treated CHF patients , a BNP-guided strategy reduced the risk of CHF-related death or hospital stay for CHF . The result was mainly obtained through an increase in ACEI and beta-blocker dosages Although previous studies have documented adherence with certain established heart failure ( HF ) quality metrics in outpatient cardiology practice s , the extent to which there is conformity with other evidence -based , guideline -driven quality metrics in out patients with HF is unknown . IMPROVE HF is a prospect i ve cohort study design ed to characterize the current management of patients with chronic HF and left ventricular ejection fraction < or=35 % in outpatient cardiology practice s. We evaluated baseline data for conformity with adjunctive HF therapies including pneumococcal vaccinization , hydralazine/isosorbide dinitrate ( HYD/ISDN ) for Black patients , statin therapy , antiplatelet therapy , smoking-cessation counseling , low-density lipoprotein cholesterol levels ( < 100 mg/dl ) , and systolic blood pressure decrease ( all patients < 140 mm Hg or [ optimal ] < 130 mm Hg ) . Baseline data were available for 15,381 patients attending 167 cardiology practice s. Patient characteristics included a median age 70 years , 71.0 % men , 9.1 % Black patients , 65.2 % with ischemic HF cause , and 61.7 % with a history of hypertension . Mean adherences or documentations of adherence were only 7.3 % for HYD/ISDN and 1.0 % for pneumococcal vaccination . Adherence to other adjunctive therapies ranged from 27.4 % to 82.0 % but none of the adjunctive treatment interventions were associated with high levels of adherence . Conformity with guideline -recommended , adjunctive HF therapies is deficient in the management of out patients with HF . Critical gaps in documentation or delivery of care exist , especially for the use of pneumococcal vaccination and HYD/ISDN . In conclusion , improved processes of care , better documentation , and /or increased measures to promote adherence to all primary and adjunctive therapies for HF are needed OBJECTIVES This study was design ed to investigate whether the addition of N-terminal pro-B-type natriuretic peptide-guided , intensive patient management ( BM ) to multidisciplinary care ( MC ) improves outcome in patients following hospitalization due to heart failure ( HF ) . BACKGROUND Patients hospitalized due to HF experience frequent rehospitalizations and high mortality . METHODS Patients hospitalized due to HF were r and omized to BM , MC , or usual care ( UC ) . Multidisciplinary care included 2 consultations from an HF specialist who provided therapeutic recommendations and home care by a specialized HF nurse . In addition , BM included intensified up-titration of medication by HF specialists in high-risk patients . NT-proBNP was used to define the level of risk and to monitor wall stress . This monitoring allowed for anticipation of cardiac decompensation and adjustment of medication in advance . RESULTS A total of 278 patients were r and omized in 8 Viennese hospitals . After 12 months , the BM group had the highest proportion of antineurohormonal triple-therapy ( difference among all groups ) . Accordingly , BM reduced days of HF hospitalization ( 488 days ) compared with the hospitalization for the MC ( 1,254 days ) and UC ( 1,588 days ) groups ( p < 0.0001 ; significant differences among all groups ) . Using Kaplan-Meier analysis , the first HF rehospitalization ( 28 % ) was lower in the BM versus MC groups ( 40 % ; p = 0.06 ) and the MC versus UC groups ( 61 % ; p = 0.01 ) . Moreover , the combined end point of death or HF rehospitalization was lower in the BM ( 37 % ) than in the MC group ( 50 % ; p < 0.05 ) and in the MC than in the UC group ( 65 % ; p = 0.04 ) . Death rate was similar between the BM ( 22 % ) and MC groups ( 22 % ) , but was lower compared with the UC group ( 39 % ; vs. BM : p < 0.02 ; vs. MC : p < 0.02 ) . CONCLUSIONS Compared with MC alone , additional BM improves clinical outcome in patients after HF hospitalization . ( BNP Guided Care in Addition to Multidisciplinary Care ; NCT00355017 ) Background —Brain natriuretic peptide ( BNP ) and norepinephrine ( NE ) are strongly related to severity of and are independent predictors of outcome in heart failure . The long-term effects of angiotensin receptor blockers on BNP and NE in heart failure patients are not known . Methods and Results —Both BNP and NE were measured in 4284 patients r and omized to valsartan or placebo in the Valsartan Heart Failure Trial ( Val-HeFT ) at baseline and 4 , 12 , and 24 months after r and omization . The effects of valsartan were tested by ANCOVA , controlling for baseline values and concomitant ACE inhibitors and /or & bgr;-blockers . BNP and NE concentrations were similar at baseline in the 2 groups and were decreased by valsartan starting at 4 months and up to 24 months . BNP increased over time in the placebo group . At the end point , least-squares mean ( ±SEM ) BNP increased from baseline by 23±5 pg/mL in the placebo group ( n=1979 ) but decreased by 21±5 pg/mL ( n=1940 ) in the valsartan group ( P < 0.0001 ) . NE increased by 41±6 pg/mL ( n=1979 ) and 12±6 pg/mL ( n=1941 ) for placebo and valsartan , respectively ( P = 0.0003 ) . Concomitant therapy with both ACE inhibitors and & bgr;-blockers significantly reduced the effect of valsartan on BNP but not on NE ( P for interaction=0.0223 and 0.2289 , respectively ) . Conclusions —In Val-HeFT , the largest neurohormone study in patients with symptomatic chronic heart failure , BNP and NE rose over time in the placebo group . Valsartan caused sustained reduction in BNP and attenuated the increase in NE over the course of the study . These neurohormone effects of valsartan are consistent with the clinical benefits reported in Val-HeFT BACKGROUND STARBRITE , a multicenter r and omized pilot trial , tested whether outpatient diuretic management guided by B-type natriuretic peptide ( BNP ) and clinical assessment result ed in more days alive and not hospitalized over 90 days compared with clinical assessment alone . METHODS AND RESULTS A total of 130 patients from 3 sites with left ventricular ejection fraction ≤35 % were enrolled during hospitalization for heart failure ( HF ) and r and omly assigned to therapy guided by BNP and clinical assessment ( BNP strategy ) or clinical assessment alone . The clinical goal was resolution of congestion without hypotension or renal dysfunction . In the BNP arm , therapy was adjusted to achieve optimal fluid status , defined as the BNP level and congestion score obtained at the time of discharge . In the clinical assessment arm , therapy was titrated to achieve optimal fluid status , represented by the patient 's signs and symptoms at the time of discharge . Exclusion criteria were serum creatinine > 3.5 mg/dL and acute coronary syndrome . Follow-up was done in HF clinics . BNP was measured with the use of a rapid assay test . There was no significant difference in number of days alive and not hospitalized ( hazard ratio 0.72 , 95 % confidence interval 0.41 - 1.27 ; P = .25 ) , change in serum creatinine , or change in systolic blood pressure ( SBP ) . BNP strategy was associated with a trend toward a lower blood urea nitrogen ( 24 mg/dL vs 29 mg/dL ; P = .07 ) ; BNP strategy patients received significantly more angiotensin-converting enzyme ( ACE ) inhibitors , beta-blockers , and the combination of ACE inhibitor or angiotensin receptor blocker plus beta-blockers . CONCLUSIONS BNP strategy was not associated with more days alive and not hospitalized , but the strategy appeared to be safe and was associated with increased use of evidence -based medications BACKGROUND Angiotensin-converting enzyme ( ACE ) inhibitors are established as first-line therapy in chronic heart failure ( CHF ) . However , conflicting results exist regarding the dose-effect relation of ACE inhibitors . METHODS We investigated 45 patients ( age 55 + /- 10 years ) with stable CHF who presented with a maintenance dosage of enalapril of either 5 mg given twice daily ( E10 ; n = 16 ) , 10 mg given twice daily ( E20 ; n = 18 ) , or 20 mg given twice daily ( E40 ; n = 11 ) . This dosage was changed 3 times to treat all patients with lower , higher , and the initial dosages for 4 weeks each . Neurohormones ( atrial natriuretic peptide [ ANP ] , brain natriuretic peptide [ BNP ] , and norepinephrine ) and enalaprilat trough levels were measured , and ergospirometry was performed . RESULTS Changes in enalapril dose and enalaprilat level were concordant in 82 % of patients , indicating good compliance . After augmentation of enalapril to 40 mg daily , patients in the E10 Output:	Furthermore , between-group BNP changes seemed to be a significant modifier to the effects of BNP-guided therapy on clinical outcomes , and BNP-guided therapy may improve the clinical outcomes of CHF patients if substantial reduction of BNP can be achieved . In addition , BNP-guided therapy was not associated with increased risk for serious adverse events . BNP-guided therapy may improve the clinical outcomes of CHF patients if substantial reduction of BNP can be achieved .
MS2808	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Despite recent declines in both incidence and mortality ( 1 ) , colorectal cancer remains the second most common cause of death from cancer in the United States ( 2 ) . Screening for colorectal cancer reduces mortality by allowing physicians to detect cancer at earlier , more treatable stages , as well as to identify and remove adenomatous polyps ( asymptomatic benign precursor lesions that may lead to colorectal cancer ) . Many tests are available for screening , such as fecal occult blood tests ( FOBTs ) , flexible sigmoidoscopy , and colonoscopy . Screening with FOBT ( Hemoccult II , Beckman Coulter , Fullerton , California ) has been shown to reduce colorectal cancer mortality by 15 % to 33 % in r and omized , controlled trials ( 35 ) , and screening with more sensitive FOBTs , flexible sigmoidoscopy , colonoscopy , or combinations of these tests may reduce the burden of colorectal cancer even more ( 6 , 7 ) . In the absence of adequate clinical trial data on several recommended screening strategies , microsimulation modeling can provide guidance on the risks , benefits , and testing re sources required for different screening strategies to reduce the burden of colorectal cancer . In July 2002 , the U.S. Preventive Services Task Force ( USPSTF ) concluded that there was sufficient evidence to recommend strongly that all average-risk adults 50 years of age or older should be offered colorectal cancer screening ( 8) . However , the logistics of screening , such as the type of screening test , screening interval , and age at which to stop screening , were not evaluated in terms of the balance of benefits and potential harms . The USPSTF has again addressed recommendations for colorectal cancer screening with a systematic review of the evidence ( 9 ) on screening tests . For this assessment , the USPSTF requested a decision analysis to project expected outcomes of various strategies for colorectal cancer screening . Two independent microsimulation modeling groups from the Cancer Intervention and Surveillance Modeling Network ( CISNET ) , funded by the National Cancer Institute , used a comparative modeling approach to compare life-years gained relative to re source use of different strategies for colorectal cancer screening . Methods We used 2 microsimulation models , MISCAN ( MIcrosimulation Screening Analysis ) ( 1012 ) and SimCRC ( Simulation Model of Colorectal Cancer ) ( 13 ) , to estimate the life-years gained relative to no screening and the colonoscopies required ( that is , an indicator for re source use and risk for complications ) for different colorectal cancer screening strategies defined by test , age at which to begin screening , age at which to stop screening , and screening interval . We aim ed to identify a set of recommendable strategies with similar clinical benefit and an efficient use of colonoscopy re sources . Using 2 models ( that is , a comparative modeling approach ) adds credibility to the results and serves as a sensitivity analysis on the underlying structural assumptions of the models , particularly pertaining to the unobservable natural history of colorectal cancer . Microsimulation Models The Appendix describes the MISCAN and SimCRC models , and st and ardized model profiles are available at cisnet.cancer.gov/profiles/. In brief , both models simulate the life histories of a large population of individuals from birth to death . As each individual ages , there is a chance that an adenoma will develop . One or more adenomas can occur in an individual , and each adenoma can independently develop into pre clinical ( that is , undiagnosed ) colorectal cancer ( Figure 1 ) . The risk for developing an adenoma depends on age , sex , and baseline individual risk . The models track the location and size of each adenoma ; these characteristics influence disease progression and the chance that the adenoma will be found by screening . The size of adenomas can progress from small ( 5 mm ) to medium ( 6 to 9 mm ) to large ( 10 mm ) . Some adenomas eventually become malignant , transforming to stage I pre clinical cancer . Pre clinical cancer has a chance of progressing through stages I to IV and may be diagnosed by symptoms at any stage . Survivorship after diagnosis depends on the stage of disease . Figure 1 . Natural history of disease as modeled by the Microsimulation Screening Analysis and Simulation Model of Colorectal Cancer models . The opportunity to intervene in the natural history through screening is noted . The natural history component of each model was calibrated to 19751979 clinical incidence data ( 14 ) and adenoma prevalence from autopsy studies in the same period ( 1524 ) . We used this period because incidence rates and adenoma prevalence had not yet been affected by screening . We corrected the adenoma prevalence for studies of non-U.S. population s by using st and ardized colorectal cancer incidence ratios . The models use all-cause mortality estimates from the U.S. life tables and stage-specific data on colorectal cancer survival from the 19961999 Surveillance , Epidemiology , and End Results program ( 14 ) . Table 1 compares outcomes from the natural history components of the models . Table 1 . Comparison of the Natural History Outcomes from the Microsimulation Screening Analysis ( MISCAN ) and Simulation Model of Colorectal Cancer ( SimCRC ) Models The effectiveness of a screening strategy is modeled through a test 's ability to detect lesions ( that is , adenomas or pre clinical cancer ) . Once screening is introduced , a simulated person who has an underlying lesion has a chance of having it detected during a screening round depending on the sensitivity of the test for that lesion and whether the lesion is within the reach of the test . Screened persons without an underlying lesion can have a false-positive test result and undergo unnecessary follow-up colonoscopy . Hyperplastic polyps are not modeled explicitly , but their detection is reflected in the specificity of the screening tests . The models incorporate the risk for fatal complications associated with perforation during colonoscopy . Both models have been vali date d against the long-term reductions in incidence and mortality of colorectal cancer with annual FOBT reported in the Minnesota Colon Cancer Control Study ( 3 , 25 , 26 ) and show good concordance with the trial results . Strategies for Colorectal Cancer Screening In consultation with the USPSTF , we included the following basic strategies : 1 ) no screening , 2 ) colonoscopy , 3 ) FOBT ( Hemoccult II , Hemoccult SENSA [ Beckman Coulter ] , or fecal immunochemical testing ) , 4 ) flexible sigmoidoscopy ( with biopsy ) , and 5 ) flexible sigmoidoscopy combined with Hemoccult SENSA . For each basic strategy , we evaluated start ages of 40 , 50 , and 60 years and stop ages of 75 and 85 years . For the FOBT strategies , we considered screening intervals of 1 , 2 , and 3 years , and for the sigmoidoscopy and colonoscopy strategies , we considered intervals of 5 , 10 , and 20 years . These variations result ed in 145 strategies : 90 single-test strategies , 54 combination-test strategies , and 1 no-screening strategy . The stop age reflects the oldest possible age at which to screen , but the actual stopping age is dictated by the start age and screening interval . In the base case , we assumed 100 % adherence for screening tests , follow-up of positive findings , and surveillance of persons found to have adenomas . Individuals with a positive FOBT result or with an adenoma detected by sigmoidoscopy were referred for follow-up colonoscopy . For years in which both tests were due for the combined strategy , the FOBT was performed first ; if the result was positive , the patient was referred for follow-up colonoscopy . In those years , flexible sigmoidoscopy was done only for patients with a negative FOBT result . If findings on follow-up colonoscopy were negative , the individual was assumed to undergo subsequent screening with colonoscopy with a 10-year interval ( as long as results of the repeated colonoscopy were negative ) and did not return to the initial screening schedule , as is the recommendation of the U.S. Multi-Society Task Force and American Cancer Society ( 7 , 27 ) . All individuals with an adenoma detected were followed with colonoscopy surveillance per the Multi-Society guidelines ( 27 , 28 ) . The surveillance interval depended on the number and size of the adenomas detected on the last colonoscopy ; it ranged from 3 to 5 years and was assumed to continue for the remainder of the person 's lifetime . We estimated the test characteristics of colorectal cancer screening from a review of the available literature ( Table 2 ) ( 29 ) . We conducted this review independently of and parallel in time with the systematic evidence review performed for the USPSTF ( 9 ) . Table 2 . Test Characteristics Used in the Microsimulation Screening Analysis and Simulation Model of Colorectal Cancer Models Evaluation of Outcomes Determination of Efficient Strategies The most effective strategy was defined as the one with the greatest life-years gained relative to no screening . However , it is important to consider the relative intensity of test use required to achieve those gains . The more effective strategies tended to be associated with more colonoscopies on average in a person 's lifetime , which translated into an increased risk for colonoscopy-related complications . We used an approach that mirrors that of cost-effectiveness analysis ( 30 ) to identify the set of efficient , or dominant , strategies within each test category . A strategy was considered dominant when no other strategy or combination of strategies provided more life-years with the same number of colonoscopies . We conducted this analysis separately for each of the 5 basic screening strategies because the number of noncolonoscopy tests differed by strategy . We then ranked the efficient screening strategies by increasing effectiveness and calculated the incremental number of colonoscopies ( COL ) per 1000 , the incremental life-years gained ( LYG ) per 1000 , and the incremental number of colonoscopies necessary to achieve 1 year of life ( Objective : This is the first study to evaluate the association between colonic screening and colorectal cancer risk among Canadians . Methods : A case – control study was conducted . Cases were diagnosed with cancer of the colorectum , between 1997 and 2000 , aged 20 to 74 years , identified through the population -based Ontario Cancer Registry and recruited by the Ontario Familial Colorectal Cancer Registry . Controls were a sex- and age-matched r and om sample of the population of Ontario . 971 cases and 1944 controls completed question naires ( including colorectal screening history and many risk factors ) . Multivariate logistic regression analysis was used to obtain adjusted odds ratios ( OR ) estimates . Results : Having had a fecal occult blood screen was associated with reduced colorectal cancer risk ( OR=0.76 ; 95 % confidence interval ( CI ) : 0.59 , 0.97 ) . Having had a screening sigmoidoscopy was associated with a halving of colorectal cancer risk ( OR = 0.52 ; 95 % CI : 0.34 , 0.80 ) . Having had a screening colonoscopy did not significantly reduce colorectal cancer risk ( OR = 0.69 ; 95 % CI : 0.44 , 1.07 ) ; however , having had either screening endoscopy was associated with a significant reduction in colorectal cancer risk ( OR = 0.62 ; 95 % CI : 0.44 , 0.87 ) . Findings differed slightly by anatomic sub-site ( proximal and distal colorectum ) . Conclusions : We report a reduction in colorectal cancer risk among persons who underwent colorectal cancer screening ; in particular , sigmoidoscopy . Findings are of great importance for the prevention of colorectal cancer OBJECTIVES We compared the effectiveness of a telephone outreach approach versus a direct mail approach in improving rates of colorectal cancer ( CRC ) screening in a predominantly Black population . METHODS A r and omized trial was conducted between 2000 and 2003 that followed 456 participants in the New York metropolitan area who had not had recent CRC screening . The intervention group received tailored telephone outreach , and the control group received mailed printed material s. The primary outcome was medically documented CRC screening 6 months or less after r and omization . RESULTS CRC screening was documented in 61 of 226 ( 27.0 % ) intervention participants and in 14 of 230 ( 6.1 % ) controls ( prevalence rate difference=20.9 % ; 95 % CI = 14.34 , 27.46 ) . Compared with the control group , the intervention group was 4.4 times more likely to receive CRC screening within 6 months of r and omization . CONCLUSIONS Tailored telephone outreach can increase CRC screening in an urban minority population BACKGROUND : National guidelines recommending colorectal cancer ( CRC ) screening for average risk Canadians were released in 2001 . The current study determined rates of CRC screening and predictors of screening 3 yr after the guidelines were released . METHOD : A population -based r and om digit dial telephone survey of 1,808 Alberta men and women aged 50–74 yr assessed awareness about , and self-reported rates of , screening . RESULTS : More average risk women than men reported a recent screening with a home fecal occult blood test ( FOBT ) ( 14.0 % vs 9.8 % , P = 0.013 ) but men had slightly higher rates of screening endoscopy in the past 5 yr ( 4.3 % vs 1.6 % , P = 0.003 ) . Overall , only 14.3 % of average risk adults ( N = 1,476 ) were up-to- date on Output:	Analysis of national survey data showed higher prevalences among men aged 55 years and older than for women of the same age . Prevalences were highest for people aged 70 to 79 years . Prevalence estimates from the United States indicate that a considerable and increasing proportion of the population at risk has had at least 1 colonoscopy or sigmoidoscopy in their lives , although differences between age and sex groups persist .
MS2809	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective To evaluate the benefits of paramedic practitioners assessing and , when possible , treating older people in the community after minor injury or illness . Paramedic practitioners have been trained with extended skills to assess , treat , and discharge older patients with minor acute conditions in the community . Design Cluster r and omised controlled trial involving 56 clusters . Weeks were r and omised to the paramedic practitioner service being active ( intervention ) or inactive ( control ) when the st and ard 999 service was available . Setting A large urban area in Engl and . Participants 3018 patients aged over 60 who called the emergency services ( n=1549 intervention , n=1469 control ) . Main outcome measures Emergency department attendance or hospital admission between 0 and 28 days ; interval from time of call to time of discharge ; patients ' satisfaction with the service received . Results Overall , patients in the intervention group were less likely to attend an emergency department ( relative risk 0.72 , 95 % confidence interval 0.68 to 0.75 ) or require hospital admission within 28 days ( 0.87 , 0.81 to 0.94 ) and experienced a shorter total episode time ( 235 v 278 minutes , 95 % confidence interval for difference −60 minutes to −25 minutes ) . Patients in the intervention group were more likely to report being highly satisfied with their healthcare episode ( relative risk 1.16 , 1.09 to 1.23 ) . There was no significant difference in 28 day mortality ( 0.87 , 0.63 to 1.21 ) . Conclusions Paramedics with extended skills can provide a clinical ly effective alternative to st and ard ambulance transfer and treatment in an emergency department for elderly patients with acute minor conditions . Trial registration IS RCT N27796329 Background : A scheme to train paramedics to undertake a greater role in the care of older people following a call for an emergency ambulance was developed in a large city in the UK . Objectives : To assess the cost effectiveness of the paramedic practitioner ( PP ) scheme compared with usual emergency care . Methods : A cluster r and omised controlled trial was undertaken of PP compared with usual care . Weeks were allocated to the study group at r and om to the PP scheme either being active ( intervention ) or inactive ( control ) . Re source use data were collected from routine sources , and from patient-completed question naires for events up to 28 days . EQ-5D data were also collected at 28 days . Results : Whereas the intervention group received more PP contact time , it reduced the proportion of emergency department ( ED ) attendances ( 53.3 % vs 84.0 % ) and time in the ED ( 126.6 vs 211.3 minutes ) . There was also some evidence of increased use of health services in the days following the incident for patients in the intervention group . Overall , total costs in the intervention group were £ 140 lower when routine data were considered ( p = 0.63 ) . When the costs and QALY were considered simultaneously , PP had a greater than 95 % chance of being cost effective at £ 20 000 per QALY . Conclusion : Several changes in re source use are associated with the use of PP . Given these economic results in t and em with the clinical , operational and patient-related benefits , the wider implementation and evaluation of similar schemes should be considered OBJECTIVES To evaluate paramedics ' ability to identify elderly at risk and refer them for assessment and service . DESIGN A prospect i ve nonr and omized open trial . SETTING Akron , Ohio , a midsize city with a well-developed advanced life support emergency medical services system . TYPE OF PARTICIPANTS One hundred thirty firefighter paramedics evaluated 6,000 elderly patients . Assessment s were performed by trained geriatric assessors . INTERVENTION Regardless of the reason for the call , paramedics screened all emergency medical services users age 60 and older for medical , mental health , social , and environmental problems . Identified cases were referred to the Area Agency on Aging for assessment and follow-up . MAIN RESULTS Paramedics identified 197 people with possible problems , 124 of whom received an assessment . The remainder could not be assessed due to death , moving , referral , or transfer to a long-term care facility . Assessors confirmed the presence of a problem in 121 of 124 assessed cases , a positive predictive value of 98 % . The program was useful for 94 people , 48 % of those identified and assessed . CONCLUSION Paramedics can serve as case finders for at-risk elderly , and effective linkage to service agencies can occur UNLABELLED Residential carbon monoxide ( CO ) poisoning represents a significant cause of unintentional morbidity and mortality in the United States . Screening by fire departments and utility companies is usually limited to instances in which there are symptoms of CO poisoning or there is activation of a home CO detector . OBJECTIVES To determine whether emergency medical services ( EMS ) personnel can perform routine CO screening during 911 calls . METHODS A prospect i ve observational study was conducted in an urban EMS system using emergency medical technicians ( EMTs ) to screen for elevated CO levels during emergency responses . The EMTs carried h and -held CO meters that detect as little as one part per million of CO . Readings were taken at the patient 's side during indoor patient contacts . If time allowed , a brief question naire was then administered to patients or by-st and ers concerning knowledge about CO poisoning , type of household heating system , and presence of home CO detectors . RESULTS In a three-month convenience sample of emergency responses , there were 264 residential CO readings obtained . There were nine ( 3.4 % ) positive residential readings , all with chief complaints believed to be unrelated to CO toxicity . Two hundred twelve surveys were completed during these emergency responses , with 145 of 212 ( 68 % ) participants familiar with the term " carbon monoxide poisoning . " Only 54 of 145 ( 37 % ) participants could name any signs or symptoms of CO poisoning . Of those surveyed , 133 of 212 ( 63 % ) participants reported an oil- or gas-powered heating system in their residence . Carbon monoxide detectors were absent in 185 of 212 ( 87 % ) residences , including all domiciles in which a positive CO reading was obtained . CONCLUSIONS Emergency medical services personnel can perform routine CO screening and detect occult elevations in CO levels during 911 responses . Public knowledge of CO poisoning is limited and the use of home CO detectors is rare in this study population INTRODUCTION This study evaluates whether a continuing education program for paramedics , focusing on Children with Special Health Care Needs , improved paramedics ' assessment and management . METHODS Emergency Medical Services responses for children , 21 years of age or younger , with a congenital or acquired condition or a chronic physical or mental illness , were identified . The responses before and after the specialized education program were review ed by a multidisciplinary team to evaluate assessment and management of the children . Inter review er agreement between the nurses on the team and between the physicians on the team was assessed . We also evaluated whether there was an improvement in assessment and care by paramedics completing our education program . RESULTS Significant improvement was seen in appropriate assessment and overall care by paramedics who completed our specialized education program . Review ers also noted an appropriate rating for the initial assessment category more often for responses involving paramedics who had the training . Agreement on whether assessment and treatment was appropriate for all five review ers varied considerably , ranging from 32 % to 93 % . Overall there was a high percentage of agreement ( > 70 % ) between the nurses and between the physicians on most items . However , kappa statistics did not generally reflect good agreement except for most of the focused assessment items and some treatment and procedure items . CONCLUSION Most of the documentation on the EMS records indicated appropriate assessment and treatment during all responses for Children with Special Health Care Needs . Nevertheless , the results indicate that paramedics may improve their assessment and management of these children after specialized continuing education The aim of this study was to carry out a critical appraisal to detect the occurrence of publication bias , specifically positive- outcome bias , in Brazilian dental journals . A convenience sample of twenty-eight dental journals published in Brazil between 1994 and 2003 was selected ( 564 issues containing 5,453 articles ) . Each article was classified according to method ological design ; 1,064 were classified as case reports . A simple r and om sample of 435 articles comprised the final study sample and was su bmi tted to a critical appraisal by previously trained raters . Although a great part of case reports achieve proper structural aspects , most authors did not consider important aspects that could help the decision making process , such as discussion of alternative approaches , limitation of the performed procedures , lack of long-term clinical follow-up , possible variations in treatment outcome , and failure to discuss limitations of study design . In addition , unanimous reports of successful outcomes of clinical interventions strongly suggest that publication of case reports was influenced by positive outcome bias , which may influence readers ' clinical decision making process Output:	There is valuable evidence for paramedic assessing and managing patients autonomously to reduce Emergency Department conveyance which is acceptable to patients and carers . This review identifies many viable extra skills for paramedics but the evidence is not strong enough to guide policy .
MS2810	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Forty eight elderly Thai patients , 12 demented , 36 non-demented who consecutively attended a geriatric clinic , at Chulalongkorn University Hospital , with a memory problem were recruited in the study which aim ed to determine the validity of the clock-drawing test ( CDT ) and Chula mental test ( CMT ) . Subjects took the Chula Mental Test ( CMT ) and were asked to draw a clock on a preprinted 12 centimeters circle showing the time of 11:10 . Clocks were scored using the Chula Clock-drawing Scoring System ( CCSS ) . Ten subjects voluntarily participated and completed the WAIS test . The best cutoff score of the CMT and the CDT using diagnosis of dementia as a gold st and ard were 15 and 7 respectively . Sensitivity and specificity for detecting dementia by the CDT were 100 per cent and 94.1 per cent respectively . Sensitivity and specificity for detecting dementia by the CMT were 83.3 per cent 91.7 per cent . The likelihood ratio ( 95 % confidence interval ) of the CMT and the CDT were 10 ( 3.3 - 30.4 ) and 17 ( 4.4 - 65.2 ) respectively . There was a good correlation of the CDT score and the CMT score with the WAIS score . Although the CDT was better than the CMT in literate patients , the CDT had limitation of use among illiterate patients but not the CMT . The benefits of simultaneously application on dementia screening was shown . This study showed that the CDT was a valuable , brief method of dementia screening in elderly Thai patients with memory problems BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions OBJECTIVES To assess the usefulness , relative ease of administration , and patient acceptance of the clock drawing test as well as the time and change test for detecting dementia in Chinese elderly adults . DESIGN Prospect i ve case-controlled study . SETTING Memory clinic and geriatric clinic of a district hospital , Hong Kong . PARTICIPANTS A convenient sample of 85 subjects aged 65 years or older attending the two clinics during the period from September 2002 to June 2003 . MAIN OUTCOME MEASURES The clock drawing test scored according to Lam 's method ; the time and change test with modification to the making change task ; and the Chinese version of the Mini-Mental State Examination . RESULTS Demented subjects were matched with non-demented ones with respect to age , sex , educational level , and co-morbidity status . The clock drawing test had a comparable sensitivity ( 89.4 % ) but a lower specificity ( 47.1 % ) when compared with that of the Chinese version of the Mini-Mental State Examination ( 96.0 and 76.5 % , respectively ) . In contrast , the time and change test had a lower sensitivity ( 62.7 % ) but higher specificity ( 94.1 % ) . Both tests took significantly less time to complete than the Chinese version of the Mini-Mental State Examination . All except four subjects completed the clock drawing test while all subjects accepted the time and change test well . CONCLUSIONS The Chinese version of the Mini-Mental State Examination is still the best among the three tests despite the longer time to completion . The clock drawing test may be a good alternative to the Mini-Mental State Examination as an effective screening test for dementia when time does not permit . The time and change test , although time-saving , is not suitable to be used alone because of its low sensitivity BACKGROUND As elderly population s grow , dementia detection in the community is increasingly needed . Existing screens are largely unused because of time and training requirements . We developed the Mini-Cog , a brief dementia screen with high sensitivity , specificity , and acceptability . Here we describe the development of its scoring algorithm , its receiver operating characteristics ( ROC ) , and the generalizability of its clock drawing scoring system . SAMPLE AND METHODS A total of 249 multi-lingual older adults were examined . Scores on the three-item recall task and the clock drawing task ( CDT-CERAD version ) were combined to create an optimal algorithm . Receiver operating characteristics for seven alternatives were compared with those of the MMSE and the CASI using expert raters . To assess the CDT scoring generalizability , 20 naïve raters , without explicit instructions or prior CDT exposure , scored 80 r and omly selected clocks as " normal " or " abnormal " ( 20 from each of four CERAD categories ) . RESULTS An algorithm maximizing sensitivity and correct diagnosis was defined . Its ROC compared favorably with those of the MMSE and CASI . CDT concordance between naïve and trained raters was > 98 % for normal , moderately and severely impaired clocks , but lower ( 60 % ) for mildly impaired clocks . Recalculation of the Mini-Cog 's performance , assuming that naïve raters would score all mildly impaired CDTs in the full sample as normal , retained high sensitivity ( 97 % ) and specificity ( 95 % ) . CONCLUSION The Mini-Cog algorithm performs well with simple clock scoring techniques . The results suggest that the Mini-Cog may be used successfully by relatively untrained raters as a first-stage dementia screen . Further research is needed to characterize the Mini-Cog 's utility when population dementia prevalences are low The ten‐point clock test is administered by tracing an 11·4 cm ( 4 1/2 inch ) diameter circle on a piece of paper and asking the patient to ‘ Write the numbers in the face of a clock ’ . The patient is then asked to ‘ Make the clock say 10 minutes after 11 ’ . The spacing of the numbers and the positions of the h and s are used to score the test . A score of less than eight points identified 71 % of patients with Alzheimer 's disease who had a Mini‐Mental State Examination score of greater than 23 . The specificity measured in elderly controls was 82 % . The test may prove useful in screening for early stage Alzheimer 's disease . Copyright © 1999 John Wiley & Sons , OBJECTIVE To assess the accuracy of clock drawing for detecting dementia in a multicultural , non-English-speaking- background population . DESIGN A prospect i ve cohort study . SETTING A general geriatric medical outpatient clinic in southwest Sydney , Australia . PARTICIPANTS Ninety-three consecutive new patients to the clinic who had a non-English-speaking- background country of birth ( mean age 78.0 years ) . MEASUREMENTS The clock drawing test was conducted at the beginning of each clinic visit by a blinded investigator . Each patient was then assessed by a geriatrician who collected demographic data , administered the Modified Barthel Index , the Geriatric Depression Scale , and the Folstein Mini-Mental State Examination , and categorized each patient as normal or demented , according to DSM-IV criteria . Interpreters were used for participants who spoke a language other than English or who requested them . Each clock drawing was scored according to the 4-point CERAD scale and the previously published methods of Mendez , Shulman , Sunderl and , Watson , and Wolf-Klein . Scoring was evaluated for reliability and predictive accuracy , using receiver operating characteristic ( ROC ) curve analysis . Logistic regression analysis was used to assess the potential interaction between level of education and each of the clock scoring methods . RESULTS Using ROC curve analysis , there was no significant difference between the clock scoring methods ( area under the curve varied from 0.60 to 0.72 ) . The most sensitive was the Mendez scoring method ( 98 % ) , with a specificity of 16 % . Specificity above 50 % was found only for the Wolf-Klein method , with an intermediate sensitivity of 78 % . CONCLUSIONS There were no significant differences in the clock scoring methods used to detect dementia . Performance of the clock drawing test was modest at best with low levels of specificity across all methods . Scored according to these methods , clock drawing was not a useful predictor of dementia in our multicultural population INTRODUCTION The Clock Drawing Test ( CDT ) has been used in recent years as a simple neuropsychological instrument to assess cognitive deterioration associated with dementia , even though uniform operative criteria with respect to its application and scoring have not been established . OBJECTIVE To present application normatives and establish the most relevant psychometric criteria of the CDT in a sample of healthy subjects ( HS ) and patients with Alzheimer 's disease ( AD ) . PATIENTS AND METHODS 56 patients were selected of which 35 were female and 21 were male . The patients ' mean age was 72.7 with a st and ard deviation of 7.64 . All of whom where probable AD patients according to the NINCDS-ADRDA criteria at stage 1 CDR . The group of HS was made up of 56 control subjects ( 34 female , 22 male ) with a mean age of 72.14 and a st and ard deviation of 7.2 . The CDT was applied in both its comm and ( COM ) and copy ( COP ) experimental conditions . RESULTS The main psychometric parameters analysed in the studied series showed the following values : internal consistency ( Cronbach 's alpha coefficient 0.9029 ) ; cut off point CT COM 6 with 92.80 , sensitivity ; false negatives ( FN ) 7.2 with a specificity rating 93.48 ; false positive ( FP ) 6.52 with 93.16 efficacy ; cut off point CT COP 8 with 73.11 sensitivity ; FN 26.89 with 90.58 specificity ; FP 9.42 with 82.49 efficacy . CONCLUSION The CDT can be used to discriminate between HS and those in the initial stages of AD in the given sample using the established application and scoring criteria OBJECTIVE To develop a simple , readily administered and scored screening test for dementia utilizing the clock-drawing task . DESIGN Retrospective analysis of clock-drawing errors and prospect i ve validations . SETTING Hospital-based outpatient geriatric assessment clinic , rehabilitation service , apartment building for older adults , and long-term care facility . PARTICIPANTS Convenience sample of patients attending the geriatric assessment clinic , patients on the rehabilitation service , or residents of the above sites . MEASUREMENTS Sensitivity and specificity of a clock-scoring system in identifying patients with dementia and the comparison of this system with the Short Blessed Test ( SBT ) in the diagnosis of dementia and in the prospect i ve validation of the test . RESULTS Of the 10 clock-drawing errors evaluated , placement of digits in a pre-drawn circle had the greatest sensitivity and specificity in distinguishing patients with irreversible dementia from patients with other disorders who did not meet NINCDS-ADRDA criteria for probable dementia . The derived scoring system had a sensitivity of 87 % and a specificity of 82 % , compared with a sensitivity of 82 % and a specificity of 88 % for the SBT in identifying dementia . Test-retest reliability for the distinction between demented and non-demented was 82 % , with a Kappa of 0.63 for the clock completion , and 82 % , with a Kappa of 0.62 for the SBT . Inter-rater reliability for clock completion was 0.90 to 0.93 . CONCLUSION A simple , completely objective scoring system for a clock completion test has been developed which involves only the number of digits placed in the fourth quadrant of a pre-drawn circle . This readily administered test is as effective in screening for dementia as the longer six-item SBT Causes of cognitive impairment in the elderly include dementia , delirium , toxic effects of medications , trauma , and psychiatric illness . Dementia is the most common cause , and it implies a decline in cognitive function severe enough to interfere with social functioning . The estimated prevalence of dementia is Output:	The correlation with other st and ard screening tests was statistically significant in most studies , but the results were influenced by age , education and language . In studies that included patients with mild or question able dementia , the CDT had a low sensitivity and variable specificity . Conclusion : The CDT has the characteristics of a good screening method for moderate and severe dementia .
MS2811	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To prospect ively examine the effect of weight loss 1 year after laparoscopic adjustable gastric b and surgery on a broad range of health outcomes in 50 diabetic subjects . RESEARCH DESIGN AND METHODS A total of 50 ( 17 men , 33 women ) of 51 patients with type 2 diabetes , from a total of 500 consecutive patients , were studied preoperatively and again 1 year after surgery . RESULTS Preoperative weight and BMI ( means + /- SD ) were 137 + /- 30 kg and 48.2 + /- 8 kg/m(2 ) , respectively ; at 1 year , weight and BMI were 110 + /- 24 kg and 38.7 + /- 6 kg/m(2 ) , respectively . There was significant improvement in all measures of glucose metabolism . Remission of diabetes occurred in 32 patients ( 64 % ) , and major improvement of glucose control occurred in 13 patients ( 26 % ) ; glucose metabolism was unchanged in 5 patients ( 10 % ) . HbA(1c ) was 7.8 + /- 3.2 % preoperatively and 6.2 + /- 2.7 % at 1 year ( P < 0.001 ) . Remission of diabetes was predicted by greater weight loss and a shorter history of diabetes ( pseudo r(2 ) = 0.44 , P < 0.001 ) . Improvement in diabetes was related to increased insulin sensitivity and beta-cell function . Weight loss was associated with significant improvements in fasting triglyceride level , HDL cholesterol level , hypertension , sleep , depression , appearance evaluation , and health-related quality of life . Early complications occurred in 6 % of patients ( wound infections in 4 % , respiratory support in 2 % ) , and late complications occurred in 30 % of patients ( gastric prolapse in 20 % , b and erosion in 6 % , and tubing leaks in 4 % ) . All late complications were successfully revised surgically . CONCLUSIONS Modern laparoscopic weight-loss surgery is effective in managing the broad range of health problems experienced by severely obese individuals with type 2 diabetes . Surgery should be considered as an early intervention Abstract OBJECTIVE : To examine the impact of a nurse-coordinated intervention delivered to patients with non-insulin-dependent diabetes mellitus between office visits to primary care physicians . DESIGN : R and omized , controlled trial . SETTING : Veterans Affairs general medical clinic . PATIENTS : 275 veterans who had NIDDM and were receiving primary care from general internists . INTERVENTION : Nurse-initiated contacts were made by telephone at least monthly to provide patient education ( with special emphasis on regimens and significant signs and symptoms of hyperglycemia and hypoglycemia ) , reinforce compliance with regimens , monitor patients ’ health status , facilitate resolution of identified problems , and facilitate access to primary care . MEASUREMENTS : Glycemic control was assessed using glycosylated hemoglobin ( GHb ) and fasting blood sugar ( FBS ) levels . Health-related quality of life ( HRQOL ) was measured with the Medical Outcomes Study SF-36 , and diabetes-related symptoms were assessed using patients ’ self-reports of signs and symptoms of hyper- and hypoglycemia during the previous month . MAIN RESULTS : At one year , between-group differences favored intervention patients for FBS ( 174.1 mg/dL vs 193.1 mg/dL , p=0.011 ) and GHb ( 10.5 % vs 11.1 % , p=0.046 ) . Statistically significant differences were not observed for either SF-36 scores ( p=0.66 ) or diabetes-related symptoms ( p=0.23 ) . CONCLUSIONS : The intervention , design ed to be a pragmatic , low-intensity adjunct to care delivered by physicians , modestly improved glycemic control but not HRQOL or diabetes-related symptoms OBJECTIVE To assess the efficacy of a lifestyle intervention program that can be readily translated into clinical practice for obese patients with type 2 diabetes . RESEARCH DESIGN AND METHODS The study consisted of a 12-month r and omized controlled trial of 147 health plan members with type 2 diabetes and obesity ( BMI > or=27 kg/m(2 ) ) . Participants were r and omized to lifestyle case management or usual care . Case management entailed individual and group education , support , and referral by registered dietitians ; intervention cost was US dollars 350 per person . Individuals treated with usual care received educational material . Both groups received ongoing primary care . Outcomes were difference between groups for change in weight ( kilograms ) , waist circumference ( centimeters ) , HbA(1c ) , fasting lipid levels , use of prescription medications , and health-related quality of life . RESULTS Case management result ed in greater weight loss ( P < 0.001 ) , reduced waist circumference ( P < 0.001 ) , reduced HbA(1c ) level ( P = 0.02 ) , less use of prescription medications ( P = 0.03 ) , and improved health-related quality of life ( P < 0.001 ) compared with usual care . The 12-month group difference in weight loss and waist circumference was 3.0 kg ( 95 % CI -5.4 to -0.6 ) and -4.2 cm ( -6.8 to -1.6 ) . HbA(1c ) differences were greatest at 4 months ( -0.59 % , P = 0.006 ) but not significant by 12 months ( -0.19 % , P = 0.45 ) . Participants in the case management group lowered their use of medications , primarily diabetes medications , by 0.8 medications per day more than participants treated with usual care ( P = 0.03 ) . In seven of nine quality -of-life domains , the case management group improved compared with usual care ( P < 0.05 ) . CONCLUSIONS Moderate-cost dietitian-led lifestyle case management may improve diverse health indicators among obese patients with type 2 diabetes OBJECTIVE To evaluate the impact of primary care group visits ( chronic care clinics ) on the process and outcome of care for diabetic patients . RESEARCH DESIGN AND METHODS We evaluated the intervention in primary care practice s r and omized to intervention and control groups in a large-staff model health maintenance organization ( HMO ) . Patients included diabetic patients > or = 30 years of age in each participating primary care practice , selected at r and om from an automated diabetes registry . Primary care practice s were r and omized within clinics to either a chronic care clinic ( intervention ) group or a usual care ( control ) group . The intervention group conducted periodic one-half day chronic care clinics for groups of approximately 8 diabetic patients in their respective doctor 's practice . Chronic care clinics consisted of st and ardized assessment s ; visits with the primary care physician , nurse , and clinical pharmacist ; and a group education/peer support meeting . We collected self-report question naires from patients and data from administrative systems . The question naires were mailed , and telephoned interviews were conducted for nonrespondents , at baseline and at 12 and 24 months ; we queried the process of care received , the satisfaction with care , and the health status of each patient . Serum cholesterol and HbA1c levels and health care use and cost data was collected from HMO administrative systems . RESULTS In an intention-to-treat analysis at 24 months , the intervention group had received significantly more recommended preventive procedures and helpful patient education . Of five primary health status indicators examined , two ( SF-36 general health and bed disability days ) were significantly better in the intervention group . Compared with control patients , intervention patients had slightly more primary care visits , but significantly fewer specialty and emergency room visits . Among intervention participants , we found consistently positive associations between the number of chronic care clinics attended and a number of outcomes , including patient satisfaction and HbA1c levels . CONCLUSIONS Periodic primary care sessions organized to meet the complex needs of diabetic patients imrproved the process of diabetes care and were associated with better outcomes OBJECTIVES The current study was conducted to compare the effectiveness of delivering diabetes education in either a group or individual setting using a consistent , evidence -based curriculum . RESEARCH DESIGN AND METHODS A total of 170 subjects with type 2 diabetes were r and omly assigned to either group ( n = 87 ) or individual ( n = 83 ) educational setting s. Subjects received education in four sequential sessions delivered at consistent time intervals over a 6-month period . Outcomes included changes in knowledge , self-management behaviors , weight , BMI , HbA(1c ) , health-related quality of life , patient attitudes , and medication regimen . Changes were assessed at baseline and after the 2-week , 3-month , and 6-month education sessions . RESULTS Both educational setting s had similar improvements in knowledge , BMI , health-related quality of life , attitudes , and all other measured indicators . HbA(1c ) decreased from 8.5 + /- 1.8 % at baseline to 6.5 + /- 0.8 % at 6 months ( P < 0.01 ) in the study population as a whole . Subjects assigned to the individual setting had a 1.7 + /- 1.9 % reduction in HbA(1c ) ( P < 0.01 ) , whereas subjects assigned to the group setting had a 2.5 + /- 1.8 % reduction in HbA(1c ) ( P < 0.01 ) . The difference in HbA(1c ) improvement was marginally greater in subjects assigned to group education versus individualized education ( P = 0.05 ) . CONCLUSIONS This study demonstrates that diabetes education delivered in a group setting , when compared with an individual setting , was equally effective at providing equivalent or slightly greater improvements in glycemic control . Group diabetes education was similarly effective in delivering key educational components and may allow for more efficient and cost-effective methods in the delivery of diabetes education programs AIM The aim of our study was to describe investigate and association between improved glycaemic control on quality of life ( QoL ) during 1 year of treatment in a sample of 94 Type 2 diabetic patients referred for insulin therapy to an outpatient department ( OPD ) . Treatment was aim ed at achieving acceptable glycaemic control by means of maximizing oral therapy , if necessary switching over to insulin therapy , and information and education provided by a diabetes specialist nurse and dietitian . METHODS QoL was measured using a disease-specific ( Diabetes Health Profile ( DHP ) ) and a generic question naire ( R AND -36 ) . After 1 year the medical examination and QoL measurements were repeated . The association between 1-year changes in QoL and achievement of good metabolic control ( final glycosylated haemoglobin ( HbA1c ) < or = 8 % ) , switch to insulin therapy , and presence of hyperglycaemic complaints at baseline was analysed after adjustment for appropriate confounders . RESULTS After 1 year , mean HbA1c was reduced from 10.4 % to 7.8 % . Also QoL improved in the total group . Patients who achieved good glycaemic control after 1 year ( 61 % ) improved in a similar manner as the others . Patients switched over to insulin ( 65 % ) improved in a similar manner as the others , but at the final examination they experienced more problems with social functioning and pain . Patients with hyperglycaemic complaints at baseline ( 49 % ) improved more in QoL than those without , especially in physical functioning , vitality and health change , but at the final examination still scored lower on a majority of the DHP and R AND -36 dimensions . CONCLUSION Symptoms of hyperglycaemia predict the strength of an association between improvements of glycaemic control and OBJECTIVE To compare the efficacy and safety of continuous subcutaneous insulin infusion ( CSII ) and multiple daily injection ( MDI ) in older adults with insulin-treated type 2 diabetes and to assess treatment satisfaction and quality of life . RESEARCH DESIGN AND METHODS Adults ( n = 107 ) > or = 60 years of age ( mean age 66 years ) with insulin-treated type 2 diabetes ( mean duration 16 years , BMI 32 kg/m(2 ) , and HbA(1C ) [ A1C ] 8.2 % ) were r and omized to CSII ( using insulin lispro ) or MDI ( using insulin lispro and insulin glargine ) in a two-center , 12-month , prospect i ve , r and omized , controlled clinical trial . Efficacy was assessed with A1C , safety by frequency of hypoglycemia , and treatment satisfaction and quality of life with the Diabetes Quality of Life Clinical Trial Question naire and the 36-item short-form health survey , version 2 . RESULTS Forty-eight CSII subjects ( 91 % ) and 50 MDI subjects ( 93 % ) completed the study . Mean A1C fell by 1.7 + /- 1.0 % in the CSII group to 6.6 % and by 1.6 + /- 1.2 % in the MDI group to 6.4 % . The difference in A1C between treatment groups was not statistically significant ( P = 0.20 ) . Eighty-one percent of CSII subjects and 90 % of MDI subjects experienced at least one episode of minor ( self-treated ) hypoglycemia ( P = 0.17 ) , and three CSII and six MDI Output:	Interventions generally demonstrated improvement in HRQL . Conclusions : A variety of interventions can improve HRQL among adults with diabetes , but the magnitude of effects varied with the interventions .
MS2812	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Many cystic fibrosis patients with Pseudomonas lung infections receive intravenous ( IV ) antibiotics and chest physiotherapy ( CPT ) at home . Previous studies have suggested that home care , in the setting of a clinical study , is as efficacious as hospital care . This report compares the outcomes of home care with minimal supervision to outcomes of hospital care . We compared two groups of similar age and severity of lung impairment . Patients met strict definitions for home or hospital treatment ( 27 home care courses/33 hospital care courses ) . Five patients completed six courses of both home care and hospital treatment . Treatment in both groups included intravenous antibiotics and CPT . Primary outcome measures included changes in pulmonary function between the start of treatment and after 2 weeks of therapy , duration of treatment , and intervals between antibiotic courses . In hospitalized patients , forced vital capacity ( FVC ) increased by 17.4 + /- 3.1 % ( mean + /- SEM ) , and forced expiratory volume in one second ( FEV1 ) increased by 23.3 + /- 4.1 % , both significant at P < 0.001 . The FVC and FEV1 of patients treated at home increased by 10.2 + /- 2.0 % and 13.7 + /- 2.6 % respectively , neither of which was a significant improvement . Similar results were found in the five patients completing both home and hospital courses . The average duration of treatment was twice as long and time between IV antibiotic courses only two-thirds as long for those treated at home compared with the hospitalized patients . Previous reports have cl aim ed that home care in the setting of a prospect i ve study is as efficacious as hospital care . Our experience indicates that routine home care with minimal supervision of patients is less effective than hospital care . Furthermore , home care as delivered to patients in this report increased the overall cost of care by as much as 30 % because of longer and more frequent courses of antibiotic therapy Abstract . Background : Home intravenous antibiotic treatment has added to therapeutic options against Pseudomonas aeruginosa in cystic fibrosis ( CF ) patients leading to increased flexibility . A prospect i ve clinical study was carried out to compare home and hospital iv antibiotic treatment in CF patients with chronic P. aeruginosa infection . Patients and Methods : Treatment courses were planned selectively , exacerbations were excluded . 28 consecutive hospital courses ( group 1 ) were compared with 30 home care courses ( group 2 ) . Chest physiotherapy and nutrition therapy were carried on in both groups . Antibiotic treatment in both groups consisted of tobramycin and ceftazidime , with equal dosage and application . Groups were compared using clinical , inflammatory and microbiological parameters . Results : There was a significant difference ( p ≤ 0.05 ) in peripheral leukocyte counts before and after therapy in both groups . The same was true for forced expiratory volume in 1 sec ( FEV1 ; p ≤ 0.05 ) , weight for height ( p ≤ 0.005 ) and for Pseudomonas counts ( p ≤ 0.005 ) in sputa . There was no statistical difference between the two groups for any of the parameters tested . Conclusion : It is concluded that , when exacerbations are excluded , home iv therapy is an effective therapeutic option in CF . Long-term comparison is still needed to effectively evaluate the pros and cons of home and hospital antibiotic treatment in CF In this study , we set out to determine if home intravenous ( i.v . ) antibiotic therapy in adult patients with cystic fibrosis ( CF ) is a feasible , effective and less costly alternative to hospitalization , and to assess the impact of home therapy on quality of life . The study was a prospect i ve , r and omized , two-factor mixed design involving adults presenting with respiratory exacerbations of CF . Patients were r and omized such that they were discharged home after 2 - 4 days , or remained in hospital . Seventeen patients had 31 admissions ( 13 home and 18 hospital ) . Following 10 days of therapy , there were no significant differences between home or hospital arms with respect to body weight , 12 minute walking distance , sputum weight , pulse oximetry , or improvement in lung function ( forced expiratory volume in one second ( FEV1 ) , or forced vital capacity ( FVC ) ) . Patients who remained in hospital were less fatigued and noted a greater degree of mastery . Patients discharged early noted less disruption to their family life , personal life and sleeping pattern . The total cost for the home therapy arm was approximately half that of the hospital therapy arm . Home intravenous antibiotic therapy in patients with cystic fibrosis was a feasible , cost-effective alternative to receiving therapy in hospital . Although there was no clinical compromise associated with home therapy , there were advantages and disadvantages in terms of quality of life METHODS 14 patients with cystic fibrosis and chronic pulmonary pseudomonas infection received four courses of two-week intravenous antibiotic therapy at home and during hospitalisation over an 18-month period . Following a controlled , intra-individual cross-over design , two courses of home therapy were followed by two courses of hospital treatment or vice versa . Parameters for inflammation , lung function , and body mass index were obtained at the beginning and end of each intravenous antibiotic therapy . Health-related quality of life , i.e. physical , emotional , social and functional components as well as happiness and medical care , was assessed at the end of each course . RESULTS There was a trend towards better reduction of infection ( p = 0.20 for leukocyte reduction ) and improvement of lung function ( p = 0.20 for FEV1 improvement ) with hospital intravenous antibiotic therapy , although the differences did not attain statistical significance . Quality of life during therapy was significantly higher with home therapy regarding social ( p < 0.01 ) , functional and emotional subscales and happiness ( all p < 0.05 ) . The necessity for professional help and support from family and /or partner was emphasised . Individual answers showed that home therapy has the advantage of self-determination and continuity of daily life . Parents and partners felt impaired by day and night intravenous therapy at home . CONCLUSION From our data we conclude that home intravenous antibiotic therapy is a useful option for a selected subgroup of patients with cystic fibrosis , but professional support and family aid is important to gain an effect similar to hospital treatment In a prospect i ve , r and omised , cross-over study including cystic fibrosis patients with indications for HIVAT ( home intravenous antibiotic treatment ) the prospect of pharmaceutical intervention was investigated . A comparison between the use of disposable infusion devices with antibiotics from the pharmacy and when the patients prepared the drugs themselves was performed . During a first treatment course the patients received either infusion devices during 5 days or reconstituted the drugs themselves during 5 days , or vice versa . During a second treatment course the order was the reversed . Eight patients were included , out of which six completed the original design as a cross-over study , yielding a total of 550 doses of antibiotics . The patients preferred infusion devices from the pharmacy prepared according to GMP ( Good Manufacturing Practice ) as opposed to reconstituting the antibiotics themselves . Points of view presented included no anxiety over the correct dosage of drugs and less disruption of family and social life . In a practical sense , portable devices are more expensive than the preparation of the drugs by the patients themselves . However , when comparing with in-hospital treatment the direct costs for a hospital stay exceed that of the devices . Another part of the study evaluated the quality of life using a modified form of SEIQoL-DW ( Schedule for the Evaluation of Individual Quality of Life - Direct Weighting ) . Twenty patients took part in the study and the overall quality of life scores increased significantly when patients received infusion devices compared to reconstituting the drugs themselves Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . OBJECTIVE Despite widespread adoption of home care services , few r and omised trials have compared health outcomes in the hospital and at home . We report a prospect i ve , r and omised trial of home versus hospital therapy in adults receiving intravenous ( IV ) antibiotics . Our objective was to show that home care is a feasible alternative to hospitalisation over a broad range of infections , without compromise to quality of life ( QOL ) or clinical outcomes . METHODS Consenting adults requiring IV antibiotics were r and omised to complete therapy at home or in hospital . Short Form 36 and Perceived Health Competence Scale ( PHCS ) were used for assessment of QOL . Statistical analysis used unpaired t-tests , Mann-Whitney tests and ANOVA . RESULTS One hundred and twenty-nine admissions were referred . Recruitment was hampered by patient preference for one therapy over another . 82 ( 62 % ) were included and r and omised : 44 to home , 38 to hospital ; the two groups had comparable characteristics . There were no differences in improvements in QOL and PHCS scores between the two groups after treatment . Treatment duration was median 11.5 days ( range 3 - 57 ) and 11 days ( range 4 - 126 ) for home and hospital groups , respectively . Home therapy costs , approximately , half that of hospital therapy . Time to readmission was longer after hospital therapy . CONCLUSION Out study showed that home IV therapy is well tolerated , is less costly , is not associated with any major disadvantage to QOL or clinical outcomes compared to hospital therapy , and is an appropriate treatment option for selected patients A controlled prospect i ve study was undertaken to compare the efficacy and benefits of home and hospital treatment for patients with exacerbations of pulmonary disease caused by cystic fibrosis . A total of 41 home and 41 hospital treatments were analyzed . Home and hospital patients were matched according to sex , age , pulmonary function tests , and arterial blood gas values . Both home and hospital treatments result ed in statistically significant improvement in pulmonary function . A comparison of these values did not show any statistically significant difference between groups at admission or discharge . Furthermore , the mean number of treatment days for both groups , individually determined by the primary physician , was equivalent ( home 17.7 + /- 1.1 days , hospital 18.1 + /- 4.1 ) . The mean charge for a home treatment was approximately $ 10,000 , and for a hospital treatment $ 18,000 . Sixty-five percent of home care patients and 68 % of hospital patients required retreatment for pulmonary exacerbations within the study period ; the interval between pulmonary exacerbations for the two groups was not significantly different . In addition , 85 % of patients receiving treatment at home were able to maintain at least some of their school or work activities . These data indicate that home therapy for cystic fibrosis patients with pulmonary exacerbations is less costly and is as effective as in-hospital therapy Output:	Home participants underwent fewer investigations than hospital participants ( P < 0.002 ) and general activity was higher in the home group . No significant differences were found for clinical outcomes , adverse events , complications or change of intravenous lines , or time to next admission . Home participants received less low-dose home maintenance antibiotic . Quality of life measures showed no significant differences for dyspnoea and emotional state , but fatigue and mastery were worse for home participants , possibly due to a higher general activity and need of support . Personal , family , sleeping and eating disruptions were less important for home than hospital admissions . Home therapy was cheaper for families and the hospital . It suggests that , in the short term , home therapy does not harm individuals , entails fewer investigations , reduces social disruptions and can be cost-effective . There were both advantages and disadvantages in terms of quality of life .
MS2813	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND To compare the results of radiofrequency ablation ( RFA ) with hepatic resection in the treatment of hepatocellular carcinoma ( HCC ) within the Milan criteria . METHODS A nonr and omized comparative study was performed with 111 consecutive patients who underwent laparoscopic RFA ( n = 31 ) or curative hepatic resection ( n = 80 ) for HCC within Milan criteria . RESULTS Procedure related complications were less often and severe after RFA than resection ( 3.2 % vs. 25 % ) . There was no significant difference in hospital mortality ( 0 % vs. 3.8 % ) . Hospital stay was significantly shorter in the RFA group than in the resection group ( mean , 3.8 vs. 6.8 days ) . The 1- , 3- , and 5-year disease-free survival rates for the RFA group and the resection group were 76 % , 40 % , 40 % and 76 % , 60 % , 60 % , respectively . Disease-free survival was significantly lower in the RFA group than in the resection group . The corresponding 1- , 3- , and 5-year overall survival rates for the RFA group and the resection group were 100 % , 92 % , 84 % , and 92 % , 75 % , 71 % , respectively . The overall survival for RFA and resection were not significantly different . CONCLUSIONS Our result showed comparable overall survival between RFA and surgery , although RFA was associated with a significantly higher tumor recurrence rate . RFA had the advantages over surgical resection in being less invasive and having lower morbidity Abstract Background Hepatocellular carcinoma ( HCC ) is a primary tumor of the liver with poor prognosis . For early stage HCC , treatment options include surgical resection , liver transplantation , and percutaneous ablation . Percutaneous ablative techniques ( radiofrequency and microwave techniques ) emerged as best therapeutic options for nonsurgical patients . Aims We aim ed to determine the safety and efficacy of radiofrequency and microwave procedures for ablation of early stage HCC lesions and prospect ively follow up our patients for survival analysis . Patients and methods One Hundred and 11 patients with early HCC are managed in our multidisciplinary clinic using either radiofrequency or microwave ablation . Patients are assessed for efficacy and safety . Complete ablation rate , local recurrence , and overall survival analysis are compared between both procedures . Results Radiofrequency ablation group ( n = 45 ) and microwave ablation group ( n = 66 ) were nearly comparable as regards the tumor and patients characteristics . Complete ablation was achieved in 94.2 and 96.1 % of patients managed by radiofrequency and microwave ablation techniques , respectively ( p value 0.6 ) with a low rate of minor complications ( 11.1 and 3.2 , respectively ) including subcapsular hematoma , thigh burn , abdominal wall skin burn , and pleural effusion . Ablation rates did not differ between ablated lesions ≤3 and 3–5 cm . A lower incidence of local recurrence was observed in microwave group ( 3.9 vs. 13.5 % in radiofrequency group , p value 0.04 ) . No difference between both groups as regards de novo lesions , portal vein thrombosis , and abdominal lymphadenopathy . The overall actuarial probability of survival was 91.6 % at 1 year and 86.1 % at 2 years with a higher survival rates noticed in microwave group but still without significant difference ( p value 0.49 ) . Conclusion Radiofrequency and microwave ablations led to safe and equivalent ablation and survival rates ( with superiority for microwave ablation as regards the incidence of local recurrence ) Background R and omized trials suggest that radiofrequency ablation ( RFA ) may be more effective than percutaneous ethanol injection ( PEI ) in the treatment of hepatocellular carcinoma ( HCC ) . However , the survival advantage of RFA needs confirmation in daily practice . Methods We conducted a population -based cohort study using the Taiwan Cancer Registry , National Health Insurance cl aim data base and National Death Registry data from 2004 through 2009 . Patients receiving PEI or RFA as first-line treatment for newly-diagnosed stage I-II HCC were enrolled . Results A total of 658 patients receiving RFA and 378 patients receiving PEI treatment were included for final analysis . The overall survival ( OS ) rates of patients in the RFA and PEI groups at 5-year were 55 % and 42 % , respectively ( p < 0.01 ) . Compared to patients that received PEI , those that received RFA had lower risks of overall mortality and first-line treatment failure ( FTF ) , with adjusted hazard ratios ( HRs ) [ 95 % confidence interval ( CI ) ] of 0.60 ( 0.50 - 0.73 ) for OS and 0.54 ( 0.46 - 0.64 ) for FTF . The favorable outcomes for the RFA group were consistently significant for patients with tumors > 2 cm as well as for those with tumors < 2 cm . Consistent results were also observed in other subgroup analyses defined by gender , age , tumor stage , and co-morbidity status . Conclusion RFA provides better survival benefits than PEI for patients with unresectable stage I-II HCC , irrespective of tumors > 2 cm or ≤ 2 cm , in contemporary clinical practice Evidence of relative effectiveness of local treatments for hepatocellular carcinoma ( HCC ) is scanty . We investigated , in a retrospective cohort study , whether surgical resection , radiofrequency ablation ( RFA ) , percutaneous ethanol injection ( PEI ) , and transarterial embolization with ( TACE ) or without ( TAE ) chemotherapy result ed in different survival in clinical practice . All patients first diagnosed with HCC and treated with any locoregional therapy from 1998 to 2002 in twelve Italian hospitals were eligible . Overall survival ( OS ) was the unique endpoint . Three main comparisons were planned : RFA versus PEI , surgical resection versus RFA/PEI ( combined ) , TACE/TAE versus RFA/PEI ( combined ) . Propensity score method was used to minimize bias related to non r and om treatment assignment . Overall 425 subjects were analyzed , with 385 ( 91 % ) deaths after a median followup of 7.7 years . OS did not significantly differ between RFA and PEI ( HR 1.11 , 95 % CI 0.79 - 1.57 ) , between surgery and RFA/PEI ( HR 0.95 , 95 % CI 0.64 - 1.41 ) and between TACE/TAE and RFA/PEI ( HR 0.88 , 95 % CI 0.66 - 1.17 ) . 5-year OS probabilities were 0.14 for RFA , 0.18 for PEI , 0.27 for surgery , and 0.15 for TACE/TAE . No locoregional treatment for HCC was found to be more effective than the comparator . Adequately powered r and omized clinical trials are still needed to definitely assess relative effectiveness of locoregional HCC treatment BACKGROUND AND STUDY AIMS Hepatocellular carcinoma ( HCC ) is a major burden on health-care systems worldwide . Although radiofrequency ablation ( RFA ) is currently considered the best technique for coagulative necrosis , the superiority of concomitant use of RFA and percutaneous ethanol injection ( PEI ) needs to be determined . The study was design ed to compare efficacy , safety and rate of survival of patients with HCC assigned to receive combined PEI-RFA versus RFA alone and versus PEI alone . PATIENTS AND METHODS This 3-year study enrolled 90 cirrhotic patients with HCC ( Child 's class A or B , but not class C ) . They were r and omly assigned for either PEI-RFA ( group I ) , RFA alone ( group II ) or PEI alone ( group III ) . The primary end point was ablation of the tumour . The secondary end point was rate of survival and recurrence . RESULTS After the first session , complete ablation was significantly higher in the combination group ( 87.9 % ) compared with the RFA group ( 54.54 % ) . After the second session , complete ablation was achieved in 97.0 % of the combination group and in 84.8 % of the RFA group . Regarding the PEI group , 75 % had complete ablation , whereas 25 % had partial ablation after multiple sessions . The survival rate , 1.5 years later , was significantly higher in group I ( 86.7 % ) compared with group III ( 63.3 % ) . The overall incidence of serious adverse events was nil . CONCLUSION Combined treatment is superior to RFA alone and to PEI alone , in safety and efficacy in patients with HCC Purpose Although there are several prospect i ve clinical studies comparing radiofrequency ablation ( RFA ) and hepatic resection ( HR ) for the treatment of hepatocellular carcinoma , there are few trials that have been performed in strictly homogeneous patients . Methods Patients who were newly diagnosed with a solitary hepatocellular carcinoma were r and omized to the HR or RFA group . Inclusion criteria were as follows : age ≥ 20 years but ≤ 70 years , Child-Pugh class A , maximal diameter of the tumor ≥ 2 cm but ≤ 4 cm , no previous treatment history , and platelet count > 80,000/mm3 . Results Although the study was early terminated , 29 and 34 patients were enrolled in the HR and RFA groups , respectively , and prospect ively followed on an intention-to-treat basis . The 5-year overall survival rates were 83.4 % and 86.2 % in the HR and RFA groups , respectively , which were not significantly different ( P = 0.812 by log-rank , P = 0.990 by Breslow ) . The 3- and 5-year disease-free survival rates in the HR group were significantly superior to those in the RFA group ( 66.7 % , 44.4 % vs. 44.1 % , 31.2 % , P = 0.071 by log-rank , P = 0.023 by Breslow ) . Intrahepatic local recurrence tended to develop more frequently in the RFA group ( P = 0.042 ) , while the frequency of intrahepatic distant and extrahepatic recurrence was similar bet ween the 2 groups . There were no significant differences in the frequency and severity of complications between the 2 groups . Conclusion HR was significantly superior to RFA in terms of disease-free survival ; however , the overall survival was excellent in both groups Objective : To compare the results of percutaneous local ablative therapy ( PLAT ) with surgical resection in the treatment of solitary and small hepatocellular carcinoma ( HCC ) . Summary Background Data : PLAT is effective in small HCC . Whether it is as effective as surgical resection in the long-term survivals remains unknown . Methods : We conducted a prospect i ve r and omized trial on 180 patients with a solitary HCC ≦5 cm to receive either PLAT or surgical resection . The patients were regularly followed up after treatment with physical examination , blood , and radiologic tests . Results : Of the 90 patients who were r and omized to PLAT , only 71 received PLAT because 19 withdrew their consent . Of the 90 patients who were r and omized to surgical resection , a single Couinaud liver segment resection was carried out in 69 patients , 2 segments in 16 patients , and 3 or more segments in 3 patients . Ethanol injection was given during open surgery in 2 patients . Only 1 patient died after surgical resection within the same hospital admission . Posttreatment complications were more often and severe after surgery than PLAT . The 1- , 2- , 3- , and 4-year overall survival rates after PLAT and surgery were 95.8 % , 82.1 % , 71.4 % , 67.9 % and 93.3 % , 82.3 % , 73.4 % , 64.0 % , respectively . The corresponding disease-free survival rates were 85.9 % , 69.3 % , 64.1 % , 46.4 % and 86.6 % , 76.8 % , 69 % , 51.6 % , respectively . Statistically , there was no difference between these 2 treatments . Conclusion : PLAT was as effective as surgical resection in the treatment of solitary and small HCC . PLAT had the advantage over surgical resection in being less invasive The effect of percutaneous microwave ablation and laparoscopic resection on the prognosis of liver cancer was investigated . Ninety patients with liver cancer treated at our hospital from March 2010 to March 2012 were divided into group A and group B ( n=45 ) by using a r and om number table , and the surgical conditions and the prognosis were compared . The surgical conditions of patients in group A were significantly better than those in group B ( P<0.05 ) . The incidence of complications in group A was 6.67 % , which was obviously lower than that of group B ( P<0.05 ) . The local recurrence rate of group A was 20.00 % , and that of group B was 8.89 % , which showed a significant difference ( P<0.05 ) . The two groups did not differ significantly in terms of either total recurrence rate ( P>0.05 ) or 1-year , 2-year and 3-year survival ( P>0.05 ) . Both Output:	There was little evidence of inconsistency between direct and indirect evidence . Conclusion The comparison of different treatment strategies for HCC indicated that RES is associated with longer survival .
MS2814	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Split- thickness skin graft is one of the most common operations in plastic surgery . It is always painful and patient discomfort from donor site often is more significant than recipient site . There is not still a st and ard method for treatment of the donor site . The purpose of this study was to determine the best method of dressing the donor site among three different methods with respect to the rate of healing , pain , secretion , infection and cost . METHODS The study includes 60 patients that were r and omly divided into three groups . Donor site and thickness of the graft was the same and were dressed with one of the methods including Method A : Paraffin fine mesh gauze , Method B : Nitrofurazone soaked fine mesh gauze and Method C : Dry fine mesh gauze . Each method included an intermediate layer of sterile plastic sheet witch was covered with 10 layers of dry gauze . Comparison with respect to the rate of healing , pain , secretion , infection and cost was done . RESULTS Thirty seven patients were men and 23 were women . The mean age of the patients was 27.2 years . There was a significant difference between three methods in average time of repair and superiority of dressing with Method B was noted . Pain severity was the least in Method B and difference between the methods was significant . Dressing with Method B had the least secretion and there was a statistically significant difference between three methods . There was no statistically significant difference in cost of the management . CONCLUSION This study showed that dressing the donor site with nitrofurazone ointment soaked gauze used as the first layer of dressing and intermediate layer of sterile plastic sheet which was covered with 10 layers of dry gauze was the best method of dressing and had the least complications Accelerating the healing process and reducing pain during healing are beneficial for the following reasons : faster return to work , lower risk of wound infection , improved quality of life , and possibly reduced need for analgesia . This clinical study assessed the effectiveness of a new oxygen-diffusion dressing ( OxyB and ; Oxyb and Technologies , St. Louis , MO ) compared with st and ard Xeroform gauze dressings ( Convidien , Mansfield , MA ) , in the care of skin-graft donor sites in burn patients . Time to healing was the primary endpoint , and pain scores and cosmetic outcome were also assessed . This was a prospect i ve , r and omized , controlled study of burn patients undergoing harvesting of two donor sites . Patients were followed at predetermined time points for 30 to 45 days to determine the time to reepithelialization , cosmetic appearance , and pain . Subjects were adult burn patients with less than 30 % TBSA burns admitted to the burn center , who required excision and grafting . Twenty patients were enrolled , of whom 17 completed the study . Average age was 35 years . Average burn size was 9.2 % TBSA . Patients underwent harvesting of split-thickness skin grafts with one donor wound dressed with OxyB and and the other dressed in Xeroform gauze . Wounds were inspected and photographed on postoperative days 4 and 8 , and then every 2 days until the donor wounds were healed . Pain scores at each site were also collected at these visits ( rated by patients on a scale from 0 to 10 ) . Mean time to wound healing for OxyB and was 9.3 ± 1.7 days ; for Xeroform , 12.4 ± 2.7 days ( P < .001 ) . Pain scores were lower ( P < .01 ) at the OxyB and site compared with the Xeroform site at all time points during postoperative days 4 to 12 . There was no difference in the cosmetic outcome of the wounds at 30 to 45 days postoperatively . This study revealed a decrease in the time to healing and in pain at donor sites dressed with an oxygen-diffusion dressing An ongoing objective of burn research is to evaluate wound dressings and develop new treatments to expedite wound healing . This was a single-center , prospect i ve , r and omized , controlled study to evaluate the effectiveness of Aquacel Ag as a dressing for autogenous skin donor sites compared with Xeroform . We hypothesized that donor sites treated with Aquacel Ag would heal faster . Patients were considered for enrollment if they required skin grafting with two donor sites > 100 cm2 at least 2 inches apart . Dressings were observed daily starting on post-op day # 2 until discharge and then weekly in the outpatient burn clinic . Assessment s evaluated pain , infection , and reapplication . Photographs were taken on post-op day # 2 , upon “ 90 % re-epithelialization , ” and at post-op day # 30–45 . Scar assessment s and blinded photographic review s were completed to assess cosmetic healing . Twenty-nine patients completed the study . Re-epithelialization occurred faster with Xeroform ( 15.2 days vs 17.6 days ) . Daily pain scores were higher with Xeroform ( 6.72 vs 5.68 ) and Aquacel Ag needed to be replaced more often ( 1.72 times vs 0.10 times ) . Three patients developed donor site infections with Aquacel Ag . Scar scores between the donor sites were not statistically significant . The blinded photo review concluded that Xeroform had a better cosmetic outcome ( 24 vs 10 % ) . Although patients complained of more pain with Xeroform , it demonstrated shorter healing times and better cosmetic outcomes . Aquacel Ag needed to be replaced more often and represented the only three donor site infections The present study was performed in China to compare the efficacy and safety of an advanced wound dressing made of crystalline cellulose ( Veloderm ® ) to a conventional treatment of three Vaseline gauzes in the management of skin donor sites of burns or reconstructive plastic surgery . In this prospect i ve , multicenter , open-labeled , r and omized clinical trial performed in three Chinese burn centers in China , 96 patients who required autologous split skin graft were r and omized into either the test ( Veloderm ® ) group or the control ( Vaseline gauze ) group . Average healing times in the test group and in the control group were 8.40±2.90 and 8.92±2.58 days , respectively , with median values of 7.00 and 8.00 days , respectively : the difference between two groups was statistically significant ( P=.045 ) . Scores for exu date s , pain intensity , and peripheral erythema showed no difference between the groups ; however , composite scores of three variables on day 10 postoperatively was significantly lower in the test group ( 0.00±0.00 vs 0.13±0.49 ; P = .043 ) . The need for a dressing change was also significantly lower in the test group ( 12.5 vs 31.25 % ; P = .036 ) . Veloderm ® is a safe and effective dressing that may offer some advantages over the traditional application of Vaseline gauze in the management of donor sites in burn or reconstructive plastic surgery patients Skin graft is a st and ard therapeutic technique in patients with deep ulcers , but managing donor site after grafting is very important . Although several modern dressings are available to enhance the comfort of donor site , using techniques that accelerate wound healing may enhance patient satisfaction . Low-level laser therapy ( LLLT ) has been used in several medical fields , including healing of diabetic , surgical , and pressure ulcers , but there is not any report of using this method for healing of donor site in burn patients . The protocol s and informed consent were review ed according to Medical Ethics Board of Shahid Beheshti University of Medical Sciences ( IR.SBMU.REC.1394.363 ) and Iranian Registry of Clinical Trials ( I RCT 2016020226069N2 ) . Eighteen donor sites in 11 patients with grade 3 burn ulcer were selected . Donor areas were divided into 2 parts , for laser irradiation and control r and omly . Laser area was irradiated by a red , 655-nm laser light , 150 mW , 2 J/cm2 , on days 0 ( immediately after surgery ) , 3 , 5 , and 7 . Dressing and other therapeutic care for both sites were the same . The patients and the person who analyzed the results were blinded . The size of donor site reduced in both groups during the 7-day study period ( P < 0.01 ) and this reduction was significantly greater in the laser group ( P = 0.01 ) . In the present study , for the first time , we evaluate the effects of LLLT on the healing process of donor site in burn patients . The results showed that local irradiation of red laser accelerates wound healing process significantly This study aim ed to investigate whether previous findings from a small retrospective study could be replicated prospect ively . The previous study showed that patients with an existing diagnosis of psychosis or depression , admitted to a burns service , had longer hospital stays and longer wound healing times when compared with controls matched for burn injury but without a pre-existing psychiatric condition [ 1 ] . In this study it was hypothesised that those patients without pre-existing psychiatric diagnosis , but with high levels of psychological distress after burn would also show a similar pattern of delayed recovery to those with a pre-existing psychiatric illness . In addition , we examined potential mechanisms for slowed recovery , including ; adherence with treatment ; delayed discharge on social grounds and psychological distress . It was hypothesised that patients with pre-existing psychiatric diagnosis would exhibit poorer adherence and delayed placement due to social reasons , compared to patients without pre-existing psychiatric diagnoses . 107 consecutive admissions to a burns service over a seven-month period were included in the study . Psychiatric history and level of psychological distress post-burn were collected for all patients as part of routine psychological screening . Patients were compared on the following outcome variables : number of days spent in hospital and number of procedures required . 24 % ( n=27 ) were found to have a pre-existing psychiatric diagnosis . This group were also found to have significantly longer hospital stays ( Mann-Whitney U=585.50 , p<0.01 ) and required more surgical procedures than the group without a psychiatric history ( Mann-Whitney U=569.00 , p=<0.001 ) . The pattern of results for the group with high psychological distress but without pre-existing psychiatric diagnoses mirrored that of the group with pre-existing psychiatric diagnoses , suggesting that heightened psychological distress alone , has a significant delaying effect upon the rate of recovery ( Kruskal-Wallis X=24.75 , p<0.01 ) . An exploratory model entering all the variables stepwise at the same stage identified poor adherence and delayed discharge issues as making significant contributions to the final model ( r=0.81 adjusted r(2)=62.9 , F ( 4 , 42)=20.48 , p<0.001 ) . In conclusion , this study supports the role of psychosocial factors , such as pre-existing psychiatric diagnosis and in hospital psychological distress , in contributing the recovery of survivors of burns . This suggests that identifying and working with these difficulties may impact not only on psychosocial , but also physical aspects of recovery OBJECTIVES : To compare postoperative healing of split-thickness skin graft ( STSG ) donor sites using traditional dressings ( paraffin gauze ) or modern wound dressings ( alginate dressing and polyurethane film ) in a r and omized controlled trial . METHOD : Thirty patients were r and omly assigned to treatment of an STSG donor site with an alginate dressing and a polyurethane film or nonadherent paraffin gauze . Outcome variables were pain ( measured with a visual analog scale ) , amount of dressing changes , healing time , cosmetic outcome , treatment costs , and overall satisfaction with the procedure . RESULTS : There was no significant difference in pain ( postoperative day 1 : 2.1 vs 1.2 , P = .26 ; postoperative days 5–7 : 1.0 vs 0.9 , P = .47 ; final removal : 1.9 vs 1.0 , P = .19 ) and time to healing ( 18.1 vs 15.4 days , P = .29 ) between alginate/polyurethane film dressing and nonadherent paraffin gauze . The semiocclusive dressings with polyurethane film required multiple dressing changes , whereas the nonadherent paraffin gauze could be left in place until complete epithelialization . Treatment costs were substantially lower for paraffin gauze . CONCLUSIONS : Semiocclusive dressings with alginate dressings and polyurethane film showed no advantages over treatment with paraffin gauze . With lower costs and better patient acceptance , paraffin gauze dressings were the preferred treatment for STSG donor sites BACKGROUND This paper presents the results of the first part of the clinical study of temporary biosynthetic dermal skin substitute based a on collagen and hyaluronic acid , named Coladerm H/HM . The aim of this study was to evaluate safety and effects of Coladerm H/HM in covering the split-thickness skin graft donor sites in humans . This membrane was applied to a part of the split-thickness skin graft donor site ; its effects and properties were compared to st and ard dressing used for covering the split-thickness skin graft donor sites at the Department of Burns and Reconstructive Surgery , University Hospital Bratislava , Slovakia , Dermazin ® ( Lek ) + Acidum Aceticum 1 % ( magistraliter ) , which were applied together to the rest of the donor site . MATERIAL AND METHODS Twenty patients were r and omly selected with the following criteria : age of 18 - 65 years , no severe accompanying diseases such as diabetes , renal failure , immune disorders , severe arteriosclerosis , severe allergic conditions . Evaluation Output:	Conclusion : The literature on STSG donor-site dressings has not yet identified an ideal dressing .
MS2815	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Blood glucose control is fundamental albeit not enough to prevent diabetic macrovascular complications . Dipeptidyl peptidase-4 ( DPP-4 ) inhibitors are effective in improving metabolic parameters in patients with type 2 diabetes mellitus ( T2DM ) but little is known about its cardiovascular effects . We compared the DPP-4 inhibitor sitagliptin with bedtime NPH insulin ( NPH ) as add-on therapy in patients with T2DM , aim ing to ascertain which drug would have additional cardioprotective effects . Methods Thirty-five T2DM patients inadequately controlled with metformin plus glyburide were r and omized to receive sitagliptin ( n = 18 ) or NPH ( n = 17 ) for 24 weeks . Fasting plasma glucose , HbA1c , lipid profile , C-reactive protein , active glucagon-like peptide ( aGLP-1 ) levels , 24-hour ambulatory blood pressure measurement and comprehensive 2-dimensional echocardiogram were determined before and after treatments . Results Both sitagliptin and NPH therapies decreased HbA1c levels after 24 weeks . Fasting plasma glucose and triglyceride levels decreased in the NPH group whereas only sitagliptin increased aGLP-1 levels . Left ventricular diastolic dysfunction ( LVDD ) was detected in 58.6 % of twenty-nine patients evaluated . Beneficial effects in LVDD were observed in 75 % and 11 % of patients treated with sitagliptin and NPH , respectively ( p = 0.015 ) . Neither therapy changed C-reactive protein or blood pressure . Conclusions Sitagliptin and bedtime NPH were similarly effective on glucose control . Improvement in LVDD in T2DM patients treated with sitagliptin was suggested , probably related to the increase of aGLP-1 levels . Therefore , DPP-4 inhibitor seems to have cardioprotective effects independent of glucose control and may have a role in the prevention of diabetic cardiomyopathy Abstract Background Diabetes is associated closely with an increased risk of cardiovascular events , including diastolic dysfunction and heart failure that leads to a shortening of life expectancy . It is therefore extremely valuable to evaluate the impact of antidiabetic agents on cardiac function . However , the influence of dipeptidyl peptidase 4 inhibitors on cardiac function is controversial and a major matter of clinical concern . We therefore evaluated the effect of sitagliptin on echocardiographic parameters of diastolic function in patients with type 2 diabetes as a sub- analysis of the PROLOGUE study . Methods Patients in the PROLOGUE study were assigned r and omly to either add-on sitagliptin treatment or conventional antidiabetic treatment . Of the 463 patients in the overall study , 115 patients ( 55 in the sitagliptin group and 60 in the conventional group ) who had complete echocardiographic data of the ratio of peak early diastolic transmitral flow velocity ( E ) to peak early diastolic mitral annular velocity ( e′ ) at baseline and after 12 and 24 months were included in this study . The primary endpoint of this post hoc sub- analysis was a comparison of the changes in the ratio of E to e′ ( E/e′ ) between the two groups from baseline to 24 months . Results The baseline-adjusted change in E/e′ during 24 months was significantly lower in the sitagliptin group than in the conventional group ( −0.18 ± 0.55 vs. 1.91 ± 0.53 , p = 0.008 ) , irrespective of a higher E/e′ value at baseline in the sitagliptin group . In analysis of covariance , sitagliptin treatment was significantly associated with change in E/e′ over 24 months ( β = −9.959 , p = 0.001 ) , independent of other clinical variables at baseline such as blood pressure , HbA1c , and medications for diabetes . Changes in other clinical variables including blood pressure and glycemic parameters , and echocardiographic parameters , such as cardiac structure and systolic function , were comparable between the two groups . There was also no significant difference in the serum levels of N-terminal-pro brain natriuretic peptide and high-sensitive C-reactive protein between the two groups during the study period . Conclusions Adding sitagliptin to conventional antidiabetic regimens in patients with T2DM for 24 months attenuated the annual exacerbation in the echocardiographic parameter of diastolic dysfunction ( E/e′ ) independent of other clinical variables such as blood pressure and glycemic control . Trial registration UMIN000004490 ( University Hospital Medical Information Network Clinical Trials ) . https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005356 ; registered November 1 , Background Glycemic variability is associated with the development of diabetic complications through the activation of oxidative stress . This study aim ed to evaluate the effects of a dipeptidyl peptidase 4 inhibitor , vildagliptin , or a thiazolidinedione , pioglitazone , on glycemic variability and oxidative stress in patients with type 2 diabetes . Methods In this open label , r and omised , active-controlled , pilot trial , individuals who were inadequately controlled with metformin monotherapy were assigned to either vildagliptin ( 50 mg twice daily , n=17 ) or pioglitazone ( 15 mg once daily , n=14 ) treatment groups for 16 weeks . Glycemic variability was assessed by calculating the mean amplitude of glycemic excursions ( MAGE ) , which was obtained from continuous glucose monitoring . Urinary 8-iso prostagl and in F2α , serum oxidised low density lipoprotein , and high-sensitivity C-reactive protein were used as markers of oxidative stress or inflammation . Results Both vildagliptin and pioglitazone significantly reduced glycated hemoglobin and mean plasma glucose levels during the 16-week treatment . Vildagliptin also significantly reduced the MAGE ( from 93.8±38.0 to 70.8±19.2 mg/dL , P=0.046 ) , and mean st and ard deviation of 24 hours glucose ( from 38±17.3 to 27.7±6.9 , P=0.026 ) ; however , pioglitazone did not , although the magnitude of decline was similar in both groups . Markers of oxidative stress or inflammation including urinary 8-iso prostagl and in F2α did not change after treatment in both groups . Conclusion In this 16-week treatment trial , vildagliptin , but not pioglitazone , reduced glycemic variability in individuals with type 2 diabetes who was inadequately controlled with metformin monotherapy , although a reduction of oxidative stress markers was not observed The aim of the study was to compare the effects of the addition of sitagliptin or metformin to pioglitazone monotherapy in poorly controlled type 2 diabetes mellitus patients on body weight , glycemic control , beta-cell function , insulin resistance , and inflammatory state parameters . One hundred fifty-one patients with uncontrolled type 2 diabetes mellitus ( glycated hemoglobin [ HbA(1c ) ] > 7.5 % ) in therapy with pioglitazone 30 mg/d were enrolled in this study . We r and omized patients to take pioglitazone 30 mg plus sitagliptin 100 mg once a day , or pioglitazone 15 mg plus metformin 850 mg twice a day . We evaluated at baseline and after 3 , 6 , 9 , and 12 months these parameters : body weight , body mass index , HbA(1c ) , fasting plasma glucose ( FPG ) , postpr and ial plasma glucose ( PPG ) , fasting plasma insulin ( FPI ) , homeostasis model assessment insulin resistance index ( HOMA-IR ) , homeostasis model assessment beta-cell function index , fasting plasma proinsulin ( Pr ) , Pr/FPI ratio , adiponectin , resistin ( R ) , tumor necrosis factor-alpha ( TNF-alpha ) , and high-sensitivity C-reactive protein . A decrease of body weight and body mass index was observed with metformin , but not with sitagliptin , at the end of the study . We observed a comparable significant decrease of HbA(1c ) , FPG , and PPG and a significant increase of homeostasis model assessment beta-cell function index compared with baseline in both groups without any significant differences between the 2 groups . Fasting plasma insulin , fasting plasma Pr , Pr/FPI ratio , and HOMA-IR values were decreased in both groups even if the values obtained with metformin were significantly lower than the values obtained with sitagliptin . There were no significant variations of ADN , R , or TNF-alpha with sitagliptin , whereas a significant increase of ADN and a significant decrease of R and TNF-alpha values were recorded with metformin . A significant decrease of high-sensitivity C-reactive protein value was obtained in both groups without any significant differences between the 2 groups . There was a significant correlation between HOMA-IR decrease and ADN increase , and between HOMA-IR decrease and R and TNF-alpha decrease in pioglitazone plus metformin group after the treatment . The addition of both sitagliptin or metformin to pioglitazone gave an improvement of HbA(1c ) , FPG , and PPG ; but metformin led also to a decrease of body weight and to a faster and better improvement of insulin resistance and inflammatory state parameters , even if sitagliptin produced a better protection of beta-cell function OBJECTIVE : To evaluate the effect of dipeptidyl-peptidase-4 ( DPP-4 ) inhibitor vildagliptin on high sensitivity C-reactive protein ( hsCRP ) and arterial stiffness ( AS ) in patients with type 2 diabetes ( T2DM ) . DESIGN : Sixty-four drug-naive diabetic patients , with inadequate glycemic control , participated in this r and omized , open-label study . Half of the patients received metformin 1700 mg/d and the other half of them received metformin 1700 mg/d plus vildagliptin 100 mg/d . AS was measured by carotid-femoral Pulse Wave Velocity ( cfPWV ) . Body weight ( BW ) , body mass index ( BMI ) , blood pressure ( BP ) , hsCRP , glycosylated hemoglobin ( HbA1c ) , fasting plasma glucose ( FPG ) , lipid profile , albumin/creatinine ratio ( ACR ) , fasting insulin , C-peptide , homeostasis model assessment of insulin resistance ( HOMA-IR ) and homeostasis model assessment of β-cell function ( HOMA-β ) were also assessed at baseline and after 6 months . RESULTS : Vildagliptin in combination with metformin had a beneficial influence on hsCRP , HbA1c , C-peptide and HOMA-β index ( p < 0.05 ) but had no effect on cfPWV , BP , BW , BMI , lipid profile , ACR and HOMA-IR compared with metformin alone ( p = NS ) . CONCLUSIONS : We have found that the addition of vildagliptin to metformin for a period of six months decreased hsCRP , improved glycemic control and β-cell function but had no effect on AS in drug-naive patients with T2DM OBJECTIVE Recent experimental studies have shown that dipeptidyl peptidase 4 ( DPP-4 ) inhibitors have antiatherosclerotic benefits in glucagon-like peptide 1–dependent and –independent manners . The current study investigated the effects of alogliptin , a DPP-4 inhibitor , on the progression of carotid atherosclerosis in patients with type 2 diabetes mellitus ( T2DM ) . RESEARCH DESIGN AND METHODS This prospect i ve , r and omized , open-label , blinded-end point , multicenter , parallel-group , comparative study included 341 patients with T2DM free of a history of apparent cardiovascular diseases recruited at 11 clinical units and r and omly allocated to treatment with alogliptin ( n = 172 ) or conventional treatment ( n = 169 ) . Primary outcomes were changes in mean common and maximum intima-media thickness ( IMT ) of the carotid artery measured by carotid arterial echography during a 24-month treatment period . RESULTS Alogliptin treatment had a more potent glucose-lowering effect than the conventional treatment ( −0.3 ± 0.7 % vs. −0.1 ± 0.8 % , P = 0.004 ) without an increase of hypoglycemia . Changes in the mean common and the right and left maximum IMT of the carotid arteries were significantly greater after alogliptin treatment than after conventional treatment ( −0.026 mm [ SE 0.009 ] vs. 0.005 mm [ SE 0.009 ] , P = 0.022 ; −0.045 mm [ SE 0.018 ] vs. 0.011 mm [ SE 0.017 ] , P = 0.025 , and −0.079 mm [ SE 0.018 ] vs. −0.015 mm [ SE 0.018 ] , P = 0.013 , respectively ) . CONCLUSIONS Alogliptin treatment attenuated the Output:	Conclusions DDP-4i effectively reduced serum CRP levels and showed no stronger effect than traditional oral antidiabetic agents .
MS2816	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Sepsis is an important cause of neonatal death and perinatal brain damage , particularly in preterm infants . While effective antibiotic treatment is essential treatment for sepsis , resistance to antibiotics is increasing . Adjuvant therapies , such as intravenous immunoglobulin , therefore offer an important additional strategy . Three Cochrane systematic review s of r and omised controlled trials in nearly 6,000 patients suggest that non-specific , polyclonal intravenous immunoglobulin is safe and reduces sepsis by about 15 % when used as prophylaxis but does not reduce mortality in this situation . When intravenous immunoglobulin is used in the acute treatment of neonatal sepsis , however , there is a suggestion that it may reduce mortality by 45 % . However , the existing trials of treatment were small and lacked long-term follow-up data . This study will assess reliably whether treatment of neonatal sepsis with intravenous immunoglobulin reduces mortality and adverse neuro-developmental outcome . Methods and design A r and omised , placebo controlled , double blind trial . Babies with suspected or proven neonatal sepsis will be r and omised to receive intravenous immunoglobulin therapy or placebo . Eligibility criteria Babies must be receiving antibiotics and have proven or suspected serious infection AND have at least one of the following : birthweight less than 1500 g OR evidence of infection in blood culture , cerebrospinal fluid or usually sterile body fluid OR be receiving respiratory support via an endotracheal tube AND there is substantial uncertainty that intravenous immunoglobulin is indicated . Exclusion criteria Babies are excluded if intravenous immunoglobulin has already been given OR intravenous immunoglobulin is thought to be needed OR contra-indicated . Trial treatment Babies will be given either 10 ml/kg of intravenous immunoglobulin or identical placebo solution over 4–6 hours , repeated 48 hours later . Primary outcome Mortality or major disability at two years , corrected for gestational age . Data collection Data will be collected at discharge from hospital and at 2 years of age ( corrected for gestation ) using a parental question naire and a health status question naire completed during a face-to-face follow-up appointment with the child 's paediatrician . Trial registration Current Controlled Trials ISCRTN94984750 In a prospect i ve double‐blind study , st and ard intravenous immunoglobulin ( IVIG ) was compared with an IgM‐enriched IVIG in the treatment of neonatal sepsis . The two treatment groups were also compared with matched controls . One hundred and thirty babies ( 65 in each group ) ranging from 0 to 24 days old , 480 to 4200 g in weight and born between 24 and 42 weeks of gestation who had , or were suspected of having , sepsis were given either st and ard IVIG or IgM‐enriched IVIG ( 250 mg/kg per day ) for 4 days in addition to supportive and antibiotic therapy . A further 65 babies who received similar supportive , antibiotic and fluids but not IVIG were used as matched controls . Mortality from infection in ‘ culture proven sepsis ’ was 3/44 ( 6·8 % ) in the IgM‐enriched IVIG group , 6/42 ( 14·2 % ) in the st and ard IVIG group , and 11/43 ( 25·5 % ) in the control group ( P = 0·017 , IgM versus control , P = 019 st and ard IVIG versus control ) . There was no statistical difference in the outcome between the two immunoglobulin therapy groups ( P = 0·25 ) . The study indicates that IVIG improves outcome in neonatal sepsis when used as an adjunct to supportive and antibiotic therapy , but larger studies are required to confirm this OBJECTIVE To evaluate the effect of pentaglobin treatment on clinical and laboratory parametres and the major morbidities in very low birthweight neonates with nosocomial sepsis before and after pentaglobin treatment . METHODS The prospect i ve interventional study was conducted from January 1 to December 31 , 2010 , at the neonatal intensive care unit ( NICU ) of the Bakirköy Dr. Sadi Konuk Training and Research Hospital , Istanbul , Turkey . Pentaglobin was initiated on the day of diagnosis of nosocomial sepsis to 13 pre-term neonates as a support therapy in addition to antibiotics ; 5 ml/kg per day of pentaglobin was infused over a 4-hour period on 3 consecutive days . Clinical and laboratory parametres and major morbidities were recorded before and after pentaglobin treatment and compared using NCSS software . RESULTS Of the total , 8 ( 66 % ) were females and 5 ( 40 % ) males . Following pentaglobin therapy , the immature-to-total neutrophil ratio and C-reactive protein levels were significantly decreased , and the capillary pH and base excess were significantly increased ( p < 0.05 ) . The axillary temperature , non-invasive blood pressure , haemoglobin , leukocyte , and thrombocyte values did not significantly differ before and after treatment ( p > 0.05 ) . Coagulase-negative staphylococci ( n = 3 ; 23 % ) , Klebsiella pneumoniae ( n = 2 ; 15.3 % ) , and Pseudomonas aeruginosa ( n = 1 ; 7.7 % ) were identified in blood cultures . The presence of intraventricular haemorrhages , necrotising enterocolitis , periventricular leukomalacia , and patent ductus arteriosus was not changed following the treatment . Adverse effects and mortality were not observed during or after the therapy . CONCLUSION Pentaglobin treatment of nosocomial sepsis could be used as an adjunct therapy without any adverse short-term reactions , even in very low birthweight pre-term infants Thirty-seven neonates with confirmed septicemia through hemoculture were studied . Of them , 18 were treated with antibiotic and the other 19 were given 500 mg/kg of intravenous immunoglobin with a pH of 4.25 ( IGIV ) . The greater part of the neonates in this study were full-term or near full-term . There were no differences in age , gestational age and weight , nor in mortality , the bacterias found and the clinical manifestations which were seen in both groups . Yet , the hospitalary stay was shorter for those in the group treated with IGIV ( 13.9 + /- 5.7 days ) than in the trial group ( 24.4 + /- 10.3 days ) ; as well as some clinical manifestations like diarrhea and splenomegalia ( P < 0.05 ) . The serum of the neonates from the IGIV group showed a greater capacity of opsonization and inhibition of bacterial growth than those in the trial group ( P < 0.001 ) , coinciding with an increase of 300 mg/dL in the serum levels of IgG of the group treated with IGIV from the 3rd day of the study and the C4 and B-Properdine factor serum levels from the 7th day of the study , while in the trial group , there were no changes in these factors ( P < 0.001 ) . Even though no differences were seen in the mortality rate due to septicemia , the results suggest a much shorter evolution of the illness in patients treated with IGIV . In addition , the serum of those patients treated with IGIV showed in in vitro studies , a better bacteriostatic activity and a better capacity to opsonize the bacterias isolated in the hemocultures . ( ABSTRACT TRUNCATED AT 250 WORDS Despite the development of newer generation of antibiotics , mortality from neonatal sepsis remains high . In a prospect i ve , r and omized study , we investigated the use of IgM-enriched immunoglobulin therapy in neonatal sepsis . Two groups of 30 infants each ( matched for gestational age , sex , weight , and other variables ) were r and omly allocated to receive either antibiotics alone ( control group ) or antibiotics plus 5 mL/kg/d for four days of IgM-enriched immunoglobulin intravenously ( immunotherapy group ) . Mortality from sepsis in the control group was 20 % ( 6/30 ) , while in the immunotherapy group it was 3.3 % ( 1/30 ) . We conclude that IgM-enriched immunoglobulin therapy in conjunction with antibiotic therapy significantly reduces mortality from neonatal sepsis OBJECTIVE Early-onset sepsis ( occurring within 72 hours of birth ) is included in the differential diagnosis of most very low birth weight ( VLBW ) neonates . To determine the current incidence of early-onset sepsis , risk factors for disease , and the impact of early-onset sepsis on subsequent hospital course , we studied a cohort of 7861 VLBW neonates ( 401 to 1500 gm ) admitted to the 12 National Institute of Child Health and Human Development ( NICHD ) Neonatal Research Network centers during a 32-month period ( 1991 - 1993 ) . METHODS The NICHD Neonatal Research Network maintains a prospect ively collected registry on all VLBW neonates born or cared for at participating centers . Data from this registry were analyzed retrospectively . RESULTS Blood culture-proven early-onset sepsis was uncommon , occurring in only 1.9 % of VLBW neonates . Group B streptococcus was the most frequent pathogen associated with early-onset sepsis ( 31 % ) , followed by Escherichia coli ( 16 % ) and Haemophilus influenzae ( 12 % ) . Decreasing gestational age was associated with increased rates of infection . Antibiotic therapy for suspected sepsis is frequently initiated at birth in VLBW neonates . Almost half of the infants in this cohort were considered to have clinical sepsis and continued to receive antibiotics for 5 or more days , despite a negative blood culture result in 98 % of cases . These findings underscore the difficulty of ruling out sepsis in the symptomatic immature neonate and the special concern for culture-negative clinical sepsis in the face of maternal antibiotic use . Neonates with early-onset sepsis were significantly more likely to have subsequent comorbidities , including severe intraventricular hemorrhage , patent ductus arteriosus , and prolonged assisted ventilation . Although 26 % of VLBW neonates with early-onset sepsis died , only 4 % of the 950 deaths that occurred in the first 72 hours of life were attributed to infection . For those infants discharged alive , early-onset sepsis was associated with a significantly prolonged hospital stay ( 86 vs 69 days ; p < 0.02 ) . CONCLUSIONS Early-onset sepsis remains an important but uncommon problem among VLBW preterm infants . Improved diagnostic strategies are needed to enable the clinician to distinguish between the infected and the uninfected VLBW neonate with symptoms and to target continued antibiotic therapy to those who are truly infected Newborn infants may have IgG deficiencies that increase their susceptibility to bacterial infection . To determine whether intravenous immune globulin ( IVIG ) therapy improves survival rates in early-onset sepsis , we prospect ively entered 753 neonates ( birth weight 500 to 2000 gm , gestation less than or equal to 34 weeks , age less than or equal to 12 hours ) into a multicenter , double-blind , controlled trial . Blood culture specimens were obtained and infants r and omly assigned to receive 10 ml ( per kilogram ) intravenously of a selected IVIG ( 500 mg/kg ) or albumin ( 5 mg/kg ) preparation . Maternal and neonatal risk factors were not different between groups . Thirty-one babies ( 4.2 % ) had early-onset sepsis ; the causative organisms were group B streptococcus ( 12 babies ) , Escherichia coli ( 6 ) , and others ( 13 ) . Of these 31 neonates , 7 ( 23 % ) died . Total serum IgG was higher for 7 days after IVIG therapy than after albumin treatment ( p less than 0.05 ) . During these 7 days , 5 ( 30 % ) of 17 albumin-treated and none of 14 IVIG-treated patients died ( p less than 0.05 ) . The survival rate at 56 days of age , however , was not significantly improved . Group B streptococcus type-specific IgG antibody was significantly increased after IVIG treatment and appeared to be related to the amount of IVIG specific antibody . Infusion-related adverse reactions were less frequent in patients receiving IVIG therapy ( 0.5 % ) than in those receiving albumin . The IVIG therapy in neonates with early-onset sepsis , while reducing the early mortality rate , did not significantly affect the overall survival rate . Further studies are necessary to confirm these findings and to determine more effective therapeutic regimens The therapeutic effect of a polyvalent immunoglobulin preparation for intravenous use was tested in 82 newborns with bacterial infections . 35 of the children had neonatal sepsis , whereas in the other 47 bacteremia was not detectable . Treatment consisted either of antibiotics only or of antibiotics combined w Output:	The undisputable results of the INIS trial , which enrolled 3493 infants , and our meta-analyses ( n = 3973 ) showed no reduction in mortality during hospital stay , or death or major disability at two years of age in infants with suspected or proven infection . Although based on a small sample size ( n = 266 ) , this up date provides additional evidence that IgM-enriched IVIG does not significantly reduce mortality during hospital stay in infants with suspected infection .
MS2817	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Traumatic stress due to conflict and war causes major mental health problems in many re source -poor countries . The objective of this study was to examine whether trained lay counselors can carry out effective treatment of posttraumatic stress disorder ( PTSD ) in a refugee settlement . In a r and omized controlled dissemination trial in Ug and a with 277 Rw and an and Somalian refugees who were diagnosed with PTSD the authors investigated the effectiveness of psychotherapy administered by lay counselors . Strictly manualized narrative exposure therapy ( NET ) was compared with more flexible trauma counseling ( TC ) and a no-treatment monitoring group ( MG ) . Fewer participants ( 4 % ) dropped out of NET treatment than TC ( 21 % ) . Both active treatment groups were statistically and clinical ly superior to MG on PTSD symptoms and physical health but did not differ from each other . At follow-up , a PTSD diagnosis could not be established anymore in 70 % of NET and 65 % TC participants , whereas only 37 % in MG did not meet PTSD criteria anymore . Short-term psychotherapy carried out by lay counselors with limited training can be effective to treat war-related PTSD in a refugee settlement OBJECTIVE Becoming a refugee is a potent risk factor for indicators of psychological distress such as depression , generalized stress , and posttraumatic stress disorder ( PTSD ) , though research into this vulnerable population has been scant , with even less work focusing on interventions . The current study applied principles from self-determination theory ( SDT ; Ryan & Deci , 2000 ) to develop and test an intervention aim ed at increasing need-satisfying experiences in refugees of Syrian civil unrest . METHOD Forty-one refugees who fled Syria during the past 24 months and resettled in Jordan participated in the study and were r and omly assigned to receive the intervention or a neutral comparison . RESULTS The 1-week-long intervention alleviated some of the need frustration likely associated with refugee status , a major aim of the intervention , and also lowered refugees ' self-reported symptoms of depression and generalized stress as compared to the comparison condition , though it did not reduce symptoms of PTSD . CONCLUSIONS Discussion focuses on how these findings speak to the universal importance of need satisfaction for mental health , and how need-satisfying experiences can help buffer against the profound stress of being a refugee . Avenues for longer-term or more intensive interventions that may target more severe outcomes of refugee experiences , such as PTSD symptoms , are also discussed . ( PsycINFO Data base OBJECTIVE There has been uncertainty about whether refugees and asylum seekers with PTSD can be treated effectively in st and ard psychiatric setting s in industrialized countries . In this study , Narrative Exposure Therapy ( NET ) was compared to Treatment As Usual ( TAU ) in 11 general psychiatric health care units in Norway . The focus was on changes in symptom severity and in the diagnostic status for PTSD and depression . METHOD Refugees and asylum seekers fulfilling the DSM-IV criteria for PTSD ( N = 81 ) were r and omized with an a-priori probability of 2:1 to either NET ( N = 51 ) or TAU ( N = 30 ) . The patients were assessed with Clinician Administered PTSD Scale , Hamilton rating scale for depression and the MINI Neuropsychiatric Interview before treatment , and again at one and six months after the completion . RESULTS Both NET and TAU gave clinical ly relevant symptom reduction both in PTSD and in depression . NET gave significantly more symptom reduction compared to TAU as well as significantly more reduction in participants with PTSD diagnoses . No difference in treatment efficacy was found between refugees and asylum seekers . CONCLUSIONS The study indicated that refugees and asylum seekers can be treated successfully for PTSD and depression in the general psychiatric health care system ; NET appeared to be a promising treatment for both groups We examined the feasibility , acceptability , and therapeutic efficacy of a culturally adapted cognitive – behavior therapy ( CBT ) for twelve Vietnamese refugees with treatment-resistant posttraumatic stress disorder ( PTSD ) and panic attacks . These patients were treated in two separate cohorts of six with staggered onset of treatment . Repeated measures Group × Time ANOVAs and between-group comparisons indicated significant improvements , with large effect sizes ( Cohen 's d ) for all outcome measures : Harvard Trauma Question naire ( HTQ ; d=2.5 ) ; Anxiety Sensitivity Index ( ASI ; d=4.3 ) ; Hopkins Symptom Checklist-25 ( HSCL-25 ) , anxiety subscale ( d=2.2 ) ; and Hopkins Symptom Checklist-25 , depression subscale ( d=2.0 ) scores . Likewise , the severity of ( culturally related ) headache- and orthostasis-cued panic attacks improved significantly across Little is known about the usefulness of psychotherapeutic approaches for traumatized refugees who continue to live in dangerous conditions . Narrative exposure therapy ( NET ) is a short-term approach based on cognitive-behavioral therapy and testimony therapy . The efficacy of narrative exposure therapy was evaluated in a r and omized controlled trial . Sudanese refugees living in a Ug and an refugee settlement ( N = 43 ) who were diagnosed as suffering from posttraumatic stress disorder ( PTSD ) either received 4 sessions of NET , 4 sessions of supportive counseling ( SC ) , or psychoeducation ( PE ) completed in 1 session . One year after treatment , only 29 % of the NET participants but 79 % of the SC group and 80 % of the PE group still fulfilled PTSD criteria . These results indicate that NET is a promising approach for the treatment of PTSD for refugees living in unsafe conditions BACKGROUND Previous research indicates a high prevalence of post-traumatic stress disorder ( PTSD ) and depression among refugees . Eye movement desensitization and reprocessing ( EMDR ) is an effective treatment for PTSD for victims of natural disasters , car accidents or other traumatic events . The current study examined the effect of EMDR on symptoms of PTSD and depression by comparing the treatment with a wait-list control condition in Syrian refugees . METHOD Adult refugees located in Kilis Refugee Camp at the Turkish-Syrian border with a PTSD diagnosis were r and omly allocated to either EMDR ( n = 37 ) or wait-list control ( n = 33 ) conditions . All participants were assessed with the Mini-International Neuropsychiatric Interview Plus at pre-intervention , at 1 week after finishing the intervention and at 5 weeks after finishing the intervention . The main outcome measures were the Harvard Trauma Question naire ( HTQ ) and the Impact of Event Scale-Revised . The Beck Depression Inventory and the Hopkins Symptoms Checklist-25 were included as secondary outcome measures . The Trial Registration no. is NCT01847742 . RESULTS Mixed-model analyses adjusted for the baseline scores indicated a significant effect of group at post-treatment indicating that the EMDR therapy group showed a significantly larger reduction of PTSD symptoms as assessed with the HTQ . Similar findings were found on the other outcome measures . There was no effect of time or group × time interaction on any measure , showing that the difference between the groups at the post-treatment was maintained to the 5-week follow-up . CONCLUSIONS EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees with PTSD located in a refugee camp Background Traumatised asylum seekers and refugees are clinical ly considered a complex population . Discussion exists on whether with this population treatment guidelines for post-traumatic stress disorder ( PTSD ) should be followed and Trauma-Focused Cognitive-Behavioural Therapy ( TF-CBT ) or Eye Movement Desensitisation and Reprocessing ( EMDR ) should be applied , or whether a phased model starting with stabilisation is preferable . Some clinicians fear that trauma-focused interventions may lead to unmanageable distress or may be ineffective . While cognitive-behavioural interventions have been found to be effective with traumatised refugees , no studies concerning the efficacy of EMDR with this population have been conducted as yet . Objective In preparation for a r and omised trial comparing EMDR and stabilisation with traumatised refugees , a pilot study with 20 participants was conducted . The objective was to examine feasibility of participation in a r and omised trial for this complex population and to examine acceptability and preliminary efficacy of EMDR . Design Participants were r and omly allocated to 11 sessions of either EMDR or stabilisation . Symptoms of PTSD ( SCID-I , HTQ ) , depression and anxiety ( HSCL-25 ) , and quality of life ( WHOQOL-BREF ) were assessed at pre- and post-treatment and 3-month follow-up . Results Participation of traumatised refugees in the study was found feasible , although issues associated with complex traumatisation led to a high pre-treatment attrition and challenges in assessment s. Acceptability of EMDR was found equal to that of stabilisation with a high drop-out for both conditions . No participants dropped out of the EMDR condition because of unmanageable distress . While improvement for EMDR participants was small , EMDR was found to be no less efficacious than stabilisation . Different symptom courses between the two conditions , with EMDR showing some improvement and stabilisation showing some deterioration between pre-treatment and post-treatment , justify the conduct of a full trial . Conclusion With some adaptations in study design , inclusion of a greater sample is justifiable to determine which treatment is more suitable for this complex population . For the abstract or full text in other language s , please see Supplementary files under Reading Tools BACKGROUND Little evidence exists on the treatment of traumatised refugees . AIMS To estimate treatment effects of flexible cognitive-behavioural therapy ( CBT ) and antidepressants ( sertraline and mianserin ) in traumatised refugees . METHOD R and omised controlled clinical trial with 2 × 2 factorial design ( registered with Clinical trials.gov , NCT00917397 , EUDRACT no. 2008 - 006714 - 15 ) . Participants were refugees with war-related traumatic experiences , post-traumatic stress disorder ( PTSD ) and without psychotic disorder . Treatment was weekly sessions with a physician and /or psychologist over 6 months . RESULTS A total of 217 of 280 patients completed treatment ( 78 % ) . There was no effect on PTSD symptoms , no effect of psychotherapy and no interaction between psychotherapy and medicine . A small but significant effect of treatment with antidepressants was found on depression . CONCLUSIONS In a pragmatic clinical setting , there was no effect of flexible CBT and antidepressants on PTSD , and there was a small-to-moderate effect of antidepressants and psychoeducation on depression in traumatised refugees Background The most common mental health problems among refugees are depression and posttraumatic stress disorder ( PTSD ) . Eye movement desensitization and reprocessing ( EMDR ) is an effective treatment for PTSD . However , no previous r and omized controlled trial ( RCT ) has been published on treating PTSD symptoms in a refugee camp population . Objective Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees . Method Twenty-nine adult participants with PTSD symptoms were r and omly allocated to either EMDR sessions ( n=15 ) or wait-list control ( n=14 ) . The main outcome measures were Impact of Event Scale-Revised ( IES-R ) and Beck Depression Inventory ( BDI-II ) at posttreatment and 4-week follow-up . Results Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group ( d=1.78 , 95 % CI : 0.92–2.64 ) . The EMDR group also had a lower depression score after treatment as compared with the wait-list group ( d=1.14 , 95 % CI : 0.35–1.92 ) . Conclusion The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp . Larger RCTs to verify the ( cost- ) effectiveness of EMDR in similar population s are needed Background Little is known about the neurobiological foundations of psychotherapy for Posttraumatic Stress Disorder ( PTSD ) . Prior studies have shown that PTSD is associated with altered processing of threatening and aversive stimuli . It remains unclear whether this functional abnormality can be changed by psychotherapy . This is the first r and omized controlled treatment trial that examines whether narrative exposure therapy ( NET ) causes changes in affective stimulus processing in patients with chronic PTSD . Methods 34 refugees with PTSD were r and omly assigned to a NET group or to a waitlist control ( WLC ) group . At pre-test and at four-months follow-up , the diagnostics included the assessment of clinical variables and measurements of neuromagnetic oscillatory brain activity ( steady-state visual evoked fields , ssVEF ) result ing from exposure to aversive pictures compared to neutral pictures . Results PTSD as well as depressive symptom severity scores declined in the NET group , whereas symptoms persisted in the WLC group . Only in the NET group , parietal and occipital activity towards threatening pictures increased significantly after therapy . Conclusions Our results indicate that NET causes an increase of activity associated with cortical top-down regulation of attention towards aversive pictures . The increase of attention allocation to potential threat cues might allow treated patients to re-appraise the actual danger Output:	RESULTS This review found medium to high quality evidence supporting the use of narrative exposure therapy ( NET ) . A lack of culturally adapted treatments was apparent and there was less evidence to support st and ard cognitive behavioural therapy ( CBT ) , Eye Movement Desensitisation and Reprocessing ( EMDR ) and multidisciplinary treatments . CONCLUSION NET produced positive outcomes in refugees from a diverse range of background s and trauma types .
MS2818	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To compare antimüllerian hormone ( AMH ) and antral follicle count ( AFC ) as predictors of ovarian response to controlled ovarian stimulation at individual fertility clinics . DESIGN Retrospective analysis of individual study center data in two multicenter trials . Centers that provided > 10 patients were included in the analysis . SETTING A total of 19 ( n = 519 patients ) and 18 study centers ( n = 686 patients ) participating in a long GnRH agonist trial ( MERIT ) and a GnRH antagonist trial ( MEGASET ) , respectively . PATIENT(S ) Infertile women of good prognosis . INTERVENTION(S ) Long GnRH agonist or GnRH antagonist cycles . MAIN OUTCOME MEASURE(S ) Correlation between AMH and AFC , and oocyte yield by each study center for each trial . RESULTS ( S ) Antimüllerian hormone was more strongly correlated with oocyte yield than AFC : r = 0.56 vs. r = 0.28 in the GnRH agonist cohort , and r = 0.55 vs. r = 0.33 in the GnRH antagonist cohort . The correlation was numerically higher for AMH than for AFC at a significantly higher proportion of study centers : 17 ( 89 % ) and 15 ( 83 % ) centers in the long GnRH agonist and GnRH antagonist trial , respectively . Assessment of the relative capacity of AMH and AFC for predicting oocyte yield demonstrated that AMH dominated the model : AMH , R(2 ) = 0.29 and 0.23 ; AFC : R(2 ) = 0.07 and 0.07 ; AMH + AFC : R(2 ) = 0.30 and 0.23 for long GnRH agonist and GnRH antagonist trials , respectively . CONCLUSIONS ( S ) Antimüllerian hormone was a stronger predictor of ovarian response to gonadotropin therapy than AFC at the study center level in both r and omized trials utilizing GnRH agonist and GnRH antagonist protocol s. Antral follicle count provided no added predictive value beyond AMH Background : Assessment of ovarian reserve before an in vitro fertilization cycle ( IVF ) is one among the many factors that predicts a successful cycle . Individualized protocol based on ovarian reserve is design ed to optimize the pregnancy outcome without compromising the patient safety . Although authors have shown that anti-Mullerian hormone-tailored ( AMH ) protocol s have reduced the treatment burden and improved pregnancy rates , a few others have question ed its efficacy . Aims : The aim of this study was to decide whether the AMH-tailored protocol or the conventional protocol better decides IVF outcomes . Setting and Design : Prospect i ve r and omized controlled trial conducted at a tertiary level university hospital . Material s and Methods : Patients undergoing their first IVF cycle who fulfilled the inclusion criteria were recruited and r and omized to each group . Serum follicle-stimulating hormone was done for the patients on day 2 or 3 of a prior menstrual cycle , and serum AMH was done in the preceding cycle . Statistical Analysis : Analysis was performed using SPSS software version 16 . Results and Conclusion : There were 100 patients in each group . A total of 83 patients underwent embryo transfer in the conventional group and 78 patients in the AMH group . The clinical pregnancy rates per initiated cycle ( 36.4 % vs. 33.3 % ) and per embryo transfer ( 45.1 % vs. 41.3 % ) were similar in both the groups . There was no statistical difference in the number of cycles cancelled due to poor response or the risk of ovarian hyperstimulation syndrome in both the groups . Hence , this study showed the similar effectiveness of AMH-tailored protocol and conventional protocol in women undergoing IVF Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background The initial dose of recombinant Follicle Stimulating Hormone [ rFSH ] to be used in assisted reproduction treatment depends on several factors , mainly the cause of the infertility and the patient ’s age . For young patients [ ≤35 years ] usually an initial dose of around 150 IU of rFSH is recommended , but there are no studies proving that this should actually be the st and ard initial dose . We aim ed to report the experience of a low-cost Human Reproduction Center where a dose of 100 IU of rFSH was used for controlled ovarian hyperstimulation [ COH ] . Findings An observational prospect i ve study was performed on 212 women aged ≤38 years old that underwent high-complexity assisted reproduction treatments . The patients ’ infertility was mainly caused by tuboperitoneal , idiopathic or male factors . Controlled ovarian stimulation was performed using 100 IU of rFSH . Regarding the COH , 53.8 % of the patients presented a satisfactory response , 25.9 % low response , 14.2 % hyper-response , and 6.1 % developed ovarian hyperstimulation syndrome . Of the 55 patients with poor response , 20 started a new cycle with an initial dose of 200 IU of rFSH ; 65 % showed a satisfactory response , 10 % a poor response , 20 % a hyper-response , and 5 % developed OHSS . Conclusion The initial dose of 100 IU of rFSH was considered adequate for controlled ovarian hyperstimulation , meeting the aim to reduce the costs of the assisted reproduction treatment OBJECTIVE To compare the efficacy and safety of follitropin delta , a new human recombinant FSH with individualized dosing based on serum antimüllerian hormone ( AMH ) and body weight , with conventional follitropin alfa dosing for ovarian stimulation in women undergoing IVF . DESIGN R and omized , multicenter , assessor-blinded , noninferiority trial ( ESTHER-1 ) . SETTING Reproductive medicine clinics . PATIENT(S ) A total of 1,329 women ( aged 18 - 40 years ) . INTERVENTION(S ) Follitropin delta ( AMH < 15 pmol/L : 12 μg/d ; AMH ≥15 pmol/L : 0.10 - 0.19 μg/kg/d ; maximum 12 μg/d ) , or follitropin alfa ( 150 IU/d for 5 days , potential subsequent dose adjustments ; maximum 450 IU/d ) . MAIN OUTCOMES MEASURE(S ) Ongoing pregnancy and ongoing implantation rates ; noninferiority margins -8.0 % . RESULT ( S ) Ongoing pregnancy ( 30.7 % vs. 31.6 % ; difference -0.9 % [ 95 % confidence interval ( CI ) -5.9 % to 4.1 % ] ) , ongoing implantation ( 35.2 % vs. 35.8 % ; -0.6 % [ 95 % CI -6.1 % to 4.8 % ] ) , and live birth ( 29.8 % vs. 30.7 % ; -0.9 % [ 95 % CI -5.8 % to 4.0 % ] ) rates were similar for individualized follitropin delta and conventional follitropin alfa . Individualized follitropin delta result ed in more women with target response ( 8 - 14 oocytes ) ( 43.3 % vs. 38.4 % ) , fewer poor responses ( fewer than four oocytes in patients with AMH < 15 pmol/L ) ( 11.8 % vs. 17.9 % ) , fewer excessive responses ( ≥15 or ≥20 oocytes in patients with AMH ≥15 pmol/L ) ( 27.9 % vs. 35.1 % and 10.1 % vs. 15.6 % , respectively ) , and fewer measures taken to prevent ovarian hyperstimulation syndrome ( 2.3 % vs. 4.5 % ) , despite similar oocyte yield ( 10.0 ± 5.6 vs. 10.4 ± 6.5 ) and similar blastocyst numbers ( 3.3 ± 2.8 vs. 3.5 ± 3.2 ) , and less gonadotropin use ( 90.0 ± 25.3 vs. 103.7 ± 33.6 μg ) . CONCLUSION ( S ) Optimizing ovarian response in IVF by individualized dosing according to pretreatment patient characteristics results in similar efficacy and improved safety compared with conventional ovarian stimulation . CLINICAL TRIAL REGISTRATION NUMBER NCT01956110 BACKGROUND Anti-Müllerian hormone ( AMH ) , secreted by the granulosa cells of preantral and small antral follicles , has been described as a potential marker of the ovarian reserve . The aim of this prospect i ve study is to investigate the variations of AMH during the menstrual cycle in a young selected population of normo-ovulatory women and to analyse the correlation with other cyclic hormones . METHODS Twenty healthy volunteers from 19 to 35 years old , with regular menstrual cycles ( 26 - 31 days ) , normal ovulation ( day 10 - 16 ) , normal hormonal profile and normal body mass index ( 18 - 26 kg/m2 ) were recruited . AMH , inhibin B , LH , FSH , estradiol and progesterone were measured on days 3 , 7 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 18 , 21 and 25 of a spontaneous cycle . RESULTS AMH serum levels , either expressed by cycle day or aligned according to the ovulation day , did not show any significant variations during the menstrual cycle . CONCLUSIONS No significant fluctuation of the AMH level during the menstrual cycle was observed . Therefore , this hormone is particularly interesting for clinical evaluation of the ovarian reserve as it may be used at any time during the cycle This pilot study compared the efficacy and safety of two simple dosing algorithms , one based on anti-Müllerian Hormone ( AMH ) and the other on the antral follicle count ( AFC ) , to determine the starting dose of recombinant FSH ( rFSH ) for ovarian stimulation in 348 women . Patients were r and omized to a predefined AMH- or AFC-based algorithm . The proportion of cycles with the desired response was similar when rFSH dose was determined using AMH or AFC ( 35.2 % versus 28.4 % ) . There was a significant difference between the groups in the proportion of cycles with a hyperresponse ( 8.6 % and 17.4 % , but the incidence of ovarian hyperstimulation syndrome was similar ( 1.1 % and 4.6 % ) . There were no significant differences between two groups in outcomes , including implantation ( 19.3 % versus 19.0 % ) , clinical pregnancy ( 38.0 % versus 46.9 % ) , multiple pregnancy ( 16.5 % versus 15.2 % ) and miscarriage ( 7.0 % versus 8.3 % ) . However , statistically significant differences in ovarian response were evident among the AMH and AFC subgroups : for AMH , Desired and Hypo ; for AFC , Hypo and Hyper . This pilot study provides information for developing protocol s to further vali date the use of either AMH or AFC to guide the starting dose of rFSH in ovarian stimulation . The ideal outcome for couples undergoing IVF treatment is the birth of a healthy baby . One factor that might influence this is retrieving an adequate number of eggs , which are obtained using various treatment protocol s. A group of drugs called gonadotrophins have been used for more than 20years to stimulate the ovaries to produce eggs . However , the dose to start treatment has not been clearly defined . A few studies have looked at ways to use the best gonadotrophin dose for each woman , but to be useful in the clinic any approach needs to be simple and easy to use . This study compared the effectiveness and safety of two simple approaches to determining the starting dose of recombinant FSH ( rFSH ) for ovarian stimulation in women undergoing IVF . One was based on the concentration of a hormone secreted by developing eggs ( anti-Müllerian hormone ; AMH ) and the other on the number of developing follicles ( antral follicle count ; AFC ) . The number of cycles achieving the desired response in terms of number of eggs was similar when rFSH dose was guided using AMH or AFC , and the incidence of ovarian hyperstimulation syndrome was also similar . In addition , rates of clinical pregnancy , multiple pregnancy and miscarriage did not differ between the two groups . However , patients with low AMH concentrations or low AFC had a poor response to ovarian stimulation . This pilot study provides useful information from which new studies can further assess these approaches to personalizing treatment during IVF CONTEXT Anti-Müllerian hormone ( AMH ) , a quantitative marker for ovarian reserve , has been suggested to be independent of the classical endocrine fluctuations of the menstrual cycle . OBJECTIVE The objective of the study was to determine whether AMH levels are constant throughout the menstrual cycle , compared with those of FSH , LH , and estradiol . DESIGN / PATIENTS Frequent blood sampling was performed in 44 fertile , regularly cycling , female volunteers during one full menstrual cycle . SETT Output:	The other four secondary outcomes were in the favor of the conventional group but with no statistically significant difference . AMH-based stimulation has the same results of pregnancy rate and risk of OHSS and can reduce the dose of rFSH and duration of stimulation
MS2819	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Placebo treatment can significantly influence subjective symptoms . However , it is widely believed that response to placebo requires concealment or deception . We tested whether open-label placebo ( non-deceptive and non-concealed administration ) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome ( IBS ) . Methods Two-group , r and omized , controlled three week trial ( August 2009-April 2010 ) conducted at a single academic center , involving 80 primarily female ( 70 % ) patients , mean age 47±18 with IBS diagnosed by Rome III criteria and with a score ≥150 on the IBS Symptom Severity Scale ( IBS-SSS ) . Patients were r and omized to either open-label placebo pills presented as “ placebo pills made of an inert substance , like sugar pills , that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes ” or no-treatment controls with the same quality of interaction with providers . The primary outcome was IBS Global Improvement Scale ( IBS-GIS ) . Secondary measures were IBS Symptom Severity Scale ( IBS-SSS ) , IBS Adequate Relief ( IBS-AR ) and IBS Quality of Life ( IBS-QoL ) . Findings Open-label placebo produced significantly higher mean ( ±SD ) global improvement scores ( IBS-GIS ) at both 11-day midpoint ( 5.2±1.0 vs. 4.0±1.1 , p<.001 ) and at 21-day endpoint ( 5.0±1.5 vs. 3.9±1.3 , p = .002 ) . Significant results were also observed at both time points for reduced symptom severity ( IBS-SSS , p = .008 and p = .03 ) and adequate relief ( IBS-AR , p = .02 and p = .03 ) ; and a trend favoring open-label placebo was observed for quality of life ( IBS-QoL ) at the 21-day endpoint ( p = .08 ) . Conclusion Placebos administered without deception may be an effective treatment for IBS . Further research is warranted in IBS , and perhaps other conditions , to eluci date whether physicians can benefit patients using placebos consistent with informed consent . Trial Registration Clinical Trials.gov Background Several studies demonstrated that placebo treatment may have a significant impact on many different symptoms . While in the traditional view concealment of the placebo is essential , recent studies report intriguing evidence that placebos may work even without deception . For example , it has been demonstrated that open-label placebos can improve symptoms in allergic rhinitis . However , the mechanisms of how placebos without concealment work remain unknown . Trial design In order to examine expectancy effects we conducted a r and omized controlled trial ( N = 46 ) , in which patients with allergic symptoms received either placebos without deception or no pills at all . In half of those patients we induced positive expectations about the placebo effect . After two weeks we tested whether symptoms and quality of life had changed . Results Results revealed that open-label placebos improved allergic symptoms more than the control group . Inducing positive expectations had no effects on the improvement of allergic symptoms ( the primary and more objective outcome ) , but on mental sum scores of the quality of life question naire . Conclusions Placebos without deception can improve symptoms in allergic rhinitis . Positive expectations do not contribute to the efficacy of open-label placebos , but seem to have an effect on more global and subjective well-being ( mental or emotional quality of life ) . Clinical trial registration number German Clinical Trials Register , Research into placebo effects has convincingly shown that inducing positive outcome expectations can reduce pain and other physical sensations . However , the comparative effects of different expectation inductions , such as verbal suggestion or mental imagery , and their generic effects on physical sensitivity , to different sensations such as pain , itch , and fatigue , are still largely unknown . In the current study , we assessed the individual and combined effects of verbal suggestion and imagery on pain , itch , and fatigue as indicators of physical sensitivity in a r and omized study design . Healthy participants ( n = 116 ) were given an inert ( placebo ) capsule that was said to be effective for reducing physical sensitivity in either the majority ( positive verbal suggestion ) or the minority ( control verbal suggestion ) of users . Subsequently , they imagined either their best possible health ( positive imagery ) or a typical day ( control imagery ) . Sensitivity to pain , itch , and fatigue was tested using a cold pressor test , histamine iontophoresis , and a bicycle test , respectively . Heart rate and skin conductance were recorded continuously . Results showed that positive verbal suggestion and imagery successfully induced positive expectations , but they did not affect physical sensitivity , as indicated by sensitivity to pain , itch , or fatigue , or concurrent physiological responses . These results could indicate that the specificity and concreteness of expectation inductions might be important for their applicability in the treatment of physical symptoms . Trial Registration Nederl and s Trial Register PURPOSE To investigate suggestion-induced placebo effects in inflammatory skin reactions . METHODS A healthy sample of volunteers ( N = 48 ) attended two laboratory sessions . In each , a local short term inflammatory skin reaction was induced with histamine . Participants were told that one session was a control session and the other was a treatment session in which an antihistamine cream would be applied to the arm to reduce the size of the weal and the experience of itch . Inert aqueous cream was applied in both sessions . Participants were r and omly allocated to undergo either the control or the treatment session first . RESULTS The placebo manipulation successfully reduced self-reported itch from the control to the placebo treatment session , but no placebo effect was demonstrated in weal size . Order effects were observed such that only those who underwent control procedures first had a smaller weal in the placebo treatment session as compared to the control session . The same order effect was seen for reported itch at one minute post histamine administration , but this disappeared at the three and five minute measures . CONCLUSION Findings suggest that explicit verbal suggestion can reduce the experience of itch . In addition to conscious awareness , a concrete representation of the suggested changes gained from prior experience to the stimulus may be an important component of placebo effects on inflammatory skin reactions Cutaneous reactivity to challenge with dinitrochlorobenzene ( DNCB ) and diphenylcyclopropenone ( DCP ) was studied in 16 volunteers following hypnotic suggestions to increase and decrease response during sensitization . The immunoreactivity to DNCB and DCP was modulated by direct suggestions and guided imagery under hypnosis . The volunteers were highly susceptible subjects selected by means of the Harvard Group Scale of Hypnotic Susceptibility . Form A. Measurement of skin reactions to the challenge I month after sensitization was performed double blindly . Results showed a significant ( P<0.01 ) difference in visually scored reactions to DCP and DNCB between the group instructed to increase reaction to DCP and decrease reaction to DNCB and the group given the opposite instructions . A non‐significant difference ( P= 0.055 ) in skin thickness measured by ultrasound was found between the two groups . The study supports previous reports of experimental modulation of immunoreactivity and indicates that the specific immunnnological processes involved in the development of allergic reactions may be susceptible to psychological factors The therapeutic results of hypnosis with relaxation therapy were evaluated in 15 patients with chronic urticaria of 7.8 years ' average duration . Compared with baseline and control session values , the hypnosis session provided relief of pruritus as measured by three self-report parameters . There was no change in the number of hives . All subjects were given a st and ard test for hypnotizability . Assuming that the results were not biased by their preceding relaxation sessions , we determined that six subjects were hypnotizable and nine were nonhypnotizable . Subjects in both groups improved symptomatically , but hypnotizable subjects had fewer hives and became more symptomatic during the control ( testing and history taking ) session . Hypnotizable subjects also more frequently related stress as a causative factor . At a follow-up examination five to 14 months after the completion of the experimental sessions , six patients were free of hives and an additional seven reported improvement We conducted r and omized clinical trials to examine the impact of direct-to-consumer advertisements on the efficacy of a br and ed drug . We compared the objective ly measured , physiological effect of Claritin ( Merck & Co. ) , a leading antihistamine medication , across subjects r and omized to watch a movie spliced with advertisements for Claritin or advertisements for Zyrtec ( McNeil ) , a competitor antihistamine . Among subjects who test negative for common allergies , exposure to Claritin advertisements rather than Zyrtec advertisements increases the efficacy of Claritin . We conclude that br and ed drugs can interact with exposure to television advertisements Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Objective : To test the hypothesize that psoriasis patients treated under a partial schedule of pharmacologic ( corticosteroid ) reinforcement would show less severe symptoms and relapse than those given the same amount of drug under st and ard conditions . Behavioral conditioning as an inherent component of many pharmacotherapeutic protocol s has never been examined . Methods : A double-blind , simple r and omization intervention was conducted with 46 patients from California and New York . Initially , lesions were treated with 0.1 % acetonide triamcinolone under st and ard treatment conditions . Thereafter , a St and ard Therapy group continued on continuous reinforcement ( active drug every treatment ) with 100 % of the initial dose ; Partial Reinforcement patients received a full dose 25 % to 50 % of the time and placebo medication other times ; Dose Control patients received continuous reinforcement with 25 % to 50 % of the initial dose . Results : Severity of disease scores in California neither supported nor refuted the hypothesis . In New York , where there was no difference between Partial Reinforcement and Dose Control groups at baseline , partial reinforcement effected a greater reduction in lesion severity than Dose Control conditions and did not differ from St and ard Therapy patients receiving two to four times more drug . For the entire population , the frequency of relapse under partial reinforcement ( 26.7 % ) was lower than in Dose Control patients ( 61.5 % ) and did not differ from full-dose treatment ( 22.2 % ) . Conclusions : A partial schedule of pharmacotherapeutic reinforcement could maintain psoriasis patients with a cumulative amount of corticosteroid that was relatively ineffective when administered under st and ard treatment conditions . Conceivably , corticosteroid administration only one quarter or half as frequently as currently prescribed is sufficient to treat psoriasis . We posit , however , that these preliminary observations implicate conditioning processes in— and for the design of — regimens of pharmacotherapy . PSS = Psoriasis Severity Scale ; CS = conditioned stimulus ; UCS = unconditioned stimulus To clarify the contribution of stress to classical conditioning-associated asthmatic responses , the effect of fasting stress on conditioned histamine release was investigated in a guinea pig model of asthma . The animals were r and omly divided into 2 groups for Experiment 1 and 2 , and received a conditioning procedure in which ovalbumin ( OA ) as an unconditioned stimulus ( US ) and dimethylsulfide ( DMS , sulfur smelling ) as a conditioned stimulus ( CS ) were simultaneously inhaled after fasting for 16 h. Then , one group was given food as a reward for respiratory distress , and the other group was denied it for more than 3 h , while being placed in front of the feeding group . After this procedure was repeated 5 times , the plasma histamine levels in response to the CS were measured in half of each group in Experiment 1 , and the respiratory resistance ( Rrs ) was assessed similarly in the other half of each group in Experiment 2 . The same experiments were again performed after exchanging assignments of feeding group or fasting group in both experiments . The control groups in both experiments received the CS and the US 10 times separately in a r and om order under 16 h fasting conditions and were provided food after the exposures . After these pseudo-conditioning presentations , the plasma histamine levels or the Rrs in response to the CS were measured . In Experiment 1 , the plasma histamine levels in the fasting stress group after the first conditioning sessions were significantly higher than those of the other groups . This difference was not observed when the groups were exchanged . In Experiment 2 , the fasting stress group showed higher values in the Rrs compared to the other groups , irrespective of the first or second conditionings ; however , they were not significant . The present study indicates that fasting stress after the conditioning procedures exacerbates the following conditioned histamine release , although the stress effect on bronchoconstriction was not confirmed Abstract This r and omized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo ( OLP ) treatment to treatment as usual ( TAU ) for 3 weeks . Pain severity was assessed on three 0- to 10-point Numeric Rating Scales , scoring maximum pain , minimum pain , and usual pain , and a composite , primary outcome , total pain score . Our other primary outcome was back-related dysfunction , assessed on the Rol and –Morris Disability Question naire . In an exploratory follow-up , participants on TAU received placebo pills for 3 additional weeks . We r and omized 97 adults reporting persistent low back pain for more than 3 months ' duration and diagnosed by a board-certified pain specialist . Eighty-three adults completed the trial . Compared to TAU , OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and Output:	Overall , studies consistently show that placebo and nocebo effects can be induced by various methods ( e.g. , suggestions , conditioning and social cues ) , despite high heterogeneity across studies . Effects of suggestions were found consistently across subjective and behavioral parameters ( e.g. , itch and scratching in humans ) , whereas conditioning was likely to impact physiological parameters under certain conditions ( e.g. , conditioning of histamine levels in stressed rodents ) . Brain areas responsible for itch processing were associated with nocebo effects .
MS2820	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: ABSTRACT Aim : Gemcitabine ( GEM ) and nab-paclitaxel ( nab-P ) significantly improved overall survival over GEM in metastatic pancreatic adenocarcinoma ( PA ) . Given the synergism of taxanes with platinum compounds and fluoropyrimidines , we determined the recommended phase 2 dose ( RP2D ) of nab-P in combination with cisplatin , capecitabine , and GEM ( PAXG regimen ) in a phase Ib trial in patients ( pts ) with stage III PA ( NCT01730222 ) . Methods : GEM , cisplatin and capecitabine were given at fixed dose ( 800 , 30 , and 1250 mg/m2 , respectively ) q 2 weeks . Doses of nab-P were escalated in cohorts of 3 to 6 pts from 100 ( level 1 ) , to 125 ( level 2 ) and 150 mg/m2 ( level 3 ) q 2 weeks . The maximum tolerated dose ( MTD ) was defined as the dose at which > 2 out of 3 - 6 pts developed dose-limiting toxicity ( DLT ) during the first month of therapy . DLT was defined as G ≥ 4 neutropenia lasting ≥ 7 days ; G ≥ 3 febrile neutropenia , fever ≥38.5 ° C , thrombocytopenia , diarrhea , nausea or vomiting ; G ≥ 2 neurological toxicity or failure to recover to grade ≤ 1 toxicity ( except alopecia ) or to baseline values after delaying the initiation of next cycle by > 2 weeks . Results : Between Dec 2012 and Mar 2014 , 23 pts ( 16 males ; median age 63 years ) with unresectable ( according to a surgical team performing > 100 duodenocephalopancreasectomy/year ) stage III PA , were enrolled at a single institution ( 3 at level 1 , 5 at level 2 , 15 at level 3 ) . To date , 197 cycles of PAXG were administered . Therapy is ongoing in 5 pts at level 3 . No DLT has occurred . Worse per patient toxicity was G3/4 neutropenia 29/29 % ; G3 fatigue 14 % ; G3 neuropathy , anemia , nausea , diarrhea 7 % . After 123 cycles at 150 mg/m2 the nab-P dose-intensity was 90 % . To date , a partial response ( PR ) was observed in 15 pts ( 65 % ) and stable disease ( SD ) in 8 pts ; among 20 pts with positive PET scan a complete response was observed in 8 ( 40 % ) , PR in 10 ( 50 % ) , SD in 2 ; 19 pts had elevated basal CA19 - 9 which was reduced by > 50 % in 18 ( 95 % ) ; 15/16 ( 94 % ) pts with mature follow-up were progression-free at 6 months from therapy start . Conclusions : The RP2D of nab-P in the PAXG regimen was 150 mg/m2 every 2 weeks . Preliminary results are promising and a phase II r and omized trial with this regimen is ongoing . Disclosure : M. Reni : Participation in an Advisory Board : Merck ; Celgene ; CLOVIS ; Genentech ; Boehringer L. Gianni : advisory board Celgene . All other authors have declared no conflicts of interest Purpose Addition of either nab-paclitaxel or erlotinib to gemcitabine to treat advanced pancreatic cancer has demonstrated overall survival benefit . This study was conducted to evaluate the tolerability and safety of combining all three drugs and assess preliminary evidence of efficacy . Methods In this open-label , phase 1b study , patients with previously untreated , advanced pancreatic cancer were treated in 28-day cycles with intravenous gemcitabine/nab-paclitaxel on days 1 , 8 , and 15 , and once daily oral erlotinib . A st and ard “ 3 + 3 ” design was used . Dose level 1 ( DL1 ) for gemcitabine (mg/m2)/nab-paclitaxel (mg/m2)/erlotinib ( mg ) was 1000/125/100 , respectively , with de-escalation to DL−1 ( 1000/100/100 ) , DL−2b ( 1000/75/100 ) , and DL−3 ( 1000/75/75 ) . The maximum tolerated dose ( MTD ) was defined by occurrence of dose-limiting toxicity ( DLT ) in ≤1 of six patients within the first cycle . Efficacy was assessed with CT scans performed at two-cycle intervals . Results Nineteen patients were enrolled . DLTs occurred in two patients at DL1 , three patients at DL−1 , two patients at DL−2b , and one patient at DL−3 . The MTD for the combination of gemcitabine/nab-paclitaxel/erlotinib was DL−3 ( 1000/75/75 ) . In analyses of efficacy among 14 evaluable patients , partial responses were observed in four of six patients at DL1 , one of two patients at DL−2b , and two of six patients at DL−3 . Conclusion The addition of erlotinib to gemcitabine and nab-paclitaxel is not tolerable at st and ard single-agent dosing of all drugs . However , significant clinical activity was noted , even at DL−3 . Further study of the combination will need to incorporate reduced dosing PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer . METHODS American Society of Clinical Oncology convened an Expert Panel of medical oncology , radiation oncology , surgical oncology , gastroenterology , palliative care , and advocacy experts and conducted a systematic review of the literature from January 2002 to June 2015 . Outcomes included overall survival , disease-free survival , progression-free survival , and adverse events . RESULTS Twenty-six r and omized controlled trials met the systematic review criteria . RECOMMENDATIONS A multiphase computed tomography scan of the chest , abdomen , and pelvis should be performed . Baseline performance status and comorbidity profile should be evaluated . The goals of care , patient preferences , psychological status , support systems , and symptoms should guide decisions for treatments . A palliative care referral should occur at first visit . Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile . There is no clear evidence to support one regimen over another . The gemcitabine-based combinations and treatments recommended in the metastatic setting ( eg , fluorouracil , leucovorin , irinotecan , and oxaliplatin and gemcitabine plus nanoparticle albumin-bound paclitaxel ) have not been evaluated in r and omized controlled trials involving locally advanced , unresectable pancreatic cancer . If there is local disease progression after induction chemotherapy , without metastasis , then radiation therapy or stereotactic body radiotherapy may be offered also with an Eastern Cooperative Oncology Group performance status ≤ 2 and an adequate comorbidity profile . If there is stable disease after 6 months of induction chemotherapy but unacceptable toxicities , radiation therapy may be offered as an alternative . Patients with disease progression should be offered treatment per the ASCO Metastatic Pancreatic Cancer Treatment Guideline . Follow-up visits every 3 to 4 months are recommended . Additional information is available at www.asco.org/ guidelines /LAPC and www.asco.org/ guidelines /MetPC and www.asco.org/ guidelines wiki PURPOSE The trial objectives were to identify the maximum-tolerated dose ( MTD ) of first-line gemcitabine plus nab-paclitaxel in metastatic pancreatic adenocarcinoma and to provide efficacy and safety data . Additional objectives were to evaluate positron emission tomography ( PET ) scan response , secreted protein acidic and rich in cysteine ( SPARC ) , and CA19 - 9 levels in relation to efficacy . Subsequent pre clinical studies investigated the changes involving the pancreatic stroma and drug uptake . PATIENTS AND METHODS Patients with previously untreated advanced pancreatic cancer were treated with 100 , 125 , or 150 mg/m(2 ) nab-paclitaxel followed by gemcitabine 1,000 mg/m(2 ) on days 1 , 8 , and 15 every 28 days . In the pre clinical study , mice were implanted with human pancreatic cancers and treated with study agents . RESULTS A total of 20 , 44 , and three patients received nab-paclitaxel at 100 , 125 , and 150 mg/m(2 ) , respectively . The MTD was 1,000 mg/m(2 ) of gemcitabine plus 125 mg/m(2 ) of nab-paclitaxel once a week for 3 weeks , every 28 days . Dose-limiting toxicities were sepsis and neutropenia . At the MTD , the response rate was 48 % , with 12.2 median months of overall survival ( OS ) and 48 % 1-year survival . Improved OS was observed in patients who had a complete metabolic response on [(18)F]fluorodeoxyglucose PET . Decreases in CA19 - 9 levels were correlated with increased response rate , progression-free survival , and OS . SPARC in the stroma , but not in the tumor , was correlated with improved survival . In mice with human pancreatic cancer xenografts , nab-paclitaxel alone and in combination with gemcitabine depleted the desmoplastic stroma . The intratumoral concentration of gemcitabine was increased by 2.8-fold in mice receiving nab-paclitaxel plus gemcitabine versus those receiving gemcitabine alone . CONCLUSION The regimen of nab-paclitaxel plus gemcitabine has tolerable adverse effects with substantial antitumor activity , warranting phase III evaluation Output:	Ongoing trials are investigating nab-P/Gem with or without other agents across disease setting s. Discussion Studies conducted after MPACT have demonstrated that nab-P/Gem is an effective regimen for the first-line treatment of MPC for a wide range of patients . Ongoing studies will yield valuable insights on the utility of nab-P – containing regimens to improve patient outcomes in PC in both earlier-stage and advanced disease
MS2821	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : Radiotracer and blue dye mapping of sentinel lymph nodes ( SLN ) have been advocated as accurate methods to stage the clinical ly negative axilla in breast cancer patients . The technical aspects of SLN biopsy are not fully characterized . In this study we compare the results of intraparenchymal ( IP ) and intradermal ( ID ) injection of Tc-99 m sulfur colloid , to establish an optimal method for SLN localization . Methods : 200 consecutive patients had SLN biopsy performed by a single surgeon . Of these , 100 ( Group I ) had IP injection and 100 ( Group II ) had ID injection of Tc-99 m sulfur colloid . All patients had IP injection of blue dye as well . Endpoints included ( 1 ) successful SLN localization by lymphoscintigraphy , ( 2 ) successful SLN localization at surgery , and ( 3 ) blue dye – isotope concordance ( uptake of dye and isotope by the same SLN ) . Results : Isotope SLN localization was successful in 78 % of Group I and 97 % of group II patients ( P < .001 ) . When isotope was combined with blue dye , SLN were found in 92 % of group I and 100 % of Group II ( P < .01 ) . In cases where both dye and isotope were found in the axilla , dye mapped the same SLN as radiotracer in 97 % of Group I and 95 % of Group II patients . Conclusions : The dermal and parenchymal lymphatics of the breast drain to the same SLN in most patients . Because ID injection is easier to perform and more effective , this technique may simplify and optimize SLN localization BACKGROUND AND OBJECTIVE We performed a pilot study on 30 consecutive patients undergoing sentinel node ( sN ) biopsy by radioguided surgery and vital blue dye mapping to determine whether there is a single sN for each breast independent of tumor site or an sN specifically related to the site of the breast neoplasm . METHODS There were 6 groups of 5 patients ; each patient had a subdermal injection of radiotracer on the tumor site plus a second injection of radiotracer that was changed in every subset of patients to test whether modifying the site or the route of injection could have impaired the proper detection of the sN. RESULTS " False " sN were detected only in patients who had a second injection of radiotracer away from the tumor site ; this occurred in 2 of 5 patients ( 40 % ) in group I , in 3 of 5 patients ( 60 % ) in group II , in all patients in group III , and in 3 of 5 patients ( 60 % ) in group IV . The different route of injection ( peritumoral or subdermal ) always on the tumor site that was tested in groups V and VI did not impair the proper detection of the sN. CONCLUSIONS Our findings support the hypothesis of a precise topographic correspondence between the primary tumor and its specific sN more than the existence of a first sN in the axillary basin , which indiscriminately drains all quadrants of the breast , like " a neck of a bottle . " This should be considered for the proper selection of the injection site of either vital blue dye or radiopharmaceuticals Background Sentinel lymph node ( SLN ) mapping with radioisotope and blue dye is rapidly becoming the st and ard of care for breast cancer . The optimal location for injection of radioisotope and blue dye is still being investigated . The goal of this study was to determine whether blue dye injection into the subareolar ( SA ) location localized the same sentinel nodes as the peritumoral ( PT ) location for patients with breast cancer . Methods Three hundred thirty-two patients with biopsy-proven operable breast cancer or ductal carcinoma in situ at two institutions underwent SLN mapping . Eighty-three patients had PT injection of blue dye ( group 1 ) , and 249 patients had SA injection of blue dye ( group 2 ) . All patients underwent PT injection of99mTc-labeled sulfur colloid . Results The two groups were similar in age , previous biopsy type , and tumor size , location , and histology . The mean number of SLNs identified was 2.4 ( range , 0–9 ) in group 1 and 2.5 ( range , 0–11 ) in group 2 . The SLN identification rate was 95 % for group 1 and 97 % for group 2 . The isotope success rate was 94 % for both groups . The blue dye success rate was 84 % for group 1 and 90 % for group 2 . The isotope/blue dye concordance rate was 87 % for group 1 and 90 % for group 2 . At a median follow-up of 28 months ( range , 14 to 40 ) , there were no axillary recurrences in any of the 332 patients . Conclusions These data suggest that delivery of mapping reagents in the SA and PT locations identifies similar lymph nodes . Because of simplicity and the similarity in node identification between SA and PT injection , further investigation of the SA site for delivery of SLN mapping reagents for breast cancer is warranted Background Preoperative parenchymal or peritumoral ( PT ) injection of 99mTc-labeled sulfur colloid ( TcSC ) is the st and ard method for sentinel lymph node ( SLN ) identification in patients with breast cancer . Limitations of this method include variable identification rates , slow transit times , and painful injections . We hypothesize that TcSC will travel to the SLN within minutes after injection into the subareolar ( SA ) lymphatics , thus making an intraoperative injection technique feasible . Methods One hundred twenty-two women with invasive breast cancer were enrolled onto this prospect i ve study . Immediately after the induction of general anesthesia , patients were injected with 1 to 2 mCi of filtered TcSC in the SA location . Then , 5 mL of 1 % isosulfan blue dye was injected into the PT location . The SLN or SLNs were identified as radioactive , blue , or both and removed for pathologic evaluation . Results The mean patient age was 56 years . The mean tumor size was 1.5 cm . In 86.1 % of patients , a transcutaneous axillary “ hot spot ” was identified by h and held gamma probe . The mean time from TcSC injection to axillary incision was 17.6 minutes . At least one SLN was identified in 99.2 % of patients . The mean number of SLNs identified per patient was 1.83 . The mean count of radioactive SLNs was 2715 cps . In 97.2 % of patients , blue SLNs were also radioactive . Conclusions TcSC injected into the SA lymphatics rapidly drains to the SLN . The radioactive SLN is easily and quickly identified after an intraoperative SA TcSC injection . The simplicity of this method eliminates the inherent problems associated with st and ard PT injection First published in 1996 , the CONSORT guidelines were created to address inadequate reporting of clinical trials , especially individually r and omized , two-group , parallel trials . The original guidelines were developed by a team of statisticians , epidemiologists , and biomedical editors and were revised in 2001 and again in 2010 ( Moher , Schultz , & Altman , 2001 ; Schulz , Altman , & Moher , 2010 ) . The intent of the CONSORT checklist and flow diagram was to provide a template for authors to fully and accurately describe research methodology . Moher and colleagues ( 2001 ) asserted that whereas inadequate reporting hinders interpretation , it also “ borders on unethical practice when biased results receive false credibility ” ( p. 4 ) . The latest CONSORT statement , checklist , flow diagram , and explanation and elaboration document are available on the website ( http://www.consort-statement.org ) or from one of several publications such as Schulz and colleagues ( 2010 ) . The CONSORT guidelines can be useful whether or not the study was design ed as a r and omized controlled trial ( RCT ) . Although most applicable to an RCT , the author of a quantitative study who chooses only the relevant checklist elements will still benefit from prompts to include the appropriate information in the introduction , methods , results , and discussion sections . Fuzzy reporting and omission of critical information comprise the majority of review ers ’ comments and queries back to authors of manuscripts su bmi tted for peer review . For example , authors frequently omit adequate description of the “ setting s and locations where the data were collected ” and have a tendency to gloss over limitations that should include “ sources of potential bias , imprecision , and , if relevant , multiplicity of analyses ” ( Schulz et al. , 2010 , p. 2 ) . PRISMA : PREFERRED REPORTING ITEMS FOR SYSTEMATIC REVIEW S AND AIMS Identification of sentinel lymph nodes ( SLN ) may depend on the tissue plane of tracer injection . To explore this , we developed a dual-isotope technique to compare the lymphatic drainage basins accessed by intradermal and parenchymal injections . METHODS Fifteen breast cancer patients had simultaneous parenchymal and intradermal injections of (99m)Tc-labelled human immunoglobulin G ( HIG ) and (111)In-HIG , respectively , 2 - 4h before axillary lymph node clearance surgery . All 228 freshly dissected nodes were assayed by well counting and examined for metastatic disease by haematoxylin/eosin staining and immuno-histochemistry . RESULTS Total nodal uptake following intradermal injection was 10 times more than after parenchymal injection . Tracer uptake within the first three draining nodes divided patients into three groups ; four ( group 1 ) had identical 1st , 2nd and 3rd echelon nodes , six ( group 2 ) had identical 1st and 2nd echelon nodes and five ( group 3 ) had different 1st echelon nodes . With respect to the first , second and third groups , there was close , moderate and poor correlation ( Pearson ) , respectively , between individual nodal counts accumulated from the two injection sites . Of eight patients with nodal disease , the SLN identified by intradermal and parenchymal injections contained disease in seven and four patients , respectively . CONCLUSIONS Comparison of nodal tracer distributions from the two injection planes allows a functional model to be developed with two possible routes of drainage from the parenchymal plane , one joining the tract from the areolar plexus and the other passing independently to the axilla which builds upon Sappey 's original anatomical model . This may explain the variable uptake , discordance and false negative SLN identification BACKGROUND Sentinel lymph node ( SLN ) biopsy is fast becoming the st and ard for testing lymph node involvement in many institutions . However , questions remain as to the best method of injection . The authors hypothesized that a subareolar injection of material would drain to the same lymph node as a peritumoral injection , regardless of the location of the tumor . METHODS To test this theory , 68 patients with 69 operable invasive breast carcinomas and clinical ly node-negative disease were enrolled in this single-institution Institutional Review Board-approved trial . Patients were injected with 1.0 mCi of technetium-99 sulfur colloid ( unfiltered ) in the subareolar area of the tumor-bearing breast . Each patient received an injection of 2 to 5 cc of isosulfan blue around the tumor . Radioactive SLNs were identified using a h and -held gamma detector probe . RESULTS The average age of patients entered into this trial was 55.2 + /- 13.4 years . The average size of the tumors was 1.48 + /- 1.0 cm . Thirty-two percent of the patients had undergone previous excisional breast biopsies . Of the 69 lesions , 62 ( 89.9 % ) had SLNs located with the blue dye and 65 ( 94.2 % ) with the technetium . In four patients , the SLN was not located with either method . All blue SLNs were also radioactive . All located SLNs were in the axilla . Of the 62 patients in which the SLNs were located with both methods , an average of 1.5 + /- 0.7 SLNs were found per patient , of which 23.2 % had metastatic disease . All four patients in which no SLN was located with either method had undergone prior excisional biopsies . CONCLUSIONS The results of this study suggest that subareolar injection of technetium is as accurate as peritumoral injection of blue dye . Central injection is easy and avoids the necessity for image-guided injection of nonpalpable breast lesions . Finally , subareolar injection of technetium avoids the problem of overlap of the radioactive zone of diffusion of the injection site with the radioactive sentinel lymph node , particularly in medial and upper outer quadrant lesions UNLABELLED AIM of this study was to determine whether the sentinel lymph nodes ( SLNs ) can be accurately identified in breast cancer patients with intradermal injection of the radiotracer above the primary tumour in comparison to peritumoural injection . METHODS In 45 women with breast cancer we performed lymphoscintigraphy on two separate days . We injected Tc-99 m nanocolloid on the first day peritumourally , and on a separate day intradermally . The results of both investigations using different injection sites were compared in order to determine the number and location of SLNs . RESULTS The SLN identification rate using peritumoural injection was 71 % ( 32 of 45 patients ) and 96 % ( 43 out of 45 patients ) using intradermal injection . In 62 % ( 28 of 45 patients ) the number Output:	Axillary lymphatic drainage concordance between superficial and deep sentinel node mapping material in breast cancer patients is fairly high and clinical ly acceptable . However , both injection techniques can complement each other and the combined superficial/deep injection technique seems to be more successful clinical ly and can decrease the overall false negative rate
MS2822	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE This phase II study of sorafenib , an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases , assessed efficacy , toxicity , pharmacokinetics , and biomarkers in advanced hepatocellular carcinoma ( HCC ) patients . METHODS Patients with inoperable HCC , no prior systemic treatment , and Child-Pugh ( CP ) A or B , received continuous , oral sorafenib 400 mg bid in 4-week cycles . Tumor response was assessed every two cycles using modified WHO criteria . Sorafenib pharmacokinetics were measured in plasma sample s. Biomarker analysis included phosphorylated extracellular signal regulated kinase ( pERK ) in pretreatment biopsies ( immunohistochemistry ) and blood-cell RNA expression patterns in selected patients . RESULTS Of 137 patients treated ( male , 71 % ; median age , 69 years ) , 72 % had CP A , and 28 % had CP B. On the basis of independent assessment , three ( 2.2 % ) patients achieved a partial response , eight ( 5.8 % ) had a minor response , and 46 ( 33.6 % ) had stable disease for at least 16 weeks . Investigator-assessed median time to progression ( TTP ) was 4.2 months , and median overall survival was 9.2 months . Grade 3/4 drug-related toxicities included fatigue ( 9.5 % ) , diarrhea ( 8.0 % ) , and h and -foot skin reaction ( 5.1 % ) . There were no significant pharmacokinetic differences between CP A and B patients . Pretreatment tumor pERK levels correlated with TTP . A panel of 18 expressed genes was identified that distinguished " nonprogressors " from " progressors " with an estimated 100 % accuracy . CONCLUSION Although single-agent sorafenib has modest efficacy in HCC , the manageable toxicity and mechanisms of action support a role for combination regimens with other anticancer agents BACKGROUND Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics : both tumour shrinkage ( objective response ) and disease progression are useful endpoints in clinical trials . Since RECIST was published in 2000 , many investigators , cooperative groups , industry and government authorities have adopted these criteria in the assessment of treatment outcomes . However , a number of questions and issues have arisen which have led to the development of a revised RECIST guideline ( version 1.1 ) . Evidence for changes , summarised in separate papers in this special issue , has come from assessment of a large data warehouse ( > 6500 patients ) , simulation studies and literature review s. HIGHLIGHTS OF REVISED RECIST 1.1 : Major changes include : Number of lesions to be assessed : based on evidence from numerous trial data bases merged into a data warehouse for analysis purpose s , the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total ( and from five to two per organ , maximum ) . Assessment of pathological lymph nodes is now incorporated : nodes with a short axis of 15 mm are considered measurable and assessable as target lesions . The short axis measurement should be included in the sum of lesions in calculation of tumour response . Nodes that shrink to < 10 mm short axis are considered normal . Confirmation of response is required for trials with response primary endpoint but is no longer required in r and omised studies since the control arm serves as appropriate means of interpretation of data . Disease progression is clarified in several aspects : in addition to the previous definition of progression in target disease of 20 % increase in sum , a 5 mm absolute increase is now required as well to guard against over calling PD when the total sum is very small . Furthermore , there is guidance offered on what constitutes ' unequivocal progression ' of non-measurable/non-target disease , a source of confusion in the original RECIST guideline . Finally , a section on detection of new lesions , including the interpretation of FDG-PET scan assessment is included . Imaging guidance : the revised RECIST includes a new imaging appendix with up date d recommendations on the optimal anatomical assessment of lesions . FUTURE WORK A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI . It was concluded that , at present , there is not sufficient st and ardisation or evidence to ab and on anatomical assessment of tumour burden . The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression . As is detailed in the final paper in this special issue , the use of these promising newer approaches requires appropriate clinical validation studies Objectives The aim of this single , r and omized study was to explore the efficacy of postoperative transarterial chemoembolization ( TACE ) and portal vein chemotherapy ( PVC ) for patients with hepatocellular carcinoma ( HCC ) complicated by portal vein tumor thrombosis ( PVTT ) and to evaluate prognostic factors . Methods The study cohort consisted of 112 patients with HCC and PVTT r and omly divided into three groups : Group A ( 37 patients ) , operation only ; Group B ( 35 patients ) , operation plus TACE ; Group C ( 40 patients ) , operation plus TACE and PVC . Disease-free survival rates and prognostic factors were analyzed . Results Most of the side effects and complications were related to the operation , catheters , and local chemotherapy and included liver decompensation ( 15.0 % ) , catheter obstruction ( 11.6 % ) , and nausea and loss of appetite ( 22.1 % ) . The disease-free survival curve was significantly different among the three groups , as estimated by the Kaplan-Meier method ( both P < 0.05 ) . Group C showed a significantly higher disease-free survival rate than Group A ( P < 0.05 ) , but no statistical differences were found between group A and group B , and group B and group C ( both P > 0.05 ) . Tumor size , tumor number , PVTT location , and treatment modalities were independent prognostic factors ( P < 0.05 ) . Conclusion Postoperative TACE combined with PVC may benefit the survival of patients with HCC complicated by PVTT in the short-term ( less than 60 months ) , but long-term efficacy is not yet certain and needs to be confirmed by further studies Sorafenib , an oral multikinase inhibitor , shows efficacy in renal cell and hepatocellular carcinoma ( HCC ) and is well tolerated when combined with doxorubicin in other solid tumours . Eighteen patients with inoperable HCC received doxorubicin 60 mg/m(2 ) IV for up to six 3-week cycles . Sorafenib 400 mg bid was administered continuously starting day 4 . Patients discontinuing doxorubicin were eligible for sorafenib monotherapy . The most frequent grade 3 - 4 drug-related adverse events were neutropaenia ( 61 % ) , leukopaenia ( 45 % ) and diarrhoea ( 17 % , grade 3 ) . Seven of eight patients who completed six cycles of doxorubicin continued treatment with sorafenib for at least 3 months . Doxorubicin moderately increased AUC ( 21 % ) and C(max ) ( 33 % ) when administered with sorafenib . The disease control rate for 16 evaluable patients was 69 % . Sorafenib plus doxorubicin appears to be well tolerated and more effective in the treatment of HCC than doxorubicin alone . Follow-up with single-agent sorafenib in these patients also appears to be well tolerated Purpose The BCLC staging classification has been widely endorsed to predict the prognosis of patients with HCC . However , its validity as a means of therapeutic instructions needs to be challenged . This study aim ed to evaluate perioperative and long-term outcomes of surgical resection in patients with advanced hepatocellular carcinoma ( HCC ) according to the Barcelona Clinic Liver Cancer ( BCLC ) staging . Methods This study used a prospect ively maintained data base consisting of a consecutive series of 511 Chinese patients with advanced HCC who underwent surgical resection in a hepatobiliary surgical center from 2001 to 2007 . Mortality , morbidity , long-term overall survival ( OS ) and disease-free survival ( DFS ) were evaluated . Results Hospital mortality was 2.3 % , and overall morbidity was 31.3 % . After a median follow-up period of 27.8 months ( range , 0–112 months ) , the 1- , 3- and 5-year OS rate was 69.9 , 41.2 and 30.5 % , and the 1- , 3- and 5-year DFS rate was 48.2 , 30.3 and 24.0 % , respectively . The 1- , 3- and 5-year OS and DFS rates were significantly poorer in patients with vascular invasion and /or extrahepatic spread than those in patients without ( both P < 0.001 ) , and also poorer in patients with biliary invasion than those in patients without ( both P < 0.05 ) . Conclusions Surgical resection could be considered in part of patients with advanced HCC ( BCLC stage C ) , with low mortality , acceptable morbidity and favorable survival benefits . These results imply that BCLC recommendations for treatment schedules of advanced HCC need to be re-evaluated PURPOSE To determine the safety and efficacy of transarterial chemoembolization ( TACE ) combined with sorafenib ( hereafter , TACE-sorafenib ) in patients with hepatocellular carcinoma ( HCC ) and portal vein tumor thrombus ( PVTT ) . MATERIAL S AND METHODS This study was approved by the institutional review board , and the requirement for informed consent was waived . The medical records of consecutive patients with HCC and PVTT who underwent TACE-sorafenib or TACE alone from January 2010 to December 2012 were retrospectively evaluated . Sorafenib ( 400 mg ) was administered twice daily . Outcomes of patients who underwent TACE-sorafenib were compared with outcomes of patients who underwent TACE by using the Kaplan-Meier method according to types of PVTT : PVTT in the main portal vein ( type A ) , PVTT in the first-order portal vein branch ( type B ) , and PVTT in second- or lower-order portal vein branches ( type C ) . RESULTS Ninety-one patients were included in the analysis ; 46 patients underwent TACE-sorafenib and 45 underwent TACE . TACE-sorafenib showed significant survival benefits compared with TACE in patients with type B ( median survival , 13 months vs 6 months ; P = .002 ) or type C ( median survival , 15 months vs 10 months ; P = .003 ) PVTT . TACE-sorafenib and main PVTT were the independent prognostic factors for survival at uni- and multivariate analysis . Liver function after TACE-sorafenib worsened only in patients with main PVTT . Sorafenib-related adverse events of grade 3 or higher occurred in 16 patients ( 35 % ) . CONCLUSION TACE-sorafenib side effects were acceptable , and this treatment may improve overall survival in patients with HCC with first-order or lower-branch PVTT when compared with patients who underwent TACE alone BACKGROUND The survival benefit of combining sorafenib and transarterial chemoembolization ( TACE ) therapy compared with sorafenib monotherapy for patients with advanced hepatocellular carcinoma ( HCC ) and main portal vein tumor thrombosis ( MPVTT ) is unclear . METHODS Between January 2009 and June 2013 , 183 consecutive patients with advanced HCC ( Barcelona Clinic Liver Cancer stage C ) and MPVTT were retrospectively review ed . Of these , 89 patients with advanced HCC and MPVTT were enrolled in this study : 45 were treated with combination therapy ( sorafenib-TACE group ) , and the other 44 treated with sorafenib monotherapy ( sorafenib group ) . RESULTS The mean number of TACE sessions per patient was 2.6 ( range : 1 - 5 ) . The median duration of sorafenib in the sorafenib-TACE group and sorafenib group was 5.6 months and 5.4 months , respectively . The disease control rate was similar between the two groups . Median time to progression was 3.0 months ( 95 % confidence interval [ CI ] : 2.2 , 3.7 ) in the sorafenib-TACE group , and 3.0 months ( 95 % CI : 2.1 , 3.8 ) in the sorafenib group ( p = .924 ) . Median overall survival was 7.0 months ( 95 % CI : 6.1 , 7.8 ) and 6.0 months ( 95 % CI : 4.7 , 7.3 ) in the sorafenib-TACE group and the sorafenib group , respectively ( p = .544 ) . The adverse events related to sorafenib were comparable between the two groups . Twenty-one adverse events of grade 3 - 4 related to TACE occurred in 12 patients ( 26.7 % ) , and 2 of them died ( 4.4 % ) . CONCLUSION This study demonstrated no advantage of combination therapy over sorafenib monotherapy . Considering the patients ' morbidity after TACE , sorafenib monotherapy is appropriate for managing patients with advanced HCC and MPVTT Output:	TACE-S with PVTT had better outcomes in the first-order portal vein branch and lower-order portal vein branches than in the main portal vein and upper branches to superior mesenteric vein . CONCLUSIONS TACE-S may improve OS , ORR , TTP and DCR for HCC patients with PVTT compared to TACE
MS2823	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Matched groups of primigravid women received one of three antenatal training programmes : normal antenatal classes , normal classes plus electromyography biofeedback relaxation training , or normal classes plus skin-conductance biofeedback relaxation training . Myographic training was found to be effective within conventional antenatal constraints , whereas skin-conductance training was not . The women reported use of biofeedback training and related skills to be of some benefit during early labour . However , no difference between effectively trained electromyographic , ineffectively trained skin-conductance and control groups was found on labour and delivery performance measures Two studies were conducted to examine the effects of music on analogued labor pain using volunteer nulliparous subjects who were r and omly assigned to treatment groups ( n = 10 per group ) . Assessment s of the treatments were made in a 1-hour session involving twenty 80-second exposures to a laboratory pain stimulus patterned to resemble labor contractions . In the first experiment , it was hypothesized that subjects listening to easy-listening music would report lower pain ratings and cardiovascular responses than subjects listening to rock music , self-selected music , or a dissertation ( placebo-attention ) and subjects in a no-treatment control group . No significant group effects were found ; significant time effects were found for heart rate , systolic and diastolic blood pressure . Subjects spontaneously reported using imagery as a pain reduction technique . In the second study a combination of music and imagery was examined by r and omly assigning subjects to one of five groups : self-generated imagery with music ( SIM ) , guided imagery with music ( GIM ) , self-generated imagery without music ( SI ) , guided imagery without music ( GI ) , or no-treatment control . Again , no significant group effects were obtained . Significant time effects were obtained for heart rate , systolic and diastolic blood pressure British physician , Dr. Grantly Dick-Read , was the first to suggest the “ fear-tension-pain ” cycle in his work Natural Childbirth ( 1933 ) . As a result of his underst and ing of how this cycle affected birthing , he recommended women prepare for childbirth . Research studies from around the world have shown that the use of hypnosis for childbirth results in : ∗ shorter labors ∗ reduced use of pain medication ∗ higher Apgar scores ∗ reduced cesarean and forceps A study of the effects of biofeedback on the pain of childbirth was conducted . Forty primigravidae were r and omly assigned to either an experimental group or a control group . The experimental group was given a series of training sessions in biofeedback and used biofeedback equipment during labor . All subjects were monitored during the labor and delivery period for their reports of pain using a visual analogue scale ( VAS ) and a verbal descriptor scale ( VDS ) . Results showed that women using biofeedback during childbirth reported significantly lower pain : from admission to labor and delivery ( p less than 0.05:VDS ; p less than 0.01:VAS ) , at delivery ( p less than 0.005:VDS ) , and 24-hr postpartum ( p less than 0.01:VDS ) . Also , women in the biofeedback group labored an average of 2 hr less and used 30 % fewer medications . The results of this study suggest that EMG biofeedback may be effective in reducing levels of acute pain experienced by childbearing women CONTEXT A prior national survey documented the high prevalence and costs of alternative medicine use in the United States in 1990 . OBJECTIVE To document trends in alternative medicine use in the United States between 1990 and 1997 . DESIGN Nationally representative r and om household telephone surveys using comparable key questions were conducted in 1991 and 1997 measuring utilization in 1990 and 1997 , respectively . PARTICIPANTS A total of 1539 adults in 1991 and 2055 in 1997 . MAIN OUTCOMES MEASURES Prevalence , estimated costs , and disclosure of alternative therapies to physicians . RESULTS Use of at least 1 of 16 alternative therapies during the previous year increased from 33.8 % in 1990 to 42.1 % in 1997 ( P < or = .001 ) . The therapies increasing the most included herbal medicine , massage , megavitamins , self-help groups , folk remedies , energy healing , and homeopathy . The probability of users visiting an alternative medicine practitioner increased from 36.3 % to 46.3 % ( P = .002 ) . In both surveys alternative therapies were used most frequently for chronic conditions , including back problems , anxiety , depression , and headaches . There was no significant change in disclosure rates between the 2 survey years ; 39.8 % of alternative therapies were disclosed to physicians in 1990 vs 38.5 % in 1997 . The percentage of users paying entirely out-of-pocket for services provided by alternative medicine practitioners did not change significantly between 1990 ( 64.0 % ) and 1997 ( 58.3 % ) ( P=.36 ) . Extrapolations to the US population suggest a 47.3 % increase in total visits to alternative medicine practitioners , from 427 million in 1990 to 629 million in 1997 , thereby exceeding total visits to all US primary care physicians . An estimated 15 million adults in 1997 took prescription medications concurrently with herbal remedies and /or high-dose vitamins ( 18.4 % of all prescription users ) . Estimated expenditures for alternative medicine professional services increased 45.2 % between 1990 and 1997 and were conservatively estimated at $ 21.2 billion in 1997 , with at least $ 12.2 billion paid out-of-pocket . This exceeds the 1997 out-of-pocket expenditures for all US hospitalizations . Total 1997 out-of-pocket expenditures relating to alternative therapies were conservatively estimated at $ 27.0 billion , which is comparable with the projected 1997 out-of-pocket expenditures for all US physician services . CONCLUSIONS Alternative medicine use and expenditures increased substantially between 1990 and 1997 , attributable primarily to an increase in the proportion of the population seeking alternative therapies , rather than increased visits per patient Objective To investigate acupuncture treatment during labour with regard to pain intensity , degree of relaxation and outcome of the delivery Objective To evaluate the effectiveness of acupuncture as an analgesic during labor . Design A r and omized , unblinded , controlled study . Setting A labor ward in a University Hospital . Patients Parturients at term . Interventions One group received acupuncture ( N = 106 ) ; another did not ( N = 92 ) . A second control group ( N = 92 ) , drawn from the labor ward protocol , consisted of patients who met the eligibility criteria for the study and were matched to the “ no acupuncture ” group by parity , but who had not been offered the opportunity to take part . Outcome measure “ effectiveness of acupuncture ” was measured by the requirement for use of meperidine . Results Meperidine was given to 11 % of the acupuncture group , 37 % of the no acupuncture group ( P < 0.0001 ) , and 29 % of the control group . The use of other analgesics was also lower in the acupuncture group . Patient satisfaction was high : 89 of 103 patients asked said they would want acupuncture during another labor . Conclusions Acupuncture during labor reduced the requirement for other painkillers and has high patient satisfaction in this r and omized , unblinded , controlled study The benefits of hypnotic analgesia as an adjunct to childbirth education were studied in 60 nulliparous women . Subjects were divided into high and low hypnotic susceptibility groups before receiving 6 sessions of childbirth education and skill mastery using an ischemic pain task . Half of the Ss in each group received a hypnotic induction at the beginning of each session ; the remaining control Ss received relaxation and breathing exercises typically used in childbirth education . Both hypnotic Ss and highly susceptible Ss reported reduced pain . Hypnotically prepared births had shorter Stage 1 labors , less medication , higher Apgar scores , and more frequent spontaneous deliveries than control Ss ' births . Highly susceptible , hypnotically treated women had lower depression scores after birth than women in the other 3 groups . We propose that repeated skill mastery facilitated the effectiveness of hypnosis in our study OBJECTIVE To determine the effect of breathing techniques and nurse-administered massage on the pain perception of pregnant woman during labour . SETTING AND PARTICIPANTS The present study was conducted among pregnant women ( 75 % primiparous ) admitted to the SSK Bakirkoy Women and Children 's Hospital ( Istanbul , Turkey ) between January 1 , and September 1 , 2000 . The patients were in their 38th to 42nd week of pregnancy , not at high risk and expected to have normal vaginal delivery . They were selected from volunteers by nonr and om sampling . STUDY DESIGN The present study involved 40 cases , with 20 in the experimental group and 20 in the control group . Data were obtained through the visual analogue scale , inspection form , observation form and postnatal interview form . The study investigators provided information about labour , breathing techniques and massage to the pregnant women assigned to the experimental group at the beginning of labour ( latent phase ) . A study investigator also accompanied them during labour . These women received nurse-administered massage and were encouraged to breathe and perform self-administered massage . They were also instructed to change their positions and to relax . RESULTS AND CONCLUSION Study results demonstrated that nursing support and patient-directed education concerning labour and nonpharmacological pain control methods ( eg , breathing and cutaneous stimulation techniques ) were effective in reducing the perception of pain by pregnant women ( when provided in the latent labour phase before delivery ) , leading to a more satisfactory birth experience Acupuncture treatment and control group interventions in parallel-group r and omised trials of acupuncture are not always precisely reported . In an attempt to improve st and ards , an international group of experienced acupuncturists and research ers devised a set of recommendations , design ating them STRICTA : ST and ards for Reporting Interventions in Controlled Trials of Acupuncture . In a further consensus-building round , the editors of several journals helped redraft the recommendations . These follow the Consoli date d St and ards for Reporting Trials ( CONSORT ) format , acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies . Participating journal editors are publishing the STRICTA recommendations and requesting prospect i ve authors to adhere to them when preparing reports for publication . Other journals are invited to adopt these recommendations . The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported , thereby facilitating an improvement in critical appraisal , analysis and replication of trials Labor pain is often severe , and analgesic medication may not be indicated . In this r and omized controlled trial we examined the effects of music on sensation and distress of pain in Thai primiparous women during the active phase of labor . The gate control theory of pain was the theoretical framework for this study . R and omization with a computerized minimization program was used to assign women to a music group ( n = 55 ) or a control group ( n = 55 ) . Women in the intervention group listened to soft music without lyrics for 3 hours starting early in the active phase of labor . Dual visual analog scales were used to measure sensation and distress of pain before starting the study and at three hourly posttests . While controlling for pretest scores , one-way repeated measures analysis of covariance indicated that those in the music group had significantly less sensation and distress of pain than did the control group ( F ( 1 , 107 ) = 18.69 , p < .001 , effect size = .15 , and F ( 1 , 107 ) = 14.87 , p < .001 , effect size = .12 ) , respectively . Sensation and distress significantly increased across the 3 hours in both groups ( p < .001 ) , except for distress in the music group during the first hour . Distress was significantly lower than sensation in both groups ( p < .05 ) . In this controlled study , music -- a mild to moderate strength intervention -- consistently provided significant relief of severe pain across 3 hours of labor and delayed the increase of affective pain for 1 hour . Nurses can provide soft music to laboring women for greater pain relief during the active phase when contractions are strong and women suffer OBJECTIVE The purpose of this study was to evaluate the effects of SP6 acupressure on labor pain and delivery time in women in labor . DESIGN R and omized clinical trial . SETTING /LOCATION Delivery room in a university hospital . PARTICIPANTS Seventy-five ( 75 ) women in labor were r and omly assigned to either the SP6 acupressure ( n = 36 ) or SP6 touch control ( n = 39 ) group . The participants were matched according to parity , cervical dilation , labor stage , rupture of amniotic membrane , and husb and 's presence during labor . There were no additional oxytocin augmentation or administration of analgesics during the study period . INTERVENTION The 30-minute acupressure or touch on SP6 acupoint was performed . OUTCOME MEASURES Labor pain was measured four times using a structured question naire , a subjective labor pain scale ( visual-analogue scale [ VAS ] ) : before intervention , immediately after the intervention , and 30 and 60 minutes after the intervention . Length of delivery time was calculated in two stages : from 3 cm cervical dilation to full cervical dilatation , and full cervical dilatation to the delivery . RESULTS There were significant differences between the groups in subjective labor pain scores at all time points following the intervention : immediately Output:	REVIEW ER 'S CONCLUSIONS Acupuncture and hypnosis may be beneficial for the management of pain during labour .
MS2824	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Atopic dermatitis ( AD ) often develops in infancy as the first manifestation of the atopic phenotype . Wheezing is also common in infancy , but it is less clear whether infant wheezing should be considered as an atopic phenotype . If infant wheeze and AD share a common aetiology , this would indicate that infant wheezing is an atopic phenotype . OBJECTIVE To investigate whether potential risk factors for infant wheeze and AD have similar effects on these 2 phenotypes , indicating a common etiology . METHODS A total of 34.793 mother-child pairs enrolled in the Danish National Birth Cohort were followed prospect ively . Information on wheezing episodes , AD , and prenatal , perinatal , and postnatal risk factors was collected by interview at 12 and 30 weeks of gestation , at 6 and 18 months of age , and by linkage to the Danish Medical Birth Register . Data were analyzed by binary and polytomous logistic regression models . RESULTS The following variables had significantly differential effects on infant wheezing and AD : parental hay fever , parental asthma , parental AD , sex , maternal age , maternal occupation , smoking during pregnancy , season of birth , birth weight , gestational age , head circumference , breast-feeding , number of older siblings , day care attendance , and pets in the home . CONCLUSION The majority of risk factors had differential effects on infant wheeze and AD indicative of a different etiology . Infant wheezing does not seem to be etiologically linked to the epidemic of atopic disease , and infant wheezing should not be used as an indicator of the atopic phenotype BACKGROUND AND METHODS Phase III of the International Study of Asthma and Allergies in Childhood ( ISAAC ) was conducted in eight Pacific countries , five of which ( Samoa , Fiji , Tokelau , French Polynesia and New Caledonia ) collected environmental question naire ( EQ ) data . We report the findings of the EQ analyses below . RESULTS The major factors associated with current wheeze were regular margarine consumption ( prevalence odds ratio [ POR ] 1.19 , 95%CI 1.01 - 1.40 ) , paracetamol use ( POR 1.35 , 95%CI 1.11 - 1.64 ) , electric cooking ( POR 1.42 , 95%CI 1.11 - 1.80 ) , regular exercise ( POR 1.44 , 95%CI 1.18 - 1.75 ) and maternal smoking ( POR 1.16 , 95%CI 1.01 - 1.33 ) . Protective factors included having older siblings ( two or more POR 0.69 , 95%CI 0.58 - 0.82 ; one POR 0.86 , 95%CI 0.71 - 1.05 ) , and being born in the country of the survey ( POR 0.74 , 95%CI 0.63 - 0.87 ) . Risk factors for rhinoconjunctivitis included regular consumption of meat , butter , margarine and nuts , regular exercise , regular television viewing , paracetamol use and passive smoking . Eczema was associated with regular meat , pasta and butter consumption , regular television viewing , paracetamol use and passive smoking . CONCLUSIONS Regular meat and margarine consumption , paracetamol use , electric cooking and passive smoking are risk factors for symptoms of asthma , rhinoconjunctivitis and eczema in the Pacific . However , most of these associations were weak , and account for only a small proportion of cases Background : Several cross‐sectional population ‐based studies have reported a negative association between smoking and allergic sensitization to aeroallergens . In a prospect i ve study , we investigated the association between smoking and the development ( incidence ) of allergic sensitization as reflected by skin prick test ( SPT ) positivity and specific IgE positivity The present study aim ed to investigate the prevalence of atopic dermatitis in primary schoolchildren in Denizli , Turkey , and to determine the possible risk factors for atopic dermatitis in home environment . A self-administered question naire was h and led to the parents of 2,100 children aged 7 to 15 years , from three r and omized primary schools and 1,644 ( 78.9 % ) completed and returned the question naire . The question naire included the United Kingdom Working Party diagnostic criteria and asked about conditions that could affect the course of atopic dermatitis . The prevalence of atopic dermatitis and coexisting factors that may affect the course of the disease were evaluated in 1,644 children ( 825 girls and 819 boys ) . The prevalence of atopic dermatitis was detected as 4.9 % . Passive smoking , heating systems either in the house or in the child 's bedroom , and the number of people living in the house had no significant effect ( p > 0.005 ) . The difference in prevalence of atopic dermatitis between developed and developing countries is striking . The determination of the factors that have an influence in this issue will probably enable us to change the course and frequency of atopic dermatitis Output:	Active and passive exposure to smoke are associated with increased AD prevalence
MS2825	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective : Compare results of cochlear implantation in younger and older adults in the domains of disability and h and icap , as well as in tests of word recognition and localization , across unilateral implant ( CI ) , bilateral ( CI + CI ) , and CI with an acoustic hearing aid in the nonimplanted ear ( CI + HA ) . Design : Three parts : retrospective ( postimplant only ) analysis ; prospect i ve ( preimplant versus postimplant ) ; correlation between age and benefit from CI versus CI + CI . Two age groups , older and younger than 60 years , for the first 2 analyses ; age is a continuous variable for the third analysis . Setting : Tertiary referral hospital clinic . Patients : Postlingually severely-to-profoundly hearing-impaired adults : Totals of 68 CI , 36 CI + CI , and 38 CI + HA in the retrospective part of the study ; totals of 30 CI , 18 CI + CI , and 16 CI + HA in the prospect i ve parts . Numbers vary from these totals on individual measures . Interventions : Patients receive either 1 or 2 cochlear implants ; some with 1 CI opt to retain a hearing aid in the nonimplanted ear . Outcome Measures : Principal measures : Hearing H and icap Inventory for the Elderly , Hearing H and icap Question naire , Speech , Spatial and Qualities of Hearing Scale , word recognition test , and soundfield localization test . The study is exploratory , but proceeding from a null hypothesis of no expected contrast as a function of patient age . Results : All patient groups show significant benefit after implantation . No significant age-related differences are observed in patients with unilateral implant , nor in CI + HA group . In the CI + CI group , the younger cohort showed very substantial increases in both performance and self-rated abilities ; the older cohort provides more mixed outcomes . Conclusion : Results for the CI group confirm and extend earlier research . The result for the younger group of CI + CI patients demonstrates the consistent incremental benefit obtained from a bilateral procedure . The mixed outcome observed in the older CI + CI group might be due to individual differences in interaction between effects of aging and the ability to integrate binaural cues Objective : The purpose of the study was to investigate sound localization with bilateral and unilateral cochlear implants . Design : Sound localization tests were performed on 20 bilaterally implanted MED-EL COMBI 40/40 + users . All subjects were bilaterally implanted during adolescence or later . Sound localization was tested in the frontal horizontal plane by using 9 equally spaced loudspeakers and speech-shaped noise bursts at r and omized levels . Results : The group of subjects who were bilaterally deafened after 5 to 6 yr of age ( 18 subjects ) showed a statistically significant improvement in sound localization when using both implants , compared with when using only one . The mean deviation between the presentation azimuth and the response azimuth was 16.6 ° when using both implants , which was on average 37.1 ° smaller than when using one implant only . When adjusted for the localization error that was constant across loudspeakers , the mean deviation was 15.9 ° for bilateral implant use , representing an improvement of 30.1 ° over unilateral implant use . Statistical analysis showed that in this group , performance measures were not correlated with subject details such as age at onset of deafness or duration of unilateral implant use . In contrast , subjects who were bilaterally deafened before 6 yr of age ( 2 subjects ) did not show a benefit in sound localization from bilateral implants . Conclusions : Bilateral cochlear implants offer a substantial benefit in sound localization to late-deafened , late-implanted subjects . The very limited data from early-deafened subjects implanted at a later age could suggest that these subjects may not benefit in sound localization from bilateral cochlear implants . It is possible that early implantation for early deafened subjects might allow better acquisition of spatial hearing , thus leading to improved localization performance OBJECTIVES To evaluate sound and speech perception and quality of life in prelingually deafened adults implanted with state of the art devices . To investigate which patient factors influence postoperative performance . STUDY DESIGN Prospect i ve intervention study . METHODS Eight prelingually deafened subjects ( with onset of severe hearing impairment before the age of 4 years and functioning in an oral-aural setting ) participated in this study . Subjects were implanted at a mean age of 36 ( range , 21 - 55 ) years with a CII or 90 K cochlear implant ( Advanced Bionics Corp. ) . All subjects completed st and ard speech perception tests as well as quality of life measures ( Health Utility Index Mark-II , Nijmegen Cochlear Implant Question naire , visual analogue scale for subject 's hearing and health ) at different points in time . Postoperative scores were compared with each other and with the baseline preoperative scores . The relationship between nine patient variables and the postoperative consonant-vowel-consonant ( CVC ) phoneme score was also investigated . RESULTS Significant improvement was measured for CVC word and phoneme scores and several quality of life measures . Postoperative speech perception correlated with a new and promising factor named quality of a patient 's own speech production ( QoSP ) . CONCLUSION With state of the art implants , speech perception and quality of life do improve in prelingually deafened adults . More importantly , the prognostic value of QoSP should be investigated further Objective : Preliminary studies show that bilateral cochlear implantation improves speech-recognition ability in many subjects ; however , the magnitude of this improvement has been variable . The objective of our research was to explore means to better differentiate the binaural benefit that many patients who receive bilateral cochlear implants ( CIs ) describe . Hypothesis : Binaural improvements in speech-perception performance will be consistently evident across patients when they are tested in more challenging listening situations . Design : This was a prospect i ve clinical study . Speech-perception performance was compared between the unilateral and bilateral cochlear implant conditions . Because the purpose was to investigate testing parameters that would demonstrate binaural benefit , word- and sentence-recognition tests were administered under several stimulation conditions : with and without noise and at three presentation levels . In addition , all subjects completed the Abbreviated Profile of Hearing Aid Benefit as a measure of subjective benefit . Subjects were adult cochlear implant recipients . Three device manufacturers were represented ( Advanced Bionics Corporation , Cochlear Americas , and the Med-El Corporation ) ; three patients received simultaneous implantation , and the other four patients received sequential CIs . The setting was a comprehensive cochlear implant program/tertiary referral center . The main outcomes measures were speech-recognition scores in percent correct , mean score difference for unilateral versus bilateral conditions , and subjective benefit scores . Results : The most significant improvements in binaural cochlear implant use were found when subjects were tested with sentence material presented at 60 dB SPL with a + 8 dB signal-to-noise ratio . Six of seven subjects showed significant binaural improvement , with a mean improvement score of 12.43 % ( SD = 5.32 ) . All subjects preferred the binaural listening condition . Measured improvements in quality of life were seen . Conclusions : Preliminary study findings suggest that significant cochlear implant binaural benefit in speech perception may be observed when testing in more difficult listening situations ( i.e. , lower presentation levels and in noise ) . According to the outcome of our study , testing the binaural benefit of CIs requires consideration of suitable test material s and stimulation parameters OBJECTIVE To present the results of a survey administered to a group of early-deafened cochlear implants adults and to report the level of perceived benefit . DESIGN Prospect i ve . SETTING Large tertiary referral centre . METHOD A 47-item question naire design ed to evaluate cochlear implant use and benefit was sent to 42 early-deafened adult cochlear implant users . The question naire can be divided into seven subcategories : time of use , associated symptoms , communication , employment status and function , socialization , perceived benefit , and the impact on quality of life . Responses from 30 patients were received . RESULTS The majority of our patients use their cochlear implant all of their waking hours . The majority of patients continue to depend on lip-reading and hearing as their main mode of communication , although they reported improved lip-reading skills with their cochlear implant . Twenty-three patients ( 76.7 % ) were employed . Eleven patients had a change in employment subsequent to cochlear implantation , nine ( 81.8 % ) of whom attributed this to their cochlear implant . Our patients als reported greater independence , a greater sense of safety in their environment , and an improved social life . Twenty-nine patients ( 96.7 % ) said that they were satisfied with their implant , 28 ( 93.3 % ) said that they would go through the same process again , and 27 ( 90 % ) said that they would recommend it to a friend in a similar situation . Twenty-nine patients ( 96.7 % ) stated that the cochlear implant has had a positive effect on their quality of life . Family and peer support , prior auditory-verbal therapy , and a positive attitude were the most commonly cited factors in successful cochlear implant use . CONCLUSIONS Early-deafened adult cochlear implant users perceive significant benefit from cochlear implantation . Importantly , family and peer support , prior auditory-verbal therapy , and a positive attitude are considered important factors in maximizing this benefit Cochlear implants are indicated for elderly patients with severe-to-profound hearing loss ( sensorineural hearing loss ≥ 70 dB ) . Their use has been limited , possibly by the misconception that elderly patients will perform poorly . To document the performance of older adults ( ≥65 years old ) , we undertook a retrospective analysis of our postlingually deafened adult patients who underwent implantation with the CLARION Multi- Strategy Cochlear Implant and underwent formal audiologic analysis ( sentence recognition [ Central Institute for the Deaf , CID ] and monosyllabic word recognition [ consonant-noun-consonant , CNC ] ) . Both younger ( n = 20 ; mean age = 46.9 years ) and older ( n = 16 ; mean age = 71.5 years ) adults showed statistically significant increases in CID and CNC scores after cochlear implantation . No statistically significant difference could be detected in operative time , anesthesia time , length of hospitalization , or CID or CNC scores between the two age groups . We conclude that age should not be a criterion for deciding who should receive cochlear implants . ( Otolaryngol Head Neck Surg 2000;123:419 - 24 . Objective : The purpose of this 4-year longitudinal study was to assess the stability of the binaural benefits of head shadow , summation , and squelch for bilateral cochlear implant recipients and to quantify these benefits for the underst and ing of speech in noise . Design : This is a prospect i ve study of 9 patients who received simultaneous bilateral insertion of MED-EL COMBI + 40 cochlear implants in a single-stage operation at the University of North Carolina , Chapel Hill , NC . Each patient had postlingual deafness of short duration before insertion of the device . Each year , the patients were tested for word recognition using consonant-nucleus-consonant words in quiet and speech perception in noise using City University of New York sentences . These tests were administered using direct audio input to the implants . Head-related transfer functions were used to simulate speech in noise testing in a spatial environment . Speech was always presented at midline ( 0 ° ) , and the noise masker was presented at either side or midline ( −90 , 0 , + 90 degrees ) . Results : The binaural benefits of head shadow and summation effects developed early in the postoperative period and remained stable throughout the follow-up period . Squelch developed more slowly and was first demonstrated at 12 months after implantation but continued to increase beyond the first year of follow-up . Conclusion : Benefits of head shadow and summation emerge early and remain stable . However , squelch has the most protracted period of development , with increasing benefit after a year or more of implant experience . These data support the idea that binaural integration continues several years after insertion of bilateral cochlear implant devices Objective : To evaluate speech performance , in quiet and noise , and localization ability in adult patients who had undergone bilateral and simultaneous implantation . Study Design : Prospect i ve multi-center study . Methods : Twenty-seven adult patients with profound or total hearing loss were bilaterally implanted in a single-stage procedure , and simultaneously activated ( Med-El , Combi 40/40 + ) . Subjects were assessed before implantation and at 3 , 6 and 12 months after switch-on . Speech perception tests in monaural and binaural conditions were performed in quiet and in noise using disyllabic words , with speech coming from the front and a cocktail party background noise coming from 5 loudspeakers . Sound localization measurements were also performed in background noise coming from 5 loudspeakers positioned from –90 ° to + 90 ° azimuth in the horizontal plane , and using a speech stimulus . Results : There was a bilateral advantage at 12 months in quiet ( 77 ± 5.0 % in bilateral condition , 67 ± 5.3 % for the better ear , p < 0.005 ) and in noise ( signal-to-noise ratio + 15 dB : 63 ± 5.9 % in bilateral condition , 55 ± 6.9 % for the better ear , p < 0.05 ) . Considering unilateral speech scores recorded in quiet at 12 months , subjects were categorized as ‘ good performers ’ ( speech comprehension score ≥60 % for the better ear , n = 19 ) and ‘ poor performers ’ ( n = 8) . Subjects were also categorized as ‘ asymmetrical ’ ( difference between their 2 unilateral speech scores ≥ Output:	With regard to CI in elderly patients , the selected studies document an improvement of the quality of life and perceptive abilities after CI , even if the benefits were found to be inferior in patients over 70 years at the time of surgery . Thus , from the results of the studies included in the review , advanced age is not a contraindication for the CI procedure . With respect to unilateral CI , bilateral CI offers advantages in hearing in noise , in sound localization and less during hearing in a silent environment . However , high interindividual variability is reported in terms of benefits from the second implant . With regard to CI in prelingually deaf adults , the selected studies document benefits deriving from the CI procedure in terms of improvement of perceptive abilities and in the quality of life after CI , as well as subjectively perceived benefits .
MS2826	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Despite their beneficial effects on weight loss and blood lipids , high-protein ( HP ) diets have been shown to increase insulin resistance and diabetes risk , whereas high-cereal-fiber ( HCF ) diets have shown the opposite effects on these outcomes . OBJECTIVE We compared the effects of isoenergetic HP and HCF diets and a diet with moderate increases in both cereal fibers and dietary protein ( Mix diet ) on insulin sensitivity , as measured by using euglycemic-hyperinsulinemic clamps with infusion of [6,6-(2)H(2)]glucose . DESIGN We r and omly assigned 111 overweight adults with features of the metabolic syndrome to 1 of 4 two-phased , 18-wk isoenergetic diets by group-matching . Per 3-d food protocol s , the percentages of energy derived from protein and carbohydrates and the intake of cereal fiber per day , respectively , were as follows-after 6 wk : 17 % , 52 % , and 14 g ( control ) ; 17 % , 52 % , and 43 g ( HCF ) ; 28 % , 43 % , and 13 g ( HP ) ; 23 % , 44 % , and 26 g ( Mix ) ; after 18 wk : 17 % , 51 % , and 15 g ( control ) ; 17 % , 51 % , and 41 g ( HCF ) ; 26 % , 45 % , and 14 g ( HP ) ; and 22 % , 46 % , and 26 g ( Mix ) . Eighty-four participants completed the study successfully and were included in the final analyses . Adherence was supported by the provision of tailored dietary supplements twice daily in all groups . RESULTS Insulin sensitivity expressed as an M value was 25 % higher after 6 wk of the HCF diet than after 6 wk of the HP diet ( subgroup analysis : 4.61 ± 0.38 compared with 3.71 ± 0.36 mg · kg(-1 ) · min(-1 ) , P = 0.008 ; treatment × time interaction : P = 0.005 ) . Effects were attenuated after 18 wk ( treatment × time interaction : P = 0.054 ) , which was likely explained by lower adherence to the HP diet . HP intake was associated with a tendency to increased protein expression in adipose tissue of the translation initiation factor serine-kinase-6 - 1 , which is known to mediate amino acid-induced insulin resistance . Biomarkers of protein intake indicated interference of cereal fibers with dietary protein absorption . CONCLUSION Greater changes in insulin sensitivity after intake of an isoenergetic HCF than after intake of an HP diet might help to explain the diverse effects of these diets on diabetes risk . This trial is registered at clinical trials.gov as NCT00579657 OBJECTIVE Phytoestrogen consumption has been shown to reduce risk factors for cardiovascular disease . Type 2 diabetes confers an adverse cardiovascular risk profile particularly in women after menopause . The aim of this study was to determine whether a dietary supplement with soy protein and isoflavones affected insulin resistance , glycemic control , and cardiovascular risk markers in postmenopausal women with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 32 postmenopausal women with diet-controlled type 2 diabetes completed a r and omized , double blind , cross-over trial of dietary supplementation with phytoestrogens ( soy protein 30 g/day , isoflavones 132 mg/day ) versus placebo ( cellulose 30 g/day ) for 12 weeks , separated by a 2-week washout period . RESULTS Compliance with the dietary supplementation was > 90 % for both treatment phases . When compared with the mean percentage change from baseline seen after 12 weeks of placebo , phytoestrogen supplementation demonstrated significantly lower mean values for fasting insulin ( mean + /- SD 8.09 + /- 21.9 % , P = 0.006 ) , insulin resistance ( 6.47 + /- 27.7 % , P = 0.003 ) , HbA(1c ) ( 0.64 + /- 3.19 % , P = 0.048 ) , total cholesterol ( 4.07 + /- 8.13 % , P = 0.004 ) , LDL cholesterol ( 7.09 + /- 12.7 % , P = 0.001 ) , cholesterol/HDL cholesterol ratio ( 3.89 + /- 11.7 % , P = 0.015 ) , and free thyroxine ( 2.50 + /- 8.47 % , P = 0.004 ) . No significant change occurred in HDL cholesterol , triglycerides , weight , blood pressure , creatinine , dehydroepi and rosterone sulfate , and rostenedione , and the hypothalamic-pituitary-ovarian axis hormones . CONCLUSIONS These results show that dietary supplementation with soy phytoestrogens favorably alters insulin resistance , glycemic control , and serum lipoproteins in postmenopausal women with type 2 diabetes , thereby improving their cardiovascular risk profile BACKGROUND Red meat consumption has been associated with an increased risk of chronic diseases . However , its relationship with mortality remains uncertain . METHODS We prospect ively observed 37 698 men from the Health Professionals Follow-up Study ( 1986 - 2008 ) and 83 644 women from the Nurses ' Health Study ( 1980 - 2008 ) who were free of cardiovascular disease ( CVD ) and cancer at baseline . Diet was assessed by vali date d food frequency question naires and up date d every 4 years . RESULTS We documented 23 926 deaths ( including 5910 CVD and 9464 cancer deaths ) during 2.96 million person-years of follow-up . After multivariate adjustment for major lifestyle and dietary risk factors , the pooled hazard ratio ( HR ) ( 95 % CI ) of total mortality for a 1-serving-per-day increase was 1.13 ( 1.07 - 1.20 ) for unprocessed red meat and 1.20 ( 1.15 - 1.24 ) for processed red meat . The corresponding HRs ( 95 % CIs ) were 1.18 ( 1.13 - 1.23 ) and 1.21 ( 1.13 - 1.31 ) for CVD mortality and 1.10 ( 1.06 - 1.14 ) and 1.16 ( 1.09 - 1.23 ) for cancer mortality . We estimated that substitutions of 1 serving per day of other foods ( including fish , poultry , nuts , legumes , low-fat dairy , and whole grains ) for 1 serving per day of red meat were associated with a 7 % to 19 % lower mortality risk . We also estimated that 9.3 % of deaths in men and 7.6 % in women in these cohorts could be prevented at the end of follow-up if all the individuals consumed fewer than 0.5 servings per day ( approximately 42 g/d ) of red meat . CONCLUSIONS Red meat consumption is associated with an increased risk of total , CVD , and cancer mortality . Substitution of other healthy protein sources for red meat is associated with a lower mortality risk BACKGROUND & AIMS Type 2 diabetes ( DM ) disproportionally affects African Americans . Data on the association between egg consumption and risk of DM are sparse . We sought to examine whether egg consumption is associated with the prevalence and incidence of DM among African Americans . METHODS We analyzed baseline data from 4568 participants of the Jackson Heart Study . Egg consumption was obtained using a food frequency question naire design ed for this population . We used generalized estimating equations to calculate adjusted prevalence ratios of DM and Cox regression to estimate hazard ratios of DM with corresponding 95 % confidence intervals ( CI ) . RESULTS The average age was 55 ± 13 years and 64 % of subjects were women . The median frequency of egg consumption was 2/week for men and 1/week for women . The prevalence of DM was 22 % overall ( 21 % of men and 23 % of women ) . Multivariable adjusted prevalence ratio [ PR ( 95 % CI ) ] for DM were : 1.00 ( ref ) , 1.14 ( 0.90 - 1.44 ) , 1.33 ( 1.04 - 1.70 ) , 1.33 ( 1.06 - 1.68 ) , 1.26 ( 0.99 - 1.61 ) , and 1.52 ( 1.17 - 1.97 ) for egg consumption of < 1/month , 1 - 3/month , 1/week , 2/week , 3 - 4/week , and 5+/week , respectively , p for linear trend 0.0024 . Corresponding multivariable adjusted hazard ratios were 1.00 ( ref ) , 0.88 ( 0.65 - 1.19 ) , 0.94 ( 0.68 - 1.30 ) , 0.91 ( 0.66 - 1.25 ) , 1.11 ( 0.81 - 1.52 ) , and 1.17 ( 0.81 - 1.70 ) , respectively , during a mean follow up of 7.3 years ( p for linear trend 0.22 ) . CONCLUSIONS While egg consumption was positively associated with prevalent DM , prospect i ve analysis did not show an association of egg intake with incidence of DM among African Americans BACKGROUND & AIMS The effect of total dairy products , milk , and calcium intake on risk of type 2 diabetes ( T2D ) is uncertain , particularly in the Chinese population . METHODS The present study was based on a prospect i ve cohort of 63,257 Chinese men and women aged 45 - 74 years during enrollment ( 1993 - 1998 ) in Singapore . Dietary information was obtained using a vali date d 165-item semi-quantitative food-frequency question naire . Information about newly diagnosed T2D was collected by self-report during two follow-up interviews in 1999 - 2004 and 2006 - 2010 . Cox proportional hazard regression method was used to estimate hazard ratios ( HRs ) and their 95 % confidence intervals ( CIs ) in 45,411 eligible participants . RESULTS Incidence rate ( 95 % CI ) of T2D was 10.5 ( 10.2 - 10.8 ) per 1000 person-years . Intake of dairy food was significantly associated with reduced T2D risk ; compared with the lowest quartile , HRs ( 95 % CI ) for the second , third and fourth quartiles of dairy intake were 0.98 ( 0.91 - 1.06 ) , 0.96 ( 0.89 - 1.03 ) and 0.90 ( 0.83 - 0.98 ) , respectively , after adjustment for potential confounders at baseline ( P-trend = 0.01 ) . Daily drinkers of milk had a significant 12 % reduction in T2D risk compared with non-drinkers . While dairy calcium was associated with a decreased risk of T2D ( HR comparing extreme quartiles 0.84 ; 95 % CI 0.76 - 0.93 ; P-trend = 0.001 ) , no association was found for non-dairy calcium ( HR 1.02 ; 95 % CI 0.92 - 1.14 ; P-trend = 0.61 ) . CONCLUSIONS In this large cohort study of Chinese adults , dairy product intake and daily milk consumption was associated with a statistically significant , although modest , decrease in risk of developing T2D , which may be independent of its calcium content Objective To examine relationships between fish consumption and plasma selenium ( Se ) and red blood-cell fatty acid ( RBC FA ) profile in aged subjects . We hypothesised that the importance of Se has been underestimated when interpreting the beneficial effect of fish consumption on health . Design Cross-sectional analysis of data from a prospect i ve cohort study . Setting The EVA study in Nantes , France (1991–2002).Subjects200 subjects aged 69 y with information on RBC FAs , plasma Se and completed food frequency question naires . Methods We examined correlations between the most abundant FAs , Se and number of fish meals per week . Linear regression models were used . Results Plasma Se was negatively correlated with RBC 6 poly-unsaturated FA ( PUFAs ) and positively with 3 PUFAs . Plasma Se , RBC 3 PUFAs , docosahexaenoic acid ( DHA ) and eicosapentaenoic acid ( EPA ) increased with fish consumption . Conversely , levels of 6 PUFAs were lower in the highest fish consumption group . All associations between plasma Se and fish consumption remained significant when adjusting for 6 PUFAs alone or additionally for age , sex , education , diabetes , hypertension , d Output:	This meta- analysis shows that total protein and animal protein could increase the risk of T2DM in both males and females , and plant protein decreases the risk of T2DM in females . The association between high-protein food types and T2DM are also different . Red meat and processed meat are risk factors of T2DM , and soy , dairy and dairy products are the protective factors of T2DM . Egg and fish intake are not associated with a decreased risk of T2DM .
MS2827	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIMS AND OBJECTIVES To detect problems when classifying pressure ulcers and to examine whether an e-learning program is able to increase the classification skills of qualified nurses and nursing students . BACKGROUND Both the distinction between pressure ulcer grade s and the differentiation between moisture lesions is difficult . Misclassification and incorrect identification of the lesions results in inadequate preventive and therapeutic measures . Education and training are important for spreading evidence -based insights about this topic . DESIGN Repeated measure design , consisting of one pretest and three posttests . METHODS The experimental intervention consisted of a one-hour session during which the participants independently went over an e-learning program . The control intervention consisted of a one-hour lecture . Both interventions had the same learning contents . A convenience sample of 212 qualified nurses and 214 final-year nursing students was r and omly assigned to an experimental- and a control group . RESULTS In the pretest , the classification skills were low . After the intervention , these skills improved significantly in both groups . The nursing students achieved better results when using the e-learning program . Among the qualified nurses , there was no difference between the learning methods . Although the classification skills decreased in the posttests , they did not drop under the level of the pretest . CONCLUSION The actual classification system does not provide the necessary information about the severity of a pressure ulcer . The differential diagnosis between a moisture lesion was complicated . The classification skills of the qualified nurses and nursing students increased by both learning methods . Repetition remains , however , necessary . RELEVANCE TO CLINICAL PRACTICE Both instruction methods are adequate to acquire the knowledge about the differences between moisture lesions and pressure ulcers . E-learning allows study ing in one 's own time and place , and could therefore be very suitable for repetition of the training . How to organise this training could be a subject for further research OBJECTIVE Nurses need to be competent and confident in performing drug calculations to ensure patient safety . The purpose of this study is to compare an interactive e-drug calculations package , developed using Cognitive Load Theory as its theoretical framework , with traditional h and out learning support on nursing students ' drug calculation ability , self-efficacy and support material satisfaction . DESIGN A cluster r and omised controlled trial comparing the e-package with traditional h and out learning support was conducted with a September cohort ( n=137 ) and a February cohort ( n=92 ) of second year diploma nursing students . Students from each cohort were geographically dispersed over 3 or 4 independent sites . MEASUREMENTS Students from each cohort were invited to participate , halfway through their second year , before and after a 12 week clinical practice placement . During their placement the intervention group received the e-drug calculations package while the control group received traditional ' h and out ' support material . Drug calculation ability and self-efficacy tests were given to the participants pre- and post-intervention . Participants were given the support material satisfaction scale post-intervention . RESULTS Students in both cohorts r and omised to e-learning were more able to perform drug calculations than those receiving the h and out ( September : mean 48.4 % versus 34.7 % , p=0.027 ; February : mean 47.6 % versus 38.3 % , p=0.024 ) . February cohort students using the e-package were more confident in performing drug calculations than those students using h and outs ( self-efficacy mean 56.7 % versus 45.8 % , p=0.022 ) . There was no difference in improved self-efficacy between intervention and control for students in the September cohort . Students who used the package were more satisfied with its use than the students who used the h and out ( mean 29.6 versus 26.5 , p=0.001 ) , particularly with regard to the package enhancing their learning ( p=0.023 ) , being an effective way to learn ( p=0.005 ) , providing practice and feedback ( p<0.001 ) , being accessible ( p=0.027 ) , user friendly ( p=0.02 ) and providing learning enjoyment ( p=0.022 ) . CONCLUSION It is essential that nurses are educated and supported to become , and remain , confident and competent in performing drug calculations . This study found the e-drug calculations package , based on Cognitive Load Theory , to be significantly more effective than a h and out in improving students ' drug calculation ability and self-efficacy , with students who used the package being significantly more satisfied with its use than students who used the h and out . This package could particularly be useful for the continuing professional development of any healthcare professional involved in drug calculations Oral healthcare providers have a clinical opportunity for early detection of disordered eating behaviors because they are often the first health professionals to observe overt oral and physical signs . Curricula regarding early recognition of this oral/systemic medical condition are limited in oral health educational programs . Web-based learning can supplement and reinforce traditional learning and has the potential to develop skills . The study purpose was to determine the efficacy of a theory-driven Web-based training program to increase the capacity of oral health students to perform behaviors related to the secondary prevention of disordered eating behaviors . Using the Reach , Effectiveness , Adoption , Implementation and Maintenance evaluation framework , a longitudinal group-r and omized controlled trial involving 27 oral health classes from 12 oral health education programs in the United States was implemented to assess the efficacy of the Web-based training on attitudes , knowledge , self-efficacy and skills related to the secondary prevention of disordered eating behaviors . Mixed-model analysis of covariance indicated substantial improvements among students in the intervention group ( effect sizes : 0.51 - 0.83 ) on all six outcomes of interest . Results suggest that the Web-based training program may increase the capacity of oral healthcare providers to deliver secondary prevention of disordered eating behaviors . Implication s and value of using the Reach , Effectiveness , Adoption , Implementation and Maintenance framework are discussed The objective of this study was to evaluate the effectiveness of e-learning as a supplement to on-campus education for the acquisition of skills in palpation and ultrasound examination of the knee in a physiotherapy degree course . Forty-six students ( 28 females ) from the University of Granada , with a mean age of 21.5 yrs , received 4 h of theoretical and practical on-campus training on palpation and ultrasound examination of the knee joint . They were then r and omly distributed into two groups : experimental , with free access to the ECOFISIO website on musculoskeletal palpation and ultrasound assessment ; and control , with access to documents and books on the topic . Structured objective clinical evaluation ( SOCE ) and multiple-choice question naire ( MCQ ) were used to assess the educational intervention . We also measured the time taken by the students to generate a reliable ultrasound image and to localize a specific knee structure by palpation . There was no significant intergroup difference in the acquisition of theoretical knowledge as assessed by the MCQ ( p = 0.39 ) . Scores were significantly higher in the experimental group than in the control group for skills in palpation ability ( p = 0.041 ) and ultrasound assessment ( p < 0.001 ) of the knee . Students in the e-learning group needed less time to palpate the musculoskeletal structure ( p = 0.041 ) but more time ( p = 0.012 ) to obtain their superior ultrasound images . In conclusion , these results contribute evidence that e-learning is an effective educational strategy for physiotherapy students to acquire skills in palpation and ultrasound imaging of the knee as a supplement to on-campus education The purpose of the study was to assess the effectiveness of supplementing traditional classroom teaching with Web-based learning design when teaching intramuscular injection nursing skills . Four clusters of nursing students at a junior college in eastern Taiwan were r and omly assigned to experimental and control groups . A total of 147 students ( 80 in the experimental group , 67 in the control group ) completed the study . All participants received the same classroom lectures and skill demonstration . The experimental group interacted using a Web-based course and were able to view the content on dem and . The students and instructor interacted via a chatroom , the bulletin board , and e-mail . Participants in the experimental group had significantly higher scores on both intramuscular injection knowledge and skill learning . A Web-based design can be an effective supplementing learning tool for teaching nursing knowledge and skills Purpose Computer-based methods of instruction offer the possibility of helping medical students to learn clinical skills and professionalism . Without rigorous documentation of its pedagogic advantages , the utility of Internet-based teaching is not solidly grounded . The authors carried out a prospect i ve , r and omized study of educational outcomes , comparing a traditional classroom course in clinical ethics with the same course supplemented by Internet-based discussion . Methods Introduction to Clinical Ethics is a sophomore medical school course that teaches a specific method for analyzing clinical ethical problems . One sophomore class was r and omly assigned to either classroom teaching alone ( traditional group ; n = 65 ) or classroom teaching supplemented with Internet-based discussion s of cases illustrating ethical issues ( Internet component group ; n = 62 ) . A final case analysis comprehensively evaluated students ' underst and ing of the analytic method taught in the course . Grade s for both groups on the final case analyses , which were rated by two external review ers , were compared . Results The students ' underst and ing of ethical analysis , as measured by grade s of external review ers on the final paper , was significantly higher for those in the course with the Internet component than it was for those in the traditional course ( 3.0 ± 0.6 and 2.6 ± 0.7 , respectively ; p < .005 ) . Conclusion The study documents the incremental value of Internet-based teaching of clinical ethics to sophomore medical students Background Electronic Voting Systems have been used for education in a variety of disciplines . Outcomes from these studies have been mixed . Because results from these studies have been mixed , we examined whether an EVS system could enhance a lecture 's effect on educational outcomes . Methods A cohort of 127 Year 5 medical students at the University of Adelaide was stratified by gender , residency status and academic record then r and omised into 2 groups of 64 and 63 students . Each group received consecutive 40-minute lectures on two clinical topics . One group received the EVS for both topics . The other group received traditional teaching only . Evaluation was undertaken with two , 15- question multiple-choice question naires ( MCQ ) assessing knowledge and problem solving and undertaken as a written paper immediately before and after the lectures and repeated online 8–12 weeks later . St and ardised institutional student question naires were completed for each lecture and independent observers assessed student behaviour during the lectures . Lecturer 's opinions were assessed by a question naire developed for this study . Results Two-thirds of students r and omised to EVS and 59 % of students r and omised to traditional lectures attended . One-half of the students in the EVS group and 41 % in the traditional group completed all question naires . There was no difference in MCQ scores between EVS and traditional lectures ( p = 0.785 ) . The cervical cancer lectures showed higher student ranking in favour of EVS in all parameters . The breast cancer lectures showed higher ranking in favour of traditional lectures in 5 of 7 parameters ( p < 0.001 ) . The observed higher-order lecturer-students interactions were increased in the EVS lecture for one lecturer and reduced for the other . Both lecturers felt that the EVS lectures were difficult to prepare , that they were able to keep to time in the traditional lectures , that the educational value of both lecture styles was similar , and that they were neutral-to-slightly favourably disposed to continue with the EVS technology . The 2 lecturers disagreed regarding the ease of preparation of the traditional lecture , their ability to keep to time in the EVS lecture , and personal satisfaction with the EVS lecture . The lecturers felt that EVS encouraged student participation and helped identify where students were having difficulty . Conclusion In this setting , EVS technology used in large group lectures did not offer significant advantages over the more traditional lecture format OBJECTIVE The purpose of this study is to compare whether students ' learning outcomes would be better in a design ed learning environment ( WebCT ) than in a conventional web site ( WWW ) with similar course material but without special learning tools . CONTEXT Third-year medical students in an introductory course on medical informatics at the University of Helsinki , Finl and . METHODS Students were r and omly assigned to a WebCT group ( n=39 ) and a WWW group ( n=46 ) . The students in the WebCT group utilized the course material in general discussion groups , special discussion s about lectures , quizzes and students ' own notes . The WWW group had access only to the course material . The learning outcome was assessed by administering an on-line examination and the learning experience of the students was assessed by an on-line quiz . RESULTS The course grade was significantly higher in the WebCT group as compared to the WWW group . This finding was more prominent among females . The students of the WebCT group also experienced significantly more improvement in collaboration with the use of computers than the students in the WWW group . CONCLUSIONS Based on our results , web-based learning seems to be more effective when students are provided with specially design ed learning tools OBJECTIVES To compare the effectiveness of small-group training in correct inhaler technique with self-directed Internet-based training . DESIGN Pharmacy students were r and omly allocated to 1 of 2 groups : small-group training ( n = 123 ) or self-directed Internet-based training ( n = 113 ) . Prior to intervention delivery , all participants were given a placebo Turbuhaler and product information leaflet and received inhaler technique training based on their group . Technique was assessed following training and predictors of correct inhaler technique were examined . ASSESSMENT There was a significant improvement in the number of participants demonstrating correct technique in both groups ( small group training , 12 % to 63 % ; p < 0.05 ; and Internet-based training , 9 % to 59 % ; p < 0.05 ) post intervention , with no significant difference between the groups in the percent change ( n = 23 Output:	The current evidence base suggests that online eLearning is equivalent , possibly superior to traditional learning .
MS2828	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Post-thrombotic syndrome varies from mild oedema to incapacitating swelling with pain and ulceration . We investigated the rate of post-thrombotic syndrome after a first episode of deep-vein thrombosis and assessed the preventive effect of direct application of a sized-to-fit grade d compression stocking . METHODS Patients with a first episode of venogram-proven proximal deep-vein thrombosis were r and omly assigned no stockings ( the control group ) or made-to-measure grade d compression elastic stockings for at least 2 years . Post-thrombotic syndrome was assessed with a st and ard scoring system that combined clinical characteristics and objective leg measurements . Patients were assessed every 3 months during the first 2 years , and every 6 months thereafter for at least 5 years . The cumulative incidence of mild-to-moderate post-thrombotic syndrome was the primary outcome measure . FINDINGS Of the 315 consecutive out patients considered for inclusion , 44 were excluded and 77 did not consent to take part . 194 patients were r and omly assigned compression stockings ( n = 96 ) or no stockings ( n = 98 ) . The median follow-up was 76 months ( range 60 - 96 ) in both groups . Mild-to-moderate post-thrombotic syndrome ( score > or = 3 plus one clinical sign ) occurred in 19 ( 20 % ) patients in the stocking group and in 46 ( 47 % ) control-group patients ( p < 0.001 ) . 11 ( 11 % ) patients in the stocking group developed severe post-thrombotic syndrome ( score > or = 4 ) , compared with 23 ( 23 % ) patients in the control group ( p < 0.001 ) . In both groups , most cases of post-thrombotic syndrome occurred within 24 months of the acute thrombotic event . INTERPRETATION About 60 % of patients with a first episode of proximal deep-vein thrombosis develop post-thrombotic syndrome within 2 years . A sized-to-fit compression stocking reduced this rate by about 50 % Fibrinolytic treatment of acute deep vein thrombosis ( DVT ) of the leg with high-dose streptokinase ( SK ) ( 100,000 U/h ) in 39 cases , or low-dose SK ( approx 10,000 U/h ) in combination with low-dose heparin in 41 cases , was studied in a prospect i ve r and omized trial . The degree of thrombolysis was similar in both groups and did not correlate with age or size of the thrombus or with fibrinogen level . The degree of late recanalization was also similar in both groups . There were however significantly more patients with postthrombotic changes in the low-dose group than in the high-dose group after a mean follow-up time of 31 and 38 months respectively . In the low-dose group 2 intracranial hemorrhages occurred ( one was fatal ) and one patient died of pulmonary embolism , but there were significantly less allergic side effects to SK . There were no cases of such serious side effects in the highdose group . Although low-dose SK has equal thrombolytic effect it seems inferior to high-dose SK , since it probably causes more severe hemorrhagic side-effects In a prospect i ve study , 174 patients ( 118 women and 56 men , average age 44 years , range 14 to 82 ) with proximal extensive thrombosis received streptokinase ( 100,000 U/hour ) for an average of 2.8 days ( range 0.5 to 7 ) through the catheter of a temporary caval filter . Twenty-seven of 45 ( 60 % ) patients with nonocclusive clots were completely free of clots at the second phlebography versus 17 of 116 ( 14 % ) with occlusive clots ( p less than 0.001 ) . Among nonocclusive clots , proximal ones ( caval , iliac and femoral ) were more easily lysed than popliteal clots ( 88 of 116 [ 76 % ] vs 26 of 58 [ 45 % ] ; p less than 0.001 ) . In 41 of 132 ( 31 % ) patients , a daily injection of contrast medium through the filter-carrying catheter enabled the observation of a clot in the filter , which was lysed by streptokinase . Seventy patients with follow-up greater than 2 years ( median 34 months ) were examined clinical ly . Nineteen of 22 ( 86 % ) patients with venograms free of clots at discharge were free of clinical sequelae versus 16 of 48 ( 33 % ) without normal venograms ( p less than 0.001 ) . It is concluded that : ( 1 ) in the case of occlusive clots , only a few patients were normalized after streptokinase ; ( 2 ) proximal nonocclusive clots were most effectively lysed ; ( 3 ) when venograms were free of clots at discharge , the majority of patients did not have venous sequelae at follow-up ; and ( 4 ) embolic migration seems to occur frequently with streptokinase Twenty patients with clinical signs of deep vein thrombosis of a duration not exceeding 72 hours , and with the condition confirmed phlebographically , were r and omly allocated to one of two groups in a double-blind study . In group 1 the patients received urokinase in a low-dose regimen of 200 000 Ploug units during the first 24 hours , followed by infusion of heparin , 40 000 units daily during the next 5 days . Patients in group 2 received heparin only , 40 000 units daily for 6 days . The clinical course was assessed daily . When the infusion period was completed , the phlebography was repeated , and the results of the two examinations were compared with respect to extent of filling defects and the degree of non-filling of the deep veins . We found no superiority in the regimen consisting of urokinase preceding heparin infusion , compared with that of heparin infusion alone . Most of the patients improved clinical ly during the 6-day infusion period , but the degree of thrombosis , evaluated phlebographically , was unaltered or even deteriorated during the period in all patients except two . Overt bleeding was noted in 6 patients Nineteen cases were reinvestigated 8 - 14 years after treatment with SK or heparin . Judging from personal interviews , foot volumometry and phlebography , treatment with SK appears to be more preferable since it was less often followed by late severe postthrombotic changes In a prospect i ve study all positive phlebographies within the well-defined population of the city of Malmö , Sweden , during 1987 were studied in order to determine the incidence of deep venous thrombosis ( DVT ) . Epidemiological data were analysed for the detection of patient groups at increased risk of DVT . The incidence was found to be equal for both sexes , i.e. 1.6 per 1000 inhabitants a year . Risk factors were found to be in accordance with earlier studies . The median age for men was 66 years , compared to 72 years for women . At diagnosis of DVT , 19 % of subjects had a known malignancy and within 1 year 5 % ( 19 cases ) developed a new malignancy . Of the men , 29 % had postoperative or post-traumatic ( fracture ) DVT , compared to 46 % of the women . Fewer patients with DVT than expected ( 39 % ) belonged to blood group 0 ( 31 % ) ( P less than 0.005 ) . Pulmonary embolism ( PE ) was clinical ly suspected in only 5 % of cases , and diagnosis was verified scintigraphically in 2 % of cases . None of these died of PE , but of 6 patients who were found to have PE at autopsy , four died about 4 weeks after the DVT was diagnosed In a prospect i ve and r and omized multicenter trial the efficacy of intermittent regional and systemic thrombolytic therapy for DVT was evaluated . 137 patients with phlebographically confirmed acute DVT above the calf region were treated with 20 mg of rt-PA for 4 h each day . Thrombolysis was applied either locally via a dorsal pedal vein of the firmly b and aged affected leg or systemically using a cubital vein . Treatment lasted for 4 - 7 days , and during this time unfractionated heparin was applied continuously with the dosage adjusted according to aPTT ( 1.5 - 2.0 times the normal value ) . A second phlebography was performed within 24 h after the end of treatment . Results were evaluated by an independent radiologist who was unaware of the treatment given . Significant thrombolytic results ( e.g. lysis of more than 50 % of the original thrombus and complete recanalization of all affected veins ) were reached in only 1/3 of all patients . Rates of recanalization did not differ in both groups and bleeding complications occurred in 26.5 % . We conclude that intermittent local or systemic application of 20 mg rt-PA seems to be ineffective in the treatment of DVT Bolus urokinase ( Abbokinase ) is effective for initial treatment of deep venous thrombosis but is associated with a high rate of rigors . This r and omized controlled trial was undertaken among patients with deep venous thrombosis to evaluate the efficacy and safety of a novel thrombolytic agent , recombinant urokinase ( rUK ) , administered as three bolus infusions of 1 million U over a 24-hour period versus heparin alone . Of 361 patients with DVT screened , 17 ( 5 % ) were enrolled . Recent surgery was the most common reason for exclusion ( n = 113 , 31 % ) . Images of the patients were obtained at baseline , 24 to 48 hours after r and omization , and before hospital discharge . Two patients in each treatment group had minor clot progression . One patient in the heparin group had no change ; all other patients showed mild ( < 50 % ; n = 5 in each group ) or moderate ( > 50 % ; n = 1 in each group ) improvement . No bleeding complications or rigors developed in patients r and omized to rUK . Mean bleeding times among patients given rUK were not significantly different from mean values of patients given heparin at any of the measured time points available for comparison ( 331 vs 387 seconds at baseline and 381 vs 416 seconds at 24 hours ) . However , mean fibrinogen levels declined with successive urokinase boluses and were significantly lower than levels in patients treated with heparin at 24 ( 233 mg/dl vs 466 mg/dl , p = 0.01 ) and 48 hours ( 270 mg/dl vs 474 mg/dl , p = 0.02 ) . Although bolus rUK had a favorable safety profile , rUK was no more effective than heparin in achieving clot lysis at the doses used in this trial A controlled , prospect i ve study comparing streptokinase and heparin treatment has been completed in 51 patients presenting with acute proximal venous thrombosis of less than 8 days ' clinical duration . Patients were studied by means of pre‐treatment , post‐treatment , 3‐ and 12‐monthly phlebography and pulmonary perfusion scanning and were followed up at 3‐monthly intervals PURPOSE To compare the efficacy and safety of recombinant human tissue-type plasminogen activator ( rt-PA , supplied as Activase ) with heparin alone or rt-PA plus heparin in the treatment of venographically documented proximal deep venous thrombosis ( DVT ) of the leg . PATIENTS AND METHODS Sixty-four patients underwent 65 r and omizations to rt-PA alone ( n = 36 ) , rt-PA plus heparin ( n = 17 ) , or heparin alone ( n = 12 ) in a prospect i ve , multicenter , r and omized , open-label trial , with efficacy assessed by a radiology panel unaware of treatment assignment . Patients r and omly assigned to rt-PA received 0.05 mg/kg/hour for 24 hours via a peripheral vein , with a maximum dose of 150 mg . All patients then received heparin and warfarin for the remainder of the hospitalization . Follow-up venography was performed 24 to 36 hours after initiation of therapy . RESULTS Complete or more than 50 % lysis occurred in 10 ( 28 % ) patients treated with rt-PA , five ( 29 % ) patients with rt-PA plus heparin , and no patient treated with heparin . No lysis occurred in 16 ( 44 % ) patients treated with rt-PA plus heparin , and 10 ( 83 % ) patients who received heparin alone ( p = 0.04 ) . There was one major complication , a nonfatal intracranial hemorrhage in a patient who received rt-PA alone . At 7 to 10 days after initiation of treatment , the level of serum glutamic oxaloacetic transaminase nearly doubled among all patients , including those assigned to receive heparin alone . CONCLUSION ( 1 ) rt-PA and rt-PA plus heparin cause more clot lysis than heparin alone ; ( 2 ) the addition of heparin to rt-PA does not improve the lysis rate ; ( 3 ) DVT treated with heparin is commonly associated with a rise in the transaminase level ; ( 4 ) Output:	The authors determined that thrombolysis therapy results in greater lysis and complication rates than does anticoagulation alone . The authors also found that PTS incidence is lower in patients treated with thrombolytics . Therefore , the authors conclude that although the lysis rate is greater for thrombolytic agents , they can not be recommended routinely for DVT treatment
MS2829	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Whether asthma morbidity in minority groups can be reduced by preventative health care measures delivered in the relevant ethnic dialects requires further evaluation . This study reports clinical outcomes and quality of life from a community based project investigating white European ( W/E ) and Indian subcontinent ( ISC ) ethnic groups with asthma living in deprived inner city areas of Birmingham , UK . METHODS Six hundred and eighty nine asthmatic subjects ( 345 W/E , 344 ISC ) of mean ( SD ) age 34.5 ( 15 ) years ( range 11–59 ) and mean forced expiratory volume in one second ( FEV1 ) of 80 % predicted were interviewed in English , Punjabi , Hindi , or Urdu . Subjects r and omised to the active limb of a prospect i ve , open , r and omised , controlled , parallel group , 12 month follow up study underwent individually based asthma education and optimisation of drug therapy with four monthly follow up ( active intervention ) . Control groups were seen only at the beginning and end of the study . Urgent or emergency interactions with primary and secondary health care ( clinical outcomes ) and both cross sectional and longitudinal data from an Asthma Quality of Life Question naire ( AQLQ ) were analysed . RESULTS Clinical outcomes were available for 593 subjects . Fewer of the active intervention group consulted their GP ( 41.8 % versus 57.8 % , odds ratio ( OR ) 0.52 ( 95 % CI 0.37 to 0.74 ) ) or were prescribed antibiotics ( 34.9 % versus 51.2 % , OR 0.51 ( 95 % CI 0.36 to 0.72 ) ) , but by ethnicity statistically significant changes occurred only in the W/E group with fewer also attending A&E departments and requiring urgent home visits . Active intervention reduced the number of hospital admissions ( 10 versus 30 ) , GP consultations ( 341 versus 476 ) , prescriptions of rescue oral steroids ( 92 versus 177 ) , and antibiotics ( 220 versus 340 ) , but again significant improvements by ethnicity only occurred in the active W/E group . AQLQ scores were negatively skewed to the higher values ; regression analysis showed that lower values were associated with ISC ethnicity . Longitudinal changes ( for 522 subjects ) in the mean AQLQ scores were small but statistically significant for both ethnic groups , with scores improving in the active and worsening in the control groups . CONCLUSIONS Active intervention only improved clinical outcomes in the W/E group . AQLQ scores , although lower in the ISC group , were improved by active intervention in both ethnic groups Background . Asthma , a leading chronic disease of children , currently affects about 6.2 million ( 8.5 % ) children in the United States . Despite advances in asthma research and availability of increasingly effective therapy , many children do not receive appropriate medications to control the disease , have overreliance on reliever medication , and lack systematic follow-up care . The situation is even worse for poor inner-city and minority children who have significantly worse asthma rates , severity , and outcomes . National Asthma Education and Prevention Program Guidelines recommend a multimodal , chronic care approach . Objective . The authors assessed the effectiveness of practice re design and computerized provider feedback in improving both practitioner adherence to National Asthma Education and Prevention Program Guidelines ( NAEPP ) , and patient outcomes in 295 poor minority children across four Federally Qualified Health Centers ( FQHC ) . Methods . In a nonr and omized , two-group ( intervention versus comparison ) , two-phase trial , all sites were provided re design support to provide quarterly well-asthma visits using structured visit forms , community health workers for outreach and follow-up , a Web-based disease registry for tracking and scheduling , and a provider education package . Intervention sites were given an additional Web-based , computerized patient-specific provider feedback system that produced a guideline -driven medication assessment prompt . Results . Logistic regression results showed that providers at intervention sites were more than twice as likely on average to prescribe guideline -appropriate medications after exposure to our feedback system during the Phase I enrollment period than providers at comparison sites ( exp(B ) = 2.351 , confidence interval [ CI ] = 1.315–4.204 ) . In Phase II ( the postenrollment visit period ) , hierarchical linear models ( HLMs ) and latent growth curves were used to show that asthma control improved significantly by .19 ( SE = .05 ) on average for each of the remaining four visits ( about 11 % of a st and ard deviation ) , and improved even more for patients at intervention sites . These results show that implementation of practice re design support guided by a pediatric chronic care model can improve provider adherence to treatment guidelines as well as patients ’ asthma control . Conclusions . The addition of patient-specific feedback for providers results in quicker adoption of guideline recommendations and potentially greater improvements in asthma control compared to the basic practice re design support alone OBJECTIVE To assess the outcomes of an education intervention for childhood asthma conducted by Australian Indigenous health care workers ( IHCWs ) . DESIGN AND SETTING R and omised controlled trial in a primary health care setting on Thursday Isl and and Horn Isl and , and in Bamaga , Torres Strait region of northern Australia , April 2005 to March 2007 . PARTICIPANTS 88 children , aged 1 - 17 years , with asthma diagnosed by a respiratory physician ( intervention group , 35 ; control group , 53 ; 98 % Indigenous children ) . INTERVENTIONS Children were r and omly allocated to : ( i ) three additional asthma education sessions with a trained IHCW , or ( ii ) no additional asthma education . Both groups were re-assessed at 12 months . MAIN OUTCOME MEASURES Primary endpoint : number of unscheduled visits to hospital or a doctor caused by asthma exacerbation . SECONDARY OUTCOMES measures of quality of life ( QoL ) and functional severity index ; asthma knowledge and underst and ing of asthma action plans ( AAPs ) ; and school days missed because of wheezing . RESULTS The groups were comparable at baseline ( except for asthma severity , which was adjusted for in the analysis ) . There were no significant differences in the primary outcome ( number of unscheduled medical visits for asthma ) . School children in the intervention group missed fewer school days because of wheezing ( 100 % < 7 days v 21 % of those in the control group missed 7 - 14 days ) . Significantly more carers in the intervention group could answer questions about asthma medication , knew where their AAP was kept ( 84 % v 56 % ) , and were able to describe the plan ( 67 % v 40 % ) . In both the intervention and control groups ( before- and -after comparison ) , there was a significantly reduced frequency of asthma exacerbations , as well as an improved QoL score and functional severity index , with no significant differences between the groups . CONCLUSIONS A community-based asthma education program conducted by trained IHCWs improves some important asthma outcomes in Indigenous children with asthma . TRIAL REGISTRATION Australian Clinical Trials Registry ACTRN012605000718640 OBJECTIVE To describe the management of asthma in children in a remote indigenous community and the delivery of subspecialist service through the indigenous health-care model . METHODOLOGY Children referred by indigenous health-care workers were evaluated prospect ively by paediatric respiratory physicians , based on a st and ardized protocol , at a primary health care setting at Thursday Isl and , Queensl and . RESULTS Forty of the 54 children referred with a provisional diagnosis of asthma did have asthma , with 30 % having persistent asthma . Only 59 % of parents knew the dose of the medication prescribed and 80 % had minimal knowledge of the medications . In 88 % of children , the management of asthma was improved by introduction of an appropriate spacer device and changing the dose and type of medications . CONCLUSIONS The management of children with asthma in the Torres region can be improved substantially by the use of age appropriate delivery devices and medications , and improving knowledge of asthma . Specialist delivery service to remote indigenous communities can be effectively delivered in partnership with the indigenous health service . The high proportion of persistent asthma in the Torres Straits community in comparison to urbanised Australia raises issues of inequity of appropriate medical service delivery to remote indigenous communities OBJECTIVE : Because asthma disproportionately affects minorities , we evaluated the effects of parent mentors ( PMs ) on asthma outcomes in minority children . METHODS : This r and omized , controlled trial allocated minority asthmatic children to the PM intervention or traditional asthma care . Intervention families were assigned PMs ( experienced parents of asthmatic children who received specialized training ) . PMs met monthly with children and families at community sites , phoned parents monthly , and made home visits . Ten asthma outcomes and costs were monitored for 1 year . Outcomes were examined by using both intention-to-treat analyses and stratified analyses for high participants ( attending ≥25 % of community meetings and completing ≥50 % of PM phone interactions ) . RESULTS : Patients were r and omly assigned to PMs ( n = 112 ) or the control group ( n = 108 ) . In intention-to-treat analyses , intervention but not control children experienced significantly reduced rapid-breathing episodes , asthma exacerbations , and emergency department ( ED ) visits . High participants ( but not controls or low participants ) experienced significantly reduced wheezing , asthma exacerbations , and ED visits and improved parental efficacy in knowing when breathing problems are controllable at home . Mean reductions in missed parental work days were greater for high participants than controls . The average monthly cost per patient for the PM program was $ 60.42 , and net savings of $ 46.16 for high participants . CONCLUSIONS : For asthmatic minority children , PMs can reduce wheezing , asthma exacerbations , ED visits , and missed parental work days while improving parental self-efficacy . These outcomes are achieved at a reasonable cost and with net cost savings for high participants . PMs may be a promising , cost-effective means for reducing childhood asthma disparities BACKGROUND Despite significant medical advances , many ethnic and racial minority children who live in inner cities continue to experience disproportionately high levels of asthma morbidity and mortality compared with white children . As a result , a growing number of psychosocial asthma management interventions are being developed to address their needs ; however , only a few of these interventions have incorporated cultural variables into their treatments and have had their efficacy evaluated . OBJECTIVE To examine the efficacy of the Multifamily Asthma Group Treatment ( MFAGT ) , design ed to enhance asthma management and reduce emergency department ( ED ) visits among African American and Hispanic families . METHODS Twenty-four African American and Hispanic families who have children with asthma were r and omly assigned to either the MFAGT or the St and ard Psychoeducational Asthma Intervention . Differences in the number of ED visits and the level of asthma management in both groups were compared 1 year before and 1 year after the intervention . In addition , these groups were contrasted to a control group that did not receive any psychoeducational intervention . RESULTS The MFAGT was significantly ( P = .04 ) more effective than the St and ard Psychoeducational Asthma Intervention and the control in decreasing ED visits and increasing parental asthma knowledge . CONCLUSIONS These preliminary results suggest that the MFAGT is efficacious in enhancing asthma management and in reducing ED visits in inner-city African American and Hispanic children from a lower socioeconomic background Although asthma self-management plans are widely recommended as essential in the long-term treatment of adult asthma , there have been few studies examining their use . Our objective was to assess the effect of a " credit card " adult asthma self-management plan in a community experiencing major health problems from asthma , by means of a before and after intervention trial of the efficacy of the " credit card " plan , when introduced through community-based asthma clinics . The participants were 69 Maori people with asthma . The " credit card " plan consisted of written guidelines for the self-management of asthma , based on self- assessment of asthma severity , printed on a plastic card . On one side , management guidelines were based on the interpretation of peak expiratory flow rate ( PEFR ) recordings , whilst the reverse side was based on symptoms . The outcome measures used were before and after comparison of markers of asthma morbidity and requirement for acute medical treatment ; and a structured question naire assessing the acceptability and use of the credit card plan . Following the introduction of the plan , the mean PEFR increased from 347 to 389 l.min-1 , the percentage of nights woken fell from 30.4 to 16.9 % , and the number of days " out of action " fell from 3.8 to 1.7 % . The requirements for acute medical treatment also fell during the intervention period . Most participants commented favourably on the content and usefulness of the plan . In the situation of worsening asthma , 28 % of subjects found the peak flow side of the card most helpful , 7 % the symptoms side , and 48 % found both sides equally helpful . ( ABSTRACT TRUNCATED AT 250 WORDS The aim of this study was to evaluate the effectiveness of an asthma education programme in moderate and severe asthma patients in a longitudinal , prospect i ve and r and omized study with a control group . Fifty-three asthmatic patients were studied , 26 of whom were Output:	The involvement of IHW in asthma programs targeted for their own ethnic group in 2 small trials was beneficial in improving most , but not all asthma outcomes in children with asthma . It is very likely that involvement of an IHW is beneficial .
MS2830	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Jeremy Keenan and colleagues report that during a cluster-r and omized clinical trial in Ethiopia , nasopharyngeal pneumococcal resistance to macrolides was significantly higher in communities r and omized to receive azithromycin compared with untreated control communities ABSTRACT Mean fecal global yeast counts increased similarly during 7 days of treatment with telithromycin ( 800 mg once daily ) or amoxicillin-clavulanic acid ( amoxiclav ) ( 1 g of amoxicillin and 125 mg of clavulanic acid 3 times daily ) in human volunteers and decreased slowly thereafter . On skin , coagulase-negative staphylococci of decreased susceptibility ( DS ) to telithromycin increased in the telithromycin group , whereas those with DS to methicillin increased in the amoxiclav group . A similar antibiotic-related shift towards homologous DS was observed for oral nongroupable streptococci ( NGS ) , but in addition , the prevalence of NGS resistant to both classes of antibiotics was significantly greater in the amoxiclav group at days 8 ( P < 0.01 ) and 45 ( P < 0.015 ) Background Synthesis of multiple r and omized controlled trials ( RCTs ) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions . Filtering of search es is time consuming , and no single method fulfills the principal requirements of speed with accuracy . Automation of systematic review s is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making . We developed Rayyan ( http://rayyan.qcri.org ) , a free web and mobile app , that helps expedite the initial screening of abstract s and titles using a process of semi-automation while incorporating a high level of usability . For the beta testing phase , we used two published Cochrane review s in which included studies had been selected manually . Their search es , with 1030 records and 273 records , were uploaded to Rayyan . Different features of Rayyan were tested using these two review s. We also conducted a survey of Rayyan ’s users and collected feedback through a built-in feature . Results Pilot testing of Rayyan focused on usability , accuracy against manual methods , and the added value of the prediction feature . The “ taster ” review ( 273 records ) allowed a quick overview of Rayyan for early comments on usability . The second review ( 1030 records ) required several iterations to identify the previously identified 11 trials . The “ suggestions ” and “ hints , ” based on the “ prediction model , ” appeared as testing progressed beyond five included studies . Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements . The survey respondents reported 40 % average time savings when using Rayyan compared to others tools , with 34 % of the respondents reporting more than 50 % time savings . In addition , around 75 % of the respondents mentioned that screening and labeling studies as well as collaborating on review s to be the two most important features of Rayyan . As of November 2016 , Rayyan users exceed 2000 from over 60 countries conducting hundreds of review s totaling more than 1.6 M citations . Feedback from users , obtained mostly through the app web site and a recent survey , has highlighted the ease in exploration of search es , the time saved , and simplicity in sharing and comparing include-exclude decisions . The strongest features of the app , identified and reported in user feedback , were its ability to help in screening and collaboration as well as the time savings it affords to users . Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of review ers ABSTRACT To investigate the effect of slow-release ( SR ) clarithromycin on colonization and the development of resistance in oropharyngeal and nasal flora , a double-blind , r and omized , placebo-controlled trial was performed with 8 weeks of follow-up . A total of 296 patients with documented coronary artery disease were r and omized in the preoperative outpatient clinic to receive a daily dose of SR clarithromycin ( 500 mg ) ( CL group ) or placebo tablets ( PB group ) until the day of surgery . Nose and throat swabs were taken before the start of therapy , directly after the end of therapy , and 8 weeks later . The presence of potential pathogenic bacteria was determined , and if they were isolated , MIC testing was performed . Quantitative culture on media with and without macrolides was performed for the indigenous oropharyngeal flora . In addition , analysis of the mechanism of resistance was performed with the macrolide-resistant indigenous flora . Basic patient characteristics were comparable in the two treatment groups . The average number of tablets taken was 15 ( st and ard deviation = 6.4 ) . From the throat swabs , Haemophilus parainfluenzae was isolated and carriage was not affected in either of the treatment groups . Nasal carriage of Staphylococcus aureus , however , was significantly reduced in the CL group ( from 35.3 to 4.3 % ) compared to the PB group ( from 32.4 to 30.3 % ) ( P < 0.0001 ; relative risk [ RR ] , 7.0 ; 95 % confidence interval [ CI ] , 3.1 to 16.0 ) . Resistance to clarithromycin was present significantly more frequently in H. parainfluenzae in the CL group after treatment ( P = 0.007 ; RR , 1.6 ; 95 % CI , 1.1 to 2.3 ) ; also , the percentage of patients with resistance to macrolides in the indigenous flora after treatment was significantly higher in the CL group ( 31 to 69 % ) ( P < 0.0001 ; RR , 1.9 ; 95 % CI , 1.4 to 2.5 ) . This persisted for at least 8 weeks . This study shows that besides the effective elimination of nasal carriage of S. aureus , treatment with SR clarithromycin for approximately 2 weeks has a marked and sustained effect on the development of resistance in the oropharyngeal flora for at least 8 weeks BACKGROUND Acute otitis media is the leading reason for antibiotic prescriptions in childhood . The increase in antibiotic resistance of Streptococcus pneumoniae is generally attributed to the extensive use of antibiotics and the selective pressure on the bacterial strains of the nasopharyngeal flora . OBJECTIVE To evaluate the change in nasopharyngeal carriage of S. pneumoniae during antibiotic therapy prescribed for acute otitis media . METHODS Between October , 1993 , and March , 1994 , we conducted a clinical trial comparing cefpodoxime-proxetil and amoxicillin-clavulanate in acute otitis media . From 364 children , 4 months to 4.5 years old , a nasopharyngeal sample was obtained before and after treatment . Antibiotic susceptibility was established by determining minimal inhibitory concentrations by the agar dilution method . Serotype and r and omly amplified polymorphic DNA analysis were used to compare pre- and posttreatment S. pneumoniae strains . RESULTS The risk for a child to carry penicillin-resistant S. pneumoniae ( MIC > or = 0.125 mg/l ) did not increase after antibiotic treatment : 84 of 364 ( 23.1 % ) before , 70 of 364 ( 19.2 % ) after . There was a significant decrease of penicillin-susceptible S. pneumoniae carriage , 117 of 364 ( 32.1 % ) before treatment compared with 24 of 364 ( 6.6 % ) ( P = 0.0001 ) after treatment . However , among the children carrying S. pneumoniae at the end of the treatment there was an increase in the percentage of penicillin-resistant pneumococci : 84 of 201 ( 41.8 % ) before treatment and 70 of 94 ( 74.5 % ) after treatment . Among the 94 children carrying S. pneumoniae at the end of the treatment , 22 did not harbor pneumococcus before , 16 carried another genotypically different serotype and 56 harbored the same serotype . Among these 56 children 2 patients harbored strains that had increased MICs for the tested beta-lactam antibiotics . The r and omly amplified polymorphic DNA analysis showed that in one case , the strains were genetically different . CONCLUSIONS These data illustrate that antibiotic therapy did not increase the rate at which children carried penicillin-resistant S. pneumoniae , but there was an increase in the rate of resistance among the children carrying pneumococci at the end of the treatment , mainly as a result of reduction of susceptible strains Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more PURPOSE To assess the ecologic impact , in terms of selection of beta-lactamase-producing respiratory tract bacteria , of a single course of peroral beta-lactam antibiotics . PATIENTS AND METHODS One-hundred fifty consecutive children with clinical signs of bacterial respiratory tract infection were r and omly assigned to a seven-day course of treatment with either penicillin V , amoxicillin , or cefaclor . Bacteriologic specimens were collected before treatment , at its termination , and at follow-up four weeks later . RESULTS All three drugs investigated caused a similar increase in beta-lactamase-producing bacteria , both in absolute and relative terms , an increase that persisted over a period of at least one month after completion of treatment . CONCLUSION Penicillin V , amoxicillin , and cefaclor all act as selective agents for beta-lactamase-producing bacteria in the upper respiratory tract . Treatment with a peroral beta-lactam antibiotic puts patients at risk of becoming persistent carriers of beta-lactamase-producing bacteria CONTEXT Emerging drug resistance threatens the effectiveness of existing therapies for pneumococcal infections . Modifying the dose and duration of antibiotic therapy may limit the spread of resistant pneumococci . OBJECTIVE To determine whether short-course , high-dose amoxicillin therapy reduces risk of posttreatment resistant pneumococcal carriage among children with respiratory tract infections . DESIGN AND SETTING R and omized trial conducted in an outpatient clinic in Santo Domingo , Dominican Republic , October 1999 through July 2000 . PARTICIPANTS Children aged 6 to 59 months who were receiving antibiotic prescriptions for respiratory tract illness ( n = 795 ) . INTERVENTIONS Children were r and omly assigned to receive 1 of 2 twice-daily regimens of amoxicillin : 90 mg/kg per day for 5 days ( n = 398 ) or 40 mg/kg per day for 10 days ( n = 397 ) . MAIN OUTCOME MEASURES Penicillin-nonsusceptible Streptococcus pneumoniae carriage , assessed in nasopharyngeal specimens collected at days 0 , 5 , 10 , and 28 ; baseline risk factors for nonsusceptible pneumococcal carriage ; and adherence to regimen , compared between the 2 groups . RESULTS At the day 28 visit , risk of penicillin-nonsusceptible pneumococcal carriage was significantly lower in the short-course , high-dose group ( 24 % ) compared with the st and ard-course group ( 32 % ) ; relative risk ( RR ) , 0.77 ; 95 % confidence interval ( CI ) , 0.60 - 0.97 ; P = .03 ; risk of trimethoprim-sulfamethoxazole nonsusceptibility was also lower in the short-course , high-dose group ( RR , 0.77 ; 95 % CI , 0.58 - 1.03 ; P = .08 ) . The protective effect of short-course , high-dose therapy was stronger in households with 3 or more children ( RR , 0.72 ; 95 % CI , 0.52 - 0.98 ) . Adherence to treatment was higher in the short-course , high-dose group ( 82 % vs 74 % ; P = .02 ) . CONCLUSION Short-course , high-dose outpatient antibiotic therapy appears promising as an intervention to minimize the impact of antibiotic use on the spread of drug-resistant pneumococci Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies We conducted a multicenter prospect i ve study to document changes in nasopharyngeal carriage of Streptococcus pneumoniae , Haemophilus influenzae , and Branhamella catarrhalis during antibiotic therapy . A cohort of 629 children with respiratory tract infections underwent nasopharyngeal sampling before and Output:	Conclusions Resistance generally increased soon after antibiotic use .
MS2831	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The inconsistent effect of hypothermia treatment on severe brain injury in previous trials might be because hypothermia was induced too late after injury . We aim ed to assess whether very early induction of hypothermia improves outcome in patients with severe brain injury . METHODS The National Acute Brain Injury Study : Hypothermia II ( NABIS : H II ) was a r and omised , multicentre clinical trial of patients with severe brain injury who were enrolled within 2·5 h of injury at six sites in the USA and Canada . Patients with non-penetrating brain injury who were 16 - 45 years old and were not responsive to instructions were r and omly assigned ( 1:1 ) by a r and om number generator to hypothermia or normothermia . Patients r and omly assigned to hypothermia were cooled to 35 ° C until their trauma assessment was completed . Patients who had none of a second set of exclusion criteria were either cooled to 33 ° C for 48 h and then gradually rewarmed or treated at normothermia , depending upon their initial treatment assignment . Investigators who assessed the outcome measures were masked to treatment allocation . The primary outcome was the Glasgow outcome scale score at 6 months . Analysis was by modified intention to treat . This trial is registered with Clinical Trials.gov , NCT00178711 . FINDINGS Enrolment occurred from December , 2005 , to June , 2009 , when the trial was terminated for futility . Follow-up was from June , 2006 , to December , 2009 . 232 patients were initially r and omised a mean of 1·6 h ( SD 0·5 ) after injury : 119 to hypothermia and 113 to normothermia . 97 patients ( 52 in the hypothermia group and 45 in the normothermia group ) did not meet any of the second set of exclusion criteria . The mean time to 35 ° C for the 52 patients in the hypothermia group was 2·6 h ( SD 1·2 ) and to 33 ° C was 4·4 h ( 1·5 ) . Outcome was poor ( severe disability , vegetative state , or death ) in 31 of 52 patients in the hypothermia group and 25 of 56 in the normothermia group ( relative risk [ RR ] 1·08 , 95 % CI 0·76 - 1·53 ; p=0·67 ) . 12 patients in the hypothermia group died compared with eight in the normothermia group ( RR 1·30 , 95 % CI 0·58 - 2·52 ; p=0·52 ) . INTERPRETATION This trial did not confirm the utility of hypothermia as a primary neuroprotective strategy in patients with severe traumatic brain injury Objectives : Therapeutic hypothermia has been of topical interest for many years and with the publication of two international , multicenter r and omized controlled trials , the evidence base now needs updating . The aim of this systematic review of r and omized controlled trials is to assess the efficacy of therapeutic hypothermia in adult traumatic brain injury focusing on mortality , poor outcomes , and new pneumonia . Data Sources : The following data bases were search ed from January 1 , 2011 , to January 26 , 2018 : Cochrane Central Register of Controlled Trial , MEDLINE , PubMed , and EMBASE . Study Selection : Only foreign articles published in the English language were included . Only articles that were r and omized controlled trials investigating adult traumatic brain injury sustained following an acute , closed head injury were included . Two authors independently assessed at each stage . Data Extraction : Quality was assessed using the Cochrane Collaboration ’s tool for assessing the risk of bias . All extracted data were combined using the Mantel-Haenszel estimator for pooled risk ratio with 95 % CIs . p value of less than 0.05 was considered statistically significant . All statistical analyses were conducted using RevMan 5 ( Cochrane Collaboration , Version 5.3 , Copenhagen : The Nordic Cochrane Centre , The Cochrane Collaboration , 2014 ) . Data Synthesis : Twenty-two studies with 2,346 patients are included . R and omized controlled trials with a low risk of bias show significantly more mortality in the therapeutic hypothermia group ( risk ratio , 1.37 ; 95 % CI , 1.04–1.79 ; p = 0.02 ) , whereas r and omized controlled trials with a high risk of bias show the opposite with a higher mortality in the control group ( risk ratio , 0.70 ; 95 % CI , 0.60–0.82 ; p < 0.00001 ) . Conclusions : Overall , this review is in-keeping with the conclusions published by the most recent r and omized controlled trials . High- quality studies show no significant difference in mortality , poor outcomes , or new pneumonia . In addition , this review shows a place for fever control in the management of traumatic brain injury BACKGROUND Induction of hypothermia in patients with brain injury was shown to improve outcomes in small clinical studies , but the results were not definitive . To study this issue , we conducted a multicenter trial comparing the effects of hypothermia with those of normothermia in patients with acute brain injury . METHODS The study subjects were 392 patients 16 to 65 years of age with coma after sustaining closed head injuries who were r and omly assigned to be treated with hypothermia ( body temperature , 33 degrees C ) , which was initiated within 6 hours after injury and maintained for 48 hours by means of surface cooling , or normothermia . All patients otherwise received st and ard treatment . The primary outcome measure was functional status six months after the injury . RESULTS The mean age of the patients and the type and severity of injury in the two treatment groups were similar . The mean ( + /-SD ) time from injury to r and omization was 4.3+/-1.1 hours in the hypothermia group and 4.1+/-1.2 hours in the normothermia group , and the mean time from injury to the achievement of the target temperature of 33 degrees C in the hypothermia group was 8.4+/-3.0 hours . The outcome was poor ( defined as severe disability , a vegetative state , or death ) in 57 percent of the patients in both groups . Mortality was 28 percent in the hypothermia group and 27 percent in the normothermia group ( P=0.79 ) . The patients in the hypothermia group had more hospital days with complications than the patients in the normothermia group . Fewer patients in the hypothermia group had high intracranial pressure than in the normothermia group . CONCLUSIONS Treatment with hypothermia , with the body temperature reaching 33 degrees C within eight hours after injury , is not effective in improving outcomes in patients with severe brain injury Background Clinical trials in traumatic brain injury ( TBI ) are challenging . Previous trials of complex interventions were conducted in high-income countries , reported long lead times for site setup and low screened-to-recruitment rates . In this report we evaluate the internal pilot phase of an international , multicentre TBI trial of a complex intervention to assess : design and implementation of an online case report form ; feasibility of recruitment ( sites and patients ) ; feasibility and effectiveness of delivery of the protocol . Methods All aspects of the pilot phase of the trial were conducted as for the main trial . The pilot phase had oversight by independent Steering and Data Monitoring committees . Results Forty sites across 12 countries gained ethical approval . Thirty seven of 40 sites were initiated for recruitment . Of these , 29 had screened patients and 21 r and omized at least one patient . Lead times to ethics approval ( 6.8 weeks ) , hospital approval ( 18 weeks ) , interest to set up ( 61 weeks ) , set up to screening ( 11 weeks ) , and set up to r and omization ( 31.6 weeks ) are comparable with other international trials . Sixteen per cent of screened patients were eligible . We found 88 % compliance rate with trial protocol . Conclusion The pilot data demonstrated good feasibility for this large international multicentre r and omized controlled trial of hypothermia to control intracranial pressure . The sample size was reduced to 600 patients because of homogeneity of the patient group and we showed an optimized cooling intervention could be delivered . Trial registration Current Controlled Trials : IS RCT N34555414 BACKGROUND In patients with traumatic brain injury , hypothermia can reduce intracranial hypertension . The benefit of hypothermia on functional outcome is unclear . METHODS We r and omly assigned adults with an intracranial pressure of more than 20 mm Hg despite stage 1 treatments ( including mechanical ventilation and sedation management ) to st and ard care ( control group ) or hypothermia ( 32 to 35 ° C ) plus st and ard care . In the control group , stage 2 treatments ( e.g. , osmotherapy ) were added as needed to control intracranial pressure . In the hypothermia group , stage 2 treatments were added only if hypothermia failed to control intracranial pressure . In both groups , stage 3 treatments ( barbiturates and decompressive craniectomy ) were used if all stage 2 treatments failed to control intracranial pressure . The primary outcome was the score on the Extended Glasgow Outcome Scale ( GOS-E ; range , 1 to 8 , with lower scores indicating a worse functional outcome ) at 6 months . The treatment effect was estimated with ordinal logistic regression adjusted for prespecified prognostic factors and expressed as a common odds ratio ( with an odds ratio < 1.0 favoring hypothermia ) . RESULTS We enrolled 387 patients at 47 centers in 18 countries from November 2009 through October 2014 , at which time recruitment was suspended owing to safety concerns . Stage 3 treatments were required to control intracranial pressure in 54 % of the patients in the control group and in 44 % of the patients in the hypothermia group . The adjusted common odds ratio for the GOS-E score was 1.53 ( 95 % confidence interval , 1.02 to 2.30 ; P=0.04 ) , indicating a worse outcome in the hypothermia group than in the control group . A favorable outcome ( GOS-E score of 5 to 8 , indicating moderate disability or good recovery ) occurred in 26 % of the patients in the hypothermia group and in 37 % of the patients in the control group ( P=0.03 ) . CONCLUSIONS In patients with an intracranial pressure of more than 20 mm Hg after traumatic brain injury , therapeutic hypothermia plus st and ard care to reduce intracranial pressure did not result in outcomes better than those with st and ard care alone . ( Funded by the National Institute for Health Research Health Technology Assessment program ; Current Controlled Trials number , IS RCT N34555414 . ) Traumatic brain injury ( TBI ) is a significant cause of disability and death and a huge economic burden throughout the world . Much of the morbidity associated with TBI is attributed to secondary brain injuries result ing in hypoxia and ischemia after the initial trauma . Intracranial hypertension and decreased partial brain oxygen tension ( PbtO2 ) are targeted as potentially avoidable causes of morbidity . Therapeutic hypothermia ( TH ) may be an effective intervention to reduce intracranial pressure ( ICP ) , but could also affect cerebral blood flow ( CBF ) . This is a retrospective analysis of prospect ively collected data from 17 patients admitted to the Western General Hospital , Edinburgh . Patients with an ICP > 20 mmHg refractory to initial therapy were r and omized to st and ard care or st and ard care and TH ( intervention group ) titrated between 32 ° C and 35 ° C to reduce ICP . ICP and PbtO2 were measured using the Licox system and core temperature was recorded through rectal thermometer . Data were analyzed at the hour before cooling , the first hour at target temperature , 2 consecutive hours at target temperature , and after 6 hours of hypothermia . There was a mean decrease in ICP of 4.3±1.6 mmHg ( p<0.04 ) from 15.7 to 11.4 mmHg , from precooling to the first epoch of hypothermia in the intervention group ( n=9 ) that was not seen in the control group ( n=8 ) . A decrease in ICP was maintained throughout all time periods . There was a mean decrease in PbtO2 of 7.8±3.1 mmHg ( p<0.05 ) from 30.2 to 22.4 mmHg , from precooling to stable hypothermia , which was not seen in the control group . This research supports others in demonstrating a decrease in ICP with temperature , which could facilitate a reduction in the use of hyperosmolar agents or other stage II interventions . The decrease in PbtO2 is not below the suggested treatment threshold of 20 mmHg , but might indicate a decrease in CBF Although mild therapeutic hypothermia is an effective neuroprotective strategy for cardiac arrest/resuscitated patients , and asphyxic newborns , recent r and omized controlled trials ( RCTs ) have equally shown good neurological outcome between targeted temperature management at 33 ° C versus 36 ° C , and have not shown consistent benefits in patients with traumatic brain injury ( TBI ) . We aim ed to determine the effect of therapeutic hypothermia , while avoiding some limitations of earlier studies , which included patient selection based on Glasgow coma scale ( GCS ) , delayed initiation of cooling , short duration of cooling , inter-center variation in patient care , and relatively rapid rewarming . We conducted a multicenter RCT in patients with severe TBI ( GCS 4 - 8 ) . Patients were r and omly assigned ( 2:1 allocation ratio ) to either therapeutic hypothermia ( 32 - 34 ° C , n Output:	Even more compelling was the report that when these studies were stratified according to risk of bias , data from the higher- quality studies showed that hypothermia was effective when delivered immediately or soon after injury .
MS2832	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Healthy eating , such as the regular inclusion of fruits and vegetables in one 's diet , is essential for maintaining optimal weight , maximizing brain and immune system functioning , and reducing the risk for disease . Despite its importance , few students meet recommended guidelines for healthy dietary behavior . The current study was design ed to test the efficacy of two ehealth intervention approaches for increasing healthy eating behaviors among university students . METHODS Student volunteers from an introductory psychology class at a northeastern US university participated for class credit ( n=154 ) . Students were r and omized to either an assessment only ( AO ) , web-based nutrition intervention only ( WBO ) , or web-intervention with daily text-messaging condition ( WB+M ) . Participants completed measures of vegetable and fruit consumption and frequency of meals with design ated healthy food selection s at baseline and one-month follow-up . RESULTS Only the WB+M intervention significantly increased the likelihood of attaining vegetable consumption st and ards and increased the frequency of design ated healthy food choice options guidelines at follow-up compared to the AO condition . CONCLUSIONS Findings suggest that delivering a brief web-based intervention with daily text messages about personal nutrition and fitness goals may support healthier eating patterns among students The transition to college has been identified as a critical period for increases in overweight status . Overweight college students are at-risk of becoming obese adults , and , thus prevention efforts targeting college age individuals are key to reducing adult obesity rates . The current study evaluated an Internet intervention with first year college students ( N=170 ) r and omly assigned to one of four treatment conditions : 1 ) no treatment , 2 ) 6-week online intervention 3 ) 6-week weight and caloric feedback only ( via email ) , and 4 ) 6-week combined feedback and online intervention . The combined intervention group had lower BMI s at post-testing than the other three groups . This study demonstrated the effectiveness and feasibility of an online intervention to prevent weight gain among college students Background : Adequate calcium consumption during early adulthood can help prevent osteoporosis in women . Purpose : The effects of gain-framed , targeted messaging on calcium intake were examined over 12 months . Methods : Young women ( 18–19 years ) not consuming sufficient calcium were r and omly assigned to receive st and ard care material s ( control ) or gain-framed , targeted material s ( experimental ) . Health belief model ( HBM ) constructs , calcium intake and markers of bone formation , resorption and bone mineral density were assessed at various time points throughout the year . Results : Calcium intake increased significantly more in the experimental versus the control condition ( p < 0.01 ) . Self-efficacy was the only HBM construct to improve significantly more in the experimental condition versus control ( p = 0.05 ) . The HBM did not mediate changes in calcium intake . Measures of bone health did not differ between conditions by the end of this nonpharmacological intervention ( p 's > 0.05 ) . Conclusions : It is possible to increase young women 's calcium consumption through gain-framed , targeted messages Introduction Graphic warnings ( GWs ) on cigarette packs are widely used internationally and perhaps will be in the US but their impact is not well understood . This study tested support for competing hypotheses in different subgroups of young adults defined by their history of cigarette smoking and individual difference variables ( e.g. , psychological reactance ) . One hypothesis predicted adaptive responding ( GWs would lower smoking-related intentions ) and another predicted defensive responding ( GWs would raise smoking-related intentions ) . Methods Participants were an online sample of 1,169 Americans ages 18–24 , who were r and omly assigned either to view nine GWs design ed by the FDA or to a no-label control . Both the intention to smoke in the future and the intention to quit smoking ( among smokers ) were assessed before and after message exposure . Results GWs lowered intention to smoke in the future among those with a moderate lifetime smoking history ( between 1 and 100 cigarettes ) , and they increased intention to quit smoking among those with a heavy lifetime smoking history ( more than 100 cigarettes ) . Both effects were limited to individuals who had smoked in some but not all of the prior 30 days ( i.e. , occasional smokers ) . No evidence of defensive “ boomerang effects ” on intention was observed in any subgroup . Conclusion Graphic warnings can reduce interest in smoking among occasional smokers , a finding that supports the adaptive-change hypothesis . GWs that target occasional smokers might be more effective at reducing cigarette smoking in young adults OBJECTIVES To develop and test the effectiveness of a mobile-phone based ecological momentary intervention ( EMI ) to increase fruit and vegetable ( FV ) consumption in low-consuming young adults . METHODS A two-week r and omised controlled trial of low-FV consuming young adults ages 18 - 25 years ( n = 171 ) compared three conditions : ecological momentary intervention ( EMI ) , fruit and vegetable intervention ( FVI ) , and a diet-as-usual control ( ANZCTRN12615000183583 ) . Participants in the EMI condition were sent two targeted text messages a day for 13 days and were asked to increase daily FV consumption to at least five servings . These messages were design ed , using the Health Action Process Approach , to address salient beliefs identified as effective in a preliminary focus group investigation . Participants in the FVI condition were provided two servings of FV a day ( carrots , kiwifruit or oranges , and apples ) to eat in addition to their current diet . Control participants ate their normal diet . Participants reported their daily servings of FV each evening during the study using a smartphone-delivered survey . Blood sample s testing plasma vitamin C and total carotenoids were taken pre- and post-intervention as an objective biomarker of FV intake . RESULTS Participants in the EMI and FVI conditions reported higher daily servings of FV - approximately + 1 serving per day more compared to control ( EMI = 3.7 servings/day ; FVI = 3.7 servings/day ; Control = 2.8 servings/day ) and approximately + 1.2 servings compared to baseline . Increases in objective biomarkers for the experimental conditions supported the validity of self-reported FV consumption . CONCLUSIONS Our results provide initial proof of concept that EMI strategies ( with minor financial assistance ) are as effective as giving FV in increasing FV consumption in educated , low-consuming young adults Background The college experience is often the first time when young adults live independently and make their own lifestyle choices . These choices affect dietary behaviors , exercise habits , techniques to deal with stress , and decisions on sleep time , all of which direct the trajectory of future health . There is a need for effective strategies that will encourage healthy lifestyle choices in young adults attending college . Objective This preliminary r and omized controlled trial tested the effect of coaching and text messages ( short message service , SMS ) on self-selected health behaviors in the domains of diet , exercise , stress , and sleep . A second analysis measured the ripple effect of the intervention on health behaviors not specifically selected as a goal by participants . Methods Full-time students aged 18 - 30 years were recruited by word of mouth and campuswide advertisements ( flyers , posters , mailings , university website ) at a small university in western Pennsylvania from January to May 2015 . Exclusions included pregnancy , eating disorders , chronic medical diagnoses , and prescription medications other than birth control . Of 60 participants , 30 were r and omized to receive a single face-to-face meeting with a health coach to review results of behavioral question naires and to set a health behavior goal for the 8-week study period . The face-to-face meeting was followed by SMS text messages design ed to encourage achievement of the behavioral goal . A total of 30 control subjects underwent the same health and behavioral assessment s at intake and program end but did not receive coaching or SMS text messages . Results The texting app showed that 87.31 % ( 2187/2505 ) of messages were viewed by intervention participants . Furthermore , 28 of the 30 intervention participants and all 30 control participants provided outcome data . Among intervention participants , 22 of 30 ( 73 % ) showed improvement in health behavior goal attainment , with the whole group ( n=30 ) showing a mean improvement of 88 % ( 95 % CI 39 - 136 ) . Mean improvement in any behavioral domains was not seen in the control group . Intervention participants also increased their exercise significantly compared with controls , regardless of their self-selected goal category . The increased exercise was paralleled by significantly lower fasting glucose levels . Conclusions The health coaching session plus tailored SMS text messages improved self-selected health behaviors with a modest ripple effect to include unselected health behaviors . Trial Registration Clinical trials.gov NCT02476604 ; https:// clinical trials.gov/ct2/show/NCT02476604 ( Archived by WebCite at http://www.webcitation.org/6qAAryS5 t This study tests whether the effectiveness of implementation intention-based interventions to increase fruit and vegetable intake in a young adult population can be enhanced using additional pre-intervention instructions and alternative formats ; namely , an ‘ if-then ’ implementation intention versus a more general , ‘ global ’ plan that does not explicitly link a situational cue with a goal -directed response . Participants ( N = 557 ) completed pre-test measures of planning , motivation and behaviour with respect to increasing their fruit and vegetable intake before being r and omised to a 3 ( intervention format : control vs. ‘ if-then ’ vs. ‘ global ’ implementation intentions ) × 2 ( pre-intervention instruction vs. no pre-intervention instruction ) between- participants design . Results revealed a significant intervention format by time interaction , such that intake significantly increased by 0.50 portions in the if-then format condition compared with 0.31 in the global format and 0.01 in the control condition . These results suggest that ‘ if-then ’ manipulations are superior in promoting behaviour change in an applied setting . The use of pre-intervention instructions had no additional effect on behaviour , providing evidence for the efficacy of implementation intentions even when experimenter dem and is reduced . Evidence is also presented to suggest that reported increases in intake are not related to dem and characteristics Background Using various models of behavior change , a number of studies in the area of nutrition education have confirmed that nutrition habits and behaviors can be improved . Objectives This study sought to determine the effects of education on patterns of dietary consumption among medical students at the military university of Tehran , with a view to correcting those patterns . Methods In this quasi-experimental study , 242 medical students from the Military University of Tehran were chosen by convenience sampling and then divided into control ( n = 107 ) and intervention groups ( n = 135 ) by block r and omization . The self-administered question naire involving six categories of item ( knowledge , perceived benefits , perceived barriers , perceived threats , self-efficacy and behavior ) has been vali date d ( Cronbach alpha > 0.7 for each ) . Results Following the educational intervention , the mean score of knowledge , health belief model ( HBM ) structure , and behavior of students in relation to healthy patterns of food intake increased significantly ( P < 0.05 ) . The mean pre-intervention knowledge score was 6.76 ( 1.452 ) , referring to threats to HBM constructs including perceived threat 2.93 ( 1.147 ) , perceived benefits 7.28 ( 1.07 ) , perceived barriers 5.44 ( 1.831 ) , self- efficacy 4.28 ( 1.479 ) , and behavior 8.84 ( 2.527 ) . The post-intervention scores all improved as follows : knowledge 8.3 ( 1.503 ) , perceived threats 3.29 ( 1.196 ) , perceived benefits 7.71 ( 0.762 ) , perceived barriers 5.9 ( 1.719 ) , self- efficacy 4.6 ( 1.472 ) , and behavior 9.45 ( 2.324 ) . This difference in mean scores for knowledge , health belief structures and employee behavior before and after educational intervention was significant ( P ≤ 0.05 ) . Conclusions The significant improvement in the experimental group ’s mean knowledge , HBM structures , and behavior scores indicates the positive effect of the intervention This study evaluated the efficacy of a theory of planned behaviour ( TPB ) based intervention to increase fruit and vegetable consumption . The extent to which fruit and vegetable consumption and change in intake could be explained by the TPB was also examined . Participants were r and omly assigned to two levels of intervention frequency matched for intervention content ( low frequency n=92 , high frequency n=102 ) . Participants received TPB-based email messages design ed to increase fruit and vegetable consumption , messages targeted attitude , subjective norm and perceived behavioural control ( PBC ) . Baseline and post-intervention measures of TPB variables and behaviour were collected . Across the entire study cohort , fruit and vegetable consumption increased by 0.83 servings/day between baseline and follow-up . Intention , attitude , subjective norm and PBC also increased ( p<.05 ) . The TPB successfully modelled fruit and vegetable consumption at both time points but not behaviour change . The increase of fruit and vegetable consumption is a promising preliminary finding for those primarily interested in increasing fruit and vegetable consumption . However , those interested in theory development may have concerns about the use of this model to explain behaviour change in this context . More high quality experimental tests of the theory are needed to confirm this result Aim : The aim of the study was to develop and implement an obesity and weight gain prevention program targeted to a high-risk group . Method : Women , 18–28 years old , with at least one severely obese parent , were r and omized to the inter Output:	The review highlights the potential of behavioural interventions to improve young adults ’ fruit and vegetable intake but was less convincing for other dietary outcomes .
MS2833	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The efficacy and safety of the 300-index of reactivity ( IR ) dose of 5-grass-pollen sublingual immunotherapy ( SLIT ) tablets ( Stallergènes , Antony , France ) have been demonstrated for the treatment of hay fever in adults . OBJECTIVE We sought to assess the efficacy and safety of this tablet in children and adolescents with grass pollen-related allergic rhinitis . METHODS In this multinational , r and omized , double-blind , placebo-controlled study , 278 children ( 5 - 17 years of age ) with grass pollen-related rhinoconjunctivitis ( confirmed by means of a positive grass pollen skin prick test response and serum-specific IgE measurement ) received once-daily SLIT tablets or placebo . Treatment was initiated 4 months before the estimated pollen season and continued throughout the season . The primary outcome was the rhinoconjunctivitis total symptom score ( RTSS ) , a sum of 6 individual symptom scores : sneezing , runny nose , itchy nose , nasal congestion , watery eyes , and itchy eyes . Secondary end points included rescue medication intake , individual scores , and safety . RESULTS The intent-to-treat population included 266 children ( mean age , 10.9 + /- 3.22 years ) . The RTSS for the 300-IR group was highly significantly different from that of the placebo group ( P = .001 ) . The 300-IR group showed a mean improvement for the RTSS of 28.0 % over that seen with placebo and a median improvement of 39.3 % . Significant differences between the 300-IR and placebo groups were also observed regarding rescue medication score and proportion of days using rescue medication during the pollen season ( P = .0064 and P = .0146 , respectively ) . Adverse events were generally mild or moderate in intensity and expected . No serious side effects were reported . CONCLUSION Five-grass-pollen SLIT tablets ( 300 IR ) reduce both symptom scores and rescue medication use in children and adolescents with grass pollen-related rhinoconjunctivitis BACKGROUND This is an interim analysis of a r and omized , double-blind , placebo-controlled phase III trial with 3 years of daily treatment with grass tablet immunotherapy ( GRAZAX ; ALK-Abelló A/S , Hørsholm , Denmark ) or placebo , followed by 2 years of follow-up to assess the persistent efficacy . OBJECTIVE We sought to evaluate the efficacy and safety of specific immunotherapy with grass allergen tablets compared with placebo after treatment covering 2 consecutive grass pollen seasons . METHODS The interim analyses included 351 adult participants with moderate-to-severe allergic rhinoconjunctivitis caused by grass pollen . Participants were treated with active ( n = 189 ) or placebo ( n = 162 ) tablets for an average of 22 months . All participants were allowed to use symptomatic rescue medication . RESULTS The primary efficacy analysis showed highly significant mean reductions of 36 % in rhinoconjunctivitis symptom score ( P < .0001 ; median reduction , 44 % ) and 46 % in rhinoconjunctivitis medication score ( P < .0001 ; median reduction , 73 % ) in the active group relative to the placebo group . Mean rhinoconjunctivitis quality of life was 33 % better ( P < .0001 ; median , 40 % ) . Clinical improvements were paralleled by significant changes in allergen-specific immunoglobulins . The treatment was well tolerated , and adverse events led to withdrawal in less than 1 % of participants . There were no serious adverse events related to treatment . CONCLUSION Grass allergen tablet immunotherapy showed progressive immunologic changes and highly significant efficacy over 2 years of continued treatment Background : Local application of allergen extracts in specific immunotherapy is accompanied by increased compliance and significantly reduced side effects . However , efficacy of local immunotherapy in children has yet not been sufficiently demonstrated . This study was performed to determine clinical efficacy of high dose sublingual swallow immunotherapy ( SLIT ) by a double‐blind placebo‐controlled study in children with grass pollen allergy using high dose allergen extracts UNLABELLED SAFETY and efficacy of sublingual ( sublingual-swallow ) immunotherapy ( IT ) with house dust mite extract were evaluated in 30 children ( 6 - 15 2/3 years of age ) over the first 12 months of an ongoing study . The cumulative dose was 570 micrograms Der p I ( five times that administered with subcutaneous therapy ) . SAFETY One patient on active treatment dropped out after 8 weeks because of a subjective feeling of severe weakness , question ably induced by the therapy . Five patients on active therapy and one patient on placebo reported minor local side effects . EFFICACY Pulmonary symptoms were reduced after 12 months in actively treated asthmatics , but this was not consistent with the lack of improvement in bronchial reactivity , skin sensitivity and specific IgG and IgG4 against D.pt . in this group . In patients with rhinitis nasal sensitivity was reduced in the placebo group without concomitant improvement in the nasal symptom score . Specific IgE ( D.pt . and D.f . ) increased significantly more in the active treatment group after 3 and 12 months . We conclude that sublingual IT over 12 months with the fivefold Der p 1 dose of subcutaneous IT was well tolerated , but there was no consistent clinical or immunological benefit compared to placebo BACKGROUND Cross-reactivity between the major birch pollen allergen , Bet v 1 , and the apple protein , Mal d 1 , frequently causes food allergy . OBJECTIVE To investigate the effects of successful sublingual immunotherapy ( SLIT ) with birch pollen extract on apple allergy and the immune response to Bet v 1 and Mal d 1 . METHODS Before and after 1 year of SLIT , Bet v 1-sensitized patients with oral allergy syndrome to apple underwent nasal challenges with birch pollen and double-blind placebo-controlled food challenges with apple . Bet v 1-specific and Mal d 1-specific serum antibody levels and proliferation in P BMC s and allergen-specific T-cell lines ( TCLs ) were determined . Bet v 1-specific TCLs were mapped for T-cell epitopes . RESULTS In 9 patients with improved nasal provocation scores to birch pollen , apple-induced oral allergy syndrome was not significantly reduced . Bet v 1-specific IgE and IgG(4 ) levels significantly increased . Bet v 1-specific T-cell responses to all epitopes and those cross-reactive with Mal d 1 significantly decreased . However , neither Mal d 1-specific IgE and IgG(4 ) levels nor Mal d 1-induced T-cell proliferation changed significantly . In contrast , Mal d 1-specific TCLs showed increased responses to Mal d 1 after 1 year of SLIT . CONCLUSION This longitudinal study indicates that pollen SLIT does not efficiently alter the immune response to pollen-related food allergens , which may explain why pollen-associated food allergy is frequently not ameliorated by pollen immunotherapy even if respiratory symptoms significantly improve . CLINICAL IMPLICATION S SLIT with birch pollen may have no clinical effect on associated apple allergy A double-blind , placebo-controlled study of immunotherapy was conducted in 31 patients with allergic rhinitis due to Parietaria pollen to evaluate the efficacy and safety of high doses of allergen via the sublingual route . The patients were assessed before and after a 10-month period of treatment by clinical ( symptom-medication scores and specific nasal reactivity ) and immunological ( total IgE , specific IgE , IgG and IgG4 antibodies ) parameters . High doses of Parietaria extract corresponding to a cumulative dose of 105 BU for each patient were administered with negligible side effects . The actively treated patients had significantly lower medication scores than those on placebo ( p < 0.05 ) when the maximum pollen count was recorded , and at the end of the trial they showed a significant decrease in nasal reactivity ( p < 0.02 ) and a significant increase in serum specific IgG4 ( p = 0.02 ) . No differences were detected in any of these parameters in the placebo group . Possible explanations for the mechanisms of sublingual immunotherapy are proposed OBJECTIVE To evaluate the safety and efficacy of sublingual immunotherapy with ' Dermatophagoides Farinae Drops ' in D. farinae allergic asthma and /or rhinitis patients . METHODS A 25-week double-blind , placebo-controlled , multi-centered trail was conducted in 278 children ( aged 4 - 18 yr ) with mite-induced asthma and /or rhinitis . Patients were r and omly assigned to receive sublingual immunotherapy ( SLIT ) with ' Dermatophagoides Farinae Drops ' ( n = 139 ) or placebo ( n = 139 ) for 25 weeks and the dosage and administration strictly followed the manufacturer 's instructions . At the beginning of the 2nd , 3rd , 4th , 6th , 10th , 14th , 18th , 22nd week of the treatment , the patients were asked to accept follow-up visit , during the clinical trial all patients and parents were asked to keep a daily record of their asthma symptom scores , rescue medicine use , rhinitis symptom scores , morning and evening peak expiratory flow . Asthma symptom scores , reduction in use of rescue medicine , rhinitis symptom scores , lung function tests , skin sensitivity to mite , mite-specific immunoglobulin ( Ig ) E and IgG4 , and quality of life and adverse effect were assessed during the study . RESULT ( 1 ) Of the 278 children , 27 dropped out before the study completion . ( 2 ) After 25 weeks of treatment , the median variability of PEFR was -1.38 for SLIT group and -0.90 for the placebo ( P < 0.05 ) . ( 3 ) Besides , the mean variability of medicine score of asthma was -0.08 for SLIT group and 0.52 for the plcebo ( P < 0.05 ) . ( 4 ) The median variability of rhinitis symptom score was -1.96 for SLIT group and -1.03 for the placebo ( P < 0.01 ) . ( 5 ) The rescue medicine usage of SLIT reduced but did not show significant differences between SLIT and placebo . ( 6 ) After 25 weeks treatment , the increase of D. farinae specific IgE antibody of two groups were similar , while specific IgG4 increased significantly in SLIT compared to the patients in control one ( P < 0.01 ) ; ( 7 ) No severe adverse events happened in the trial and the most-likely adverse events were mild asthma and local rash . CONCLUSION Dermatophagoides Farinae Drops is safe and effective in treating allergic asthma and atopic rhinitis BACKGROUND Allergen immunotherapy ( desensitization ) by injection is effective for seasonal allergic rhinitis and has been shown to induce long-term disease remission . The sublingual route also has potential , although definitive evidence from large r and omized controlled trials has been lacking . OBJECTIVE The aim was to confirm the efficacy of a rapidly dissolving grass allergen tablet ( GRAZAX , ALK-Abelló , Hørsholm , Denmark ) compared with placebo in patients with seasonal rhinoconjunctivitis . METHODS A longitudinal , double-blind , placebo-controlled , parallel-group study that included 51 centers from 8 countries . Subjects were r and omized ( 1:1 ) to receive a grass allergen tablet or placebo once daily . A total of 634 subjects with a history of grass pollen-induced rhinoconjunctivitis for at least 2 years and confirmation of IgE sensitivity ( positive skin prick test and serum-specific IgE ) were included in the study . Subjects commenced treatment at least 16 weeks before the grass pollen season , and treatment was continued throughout the entire season . RESULTS The primary efficacy analysis showed a reduction of 30 % in rhinoconjunctivitis symptom score ( P < .0001 ) and a reduction of 38 % in rhinoconjunctivitis medication score ( P < .0001 ) compared with placebo . Side effects mainly comprised mild itching and swelling in the mouth that was in general well tolerated and led to treatment withdrawal in less than 4 % of participants . There were no serious local side effects and no severe systemic adverse events . CONCLUSION Sublingual immunotherapy with grass allergen tablets was effective in grass pollen-induced rhinoconjunctivitis . The tablet was well tolerated with minor local side effects . CLINICAL IMPLICATION S The grass allergen tablet represents a safe alternative to injection immunotherapy suitable for home use BACKGROUND Sublingual immunotherapy ( SLIT ) is accepted as a safe and effective route for the treatment of grass pollen allergy , but clarification of its clinical and biological efficacy requires more study . OBJECTIVE To evaluate the efficacy , safety , and compliance of SLIT with a st and ardized 3-grass pollen extract in patients with grass pollen seasonal allergic rhinoconjunctivitis , with or without mild asthma . METHODS This multicenter , r and omized , double-blind study included 127 patients ( aged 12 - 41 years ; mean age , 24.9 years ) with grass pollen seasonal allergic rhinoconjunctivitis , with or without mild asthma . They received either SLIT with a high-dose , st and ardized , 3 Output:	Overall , SLIT is moderately effective in reducing total and individual ocular symptom scores in participants with ARC and AC .
MS2834	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Purpose Triple therapy using salmeterol/fluticasone propionate ( FP ) and tiotropium bromide is commonly used to treat chronic obstructive pulmonary disease ( COPD ) , but sparse efficacy data exist in COPD patients with fewer symptoms and with a lower dose of inhaled corticosteroid in Japanese patients . The effects of of salmeterol/fluticasone propionate 50/250 μg ( SFC250 ) twice daily plus tiotropium 18 μg ( TIO ) once daily and individual treatments on lung function were compared . Patients and methods Fifty three Japanese COPD patients participated in this r and omized , double-blind , double-dummy , Williams square design crossover study . Lung function was assessed by plethysmography and spirometry . Results The primary endpoint of postdose specific airway conductance area under the curve ( AUC0–4h ) on day 28 was significantly higher following SFC250 + TIO ( 0.854 ) compared with TIO ( 0.737 , 15.8 % ) and SFC250 ( 0.663 , 28.8 % ) alone . SFC250 + TIO significantly improved trough forced expiratory volume in 1 second from baseline versus TIO ( 0.161 L , P<0.001 ) and SFC250 ( 0.103 L , P=0.008 ) . SFC250 + TIO significantly improved residual volume compared with TIO ( P<0.001 ) and SFC250 ( P=0.003 ) on day 28 . Nonsignificant improvements were seen in trough inspiratory capacity , total lung capacity , and thoracic gas volume . There was no mean change seen in rescue medication . Conclusion Triple therapy using SFC250 + TIO was well tolerated and gave a greater improvement in bronchodilation compared with TIO and SFC250 alone in Japanese patients with COPD . There was improvement in few symptoms , but no mean change was seen in patient-reported outcomes measured by rescue medication use Purpose : To provide information on the efficacy and safety of Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a Metered-Dose-Inhaler 230/42mcg ( FSC MDI ) and its comparable dose of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg ( FSC DISKUS ) in patients with COPD . Methods : This multicenter , r and omized , double-blind , 12 week study was design ed to evaluate FSC MDI treatment responses as compared with FSC DISKUS . The primary comparison of interest was non-inferiority between the FSC MDI treatment group and the FSC DISKUS treatment group assessed in terms of 2-hour post-dose FEV1 change from baseline at endpoint . The non-inferiority criterion bound was 75mL ( lower confidence limit of -75mL ) . Inclusion criteria : Male or female aged ≥ 40 , post-bronchodilator FEV1 ≤ 70 % predicted normal , FEV1/FVC ≤ 70 % and ≥ 10 pack years smoking history . Adverse events were recorded by patients throughout the study on daily diary cards . Adverse events were collected in eCRFs at all clinic visits and during a final follow-up phone call . Results : Patients ( N=247 ) were r and omized to FSC MDI ( FEV1 % 49.3 ± 12.3 , FEV1/FVC 50.5 ± 10.0 ) and FSC DISKUS ( FEV1 % 48.4 ± 11.0 , FEV1/FVC 50.3 ± 10.3 ) . From an ANCOVA model the least squares ( LS ) mean difference ( FSC MDI– FSC DISKUS ) for the 2-hour post dose FEV1 at endpoint was -2.0mL ( 95 % CI -64mL , 59mL ) . Pre-dose FEV1 , FVC , PEF , and albuterol use were also similar between the two formulations . The most common adverse events ( AE ) during treatment were headache ( 8 % and 6 % of patients ) , nasopharyngitis ( 4 % and 6 % ) , cough ( 3 % and 4 % ) , and sinusitis ( 2 % and 5 % ) for FSC MDI and FSC DISKUS , respectively . Pneumonia was recorded as an AE for 2 ( 2 % ) patients in the FSC DISKUS arm . Conclusion : This is the first study to demonstrate that FSC MDI has a similar efficacy and safety profile to FSC DISKUS in COPD patients Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results Long-acting muscarinic antagonist ( LAMA ) or long-acting β2-agonist ( LABA ) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease ( COPD ) . Although the efficacy of LAMAs and LABAs has been well established through r and omized controlled trials ( RCTs ) , questions remain regarding their cardiovascular ( CV ) safety . Furthermore , while the safety of LAMA and LABA monotherapy has been extensively studied , data are lacking for LAMA/LABA combination therapy , and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically design ed to assess this . Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities . However , severe CV and other comorbidities are often exclusion criteria for RCTs , contributing to a lack in external validity and generalizability . Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs . We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies , and explore the advantages and limitations of data derived from each study type . We also describe an ongoing prospect i ve , observational , comparative post-authorization safety study of a LAMA/LABA combination therapy ( umeclidinium/vilanterol ) and LAMA monotherapy ( umeclidinium ) versus tiotropium , with a focus on the relative merits of the study design Background : Patients with chronic obstructive pulmonary disease ( COPD ) often experience symptoms and problems with activities early in the morning . This is the first study to compare the effect of budesonide/formoterol and salmeterol/fluticasone on lung function , symptoms and activities early in the morning . Methods : Lung function ( peak expiratory flow [ PEF ] and forced expiratory volume in 1 second [ FEV 1 ] ) and symptoms were measured at bedside and activities were measured during the morning using a six-item question naire concerning basic morning routines . In a r and omised , double-blind , multicentre , cross-over study , 442 patients with COPD aged ≥40 years ( pre-bronchodilator FEV1 ≤50 % ; FEV1/vital capacity < 70 % ) received budesonide/formoterol ( 320/9 µg , one inhalation twice daily ) dry powder inhaler ( DPI ) or salmeterol/fluticasone ( 50/500 µg , one inhalation twice daily ) DPI daily , for 1 week each , separated by a 1- to 2-week washout . Lung function ( PEF and FEV1 ) shortly after rising from bed in the morning , symptoms and basic morning activities were assessed by electronic diary ( e-Diary ) recordings . Results : Budesonide/formoterol and salmeterol/fluticasone treatment increased morning PEF 5 minutes post-dose , measured as a mean improvement from baseline over the full study period ( primary endpoint ; adjusted mean change : 15.1 l/min and 14.2 l/min , respectively [ difference 1.0 l/min ; p = 0.603 ] ) . Mean morning FEV1 improved more following budesonide/ formoterol treatment versus salmeterol/fluticasone at 5 minutes ( 0.12 l versus 0.09 l ; p = 0.090 ) and 15 minutes ( 0.14 l versus 0.10 l ; p < 0.05 ) post-dose . Budesonide/formoterol demonstrated a more rapid onset of effect as reflected by increases in e-Diary-recorded PEF and FEV 1 from pre-dose to 5 and 15 minutes post-dose ( all p < 0.001 ) and spirometry at the clinic measured after the first dose ( FEV1 p < 0.001 ; 5 minutes post-dose ) . Improvements in symptom scores within 15 minutes after drug administration were similar for both drugs , but budesonide/formoterol treatment result ed in significantly greater improvements in total morning activities score ( getting washed , dried , dressed , eating breakfast and walking around the home ; 0.22 versus 0.12 respectively , p < 0.05 ) . Both treatments were well tolerated . Conclusions : Short-term treatment with budesonide/formoterol DPI or salmeterol/fluticasone DPI was effective in patients with COPD . Budesonide/formoterol had a more rapid onset of effect compared with salmeterol/fluticasone and result ed in greater improvements in ability to perform morning activities despite the lower inhaled corticosteroid dose The Indacaterol : Switching Non-exacerbating Patients with Moderate COPD From Salmeterol/Fluticasone to Indacaterol ( INSTEAD ) study investigated the effect of switching patients at low risk of chronic obstructive pulmonary disease ( COPD ) exacerbations from salmeterol/fluticasone ( SFC ; inhaled corticosteroid ( ICS ) regimen ) to indacaterol monotherapy ( non-ICS regimen ) . This 26-week , double-blind , double-dummy , parallel-group , phase IV study , r and omised 581 patients with moderate COPD to indacaterol 150 μg once daily or SFC 50/500 μg twice daily . Patients had been receiving SFC 50/500 μg for ≥3 months , with no COPD exacerbations for more than a year before the study ( patients for whom ICS is not recommended ) . The primary objective was to demonstrate non-inferiority of indacaterol to SFC , measured by trough forced expiratory volume in 1 second ( FEV1 ) after 12 weeks ( non-inferiority margin of 0.06 L ) . The primary objective was met , with a mean treatment difference of 9 mL ( 95 % CI -45–26 mL ) . There were no significant differences between treatments in terms of breathlessness ( transition dyspnoea index ) or health status ( Saint George ’s Respiratory Question naire ) at weeks 12 or 26 , or rescue medication use or COPD exacerbation rates over 26 weeks . Safety profiles of both treatments were as expected . This study demonstrated that patients with moderate COPD and no exacerbations in the previous year can be switched from SFC to indacaterol 150 μg with no efficacy loss . Moderate COPD patients can switch from salmeterol/fluticasone to indacaterol with no efficacy loss Objectives To test the reliability , validity and responsiveness of the 13-item Shortness of Breath with Daily Activities ( SOBDA ) question naire , and determine the threshold for response and minimal important difference ( MID ) . Design 6 week , r and omised , double-blind , placebo-controlled study . Setting 40 centres in the USA between 29 October 2009 and 1 July 2010 . Primary and secondary outcome measures 547 patients with chronic obstructive pulmonary Output:	FP/SAL is recommended for the initiation therapy just in a small percentage of symptomatic patients that are at high risk of exacerbation with blood eosinophil counts ≥300 cells per μl .
MS2835	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Thickening of formula feedings is part of the therapeutic approach for gastroesophageal reflux ( GER ) in infants . However , its mechanism of action , especially regarding the occurrence of nonacid ( pH > 4 ) GER , has not yet been clearly described . The aim of this r and omized , placebo-controlled crossover study was to examine the influence of formula thickened with carob ( St. John 's bread ) bean gum on acid and nonacid GER . METHODS Infants with recurrent regurgitation and without other symptoms were fed alternately ( A-B-A-B-A-B ) with thickened ( A ) and nonthickened ( B ) but otherwise identical formula . Documentation of GER episodes during the study was performed by simultaneous intraesophageal impedance measurement ( intraluminal electrical impedance ; IMP ) and pH monitoring . The IMP technique is able to detect bolus movements inside a luminal organ . The use of multiple measuring segments on a single catheter allowed the analysis of direction , height , and duration of the bolus transport . Continuous videorecording and visual surveillance of regurgitation frequency and amount result ed in a severity score . RESULTS Fourteen infants ( 42 + /- 32 days old ) were examined during 6 feeding intervals each for a total measuring time of 342 hours . A total of 1183 GER episodes and 83 episodes of regurgitation were registered . Regurgitation frequency ( 15 vs 68 episodes ) and amount ( severity score 0.6 vs 1.8 ) were significantly lower after feedings with thickened formula . The difference regarding the occurrence of GER documented by IMP was also pronounced ( 536 vs 647 episodes ) . Although not statistically significant , maximal height reached by the refluxate in the esophagus was decreased after thickened feedings . Mean GER duration and the frequency of acid ( pH < 4 ) GER were not altered . CONCLUSIONS Thickened feeding has a significant effect on the reduction of regurgitation frequency and amount in otherwise healthy infants . This effect is caused by a reduction in the number of nonacid ( pH > 4 ) GER episodes , but also because of a decrease of mean reflux height reached in the esophagus . However , the occurrence of acid GER is not reduced . The combination of IMP and pH monitoring allows the complete registration and description of these GER episodes . Thickening of formula feedings with carob bean gum is an efficient therapy for uncomplicated GER in infants Gastro-oesophageal reflux ( GOR ) occurs mainly during postcibal ( PC ) periods . The duration of PC gastric acidity and the incidence of GOR were analysed in 11 asymptomatic premature infants . GOR was studied during PC periods of 120 min and also during the following 120 min defined as fasting ( FT ) periods . These infants were subjected to simultaneous continuous gastric and oesophageal pH monitoring using a double-blind crossover technique . Two formulae with different fat contents ( 2.6 vs 3.6 g/100 ml ) and different carbohydrate concentrations ( 8.1 vs 7.3 g/100 ml ; malto-dextrin 2.8 vs 1.9 g/100 ml ) were given . Gastric acidity ( pH<4 ) in the PC periods lasted significantly ( P<0.001 ) longer ( 68 min±10 ) with the low fat/high malto-dextrin formula versus 43 min±11 with the high fat/low malto-dextrin formula . Oesophageal pH monitoring data were within normal limits for the total investigation time in all infants . During PC periods acid GOR was detected more frequently in the group with a low fat formula . More PC GOR was recorded when the gastric acidity time was longer An open multicenter study was performed to assess the efficacy and safety of alginic acid in two different dosages in 76 pediatric patients with gastroesophageal reflux confirmed by pH monitoring . Among the 69 patients in whom endoscopy was carried out before treatment , 18 had erythematous esophagitis and 5 had erosive esophagitis . Irrespective of the dosage used , the frequency of regurgitation and vomiting decreased significantly ( p < 0.00001 and p = 0.01 , respectively ) . Clinical and biochemical tolerance were outst and ing and no adverse effects were recorded . On the basis of these data , the recommended dosage is 1 to 2 ml/kg/day in divided doses after meals To evaluate a pre-thickened formula ( Enfamil AR1/2 ) for regurgitant gastroesophageal reflux , 104 infants were enrolled in a 5-week , multi center , double-blind , r and omized , place bo controlled parallel group trial . The Enfamil AR group showed greater symptom reduction by the end of the first week : percent feedings with any regurgitation ( p=0.045 ) , total regurgitation volume score ( p=0.035 ) , and percent feedings with choke-gag-cough ( p=0.004 ) . The most symptomatic infants at baseline had a reduction in trouble sleeping significantly with Enfamil AR by the end of the study ( p=0.030 ) . This formula flows through a st and ard nipple , reduces regurgitation and choking-gagging-coughing within a week , and improves sleep in the most symptomatic babies by 5 weeks , without causing constipation Summary The role of delayed gastric emptying ( GE ) in the pathogenesis of gastroesophageal reflux ( GER ) in infants is controversial at present . GE has been shown to be altered by the composition and osmolality of the feedings . This prospect i ve study was undertaken to assess the changes in the GE and the percentage of time GER was detected by scintigraphy using three different formulas on consecutive days in infants with GER . Twenty-eight infants under 1 year of age diagnosed to have GER by extended intraesophageal pH monitoring ( pH being < 4.0 for > 5 % of the duration of the test ) , underwent scintigraphy on three consecutive days using the same volume per single feeding of a casein-predominant , soy , or a wheyhydrolysate formula in a r and omized order . The formulas were isocaloric . Gastric emptying and percentage of GER into the esophagus were estimated for 60 min following these feedings . Mean GER percent during the study was 20.39 , 17.68 , and 16.34 on casein-predominant , soy , and whey-hydrolysate formulas , respectively , and was not significantly different . Mean values of GE were 39.7 % , 44.6 % , and 48.5 % on casein , soy , and whey formula , respectively . No significant difference in GE was also observed between casein-predominant and soy formula . However , a significant difference was observed ( p < 0.05 ) on GE between casein-predominant and whey-hydrolysate feedings . Our data suggest that formula selection may be important in the treatment of conditions associated with delayed gastric emptying To determine whether thickening of infant formula feedings with rice cereal increases coughing , we studied 25 infants from birth to 6 months of age , referred for evaluation of gastroesophageal reflux . Coughing was blindly quantified after each of a pair of isocaloric meals ( one thickened and one unthickened ) . Coughing was more frequent after thickened feedings than after unthickened feedings We compared the efficacy of the prokinetic agent cisapride with that of Gaviscon ( an alginate/alkaline compound ) plus Carobel ( carob seed flour ) in the treatment of gastrooesophageal reflux ( GOR ) . Fifty infants with confirmed GOR received either oral cisapride ( 0.8 mg/kg/day ) or Gaviscon plus Carobel for one month in a r and omised , parallel group study . Parental evaluations , diary scores , and 24 hour lower oesophageal pH recordings before and at the end of each treatment were compared . In the cisapride group 14/26 ( 53 % ) were considered better by their parents compared with 19/24 ( 79 % ) of those who received Gaviscon plus Carobel . Diary scores , range ( 0.00 - 1.00 ) , improved in both groups with the median change being greater in the Gaviscon plus Carobel group ( -0.21 ) than the cisapride group ( -0.15 ) . Five of 17 pH variables had significantly improved from baseline in infants who had received cisapride compared with 11/17 in those receiving Gaviscon plus Carobel . However , unpaired analysis of diary and pH data showed no significant differences between the two groups . We conclude that first line treatment of GOR with cisapride is no more effective than conventional treatment with Gaviscon plus Carobel We assessed the efficacy of a natural clay ( smectite ) on the frequency and the duration of acid ( pH less than 4 ) and very acid ( pH less than 3 ) gastroesophageal reflux ( GER ) measured by 24-hour continuous pH recording ( CPR ) . Twenty newborn infants were enrolled in this double-blind controlled study owing to pathological CPR in supine position . After inclusion , all the patients were maintained in the 30-degree elevated prone position and received either smectite ( 3 g/day ; n = 10 ) or placebo ( n = 10 ) for 7 days . On the 8th day , a second 24-hour CPR was performed in supine position . The postural therapy alone ( placebo group ) was followed by a significant decrease in the numbers of acid GER ( p less than 0.05 ) during the second CPR . The combination of postural therapy and smectite treatment was followed by a decrease in the number of acid ( p less than 0.05 ) and very acid GER ( p = 0.01 ) , the percentages of time spent at pH below 4 ( p less than 0.05 ) and 3 ( p less than 0.01 ) and the maximal duration of acid GER ( p less than 0.05 ) The aim of the present study was to compare the efficacy and safety of a new aluminium-free formulation of alginate with placebo in infants with recurrent gastro-oesophageal reflux . This was a double-blind , r and omised , parallel-group study conducted at 25 centres in the UK . Of the 90 paediatric patients recruited in a general practice setting , 42 were r and omised to receive alginate and 48 to receive placebo . Infants were assessed before treatment and again after seven and 14 days of treatment . Analyses were based on the last , valid , non-missing observation for each variable for the intent-to-treat ( ITT ) population of 42 alginate and 46 placebo patients . For the primary efficacy measure ( number of vomitting/regurgitation episodes ) , alginate was significantly superior to placebo ( p = 0.009 ) . For the secondary efficacy measure ( severity of vomiting ) , a trend in favour of alginate was observed ( p = 0.061 ) . Patients receiving alginate achieved superior assessment s of treatment outcome by both investigators ( p = 0.008 ) and parent/guardians ( p = 0.002 ) alike . In addition , alginate achieved a significantly greater reduction in the mean severity of vomiting episodes recorded in a daily diary compared with placebo ( p = 0.027 ) and result ed in more patients having at least 10 % symptom-free days ( p = 0.027 ) . For none of the variables measured did placebo have a superior effect . More than one-half of all patients experienced some adverse event , although no statistically significant differences were observed between the two treatment groups ( p > 0.1 ) , and adverse events accounted for withdrawal in only 12.5 % of the patients ( alginate , n = 4 ; placebo , n = 7 ) . Aluminium-free alginate demonstrated superior efficacy over placebo in treating recurrent gastro-oesophageal reflux in paediatric patients . The safety profile of alginate was similar to that of placebo Output:	REVIEW ER 'S CONCLUSIONS There is no evidence from r and omised controlled trials to support or refute the efficacy of feed thickeners in newborn infants with GOR . Given the absence of evidence , we can not recommend using thickening agents for management of GOR in newborn infants
MS2836	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Purpose Systematic monitoring of sedation , pain and delirium in the ICU is of paramount importance in delivering adequate patient care . While the use of systematic monitoring instruments is widely agreed upon , these tools are infrequently implemented into daily ICU care . The aim of this study is to compare the effectiveness of two different training strategies ( training according to the local st and ard vs. modified extended method ) on the implementation rate of scoring instruments on the ICU . Methods In this experimental cohort study we analyzed the frequency of scoring on three surgical ICUs before and after training , and in a 1 year follow-up . A modified extended training included establishing a local support team helping to resolve immediate problems . In addition we evaluated the impact on patients ’ outcome . Results ICUs trained by the modified extended method showed increased documentation rates of all scores per patient and day . In a 1 year follow-up , increased scoring rates for all scores were maintained . Scoring rates with training according to the local st and ard training protocol did not increase significantly . Implementation of delirium and pain monitoring were associated with a decrease in mortality [ odds ratio ( OR ) 0.451 ; 95 % confidence interval ( CI ) : 0.22–0.924 , and , respectively , OR 0.348 ; 95 % CI : 0.140–0.863 ] . Monitoring had no significant influence on ventilation time or ICU length of stay . Conclusions A modified extended training strategy for ICU monitoring tools ( sedation , pain , delirium ) leads to higher intermediate and long-term implementation rates and is associated with improved patient outcome . However , these findings may have been biased by unmeasured confounders There has been growing interest in determining the possible immune consequences of opioid administration for the management of postoperative pain . We studied the effects of morphine and tramadol on pain and immune function during the postoperative period in 30 patients undergoing abdominal surgery for uterine carcinoma . Phytohemoagglutinin-induced T lymphocyte proliferation and natural killer cell activity were evaluated immediately before and after surgery , and 2 h after the acute administration of either 10 mg of morphine IM or 100 mg tramadol IM for pain . In all patients , phytohemagglutinin-induced lymphoproliferation was significantly depressed by surgical stress . However , in the morphine-treated group , proliferative values remained lower than basal levels for 2 h after treatment , whereas in tramadol-administered patients proliferative values returned to basal levels . Natural killer cell activity was not significantly affected by surgery nor by morphine administration , whereas tramadol significantly enhanced the activity of natural killer cells . Both drugs produced a comparable reduction in postoperative pain . We conclude that , as previously observed in the experimental animal , tramadol and morphine , when administered in analgesic doses , induce different immune effects . Implication s Recent studies suggest that opioids can have an adverse impact on the immune system . Because surgical stress also induces immune dysfunction , the search for analgesic drugs devoid of immunosuppressive effects is of import . This study compared the effects on immune responses of morphine and of the atypical opioid analgesic , tramadol , given for postoperative pain to gynecological cancer patients . Tramadol and morphine showed comparable analgesic activity ; however , tramadol , in contrast to morphine , induced an improvement of postoperative immunosuppression and , therefore , may be preferred to morphine for the treatment of postoperative pain Objective To establish the validity and reliability of a new behavioral pain scale ( BPS ) for critically ill se date d adult patients . Design Prospect i ve evaluation . Setting Ten-bed trauma and surgical intensive care unit in a university teaching hospital . Patients Thirty mechanically ventilated patients who were receiving analgesia and sedation . Intervention Assessment s with the BPS were completed consecutively at st and ardized times ( morning , afternoon , night ) by pairs of evaluators ( nurse and nurse ’s aide ) . They collected physiologic parameters and BPS results before and during care procedures : nonnociceptive ( group 1 , compression stockings application and central venous catheter dressing change ) , nociceptive ( group 2 , endotracheal suctioning and mobilization ) , and retested nociceptive ( group 3 ) . The BPS score was the sum of three items that had a range score of 1–4 : facial expression , movements of upper limbs , and compliance with mechanical ventilation . Measurements and Main Results Two hundred and sixty nine assessment s were completed , including 104 , 134 , and 31 measurements in groups 1 , 2 and 3 , respectively . There was no difference in Ramsay scale scores between the three groups ( Ramsay 4–6 ) . Nociceptive stimulations ( group 2 ) result ed in significantly higher BPS values than nonnociceptive ones ( group 1 , 4.9 vs. 3.5 , p < .01 ) , whereas the two groups had comparable BPS values before stimulation ( 3.1 vs. 3.0 ) . A trend was found in group 2 between the dosage of sedation/analgesia and BPS : the higher the dosage , the lower BPS values and BPS changes to nociceptive stimulation . Group 3 had BPS values similar to group 2 at rest ( 3.2 vs. 3.2 ) and during the procedure ( 4.4 vs. 4.5 ) , with good interrater correlations ( r2 = .71 and .50 , respectively ) . Conclusions These results indicate that the expression of pain can be scored validly and reliably by using the BPS in se date d , mechanically ventilated patients . Further studies are warranted regarding the utility of the BPS in making clinical decisions about the use of analgesic drugs in the intensive care unit Objective : To measure the impact of implementation of the systematic evaluation of pain and agitation by nurses using the Behavioral Pain Scale ( BPS ) , the Numerical Rating Scale ( NRS ) for pain , and the Richmond Agitation Sedation Scale ( RASS ) associated with medical staff education in analgesia and sedation management in intensive care unit ( ICU ) patients . Design : Two-phase , prospect i ve , controlled study . Setting : Twelve-bed medical-surgical ICU in a university hospital . Patients : Consecutive patients staying > 24 hrs in ICU . Interventions : BPS , NRS , and RASS were measured twice daily , at rest , by independent observers during 21 wks ( control group ) and after 4 wks of training , by nurses during 29 wks ( intervention group ) . In the intervention group , the treating physician was alerted in case of pain defined by BPS > 5 or NRS > 3 or in case of agitation defined by RASS > 1 . Measurements and Main Results : A total of 230 patients were included ( control group , n = 100 ; intervention group , n = 130 ) . Baseline characteristics were not significantly different . The incidence of pain and agitation decreased significantly in the intervention group : 63 % vs. 42 % ( p = .002 ) and 29 % vs. 12 % ( p = .002 ) , respectively . Rate of severe pain and agitation events defined by NRS > 6 and RASS > 2 , respectively , also decreased significantly . There were significantly more therapeutic changes in the intervention group in the way of an escalation but also in the way of a de-escalation for analgesic and psychoactive drugs . Compared with the control group , there was a marked decrease in the duration of mechanical ventilation ( 120 [ interquartile range 48–312 ] vs. 65 ( 24–192 ) hrs , p = .01 ) and nosocomial infections rate ( 17 % vs. 8 % , p < .05 ) in the intervention group . There was no significant difference in median length of stay ( 9 [ 4 , 15 ] vs. 7 [ 4 , 13 ] days ) and mortality in ICU ( 12 vs. 15 % ) . Conclusions : Systematic evaluation of pain and agitation , and analgesics and sedatives need was associated with a decrease in incidence of pain and agitation , duration of mechanical ventilation and nosocomial infections Background : Critically ill patients frequently experience pain , but assessment rates remain below 40 % in mechanically ventilated patients . Whether pain assessment affects patient outcomes is largely unknown . Methods : As part of a prospect i ve cohort study of mechanically ventilated patients who received analgesia on day 2 of their stay in the intensive care unit ( ICU ) , the investigators performed propensity-adjusted score analysis to compare the duration of ventilator support and duration of ICU stay between 513 patients who were assessed for pain and 631 patients who were not assessed for pain . Results : Patients assessed for pain on day 2 were more likely to receive sedation level assessment , nonopioids , and dedicated analgesia during painful procedures than patients whose pain was not assessed . They also received fewer hypnotics and lower daily doses of midazolam . Patients with pain assessment had a shorter duration of mechanical ventilation ( 8 vs. 11 days ; P < 0.01 ) and a reduced duration of stay in the ICU ( 13 vs. 18 days ; P < 0.01 ) . In propensity-adjusted score analysis , pain assessment was associated with increased odds of weaning from the ventilator ( odds ratio , 1.40 ; 95 % confidence interval , 1.00–1.98 ) and of discharge from the ICU ( odds ratio , 1.43 ; 95 % confidence interval , 1.02–2.00 ) . Conclusions : Pain assessment in mechanically ventilated patients is independently associated with a reduction in the duration of ventilator support and of duration of ICU stay . This might be related to higher concomitant rates of sedation assessment s and a restricted use of hypnotic drugs when pain is assessed BACKGROUND Pain can adversely affect a patient 's physiological and psychological recovery , yet little is known about the pain experience of cardiac surgical patients . OBJECTIVES To examine nursing practice regarding analgesic administration and measure pain intensity and patient satisfaction with pain management practice s. METHODS To establish baseline nursing practice regarding analgesic administration , charts were review ed retrospectively in 50 adult cardiac surgical patients , and the same information was collected concurrently for a prospect i ve sample of 51 patients . The subjects completed visual analogue scales as a measure of pain intensity twice daily while in the cardiothoracic intensive care unit and Pain Relief Satisfaction Question naires on the day after transfer from the unit . RESULTS Patients in the prospect i ve group received significantly more analgesia . Pain intensity was moderate ( 4 or greater on the Visual Analogue Scale ) . Women had higher overall visual analogue scale scores than did men , 4.57 versus 3.70 . Patients in whom an internal mammary artery had been used as a bypass graft had significantly higher scores compared with patients with vein grafts . The Pain Relief Satisfaction Question naire responses indicated that 96 % of the patients experienced effective pain management in the cardiothoracic intensive care unit . CONCLUSIONS Despite receiving analgesic doses twice those reported elsewhere for similar population s , the patients in this study reported moderate pain intensity . This finding was confounded by the fact that 96 % expressed satisfaction with their pain management in the cardiothoracic intensive care unit . Frequent assessment and documentation of both pain and pain relief from interventions are necessary if the healthcare team is to implement an individualized analgesic regimen Background : The authors conducted a patient-based survey of practice s to fully describe the assessment and the management of pain and sedation of a large cohort of mechanically ventilated patients during their first week of intensive care unit ( ICU ) stay . Methods : A total of 1,381 adult patients were included in a prospect i ve , observational study in 44 ICUs in France . Pain and sedation assessment , analgesic and sedative use , and analgesic management during procedural pain were collected on days 2 , 4 , and 6 of the ICU stay . Results : The observed rates of assessment on day 2 for sedation ( 43 % ) and analgesia ( 42 % ) were significantly smaller than that of use of sedatives ( 72 % ) and opioids ( 90 % ) , also noted on days 4 and 6 . The use of protocol s/ guidelines for sedation/analgesia in the ICU reduced the proportion of patients who were treated , although not evaluated . A large proportion of assessed patients were in a deep state of sedation ( 40–50 % ) . Minor changes in the dosages of the main prescribed agents for sedation ( midazolam , propofol ) and analgesia ( sufentanil , fentanyl , morphine , remifentanil ) were found across 6 days of the patient ’s ICU stay . Procedural pain was specifically managed for less than 25 % of patients ; during those procedures , the proportion of patients with pain significantly increased from the baseline pain evaluation . Conclusions : Excessively deep states of sedation and a lack of analgesia during painful procedures must be prevented . To facilitate systematic pain and sedation assessment and to adjust daily drug dosages accordingly , it seems crucial to promote educational programs and elaboration of protocol s/ guidelines in the ICU BACKGROUND Administration of analgesics per patient request or r and om pain assessment s may provide inadequate pain management . OBJECTIVE To examine the impact of nurses ' use of a st and ardized pain flowsheet to document pain assessment and pharmacologic management on patient-reported pain intensity . METHODS A pre-post intervention design was used to compare 61 patients . In the preimplementation group , traditional charting of pain presence or absence was documented in the narrative notes and pharmacologic management was recorded on the medication profile . In the postimplementation group , the intensity of pain and pharmacologic management were documented on a pain flowsheet . Within 24 hours after transfer to the step-down unit , patients were interviewed Output:	Implementation of systematic approaches to pain assessment appears to associate with more frequent documented reports of pain and more efficient decisions for pain management . There was evidence of favorable effects on pain intensity , duration of mechanical ventilation , length of ICU stay , mortality , adverse events , and complications . This systematic review demonstrates a link between systematic pain assessment and outcome in critical illness .
MS2837	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In this prospect i ve , multicenter , double-blind study , the efficacy of ciprofloxacin was compared with that of clarithromycin as therapy for patients with acute bacterial exacerbations of chronic bronchitis ( ABECB ) from whom a pretherapy pathogen was isolated ; the efficacy was measured by the infection-free interval . Clinical and microbiological responses at the end of therapy were secondary efficacy variables . Patients r and omly received either ciprofloxacin or clarithromycin ( 500 mg twice a day for 14 days ) . Three hundred seventy-six patients with acute exacerbations of chronic bronchitis were enrolled in the study of whom 234 had an ABECB . Clinical resolution was observed in 90 % ( 89 of 99 ) of ciprofloxacin recipients and 82 % ( 75 of 91 ) of clarithromycin recipients for whom efficacy could be evaluated . The median infection-free interval was 142 days for ciprofloxacin recipients and 51 days for clarithromycin recipients ( P = .15 ) . Bacteriologic eradication rates were 91 % ( 86 of 95 ) for ciprofloxacin recipients and 77 % ( 67 of 87 ) for clarithromycin recipients ( P = .01 ) . In summary , compared with clarithromycin , treatment of ABECB with ciprofloxacin was associated with a trend toward a longer infection-free interval and a statistically significantly higher bacteriologic eradication rate In an open r and omized study 218 out patients ( 159 males and 59 females ) ranging between 18 and 85 years of age ( mean 61.9 ) suffering from bacterial exacerbation of chronic bronchitis have been r and omly treated : 79 with co-amoxiclav ( amoxicillin 875 mg+clavulanic acid 125 mg ) twice daily , 69 with cefixime ( 400 mg ) once daily , and 70 with ciprofloxacin ( 500 mg ) twice daily for an average period of 10 days . Before treatment start , 234 bacterial strains ( 105 Gram-positive and 129 Gram-negative ) were isolated as the cause of exacerbation ; the leading pathogens were Streptococcus pneumoniae and Haemophilus spp . Eradication rates at the end of treatment were 82.2 % for the co-amoxiclav group , 77.6 % for the cefixime group , and 81.2 % for ciprofloxacin group . Clinical success ( cure+improvement ) was obtained in 90.8 % of the cases treated with co-amoxiclav , in 80.9 % for the cefixime group and in 85.7 % of patients treated with ciprofloxacin . Seven adverse events ( 8.9 % ) of which 4 cases of diarrhea and 3 of itching , were recorded in the co-amoxiclav group . Eleven adverse events ( 14.7 % ) were recorded in the cefixime group including gastrointestinal disturbances in 6 patients and mild to moderate increase of liver function in 2 . Nine adverse events ( 12.9 % ) occurred in the ciprofloxacin group , including insomnia in 3 patients , gastrointestinal disturbances in 2 , and serious increase of liver function tests in one patient . It can be concluded that there were no statistically significant differences among the three treatment groups . However , co-amoxiclav demonstrated a higher efficacy rate than cefixime and ciprofloxacin and was better tolerated . Therefore , it can be used as a first-choice drug in the treatment of exacerbation of chronic bronchitis Chronic bronchitis is common among adults and infectious exacerbations contribute considerably to morbidity and mortality . We aim ed to compare the safety and efficacy of moxifloxacin to azithromycin for the treatment of patients with acute exacerbations of chronic bronchitis ( AECB ) of suspected bacterial origin . Between October 1998 and April 1999 , 567 patients with AECB were enrolled at 37 centers across the United States and Canada of which 280 ( 49 % ) had acute bacterial exacerbation of chronic bronchitis ( i.e. pretherapy pathogen ) . Patients were r and omized to either oral moxifloxacin 400 mg administered once daily for 5 days or azithromycin for 5 days ( 500 mg qd x 1 , then 250 mg qd x 4 ) . For the purpose of study blinding , all patients received encapsulated tablets . The main outcome measure was clinical response at the test-of-cure visit ( 14 - 21 days post-therapy ) . Secondary measures included bacteriologic response and a time-course of bacteriological eradication ( one center only ) . Three patient population s were analysed for efficacy : clinical ly-valid , microbiologically-valid ( i.e. those with a pretherapy pathogen ) , and intent-to-treat ( i.e. received at least one dose of study drug ) . For the efficacy-valid group , clinical response at the test-of-cure visit was 88 % for patients in each treatment group . In 237 microbiologically-valid patients , corresponding clinical resolution rates were 88 % for 5-day moxifloxacin vs. 86 % for 5-day azithromycin . Bacteriological eradication rates at the end of therapy were 95 % for 5-day moxifloxacin and 94 % for the azithromycin group . Corresponding eradication rates at the test-of-cure visit were 89 % and 86 % , respectively . Of note , eradication rates at test-of-cure for Haem . philos influenzae and H. parainfluenzae for moxifloxacin were 97 % and 88 % compared to 83 % and 62 % respectively for azithromycin . Among 567 intent-to-treat patients ( 283 moxifloxacin and 284 azithromycin ) , drug-related events were reported for 22 % and 17 % , respectively . Diarrhea and nausea were the most common drug-related events reported in each treatment group . Moxifloxacin 400 mg once daily for 5 days was found to be clinical ly and bacteriologically equivalent to 5-day azithromycin for the treatment of AECB of proven bacterial etiology . Given its excellent in-vitro activity , especially against antibiotic-resistant respiratory pathogens , and its acceptable safety profile , moxifloxacin should be considered an effective alternative therapy for patients with AECB of suspected bacterial origin The objective of this r and omized , double-blind study was to compare the clinical efficacy of levofloxacin at two different dosages with that of cefuroxime axetil in patients with acute purulent exacerbations of chronic bronchitis and , in particular , to assess the impact of the susceptibility to levofloxacin on the clinical findings . In total , 124 evaluable patients were treated for 7 days with oral levofloxacin 250 mg or 500 mg od , or cefuroxime axetil 250 mg bd . Sputum cultures were monitored pre-treatment , and at 1 and 7 days after the end of treatment . The susceptibility of Streptococcus pneumoniae isolates was tested by agar dilution in Columbia blood agar and by disc diffusion , but all other isolates were tested solely by the disc diffusion method . A greater number of infections were eradicated by levofloxacin than by cefuroxime axetil : infections were eradicated in 68 % of patients receiving the 500 mg dosage and in 63 % of those taking 250 mg levofloxacin , whereas the eradication rate with the comparator drug was much lower ( 48 % ) . Against all pre-treatment S. pneumoniae isolates ( n = 39 ) , the MICs of levofloxacin were between 0.25 and 2 mg/L ( geometric mean 0.95 mg/L ) , similar to those of the post-treatment strains ( n = 32 ; mean 1.11 mg/L ) . All except one of the S. pneumoniae isolates were susceptible to penicillin G ( MIC < or = 0.06 mg/L ) , and the remaining isolate was inhibited by 0.5 mg/L of penicillin G , but was fully susceptible to levofloxacin . Some pretreatment strains of Pseudomonas aeruginosa were resistant to levofloxacin , but many more resistant strains were encountered afterwards . All strains of Moraxella catarrhalis and Haemophilus influenzae were highly susceptible to levofloxacin in the disc diffusion tests . All the antimicrobial agents used in the study were well tolerated : only two patients discontinued treatment because of adverse drug effects . The results of this study indicated that , although there were some failures in patients with S. pneumoniae and P. aeruginosa infections , resistance to levofloxacin did not emerge rapidly among strains of S. pneumoniae during therapy with levofloxacin , and that natural resistance among pneumococci , H. influenzae and M. catarrhalis was rare This investigation compared the efficacy of oral formulations of amoxycillin/clavulanate and ciprofloxacin in acute exacerbations of chronic bronchitis . Forty patients were r and omized to receive either Augmentin ( 1,000 mg amoxycillin + 250 mg clavulanate ) tds or ciprofloxacin ( 500 mg ) bd . During and before therapy sputum sample s were taken for bacteriology , sputum volume measurement and histamine determination . Lung function was also monitored . From sputum , 143 bacterial isolates and 15 yeast strains were obtained before therapy . During therapy with amoxycillin/clavulanate the incidence of Gram-positive isolates decreased significantly whereas ciprofloxacin left their frequency unchanged . On the other h and , ciprofloxacin more effectively diminished the incidence of Gram-negative isolates . Yeasts were grown from the sputum of several patients before and during therapy . Their number did not increase during amoxycillin/clavulanate therapy while it increased under ciprofloxacin . The groups showed no significant differences with regard to sputum production , histamine concentration or lung function . The majority of patients ( 28/40 ) acknowledged improvement of their symptoms . There was no significant difference between the groups . On the basis of these results both amoxycillin/clavulanate and ciprofloxacin appear of similar value for treatment of patients with exacerbations of chronic bronchitis In this multinational , r and omized , double-blind study , the efficacy and safety of a 5 day course of moxifloxacin 400 mg orally od was compared with that of a 7 day course of clarithromycin 500 mg orally bd . in 750 patients with acute exacerbations of chronic bronchitis , characterized by at least two of the symptoms : sputum purulence , increased sputum volume or increased dyspnoea . Seven days after the end of therapy , clinical cure was achieved for 89 % ( 287 of 322 ) of efficacy-evaluable patients in the moxifloxacin group and 88 % ( 289 of 327 ) of patients in the clarithromycin group ( 95 % CI , -3.9 % , 5.8 % ) . At follow-up ( 21 - 28 days post-treatment ) , the continued clinical cure rates were 89 % ( 256 of 287 ) for moxifloxacin and 89 % ( 257 of 289 ) for clarithromycin . A total of 342 pathogenic bacteria were isolated from the sputum of 287 patients . The most common pathogens were Haemophilus influenzae ( 37 % ) , Streptococcus pneumoniae ( 31 % ) and Moraxella catarrhalis ( 18 % ) . Seven days post-treatment , a successful bacteriological response was obtained for 77 % ( 89 of 115 ) of patients in the moxifloxacin group and 62 % ( 71 of 114 ) of patients in the clarithromycin group , indicating superiority of moxifloxacin ( 95 % CI , 3.6 % , 26.9 % ) . Both treatments were well tolerated with few adverse events . This study demonstrated that for the treatment of acute exacerbations of chronic bronchitis a 5 day course of moxifloxacin 400 mg od was clinical ly equivalent and bacteriologically superior to a 7 day course of clarithromycin 500 mg bd OBJECTIVE This study compared the use and efficacy of ciprofloxacin to cefuroxime axetil for adult patients with acute bacterial sinusitis . METHOD We conducted a prospect i ve , r and omized , double-blind pilot study of Output:	RESULTS The results of the comparative and single meta-analyses revealed no major differences between the new fluoroquinolones . Results indicate that , in general , fluoroquinolones had similar efficacy , overall safety and dropout rates
MS2838	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Purpose Transcutaneous electrical stimulation ( TES ) speeds up colonic transit in children with slow-transit constipation ( STC ) . This study examined if concurrent upper gastrointestinal dysmotility ( UGD ) affected response to TES . Methods Radio-nuclear transit studies ( NTS ) were performed before and after TES treatment of STC as part of a larger r and omised controlled trial . UGD was defined as delayed gastric emptying and /or slow small bowel transit . Improvement was defined as increase of ≥1 Geometric Centre ( median radiotracer position at each time [ small bowel = 1 , toilet = 6 ] ) . Results Forty-six subjects completed the trial , 34 had NTS after stimulation ( 21 M , 8–17 years , mean 11.3 years ; symptoms > 9 years ) . Active stimulation increased transit in > 50 % versus only 25 % with sham ( p = 0.04 ) . Seventeen children also had UGD . In children with STC and either normal upper GI motility ( NUGM ) and UGD , NTS improved slightly after 1 month ( 57 vs. 60 % ; p = 0.9 ) and more after 2 months ( 88 vs. 40 % ; p = 0.07 ) . However , mean transit rate significantly increased with NUGM , but not UGD ( 5.0 ± 0.2 : 3.6 ± 0.6 , p < 0.01 ) . Conclusion Transcutaneous electrical stimulation was beneficial for STC , with response weakly associated with UGD . As measured by NTS , STC children with NUGM responded slightly more , but with significantly greater increased transit compared to those with UGD . Higher numbers are needed to determine if the difference is important PURPOSE Idiopathic slow transit constipation ( STC ) describes a clinical syndrome characterised by intractable constipation . It is diagnosed by demonstrating delayed colonic transit on nuclear transit studies ( NTS ) . A possible new treatment is interferential therapy ( IFT ) , which is a form of electrical stimulation that involves the transcutaneous application of electrical current . This study aim ed to ascertain the effect of IFT on colonic transit time . METHODS Children with STC diagnosed by NTS were r and omised to receive either 12 real or placebo IFT sessions for a 4-week period . After a 2-month break , they all received 12 real IFT sessions-again for a 4-week period . A NTS was repeated 6 to 8 weeks after cessation of each treatment period where able . Geometric centres ( GCs ) of activity were calculated for all studies at 6 , 24 , 30 , and 48 hours . Pretreatment and posttreatment GCs were compared by statistical parametric analysis ( paired t test ) . RESULTS Thirty-one pretreatment , 22 postreal IFT , and 8 postplacebo IFT studies were identified in 26 children ( mean age , 12.7 years ; 16 male ) . Colonic transit was significantly faster in children given real treatment when compared to their pretreatment NTS at 24 ( mean CG , 2.39 vs 3.04 ; P < or = .0001 ) , 30 ( mean GC , 2.79 vs 3.47 ; P = .0039 ) , and 48 ( mean GC , 3.34 vs 4.32 ; P = .0001 ) hours . By contrast , those children who received placebo IFT had no significant change in colonic transit . CONCLUSIONS Transcutaneous electrical stimulation with interferential therapy can significantly speed up colonic transit in children with slow transit constipation AIMS Transcutaneous electrical stimulation ( TES ) was used to treat children with slow-transit constipation ( STC ) for 1 to 2 months in a r and omized controlled trial during 2006 to 2008 . We aim ed to determine long-term outcomes , hypothesizing that TES produced sustained improvement . METHODS Physiotherapists administered 1 to 2 months of TES to 39 children ( 20 minutes , 3 times a week ) . Fifteen continued to self-administer TES ( 30 minutes daily for more than 2 months ) . Mean long-term follow-up of 30 of 39 patients was conducted using question naire review 3.5 years ( range 1.9 - 4.7 years ) later . Outcomes were evaluated by confidence intervals or paired t test . RESULTS Seventy-three percent of patients perceived improvement , lasting more than 2 years in 33 % and less than 6 months in 25 % to 33 % . Defecation frequency improved in 30 % . Stools got wetter in 62 % after stimulation and then drier again . Soiling improved in 75 % and abdominal pain in 59 % . Laxative use stopped in 52 % , and 43 % with appendicostomies stopped washouts . Soiling/Holschneider continence score improved in 81 % ( P = .0002 ) . Timed sits switched to urge-initiated defecations in 80 % patients . Eighty percent of relapsed patients elected to have home stimulation . CONCLUSION TES holds promise for STC children . Improvement occurred in two thirds of children , lasting more than 2 years in one third , whereas symptoms recurred after 6 months in one third of children PURPOSE Transcutaneous electrical stimulation ( TES ) ( 3 sessions/wk ) over the abdomen stimulated bowel functions in a r and omized controlled trial . This pilot study assessed whether daily TES at home with a safe , portable machine would be possible and more efficacious than trial results . METHODS Eleven patients ( 6 male/5 female ; mean age , 14 years ; range , 12 - 18 years ) with slow-transit constipation who relapsed or responded poorly in the trial were recruited ( 11 + /- 5 months later ) . An EPM-IF-4160 ( Fuji Dynamics , Hong Kong ) portable machine ( sine waveform , 4 kHz carrier frequency , 80 - 160 Hz beat frequency , intensity <33 mA ) delivering interferential current ( 2 electrodes over epigastrium + 2 over kidneys ) was applied 1 hour daily at home . Continence diaries were kept for 1 month before and 2 months during treatment . RESULTS All children completed more than 1 month of treatment after baseline recording . Defecation increased in 9 of 11 children , and soiling decreased in 4 of 11 children . There was a significant increase in total episodes of defecation per week ( mean + /- SD , 2.5 + /- 2.1 vs 6.7 + /- 4.4 ; P = .008 ) and a nonsignificant decrease in soiling ( 3.8 + /- 1.6 vs 1.1 + /- 0.5 episodes/wk , P = .1 ) . Daily stimulation does not affect abdominal pain . No adverse events occurred . CONCLUSIONS Daily TES at home is safe and significantly improved bowel function in children who did not respond to 3 times per week of TES . Home TES may be a novel treatment of intractable slow transit constipation , avoiding hospital visits BACKGROUND Slow transit constipation ( STC ) causes intractable symptoms not responsive to medical treatment . Children have irregular bowel motions , colicky abdominal pain , and frequent soiling . Transcutaneous electrical stimulation using interferential current ( interferential therapy [ IFT ] ) is a novel treatment of STC . This study assessed quality of life ( QOL ) in STC children before and after IFT treatment . METHODS Eligible STC children were r and omized to receive either real or placebo IFT ( 12 sessions for 4 weeks ) . Question naires ( Pediatric Quality of Life Inventory ) were administered before and 6 weeks after treatment , with parallel parent and child self-report scales . Higher scores indicate better QOL . Holschneider and Templeton scores were also obtained . The QOL scores were compared using paired t tests . RESULTS Thirty-three children ( 21 male ) , with a mean age of 11.8 years ( range , 7.4 - 16.5 years ) , were recruited ; 16 received real IFT . Child-perceived QOL was improved after real IFT compared with baseline ( 81.1 vs 72.9 , P = .005 ) but not after placebo IFT ( 78.1 vs 74.9 , P = .120 ) . The Holschneider score improved after real IFT ( 10 vs 8 , P = .015 ) but not after placebo IFT ( 9 vs 8 , P = .112 ) . Parentally perceived QOL was similar after real IFT ( 70.1 vs 70.3 , P = .927 ) and placebo IFT ( 70.2 vs 69.8 , P = .899 ) . There were no differences in Templeton scores . CONCLUSION Interferential therapy is a novel therapy for children with STC that improves their self-perceived QOL PURPOSE This study aim ed to test the effectiveness of home transcutaneous electrical stimulation ( TES ) when patients with slow-transit constipation ( STC ) were trained by a naive clinician . METHODS A surgeon was trained to teach the TES method to STC children who then self-administered at home ( 1 hour a day , 3 - 6 months ) using a battery-powered interferential stimulator . Bowel diaries , PedsQL4.0 question naires , and radio-nuclear colonic transit studies were completed before and after treatment . RESULTS Thirty-two children ( 16 female ; mean age , 8.3 years ; range , 3 - 17 years ) self-administered 3 to 6 months of TES . Three did not return diaries . Group 1 ( n = 13 ) started with less than 3 bowel actions per week , and group 2 ( n = 16 ) , with more than 3 bowel actions per week . Defecation frequency increased in 69 % of group 1 ( mean , 1.4 - 3.0 per week ; P = .02 ) . Soiling frequency decreased in 50 % of group 2 ( 5.4 - 1.9 per week , P = .04 ) . Of 13 patients , 7 improved with development of urge-initiated defecation . Abdominal pain decreased in 48 % ( 1.6 episodes per week to 0.9 per week , P = .06 ) . Stool consistency improved in 56 % . There was significant improvement in child-reported and parent-reported PedsQL Scores . Colonic transit improved in 13 of 25 patients . CONCLUSION Home TES provides a new treatment for STC children , with 50 % of treatment-resistant patients benefited . Success requires clinician training and close patient contact . Transcutaneous electrical stimulation increased defecation and reduced soiling The second part of the Consensus Statement of the Italian Association of Hospital Gastroenterologists and Italian Society of Colo-Rectal Surgery reports on the treatment of chronic constipation and obstructed defecation . There is no evidence that increasing fluid intake and physical activity can relieve the symptoms of chronic constipation . Patients with normal-transit constipation should increase their fibre intake through their diet or with commercial fibre . Osmotic laxatives may be effective in patients who do not respond to fibre supplements . Stimulant laxatives should be reserved for patients who do not respond to osmotic laxatives . Controlled trials have shown that serotoninergic enterokinetic agents , such as prucalopride , and prosecretory agents , such as lubiprostone , are effective in the treatment of patients with chronic constipation . Surgery is sometimes necessary . Total colectomy with ileorectostomy may be considered in patients with slow-transit constipation and inertia coli who are resistant to medical therapy and who do not have defecatory disorders , generalised motility disorders or psychological disorders . R and omised controlled trials have established the efficacy of rehabilitative treatment in dys-synergic defecation . Many surgical procedures may be used to treat obstructed defecation in patients with acquired anatomical defects , but none is considered to be the gold st and ard . Surgery should be reserved for selected patients with an impaired quality of life . Obstructed defecation is often associated with pelvic organ prolapse . Surgery with the placement of prostheses is replacing fascial surgery in the treatment of pelvic organ prolapse , but the efficacy and safety of such procedures have not yet been established Output:	Conclusions This systemic review found moderate support for the effectiveness of electrical stimulation therapy in slow transit constipation in children .
MS2839	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE : To compare discontinuation rates of the levonorgestrel and copper intrauterine devices ( IUDs ) among women with human immunodeficiency virus . METHODS : A double-masked r and omized trial was conducted at Mulago Hospital , Ug and a. Women received either a copper or levonorgestrel IUD . The primary outcome was discontinuation of intrauterine contraception within 1 year of placement . The secondary outcomes were incidence of side effects and severe adverse events . To discern a difference of 10 % from a copper IUD discontinuation rate of 18 % , power of 80 % , and 95 % confidence interval ( CI ) , a sample size of 351 per arm was estimated . Analysis of the primary outcome was by intension-to-treat principle . RESULTS : From September 2013 to December 2014 , 979 were screened and 703 r and omized as follows : 349 to the copper group and 354 to the levonorgestrel group . In total , 8.6 % ( 29/338 ) women in the copper group compared with 8.1 % ( 27/334 ) in the levonorgestrel group discontinued intrauterine conception within 1 year of placement ( incidence rate ratio 1.1 [ 95 % CI 0.64–1.96 ] ) . Overall , the incidence of heavy bleeding was higher in the copper group ( 37 % [ 125/338 ] ) than in the levonorgestrel group ( 19.5 % [ 65/334 ] ) . However , the incidence of amenorrhea , which occurred in 3.3 % ( 11/338 ) of women , was lower in the copper group than the 19.8 % ( 66/334 ) of women who reported amenorrhea in the levonorgestrel group . CONCLUSION : There was no difference in discontinuation rates between the copper and levonorgestrel devices . Women in the levonorgestrel group had reduced incidence of heavy bleeding and a higher incidence of amenorrhea compared with those in the copper group . CLINICAL TRIAL REGISTRATION : Pan African Clinical Trial Registry , www.pactr.org , PACTR 201308000561212 . LEVEL OF EVIDENCE : Objective : To determine the effect of cryotherapy on HIV-1 cervical shedding . Design : Prospect i ve cohort study . Methods : Five hundred HIV-positive women enrolled at an HIV treatment clinic in Nairobi , Kenya were screened for cervical cancer . Women diagnosed with cervical intraepithelial neoplasia stage 2 or 3 ( CIN 2/3 ) by histology were offered cryotherapy treatment . The first 50 women had cervical swabs taken at baseline and at 2 and 4 weeks following treatment . Swabs were analyzed for HIV-1 RNA and compared using General Estimating Equation ( GEE ) with binomial or Gaussian links . Results : Of the 50 women enrolled , 40 were receiving antiretroviral therapy ( ART ) and 10 were not receiving ART at the time of cryotherapy and during study follow-up . Among all women , the odds of detectable cervical HIV-1 RNA did not increase at 2 weeks [ odds ratio ( OR ) 1.18 ; 95 % confidence interval ( CI ) 0.65–2.13 ] or 4 weeks ( OR 1.29 ; 95 % CI 0.71–2.33 ) following cryotherapy . Among 10 women not receiving ART , the OR of detectable shedding at 2 weeks was higher , but not statistically significant ( OR 4.02 ; 95 % CI 0.53–30.79 ; P = 0.2 ) , and at 4 weeks remained unchanged ( OR 1.00 ; 95 % CI 0.27–3.74 ) . Conclusion : There was no increase in detectable cervical HIV-1 RNA among HIV-positive women after cryotherapy . The risk of HIV-1 transmission after cryotherapy may not be significant , particularly among women already on ART at the time of cervical treatment . However , further investigation is needed among women not receiving ART OBJECTIVE To assess outcome in HIV-positive women undergoing the loop electrosurgical excision procedure ( LEEP ) . METHOD A prospect i ve study was conducted with 789 out patients undergoing LEEP at Chiang Mai University Hospital between October 2004 and June 2008 . RESULTS The 70 HIV-positive women ( 8.9 % ) were younger ( P<0.001 ) and had a lower parity ( P<0.001 ) than the remaining women . The proportion of women undergoing LEEP for persistent low- grade lesions was higher ( 8.6 % vs 1.9 % ) and the prevalence of margin involvement was higher ( 60.0 % vs 49.4 % ) among the HIV-positive women . After adjusting for age , parity , menopausal status , size of excised lesion , and histopathologic result , HIV infection was not significantly associated with LEEP complications ( adjusted odds ratio , 0.41 ; 95 % confidence interval , 0.15 - 1.15 ) . CONCLUSION The higher risk of resection margin involvement in HIV-infected women was not associated with LEEP complications STUDY QUESTION Does laboratory testing after syndromic screening for sexually transmitted infections ( STIs ) reduce the rate of intrauterine contraception ( IUC ) removal among women living with HIV/AIDS ( WLHA ) ? SUMMARY ANSWER Additional laboratory testing after syndromic screening for STIs did not affect the likelihood that a woman would remove an IUC immediately or within 1 year of IUC use or the frequency of post-insertion unscheduled clinic visits . In low-risk WLHA , the incidence rate of IUC removal is low with or without laboratory testing . WHAT IS KNOWN ALREADY Fear of infectious morbidity remains an obstacle to uptake of IUC by WLHA . The value of laboratory testing after syndromic screening for STI before the insertion of IUC remains uncertain . STUDY DESIGN , SIZE , DURATION We enrolled WLHA from 2 September to 6 December 2013 and followed them up to 31 December 2014 . After syndromic screening , 703 women free of STIs were r and omized to either additional laboratory screening or no additional screening for STI before IUC insertion . The r and omization sequence was generated by an independent statistician and r and omization numbers placed in opaque sequentially numbered sealed envelopes . All women r and omized had an IUC inserted and in all 672 participants completed the 1-year follow-up . The study staff who followed up the participants were blinded to the study allocation groups . Incidence rate ratios ( IRRs ) were used to compare the incidence rates of IUC removal , unscheduled clinic attendance and IUC continuation between the two groups . PARTICIPANTS / MATERIAL S , SETTING , METHODS Women eligible to participate were 18 - 49 years old at study entry , in a relationship with a male partner , wanted to avoid pregnancy for at least 1 year and were undergoing HIV/AIDS care at Mulago Hospital , Ug and a. Participants completed a baseline question naire and up to four follow-up question naires until discontinuation of IUC , loss to follow-up or end of study observation after 12 months . MAIN RESULTS AND THE ROLE OF CHANCE The rate of IUC removal was 8.8 % ( 29/331 ) in the no additional screening group and 8.0 % ( 27/341 ) in the additional laboratory screening group [ IRR 1.1 ( 95 % CI 0.63 - 1.93 ) ] . Unscheduled clinic attendances were similar in the two groups at 1 year of IUC insertion : 13.6 % ( 45/331 ) in the no additional screening group and 12.3 % ( 42/241 ) in the additional laboratory screening group . During the 1-year follow-up , only five women , three from the no additional screening group and two from the additional laboratory screening group , developed pelvic inflammatory disease ( PID ) , as defined by established diagnostic criteria . LIMITATIONS , REASONS FOR CAUTION We were not able to carry out STI risk assessment directly from the men thus women with high-risk partners could have been included in the study and this may be responsible for the lack of a demonstrable effect of additional laboratory screening on incidence rates of IUC removals and unscheduled clinic attendance . The diagnosis of PID was based on clinical signs and symptoms ; therefore , sub clinical PID could have been missed . WIDER IMPLICATION S OF THE FINDINGS Among WLHA , the incidence rate of IUC removal is low and IUC continuation high . Syndromic screening for STIs could be sufficient in indentifying WLHA who are suitable for IUC use . However , our findings are only generalizable to women in HIV/AIDS care who have access to good follow-up . STUDY FUNDING /COMPETING INTERESTS The study was supported by Medical Education for Equitable Services to all Ug and ans , a Medical Education Partnership Initiative grant number 5R24TW008886 from the office of Global AIDS Coordinator and the US Department of Health and Human Services , Health Re sources and Services Administration and National Institutes of Health . Additional funding was from the Swedish International Development Agency , Swedish Research Council ( SIDA/VR ) . The authors have no competing interests to declare . TRIAL REGISTRATION NUMBER This trial was registered at Pan African Clinical Trial , Registry . PACTR 201308000561212 BACKGROUND Plasma HIV-1 RNA concentration has been the best predictor for risk of heterosexual and perinatal transmission . However , direct contact with HIV-1 present locally in the genital tract might be necessary for transmission . We aim ed to assess the relation between HIV-1 shedding ( RNA or culturable virus ) in female genital secretions and other factors that might affect HIV-1 shedding . METHODS This was a cross-sectional study within the Women 's Interagency HIV Study ( WIHS ) , a prospect i ve longitudinal cohort study of HIV-infected women . We enrolled 311 HIV positive women from Jan 30 , 1997 to July 1 , 1998 . We did clinical assessment s , cultured HIV-1 , and measured RNA in peripheral blood mononuclear cells ( P BMC ) and genital secretions . We compared the results with univariate and multivariate analyses . Presence of HIV-1 RNA or culturable virus in genital secretions was defined as HIV-1 shedding . FINDINGS HIV-1 RNA was present in genital secretions of 57 % ( 152/268 ) of women whereas infectious virus was detected only in 6 % ( 17/271 ) . Genital tract HIV-1 shedding was found in 80 % ( 130/163 ) of women with detectable plasma RNA and 78 % ( 116/148 ) of women with positive P BMC cultures . 33 % ( 27/83 ) of women with less than 500 copies/mL plasma RNA and 39 % ( 35/90 ) of those with negative P BMC cultures also had genital tract shedding . INTERPRETATION Plasma RNA concentration , both qualitatively and quantitatively , was the most important factor in predicting genital HIV-1 shedding , even among women receiving potent antiretroviral therapy . However , HIV-1 shedding did occur in women with less than 500 copies/mL plasma HIV-1 RNA . This finding suggests that a separate reservoir of HIV-1 replication may exist in some women BACKGROUND The effects of estrogen-containing contraceptives on disease activity in women with systemic lupus erythematosus have not been determined . METHODS We conducted a single-blind clinical trial involving 162 women with systemic lupus erythematosus who were r and omly assigned to combined oral contraceptives , a progestin-only pill , or a copper intrauterine device ( IUD ) . Disease activity was assessed at 0 , 1 , 2 , 3 , 6 , 9 , and 12 months according to the Systemic Lupus Erythematosus Disease Activity Index ( SLEDAI ) . The primary outcome was global disease activity , which we estimated by measuring the area under the SLEDAI curve . Secondary outcomes included the maximum SLEDAI score , change in SLEDAI score , incidence of lupus flares , median time to first flare , systemic lupus erythematosus treatment , and adverse events . The results were analyzed by the intention-to-treat method . RESULTS At baseline , all demographic features and disease characteristics were similar in the three groups . The mean ( + /-SD ) SLEDAI score was 6.1+/-5.6 in the group assigned to combined oral contraceptives , 6.4+/-4.6 in the group assigned to the progestin-only pill , and 5.0+/-5.3 in the group assigned to the IUD ( 54 patients in each group ) ( P=0.36 ) . Disease activity remained mild and stable in all groups throughout the trial . There were no significant differences among the groups during the trial in global or maximum disease activity , incidence or probability of flares , or medication use . The median time to the first flare was three months in all groups . Thromboses occurred in four patients ( two in each of the two groups receiving hormones Output:	The remaining studies generally found low or no incidence of PID among IUD users . No direct evidence addresses potential differences in HIV disease progression or transmission by HIV disease severity . CONCLUSION Limited evidence of fair to poor quality found no differences in infectious complications when comparing IUD complication rates among women with varying levels of HIV disease severity . One study found that IUD use was not associated with HIV transmission , and studies generally found no differences in genital viral shedding or disease progression ; however , there was little direct evidence to address potential differences related to HIV severity
MS2840	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Importance RAS wild-type ( wt ) status is necessary but not sufficient for response to anti-epidermal growth factor receptor ( EGFR ) agents in advanced colorectal cancer ( aCRC ) . RNA expression of EGFR lig and s epiregulin ( EREG ) and amphiregulin ( AREG ) may correlate with EGFR-targeted therapy efficacy in aCRC , so may represent a much-needed additional predictive marker for these drugs . Objective To examine a novel lig and model in a r and omized clinical trial of panitumumab , irinotecan , and ciclosporin in colorectal cancer ( PICCOLO ) with with the a priori hypothesis that high tumor expression of either AREG or EREG would predict panitumumab therapy benefit in RAS-wt patients ; and low expression , lack of efficacy . Design , Setting , and Participants Prospect ively planned retrospective biomarker study from the PICCOLO trial , which tested the addition of panitumumab to irinotecan therapy in patients with KRAS wt aCRC who experienced failure with prior fluoropyrimidine treatment . The analysis was conducted between 2012 and 2014 . A predefined dichotomous model classified tumors as " high expressor " ( either EREG or AREG in top tertile for messenger RNA level ) or " low expressor " ( neither EREG nor AREG in top tertile ) . Lig and expression was assessed as a prognostic and predictive biomarker . Expression of AREG/EREG and RAS and BRAF mutations were assessed in archival tumor tissue . Main Outcomes and Measures Primary end point was progression-free survival ( PFS ) ; secondary end points were response rate and overall survival ( OS ) . Results Of the 696 PICCOLO trial patients in the irinotecan-vs-irinotecan with panitumumab r and omization , 331 had sufficient tumor tissue available and measurement of lig and expression was successful in 323 . High lig and expression was not prognostic for OS ( hazard ratio [ HR ] , 0.79 [ 95 % CI , 0.58 - 1.09 ] ; P = .15 ) or PFS ( HR , 0.93 [ 95 % CI , 0.68 - 1.27 ] ; P = .64 ) . The primary population had RAS wt aCRC ( n = 220 ) ; for RAS wt patients with high lig and expression , median ( interquartile range [ IQR ] ) PFS was 8.3 [ 4.0 - 11.0 ] months ( irinotecan with panitumumab ) vs 4.4 [ 2.8 - 6.7 ] months ( irinotecan alone ) ; HR , 0.38 [ 95 % CI , 0.24 - 0.61 ] ; P < .001 ) . In RAS wt patients with low lig and expression , median ( IQR ) PFS was 3.2 [ 2.7 - 8.1 ] months ( irinotecan with panitumumab ) vs 4.0 [ 2.7 - 7.5 ] months ( irinotecan ) ; HR , 0.93 [ 95 % CI , 0.64 - 1.37 ] ; P = .73 ; interaction test results were significant [ P = .01 ] ) . Less marked effects were seen for response rate ( interaction P = .17 ) and OS ( interaction P = .11 ) . Conclusions and Relevance High lig and expression is a predictive marker for panitumumab therapy benefit on PFS in RAS wt patients ; conversely , patients with low lig and expression gained no benefit . The current " opt-in " strategy for anti-EGFR therapy in all patients with RAS wt aCRC should be question ed . Expression of EREG/AREG is a useful biomarker for anti-EGFR therapy ; optimization for clinical use is indicated . Trial Registration is rct n Identifier : IS RCT N93248876 The epidermal growth factor receptor ( EGFR ) , which participates in signalling pathways that are deregulated in cancer cells , is frequently mutated in colorectal-cancer cells . Cetuximab is a monoclonal antibody that specifically blocks the EGFR . We evaluated the efficacy of cetuximab in weekly combination with irinotecan in metastatic colorectal cancer patients refractory to previous treatments based on oxaliplatin or irinotecan . We included 55 heavily pretreated patients ( colon/rectum : 34/11 , M/F : 16/29 , median age 63 years , range : 27–79 ) whose disease had progressed during or within an oxaliplatin-based first-line chemotherapy and a irinotecan-based second-line regimen . Patients were followed for tumour response and were also evaluated for the time to tumour progression , and safety of treatment . Cetuximab was given at an initial dose of 400 mg m−2 , followed by weekly infusions of 250 mg m−2 . Irinotecan was administered weekly at the dose of 90 mg m−2 . All patients were assessable for treatment efficacy and safety response rate was 25.4 % ( 95 % CI : 21.7–39.6 % ) ; 38.2 % ( 95 CI : 18.6–39.8 % ) of patients showed a disease stability as the best response . As a consequence , the overall tumour control rate was 63.6 % ( 95 % CI : 46.4–70.6 % ) . The median time to progression was 4.7 months ( 95 % CI : 2.5–7.1 months ) and the median survival time was 9.8 months ( 95 % CI : 3.9–10.1 months ) . The most common G3 - 4 noncutaneous side toxicities were : diarrhoea ( 16.4 % ) , fatigue ( 12.7 % ) and stomatitis ( 7.3 % ) . 89.1 % of patients developed skin toxicity and 32.6 % of cases was of grade 3–4 . No allergic reactions were identified at any courses in any patients . Fever was documented in 27.3 % of patients and was most commonly recorded after the first administration . Cetuximab has clinical ly significant activity even in heavily pretreated colorectal cancer patients progressed after both oxaliplatin and irinotecan-based chemotherapy regimens BACKGROUND Cetuximab , an IgG1 chimeric monoclonal antibody against epidermal growth factor receptor ( EGFR ) , has activity against colorectal cancers that express EGFR . METHODS From December 2003 to August 2005 , 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine , irinotecan , and oxaliplatin or had contraindications to treatment with these drugs underwent r and omization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care ( 287 patients ) or best supportive care alone ( 285 patients ) . The primary end point was overall survival . RESULTS In comparison with best supportive care alone , cetuximab treatment was associated with a significant improvement in overall survival ( hazard ratio for death , 0.77 ; 95 % confidence interval [ CI ] , 0.64 to 0.92 ; P=0.005 ) and in progression-free survival ( hazard ratio for disease progression or death , 0.68 ; 95 % CI , 0.57 to 0.80 ; P<0.001 ) . These benefits were robust after adjustment in a multivariable Cox proportional-hazards model . The median overall survival was 6.1 months in the cetuximab group and 4.6 months in the group assigned to supportive care alone . Partial responses occurred in 23 patients ( 8.0 % ) in the cetuximab group but in none in the group assigned to supportive care alone ( P<0.001 ) ; the disease was stable in an additional 31.4 % of patients assigned to cetuximab and in 10.9 % of patients assigned to supportive care alone ( P<0.001 ) . Quality of life was better preserved in the cetuximab group , with less deterioration in physical function and global health status scores ( both P<0.05 ) . Cetuximab treatment was associated with a characteristic rash ; a rash of grade 2 or higher was strongly associated with improved survival ( hazard ratio for death , 0.33 ; 95 % CI , 0.22 to 0.50 ; P<0.001 ) . The incidence of any adverse event of grade 3 or higher was 78.5 % in the cetuximab group and 59.1 % in the group assigned to supportive care alone ( P<0.001 ) . CONCLUSIONS Cetuximab improves overall survival and progression-free survival and preserves quality -of-life measures in patients with colorectal cancer in whom other treatments have failed . ( Clinical Trials.gov number , NCT00079066 [ Clinical Trials.gov ] . ) The authors explored the association of skin toxicity ( ST ) severity as measured by patient‐reported ST and Common Terminology Criteria for Adverse Events ( CTCAE ) grading with efficacy of panitumumab , a fully human antiepidermal growth factor receptor antibody , from a phase 3 metastatic colorectal cancer ( CRC ) trial Output:	Results Pooled data revealed that the occurrence of ST and ETS ≥20 % ( v < 20 % ) during anti-EGFR MoAb treatment were both associated with better OS , PFS and ORR . This association could not be disturbed by KRAS status . Mean changes in safety follow-up life health state from baseline appeared unaffected by ST . Only mCRC patients with wild-type KRAS tumor who suffered grade 2 + ST could benefit from additional anti-EGFR treatment to chemotherapy or best supportive care ( BSC ) alone . ETS was also a predictor for absolute survival benefit acquired from additional anti-EGFR treatment for patients with wild-type KRAS tumors , and the more early shrinkage the tumor was , the much benefit was observed . ConclusionS T and ETS are predictive of absolute benefit acquired from anti-EGFR treatment in mCRC patients with wild-type KRAS tumors .
MS2841	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Codeine is generally accepted as the st and ard antitussive against which new antitussive medications are compared . This presents a problem because the support for codeine 's antitussive activity comes from studies on cough in animals , and chronic and induced cough models in man , whereas antitussives are almost exclusively used for the treatment of cough associated with acute upper respiratory tract infection ( URTI ) . The aims of this study were twofold . Firstly , to study the antitussive efficacy of codeine in cough associated with URTI and , secondly , to vali date a sound meter as tool for quantifying cough . The efficacy of codeine was assessed in a double-blind , stratified , placebo-controlled , parallel-group , clinical trial using three different measures of cough : cough sound-pressure levels ( CSPLs ) measured on a sound meter ; subjective scores of cough severity ; and cough frequency recorded by means of a microphone connected to an ink-pen recorder . A group of 82 subjects ( 51 females and 31 males ; mean age 23.5 years , range 18 - 46 years ) with cough owing to acute URTI were included in the study . The study took place on two separate study days . On study day 1 cough measurements were made before and 90 min after treatment with a single dose of either 50 mg codeine or matched placebo in capsule form . The same three measures of cough were repeated 2 - 5 days later ( study day 2 ) . On study day 1 a highly significant ( P < 0.0001 ) decrease in all three measures of cough was found after treatment with both placebo and codeine yet there was no significant difference between the treatment groups . A highly significant ( P < 0.0001 ) decrease in the three measures of cough was also found between days 1 and 2 . The results demonstrate that codeine is no more effective than placebo in reducing cough associated with acute URTI , as measured by CSPLs , cough frequency or subjective symptom scores . This result might be explained on the basis of two central pathways for cough ; a reflex pathway via the brain-stem which is sensitive to codeine and a voluntary pathway via the cortex which is unaffected by codeine . The results also demonstrate that the sound-level meter appears to be a potentially useful investigative tool for the assessment of cough and antitussive efficacy To determine whether the cough of the common cold arises from upper respiratory stimuli and whether antihistamine-decongestant therapy is an effective treatment for this cough , we prospect ively evaluated volunteers with uncomplicated common colds in a r and omized , double-blind , placebo-controlled study . After completing a st and ardized question naire and undergoing a physical examination , throat-culturing , and pulmonary function testing , subjects took the active drug or identical-appearing placebo for 7 days while they kept a diary in which they ranked the severity of 17 symptoms for 14 days . Pulmonary function testing was repeated , on average , on Days 4 , 8 , and 14 . Forty-six percent of the variation in cough severity could be explained by throat-clearing and 47 % of the variation in throat-clearing severity by postnasal drip . FIF50 % , the only physiologic parameter that significantly correlated with cough , rose as cough severity fell . Antihistamine-decongestant therapy reduced postnasal drip and significantly decreased the severity of cough , nasal obstruction , nasal discharge , and throat-clearing during the first few days of the common cold . In addition , cough was 20 to 30 % less prevalent in the active drug group within 3 days of starting therapy . We conclude that the cough of the common cold arose from upper respiratory tract stimuli and that cough and other cardinal symptoms of the common cold were reduced with antihistamine-decongestant therapy when these symptoms were at their worst The efficacy of guaifenesin in reducing cough frequency in young adults with acute respiratory disease was evaluated by both an objective cough counting system and a question naire . A guaifenesin cough preparation and the syrup vehicle were administered in a double-blind manner . Coughs were recorded on tape over a 24-hour baseline evaluation period and a 36-hour treatment period for 42 patients . A pronounced diurnal variation in cough frequency was observed . The evaluation of efficacy was based upon comparisons between equivalent six-hour time periods of successive days . No antitussive effect of guaifenesin was demonstrated . The question naire was administered to 65 patients , including the 42 whose coughs were recorded . Of 26 patients with productive cough receiving guaifenesin , 25 ( 96 percent ) reported a decrease in sputum thickness compared to 13 ( 54 percent ) of 24 patients receiving the vehicle ( p = 0.01 , Fisher exact test ) . Twenty-three of 26 ( 88 percent ) patients receiving guaifenesin also reported reduction in sputum quantity compared to 15 of 24 ( 62.5 percent ) receiving the vehicle ( p = 0.07 , Fisher exact test ) . The diurnal variation in cough frequency measured by the tape recording was not apparent from the subjective cough frequency estimates obtained by the question naire A double blind vs placebo study was carried out to study the effect of letosteine on the symptoms and clinical course of paediatric patients suffering from acute febrile bronchitis . Forty children were recruited for the research : 20 were treated with letosteine in a dose of 25 mg x 3 g/die and 20 with placebo ; treatment lasted 10 days . The following parameters were assessed during the trial : body temperature , cough , thoracic objectivity , respiratory function indices . The results of the study show that in the letosteine treated group there is a statistically significant decrease in fever , a favourable evolution of thoracic objectivity and an improvement in certain respiratory function parameters ( MEF 75 , PEF ) . It is concluded that treatment with letosteine leads to a significant increase in the rate of regression of thoracic symptomatology and a faster , more substantial reduction in fever in children suffering from acute bronchitis . This is probably the result of drug action on mucus viscosity , restoring optimal mucociliary clearance , and through action fostering the penetration of antibacterial substances into the mucus Codeine is often used as a st and ard antitussive against which new antitussives are compared . However there is little information available about the effects of codeine on cough associated with upper respiratory tract infection . The present study investigated the effects of codeine syrup B.P. ( 30 mg/10 ml , q.d.s . ) or syrup vehicle on cough frequency and the subjective severity of cough during a 3-h laboratory phase and a 4-day home phase of treatment . Cough frequency and subjective scores of cough severity were significantly decreased during the 3-h laboratory phase but at no time point was there a significant difference between the codeine- and placebo-treated groups . The results of the 4-day home phase diary were similar to those of the laboratory phase as at no time point was there a significant difference between the mean scores for the codeine- and placebo-treated groups . The results indicate that codeine , either as a single 30-mg dose or in a total daily dose of 120 mg , is no more effective than the syrup vehicle in controlling cough associated with acute upper respiratory tract infection We tested the hypothesis that antihistamine-decongestant combinations cause no clinical ly significant relief of the symptoms of upper respiratory tract infections in young children by r and omly assigning 96 children to one of three treatment groups : antihistamine-decongestant , placebo , and no treatment . There were no differences among the three study groups in the proportion of children considered " better " overall by the parent 48 hours after the initial assessment ( drug , 67 % ; placebo , 71 % ; no treatment , 57 % ; p = 0.53 ) . There were no differences among groups in individual or composite symptom score changes . Two thirds of parents whose children were eligible for the drug trial believed that their child needed medicine for cold symptoms . In the proportion of parents believing that their child needed medicine , there was no difference between those who consented to participate and those who refused . Parents who wanted medicine at the initial visit reported more improvement at follow-up , regardless of whether the child received drug , placebo , or no treatment . We conclude that there is no clinical ly significant improvement in symptoms of upper respiratory tract infection , including no significant placebo effect , in young children for whom an antihistamine-decongestant is prescribed The efficacy of an antitussive-beta 2-sympathomimetic combination ( dextromethorphan-salbutamol ) was compared with that of a plain antitussive ( dextromethorphan ) and a placebo in a double-blind trial in 108 out- patients with cough associated with acute respiratory infection . The dextromethorphan-salbutamol combination was superior to dextromethorphan or placebo in the suppression of cough at night , although a spontaneous improvement occurred in all treatment groups during the 4-day treatment period . No statistically significant differences between the treatments were shown in the symptom scores for the cough frequency and severity during the day , sputum quantity or ease of expectoration . A significant improvement in cough during the day was observed in all treatment groups . The results suggest that the use of antitussives is usually unnecessary ; the only indication might be symptomatic relief , especially at night . An antitussive combined with a beta 2-sympathomimetic might be the most effective treatment in this type of cough The antitussive efficacy and tolerability of dropropizine and of its enantiomer levodropropizine were evaluated in children with non-productive cough ; 258 were evaluable for tolerability and 254 for efficacy . Patients r and omly received either 1 mg/kg dropropizine or 2 mg/kg levodropropizine orally , three times daily for 3 days . There were statistically significant decreases in the frequency of coughing spells and nocturnal awakenings after both levodropropizine and dropropizine treatments ( P < 0.001 ) . Gastrointestinal symptoms were mild in the two groups ; somnolence was twice as frequent in the dropropizine group ( 10.3 % vs 5.3 % ) and the difference is clinical ly relevant , though not statistically significant . Levodropropizine is as effective as an antitussive as dropropizine , but appears to carry a lower risk of daytime somnolence To test the hypothesis that codeine and dextromethorphan are effective in alleviating the symptoms of acute cough , we conducted a r and omized , controlled trial . Eligible patients were children 18 months to 12 years of age , seen in private pediatric practice s , with significant night cough of less than 14 days ' duration . Study patients were r and omly selected to receive codeine , dextromethorphan , or placebo at bedtime for 3 consecutive nights . Outcomes were assessed by the use of a parent question naire rating the severity of symptoms at the initiation of therapy , and after each night of the study . Every patient had a cough score ( range 0 to 4 ) and composite symptom score ( range 0 to 9 ) computed for each day of the study . One hundred forty-one doses of study medication were evaluated in 49 patients , including 13 children receiving placebo , 19 dextromethorphan , and 17 codeine . Mean cough and composite symptom scores decreased in each of the three treatment groups on each day of the study ; there were no significant differences . Regression analysis , with reduction in cough score as the outcome of interest , showed that neither dextromethorphan nor codeine was significantly more effective than placebo ( p = 0.41 and 0.70 , respectively ) . Reduction in cough score was positively correlated with the severity of cough at the start of treatment ( p = 0.007 ) . Our data suggest that , in the doses used , neither codeine nor dextromethorphan is superior to placebo in treating night cough in children OTHER investigators,1 - 6utilizing various techniques , have attempted to determine objective ly the response of cough to antitussive medication . Volunteer adult patients were used almost exclusively in those studies . The techniques employed have consisted of induction of cough by artificial means , such as successive inhalations of an irritant aerosol , and of assay of antitussive activity of cough medications based on reduction in number of coughs provoked by the irritant . The irritant usually was citric acid or acetylcholine . While the data obtained gave a valid indication of a cough-suppressing effect , experimental production of cough by chemical or mechanical irritants is subject to certain limitations and criticisms . First , the healthy volunteer after repeated exposure develops a tolerance to the irritant , especially when the latter is citric acid . Second , the frequency and intensity of artificially induced cough vary with the concentration of the irritant and the interval between challenges . Third , the artificially induced One hundred and thirty out- patients , affected by acute and chronic cough caused by upper respiratory tract inflammation , took part in two clinical studies aim ed at evaluating the efficacy and tolerability of glaucine , a new antitussive agent . The first study involved 90 patients in a double-blind comparative trial of glaucine and codeine : both treatments were administered as a syrup at a dosage of 30 mg 3-times daily for 7 days . The cough suppressant effect of the two treatments was checked by the physician and the patient using a 4-point scale ( from absent to severe ) , and by the patient using a visual analogue scale . Mean scores of the physician 's evaluation decreased from 3.0 to 1.10 after codeine and from 3.0 to 0.47 after glaucine ( p less than 0.001 between treatments ) Output:	2 . Antihistamines were no more effective than placebo in relieving cough symptoms . REVIEW ERS ' CONCLUSIONS There is no good evidence for or against the effectiveness of OTC medicines in acute cough . More evidence about the effectiveness of OTC cough preparations would be helpful , as identification of effective self-care treatments may help reduce the burden of days lost at work due to acute cough as well as the number of consultations in primary care . Identification of ineffective preparations could avoid costs for consumers and health care providers
MS2842	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Treatment of patients with malignant pleural effusions is mostly palliative . Tetracycline and bleomycin are the two most commonly used agents for the treatment of pleurodesis . In this study , the authors used a combination of the two drugs for this particular purpose Summary The current prospect i ve r and omized study was design ed to compare the effects of intracavitary ( i.c . ) chemotherapy vs immunotherapy vs immunochemotherapy for malignant effusion . Between 1992 and 1995 , a total of 42 patients with malignant effusion were registered , and 41 patients were eligible for statistical analysis . The primary diseases of the eligible patients included 27 gastric , four colorectal , four pancreatic , three lung , two liver and one oesophageal cancers . The patients with malignant effusion were r and omly assigned into one of three i.c . therapeutic regimens : chemotherapy alone with weekly injection of anticancer agents ( ACAs : cisplatin , mitomycin-C , adriamycin , etc . ) ( Group A , n = 13 ) ; immunotherapy alone with weekly injection of streptococcal preparation OK-432 ( Group B , n = 14 ) ; or immunochemotherapy with ACAs and OK-432 ( Group C , n = 14 ) . The response of the effusion , patient survival and the kinetics of cytokines in the effusion were compared . There were no differences in the patients ’ background s. The side-effects of the regimens included pain , anorexia , fever , leucopenia and anaemia and there were no differences in their incidence among the three groups . One patient died after cisplatin ( CDDP ) administration in Group A. Cytologic examination revealed that tumour cells in the effusion disappeared in 23 % of Group A cases , 36 % of Group B cases and 36 % of Group C cases . The malignant effusion did not disappear in any of the Group A cases ; however , the effusion disappeared in 29 % of Group B cases and 43 % of Group C cases ( P = 0.03 , Group A vs Group C ) . Furthermore , the 50 % survival period was 1.6 months for Group A , 2.4 months for Group B and 3.5 months for Group C. The 6-month survival rate was 7 % for Group A , 6 % for Group B and 34 % for Group C , and the 1-year survival rate was 0 % , 0 % and 17 % respectively ( P = 0.048 , Group A vs Group C by the log-rank test ) . The analysis of the cytokine kinetics revealed a prominent increase in the level of interleukin-6 in the effusion in Group C. These results suggest that i.c . immunochemotherapy with OK-432 and ACAs may be more beneficial than i.c . chemotherapy alone or immunotherapy alone STUDY OBJECTIVE To determine the feasibility of rapid pleurodesis in patients with malignant pleural effusions in order to reduce hospital length of stay in patients with a limited life expectancy . DESIGN Prospect i ve case series . SETTING Two university hospital programs . PATIENTS Thirty-eight patients with symptomatic pleural effusions associated with malignancy . INTERVENTIONS A 14F catheter was inserted percutaneously into the pleural space after radiographic confirmation of free fluid by lateral decubitus views . Following radiographic confirmation of complete fluid evacuation , a sclerosing agent ( ie , talc slurry or bleomycin ) was instilled into the pleural space . This was accomplished within 2 h of chest tube insertion , unless the tube was inserted in the evening or if the lung was trapped . After clamping the tube for 90 min , the pleural space was drained for 2 h , after which the chest tube was removed . The intervention was scored as " successful " if no radiographic evidence of fluid reaccumulation was noted at 4 weeks . A " partial successful " score indicated reaccumulation of fluid that did not produce symptoms and did not require repeat pleural drainage of any sort . All other outcomes were scored as " unsuccessful . " MEASUREMENTS AND RESULTS Forty chest tubes were inserted into 38 patients . Four procedures revealed the presence of a trapped lung and did not result in any attempt at pleurodesis . Five patients who received pleurodesis died in less than 1 month and therefore were not evaluable . Two patients had technical problems with the chest tube and were not evaluable . Of the remaining 29 procedures , drainage procedures with pleurodesis were performed in 27 patients , a complete response was seen in 14 patients ( 48 % ) , a partial response was seen in 9 patients ( 31 % ) , and 6 patients ( 21 % ) did not respond to pleurodesis . Chemical pleurodesis was completed as an outpatient procedure in only two patients . In one of these , the outcome was unsuccessful . In the remainder , insertion of the chest tube in the evening or additional medical problems necessitated hospital admission , but the entire procedure was completed within 24 h. CONCLUSIONS Chemical pleurodesis can be accomplished with good results in < 24 h in the majority of patients with malignant pleural effusions In a controlled r and omized trial , 46 patients with pleural effusions secondary to breast cancer were treated at first diagnosis with either intracavitary mustine or talc , to determine which agent produced the more effective pleurodesis . Of the 37 evaluable patients , control of the effusion was achieved in 9/17 ( 56 % ) of those treated with mustine and 18/20 ( 90 % ) of the talc group ( P > 0.025 ) . This suggests that early treatment with intracavitary talc can effectively palliate this complication of breast cancer Thirty two patients with malignant pleural effusion were r and omly allocated to treatment with intrapleural Corynebacterium parvum or tetracycline hydrochloride in an attempt to prevent symptomatic recurrence of pleural fluid . Success in preventing recurrence of fluid at one month , using up to 2 doses of each drug , was 14 of 16 cases for Corynebacterium parvum , 5 of 9 for tetracycline given via an intercostal needle , and 6 of 7 for tetracycline given through an intercostal tube . These difference were not statistically significant . Corynebacterium parvum was significantly more likely to produce pyrexia equal or greater than 38 degrees C ( P less than 0.001 ) and pain requiring analgesia ( P less than 0.05 ) than tetracycline hydrochloride . Corynebacterium parvum is a useful agent for the management of malignant pleural effusion , but is associated with more side effects than tetracycline Malignant pleural effusions are commonly managed with tube thoracostomy drainage followed by chemical pleurodesis . Both tetracycline and bleomycin have been shown to be effective for intrapleural instillation , although neither agent has definitively proved advantages over the other . The aim of the present study was to compare these two agents in terms of response rate and toxicity profile . A prospect i ve , r and omized trial was carried out in a single centre . Between May 1993 and January 1996 , 62 evaluable patients with proved malignant pleural effusion were allocated to receive either intrapleural tetracycline ( 1.5 g ) or bleomycin ( 60 mg ) after the same drainage procedure . Demographic , clinical and fluid parameter data were comparable in both groups . Response was evaluated at 1 , 3 and 6 months after pleurodesis . Mean survival and time to relapse did not differ between the two groups . No statistically significant differences were found in terms of efficacy at each evaluation time . Overall , 16 ( 52 % ) and 20 ( 64 % ) patients had a recurrence of pleural effusion during follow-up in the tetracycline and bleomycin arms , respectively . Fever was most common in bleomycin-treated patients ( p=0.024 ) while pain was most frequent in the tetracycline arm ( nonsignificant ) . Since no study agent was superior to the other in this trial , we suggest that economic costs , drug availability and medical skill should be considered in the choice of a sclerosing agent Fifty-eight patients with malignant pleural effusions were entered into a prospect ively r and omized clinical trial comparing the efficacy of a local instillation of bleomycin or corynebacterium parvum ( C. parvum ) in controlling fluid reaccumulation after simple needle aspiration ( thoracentesis ) . The response was assessed at 30 days by chest X-ray and clinical examination . There were 44 evaluable patients ; 18 of 25 ( 72 % ) of those receiving bleomycin and 9/19 ( 47 % ) of those who had C. parvum gained a complete or partial response . This difference in response rate was not statistically significant ( p = 0.13 ) . The majority of patients had an effusion from a primary breast carcinoma and the response in this group was almost statistically significant ( p = 0.06 ) with 74 % of bleomycin patients and 43 % of C. parvum patients responding . Fever following instillation was more common with C. parvum ( 53 % of patients compared with 24 % after bleomycin , p = 0.02 ) , whereas nausea was more common after bleomycin ( 28 % vs. 10.5 % , p = 0.16 ) . Local chest pain after aspiration occurred in 52 % of the bleomycin group and 47 % of the C. parvum subjects . There was no significant difference between the groups in age , sex , tumour type , presenting symptoms , volume of aspirate , systemic therapy or number of previous aspirations . Both of these agents appeared to be active in the control of malignant pleural effusions although the response rate was higher with bleomycin and overall , both have acceptable levels of toxicity BACKGROUND --A study was undertaken to compare the efficacy of short term tube thoracostomy drainage with st and ard tube thoracostomy drainage before instillation of tetracycline for sclerotherapy of malignant pleural effusions . METHODS --The study consisted of a r and omised clinical trial in a sequential sample of 25 patients with malignant pleural effusions documented cytopathologically . Fifteen patients were r and omly assigned to group 1 ( st and ard protocol ) and 10 to group 2 ( short term protocol ) . Patients in group 1 had tube thoracostomy suction drainage until radiological evidence of lung re-expansion was obtained and the amount of fluid drained was < 150 ml/day , before tetracycline ( 1.5 g ) was instilled . The chest tube was removed when the amount of fluid drained after instillation was < 150 ml/day . Patients in group 2 also had suction drainage , but the tetracycline ( 1.5 g ) was instilled when the chest radiograph showed the lung to be re-exp and ed and the effusion drained , which was usually within 24 hours . The chest tube was removed the next day . RESULTS --The response to tetracycline sclerotherapy in the two groups was the same ( 80 % ) but the duration of chest tube drainage was significantly shorter for patients in group 2 ( median two days ) than for those in group 1 ( median seven days ) . CONCLUSIONS --The duration of chest tube drainage before sclerotherapy for malignant pleural effusions need not be influenced by the amount of fluid drained daily but by radiographic evidence of fluid evacuation and lung re-expansion . Shorter duration of drainage will reduce the length of hospital stay without sacrificing the efficacy of pleurodesis BACKGROUND Talc has been generally accepted to be the most effective sclerosant for chemical pleurodesis , although the optimal route of administration remains unclear . METHODS We design ed a prospect i ve , r and omized study to compare video-assisted thoracoscopic talc insufflation with bedside talc slurry in the treatment of malignant pleural effusion . From September 1993 to November 1995 , 57 patients were recruited and r and omized to either video-assisted thoracoscopic talc insufflation under general anesthesia ( n = 28 ) or talc slurry by the bedside ( n = 29 ) . Patients with poor general condition ( Karnofsky score less than 30 % ) , poor pulmonary function ( forced expiratory volume in 1 second less than 0.5 L ) , or trapped lungs were excluded from this study . Five grams of purified talc was used for either video-assisted thoracoscopic talc insufflation or talc slurry . RESULTS There was no statistically significant difference between the two groups of patients with respect to age , sex ratio , chest drainage duration , postprocedural hospital stay , parenteral narcotics requirement , complications , or procedure failure ( ie , recurrence ) . CONCLUSIONS Video-assisted thoracoscopic talc insufflation has not been shown to be a superior approach compared with talc slurry in our study . Because the former dem and s more re sources , we advocate that talc slurry should be considered as the procedure of choice in the treatment of symptomatic malignant pleural effusion in patients who do not have trapped lungs The efficacy and safety of intrapleural LC9018 ( Yakult Co. Ltd. , Tokyo , Japan ) with or without doxorubicin ( Adriamycin ; Adria Laboratories , Columbus , OH ) were evaluated in a r and omized , controlled trial performed in 95 patients with malignant pleural effusions secondary to lung cancer . Seventy‐six patients were eligible for the assessment of efficacy . The response Output:	The use of sclerosants ( mitozantrone , talc and tetracycline combined)compared with control ( instillation of isotonic saline or equivalent pH isotonic saline or tube drainage alone ) was associated with an increased efficacy of pleurodesis . REVIEW ER 'S CONCLUSIONS The available evidence supports the need for chemical sclerosants for successful pleurodesis , the use of talc as the sclerosant of choice , and thoracoscopic pleurodesis as the preferred technique for pleurodesis based on efficacy . There was no evidence for an increase in mortality following talc pleurodesis
MS2843	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Expansion of access to effective treatments for heroin dependence is a worldwide health priority that will also reduce HIV transmission . We compared the efficacy of naltrexone , buprenorphine , and no additional treatment , in patients receiving detoxification and subsequent drug counselling , for maintenance of heroin abstinence , prevention of relapse , and reduction of HIV risk behaviours . METHODS 126 detoxified heroin-dependent patients , from an outpatient research clinic and detoxification programme in Malaysia , were r and omly assigned by a computer-generated r and omisation sequence to 24 weeks of manual-guided drug counselling and maintenance with naltrexone ( n=43 ) , buprenorphine ( n=44 ) , or placebo ( n=39 ) . Medications were administered on a double-blind and double-dummy basis . Primary outcomes , assessed by urine testing three times per week , were days to first heroin use , days to heroin relapse ( three consecutive opioid-positive urine tests ) , maximum consecutive days of heroin abstinence , and reductions in HIV risk behaviours over 6 months . The study was terminated after 22 months of enrolment because buprenorphine was shown to have greater efficacy in an interim safety analysis . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00383045 . FINDINGS We observed consistent , linear contrasts in days to first heroin use ( p=0.0009 ) , days to heroin relapse ( p=0.009 ) , and maximum consecutive days abstinent ( p=0.0007 ) , with all results best for buprenorphine and worst for placebo . Buprenorphine was associated with greater time to first heroin use than were naltrexone ( hazard ratio 1.87 [ 95 % CI 1.21 - 2.88 ] ) or placebo ( 2.02 [ 1.29 - 3.16 ] ) . With buprenorphine , we also recorded significantly greater time to heroin relapse ( 2.17 [ 1.38 - 3.42 ] ) , and maximum consecutive days abstinent than with placebo ( mean days 59 [ 95 % CI 43 - 76 ] vs 24 [ 13 - 35 ] ; p=0.003 ) ; however , for these outcomes , differences between buprenorphine and naltrexone were not significant . Differences between naltrexone and placebo were not significant for any outcomes . HIV risk behaviours were significantly reduced from baseline across all three treatments ( p=0.003 ) , but the reductions did not differ significantly between the three groups . INTERPRETATION Our findings lend support to the widespread dissemination of maintenance treatment with buprenorphine as an effective public-health approach to reduce problems associated with heroin dependence Federal probationers or parolees with a history of opioid addiction were referred by themselves or their probation/parole officer for a naltrexone treatment study . Participation was voluntary and subjects could drop out of the study at any time without adverse consequences . Following orientation and informed consent , 51 volunteers were r and omly assigned in a 2:1 ratio to a 6-month program of probation plus naltrexone and brief drug counseling , or probation plus counseling alone . Naltrexone subjects received medication and counseling twice a week ; controls received counseling at similar intervals . All therapy and medication were administered in an office located adjacent to the federal probation department . Fifty-two percent of subjects in the naltrexone group continued for 6 months and 33 % remained in the control group . Opioid use was significantly lower in the naltrexone group . The overall mean percent of opioid positive urine tests among the naltrexone subjects was 8 % , versus 30 % for control subjects ( p < .05 ) . Fifty-six percent of the controls and 26 % of the naltrexone group ( p < .05 ) had their probation status revoked within the 6-month study period and returned to prison . Treatment with naltrexone and brief drug counseling can be integrated into the Federal Probation/Parole system with favorable results on both opioid use and re-arrest rates The goals of this study were two-fold : ( 1 ) to test the hypothesis that retention of patients in naltrexone treatment could be improved by educating and preparing them for it while enrolled in a LAAM ( l-alpha-acetylmethadol ) detoxification program ; and ( 2 ) to compare the safety and efficacy of 60 mg vs. 120 mg administered thrice weekly in a double-blind , sequential trial design . Patients were allowed a maximum of 365 days on naltrexone , and a maximum of four admissions ; 119 patients received at least one dose of naltrexone . We found no clinical ly important differences between the two dosages , and retention in treatment was similar to that reported in earlier clinical trials . Slightly more than half the patients ever used heroin while receiving naltrexone , and only 9 % of all urine tests were positive for opiates . Craving for heroin decreased dramatically by the end of the first week . We found no side-effect or toxicity due to naltrexone AIM To investigate the efficacy of low doses of naltrexone in relapse prevention for heroin dependence . DESIGN Double blind , r and omised comparison of three groups-Group 1 taking 50 mg per day , Group 2 : 0.5 mg per day , and Group 3 : 0.05 mg per day . PARTICIPANTS Sixty-six dependent heroin users . INTERVENTIONS After detoxification followed by 1 week on 50 mg per day naltrexone , participants were r and omised to trial medication . All were offered counselling and monitored with weekly clinical review s. Research interviews were conducted at three and 6 months . OUTCOME MEASURES Retention in treatment and heroin use at 3 and 6 months . Secondary outcome measures were side effects and craving . FINDINGS Mean days retained in r and omised treatment were-Group 1 : 58.9 days ; Group 2 : 46.6 days ; and Group 3 : 47.8 days . Differences in retention were not significant using survival analysis . However , nine of the first 60 participants , transferred to the 50 mg dose , and one transferred to a lower dose ( chi-square = 0.142 ; P = 0.018 ) . At follow-up , there was no relationship between abstinence from heroin and naltrexone dose , nor between level of heroin use and dose . There were no differences between groups in craving or depression . CONCLUSION Low doses of naltrexone had no discernible advantage , and participants preferred 50 mg per day . Despite preference for blocking doses of naltrexone , outcomes appeared to be independent of naltrexone dose The effectiveness of antagonist maintenance with oral naltrexone for opioid dependence has been limited by high dropout rates . Behavioral Naltrexone Therapy ( BNT ) was developed to improve retention on oral naltrexone by integrating voucher incentives , Motivational and Cognitive Behavioral therapies , and a significant other for monitoring medication adherence . In a 6-month , r and omized , controlled trial in heroin dependent patients , BNT ( N = 36 ) improved retention in treatment compared to a st and ard treatment control ( Compliance Enhancement ( CE ) ; N = 33 ) ( log rank = 4.28 ; p = .04 ) . Most patients retained beyond 3 months achieved abstinence from opioids , but retention at 6 months was only 22 % on BNT and 9 % on CE . A systematic review of related controlled trials revealed similar effect sizes in the small to medium range , and substantial dropout . There may be a limit on the extent to which behavioral therapy can overcome poor adherence to oral naltrexone . Future research should consider combinations of behavioral methods with new long-acting injectable or implantable naltrexone formulations In a double blind study , out of 31 newly abstinent patients who underwent opioid free detoxification , 15 were started on the opiate antagonist Naltrexone for 2 months , and 16 were put on placebo for the same period . Given Naltrexone 's known efficacy in blocking euphorigenic effects of opioid intake , and in decreasing cravings for the drug , the authors have tried to assess eventual drug taking , specifically in the context of suburban housing projects , and evaluate the rate of retention in a rehabilitative program for both the Naltrexone and placebo groups . An Opioid free condition was followed up for a year , also respecting double blind conditions . Naltrexone did not appear to be superior to the placebo with regards to retention rate . In the Naltrexone group ( n = 15 ) , 9 finished the two-month treatment , and 8 remained opioid-free for a year . In the placebo group ( n = 16 ) , 8 finished the 2 month trial and 6 remained opioid-free for a year . Naltrexone blocked opioid-induced euphoria and decreased the craving for opium , but it did not inhibit drug usage . The retention rate registered during the course of the study , as well as an opioid-free condition in the follow-up year , correlated with a patient profile defined by good social functioning and stable relationships . The inherent method ological limitations of this study did not allow for the discrimination of the role of non-pharmacological factors , such as psychotherapy , supportive family framework , community assistance , and staff motivation , concerning the clinical results . Further investigation of Naltrexone in larger sample s is needed Naltrexone and placebo as adjuvant treatment of opioid dependence were compared in a double-blind , controlled clinical trial in 50 heroin addicts . The overall efficacy was assessed by the degree of treatment acceptance , percentage of relapse in heroin consumption , presence of side effects , and overall retention on naltrexone . A total of 50 patients of both sexes , aged from 18 to 30 years , who fulfilled DSM-III-R criteria for opioid dependence were included in the study . All patients completed detoxification with clonidine on an inpatient basis for 2 weeks and subsequently , on an out-patient basis , received oral naltrexone ( 350 mg per week ) for a month . At the beginning of the second month patients were r and omly allocated to treatment with naltrexone ( 28 patients ) or placebo ( 22 patients ) until a 6-month treatment period in a double-blind fashion had been completed . During the study period ( 1 year ) all patients followed the same therapeutic schedule . Patients in both groups were comparable in terms of socio-demographic data and toxicological history . The efficacy of naltrexone was not superior to that of placebo as there were no significant differences in acceptance of treatment , retention rates , opioid and other drug consumption , drug compliance or side effects This r and omized placebo-controlled trial tested the efficacy of oral naltrexone with or without fluoxetine for preventing relapse to heroin addiction and for reducing HIV risk , psychiatric symptoms , and outcome . All patients received drug counseling with parental or significant-other involvement to encourage adherence . Patients totaling 414 were approached , 343 gave informed consent , and 280 were r and omized ( mean age , 23.6 + /- 0.4 years ) . At 6 months , two to three times as many naltrexone patients as naltrexone placebo patients remained in treatment and had not relapsed , odds ratio ( OR ) = 3.5 ( 1.96 - 6.12 ) , p < .0001 . Overall , adding fluoxetine did not improve outcomes , OR = 1.35 ( 0.68 - 2.66 ) , p = .49 ; however , women receiving naltrexone and fluoxetine showed a trend toward a statistically significant advantage when compared to women receiving naltrexone and fluoxetine placebo , OR = 2.4 ( 0.88 - 6.59 ) , p = .08 . HIV risk , psychiatric symptoms , and overall adjustment were markedly improved among all patients who remained on treatment and did not relapse , regardless of group assignment . More widespread use of naltrexone could be an important addition to addiction treatment and HIV prevention in Russia The efficacy of Naltrexone in preventing reabuse of heroin among heroin addicts in Israel was studied in a double-blind , controlled design . Naltrexone ( or placebo ) treatment was given as part of a general treatment plan that continued for 12 weeks . Thirty-two addicts who successfully completed a detoxification program and met research criteria , were included in the study . Fifty milligrams of Naltrexone were taken orally three times a week ( 25 mg twice a week for the first 2 weeks ) . The follow-up procedure included an interview , urine tests , and screening for possible adverse effects . In addition , social and psychological parameters were evaluated . Fewer heroin-positive urine tests were found the Naltrexone group than in the placebo group . Throughout the entire study , the number of drug-free patients in the Naltrexone group was higher than in the placebo group . The Naltrexone group showed a significant improvement in most psychological parameters as compared with the placebo group . No differences were found in compliance or ratio of adverse effects between the Naltrexone and placebo groups . The concept " heroin abuse load " based on daily heroin consumption and duration of addiction enabled us to predict which addicts would complete the treatment program . The results suggest that heroin addicts in Israel may benefit from treatment with Naltrexone Good results in detoxification methods have been reached using both together clonidine and op Output:	Naltrexone was not superior to benzodiazepines and to buprenorphine for retention and abstinence and side effects . The findings of this review suggest that oral naltrexone did not perform better than treatment with placebo or no pharmacological agent with respect to the number of participants re-incarcerated during the study period . If oral naltrexone is compared with other pharmacological treatments such as benzodiazepine and buprenorphine , no statistically significant difference was found . The conclusion of this review is that the studies conducted have not allowed an adequate evaluation of oral naltrexone treatment in the field of opioid dependence . Consequently , maintenance therapy with naltrexone can not yet be considered a treatment which has been scientifically proved to be superior to other kinds of treatment
MS2844	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Introduction In large-animal acute myocardial infa rct ion ( AMI ) models , Wharton 's jelly ( umbilical cord matrix ) mesenchymal stem cells ( WJMSCs ) effectively promote angiogenesis and drive functional myocardial regeneration . Human data are lacking . Aim To evaluate the feasibility and safety of a novel myocardial regeneration strategy using human WJMSCs as a unique , allogenic but immuno-privileged , off-the-shelf cellular therapeutic agent . Material and methods The inclusion criterion was first , large ( LVEF ≤ 45 % , CK-MB > 100 U/l ) AMI with successful infa rct -related artery primary percutaneous coronary intervention reperfusion ( TIMI ≥ 2 ) . Ten consecutive patients ( age 32–65 years , peak hs-troponin T 17.3 ±9.1 ng/ml and peak CK-MB 533 ±89 U/l , sustained echo LVEF reduction to 37.6 ±2.6 % , cMRI LVEF 40.3 ±2.7 % and infa rct size 20.1 ±2.8 % ) were enrolled . Results 30 × 106 WJMSCs were administered ( LAD/Cx/RCA in 6/3/1 ) per protocol at ≈ 5–7 days using a cell delivery-dedicated , coronary-non-occlusive method . No clinical symptoms or ECG signs of myocardial ischemia occurred . There was no epicardial flow or myocardial perfusion impairment ( TIMI-3 in all ; cTFC 45 ±8 vs. 44 ±9 , p = 0.51 ) , and no patient showed hs-troponin T elevation ( 0.92 ±0.29 ≤ 24 h before vs. 0.89 ±0.28 ≤ 24 h after ; decrease , p = 0.04 ) . One subject experienced , 2 days after cell transfer , a transient temperature rise ( 38.9 ° C ) ; this was reactive to paracetamol with no sequel . No other adverse events and no significant arrhythmias ( ECG Holter ) occurred . Up to 12 months there was one new , non-index territory lethal AMI but no adverse events that might be attributable to WJMSC treatment . Conclusions This study demonstrated the feasibility and procedural safety of WJMSC use as off-the-shelf cellular therapy in human AMI and suggested further clinical safety of WJMSC cardiac transfer , providing a basis for r and omized placebo-controlled endpoint-powered evaluation Background The use of adult stem cells is limited by the quality and quantity of host stem cells . It has been demonstrated that Wharton ’s jelly – derived mesenchymal stem cells ( WJMSCs ) , a primitive stromal population , could integrate into ischemic cardiac tissues and significantly improve heart function . In this r and omized , controlled trial , our aim was to assess the safety and efficacy of intracoronary WJMSCs in patients with ST-elevation acute myocardial infa rct ion ( AMI ) . Methods In a multicenter trial , 116 patients with acute ST-elevation MI were r and omly assigned to receive an intracoronary infusion of WJMSCs or placebo into the infa rct artery at five to seven days after successful reperfusion therapy . The primary endpoint of safety : the incidence of adverse events ( AEs ) within 18 months , was monitored and quantified . The endpoint of efficacy : the absolute changes in myocardial viability and perfusion of the infa rct ed region from baseline to four months , global left ventricular ejection fraction ( LVEF ) from baseline to 18 months were measured using F-18-fluorodeoxyglucose positron emission computed tomography ( F-18-FDG-PET ) and 99mTc-sestamibi single-photon emission computed tomography ( 99mTc-SPECT ) , and two-dimensional echocardiography , respectively . Results During 18 months follow-up , AEs rates and laboratory tests including tumor , immune , and hematologic indexes were not different between the two groups . The absolute increase in the myocardial viability ( PET ) and perfusion within the infa rct ed territory ( SPECT ) was significantly greater in the WJMSC group [ 6.9 ± 0.6 % ( 95 % CI , 5.7 to 8.2 ) ] and [ 7.1 ± 0.8 % ( 95 % CI , 5.4 to 8.8 ) than in the placebo group [ 3.3 ± 0.7 % ( 95 % CI , 1.8 to 4.7 ) , P < 0.0001 ] and 3.9 ± 0.6(95 % CI , 2.8 to 5.0 ) , P = 0.002 ] at four months . The absolute increase in the LVEF at 18 months in the WJMSC group was significantly greater than that in the placebo group [ 7.8 ± 0.9 ( 6.0 to approximately 9.7 ) vs. 2.8 ± 1.2 ( 0.4 to approximately 5.1 ) , P = 0.001 ] . Concomitantly , the absolute decreases in LV end-systolic volumes and end-diastolic volumes at 18 months in the WJMSC group were significantly greater than those in the placebo group ( P = 0.0004 , P = 0.004 , respectively ) . Conclusions Intracoronary infusion of WJMSCs is safe and effective in patients with AMI , providing clinical ly relevant therapy within a favorable time window . This study encourages additional clinical trials to determine whether WJMSCs may serve as a novel alternative to BMSCs for cardiac stem cell-based therapy . Trial registration Clinical Trials NCT01291329 ( 02/05/2011 ) In experimental studies , mesenchymal stem cell ( MSC ) transplantation in acute myocardial infa rct ion ( AMI ) models has been associated with enhanced neovascularization and myogenesis . Clinical data however , are scarce . Therefore , the present study evaluates the safety and feasibility of intramyocardial MSC injection in nine patients , shortly after AMI during short-term and 5-year follow-up . Periprocedural safety analysis demonstrated one transient ischemic attack . No other adverse events related to MSC treatment were observed during 5-year follow-up . Clinical events were compared to a nonr and omized control group comprising 45 matched controls . A 5-year event-free survival after MSC-treatment was comparable to controls ( 89 vs. 91 % , P = 0.87 ) . Echocardiographic imaging for evaluation of left ventricular function demonstrated improvements up to 5 years after MSC treatment . These findings were not significantly different when compared to controls . The present safety and feasibility study suggest that intramyocardial injection of MSC in patients shortly after AMI is feasible and safe up to 5-year follow-up Recent studies suggest that the intracoronary administration of bone marrow (BM)-derived mesenchymal stem cells ( MSCs ) may improve left ventricular function in patients with acute myocardial infa rct ion ( AMI ) . However , there is still argumentative for the safety and efficacy of MSCs in the AMI setting . We thus performed a r and omized pilot study to investigate the safety and efficacy of MSCs in patients with AMI . Eighty patients with AMI after successful reperfusion therapy were r and omly assigned and received an intracoronary administration of autologous BM-derived MSCs into the infa rct related artery at 1 month . During follow-up period , 58 patients completed the trial . The primary endpoint was changes in left ventricular ejection fraction ( LVEF ) by single-photon emission computed tomography ( SPECT ) at 6 month . We also evaluated treatment-related adverse events . The absolute improvement in the LVEF by SPECT at 6 month was greater in the BM-derived MSCs group than in the control group ( 5.9%±8.5 % vs 1.6%±7.0 % ; P=0.037 ) . There was no treatment-related toxicity during intracoronary administration of MSCs . No significant adverse cardiovascular events occurred during follow-up . In conclusion , the intracoronary infusion of human BM-derived MSCs at 1 month is tolerable and safe with modest improvement in LVEF at 6-month follow-up by SPECT . ( Clinical Trials.gov registration number : NCT01392105 BACKGROUND The study assessed long-term safety and efficacy of intramyocardial injection of autologous bone-marrow derived mesenchymal stromal cells ( BMMSCs ) in patients with severe stable coronary artery disease ( CAD ) and refractory angina . METHODS Thirty-one patients with severe stable CAD and refractory angina were included . Patients had reversible myocardial ischemia and no further revascularization options . Autologous BMMSCs were isolated , culture exp and ed and stimulated with vascular endothelial growth-factor to facilitate endothelial differentiation . BMMSCs were injected into an ischemic , viable region of the myocardium . Patients were followed for 3 years . RESULTS We found significant clinical improvements in exercise time ( p=0.0016 ) , angina class ( CCS ) ( p<0.0001 ) , weekly number of angina attacks ( p<0.0001 ) and use of nitroglycerine from ( p=0.0017 ) . In the Seattle Angina Question naire there were significant improvements in physical limitation score , angina stability score , angina frequency score and quality of life score ( all p<0.0001 ) . When comparing all hospital admissions from 3 years before to 3 years after treatment , we observed highly reduced admission rates for stable angina ( p<0.0001 ) , revascularization ( p=0.003 ) and overall cardiovascular disease ( p<0.0001 ) . No early or late side-effects of the treatment were observed . CONCLUSIONS The final 3-year follow-up data after intramyocardial injection of autologous BMMSCs , in patients with severe CAD and refractory angina , demonstrated sustained clinical effects , reduced hospital admissions for cardiovascular disease and excellent long-term safety . The results indicate that autotransplantation of BMMSCs to the heart does not only improve symptoms but also slows down disease progression Bone marrow stem cells are able to repair infa rct ed human myocardium following intracoronary transplantation via the infa rct -relative artery . However , traditional reperfusion strategies fail to open the artery in some patients , making effective delivery impossible . Our previous study demonstrated a safe and efficient approach to delivering bone marrow stem cells via a noninfa rct ed artery in an animal myocardial infa rct ion model . The objective of the present study was to evaluate the safety and feasibility of autologous bone marrow mesenchymal stem cell transplantation via such an approach in patients with acute myocardial infa rct ion ( AMI ) . Sixteen patients with anterior AMI who had successfully undergone percutaneous coronary intervention ( PCI ) were enrolled in this pilot , r and omized study . Three weeks after PCI , cultured bone marrow mesenchymal stem cells were injected into the myocardium via either the infa rct -relative artery ( left anterior descending branch artery , LAD ) or a noninfa rct -relative artery ( right coronary artery , RCA ) . The safety and feasibility of the cell infusion were evaluated during the procedure and during 6 months of follow-up . In addition , 2D echocardiography , technetium-99 m methoxyisobutylisonitrile ( 99mTc-MIBI ) and 18F-deoxyglucose single photon emission computed tomography were employed to examine cardiac function , myocardial perfusion , and viable cardiomyocytes , respectively , at day 4 after PCI and 6 months after the cell infusion . There were no arrhythmia and any other side-effects , including infections , allergic reactions or adverse clinical events , during , immediately after , or 6 months after cell transplantation . Cardiac function and myocardial perfusion had improved 6 months after PCI/bone marrow stem cells transplantation . Viable cardiomyocytes metabolism was detected in the infa rct ed areas in both groups after the cell infusion , as demonstrated by 18F-deoxyglucose . Intracoronary infusion of autologous bone marrow mesenchymal stem cells via a noninfa rct -relative artery appears safe and feasible in the treatment of patients with AMI BACKGROUND The infa rct size determines the long-term prognosis of patients with acute myocardial infa rct ion ( AMI ) . There is a growing interest in repairing scar area by transplanting bone marrow stem cells . However , effectiveness of intracoronary injection of bone marrow mesenchymal stem cells ( BMSCs ) in patients with AMI still remains unclear . METHODS Sixty-nine patients with AMI after percutaneous coronary intervention ( PCI ) were r and omly divided into intracoronary injection of BMSCs ( n = 34 ) and saline ( control group , n = 35 ) groups . Serial single positron emission computer tomography ( SPECT ) , cardiac echo and cardiac electromechanical mapping were done at the design ed time intervals until six months after transplantation of BMSCs or Output:	Results from our systematic review suggest that MSC therapy for ischemic heart disease appears to be safe .
MS2845	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND 13 - 18 % of all preschool children have severe behavioral problems at least transiently , sometimes with long-term adverse consequences . In this study , the social training program " Lubo aus dem All ! - Vorschulalter " ( Lubo from Outer Space , Preschool Version ) was evaluated in a kindergarten setting . METHODS 15 kindergartens were r and omly assigned to either an intervention group or a control group , in a 2:1 ratio . The intervention was design ed to strengthen emotional knowledge and regulation , the ability to take another person 's point of view , communication skills , and social problem solving . The control group continued with conventional kindergarten activities . The primary endpoint was improvement in social-cognitive problem solving strategies , as assessed with the Wally Social Skills and Problem Solving Game ( Wally ) . Secondary endpoints were improvement in prosocial behavior and reduction in problematic behavior , as assessed with the Preschool Social Behavior Question naire ( PSBQ ) and the Caregiver-Teacher Report Form ( C-TRF ) . Data were collected before and after the intervention and also 5 months later . Mixed models were calculated with r and om effects to take account of the cluster design and for adjustment for confounding variables . RESULTS 221 children in kindergarten , aged 5 - 6 years , were included in the study . R and omization was unsuccessful : the children in the intervention group performed markedly worse on the tests carried out before the intervention . Five months after the end of the intervention , the social-cognitive problem solving strategies of the children in the intervention group had improved more than those of the children in the control group : the intergroup difference in improvement was 0.79 st and ard deviations of the Wally test ( 95 % confidence interval [ CI ] 0.13 - 1.46 ) . This effect was just as marked 5 months later ( 0.63 , 95 % CI 0.03 - 1.23 ) . Prosocial behavior , as measured by the PSBQ , also improved more in the intervention group , with an intergroup difference of 0.37 st and ard deviations ( 95 % CI 0.05 - 0.71 ) . CONCLUSION An age-appropriate program to prevent behavioral disorders among kindergarten children improved both the children 's knowledge of prosocial problem solving strategies and their prosocial behavior Self-regulatory abilities are robust predictors of important outcomes across the life span , yet they are rarely taught explicitly in school . Using a r and omized controlled design , the present study investigated the effects of a 12-week mindfulness-based Kindness Curriculum ( KC ) delivered in a public school setting on executive function , self-regulation , and prosocial behavior in a sample of 68 preschool children . The KC intervention group showed greater improvements in social competence and earned higher report card grade s in domains of learning , health , and social-emotional development , whereas the control group exhibited more selfish behavior over time . Interpretation of effect sizes overall indicate small to medium effects favoring the KC group on measures of cognitive flexibility and delay of gratification . Baseline functioning was found to moderate treatment effects with KC children initially lower in social competence and executive functioning demonstrating larger gains in social competence relative to the control group . These findings , observed over a relatively short intervention period , support the promise of this program for promoting self-regulation and prosocial behavior in young children . They also support the need for future investigation of program implementation across diverse setting Deficits in behavioral and cognitive regulation are prevalent in children reared in poverty relative to more affluent children due to the effects of adverse conditions on the developmental underpinnings of these skills . Despite evidence to suggest that these emergent processes are susceptible to environmental inputs , research documenting short-term intervention program influences on these regulatory domains in young impoverished children is limited . We sought to determine the proximal effects of a universal school-based intervention ( the PATHS Curriculum ) on social , emotional , relational , and cognitive outcomes in urban poor kindergarten children . Four schools in high-poverty neighborhoods with similar demographic characteristics were r and omly assigned to either PATHS or an attentional control . Teacher-reported measures of behavior ( e.g. , attention , concentration , aggression ) , peer nominations ( e.g. , likability , aggression , acceptance ) , and tasks gauging inhibitory control were administered in the fall of kindergarten and again in the spring after one academic year ( about 6 months ) of PATHS . Children who received PATHS exhibited significantly greater improvements than control students across all teacher-rated behavioral measures of social competence ( i.e. , emotion regulation , prosocial behavior , peer relations ) and behavioral problems ( i.e. , aggression , internalizing behaviors , impulsivity and hyperactivity ) at post-test as well as improvements in motor inhibition . This line of research constitutes an important frontier for prevention research given the implication s for improving ultimate outcomes for otherwise disadvantaged children This study evaluated the post-treatment outcome effects of a classroom-based social skills program for pre-kindergarten children , using a teacher-consultation model . The pre-K RECAP ( Reaching Educators , Children , and Parents ) program is a semi-structured , cognitive-behavioral skills training program that provides teachers with in-classroom consultation on program implementation and classroom-wide behavior management . Data on children 's social skills and behavior problems were collected from parents and teachers at pre- and post-treatment , for 149 children aged 4–5 years ( of whom 56 % were girls ) . Significant treatment effects were found for teacher but not parent reports , with treatment group children improving significantly more than comparison group children in their teacher-rated social skills and internalizing and externalizing problems . These results provide some preliminary support for the efficacy of the program on children 's social skills and behavior problems , and for a teacher-consultation model for training teachers to implement school-based mental health programs Annual screenings of preschool children at kindergarten registration identified 158 children having high levels of aggressive , hyperactive , impulsive , and inattentive behavior . These " disruptive " children were r and omly assigned to four treatment conditions lasting the kindergarten school year : no treatment , parent training only , full-day treatment classroom only , and the combination of parent training with the classroom treatment . Results showed that parent training produced no significant treatment effects , probably owing largely to poor attendance . The classroom treatment produced improvement in multiple domains : parent ratings of adaptive behavior , teacher ratings of attention , aggression , self-control , and social skills , as well as direct observations of externalizing behavior in the classroom . Neither treatment improved academic achievement skills or parent ratings of home behavior problems , nor were effects evident on any lab measures of attention , impulse control , or mother-child interactions . It is concluded that when parent training is offered at school registration to parents of disruptive children identified through a brief school registration screening , it may not be a useful approach to treating the home and community behavioral problems of such children . The kindergarten classroom intervention was far more effective in reducing the perceived behavioral problems and impaired social skills of these children . Even so , most treatment effects were specific to the school environment and did not affect achievement skills . These findings must be viewed as tentative until follow-up evaluations can be done to determine the long-term outcomes of these interventions Separate studies of rural and urban Head Start systems tested the hypothesis that an emotion-based prevention program ( EBP ) would accelerate the development of emotion and social competence and decrease agonistic behavior and potential precursors of psychopathology . In both studies , Head Start centers were r and omly assigned to treatment and control/comparison group conditions . In Study 1 ( rural community ) , results of hierarchical linear modeling analyses showed that compared to the control condition ( Head Start as usual ) , EBP produced greater increases in emotion knowledge and emotion regulation and greater decreases in children 's negative emotion expressions , aggression , anxious/depressed behavior , and negative peer and adult interactions . In Study 2 ( inner city ) , compared to the established prevention program I Can Problem Solve , EBP led to greater increases in emotion knowledge , emotion regulation , positive emotion expression , and social competence . In Study 2 , emotion knowledge mediated the effects of EBP on emotion regulation , and emotion competence ( an aggregate of emotion knowledge and emotion regulation ) mediated the effects of EBP on social competence This article reports findings from a cluster-r and omized study of an integrated literacy- and math-focused preschool curriculum , comparing versions with and without an explicit socioemotional lesson component to a business-as-usual condition . Participants included 110 classroom teachers from r and omized classrooms and approximately eight students from each classroom ( N = 760 ) who averaged 4.48 ( SD = 0.44 ) years of age at the start of the school year . There were positive impacts of the two versions of the curriculum on language , phonological awareness , math , and socioemotional outcomes , but there were no added benefits to academic or socioemotional outcomes for the children receiving explicit socioemotional instruction . Results are discussed with relevance to early childhood theory , policy , and goals of closing the school readiness gap ABSTRACT The present study investigates whether training preschool children in the active use of emotional state talk plays a significant role in bringing about greater underst and ing of emotion terms and improved emotion comprehension . Participants were 100 preschool children ( M=52 months ; SD=9·9 ; range : 35 - 70 months ) , r and omly assigned to experimental or control conditions . They were pre- and post-tested to assess their language comprehension , metacognitive language comprehension and emotion underst and ing . Analyses of pre-test data did not show any significant differences between experimental and control groups . During the intervention phase , the children were read stories enriched with emotional lexicon . After listening to the stories , children in the experimental group took part in conversational language games design ed to stimulate use of the selected emotional terms . In contrast , the control group children did not take part in any special linguistic activities after the story readings . Analyses revealed that the experimental group outperformed the control group in the underst and ing of inner state language and in the comprehension of emotion This paper reports the results from a r and omized clinical trial evaluating an adaptation of the Promoting Alternative Thinking Strategies curriculum ( PATHS ) for preschool-age children in Head Start . PATHS is a universal , teacher-taught social-emotional curriculum that is design ed to improve children ’s social competence and reduce problem behavior . Twenty classrooms in two Pennsylvania communities participated in the study . Teachers in the 10 intervention classrooms implemented weekly lessons and extension activities across a 9-month period . Child assessment s and teacher and parent reports of child behavior assessment s were collected at the beginning and end of the school year . Analysis of covariance was used to control for baseline differences between the groups and pretest scores on each of the outcome measures . The results suggest that after exposure to PATHS , intervention children had higher emotion knowledge skills and were rated by parents and teachers as more socially competent compared to peers . Further , teachers rated intervention children as less socially withdrawn at the end of the school year compared to controls . Editors ’ Strategic Implication s : n Findings from this and other r and omized clinical trials confirm that the Preschool PATHS program is clearly a promising practice for improving children ’s social and emotional competence . Head Start and school programs will find these multi-informant data to be of interest as they consider a curriculum to help prepare children for school entry Behavior problems among preschool children are common . They are important targets for intervention because early externalizing problems and self-regulation issues tend to persist without appropriate attention , and can affect later mental health and school achievement outcomes . However , few preschool curricula addressing social and emotional development exist , and evidence for effects are mixed . In this study , the Second Step Pre/Kindergarten Social and Emotional Learning curriculum was adapted and tested in a small cluster r and omized pilot study of community preschool classrooms to determine if it could improve outcomes in : ( 1 ) individual children ’s teacher-rated behavior problems and prosocial skills ; ( 2 ) classroom climate ( classroom interactions and two measures of disruptive behavior ) ; and ( 3 ) teacher interaction skills . Year 1 outcomes were modest and were accounted for by baseline differences . In Year 2 , classroom climate , measured by independent observers , differed significantly in intervention classrooms , largely because of declines in control classrooms , and there was some evidence for better teacher interaction skills in intervention classrooms . The pattern of effects suggests important impacts on classroom quality worth investigating in a larger study . Both fidelity and implementation rates , as well as positive teacher responses to the curriculum , indicate potential for widespread adoption Using information from research on the neuroplasticity of selective attention and on the central role of successful parenting in child development , we developed and rigorously assessed a family-based training program design ed to improve brain systems for selective attention in preschool children . One hundred forty-one lower socioeconomic status preschoolers enrolled in a Head Start program were r and omly assigned to the training program , Head Start alone , or an active control group . Electrophysiological measures of children ’s brain functions supporting selective attention , st and ardized measures of cognition , and parent-reported child behaviors all favored children in the treatment program relative to both control groups . Positive changes were also observed in the parents themselves . Effect sizes ranged from one-quarter to half of a st and ard deviation . These results lend impetus to the further development and broader implementation of evidence -based education programs that target at-risk families Despite reports of positive effects of high- quality child care , few experimental studies have examined the process of improving low- quality center-based care for toddler-age children . In this article , we report intervention effects on child care teachers ' behaviors and children 's social , emotional , behavioral , early literacy , language , and math outcomes as well as the teacher-child relationship . The intervention targeted the use of a set of responsive teacher practice s , derived from attachment and sociocultural theories , and a comprehensive curriculum . Sixty-five childcare classrooms serving low-income 2- and 3-year-old children were r and omized into 3 conditions : business-as-usual control , Responsive Early Childhood Curriculum ( RECC ) Output:	Meaning Early childhood is a crucial period for children ’s social , emotional , and cognitive development , and these findings highlight what appears to be benefit of social and emotional learning interventions for young children across developmental domains
MS2846	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Knowledge of symptom prevalence and adequate assessment of such symptoms at the end of life is important in clinical practice . We determined the frequency and severity of symptom distress and delirium using the Edmonton Assessment Scale ( ESAS ) and the Memorial Delirium Assessment Scale ( MDAS ) and evaluated the clinical utility of the Nursing Delirium Screening Scale ( Nu-DESC ) as scored by a caregiver as a screening tool for delirium . METHOD We conducted a secondary analysis of the data from a previous r and omized controlled trial on parenteral hydration at the end of life of patients admitted to home hospice . Only patients that had assessment s within the last week of life were included . We collected the ESAS , MDAS , Nu-DESC , and Richmond Agitation Sedation Scale ( RASS ) results . The sensitivity and specificity of the Nu-DESC were then calculated . RESULTS Some 78 of 261 patients were included in our study , 62 ( 80 % ) of which had moderate-to-severe symptoms corresponding to an ESAS score > 4 . These symptoms include : 73 ( 94 % ) anorexia , 63 ( 81 % ) fatigue , 56 ( 73 % ) drowsiness , 58 ( 75 % ) decreased well-being , and 39 ( 51 % ) pain . Delirium was diagnosed in 34 ( 44 % ) of patients using the MDAS . The Nu-DESC was found to have a sensitivity of 35 % , a specificity of 80 % , a positive predictive value ( PPV ) of 58 % , and an negative predictive value ( NPV ) of 61 % when used by caregivers . SIGNIFICANCE OF RESULTS Hospice patients at the end of life have a high rate of symptom distress and delirium . The Nu-DESC is not a reliable tool for screening delirium when scoring is conducted by a caregiver . Our study illustrates the need for routine use of assessment tools to improve care Introduction : Patients with end-stage interstitial lung disease ( ILD ) do not appear to receive adequate palliative care despite apparent suffering before death . The aim of this study was to evaluate their signs , symptoms , and treatment received before death . Methods : Patients with ILD and lung cancer ( LC ) who were hospitalized and died in our hospital were enrolled retrospectively . Signs and symptoms and treatments at 7 days , 3 days , and 1 day before death were evaluated and compared between the two groups of patients . Results : A total of 23 patients with ILD and 59 patients with LC group were eligible for participation . Significantly more LC patients had loss of consciousness than ILD patients on 7 days ( ILD : LC = 1 [5.6%]:24 [ 41 % ] , P = 0.013 ) , 3 days ( 1 [5.6%]:33 [ 56 % ] , P < 0.001 ) . Significantly more ILD patients had dyspnea than LC patients on 3 days ( 16 [89%]:38 [ 64 % ] , P = 0.047 ) 1 day before death ( 21 [91%]:33 [ 56 % ] , P = 0.001 ) . On 1 day before death , significantly more LC patients received morphine than ILD patients ( 2 [ 8.7 % ] : 14 [ 24 % ] , P = 0.015 ) . More ILD patients received sedation ( 11 [ 48 % ] : 11 [ 19 % ] , P = 0.007 ) . Conclusions : End-stage ILD patients may experience dyspnea more frequently than terminal LC patients , and they need sedation . Morphine should be administered to ILD patients who have dyspnea . Additional prospect i ve studies are needed Importance The use of benzodiazepines to control agitation in delirium in the last days of life is controversial . Objective To compare the effect of lorazepam vs placebo as an adjuvant to haloperidol for persistent agitation in patients with delirium in the setting of advanced cancer . Design , Setting , and Participants Single-center , double-blind , parallel-group , r and omized clinical trial conducted at an acute palliative care unit at MD And erson Cancer Center , Texas , enrolling 93 patients with advanced cancer and agitated delirium despite scheduled haloperidol from February 11 , 2014 , to June 30 , 2016 , with data collection completed in October 2016 . Interventions Lorazepam ( 3 mg ) intravenously ( n = 47 ) or placebo ( n = 43 ) in addition to haloperidol ( 2 mg ) intravenously upon the onset of an agitation episode . Main Outcomes and Measures The primary outcome was change in Richmond Agitation-Sedation Scale ( RASS ) score ( range , −5 [ unarousable ] to 4 [ very agitated or combative ] ) from baseline to 8 hours after treatment administration . Secondary end points were rescue neuroleptic use , delirium recall , comfort ( perceived by caregivers and nurses ) , communication capacity , delirium severity , adverse effects , discharge outcomes , and overall survival . Results Among 90 r and omized patients ( mean age , 62 years ; women , 42 [ 47 % ] ) , 58 ( 64 % ) received the study medication and 52 ( 90 % ) completed the trial . Lorazepam + haloperidol result ed in a significantly greater reduction of RASS score at 8 hours ( −4.1 points ) than placebo + haloperidol ( −2.3 points ) ( mean difference , −1.9 points [ 95 % CI , −2.8 to −0.9 ] ; P < .001 ) . The lorazepam + haloperidol group required less median rescue neuroleptics ( 2.0 mg ) than the placebo + haloperidol group ( 4.0 mg ) ( median difference , −1.0 mg [ 95 % CI , −2.0 to 0 ] ; P = .009 ) and was perceived to be more comfortable by both blinded caregivers and nurses ( caregivers : 84 % for the lorazepam + haloperidol group vs 37 % for the placebo + haloperidol group ; mean difference , 47 % [ 95 % CI , 14 % to 73 % ] , P = .007 ; nurses : 77 % for the lorazepam + haloperidol group vs 30 % for the placebo + haloperidol group ; mean difference , 47 % [ 95 % CI , 17 % to 71 % ] , P = .005 ) . No significant between-group differences were found in delirium-related distress and survival . The most common adverse effect was hypokinesia ( 3 patients in the lorazepam + haloperidol group [ 19 % ] and 4 patients in the placebo + haloperidol group [ 27 % ] ) . Conclusions and Relevance In this preliminary trial of hospitalized patients with agitated delirium in the setting of advanced cancer , the addition of lorazepam to haloperidol compared with haloperidol alone result ed in a significantly greater reduction in agitation at 8 hours . Further research is needed to assess generalizability and adverse effects . Trial Registration clinical trials.gov Identifier : Introduction Continuous palliative sedation ( PS ) is currently titrated based on clinical observation ; however , it is often unclear if patients are still aware of their suffering . The aim of this prospect i ve study is to characterize the level of consciousness in patients undergoing PS using Bispectral Index ( BIS ) monitoring . Patients and methods We enrolled consecutive patients with refractory symptoms requiring PS . We documented the level of sedation using Ramsay Sedation Scale ( RSS ) and BIS at 0 , 2 , 4 , 6 , 12 , and 24 h during the first day of PS and examined their degree of association . Intravenous midazolam or propofol was titrated according to the sedation level . Results Twenty patients on PS were recruited and had BIS continuous monitoring . Delirium was the most frequent reason for PS ( n = 15 , 75 % ) . The median time of sedation was 24.5 h ( interquartile range 6–46 ) . The average time to achieve the desired sedation level was 6 h , and dose titration was required in 80 % of the cases . At baseline , 14 ( 70 % ) patients were considered to be awake according to RSS ( i.e. , 1–3 ) and 19 ( 95 % ) were awake according to BIS ( i.e. , > 60 % ) . This proportion decreased to 31 and 56 % at 4 h , 27 % and 53 at 6 h , and 22 and 33 % at 24 h. RS and BIS had moderate correlation ( rho = −0.58 to −0.65 ) ; however , a small proportion of patients were found to be awake by BIS ( i.e. , ≥60 % ) despite clinical observation ( i.e. , RSS 4–6 ) indicating otherwise . Conclusions The BIS is a noninvasive , bedside , real-time continuous monitoring method that may facilitate the objective assessment of level of consciousness and dose titration in patients undergoing PS CONTEXT Knowledge of determinants that are associated with the administration of continuous palliative sedation ( CPS ) helps physicians identify patients who are at risk of developing refractory symptoms , thereby enabling proactive care planning . OBJECTIVES This study aims to explore which patient-related factors at admission are associated with receiving CPS later in the terminal phase of life . METHODS A prospect i ve multicenter observational study was performed in six Dutch hospices and three nursing home-based palliative care units . The association between patient-related variables at admission ( age , gender , diagnosis , use of opioids or psycholeptics , number of medications , Karnofsky Performance Status scale score , Edmonton Symptom Assessment System distress score , and Glasgow Coma Scale score ) and the administration of CPS at the end of life was analyzed . RESULTS A total of 467 patients died during the study period , of whom 130 received CPS . In univariate analysis , statistically significant differences were noted between the se date d and nonse date d patients with respect to younger age ( P = 0.009 ) , malignancy as a diagnosis ( P = 0.05 ) , higher Karnofsky Performance Status score ( P = 0.03 ) , the use of opioids ( P < 0.001 ) , the use of psycholeptics ( P = 0.003 ) , and higher Edmonton Symptom Assessment System distress score ( P = 0.05 ) . Multivariate logistic regression analysis showed that only the use of opioids at admission ( odds ratio 1.90 ; 95 % confidence interval 1.18 - 3.05 ) was significantly associated with the administration of CPS . CONCLUSION Physicians should be aware that patients who use opioids at admission have an increased risk for the administration of CPS at the end of life . In this group of patients , a comprehensive personalized care plan starting at admission is m and atory to try to prevent the development of refractory symptoms . Further research is recommended , to identify other determinants of the administration of CPS and to investigate which early interventions will be effective to prevent the need for CPS in patients at high risk CONTEXT If regular therapies can not relieve symptoms sufficiently in the last days of life , continuous palliative sedation may serve to reduce consciousness . Sedation level can be measured with EEG monitoring with the bispectral index ( BIS ) monitor . OBJECTIVES To determine the feasibility and validity of BIS monitoring in terminally ill patients . METHODS In this prospect i ve study , BIS registration s were performed in unconscious end-of-life patients admitted to a palliative care center . Vali date d scores were used to measure level of sedation ( Ramsay score ) , pain ( Numeric Rating Scale or Rotterdam Elderly Pain Observations Scale ) , delirium ( Delirium Observation Screening score ) , and overall comfort ( Numeric Rating Scale ) . Validity and sensitivity to change of BIS values were considered , and the effects of medication and the time till death on BIS values were evaluated in a linear mixed model analysis . RESULTS Fifty-eight patients were included for analysis . BIS monitoring was acceptable to patients , relatives , and medical staff . BIS values were moderately correlated with Ramsay scores ( 0.46 ) but were highly variable for deeply se date d patients . BIS values changed significantly before and after a midazolam dose ( P < 0.001 ) . Midazolam treatment result ed on average in a statistically significant reduction of the BIS values ( -4.5 , 95 % CI -7.0 to -2.0 ) , whereas morphine and haloperidol did not . CONCLUSION This is one of the first validation studies in which BIS monitoring in end-of-life patients is described . BIS monitoring is feasible in unconscious terminally ill patients . However , based on our results , the wide range of BIS values in deeply se date d and comfortable patients seems to hamper its use in daily clinical practice Purpose To describe the practice of palliative sedation ( PS ) in patients with advanced cancer in a specialized palliative care ( PC ) unit in Colombia . Methods Descriptive prospect i ve study including all adults with cancer hospitalized under PS in a cancer institute between January and July 2015 in Colombia . Variables examined were diagnosis , physical functioning , symptoms at the start of sedation , medications and dosages used , and type , level , and time of sedation . Descriptive and correlational statistics were obtained . Results Sixty-six patients were included , 70 % of which were women . The patients had an average age of 61 years ( range 24–87 ) , and Output:	Conclusion : An increasing number of studies in palliative care are using observational measures of level of consciousness . However , only a few of these tools have been tested for their psychometric performance in that context .
MS2847	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Chronic diseases represent a major challenge for health care and social services . A number of people with chronic diseases require more services due to characteristics that increase their vulnerability . Given the burden of increasingly vulnerable patients on primary care , a pragmatic intervention in four Family Medicine Groups ( primary care practice s in Quebec , Canada ) has been proposed for individuals with chronic diseases ( diabetes , cardiovascular diseases , respiratory diseases , musculoskeletal diseases and /or chronic pain ) who are frequent users of hospital services . The intervention combines case management by a nurse with group support meetings encouraging self-management based on the Stanford Chronic Disease Self-Management Program . The goals of this study are to : ( 1 ) analyze the implementation of the intervention in the participating practice s in order to determine how the various context s have influenced the implementation and the observed effects ; ( 2 ) evaluate the proximal ( self-efficacy , self-management , health habits , activation and psychological distress ) and intermediate ( empowerment , quality of life and health care use ) effects of the intervention on patients ; ( 3 ) conduct an economic analysis of the efficiency and cost-effectiveness of the intervention . Methods / Design The analysis of the implementation will be conducted using realistic evaluation and participatory approaches within four categories of stakeholders ( Family Medicine Group and health centre management , Family Medicine Group practitioners , patients and their families , health centre or community partners ) . The data will be obtained through individual and group interviews , project documentation review s and by documenting the intervention . Evaluation of the effects on patients will be based on a pragmatic r and omized before-after experimental design with a delayed intervention control group ( six months ) . Economic analysis will include cost-effectiveness and cost-benefit analysis . Discussion The integration of a case management intervention delivered by nurses and self-management group support into primary care practice s has the potential to positively impact patient empowerment and quality of life and hopefully reduce the burden on health care . Decision-makers , managers and health care professionals will be aware of the factors to consider in promoting the implementation of this intervention into other primary care practice s in the region and elsewhere . Trial Registration Background Care management programmes are an effective approach to care for high risk patients with complex care needs result ing from multiple co-occurring medical and non-medical conditions . These patients are likely to be hospitalized for a potentially " avoidable " cause . Nurse-led care management programmes for high risk elderly patients showed promising results . Care management programmes based on health care assistants ( HCAs ) targeting adult patients with a high risk of hospitalisation may be an innovative approach to deliver cost-efficient intensified care to patients most in need . Methods / Design PraCMan is a cluster r and omized controlled trial with primary care practice s as unit of r and omisation . The study evaluates a complex primary care practice -based care management of patients at high risk for future hospitalizations . Eligible patients either suffer from type 2 diabetes mellitus , chronic obstructive pulmonary disease , chronic heart failure or any combination . Patients with a high likelihood of hospitalization within the following 12 months ( based on insurance data ) will be included in the trial . During 12 months of intervention patients of the care management group receive comprehensive assessment of medical and non-medical needs and re sources as well as regular structured monitoring of symptoms . Assessment and monitoring will be performed by trained HCAs from the participating practice s. Additionally , patients will receive written information , symptom diaries , action plans and a medication plan to improve self-management capabilities . This intervention is addition to usual care . Patients from the control group receive usual care . Primary outcome is the number of all-cause hospitalizations at 12 months follow-up , assessed by insurance cl aims data . Secondary outcomes are health-related quality of life ( SF12 , EQ5D ) , quality of chronic illness care ( PACIC ) , health care utilisation and costs , medication adherence ( MARS ) , depression status and severity ( PHQ-9 ) , self-management capabilities and clinical parameters . Data collection will be performed at baseline , 12 and 24 months ( 12 months post-intervention ) . Discussion Practice -based care management for high risk individuals involving trained HCAs appears to be a promising approach to face the needs of an aging population with increasing care dem and s . Trial registration Current Controlled Trials IS RCT OBJECTIVE To examine to what extent general practitioners in consultations after a geriatric assessment set shared health priorities with older patients experiencing multimorbidity and to what extent this was facilitated through patient-centered behavior . METHODS Observation of consultations embedded in a cluster r and omized controlled trial,(1 ) in which 317 patients from 41 general practice s received the STEP assessment followed by a care planning consultation with their GPs . GPs in the intervention group used a structured procedure for setting health ( care ) priorities in contrast to control GPs . A sample of 43 consultations ( 24 intervention ; 19 control ) were recorded , transcribed and analyzed with regard to priority setting and patient-centeredness . RESULTS Patient-centeredness was only moderately apparent in consultations dealing with complex care plans for older patients with multimorbidity . The shared determination of health priorities seemed unusual for both doctors and patients and was rarely practice d , albeit more frequently in intervention consultations . CONCLUSION Setting health care priorities with patients experiencing multimorbidity is ethically desirable and medically appropriate . Yet a short structured guide for doctors can not easily achieve this . PRACTICE IMPLICATION S More research is needed in regard to h and ling complex health needs of older patients . It requires a professional approach and training in patient-centered holistic care planning Background Care management interventions in the German health-care system have been evaluated with promising results , but further research is necessary to explore their full potential in the context of multi-morbidity . Our aim in this trial is to assess the efficacy of a primary care practice network – based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions . Methods / Design The study is design ed as a prospect i ve , 18-month , multicentre , investigator-blinded , two-arm , open-label , individual-level , r and omized parallel-group superiority trial . We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient . Data will be collected at baseline ( T0 ) , at the primary endpoint after 9 months ( T1 ) and at follow-up after 18 months ( T2 ) . The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities ( SDSCA-G ) . The secondary outcomes will be the differences between the intervention and control groups in : changes in scores on the SDSCA-G subscales , glycosylated haemoglobin A level , health-related quality of life , self-efficacy , differences in ( severe ) symptomatic hypoglycaemia , cost-effectiveness and financial family burden . The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements : ( 1 ) three home visits , including structured assessment of medical and social needs ; ( 2 ) 24 structured telephone monitoring contacts ; and ( 3 ) self-monitoring of blood glucose levels after T1 in 3-month intervals . The control group will receive usual care . The confirmatory primary analysis will be performed following the intention-to-treat ( ITT ) principle . The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle . In health economic evaluations , we will estimate the incremental cost-effectiveness ratios . Discussion We hope that the results of this study will provide insights into the efficacy of practice network – based care management among patients with complex health-care needs . Trial registration Current Controlled Trials IS RCT N83908315 ( IS RCT N assigned 25 February 2014 ) Background Frail elderly people need an integrated and coordinated care . The two-armed study " Continuum of care for frail elderly people " is a multi-professional and multidimensional intervention for frail community-dwelling elderly people . It was design ed to evaluate whether the intervention programme for frail elderly people can reduce the number of visits to hospital , increase satisfaction with health and social care and maintain functional abilities . The implementation process is explored and analysed along with the intervention . In this paper we present the study design , the intervention and the outcome measures as well as the baseline characteristics of the study participants . Methods / design The study is a r and omised two-armed controlled trial with follow ups at 3 , 6 and 12 months . The study group includes elderly people who sought care at the emergency ward and discharged to their own homes in the community . Inclusion criteria were 80 years and older or 65 to 79 years with at least one chronic disease and dependent in at least one activity of daily living . Exclusion criteria were acute severely illness with an immediate need of the assessment and treatment by a physician , severe cognitive impairment and palliative care . The intention was that the study group should comprise a representative sample of frail elderly people at a high risk of future health care consumption . The intervention includes an early geriatric assessment , early family support , a case manager in the community with a multi-professional team and the involvement of the elderly people and their relatives in the planning process . Discussion The design of the study , the r and omisation procedure and the protocol meetings were intended to ensure the quality of the study . The implementation of the intervention programme is followed and analysed throughout the whole study , which enables us to generate knowledge on the process of implementing complex interventions . The intervention contributes to early recognition of both the elderly peoples ' needs of information , care and rehabilitation and of informal caregivers ' need of support and information . This study is expected to show positive effects on frail elderly peoples ' health care consumption , functional abilities and satisfaction with health and social care . Trial registration Clinical Trials.gov : OBJECTIVE Sub clinical depression is one of the most frequent mental comorbidities in patients with diabetes and is associated with a poorer long-term prognosis . Since there is a lack of specific intervention concepts for this patient group , a self-management – oriented group program ( DIAMOS [ Diabetes Motivation Strengthening ] ) was newly developed and evaluated in a r and omized trial . RESEARCH DESIGN AND METHODS DIAMOS is composed of cognitive behavioral interventions aim ing at the reduction of diabetes distress . The active control group ( CG ) received diabetes education . The primary outcome was depressive symptoms . Secondary outcomes were diabetes distress , well-being , self-care behavior , diabetes acceptance , diabetes treatment satisfaction , HbA1c , and sub clinical inflammation . RESULTS Two hundred fourteen participants ( mean age 43.3 ± 13.3 years , female sex 56.5 % , type 2 diabetes 34.1 % , mean diabetes duration 14.2 ± 10.5 years , HbA1c 8.9 ± 1.8 % , BMI 28.7 ± 71 kg/m2 ) were r and omized . The 12-month follow-up revealed a significantly stronger reduction of depressive symptoms ( Center for Epidemiologic Studies Depression Scale score ) in the DIAMOS group compared with the CG ( Δ3.9 [ 95 % CI 0.6–7.3 ] , P = 0.021 ) . Of the secondary variables , the Patient Health Question naire-9 ( Δ1.7 [ 95 % CI 0.2–3.2 ] , P = 0.023 ) , Problem Areas in Diabetes scale ( Δ8.2 [ 95 % CI 3.1–13.3 ] , P = 0.002 ) , and Diabetes Distress Scale scores ( Δ0.3 [ 95 % CI 0.1–0.5 ] , P = 0.012 ) displayed significant treatment effects . Moreover , the risk of incident major depression in the DIAMOS group was significantly reduced ( odds ratio 0.63 [ 95 % CI 0.42–0.96 ] , P = 0.028 ) . Inflammatory variables were not substantially affected . CONCLUSIONS DIAMOS is more effective in lowering depressive symptoms and diabetes-related distress in diabetic patients with sub clinical depression . DIAMOS also has a preventive effect with respect to the incidence of major depression BACKGROUND In the Medicare Modernization Act of 2003 , Congress required the Centers for Medicare and Medicaid Services to test the commercial disease-management model in the Medicare fee-for-service program . METHODS The Medicare Health Support Pilot Program was a large , r and omized study of eight commercial programs for disease management that used nurse-based call centers . We r and omly assigned patients with heart failure , diabetes , or both to the intervention or to usual care ( control ) and compared them with the use of a difference-in-differences method to evaluate the effects of the commercial programs on the quality of clinical care , acute care utilization , and Medicare expenditures for Medicare fee-for-service beneficiaries . RESULTS The study included 242,417 patients ( 163,107 in the intervention group and 79,310 in the control group ) . The eight commercial disease-management programs did not reduce hospital admissions or emergency room visits , as compared with usual care . We observed only 14 significant improvements in process-of-care measures out of 40 comparisons . These modest improvements came at substantial cost to the Medicare program in fees paid to the disease-management companies ( $ 400 million ) , with no demonstrable savings in Medicare expenditures . CONCLUSIONS In this large study , commercial disease-management programs using nurse-based call centers achieved only modest improvements in quality -of-care measures , with Output:	There was little or no difference in clinical outcomes ( based on moderate certainty evidence ) . It is possible that the findings may change with the inclusion of large ongoing well-organised trials in future up date s. The results suggest an improvement in health outcomes if interventions can be targeted at risk factors such as depression , or specific functional difficulties in people with multimorbidity
MS2848	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The lay caregiving role is integral to advanced cancer care but places carers ' health at risk . A supportive General Practitioner ( GP ) can help primary lay carers manage their health , if they disclose their concerns . A Needs Assessment Tool for Caregivers ( NAT-C ) was developed for carers to self-complete and use as the basis of a GP consultation , then tested in a r and omised controlled trial . This paper reports a qualitative research study to determine the usefulness and acceptability of the NAT-C in the Australian primary care setting . Convenience sample s of 11 carers and 5 GPs were interviewed between September 2010 and December 2011 regarding their experiences with and perceptions of the NAT-C. Open-ended questions were used , and the transcripts were analysed qualitatively to identify themes and patterns . Three major themes were identified : ( a ) Acceptability of the intervention ; ( b ) Impact of the intervention on the GP-patient relationship ; and ( c ) Place of the intervention in advanced cancer care . This simple checklist was acceptable to carers , although some were uncertain about the legitimacy of discussing their own needs with their GP . Carer- patients could not be certain whether a GP would be willing or equipped to conduct a NAT-C-based consultation . Such consultations were acceptable to most GPs , although some already used a holistic approach while others preferred brief symptom-based consultations . Although the NAT-C was acceptable to most carers and GPs , supportive consultations take time . This raises organisational issues to be addressed so carers can seek and benefit from their GP 's support CONTEXT A clear underst and ing of what patients , families , and health care practitioners view as important at the end of life is integral to the success of improving care of dying patients . Empirical evidence defining such factors , however , is lacking . OBJECTIVE To determine the factors considered important at the end of life by patients , their families , physicians , and other care providers . DESIGN AND SETTING Cross-sectional , stratified r and om national survey conducted in March-August 1999 . PARTICIPANTS Seriously ill patients ( n = 340 ) , recently bereaved family ( n = 332 ) , physicians ( n = 361 ) , and other care providers ( nurses , social workers , chaplains , and hospice volunteers ; n = 429 ) . MAIN OUTCOME MEASURES Importance of 44 attributes of quality at the end of life ( 5-point scale ) and rankings of 9 major attributes , compared in the 4 groups . RESULTS Twenty-six items consistently were rated as being important ( > 70 % responding that item is important ) across all 4 groups , including pain and symptom management , preparation for death , achieving a sense of completion , decisions about treatment preferences , and being treated as a " whole person . " Eight items received strong importance ratings from patients but less from physicians ( P<.001 ) , including being mentally aware , having funeral arrangements planned , not being a burden , helping others , and coming to peace with God . Ten items had broad variation within as well as among the 4 groups , including decisions about life-sustaining treatments , dying at home , and talking about the meaning of death . Participants ranked freedom from pain most important and dying at home least important among 9 major attributes . CONCLUSIONS Although pain and symptom management , communication with one 's physician , preparation for death , and the opportunity to achieve a sense of completion are important to most , other factors important to quality at the end of life differ by role and by individual . Efforts to evaluate and improve patients ' and families ' experiences at the end of life must account for diverse perceptions of quality . JAMA . 2000;284:2476 - 2482 Background Due to a rising number of deaths from cancer and other chronic diseases a growing number of people experience complex symptoms and require palliative care towards the end of life . However , population -based data on the number of people receiving palliative care in Europe are scarce . The objective of this study is to examine , in four European countries , the number of people receiving palliative care in the last three months of life and the factors associated with receiving palliative care . Methods Cross-national retrospective study . Over two years ( 2009–2010 ) , GPs belonging to representative epidemiological surveillance networks in Belgium , the Netherl and s , Italy , and Spain registered weekly all deaths of patients ( ≥18 years ) in their practice s and the care they received in the last three months of life using a st and ardized form . Sudden deaths were excluded . Results We studied 4,466 deaths . GPs perceived to have delivered palliative care to 50 % of patients in Belgium , 55 % in Italy , 62 % in the Netherl and s , and 65 % in Spain ( p<.001 ) . Palliative care specialists attended to 29 % of patients in the Netherl and s , 39 % in Italy , 45 % in Spain , and 47 % in Belgium ( p<.001 ) . Specialist palliative care lasted a median ( inter-quartile range ) of 15 ( 23 ) days in Belgium to 30 ( 70 ) days in Italy ( p<.001 ) . Cancer patients were more likely than non-cancer patients to receive palliative care in all countries as were younger patients in Italy and Spain with regard to specialist palliative care . Conclusions Although palliative care is established in the countries studied , there are considerable differences in its provision . Two potentially underserved groups emerge non-cancer patients in all countries and older people in Italy and Spain . Future research should examine how differences in palliative care use relate to both patient characteristics and existing national health care policies OBJECTIVE Despite being ideally placed to provide care to patients with terminal illness , many general practitioners ( GPs ) are not involved in palliative care . This study aim ed to determine the level of participation of Australian urban GPs in palliative care , and to determine the main barriers facing them in providing this care . DESIGN Cross-sectional postal survey . PARTICIPANTS AND SETTING Between March and May 2007 a r and om sample of 500 GPs from southwestern and northern regions of Sydney were surveyed . MAIN OUTCOME MEASURES Involvement in palliative care ; personal and professional characteristics of the GPs related to the provision of palliative care ; GPs ' views on barriers to their involvement in palliative care ; GPs ' confidence levels across different issues in palliative medicine . RESULTS Response rate was 61 % and of these 25 % of GPs were not involved in palliative care . GPs not providing palliative care were more likely to be younger , have less GP experience , work less hours , be an employee rather than a practice owner , and educated overseas . Main barriers to GPs ' involvement in palliative care were lack of interest and knowledge , home visits , problems with after-hours care due to family and personal commitments . GPs felt least confident about psychosocial problems and technical aspects of palliative medicine . CONCLUSION About one quarter of GPs surveyed are not involved in palliative care . Strategies to increase GPs ' involvement should aim at increasing their knowledge and interest in palliative care . Innovations in service provider models are required to overcome the barriers to provision of after-hours care Objective To investigate the impact of advance care planning on end of life care in elderly patients . Design Prospect i ve r and omised controlled trial . Setting Single centre study in a university hospital in Melbourne , Australia . Participants 309 legally competent medical in patients aged 80 or more and followed for six months or until death . Interventions Participants were r and omised to receive usual care or usual care plus facilitated advance care planning . Advance care planning aim ed to assist patients to reflect on their goals , values , and beliefs ; to consider future medical treatment preferences ; to appoint a surrogate ; and to document their wishes . Main outcome measures The primary outcome was whether a patient ’s end of life wishes were known and respected . Other outcomes included patient and family satisfaction with hospital stay and levels of stress , anxiety , and depression in relatives of patients who died . Results 154 of the 309 patients were r and omised to advance care planning , 125 ( 81 % ) received advance care planning , and 108 ( 84 % ) expressed wishes or appointed a surrogate , or both . Of the 56 patients who died by six months , end of life wishes were much more likely to be known and followed in the intervention group ( 25/29 , 86 % ) compared with the control group ( 8/27 , 30 % ; P<0.001 ) . In the intervention group , family members of patients who died had significantly less stress ( intervention 5 , control 15 ; P<0.001 ) , anxiety ( intervention 0 , control 3 ; P=0.02 ) , and depression ( intervention 0 , control 5 ; P=0.002 ) than those of the control patients . Patient and family satisfaction was higher in the intervention group . Conclusions Advance care planning improves end of life care and patient and family satisfaction and reduces stress , anxiety , and depression in surviving relatives . Trial registration Australian New Zeal and clinical trials registry ACTRN12608000539336 BACKGROUND : Discussion s of end-of-life care should be held prior to acute , disabling events . Many barriers to having such discussion s during primary care exist . These barriers include time constraints , communication difficulties , and perhaps physicians ’ anxiety that patients might react negatively to such discussion s. OBJECTIVE : To assess the impact of discussion s of advance directives on patients ’ satisfaction with their primary care physicians and outpatient visits . DESIGN : Prospect i ve cohort study of patients enrolled in a r and omized , controlled trial of the use of computers to remind primary care physicians to discuss advance directives with their elderly , chronically ill patients . SETTING : Academic primary care general internal medicine practice affiliated with an urban teaching hospital . PARTICIPANTS : Six hundred eighty-six patients who were at least 75 years old , or at least 50 years old with serious underlying disease , and their 87 primary care physicians ( 57 residents , 30 faculty general internists ) participated in the study . MEASUREMENTS AND MAIN RESULTS : We assessed patients ’ satisfaction with their primary care physicians and visits via interviews held in the waiting room after completed visits . Controlling for satisfaction at enrollment and physician , patient , and visit factors , discussing advance directives was associated with greater satisfaction with the physician ( P=.052 ) . At follow-up , the strongest predictor of satisfaction with the primary care visit was having previously discussed advance directives with that physician ( P=.004 ) , with a trend toward greater visit satisfaction when discussion s were held during that visit ( P=.069 ) . The percentage of patients scoring a visit as “ excellent ” increased from 34 % for visits prior without advance directive discussion s to 51 % for visits with such discussion s ( P=.003 ) . CONCLUSIONS : Elderly patients with chronic illnesses were more satisfied with their primary care physicians and outpatient visits when advanced directives were discussed . The improvement in visit satisfaction was substantial and persistent . This should encourage physicians to initiate such discussion s to overcome communication barriers that might result in reduced patient satisfaction levels OBJECTIVE Late or non-referral of patients to specialist palliative care ( SPC ) services may affect patients ' and their carers ' quality of care . General practitioners ( GPs ) are key professionals in linking people with SPC . The aim of this article is to assess GPs ' perceptions and SPC referrals for their patients with advanced cancer and differences between metropolitan ( M GPs ) and non-metropolitan GPs ( NM GPs ) . METHOD Self-report survey mailed to a stratified r and om sample of 1,680 Australian GPs was used . RESULTS Thirty-one percent ( 469 ) of eligible GPs returned surveys . More M GPs than NM GPs reported referring > 60 % of their patients for SPC ( p = 0.014 ) ; and that a more comprehensive range of SPC services was available . The most frequently reported referral prompts were : presence of terminal illness ( M GPs , 71 % , NM GPs , 66 % , ns ( not significant ) ) ; future need for symptom control ( 69 % vs. 59 % , ns ) and uncontrolled physical symptoms ( 63 % vs. 54 % , ns ) . Reasons for not referring were : doctor 's ability to manage symptoms ( 62 % vs. 68 % , ns ) and the absence of symptoms ( 29 % vs. 18 % , p = 0.025 ) . Higher referral was associated with : having a palliative care physician or consultative service available ; agreeing that all patients with advanced cancer should be referred , and agreeing that with SPC , the needs of the family are better met . SIGNIFICANCE OF RESULTS Referrals for SPC were primarily disease-related rather than for psychological and emotional concerns . Measures are needed to encourage referrals based upon psychosocial needs as well as for physical concerns , and to support GPs caring for people with advanced cancer in areas with fewer comprehensive SPC services We surveyed primary care physicians about their involvement and perceived skills in palliative care . A survey instrument asked how frequently internal medicine and family practice physicians performed 10 palliative care items . Subjects rated their skills in each area . A majority of physicians always or frequently performed all 10 palliative care items , but fewer than 50 % of respondents adequately attended to the spiritual needs and economic problems of patients . Interest in palliative care was associated with an increased frequency in performing palliative care items ( P = 0.036 ) , while training in palliative care was associated with better perceived performance ( P = 0.05 ) . Only 36 % of respondents had received training in palliative care . Internists and family practitioners provide palliative care to patients , but feel their skills are lacking in certain areas . Training may improve care to patients at the end of life The objectives of this study were to establish the extent to which UK primary care has adopted recommended practice s on supportive and palliative care of adults with cancer , and to relate this to participation in national initiatives . We conducted a cross-sectional postal question naire survey of a r Output:	Patients and carers expect their GPs to be competent in all aspects of palliative care . They valued easy access to their GP , a multidisciplinary approach to care and well-coordinated and informed care . They also wanted their care team to communicate openly , honestly and empathically , particularly as the patient deteriorated . ACP and the involvement of GPs were important factors which contributed to patients being cared for and dying in their preferred place . Patients and carers prefer a holistic approach to care . This review shows that GPs have an important role in ACP and that their involvement facilitates dying in the place of preference .
MS2849	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Diabetic retinopathy ( DR ) is a common microvascular complication of diabetes mellitus , and more than 75 % of patients who have had diabetes for more than 20 years will have some degree of DR . This disease is highly destructive to self-esteem and puts a high burden on public health and pension systems due to the effects that it has on people of working age . The current mainstay of treatment is laser photocoagulation , which causes impairment of vision and discomfort to patients . Thus , finding a systemic drug that could act on all microcirculation and prevent direct manipulation of the eyes would be highly desirable . Objective To assess the efficacy and safety of the drugs in the statin and /or fibrate groups for the prevention and treatment of DR . Methods In this systematic review , we will select r and omized controlled trials of fibrates or statins used for the treatment or prevention of DR . Our search strategy will include free text terms and controlled vocabulary ( eg , MeSH , Emtree ) for , “ diabetic retinopathy ” , “ statins ” , “ fibrates ” , “ hypolipidemic agents ” , and for drugs from both groups . Data bases that will be used include Medical Literature Analysis and Retrieval System/ PubMed , Embase , Cochrane Central Register of Controlled Trials , Latin American and Caribbean Center on Health Sciences Information , Clinical trials.gov , World Health Organization International Clinical Trials Registry Platform , and OpenGrey , and we will not have language or date limits . Two review authors will independently select eligible studies and assess the risk of bias using the Cochrane Collaboration ’s tool . We will report structured summaries of the included studies and , if possible , conduct meta-analyses . Results This is a protocol for a systematic review , therefore results are not available . We registered a short version of this protocol before progressing in the review and we are currently in the process of selecting the studies for inclusion . Conclusions Intensive glucose control and lowering blood pressure and lipids are mechanisms that protect macrocirculation in diabetic patients . Both macrovascular and microvascular events in diabetic patients appear to have a common pathway , starting with endothelial injury . Thus , prevention and treatment of microvascular events may benefit from the same interventions . In the review for which we have written this protocol , we will assess whether the use of lipid-lowering oral drugs of the statin and /or fibrate groups may prevent and /or retard progression of DR , with the added benefit of preserving visual acuity . Trial Registration PROSPERO A three-year trial of Atromid treatment in exudative diabetic retinopathy was carried out in twenty-three patients and twenty-five controls . In comparison with those of the controls the eyes of the Atromid-treated patients showed a highly significant decrease in hard waxy exu date s ( p = < 0.0001 ) which was not , however , accompanied by appreciable improvement in visual acuity . No improvement in the vascular retinal lesions occurred . The initial severity of the exudative lesions was not related to the fasting serum cholesterol or triglyceride levels ; there was also no correlation between the effect of Atromid on the exu date s and on these serum lipids . The way in which Atromid might influence exu date deposition and its possible use in the treatment of exudative diabetic retinopathy are discussed Background Synthesis of multiple r and omized controlled trials ( RCTs ) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions . Filtering of search es is time consuming , and no single method fulfills the principal requirements of speed with accuracy . Automation of systematic review s is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making . We developed Rayyan ( http://rayyan.qcri.org ) , a free web and mobile app , that helps expedite the initial screening of abstract s and titles using a process of semi-automation while incorporating a high level of usability . For the beta testing phase , we used two published Cochrane review s in which included studies had been selected manually . Their search es , with 1030 records and 273 records , were uploaded to Rayyan . Different features of Rayyan were tested using these two review s. We also conducted a survey of Rayyan ’s users and collected feedback through a built-in feature . Results Pilot testing of Rayyan focused on usability , accuracy against manual methods , and the added value of the prediction feature . The “ taster ” review ( 273 records ) allowed a quick overview of Rayyan for early comments on usability . The second review ( 1030 records ) required several iterations to identify the previously identified 11 trials . The “ suggestions ” and “ hints , ” based on the “ prediction model , ” appeared as testing progressed beyond five included studies . Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements . The survey respondents reported 40 % average time savings when using Rayyan compared to others tools , with 34 % of the respondents reporting more than 50 % time savings . In addition , around 75 % of the respondents mentioned that screening and labeling studies as well as collaborating on review s to be the two most important features of Rayyan . As of November 2016 , Rayyan users exceed 2000 from over 60 countries conducting hundreds of review s totaling more than 1.6 M citations . Feedback from users , obtained mostly through the app web site and a recent survey , has highlighted the ease in exploration of search es , the time saved , and simplicity in sharing and comparing include-exclude decisions . The strongest features of the app , identified and reported in user feedback , were its ability to help in screening and collaboration as well as the time savings it affords to users . Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of review ers PURPOSE To report additional ocular outcomes of intensive treatment of hyperglycemia , blood pressure , and dyslipidemia in the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) study . DESIGN Double 2 × 2 factorial , multicenter , r and omized clinical trials in people with type 2 diabetes who had cardiovascular disease or cardiovascular risk factors . In the glycemia trial , targets of intensive and st and ard treatment were : hemoglobin A1c < 6.0 % and 7.0 % to 7.9 % , respectively , and in the blood pressure trial : systolic blood pressures of < 120 and < 140 mmHg , respectively . The dyslipidemia trial compared fenofibrate plus simvastatin with placebo plus simvastatin . PARTICIPANTS Of the 3472 ACCORD Eye Study participants enrolled , 2856 had 4-year data ( 85 % of survivors ) . METHODS Eye examinations and fundus photographs were taken at baseline and year 4 . Photographs were grade d central ly for retinopathy severity and macular edema using the Early Treatment Diabetic Retinopathy Study ( ETDRS ) methods . MAIN OUTCOME MEASURES Three or more steps of progression on the ETDRS person scale or treatment of retinopathy with photocoagulation or vitrectomy . RESULTS As previously reported , there were significant reductions in the primary outcome in the glycemia and dyslipidemia trials , but no significant effect in the blood pressure trial . Results were similar for retinopathy progression by 1 , 2 , and 4 or more steps on the person scale and for ≥ 2 steps on the eye scale . In the subgroup of patients with mild retinopathy at baseline , effect estimates were large ( odds ratios , ∼0.30 ; P < 0.001 ) , but did not reach nominal significance for participants with no retinopathy or for those with moderate to severe retinopathy at baseline . CONCLUSIONS Slowing of progression of retinopathy by intensive treatment of glycemia was observed in ACCORD participants , whose average age and diabetes duration were 62 and 10 years , respectively , and who had cardiovascular disease or cardiovascular risk factors . The effect seemed stronger in patients with mild retinopathy . Similar slowing of progression was observed in patients treated with fenofibrate , with no effect observed with intensive blood pressure treatment . This is the second study to confirm the benefits of fenofibrate in reducing diabetic retinopathy progression , and fenofibrate should be considered for treatment of diabetic retinopathy INTRODUCTION Lipid-lowering drugs preserve vision and reduce the risk of hard exu date s in clinical ly-significant macular edema(CSME ) in diabetics with an abnormal lipid profile . But their role in reducing CSME in diabetics with a normal lipid profile is not yet known . OBJECTIVE To evaluate the role of atorvastatin in CSME in diabetics with a normal lipid profile . MATERIAL S AND METHODS A prospect i ve , r and omized clinical trial was carried out . Thirty CSME patients with a normal lipid profile were r and omly divided into Group A and B. Atorvastatin had been started in Group A four weeks prior to laser treatment . The main outcome measures were any improvement or deterioration in visual acuity and macular edema and hard exu date s at six months follow-up . STATISTICS Both the groups were compared using unpaired t test for quantitative parameters and chi-square test for qualitative parameters . A p value of less than 0.05 was taken as significant . RESULTS Visual acuity , macular edema and hard exu date s resolution was not significantly different in the two groups ( P = 0.14 , 0.62 , 0.39 respectively ) . CONCLUSION Atorvastatin does not affect treatment outcome in CSME with a normal lipid profile over a short term follow-up OBJECTIVE To evaluate the relationship between serum lipid levels , retinal hard exu date , and visual acuity in patients with diabetic retinopathy . DESIGN Observational data from the Early Treatment Diabetic Retinopathy Study . PARTICIPANTS Of the 3711 patients enrolled in the Early Treatment Diabetic Retinopathy Study , the first 2709 enrolled had serum lipid levels measured . MAIN OUTCOME MEASURES Baseline fasting serum lipid levels , best-corrected visual acuity , and assessment of retinal thickening and hard exu date from stereoscopic macular photographs . RESULTS Patients with elevated total serum cholesterol levels or serum low-density lipoprotein cholesterol levels at baseline were twice as likely to have retinal hard exu date s as patients with normal levels . These patients were also at higher risk of developing hard exu date during the course of the study . The risk of losing visual acuity was associated with the extent of hard exu date even after adjusting for the extent of macular edema . CONCLUSIONS These data demonstrate that elevated serum lipid levels are associated with an increased risk of retinal hard exu date in persons with diabetic retinopathy . Although retinal hard exu date usually accompanies diabetic macular edema , increasing amounts of exu date appear to be independently associated with an increased risk of visual impairment . Lowering elevated serum lipid levels has been shown to decrease the risk of cardiovascular morbidity . The observational data from the Early Treatment Diabetic Retinopathy Study suggest that lipid lowering may also decrease the risk of hard exu date formation and associated vision loss in patients with diabetic retinopathy . Preservation of vision may be an additional motivating factor for lowering serum lipid levels in persons with diabetic retinopathy and elevated serum lipid levels Besides hyperglycemia and hypertension , a recently recognized risk factor for diabetic retinopathy ( DR ) appears to be hyperlipidemia . While studies using earlier generation lipid lowering agents in DR were disappointing , a r and omized trial using HMG-CoA Reductase Inhibitors has strong rationale , though hitherto not attempted . The aim of the present study was to compare the HMG-CoA Reductase Inhibitor , simvastatin , with placebo in patients having DR in a double-blind r and omized placebo-controlled trial . Fifty patients with diabetes mellitus ( Type 1 and 2 ) with good glycemic control and hypercholesterolemia and having DR ( non- clinical ly significant macular edema and visual acuity 6/24 or better ) in either or both eyes were r and omized to simvastatin 20-mg per day or placebo , and were followed up for 180 days . On simvastatin therapy , total cholesterol and low-density lipoprotein cholesterol ( LDL-C ) decreased ( P < 0.001 , respectively ) , and the level of high-density lipoprotein cholesterol ( HDL-C ) increased ( P < 0.001 ) . VA improved in four patients using simvastatin , ( not statistically different from placebo group ) and worsening of VA occurred in seven patients in the placebo group and none in the simvastatin group ( P = 0.009 ) . Fundus fluorescein angiography and color fundus photograph showed improvement in one patient in the simvastatin group , while seven patients showed worsening in the placebo group ( P = 0.009 ) . The observations of the current study suggest that the HMG-CoA Reductase Inhibitor simvastatin significantly retards the progression of retinopathy in diabetic patients with hypercholesterolemia . The potential of this class of drugs for the primary prevention of DR and other microvascular complications needs to be explored further AIM Hyperlipidemia and diabetic retinopathy increase the risk of cardiovascular disease ( CVD ) . The st and ard versus intEnsive statin therapy for hypercholesteroleMic Patients with diAbetic retinopaTHY ( EMPATHY ) study examines whether intensive lipid-lowering therapy is superior to st and ard therapy in reducing the incidence of cardiov Output:	Overall , adverse events seemed to be similar between fibrate and placebo , but again based on the width of the confidence intervals , an important increase of adverse events can not be rule out . Based on these findings , we are uncertain about the effects of statins for DR .
MS2850	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To compare the effectiveness of annual topical application of silver diamine fluoride ( SDF ) solution , semi-annual topical application of SDF solution , and annual application of a flowable high fluoride-releasing glass ionomer in arresting active dentine caries in primary teeth . METHODS A total of 212 children , aged 3 - 4 years , were r and omly allocated to one of three groups for treatment of carious dentine cavities in their primary teeth : Gp1-annual application of SDF , Gp2-semi-annual application of SDF , and Gp3-annual application of glass ionomer . Follow-up examinations were carried out every six months to assess whether the treated caries lesions had become arrested . RESULTS After 24 months , 181 ( 85 % ) children remained in the study . The caries arrest rates were 79 % , 91 % and 82 % for Gp1 , Gp2 and Gp3 , respectively ( p=0.007 ) . In the logistic regression model using GEE to adjust for clustering effect , higher caries arrest rates were found in lesions treated in Gp2 ( OR=2.98 , p=0.007 ) , those in anterior teeth ( OR=5.55 , p<0.001 ) , and those in buccal/lingual smooth surfaces ( OR=15.6 , p=0.004 ) . CONCLUSION Annual application of either SDF solution or high fluoride-releasing glass ionomer can arrest active dentine caries . Increasing the frequency of application to every 6 months can increase the caries arrest rate of SDF application . CLINICAL SIGNIFICANCE Arrest of active dentine caries in primary teeth by topical application of SDF solution can be enhanced by increasing the frequency of application from annually to every 6 months , whereas annual paint-on of a flowable glass ionomer can also arrest active dentine caries and may provide a more aesthetic outcome Background Early childhood caries discloses a distinct clinical pattern , and the teeth most often involved are the maxillary central incisors , lateral incisors , and the maxillary and man-dibular first molars . The maxillary incisors are most severely affected , with deep carious lesions usually involving the pulp . Teeth that have been endodontically treated often have little coronal tooth tissue remaining and as such require a post to retain the core and restoration .This study evaluated and compared the efficacy of EverStick glass fiber-reinforced composite post with ParaPost Taper Lux in primary maxillary anterior teeth . Aim An in vivo study was conducted to evaluate and compare the longevity and failures of two fiber post systems in primary maxillary anterior teeth . Material s and methods A total of 60 severely mutilated primary maxillary anterior teeth from children aged 3 to 5 years were selected according to the inclusion criteria . These teeth were treated endodontically and were r and omly assigned into two groups with 30 sample s in each group , group I : EverStick glass fiber-reinforced composite post , group II : ParaPost Taper Lux post . The evaluation of dislodgment of posts , secondary caries , root fracture , and post fracture was carried out clinical ly and radiographically during every follow-up at 3 , 6 , 9 , and 12 months interval . Results Statistical tests ( Chi-square test , Fisher ’s exact probability test ) suggested that dislodgment of the posts was significant between the two groups at 6 , 9 , and 12 months follow-ups . But within the group during subsequent follow-up intervals , dislodgment of posts as a mode of failure was not statistically significant . However , clinical ly failures were seen in both the study groups . Conclusion Fiber post system has proved to be successful clinical ly in both primary and permanent teeth due to the mono-block effect with luting agent , post system , core material , and bonding to dentin . Thus , today the EverStick glass fiber post system provides a novel way of fabricating cost-effective and less time-consuming custom-made post in treating mutilated maxillary anteriors . How to cite this article Sawant A , Chunawalla Y , Morawala A , Kanchan NS , Jain K , Talathi R. Evaluation of Novel Glass Fiber-reinforced Composite Technique for Primary Anterior Teeth with Deep Carious Lesions : A 12-month Clinical Study . Int J Clin Pediatr Dent 2017;10(2):126 - 130 OBJECTIVE To compare the effectiveness of three applications of silver diammine fluoride ( SDF ) solution at yearly interval and three applications of SDF solution or sodium fluoride ( NaF ) varnish at weekly interval at baseline in arresting active caries in the primary teeth of preschool children . METHODS Children aged 3 - 4 years ( n = 371 ) who had at least one active caries lesion ( ICDAS codes 3 - 6 ) in their primary teeth were r and omly allocated into three groups : Group 1 - annual application of 30 % SDF solution ; Group 2 - three applications of 30 % SDF at weekly intervals ; and Group 3 - three applications of 5 % NaF varnish at weekly intervals . Follow-up examinations were performed every 6 mo nths by the same masked examiner . RESULTS After 30 months , 309 ( 83 % ) children with 1877 caries lesions remained in the study . For cavitated lesions ( ICDAS code 5 or 6 ) , the caries arrest rate of Group 1 ( 48 % ) was significantly higher than those of Group 2 ( 33 % ) and Group 3 ( 34 % ) , ( p < 0.001 ) . Results of multi-level survival analysis showed that the arrest times of cavitated lesions in both SDF groups ( Groups 1 and 2 ) were significantly shorter than that of the NaF varnish group . For moderate caries lesions without visible dentine ( ICDAS code 3 or 4 ) , the caries arrest rates were 45 % , 44 % and 51 % in Groups 1 , 2 and 3 , respectively ( p > 0.05 ) . Presence of plaque on caries lesion , tooth type and tooth surface type had an influence on caries arrest . CONCLUSION Over a 30-month period , annual applications of SDF solution is more effective than three weekly applications of NaF varnish or SDF solution at baseline in arresting active cavitated dentine caries lesions in primary teeth . CLINICAL SIGNIFICANCE As annual application of SDF solution was found to be more effective than 3 weekly applications of NaF varnish or SDF solution at baseline in arresting active cavitated dentine caries lesions , the former application protocol is preferred for young children who are available for regular caries arrest treatment Objective : We aim ed to evaluate the efficacy of oral hygiene instruction , fluoride varnish and casein phosphopeptide-amorphous calcium phosphate ( CPP-ACP ) for remineralizing white spot lesions ( WSL ) , and the effect of these on the dmft index in primary teeth . Subjects and Methods : In this 1-year , r and omized clinical trial , 140 children aged 12 - 36 months with WSL in the anterior maxillary teeth were selected and r and omly divided into 4 groups of 35 children each . Group 1 ( control ) received no preventive intervention . In group 2 , there was oral hygiene and dietary counseling . In group 3 , there was oral hygiene and the application of fluoride varnish at 4 , 8 and 12 months after baseline . In group 4 , there was oral hygiene and tooth mousse was applied by the parents twice a day over a 12-month period . At baseline and 4 , 8 and 12 months after the intervention , the size of WSL in millimeters and the dmft index were recorded . One hundred and twenty-two children completed the study . Data were analyzed using the repeated- measures ANOVA test . Results : In group 1 , the mean percent WSL area and dmft index values had increased significantly at 12 months after baseline ( p < 0.001 ) . The interventions led to significant decreases in the size of the WSL ; the greatest reduction was in group 4 ( 63 % ) followed by group 3 ( 51 % ) and group 2 ( 10 % ) after 12 months . The smallest increase in the dmft index was in group 4 ( 0.17 ) , followed by groups 3 ( 0.3 ) and 2 ( 0.42 ) . However , there were no significant differences between the groups ( p < 0.001 ) . Conclusions : Oral hygiene along with four fluoride varnish applications or constant CPP-ACP during the 12- month period reduced the size of WSL in the anterior primary teeth and caused a small increase in dmft index values Untreated dental caries in Chinese pre-school children is common . This prospect i ve controlled clinical trial investigated the effectiveness of topical fluoride applications in arresting dentin caries . Three hundred seventy-five children , aged 3 - 5 years , with carious upper anterior teeth were divided into five groups . Children in the first and second groups received annual applications of silver diamine fluoride solution ( 44,800 ppm F ) . Sodium fluoride varnish ( 22,600 ppm F ) was applied every three months to the lesions of children in the third and fourth groups . For children in the first and third groups , soft carious tissues were removed prior to fluoride application . The fifth group was the control . Three hundred eight children were followed for 30 months . The respective mean numbers of arrested carious tooth surfaces in the five groups were 2.5 , 2.8 , 1.5 , 1.5 , and 1.3 ( p < 0.001 ) . Silver diamine fluoride was found to be effective in arresting dentin caries in primary anterior teeth in pre-school children BACKGROUND The aim of this study was to evaluate the effect of fluoride varnish on enamel caries progression in the primary dentition . METHODS One hundred forty-two children in Head Start schools ( 3 to 5 years old ) were r and omized into the varnish and control groups . Children in the varnish group received fluoride varnish ( Duraphat , Colgate-Palmolive Co. ) at baseline and after four months , and children in the control group received no professional fluoride applications . Two calibrated examiners performed the examinations at baseline and at nine months . RESULTS At nine months , the authors found that in the control group , 37.8 percent of active enamel lesions on occlusal , buccal and lingual surfaces became inactive , 3.6 percent progressed and 36.9 percent did not change . In the varnish group , 81.2 percent became inactive , 2.4 percent progressed and 8.2 percent did not change . The difference between the groups was statistically significant ( P < .0001 ) . The mean decayed surfaces , or ds , value in the varnish group was significantly lower after nine months than it was at baseline ( P < .0001 ) . When enamel lesions were included in the data analysis ( along with dentinal lesions ) , the decayed with initial enamel lesions , missing and filled surfaces , or dEmfs , values ; decayed with initial enamel lesions , missing and filled teeth , or dEmft , values ; and decayed surfaces with initial enamel lesions , or dEs , values were significantly lower in the varnish group after nine months than they were at baseline ( P < .0001 ) . CONCLUSIONS These results suggest that fluoride varnish applications may be an effective measure in reversing active pit- and -fissure enamel lesions in the primary dentition . CLINICAL IMPLICATION S Fluoride varnishes are safe , easy to apply and well-accepted by patients . This study shows that fluoride varnish may offer an efficient , nonsurgical alternative for the treatment of decay in children A pragmatic r and omised controlled trial comparing a minimally invasive approach based on atraumatic restorative treatment ( ART ) procedures ( test ) was tested against the st and ard-care approach ( control ) to treat early childhood caries ( ECC ) in a primary -care setting in Perth , W.A. , Australia . Parent/child dyads with ECC were allocated to the test or control group using stratified block r and omisation . Children were examined at baseline and follow-up by two calibrated examiners blinded to group allocation status . Dental therapists trained in ART provided treatment to the test group and dentists treated the control group . Restoration quality was evaluated at follow-up using the ART criteria . Data were analysed on an intention-to-treat basis ; test of proportions , Wilcoxon rank test and logistic regression , controlling for clustering of teeth , were used . Two hundred and fifty-four children were r and omised ( test = 127 and control = 127 ) . There was no statistically significant difference in age , sex and baseline caries experience between the test and control groups . At follow-up ( mean interval 11.4 months , SD 3.1 ) , 220 children were examined ( test = 115 and control = 105 ) and 597 teeth ( test = 417 and control = 180 ) were evaluated for restoration quality , of which 16.8 % ( test ) and 6.7 % ( control ) were judged to have failed ( required replacement ; p < 0.01 ) . Intention-to-treat , multiple logistic regression found multisurface restorations ( OR = 10.4 ) had significantly higher odds of failure , while referral for specialist paediatric care had significantly lower odds of restoration failure ( OR = 0.2 ) . The ART-based approach enabled more children and teeth to be treated , and multisurface restoration and treatment in a primary -care setting had higher odds of restoration failure AIM This r and omised clinical trial ( RCT ) compared the clinical outcomes of three aesthetic full-coronal restorations ( composite strip Output:	For RA in carious anterior upper primary teeth , a low level of evidence was found for higher failure rates of glass ionomer cement and composite fillings than composite strip crowns even if placed under general anaesthesia and especially compared to other crowns ( stainless steel and zirconia ) .
MS2851	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This study was intended to establish the pathogenic significance of sport and exercise in the development of eating disorders . Hospitalized eating disordered patients and an age-matched control group were assessed . Historical and current physical activity data were collected . An indepth interview was also conducted to ascertain the age of onset of the diagnostic symptoms for eating disorders , and to determine whether : ( i ) exercising pre date d dieting ; ( ii ) patients had been involved in competitive athletics ; ( iii ) exercise was excessive ; and ( iv ) weight loss was inversely related to level of exercise . The results indicated that patients were more physically active than controls from adolescence onwards , and prior to the onset of the primary diagnostic criteria for anorexia nervosa . A content analysis of the interview data indicated that 78 % of patients engaged in excessive exercise , 60 % were competitive athletes prior to the onset of their disorder , 60 % reported that sport or exercise pre- date d dieting , and 75 % cl aim ed that physical activity levels steadily increased during the period when food intake and weight loss decreased the most . Together our results suggest that overactivity should not be routinely viewed as a secondary symptom in anorexia nervosa , equivalent to other behaviours . For a number of anorexic women , sport/exercise is an integral part of the pathogenesis and progression of self-starvation Anorexia nervosa ( AN ) and obsessive-compulsive disorder ( OCD ) are highly comorbid , and appear to share a common neurophysiological dysfunction that contributes to the obsessional thoughts and compulsive behaviours seen in both disorders . Obsessive-compulsive personality ( OCP ) traits are also important risk factors for AN . Since excessive exercise has also been associated with greater obsessionality , we hypothesised that AN patients with a hyperactive behavioural profile represent a phenotype more closely linked to OCD than their non-exercising counterparts . We examined prospect ively 50 female AN-Restrictor patients whom we classified as " excessive " or " non-excessive " based on their exercise status i ) at admission and ii ) over the lifetime of their illness . Vali date d measures of OCD symptoms and OCP traits were obtained at admission and after refeeding at discharge . On both classification methods , excessive exercisers had greater OCD symptoms and OCP traits than the non-excessive group , but did not differ on body mass index . OCD symptoms , but not OCP traits , decreased between admission and discharge . Findings support our prediction that AN patients with excessive physical activity constitute a subtype of the disorder with strong links to OCD . Indeed , this phenotype may be a culture-bound variant of OCD OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity BACKGROUND Anorexia nervosa is a disorder of unknown etiology with a high rate of relapse and no known treatment . Because anorexia nervosa shares some similarities with obsessive compulsive disorder , we hypothesized that a serotonin-specific medication might be useful in the treatment of this illness . METHOD We administered an open trial of fluoxetine to 31 patients with DSM-III-R anorexia nervosa . Most anorexics were started on fluoxetine treatment after inpatient weight restoration and then discharged from the hospital and followed up as out patients . RESULTS At the time of follow-up ( 11 + /- 6 months on fluoxetine ) , 29 of the 31 patients had maintained their weight at or above 85 % average body weight ( 97 % + /- 13 % average body weight for the group ) . We judged response as good in 10 , partial in 17 , and poor in 4 anorexics as measured by improvements in eating behavior , mood , and obsessional symptoms . Restrictor anorexics responded significantly better than bulimic and /or purging-type anorexics . CONCLUSION This open trial suggests that fluoxetine may help patients with anorexia nervosa maintain a healthy body weight as out patients . The reasons for the positive effects of fluoxetine are uncertain , but the agent may help by improving eating behavior and /or reducing obsessionality , depression , and anxiety . It is important to emphasize that this was not a double-blind , placebo-controlled study . Thus we can not be certain of the efficacy of fluoxetine and caution that fluoxetine should not be used as the sole treatment of anorexia nervosa at this time OBJECTIVE This study considered whether the prevalence and type of anxiety and psychoactive substance use disorder ( PSUD ) diagnoses differ between women with spectrum anorexia nervosa ( AN ) ( N=40 ) and women with major depressive disorder ( N = 58 ) participating in outpatient clinical trials . METHOD Anxiety and PSUD diagnoses ( according to criteria in the 3rd Rev. ed . of the Diagnostic and Statistical Manual of Mental Disorders ) were assessed using structured clinical interviews . Comparisons were made between AN subtypes ( restricting or binge eating/purging ) and by history of depression within the AN sample . RESULTS A high prevalence of obsessive-compulsive disorder ( OCD ) was found in women with AN . However , social phobia , simple phobia , and PSUD were significantly elevated in both women with depression and women with AN . Prevalences were similar for anxiety and PSUD diagnoses between AN subtypes . DISCUSSION Women with anorexia or depression were comparable in all respects , except for the elevated OCD prevalence in AN , emphasizing the need to use clinical comparison groups to avoid inadvertently attributing elevated prevalences of comorbid conditions to specific disorders In the present study , the structure of obsessive-compulsive symptoms was investigated by means of the Padua Inventory ( PI ) . Simultaneous Components Analysis on data from obsessive-compulsives ( n = 206 ) , patients with other anxiety disorders ( n = 222 ) , and a non clinical sample ( n = 430 ) revealed a five-factor solution . These factors are : ( I ) impulses ; ( II ) washing ; ( III ) checking ; ( IV ) rumination ; and ( V ) precision . Forty-one items were selected as measure of these factors . The reliability for the five subscales , assessing each of the five factors , was found to be satisfactory to excellent . Four subscales ( washing , checking , rumination and precision ) discriminated between panic disorder patients , social phobics and normals on the one h and and obsessive compulsives on the other . The Impulses subscale discriminated between obsessive-compulsives on the one h and and normals on the other , but not between obsessive-compulsives and social phobics or panic patients . Some evidence in support of the construct validity was found . The Padua Inventory-Revised ( 41-items ) appears to measure the structure of obsessive compulsive symptoms : The main types of behaviours and obsessions as seen clinical ly are assessed by this question naire , apart from obsessional slowness Output:	Conclusion There is evidence from the literature to suggest that there is a positive relationship between OCPD and excessive exercise in patients with AN .
MS2852	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Functional neuroimaging studies implicate anterior cingulate and limbic dysfunction in major depressive disorder ( MDD ) and responsiveness to antidepressants . Diffusion tensor imaging ( DTI ) enables characterisation of white matter tracts that relate to these regions . AIMS To examine whether DTI measures of anterior cingulate and limbic white matter are useful prognostic biomarkers for MDD . METHOD Of the 102 MDD out- patients from the International Study to Predict Optimized Treatment for Depression ( iSPOT-D ) who provided baseline magnetic resonance imaging ( MRI ) data , 74 completed an 8-week course of antidepressant medication ( r and omised to escitalopram , sertraline or extended-release venlafaxine ) and were included in the present analyses . Thirty-four matched controls also provided DTI data . Fractional anisotropy was measured for five anterior cingulate-limbic white matter tracts : cingulum cingulate and hippocampus bundle , fornix , stria terminalis and uncinate fasciculus . ( Trial registered at Clinical Trials.gov : NCT00693849 . ) RESULTS A cross-vali date d logistic regression model demonstrated that altered connectivity for the cingulum part of the cingulate and stria terminalis tracts significantly predicted remission independent of demographic and clinical measures with 62 % accuracy . Prediction improved to 74 % when age was added to this model . CONCLUSIONS Anterior cingulate-limbic white matter is a useful predictor of antidepressant treatment outcome in MDD Diffusion Tensor magnetic resonance imaging and computational neuroanatomy are used to quantify postnatal developmental patterns of C57BL/6J mouse brain . Changes in neuronal organization and myelination occurring as the brain matures into adulthood are examined , and a normative baseline is developed , against which transgenic mice may be compared in genotype-phenotype studies . In early postnatal days , gray matter-based cortical and hippocampal structures exhibit high water diffusion anisotropy , presumably reflecting the radial neuronal organization . Anisotropy drops rapidly within a week , indicating that the underlying brain tissue becomes more isotropic in orientation , possibly due to formation of a complex r and omly intertwined web of dendrites . Gradual white matter anisotropy increase implies progressively more organized axonal pathways , likely reflecting the myelination of axons forming tightly packed fiber bundles . In contrast to the spatially complex pattern of tissue maturation , volumetric growth is somewhat uniform , with the cortex and the cerebellum exhibiting slightly more pronounced growth . Temporally , structural growth rates demonstrate an initial rapid volumetric increase in most structures , gradually tapering off to a steady state by about 20 days . Fiber maturation reaches steady state in about 10 days for the cortex , to 30 - 40 days for the corpus callosum , the hippocampus , and the internal and external capsules Background Due to a lack of evidence , there is no consistent age of onset to define early onset ( EO ) versus later onset ( LO ) major depressive disorder ( MDD ) . Fractional anisotropy ( FA ) , derived from diffusion tensor imaging ( DTI ) , has been widely used to study neuropsychiatric disorders by providing information about the brain circuitry , abnormalities of which might facilitate the delineation of EO versus LO MDD . Method In this study , 61 pairs of untreated , non-elderly , first-episode MDD patients and healthy controls ( HCs ) aged 18–45 years old received DTI scans . The voxel-based analysis method ( VBM ) , classification analysis , using the Statistical Package for the Social Sciences ( SPSS ) , and regression analyses were used to determine abnormal FA clusters and their correlations with age of onset and clinical symptoms . Results Classification analysis suggested in the best model that there were two subgroups of MDD patients , delineated by an age of onset of 30 years old , by which MDD patients could be divided into EO ( 18–29 years old ) and LO ( 30–45 years old ) groups . LO MDD was characterized by decreased FA , especially in the white matter ( WM ) of the fronto-occipital fasciculus and posterior limb of internal capsule , with a negative correlation with the severity of depressive symptoms ; in marked contrast , EO MDD showed increased FA , especially in the WM of the corpus callosum , corticospinal midbrain and inferior fronto-occipital fasciculus , while FA of the WM near the midbrain had a positive correlation with the severity of depressive symptoms . Conclusion Specific abnormalities of the brain circuitry in EO vs. LO MDD were delineated by an age of onset of 30 years old , as demonstrated by distinct abnormal FA clusters with opposite correlations with clinical symptoms . This DTI study supported the evidence of an exact age for the delineation of MDD , which could have broad multidisciplinary importance . Trial Registration Clinical Trials.gov BACKGROUND Neuroimaging studies have shown that major depressive disorder ( MDD ) is accompanied by structural and functional abnormalities in specific brain regions and connections ; yet , little is known about alterations of the topological organization of whole-brain networks in MDD patients . METHODS Thirty drug-naive , first-episode MDD patients and 63 healthy control subjects underwent a resting-state functional magnetic resonance imaging scan . The whole-brain functional networks were constructed by thresholding partial correlation matrices of 90 brain regions , and their topological properties ( e.g. , small-world , efficiency , and nodal central ity ) were analyzed using graph theory-based approaches . Nonparametric permutation tests were further used for group comparisons of topological metrics . RESULTS Both the MDD and control groups showed small-world architecture in brain functional networks , suggesting a balance between functional segregation and integration . However , compared with control subjects , the MDD patients showed altered quantitative values in the global properties , characterized by lower path length and higher global efficiency , implying a shift toward r and omization in their brain networks . The MDD patients exhibited increased nodal central ities , predominately in the cau date nucleus and default-mode regions , including the hippocampus , inferior parietal , medial frontal , and parietal regions , and reduced nodal central ities in the occipital , frontal ( orbital part ) , and temporal regions . The altered nodal central ities in the left hippocampus and the left cau date nucleus were correlated with disease duration and severity . CONCLUSIONS These results suggest that depressive disorder is associated with disruptions in the topological organization of functional brain networks and that this disruption may contribute to disturbances in mood and cognition in MDD patients OBJECTIVE The polymorphism BDNF val66met of the brain derived neurotrophic factor ( BDNF ) is common , may increase the risk for depression , and affects BDNF secretion , critical for neuronal survival , plasticity , neurogenesis , and synaptic connectivity . Our objectives were : 1 ) to test the hypothesis that BDNF(val/met ) status influences the remission rate of geriatric depression ; 2 ) to explore whether the relationship between BDNF allelic status to remission is influenced by the presence of microstructural white matter abnormalities . METHOD Non-demented older subjects with major depression had a 2-week placebo period , after which those with a Hamilton Depression Rating Scale ( HDRS ) of 18 or greater received escitalopram 10 mg daily for 12 weeks . Fractional anisotropy was determined in specific regions using the Reproducible Object Quantification Scheme ( ROQS ) software that operates on non-normalized data . RESULTS BDNF(met ) carriers were more likely to achieve remission than BDNF(val/val ) homozygotes after 12 weeks of treatment with escitalopram 10 mg daily . Microstructural abnormalities in the corpus callosum , left superior corona radiata , and right inferior longitudinal fasciculum were also associated with lower remission rate . However , there were no significant interactions between BDNF(val66met ) status and microstructural abnormalities in predicting remission . LIMITATIONS Small number of subjects , focus on a single BDNF polymorphism , fixed antidepressant dose . CONCLUSIONS Depressed older BDNF(met ) carriers had a higher remission rate than BDNF(val/val ) homozygotes . This effect was not related to microstructural white matter abnormalities , which predicted remission independently . We speculate that the relationship between BDNF(val66met ) and remission is due to different effects of BDNF in brain structures related to mood regulation This study was conducted to eluci date the effects of electroconvulsive therapy ( ECT ) on frontal white matter in late-life depressed patients . Diffusion tensor imaging was performed on 8 late-life depressed patients and 12 healthy age-matched controls . The patients were scanned before and after a course of ECT . Fractional anisotropy ( FA ) was determined in the frontal and temporal regions and the corpus callosum . A significant white matter FA reduction was found in widespread frontal and temporal brain regions in patients with depression before ECT treatment compared with controls . A significant increase in frontal white matter FA was seen following ECT treatment . A course of bilateral ECT ameliorated white matter integrity in frontal brain regions . This suggests a strong relationship with the antidepressant action of ECT BACKGROUND Repetitive transcranial magnetic stimulation ( rTMS ) is an effective treatment for treatment-resistant depression ( TRD ) , but its therapeutic mechanisms are unclear . White matter abnormalities are thought to cause network dysfunction underlying TRD . Diffusion tensor imaging ( DTI ) is an ideal tool for examining neural connections and the integrity of white matter . Few studies have used DTI to investigate the impact of rTMS on alterations of whiter matter in TRD . METHOD 30 young treatment-resistant unipolar depression patients ( 19 males and 11 females ) were enrolled in a double-blind , r and omized high-frequency ( 15 Hz ) rTMS treatment study . Seventeen patients were treated with real stimulation , and 13 were treated with sham stimulation . White-matter fractional anisotropy ( FA ) was evaluated using voxel-based analysis ( VBA ) of FA maps derived from DTI before and after treatment . Twenty-five age- and gender-matched subjects were examined as a control group . RESULTS In an exploratory VBA method , clusters of fifty voxels or greater that survived a family-wise error (FWE)-corrected threshold of p<0.05 were considered significant . The results revealed significantly reduced FA in the left middle frontal gyrus , with peak coordinates [ -18 46 -14 ] in TRD patients . This reduced FA was significantly improved after active rTMS treatment , but not sham stimulation . FA increases were correlated with decreased depressive symptoms . LIMITATIONS This study requires replication and further clarification in a larger patient population , and optimization of stimulation locations and methods . CONCLUSIONS These results suggest that the efficacy of rTMS on TRD is related to increased white-matter FA in the left middle frontal gyrus Output:	Results Both pooled and subgroup meta-analyses in medication washout patients showed robust fractional anisotropy ( FA ) reductions in white matter of the right cerebellum hemispheric lobule , body of the corpus callosum ( CC ) and bilateral superior longitudinal fasciculus III ( SLF III ) , whereas FA reductions in the genu of the CC and right anterior thalamic projections were seen in only medication-naive patients . Fibre tracking showed that the main tracts with observed FA reductions included the right cerebellar tracts , body of the CC , bilateral SLF III and arcuate fascicle . Conclusion By excluding the confounding influences of current medication status , findings from the present study may provide a better underst and ing of the underlying neuropathology of MDD
MS2853	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The purpose of this prospect i ve study was to report the long-term risks of rotator cuff tear enlargement and symptom progression associated with degenerative asymptomatic tears . METHODS Subjects with an asymptomatic rotator cuff tear in one shoulder and pain due to rotator cuff disease in the contralateral shoulder enrolled as part of a prospect i ve longitudinal study . Two hundred and twenty-four subjects ( 118 initial full-thickness tears , fifty-six initial partial-thickness tears , and fifty controls ) were followed for a median of 5.1 years . Vali date d functional shoulder scores were calculated ( visual analog pain scale , American Shoulder and Elbow Surgeons [ ASES ] , and simple shoulder test [ SST ] scores ) . Subjects were followed annually with shoulder ultrasonography and clinical evaluations . RESULTS Tear enlargement was seen in 49 % of the shoulders , and the median time to enlargement was 2.8 years . The occurrence of tear-enlargement events was influenced by the severity of the final tear type , with enlargement of 61 % of the full-thickness tears , 44 % of the partial-thickness tears , and 14 % of the controls ( p < 0.05 ) . Subject age and sex were not related to tear enlargement . One hundred subjects ( 46 % ) developed new pain . The final tear type was associated with a greater risk of pain development , with the new pain developing in 28 % of the controls , 46 % of the shoulders with a partial-thickness tear , and 50 % of those with a full-thickness tear ( p < 0.05 ) . The presence of tear enlargement was associated with the onset of new pain ( p < 0.05 ) . Progressive degenerative changes of the supraspinatus muscle were associated with tear enlargement , with supraspinatus muscle degeneration increasing in 4 % of the shoulders with a stable tear compared with 30 % of the shoulders with tear enlargement ( p < 0.05 ) . Nine percent of the shoulders with a stable tear showed increased infraspinatus muscle degeneration compared with 28 % of those in which the tear had enlarged ( p = 0.07 ) . CONCLUSIONS This study demonstrates the progressive nature of degenerative rotator cuff disease . The risk of tear enlargement and progression of muscle degeneration is greater for shoulders with a full-thickness tear , and tear enlargement is associated with a greater risk of pain development across all tear types . LEVEL OF EVIDENCE Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence BACKGROUND Presently , there are no approved nonoperative therapies for the ongoing treatment of persistent shoulder pain . Preliminary data suggest that intra-articular sodium hyaluronate injections may be beneficial for the treatment of persistent shoulder pain result ing from various etiologies . The present study evaluated the efficacy and safety of sodium hyaluronate ( Hyalgan ; molecular weight , 500 to 730 kDa ) for these patients . METHODS Six hundred and sixty patients with persistent shoulder pain and limitation result ing from glenohumeral joint osteoarthritis , rotator cuff tear , and /or adhesive capsulitis who had had a failure of conventional therapy were enrolled in this double-blind , r and omized , phosphate-buffered saline solution-controlled study , and 456 patients completed twenty-six weeks of follow-up . Patients were r and omized to receive either five weekly intra-articular injections of sodium hyaluronate , three weekly intra-articular injections of sodium hyaluronate followed by two weekly intra-articular injections of saline solution , or five weekly intra-articular injections of saline solution . The main outcomes were improvement in terms of shoulder pain on movement at thirteen weeks after the initiation of treatment ( as assessed with use of a 100-mm visual analog scale ) and the treatment effect throughout twenty-six weeks . RESULTS For the overall intent-to-treat population , patients who were managed with sodium hyaluronate had greater pain relief than controls did ; significant differences were noted at Week 7 ( for the five-injection hyaluronate group ) , Week 17 ( for the three and five-injection hyaluronate groups ) , and Week 26 ( for the three-injection hyaluronate group ) . Analysis of the stratified population s clearly established that this effect was due to benefits experienced by the patients with osteoarthritis . The treatment effect through twenty-six weeks was significant in patients with osteoarthritis in the three-injection ( p = 0.003 ) and five-injection ( p = 0.002 ) groups , with no significant difference for either regimen in patients without osteoarthritis . The safety profile was very favorable , with no product-related serious adverse effects and no between-group differences for any reported adverse event . CONCLUSIONS Although the primary end point of this study ( that is , improvement in terms of shoulder pain at thirteen weeks ) was not achieved , the overall findings , including secondary end points , indicate that sodium hyaluronate ( 500 to 730 kDa ) is effective and well tolerated for the treatment of osteoarthritis and persistent shoulder pain that is refractory to other st and ard nonoperative interventions PURPOSE To assess the effectiveness of a specific nonoperative physical therapy program in treating atraumatic full-thickness rotator cuff tears using a multicenter prospect i ve cohort study design . MATERIAL S AND METHODS Patients with atraumatic full-thickness rotator cuff tears who consented to enroll provided data via question naire on demographics , symptom characteristics , comorbidities , willingness to undergo surgery , and patient-related outcome assessment s ( Short Form 12 score , American Shoulder and Elbow Surgeons score , Western Ontario Rotator Cuff score , Single Assessment Numeric Evaluation score , and Shoulder Activity Scale ) . Physicians recorded physical examination and imaging data . Patients began a physical therapy program developed from a systematic review of the literature and returned for evaluation at 6 and 12 weeks . At those visits , patients could choose 1 of 3 courses : ( 1 ) cured ( no formal follow-up scheduled ) , ( 2 ) improved ( continue therapy with scheduled re assessment in 6 weeks ) , or ( 3 ) no better ( surgery offered ) . Patients were contacted by telephone at 1 and 2 years to determine whether they had undergone surgery since their last visit . A Wilcoxon signed rank test with continuity correction was used to compare initial , 6-week , and 12-week outcome scores . RESULTS The cohort consists of 452 patients . Patient-reported outcomes improved significantly at 6 and 12 weeks . Patients elected to undergo surgery less than 25 % of the time . Patients who decided to have surgery generally did so between 6 and 12 weeks , and few had surgery between 3 and 24 months . CONCLUSION Nonoperative treatment using this physical therapy protocol is effective for treating atraumatic full-thickness rotator cuff tears in approximately 75 % of patients followed up for 2 years HYPOTHESIS The purpose of this cross-sectional study is to determine whether the duration of symptoms influences the features seen in patients with atraumatic , full-thickness rotator cuff tears . Our hypothesis is that an increasing duration of symptoms will correlate with more advanced findings of rotator cuff tear severity on magnetic resonance imaging , worse shoulder outcome scores , more pain , decreased range of motion , and less strength . METHODS We enrolled 450 patients with full-thickness rotator cuff tears in a prospect i ve cohort study to assess the effectiveness of nonoperative treatment and factors predictive of success . The duration of patient symptoms was divided into 4 groups : 3 months or less , 4 to 6 months , 7 to 12 months , and greater than 12 months . Data collected at patient entry into the study included ( 1 ) demographic data , ( 2 ) history and physical examination data , ( 3 ) radiographic imaging data , and ( 4 ) vali date d patient-reported measures of shoulder status . Statistical analysis included a univariate analysis with the Kruskal-Wallis test and Pearson test to identify statistically significant differences in these features for different duration s of symptoms . RESULTS A longer duration of symptoms does not correlate with more severe rotator cuff disease . The duration of symptoms was not related to weakness , limited range of motion , tear size , fatty atrophy , or vali date d patient-reported outcome measures . CONCLUSIONS There is only a weak relationship between the duration of symptoms and features associated with rotator cuff disease BACKGROUND The purpose s of this study were to identify changes in tear dimensions , shoulder function , and glenohumeral kinematics when an asymptomatic rotator cuff tear becomes painful and to identify characteristics of individuals who develop pain compared with those who remain asymptomatic . METHODS A cohort of 195 subjects with an asymptomatic rotator cuff tear was prospect ively monitored for pain development and examined annually for changes in various parameters such as tear size , fatty degeneration of the rotator cuff muscle , glenohumeral kinematics , and shoulder function . Forty-four subjects were found to have developed new pain , and the parameters before and after pain development were compared . The forty-four subjects were then compared with a group of fifty-five subjects who remained asymptomatic over a two-year period . RESULTS With pain development , the size of a full-thickness rotator cuff tear increased significantly , with 18 % of the full-thickness tears showing an increase of > 5 mm , and 40 % of the partial-thickness tears had progressed to a full-thickness tear . In comparison with the assessment s made before the onset of pain , the American Shoulder and Elbow Surgeons scores for shoulder function were significantly decreased and all measures of shoulder range of motion were decreased except for external rotation at 90 ° of abduction . There was an increase in compensatory scapulothoracic motion in relation to the glenohumeral motion during early shoulder abduction with pain development . No significant changes were found in external rotation strength or muscular fatty degeneration . Compared with the subjects who remained asymptomatic , the subjects who developed pain were found to have significantly larger tears at the time of initial enrollment . CONCLUSIONS Pain development in shoulders with an asymptomatic rotator cuff tear is associated with an increase in tear size . Larger tears are more likely to develop pain in the short term than are smaller tears . Further research is warranted to investigate the role of prophylactic treatment of asymptomatic shoulders to avoid the development of pain and loss of shoulder function Objective : Assess platelet rich plasma ( PRP ) injection for rotator cuff tendinopathy ( RCT ) . Design : Prospect i ve open label study with 1-year follow-up . Methods : Participants recruited from an outpatient sports medicine clinic had clinical ly and magnetic resonance image (MRI)—demonstrated RCT refractory to physical therapy and corticosteroid injection . They received one ultrasound-guided injection of 3.0 mL of 1 % xylocaine followed by 3.5 mL of PRP at the lesion and surrounding tendon . Primary outcome : 0—10 visual analog scale ( VAS ; baseline , 8 , 12 , and 52 weeks ) . Secondary outcomes : functional shoulder tests assessing rotator cuff strength and endurance ( at baseline and 8 and 12 weeks ) , MRI severity ( 1—5 points [ at baseline and 4 and 8 weeks ] ) , and patient satisfaction ( 52 weeks ) . Results : Eighteen participants with 19 assessed shoulders reported VAS pain score improvement from 7.5 ± 0.3 points to 0.5 ± 0.3 points by week 12 and 0.4 ± 0.2 ( P = .0001 ) points at week 52 . Functional outcomes significantly improved ; the largest effect was seen in the external rotation test : 33.5 ± 5.7 seconds to 62.6 ± 7.2 seconds at week 12 ( P = .0001 ) . MRI appearance improved by 1 to 3 points in 16 of 18 assessed shoulders . Seventeen participants were “ completely satisfied ” ( 12 ) or “ satisfied ” ( 5 ) . One participant was “ unsatisfied . ” Conclusions : A single ultrasound-guided , intralesional injection of PRP result ed in safe , significant , sustained improvement of pain , function , and MRI outcomes in participants with refractory RCT . R and omized multidisciplinary effectiveness trials that add ultrasound and vali date d clinical outcome measures are needed to further assess PRP for RCT Background : Patient activity level may be an important prognostic variable relating to outcomes in patients with shoulder disorders . Little is known about the predictors of activity level in patients with shoulder disorders . Hypothesis : Tear size and patient variables would be predictive of shoulder activity level in a cohort of patients who have selected initial nonoperative treatment for a symptomatic , atraumatic rotator cuff tear on magnetic resonance imaging ( MRI ) . Study Design : Cross-sectional study ; Level of evidence , 3 . Methods : Patients with an atraumatic rotator cuff tear on MRI were prospect ively enrolled in the Multicenter Orthopaedic Outcomes Network ( MOON ) shoulder study of nonoperative treatment . As part of routine data collection , these patients were asked to complete a previously vali date d shoulder activity scale . A regression analysis was performed to assess the association of shoulder activity level to rotator cuff tear characteristics , including tendon involvement and retraction , and patient factors such as age , sex , smoking , and occupation . Results : A total of 434 patients ( 220 male , 214 female ) with a mean age of 62.7 years ( range , 31 - 90 years ) completed the activity scale . Shoulder activity was not associated with severity of the rotator cuff tear , but it was negatively associated with age ( P = .0001 ) and female sex ( P = .001 Output:	Evidence suggests it is safe to monitor symptomatic rotator cuff tears , as tear size and symptoms are not correlated with pain , function , and /or ultimate outcome . CONCLUSIONS complete rotator cuff tears may be effectively treated with injections , exercise in the short and intermediate terms respectively . Negative effect of corticosteroids on rotator cuff tissue has not been demonstrated .
MS2854	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This study reports a prospect i ve clinical trial comparing a carbon fibre reinforced carbon ( CFRC ) endodontic post with a conventional prefabricated post . Twenty-seven single rooted maxillary anterior teeth in 18 patients ( nine males and nine females ; age range 18 - 60 years ) were restored either with a CFRC post or a wrought precious alloy control . Cast type III gold alloy cores were used in conjunction with both post groups . The CRFC posts ( n = 16 ) were cemented with a composite luting agent and the conventional posts ( control ) were cemented with zinc phosphate . Four failures were recorded in the CFRC post group at 24 , 29 , 56 and 87 months , compared with one failure in the control group at 84 months . These results suggest that post-retained crowns utilizing a CFRC material and a composite resin luting agent do not perform as well as conventional wrought precious alloy posts AIMS AND METHODS The purpose of this retrospective , non-r and omised cohort study was to evaluate the success rate of 775 endodontically treated teeth depending on the restoration type . A total of 508 patients with 775 endodontically treated teeth were examined during at least 12 months . The radiographic controls , time span between root canal filling and definitive restoration , restoration material type , inserted post system type and the occurrence of possible endodontically as well as restorative post-operative complications were recorded . RESULTS 18.3 % of the 775 investigated teeth were incisors and canines , 33.5 % were premolars and 48.2 % molars . Pre-fabricated and casted metal post systems were used only in 15.6 % of the endodontically treated teeth ( 18.4 % incisors and canines , 44.8 % premolars , 36.8 % molars ) . 6.6 % of the teeth had endodontically related symptoms or severe complications , whereas in 13.2 % of the teeth restored with metal posts showed complications , such as root or crown fractures . The Cox-Regression analysis showed that teeth restored with a post system had a statistically significant higher failure rate ( p = 0.044 ) than those which had been restored without posts . CONCLUSIONS The results showed a high success rate for endodontically treated teeth when the final restoration was placed within a short period of time ( two weeks ) . A higher tooth loss was observed when metal post systems were employed suggesting that pre caution is recommended when these types of posts are inserted STATEMENT OF PROBLEM Crowns have been considered the restoration of choice for endodontically treated teeth , but their selection has been based primarily on anecdotal evidence . PURPOSE This study tested the hypothesis that crown placement ( coronal coverage ) is associated with improved survival of endodontically treated teeth when preaccess , endodontic , and restorative factors are controlled . MATERIAL AND METHODS A University of Iowa College of Dentistry treatment data base was used to identify permanent teeth that had undergone initial obturation between July 1 , 1985 , and December 31 , 1987 . Study patients were restricted to persons with at least 1 dental visit in each 2-year interval from 1985 to 1996 ; a simple r and om sample of 280 patients ( n = 400 teeth ) was selected . Dental charts , radiographs , and computerized data bases were examined to ascertain variables of interest and to verify study inclusion criteria . Kaplan-Meier survival estimates were generated for the 203 teeth that satisfied study inclusion criteria . Multivariate Cox proportional hazards regression models were developed , with st and ard errors adjusted to account for clustering of teeth within patients . RESULTS When tooth type and radiographic evidence of caries at access were controlled , the final Cox model showed that endodontically treated teeth not crowned after obturation were lost at a 6.0 times greater rate than teeth crowned after obturation ( 95 % confidence interval : 3.2 to 11.3 ) . CONCLUSION Within the limitations of this study , a strong association between crown placement and the survival of endodontically treated teeth was observed . These results may impact treatment planning if long-term tooth retention is the primary goal Through a st and ardized procedure using clinical examination , interviews , and dental history , this 2-year study documents 100 cases of tooth fracture in 98 patients . For comparison , pertinent information was also recorded for more than 2,000 teeth in a r and omly selected sample population . Two chief types of fracture were found : incomplete crown-root fractures and root fractures associated with earlier endodontic therapy BACKGROUND A prospect i ve study was started in 1995 to evaluate the success of carbon fibre reinforced epoxy resin ( CFRR ) posts used to restore endodontically treated teeth . All the teeth in the study had lost more than 50 % of their coronal structure . METHODS Fifty-nine carbon fibre Composiposts cemented with Metabond and built up with Core Paste cores were placed into the teeth of 47 patients . Each tooth received a full-coverage restoration ( porcelain fused to metal crown ) and was followed for 6.7 - 45.4 months ( average = 28.0 months , st and ard deviation = 10.7 ) . RESULTS Results for 52 teeth in 42 patients were analyzed . There were no fractures . The overall failure rate was 7.7 % and the cumulative survival rate was 89.6 % at the end of the follow-up period . The only statistically significant finding ( p = 0.04 ) was that posts in lower premolars were at higher risk of failure . CONCLUSION CFRR posts are among the most predictable systems available today . CFRR posts in the upper anterior teeth are associated with a higher success rate and longer life than those placed in premolars , especially lower premolars . This study contributes to the growing body of evidence that supports the use of CFRR posts in the restoration of endodontically treated teeth PURPOSE This study prospect ively evaluated the clinical performance of three types of translucent posts over a follow-up period of between 2 and 3 years . MATERIAL S AND METHODS Selected were 225 patients with one premolar in need of endodontic treatment , followed by restoration with a fiber post and porcelain crown . The sample was r and omly divided into three groups of 75 patients each . The same type of post was used in all patients within a group : group 1 = Aesthetic Plus ; group 2 = DT ; and group 3 = FRC Postec . For bonding the post , a light-curing adhesive ( One-Step ) and a dual-curing resin cement ( Duo-Link ) were applied in group 1 and 2 roots , whereas self-curing material s ( Excite DSC as adhesive and MultiLink as resin cement ) were used in group 3 . After 6 , 12 , and 24 months , patients were recalled , and a clinical and radiographic examination was performed . For some patients , 30-month follow-up data were also collected . RESULTS Debonding of the post occurrred in eight cases ( 3.5 % ) ; in another six cases , a recurrence of the periapical lesion was reported . CONCLUSION The statistical analysis did not reveal any significant difference in the survival rate of the tested posts , suggesting that all are equally and sufficiently reliable for clinical use PURPOSE In the present prospect i ve study , four different post- and -core systems were evaluated over a period of up to 10 years . MATERIAL S AND METHODS Fifty endodontically treated teeth in 31 patients were r and omized to one of four groups for post- and -core placement : Group 1 received conventional tapered cast posts and cores ( n = 14 ) ; group 2 received ParaPost system prefabricated gold posts with cast cores ( n = 13 ) ; group 3 received ParaPost system cast posts and cores ( n = 13 ) ; and group 4 received Radix-Anchor posts ( n = 10 ) . Clinical and radiologic evaluations were made . RESULTS One post and core in group 2 was functioning well 58 months after placement when the patient died . No posts and cores in groups 1 or 2 had been lost or had any complications , one in group 3 had been lost because of a root fracture after 108 months , and two in group 4 had been lost after 54 and 88 months , respectively , because of loss of retention . The final treatment result for 46 of the 49 remaining posts ( 30 patients ) was successful . The overall failure rate was 6 % . There were no statistically significant differences between the four groups . CONCLUSION If recommended procedures are strictly followed , posts and cores can serve as abutments for fixed single crowns with satisfactory long-term results OBJECTIVES The aim of this study is to provide prospect i ve clinical data for the survival of postendodontic reconstructions of teeth with varying degrees of hard tissue loss using tapered or parallel-sided post shapes . METHODS Eighty-three patients got 105 glass fibre reinforced posts of tapered ( Luscent Anchors , Dentatus , Sweden ) and parallel-sided , serrated ( FibreKor , Jeneric Pentron , USA ) post shape . A dual curing hybrid composite Compolute ( 3 M ESPE , Germany ) was used as luting material , EBS-Multi ( 3 M ESPE ) as adhesive system and Clearfil Core ( Kuraray , Japan ) for core built-up . The restorations were followed for a minimum of 24 months . The statistical analysis was performed on a r and om sub- sample of one restoration per subject . The Fisher exact test was used to compare frequencies of failures after 12 and 24 month . A Kaplan-Meier- analysis was used to analyse time-to-failure in both groups . Differences of survival time between post types were tested with the log-rank test . RESULTS 3.8 % of the restorations failed after 12 month , 12.8 % after 24 month , respectively . The main failure type observed was post fractures . All but one failed teeth could be restored . There was no difference in failure frequency between post types after 12 or 24 months . The log-rank test showed no differences in survival between the two types of post ( p=0.37 ) . CONCLUSION Parallel-sided and tapered glass fibre posts result after 2 years of clinical service in an equal rate of survival PURPOSE This prospect i ve clinical follow-up evaluated the acceptability of quartz fiber-reinforced epoxy posts used in endodontically treated teeth over a 30-month period . MATERIAL S AND METHODS In 132 patients , 180 endodontically treated teeth were restored using AEstheti-Plus quartz-fiber posts . The posts were luted with the All-Bond 2 adhesive system and C&B Resin Cement according to the manufacturer 's recommendations . The core was made with Core-Flo or Bis-Core , and all-ceramic crowns or metal-ceramic crowns were applied as final restorations . The parameters considered as clinical failure were displacement , detachment , or fracture of posts ; core or root fracture ; and crown or prosthesis decementation . Patients were reevaluated at 6 , 12 , 24 , and 30 months . RESULTS One cohesive failure involving a margin of the composite core was observed after 2 weeks , and two adhesive fractures were seen after 2 months . These failures were located between the cement and the dentin walls of the canals . All three failures occurred during removal of the temporary crown . The percentage of failures was thus 1.7 % over a 30-month period , but it was possible to successfully replace the restoration in all three failed cases . CONCLUSION Over a 30-month period , the rehabilitation of endodontically treated teeth using quartz-fiber posts showed good clinical results . No crown or prosthesis decementation was observed , and no post , core , or root fractures were recorded Prospect i ve clinical studies comparing the results of different types of restorations of endodontically treated teeth are lacking . This study compared the clinical success rate of endodontically treated premolars restored with fiber posts and direct composite to the restorations of premolars using amalgam . Premolars with Class II carious lesions were selected and r and omly assigned to one of two experimental groups : ( 1 ) restoration with amalgam or ( 2 ) restoration with fiber posts and composite . One hundred and nine teeth were included in Group 1 and 110 in Group 2 . Patients were recalled after 1 , 3 and 5 years . No statistically significant difference was found between the proportion of failed teeth in the two experimental groups . Significant differences were observed between the proportion of root fractures ( p=0.029 ) and caries ( p=0.047 ) , with more root fractures and less caries observed in the teeth restored with amalgam at the five-year recall . Within the limits of this study , it can be concluded that restorations with fiber posts and composite were found to be more effective than amalgam in preventing root fractures but less effective in preventing secondary caries STATEMENT OF PROBLEM Little information exists regarding the outcome of crown build-ups on endodontically treated teeth restored with metal-ceramic crowns or with only a direct-placed composite . PURPOSE The aim of this study was to evaluate the clinical success rate of endodontically treated premolars restored with fiber posts and direct composite restorations and compare that treatment with a similar treatment of full-coverage with metal-ceramic crowns . MATERIAL AND METHODS Subjects included in this study had one maxillary or m and ibular premolar for which endodontic treatment and crown build up was indicated and met specific inclusion /exclusion criteria . Only premolars with Class II carious lesions and preserved cusp structure were included . Subjects were r and omly assigned to 1 of the following 2 experimental groups : ( 1 ) teeth endodontically treated and restored with adhesive techniques and composite or ( 2 ) teeth endodontically treated , restored with adhesive techniques and Output:	Thus fewer failures occurred when using non-metal posts but the evidence is unreliable . Our systematic review could not specify which type of post and core system should be used when two or three dentine walls remain .
MS2855	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The powers of the low-frequency ( LF ) and high-frequency ( HF ) oscillations characterizing heart rate variability ( HRV ) appear to reflect , in their reciprocal relationship , changes in the state of the sympathovagal balance occurring during numerous physiological and pathophysiological conditions . However , no adequate information is available on the quantitative resolution of this methodology . METHODS AND RESULTS We studied 22 healthy volunteers ( median age , 46.5 years ) who were subjected after a rest period to a series of passive head-up tilt steps r and omly chosen from the following angles : 15 degrees , 30 degrees , 45 degrees , 60 degrees , and 90 degrees . From the continuous ECG , after appropriate analog-to-digital conversion , a personal computer was used to compute , with an autoregressive methodology , time and frequency domain indexes of RR interval variability . Spectral and cross-spectral analysis with the simultaneously recorded respiratory signal excluded its contribution to LF . Age was significantly correlated to variance and to the absolute values in milliseconds squared of very-low-frequency ( VLF ) , LF , and HF components . The tilt angle was correlated to both LF and HF ( expressed in normalized units [ nu ] ) and to the LF-to-HF ratio ( r = .78 , -.72 , and .68 ; respectively ) . Lower levels of correlation were found with HF ( in ms2 ) and RR interval . No correlation was present between tilt angle and variance , VLF , or LF ( in ms2 ) . Individual analysis confirmed that the use of nu provided the greatest consistency of results . CONCLUSIONS Spectral analysis of HRV , using nu or LF-to-HF ratio , appears to be capable of providing a noninvasive quantitative evaluation of grade d changes in the state of the sympathovagal balance OBJECTIVE To assess as whether insomniacs have higher nighttime blood pressure ( BP ) and a blunted day-to-night BP reduction , recognized markers of increased risk of cardiovascular morbidity and mortality . DESIGN Prospect i ve case-control study . SETTING University hospital-based sleep research laboratory . PARTICIPANTS Thirteen normotensive subjects with chronic primary insomnia ( 9 women , 42 + /- 7 y ) and 13 sex- and age-matched good sleepers . MEASUREMENTS AND RESULTS Subjects underwent 2-week sleep diary and 3 sleep studies to provide subjective and objective sleep variables , and 24-h beat-to-beat BP recording to provide daytime , night-time and day-to-night BP changes ([nighttime-daytime]/daytime)*100 ) ( BP dipping ) . Spectral analysis of the electroencephalogram ( EEG ) was also performed during sleep of night 3 to assess EEG activity in the beta frequency ( 16 - 32 Hz ) , a measure of brain cortical activation . Nighttime SBP was higher ( 111 + /- 15 vs 102 + /- 12 mm Hg , P < 0.01 ) and day-to-night SBP dipping was lower (-8 % + /- 6 % vs -15 % + /- 5 % , P < 0.01 ) in insomniacs than good sleepers . Insomniacs also had higher activity in EEG beta frequency ( P < 0.05 ) . Higher nighttime SBP and smaller SBP dipping were independently associated with increased EEG beta activity ( P < 0.05 ) . CONCLUSIONS Higher nighttime SBP and blunted day-to-night SBP dipping are present in normotensive subjects with chronic insomnia and are associated with a hyperactivity of the central nervous system during sleep . An altered BP profile in insomniacs could be one mechanism implicated in the link between insomnia and cardiovascular morbidity and mortality documented in epidemiological studies Entropy , as it relates to dynamical systems , is the rate of information production . Methods for estimation of the entropy of a system represented by a time series are not , however , well suited to analysis of the short and noisy data sets encountered in cardiovascular and other biological studies . Pincus introduced approximate entropy ( ApEn ) , a set of measures of system complexity closely related to entropy , which is easily applied to clinical cardiovascular and other time series . ApEn statistics , however , lead to inconsistent results . We have developed a new and related complexity measure , sample entropy ( SampEn ) , and have compared ApEn and SampEn by using them to analyze sets of r and om numbers with known probabilistic character . We have also evaluated cross-ApEn and cross-SampEn , which use cardiovascular data sets to measure the similarity of two distinct time series . SampEn agreed with theory much more closely than ApEn over a broad range of conditions . The improved accuracy of SampEn statistics should make them useful in the study of experimental clinical cardiovascular and other biological time series Objectives : The prevalence of insomnia is very high in our society . Although pharmacological treatment of insomnia is available , most hypnotics have been shown to alter sleep architecture and have many adverse effects . Gabapentin was originally design ed for antiepileptic therapy ; however , some studies reported that its use increases slow-wave sleep in healthy volunteers or patients . Our goal was to evaluate the benefits of gabapentin in the treatment of primary insomnia in patients . Methods : Eighteen patients with primary insomnia participated in the study . They received gabapentin treatment for at least 4 weeks . All patients received polysomnography , a biochemical blood test , and neuropsychological tests before and after the treatment period . All measures were analyzed with Student t test to examine the treatment effects of gabapentin , except that the measures of heart rate variability were analyzed with analysis of variance . Results : Polysomnographic study revealed increased sleep efficiency and slow-wave sleep , decreased wake after sleep onset , and spontaneous arousal index after gabapentin treatment . The biochemical blood test revealed decreased prolactin levels in the morning after treatment . Electroencephalographic power spectral analysis showed increased delta-2 and theta power in sleep stage 1 and decreased sigma activity power in sleep stages N2 and N3 after gabapentin treatment . Heart rate variability analyses also showed a significant increase in normalized high frequency percentage in sleep stages N2 and N3 and low frequency-high frequency ratio in sleep stage N2 after treatment . In addition , neuropsychological tests revealed the elevation of visual motor processing speed after gabapentin treatment . Conclusions : Gabapentin enhances slow-wave sleep in patients with primary insomnia . It also improves sleep quality by elevating sleep efficiency and decreasing spontaneous arousal . The results suggest that gabapentin may be beneficial in the treatment of primary insomnia STUDY OBJECTIVES To examine the joint effect of insomnia and objective short sleep duration on hypertension risk . DESIGN Representative cross-sectional study . SETTING Sleep laboratory . PARTICIPANTS 1,741 men and women r and omly selected from central Pennsylvania . INTERVENTIONS None . MEASUREMENTS Insomnia was defined by a complaint of insomnia with a duration > or = 1 year , while poor sleep was defined as a complaint of difficulty falling asleep , staying asleep , or early final awakening . Polysomnographic sleep duration was classified into 3 categories : > or = 6 h sleep ( top 50 % of the sample ) ; 5 - 6 h ( approximately the third quartile of the sample ) ; and < or = 5 h ( approximately the bottom quartile of the sample ) . Hypertension was defined based either on blood pressure measures or treatment . We controlled for age , race , sex , body mass index , diabetes , smoking , alcohol use , depression , sleep disordered breathing ( SDB ) , and sampling weight . RESULTS Compared to the normal sleeping and > 6 h sleep duration group , the highest risk of hypertension was in insomnia with < 5 h sleep duration group ( OR [ 95 % CI ] 5.1 [ 2.2 , 11.8 ] ) , and the second highest in insomnia who slept 5 - 6 hours ( OR 3.5 [ 1.6 , 7.9 ] P < 0.01 ) . The risk for hypertension was significantly higher , but of lesser magnitude , in poor sleepers with short sleep duration . CONCLUSIONS Insomnia with short sleep duration is associated with increased risk of hypertension , to a degree comparable to that of other common sleep disorders , e.g. , SDB . Objective sleep duration may predict the severity of chronic insomnia a prevalent condition whose medical impact has been apparently underestimated Background Clinical presentation phenotypes of obstructive sleep apnoea ( OSA ) and their association with comorbidity as well as impact on adherence to continuous positive airway pressure ( CPAP ) treatment have not been established . Methods A prospect i ve follow-up cohort of adult patients with OSA ( apnoea-hypopnoea index ( AHI ) of ≥5/h ) from 17 European countries and Israel ( n = 6,555 ) was divided into four clinical presentation phenotypes based on daytime symptoms labelled as excessive daytime sleepiness ( “ EDS ” ) and nocturnal sleep problems other than OSA ( labelled as “ insomnia ” ) : 1 ) EDS ( daytime+/nighttime- ) , 2 ) EDS/insomnia ( daytime+/nighttime+ ) , 3 ) non-EDS/non-insomnia ( daytime-/nighttime- ) , 4 ) and insomnia ( daytime-/nighttime+ ) phenotype . Results The EDS phenotype comprised 20.7 % , the non-EDS/non-insomnia type 25.8 % , the EDS/insomnia type 23.7 % , and the insomnia phenotype 29.8 % of the entire cohort . Thus , clinical presentation phenotypes with insomnia symptoms were dominant with 53.5 % , but only 5.6 % had physician diagnosed insomnia . Cardiovascular comorbidity was less prevalent in the EDS and most common in the insomnia phenotype ( 48.9 % vs. 56.8 % , p<0.001 ) despite more severe OSA in the EDS group ( AHI 35.0±25.5/h vs. 27.9±22.5/h , p<0.001 , respectively ) . Psychiatric comorbidity was associated with insomnia like OSA phenotypes independent of age , gender and body mass index ( HR 1.5 ( 1.188–1.905 ) , p<0.001 ) . The EDS phenotype tended to associate with higher CPAP usage ( 22.7 min/d , p = 0.069 ) when controlled for age , gender , BMI and sleep apnoea severity . Conclusions Phenotypes with insomnia symptoms comprised more than half of OSA patients and were more frequently linked with comorbidity than those with EDS , despite less severe OSA . CPAP usage was slightly higher in phenotypes with EDS INTRODUCTION Impaired heart rate variability ( HRV ) is associated with poor outcome in diabetic patients . The present prospect i ve study compared spectral components of HRV obtained by either fast Fourier transform ( FFT ) or autoregressive ( AR ) analyses in diabetic patients . METHODS Thirty patients ( 49+/-12 years ; 11 F/19 M ; 60 % with insulin-dependent type 1 diabetes ) underwent 24-h ambulatory electrocardiographic recordings which comprised a 10-min resting period at the onset ( n=30 ) and end ( n=12 ) of the monitoring . Spectral analysis was applied to 5-min sequences at rest , and the total power and power spectra integrated over the very low ( VLF ) , low ( LF ) , and high ( HF ) frequency b and s were obtained . RESULTS Fifteen patients had moderately depressed HRV and two patients had highly depressed HRV ( st and ard deviation of the RR intervals over 24-h<100 ms and < 50 ms , respectively ) . Both raw data and ln-transformed data were significantly different between FFT and AR . All spectra component were obtained in each patient using FFT . Using AR , the LF/HF ratio could not be estimated or was zero in 4 and 11 patients , respectively . The AR results were more sensitive than FFT results to minor changes ( + /-5 % ) in the timing of the onset of analysis . The day-to-day reproducibility of FFT was better than that of AR . Finally , using FFT , the LF/HF ratio , LFnu , and HFnu were essentially redundant ( nu = normalized units ) . CONCLUSIONS The spectral components of short-term HRV calculated by using the FFT and AR methods were not interchangeable and FFT analysis must be preferred in diabetic patients AIMS Heart rate variability has been proposed as an indicator of cardiovascular health . Since women have a lower cardiovascular risk , we hypothesized that there are gender differences in autonomic modulation . METHODS AND RESULTS In 276 healthy subjects ( 135 women , 141 men ) between 18 and 71 years of age , 24 h heart rate and heart rate variability were determined . All heart rate variability parameters , except for pNN50 and high frequency power , were higher in men . After adjustment for heart rate , we obtained gender differences for : the st and ard deviation ( P=0.049 ) , the st and ard deviation of the 5 min average ( P=0.047 ) , low frequency power ( absolute values , P=0.002 ; normalized units , P<0.001 ) and ratio low frequency/high frequency ( P<0.001 ) . There were no significant gender differences in heart rate variability parameters denoting vagal modulation . Gender differences were confined to age categories of less than 40 years of age . The majority of heart rate variability parameters decreased with age . Only in men , was a higher body mass index associated with a higher heart rate and with lower heart rate variability parameters ( P<0.001 ) . CONCLUS Output:	Autonomic regulation tends to be consistent between insomniacs , as long as they are grouped according to their respective phenotype , as shown in the insomnia subgroup with objective ly short sleep duration . Our hypothesis is that these differences in the expression of cardiovascular activity could be explained by the heterogeneity of the disorder . Therefore , the determination of insomnia phenotypes , and the study of cardiovascular measures , rather than heart rate variability alone , will give more insight into the link between insomnia and cardiovascular regulation . This study suggests that cardiovascular activity differs between insomniacs and controls .
MS2856	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background and Purpose — Based on the hypothesis of glutamate-induced neurotoxicity ( excitotoxicity ) in cerebral ischemia , this study examined the efficacy and tolerability of memantine , an uncompetitive N-methyl-d-aspartate antagonist , in the treatment of mild to moderate vascular dementia . Methods — In this multicenter , 28-week trial carried out in France , 321 patients received 10 mg/d memantine or placebo twice a day ; 288 patients were valid for intent-to-treat analysis . Patients had to meet the criteria for probable vascular dementia and have a Mini-Mental State ( MMSE ) score between 12 and 20 at inclusion . The 2 primary end points were the cognitive subscale of the Alzheimers Disease Assessment Scale ( ADAS-cog ) and the global Clinician ’s Interview Based Impression of Change ( CIBIC-plus ) . Results — After 28 weeks , the mean ADAS-cog scores were significantly improved relative to placebo . In the intention-to-treat population , the memantine group mean score had gained an average of 0.4 points , whereas the placebo group mean score had declined by 1.6 points , ie , a difference of 2.0 points ( 95 % confidence interval , 0.49 to 3.60 ) . The response rate for CIBIC-plus , defined as improved or stable , was 60 % with memantine compared with 52 % with placebo ( P = 0.227 , intention to treat ) . Among the secondary efficacy parameters , which were analyzed in the per- protocol subset , MMSE was significantly improved with memantine compared with deterioration with placebo ( P = 0.003 ) . The Gottfries-Brane-Steen Scale intellectual function subscore and the Nurses ’ Observation Scale for Geriatric Patients disturbing behavior dimension also showed differences in favor of memantine ( P = 0.04 and P = 0.07 , respectively ) . Memantine was well tolerated with a frequency of adverse events comparable to placebo . Conclusions — In patients with mild to moderate vascular dementia , memantine 20 mg/d improved cognition consistently across different cognitive scales , with at least no deterioration in global functioning and behavior . It was devoid of concerning side effects BACKGROUND The Consortium to Investigate Vascular Impairment of Cognition ( CIVIC ) is a Canadian , multi-centre , clinic-based prospect i ve cohort study of patients with Vascular Cognitive Impairment ( VCI ) . We report its organization and the impact of diagnostic criteria on the study of VCI . METHODS Nine memory disability clinics enrolled patients and recorded their usual investigations and care . A case report form included all vascular dementia ( VaD ) individual criteria for each of four sets ( National Institute of Neurological Disorders and Stroke ( NINDS-AIREN ) , Alzheimer 's Disease Diagnostic Treatment Centers ( ADDTC ) , the ICD-10 Classification of Mental and Behavioural Disorders ( ICD-10 ) , and the Diagnostic and Statistical Manual of Mental Disorders ( DSM-IV ) ) of consensus-based diagnostic criteria and for the Hachinski Ischemia Score ( HIS ) . Investigators , having completed the case report form , were asked to make a clinical judgement about the cognitive diagnosis based on the best available information , including neuroimaging . RESULTS Of 1,347 patients ( mean age 72 years ; 56 % women ) , 846 ( 63 % ) were diagnosed with dementia and 324 ( 24 % ) were diagnosed with VCI . The proportion of patients diagnosed with VaD by the diagnostic criteria was : 23.9 % ( n = 322 ) by DSM-IV , 10.2 % ( n = 137 ) by HIS , 4.3 % ( n = 58 ) by ICD-10 , 3.8 % ( n = 51 ) by ADTCC , and 3.6 % ( n = 48 ) by NINDS-AIREN . Judged against a clinical diagnosis of VaD , the sensitivity/specificity of each was : DSM-IV ( 0.77/0.80 ) ; HIS ( 0.41/0.92 ) ; ICD-10 ( 0.29/0.98 ) ; ADTCC ( 0.24/0.98 ) ; NINDS-AIREN ( 0.42/0.995 ) . Compared with a clinical diagnosis of VCI , sensitivities were lower for the diagnostic criteria , reflecting the exclusion of patients who did not have dementia . CONCLUSIONS Consensus-based criteria for VaD omit patients who do not meet dementia criteria that are modeled on Alzheimer 's disease . Even for patients who do , the proportion identified with VaD varies widely . Criteria based on empirical analyses need to be developed and vali date Objective : To evaluate the efficacy and tolerability of donepezil in patients with vascular dementia ( VaD ) . Methods : Patients ( n = 616 ; mean age , 75.0 years ) with probable or possible VaD , according to National Institute of Neurological Disorders and Stroke – Association Internationale pour la Recherche en l’Enseignement en Neurosciences criteria , were r and omized to receive donepezil 5 mg/day ( n = 208 ) , donepezil 10 mg/day ( after 5 mg/day for the first 28 days ) ( n = 215 ) , or placebo ( n = 193 ) for 24 weeks . Results : Seventy-six percent of the patients enrolled had probable VaD. A total of 75.3 % of the 10 mg donepezil group and 80.8 % of the 5 mg group completed the study compared with 83.4 % of the placebo group . Both donepezil-treated groups showed improvements in cognitive function on the Alzheimer ’s Disease Assessment Scale – cognitive subscale compared with placebo , with a mean endpoint treatment difference , as measured by the change from baseline score , of approximately 2 points ( donepezil 5 mg , −1.65 [ p = 0.003 ] ; 10 mg , −2.09 [ p = 0.0002 ] ) . Greater improvements on the Clinician ’s Interview-Based Impression of Change – plus version were observed with both donepezil groups than with the placebo group ( overall donepezil treatment vs placebo p = 0.008 ) ; 25 % of the placebo group showed improvement compared with 39 % ( p = 0.004 ) of the 5 mg group and 32 % ( p = 0.047 ) of the 10 mg group . Withdrawal rates due to adverse events were low ( placebo , 8.8 % ; donepezil 5 mg , 10.1 % ; 10 mg , 16.3 % ) . Conclusions : Donepezil-treated patients demonstrated significant improvements in cognition and global function compared with placebo-treated patients , and donepezil was well tolerated Little is known about progression , short of dementia , in vascular cognitive impairment . In the Canadian Study of Health and Aging , 149 participants ( 79.3 ± 6.7 years ; 61 % women ) were found to have vascular cognitive impairment , no dementia ( CIND ) . After 5 years , 77 participants ( 52 % ) had died and 58 ( 46 % ) had developed dementia . Women were at greater risk of dementia ( OR 2.1 , 1.0 to 4.5 ) . Of 32 participants alive without dementia , cognition had deteriorated in seven and improved in four . Half of those with vascular CIND developed dementia within 5 years , suggesting a target for preventive interventions Background and Purpose — Clinical observations suggest that patients with vascular dementia ( VaD ) may benefit from treatment with cholinesterase inhibitors . This study evaluated the efficacy and safety of donepezil for relieving symptoms of dementia in VaD. Methods — Patients ( n=603 ; mean age , 73.9 years ; 55.2 % men ) with probable ( 70.5 % ) or possible ( 29.5 % ) VaD , according to criteria of the National Institute of Neurological Disorders and Stroke ( NINDS ) and the Association Internationale pour la Recherche et l’Enseignement en Neurosciences ( AIREN ) , were r and omized to 24 weeks of treatment with donepezil 5 mg/d ( n=198 ) , donepezil 10 mg/d ( 5 mg/d for first 28 days ; n=206 ) , or placebo ( n=199 ) . Analyses were based on the intent-to-treat population . Results — At week 24 , both donepezil groups showed significant improvement in cognition versus placebo on the Alzheimer ’s Disease Assessment Scale – cognitive subscale ( mean change from baseline score effect size : donepezil 5 mg/d , −1.90 ; P = 0.001 ; donepezil 10 mg/d , −2.33 ; P < 0.001 ) . Significant improvements in patients ’ global function were seen versus placebo at week 24 ( observed cases ) , on the Clinician ’s Interview-Based Impression of Change – Plus version only for patients on donepezil 5 mg/d ( P = 0.014 ) , and on the Sum of the Boxes of the Clinical Dementia Rating only for patients on 10 mg/d ( P = 0.007 ) . Donepezil-treated patients showed significant benefits in activities of daily living over placebo on the Alzheimer ’s Disease Functional Assessment and Change Scale ( mean change from baseline score effect size at week 24 : donepezil 5 mg/d , −1.31 , P = 0.02 ; donepezil 10 mg/d , −1.31 , P = 0.02 ) . Donepezil was well tolerated . Withdrawal rates due to adverse events were relatively low ( placebo , 11.1 % ; donepezil 5 mg/d , 11.1 % ; donepezil 10 mg/d , 21.8 % ; P = 0.005 versus placebo ) . Conclusions — These data demonstrate that donepezil is an effective and well-tolerated treatment for VaD and show it may have an important place in the management of this condition Output:	Due to insufficient evidence , rivastigmine could not yet be recommended for the treatment of vascular dementia . Memantine appeared to be safe and well tolerated but did not demonstrate effectiveness across all cognitive outcomes and clinical global measures . Conclusion : Acetylcholinesterase inhibitors and NMDA receptor antagonists , in general , displayed promise as treatments for patients with vascular dementia and vascular cognitive impairment . The most effective , evidence -based treatments were donepezil and galantamine
MS2857	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Data regarding validity of clinical and radiographic findings in diagnosing patellofemoral pain syndrome are inconclusive . We prospect ively assessed how sensitive and specific key patellofemoral physical examination tests are , and evaluated the prevalence of physical examination and radiographic findings . Sixty-one infantry soldiers with patellofemoral pain syndrome and 25 control subjects were evaluated . The sensitivity of the patellar tilt , active instability , patella alta , and apprehension tests was low ( less than 50 % ) ; specificity ranged between 72 % and 100 % . Although the prevalence of positive patellar tilt and active instability tests was significantly greater in subjects with patellofemoral pain syndrome , there were no significant differences between the groups in the results of the other two tests . Soldiers with patellofemoral pain syndrome presented with increased quadriceps angle , lateral and medial retinacular tenderness , patellofemoral crepitation , squinting patella , and reduced mobility of the patella . There were no differences between the groups in the prevalence of lower limb and foot posture alignment and knee effusion . Plain radiography showed increased patellar subluxation in soldiers with patellofemoral pain syndrome . Other radiographic measures ( sulcus angle , Laurin angle , Merchant angle , and Insall-Salvati index ) were similar in both groups . We provide evidence regarding the validity of clinical and radiographic features commonly used for diagnosing patellofemoral pain syndrome . Physical examinations were more useful than plain radiography . Level of Evidence : Diagnostic study , Level I. See the Guidelines for Authors for a complete description of levels of evidence Background The goals of this study were to ( 1 ) define the epidemiology of acute patellar dislocation , ( 2 ) determine the risk of subsequent patellar instability episodes ( subluxation and /or redislocation ) during the study period , and ( 3 ) identify risk factors for subsequent instability episodes . Study Design Prospect i ve cohort study . Methods The authors prospect ively followed 189 patients for a period of 2 to 5 years . Historical data , injury mechanisms , and physical and radiographic measurements were recorded to identify potential risk factors for poor outcomes . Results Risk was highest among females 10 to 17 years old . Patients presenting with a prior history of instability were more likely to be female ( P < .05 ) and were older than first-time dislocation patients ( P < .05 ) . Fewer first-time dislocators ( 17 % ) had episodes of instability during follow-up than patients with a previous history of instability ( 49 % ) ( P < .01 ) . After adjusting for demographics , patients with a prior history had 7 times higher odds of subsequent instability episodes during follow-up than first time dislocators ( adjusted odds ratio = 6.6 , P < .001 ) . Conclusions Patellar dislocators who present with a history of patellofemoral instability are more likely to be female , are older , and have greater risk of subsequent patellar instability episodes than first-time patellar dislocators . Risk of recurrent patellar instability episodes in either knee is much higher in this group than in first-time dislocators Different surgical techniques have been described to correct trochlear dysplasia , without clear descriptions of the various types of trochlear dysplasia . In describing trochlear dysplasia , there exist no clear criteria to distinguish between decreased trochlear depth ( heightened trochlea floor ) and flattened lateral and /or medial condylar height . The current study aims to build a data base of axial MRI measurements of normal and abnormal trochlear shape to create a foundation for the selection of the necessary surgical correction to more normal trochlear anatomy . We prospect ively examined 152 subjects : 30 patients with patellar instability due to trochlea dysplasia and 122 subjects without any symptoms or objective findings related to the patellofemoral joint . MRI was performed in both groups . The height of the medial and lateral condyle , and the center of the trochlea was measured on axial MR images . The height of these different locations was compared to the total width of the femoral condyle and expressed in percentages . The statistical analysis was conducted with the Student ’s t test at SPSS software . For intraobserver reliability 20 r and omly taken MRI were evaluated twice . The intraobserver reliability was determined by calculating the kappa values investigated parameter . In normal subjects , the height of the lateral condyle was 81 % of the width of the femoral condyle ( 100 units),the trochlear central height was 73 % , the medial condylar height was 76 % . In patients with patellar instability , the lateral condylar height was 82 % and showed no significant difference compared to the normal group ( P = 0.082 ) . The trochlear central ( 77 % ) and medial condylar height ( 79 % ) were significantly different ( P < 0.001 ) compared to the normal subjects . The location of pathology in patients with patellar instability was decreased lateral condylar height in five cases ( 16.6 % ) and decreased central /medial height in 25 cases ( 83.4 % ) . A height of the lateral condyle < 77 % was documented to be pathologic . There was also a significant difference ( P < 0.001 ) between males and females comparing the different heights of the trochlea to the total width of the femoral condyle . The result ant percentages of all three height measurements , the lateral , central , and medial heights , were greater in males than in females . The intraobserver reliability was perfect for all investigated parameters . In conclusion , ( 1 ) the presented measurement scheme on axial MRI is a reliable method to calculate the height of the trochlea in different locations , ( 2 ) a more objective assessment of the trochlear pathology is possible , ( 3 ) in five of six cases the pathology is located in the center and /or medial trochlea , and ( 4 ) in our series of patellofemoral instability patients , most would benefit from a deepening trochleaplasty as the surgical procedure of choice to correct dysplasia Objective Recent advances in surgical intervention for patellar instability have led to a need for long-term radiological monitoring . The aim of this study is to determine whether or not magnetic resonance imaging ( MRI ) or ultrasound ( US ) can replace computed tomography ( CT ) as the st and ard of care for the evaluation of the femoral sulcus . Material s and methods This was a prospect i ve study comparing the reliability of CT , magnetic resonance ( MR ) , and US for measuring the femoral sulcus in patients with patellar instability . Twenty-four patients were recruited to undergo a CT , MR , and US examination of each knee . Two observers independently measured femoral sulcus angles from subchondral bone and hyaline cartilage on two occasions . Intraclass correlations and generalizability coefficients were calculated to measure the reliability of each of the techniques . Thereafter , two observers measured the femoral sulcus angle from ultrasound images recorded by two independent operators to estimate interobserver and interoperator reliability . Results Forty-seven knees were examined with CT and US and 44 with MRI . The sulcus angle was consistently smaller when measured from subchondral bone compared to cartilage ( 5–7 ° ) . Interobserver reliability for CT , MR , and US measurements from subchondral bone were 0.87 , 0.80 , and 0.82 and from cartilage 0.80 , 0.81 , and 0.50 . Generalizability coefficients of measurements from subchondral bone for CT , MR , and US were 0.87 , 0.76 , and 0.81 and for cartilage 0.76 , 0.73 , and 0.05 . Most of the variability in the US occurred at image acquisition rather than measurement . Conclusion In patients with patellar instability , CT and MR are reliable techniques for measuring the femoral sulcus angle but US , particularly of the articular cartilage , is not . MR is therefore the most suitable tool for longitudinal studies of the femoral sulcus We prospect ively studied the characteristics and early recovery of an unselected population of patients who had acute first-time lateral patellar dislocation . The recovery program used st and ardized rehabilitation , emphasizing range of motion , muscle strength , and return of function . Patients returned to stressful activities including sports as tolerated when they regained full passive range of motion , had no effusion , and when quadriceps muscle strength was at least 80 % compared with the noninjured limb . Seventy-four patients met the enrollment criteria ; 37 men and 37 women . The average age was 19.9 years , and preinjury sports participation was similar to that of ligament-injury patients . Four percent of patients ( N 3 ) had a history of birth complications , 3 % ( N 2 ) had a history of lower extremity problems as an infant or child , and 9 % ( N 7 ) had a family history of patellar dislocation . Radiographs revealed a 50 % incidence ( N 37 ) of patella alta ; all patients demonstrated lateral patellar overhang . Patients regained range of motion ( mean , 0 ° to 132 ° ) by 6 weeks . Sports participation remained significantly reduced throughout the first 6 months after injury , with the greatest limitations in kneeling and squatting . At 6 months , 58 % of patients ( N 43 ) noted limitation in strenuous activities . The patients who had acute primary patellar dislocation were young and active . Most injuries occurred during sports , and few patients had abnormal physical features , contradicting any stereotype of an overweight , sedentary , adolescent girl whose patella dislocates with little or no trauma Minor degrees of malalignment of the patella and anatomical abnormalities including a flattened sulcus angle and an increased ratio between patellar tendon length and patellar length ( PT : P ) have been suggested as predisposing factors in the causation of chondromalacia patellae , as well as patellar instability . In order to confirm or refute this hypothesis a prospect i ve study has been performed comparing the congruence and sulcus angles and the PT : P ratio in a group of 35 patients with chondromalacia confirmed by arthroscopy and a group of 33 patients with instability , with those of a group of 50 knees in normal volunteers . While there was a statistically significant correlation between an increased sulcus and congruence angle and a high-riding patella in patients with instability , no correlation could be identified in patients with idiopathic chondromalacia This is a prospect i ve study of 431 patients ( 862 knees ) with patellofemoral pain , patellar dislocation , or other abnormalities of the knee joint . There were 217 asymptomatic knees with no contralateral problems for comparison . All patients had a history and physical and radiographic examination of both knees . The radiographs included st and ard anteroposterior views , axial views at 30 ° of knee flexion , and st and ing lateral views at 0 ° and 30 ° of flexion . The presence of patellar tilt or subluxation was noted on the axial view . The lateral view of the patella , with precise overlap of the posterior femoral condyles , allowed determination of relationships between the patella 's medial edge , median ridge , and lateral edge to assess patellar tilt . Sixty-two percent of patients with patellar dislocations demonstrated subluxation on the axial view , while 98 % demonstrated an abnormal lateral view . Eighteen percent of the control knees revealed evidence of subluxation on the axial view while 35 % demonstrated subluxation on the extended lateral view . The axial view demonstrated 62 % sensitivity for dislocation , while the lateral view taken in full extension demonstrated 98 % sensitivity . The specificity for previous dislocation was 82 % for the axial view and 93 % for the lateral flexed view . Given the high sensitivity of the lateral view for detecting prior patellar dislocation , a normal result on this view can virtually eliminate the question of previous dislocation . Also , with the high specificity of the axial view and lateral view with knee flexion , the two views combined can confirm a clinical impression of patellofemoral malalignment The present study compares the repeatability of patellofemoral malalignment ( PFM ) indices obtained by 20 degree flexion axial radiography ( AR ) and computerized tomography ( CT ) with 0 degree and 20 degree flexion of the knees in children and adolescents . Thirty-one patients with a mean age of 14.2 years ( range 8 to 19.2 years ) suffering from PFM were examined using these two radiographic techniques . The lateral patellofemoral angle ( LPA ) , the lateral patellar tilt ( LPT ) , and the lateral patellar displacement ( LPD ) were measured by by two different investigators on different occasions , and the agreement of these indices between CT and AR was evaluated according to Bl and and Altman 's statistical method . LPT and LPD obtained by AR were more reliable and repeatable than those obtained by CT . The quadriceps muscle contraction exacerbates PFM indices significantly with the knees in full extension ( P = 0.0001 ) . LPT and LPD measured at 20 degrees AR show reliably the two pathological components ( the patellar tilt and the lateral patellar displacement ) of PFM which are necessary for diagnosis and treatment planning . CT with quadriceps contractions is better in qualitative screening of more subtle cases of PFM Output:	The findings indicated that there was acceptable inter-observer and intra-observer reliability and validity for different methods of assessing patellar height and the sulcus angle with X-ray , MRI and CT methods , and the tibial tubercle-trochlear groove ( TT-TG ) assessed using CT . There was poor reliability or validity for the assessment of severity of trochlear dysplasia and the sulcus angle using US . Conclusion There is insufficient evidence to determine the reliability , validity , sensitivity or specificity of tests such as the congruence angle , lateral patellar displacement , lateral patellar tilt , trochlear depth , boss height , the crossing sign or Wiberg patellar classification .
MS2858	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Despite improvements in treatment of localized prostate cancer , local recurrence remains a significant problem . A total of 46 patients with proven local cancer recurrence following external beam radiotherapy entered a prospect i ve clinical trial using ultrasound-guided cryosurgery to ablate the residual prostate gl and . Persistent complications included one urethra – rectal fistula , incontinence ( 2 ) , retention ( 3 ) , and treatment induced erectile dysfunction ( 7 ) . Using the PSA definitions for biochemical failure as PSA ⩾0.3 ng/ml , the Kaplan – Meier plots showed the incidence of patients to be free of biochemical recurrence at 51 and 44 % at 1 and 2 y , respectively . For a PSA ⩾1.0 , the values at 1 and 2 y were 72 and 58 % PURPOSE Few patients with locally recurrent prostate cancer after external beam ( EB ) or interstitial ( I ) radiotherapy ( RT ) are considered c and i date s for salvage radical prostatectomy ( RP ) due to high reported rates of major complications and urinary incontinence . We report the morbidity associated with salvage RP in 100 consecutive patients . MATERIAL S AND METHODS From 1984 to 2003 salvage RP was performed for recurrent prostate cancer following EBRT in 58 cases , and IRT in 42 ( 28 retropubic ) and ( 14 transperineal ) . Clinical information was obtained from a prospect i ve data base . RESULTS Since 1993 , the major complication rate has decreased significantly ( 13 % vs 33 % , p = 0.02 ) , including the rectal injury rate ( 2 % vs 15 % , p = 0.01 ) . Compared with retropubic IRT and /or pre-radiotherapy pelvic lymph node dissection the risk of major complications following EBRT or transperineal IRT was significantly less ( OR 0.2 , p = 0.006 ) . At 5 years an estimated 39 % of patients were dry and 68 % required 1 pad daily or less . A total of 23 patients with moderate-severe incontinence underwent artificial sphincter placement . The anastomotic stricture rate was 30 % . The 5-year potency rate was 28 % following unilateral or bilateral nerve sparing RP and 45 % in previously potent patients . CONCLUSIONS Due to patient selection the major complication rate after salvage RP has improved significantly with time and it is similar to that of st and ard RP . Rates of anastomotic stricture and moderate to severe incontinence are higher than those observed after st and ard RP . However , most patients recover reasonable urinary continence and a substantial number of select patients recover potency . The acceptable morbidity profile of salvage RP following EBRT and transperineal IRT should persuade more physicians to consider patients for this potentially curative procedure Objectives In this study , we evaluate the outcomes of salvage cryotherapy for locally recurrent prostate cancer within the COLD ( cryo online data ) Registry . Furthermore , we assess the results of salvage cryotherapy ( with intermediate follow-up ) stratified by pre-treatment prostate-specific antigen ( PSA ) levels to determine which patients may best be suited for treatment . Methods The COLD registry was developed as a prospect i ve , central ly collected data base among patients undergoing salvage cryoablation for locally recurrent prostate cancer following primary prostate radiotherapy with curative intent . Of the patients undergoing salvage cryotherapy ( without neoadjuvant hormonal ablative therapy ) , complete medical records were available in 156 patients , with their mean follow-up being 3.8 years ( 0.9–12.7 years ) . The treatment outcomes of salvage cryotherapy were assessed using the Phoenix definition ( nadir PSA + 2 ng/ml ) of biochemical failure . Results Of our entire study population , the biochemical disease-free survival ( bDFS ) rates at 1 , 2 , and 3 years were 89.0 , 73.7 , and 66.7 % , respectively . Stratification of our patients into two subgroups is based on their pre-treatment total serum PSA values < 5 and ≥5 ng/ml , and bDFS rates at 3 years for these two subgroups were 78.3 and 52.9 % , respectively . A Kaplan – Meier analysis of bDFS stratified by these same pre-treatment PSA values revealed that the subset of patients with a PSA ≥ 5 ng/ml had statistically significant poorer bDFS rates ( P = 0.01 ) . Conclusions Salvage prostate cryotherapy is a potentially curative local salvage therapy . The importance of early referral when patients have a pre-treatment PSA < 5 ng/ml is essential to optimize treatment outcomes The authors prospect ively evaluated the late gastrointestinal ( GI ) and genitourinary ( GU ) toxicity and prostate‐specific antigen ( PSA ) control of magnetic resonance imaging (MRI)‐guided brachytherapy used as salvage for radiation therapy ( RT ) failure PURPOSE Radiation Therapy Oncology Group protocol 85 - 31 was design ed to evaluate the effectiveness of adjuvant and rogen suppression , using goserelin , in unfavorable prognosis carcinoma of the prostate treated with definitive radiotherapy ( RT ) . METHODS AND MATERIAL S Eligible patients were those with palpable primary tumor extending beyond the prostate ( clinical Stage T3 ) or those with regional lymphatic involvement . Patients who had undergone prostatectomy were eligible if penetration through the prostatic capsule to the margin of resection and /or seminal vesicle involvement was documented histologically . Stratification was based on histologic differentiation , nodal status , acid phosphatase status , and prior prostatectomy . The patients were r and omized to either RT and adjuvant goserelin ( Arm I ) or RT alone followed by observation and application of goserelin at relapse ( Arm II ) . In Arm I , the drug was to be started during the last week of RT and was to be continued indefinitely or until signs of progression . RESULTS Between 1987 and 1992 , when the study was closed , 977 patients were entered : 488 to Arm I and 489 to Arm II . As of July 2003 , the median follow-up for all patients was 7.6 years and for living patients was 11 years . At 10 years , the absolute survival rate was significantly greater for the adjuvant arm than for the control arm : 49 % vs. 39 % , respectively ( p = 0.002 ) . The 10-year local failure rate for the adjuvant arm was 23 % vs. 38 % for the control arm ( p < 0.0001 ) . The corresponding 10-year rates for the incidence of distant metastases and disease-specific mortality was 24 % vs. 39 % ( p < 0.001 ) and 16 % vs. 22 % ( p = 0.0052 ) , respectively , both in favor of the adjuvant arm . CONCLUSION In a population of patients with unfavorable prognosis carcinoma of the prostate , and rogen suppression applied as an adjuvant after definitive RT was associated not only with a reduction in disease progression but in a statistically significant improvement in absolute survival . The improvement in survival appeared preferentially in patients with a Gleason score of 7 - 10 PURPOSE A positive post-irradiation prostatic biopsy associated with an increasing prostate specific antigen level but no palpable evidence of local progression may identify a subgroup of patients who could be cured by salvage surgical therapy . MATERIAL S AND METHODS Between 1967 and 1992 , 132 patients underwent salvage surgery , including radical retropubic prostatectomy in 79 , anterior exenteration in 38 , total exenteration in 5 and bilateral pelvic lymphadenectomy only in 10 . RESULTS The 10-year cancer-specific survival rate in the prostatectomy group was 72 % . Local control was equivalent among the surgical groups . Radical retropubic prostatectomy patients with negative surgical margins and nonaneuploid tumors demonstrated a significant survival advantage . Adjuvant hormonal therapy improved the disease-free survival rate in patients with nonaneuploid tumors . CONCLUSIONS Radical retropubic prostatectomy can achieve excellent survival with low morbidity in select patients . Patients with clinical stage T2 or less disease and with prostate specific antigen detected cancers ( 52 % and 75 % , respectively ) had pathological stage T2 disease . Thus , by using modern diagnostic techniques patients can be identified who may be cured with salvage surgery PURPOSE We review our 20-year experience with salvage radical prostatectomy to determine prognostic variables predictive of oncological control of radiorecurrent prostate cancer . Using a st and ardized question naire we also evaluate outcome data regarding the long-term sexual and urinary effects of salvage radical prostatectomy . MATERIAL S AND METHODS Between 1983 and 2002 salvage radical prostatectomy was performed in 51 patients with locally recurrent prostate cancer following definitive radiotherapy . Clinical information was obtained from a prospect i ve data base . Quality of life data were collected using the UCLA Prostate Cancer Index , a vali date d , patient administered instrument . RESULTS At 5 years 47 % of patients were progression-free without and rogen deprivation therapy . Among patients with pT2 disease 100 % were progression-free at 5 years , compared with 35 % of patients with pT3N0 disease or higher and 0 % of patients with node positive ( pTxN+ ) disease ( p < 0.001 ) . Preoperative PSA 5.0 ng/ml or less was predictive of organ confined disease , and strongly associated with prolonged progression-free and overall survival ( p < 0.001 and 0.01 , respectively ) . Mean urinary function scores for patients with or without an artificial urinary sphincter compared favorably with scores reported after st and ard , nonsalvage prostatectomy . Sexual dysfunction was nearly uniform in patients undergoing st and ard salvage radical prostatectomy but implantation of a penile prosthesis was associated with a clinical ly significant improvement in sexual function . CONCLUSIONS When initiated early in the course of recurrent disease , salvage radical prostatectomy provides excellent oncological control of radiorecurrent prostate cancer without the need for and rogen ablation . Implantation of an artificial urinary sphincter and inflatable penile prosthesis devices in patients with postoperative urinary incontinence or erectile dysfunction results in significantly improved quality of life parameters INTRODUCTION Prostate cancer recurrence following primary radiation is common . If the recurrence remains localized to the prostate gl and , surgical removal may result in long-term local control or cure . Despite the well-established oncological outcomes , salvage prostatectomy is infrequently performed or reported . We present our experience with salvage prostatectomy at a Canadian centre . METHODS We identified all patients undergoing salvage prostatectomy at the Vancouver General Hospital between 1995 and 2010 from a prospect ively recorded and maintained prostate cancer data base . Details regarding initial presentation , delivery of radiotherapy , clinical features at the time of recurrence , as well as oncological and functional outcomes , were collected . Information regarding postoperative morbidity was collected prospect ively and confirmed by retrospective chart review . RESULTS Over a 15-year period , salvage prostatectomy was successfully completed in 21 patients . With a median follow-up period of 68 months ( range : 2 - 122 ) , 9 ( 43 % ) patients experienced a biochemical recurrence , with most failing within the first 2 years of surgery . There were 3 deaths in the cohort , all from prostate cancer , giving a prostate cancer specific and overall survival of 86 % . The main postoperative morbidity was bladder neck contracture , occurring in 40 % . One patient each developed a recto-urethral fistula and osteitis pubis . Physician-recorded data regarding continence was available in 13 ( 62 % ) . Of these 13 patients , 10 ( 85 % ) men were recorded as dry or using 1 pad per day . CONCLUSIONS This is the first Canadian centre to report that salvage prostatectomy can be performed with favourable oncological and functional outcomes PURPOSE Salvage radical prostatectomy is associated with a higher complication rate than radical prostatectomy without prior radiotherapy but the magnitude of the increase is not well delineated . MATERIAL S AND METHODS A total of 3,458 consecutive patients underwent open radical prostatectomy and 98 underwent open salvage radical prostatectomy from January 1999 to June 2007 . Data were collected from prospect i ve surgical and institutional morbidity data bases , and retrospectively from billing records and medical records . Medical and surgical complications were captured , grade d by the modified Clavien classification and classified by time of onset . RESULTS Median followup after salvage radical prostatectomy and radical prostatectomy was 34.5 and 45.5 months , respectively . Patients with salvage had significantly higher median age , modified Charlson comorbidity score , clinical and pathological stage , and Gleason score . They were less likely to have organ confined disease and more likely to have seminal vesicle invasion and nodal metastasis . There was no significant difference in median operative time , blood loss or transfusion rate . The salvage group had a higher adjusted probability of medical and surgical complications , including urinary tract infection , bladder neck contracture , urinary retention , urinary fistula , abscess and rectal injury . Only Output:	Meta-regression adjusting for confounders found no significant difference in oncologic outcomes between SRP and nonsurgical salvage modalities . SBT , SCT , and SHIFU appeared to have better continence outcomes than SRP . Oncologic outcomes are comparable for SRP and all three nonsurgical salvage modalities . We found no significant differences in toxicity outcomes among modalities ; however , SRP appears to be associated with worse rates of urinary incontinence than SBT , SCT , and SHIFU . Oncologic and toxicity outcomes appear to be similar ; however , all nonsurgical salvage modalities may be associated with better continence outcomes
MS2859	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Three hundred eleven employees of the National Institutes of Health volunteered to take 1 gm of ascorbic acid or lactose placebo in capsules three times a day for nine months . At the onset of a cold , the volunteers were given an additional 3 gm daily of either a placebo or ascorbic acid . One hundred ninety volunteers completed the study . Dropouts were defined as those who missed at least one month of drug ingestion . They represented 44 % of the placebo group and 34 % of those taking ascorbic acid . Analysis of these data showed that ascorbic acid had at best only a minor influence on the duration and severity of colds , and that the effects demonstrated might be explained equally well by a break in the double blind CONTEXT Depression and low perceived social support ( LPSS ) after myocardial infa rct ion ( MI ) are associated with higher morbidity and mortality , but little is known about whether this excess risk can be reduced through treatment . OBJECTIVE To determine whether mortality and recurrent infa rct ion are reduced by treatment of depression and LPSS with cognitive behavior therapy ( CBT ) , supplemented with a selective serotonin reuptake inhibitor ( SSRI ) antidepressant when indicated , in patients enrolled within 28 days after MI . DESIGN , SETTING , AND PATIENTS R and omized clinical trial conducted from October 1996 to April 2001 in 2481 MI patients ( 1084 women , 1397 men ) enrolled from 8 clinical centers . Major or minor depression was diagnosed by modified Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and severity by the 17-item Hamilton Rating Scale for Depression ( HRSD ) ; LPSS was determined by the Enhancing Recovery in Coronary Heart Disease Patients ( ENRICHD ) Social Support Instrument ( ESSI ) . R and om allocation was to usual medical care or CBT-based psychosocial intervention . INTERVENTION Cognitive behavior therapy was initiated at a median of 17 days after the index MI for a median of 11 individual sessions throughout 6 months , plus group therapy when feasible , with SSRIs for patients scoring higher than 24 on the HRSD or having a less than 50 % reduction in Beck Depression Inventory scores after 5 weeks . MAIN OUTCOME MEASURES Composite primary end point of death or recurrent MI ; secondary outcomes included change in HRSD ( for depression ) or ESSI scores ( for LPSS ) at 6 months . RESULTS Improvement in psychosocial outcomes at 6 months favored treatment : mean ( SD ) change in HRSD score , -10.1 ( 7.8 ) in the depression and psychosocial intervention group vs -8.4 ( 7.7 ) in the depression and usual care group ( P<.001 ) ; mean ( SD ) change in ESSI score , 5.1 ( 5.9 ) in the LPSS and psychosocial intervention group vs 3.4 ( 6.0 ) in the LPSS and usual care group ( P<.001 ) . After an average follow-up of 29 months , there was no significant difference in event-free survival between usual care ( 75.9 % ) and psychosocial intervention ( 75.8 % ) . There were also no differences in survival between the psychosocial intervention and usual care arms in any of the 3 psychosocial risk groups ( depression , LPSS , and depression and LPSS patients ) . CONCLUSIONS The intervention did not increase event-free survival . The intervention improved depression and social isolation , although the relative improvement in the psychosocial intervention group compared with the usual care group was less than expected due to substantial improvement in usual care patients CONTEXT Significant symptoms of depression are common in the older community-dwelling population . Although depressive symptoms and disability may commonly occur in the same person , whether depressive symptoms contribute to subsequent functional decline has not been eluci date d. OBJECTIVE To determine whether depressive symptoms in older persons increase the risk of subsequent decline in physical function as measured by objective performance-based tests . DESIGN A 4-year prospect i ve cohort study . SETTING The communities of Iowa and Washington counties , Iowa . PARTICIPANTS A total of 1286 persons aged 71 years and older who completed a short battery of physical performance tests in 1988 and again 4 years later . MAIN OUTCOME MEASURES Baseline depressive symptoms were assessed by the Center for Epidemiological Studies Depression Scale . Physical performance tests included an assessment of st and ing balance , a timed 2.4-m ( 8-ft ) walk , and a timed test of 5 repetitions of rising from a chair and sitting down . RESULTS After adjustment for baseline performance score , health status , and sociodemographic factors , increasing levels of depressive symptoms were predictive of greater decline in physical performance over 4 years ( odds ratio for decline in those with depressed mood vs those without , 1.55 ; 95 % confidence interval [ CI ] , 1.02 - 2.34 ) . Even among those at the high end of the functional spectrum , who reported no disability , the severity of depressive symptoms predicted subsequent decline in physical performance ( odds ratio for decline , 1.03 ; 95 % CI , 1.00 - 1.08 ) . CONCLUSIONS This study provides evidence that older persons who report depressive symptoms are at higher risk of subsequent physical decline . These results suggest that prevention or reduction of depressed mood could play a role in reducing functional decline in older persons The purpose of this study was to evaluate the effect of stress management training on quality of life , functional capacity , and heart rate variability in elderly patients with New York Heart Association class I-III congestive heart failure ( CHF ) . While substantial research exists on stress management training for patients with coronary heart disease , there are few data on the value of psychosocial training on patients with CHF . Thirty-three multiethnic patients ( mean age , 66+/-9 years ) were assigned through incomplete r and omization to one of two treatment groups or a wait-listed control group . The 14 participants who completed the treatment attended eight training sessions during a 10-week period . The training consisted of 75-minute sessions adapted from the Freeze-Frame stress management program developed by the Institute of HeartMath . Subjects were assessed at baseline and again at the completion of the training . Depression , stress management , optimism , anxiety , emotional distress , and functional capacity were evaluated , as well as heart rate variability . Significant improvements ( p<0.05 ) were noted in perceived stress , emotional distress , 6-minute walk , and depression , and positive trends were noted in each of the other psychosocial measures . The 24-hour heart rate variability showed no significant changes in autonomic tone . The authors noted that CHF patients were willing study participants and their emotional coping and functional capacity were enhanced . This program offers a simple and cost-effective way to augment medical management of CHF . Given the incompleteness of CHF medical management and the exploding interest in complementary medical intervention , it seems imperative that further work in psychosocial treatment be undertaken We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11 & NA ; Previous research has documented high rates of noncompliance to prescribed medical therapy in patients recovering from myocardial infa rct ion ( MI ) . This study was undertaken to determine if patients who subsequently drop out of a structured cardiac rehabilitation program could be prospect ively distinguished from those who remain in the program based upon their initial baseline characteristics . Thirty‐five consecutive patients with recent MIs underwent comprehensive physical and psychological assessment s at entry into the program , and were followed for a period of 1 year . The 14 patients who dropped out of the program could be distinguished from the compliers on the basis of their reduced left ejection fraction assessed by first pass radionuclide angiography at rest and during peak exercise . In addition , their psychological profiles assessed by the MMPI indicated the dropouts were more depressed , hypochondriacal , anxious , and introverted and had lower ego strength than those who remained in the program . Statistical analysis further indicated that psychological variables were associated with noncompliance independently of physical status . These findings suggest that MI patients who are unlikely to adhere to this form of medical therapy may be prospect ively identified based upon their initial physical and psychological characteristics OBJECTIVE To determine if the diagnosis of major depression in patients hospitalized following myocardial infa rct ion ( MI ) would have an independent impact on cardiac mortality over the first 6 months after discharge . DESIGN Prospect i ve evaluation of the impact of depression assessed using a modified version of the National Institute of Mental Health Diagnostic Interview Schedule for major depressive episode . Cox proportional hazards regression was used to evaluate the independent impact of depression after control for significant clinical predictors in the data set . SETTING A large , university-affiliated hospital specializing in cardiac care , located in Montreal , Quebec . PATIENTS All consenting patients ( N = 222 ) who met established criteria for MI between August 1991 and July 1992 and who survived to be discharged from the hospital . Patients were interviewed between 5 and 15 days following the MI and were followed up for 6 months . There were no age limits ( range , 24 to 88 years ; mean , 60 years ) . The sample was 78 % male . PRIMARY OUTCOME MEASURE Survival status at 6 months . RESULTS By 6 months , 12 patients had died . All deaths were due to cardiac causes . Depression was a significant predictor of mortality ( hazard ratio , 5.74 ; 95 % confidence interval , 4.61 to 6.87 ; P = .0006 ) . The impact of depression remained after control for left ventricular dysfunction ( Killip class ) and previous MI , the multivariate significant predictors of mortality in the data set ( adjusted hazard ratio , 4.29 ; 95 % confidence interval , 3.14 to 5.44 ; P = .013 ) . CONCLUSION Major depression in patients hospitalized following an MI is an independent risk factor for mortality at 6 months . Its impact is at least equivalent to that of left ventricular dysfunction ( Killip class ) and history of previous MI . Additional study is needed to determine whether treatment of depression can influence post-MI survival and to assess possible underlying mechanisms A relationship between cigarette smoking and major depressive disorder was suggested in previous work involving nonr and omly selected sample s. We conducted a test of this association , employing population -based data ( n = 3213 ) collected between 1980 and 1983 in the St Louis Epidemiologic Catchment Area Survey of the National Institute of Mental Health . A history of regular smoking was observed more frequently among individuals who had experienced major depressive disorder at some time in their lives than among individuals who had never experienced major depression or among individuals with no psychiatric diagnosis . Smokers with major depression were also less successful at their attempts to quit than were either of the comparison groups . Gender differences in rates of smoking and of smoking cessation observed in the larger population were not evident among the depressed group . Furthermore , the association between cigarette smoking and major depression was not ubiquitous across all psychiatric diagnoses . Other data are cited indicating that when individuals with a history of depression stop smoking , depressive symptoms and , in some cases , serious major depression may ensue To determine whether participating in physical activity affects psychological well-being in an adolescent population , 147 adolescents completed self-reports of exercise and psychological stress and well-being . Analysis revealed that those who reported greater physical activity also reported less stress and lower levels of depression . Adolescents who experienced a higher incidence of life events also demonstrated a strong association between stress and anxiety/depression/hostility . To investigate the effects of exercise training on psychological well-being , adolescents were assigned to either high or moderate intensity aerobic training , flexibility training or a control group . The training groups met twice per week for 25 - 30 min . Aerobic fitness levels , heart rate , blood pressure and self-report of stress and well-being were measured prior to and following 10 weeks of training . Post-training fitness measures confirmed the effectiveness of the high intensity aerobic exercise and between groups differences for physiological and some psychological measures were found . Subjects undergoing high intensity exercise reported significantly less stress than subjects in the remaining three groups . The relationship between stress and anxiety/depression/hostility for the high intensity group was considerably weakened at the end of the training period . For the remaining subjects , however , this relationship was , if anything , strengthened . This experiment provides evidence to suggest that in an adolescent population , high intensity aerobic exercise has positive effects on well-being The frequency of ventricular premature complexes and the degree of impairment of left ventricular ejection fraction are major predictors of cardiac mortality and sudden death in the year after acute myocardial infa rct ion . Recent studies have implicated psychosocial factors , Output:	The primary outcome was a significant reduction in depression . Depression is common among patients with heart failure .
MS2860	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The purpose of this study was to test the hypothesis that athletes having a slower oxygen uptake ( V̇O2 ) kinetics would benefit more , in terms of time spent near V̇O2max , from an increase in the intensity of an intermittent running training ( IT ) . After determination of V̇O2max , vV̇O2max ( i.e. the minimal velocity associated with V̇O2max in an incremental test ) and the time to exhaustion sustained at vV̇O2max ( Tlim ) , seven well-trained triathletes performed in r and om order two IT sessions . The two IT comprised 30-s work intervals at either 100 % ( IT100 % ) or 105 % ( IT105 % ) of vV̇O2max with 30-s recovery intervals at 50 % of vV̇O2max between each repeat . The parameters of the V̇O2 kinetics ( td1 , τ1 , A1 , td2 , τ2 , A2 , i.e. time delay , time constant and amplitude of the primary phase and slow component , respectively ) during the Tlim test were modelled with two exponential functions . The highest V̇O2 reached was significantly lower ( P<0.01 ) in IT100 % run at 19.8 ( 0.9 ) km.h−1 [ 66.2 ( 4.6 ) ml.min−1.kg−1 ] than in IT105 % run at 20.8 ( 1.0 ) km.h−1 [ 71.1 ( 4.9 ) ml.min−1.kg−1 ] or in the incremental test [ 71.2 ( 4.2 ) ml.min−1.kg−1 ] . The time sustained above 90 % of V̇O2max in IT105 % [ 338 ( 149 ) s ] was significantly higher ( P<0.05 ) than in IT100 % [ 168 ( 131 ) s ] . The average Tlim was 244 ( 39 ) s , τ1 was 15.8 ( 5.9 ) s and td2 was 96 ( 13 ) s. τ1 was correlated with the difference in time spent above 90 % of V̇O2max ( r=0.91 ; P<0.01 ) between IT105 % and IT100 % . In conclusion , athletes with a slower V̇O2 kinetics in a vV̇O2max constant-velocity test benefited more from the 5 % rise of IT work intensity , exercising for longer above 90 % of V̇O2max when the IT intensity was increased from 100 to 105 % of vV̇O2max The objective of this study was to analyze the effect of two different high-intensity interval training ( HIT ) programs on selected aerobic physiological indices and 1500 and 5000 m running performance in well-trained runners . The following tests were completed ( n=17 ) : ( i ) incremental treadmill test to determine maximal oxygen uptake ( VO2 max ) , running velocity associated with VO2 max ( vVO2 max ) , and the velocity corresponding to 3.5 mmol/L of blood lactate concentration ( vOBLA ) ; ( ii ) submaximal constant-intensity test to determine running economy ( RE ) ; and ( iii ) 1500 and 5000 m time trials on a 400 m track . Runners were then r and omized into 95 % vVO2 max or 100 % vVO2 max groups , and undertook a 4 week training program consisting of 2 HIT sessions ( performed at 95 % or 100 % vVO2 max , respectively ) and 4 submaximal run sessions per week . Runners were retested on all parameters at the completion of the training program . The VO2 max values were not different after training for both groups . There was a significant increase in post-training vVO2 max , RE , and 1500 m running performance in the 100 % vVO2 max group . The vOBLA and 5000 m running performance were significantly higher after the training period for both groups . We conclude that vOBLA and 5000 m running performance can be significantly improved in well-trained runners using a 4 week training program consisting of 2 HIT sessions ( performed at 95 % or 100 % vVO2 max ) and 4 submaximal run sessions per week . However , the improvement in vVO2 max , RE , and 1500 m running performance seems to be dependent on the HIT program at 100 % vVO2 max Context : A high number of recreational runners sustain a running-related injury each year . To reduce injury risk , alterations in running form have been suggested . One simple strategy for running stride frequency or length has been commonly advocated . Objective : To characterize how running mechanics change when stride frequency and length are manipulated . Data Sources : In January 2012 , a comprehensive search of PubMed , CINAHL Plus , SPORTD iscus , PEDro , and Cochrane was performed independently by 2 review ers . A second search of the data bases was repeated in June 2012 to ensure that no additional studies met the criteria after the initial search . Study Selection : Inclusion criteria for studies were an independent variable including manipulation of stride frequency or length at a constant speed with outcome measures of running kinematics or kinetics . Study Design : Systematic review . Level of Evidence : Level 3 . Data Extraction : Two review ers independently appraised each article using a modified version of the Quality Index , design ed for assessing bias of nonr and omized studies . Results : Ten studies met the criteria for this review . There was consistent evidence that increased stride rate result ed in decreased center of mass vertical excursion , ground reaction force , shock attenuation , and energy absorbed at the hip , knee , and ankle joints . All but 1 study had a limited number of participants , with several method ological differences existing among studies ( eg , overground and treadmill running , duration of test conditions ) . Although speed was held constant during testing , it was individually self-selected or fixed . Most studies used only male participants . Conclusion : Despite procedural differences among studies , an increased stride rate ( reduced stride length ) appears to reduce the magnitude of several key biomechanical factors associated with running injuries The purpose of this study was to examine physiological strain and muscular performance responses of well trained athletes during two intermittent running exercise protocol s at the velocity associated with VO2max . Ten national level middle-distance runners ( VO2max 69.4+/-5.1 ; mean+/-SD ) performed in r and om order two 28 min treadmill running exercises : 14 bouts of 60 s runs with 60 s rest ( IR60 ) and 7 bouts of 120 s runs with 120 s rest between each run ( IR120 ) . During IR120 peak oxygen uptake ( 12 % ) , peak heart rate ( 3 % ) and peak blood lactate ( 79 % ) were significantly higher than during IR60 ( P < 0.001 ) and almost the same as in the VO2max test . In IR120 the relative aerobic energy release calculated on the basis of the accumulated oxygen deficit during the running bouts was significantly higher than in IR60 ( 81.5+/-2.7 vs. 70.2+/-2.6 % , P<0.001 ) likewise the sum oxygen consumption during the 14 min running ( P < 0.001 ) , while during the 14 min recovery it was as much lower ( P < 0.001 ) . There were no changes either during or between the IR60 and IR120 protocol s with regard to the muscular performance parameters , stride length or height of maximal vertical jumps . In conclusion , during intermittent running at the velocity associated with VO2max doubling the duration of work and rest bouts from 60 s to 120s increased the physiological strain of well trained athletes to the same level as at exhaustion in the VO2max test but the muscular performance variables were not influenced PURPOSE To quantify the relationship between total training load and running performance during the most important competitions of the season ( national cross-country championships , 4.175- and 10.130-km races ) . METHODS Eight well-trained , subelite endurance runners ( age ( mean+/-SD ) : 23+/-2 yr ; VO2max : 70.0+/-7.3 mL.kg.min ) performed a maximal cardiorespiratory exercise test before the training period to determine ventilatory threshold ( VT ) and respiratory compensation threshold ( RCT ) . Heart rate was continuously recorded using telemetry during each training session over a 6-month macrocycle , design ed to achieve peak performance during the aforementioned cross-country races , lasting from late August to the time that these races were held , that is , mid-February . This allowed us to quantify the total cumulative time spent in three intensity zones calculated as zone 1 ( low intensity , lower than the VT ) ; zone 2 ( moderate intensity , between VT and RCT ) ; and zone 3 ( high intensity , above the RCT ) . RESULTS Total training time in zone 1 ( 4581+/-979 min ) was significantly higher ( P<0.001 ) than that accumulated in zones 2 ( 1354+/-583 min ) and 3 ( 487+/-154 min ) . Total time in zone 2 was significantly higher than time in zone 3 ( P<0.05 ) . A correlation coefficient of r=-0.79 ( P=0.06 ) and r=-0.97 ( P=0.008 ) was found between the total training time spent in zone 1 and performance time during the short and long cross-country races , respectively . CONCLUSIONS Our findings suggest that total training time spent at low intensities might be associated with improved performance during highly intense endurance events , especially if the event duration is approximately 35 min . Interventional studies ( i.e. , improving or reducing training time in zone 1 ) are needed to corroborate our findings and to eluci date the physiological mechanisms behind them Beneficial systemic effects of regular physical exercise have been demonstrated to reduce risks of a number of age-related disorders . Antioxidant capacity adaptations are amongst these fundamental changes in response to exercise training . However , it has been cl aim ed that acute physical exercise performed at high intensity ( > 60 % of maximal oxygen uptake ) may result in oxidative stress , due to reactive oxygen species being generated excessively by enhanced oxygen consumption . The aim of this study was to evaluate the effect of high-intensity discontinuous training ( HIDT ) , characterized by repeated variations of intensity and changes of redox potential , on oxidative damage . Twenty long-distance masters runners ( age 47.8±7.8 yr ) on the basis of the individual values of gas exchange threshold were assigned to a different 8-weeks training program : continuous moderate-intensity training ( MOD , n = 10 ) or HIDT ( n = 10 ) . In both groups before ( PRE ) and after ( POST ) training we examined the following oxidative damage markers : thiobarbituric acid reactive substances ( TBARS ) as marker of lipid peroxidation ; protein carbonyls ( PC ) as marker of protein oxidation ; 8-hydroxy-2-deoxy-guanosine ( 8-OH-dG ) as a biomarker of DNA base modifications ; and total antioxidant capacity ( TAC ) as indicator of the overall antioxidant system . Training induced a significant ( p<0.05 ) decrease in resting plasma TBARS concentration in both MOD ( 7.53±0.30 and 6.46±0.27 µM , PRE and POST respectively ) and HIDT ( 7.21±0.32 and 5.85±0.46 µM , PRE and POST respectively ) . Resting urinary 8-OH-dG levels were significantly decreased in both MOD ( 5.50±0.66 and 4.16±0.40 ng mg−1creatinine , PRE and POST respectively ) and HIDT ( 4.52±0.50 and 3.18±0.34 ng mg−1creatinine , PRE and POST respectively ) . Training both in MOD and HIDT did not significantly modify plasma levels of PC . Resting plasma TAC was reduced in MOD while no significant changes were observed in HIDT . In conclusion , these results suggest that in masters runners high-intensity discontinuous does not cause higher level of exercise-induced oxidative stress than continuous moderate-intensity training , inducing similar beneficial effects on redox homeostasis This study compared running velocity , physiological responses , and perceived exertion during self-paced interval training bouts differing only in work bout duration . Twelve well-trained runners ( nine males , three females , 28+/-5 years , VO2 max 65+/-6 mL min(-1 ) kg(-1 ) ) performed preliminary testing followed by four " high-intensity " interval sessions ( Latin squares , 1 session week(-1 ) over 4 weeks ) consisting of 24 x 1 , 12 x 2 , 6 x 4 , or 4 x 6-min running bouts with a 1:1 work-to-rest interval ( total session duration 48 min ) . The average running velocity decreased ( 93 % , 88 % , 86 % , 84 % vVO2 max , P < 0.01 ) with increasing work duration . Peak VO2 averaged about 92+/-4 % of VO2 max for 2- , 4- , and 6-min intervals compared with only 82+/-5 % for 1-min bouts ( P < 0.001 ) . Six of 12 athletes achieved their highest average VO2 and heart rate during 4-min intervals . The average RPEpeak ( rating scale of perceived exertion ) was approximately 17+/-1 for all four interval sessions . RPE increased by 2 - 4 U during an interval Output:	Conclusion HIIT-based running plans ( 2 to 3 HIIT sessions per week , combining HIIT and CR runs ) show athletic performance improvements in endurance runners by improving maximal oxygen uptake and running economy along with muscular and metabolic adaptations .
MS2861	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIMS ( i ) To evaluate the effect of receiving one of two brief interventions in reducing alcohol consumption among general hospital patients compared with usual care . ( ii ) To assess whether a brief intervention of self-efficacy enhancement was superior to a self-help booklet in reducing alcohol consumption . DESIGN A three-arm cluster r and omized controlled trial . SETTING Seven general medical , six general surgical , one dermatology and two otolaryngology wards of a large teaching hospital covering a large urban and rural area . PARTICIPANTS A total of 215 of 789 in- patients aged 18 - 75 years , who screened positive for alcohol consumption in excess of national recommended limits according to a 7-day retrospective drinking diary . INTERVENTIONS Participants were allocated to receive one of three interventions : ( i ) face-to-face self-efficacy enhancement ; ( ii ) a self-help booklet ; or ( iii ) usual care . MEASUREMENTS The primary outcome measure was change in reported alcohol consumption at 6-month follow-up as measured by a 7-day retrospective drinking diary . Secondary outcomes were change in : number of alcohol drinking days in last week ; the maximum units of alcohol consumed on any one day in last week ; and Drinking Refusal Self-efficacy Expectancy Question naire score . FINDINGS Compared to the usual care group the self-efficacy enhancement group ( -10.1 units 95 % CI -16.1 to -4.1 ) and the self-help booklet group ( -10.0 units 95 % CI -16.0 to -3.9 ) had greater reductions in self-reported weekly alcohol consumption . There was no evidence that self-efficacy enhancement was superior to the self-help booklet ( P = 0.96 ) . CONCLUSIONS Brief interventions delivered in hospital offer simple means of helping heavy drinkers to reduce their alcohol consumption Background Patients with hazardous alcohol intake are overrepresented in emergency departments and surgical wards . These patients have an increased risk of postoperative complications with prolonged hospital stays and admissions to intensive care unit after surgery . In elective surgery , preoperative alcohol cessation interventions can reduce postoperative complications , but no studies have investigated the effect of alcohol cessation intervention at the time of acute fracture surgery . This protocol describes a r and omised clinical trial that aims to evaluate the effect of a new gold st and ard programme for alcohol cessation intervention in the perioperative period regarding postoperative complications , alcohol intake and cost-effectiveness . Methods / Design Patients with hazardous alcohol intake undergoing ankle fracture surgery will be recruited into the trial from multiple orthopaedic wards at university hospitals in Denmark , Sweden and Norway . Included patients will be r and omly allocated to either st and ard care or the gold st and ard programme aim ed at complete alcohol abstinence before , during and 6 weeks after surgery . It includes a structured patient education programme and weekly interventions meetings at the orthopaedic outpatient clinic . Furthermore , patients are provided with thiamine and B-vitamins , alcohol withdrawal prophylaxis and treatment , and disulfiram to support abstinence . Alcohol intake is biochemically vali date d ( blood , urine and breath tests ) at the weekly intervention meetings and follow-up visits . Follow-up assessment s will be conducted 6 weeks and 3 , 6 , 9 and 12 months after surgery for all patients . The effect of the gold st and ard programme will be assessed comparing the outcome measures between the intervention and control group at each follow-up point . Discussion The study will provide new knowledge about how to prevent alcohol-related postoperative complications at the time of acute fracture surgery . If effective , the results will be a benefit for the clinical course , patients and society alike . Trial registration The protocol is registered in Clinical Trials.gov ( I d : NCT00986791 ) PURPOSE The proximate use of illicit drugs or alcohol ( substance use ) is the most common precipitator of facial injuries among socioeconomically disadvantaged population s. Reducing these risky behaviors could minimize adverse health sequelae and potential reinjury . The objective of our study was to test whether a culturally competent , personalized motivational intervention incorporated into surgical care could significantly reduce existing substance use behaviors in facial injury patients . PATIENTS AND METHODS Substance-using subjects ( n = 218 ) presenting with facial injuries to a level 1 trauma center were r and omly assigned to either a personalized motivational intervention ( PMI ) condition or a health-information ( HI ) control condition . After a brief assessment of the individual 's substance use severity and willingness to change these behaviors , both groups attended 2 counseling sessions with a trained interventionist . The PMI subjects ( n = 118 ) received individualized , motivational interventions , whereas the HI subjects ( n = 100 ) received only general health information . Both groups were reassessed at 6 and 12 months postinjury , and changes in substance-use patterns were measured to assess the effects of intervention . RESULTS The PMI and HI groups were closely matched on their sociodemographic and substance use characteristics . Subjects in the PMI group showed statistically significant declines in drug use at both the 6- and 12-month assessment s. The intervention 's effect on lowering illicit drug use was greatest at the 6-month assessment but had weakened by the 1-year follow-up . The efficacy of the PMI was moderated by an individual 's initial drug use severity ; individuals with greater drug use dependency at baseline were seen to have larger intervention effects , as did individuals who were most aware of their drug problem and willing to change their substance use behaviors . Unlike illicit drug use , changes in alcohol use did not differ significantly between the intervention and control groups , irrespective of an individuals ' recognition of the alcohol problem or willingness to take steps to address it . CONCLUSION A culturally competent , motivational intervention integrated into the care of vulnerable patients with facial injury can reduce illicit drug use behaviors . Subgroups of injured patients appear to benefit most from such personalized motivational interventions . A better articulation of target population s , intervention content , and delivery would allow for directed interventions and an appropriate focusing of limited time and health care re sources Abstract Objective : To evaluate the influence of preoperative abstinence on postoperative outcome in alcohol misusers with no symptoms who were drinking the equivalent of at least 60 g ethanol/day . Design : R and omised controlled trial . Setting : Copenhagen , Denmark . Subjects : 42 alcoholic patients without liver disease admitted for elective colorectal surgery . Interventions : Withdrawal from alcohol consumption for 1month before operation ( disulfiram controlled ) compared with continuous drinking . Main outcome measures : Postoperative complications requiring treatment within the first month after surgery . Perioperative immunosuppression measured by delayed type hypersensitivity ; myocardial ischaemia and arrhythmias measured by Holter tape recording ; episodes of hypoxaemia measured by pulse oximetry . Response to stress during the operation were assessed by heart rate , blood pressure , serum concentration of cortisol , and plasma concentrations of glucose , interleukin 6 , and catecholamines . Results : The intervention group developed significantly fewer postoperative complications than the continuous drinkers ( 31 % v 74 % , P=0.02 ) . Delayed type hypersensitivity responses were better in the intervention group before ( 37 mm2 v 12 mm2 , P=0.04 ) , but not after surgery ( 3 mm2 v 3 mm2 ) . Development of postoperative myocardial ischaemia ( 23 % v 85 % ) and arrhythmias ( 33 % v 86 % ) on the second postoperative day as well as nightly hypoxaemic episodes ( 4 v 18 on the second postoperative night ) occurred significantly less often in the intervention group . Surgical stress responses were lower in the intervention group ( P≤0.05 ) . Conclusions : One month of preoperative abstinence reduces postoperative morbidity in alcohol abusers . The mechanism is probably reduced pre clinical organ dysfunction and reduction of the exaggerated response to surgical stress We have compared 2 % lignocaine 3.5 ml with 0.5 % hyperbaric bupivacaine 3 ml in a r and omized , double-blind study in 30 patients undergoing subarachnoid anaesthesia for transurethral surgery . A sensory level of T10 was produced more quickly ( P = 0.0001 ) and maximum height reached sooner ( P = 0.0002 ) with lignocaine , although there was a greater reduction in systolic arterial pressure ( P = 0.03 ) and a trend towards slower heart rates ( P = 0.056 ) . Return of full sensory and motor function occurred earlier with lignocaine ( P = 0.00005 and P = 0.02 ) Objectives We compared the effectiveness of the Gold St and ard Programme ( a comprehensive smoking cessation intervention commonly used in Denmark ) with other face-to-face smoking cessation programmes in Denmark after implementation in real life , and we identified factors associated with successful quitting . Design Prospect i ve cohort study . Setting A total of 423 smoking cessation clinics from different setting s reported data from 2001 to 2013 . Participants In total , 82 515 patients were registered . Smokers ≥15 years old and attending a programme with planned follow-up were included . Smokers who did not want further contact , who intentionally were not followed up or who lacked information about the intervention they received were excluded . A total of 46 287 smokers were included . Interventions Various real-life smoking cessation interventions were identified and compared : The Gold St and ard Programme , Come & Quit , crash courses , health promotion counselling ( brief intervention ) and other interventions . Main outcome Self-reported continuous abstinence for 6 months . Results Overall , 33 % ( 11 184 ) were continuously abstinent after 6 months ; this value was 24 % when non-respondents were considered smokers . The follow-up rate was 74 % . Women were less likely to remain abstinent , OR 0.83 ( CI 0.79 to 0.87 ) . Short interventions were more effective among men . After adjusting for confounders , the Gold St and ard Programme was the only intervention with significant results across sex , increasing the odds of abstinence by 69 % for men and 31 % for women . In particular , compliance , and to a lesser degree , mild smoking , older age and not being disadvantaged were associated with positive outcomes for both sexes . Compliance increased the odds of abstinence more than 3.5-fold . Conclusions Over time , Danish smoking cessation interventions have been effective in real life . Compliance is the main predictor of successful quitting . Interestingly , short programmes seem to have relatively strong effects among men , but the absolute numbers are very small . Only the comprehensive Gold St and ard Programme works across sexes Patients admitted to an emergency surgical ward were screened for alcohol problems and r and omized between an extensive alcohol counseling and a brief assessment followed by feedback of risky alcohol consumption . Some 165 patients were assessed for risk consumption and followed up 6 to 12 months , and it was found that patients in both interventions significantly reduced the amount they drank per occasion although they drank as often as before . The patients had also moved to a stage more ready to change . No differences in effect were found between the interventions . A brief assessment with feedback about risk consumption can be done on an emergency surgical ward by the surgical staff with a few hours of training and may reduce risky alcohol consumption significantly Background : Although alcohol use disorders ( AUDs ) have enormous public health consequences , the rate of diagnosis of AUDs remains unsatisfactorily low . The primary aim of this study was to compare the detection of AUDs by anesthesiologists in a large preoperative assessment clinic to that by computerized self- assessment of the Alcohol Use Disorder Identification Test . Secondary outcome measures were to compare the actions taken by anesthesiologists upon a finding of an AUD . Methods : One thous and five hundred fifty-six patients were included . Before preoperative assessment , patients were asked to complete the Alcohol Use Disorder Identification Test ( positive scores : men ≥ 8 , women ≥ 5 ) using a computer . The authors performed a retrospective chart analysis of the anesthesiologists ’ actions upon a finding of an AUD . The anesthesiologists were blinded to the results of the computer-based assessment and to the subsequent chart analysis . Results : The prevalence rate of AUDs determined by the anesthesiologists was 6.9 % ( 107 of 1,556 ) , whereas the proportion of patients positive for an AUD using the computerised Alcohol Use Disorder Identification Test was 18.1 % ( 282 of 1,556 ) ( P < 0.001 ) . The detection rate by the anesthesiologists of AUDs among men was significantly higher than among women ( P < 0.001 ) as well as in the elderly compared with younger patients ( P < 0.001 ) . Action taken by anesthesiologists was mainly based on evaluating quantity of alcohol consumption . Conclusion : The computer-based self- assessment increases detection rates of AUDs in busy setting s such as a preoperative assessment clinic . Prevalence rates of AUDs are underestimated . Best- practice guidelines for detection of AUDs are not implemented in the daily clinical routine . Barrier analysis is urgently required Background : Preoperative alteration of T cell – mediated immunity as well as an altered immune response to surgical stress were found in long-term alcoholic Output:	Results show differences between the three clinical studies regarding outcome measurement and intensity of the interventions . Investigators describe more successful quitters at the end of the intervention programme than among controls . Intensive alcohol cessation interventions offered for four to eight weeks to participants undergoing all types of surgical procedures to achieve complete alcohol cessation before surgery probably reduced the number of postoperative complications . The included participants may represent a selective group , as they could have been more motivated and /or more interested in participating in clinical research or otherwise different , and effects may have been overestimated for both intervention and control groups in these studies .
MS2862	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objectives : The current study identifies young people 's preferences for HIV self-testing ( HIVST ) delivery , determines the relative strength of preferences and explores underlying behaviors and perceptions to inform youth-friendly services in southern Africa . Design : A mixed methods design was adopted in Malawi and Zimbabwe and includes focus group discussion s , in-depth interviews and discrete choice experiments . Methods : The current study was conducted during the formative phase of cluster-r and omized trials of oral-fluid HIVST distribution . Young people aged 16–25 years were purposively selected for in-depth interviews ( n = 15 ) in Malawi and 12 focus group discussion s ( n = 107 ) across countries . Representative sample s of young people in both countries ( n = 341 ) were administered discrete choice experiments on HIVST delivery , with data analyzed to estimate relative preferences . The qualitative results provided additional depth and were triangulated with the quantitative findings . Results : There was strong concordance across methods and countries based on the three triangulation parameters : product , provider and service characteristics . HIVST was highly accepted by young people , if provided at no or very low cost . Young people expressed mixed views on oral-fluid tests , weighing perceived benefits with accuracy concerns . There was an expressed lack of trust in health providers and preference for lay community distributors . HIVST addressed youth-specific barriers to st and ard HIV testing , with home-based distribution considered convenient . Issues of autonomy , control , respect and confidentiality emerged as key qualitative themes . Conclusion : HIVST services can be optimized to reach young people if products are provided through home-based distribution and at low prices , with respect for them as autonomous individuals Abstract Introduction : In the era of ambitious HIV targets , novel HIV testing models are required for hard-to-reach groups such as men , who remain underserved by existing services . Pregnancy presents a unique opportunity for partners to test for HIV , as many pregnant women will attend antenatal care ( ANC ) . We describe the views of pregnant women and their male partners on HIV self-test kits that are woman-delivered , alone or with an additional intervention . Methods : A formative qualitative study to inform the design of a multi-arm multi-stage cluster-r and omized trial , comprised of six focus group discussion s and 20 in-depth interviews , was conducted . ANC attendees were purposively sample d on the day of initial clinic visit , while men were recruited after obtaining their contact information from their female partners . Data were analysed using content analysis , and our interpretation is hypothetical as participants were not offered self-test kits . Results : Providing HIV self-test kits to pregnant women to deliver to their male partners was highly acceptable to both women and men . Men preferred this approach compared with st and ard facility-based testing , as self-testing fits into their lifestyles which were characterized by extreme day-to-day economic pressures , including the need to raise money for food for their household daily . Men and women emphasized the need for careful communication before and after collection of the self-test kits in order to minimize the potential for intimate partner violence although physical violence was perceived as less likely to occur . Most men stated a preference to first self-test alone , followed by testing as a couple . Regarding interventions for optimizing linkage following self-testing , both men and women felt that a fixed financial incentive of approximately USD$2 would increase linkage . However , there were concerns that financial incentives of greater value may lead to multiple pregnancies and lack of child spacing . In this low-income setting , a lottery incentive was considered overly disappointing for those who receive nothing . Phone call reminders were preferred to short messaging service . Conclusions : Woman-delivered HIV self-testing through ANC was acceptable to pregnant women and their male partners . Feedback on additional linkage enablers will be used to alter pre-planned trial arms Background HIV self-testing ( HIVST ) has been found to be highly effective , but no cost analysis has been undertaken to guide the design of affordable and scalable implementation strategies . Methods Consecutive HIV self-testers and facility-based testers were recruited from participants in a community cluster-r and omised trial ( IS RCT N02004005 ) investigating the impact of offering HIVST in addition to facility-based HIV testing and counselling ( HTC ) . Primary costing studies were undertaken of the HIVST service and of health facilities providing HTC to the trial population . Costs were adjusted to 2014 US$ and INT$. Recruited participants were asked about direct non-medical and indirect costs associated with accessing either modality of HIV testing , and additionally their health-related quality of life was measured using the EuroQol EQ-5D . Results A total of 1,241 participants underwent either HIVST ( n = 775 ) or facility-based HTC ( n = 446 ) . The mean societal cost per participant tested through HIVST ( US$ 9.23 ; 95 % CI : US$ 9.14-US$9.32 ) was lower than through facility-based HTC ( US$ 11.84 ; 95 % CI : US$ 10.81 - 12.86 ) . Although the mean health provider cost per participant tested through HIVST ( US$ 8.78 ) was comparable to facility-based HTC ( range : US$ 7.53-US$10.57 ) , the associated mean direct non-medical and indirect cost was lower ( US$ 2.93 ; 95 % CI : US$ 1.90-US$3.96 ) . The mean health provider cost per HIV positive participant identified through HIVST was higher ( US$ 97.50 ) than for health facilities ( range : US$ 25.18-US$76.14 ) , as was the mean cost per HIV positive individual assessed for anti-retroviral treatment ( ART ) eligibility and the mean cost per HIV positive individual initiated onto ART . In comparison to the facility-testing group , the adjusted mean EQ-5D utility score was 0.046 ( 95 % CI : 0.022 - 0.070 ) higher in the HIVST group . Conclusions HIVST reduces the economic burden on clients , but is a costlier strategy for the health provider aim ing to identify HIV positive individuals for treatment . The provider cost of HIVST could be substantially lower under less restrictive distribution models , or if costs of oral fluid HIV test kits become comparable to finger-prick kits used in health facilities We evaluated performance , accuracy , and acceptability parameters of unsupervised oral fluid ( OF ) HIV self-testing ( HIVST ) in a general population in western Kenya . In a prospect i ve validation design , we enrolled 240 adults to perform rapid OF HIVST and compared results to staff administered OF and rapid fingerstick tests . All reactive , discrepant , and a proportion of negative results were confirmed with lab ELISA . Twenty participants were video-recorded conducting self-testing . All participants completed a staff administered survey before and after HIVST to assess attitudes towards OF HIVST acceptability . HIV prevalence was 14.6 % . Thirty-six of the 239 HIVSTs were invalid ( 15.1 % ; 95 % CI 11.1–20.1 % ) , with males twice as likely to have invalid results as females . HIVST sensitivity was 89.7 % ( 95 % CI 73–98 % ) and specificity was 98 % ( 95 % CI 89–99 % ) . Although sensitivity was somewhat lower than expected , there is clear interest in , and high acceptability ( 94 % ) of OF HIV self-testing Objective To evaluate HIV self-testing performance and results interpretation among female sex workers ( FSWs ) in Kampala , Ug and a , who performed unassisted HIV self-testing . Methods In October 2016 , 104 participants used an oral HIV self-test while under observation by research assistants . Participants were not assisted on HIV self-test use prior to or during testing , and were only given the manufacturer ’s pictorial and written instructions to guide them . Research assistants recorded if participants completed and /or had difficulties with steps in the HIV self-testing process on a prespecified checklist . R and omly drawn , used HIV self-tests were interpreted by FSWs . We calculated the concordance between FSWs ’ interpretations of self-test results with those indicated in the manufacturer ’s instructions . Results Only 33 % ( 34/104 ) of participants completed all of the key steps in the HIV self-testing process , and the majority ( 86 % , 89/104 ) were observed having difficulties with at least one of these steps . Misinterpretation of HIV self-test results were common among FSWs : 23 % ( 12/56 ) of FSWs interpreted HIV-negative self-test results as HIV positive and 8 % ( 3/37 ) of FSWs interpreted HIV-positive self-test results as HIV negative . The concordance between FSWs ’ interpretations of self-test results and that indicated in the instructions was 73 % ( 95 % CI 56 % to 86 % ) for HIV-positive self-tests and 68 % ( 95 % CI 54 % to 80 % ) for HIV-negative self-tests . Conclusions FSWs in Kampala , who performed unassisted HIV self-testing , skipped steps in the HIV self-testing process and had difficulties correctly interpreting self-test results . Training on use and interpretation of HIV self-tests may be necessary to prevent errors in the HIV self-testing process and to avoid the negative consequences of false-positive and false-negative HIV self-test results among FSWs . Trial registration number NCT02846402 Output:	Perceived facilitators of the uptake of HIVST were autonomy and self-empowerment , privacy , confidentiality , convenience , opportunity to test , including couples HIV testing , and ease of use . Actual HIVST users expressed preference of oral-fluid self-testing because of ease of use , and that it is less invasive and painless compared to finger-stick/whole blood-based HIV tests . Lack of clear instructions on how to use self-test kits , and existing different products of HIVST increases rates of user errors .
MS2863	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Substitution of dietary polyunsaturated for saturated fat has long been recommended for the primary prevention of cardiovascular disease ( CVD ) , but only a few prospect i ve cohort studies have provided support for this advice . METHODS We assessed the association of dietary linoleic and total polyunsaturated fatty acid ( PUFA ) intake with cardiovascular and overall mortality in a population -based cohort of 1551 middle-aged men . Dietary fat composition was estimated with a 4-day food record and serum fatty acid composition . RESULTS During the 15-year follow-up , 78 men died of CVD and 225 of any cause . Total fat intake was not related to CVD or overall mortality . Men with an energy-adjusted dietary intake of linoleic acid ( relative risk [ RR ] 0.39 ; 95 % confidence interval [ CI ] , 0.21 - 0.71 ) and PUFA ( RR , 0.38 ; 95 % CI , 0.20 - 0.70 ) in the upper third were less likely to die of CVD than men with intake in the lower third after adjustment for age . Multivariate adjustment weakened the association somewhat . Mortality from CVD was also lower for men with proportions of serum esterified linoleic acid ( RR , 0.42 ; 95 % CI , 0.21 - 0.80 ) and PUFA ( RR , 0.25 ; 95 % CI , 0.12 - 0.50 ) in the upper vs lower third , with some attenuation in multivariate analyses . Serum and to a lesser extent dietary linoleic acid and PUFA were also inversely associated with overall mortality . CONCLUSIONS Dietary polyunsaturated and more specifically linoleic fatty acid intake may have a substantial cardioprotective benefit that is also reflected in overall mortality . Dietary fat quality seems more important than fat quantity in the reduction of cardiovascular mortality in men OBJECTIVE To examine the predictive capability of a 1-h vs 2-h postload glucose value for cardiovascular morbidity and mortality . DESIGN Prospect i ve , population -based cohort study ( Malmö Preventive Project ) with subject inclusion 1974 - 1992 . METHODS 4934 men without known diabetes and cardiovascular disease , who had blood glucose ( BG ) measured at 0 , 20 , 40 , 60 , 90 and 120 min during an OGTT ( 30 g glucose per m2 body surface area ) , were followed for 27 years . Data on cardiovascular events and death were obtained through national and local registries . Predictive capabilities of fasting BG ( FBG ) and glucose values obtained during OGTT alone and added to a clinical prediction model comprising traditional cardiovascular risk factors were assessed using Harrell 's concordance index ( C-index ) and integrated discrimination improvement ( IDI ) . RESULTS Median age was 48 ( 25th-75th percentile : 48 - 49 ) years and mean FBG 4.6 ± 0.6 mmol/L. FBG and 2-h postload BG did not independently predict cardiovascular events or death . Conversely , 1-h postload BG predicted cardiovascular morbidity and mortality and remained an independent predictor of cardiovascular death ( HR : 1.09 , 95 % CI : 1.01 - 1.17 , P = 0.02 ) and all-cause mortality ( HR : 1.10 , 95 % CI : 1.05 - 1.16 , P < 0.0001 ) after adjusting for various traditional risk factors . Clinical risk factors with added 1-h postload BG performed better than clinical risk factors alone , in predicting cardiovascular death ( likelihood-ratio test , P = 0.02 ) and all-cause mortality ( likelihood-ratio test , P = 0.0001 ; significant IDI , P = 0.0003 ) . CONCLUSION Among men without known diabetes , addition of 1-h BG , but not FBG or 2-h BG , to clinical risk factors provided incremental prognostic yield for prediction of cardiovascular death and all-cause mortality Purpose The purpose of this study is to compare the glycemic and insulinemic responses following the ingestion of recently developed diabetes-specific enteral formulas versus a st and ard and a high-fat formula . Methods Fifteen type 2 diabetes patients were selected to participate in a r and omized , double-blind , crossover study . Two enteral formulas ( 47 energy percent [ En% ] carbohydrate , 34En% fat , and 4 g fiber/200 mL ) were defined with either isomaltulose ( formula 1 ) or sucromalt ( formula 2 ) as the main carbohydrate source . For comparison , an isoenergetic diabetes-specific , high-fat ( 33En% carbohydrate , 50En% fat , 2.9 g fiber/200 mL ) and a st and ard formula ( 55En% carbohydrate , 30En% fat , 2.8 g fiber/ 200 mL ) were tested . Results Ingestion of formulas 1 and 2 and the high-fat formula result ed in an attenuated blood glucose response when compared with the st and ard formula ( P < .05 ) . In accordance , peak plasma glucose concentrations were significantly lower when compared with the st and ard formula ( 189 ± 3.6 mg/dL [ 10.5 ± 0.2 mmol/L ] , 196.2 ± 3.6 mg/dL [ 10.9 ± 0.2 mmol/L ] , 187.2 ± 3.6 mg/dL [ 10.4 ± 0.2 mmol/L ] , and 237.6 ± 3.6 mg/dL [ 13.2 ± 0.2 mmol/L ] , respectively ) . Plasma insulin responses were lower after consumption of the newly developed and high-fat formulas . Ingestion of the high-fat formula result ed in a greater postpr and ial triglyceride response ( P < .05 ) . Conclusions Diabetes-specific enteral formulas rich in slowly digestible carbohydrate sources can be equally effective in attenuating the postpr and ial blood glucose response as low-carbohydrate , high-fat enteral formulas without elevating the plasma triglyceride response Glycaemic index ( GI ) is used as an indicator to guide consumers in making healthier food choices . We compared the GI , insulin index ( II ) , and the area under the curve for blood glucose and insulin as glucose ( GR ) and insulin responses ( IR ) of a newly developed liquid nutritional formula with one commercially available liquid product with different types of carbohydrates . We then evaluated the glucose and insulin responses of two test foods with comparable energy density and protein percentage but presented in different food forms ( liquid vs. solid ) . Fourteen healthy women participated in the study . GI , II , GR , and IR were assessed after ( independent ) consumption of two liquid products and a solid breakfast meal . The two liquid foods showed comparable GI , whilst the liquid form appeared to produce lower median GI ( 25 vs. 54 ) , and II ( 52 vs. 98 ) values compared to the solid breakfast ( p < 0.02 ) . The median GR and IR for solid breakfast were respectively 44 % and 45 % higher compared to the liquid product ( p < 0.02 ) . Liquid formulas with different carbohydrate qualities produced comparable glucose responses , while foods with comparable energy density and protein percentage but different food form elicited differential effects on GI , II , GR , and IR . Nutrient quality and food form need to be taken into consideration when developing low GI products to manage glycaemic responses Background : The potential confounding effect of different amounts and proportions of macronutrients across eating patterns on meal or dietary glycemic index ( GI ) and glycemic load ( GL ) value determinations has remained partially unaddressed . Objective : The study aim ed to determine the effects of different amounts of macronutrients and fiber on measured meal GI and GL values . Design : Four studies were conducted during which participants [ n = 20 - 22 ; women : 50 % ; age : 50 - 80 y ; body mass index ( in kg/m2 ) : 25 - 30 ) ] received food challenges containing different amounts of the variable nutrient in a r and om order . Added to the st and ard 50 g available carbohydrate from white bread was 12.5 , 25 , or 50 g carbohydrate ; 12.5 , 25 , or 50 g protein ; and 5.6 , 11.1 , or 22.2 g fat from rice cereal , tuna , and unsalted butter , respectively , and 4.8 or 9.6 g fiber from oat cereal . Arterialized venous blood was sample d for 2 h , and measured meal GI and GL and insulin index ( II ) values were calculated by using the incremental area under the curve ( AUCi ) method . Results : Adding carbohydrate to the st and ard white-bread challenge increased glucose AUCi ( P < 0.0001 ) , measured meal GI ( P = 0.0066 ) , and mean GL ( P < 0.0001 ) . Adding protein ( 50 g only ) decreased glucose AUCi ( P = 0.0026 ) , measured meal GI ( P = 0.0139 ) , and meal GL ( P = 0.0140 ) . Adding fat or fiber had no significant effect on these variables . Adding carbohydrate ( 50 g ) , protein ( 50 g ) , and fat ( 11.1 g ) increased the insulin AUCi or II ; fiber had no effect . Conclusions : These data indicate that uncertainty in the determination of meal GI and GL values is introduced when carbohydrate-containing foods are consumed concurrently with protein ( equal amount of carbohydrate challenge ) but not with carbohydrate- , fat- , or fiber-containing foods . Future studies are needed to evaluate whether this uncertainty also influences the prediction of average dietary GI and GL values for eating patterns . This trial was registered at clinical trials.gov as NCT01023646 The glycaemic index ( GI ) concept was originally introduced to classify different sources of carbohydrate (CHO)-rich foods , usually having an energy content of > 80 % from CHO , to their effect on post-meal glycaemia . It was assumed to apply to foods that primarily deliver available CHO , causing hyperglycaemia . Low-GI foods were classified as being digested and absorbed slowly and high-GI foods as being rapidly digested and absorbed , result ing in different glycaemic responses . Low-GI foods were found to induce benefits on certain risk factors for CVD and diabetes . Accordingly it has been proposed that GI classification of foods and drinks could be useful to help consumers make ' healthy food choices ' within specific food groups . Classification of foods according to their impact on blood glucose responses requires a st and ardised way of measuring such responses . The present review discusses the most relevant method ological considerations and highlights specific recommendations regarding number of subjects , sex , subject status , inclusion and exclusion criteria , pre-test conditions , CHO test dose , blood sampling procedures , sampling times , test r and omisation and calculation of glycaemic response area under the curve . All together , these technical recommendations will help to implement or reinforce measurement of GI in laboratories and help to ensure quality of results . Since there is current international interest in alternative ways of expressing glycaemic responses to foods , some of these methods are discussed Elevated postpr and ial blood glucose levels constitute a global epidemic and a major risk factor for prediabetes and type II diabetes , but existing dietary methods for controlling them have limited efficacy . Here , we continuously monitored week-long glucose levels in an 800-person cohort , measured responses to 46,898 meals , and found high variability in the response to identical meals , suggesting that universal dietary recommendations may have limited utility . We devised a machine-learning algorithm that integrates blood parameters , dietary habits , anthropometrics , physical activity , and gut microbiota measured in this cohort and showed that it accurately predicts personalized postpr and ial glycemic response to real-life meals . We vali date d these predictions in an independent 100-person cohort . Finally , a blinded r and omized controlled dietary intervention based on this algorithm result ed in significantly lower postpr and ial responses and consistent alterations to gut microbiota configuration . Together , our results suggest that personalized diets may successfully modify elevated postpr and ial blood glucose and its metabolic consequences . VIDEO ABSTRACT Few studies have examined short term responses to the different contents of carbohydrate or fat in the meal , although long term effects of the high fat meal have been considered as compound risk factor for metabolic disorders . The aim of this study was to investigate the postpr and ial changes of plasma glucose , insulin and lipids upon intakes of high carbohydrate or high fat meal in young healthy women . Subjects were r and omly assigned to either the high carbohydrate meal ( HCM , 75 % carbohydrate , n=13 ) or the high fat meal ( HFM , 60 % fat , n=12 Output:	Modest exchange of carbohydrates for fats in mixed meals significantly reduces PPG and PPI and increases PPTG responses . The quantitative relationships derived here may be applied to predict responses , and to design and optimize meal macronutrient compositions in dietary intervention studies
MS2864	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: ABSTRACT Objective To analyze respiratory mechanics and hemodynamic alterations in an experimental model of chronic heart failure ( CHF ) following myocardial infa rct ion . Method Twenty-seven male adult Wistar rats were r and omized to CHF group ( n=12 ) or Sham group ( n=15 ) . Ten weeks after coronary ligation or sham surgery , the animals were anesthetized and su bmi tted to respiratory mechanics and hemodynamic measurements . Pulmonary edema as well as cardiac remodeling were measured . Results The CHF rats showed pulmonary edema 26 % higher than the Sham group . The respiratory system compliance ( Crs ) and the total lung capacity ( TLC ) were lower ( 40 % and 27 % , respectively ) in the CHF rats when compared to the Sham group ( P<0.01 ) . There was also an increase in tissue resistance ( Gti ) and elastance ( Hti ) ( 28 % and 45 % , respectively ) in the CHF group . Moreover , left ventricular end-diastolic pressure was higher ( 32 mmHg vs 4 mmHg , P<0.01 ) , while the left ventricular systolic pressure was lower ( 118 mmHg vs 130 mmHg , P=0.02 ) in the CHF group when compared to the control . Pearson ’s correlation coefficient showed a negative association between pulmonary edema and Crs ( r=–0.70 , P=0.0001 ) and between pulmonary edema and TLC ( r=–0.67 , P=0.0034 ) . Pulmonary edema correlated positively with Gti ( r=0.68 , P=0.001 ) and Hti ( r=0.68 , P=0.001 ) . Finally , there was a strong positive relationship between pulmonary edema and heart weight ( r=0.80 , P=0.001 ) . Conclusion Rats with CHF present important changes in hemodynamic and respiratory mechanics , which may be associated with alterations in cardiopulmonary interactions Background —Although heart failure is common among women with coronary disease , the risk factors for developing heart failure have not been well studied . We determined the risk factors for developing heart failure among postmenopausal women with established coronary disease . Methods and Results —This is a prospect i ve cohort study using data from the Heart and Estrogen/progestin Replacement Study ( HERS ) , a r and omized , blinded , placebo-controlled trial of 4.1 years ’ duration , and subsequent open-label observational follow-up for 2.7 years ( HERS II ) , performed at 20 US clinical centers between 1993 and 2000 . Of the 2763 postmenopausal women with established coronary disease in the HERS trial , we studied the 2391 women with no heart failure at baseline by self-report and physical examination . The primary outcome of this analysis was incident heart failure defined by hospital admission or death from heart failure . During the 6.3±1.4-year follow-up , 237 women ( 10 % ) developed heart failure . Nine predictors were identified : diabetes ( defined as a self-reported history of diabetes on treatment ) , atrial fibrillation , myocardial infa rct ion , creatinine clearance < 40 mL/min , systolic blood pressure > 120 mm Hg , current smoking , body mass index > 35 kg/m2 , left bundle-branch block , and left ventricular hypertrophy . R and omization to estrogen/progestin was not associated with heart failure ( hazard ratio=1.0 ; 95 % CI , 0.7 to 1.3 ) . Diabetes was the strongest risk factor ( adjusted hazard ratio=3.1 ; 95 % CI , 2.3 to 4.2 ) . Diabetic women with elevated body mass index or depressed creatinine clearance were at highest risk , with annual incidence rates of 7 % and 13 % , respectively . Among diabetic women , hyperglycemia was associated with heart failure risk ( adjusted hazard ratio=3.0 ; 95 % CI , 1.2 to 7.5 for fasting glucose > 300 mg/dL compared with fasting glucose 80 to 150 mg/dL ) . Conclusions —We identified 9 predictors of heart failure in postmenopausal women with coronary disease . Diabetes was the strongest risk factor , particularly when poorly controlled or with concomitant renal insufficiency or obesity BACKGROUND The effect of home-based exercise training on neurovascular control in heart failure patients is unknown . AIMS To test the hypothesis that home-based training would maintain the reduction in muscle sympathetic nerve activity ( MSNA ) and forearm vascular resistance ( FVR ) acquired after supervised training . METHODS AND RESULTS Twenty-nine patients ( 54+/-1.9 years , EF<40 % ) were r and omised into two groups : untrained control ( n=12 ) and exercise trained ( n=17 ) . Both groups underwent assessment of Quality of Life ( QoL ) , MSNA , and forearm blood flow . The exercise group underwent a 4-month supervised training program followed by 4 months of home-based training . After the initial 4 months of training , patients in the exercise group showed a significant increase in peak VO(2 ) and reduction in MSNA , compared to the untrained group , but this was not maintained during 4 months of home-based training . In contrast , the decrease in FVR ( 56+/-3 vs. 46+/-4 vs. 40+/-2 U , p=0.008 ) and the improvement in QOL that were achieved during supervised training were maintained during home-based training . CONCLUSIONS Home-based training following supervised training is a safe strategy to maintain improvements in QoL and reduction in FVR in chronic heart failure patients , but is an inadequate strategy to maintain fitness as estimated by peak VO(2 ) or reduction in neurohumoral activation This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence Stratification of the severity of heart failure has major prognostic and therapeutic implication s. OBJECTIVES The goal of this study was to test the hypothesis that exercise training reduces resting sympathetic neural activation in patients with chronic advanced heart failure . BACKGROUND Exercise training in heart failure has been shown to be beneficial , but its mechanisms of benefit remain unknown . METHODS Sixteen New York Heart Association class II to III heart failure patients , age 35 to 60 years , ejection fraction < or = 40 % were divided into two groups : 1 ) exercise-trained ( n = 7 ) , and 2 ) sedentary control ( n = 9 ) . A normal control exercise-trained group was also studied ( n = 8) . The four-month supervised exercise training program consisted of three 60 min exercise sessions per week , at heart rate levels that corresponded up to 10 % below the respiratory compensation point . Muscle sympathetic nerve activity ( MSNA ) was recorded directly from peroneal nerve using the technique of microneurography . Forearm blood flow was measured by venous plethysmography . RESULTS Baseline MSNA was greater in heart failure patients compared with normal controls ; MSNA was uniformly decreased after exercise training in heart failure patients ( 60 + /- 3 vs. 38 + /- 3 bursts/100 heart beats ) , and the mean difference in the change was significantly ( p < 0.05 ) greater than the mean difference in the change in sedentary heart failure or trained normal controls . In fact , resting MSNA in trained heart failure patients was no longer significantly greater than in trained normal controls . In heart failure patients , peak VO(2 ) and forearm blood flow , but not left ventricular ejection fraction , increased after training . CONCLUSIONS These findings demonstrate that exercise training in heart failure patients results in dramatic reductions in directly recorded resting sympathetic nerve activity . In fact , MSNA was no longer greater than in trained , healthy controls Output:	CONCLUSION Exercise training could be effective in reducing sympathetic nerve activity in patients with heart failure .
MS2865	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: There have been no systematic follow-up studies of depressed patients with documented refractoriness to antidepressants treated with lithium augmentation . To assess their longitudinal course , 66 ( 88 % ) of an original cohort of 75 such patients were followed in a retrospective , naturalistic design for 29.0 + /- SD 15.3 months . At follow-up , 29 % had poor , 23 % fair , and 48 % good outcomes . An acute marked positive response to lithium augmentation predicted a good subsequent course . Acute partial and non-responders had a less benign outcome despite subsequent treatments . These findings indicate that outcomes of patients with documented refractory depression are heterogeneous . There is a suggestion that an acute marked response to lithium augmentation is sustained regardless of the duration of taking lithium , but this must be regarded as speculative BACKGROUND Treatment-resistant depression ( TRD ) is a long-term , disabling illness . We report on the characteristics and outcomes of a large cohort of patients with a level of treatment resistance that is very substantial and who were treated for 2 years with st and ard care . METHOD This 2-year prospect i ve , multicenter , observational study ( patients enrolled from January 2001 through July 2004 ) tracked the outcomes of 124 patients with treatment-resistant , nonpsychotic major depressive disorder ( N = 109 ) or bipolar depressed phase disorder ( N = 15 ) who received treatment as usual ( TAU ) ( i.e. , any therapeutic regimen agreed to by patients and psychiatrists , including medications , electroconvulsive therapy [ ECT ] , and psychotherapy ) . Treatments could be adjusted , started , and stopped as necessary . The primary outcome , treatment response , was defined a priori as > or = 50 % improvement from baseline as measured by the 30-item Inventory of Depressive Symptomatology-Self-Report ( IDS-SR-30 ) . Remission was defined as an IDS-SR-30 score of < or = 14 . The Medical Outcomes Study ( MOS ) 36-item Short Form Health Survey ( SF-36 ) was used to monitor quality -of-life changes . RESULTS The 12- and 24-month IDS-SR-30 response rates were 11.6 % ( 13/112 ) and 18.4 % ( 19/103 ) , respectively . Of the 13 responders at 12 months , only 5 were responders at 24 months . The 12- and 24-month IDS-SR-30 remission rates were 3.6 % ( 4/112 ) and 7.8 % ( 8/103 ) , respectively . Only 1 of the 4 12-month remitters was also a remitter at 24 months . The SF-36 indicated globally poor quality of life in this sample . CONCLUSIONS Despite the wide range of treatment options available for depression , the response rates , remission rates , and quality -of-life results in this study show that most patients with a substantial degree of treatment resistance continue to have significant symptomatology and functional disability when receiving TAU BACKGROUND This paper describes the Household Survey from the National Survey of Psychiatric Morbidity . This covered a sample drawn at r and om from the population of Britain , with the exception of the Highl and s and Isl and s of Scotl and . METHODS The Postcode Address file was used as the sampling frame . Nearly 13000 adults aged 16 - 65 were selected for interview , of whom 10108 ( 79.4 % ) were successfully interviewed . Eight per cent could not be contacted and 13 % refused interview . Psychiatric assessment was carried out by lay interviewers using the CIS-R. Subjects were also screened for psychosis , and screen-positive individuals were examined by psychiatrists using SCAN . RESULTS Sixteen per cent of subjects scored above the st and ard cut-off of 12 on the CIS-R. The overall 1-week prevalence of neurotic disorder was 12.3 % in males and 19.5 % in females . Unmarried and post-marital groups had high rates of disorder , as did single parents and people living on their own . Respondents in Social Class I had notably lower rates of neurotic disorder than the remainder of the sample . Unemployment was strongly associated with disorder . Subjects living in urban areas had a higher overall prevalence , but there was no significant variation by region . Black respondents had higher rates of disorders that were entirely explained by their age , family type and social class . Individual neurotic disorders were all significantly commoner in women , with the exception of panic disorder . The 1-year prevalence of functional psychoses was 4 per 1000 , with no sex difference . Alcohol and drug dependence was considerably more prevalent in men . CONCLUSIONS For the first time , the survey provides data on the prevalence and correlates of psychiatric disorder on a nationwide sample that can be used to inform equitable and effective national psychiatric services OBJECTIVE Selective serotonin reuptake inhibitors ( SSRIs ) are widely used to treat depression , but the rates , timing , and baseline predictors of remission in " real world " patients are not established . The authors ' primary objectives in this study were to evaluate the effectiveness of citalopram , an SSRI , using measurement-based care in actual practice , and to identify predictors of symptom remission in out patients with major depressive disorder . METHOD This clinical study included out patients with major depressive disorder who were treated in 23 psychiatric and 18 primary care " real world " setting s. The patients received flexible doses of citalopram prescribed by clinicians for up to 14 weeks . The clinicians were assisted by a clinical research coordinator in the application of measurement-based care , which included the routine measurement of symptoms and side effects at each treatment visit and the use of a treatment manual that described when and how to modify medication doses based on these measures . Remission was defined as an exit score of < or=7 on the 17-item Hamilton Depression Rating Scale ( HAM-D ) ( primary outcome ) or a score of < or=5 on the 16-item Quick Inventory of Depressive Symptomatology , Self-Report ( QIDS-SR ) ( secondary outcome ) . Response was defined as a reduction of > or=50 % in baseline QIDS-SR score . RESULTS Nearly 80 % of the 2,876 out patients in the analyzed sample had chronic or recurrent major depression ; most also had a number of comorbid general medical and psychiatric conditions . The mean exit citalopram dose was 41.8 mg/day . Remission rates were 28 % ( HAM-D ) and 33 % ( QIDS-SR ) . The response rate was 47 % ( QIDS-SR ) . Patients in primary and psychiatric care setting s did not differ in remission or response rates . A substantial portion of participants who achieved either response or remission at study exit did so at or after 8 weeks of treatment . Participants who were Caucasian , female , employed , or had higher levels of education or income had higher HAM-D remission rates ; longer index episodes , more concurrent psychiatric disorders ( especially anxiety disorders or drug abuse ) , more general medical disorders , and lower baseline function and quality of life were associated with lower HAM-D remission rates . CONCLUSIONS The response and remission rates in this highly generalizable sample with substantial axis I and axis III comorbidity closely resemble those seen in 8-week efficacy trials . The systematic use of easily implemented measurement-based care procedures may have assisted in achieving these results OBJECTIVE This study investigated the influence of incomplete recovery from first lifetime major depressive episodes on long-term outcome . METHOD After their first lifetime major depressive episode , patients were divided into asymptomatic ( N=70 ) and residual subthreshold depressive symptom ( N=26 ) recovery groups and compared on longitudinal course during up to 12 years of prospect i ve naturalistic follow-up . RESULTS Patients with residual subthreshold depressive symptoms during recovery had significantly more severe and chronic future courses . Those with residual symptoms relapsed to major and minor depressive episodes faster and had more recurrences , shorter well intervals , and fewer symptom-free weeks during follow-up than asymptomatic patients . CONCLUSIONS Resolution of major depressive episodes with residual subthreshold depressive symptoms , even the first lifetime episode , appears to be the first step of a more severe , relapsing , and chronic future course . When ongoing subthreshold symptoms continue after major depressive episodes , the illness is still active , and continued treatment is strongly recommended CONTEXT There are no studies of the natural history of major depressive disorder that lack prevalence and clinic biases . OBJECTIVES To estimate risk factors for first lifetime onset and parameters of chronicity following the first episode , including duration , recovery , and recurrence , and to search for predictors of each parameter . DESIGN Prospect i ve population -based cohort study with 23 years of follow-up . SETTING East Baltimore , Maryl and , an urban setting . PARTICIPANTS Probability sample of 3481 adult household residents in 1981 , including 92 with first lifetime onset of major depressive disorder during the course of the follow-up , and 1739 other participants followed up for at least 13 years . OUTCOME MEASURES Diagnostic Interview Schedule and Life Chart Interview . RESULTS Female participants showed higher risk of onset of disorder , longer duration of episodes , and a nonsignificant tendency for higher risk of recurrence . Sex was not related to recovery . The median episode length was 12 weeks . About 15 % of 92 individuals with first episodes did not have a year free of episodes , even after 23 years . About 50 % of first episode participants recovered and had no future episodes . The evolution of the course was relatively stable from first to later episodes . Individuals with 1 or 2 short alleles of the serotonin transporter gene were at higher risk for an initial episode , but experienced episodes of shorter duration . There were few strong predictors of recovery or recurrence . CONCLUSIONS Major depressive disorder is unremitting in 15 % of cases and recurrent in 35 % . About half of those with a first-onset episode recover and have no further episodes Eighty-nine consecutive admissions with primary depressive illness were prospect ively ascertained and diagnosed in 1965 - 66 by R. E. Kendell , who also allocated each a position on a neurotic-psychotic continuum on the basis of previous discriminant function analysis . In 1983 - 84 , 94 % of the survivors were personally interviewed by a psychiatrist blind to index admission data . Operational outcome criteria were employed and longitudinal data were established for 98 % of the series . Mortality risk was doubled overall , and increased sevenfold for women under 40 years at index admission . Less than one-fifth of the survivors had remained well , and over one-third of the series suffered unnatural death or severe chronic distress and h and icap . Patients whose index episode marked their first psychiatric contact had a 50 % chance of readmission within their lifetime , but those with previous admissions had a 50 % chance of readmission within three years . Readmissions occurred even after 12 years of being symptom-free , and conversely patients recovered after as long as 15 years of illness . There was a high incidence of other disorders ( schizoaffective disorder , alcoholism , schizophrenia ) , and only four patients showed pure recurrent unipolar histories . Patients at the psychotic end of the continuum were more likely to be readmitted and to have very poor outcomes BACKGROUND To investigate the mortality rates in affective disorders due to unnatural and natural causes with respect to illness subtype and social-demographic features . METHODS Mortality data were determined from a prospect i ve study of 354 out patients with affective disorders during a follow-up period of 5 years . Death from natural and unnatural causes was compared to sex- and age-specific expectations in the general population . St and ardized mortality rates ( SMR ) in diagnostic subgroups and the influence of social-demographic features were investigated . RESULTS The observed 30 deaths represented nearly three times ( SMR , 2.9 ) the number expected on the basis of age- and sex-st and ardized reference population rates . Death from natural causes occurred with the same rate as expected ( SMR , 1.0 ) , death from unnatural causes was 28.8 times higher than expected . Women with affective disorders had a considerable high risk to die from unnatural causes ( SMR , 47.1 ) . A significant excess of unnatural death was found in all subtypes of affective disorders , particularly in recurrent major depressive episodes ( SMR , 46.7 ) . LIMITATIONS The sample was restricted in size . Therefore subgroup differences and multiple relationships of risk factors could not be analyzed with high statistical power . CONCLUSIONS The results corroborate earlier findings of excess mortality in major affective disorders and strengthen the view that suffering from recurrent major depression confers per se an important biological risk for suicide . Natural causes of death in affective disorders are comparable to expectations from reference population s. Social-demographic characteristics may contribute to an additional risk of premature death by suicide , particularly in women BACKGROUND Previous reports have described the effects of vagus nerve stimulation plus treatment as usual ( VNS+TAU ) during open trials of patients with treatment-resistant depression ( TRD ) . To better underst and these effects on long-term outcome , we compared 12-month VNS+TAU outcomes with those of a comparable TRD group . METHODS Admission criteria were similar for those receiving VNS+TAU ( n = 205 ) or only TAU ( n = 124 ) . In the primary analysis , repeated- measures linear regression was used to compare the VNS+TAU group ( monthly data ) with the TAU group ( quarterly data ) according to scores of the 30-item Inventory of Depressive Symptomatology-Self-Report ( IDS- Output:	TRD is associated with poorer clinical outcome , particularly among those who require multiple antidepressant medications .
MS2866	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Few studies have examined predictors of latent tuberculosis infection ( LTBI ) treatment completion in inner city population s in the United States . OBJECTIVE To assess LTBI treatment completion rates and predictors in an inner city cohort . METHODS Data from control groups of two sequentially conducted r and omized controlled trials of LTBI treatment were analyzed for treatment completion rates . Participants in Study A ( n = 191 ) , conducted in 1996 - 1999 , self administered daily isoniazid ( INH ) for 6 - 12 months , while participants in Study B ( n = 123 ) , conducted in 2002 - 2005 , self administered daily INH for 9 months . RESULTS Overall , 44.6 % of participants completed therapy , with significantly higher completion rates in Study B than Study A ( 37.0 % vs. 56.1 % , P = 0.001 ) . Marriage and alcohol use were significant predictors of completion ( aOR = 2.153 , 95%CI 1.301 - 3.562 ) and non-completion ( aOR = 0.530 , 95%CI 0.320 - 0.877 ) , respectively ; multivariate analysis indicated increased completion among married persons of foreign birth and among alcohol users who were homeless . Knowledge of and attitudes to tuberculosis were not significant predictors . CONCLUSIONS The design provided an opportunity to assess predictors of LTBI treatment completion in this inner city population . Social circumstances were the strongest predictors of treatment completion , suggesting that tangible social services may be more effective than educational programs in encouraging treatment completion BACKGROUND Drug users are at increased risk for latent tuberculosis infection ( LTBI ) and also at increased risk for noncompletion of medication regimens for treatment of LTBI or tuberculosis disease . Directly observed therapy ( DOT ) provided by outreach workers , the use of incentives , or both have been suggested as a means to increase adherence . OBJECTIVE To compare the independent and combined effects of monetary incentives and outreach worker provision of DOT for LTBI treatment in a sample of active drug users . METHODS The research design was a r and omized controlled trial in a community outreach program setting . Participants consisted of a volunteer sample of 163 active injection drug and crack cocaine users placed on twice weekly DOT . Condition 1 of the interventions consisted of provision of DOT by an outreach worker at a location chosen by the participant ( active outreach ) and a $ 5 per visit incentive . Condition 2 was comprised of active outreach with no monetary incentive , and Condition 3 , provision of DOT at the study community site and a $ 5 per visit incentive . The main outcome measures were percentage of medication taken as prescribed and completion of medication regimen . RESULTS The percentage of prescribed medication taken was higher for those who received incentives , either with ( 71 % ) or without ( 68 % ) active outreach , compared to those who received active outreach alone ( 13 % ) . Only 4 % of participants assigned to Condition 2 completed treatment , compared to 53 % of Condition 1 participants , and 60 % of Condition 3 participants . CONCLUSIONS Monetary incentives were clearly superior to active outreach . Active outreach in combination with monetary incentives did not increase adherence over incentives alone BACKGROUND Cases of severe and fatal liver injury were reported after a 2-month course of rifampin-pyrazinamide therapy was recommended in 2000 as an alternative to isoniazid for treatment of latent tuberculosis infection . We estimated rates of rifampin-pyrazinamide-associated liver injury and compared these with historical rates for isoniazid . METHODS We conducted a survey of state and city tuberculosis programs and other health care setting s in the United States where rifampin-pyrazinamide was prescribed . The number of rifampin-pyrazinamide therapy initiations was collected , as well as the number of occurrences of ( 1 ) asymptomatic aspartate aminotransferase serum concentration > 5 times the upper limit of normal , ( 2 ) symptomatic hepatitis ( in which the patient was not hospitalized ) , ( 3 ) hospitalization for liver injury , ( 4 ) death with liver injury , and ( 5 ) treatment completion . We also search ed a national pharmacy cl aims data base ( Verispan ) . Rates of these events were calculated . RESULTS Among 139 programs , 110 ( 79 % ) responded ; 87 ( 79 % ) had initiated rifampin-pyrazinamide therapy for a total of 8087 patients between January 2000 and June 2002 . Rates per 1000 rifampin-pyrazinamide therapy initiations during this period were 25.6 ( 95 % confidence interval [ CI ] , 22.3 - 29.3 ) for asymptomatic aspartate aminotransferase level > 5 times the upper limit of normal and 18.7 ( 95 % CI , 15.9 - 21.9 ) for hepatitis . Seven fatalities and 23 hospitalizations occurred , with rates of 0.9 ( 95 % CI , 0.4 - 1.9 ) and 2.8 ( 95 % CI , 1.8 - 4.3 ) per 1000 rifampin-pyrazinamide therapy initiations , respectively . Of 8087 patients , 64 % completed rifampin-pyrazinamide therapy . The Verispan search revealed 1 rifampin-pyrazinamide-associated hospitalization ( 2.9 hospitalizations per 1000 rifampin-pyrazinamide therapy initiations ; 95 % CI , 0.1 - 18.4 ) and no deaths . Articles on the use of isoniazid therapy for latent tuberculosis infection that were published after 1990 reported fatality rates of 0.0 - 0.3 deaths per 1000 persons . CONCLUSIONS Rates of liver injury , hospitalization , and death associated with rifampin-pyrazinamide therapy exceed rates reported for isoniazid therapy . Because earlier r and omized trials of rifampin-pyrazinamide lacked adequate statistical power to detect fatal events , the Centers for Disease Control and Prevention recommends that rifampin-pyrazinamide generally should not be used for treatment of latent tuberculosis infection SETTING Few studies have examined strategies for optimizing adherence to latent tuberculosis infection ( LTBI ) treatment programs in homeless population s. OBJECTIVES 1 ) To compare the effectiveness of an intervention program employing nurse case management and incentives ( NCMI ) vs. a control program with st and ard care and incentives on completion of LTBI treatment ; and 2 ) to compare the impact of the two programs on tuberculosis ( TB ) knowledge among participants . DESIGN A prospect i ve , two-group site-r and omized design conducted among 520 homeless adults residing in the Skid Row region of Los Angeles from 1998 to 2003 , assessing completion rates of a 6-month isoniazid ( INH ) treatment program and change in TB knowledge . RESULTS Using intent-to-treat analysis , 62 % of participants in the intervention program , compared with 39 % of controls , completed the full 6-month course of LTBI treatment with INH . Logistic regression modeling revealed that intervention participants had three times greater odds of completing INH treatment than controls . TB knowledge improved in both programs , but the increase was greater among the intervention participants ( P < 0.001 ) . CONCLUSIONS Nurse case management combined with education , incentives , and tracking dramatically improves both adherence to LTBI treatment and TB knowledge in homeless persons compared to a st and ard approach of outreach and incentives BACKGROUND A 9-month course of isoniazid monotherapy is currently recommended for the treatment of latent tuberculosis infection ( LTBI ) and has been shown to be effective in both children and adults . Reduced compliance with this regimen has forced physicians to explore shorter regimens . The aim of this study was to compare 3- and 4-month combination regimens of isoniazid plus rifampin with a 9-month regimen of isoniazid monotherapy for the treatment of LTBI in children . METHODS This prospect i ve , r and omized , controlled study was conducted over an 11-year period ( 1995 - 2005 ) . In period 1 ( 1995 - 1998 ) , 232 patients received isoniazid therapy for 9 months ( group A ) , and 238 patients received isoniazid and rifampin for 4 months ( group B ) . In period 2 ( 1999 - 2002 ) , 236 patients were treated with isoniazid and rifampin for 4 months ( group C ) , and 220 patients received the same regimen for 3 months ( group D ) . All patients were observed for > or = 3 years . RESULTS Overall compliance with treatment was good , but patients who received isoniazid monotherapy were less compliant than were those who received short-course combination therapy ( P=.011 , for group A vs. group B ; P=.510 , for group C vs. group D ) . No patient in any group developed clinical disease during the follow-up period . New radiographic findings suggestive of possible active disease were more common in patients who received isoniazid monotherapy ( 24 % ) than in those treated with shorter regimens ( 11.8 % , 13.6 % , and 11 % for groups B , C , and D , respectively ; P=.001 for group A vs. group B ; P=.418 for group C vs. group D ) . Serious drug-related adverse effects were not detected . CONCLUSIONS Short-course treatment with isoniazid and rifampin for 3 - 4 months is safe and seems to be superior to a 9-month course of isoniazid monotherapy Background Treatment of latent tuberculosis infection ( LTBI ) is a key component in U.S. tuberculosis control , assisted by recent improvements in LTBI diagnostics and therapeutic regimens . Effectiveness of LTBI therapy , however , is limited by patients ’ willingness to both initiate and complete treatment . We aim ed to evaluate the demographic , medical , behavioral , attitude-based , and geographic factors associated with LTBI treatment initiation and completion of persons presenting with LTBI to a public health tuberculosis clinic . Methods Data for this prospect i ve cohort study were collected from structured patient interviews , self-administered question naires , clinic intake forms , and U.S. census data . All adults ( > 17 years ) who met CDC guidelines for LTBI treatment between January 11 , 2008 and May 6 , 2009 at Wake County Health and Human Services Tuberculosis Clinic in Raleigh , North Carolina were included in the study . In addition to traditional social and behavioral factors , a three-level medical risk variable ( low , moderate , high ) , based on risk factors for both progression to and transmission of active tuberculosis , was included for analysis . Clinic distance and neighborhood poverty level , based on percent residents living below poverty level in a person ’s zip code , were also analyzed . Variables with a significance level < 0.10 by univariate analysis were included in log binomial models with backward elimination . Models were used to estimate risk ratios for two primary outcomes : ( 1 ) LTBI therapy initiation ( picking up one month ’s medication ) and ( 2 ) therapy completion ( picking up nine months INH therapy or four months rifampin monthly ) . Results 496 persons completed medical interviews and question naires addressing social factors and attitudes toward LTBI treatment . 26 % persons initiated LTBI therapy and 53 % of those initiating completed therapy . Treatment initiation predictors included : a non-employment reason for screening ( RR 1.6 , 95 % CI 1.0 - 2.5 ) , close contact to an infectious TB case ( RR 2.5 , 95 % CI 1.8 - 3.6 ) , regular primary care(RR 1.4 , 95 % CI 1.0 - 2.0 ) , and history of incarceration ( RR 1.7 , 95 % CI 1.0 - 2.8 ) . Persons in the “ high ” risk category for progression/transmission of TB disease had higher likelihood of treatment initiation ( p < 0.01 ) , but not completion , than those with lower risk . Conclusions Investment in social support and access to regular primary care may lead to increased LTBI therapy adherence in high-risk population Context Guidelines from the American Thoracic Society and Centers for Disease Control and Prevention for treating latent tuberculosis infection advocate 2 months of rifampin plus pyrazinamide as an effective alternative to 6 to 9 months of isoniazid or 4 months of rifampin . However , case reports have described severe liver injury in patients who were receiving the 2-month regimen . Contribution This nonr and omized , open-label trial found that the risk for grade 3 or 4 liver injury was higher in patients taking 2 months of rifampin plus pyrazinamide ( 7.7 % ) than in patients taking 6 months of isoniazid ( 1 % ) . Clinical Implication s If clinicians use the short-course regimen , they should vigilantly follow patients ' liver enzyme levels . The Editors As rates of tuberculosis cases in the United States have decreased ( 1 , 2 ) , the focus of prevention and control efforts has shifted toward identification and treatment of persons with latent tuberculosis infection who are at increased Output:	A positive effect on completion was noted in intervention studies that used short regimens and social interventions ; mixed results were found for intervention studies that used DOT or incentives . Conclusion LTBI treatment completion can be improved by using shorter regimens and social interventions .
MS2867	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Warfarin is an anticoagulant medication that is challenging to manage . Dabigatran has been approved by the FDA for stroke and systemic embolism prevention in non-valvular atrial fibrillation as an alternative to warfarin . Dabigatran does not require routine monitoring , has an established dose , and lacks many of the drug , herbal , and food interactions that afflict warfarin . To evaluate patients ’ satisfaction with their current warfarin treatment and their opinion on switching to a newly marketed medication ( dabigatran ) through a brief survey . Two separate surveys were administered to ( 1 ) evaluate the patients ’ opinion of their warfarin therapy and ( 2 ) evaluate their thoughts on switching to a newer anticoagulant . Responses were recorded on a rating scale of 1–5 ; 1 being the least and 5 being the highest . Study was conducted at the Georgia Regents Health System ( GRHS ) pharmacy-based anticoagulation clinic . Two hundred sixty patients on warfarin treatment were enrolled . Patients expressed high satisfaction with warfarin treatment ( 4.7 ± 0.78 ) . However , a vast majority of the patients were willing to switch to an agent that : requires less frequent follow-up visits ( 3.9 ± 1.35 ) ; lacks interaction with food and /or beverage ( 4.1 ± 1.25 ) ; is as efficacious as warfarin ( 3.7 ± 1.38 ) . Patients expressed that out-of-pocket cost would be a major barrier to switch to this new medication ( 1.3 ± 0.58 ) . Patients are satisfied with their warfarin treatment but willing to consider a new anticoagulant . Cost was highlighted as the most significant barrier . Efficacy , dietary freedom and less frequent visits are the major factors affecting the patients ’ decision Introduction Reporting r and omised controlled trials is a key element in order to disseminate research findings . The CONSORT statement was introduced to improve the reporting quality . We assessed the adherence to the CONSORT statement of r and omised controlled trials published 2011 in the top ten ranked journals of critical care medicine ( ISI Web of Knowledge 2011 , Thomson Reuters , London UK ) . Methods Design . We performed a retrospective cross sectional data analysis . Setting . This study was executed at the University Hospital of RWTH , Aachen . Participants . We selected the following top ten listed journals according to ISI Web of Knowledge ( Thomson Reuters , London , UK ) critical care medicine ranking in the year 2011 : American Journal of Respiratory and Critical Care Medicine , Critical Care Medicine , Intensive Care Medicine , CHEST , Critical Care , Journal of Neurotrauma , Resuscitation , Pediatric Critical Care Medicine , Shock and Minerva Anestesiologica . Main outcome measures . We screened the online table of contents of each included journal , to identify the r and omised controlled trials . The adherence to the items of the CONSORT Checklist in each trial was evaluated . Additionally we correlated the citation frequency of the articles and the impact factor of the respective journal with the amount of reported items per trial . Results We analysed 119 r and omised controlled trials and found , 15 years after the implementation of the CONSORT statement , that a median of 61,1 % of the checklist-items were reported . Only 55.5 % of the articles were identified as r and omised trials in their titles . The citation frequency of the trials correlated significantly ( rs = 0,433 ; p<0,001 and r = 0,331 ; p<0,001 ) to the CONSORT statement adherence . The impact factor showed also a significant correlation to the CONSORT adherence ( r = 0,386 ; p<0,001 ) . Conclusion The reporting quality of r and omised controlled trials in the field of critical care medicine remains poor and needs considerable improvement BACKGROUND Noncompliant patients might be at risk of thromboembolism because of the short half-life and rapid offset of dabigatran etexilate . The assessment and management of dabigatran noncompliance should be optimized . METHODS AND RESULTS A total of 150 nonvalvular atrial fibrillation patients receiving dabigatran were prospect ively enrolled and followed for drug compliance and persistence . Noncompliance was identified by question naires and interviews . The hemoclot thrombin inhibitor ( HTI ) assay was used for monitoring the plasma dabigatran levels . Sixteen patients were noncompliant ( 10.7 % ) . None of the clinical characteristics were significantly relevant to noncompliance after multivariate analysis . The dabigatran plasma level based on HTI was the only independent predictor of noncompliance ( odds ratio : 0.97 per ng/mL , P = 0.003 ) . The prothrombin time ( PT ) , international normalized ratio of PT ( INR [ PT ] ) , and activated partial thromboplastin time did not differ between compliant and noncompliant patients . During the follow-up , the persistent prescription of dabigatran was noted in 75 % of noncompliant patients without improvement in compliance . The drug discontinuation rate was higher in the noncompliant than compliant patients ( 6.7 % vs. 25 % , P = 0.035 ) . None of the patients in either group received warfarin after discontinuing dabigatran . CONCLUSIONS The assessment and management of dabigatran noncompliance is generally ignored in clinical practice . The measurement of dabigatran plasma levels by HTI could be a reliable and simple method to identify noncompliant patients CONTEXT Decision aids are tools design ed to help patients participate in the clinical decision-making process . OBJECTIVE To determine whether use of an audiobooklet ( AB ) decision aid explaining the results of a clinical trial affected the decision-making process of study participants . DESIGN R and omized controlled trial conducted from May 1997 to April 1998 . SETTING Fourteen centers that participated in the Stroke Prevention in Atrial Fibrillation ( SPAF ) III trial . PARTICIPANTS A total of 287 patients from the SPAF III aspirin cohort study , in which patients with atrial fibrillation and a relatively low risk of stroke received 325 mg/d of aspirin and were followed up for a mean of 2 years . INTERVENTION At the end of SPAF III , participants were r and omized to be informed of the study results with usual care plus use of an AB ( AB group ) vs usual care alone ( control group ) . The AB included pertinent information to help patients decide whether to continue taking aspirin or switch to warfarin . MAIN OUTCOME MEASURES Patients ' ability to make choices regarding antithrombotic therapy , and 6-month adherence to these decisions . Their knowledge , expectations , decisional conflict ( the amount of uncertainty about the course of action to take ) , and satisfaction with the decision-making process were also measured . RESULTS More patients in the AB group made a choice about antithrombotic therapy than in the control group ( 99 % vs 94 % ; P = .02 ) . Patients in the AB group were more knowledgeable and had more realistic expectations about the risk of stroke and hemorrhage ( in the AB group , 53%-80 % correctly estimated different risks ; in the control group , 16%-28 % gave correct estimates ) . Decisional conflict and satisfaction were similar for the 2 groups . After 6 months , a similar percentage of patients were still taking their initial choice of antithrombotic therapy ( 95 % vs 93 % ; P = .44 ) . CONCLUSIONS For patients with atrial fibrillation who had participated in a major clinical trial , the use of an AB decision aid improved their underst and ing of the benefits and risks associated with different treatment options and helped them make definitive choices about which therapy to take . Further studies are necessary to evaluate the acceptability and impact of decision aids in other clinical setting BACKGROUND Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use . Dabigatran is a new oral direct thrombin inhibitor . METHODS In this noninferiority trial , we r and omly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive , in a blinded fashion , fixed doses of dabigatran--110 mg or 150 mg twice daily -- or , in an unblinded fashion , adjusted-dose warfarin . The median duration of the follow-up period was 2.0 years . The primary outcome was stroke or systemic embolism . RESULTS Rates of the primary outcome were 1.69 % per year in the warfarin group , as compared with 1.53 % per year in the group that received 110 mg of dabigatran ( relative risk with dabigatran , 0.91 ; 95 % confidence interval [ CI ] , 0.74 to 1.11 ; P<0.001 for noninferiority ) and 1.11 % per year in the group that received 150 mg of dabigatran ( relative risk , 0.66 ; 95 % CI , 0.53 to 0.82 ; P<0.001 for superiority ) . The rate of major bleeding was 3.36 % per year in the warfarin group , as compared with 2.71 % per year in the group receiving 110 mg of dabigatran ( P=0.003 ) and 3.11 % per year in the group receiving 150 mg of dabigatran ( P=0.31 ) . The rate of hemorrhagic stroke was 0.38 % per year in the warfarin group , as compared with 0.12 % per year with 110 mg of dabigatran ( P<0.001 ) and 0.10 % per year with 150 mg of dabigatran ( P<0.001 ) . The mortality rate was 4.13 % per year in the warfarin group , as compared with 3.75 % per year with 110 mg of dabigatran ( P=0.13 ) and 3.64 % per year with 150 mg of dabigatran ( P=0.051 ) . CONCLUSIONS In patients with atrial fibrillation , dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin , as well as lower rates of major hemorrhage . Dabigatran administered at a dose of 150 mg , as compared with warfarin , was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage . ( Clinical Trials.gov number , NCT00262600 . BACKGROUND Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects . The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known . METHODS We conducted a r and omized , double-blind , double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation ( median follow-up , 2.8 years ) . The primary efficacy end point was stroke or systemic embolism . Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period . The principal safety end point was major bleeding . RESULTS The annualized rate of the primary end point during treatment was 1.50 % with warfarin ( median time in the therapeutic range , 68.4 % ) , as compared with 1.18 % with high-dose edoxaban ( hazard ratio , 0.79 ; 97.5 % confidence interval [ CI ] , 0.63 to 0.99 ; P<0.001 for noninferiority ) and 1.61 % with low-dose edoxaban ( hazard ratio , 1.07 ; 97.5 % CI , 0.87 to 1.31 ; P=0.005 for noninferiority ) . In the intention-to-treat analysis , there was a trend favoring high-dose edoxaban versus warfarin ( hazard ratio , 0.87 ; 97.5 % CI , 0.73 to 1.04 ; P=0.08 ) and an unfavorable trend with low-dose edoxaban versus warfarin ( hazard ratio , 1.13 ; 97.5 % CI , 0.96 to 1.34 ; P=0.10 ) . The annualized rate of major bleeding was 3.43 % with warfarin versus 2.75 % with high-dose edoxaban ( hazard ratio , 0.80 ; 95 % CI , 0.71 to 0.91 ; P<0.001 ) and 1.61 % with low-dose edoxaban ( hazard ratio , 0.47 ; 95 % CI , 0.41 to 0.55 ; P<0.001 ) . The corresponding annualized rates of death from cardiovascular causes were 3.17 % versus 2.74 % ( hazard ratio , 0.86 ; 95 % CI , 0.77 to 0.97 ; P=0.01 ) , and 2.71 % ( hazard ratio , 0.85 ; 95 % CI , 0.76 to 0.96 ; P=0.008 ) , and the corresponding rates of the key secondary end point ( a composite of stroke , systemic embolism , or death from cardiovascular causes ) were 4.43 % versus 3.85 % ( haz Output:	Severe stroke was associated with the greatest disutility among AF outcomes and most patients value the stroke prevention efficacy of therapy more than other attributes . Patients ' therapy preferences usually align with their values when individualised risk information is presented , although divergence from this is common . Patients value the attributes of NOACs but frequently do not prefer NOACs over warfarin when all therapy-related attributes are considered . In conclusion , patients ' values and preferences for SPAF antithrombotic therapy are heterogeneous and there is no substitute for directly clarifying patients ' individual values and preferences .
MS2868	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: To assess whether chlorambucil or cyclophosphamide may have a better therapeutic index in patients with idiopathic membranous nephropathy , we compared two regimens based on a 6-mo treatment , alternating every other month methylprednisolone with chlorambucil or methylprednisolone with cyclophosphamide . Patients with biopsy-proven membranous nephropathy and with a nephrotic syndrome were r and omized to be given methylprednisolone ( 1 g intravenously for 3 consecutive days followed by oral methylprednisolone , 0.4 mg/kg per d for 27 d ) alternated every other month either with chlorambucil ( 0.2 mg/kg per d for 30 d ) or cyclophosphamide ( 2.5 mg/kg per d for 30 d ) . The whole treatment lasted 6 mo ; 3 mo with corticosteroids and 3 mo with one cytotoxic drug . Among 87 patients followed for at least 1 yr , 36 of 44 ( 82 % ; 95 % confidence interval [ CI ] , 67.3 to 91.8 % ) assigned to methylprednisolone and chlorambucil entered complete or partial remission of the nephrotic syndrome , versus 40 of 43 ( 93 % ; 95 % CI , 80.9 to 98.5 % ) assigned to methylprednisolone and cyclophosphamide ( P = 0.116 ) . Of patients who attained remission of the nephrotic syndrome , 11 of 36 in the chlorambucil group ( 30.5 % ) and 10 of 40 in the cyclophosphamide group ( 25 % ) had a relapse of the nephrotic syndrome between 6 and 30 mo . The reciprocal of plasma creatinine improved in the cohort groups followed for 1 yr for both treatment groups ( P < 0.01 ) and remained unchanged when compared with basal values in the cohort groups followed for 2 and 3 yr . Six patients in the chlorambucil group and two in the cyclophosphamide group did not complete the treatment because of side effects . Four patients in the chlorambucil group but none in the cyclophosphamide group suffered from herpes zoster . One patient per group developed cancer . It is concluded that in nephrotic patients with idiopathic membranous nephropathy both treatments may be effective in favoring remission and in preserving renal function for at least 3 yr BACKGROUND We conducted a pilot trial to compare the effectiveness and safety of 2 different treatments in patients with membranous nephropathy and nephrotic syndrome . METHODS To vali date the hypothesis that the 2 treatments were equivalent , patients with biopsy-proven membranous nephropathy and nephrotic syndrome were r and omly assigned to methylprednisolone alternated with a cytotoxic drug every other month for 6 months ( group A ) or to intramuscular synthetic adrenocorticotropic hormone administered twice a week for 1 year ( group B ) . RESULTS The primary outcome measure is cumulative number of remissions as a first event . Fifteen of 16 patients in group A and 14 of 16 patients in group B entered complete or partial remission as a first event . After a median follow-up of 24 months ( interquartile range , 15 to 25 months ) , there were 4 complete remissions and 8 partial remissions in group A versus 8 complete remissions and 6 partial remissions in group B. Median proteinuria decreased from protein of 5.1 g/d ( interquartile range , 4.0 to 7.3 g/d ) to 2.1 g/d ( interquartile range , 0.4 to 3.8 g/d ; P = 0.004 ) in group A and 6.0 g/d ( interquartile range , 4.4 to 8.5 g/d ) to 0.3 g/d ( interquartile range , 0.2 to 1.9 g/d ; P = 0.049 ) in group B. Two patients from each group interrupted treatment because of side effects or inefficacy . CONCLUSION Most nephrotic patients with membranous nephropathy responded to either treatment . Proteinuria was significantly decreased with both methylprednisolone and cytotoxic agents or prolonged administration of synthetic adrenocorticotropic hormone , without significant differences between these 2 therapies In this retrospective non-r and omized study we review ed the outcome for 41 patients with membranous nephropathy older than 65 years at onset and followed for at least 1 year . Twelve of the patients never received any specific treatment ( group A ) , 15 were treated with a 6-month course of methylprednisolone alternated to chlorambucil every other month ( group B ) , and 14 received corticosteroids alone for 3 - 12 months ( group C ) . At the end of a mean follow-up of 92 + /- 61 months in group A , 53 + /- 35 in group B , and 38 + /- 25 in group C there were significantly more remissions of nephrotic syndrome in group B than in group A ( P = 0.035 ) or in group C ( P = 0.010 ) . Moreover patients in group B spent a significantly longer period without nephrotic syndrome than patients in group A ( P = 0.000 ) and C ( P = 0.000 ) . Three patients in group A and one in group B died . During the follow-up six patients of group A , two of group B , and five of group C developed renal function deterioration . In patients followed for at least 5 years the mean plasma creatinine increased from a basal of 112 + /- 29 to 239 + /- 287 mumol/l at the 5th year in group A and from 113 + /- 14 to 124 + /- 30 mumol/l in group B. The mean urine protein excretion remained unchanged in group A ( basal 4.6 + /- 2.3 versus 4.8 + /- 5.7 g/day at 5 years ) while it decreased in group B ( from a basal of 6.8 + /- 3.5 to 1.1 + /- 0.4 g/day at 5 years ) . ( ABSTRACT TRUNCATED AT 250 WORDS Patients with various forms of glomerulonephritis , but excluding those with minimal glomerular changes , were admitted to a controlled trial of a regimen which combined azathioprine in a dosage of 2·5 mg/kg/day with prednisone in a dosage of 20 mg/day ( adults ) or 0·5 mg/kg/day ( children ) . Of 149 patients included , 32 of them under the age of 15 , 72 were r and omly allocated to the “ treatment ” group and 77 to the “ control ” group . There was no evidence of benefit from the treatment group as a whole ; and the mortality was in fact higher in the treated group Patients with membranous glomerulonephritis ( MGN ) , impaired renal function and the nephrotic syndrome are at high risk of developing renal failure . Twenty-six such patients were studied with serum creatinine concentrations exceeding 135 microM , and 24-hour urine protein excretion of at least 3.5 g/day to determine the potential benefit of cyclophosphamide therapy . Cyclophosphamide ( mean 1.5 mg/kg/day ) was given to nine patients for 23 + /- 4 months . These patients were compared with 17 concurrent controls . The two groups did not differ in clinical or laboratory features at the time of biopsy or start of treatment or its equivalent . Six of the nine cyclophosphamide treated patients and 15 of the 17 controls had received prednisone therapy . The total follow-up was 49 + /- 10 months in the treated group and 50 + /- 6 months in the controls . At last observation , serum creatinine values exceeded 400 microM in eight controls ( 4 on dialysis ) and in none of the treated patients . The mean serum creatinine level was significantly lower ( P less than 0.02 ) in the treated group ( 173 + /- 24 microM ) than in controls ( 433 + /- 71 0.02 ) in the treated group ( 173 + /- 24 microM ) than in controls ( 433 + /- 71 microM ) . The mean serum albumin level and 24-hour urine protein excretion both improved significantly with treatment as compared with controls . There were four complete remissions , five partial remissions and no patient with persistent nephrotic syndrome after treatment . In the controls , there were no complete remissions , six partial remissions and 11 patients had persistent nephrotic syndrome ( P less than 0.001 ) . Thus , cyclophosphamide therapy appears to be of benefit in patients with MGN , the nephrotic syndrome and impaired renal function Because of the high rate of spontaneous remission , treatment of membranous nephropathy with prednisolone and chlorambucil is still controversial . The aim of this study was to give this therapy only to those patients at risk of developing renal insufficiency and to test the efficacy of a low-dose therapeutic regimen . Seventeen patients with more than 10 g protein excretion per day ( mean 16.9 ) and /or a deterioration in renal function ( mean serum creatinine , 162 μmol/l ) were included . Serum total protein , serum lipids , proteinuria , serum creatinine , and blood pressure were measured , along with the diuretic and antihypertensive medication . The observation time before the start of treatment was 27 ± 27 months . Steroids were given during months 1 , 3 , and 5 ( methylprednisolone 3 × 500 mg intravenously ) prednisolone 0.5 mg/kgBW daily per os for 1 week , then tapered by 0.1 mg/kg BW/week for 1 month . Chlorambucil was given during months 2 , 4 , and 6 at a dose of 0.12 mg/kgBW daily . At the end of treatment proteinuria had significantly decreased ( mean of all patients , 7.8 ± 1.4 g/d ) in all patients . Six months after the end of treatment proteinuria was significantly lower than at baseline in 14 of 17 patients . Hypoproteinemia and hyperlipidemia had improved ; diuretic and antihypertensive medication were reduced . Elevated serum creatinine decreased in 7 of 9 patients ( pretreatment , 227 ± 39 μmol/1 ; 6 months , 176 ± 28 μmol/l ) . Nonresponders with respect to serum creatinine responded with respect to proteinuria . Regarding adverse effects , two patients complained of dyspepsia while taking steroids ; during chlorambucil treatment two patients experienced nausea and lack of appetite , and one developed leukopenia ( 1600/μl ) . Chlorambucil was stopped and cell counts normalized 2 weeks later . We conclude that low-dose prednisolone/chlorambucil is both safe and efficient in the majority of patients with severe membranous nephropathy Controlled trial of cyclophosphamide in idiopathic membranous nephropathy . We evaluated cyclophosphamide treatment in a controlled prospect i ve study of 22 adult patients with clinical ly and histologically defined idiopathic membranous nephropathy . By r and om assignment , 11 patients received no drug and 11 patients received cyclophosphamide orally , 1.5 to 2.5 mg/kg/day ( mean , 1.8 ) , for one year . Before treatment , the two groups were similar in age and sex distributions , duration of illness , blood pressure , degree of proteinuria , renal function and histologic staging . After treatment , a downward trend in proteinuria was noted , with no significant difference in the quantity and rate of decrease between groups . Renal function ( C in and C PAH ) was stable in all patients , with no difference between groups . On comparing pretreatment and one-year renal biopsy specimens in eight patients in each group , regardless of treatment or clinical outcome , the appearance of the renal lesions remained the same or progressed in terms of basement membrane thickening and incorporation of subepithelial deposits , and immunofluorescence with IgG and C3 remained positive in glomerular capillaries . Cyclophosphamide dosage was decreased in five patients because of recurrent leukopenia ; no other major toxicity was observed . Beyond one year of treatment , renal function has decreased in two of eight patients in the no-drug group and in one of seven patients in the cyclophosphamide-treated group . We conclude that treatment with cyclophosphamide for one year did not have a favorable effect on proteinuria , renal function or morphologic aspects of the glomerular lesion . Essai controle du cyclophosphamide dans la nephropathie membraneuse idiopathique . Nous avons evalue le traitement par le cyclophosphamide dans une etude prospect i ve controlee de 22 malades adultes atteints de nephropathie membraneuse idiopathique cliniquement et anatomiquement definie . Au hasard , onze malade n'ont recu aucun traitement et onze autres ont eu du cyclophosphamide par voie orale a raison de 1,5 a 2,5 mg/kg par jour ( 1 Output:	In patients with MN , nephrotic syndrome and normal renal function , methylprednisolone and chlorambucil or cyclophosphamide for 6 months alternately increase the probability of nephritic syndrome remission ( evidence from SR ) and long-term renal protection ( evidence from RCT ) . Other drugs ( ACTH and cyclosporine ) are associated with nephrotic syndrome remission , but there is no evidence of significant effects on renal function ( evidence from RCT ) . In patients with impaired renal function , association of corticosteroids and cytotoxic agents is proven to cause a short-term delay of renal damage progression , even though benefits are counterbalanced by complications ( evidence from RCT ) .
MS2869	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective : The aim of this study is to evaluate the effectiveness of life review ( LR ) based on specific positive events in non-depressed older adults taking part in an active aging program . Method : Fifty-five older adults were r and omly assigned to an experimental group or an active control ( AC ) group . A six-session individual training of LR based on specific positive events was carried out with the experimental group . The AC group undertook a “ media workshop ” of six sessions focused on learning journalistic techniques . Pre-test and post-test measures included life satisfaction , depressive symptoms , experiencing the environment as rewarding , and autobiographical memory ( AM ) scales . Results : LR intervention decreased depressive symptomatology , improved life satisfaction , and increased specific memories . Discussion : The findings suggest that practice in AM for specific events is an effective component of LR that could be a useful tool in enhancing emotional well-being in active aging programs , thus reducing depressive symptoms Surviving events that have posed a serious threat to life can result in major psychological problems during the recovery period . Younger patients , with years of life ahead of them , are at risk of depression and loss of self-esteem following their ordeal , despite their physical recovery . Traditional forms of counselling and psychotherapy following traumatic events can sometimes carry a stigma and be viewed as ' disease centred ' . Reminiscence and life review therapies , used until now , with the elderly , appear to have valuable transferable benefits to younger survivors of critical illness . Life review and reminiscent interventions are holistic and person centred , techniques resonating with the essence of critical care nursing . Life review and reminiscence can be used therapeutically from an early stage to help minimize the negative psychological effects of being critically ill The purpose of this r and omized , controlled trial was to test the efficacy of a community-based intervention , the Life Story Workshop , on depressive symptoms , operationalized as depression subscale scores on the Brief Symptom Inventory 18 , in adults age 60 and older . Thirty-three men and women were r and omly assigned to one of two groups : an intervention group that attended 2-hour workshops once a week for 10 weeks or a wait-list control group . The intervention provided an opportunity for older participants to reflect on , write , and share stories about their lived and current lives . The depression subscale of the Brief Symptom Inventory 18 was administered before and after the workshops . Mean depression scores were compared using Welch 's t test . A significant improvement was measured for the intervention group compared with the control group ( p = .03 ) . This research supports the Life Story Workshop as an effective intervention for improving depressive symptoms in older adults OBJECTIVE This study was aim ed at evaluating whether a Life Review Group Program ( LRGP ) improved the self-esteem and life satisfaction in the elderly . METHODS This r and omized , controlled trial consisted of 75 elderly males from a Veterans ' Home in Northern Taiwan , 36 of whom were in the experimental group and 39 of whom were in the control group . The subjects in the experimental group participated in an 8-week LRGP . Data were collected before and after the LRGP and again 1 month after the end of the program . RESULTS The study subjects had a mean age of 78.13 years . The generalized estimating equation was used to compare alterations in the self-esteem and life satisfaction of the elderly before and after the intervention . The alterations in self-esteem and life satisfaction in the experimental group after the LRGP were significantly improved compared to the control group . One month after the LRGP was completed , the self-esteem and life satisfaction of the experimental group continued to improve when compared with pre-intervention levels . CONCLUSIONS Based on these results , the LRGP can potentially improve the self-affirmation , confidence , and self-esteem of the elderly and promote short-term life satisfaction . The results of this study provide a model for clinical evidence -based therapy , serving as a reference for related studies and evaluation of health-promoting programs , as well as improving the health and quality of care of the elderly BACKGROUND France has high rates of psychotropic drug consumption and suicide in the elderly population , but it has not yet been possible to determine whether this is due to exceptionally high morbidity rates . AIMS To describe the first longitudinal population study of psychiatric disorder undertaken in France , and to estimate current and lifetime prevalences and age of onset of psychiatric disorder . METHOD A study group of 1873 non-institutionalised persons aged 65 years and over was r and omly recruited from the Montpellier district electoral rolls . The Mini International Neuropsychiatric Interview was used to assess current and lifetime symptoms . Cases identified by the application of DSM-IV criteria were re-examined by a clinical panel . RESULTS Forty-six per cent of the study population had experienced a mental disorder in their lifetime , and 3.7 % had made a suicide attempt . Lifetime prevalence of major depression was 26.5 % and 30 % for anxiety disorders . Current prevalence rates were 14.2 % for anxiety disorders , 10.7 % for phobia , 3 % for major depression and 1.7 % for psychosis . CONCLUSIONS Results show very high rates of lifetime but not current major depression . Rates of current phobia and suicidal ideation in the very elderly are also high compared with other studies . The rates reported are likely to be underestimates This study examined the underlying variables of selected reminiscing processes to determine those that contributed to well-being . Two hundred and forty subjects r and omly selected from nursing homes and high-rises participated in one of 10 different reminiscing modalities for eight weeks . Measures of life satisfaction ( LSI-A ) , psychological well being ( ABS ) , self-esteem ( SES ) , and depression ( BDI ) were given pre- and postintervention to determine the most therapeutic treatment modalities . Results showed the most therapeutic way to reminisce was through a structured , evaluative life review performed on an individual basis . Thus , three variables contributed to successful reminiscing : individuality ( one-to-one reminiscing ) , evaluation ( a personal valuing of events ) , and structure ( covering the whole life span ) People living with AIDS ( PLWA ) are confronted with uncertainty and their own mortality at an earlier than expected age . Life review , an intervention that has the potential to increase life satisfaction in the elderly experiencing transition points in their lives , may have a similar effect when used with PLWA . Therefore , the purpose of this feasibility study was to explore the use of life review in a sample of 20 PLWA through a r and omized controlled trial of its effectiveness in decreasing depressive symptoms and in increasing self esteem , quality of life , and purpose in life . Compared to the control group , the treatment group had an improved overall quality of life and self-esteem over 12 months , less depressive symptoms over 12 months , and a greater purpose in life at 3 months . The effects that were seen were mainly small to medium effects . The findings from this feasibility study suggest the potential value of life review to enhance quality of life , purpose in life , and self-esteem , and to decrease depressive symptoms in PLWA . Further research is needed with a larger sample and with other groups such as PLWA experiencing virologic failure Background : The objective of this study was to evaluate the mid-term efficacy of life review activities on the quality of life ( QOL ) of the elderly by conducting a r and omized controlled trial , and to identify the factors that should be taken into consideration when conducting life review activities . Methods : Written consent was obtained from 80 of the 97 eligible elderly persons . After r and omly assigning them to two groups , an intervention group and a control group , group life review activities were conducted in the intervention group and discussion activities about health were conducted in the control group . In both the intervention group and the control group , life satisfaction , self-esteem , depression , and hopelessness were evaluated using self-rating scales at three points : at baseline , immediately after completion of the 8 weeks of sessions , and 3 months after completion of the intervention . Results : Repeated measures analysis of covariance showed significant differences between the two groups in the changes in scores for depression ( p = 0.04 ) and hopelessness ( p = 0.04 ) . Regarding the factors that were associated with depression and hopelessness , 3 months after completion of the intervention , depression and hopelessness of a more severe nature at baseline and having greater unresolved conflicts in the past were extracted by multiple regression analysis . Conclusions : The results suggested that group life review activities have a role in assisting the developmental stage of old age and supporting mental health , and have mid- to long-term effectiveness in maintaining and improving the QOL of the elderly Background and aims : As life expectancy rises worldwide and the population grows older , psychopathology in older adults becomes a significant public health concern and intervention methods acquire renewed importance . The aim of the present study was to assess the efficacy of Life Review as an intervention strategy in working with older women with depressive symptoms , specifically through promotion of the specificity of autobiographical memories . Methods : Twenty-two participants were r and omly assigned to experimental or control conditions . Intervention consisted of four individual sessions of Life Review , structured along 14 questions aim ed at prompting autobiographical memory specificity . Participants in the control condition did not receive intervention . Results : Results indicated a significant change in the experimental group , appearing as the reduction of depressive symptoms ( t(20)=3.58 , p<0.05 ) and an increase in life satisfaction ( t(20)=−3.83 , p<0.05 ) , as well as a significant increase in the specificity ( t(20)=−3.46 , p<0.05 ) and positivity ( t(20)=−4.23 , p<0.05 ) of autobiographical memories . All variables reached high effect sizes , with an effect size of r=0.64 regarding depressive symptoms . Conclusions : Results suggest that Life Review is a valuable tool for use with older adults , and that promotion of specific autobiographical memories is a mechanism through which the strategy attains its effectiveness OBJECTIVE We examined the effects of engaging in the occupation-based intervention of life review through writing on expressed depressive symptoms as measured with the Geriatric Depression Scale in older adults residing in senior residences . METHOD The study design was a r and omized controlled trial that took place in four senior residences in New York City . Forty-five participants ( 23 treatment , 22 wait-list control ) ≥ 65 yr old participated in the 8-wk , once-weekly autobiographical writing workshop , Share Your Life Story ( Sierpina , 2002 ) . RESULTS Depressive symptoms were significantly less prevalent for the treatment group than for the control group after the 8-wk life review program ( repeated- measures analysis of variance p = .03 ) . CONCLUSION The results suggest that the Share Your Life Story writing workshop is an effective occupation-based intervention for occupational therapists to use with older adults who reside in senior residences This pilot study sought to determine if the use of Life Review Therapy would result in lower levels of depression and higher degrees of life satisfaction in individuals with right hemisphere cerebral vascular accidents ( CVAs ) . Fourteen subjects in a southern rehabilitation center were r and omly assigned to either an experimental or control group . The experimental group received three one-hour sessions of Life Review Therapy and the control group viewed three one-hour sessions of neutral video with a follow-up discussion . Following the third session of each group , subjects were administered the Zung Scale for Depression and the Life Satisfaction Index — Form Z. A one-way ANOVA revealed a significantly lower level of depression ( p < .01 ) and a significantly higher degree of life satisfaction ( p < .01 ) in the Life Review Therapy group The aim of this study was to examine the efficacy of life review based on autobiographical retrieval practice for treating depressed older adults . Forty-three adults aged 65 - 93 with clinical ly significant depressive symptomatology and no dementia were r and omly assigned to treatment or to no treatment . The results indicated significant differences between experimental and control groups after 4 weeks of autobiographical retrieval practice . At posttest , those in the treatment condition showed fewer depressive symptoms , less hopelessness , improved life satisfaction , and retrieval of more specific events . The findings suggest that practice in autobiographical memory for specific events may be among the components of life review that account for its effectiveness and could be a useful tool in psychotherapy with older adults OBJECTIVES To study the onset and compare risk factors for pure depression ( DEP ) , pure anxiety ( ANX ) , and comorbid anxiety-depression ( ANXDEP ) in the aging population . DESIGN Prospect i ve study with 3-year intervals over a 9-year period . SETTING Data of the Longitudinal Aging Study Amsterdam were used , which is a population -based study among older adults ( 55 - 85 years at baseline ) . PARTICIPANTS Older adults free of depression and anxiety at baseline ( N = 1,712 ) . MEASUREMENTS Clinical ly relevant levels of depression and anxiety were measured with the Center for Epidemiologic Studies Depression scale > or = 16 and Hospital Anxiety and Depression Scale > or = 7 , respectively . A broad range of potential sociodemographic , health , and psychosocial risk factors for anxiety and /or depression were examined by using polytomous logistic regression analyses . RESULTS Within 9 years , 184 subjects ( 10.8 % ) developed DEP , 93 ( 5.4 % ) ANX , and 103 ( 6.0 % ) ANXDEP . Concerning sociodemographics , higher age and lower educational level were predictors for DEP . Health indicators were predictive for DEP and ANXDEP but not for ANX . Depressive symptoms at baseline were predictive for DEP , whereas initial anxiety symptoms were predictive for ANX and ANXDEP . Neuroticism increased the risk of DEP and ANXDEP . Mixed effects of psychosocial variables were found : DEP was associated with recent widowhood , whereas ANX and ANXDEP were associated with Output:	Life review is a worthwhile intervention for reducing depression and hopelessness , and improving quality of life , well-being and specific memory in older adults .
MS2870	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : Intravenous acetaminophen injection ( paracetamol ) is marketed in Europe for the management of acute pain . A repeated-dose , r and omized , double-blind , placebo-controlled , three-parallel group study was performed to evaluate the analgesic efficacy and safety of intravenous acetaminophen as compared with its prodrug ( propacetamol ) and placebo . Propacetamol has been available in many European countries for more than 20 yr . Methods : After orthopedic surgery , patients reporting moderate to severe pain received either 1 g intravenous acetaminophen , 2 g propacetamol , or placebo at 6-h intervals over 24 h. Patients were allowed “ rescue ” intravenous patient-controlled analgesia morphine . Pain intensity , pain relief , and morphine use were measured at selected intervals . Safety was monitored through adverse event reporting , clinical examination , and laboratory testing . Results : One hundred fifty-one patients ( intravenous acetaminophen : 49 ; propacetamol : 50 ; placebo : 52 ) received at least one dose of study medication . The intravenous acetaminophen and propacetamol groups differed significantly from the placebo group regarding pain relief from 15 min to 6 h ( P < 0.05 ) and median time to morphine rescue ( intravenous acetaminophen : 3 h ; propacetamol : 2.6 h ; placebo : 0.8 h ) . Intravenous acetaminophen and propacetamol significantly reduced morphine consumption over the 24-h period : The total morphine doses received over 24 h were 38.3 ± 35.1 mg for intravenous acetaminophen , 40.8 ± 30.2 mg for propacetamol , and 57 . 4 ± 52.3 mg for placebo , corresponding to decreases of −33 % ( 19 mg ) and −29 % ( 17 mg ) for intravenous acetaminophen and propacetamol , respectively . Drug-related adverse events were reported in 8.2 % , 50 % ( most of them local ) , and 17.3 % of patients treated with intravenous acetaminophen , propacetamol , and placebo , respectively . Conclusion : Intravenous acetaminophen , 1 g , administered over a 24-h period in patients with moderate to severe pain after orthopedic surgery provided rapid and effective analgesia and was well tolerated Background A multimodal and preventative approach to providing postoperative analgesia is becoming increasingly popular for children and adults , with the aim of reducing reliance on opioids . We conducted a prospect i ve , r and omized double-blind study to compare the analgesic efficacy of intravenous paracetamol and dipyrone in the early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia . Methods Sixty children scheduled for elective lower abdominal surgery under spinal anesthesia were r and omized to receive either intravenous paracetamol 15 mg/kg , dipyrone 15 mg/kg or isotonic saline . The primary outcome measure was pain at rest , assessed by means of a visual analog scale 15 min , 30 min , 1 h , 2 h , 4 h and 6 h after surgery . If needed , pethidine 0.25 mg/kg was used as the rescue analgesic . Time to first administration of rescue analgesic , cumulative pethidine requirements , adverse effects and complications were also recorded . Results There were no significant differences in age , sex , weight , height or duration of surgery between the groups . Pain scores were significantly lower in the paracetamol group at 1 h ( P = 0.030 ) and dipyrone group at 2 h ( P = 0.010 ) when compared with placebo . The proportion of patients requiring rescue analgesia was significantly lower in the paracetamol and dipyrone groups than the placebo group ( vs. paracetamol P = 0.037 ; vs. dipyrone P = 0.020 ) . Time to first analgesic requirement appeared shorter in the placebo group but this difference was not statistically significant , nor were there significant differences in pethidine requirements , adverse effects or complications . Conclusion After lower abdominal surgery conducted under spinal anesthesia in children , intravenous paracetamol appears to have similar analgesic properties to intravenous dipyrone , suggesting that it can be used as an alternative in the early postoperative period . Trial registration Clinical Trials.gov . Identifier : NCT01858402 BACKGROUND This study assessed the analgesic efficacy , side effects , and time to extubation of intravenous paracetamol when administered as an adjuvant to intravenous meperidine after major surgery in intensive care unit ( ICU ) . MATERIAL Patients were r and omized postoperatively into 2 groups in ICU . Patients received either 100 mL of serum saline intravenous ( IV ) every 6 hours and IV meperidine ( n = 20 group M ) or IV paracetamol 1 g every 6 hours and IV meperidine ( n = 20 , group MP ) into a peripheral vein for 24 hours . Behavioral Pain Scale ( BPS ) is used until extubation , and visual analog score ( VAS ) is used after extubation . When BPS and VAS values were more than 4 , meperidine , 1 mg/kg IV , was administered and noted in 2 groups . Pain scores , total meperidine consumption , time to extubation , sedation scores , and side effects are 24-hour postoperatively noted . RESULTS Behavioral Pain Scale and VAS scores are significantly lower in group paracetamol-meperidine at 24 hours ( P < .05 ) . In group MP , postoperative meperidine consumption ( 76.75 ± 18.2 mg vs. 198 ± 66.4 mg ) and extubation time ( 64.3 ± 40.6 min vs. 204.5 ± 112.7 min ) were lower than in group M ( P < .01 ) . In addition to , postoperative nausea-vomiting and sedation scores were significantly lower in group MP when compared with group M ( P < .05 ) . CONCLUSION We have demonstrated important clinical benefits by the addition of 4 g/d of paracetamol to meperidine after major surgery . This benefit has been shown in a range of patients under routine clinical conditions and therefore has important practical consequences in ICU . These data suggest that intravenous paracetamol is a useful component of the multimodal analgesia model , especially after major surgery OBJECTIVES The purpose of the present study was to determine the efficacy of intravenous ( iv ) paracetamol and iv lornoxicam on postoperative analgesia and the reduction in tramadol consumption . METHODS Sixty patients ( ASA class 1 - 2 , age : 18 - 72 years ) undergoing thyroidectomy were enrolled in the study , and were r and omized into three groups : Group L received 8 mg of iv lornoxicam , Group P received 1 g iv paracetamol and Group C received 100 cc of iv saline solution . All patients received st and ard general anesthesia . The postoperative salvage analgesic consumption was recorded at 0 - 6 , 6 - 12 and 12 - 24 hour ( h ) intervals . Pain scores were evaluated with a visual analogue scale at 15 min , and 1 , 2 , 4 , 6 , 8 , 12 , 18 , and 24 h postoperatively . RESULTS The time to first analgesic requirement was approximately 127.5 min in Group L , 162.3 in Group P and 35.5 min in Group C , and the time was found to be significantly prolonged in Group L and Group P. Pain scores were significantly lower in Group P and Group L at 15 min , and 1 , 8 , 12 , and 18 h. Twenty-four hour analgesic consumption was significantly lower in Group P and Group L compared to Group C. Supplemental analgesics requirement was as follows : 100 % in Group C , 50 % in Group L and 55 % in Group P. The degree of satisfaction with postoperative pain management was excellent in 90 % in Groups L and P , versus in only 30 % in Group C. CONCLUSION Administration of iv lornoxicam and iv paracetamol following thyroid surgery decreased the postoperative pain scores and opioid requirement , as well as the incidence of nausea and vomiting , while also prolonging the time to the first analgesic supplement BACKGROUND The purpose of this r and omized double-blind study was to compare the efficacy and safety of propacetamol 2 g ( an i.v . acetaminophen 1 g formulation ) administered as a 2-min bolus injection ( n=50 ) or a 15-min infusion ( n=50 ) with oral acetaminophen 1 g ( n=50 ) or placebo ( n=25 ) for analgesia after third molar surgery in patients with moderate to severe pain after impacted third molar removal . METHODS All patients were evaluated for efficacy during the initial 6 h period after treatment administration ( T(0 ) ) and for safety during the entire week after T(0 ) . RESULTS The onset of analgesia after propacetamol was shorter ( 3 min for bolus administration , 5 min for 15-min infusion ) than after oral acetaminophen ( 11 min ) . Active treatments were significantly better for all parameters ( pain relief , pain intensity , patient 's global evaluation , duration of analgesia ) than placebo ( P<0.05 ) . Adverse events were more frequent after propacetamol , especially pain at the injection site . Propacetamol bolus result ed in a much higher incidence of local adverse events than the infusion ( propacetamol bolus 90 % vs propacetamol infusion 52 % ) with no clinical ly significant benefits in terms of analgesic efficacy . CONCLUSION I.V. propacetamol , administered as a 15-min infusion , is a fast-acting analgesic agent . It is more effective in terms of onset of analgesia than a similar dose of oral acetaminophen Background In recent years , intravenously ( IV ) administered acetaminophen has become one of the most common perioperative analgesics . Despite its now-routine use , IV acetaminophen ’s analgesic comparative efficacy has never been compared with that of ketamine , a decades-old analgesic familiar to obstetricians , gynecologists , and anesthesiologists alike . This doubleblind clinical trial aim ed to evaluate the analgesic effects of ketamine and IV acetaminophen on postoperative pain after abdominal hysterectomy . Methods Eighty women aged 25–70 years old and meeting inclusion and exclusion criteria were r and omly allocated into two groups of 40 to receive either IV acetaminophen or ketamine intraoperatively . Postoperatively , each patient had patient-controlled analgesia . Pain and sedation ( Ramsay Sedation Scale ) were documented based on the visual analog scale in the recovery room and at 4 hours , 6 hours , 12 hours , and 24 hours after the surgery . Hemodynamic changes , adverse medication effects , and the need for breakthrough meperidine were also recorded for both groups . Data were analyzed by repeated- measures analysis of variance . Results Visual analog scale scores were significantly lower in the IV acetaminophen group at each time point ( P<0.05 ) , and this group required significantly fewer doses of breakthrough analgesics compared with the ketamine group ( P=0.039 ) . The two groups had no significant differences in terms of adverse effects . Conclusion Compared with ketamine , IV acetaminophen significantly improved postoperative pain after abdominal hysterectomy BACKGROUND Intravenous administration is the route of choice for drug therapy in the immediate postoperative period . Propacetamol ( ProAPAP ) , an injectable prodrug of paracetamol requiring reconstitution , has demonstrated efficacy in managing acute pain and fever . However , it has been associated with pain at the injection site . A stable , ready-to-use formulation of paracetamol solution infused intravenously ( IV-APAP ) has been developed and might be associated with less pain at the injection site compared with ProAPAR . OBJECTIVE The objective of this study was to assess the tolerability and efficacy of a single dose of IV APAP 1 g compared with those of a single dose of ProAPAP 2 g in patients with moderate to severe pain after minor gynecologic surgery . METHODS This single-dose , r and omized , double-blind , active-controlled,2-parallel-group study was conducted at 23 hospitals and outpatient clinics in France . After minor gynecologic surgery , patients reporting moderate to severe pain were r and omized to receive a single 15-minute infusion of IV-APAP 1 g or ProAPAP 2 g ( bioeyuivalent doses ) . Tolerability was monitored using local and systemic adverse event ( AE ) reporting , clinical examination including vital sign measurement , and patients ' ratings of acceptability of the infusion . Efficacy end points included pain intensity at 0 , 1 , 2 , 4 , and 6 hours ; median time to rescue medication ( defined as the time at which 50 % of patients requested rescue medication ) ; and percentage of patients requesting rescue medication . Patients ' satisfaction with the study drugs was assessed using patient 's global evaluation ( PGE ) and the percentage of patients willing to receive the Output:	However , this did not translate to a clinical ly meaningful reduction in opioid-induced adverse events . Adverse events occurred at similar rates with IV paracetamol or IV propacetamol and placebo . Meta- analysis did not demonstrate clinical ly meaningful differences between IV paracetamol/propacetamol and active comparators for any adverse event . Low to very low quality evidence demonstrates that both formulations are associated with few adverse events , although patients receiving IV propacetamol have a higher incidence of pain on infusion than both placebo and IV paracetamol
MS2871	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Prostate cancer incidence was prospect ively studied among 7999 men of Japanese ancestry who were first examined between 1965 and 1968 and then followed through 1986 . During this surveillance period , 174 incident cases of prostate cancer were recorded . Prostate cancer was not associated with any measure of socioeconomic status , including amount of education , type of occupation , and type of residence . There was also no relationship with the number of children , as a surrogate measure of sexual activity . Increased consumption of rice and tofu were both associated with a decreased risk of prostate cancer , while consumption of seaweeds was associated with an increased risk of prostate cancer . There was no relationship between prostate cancer and the intake of various nutrients , including total fat and total protein . Etiological implication s of these associations are discussed , but more research is needed on these dietary factors and the subsequent development of prostate cancer before any firm conclusions can be drawn Green and black tea have shown promise in the chemoprevention of prostate cancer . The objective of this study was to determine the bioavailability and bioactivity of tea polyphenols ( PP ) and theaflavins in human serum and human and mouse tissues . A decaffeinated black tea diet was administered to C57BL/6 mice . PPs and theaflavins were found in the small and large intestine , liver , and prostate in conjugated and free forms . The relative prostate bioavailability of theaflavin was 70 % higher than that of epigallocatechin gallate ( EGCG ) . In the second mouse study , a green tea ( GT ) diet was administered followed by the control diet for 1 - 5 d. Epicatechin ( EC ) , EGCG , and epicatechin gallate ( ECG ) concentrations in prostate tissue were significantly decreased after 1 d of consuming the control diet . Epigallocatechin gallate ( EGC ) , however , did not decrease significantly . For the human study , 20 men scheduled for surgical prostatectomy were r and omly assigned to consume 1.42 L daily of GT , BT , or a caffeine-matched soda control ( SC ) for 5 d before radical prostatectomy . Tea PPs were greater in prostate sample s from men consuming BT and GT than in men consuming SC ( P = 0.0025 ) . Although tea PP were not detectable in serum , ex vivo LNCaP prostate cancer cell proliferation was less when cells were grown in media containing patient serum collected after BT ( P < 0.001 ) and GT ( P = 0.025 ) consumption relative to baseline serum This is the first human study to show that tea polyphenols and theaflavins are bioavailable in the prostate where they may be active in the prevention of prostate cancer The purpose of this study was to determine the effects of short-term supplementation with the active compounds in green tea on serum biomarkers in patients with prostate cancer . Twenty-six men with positive prostate biopsies and scheduled for radical prostatectomy were given daily doses of Polyphenon E , which contained 800 mg of (−)-epigallocatechin-3-gallate ( EGCG ) and lesser amounts of (−)-epicatechin , (−)-epigallocatechin , and (−)-epicatechin-3-gallate ( a total of 1.3 g of tea polyphenols ) , until time of radical prostatectomy . Serum was collected before initiation of the drug study and on the day of prostatectomy . Serum biomarkers hepatocyte growth factor ( HGF ) , vascular endothelial growth factor ( VEGF ) , insulin-like growth factor (IGF)-I , IGF binding protein-3 ( IGFBP-3 ) , and prostate-specific antigen ( PSA ) were analyzed by ELISA . Toxicity was monitored primarily through liver function enzymes . Changes in serum components were analyzed statistically using the Wilcoxon signed rank test . Cancer-associated fibroblasts were treated with EGCG , and HGF and VEGF protein and mRNA levels were measured . HGF , VEGF , PSA , IGF-I , IGFBP-3 , and the IGF-I/IGFBP-3 ratio decreased significantly during the study . All of the liver function tests also decreased , five of them significantly : total protein , albumin , aspartate aminotransferase , alkaline phosphatase , and amylase . The decrease in HGF and VEGF was confirmed in prostate cancer – associated fibroblasts in vitro . Our results show a significant reduction in serum levels of PSA , HGF , and VEGF in men with prostate cancer after brief treatment with EGCG ( Polyphenon E ) , with no elevation of liver enzymes . These findings support a potential role for Polyphenon E in the treatment or prevention of prostate cancer Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The incidence of prostate cancer is much lower in Asian than Western population s. Given that environmental factors such as dietary habits may play a major role in the causation of prostate cancer and the high consumption of green tea in Asian population s , this low incidence may be partly due to the effects of green tea . The JPHC Study ( Japan Public Health Center-based Prospect i ve Study ) was established in 1990 for cohort I and in 1993 for cohort II . The subjects were 49,920 men aged 40 - 69 years who completed a question naire that included their green tea consumption habit at baseline and were followed until the end of 2004 . During this time , 404 men were newly diagnosed with prostate cancer , of whom 114 had advanced cases , 271 were localized , and 19 were of an undetermined stage . Green tea was not associated with localized prostate cancer . However , consumption was associated with a dose-dependent decrease in the risk of advanced prostate cancer . The multivariate relative risk was 0.52 ( 95 % confidence interval : 0.28 , 0.96 ) for men drinking 5 or more cups/day compared with less than 1 cup/day ( p(trend ) = 0.01 ) . Green tea may be associated with a decreased risk of advanced prostate cancer Pre clinical , epidemiologic , and prior clinical trial data suggest that green tea catechins ( GTC ) may reduce prostate cancer risk . We conducted a placebo-controlled , r and omized clinical trial of Polyphenon E ( PolyE ) , a proprietary mixture of GTCs , containing 400 mg (−)-epigallocatechin-3-gallate ( EGCG ) per day , in 97 men with high- grade prostatic intraepithelial neoplasia ( HGPIN ) and /or atypical small acinar proliferation ( ASAP ) . The primary study endpoint was a comparison of the cumulative one-year prostate cancer rates on the two study arms . No differences in the number of prostate cancer cases were observed : 5 of 49 ( PolyE ) versus 9 of 48 ( placebo ) , P = 0.25 . A secondary endpoint comparing the cumulative rate of prostate cancer plus ASAP among men with HGPIN without ASAP at baseline , revealed a decrease in this composite endpoint : 3 of 26 ( PolyE ) versus 10 of 25 ( placebo ) , P < 0.024 . This finding was driven by a decrease in ASAP diagnoses on the Poly E ( 0/26 ) compared with the placebo arm ( 5/25 ) . A decrease in serum prostate-specific antigen ( PSA ) was observed on the PolyE arm [ −0.87 ng/mL ; 95 % confidence intervals ( CI ) , −1.66 to −0.09 ] . Adverse events related to the study agent did not significantly differ between the two study groups . Daily intake of a st and ardized , decaffeinated catechin mixture containing 400 mg EGCG per day for 1 year accumulated in plasma and was well tolerated but did not reduce the likelihood of prostate cancer in men with baseline HGPIN or ASAP . Cancer Prev Res ; 8(10 ) ; 879–87 . © 2015 AACR Purpose Tea is one of the most commonly consumed beverages worldwide . To date , observational data from prospect i ve cohort studies investigating the relationship between green and black tea intake and prostate cancer risk are sparse and equivocal . In a population -based , prospect i ve cohort study of Chinese men in Singapore , we investigated the relationship between green and black tea intake and prostate cancer risk . Methods Tea consumption data for 27,293 men were collected at baseline ( between 1993 and 1998 ) using a vali date d food frequency question naire . After an average of 11.2 years of follow-up , 298 men had developed prostate cancer . Proportional hazards regression methods were used to assess the associations between tea intake and prostate cancer risk . Results There was no association between daily green tea intake and prostate cancer risk , compared with no green tea intake [ hazard ratio ( HR ) = 1.08 ; 95 % confidence interval ( CI ) 0.79 , 1.47 ] . For black tea , a statistically significant positive association and trend were observed for daily intake compared with no black tea intake ( HR = 1.41 , 95 % CI 1.03 , 1.92 ; p for trend < 0.01 ) Conclusions Few prospect i ve data are available from population s that have both a high level and wide range of black and green tea intake ; this study represents a unique opportunity to evaluate their individual effects on prostate cancer risk . Our findings support the notion that green tea intake does not protect against prostate cancer and that black tea intake may increase prostate cancer risk Compelling pre clinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention . We conducted a r and omized , double-blind , placebo-controlled trial of polyphenon E ( enriched green tea polyphenol extract ) in men with prostate cancer scheduled to undergo radical prostatectomy . The study aim ed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis . Participants received either polyphenon E ( containing 800 mg epigallocatechin gallate ) or placebo daily for 3 to 6 weeks before surgery . Following the intervention , green tea polyphenol levels in the prostatectomy tissue were low to undetectable . Polyphenon E intervention result ed in favorable but not statistically significant changes in serum prostate-specific antigen , serum insulin-like growth factor axis , and oxidative DNA damage in blood leukocytes . Tissue biomarkers of cell proliferation , apoptosis , and angiogenesis in the prostatectomy tissue did not differ between the treatment arms . The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on polyphenon E but was not statistically significant . The study 's findings of low bioavailability and /or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols , if occurring , may be through indirect means and /or that the activity may need to be evaluated with longer intervention duration s , repeated dosing , or in patients at earlier stages of the disease . Cancer Prev Res ; 5(2 ) ; 290–8 . © 2011 AACR In a prospect i ve study of 19 561 Japanese men , green-tea intake was not associated with a lower risk of prostate cancer ( 110 cases ) , the multivariate hazard ratio for men drinking ⩾5 cups compared with < 1 cup per day being 0.85 ( 95 % confidence interval 0.50–1.43 , trend P=0.81 ) PURPOSE To evaluate the efficacy and toxicity of green tea , prescribed as an alternative complementary ( CAM ) formulation on hormone refractory prostate cancer ( HRPC ) . METHODS Patients with HRCP were prescribed green tea extract capsules at a dose level of 250 mg twice daily . Efficacy and toxicity were evaluated during monthly visits . The primary endpoint was prostate-specific antigen ( PSA ) or measurable disease progression after a minimum of 2 months of therapy . RESULTS Nineteen patients were enrolled into the study . The treatment was generally well tolerated . Twelve patients reported at least one side effect ; only two of these were of moderate or severe grade . Primary toxicity was related to gastrointestinal irritation or caffeine intake . Four patients did not complete the minimum 2 months of therapy because of : intolerance ( two patients ) , physician stoppage ( one patient ) , death from cerebrovascular accident ( one patient ) . Fifteen patients completed at least 2 months of therapy . Nine of these patients had progressive disease within 2 months of starting therapy . Six patients developed progressive disease after additional 1 to 4 months of therapy . CONCLUSION Green tea , as CAM therapy , was found to have minimal clinical activity against hormone refractory prostate cancer Background and aims . It has been hypothesized that some aspect of a traditional ‘ Asian ’ diet , that is low in animal products and high in soya , may be associated with a reduced risk of prostate cancer . This study aim ed to examine the association between dietary intake and prostate cancer risk among 18,115 men in Hiroshima and Nagasaki , Japan , using prospect i ve data from the Life Span Study . Methods : Subjects completed a food-frequency question naire at baseline ( 1963 , 1965 and /or 1979 ) and were followed for incident prostate cancer until Output:	Findings demonstrate that green tea appears to be an effective chemopreventive agent , particularly in those with high- grade prostate intraepithelial neoplasia . However , evidence of efficacy in the treatment of PCa is currently lacking .
MS2872	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We monitored fluphenazine plasma levels in 39 schizophrenic patients who participated in a 2-year double-blind comparison of 5 mg and 25 mg of fluphenazine decanoate ( FD ) administered every 14 days . We investigated the relationship between log-transformed plasma levels at 3 , 6 , and 9 months and subsequent psychotic exacerbations with logistic regression and survival analysis . Using logistic regression , the relationship was nonsignificant at 3 months ( chi-square = .21 , df = 1 , p = .65 ) , but significant at 6 months ( chi-square = 4.38 , df = 1 , p = .04 ) and 9 months ( chi-square = 8.98 , df = 1 , p = .003 ) . Using survival analysis with fluphenazine levels as a covariate ( Cox models ) , we also found significant relationships between the fluphenazine plasma level and the risk of exacerbations at 6 months ( chi-square = 3.77 , df = 1 , p = .052 ) and 9 months ( chi-square = 12.21 , df = 1 , p = .0005 ) , but not at three months ( chi-square = 0.87 , df = 1 , p = .65 ) . These findings suggest that the measurement of fluphenazine plasma levels may be helpful in decision-making about the dosage of FD A modification of an earlier rating scale for extrapyramidal system disturbance is described , and evidence for the validity and reliability of the scale is presented . The usefulness of the scale in studies of neuroleptic drugs is discussed . By its application it is possible to quantify extrapyramidal side effects and to separate them into four principal factors Output:	There was no differences between the two for outcomes of global improvement , relapse and leaving the study early .
MS2873	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Although some evidence indicates that early detection protects against the development of lethal melanoma , no r and omized clinical trials have been conducted to measure the efficacy of early detection ( or screening ) in preventing death from this disease . Since melanoma incidence in the United States is relatively rare , a r and omized clinical trial to test the efficacy of screening would be extremely expensive . PURPOSE As an alternative to a r and omized clinical trial , we conducted a population -based , case-control study to investigate whether early detection through skin self-examination ( SSE ) is associated with a decreased risk of lethal melanoma ( includes the presence of advanced disease with distant metastases in addition to death from melanoma ) . METHODS SSE ( conducting a careful , deliberate , and purpose ful examination of the skin ) was assessed in all subjects by use of a structured question naire and personal interviews . The major exposure variable , SSE , was defined following focus-group interviews with melanoma patients and healthy control subjects . The final study population consisted of 1199 Caucasian residents of the state of Connecticut enrolled from January 15 , 1987 , through May 15 , 1989 ; 650 individuals were newly diagnosed with cutaneous melanoma , and the remaining 549 individuals were age- and sex-frequency matched control subjects from the general population . During the study interviews , nevi on the arms and backs of subjects were counted . In 5 years of follow-up ( through March 1994 ) , 110 lethal cases of melanoma were identified . The study design allowed separate estimation of the impact of SSE on reduced melanoma incidence ( primary prevention ) and survival among incident cases ( secondary prevention ) . Odds ratios ( ORs ) were used to measure the associations between SSE and melanoma and between SSE and lethal melanoma . RESULTS SSE , practice d by only 15 % of all subjects , was associated with a reduced risk of melanoma incidence ( adjusted OR = 0.66 ; 95 % confidence interval [ CI ] = 0.44 - 0.99 ; comparing case patients with control subjects ) . The data indicated further that SSE may reduce the risk of advanced disease among melanoma patients ( unadjusted risk ratio = 0.58 ; 95 % CI = 0.31 - 1.11 ) ; however , longer follow-up is required to confirm this latter estimate . If both estimates are correct , they suggest , in combination , that SSE may reduce mortality from melanoma by 63 % ( adjusted OR = 0.37 ; 95 % CI = 0.16 - 0.84 ; comparing lethal cases with general population controls ) . CONCLUSIONS AND IMPLICATION S SSE may provide a useful and inexpensive screening method to reduce the incidence of melanoma . SSE may also reduce the development of advanced disease . The results of this study need to be replicated before strategies to increase the practice of SSE are further developed and promoted BACKGROUND In epidemiologic studies , sunscreen use is associated with increased risk of cutaneous melanoma , basal cell skin cancer , and higher numbers of nevi . It has been proposed that sunscreens may encourage prolonged sun exposure because they delay sunburn occurrence . We examined whether , under habitual conditions of sunscreen use , the sun-protection factor ( SPF ) had an influence on sun-exposure duration . METHODS Before the 1997 summer holidays , we r and omly assigned 87 French and Swiss participants who were 18 - 24 years of age to receive an SPF 10 or an SPF 30 sunscreen . Neither medical personnel nor study participants were aware of their sunscreen assignment . Participants were asked to complete daily records of their sun exposure . To avoid influencing the recreational sun-exposure habits of the study participants , no recommendation was made about sun exposure or sun protection . Furthermore , participants were told that the trial end point was the number of pigmented skin lesions before and after the holidays . One subject was lost to follow-up . All statistical tests were two-sided . RESULTS The SPF 10 ( n = 44 ) and SPF 30 ( n = 42 ) groups had equivalent mean holiday duration s ( 19.4 days versus 20.2 days ) and mean quantities of sunscreen used ( 72.3 g versus 71.6 g ) . The mean cumulative sun exposures for the two groups were 58.2 hours and 72.6 hours , respectively ( P = .011 ) . The mean daily duration s of sunbathing were 2.6 and 3.1 hours , respectively ( P = .0013 ) , and , for outdoor activities , they were 3.6 and 3.8 hours , respectively ( P = .62 ) . There was no difference in sunburn experience between the two groups . CONCLUSIONS Use of higher SPF sunscreen seems to increase the duration of recreational sun exposure of young white Europeans Prospect theory suggests that people respond differentially to factually equivalent messages depending on how these messages are framed ( A. Tversky & D. Kahneman , 1981 ) . A. J. Rothman and P. Salovey ( 1997 ) relied on prospect theory to predict that messages highlighting potential " gains " should promote prevention behaviors such as sunscreen use best . This experiment compared the effectiveness of 4 differently framed messages ( 2 highlighting gains , 2 highlighting losses ) to persuade 217 beach-goers to obtain and use sunscreen . Attitudes and intentions were measured before and immediately following the delivery of the framed information , and after completing the question naire participants were given a coupon redeemable for a small bottle of sunscreen later that same day . People who read either of the 2 gain-framed brochures , compared with those who read either of the 2 loss-framed brochures , were significantly more likely to ( a ) request sunscreen , ( b ) intend to repeatedly apply sunscreen while at the beach , and ( c ) intend to use sunscreen with a sun protection factor of 15 or higher OBJECTIVE To examine the role of partner assistance in learning and implementation of an intervention design ed to promote skin self-examination ( SSE ) behaviors in persons at risk of developing melanoma . DESIGN R and omized controlled trial with immediate and 4-month follow-up visits . SETTING Clinical offices in the ambulatory care area of a hospital . Patients The study included 130 participants and their cohabiting partners drawn from a melanoma registry . Intervention The subjects were r and omly assigned to receive the intervention either as solo learning or as dyadic learning . The intervention consisted of a 10-minute demonstration of the ABCDE ( asymmetry of shape , border irregularity , color variegation , diameter > or = 6 mm , and evolution of the lesion ) rule and skills training . MAIN OUTCOME MEASURES Behavioral measures included self-reported performance of SSE and use of a body map design ed to record areas of concern found during SSE . Intentions , along with attitudinal measures such as perceived importance of SSE and self-efficacy in performing SSE , were also assessed at the 4-month follow-up visit . RESULTS The participants in the dyadic learning group were significantly more likely to report engaging in SSE behaviors ( P<.05 ) . The dyadic learning group also exhibited greater intentions to perform future SSE ( P<.01 ) , higher perceived importance of SSE ( P<.01 ) , and higher perceived self-efficacy ( P<.01 ) . CONCLUSION Dyadic learning may be more effective than solo learning in regard to interventions design ed to teach and promote health behaviors , such as SSE Background Skin cancer is the most prevalent yet most preventable cancer in the US . While protecting oneself from ultraviolet radiation ( UVR ) can largely reduce risk , rates of unprotected sun exposure remain high . Because the desire to be tan often outweighs health concerns among sunbathers , very few interventions have been successful at reducing sunbathing behavior . Sunless tanning ( self-tanners and spray tans ) , a method of achieving the suntanned look without UVR exposure , might be an effective supplement to prevention interventions . Methods and Design This cluster r and omized trial will examine whether a beach-based intervention that promotes sunless tanning as a substitute for sunbathing and includes sun damage imaging and sun safety recommendations is superior to a question naire only control group in reducing sunbathing frequency . Female beach visitors ( N = 250 ) will be recruited from 2 public beaches in eastern Massachusetts . Beach site will be the unit of r and omization . Follow-up assessment will occur at the end of the summer ( 1-month following intervention ) and 1 year later . The primary outcome is average sunbathing time per week . The study was design ed to provide 90 % power for detecting a difference of .70 hours between conditions ( st and ard deviation of 2.0 ) at 1-year with an intra-cluster correlation coefficient of 0.01 and assuming a 25 % rate of loss to follow-up . Secondary outcomes include frequency of sunburns , use of sunless tanning products , and sun protection behavior . Discussion Interventions might be improved by promoting behavioral substitutes for sun exposure , such as sunless tanners , that create a tanned look without exposure to UVR.Trial registration Abstract Objective : Whole-body skin self-examination ( SSE ) with presentation of suspicious lesions to a physician may improve early detection of melanoma . The aim of this study was to establish the prevalence and determinants of SSE in a high-risk population in preparation for a community-based r and omised controlled trial of screening for melanoma . Methods : A telephone survey reached 3110 residents older than 30 years ( overall response rate of 66.9 % ) r and omly selected from 18 regional communities in Queensl and , Australia . Results : Overall , 804 ( 25.9 % ) participants reported whole-body SSE within the past 12 months and 1055 ( 33.9 % ) within the past three years . Whole-body SSE was associated in multivariate logistic regression analysis with younger age ( < 50 years ) ; higher education ; having received either a whole-body skin examination , recommendation or instruction on SSE by a primary care physician ; giving skin checks a high priority ; concern about skin cancer and a personal history of skin cancer . Conclusion : Overall , the prevalence of SSE in the present study is among the highest yet observed in Australia , with about one-third of the adult population reporting whole-body SSE in the past threeyears . People over 50 years , who are at relatively higher risk for skin cancer , currently perform SSE less frequently than younger people BACKGROUND Melanoma is a major public health problem for which early detection may reduce mortality . Since melanoma is generally asymptomatic , this requires skin examination . We sought to evaluate the extent to which the general public has their skin examined by themselves , their partners , or health care providers and the frequency of these examinations . METHODS R and om-digit-dial survey of adult Rhode Isl and ers . RESULTS Only 9 % performed a thorough skin examination ( TSE ) at least once every few months , although over half of the sample reported conducting skin self-examination " deliberately and systematic ally . " Participants were more likely to perform TSE if they were women and if their health care provider had asked them to examine their skin . Most participants reported that their health care provider never or rarely looked at the areas of their skin in which melanoma is most likely to arise . CONCLUSIONS The reported frequency of skin self-examination depends critically on the manner of inquiry . TSE by self or a partner is uncommon , and health care providers do not routinely examine the areas of the skin on which melanomas commonly arise BACKGROUND Thorough skin self-examination ( TSSE ) has substantial potential to reduce melanoma mortality by early detection . METHODS We interviewed 2,126 patients before a scheduled routine visit with a primary care physician , at which participation in a r and omized trial was offered as part of the Check-It-Out Project . We asked about skin examination behavior and related issues . RESULTS By our a priori definition of TSSE , 18 % of participants performed this activity , but other definitions led to widely varying estimates of 12 % to 38 % . Using a partner to assist in the examination was strongly associated with TSSE . That partner was generally the spouse , and wives were more likely to assist their husb and s in these examinations than the reverse . The availability of a wall mirror was a particularly important predictor of TSSE performance . Visual impairment also affected performance . CONCLUSIONS Estimates of TSSE performance vary substantially with the questions used to elicit this information . Partners , particularly spouses , appear to play a critical role in the conduct of TSSE , and wives appear more often and more effectively engaged in this process . Appropriate circumstances , such as availability of a wall mirror , are also important factors . These findings can be used to design interventions to increase TSSE performance with the ultimate aim of reducing melanoma mortality Output:	Evidence demonstrated that individuals with MM still engaged in sunbathing , indoor tanning , and reported sunburns . Moreover , survivors reported inadequate levels of both sun protection and skin self-examinations .
MS2874	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The issue of dental fear and anxiety still poses a significant problem in treating children . Various caries management protocol s have been tried to make the dental visit more compatible to the child patients . AIM The aim of the study was to evaluate and compare the behavioral and physiological responses to chemo-mechanical caries removal ( CMCR ) and conventional drilling method ( CDM ) . MATERIAL S AND METHODS A total of 20 children with an age range of 7 to 11 years with bilateral frank carious lesions were included in this study . They were r and omized into two groups : Group A -- treated with CDM first followed by CMCR and Group B -- treated with CMCR first followed by CDM . The physiological signs ( pulse , blood pressure and oxygen saturation ) were noted prior to treatment , during treatment , post treatment and 5 min after treatment . The behavioral responses were assessed by face , legs , activity , cry , and consolability scale and facial image scale . The participants were interviewed about pain , discomfort , taste , smell , preference and overall experience after every procedure . The pediatric dentist filled in details about patient behavior , time utilized and need for local anesthesia . The results were statistically analyzed using t-test and Chi-square test appropriately ( SPSS version 11 ) . RESULTS There was no significant difference in any of the physiological parameters assessed between the two groups . Discomfort was significantly more ( P < 0.025 ) in the CDM group than CMCR group . The time taken by the dentist was significantly lesser ( P < 0.01 ) in the CDM group . CONCLUSION Techniques which enhance the behavioral response in children should be considered for a better pediatric dental practice PURPOSE The purpose of this controlled clinical trial was to compare the working time for caries removal in primary teeth , the need for local anesthesia and patient cooperation , when the chemomechanical Carisolv or the conventional mechanical method were used . METHODS The sample consisted of primary teeth of children who had occlusal or buccal carious lesions into dentin . High speed and /or low speed were used as the conventional mechanical method of caries removal . The efficiency in caries removal was judged on the basis of clinical criteria . Length of working time , need of local anesthesia , and level of patient cooperation were recorded for both methods . Statistical analysis was performed using the student 's t test and chi-square test . RESULTS Working time with the chemomechanical method was much more prolonged than with the mechanical method ( P < .001 ) , but it did not negatively affect children 's cooperation . Furthermore , the chemomechanical method reduced the need for administration of local anesthesia for Class V cavity preparations . CONCLUSIONS The chemomechanical method , although more prolonged , is effective in caries removal in primary teeth , does not influence children 's cooperation and may reduce the need of local anesthesia in Class V restorations The aim of the present study was to assess pain and the need for anesthesia during chemomechanical caries removal with Papacarie gel and the traditional method ( low-speed bur ) in pediatric patients . A r and omized , controlled , clinical trial with a “ split-mouth ” design was carried out involving 20 children ( 10 girls and 10 boys ) aged four to seven years . Forty primary teeth ( two per child ) were r and omly allocated to either Group 1 ( G1 : chemomechanical caries removal with Papacarie gel ) or Group 2 ( G2 : removal of carious dentin with low-speed bur ) . A face scale was used to classify the sensation of pain during the procedure ( 1 : absence of pain ; 2 : mild pain ; 3 : moderate pain ; 4 : moderately intense pain ; 5 : intense pain ; and 6 : extremely intense pain ) . Statistical analysis of the data was performed using the Wilcoxon-Mann-Whitney ( U ) test . Pain scores were higher in G2 , with statistically significant differences in comparison to G1 ( U = 148.0 ; W = 358.0 ; P = 0.041 ) . Chemomechanical caries removal with Papacarie provides a lesser degree of pain in comparison to conventional caries removal and does not require the use of local anesthesia . The clinical trial registration number is NCT01811420 Background : Chemomechanical caries removal is an effective alternative to the traditional rotary drilling method . The advantages of chemomechanical techniques in terms of the need for anesthesia , pain perception and patient preference are systematic ally review ed and a meta- analysis of the time required for caries removal is reported . Method : R and omized controlled studies of comparison of chemomechanical techniques with conventional rotary drill were selected from a systematic search of st and ard biomedical data bases , including the PubMed and Cochrane clinical trials . Non-repeated search results were screened for relevance and risk of bias assessment , followed by methodology assessment . Statistical models were applied to the outcome parameters - time required , pain perception , need of anesthesia and patient preference - extracted from the studies . Results : Out of the 111 non-repeated search results , 26 studies receiving a low bias score were selected for the review , and 16 r and omized clinical trials of rotary and Carisolv techniques were considered for meta- analysis . Meta- analysis by fixed effect as well as r and om effect models indicate that Carisolv takes more time ( 3.65 ± 0.05 and 4.09 ± 0.29 min ) than rotary drill ( 8.65 ± 0.09 and 8.97 ± 0.66 min ) method . Advantages of reduced pain ( 14.67 for Carisolv vs. 6.76 for rotary drill ) , need for anesthesia ( 1.59 % vs. 10.52 % ) outweigh the longer time requirement and make it the preferred ( 18.68 % vs. 4.69 % ) method . Conclusion : Chemomechanical techniques st and out as a minimally invasive and preferred method based on the meta-analyses . Evaluation of pain experienced using robust methods is needed to strengthen the evidence for their use The purpose of this study was to evaluate the clinical efficiency and patient acceptance of the chemomechanical caries removal agent Carisolv ™ in deciduous teeth . Contralateral primary molars of sixteen 7– to 9–year – old patients ( 32 teeth ) were treated with the air – motor and with Carisolv , respectively . Patients replied to a pre– and a postoperative question naire . Complete caries removal ( CCR ) was accomplished in all air – motor sessions . It was not achieved within the time limit of 15 min in 6 ( 37.5 % ) Carisolv sessions . Air – motor CCR time ranged between 6 and 18 s ( mean : 11.81 s ) . Carisolv CCR time , where accomplished within 15 min , ranged between 6 min 46 s and 13 min 57 s ( mean : 6 min 51 s ) . Preoperatively , the majority of the children reported disliking the drilling , and that they would visit the dentist more often and prefer sitting in the chair longer if they could avoid it . Postoperatively , the majority of the children reported disliking the taste of Carisolv , estimated Carisolv to have taken longer , would not recommend it to their friends , and preferred the air – motor . In conclusion , Carisolv , although a step forward in terms of solution volume required , is not in a position to replace rotary instruments for caries removal : it did not remove decay completely in one third of our sample ; it was much slower than the air – motor ; it had a chlorine taste/odor our patients disliked Prevalence , characteristics and consequences of dental anxiety in a r and omly selected sample of 645 Danish adults were explored in telephone interviews . Participation rate was 88 % . Demographics , fear of specific procedures , negative dentist contacts , general fear tendency , treatment utilization and perceived oral conditions were explored by level of dental anxiety using a modified Dental Anxiety Scale ( DAS ) . A Seattle fear survey item and a summary item from the Dental Fear Survey ( DFS ) were also included for fear description comparisons . Correlation between these indices ( DAS-DFS : rs = 0.72 ; DAS-Seattle item : rs = 0.68 ) aided semantic validation of DAS anxiety intensity levels . Extreme dental anxiety ( DAS > or = 15 ) was found in 4.2 % of the sample and 6 % reported moderate anxiety ( DAS scores 14 - 12 ) . Bivariate ( B ) and logistic regression ( L ) odds ratios ( OR ) showed that high dental anxiety was associated with gender , education and income , but not with age . Extreme dental anxiety for dentate subjects was characterized by fear of drilling ( ORL = 38.7 ) , negative dentist contacts ( ORL = 9.3 ) , general fear tendency ( ORL = 3.4 ) , avoidance of treatment ( ORL = 16.8 ) and increased oral symptoms ( ORB = 4.4 ) . Moderate dental anxiety was also related to drilling ( ORL = 22.3 ) , but with less avoidance due to anxiety ( ORL = 6.8 ) compared with low fear subjects AIM To evaluate and compare the efficacy of chemo mechanical ( carie care ) caries removal method with rotary and h and excavation by assessing the amount of time taken , the pain response experienced by the children and the amount of residual caries left out . STUDY DESIGN Twenty patients between the age groups of 5 - 7 years were selected and caries removal was done by airotor h and instruments and cariecare gel . The efficacy , time taken and pain threshold was evaluated during caries removal . RESULTS significant results were obtained when inter group comparison were made . CONCLUSION it was concluded that cariecare was efficient in caries removal and can be used as an alternative for the airotor in management of dental caries especially in children BACKGROUND Conventional methods of caries removal are commonly associated with pain , fear and discomfort . Chemomechanical methods were introduced to instill a positive dental attitude . Agents like GK-101 , Caridex , Carisolv did not prove effective alternatives owing to their high cost , need of special instruments and taste of chlorine . A new chemomechanical agent , Papacarie ® , has been introduced to overcome these deficiencies . OBJECTIVE This study was aim ed to compare the effectiveness and tolerance of Papacárie ® with the conventional method . METHOD 25 children with at least two primary teeth with broad cavitated occlusal or cervical lesion were selected . One carious tooth from each patient was r and omly treated with each of Papacarie ® and conventional drilling method , one after the other . Time taken for caries excavation , child 's pain perception , change in anxiety levels , microbial flora and child 's preference of treatment were recorded separately for both the methods . RESULT Although the mean time taken for caries removal by the Papacarie ® method was slightly longer ( P≯0.05 ) but it led to reduction in pain and anxiety ( p<0.05 ) . The viable bacterial counts were significantly reduced by either of the two methods ( P < 0 � 0001 ) . More patients preferred Papacarie ® over conventional method of treatment ( P<0.05 ) . CONCLUSION Papacárie ® method seems to be a better alternative to conventional method of caries removal The aim of this study was to evaluate the efficacy , comfort and efficiency of removing dentin caries using only h and instruments . The Carisolv ™ system for caries removal consisting of a solvent gel and a set of specially design ed h and instruments ( chemo – mechanical ) was compared to the use of conventional spoon excavators ( mechanical ) . This was a clinical r and omised controlled trial where the two techniques were compared in the same individual . The outcome variables were : complete caries removal ; pain during caries removal ; anaesthesia requested by the patient during caries removal ; time taken to remove caries . Sixty – six individuals , each with a pair of similar cavities in permanent teeth were selected . After caries removal , a ‘ blinded ’ evaluator assessed the clinical status of the cavity , with the use of a probe . The times for caries removal of the chemo – mechanical and mechanical methods were respectively : 9.2±3.8 and 8.6±3.8 min ( p>0.05 ) . There were 4 cavities arguably presenting signs of caries after cavity preparation in the 66 cavities treated with the mechanical method and 7 in the 66 chemo – mechanical cavities ( p>0,05 ) . Some pain/discomfort was reported by 21 ( 32 % ) participants when the chemo – mechanical method was used , compared with 43 ( 65 % ) when the mechanical method was used ( p<0.05 ) . During the chemo – mechanical and the mechanical treatment , 2 ( 3 % ) and 5 ( 8 % ) patients , respectively , requested local anaesthesia ( p>0.05 ) . The chemo – mechanical method appeared to be more comfortable for most patients Output:	This review showed that Carie-care ™ reduces pain during caries treatment but requires a longer time for effective treatment than conventional methods . Local anesthesia was not required in the Chemo-mechanical caries removal ( CMCR ) group . In addition , dental anxiety decreased compared to the control group , and co-operation was more positive .
MS2875	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A double blind placebo controlled trial was performed to evaluate the effects of the aldose reductase inhibitor , ponalrestat , on symptomatic diabetic neuropathy . After a 4-week placebo run-in phase , 60 patients were 2:1 r and omized to receive either 600 mg ponalrestat or placebo once daily over 12 months . Forty-six patients , 30 of whom were treated with ponalrestat and 16 with placebo , completed the study . Motor and sensory nerve conduction , thermal and vibration sensation thresholds , heart rate variation at rest , E/I ratio , pupillary dilation velocity and pupillary reflex latency were determined at baseline and after 6 and 12 months . Neuropathic symptom scores were assessed every 3 months . Among the fifteen nerve function parameters studied , only trends in favour of ponalrestat were noted for heart rate variation and E/I ratio after 6 months ( P = 0.06 ) , but no significant differences between the groups could be demonstrated during the study . No adverse reactions were observed . It is concluded that one-year treatment with ponalrestat has no beneficial effects on symptoms or electrophysiological parameters in diabetic neuropathy One hundred and ninety patients with symptomatic diabetic peripheral neuropathy took part in a double blind multicentre trial of either placebo or tolrestat 200 mg once daily for 6 months . Painful and paraesthetic symptoms , vibration sensory threshold , and nerve conduction velocity ( NCV ) were assessed as efficacy end-points during the trial . There was an equally marked improvement of painful symptoms during the trial in the tolrestat and placebo groups . A difference in the improvement of paraesthetic symptoms was found however in favour of the placebo group at 24 weeks ( p less than 0.02 ) . The deterioration in mean vibration threshold of the tolrestat group was less than placebo at 24 weeks at all 3 sites measured , and reached significance at the carpal site ( p less than 0.05 ) . Significant improvements in median motor NCV and in the mean NCV of the four motor nerves were also seen in tolrestat treated patients at 24 weeks compared to placebo ( p less than 0.05 ) . In addition , significant changes in favour of tolrestat were seen when the number of motor nerves per patient with NCV increased during the trial was analysed ( p less than 0.001 ) . Concordance analysis of patients with increased mean motor NCV and improvement in painful symptoms demonstrated a positive effect for tolrestat compared to placebo ( p less than 0.02 ) . Mild reversible elevations of hepatic transaminases were seen in a few patients treated with tolrestat , with no other significant adverse effects . Tolrestat may therefore be helpful in diabetic peripheral neuropathy , where there is little opportunity for therapeutic intervention apart from effort to achieve normoglycaemic control Background There are few repeated dose-controlled trials of N-methyl-d-aspartate glutamate receptor antagonists in patients with neuropathic pain . The authors sought to evaluate two low-affinity N-methyl-d-aspartate antagonists using a novel two-stage design . Methods The authors studied patients with painful diabetic neuropathy ( DN ) and postherpetic neuralgia ( PHN ) in two crossover trials : ( 1 ) efficacy trial ( dextromethorphan vs. memantine vs. active placebo [ lorazepam ] ) and ( 2 ) dose – response trial of the preferred active drug in responders from the first study ( 0%vs . 25%vs . 50%vs . 100 % of each patient 's maximally tolerated dose ) . Pain intensity was measured on a 20-point scale . Results Nineteen of 23 DN patients and 17 of 21 PHN patients completed the efficacy trial . Median doses for DN and PHN were 400 and 400 mg/day dextromethorphan , 55 and 35 mg/day memantine , and 1.8 and 1.2 mg/day lorazepam . In the efficacy trial , among patients with DN , dextromethorphan reduced pain intensity by a mean of 33 % from baseline , memantine reduced pain intensity by a mean of 17 % , and lorazepam reduced pain intensity by a mean of 16 % ; the proportions of subjects achieving greater than moderate pain relief were 68 % with dextromethorphan , 47 % with memantine , and 37 % with lorazepam . Mean reductions in pain intensity in patients with PHN were 6 % with dextromethorphan , 2 % with memantine , and 0 % with lorazepam . No comparison with placebo reached statistical significance in the efficacy trial . In the 10 DN subjects who responded to dextromethorphan , there was a significant dose – response effect on pain intensity ( P = 0.035 ) , with the highest dose significantly better than that of lorazepam ( P = 0.03 ) . Conclusions Dextromethorphan is effective in a dose-related fashion in selected patients with DN . This was not true of PHN , suggesting a difference in pain mechanisms . Selective approaches to pain-relevant N-methyl-d-aspartate receptors are warranted Background Peripheral diabetic neuropathy affects between 20 % and 45 % of patients with diabetes . Objective To ascertain the effect of lacosamide on pain associated with peripheral diabetic neuropathy . Methods One hundred nineteen patients with a 1 to 5-year history of pain attributed to diabetic neuropathy and a score of ≥4 on the Likert pain scale entered the multicenter , r and omized , double-blind , placebo-controlled trial . Lacosamide ( N=60 ) titrated from 100 to 400 mg/d or maximum tolerated dose and placebo ( N=59 ) were the trial interventions . Primary efficacy criterion was change in pain score on the 11-point Likert pain scale . Secondary assessment s included Short-Form McGill Pain and Short-Form-36 Quality of Life Question naires , sleep/activity interference , pain intensity , Patient and Clinical Global Impression of Change , and Profile of Mood . Patients receiving at least 1 dose of medication underwent safety evaluation . Results Ninety-four patients ( lacosamide 46 ; placebo 48 ) completed the trial . Lacosamide had significantly ( P=0.039 ) better pain relief versus placebo ( primary outcome ) . Improvements were also seen in secondary outcome measures . Adverse events occurred in 52 lacosamide and 44 placebo patients . Common adverse events , occurring in ≥5 % of patients , were headache ( lacosamide 18 % , placebo 22 % ) , dizziness ( lacosamide 15 % , placebo 8 % ) , and nausea ( lacosamide 12 % , placebo 7 % ) . Five lacosamide and 3 placebo patients withdrew for adverse events . Discussion Lacosamide seems to attenuate pain in diabetic neuropathy in doses up to 400 mg/d and improves quality of life issues Abstract Aims / Introduction : Duloxetine has been suggested to exert analgesic effects by activating the descending inhibitory system through inhibition of serotonin ( 5‐HT ) and noradrenaline ( NA ) reuptake . This r and omized controlled trial investigated the efficacy and safety of duloxetine in Japanese patients with diabetic neuropathic pain ( DNP ) . Material s and Methods : Duloxetine 40 or 60 mg/day or placebo was given orally once daily for 12 weeks . The primary efficacy measure was weekly mean 24‐h average pain severity score on the 11‐point Numerical Rating Scale . Results : At 12 weeks vs baseline , the 24‐h average pain score ( adjusted mean ± SE ) was significantly improved in the combined duloxetine ( −2.47 ± 0.18 ) and duloxetine 40 mg ( −2.41 ± 0.21 ) and 60 mg groups ( −2.53 ± 0.21 ) as compared with the placebo group ( −1.61 ± 0.18 ) . Duloxetine also exerted significant improvements over the placebo in nearly all secondary outcome measures including 24‐h worst pain , night pain , Brief Pain Inventory ( BPI ) pain scores , Patient ’s Global Impression of Improvement ( PGI‐I ) and health outcome measures , namely , various BPI interference scores . The incidence of adverse events ( AE ) was higher in the duloxetine groups than in the placebo group ( duloxetine overall , 84.8 % ; duloxetine 40 mg , 84.7 % ; duloxetine 60 mg , 84.9 % ; placebo , 73.7 % ) . Most AE were mild or moderate in severity , and resolved or relieved . There were no clinical ly significant safety concerns . Conclusions : Duloxetine 40 or 60 mg/day showed superiority over the placebo at reducing pain scores in patients with DNP . Duloxetine is safe , efficacious and clinical ly useful in the management of DNP . This trial was registered with Clinical Trials.gov ( no. NCT‐00552175 ) . ( J Diabetes Invest , doi : 10.1111/j.2040‐1124.2010.00073.x , 2010 OBJECTIVE We conducted an 8-wk controlled study with topical 0.075 % capsaicin in subjects with chronic severe painful diabetic neuropathy who were unresponsive or intolerant to conventional therapy . Capsaicin is an alkaloid found in capsicum peppers and produces desensitization to noxious thermal , chemical , and mechanical stimuli when applied topically . RESEARCH DESIGN AND METHODS In 22 r and omly assigned subjects , either capsaicin or vehicle cream was applied to painful areas 4 times/day . Pain measurements were recorded at baseline and at 2-wk intervals for 8 wk . RESULTS Capsaicin treatment was more beneficial than vehicle treatment in the overall clinical improvement of pain status , as measured by physician 's global evaluation ( P = 0.038 ) and by a categorical pain severity scale ( P = 0.057 ) . Decrease in mean pain intensity by a visual analogue scale was 16 % in capsaicin-treated and 4.1 % in vehicle-treated subjects . Mean pain relief on visual analogue scale was 44.6 and 23.2 % , respectively . In a follow-up open-label study , approximately 50 % of subjects reported improved pain control or were cured , and 25 % each were unchanged or worse . A burning sensation at the application site was noted by some subjects but both its magnitude and duration decreased with time . CONCLUSIONS Results from this preliminary study suggest that topical 0.075 % capsaicin may be of value in subjects with diabetic neuropathy and intractable pain AIMS To compare the efficacy and safety of lamotrigine and amitriptyline in controlling chronic painful peripheral neuropathy in diabetic patients . METHODS A r and omized , double-blind , crossover , active-control , clinical trial with variable dose titration was carried out ( n = 53 ) . Amitriptyline orally , at doses of 10 , 25 and 50 mg at night-time , each dose for 2 weeks , and lamotrigine orally , at doses of 25 , 50 and 100 mg twice daily , each dose for 2 weeks , by optional titration were used . There was a placebo washout period for 2 weeks between the two drugs . Assessment for pain relief , overall improvement and adverse events were carried out . RESULTS Good , moderate and mild pain relief were noted in 19 ( 41 % ) , six ( 13 % ) and seven ( 15 % ) patients on lamotrigine and 13 ( 28 % ) , five ( 11 % ) and 15 ( 33 % ) patients on amitriptyline , respectively , by patient 's global assessment of efficacy and safety . Patient and physicians global assessment , McGill pain question naire and Likert pain scale showed no significant difference between the treatments , although improvement with both treatments was seen from 2 weeks . Of the 44 adverse events reported , 33 ( 75 % ) were with amitriptyline , sedation being the commonest [ in 19 ( 43 % ) patients ] . Lamotrigine caused adverse events in 11 ( 25 % ) , of which rash in three ( 7 % ) and elevations of creatinine in four ( 9 % ) were the most common . The preferred lamotrigine dose was 25 mg twice daily . CONCLUSIONS As there are few differences between the two treatments in efficacy , lamotrigine 25 mg twice daily might be the first choice as it is associated with fewer adverse effects in our population An 8-week double-blind , multicenter , parallel study compared the safety and efficacy of topical capsaicin and oral amitriptyline in patients with painful diabetic neuropathy involving the feet . Two hundred thirty-five patients were r and omized to treatment with either capsaicin cream or amitriptyline capsules . Capsaicin-treated patients received inactive capsules , and amitriptyline-treated patients applied vehicle cream . A visual analogue scale of pain intensity and measurements of interference by pain with functional Output:	Network meta- analysis showed that SNRIs ( SMD , -1.36 [ CrI , -1.77 to -0.95 ] ) , topical capsaicin ( SMD , -0.91 [ CrI , -1.18 to -0.08 ] ) , TCAs ( SMD , -0.78 [ CrI , -1.24 to -0.33 ] ) , and anticonvulsants ( SMD , -0.67 [ CrI , -0.97 to -0.37 ] ) were better than placebo for short-term pain control . Several medications may be effective for short-term management of painful diabetic neuropathy , although their comparative effectiveness is unclear .
MS2876	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Purpose : To evaluate the safety and efficacy of the novel Passeo-18 Lux paclitaxel-coated balloon compared with the Passeo-18 uncoated balloon in patients with symptomatic de novo or restenotic femoropopliteal lesions . Methods : Sixty patients ( 34 men ; mean age 70.7±10.1 years ) in 5 European centers were enrolled in the BIOLUX P-I trial ( Clinical Trials.gov identifier NCT01056120 ) and r and omized 1:1 to either the paclitaxel-coated balloon or the uncoated balloon . The primary endpoint was late lumen loss at 6 months . Secondary endpoints were binary restenosis at 6 months , clinical ly driven target lesion revascularization ( TLR ) , change in ankle-brachial index and Rutherford classification , and major adverse events at 6 and 12 months . Results : At 6 months , patients treated with paclitaxel-coated balloons had a significantly lower late lumen loss ( 0.51±0.72 vs. 1.04±1.00 mm , p=0.033 ) and binary restenosis ( 11.5 % vs. 34.6 % , p=0.048 ) than the control group . Correspondingly , clinical ly driven TLR was lower in the paclitaxel-coated balloon group at 12 months [ 15.4 % vs. 41.7 % ( p=0.064 ) for the intention-to-treat population and 16.0 % vs. 52.9 % , ( p=0.020 ) for the as-treated population ] . No death and one minor amputation were observed compared with two deaths and two minor amputations in the control group . No major amputations or thrombosis were reported . Conclusion : The Passeo-18 Lux paclitaxel-coated balloon has been proven to be safe and effective in patients with femoropopliteal lesions , with superior performance outcomes compared with treatment with an uncoated balloon Background —Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention . A drug-eluting balloon ( DEB ) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty . Methods and Results — Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty were r and omized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons . The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses . Secondary end points were binary restenosis and Rutherford class change at 6 months , and target lesion revascularization plus major adverse clinical events ( major adverse events = death , target limb amputation , or target lesion revascularization ) at 6 and 12 months . Eighty-five patients ( 91 cases = interventional procedures ) were r and omized in 3 hospitals ( 44 to DEB and 47 to uncoated balloons ) . Average lesion length was 7.0±5.3 and 6.6±5.5 cm for DEB and control arm , respectively . Procedural success was obtained in all cases . Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss ( −0.01 mm [ 95 % CI , −0.29 ; 0.26 ] versus 0.65 mm [ 0.37 ; 0.93 ] , P=0.001 ) and fewer binary restenoses ( 3 [ 8.6 % ] versus 11 [ 32.4 % ] , P=0.01 ) . This translated into a clinical ly relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months ( 3 [ 7.1 % ] versus 15 [ 34.9 % ] , P<0.01 ) as well as target lesion revascularizations ( 3 [ 7.1 % ] versus 12 [ 27.9 % ] , P=0.02 ) . Conclusions —Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months , and re interventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up . Clinical Trial Registration —URL http://www . clinical trials.gov . Unique identifier : NCT01083030 BACKGROUND Evidence from large , r and omized , controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons ( DCBs ) is limited . Previously , the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty ( PTA ) , yet durability of the treatment effect with DCBs remains unknown . OBJECTIVES This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions . METHODS We enrolled 331 patients with symptomatic ( Rutherford 2 to 4 ) femoropopliteal lesions up to 18 cm in length . Patients were r and omly assigned in a 2:1 ratio to treatment with DCB or PTA . The 24-month assessment s included primary patency , freedom from clinical ly driven target lesion revascularization ( CD-TLR ) , major adverse events , and quality of life and functional outcomes as assessed by the EuroQOL-5D quality -of-life question naire , walking impairment question naire , and 6-min walk test . RESULTS At 24 months , patients treated with DCB showed significantly higher primary patency when compared with PTA ( 78.9 % vs. 50.1 % ; p < 0.001 ) . The rates of CD-TLR were 9.1 % and 28.3 % ( p < 0.001 ) for the DCB and PTA groups , respectively . The overall mortality rate in the DCB group was 8.1 % versus 0.9 % in the PTA group ( p = 0.008 ) . There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up . The rate of vessel thrombosis was low ( 1.5 % DCB vs. 3.8 % PTA ; p = 0.243 ) , with no new events reported between 1 and 2 years . Both groups showed similar functional improvement at 2 years , although DCB patients achieved this level of function with 58 % fewer re interventions . CONCLUSIONS The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency , lower CD-TLR , and similar functional status improvement with fewer repeat interventions . ( R and omized Trial of IN.PACT Admiral Drug Eluting Balloon vs St and ard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [ INPACT SFA I ] ; NCT01175850 ; and IN.PACT Admiral Drug-Coated Balloon vs. St and ard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [ SFA ] and Proximal Popliteal Artery [ PPA ] [ INPACT SFA II ] ; NCT01566461 ) Patients with intermittent claudication carry a high risk for cardiovascular complications . The TransAtlantic Inter-Society Consensus ( TASC ) Group estimated a five-year overall mortality of 30 % for these patients , the majority dying from cardiovascular causes . We investigated whether this evaluation is still applicable in nowadays patients . We therefore prospect ively followed 255 male patients with intermittent claudication from the CAVASIC Study during 7 years for overall mortality , vascular morbidity and mortality and local PAD outcomes . Overall mortality reached 16.1 % ( n = 41 ) . Most patients died from cancer ( n = 20 ) . Half of patients ( n = 22 ; 8.6 % ) died within the first five years . Incident cardiovascular events were observed among 70 patients ( 27.5 % ) , 54 ( 21.2 % ) during the first five years . Vascular mortality was low with 5.1 % ( n = 13 ) for the entire and 3.1 % for the first five years of follow-up . Prevalent coronary artery disease did not increase the risk to die from all or vascular causes . PAD symptoms remained stable or improved in the majority of patients ( 67 % ) . In summary , compared to TASC , the proportion of cardiovascular events did not markedly decrease over the last two decades . Vascular mortality , however , was low among our population . This indicates that nowadays patients more often survive cardiovascular events and a major number dies from cancer BACKGROUND The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis . Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery , potentially improving vessel patency by reducing restenosis . METHODS In this single-blind , r and omized trial conducted at 54 sites , we assigned , in a 2:1 ratio , 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to st and ard angioplasty . The primary efficacy end point was primary patency of the target lesion at 12 months ( defined as freedom from binary restenosis or from the need for target-lesion revascularization ) . The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death ( i.e. , death from a medical complication related to a limb ) , amputation , and reintervention . RESULTS The two groups were well matched at baseline ; 42.9 % of the patients had diabetes , and 34.7 % were current smokers . At 12 months , the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty ( 65.2 % vs. 52.6 % , P=0.02 ) . The proportion of patients free from primary safety events was 83.9 % with the drug-coated balloon and 79.0 % with st and ard angioplasty ( P=0.005 for noninferiority ) . There were no significant between-group differences in functional outcomes or in the rates of death , amputation , thrombosis , or reintervention . CONCLUSIONS Among patients with symptomatic femoropopliteal peripheral artery disease , percutaneous transluminal angioplasty with a paclitaxel-coated balloon result ed in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a st and ard balloon . The drug-coated balloon was noninferior to the st and ard balloon with respect to safety . ( Funded by Lutonix-Bard ; LEVANT 2 Clinical Trials.gov number , NCT01412541 . ) BACKGROUND There are no data available on specific causes of death from r and omized trials that have compared coronary artery bypass grafting ( CABG ) with percutaneous coronary intervention ( PCI ) . OBJECTIVES The purpose of this study was to investigate specific causes of death , and its predictors , after revascularization for complex coronary disease in patients . METHODS An independent Clinical Events Committee consisting of expert physicians who were blinded to the study treatment subclassified causes of death as cardiovascular ( cardiac and vascular ) , noncardiovascular , or undetermined according to the trial protocol . Cardiac deaths were classified as sudden cardiac , related to myocardial infa rct ion ( MI ) , and other cardiac deaths . RESULTS In the r and omized cohort , there were 97 deaths after CABG and 123 deaths after PCI during a 5-year follow-up . After CABG , 49.4 % of deaths were cardiovascular , with the greatest cause being heart failure , arrhythmia , or other causes ( 24.6 % ) , whereas after PCI , the majority of deaths were cardiovascular ( 67.5 % ) and as a result of MI ( 29.3 % ) . The cumulative incidence rates of all-cause death were not significantly different between CABG and PCI ( 11.4 % vs. 13.9 % , respectively ; p = 0.10 ) , whereas there were significant differences in terms of cardiovascular ( 5.8 % vs. 9.6 % , respectively ; p = 0.008 ) and cardiac death ( 5.3 % vs. 9.0 % , respectively ; p = 0.003 ) , which were caused primarily by a reduction in MI-related death with CABG compared with PCI ( 0.4 % vs. 4.1 % , respectively ; p < 0.0001 ) . Treatment with PCI versus CABG was an independent predictor of cardiac death ( hazard ratio : 1.55 ; 95 % confidence interval : 1.09 to 2.33 ; p = 0.045 ) . The difference in MI-related death was seen largely in patients with diabetes , 3-vessel disease , or high SYNTAX ( TAXUS Drug-El Output:	Conclusions There is increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs .
MS2877	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Tigecycline , an exp and ed broad-spectrum glycylcycline , exhibits in vitro activity against many common pathogens associated with community-acquired pneumonia ( CAP ) , as well as penetration into lung tissues that suggests effectiveness in hospitalized CAP patients . The aim of the present study was to compare the efficacy and safety of intravenous ( IV ) tigecycline with IV levofloxacin in hospitalized adults with CAP . Methods In this prospect i ve , double-blind , non-inferiority phase 3 trial , eligible patients with a clinical diagnosis of CAP supported by radiographic evidence were stratified by Fine Pneumonia Severity Index and r and omized to tigecycline or levofloxacin for 7 - 14 days of therapy . Co- primary efficacy endpoints were clinical response in the clinical ly evaluable ( CE ) and clinical modified intent-to-treat ( c-mITT ) population s at test-of-cure ( Day 10 - 21 post-therapy ) . Results Of the 428 patients who received at least one dose of study drug , 79 % had CAP of mild-moderate severity according to their Fine score . Clinical cure rates for the CE population were 88.9 % for tigecycline and 85.3 % for levofloxacin . Corresponding c-mITT population rates were 83.7 % and 81.5 % , respectively . Eradication rates for Streptococcus pneumoniae were 92 % for tigecycline and 89 % for levofloxacin . Nausea , vomiting , and diarrhoea were the most frequently reported adverse events . Rates of premature discontinuation of study drug or study withdrawal because of any adverse event were similar for both study drugs . Conclusion These findings suggest that IV tigecycline is non-inferior to IV levofloxacin and is generally well-tolerated in the treatment of hospitalized adults with CAP.Trial registration Tigecycline ( TGC ) has demonstrated clinical efficacy and safety , in comparison with imipenem/cilastatin in phase 3 clinical trials , for complicated intra-abdominal infection ( cIAI ) . The present study comprised a multicentre , open-label , r and omized study of TGC vs. ceftriaxone plus metronidazole ( CTX/MET ) for the treatment of patients with cIAI . Eligible subjects were r and omized ( 1:1 ) to receive either an initial dose of TGC ( 100 mg ) followed by 50 mg every 12 h or CTX ( 2 g once daily ) plus MET ( 1 - 2 g daily ) , for 4 - 14 days . The primary endpoint was the clinical response in the clinical ly evaluable ( CE ) population at the test of cure ( TOC ) assessment . Of 473 r and omized subjects , 376 were CE . Among these , clinical cure rates were 70.4 % ( 133/189 ) with TGC vs. 74.3 % ( 139/187 ) with CTX/MET ( 95 % CI -13.1 to 5.1 ; p 0.009 for non-inferiority ) . Clinical cure rates for subjects with Acute Physiological and Chronic Health Evaluation II scores > or = 10 were 56.8 % ( 21/37 ) with TGC vs. 58.3 % ( 21/36 ) with CTX/MET . The microbiologic response was similar between the two treatment arms , with microbiological eradication at TOC achieved in 68.1 % ( 94/138 ) of TGC-treated subjects and 71.5 % ( 98/137 ) of CTX/MET-treated subjects . ( The most frequently reported adverse events ( AEs ) for both treatment arms were nausea ( TGC , 38.6 % vs CTX/MET , 27.7 % ) and vomiting ( TGC , 23.3 % vs CTX/MET , 17.7 % ) . Overall discontinuation rates as a result of an AE were 8.9 % and 4.8 % in TGC- and comparator-treated subjects , respectively . The results obtained in the present study demonstrate that TGC monotherapy is non-inferior to a combination regimen of CTX/MET with respect to treating subjects with cIAI OBJECTIVES To compare the efficacy and safety of linezolid and vancomycin for the treatment of methicillin-resistant Staphylococcus aureus ( MRSA ) infections in Japan . METHODS Patients with nosocomial pneumonia , complicated skin and soft-tissue infections or sepsis caused by MRSA were r and omized to receive linezolid ( 600 mg every 12 h ) or vancomycin ( 1 g every 12 h ) . RESULTS One hundred patients received linezolid and 51 received vancomycin with outcomes evaluated at the end of therapy ( EOT ) and at the follow-up ( FU ) , 7 - 14 days later . At EOT , clinical success rates in the MRSA microbiologically evaluable population were 62.9 % and 50.0 % for the linezolid and vancomycin groups , respectively ; and microbiological eradication rates were 79.0 % and 30.0 % in the two groups , respectively ( P < 0.0001 ) . At FU , the clinical success rates were 36.7 % for both groups and the microbiological eradication rates were 46.8 % and 36.7 % , respectively . Reversible anaemia ( 13 % ) and thrombocytopenia ( 19 % ) were reported more frequently in linezolid patients ; laboratory analysis showed mild decrease in platelet counts with full recovery by FU . The mean platelet count in linezolid patients with thrombocytopenia was 101,000/mm(3 ) . Significantly low platelet counts ( < 50,000/mm(3 ) ) were observed more frequently in patients receiving vancomycin than in linezolid patients ( 6 % versus 3 % ) . Mean changes in haemoglobin levels between the two groups were not different . CONCLUSIONS Linezolid is as effective as vancomycin for the treatment of MRSA infections and may be more effective than vancomycin in achieving microbiological eradication . Haematological adverse events were reported more frequently in linezolid-treated patients ; analysis of laboratory data showed a mild reversible trend towards lower platelet counts Tigecycline ( TGC ) , a glycylcycline , has exp and ed activity against Gram-positive and Gram-negative , anaerobic , and atypical bacteria . Two phase 3 studies were conducted . Hospitalized patients with community-acquired pneumonia ( CAP ) were r and omized to intravenous ( IV ) TGC ( 100 mg followed by 50 mg bid ) or IV levofloxacin ( LEV ) ( 500 mg bid ) . In 1 study , patients could be switched to oral LEV after at least 3 days intravenously . The co primary efficacy end points were as follows : clinical response in clinical ly evaluable ( CE ) and clinical modified intent-to-treat ( c-mITT ) population s at test-of-cure ( TOC ) . The secondary end points were as follows : microbiologic efficacy and susceptibility to TGC for CAP bacteria . Safety evaluations were included . Eight hundred ninety-one were patients screened : 846 mITT ( TGC 424 , LEV 422 ) , 574 CE ( TGC 282 , LEV 292 ) . Most patients had Fine Pneumonia Severity Index II to IV ( 80.7 % TGC , 74.4 % LEV , mITT ) . At TOC ( CE ) , TGC cured 253/282 patients ( 89.7 % ) and LEV cured 252/292 patients ( 86.3 % ) ; the absolute difference of TGC-LEV was 3.4 % ( 95 % confidence interval [ CI ] , -2.2 to 9.1 , noninferior [ P < 0.001 ] ) . In c-mITT , TGC cured 319/394 patients ( 81.0 % ) and LEV cured 321/403 patients ( 79.7 % ) ; the absolute difference of TGC-LEV was 1.3 % ( 95 % CI -4.5 to 7.1 , noninferior [ P < 0.001 ] ) . The drug-related adverse events ( AEs ) of nausea ( 20.8 % TGC versus 6.6 % LEV ) and vomiting ( 13.2 % TGC versus 3.3 % LEV ) were significantly higher in TGC ; elevated alanine aminotransferase ( 2.8 % TGC versus 7.3 % LEV ) and aspartate aminotransferase ( 2.6 % TGC versus 6.9 % LEV ) were significantly higher in LEV . Discontinuations for AEs were low ( TGC , 26 patients [ 6.1 % ] ; LEV , 34 patients [ 8.1 % ] ) . TGC appeared safe and achieved cure rates similar to LEV in hospitalized patients with CAP Background Complicated intra-abdominal infections ( cIAI ) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria . The efficacy and safety of tigecycline , an exp and ed broad-spectrum glycylcycline antibiotic , was compared with imipenem/cilastatin ( IMI/CIS ) in patients with cIAI . Methods A prospect i ve , double-blind , multinational trial was conducted in which patients with cIAI r and omly received intravenous ( IV ) tigecycline ( 100 mg initial dose , then 50 mg every 12 hours [ q12h ] ) or IV IMI/CIS ( 500/500 mg q6h or adjusted for renal dysfunction ) for 5 to14 days . Clinical response at the test-of-cure ( TOC ) visit ( 14–35 days after therapy ) for microbiologically evaluable ( ME ) and microbiological modified intent-to-treat ( m-mITT ) population s were the co- primary efficacy endpoint population s. Results A total of 825 patients received ≥ 1 dose of study drug . The primary diagnoses for the ME group were complicated appendicitis ( 59 % ) , and intestinal ( 8.8 % ) and gastric/duodenal perforations ( 4.6 % ) . For the ME group , clinical cure rates at TOC were 80.6 % ( 199/247 ) for tigecycline versus 82.4 % ( 210/255 ) for IMI/CIS ( 95 % CI -8.4 , 5.1 for non-inferiority tigecycline versus IMI/CIS ) . Corresponding clinical cure rates within the m-mITT population were 73.5 % ( 227/309 ) for tigecycline versus 78.2 % ( 244/312 ) for IMI/CIS ( 95 % CI -11.0 , 2.5 ) . Nausea ( 31.0 % tigecycline , 24.8 % IMI/CIS [ P = 0.052 ] ) , vomiting ( 25.7 % tigecycline , 19.4 % IMI/CIS [ P = 0.037 ] ) , and diarrhea ( 21.3 % tigecycline , 18.9 % IMI/CIS [ P = 0.435 ] ) were the most frequently reported adverse events . Conclusion This study demonstrates that tigecycline is as efficacious as imipenem/cilastatin in the treatment of patients with cIAI A total of 108 children aged 4 - 17 years were r and omized to receive 7 days of azithromycin ( 10 mg/kg/day ; maximum , 500 mg/day ) or ceftriaxone ( 75 mg/kg/day ; maximum , 2.5 g/day ) , to assess the efficacy of the agents for the treatment of uncomplicated typhoid fever . Salmonella typhi was isolated from the initial cultures of blood sample s from 64 patients . A total of 31 ( 91 % ) of the 34 patients treated with azithromycin and 29 ( 97 % ) of the 30 patients treated with ceftriaxone were cured ( P>.05 ) . All 64 isolates were susceptible to azithromycin and ceftriaxone . Of the patients treated with ceftriaxone , 4 subsequently had relapse of their infection . No serious side effects occurred in any study subject . Oral azithromycin administered once daily appears to be effective for the treatment of uncomplicated typhoid fever in children . If these results are confirmed , the agent could be a convenient alternative for the treatment of typhoid fever , especially in individuals in developing countries where medical re sources are scarce Background Tigecycline , a first-in-class broad-spectrum glycylcycline antibiotic , has broad-spectrum in vitro activity against bacteria commonly encountered in complicated intra-abdominal infections ( cIAIs ) , including aerobic and facultative Gram-positive and Gram-negative bacteria and anaerobic bacteria . In the current trial , tigecycline was evaluated for safety and efficacy vs. imipenem/cil Output:	Subgroup analyses showed a benefit for clinical cure rates associated with linezolid and increased mortality associated with tigecycline . In meta-regression , clinical cure rates remained higher in patients treated with linezolid ( P=0.01 ) ; tigecycline displayed a close to significant association with increased mortality ( P=0.05 ) if compared with other bacteriostatic agents . The categorization of antibiotics into bacteriostatic and bactericidal is unlikely to be relevant in clinical practice if used for abdominal infections , skin and soft tissue infections and pneumonia .
MS2878	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: UNLABELLED Anesthetic methods used during cesarean section have advantages and disadvantages to both mothers and infants and may result in short and long term neonatal effects . OBJECTIVE To determine the effects of general and regional anesthesia on the infants , a prospect i ve , r and omized trial was performed in Siriraj Hospital , Mahidol University . MATERIAL AND METHOD 341 uncomplicated pregnant women who were to be delivered at term by Cesarean section were recruited and r and omized to receive general anesthesia , GA ( 103 ) ; epidural anesthesia , EA ( 120 ) and spinal anesthesia , SA ( 118 ) . The immediate fetal and neonatal effects were assessed by cord blood gas analysis and the infant 's Apgar scores . The Neurologic and Adaptive Capacity Scores ( NACS ) was performed within 4 hours after birth by two pediatricians who were blind to the anesthetic method . RESULT Maternal age , weight , height , duration of the operation and infants ' birth weight were not different among the study groups . In the EA and SA group , maternal systolic blood pressure decreased more than 20 per cent from the baseline in more than half . The infants ' Apgar scores at 1 and 5 minutes were 8.3 + /- 1.9 ; 8.2 + /- 1.6 ; 6.7 + /- 2.8 , and 9.7 + /- 0.9 ; 9.8 + /- 0.7 ; 9.2 + /- 1.6 in EA , SA and GA group respectively . The adaptive capacity , active tone , passive tone , general assessment and primary reflexes of the NACS were not statistically different . CONCLUSION Apgar scores of the infants whose mothers received general anesthesia were lower than infants whose mothers received regional anesthesia but the NACS were not statistically different among the three study groups Ninety healthy parturients undergoing elective caesarean section were r and omly allocated to receive either general ( n = 30 ) , epidural ( n = 30 ) or spinal ( n = 30 ) anaesthesia . Acid-base status , Apgar score and neurobehavioural status , using the neurologic and adaptive capacity scoring ( NACS ) system , were studied in the newborn . Apgar scores and acid-base parameters were similar in all the three groups . NACS testing revealed significantly more vigorous babies in the spinal anaesthesia group than in the other two groups at 15 min and 2 h interval after delivery , despite a higher incidence of maternal hypotension . We conclude that newborns tend to have a better neurobehavioural status in the early post-delivery period if their mothers receive spinal anaesthesia rather than general or epidural anaesthesia for caesarean section Objective : To compare general , epidural and combined spinal-epidural anesthesia with respect to short-term outcome of newborns delivered by elective Cesarean section of healthy parturients with normal pregnancies . Study design : A total of 238 eight pregnant women admitted to our institution between January 1998 and July 2002 , for whom elective Cesarean section was planned after 38 weeks ' gestation , were grouped according to the kind of anesthesia used for the procedure . Maternal characteristics , birth weight , Apgar scores , and maternal and umbilical artery ( UA ) acid-base parameters were analyzed . Results : Maternal pH was significantly lower and pCO2 and pO2 were significantly higher in the general anesthetic group , compared to the other two groups ( 7.38 ± 0.03 vs. 7.43 ± 0.02 and 7.43 ± 0.05 , respectively ; 35.03 ± 3.88 mmHg vs. 29.25 ± 5.05 mmHg and 29.64 ± 4.16 mmHg , respectively ; and 224.56 ± 86.77 mmHg vs. 151.28 ± 38 mmHg and 157.36 ± 53.51 mmHg , respectively , p < 0.05 ) . The pH of the UA was higher in the general anesthetic group , compared to the spinal-epidural group ( 7.29 ± 0.02 vs. 7.26 ± 0.06 , p < 0.05 ) . The pO2 as well as O2 saturation of the UA were higher when general anesthetic was administered , compared to the two regional modalities ( 15.60 ± 5.48 mmHg vs. 9.29 ± 4.41 mmHg and 9.20 ± 4.06 mmHg , respectively ; and 17.37 ± 9.79 % vs. 7.87 ± 4.98 % and 6.90 ± 5.22 % , respectively , p < 0.05 ) . UA O2 saturation fell to zero in some cases in the combined spinal-epidural group , without an evident effect on fetal well-being . No fetal acidemia was noted in any group . Neonatal outcomes were similar in the three groups studied . Conclusions : Type of anesthesia does not influence short-term outcomes in infants born via elective Cesarean section , although differences in acid-base status of both the mother and especially the newborn recommend careful use of spinal anesthesia Both epidural and general anesthesia can impair thermoregulatory mechanisms during surgery . However , there is lack of information about the effects of different methods of anesthesia on newborn temperature . The purpose of this study was to determine whether there are differences in newborn rectal temperature related to type of anesthesia . Sixty-three pregnant women were r and omly assigned to receive general or epidural anesthesia . Maternal core temperature was measured three times with a rectal probe just before anesthesia , at the beginning of surgery and at delivery . In addition , umbilical vein blood was sample d for pH. The rectal temperatures of the babies were recorded immediately after delivery , and Apgar scores were determined 1 , 5 , and 10 min after birth . The duration of anesthesia and the volume of intravenous fluid given during the procedure ( 833 + /- 144 vs 420 + /- 215 mL ) were significantly higher in the epidural group than in the general anesthesia group ( P < 0.0001 ) . Maternal rectal temperatures were not different in both groups at all measurements . In contrast , newborn rectal temperatures were lower in the epidural anesthesia group than in the general anesthesia group ( 37.4 + /- 0.3 vs 37.6 + /- 0.3 degrees C ; P < 0.05 ) immediately after birth . Furthermore , the umbilical vein pH value ( 7.31 + /- 0.05 vs 7.33 + /- 0.01 ; P < 0.05 ) and Apgar scores at the 1st-min measurement ( 8.0 + /- 0.9 vs 8.5 + /- 0.7 ; P < 0.05 ) were lower in the epidural anesthesia group than in the general anesthesia group . Since epidural anesthesia requires more iv fluid infusion and a longer time for cesarean section , it involves a risk of a mild temperature reduction for the baby which , however , did not reach the limits of hypothermia OBJECTIVE To compare general and spinal anesthesia with respect to the short-term outcome of newborns born by elective cesarean deliveries . METHODS Pregnant women admitted to our hospital from January 1999 to July 2000 , for whom elective repeat cesareans were planned after 37 weeks gestation , were allocated r and omly after their informed consent to spinal anesthesia or general anesthesia . Maternal age , gestational age , birth weight , Apgar 's score , hospital stay duration , and duration of cesarean section time were all noted . The rate of the neonatal respiratory depression , perinatal asphyxia , and admittance to the neonatal intensive care unit of the infants were documented . We also studied arterial sample s withdrawn from the cord for the pH , bicarbonate , PaO(2 ) ( oxygen pressure , arterial ) , and PaCO(2 ) ( carbon dioxide pressure , arterial ) . The serum levels of creatine kinase with myocardial-specific isoform , aspartate aminotransferase , alanine aminotransferase , and total cortisol levels of the newborns were measured and served in ruling out perinatal stress and in confirming the diagnosis of perinatal asphyxia ( and of myocardial damage ) . Statistical analyses was performed with the use of an unpaired Student 's t-test , Chi-square test , and a power calculation was done . RESULTS From the r and omly selected patients , we had 38 ( 45.2 % ) infants for general anesthesia and 46 ( 54.8 % ) for spinal anesthesia . None of our primary endpoints favored any of the study groups , and the clinical short-term outcome of the infants was similar in the neonates born both by spinal and general anesthesia ( P>0.05 ) . The biochemical assays did not rule out or confirm any differences in the occurrence of perinatal stress ( P>0.05 ) . CONCLUSION Anesthesia type does not seem to influence the short-term outcome of the newborn infants for the elective cesarean deliveries . We believe that both spinal and general anesthesia could be performed in elective term cesarean deliveries without any risk to the newborn infants OBJECTIVE To evaluate the suitability of spinal and general anaesthesia for cesarean section . METHODS The prospect i ve , double-blinded study , done between March and December 2009 , at Central Education and Research Hospital , Erzurum , Turkey , involved 60 patients undergoing elective cesarean surgery . They were grouped according to the kind of anaesthesia , with each group having 30 patients each . Postoperative pain scores , opioid requirement , side effects and patient satisfaction were compared through statistical analysis using SPSS version 10 . RESULTS Patient demographics were similar in both groups . Patients in the general anaesthesia group consumed 638.4 + /- 179.10 microg fentanyl , while patients in the spinal anaesthesia group consumed 356.3 + /- 87.1 microg . The number of patients requiring opioid via Patient Controlled Analgesia in the first 24 hours was significantly higher in the general anaesthesia group . Patient satisfaction was significantly higher in the spinal anaesthesia group . CONCLUSION Type of anaesthesia for elective cesarean section is important to provide sufficient post-operative analgesia and patient satisfaction Forty-seven healthy parturients undergoing elective Caesarean section were r and omly allocated to either general anaesthesia ( n = 24 ) or epidural anaesthesia ( n = 23 ) under st and ardized anaesthetic and surgical conditions . Seven women of the epidural group required additional systemic analgesia or sedation following delivery of the neonate . Nine of 24 newborns obtained 1-min Apgar scores below 7 after general anaesthesia compared to only 3/23 after epidural anaesthesia . The time period to establish normal colour in the babies was 2.2 min after epidural and 4.9 min after general anaesthesia . Three of the 24 general-anaesthesia newborns demonstrated a tendency to hypotonia compared to only one in the epidural group . Twenty-four hours and 7 days after delivery all infants of both groups were completely normal . At the time of delivery maternal PO2 was higher in the general anaesthesia compared to the epidural group , due to higher inspired oxygen concentrations . Comparable results were obtained in umbilical PO2 venous values ; lower pH values , however , were observed in the umbilical artery after general anaesthesia . There were no significant differences in the glucose levels between the groups . A significant correlation was established between uterine incision-delivery interval and 1-min neonatal Apgar scores in the general-anaesthesia group , but not in the epidural group . Our investigation did not show either the incision-delivery interval or the start of operation-delivery interval to play a role in neonatal outcome . Epidural anaesthesia is superior to general anaesthesia in Caesarean section under normal conditions with regard to neonatal outcome . Whether this is also true for critical conditions can not be concluded from this study Background There are no r and omized studies on neonatal outcome after spinal versus general anesthesia for cesarean delivery in preeclamptic patients with a nonreassuring fetal heart trace . This study examined both markers of neonatal hypoxia and maternal hemodynamics . Methods Seventy patients were r and omized to general ( n = 35 ) or spinal anesthesia ( n = 35 ) . The general anesthesia group received thiopentone , magnesium sulfate , and suxamethonium intravenously before intubation , followed by 50 % nitrous oxide in oxygen , 0.75–1.5 % isoflurane , and morphine after delivery . The target end-tidal partial pressure of carbon dioxide ( Pco2 ) was 30–34 mmHg . The spinal anesthesia group received 1.8 ml hyperbaric bupivacaine plus 10 & mgr;g fentanyl at the L3–L4 interspace . Heart rate and blood pressure were measured at specific time points Output:	Compared to women who had GA , women who had either epidural anaesthesia or spinal anaesthesia were found to have a significantly lower difference between pre and postoperative haematocrit . There is no evidence from this review to show that RA is superior to GA in terms of major maternal or neonatal outcomes .
MS2879	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background —Vascular cell adhesion molecule (VCAM)-1 , intercellular adhesion molecule (ICAM)-1 , and E-selectin mediate adhesion and transmigration of leukocytes to the vascular endothelial wall and may promote plaque growth and instability . In a prospect i ve study , we evaluated the effect of soluble adhesion molecules on the risk of future cardiovascular events among patients with angiographically documented coronary artery disease ( CAD ) . Methods and Results —We obtained baseline sample s from a prospect i ve cohort of 1246 patients with CAD . Besides various markers of inflammation , soluble VCAM-1 ( sVCAM-1 ) , sICAM-1 , and sE-selectin were determined . Follow-up information on cardiovascular events was obtained ( mean , 2.7 ; maximum , 4.1 years ) . Independently higher levels of sVCAM-1 ( 1932 versus 1128 ng/mL;P < 0.0001 ) , sICAM-1 ( 353 versus 287 ng/mL;P = 0.015 ) , and sE-selectin ( 81 versus 63 ng/mL;P = 0.003 ) were observed in patients with future death from cardiovascular causes . In a multivariate model , fatal risk was 2.1-fold ( 1.1 to 4.0 ) higher in patients within the top quartile of baseline sVCAM-1 concentrations compared with lower quartiles . This association was present independent of general inflammatory response as reflected by low or high C-reactive protein ( hs-CRP ) levels . In a model that simultaneously controlled for all inflammatory and soluble adhesion markers determined , only sVCAM-1 remained independently significant for future fatal cardiovascular events , with a 2.8-fold increase in risk ( P = 0.003 ) . Conclusions —Soluble adhesion molecules sVCAM-1 , sICAM-1 , and sE-selectin were significantly related to future death from cardiovascular causes among patients with documented CAD . Especially sVCAM-1 added to the predictive value of classic risk factors and hs-CRP in determining the risk of future cardiovascular death BACKGROUND Interleukin-6 ( IL-6 ) plays a central role in inflammation and tissue injury . However , epidemiological data evaluating the role of IL-6 in atherogenesis are sparse . METHODS AND RESULTS In a prospect i ve study involving 14 916 apparently healthy men , we measured baseline plasma concentration of IL-6 in 202 participants who subsequently developed myocardial infa rct ion ( MI ) and in 202 study participants matched for age and smoking status who did not report vascular disease during a 6-year follow-up . Median concentrations of IL-6 at baseline were higher among men who subsequently had an MI than among those who did not ( 1.81 versus 1 . 46 pg/mL ; P=0.002 ) . The risk of future MI increased with increasing quartiles of baseline IL-6 concentration ( P for trend < 0.001 ) such that men in the highest quartile at entry had a relative risk 2.3 times higher than those in the lowest quartile ( 95 % CI 1.3 to 4.3 , P=0.005 ) ; for each quartile increase in IL-6 , there was a 38 % increase in risk (P=0.001).This relationship remained significant after adjustment for other cardiovascular risk factors , was stable over long periods of follow-up , and was present in all low-risk subgroups , including nonsmokers . Although the strongest correlate of IL-6 in these data was C-reactive protein ( r=0.43 , P<0.001 ) , the relationship of IL-6 with subsequent risk remained after control for this factor ( P<0.001 ) . CONCLUSIONS In apparently healthy men , elevated levels of IL-6 are associated with increased risk of future MI . These data thus support a role for cytokine-mediated inflammation in the early stages of atherogenesis BACKGROUND Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events . Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol , we hypothesized that people with elevated high-sensitivity C-reactive protein levels but without hyperlipidemia might benefit from statin treatment . METHODS We r and omly assigned 17,802 apparently healthy men and women with low-density lipoprotein ( LDL ) cholesterol levels of less than 130 mg per deciliter ( 3.4 mmol per liter ) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to rosuvastatin , 20 mg daily , or placebo and followed them for the occurrence of the combined primary end point of myocardial infa rct ion , stroke , arterial revascularization , hospitalization for unstable angina , or death from cardiovascular causes . RESULTS The trial was stopped after a median follow-up of 1.9 years ( maximum , 5.0 ) . Rosuvastatin reduced LDL cholesterol levels by 50 % and high-sensitivity C-reactive protein levels by 37 % . The rates of the primary end point were 0.77 and 1.36 per 100 person-years of follow-up in the rosuvastatin and placebo groups , respectively ( hazard ratio for rosuvastatin , 0.56 ; 95 % confidence interval [ CI ] , 0.46 to 0.69 ; P<0.00001 ) , with corresponding rates of 0.17 and 0.37 for myocardial infa rct ion ( hazard ratio , 0.46 ; 95 % CI , 0.30 to 0.70 ; P=0.0002 ) , 0.18 and 0.34 for stroke ( hazard ratio , 0.52 ; 95 % CI , 0.34 to 0.79 ; P=0.002 ) , 0.41 and 0.77 for revascularization or unstable angina ( hazard ratio , 0.53 ; 95 % CI , 0.40 to 0.70 ; P<0.00001 ) , 0.45 and 0.85 for the combined end point of myocardial infa rct ion , stroke , or death from cardiovascular causes ( hazard ratio , 0.53 ; 95 % CI , 0.40 to 0.69 ; P<0.00001 ) , and 1.00 and 1.25 for death from any cause ( hazard ratio , 0.80 ; 95 % CI , 0.67 to 0.97 ; P=0.02 ) . Consistent effects were observed in all subgroups evaluated . The rosuvastatin group did not have a significant increase in myopathy or cancer but did have a higher incidence of physician-reported diabetes . CONCLUSIONS In this trial of apparently healthy persons without hyperlipidemia but with elevated high-sensitivity C-reactive protein levels , rosuvastatin significantly reduced the incidence of major cardiovascular events . ( Clinical Trials.gov number , NCT00239681 . Background Patients with chronic HCV infection have increased liver iron . Recently identified protein hepcidin synthesized in the liver , is thought to be a key regulator for iron homeostasis and is induced by infection and inflammation . Lower erythropoietin and iron supplementation requirements were previously reported in HD patients with HCV infection . We investigated the association of prohepcidin with inflammation and iron parameters in HD patients with and without chronic HCV infection . Methods Sixty patients ( 27 male , 33 female , mean age 50 ±15 years ) on chronic HD were included . Parameters related to iron metabolism ( ferritin , serum iron and total iron binding capacity ( TIBC ) ) , inflammation ( hs-CRP , TNF-α and IL-6 ) and prohepcidin levels were measured . The response to treatment ( erythropoiesis-stimulating agent ( ESA ) resistance index ) was assessed from the ratio of the weekly erythropoietin ( rhuEPO ) dose to hemoglobin ( Hb ) per unit weight . Results Serum prohepcidin levels of HCV positive patients ( 135 ± 25 ng/mL ) were significantly lower than HCV negative patients [ 148 ± 18 ng/mL , ( p = 0.025 ) ] . Serum IL-6 levels of HCV positive patients were also significantly lower than HCV negative patients ( p = 0.016 ) . Serum prohepcidin levels were positively correlated with ferritin ( r = 0.405 , p = 0.001 ) and IL-6 ( r = 0.271 , p = 0.050 ) levels in HD patients . In the HCV positive group , serum prohepcidin levels significantly correlated with ferritin levels ( r = 0.514 p = 0.004 ) . In the HCV negative group , serum prohepcidin levels significantly correlated with serum IL-6 levels ( r = 0.418 , p = 0.027 ) . In multiple regression analysis performed to predict prohepcidin in HCV positive patients , serum ferritin was found to be an independent variable ( r = 0.28 , p = 0.008 ) . Conclusions HCV positive HD patients have low levels of serum prohepcidin and IL-6 which might account for iron accumulation together with lower iron and rhuEPO requirements in these patients BACKGROUND Since inflammation is believed to have a role in the pathogenesis of cardiovascular events , measurement of markers of inflammation has been proposed as a method to improve the prediction of the risk of these events . METHODS We conducted a prospect i ve , nested case-control study among 28,263 apparently healthy postmenopausal women over a mean follow-up period of three years to assess the risk of cardiovascular events associated with base-line levels of markers of inflammation . The markers included high-sensitivity C-reactive protein ( hs-CRP ) , serum amyloid A , interleukin-6 , and soluble intercellular adhesion molecule type 1 ( sICAM-1 ) . We also studied homocysteine and a variety of lipid and lipoprotein measurements . Cardiovascular events were defined as death from coronary heart disease , nonfatal myocardial infa rct ion or stroke , or the need for coronary-revascularization procedures . RESULTS Of the 12 markers measured , hs-CRP was the strongest univariate predictor of the risk of cardiovascular events ; the relative risk of events for women in the highest as compared with the lowest quartile for this marker was 4.4 ( 95 percent confidence interval , 2.2 to 8.9 ) . Other markers significantly associated with the risk of cardiovascular events were serum amyloid A ( relative risk for the highest as compared with the lowest quartile , 3.0 ) , sICAM-1 ( 2.6 ) , interleukin-6 ( 2.2 ) , homocysteine ( 2.0 ) , total cholesterol ( 2.4 ) , LDL cholesterol ( 2.4 ) , apolipoprotein B-100 ( 3.4 ) , HDL cholesterol ( 0.3 ) , and the ratio of total cholesterol to HDL cholesterol ( 3.4 ) . Prediction models that incorporated markers of inflammation in addition to lipids were significantly better at predicting risk than models based on lipid levels alone ( P<0.001 ) . The levels of hs-CRP and serum amyloid A were significant predictors of risk even in the subgroup of women with LDL cholesterol levels below 130 mg per deciliter ( 3.4 mmol per liter ) , the target for primary prevention established by the National Cholesterol Education Program . In multivariate analyses , the only plasma markers that independently predicted risk were hs-CRP ( relative risk for the highest as compared with the lowest quartile , 1.5 ; 95 percent confidence interval , 1.1 to 2.1 ) and the ratio of total cholesterol to HDL cholesterol ( relative risk , 1.4 ; 95 percent confidence interval , 1.1 to 1.9 ) . CONCLUSIONS The addition of the measurement of C-reactive protein to screening based on lipid levels may provide an improved method of identifying persons at risk for cardiovascular events Tumor necrosis factor-alpha ( TNF-alpha ) plays a central role in the host 's immunomodulatory response to infective agents . To evaluate the TNF-alpha system in patients with chronic hepatitis C virus ( HCV ) infection , plasma , serum , and peripheral blood mononuclear cells ( P BMC ) were prospect ively collected from 53 patients and 33 healthy control subjects . Circulating TNF-alpha and TNF receptors were assayed by their respective enzyme immunoassays . In addition , TNF-alpha mRNA was quantitated in P BMC using a branched DNA assay , and production of TNF-alpha by P BMC with and without lipopolysaccharide was also assessed . Patients with chronic HCV infection had a higher level of circulating TNF-alpha compared to healthy control subjects ( 9.62 + /- 6.01 vs 3.66 + /- 1.23 pg/ml , P < 0.001 ) . They also had higher circulating levels of TNF receptors compared to control ( CD120a : Output:	Our review revealed that HCV infection significantly alters serum levels of markers of inflammation , endothelial function , and cardiac dysfunction prior to HCV treatment , and some of which may change in response to HCV therapy . Current risk stratification tools for development of CVD in the general population may not account for the increased inflammatory markers that appear to be elevated among HCV‐infected patients contributing to increased CVD risk
MS2880	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract Background : According to research findings , pain experience in neonatal period leads to short- and long-term complications that could be prevented by means of neonatal pain relief . Therefore , this study aim ed to investigate the effect of facilitated tucking position on neonatal pain during heel prick blood sampling . Methods : This is a cross over clinical trial was done on 40 premature neonates . During blood sampling , neonates were put in either facilitated tucking or routine positions r and omly and Premature Infant Pain Profile ( PIPP ) was completed for each neonate . In the next sampling time , positions were changed and the process repeated . Data were analyzed using descriptive statistics , repeated measure ANOVA , and independent t-test . Results : Results showed that the mean pain intensity in each position was increased during sampling ( p = .0001 ) and after that was decreased significantly ( p = .001 ) , but before , during , and after sampling there was no significant difference between the two positions ( p > .05 ) . Conclusions : Overall findings showed that comparing neonates in the two positions ; there was no significant difference in their pain intensity . These results are almost in contrast with many research es findings in this area . It seems there is a need to further investigation regarding this subject OBJECTIVES : To test the comparative effectiveness of 2 nonpharmacologic pain-relieving interventions administered alone or in combination across time for repeated heel sticks in preterm infants . METHODS : A multicenter r and omized controlled trial in 3 NICUs in Switzerl and compared the effectiveness of oral sucrose , facilitated tucking ( FT ) , and a combination of both interventions in preterm infants between 24 and 32 weeks of gestation . Data were collected during the first 14 days of their NICU stay . Three phases ( baseline , heel stick , recovery ) of 5 heel stick procedures were videotaped for each infant . Four independent experienced nurses blinded to the heel stick phase rated 1055 video sequences presented in r and om order by using the Bernese Pain Scale for Neonates , a vali date d pain tool . RESULTS : Seventy-one infants were included in the study . Interrater reliability was high for the total Bernese Pain Scale for Neonates score ( Cronbach ’s α : 0.90–0.95 ) . FT alone was significantly less effective in relieving repeated procedural pain ( P < .002 ) than sucrose ( 0.2 mL/kg ) . FT in combination with sucrose seemed to have added value in the recovery phase with lower pain scores ( P = .003 ) compared with both the single-treatment groups . There were no significant differences in pain responses across gestational ages . CONCLUSIONS : Sucrose with and without FT had pain-relieving effects even in preterm infants of < 32 weeks of gestation having repeated pain exposures . These interventions remained effective during repeated heel sticks across time . FT was not as effective and can not be recommended as a nonpharmacologic pain relief intervention for repeated pain exposure BACKGROUND Preterm infants manifest pain and stress by behavioural agitation and state change . Few studies have explored the effects of combining nonpharmacological interventions , i.e. non-nutritive sucking , oral sucrose , and facilitated tucking , on infants ' behaviours across painful procedures . OBJECTIVES To explore the effects of combined use of three nonpharmacological interventions ( non-nutritive sucking , oral sucrose , and facilitated tucking ) on infants ' pain- and stress-related behaviours during four assessment phases : baseline , intervention , heel stick , and recovery . DESIGN Prospect i ve , r and omised controlled trial . SETTING Level III neonatal intensive care unit in Taipei . METHOD A convenience sample of 110 infants ( gestational age 27 - 37 weeks ) needing heel sticks was r and omly assigned to five combinations of nonpharmacological treatments : ( 1 ) routine care , ( 2 ) non-nutritive sucking+facilitated tucking , ( 3 ) oral sucrose+facilitated tucking , ( 4 ) non-nutritive sucking+oral sucrose , and ( 5 ) non-nutritive sucking+oral sucrose+facilitated tucking . Outcomes were infants ' withdrawal or stress ( grimace , limb and trunk extension or squirming ) and approach or self-soothing ( sucking , sucking search , or mouthing ; h and holding or grasping ; and h and to mouth , face ) behaviours . RESULTS The frequency of infants ' withdrawal behaviours decreased significantly when they received combinations of nonpharmacological interventions before heel stick . Specifically , grimace frequency decreased by 32.2 % , 30.6 % , 19.7 % , and 13.8 % in infants receiving oral sucrose+non-nutritive sucking+facilitated tucking , non-nutritive sucking+oral sucrose , oral sucrose+facilitated tucking , and non-nutritive sucking+facilitated tucking , respectively , compared to those receiving routine care across assessment phases . Furthermore , infants ' frequency of limb and trunk extension or squirming decreased by 24.0 % when they received non-nutritive sucking+oral sucrose+facilitated tucking compared to those receiving routine care . Infants ' frequency of approach behaviours did not change significantly across all phases when they received non-nutritive sucking+oral sucrose+facilitated tucking , non-nutritive sucking+oral sucrose , and oral sucrose+facilitated tucking compared to those receiving routine care . CONCLUSIONS The combined use of nonpharmacological interventions ( non-nutritive sucking+oral sucrose+facilitated tucking ) effectively reduced the frequencies of infants ' withdrawal behaviours , i.e. grimace and limb and trunk extension or squirming . Our results provide evidence supporting clinicians ' incorporation of the combined use of facilitated tucking , oral sucrose , and non-nutritive sucking into clinical practice during painful procedures . Heel-stick procedures can be atraumatic when conducted while infants are stable and quiet , appropriately positioned , and stabilised and by offering facilitated tucking , oral sucrose , and non-nutritive sucking before gently sticking the heel and squeezing blood Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more PURPOSE To determine the effect of facilitated tucking ( FT ) on pain in preterm newborns during heel stick procedure done as a part of neonatal intensive care . METHODS This r and omized controlled cross-over pilot study included 20 preterm newborns of both sexes between gestational ages ( GA ) of 28 and 36 weeks based upon the eligibility criteria . Pain was measured using Premature Infant Pain Profile ( PIPP ) following both heel stick with FT and without FT . RESULTS The newborns had a lower PIPP score at 30 seconds ( Mean , SD : 8.80 , 3.82 ) , 60 seconds ( Mean , SD : 7.55 , 3.28 ) , 90 seconds ( Mean , SD : 7.25 , 3.06 ) and 120 seconds ( Mean , SD : 6.65 , 3.05 ) when heel stick was done with FT compared to the same procedure done without FT at 30 seconds ( Mean , SD : 11.20 , 3.44 ) , 60 seconds ( Mean , SD : 10.75 , 3.24 ) , 90 seconds ( Mean , SD : 10.60 , 3.22 ) and 120 seconds ( Mean , SD : 10.50 , 3.15 ) . A ( 2 X 4 ) factorial ANOVA showed a statistically significant difference between these two procedures in all the time periods viz . , 30 seconds ( p=0.044 ) , 60 seconds ( p=0.004 ) , 90 seconds ( p=0.002 ) and 120 seconds ( p < 0.0001 ) at 0.05 level in PIPP score and favoring FT . CONCLUSION FT is an effective non-pharmacological pain management in preterm newborns during routine neonatal intensive care BACKGROUND Preterm infants ' repeated exposure to painful procedures may contribute to negative consequences . Thus , improving preterm infants ' neurodevelopmental outcomes requires prioritising their pain management . OBJECTIVES To compare the effectiveness of two non-pharmacological pain-relief strategies ( non-nutritive sucking and facilitated tucking ) with routine care on preterm infants ' pain , behavioural , and physiological responses before , during , and after heel-stick procedures . DESIGN Prospect i ve , r and omised controlled crossover trial . SETTING Level III Neonatal Intensive Care Unit in Taipei . METHOD Thirty-four preterm infants ( gestational age 29 - 37 weeks ) needing three procedural heel sticks were recruited by convenience sampling and r and omly assigned to a sequence of three treatments ( two pain-relief interventions and the control condition ) : ( 1 ) routine care , non-nutritive sucking , facilitated tucking , ( 2 ) non-nutritive sucking , facilitated tucking , routine care , and ( 3 ) facilitated tucking , routine care , non-nutritive sucking . Each treatment condition was performed on a different day to avoid any carry-over effect . Pain was measured by the Premature Infant Pain Profile ( PIPP ) , infant behaviour by a behavioural coding scheme , and physiological signals by electrocardiogram monitors . All data were collected 3 min without stimuli ( baseline ) , during heel-stick procedures , and recovery . RESULTS Infants receiving non-nutritive sucking and facilitated tucking had significantly lower mean ( st and ard deviation ) pain scores during heel-stick procedures ( 6.39 [ 3.35 ] and 7.15 [ 3.88 ] , respectively ) than those receiving routine care ( 9.52 [ 4.95 ] ) . Infants receiving non-nutritive sucking and facilitated tucking had significantly lower odds ratios ( 0.39 , p=0.011 and 0.34 , p=0.005 , respectively ) for pain ( PIPP score≥6 ) than infants receiving routine care after adjusting for time , baseline pain scores , and infants ' characteristics . Similarly , infants receiving non-nutritive sucking and facilitated tucking had significantly lower odds ratios ( 0.23 , p<0.001 and 0.28 , p=0.03 , respectively ) for moderate-to-severe pain ( PIPP score≥12 ) than infants receiving routine care . Infants receiving facilitated tucking had lower frequency ratios for stress-related behaviours , abnormal heart rates , and decreased oxygen saturation than infants receiving routine care . CONCLUSIONS Both non-nutritive sucking and facilitated tucking effectively reduced pain scores more than routine care during heel-stick procedures . Non-nutritive sucking reduced PIPP pain scores more effectively than facilitated tucking . However , facilitated tucking showed broader effects not only on relieving pain , but also on enhancing infants ' physiological and behavioural stability during heel-stick procedures Background This study was conducted to evaluate the pain perceptions of newborns during the hepatitis B ( HBV ) vaccinations performed in the facilitated tucking position and the classical holding position , respectively . Methods The r and omized controlled experimental study was conducted between 1 September 2014 and 30 December 2014 at the neonatal intensive care unit of a Turkish university hospital . One group of infants was held in the facilitated tucking position ( the treatment group ; n = 30 ) during HBV vaccination ; infants in the other group were held in the classical holding position ( the control group ; n = 30 ) during HBV vaccination . The Neonatal Infant Pain Scale ( NIPS ) scores of the infants in the treatment and control groups were compared during procedure . Also , the infants ’ physiological parameters were compared before , during , and after the procedure . Descriptive statistics , a chi-square test , and an independent sample s t-test were used to assess the data . Results The mean pain scores of infants vaccinated in the facilitated tucking position ( 2.83 ± 1.18 ) were significantly statistically lower than the scores of infants vaccinated in the classical holding position ( 6.47 ± 1.07 ) ( p < 0.05 ) . Conclusions The pain perceptions of newborns held in the facilitated tucking position during HBV vaccination were lower . The facilitated tucking position , a non-pharmacological method , is recommended as an effective and useful method for reducing pain during the procedure Background : Premature infants not only feel and underst and the pain , but also respond more intensively compared with term infants . Non-pharmacological methods of pain control are suitable to relieve pain in painful procedures . The facilitated tucking position is considered as a non-pharmacological method of pain control in infants ; however , its impact on frequent and repeated procedural pain such as endotracheal suctioning remains to be studied . Objectives : This paper is the report of a study that examined the impact of facilitated tucking position on behavioral pain during suctioning in premature neonates . Design : This was a clinical trial study with a crossover design . Setting s : The study was conducted in a level II Neonatal Intensive Care Unit , located in a teaching hospital , affiliated to Tehran University of Medical Sciences , Tehran , Iran . Participants : Thirty four infants were enrolled Output:	Conclusion : Facilitated tucking position may improve the pain during painful procedures . What is Known : • Exposure of premature babies to painful procedures is associated with changes in brain development , regardless of other factors . • Facilitated tucking reduces the expression of pain in premature infants . What is New : • Facilitated tucking position was efficient in pain management of preterm infants when compared to routine care . • Facilitated tucking compared to opioid or oral glucose did not achieve a significant reduction in pain intensity . What is Known : • Exposure of premature babies to painful procedures is associated with changes in brain development , regardless of other factors . • Facilitated tucking reduces the expression of pain in premature infants . What is New : • Facilitated tucking position was efficient in pain management of preterm infants when compared to routine care . • Facilitated tucking compared to opioid or oral glucose did not achieve a significant reduction in pain intensity
MS2881	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Introduction Endovascular treatment of cerebral aneurysms includes follow-up imaging to identify aneurysms that may need retreatment . The aim of this study was to determine predictors of incomplete aneurysm occlusion at 1 year after endovascular coiling for ruptured cerebral aneurysms . Methods In 129 patients of the Prospect i ve Registry of Subarachnoid Aneurysms Treatment cohort , ruptured aneurysms were coiled within 14 days of onset and both initial post-coiling and 1-year follow-up digital subtraction angiography or magnetic resonance angiography were obtained . Factors predicting 1-year incomplete aneurysm occlusion ( retreatment within 1-year or residual aneurysms at 1 year ) were determined using multivariate logistic regression analyses . Results One-year incomplete aneurysm occlusion was identified in 59 patients , including ten patients who were retreated within 1-year post-coiling . Dome size ≥7.5 mm ( P = 0.007 , odds ratio ( OR ) = 5.00 , 95 % confidence interval ( CI ) = 1.55–16.15 ) , pre-treatment aneurysm re-rupture ( P = 0.023 , OR = 3.50 , 95 % CI = 1.19–10.31 ) , non-small size/small neck aneurysm ( dome size , ≥10 mm or neck size , ≥4 mm ; P = 0.022 , OR = 3.26 , 95 % CI = 1.19–8.96 ) , and residual aneurysms on immediate post-coiling angiograms ( P = 0.017 , OR = 1.43 , 95 % CI = 1.07–1.93 ) significantly predicted incomplete aneurysm occlusion at 1-year post-coiling . Conclusions In addition to the characteristics of aneurysm and initially incomplete aneurysm occlusion , this study showed pre-treatment aneurysm re-rupture to be a predictor that favors closer imaging follow-ups for coiled aneurysms Background and Purpose — We sought to better define the morbidity of endovascular Guglielmi detachable coil ( GDC ) treatment of unruptured cerebral aneurysms and to discuss its role in the prevention of subarachnoid hemorrhage . Methods — We conducted an observational study from August 1992 to June 1999 of 125 unruptured aneurysms treated with GDC in 116 patients : 91 women ( 78.4 % ) and 25 men ( 21.6 % ) , aged 30 to 78 years ( mean age , 50.6 years ) . Immediate and late clinical results were recorded for any neurological event or hemorrhage related to the treated unruptured aneurysm . Angiographic results are reported as immediate , early ( 2 to 12 months ) , intermediate ( 12 to 30 months ) , and late follow-up ( > 30 months ) . Results — Immediate angiographic results showed complete obliteration ( class 1 ) in 59 ( 47.2 % ) or residual neck ( class 2 ) in 53 aneurysms ( 42.4 % ) , leaving 6 residual aneurysms ( 4.8 % ) and 7 failures ( 5.6 % ) . Early follow-up angiograms , available in 100 treated aneurysms ( 84 % ) , revealed class 1 in 52 % and class 2 in 41 % . Intermediate angiograms , available in 53 aneurysms ( 44.5 % ) , showed class 1 in 47.2 % and class 2 in 43.4 % , while late results , available in 37 lesions ( 31.1 % ) , had class 1 and 2 in 48.6 % and 37.8 % , respectively . Six patients suffered a permanent neurological deficit at last follow-up ( 5.2 % ) , with a good outcome in 5 patients and fair outcome in 1 patient . There was no mortality . There was no aneurysmal rupture during a mean clinical follow-up of 32.1 months . Conclusions — Endovascular treatment with GDC for unruptured aneurysms is relatively safe . Its role in the prevention of aneurysmal rupture remains to be determined , preferably by a r and omized study Background Coil embolization has gained importance in the management of intracranial aneurysms over the past decade . However , the recurrence risk after embolization m and ates closer follow-up than surgical clip ligation . Currently , there is no reliable system for predicting aneurysm sac thrombosis . An aneurysm embolization grade ( AEG ) reported previously by the senior author ( EMD ) has been proposed as a tool for predicting the durability of aneurysm occlusion based on hemodynamic characteristics . Here , we present our internal validity results . Methods AEG and Raymond – Roy Occlusion Classification ( RROC ) scores were prospect ively assigned to all aneurysms coiled from June 2008 to June 2011 . The prospect ively assigned AEG and RROC scores from the cerebral angiograms were collected for data analysis and validity assessment of the AEG system . 110 consecutive patients who had aneurysm coil embolization were included in this study . Results The post-coiling AEG significantly predicted follow-up angiographic filling characteristics . Pairwise comparisons revealed that the follow-up AEG for those initially scored ‘ A ’ ( complete obliteration ) was significantly better than the contrast-flow groups . Significant differences were also noted between contrast-stasis and contrast-flow groups . A pairwise comparison between RROC scores demonstrated that only the RROC Type 1 could be used to predict follow-up occlusion durability . Stent placement in wide-neck aneurysms had no effect on initial AEG , RROC , or long-term occlusion durability . Packing density significantly predicted initial AEG and RROC , but had no effect on long-term occlusion . Conclusions The AEG system is uniquely based on angiographic filling characteristics of the aneurysm , and this study demonstrated its high predictive value for determining aneurysm sac thrombosis . Assigning an AEG to the aneurysm can guide the neurointerventionalist in discussion s with the patient regarding the probability of aneurysm recurrence and potential need for retreatment Background and Purpose — Our aim in this study was to assess the incidence and determining factors of angiographic recurrences after endovascular treatment of aneurysms . Methods — A retrospective analysis of all patients with selective endosaccular coil occlusion of intracranial aneurysms prospect ively collected from 1992 to 2002 was performed . There were 501 aneurysms in 466 patients ( mean±SD age , 54.20±12.54 years ; 74 % female ) . Aneurysms were acutely ruptured ( 54.1 % ) or unruptured ( 45.9 % ) . Mean±SD aneurysm size was 9.67±5.91 mm with a 4.31±1.97-mm neck . The most frequent sites were basilar bifurcation ( 27.7 % ) and carotid ophthalmic ( 18.0 % ) aneurysms . Recurrences were subjectively divided into minor and major ( ideally necessitating re-treatment ) . The most significant predictors of angiographic recurrence were determined by logistic regression . These results were confirmed by & khgr;2 , t tests , or ANOVAs followed , when appropriate , by Tukey ’s contrasts . Results — Short-term ( ≤1 year ) follow-up angiograms were available in 353 aneurysms ( 70.5 % ) and long-term ( > 1 year ) follow-up angiograms , in 277 ( 55 % ) , for a total of 383 ( 76.5 % ) followed up . Recurrences were found in 33.6 % of treated aneurysms that were followed up and that appeared at a mean±SD time of 12.31±11.33 months after treatment . Major recurrences presented in 20.7 % and appeared at a mean of 16.49±15.93 months . Three patients ( 0.8 % ) bled during a mean clinical follow-up period of 31.32±24.96 months . Variables determined to be significant predictors ( P < 0.05 ) of a recurrence included aneurysm size ≥10 mm , treatment during the acute phase of rupture , incomplete initial occlusions , and duration of follow-up . Conclusions — Long-term monitoring of patients treated by endosaccular coiling is m and atory BACKGROUND AND PURPOSE : The purpose of this study was to analyze angiographic and clinical results before and after additional endovascular therapy in patients with previously coiled but reopened cerebral aneurysms and to identify possible risk factors for retreatment of an aneurysm . MATERIAL S AND METHODS : Follow-up with selective digital subtraction angiography was performed in 323/596 ( 54.2 % ) patients harboring 342 aneurysms with a mean follow-up time of 28.6 months . The patients were divided into 3 groups : group A , who remained stable after initial treatment ; group B , who showed minor morphologic changes ; and group C , who underwent repeat treatment . Univariate and multivariate regression analyses were performed to determine possible risk factors for aneurysmal retreatment . RESULTS : Single or multiple retreatment was performed in 33 of 323 ( 10.2 % ) patients . Retreatment of small aneurysms ( ≤10 mm ) with small necks ( ≤4 mm ) was performed in 6 of 214 aneurysms . When summarizing all other aneurysms as a “ risk group ” ( n = 128 ) , the odds ratio ( OR ) for retreatment in the “ risk group ” was 3.11 ( 95 % CI : 1.43–6.75 ; P = .004 ) . In patients with residual aneurysm after the first treatment , OR for retreatment was 3.96 ( 95 % CI : 1.48–10.65 ; P = .006 ) , whereas a neck remnant , clinical presentation , and aneurysmal localization were not predictive . We observed no result ing morbidity and mortality from the 33 retreatment procedures . CONCLUSION : In our series , the retreatment of aneurysmal recurrences was a safe procedure . The best single predictors of aneurysmal recurrence were aneurysmal anatomy ( neck width > 4 mm and diameter > 10 mm ) and the presence of a residual aneurysm after initial treatment . A limitation in our study was the significant number of patients lost to follow-up ( 22.7 % ) Output:	RESULTS We found the Raymond scale to be predictive of retreatment , with statistically higher rates of retreatment with higher initial Raymond grade . Furthermore , we found a higher probability of rebleeding for initial grade s 2 or 3 versus grade 1 , which approached significance . The rebleed rates were probably affected by monitoring and treatment of recurrence . However , although there was a trend towards higher recurrence rates with initial grade , this was not statistically significant . The modified Raymond-Roy scale appears to provide reasonable predictive value for treated aneurysm , especially for the clinical ly more important aspects of retreatment and rebleed rates
MS2882	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND This study examined the effects of an 8-week stress reduction program based on training in mindfulness meditation . Previous research efforts suggesting this program may be beneficial in terms of reducing stress-related symptomatology and helping patients cope with chronic pain have been limited by a lack of adequate comparison control group . METHODS Twenty-eight individuals who volunteered to participate in the present study were r and omized into either an experimental group or a nonintervention control group . RESULTS Following participation , experimental subjects , when compared with controls , evidence d significantly greater changes in terms of : ( 1 ) reductions in overall psychological symptomatology ; ( 2 ) increase in overall domain-specific sense of control and utilization of an accepting or yielding mode of control in their lives , and ( 3 ) higher scores on a measure of spiritual experiences . CONCLUSIONS The techniques of mindfulness meditation , with their emphasis on developing detached observation and awareness of the contents of consciousness , may represent a powerful cognitive behavioral coping strategy for transforming the ways in which we respond to life events . They may also have potential for relapse prevention in affective disorders Background : Although mindfulness meditation interventions have recently shown benefits for reducing stress in various population s , little is known about their relative efficacy compared with relaxation interventions . Purpose : This r and omized controlled trial examines the effects of a 1-month mindfulness meditation versus somatic relaxation training as compared to a control group in 83 students ( M age=25 ; 16 men and 67 women ) reporting distress . Method : Psychological distress , positive states of mind , distractive and ruminative thoughts and behaviors , and spiritual experience were measured , while controlling for social desirability . Results : Hierarchical linear modeling reveals that both meditation and relaxation groups experienced significant decreases in distress as well as increases in positive mood states over time , compared with the control group ( p<.05 in all cases ) . There were no significant differences between meditation and relaxation on distress and positive mood states over time . Effect sizes for distress were large for both meditation and relaxation ( Cohen ’s d=1.36 and .91 , respectively ) , whereas the meditation group showed a larger effect size for positive states of mind than relaxation ( Cohen ’s d=.71 and .25 , respectively ) . The meditation group also demonstrated significant pre-post decreases in both distractive and ruminative thoughts/behaviors compared with the control group ( p<.04 in all cases ; Cohen ’s d=.57 for rumination and .25 for distraction for the meditation group ) , with mediation models suggesting that mindfulness meditation ’s effects on reducing distress were partially mediated by reducing rumination . No significant effects were found for spiritual experience . Conclusions : The data suggest that compared with a no-treatment control , brief training in mindfulness meditation or somatic relaxation reduces distress and improves positive mood states . However , mindfulness meditation may be specific in its ability to reduce distractive and ruminative thoughts and behaviors , and this ability may provide a unique mechanism by which mindfulness meditation reduces distress Psychosocial stress is a potent activator of the hypothalamus-pituitary-adrenal ( HPA ) axis . While neuroendocrine stress responses are essential for the maintenance of homeostasis , evidence suggests that excessive activation of the HPA axis constitutes a risk for disease and psychopathology . The purpose of the present study was to assess the effect of cognitive-behavioral stress management training on endocrine stress responses and cognitive appraisal under acute psychosocial stress among healthy young subjects . Forty-eight healthy , non-smoking male students without acute or chronic medical or psychiatric disorder on self report were r and omly assigned to receive group-based cognitive-behavioral stress management training either before or after a st and ardized psychosocial stress test ( Trier Social Stress Test , TSST ) . Endocrine and psychological stress responses were assessed with salivary free cortisol response and cognitive appraisal processes to the TSST . In comparison with the control group , subjects in the treatment group showed an attenuated endocrine response ( F ( 2.55/117.41 ) = 3.81 ; P = 0.02 ; effect size f(2 ) = 0.35 ) to the TSST . In addition , subjects in the SIT group had lower stress appraisal and higher control expectancies ( F ( 2/45 ) = 6.56 ; P = 0.003 , effect size f(2 ) = 0.29 ) compared to controls . Short group-based cognitive-behavioral stress management training reduces the neuroendocrine stress response to an acute stressor in healthy subjects . Therefore , stress management training may prove useful in preventing detrimental effects of stress-induced neuroendocrine The inability to cope successfully with the enormous stress of medical education may lead to a cascade of consequences at both a personal and professional level . The present study examined the short-term effects of an 8-week meditation-based stress reduction intervention on premedical and medical students using a well-controlled statistical design . Findings indicate that participation in the intervention can effectively ( 1 ) reduce self-reported state and trait anxiety , ( 2 ) reduce reports of overall psychological distress including depression , ( 3 ) increase scores on overall empathy levels , and ( 4 ) increase scores on a measure of spiritual experiences assessed at termination of intervention . These results ( 5 ) replicated in the wait-list control group , ( 6 ) held across different experiments , and ( 7 ) were observed during the exam period . Future research should address potential long-term effects of mindfulness training for medical and premedical students The challenges of providing exemplary undergraduate nursing education can not be underestimated in an era when burnout and negative mood states predictably lead to alarming rates of academic as well as career attrition . While the multi-dimensional nature of this complex issue has been extensively eluci date d , few rational strategies exist to reverse a disheartening trend recognizable early in the educational process that subsequently threatens to undermine the future viability of quality healthcare . This controlled prospect i ve crossover study examined the impact of a 6-session Recreational Music-making ( RMM ) protocol on burnout and mood dimensions as well as Total Mood Disturbance ( TMD ) in first year associate level nursing students . A total of 75 first year associate degree nursing students from Allegany College of Maryl and ( ACM ) participated in a 6-session RMM protocol focusing on group support and stress reduction utilizing a specific group drumming protocol . Burnout and mood dimensions were assessed with the Maslach Burnout Inventory and the Profile of Mood States respectively . Statistically significant reductions of multiple burnout and mood dimensions as well as TMD scores were noted . Potential annual cost savings for the typical associate degree nursing program ( $ 16,800 ) and acute care hospital ( $ 322,000 ) were projected by an independent economic analysis firm . A cost-effective 6-session RMM protocol reduces burnout and mood dimensions as well as TMD in associate degree nursing students Mindfulness-based stress reduction ( MBSR ) has shown effectiveness for a variety of mental health conditions . However , it is not known for whom the intervention is most effective . In a r and omized controlled trial ( N = 30 ) , we explored whether individuals with higher levels of pretreatment trait mindfulness would benefit more from MBSR intervention . Results demonstrated that relative to a control condition ( n = 15 ) , MBSR treatment ( n = 15 ) had significant effects on several outcomes , including increased trait mindfulness , subjective well-being , and empathy measured at 2 and 12 months after treatment . However , relative to controls , MBSR participants with higher levels of pretreatment mindfulness showed a larger increase in mindfulness , subjective well-being , empathy , and hope , and larger declines in perceived stress up to 1 year after treatment Psychosocial stress leads to a release of cortisol . While this psychoneuroendocrine response helps to maintain physiological as well as psychological equilibrium under stress , exaggerated secretion of cortisol has been shown to have negative effects on somatic health and cognitive functioning . The study set out to examine the long-term effects of cognitive-behavioral stress management training on cortisol stress responses in healthy men and women . Eighty-three healthy subjects were r and omly assigned to cognitive-behavioral stress management ( CBSM ) training or a control condition . Four months after the CBSM , 76 subjects underwent a st and ardized psychosocial stress test . Salivary cortisol responses were assessed repeatedly before and after the stress test . Subjects in the CBSM group showed significantly reduced cortisol stress responses . With regard to gender , this effect was observed in both men and women . However , the magnitude of the CBSM effect on cortisol responses was smaller in women than in men . Use of oral contraceptives in women influenced the cortisol response , but did not have an impact on the CBSM effect on cortisol . The results show that the previously reported attenuation of cortisol stress responses through CBSM persists and are observable in both men and women . Since stress-induced alterations of hypothalamus pituitary adrenal axis functioning are discussed to be involved in the onset and maintenance of both somatic and psychiatric conditions , similar interventions could be used for prevention and therapy of these detrimental stress effects Abstract The authors examined the effect of a 6-week mind/body intervention on college students ' psychological distress , anxiety , and perception of stress . One hundred twenty-eight students were r and omly assigned to an experimental group ( n = 63 ) or a waitlist control group ( n = 65 ) . The experimental group received 6 90-minute group-training sessions in the relaxation response and cognitive behavioral skills . The Symptom Checklist-90-Revised , Spielberger State-Trait Anxiety Inventory , and the Perceived Stress Scale were used to assess the students ' psychological state before and after the intervention . Ninety students ( 70 % of the initial sample ) completed the post assessment measure . Significantly greater reductions in psychological distress , state anxiety , and perceived stress were found in the experimental group . This brief mind/body training may be useful as a preventive intervention for college students , according to the authors , who called for further research to determine whether the observed treatment effect can be sustained over a longer period of time The purpose of this study was to compare the effects of Benson 's relaxation technique ( BRT ) with Benson 's technique augmented with GSR biofeedback ( i.e. , biofeedback-aided relaxation , BAR ) on the psychological stress symptoms of well college students . Seventy-eight normotensive college students were r and omly assigned to one of three groups : the BRT group , the BAR group , and a control group . The BRT and BAR students were asked to practice their respective relaxation technique daily for an eight-week period . Pre- and postintervention , all subjects were administered a state-anxiety inventory and a profile-of-mood state ( POMS ) test . Posttest analysis indicated that the BAR group had significantly lower state anxiety and POMS than the BRT and control groups ( p less than 0.05 ) . It was evident from the results that BAR did augment BRT in lowering psychological stress symptoms . Part of the effectiveness was due to the expectation of relief on the part of the BAR group . It was recommended that nurses study the effects of BAR in clinical setting This study examined the effectiveness of audiotaped imagery in reducing anxiety and improving test performance among first-year nursing students . Volunteer subjects were r and omly assigned to three groups , imagery-only , imagery/relaxation , and a no-treatment control group . Pottest state anxiety scores in these groups were significantly lower ( p = .001 ) than in the no-treatment control group . Test performance did not differ significantly ( p = .067 ) . Subjects using the audiotaped imagery reported an increased sense of well-being , improved ability to sleep , greater energy , and improved self-confidence OBJECTIVE This study aim ed to determine whether the practice of mindfulness reduces the level of stress experienced by senior medical students . METHODS We carried out a multicentre , single-blinded , r and omised controlled trial with intention-to-treat analysis in three clinical schools attached to the University of Tasmania , Hobart , Tasmania . Participants included 66 medical students in their final 2 years of study in 2009 . Participants were block-r and omised to either an intervention or a usual care control group . The intervention used an audio CD of guided mindfulness practice design ed and produced for this trial . Participants were advised to use the intervention daily over the 8 weeks of the trial . All participants completed two self-report question naires , at baseline and at 8 weeks , respectively . The intervention group also completed a question naire at 16 weeks to provide follow-up data . The primary outcome measure was the difference over time in scores on the Perceived Stress Scale ( PSS ) . The secondary outcome measure referred to differences over time in scores on the subscales of the Depression , Anxiety and Stress Scale ( DASS ) . RESULTS Mean baseline scores on the PSS and the stress component of the DASS were 15.7 ( maximal score of 40 ) and 13.2 ( maximal score of 42 ) , respectively , both of which exceed scores in age-matched normative control data . Using multivariable analysis , participants in the intervention group demonstrated significant reductions in scores on the PSS ( - 3.44 , 95 % confidence interval [ CI ] - 6.20 to - 0.68 ; p < 0.05 ) and the anxiety component of the DASS ( - 2.82 , 95 % CI - 4.99 to - 0.64 ; p < 0.05 ) . A borderline significant effect was demonstrated on the stress component of the DASS ( - 3.69 , 95 % CI - 7.38 to 0.01 ; p = 0.05 ) . Follow-up at 8 weeks post-trial revealed that the effect was maintained . CONCLUSIONS Mindfulness practice reduced stress and anxiety in senior medical students . Stress is prevalent in medical students and can have adverse effects on both student health and patients . A simple , self-administer Output:	Secondary outcomes included lower levels of depression and cortisol . This review provides evidence that cognitive , behavioral , and mindfulness interventions are effective in reducing stress in university students .
MS2883	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Despite the widespread use of continuous renal replacement therapy in critically ill patients with acute renal failure ( ARF ) , there are few data supporting its benefits over conventional intermittent hemodialysis ( IHD ) . We sought to analyze differences in survival between modalities in a study that compared continuous venovenous hemodialysis ( CVVHD ) with IHD . METHODS Eighty critically ill patients with ARF requiring dialysis were r and omized after stratification by severity of illness to treatment with CVVHD or IHD . RESULTS There were no differences in survival or renal recovery between groups . In patients who died , mean survival time was 10.7 + /- 11.2 days for the IHD group versus 14.3 + /- 16.1 days for the CVVHD group ( P = not significant ) . There was greater net volume removal in the CVVHD group during 72 hours . Declines in urine output during 72 hours were similar between groups . Mean arterial pressure off and on dialysis therapy was analyzed retrospectively . There was a significant decrease in mean arterial pressure for patients on IHD therapy not seen in those on CVVHD therapy , but this did not lead to a survival advantage . CONCLUSION Despite greater volume control , CVVHD did not lead to an improvement in survival , preservation of urine output , or renal recovery compared with IHD in patients with ARF Among critically ill patients , acute kidney injury ( AKI ) requiring dialysis is associated with mortality rates generally in excess of 50 % . Continuous renal replacement therapies ( CRRT ) often are recommended and widely used , although data to support its superiority over intermittent hemodialysis ( IHD ) are lacking . Data from the Program to Improve Care in Acute Renal Disease ( PICARD ) , a multicenter observational study of AKI , were analyzed . Among 398 patients who required dialysis , the risk for death within 60 d was examined by assigned initial dialysis modality ( CRRT [ n = 206 ] versus IHD [ n = 192 ] ) using st and ard Kaplan-Meier product limit estimates , proportional hazards ( " Cox " ) regression methods , and a propensity score approach to account for selection effects . Crude survival rates were lower for patients who were treated with CRRT than IHD ( survival at 30 d 45 versus 58 % ; P = 0.006 ) . Adjusted for age , hepatic failure , sepsis , thrombocytopenia , blood urea nitrogen , and serum creatinine and stratified by site , the relative risk for death associated with CRRT was 1.82 ( 95 % confidence interval 1.26 to 2.62 ) . Further adjustment for the propensity score did not material ly alter the association ( relative risk 1.92 ; 95 % confidence interval 1.28 to 2.89 ) . Among critically ill patients with AKI , CRRT was associated with increased mortality . Although the results could reflect residual confounding by severity of illness , these data provide no evidence for a survival benefit afforded by CRRT . Larger , prospect i ve , r and omized clinical trials to compare CRRT and IHD in severe AKI are needed The syndrome of sepsis-associated severe acute renal failure is a frequent component of sepsis-induced multiorgan failure . Continuous hemofiltration techniques are often used in its dialytic management but little is known about their impact . The aim of this study is to define the biochemical and clinical impact of continuous hemodiafiltration ( CHD ) in the management of this syndrome and to retrospectively compare it to that of conventional dialysis . A prospect i ve , cohort study and retrospective comparison with historical controls was conducted at an intensive care unit ( ICU ) of a tertiary institution . Eighty-seven consecutive septic patients with acute renal failure were treated by continuous hemodiafiltration and 40 consecutive similar patients by conventional dialysis . All new cases of severe acute renal failure with sepsis were treated by means of continuous hemodiafiltration . Historical controls were treated by means of conventional dialysis . Illness and sepsis severity were assessed on admission and prior to initiation of treatment . Biochemical variables were assessed daily . Outcome was measured as discharge from the ICU , duration of oliguria and discharge from hospital . Of the 87 patients treated by hemodiafiltration , 86 had multiorgan failure , 71 ( 81.6 % ) septic shock and 52 ( 59.8 % ) bacteremia/fungemia . Their APACHE II score on admission was 29.9 and their mean organ failure score prior to treatment was 4.3 . Hemodiafiltration result ed in a significant fall in mean urea and creatinine levels within 24 h and in the correction of acidosis . The mean alveolar-arterial gradient fell from 276 to 211 mm Hg ( p < 0.02 ) within 24 h of therapy . Complications were few and mostly related to vascular access . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Acute renal failure ( ARF ) requiring dialysis in critically ill patients is associated with an in-hospital mortality rate of 50 to 80 % . The worldwide st and ard for renal replacement therapy is intermittent hemodialysis ( IHD ) . Continuous hemodialysis and hemofiltration techniques have recently emerged as alternative modalities . These two therapies have not been directly compared . METHODS A multicenter , r and omized , controlled trial was conducted comparing two dialysis modalities ( IHD vs. continuous hemodiafiltration ) for the treatment of ARF in the intensive care unit ( ICU ) . One hundred sixty-six patients were r and omized . Principal outcome measures were ICU and hospital mortality , length of stay , and recovery of renal function . RESULTS Using intention-to-treat analysis , the overall ICU and in-hospital mortalities were 50.6 and 56.6 % , respectively . Continuous therapy was associated with an increase in ICU ( 59.5 vs. 41.5 % , P < 0.02 ) and in-hospital ( 65.5 vs. 47.6 % , P < 0.02 ) mortality relative to intermittent dialysis . Median ICU length of stay from the time of nephrology consultation was 16.5 days , and complete recovery of renal function was observed in 34.9 % of patients , with no significant group differences . Despite r and omization , there were significant differences between the groups in several covariates independently associated with mortality , including gender , hepatic failure , APACHE II and III scores , and the number of failed organ systems , in each instance biased in favor of the intermittent dialysis group . Using logistic regression to adjust for the imbalances in group assignment , the odds of death associated with continuous therapy was 1.3 ( 95 % CI , 0.6 to 2.7 , P = NS ) . A detailed investigation of the r and omization process failed to explain the marked differences in patient assignment . CONCLUSIONS A r and omized controlled trial of alternative dialysis modalities in ARF is feasible . Despite the potential advantages of continuous techniques , this study provides no evidence of a survival benefit of continuous hemodiafiltration compared with IHD . This study did not control for other major clinical decisions or other supportive management strategies that are widely variable ( for example , nutrition support , hemodynamic support , timing of initiation , and dose of dialysis ) and might material ly influence outcomes in ARF . St and ardization of several aspects of care or extremely large sample sizes will be required to answer optimally the questions originally posed by this investigation BACKGROUND Acute renal failure ( ARF ) is associated with a persistent high mortality in critically ill patients in intensive care units ( ICUs ) . Most studies to date have focused on patients with established , intrinsic ARF or relatively severe ARF due to multiple factors . None have examined outcomes of dialysis-dependent chronic renal failure [ end-stage renal disease ( ESRD ) ] patients in the ICU . We examined the incidence and outcomes of ARF in the ICU using a st and ard definition and compared these to outcomes of ICU patients with either ESRD or no renal failure . We sought to determine the impact of renal dysfunction and /or loss of organ function on outcome . METHODS We prospect ively scored 1530 admissions to eight ICUs over a 10-month period for illness severity at ICU admission using the Acute Physiological and Chronic Health Evaluation ( APACHE III ) evaluation tool . Patients were defined as having ARF based on the definition of Hou et al ( Am J Med 74:243 - 248,1983 ) design ed to detect significant measurable declines in renal function based on serum creatinine . ESRD patients were identified as being chronically dialysis-dependent prior to ICU admission and the remainder had no renal failure . Clinical characteristics at ICU admission and ICU and hospital outcomes were compared between the three groups . RESULTS We identified 254 cases of ARF , 57 cases of ESRD and 1219 cases of no renal failure for an incidence of ARF of 17 % . Roughly half the ARF patients had ARF at ICU admission and the remainder developed ARF during their ICU stay . Only 11 % of ARF patients required dialysis support . ARF patients had significantly higher acute illness severity scores than those with no renal failure , whereas patients with ESRD had intermediate severity scores . ICU mortality was 23 % for patients with ARF , 11 % for those with ESRD , and 5 % for those with no renal failure . There was no difference in outcome between patients who had ARF at ICU admission and those who developed ARF in the ICU . Patients with ARF severe enough to require dialysis had a mortality of 57 % . APACHE III predicted outcome very well in patients with no renal failure and patients with ARF at the time of scoring but underpredicted mortality in those who developed ARF after ICU admission and overestimated mortality in patients with ESRD . CONCLUSIONS ARF is common in ICU patients and has a persistent negative impact on outcomes , although the majority of ARF is not severe enough to require dialysis support . The mortality of patients with ARF from all causes is almost exactly similar to that noted using the same criteria two decades ago . More profound ARF requiring dialysis continues to have an even greater mortality . Nevertheless , acute declines in renal function are associated with a mortality that is not well explained simply by loss of organ function . The majority of ARF patients who did not require dialysis still had a considerably higher mortality than the ESRD patients , all of whom required dialysis ; while ARF patients who did require dialysis had a much higher morality than ESRD patients . APACHE III performs well and captures the mortality of patients with ARF at the time of scoring . Development of ARF after scoring has a profound effect on st and ardized mortality . We were unable to identify a unique mortality associated with ARF , but the presence of measurable renal insufficiency continues to be a sensitive marker for poor outcome A potential application of the continuous renal replacement therapies is the extracorporeal removal of inflammatory mediators in septic patients . Cytokine elimination with continuous renal replacement therapies has been demonstrated in several clinical studies , but so far without important effects on their serum concentrations . Improved knowledge of the cytokine removal mechanisms could lead to the development of more efficient treatment strategies . In the present study , 15 patients with septic shock and acute renal failure were observed during the first 24 h of treatment with continuous venovenous hemofiltration ( CVVH ) with an AN69 membrane . After 12 h , the hemofilter was replaced and the blood flow rate ( QB ) was switched from 100 ml/min to 200 ml/min or vice versa . Pre- and postfilter plasma and ultrafiltrate concentrations of selected inflammatory and anti-inflammatory cytokines were measured at several time points allowing the calculation of a mass balance . Cytokine removal was highest 1 h after the start of CVVH and after the change of the membrane ( ranging from 25 to 43 % of the prefilter amount ) , corresponding with a significant fall in the serum concentration of all cytokines . The inhibitors of inflammation were removed to the same extent as the inflammatory cytokines . Adsorption to the AN69 membrane appeared to be the main clearance mechanism , being most pronounced immediately after installation of a new membrane and decreasing steadily thereafter , indicating rapid saturation of the membrane . A QB of 200 ml/min was associated with a 75 % increase of the ultrafiltration rate and a significantly higher convective elimination and membrane adsorption than at a QB of 100 ml/min . The results indicate that optimal cytokine removal with CVVH with an AN69 membrane could be achieved with a combination of a high QB/ultrafiltration rate and frequent membrane changes BACKGROUND Mortality rates of critically ill patients with acute renal failure ( ARF ) requiring renal replacement therapy ( RRT ) are high . Intermittent and continuous RRT are available for these patients on the intensive care units ( ICUs ) . It is unknown which technique is superior with respect to patient outcome . METHODS We r and omized 125 patients to treatment with either continuous venovenous haemodiafiltration ( CVVHDF ) or intermittent haemodialysis ( IHD ) from a total of 191 patients with ARF in a tertiary-care university hospital ICU . The primary end-point was ICU and in-hospital mortality , while recovery of renal function and hospital length of stay were secondary end-points . RESULTS During 30 months , no patient escaped r and omization for medical reasons . Sixty-six patients were not r and omized for non-medical reasons . Of the 125 r and omized patients , 70 were treated with CVVHDF and 55 with IHD . The two groups were comparable at Output:	Similar to previously reported meta-analyses , we did not find a significant effect of CRRT on the OR of survival . The progressive reduction in the OR of survival with CRRT relative to IHD might reflect progressive improvements in IHD . The OR of DD was not affected by mode of RRT . In conclusion , compared with IHD , CRRT does not offer an advantage with regards to survival or DD in ARF .
MS2884	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: INTRODUCTION Although a significant amount of evidence indicates the efficacy of some antidepressants in treating psychogenic pain and somatoform disorder , very few studies have investigated their possible therapeutic action in burning mouth syndrome ( BMS ) . The purpose of this 8-week , single-blind study was to provide preliminary data on the efficacy and tolerability of amisulpride and the selective serotonin reuptake inhibitors ( SSRIs ) paroxetine and sertraline for patients with BMS . METHOD Seventy-six patients with BMS ( diagnosed according to the criteria in the literature and integrating the Diagnostic Interview Schedule-Revised for a complete psychiatric assessment ) , with no possible local or systemic causes and without concurrent major depression , were r and omly assigned to receive amisulpride ( 50 mg/day ) , paroxetine ( 20 mg/day ) , or sertraline ( 50 mg/day ) . Efficacy assessment s included a visual analogue scale ( VAS ) for pain intensity , the Hamilton Rating Scale for Depression ( HAM-D ) , the Hamilton Rating Scale for Anxiety ( HAM-A ) , and the Clinical Global Impressions scale ( CGI ) . RESULTS All 3 treatment regimens result ed in a significant improvement from baseline in burning mouth symptoms at week 8 as demonstrated by the quantitative ( mean reduction in VAS , HAM-D , and HAM-A scores ) and qualitative ( percentage of responders ) analyses . Amisulpride showed a shorter response latency than the SSRIs . No serious adverse events were reported , and the incidence of side effects did not differ among the 3 groups . None of the patients who received amisulpride withdrew from the trial , whereas withdrawal from the trial occurred within the first week of treatment in 11.5 % of patients ( N = 3 ) treated with paroxetine and in 21.7 % of patients ( N = 5 ) treated with sertraline . CONCLUSION The data suggest that amisulpride and SSRIs may be effective treatments for BMS ; they are equally effective and equally well tolerated in the short-term treatment of BMS . Amisulpride is associated with better compliance within the first week of treatment and with a shorter response latency in comparison with SSRIs . This finding may indicate that amisulpride is especially useful at the beginning of drug therapy of BMS . Double-blind , placebo-controlled trials are needed to further document the efficacy of amisulpride and SSRIs in the treatment of BMS OBJECTIVE The purpose of this study was to evaluate the efficacy of the topical use of benzydamine hydrochloride 0.15 % oral mouthwashes in the control of burning mouth syndrome symptoms . STUDY DESIGN In this double-blind , r and omized , longitudinal investigation , each of 30 patients with burning mouth syndrome was assigned to one of 3 management modalities . Those in group A received an oral rinse solution of benzydamine hydrochloride 0.15 % 3 times a day for 4 weeks , those in group B received a placebo 3 times a day for 4 weeks , and those in group C did not receive any kind of treatment . A visual analog scale was used for evaluation of the symptoms ; a Kruskal-Wallis analysis of variance exact test was performed on the result ing data . RESULTS The findings of this investigation failed to reveal significant differences among the groups . CONCLUSIONS The clinical application of benzydamine hydrochloride oral rinses in the treatment of patients with burning mouth syndrome did not demonstrate significative efficacy in comparison with use of a placebo solution AIMS An 8-week parallel , placebo-controlled , double-blind trial evaluated the efficacy of the antidepressant trazodone in the treatment of chronic burning mouth pain . METHODS Thirty-seven carefully selected women aged 39 to 71 ( mean 58.6 years ) were r and omized to receive either 200 mg of trazodone or a placebo in a similar manner . Pain and pain-related symptoms were evaluated on a visual analogue scale and other measures at 0 , 2 , 4 , and 8 weeks . RESULTS There were no significant differences between the groups in treatment effects for pain or pain-related symptoms . Seven patients in the trazodone group and 2 in the placebo group failed to complete the trial because of side effects . The most common side effects were dizziness and drowsiness . CONCLUSION In this controlled trial , trazodone failed to relieve burning mouth pain The effects of local application of estrone and progesterone on the oral mucosa was studied in sixty-one patients . These included forty-one postmenopausal women with various subjective oral complaints , ten postmenopausal women with no oral complaints , and ten normally menstruating women . Subjective complaints ( dryness , bad taste , burning sensation , and viscous saliva ) , quantity of saliva , and histologic changes in buccal mucosa were evaluated before and after treatment . Treatment comprised three modalities : an ointment containing estrone alone ; another ointment of estrone and progesterone ; and a third with a placebo base . These were massaged three times daily over the gingivae and oral mucosa for 30 days . A significant increase in secretion of saliva was observed with all three treatment modalities . Biopsies showed marked proliferative changes with all three types of ointment . A moderate improvement in subjective complaints followed all types of medication . These results indicate no specific effect of female sex hormones on the factors considered in this study . It appears that simple , repeated massage with any suitable ointment base is an effective method of inducing proliferative changes in atrophic buccal mucosa , increasing salivary secretion , and alleviating some of the subjective oral complaints of postmenopausal women & NA ; Stomatodynia is characterised by a spontaneous burning pain in the oral mucosa without known cause or recognised treatment . The purpose of this double‐blind , r and omised , multicentre parallel group study was to evaluate the efficacy of the topical use of clonazepam . Forty‐eight patients ( 4 men and 44 women , aged 65±2.1 years ) were included , of whom 41 completed the study . The patients were instructed to suck a tablet of 1 mg of either clonazepam or placebo and hold their saliva near the pain sites in the mouth without swallowing for 3 min and then to spit . This protocol was repeated three times a day for 14 days . The intensity was evaluated by a 11‐point numerical scale before the first administration and then after 14 days . Two weeks after the beginning of treatment , the decrease in pain scores was 2.4±0.6 and 0.6±0.4 in the clonazepam and placebo group , respectively ( P=0.014 ) . Similar effects were obtained in an intent‐to‐treat analysis ( P=0.027 ) . The blood concentration of clonazepam was similar whether it was measured 14 days after sucking a tablet three times a day or during the 5 h that followed sucking a single tablet ( n=5 ) . It is hypothesised that clonazepam acts locally to disrupt the mechanism(s ) underlying stomatodynia BACKGROUND Alpha-lipoic acid ( ALA ) is a potent antioxidant mitochondrial coenzyme , trometamol salt of thioctic acid , shown in clinical studies to be neuroprotective and in a preliminary study to have an effect on the symptomatology of Burning Mouth Syndrome ( BMS ) . METHODS We were interested in extending our studies as to whether alpha-lipoic acid might improve the symptomatology in BMS and therefore carried out a larger open controlled clinical study on the effects of alpha-lipoic acid on BMS symptomatology . RESULTS We have examined the effects on 4 groups of 20 patients with BMS of ALA , compared with bethanecol , Biotene and placebo , and found ALA of remarkable benefit with minimal adverse effects . CONCLUSIONS These results suggest that double-blind r and omized controlled multicenter studies of ALA are indicated The effect of cognitive therapy ( CT ) on resistant burning mouth syndrome ( BMS ) was studied . Thirty patients with resistant BMS after odontological and medical treatment were r and omly divided into two equal groups ; a therapy group ( TG ) was treated with CT and an attention/placebo group ( APG ) served as a control group . The intensity of BMS , which was estimated by the use of a visual analogue scale , was significantly reduced in the TG directly after CT was completed and was further reduced in a 6-month follow-up . The APG did not show any decrease in intensity of BMS . The results of this study indicate that , in some cases , resistant BMS probably is of psychological origin BACKGROUND Alpha-lipoic acid ( ALA ) , is a potent antioxidant mitochondrial coenzyme , the trometamol salt of thioctic acid that has been shown in clinical studies to be neuroprotective . This study examined the effect of ALA on the symptomatology of Burning mouth syndrome ( BMS ) . SUBJECTS AND METHODS Forty-two patients with BMS and no clinical or laboratory evidence of organic oral disease were divided into two groups ( Test and Control ) each of 21 subjects , matched for age and sex . The Test group were given ALA ( thioctic acid ; Tiobec ) for 30 days , as 600 mg per day orally for 20 days followed by 200 mg per day for 10 days . The Control group were given cellulose starch 100 mg per day as placebo for 30 days . All BMS patients were review ed at 10-day intervals and scored for changes in symptomatology . RESULTS Significant improvements were shown in the symptomatology of BMS in up to two-thirds of patients with BMS receiving alpha-lipoic acid , in about 15 % of those using placebo and also in up to two-thirds of those who , having tried placebo , were switched to ALA It has been suggested that placebo analgesia involves both higher order cognitive networks and endogenous opioid systems . The rostral anterior cingulate cortex ( rACC ) and the brainstem are implicated in opioid analgesia , suggesting a similar role for these structures in placebo analgesia . Using positron emission tomography , we confirmed that both opioid and placebo analgesia are associated with increased activity in the rACC . We also observed a covariation between the activity in the rACC and the brainstem during both opioid and placebo analgesia , but not during the pain-only condition . These findings indicate a related neural mechanism in placebo and opioid analgesia BACKGROUND Burning mouth syndrome ( BMS ) has features of a neuropathy and could be related to the production of the toxic free radicals that are released in stress situations . Alpha-lipoic acid is an antioxidant able to increase the levels of intracellular glutathione and eliminate free radicals . This study aim ed to examine the effectiveness of alpha-lipoic acid in the therapy of BMS . METHOD This was a double blind , controlled study conducted for two months on 60 patients with constant BMS . Comparing alpha-lipoic acid ( test ) with cellulose starch ( placebo ) , there was no laboratory evidence of deficiencies in iron , vitamins or thyroid function and no hyperglycaemia . RESULTS AND CONCLUSION Following treatment with alpha-lipoic acid , there was a significant symptomatic improvement , compared with placebo , with the majority showing at least some improvement after 2 months , thus supporting the hypothesis that burning mouth syndrome is a neuropathy . This improvement was maintained in over 70 % of patients at the 1 year follow-up Output:	CONCLUSIONS The fairly high placebo effect observed is very similar to data obtained from patients affected by atypical facial pain .
MS2885	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We carried out a prospect i ve , r and omised controlled trial on two groups of 40 patients with painful calcific tendonitis and a mean age of 48.4 years ( 32.5 to 67.3 ) . All were to undergo arthroscopic removal of the calcific deposit within six months after r and omisation . The 40 patients in group I received ultrasound-guided needling followed by high-energy shock-wave therapy and the 40 in group II had shock-wave therapy alone . In both groups one treatment consisting of 2500 impulses of shock waves with an energy flux density of 0.36 mJ/mm(2 ) was applied . The clinical and radiological outcome was assessed using the 100-point Constant shoulder scoring system and st and ardised radiographs . The mean follow-up was 4.1 months and no patient was lost to follow-up . Both groups had significant improvement in their Constant shoulder score . Radiographs showed disappearance of the calcific deposit in 60.0 % of the shoulders in group I and in 32.5 % of group II ( p < 0.05 ) . Significantly better clinical and radiological results were obtained in group I than in group II . Arthroscopic removal of the deposit was avoided in 32 patients of group I and in 22 of group II . No severe side-effects were recorded . Ultrasound-guided needling in combination with high-energy shock-wave therapy is more effective than shock-wave therapy alone in patients with symptomatic calcific tendonitis , giving significantly higher rates of elimination of the calcium deposits , better clinical results and reduction in the need for surgery OBJECTIVES To evaluate the therapeutic effect of extracorporeal shock wave therapy ( ESWT ) in shoulders with chronic calcific tendinitis , to compare the functional outcomes of ESWT and transcutaneous electric nerve stimulation ( TENS ) therapy , and to investigate which types of calcium deposit effectively respond to ESWT . DESIGN R and omized controlled trial . SETTING Outpatient clinics of the departments of physical medicine and rehabilitation and of orthopedics and traumatology of a veterans hospital in Taiwan . PARTICIPANTS Sixty patients with continuous shoulder pain for 6 months or more and with radiographically and sonographically verified calcific tendinitis . Patients were r and omly allocated to receive ESWT ( 33 shoulders ) or TENS treatment ( 30 shoulders ) . INTERVENTIONS ESWT was performed with 2000 shock waves at 2Hz and energy level between.26 and .32mJ/mm(2 ) per session . Treatment was given in 2 sessions , 14 days apart . TENS therapy was given 3 times a week for 4 weeks . MAIN OUTCOME MEASURES Mean Constant score , visual analog scale ( VAS ) , manual muscle test , and changes of sonographic size and shape of calcium deposits were calculated for 4 time points : at baseline , 2 weeks , 4 weeks , 12 weeks posttherapy . RESULTS In both groups , Constant score and VAS improved significantly at 2- , 4- , and 12-week follow-ups ( P<.05 ) , and the size of calcium deposits decreased significantly at the 4- and 12-week follow-ups . Moreover , the arc-shaped calcific plaques of the rotator cuff were markedly meliorated with ESWT . CONCLUSIONS ESWT is more effective in the treatment of chronic calcific tendinitis of the shoulder than is TENS therapy , especially for arc-type calcific plaque In a prospect i ve r and omised trial of calcifying tendinitis of the rotator cuff , we compared the efficacy of dual treatment sessions delivering 2500 extracorporeal shock waves at either high- or low-energy , via an electromagnetic generator under fluoroscopic guidance . Patients were eligible for the study if they had more than a three-month history of calcifying tendinitis of the rotator cuff , with calcification measuring 10 mm or more in maximum dimension . The primary outcome measure was the change in the Constant and Murley Score . A total of 80 patients were enrolled ( 40 in each group ) , and were re-evaluated at a mean of 110 ( 41 to 255 ) days after treatment when the increase in Constant and Murley score was significantly greater ( t-test , p = 0.026 ) in the high-energy treatment group than in the low-energy group . The improvement from the baseline level was significant in the high-energy group , with a mean gain of 12.5 ( -20.7 to 47.5 ) points ( p < 0.0001 ) . The improvement was not significant in the low-energy group . Total or subtotal resorption of the calcification occurred in six patients ( 15 % ) in the high-energy group and in two patients ( 5 % ) in the low-energy group . High-energy shock-wave therapy significantly improves symptoms in refractory calcifying tendinitis of the shoulder after three months of follow-up , but the calcific deposit remains unchanged in size in the majority of patients Background Low-energy extracorporeal shock wave therapy is an alternative treatment , with limited evidence for effectiveness , for calcific tendinitis of the rotator cuff . Hypothesis Objective localization of the calcium deposit by 3-dimensional , computer-assisted navigation reveals superior clinical and radiographic outcomes compared to localization through patient-to-therapist feedback . Study Design R and omized controlled clinical trial ; Level of evidence , 1 . Methods A prospect i ve , r and omized , single-blind study was carried out on 50 patients . The population was divided into 2 groups of equal numbers ( navigation group and feedback group ) . In all patients , treatment-resistant pain was evident for longer than 6 months . A total of 3 therapy sessions of constant low-energy focused shock wave therapy was administered in weekly intervals in both groups . Local anesthesia was not applied . Radiographs and clinical assessment , including the Constant and Murley shoulder scoring system and the visual analog scale for pain , were performed both before therapy and after 12 weeks . In the navigation group , the calcium deposit was localized using a radiographically guided , 3-dimensional , computer-assisted device . The feedback group was treated after locating the point of maximum tenderness through palpation by the therapist with feedback from the patient . Results Both groups had significant improvements in the Constant and Murley score and the visual analog scale after 12 weeks . The results from the navigation group were statistically significantly superior to those of the feedback group . In the navigation group , 6 calcium deposits disappeared and 9 altered , compared to 1 disappearance and 12 alterations in the feedback group . No severe complications occurred . Conclusion Three-dimensional , computer-assisted navigation reveals significantly better results and is therefore recommended when extracorporeal shock wave therapy is used in the treatment of calcific tendinitis of the rotator cuff Objective : To compare the effectiveness of different energy densities of extracorporeal shock wave therapy ( ESWT ) for managing chronic heel pain . Design : A r and omized clinical trial . Setting : Hospital-based practice . Subjects : Fifty-seven patients with chronic heel pain were recruited ; eight patients withdrew from the study . Interventions : Subjects were r and omized into three groups receiving : ( 1 ) a ‘ fixed ’ energy density , ( 2 ) ‘ maximum tolerable ’ energy density , or ( 3 ) control treatment once a week for three weeks . Outcome measures : Pain on palpation , pain on tension , maximum tolerable walking/st and ing duration and Foot Function Index were assessed before treatment in each treatment session and at the three-week follow-up . Results : By week 3 , the ‘ maximum tolerable ’ energy density group experienced a 66 % cumulative reduction in pain from tension , a 65 % reduction on palpation and a 112 % cumulative increase in maximum tolerable walking/st and ing duration . The ‘ fixed ’ energy density group experienced a 45 % cumulative reduction in pain from tension , a 32 % reduction in pain on palpation , and a 45 % increase in walking/st and ing tolerance . The ‘ maximum tolerable ’ energy density group also showed a significantly greater reduction in Foot Function Index scores than the other two groups . Therapeutic effects were maintained at least up to the three-week follow-up period . The control group had no significant changes in any outcome measures across time periods . Conclusion : The delivery of ESWT with a maximum tolerable energy density is a more effective treatment protocol than a fixed energy density in terms of relieving pain and restoring the functional activity of people suffering from chronic heel pain . The analgesic effects were maintained at least up to the three-week follow-up We have performed a double-blind placebo-controlled trial of moderate doses of extracorporeal shock-wave therapy ( ESWT ) for non-calcific tendonitis of the rotator cuff . Adults ( 74 ) with chronic tendonitis of the rotator cuff were r and omised to receive either active ( 1500 pulses ESWT at 0.12 mJ/mm2 ) or sham treatment , monthly for three months . All were assessed before each treatment , and at one and three months after the completion of treatment . The outcome was measured with regard to pain in the shoulder , including a visual analogue score for night pain , and a disability index . There were no significant differences between the two groups before treatment . The mean duration of symptoms in both groups was 23.3 months . Both showed significant and sustained improvements from two months onwards . There was no significant difference between them with respect to change in the Shoulder Pain and Disability Index ( SPADI ) scores or night pain over the six-month period . A mean ( + /-SD ; range ) change in SPADI of 16.1 + /- 27.2 ( 0 to 82 ) in the treatment group and 24.3 + /- 24.8 ( -11 to 83 ) in the sham group was noted at three months . At six months the mean changes were 28.4 + /- 25.9 ( -24 to 69 ) and 30.4 + /- 31.2 ( -12 to 88 ) , respectively . Similar results were noted for night pain . We conclude that there is a significant and sustained placebo effect after moderate doses of ESWT in patients with non-calcific tendonitis of the rotator cuff , but there is no evidence of added benefit when compared with sham treatment UNLABELLED The aim of a prospect i ve study was to examine the effects of high energetic shock wave treatment on the course of calcareous tendinitis of the shoulder . 20 patients were entered into the study . Shock waves were applied to the calcifications with a Lithotripter MFL 5000 in two sessions of 2000 impulses each . The shock wave producing energy was 18 kV-22 kV. 6 and 12 weeks after treatment subjective and functional condition was checked by means of a 100-points functional score ; all patients underwent x-ray control and MRI imaging . RESULTS After 12 weeks 14 patients showed a marked improvement of symptoms , the average improvement on score measuring 25 points . The x-rays of 7 patients showed a complete resorption of the calcifications , in 5 cases partial disintegration of the calcium deposits was seen . The overall morbidity was low with 14 patients developing transient hematomas ; MRI imaging showed no severe damages of bone and soft tissue Arm , neck and /or shoulder complaints are common in western societies . In the Netherl and s , general practice guidelines are issued on shoulder pain and epicondylitis only . Little is known about actual management of the total range of diagnoses . The objectives of the study are : to determine management in patients consulting the GP with a new episode of non-traumatic arm neck and shoulder complaints up to 6 months after the first consultation . To evaluate differences in management between patients with specific diagnoses versus non-specific diagnoses and between specific diagnostic groups . In a prospect i ve cohort study in general practice . We recruited 682 eligible patients . Data on diagnosis , management , patient- and complaint-characteristics were collected . Co-occurrence of treatment options was presented in scaled rectangles . After 6 months , additional diagnostic tests had been performed in 18 % of the patients , mainly radiographic examination ( 14 % ) . Further , 49 % had been referred for physiotherapy and 12 % to the medical specialist . Patients with specific diagnoses were more frequently referred for specialist treatment , and patients with non-specific diagnoses for physiotherapy . Corticosteroid injections ( 17 % ) were mainly applied specific diagnoses ( e.g. impingement syndrome , frozen shoulder , carpal tunnel and M. Quervain ) . Frequencies of prescribed medication ( 51 % ) did not differ between specific and non-specific diagnoses . In 19 % of the patients no referral , prescribed analgesics or injection was applied . Braces ( 4 % ) were mainly prescribed in epicondylitis . Overall , management most frequently consisted of prescribed analgesics and referral for physiotherapy . Specific and non-specific diagnostic subgroups differed in the frequency corticosteroid injections were applied , and referrals to physiotherapy and to a medical specialist We report a prospect i ve study of the effects of extracorporeal shock-wave therapy in 195 patients with chronic calcifying tendinitis . In part A 80 patients with chronic symptoms were r and omly assigned to a control and three subgroups which had different treatment by low-energy and high-energy shock waves . In part B 115 patients had either one or two high-energy sessions . We recorded subjective , functional and radiological findings at six months after treatment . The results showed energy-dependent success , with relief of pain ranging from 5 % in our control group up to 58 % after two high-energy sessions . The Constant scores and the radiological disintegration of calcification were also dose-dependent . Shockwave therapy should be considered for chronic pain due to calcific tendinitis which is resistant to conservative treatment A prospect i ve , controlled , r and omised trial was performed to compare the effect of high-energy extracorporeal shock wave therapy ( ESWT ) versus low-energy ESWT in treatment of rotator cuff tendinopathy . Forty adult patients were included in the study . Patients in the intervention group Output:	For calcific RC-tendinosis , strong evidence was found for effectiveness in favour of high-ESWT versus low-ESWT in short-term . Moderate evidence was found in favour of high-ESWT versus placebo in short- , mid- and long-term and versus low-ESWT in mid- and long-term . Moreover , high-ESWT was more effective ( moderate evidence ) with focus on calcific deposit versus focus on tuberculum major in short- and long-term . RSWT was more effective ( moderate evidence ) than placebo in mid-term . For non-calcific RC-tendinosis , no strong or moderate evidence was found in favour of low- , mid- or high-ESWT versus placebo , each other , or other treatments . This review shows that only high-ESWT is effective for treating calcific RC-tendinosis . No evidence was found for the effectiveness of ESWT to treat non-calcific RC-tendinosis
MS2886	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background / Objectives : Helicobacter pylori infection and iron and vitamin B12 deficiencies are widespread in economically disadvantaged population s. There is emerging evidence that H. pylori infection has a negative effect on the absorption of these micronutrients . The aim of this study was to evaluate the effect of H. pylori infection on the efficacy of micronutrient ( including iron and vitamin B12)-fortified foods supplied for 1 year in marginally nourished children . Subjects/ Methods : In all , 543 Indian children , aged 6–10 years , participated in a double-blind , r and omized controlled intervention trial , receiving foods fortified with either high ( 100 % Recommended Dietary Allowances ( RDA ) ) or low ( 15 % RDA ) amounts of iron , vitamin B12 and other micronutrients . The presence of H. pylori infection was diagnosed by the 13C-labeled urea breath test at 11 months after the start of the intervention . Blood hemoglobin , serum ferritin ( SF ) , total body iron and plasma vitamin B12 were estimated at baseline and 12 months , and differences between these time points were assessed using an independent t-test . Results : Overall , the prevalence of H. pylori infection in this group of children was 79 % . Baseline hemoglobin , SF , body iron and vitamin B12 concentrations were not associated with H. pylori infection . The response to the intervention ( either high or low amounts of iron and vitamin B12 fortification ) in terms of change in iron markers and vitamin B12 status did not differ between children with and without H. pylori infection . Conclusions : This study shows that the presence of H. pylori infection did not affect the efficacy of long-term iron and vitamin B12 fortification in these marginally nourished children Purpose The aim of this study was to assess and compare the efficacies of proton pump inhibitor-based triple therapy and bismuth-based quadruple therapy as first-line treatments for Helicobacter pylori eradication in Korean children . Methods We retrospectively review ed the data of children who had been diagnosed with H. pylori infection at the Seoul National University Bundang Hospital from March 2004 to August 2012 . The patients were r and omly assigned to receive either triple therapy consisting of omeprazole , amoxicillin , and clarithromycin for 2 weeks ( OAC group ) or quadruple therapy comprising omeprazole , amoxicillin , metronidazole , and bismuth salts for 1 week ( OAMB group ) . The patients were evaluated for eradication of H. pylori infection at 4 weeks after the completion of the treatment . Results Of the 129 children enrolled in this study , 118 ( 91.5 % ) were included in the final analysis . The eradication rates in OAC and OAMB groups were 67.7 % ( 42/62 ) and 83.9 % ( 47/56 ) , respectively , which were significantly different between the 2 treatment groups ( p=0.041 ) . The eradication rates in the OAMB group during the periods 2004 - 2006 , 2007 - 2009 , and 2010 - 2012 were superior to those in the OAC group . Conclusion This study indicated that the 1-week bismuth-based quadruple therapy , compared with the st and ard 2-week triple therapy , was significantly more successful in eradicating H. pylori infection in Korean children AIM To assess whether antibiotic resistance varies between the antrum and corpus of the stomach of patients that are either Helicobacter pylori ( H. pylori ) therapy-naive or pre-treated . METHODS H. pylori strains were isolated from antrum and corpus biopsies from 66 patients that received a diagnostic gastroduodenoscopy for variant clinical indications . Antimicrobial susceptibility to amoxicillin , clarithromycin , tetracycline , metronidazole , levofloxacin and rifabutin was tested with the E-test method on Iso-Sensitest agar with 10 vol% defibrinated horse blood . In patients with a different antibiotic susceptibility pattern between the isolates from the antrum and corpus , DNA fingerprinting via r and om amplified polymorphic DNA analysis was performed to detect differences among DNA patterns of H. pylori isolates . RESULTS Primary , secondary and tertiary resistance to clarithromycin was 6.9 % , 53.8 % and 83.3 % , retrospectively . Metronidazole and levofloxacin resistance also increased according to the number of previous treatments ( 17.2 % , 69.2 % , 83.3 % ; 13.8 % , 23.1 % , 33.3 % ) . Tertiary resistance to rifabutin was detected in 12.5 % of patients . In none of the 66 patients a resistance against amoxicillin or tetracycline was detectable . Discordant antibiotic susceptibility between antrum and corpus isolates for different antibiotics was seen in 15.2 % ( 10/66 ) of the patients . Two out of those ten patients were naive to any H. pylori antibiotic treatment . The remaining eight patients previously received at least one eradication therapy . DNA fingerprinting analysis revealed no substantial differences among DNA patterns between antrum and corpus isolates in the majority of patients suggesting an infection with a single H. pylori strain . CONCLUSION Different antibiotic susceptibility between antrum and corpus biopsies is a common phenomenon and a possible explanation for treatment failure . Resistant H. pylori strains may be missed if just one biopsy from one anatomic site of the stomach is taken for H. pylori susceptibility testing In the present study , we investigated the prevalence of anaemia and Fe deficiency anaemia ( IDA ) and explored the relationship between Helicobacter pylori infection and IDA in adolescent girls . A total of 1037 adolescent girls from Suihua , China were enrolled . Hb , serum ferritin ( SF ) , serum transferrin receptor ( sTfR ) and serum IgG antibodies to H. pylori were measured . Participants with IDA and co-existing H. pylori infection ( n 80 ) who had an intake of > 25 mg/d of Fe were assigned r and omly to the intervention and control groups . Patients in the intervention group were administered a 12-week course of oral EDTA-Na-Fe ( 60 mg Fe/dose , three times a week ) and a 2-week course of colloidal bismuth subcitrate , amoxicillin and metronidazole . Subjects in the control group were administered EDTA-Na-Fe alone . Hb , SF and sTfR were reassessed 3 months after the 12-week regimen ended . Prevalence of anaemia , Fe deficiency ( defined as SF < 12·0 μg/l ) , IDA and H. pylori infection in the population of 1037 was 19.5 , 40.4 , 17.1 and 31.2 % , respectively . The prevalence of H. pylori infection in the IDA group was 46.9 % , while the non-anaemic group had 28.1 % prevalence . A significant increase in Hb and SF and a decrease in sTfR value were found in the intervention group and the H. pylori-negative group . Findings suggest that IDA is still one of the prominent problems in adolescent girls . There is an association between H. pylori infection and IDA . Treatment of H. pylori infection is associated with a more rapid response to oral Fe therapy IMPORTANCE The long-term effectiveness of Helicobacter pylori eradication programs for preventing gastric cancer will depend on recurrence risk and individual and community factors . OBJECTIVE To estimate risk of H. pylori recurrence and assess factors associated with successful eradication 1 year after treatment . DESIGN , SETTING , AND PARTICIPANTS Cohort analysis of 1463 r and omized trial participants aged 21 to 65 years from 7 Latin American communities , who were treated for H. pylori and observed between September 2009 and July 2011 . INTERVENTIONS R and omization to 1 of 3 treatment groups : 14-day lansoprazole , amoxicillin , and clarithromycin ( triple therapy ) ; 5-day lansoprazole and amoxicillin followed by 5-day lansoprazole , clarithromycin , and metronidazole ( sequential ) ; or 5-day lansoprazole , amoxicillin , clarithromycin , and metronidazole ( concomitant ) . Participants with a positive (13)C-urea breath test ( UBT ) 6 to 8 weeks posttreatment were offered voluntary re-treatment with 14-day bismuth-based quadruple therapy . MEASUREMENTS Recurrent infection after a negative posttreatment UBT and factors associated with successful eradication at 1-year follow-up . RESULTS Among participants with UBT-negative results who had a 1-year follow-up UBT ( n=1091 ) , 125 tested UBT positive , a recurrence risk of 11.5 % ( 95 % CI , 9.6%-13.5 % ) . Recurrence was significantly associated with study site ( P = .03 ) , nonadherence to initial therapy ( adjusted odds ratio [ AOR ] , 2.94 ; 95 % CI , 1.31 - 6.13 ; P = .01 ) , and children in the household ( AOR , 1.17 ; 95 % CI , 1.01 - 1.35 per child ; P = .03 ) . Of the 281 with positive posttreatment UBT results , 138 completed re-treatment , of whom 93 tested UBT negative at 1 year . Among the 1340 who had a 1-year UBT , 80.4 % ( 95 % CI , 76.4%-83.9 % ) , 79.8 % ( 95 % CI , 75.8%-83.5 % ) , and 77.8 % ( 95 % CI , 73.6%-81.6 % ) had UBT-negative results in the triple , sequential , and concomitant groups , respectively ( P = .61 ) , with 79.3 % overall effectiveness ( 95 % CI , 77.1%-81.5 % ) . In a single-treatment course analysis that ignored the effects of re-treatment , the percentage of UBT-negative results at 1 year was 72.4 % ( 95 % CI , 69.9%-74.8 % ) and was significantly associated with study site ( P < .001 ) , adherence to initial therapy ( AOR , 0.26 ; 95 % CI , 0.15 - 0.42 ; P < .001 ) , male sex ( AOR , 1.63 ; 95 % CI , 1.25 - 2.13 ; P < .001 ) , and age ( AOR , 1.14 ; 95 % CI , 1.02 - 1.27 per decade ; P = .02 ) . One-year effectiveness among all 1463 enrolled participants , considering all missing UBT results as positive , was 72.7 % ( 95 % CI , 70.3%-74.9 % ) . CONCLUSIONS AND RELEVANCE One year after treatment for H. pylori infection , recurrence occurred in 11.5 % of participants who had negative posttreatment UBT results . Recurrence determinants ( ie , nonadherence and demographics ) may be as important as specific antibiotic regimen in determining the long-term success of H. pylori eradication interventions . Study findings are relevant to the feasibility of programs for the primary prevention of gastric cancer in high-incidence regions of Latin America . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01061437 OBJECTIVES The aim of this study was to prospect ively assess the pattern of evolution of primary resistance to antibiotics in Helicobacter pylori strains isolated from Portuguese children over a 10 year period ( 2000 - 09 ) . METHODS A total of 1115 H. pylori strains were tested for antibiotic susceptibility to clarithromycin , metronidazole , amoxicillin , ciprofloxacin and tetracycline . RESULTS H. pylori strains were isolated from children and adolescents [ ages 4 months-18 years ( mean age 10.17 ± 4.03 years ) ] , comprising 562 ( 50.4 % ) boys and 553 ( 49.6 % ) girls . Overall , the primary resistance rate was 34.7 % to clarithromycin , 13.9 % to metronidazole and 4.6 % to ciprofloxacin , while 6.9 % were resistant to two of these antibiotics simultaneously . Resistance to amoxicillin and to tetracycline was not detected . In general , the resistance rate was not associated with gender or the children 's age . European ethnicity , when compared with an African background , was associated with clarithromycin resistance [ P = 0.0 Output:	Conclusions : The primary goal of clinical investigation is to identify the cause of upper gastrointestinal symptoms rather than H pylori infection .
MS2887	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Patient discomfort is one reason for poor compliance with supportive periodontal therapy ( SPT ) . The aim of this study was to compare the levels of discomfort during SPT , using the Vector system and treatment with a conventional ultrasonic scaler . METHODS Forty-six patients with an SPT programme were debrided using both the Vector system and a conventional piezo-electric scaler ( Sirona ) in a split mouth design . A visual analogue scale was used to evaluate of pain scores upon completion of treatment . A verbal response scale(VRS ) was used to assess discomfort , vibration and noise associated with the scaling system , as well as the volume and taste of the coolant used by these systems . RESULTS Patients instrumented with the Vector system experienced approximately half the amount of pain compared with the conventional ultrasonic scaling system . The VRS showed that the Vector system caused less discomfort than the conventional ultrasonic scaling system when assessed for pain , vibration , noise and volume of coolant . These findings were all statistically significant . There was , however , no statistically significant difference between the two systems when assessed for taste . CONCLUSION During SPT the Vector system caused reduced discomforting sensations compared with conventional methods and may be useful in improving compliance with SPT programmes OBJECTIVE A study was conducted to examine the effectiveness of scaling and root planing using a new ultrasonic scaler ( Vector ) . METHODS Eighty extracted teeth affected by periodontal disease were sorted into four groups of 20 , each of which was subjected to one the following procedures : use of the Vector , Vector with polish , Enac and a Gracey scaler . The time spent on cleaning was measured . Half of the sample teeth were examined at r and om for surface roughness , and the surface texture was evaluated by means of the Remaining Calculus Index ( RCI ) and the Roughness and Loss of Tooth Substance Index ( RLTSI ) . The remaining sample s were incubated in dishes with a suspension of fibroblasts . After measuring the number of attached cells , the attachment of fibroblasts was observed by scanning electron microscopy . RESULTS The RLTSI values in the Vector and Vector with polish groups were significantly lower than those in the Enac and Gracey groups , whereas the number of attached cells in the Vector with polish group was larger than in the Enac group . Cell attachment in the Vector and Vector with polish groups proved to be better than in the Enac and Gracey groups . CONCLUSION Since use of the Vector with polish was able to provide scaling and root planing with minimal damage and tight attachment of fibroblasts , it is suggested that this may be a useful instrument for scaling and root planing BACKGROUND A recently introduced piezo-driven ultrasonic device ( Vector ) generates longitudinal oscillations . As a result , the instrument tip moves parallel to the tooth surface . By avoiding vertical oscillations , maintenance treatment with the Vector device should be less painful than treatment with conventional systems . We investigated whether patients perceive treatment with the Vector device as less painful than with a conventional ultrasonic device , and whether the clinical efficacy of the Vector device is comparable with that of the conventional ultrasonic device in maintenance patients . MATERIAL AND METHODS Thirty-eight maintenance patients with moderate to advanced periodontal disease took part in this prospect i ve , r and omized controlled clinical study . Each patients had to have at least two teeth with probing depths of > 4 mm . They were treated either with Dentsply ( n=22 ) at a reduced power setting or with the Vector device ( n=16 ) . The observation period was 6 months . Probing pocket depth , attachment level , and bleeding upon probing were assessed at six sites on each treated tooth by a blinded investigator Patient were asked to report perceived pain during instrumentation with a visual analog scale immediately after treatment , in the evening of the treatment day , and in the evenings 1 and 2 days after treatment . RESULTS Bleeding on probing , probing depth , and attachment level improved in both instrumentation groups from baseline to month 6 ; however , there was no difference between the two instrumentation modalities . The patients perceived treatment with neither instrument as unpleasant , and their perception of pain intensity both during instrumentation and on the following days did not differ . CONCLUSION In maintenance therapy , clinical efficacy of the vector device is comparable with that of conventional ultrasonic device . It makes no difference whether the ultrasonic device at a reduced power setting or the Vector device is used , since patients perceive both instruments as causing very little pain AIM To compare the effectiveness of treatment of peri-implantitis with a novel ultrasonic device , the Vector system , with that of subgingival debridement with carbon fiber curettes . MATERIAL AND METHODS The study , comprising 11 patients with at least two screw type implants with bleeding on probing ( BOP ) , probing pocket depth ( PPD ) > or = 5 mm , and at least 1.5 mm radiographic bone loss and exposed implant threads , was carried out as a single blind r and omized clinical trial . At baseline one r and omly chosen implant in each patient was treated by the Vector system ( test ) while the other implant ( control ) was treated by submucosal debridement with a carbon fiber curette . After 3 months , the same treatments were repeated . Plaque , BOP , and PPD were recorded on all implant surfaces at baseline , and after 3 and 6 months . Bone levels were recorded on radiographs taken prior to the start of the study , and after 6 months . RESULTS Oral hygiene around both test and control implants was improved at 3 and 6 months compared with baseline . At 6 months , four of the Vector-treated sites , and only one site treated with curettes , had stopped to bleed . In neither the test nor the control group , were there any differences between baseline and 6 months regarding PPD and bone levels . CONCLUSION Although there was a greater reduction in the number of sites with BOP following treatment with the Vector system than following instrumentation with carbon fiber curettes , there was no significant difference between the two methods BACKGROUND AND OBJECTIVES The aim of the present study was to investigate the in vivo effects of an Er : YAG laser ( ERL ) , an ultrasonic system and scaling and root planing ( SRP ) on the biocompatibility of periodontally diseased root surfaces in cultures of human periodontal ligament fibroblasts ( PDL ) . STUDY DESIGN / MATERIAL S AND METHODS Forty single rooted teeth , considered for extraction due to severe periodontal destruction , have been r and omly assigned to the following groups : ( 1 ) ERL at 160 mJ/pulse and 10 Hz , or ( 2 ) Vector ultrasonic system ( VUS ) , or ( 3 ) SRP using h and instruments , or ( 4 ) untreated control ( C ) . Immediately after instrumentation , all test and control teeth were extracted and root specimens ( 4 mm2 ) were prepared from all mesial and distal surfaces ( n=80 ) . Following the prescribed treatments , the root specimens were incubated with human PDL fibroblast cultures . Adherent cells were stained with methylene blue and counted using a reflected light microscope and the cell density per mm2 was calculated . Additionally , the cell morphology was investigated using SEM ( n=8 teeth ) . RESULTS Cell counts within each group yielded the following means and st and ard deviations ( cells/mm2 ) : ERL , 111+/-27 ; VUS , 75+/-25 ; SRP , 41+/-17 ; control , 25+/-11 . Analysis of variance ( ANOVA ) revealed significant differences in the number of attached cells between the test and control groups ( P<0.001 , P<0.001 , P<0.01 , respectively ) . ERL and VUS treated specimens showed significantly higher numbers of cells/mm2 than the SRP group ( P<0.001 , respectively ) . The difference between the ERL and VUS group was statistically significant ( P<0.001 ) . CONCLUSIONS The results of the present study indicate that ( i ) ERL , VUS , and SRP promote the attachment of PDL fibroblasts on previously diseased root surfaces , ( ii ) periodontally diseased root surfaces inhibit the adherence of PDL fibroblasts , and ( iii ) the surface structure of ERL and VUS instrumented roots seem to offer better conditions for the adherence of PDL fibroblasts than SRP The aim of this study was to measure subjective intensities of pain during the treatment of periodontal lesions with the Vector-system when compared to pain occurring during the treatment with conventional methods . Twenty patients , each of whom had three teeth with comparable periodontal pocket depths , were treated using three different methods : ( i ) scaling and root planing with h and instruments , ( ii ) cleaning with a conventional ultrasonic instrument ( Siroson S ) and ( iii ) cleaning with the Vector-system . The subjective intensities of pain during the treatment were measured with an intermodal intensity comparison . A visual analog scale was used for the evaluation after the treatment . The results of the intermodal intensity comparison during treatment showed that the use of the Vector-system caused less pain than the cleaning with h and instruments or the conventional ultrasonic system ( P < 0.05 ) . The intermodal intensity comparisons of cleaning with h and instruments and cleaning with the conventional ultrasonic system were not significantly different ( P > 0.05 ) . These results could be confirmed by the visual analog scale . Using the Vector-system for cleaning periodontal lesions it is possible to reduce pain sensations compared to conventional methods . Using cleaning methods that cause less discomfort and pain , it might be possible to increase the patient 's compliance during non-surgical periodontal therapy and recall The goal of this study was to determine whether an ultrasonic scaler with a modified tip is as effective as a curet in providing supportive periodontal treatment for patients , based on clinical parameters of periodontal disease . Nine patients with 10 sites exhibiting probing pocket depth > or = 3 mm were treated at 0 , 90 , and 180 days in a single-blind , split-mouth design for supportive periodontal treatment with either Gracey curets ( GC ) or an ultrasonic scaler with a modified tip ( MU ) . Clinical parameters included plaque index , gingival index , bleeding on probing , darkfield microscopy , and elastase presence . Probing pocket depths and attachment levels were measured using an electronic probe . Measurements of clinical parameters were taken at 0 , 14 , 45 , 90 , 135 , and 180 days . The results showed that treatment with MU was as effective as treatment with GC in all clinical parameters measured . Both treatment modalities were effective in reducing the elastase levels . Instrumentation time was significantly reduced with the MU ( 3.9 minutes vs. 5.9 minutes , P < 0.05 ) . The MU instrument effectively reduced the microbial environment in a significantly shorter time as compared to GC BACKGROUND Surgical periodontal treatment with enamel matrix protein derivative ( EMD ) has been shown to promote periodontal regeneration . However , it is not known whether nonsurgical periodontal therapy with additional subgingival application of EMD may also enhance periodontal regeneration . The purpose of this study was to clinical ly and histologically evaluate healing of human intrabony defects following non-surgical periodontal treatment with and without application of EMD . METHODS Sixteen patients , each of whom displayed one advanced intrabony defect around teeth or roots scheduled for extraction , were included in the study . The defects were treated as follows : 1 ) scaling and root planing with h and instruments and application of EMD ; 2 ) scaling with an ultrasonic instrument and application of EMD ; or 3 ) scaling with an ultrasonic instrument alone . Healing was uneventful in all cases . Six months after surgery , the teeth or roots were extracted together with some of their surrounding soft and hard tissues and processed for histologic evaluation . RESULTS Clinical examination revealed a probing depth reduction and a gain of clinical attachment after all 3 treatment modalities . The histological evaluation , however , revealed that healing in all 3 procedures was predominantly characterized by formation of a long junctional epithelium along the instrumented root surface and no predictable regeneration of attachment apparatus . CONCLUSION Within its limits , the present study failed to show periodontal regeneration in advanced human intrabony defects following non-surgical treatment with subgingival application of EMD OBJECTIVE The aim of this r and omised , split-mouth , controlled clinical trial was to evaluate the effectiveness of a controlled-release chlorhexidine chip ( CHX chip ) as an adjunctive therapy to scaling and root planing ( SRP ) with a newly developed ultrasonic device in supportive periodontal therapy ( SPT ) . MATERIAL S AND METHODS Twenty patients with moderate-to-severe chronic periodontitis , displaying at least four sites with probing depth ( PD ) > or = 5 mm and persistent bleeding on probing ( BOP ) , were recruited for the study . The target sites were r and omly treated with either a newly developed piezo-driven ultrasonic device Vector -- or ultrasonic system ( VUS ) + CHX chip or VUS alone without adjunctive antimicrobial treatment . The clinical parameters , plaque index ( PI ) , gingival index ( GI ) , BOP , PD and clinical attachment level ( CAL ) were recorded at baseline and after 1 , 3 and 6 months . RESULTS At baseline , there were no significant differences between test and control sites for any of the investigated parameters . The average reduction of PD and improvement in CAL was greater in the VUS + CHX chip sites than in sites treated with the VUS alone at 1 , 3 and 6 months ( P < 0.05 ) . The mean reductions on PD and CAL were 0.7 and 0.6 mm for the control sites and 2.2 and 1.9 mm for the test sites , respectively . Also , the mean reduction in BOP scores were higher in the VUS + CHX chip sites compared to VUS alone at 1 , 3 and 6 months ( P < 0.05 ) . PI scores were not significantly different between VUS + CHX chip sites and VUS alone sites at any visit . CONCLUSION These data suggest that CHX chip application following SRP with the tested ultrasonic Output:	The Vector ultrasonic scaler provided comparable clinical and microbiological periodontal healing results as scaling and root planing and conventional ultrasonic system in moderately deep pockets . The Vector ultrasonic scaler may be used as a gentle root debridement device for supportive periodontal therapy , as an alternative to other conventional ultrasonic system .
MS2888	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A prospect i ve clinical study with a r and om allocation of 47 adolescent patients to three different functional appliance groups was established and compared with an untreated control group over a 9-month period . Treatment was undertaken with either a Bionator , Twin Block , or Bass appliance . Pre- and post-treatment cephalograms were used to quantify the skeletal and dentoalveolar changes produced by the appliances and compared with those observed in the control group as a result of growth . Both the Bionator and Twin Block appliances demonstrated a statistically significant increase in m and ibular length ( 3.9 + /- 2.7 mm ; 3.7 + /- 2.1 mm , respectively ) compared with the control group ( P < 0.05 ) , with an anterior movement of pogonion and point B. Highly statistically significant increases ( P < 0.01 ) were seen in lower face heights for all the appliance groups compared with the control group . The Twin Block group showed the least forward movement of point A due to a change in the inclination of the maxillary plane . The Bionator and Twin Block groups showed statistically significant reductions in the inclination of the upper incisors to the maxillary plane ( P < 0.05 ) . The Bass group showed minimal change in the inclination of the lower labial segment to the m and ibular plane . The Bionator group demonstrated the greatest proclination of the lower labial segment ( 4.0 + /- 3.6 degrees ) . Clinical ly important changes were measured in all the appliance groups when compared with the control group . Differences were also identified between the functional appliance groups . The Twin Block appliance and , to a lesser extent , the Bionator appeared the most effective in producing sagittal and vertical changes The purpose of this study was to determine the changes in the soft tissue profile in patients treated in the mixed dentition with a bionator . Two groups of 30 individuals , between 9 and 12 years old and with Class II , Division 1 , malocclusion were matched for age , sex , observation time , and dentofacial characteristics . Patients in the first group were treated with a bionator for an average of 18.7 months , result ing in a Class I molar relationship and reduction of overjet . The second group acted as a control and individuals did not receive any form of orthodontic treatment . Pretreatment and posttreatment cephalograms were analyzed and paired t-tests were used to compare the significance of changes between the two groups . Compared with the control group , the treated group demonstrated 1.97 degrees decrease in ANB , a 3.35 mm increase in anterior facial height , 2.22 degrees decrease in soft tissue profile convexity , and 17.4 degrees increase in mentolabial angle The short- and long-term effects of the Herbst appliance on the facial profile were determined in 69 Class II , division 1 malocclusions treated for 7 months and followed for 5 - 10 years post-treatment . Forty-nine subjects exhibited a stable long-term treatment result , while 20 cases relapsed . Lateral cephalometric radiographs from before treatment , after treatment , 6 months post-treatment , and 5 - 10 years post-treatment were analysed . As a rule Herbst treatment result ed in a reduction of the facial hard and soft tissue profile convexity . In relation to the E-line , the upper lip became retrusive , while the lower lip remained , on average , unchanged . During the post-treatment period of 5 - 10 years the hard tissue profile convexity was , on average , reduced in both the stable and relapse groups . When excluding the nose in the soft tissue profile evaluation , the facial profile convexity was , on average , reduced in the stable group while it remained unchanged in the relapse group . When including the nose in the evaluation , an average increase in the profile convexity occurred in both examination groups . Furthermore , the upper and lower lips became retrusive in both groups . For all the variables , however , large individual variations existed . In conclusion , it can be said that the Herbst appliance improves the facial hard and soft tissue profiles . Due to post-treatment growth changes the long-term effects of therapy are , however , variable and unpredictable The aim of this study was to determine the change in profile attractiveness in children with Class II Division 1 malocclusion after 18 months ' treatment with functional appliances . Changes in profile attractiveness were assessed by panels of art students , dental students , and parents of orthodontic patients . Each panel consisted of an equal number of male and female raters . The raters first decided whether the initial or 18-month profile silhouette was more attractive , and then scored the degree to which it was more attractive on an unmarked visual analog scale . There were no significant differences between either male and female raters or among panels in their assessment s of the change in profile attractiveness in the whole sample . Neither were there significant differences between the change in profile attractiveness of the untreated subjects and the subjects treated with either Fränkel function regulators or Harvold activators . It is concluded that treatment with functional appliances does not lead to more attractive profiles than nontreatment A prospect i ve clinical study with a r and om allocation of 47 patients to three different functional appliance groups was established and compared with a slightly younger control group over a 9-month period . The cephalometric hard tissue changes were assessed in relation to the soft tissue changes produced and the patients were also assessed by three-dimensional ( 3D ) laser scanning of the facial soft tissues . Each ' averaged ' appliance group scan was compared with the ' averaged ' control group face . Statistically and clinical ly significant changes occurred in the group treated with the Twin Block appliance , and to a lesser extent in the group treated with the Bionator appliance . No statistically significant facial soft tissue changes could be demonstrated in the Bass appliance group . Upper lip position remained stable despite the significant overjet reduction attained in the three appliance groups . Lower lip protrusion ( up to 3.8 mm ) , lower lip length ( up to 4.0 mm ) , and soft tissue lower and total face height increased significantly in all appliance groups by varying amounts . The long-term effect of these changes needs to be fully evaluated . The laser scanning system was found to be a sensitive and accurate method of quantitatively assessing small changes in the soft tissue facial form . Significant changes of the facial tissues in the transverse plane were highlighted by this technique The aim of this study was to evaluate the effect of different functional appliances on the soft tissues as assessed by cephalometry and optical surface scanning . Forty-two patients were r and omly allocated to Bass , Twin Block ( TB ) , and Twin Block + Headgear ( TB + Hg ) groups . Lateral cephalograms and optical surface scans were recorded before and after the 10-month study period . ANOVA was used to test the cephalometric variables for differences at the 5 per cent level . The optical surface scanning and cephalometric results were consistent in the sagittal dimension . In the vertical dimension , however , the optical surface scans consistently recorded a greater increase compared with cephalometric values . No differences were detected with regard to cephalometric values at the 5 per cent level . However , the Bass appliance produced greater forward positioning of soft tissue pogonion as assessed by optical surface scanning Output:	Soft tissue changes that were reported as being statistically significant were of question able clinical significance .
MS2889	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Recent research has suggested an important role of lateral prefrontal cortex ( lPFC ) in consistent implementation of positive health behaviors and avoidance of negative health behaviors . Methods We examined whether gray matter volume in the lPFC prospect ively predicts exercise class attendance among older women ( n = 122 ) who underwent either a 52-week or 26-week exercise training intervention . Structural magnetic resonance imaging determined gray matter volume at baseline . Results Independent of intracranial volume , age , education , body composition , mobility , depressive symptoms , and general cognitive functioning , larger lPFC volume predicted greater exercise class attendance ( all p values < .05 ) . Follow-up whole-brain analyses further confirmed that regions in the lPFC-especially the left middle frontal gyrus ( p < .005)-predicted future exercise adherence as well as identified other regions , especially in the insula and temporal cortex , that predicted exercise adherence . Conclusions These findings suggest that sustained engagement in exercise training might rely in part on functions of the lPFC and that lPFC volume might be a reasonable proxy for such functions The combined effects of hyperventilation and arterial desaturation on cerebral oxygenation ( [ Formula : see text ] ) were determined using near-infrared spectroscopy . Eleven competitive oarsmen were evaluated during a 6-min maximal ergometer row . The study was r and omized in a double-blind fashion with an inspired O2 fraction of 0.21 or 0.30 in a crossover design . During exercise with an inspired O2 fraction of 0.21 , the arterial CO2 pressure ( 35 ± 1 mmHg ; mean ± SE ) and O2 pressure ( 77 ± 2 mmHg ) as well as the hemoglobin saturation ( 91.9 ± 0.7 % ) were reduced ( P < 0.05).[Formula : see text ] was reduced from 80 ± 2 to 63 ± 2 % ( P < 0.05 ) , and the near-infrared spectroscopy-determined concentration changes in deoxy- ( ΔHb ) and oxyhemoglobin ( ΔHbO2 ) of the vastus lateralis muscle increased 22 ± 3 μM and decreased 14 ± 3 μM , respectively ( P < 0.05 ) . Increasing the inspired O2fraction to 0.30 did not affect ventilation ( 174 ± 4 l/min ) , but arterial CO2 pressure ( 37 ± 2 mmHg ) , O2 pressure ( 165 ± 5 mmHg ) , and hemoglobin O2saturation ( 99 ± 0.1 % ) increased ( P < 0.05).[Formula : see text ] remained close to the resting level during exercise ( 79 ± 2 vs. 81 ± 2 % ) , and although the muscle ΔHb ( 18 ± 2 μM ) and ΔHbO2 ( -12 ± 3 μM ) were similar to those established without O2 supplementation , work capacity increased from 389 ± 11 to 413 ± 10 W ( P < 0.05 ) . These results indicate that an elevated inspiratory O2fraction increases exercise performance related to maintained cerebral oxygenation rather than to an effect on the working muscles Background Dementia is more common in older than in younger people , and as a result of the ageing of the population in developed countries , it is becoming more prevalent . Drug treatments for dementia are limited , and the main support offered to people with dementia and their families is generally services to mitigate against loss of function . Physical exercise is a c and i date non-pharmacological treatment for dementia . Methods / Design DAPA is a r and omised controlled trial funded by the National Institute for Health Research Health Technology Assessment programme to estimate the effect of a 4-month , moderate- to hard-intensity exercise training programme and subsequent advice to remain active , on cognition ( primary outcome ) at 12 months in people with mild to moderate dementia . Community-dwelling participants ( with their carers where possible ) , who are able to walk 3 metres without human assistance , able to undertake an exercise programme and do not have any unstable or terminal illness are recruited . Participants are then r and omised by an independent statistician using a computerised r and om number generator to usual care or exercise at a 2:1 ratio in favour of exercise . The exercise intervention comprises 29 , 1-hour-long exercise classes , run twice weekly at suitable venues such as leisure centres , which include aerobic exercise ( on static bikes ) and resistance exercise ( using weights ) . Goals for independent exercise are set while the classes are still running , and supported thereafter with phone calls . The primary outcome is measured using ADAS-cog . Secondary outcome measures include behavioural symptoms , functional ability , quality of life and carer burden . Primary and secondary outcomes will be measured at baseline and at 6 and 12 months after r and omisation , by research ers masked to participant r and omisation in the participants ’ own homes . An economic evaluation will be carried out in parallel to the RCT , as will a qualitative study capturing the experiences of participants , carers and staff delivering the intervention . Discussion The DAPA study will be the first large , r and omised trial of the cognitive effects of exercise on people with dementia . The intervention is design ed to be capable of being delivered within the constraints of NHS service provision , and the economic evaluation will allow assessment of its cost-effectiveness . Trial registration DAPA was registered with the IS RCT N data base on 29 July 2011 , registration number IS RCT N32612072 BACKGROUND Over half of stroke survivors have cognitive impairment , which impedes rehabilitation and functional recovery . Evidence suggests a single session of aerobic exercise improves cognitive functions among healthy adults . Whether this holds true for stroke survivors is unclear . The objective of this study was to examine whether one session of moderate-intensity aerobic exercise improves the cognitive control and attention of stroke survivors . METHODS Nine people with chronic stroke ( ≥6 months poststroke ) performed a modified Eriksen Flanker task with concurrent electroencephalography ( EEG ) before and immediately , 20 minutes , and 40 minutes after 20 minutes of moderate-intensity exercise and after 20 minutes of rest . The sessions were in r and omized order . Accuracy and response time were recorded for congruent and incongruent stimuli . Differences in accuracy , response time , and event-related potentials ( P300 , reflective of decision making ) were analyzed using repeated measures analysis of variance . RESULTS Improvements in EEG measures were noted after exercise . P300 amplitude at Fz was greater 40 minutes after exercise compared with after rest ( P = .007 ) . P300 latency was also shorter at 20 minutes after exercise compared with after rest for both congruent ( 465.8 milliseconds versus 500.0 milliseconds ; P = .02 ) and incongruent ( 468.0 milliseconds versus 532.0 milliseconds ; P = .003 ) conditions at the central electrode on the lesional side . Differences in behavioral performance after exercise were not significant . CONCLUSIONS Preliminary results suggest that aerobic exercise improves cortical processes underlying cognitive control and attention 20 - 40 minutes postexercise . Future research should confirm results in a larger sample and examine whether attention-dem and ing rehabilitation in this window has improved outcomes UNLABELLED Repeated maximal-intensity short- duration exercise ( sprint interval training , SIT ) can produce muscle adaptations similar to endurance training ( ET ) despite a much reduced training volume . However , most SIT data use cycling , and little is known about its effects on body composition or maximal cardiac output ( Qmax ) . PURPOSE The purpose of this study was to assess body composition , 2000-m run time trial , VO(2max ) , and Q(max ) effects of run SIT versus ET . METHODS Men and women ( n = 10 per group ; mean ± SD : age = 24 ± 3 yr ) trained three times per week for 6 wk with SIT , 30-s all-out run sprints ( manually driven treadmill ) , four to six bouts per session , 4-min recovery per bout , versus ET , 65 % VO(2max ) for 30 to 60 min·d(-1 ) . RESULTS Training improved ( P < 0.05 ) body composition , 2000-m run time trial performance , and VO(2max ) in both groups . Fat mass decreased 12.4 % with SIT ( mean ± SEM ; 13.7 ± 1.6 to 12.0 ± 1.6 kg ) and 5.8 % with ET ( 13.9 ± 1.7 to 13.1 ± 1.6 kg ) . Lean mass increased 1 % in both groups . Time trial performance improved 4.6 % with SIT ( -25.6 ± 8.1 s ) and 5.9 % with ET ( -31.9 ± 6.3 s ) . VO(2max ) increased 11.5 % with SIT ( 46.8 ± 1.6 to 52.2 ± 2.0 mL·kg·(-1)·min(-1 ) ) and 12.5 % with ET ( 44.0 ± 2.0 to 49.5 ± 2.6 mL·kg·(-1)·min(-1 ) ) . None of these improvements differed between groups . In contrast , Q(max ) increased by 9.5 % with ET only ( 22.2 ± 2.0 to 24.3 ± 1.6 L·min(-1 ) ) . CONCLUSIONS Despite a fraction of the time commitment , run SIT induces similar body composition , VO(2max ) , and performance adaptations as ET , but with no effect on Q(max ) . These data suggest that adaptations with ET are of central origin primarily , whereas those with SIT are more Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Brain-derived neurotrophic factor ( BDNF ) plays a role in the maintenance and function of neurons . Although persons with Alzheimer ’s disease have lower cortical levels of BDNF , evidence regarding the association between circulating BDNF and cognitive function is conflicting . We sought to determine the correlates of BDNF level and whether BDNF level was prospect ively associated with cognitive decline in healthy older adults . We measured serum BDNF near baseline in 912 individuals . Cognitive status was assessed repeatedly with the modified Mini-Mental Status Examination and the Digit Symbol Substitution test over the next 10 years . We evaluated the association between BDNF and cognitive decline with longitudinal models . We also assessed the association between BDNF level and demographics , comorbidities and health behaviors . We found an association between serum BDNF and several characteristics that are also associated with dementia ( race and depression ) , suggesting that future studies should control for these potential confounders . We did not find evidence of a longitudinal association between serum BDNF and subsequent cognitive test trajectories in older adults , although we did identify a potential trend toward a cross-sectional association . Our results suggest that serum BDNF may have limited utility as a biomarker of prospect i ve cognitive decline Brain blood vessels contain muscarinic receptors that are important for cerebral blood flow ( CBF ) regulation , but whether a cholinergic receptor mechanism is involved in the exercise-induced increase in cerebral perfusion or affects cerebral metabolism remains unknown . We evaluated CBF and cerebral metabolism ( from arterial and internal jugular venous O(2 ) , glucose and lactate differences ) , as well as the middle cerebral artery mean blood velocity ( MCA V(mean ) ; transcranial Doppler ultrasound ) during a sustained static h and grip contraction at 40 % of maximal voluntary contraction ( n = 9 ) and the MCA V(mean ) during ergometer cycling ( n = 8) . Separate , r and omized and counterbalanced trials were performed in control ( no drug ) conditions and following muscarinic cholinergic receptor blockade by glycopyrrolate . Glycopyrrolate increased resting heart rate from approximately 60 to approximately 110 beats min(-1 ) ( P < 0.01 ) and cardiac output by approximately 40 % ( P < 0.05 ) , but did not affect mean arterial pressure . The central cardiovascular responses to exercise with glycopyrrolate were similar to the control responses , except that cardiac output did not increase during static h and grip with glycopyrrolate . Glycopyrrolate did not significantly affect cerebral metabolism during static h and grip , but a parallel increase in MCA V(mean ) ( approximately 16 % ; P < 0.01 ) and CBF ( approximately 12 % ; P < 0.01 ) during static h and grip , as well as the increase in MCA V(mean ) during cycling ( approximately 15 % ; P < 0.01 ) , were abolished by glycopyrrolate ( P < 0.05 ) . Thus , during both cycling and static h and grip , a cholinergic receptor mechanism is important for the exercise-induced increase in cerebral perfusion without affecting the cerebral metabolic rate for oxygen The new and recent advances in neuroelectric and neuroimaging technologies provide a new era for further exploring and underst and ing how brain and cognition function can be stimulated by environmental factors , such as exercise , and particularly to study whether physical exercise influences brain development in early ages . The Output:	Conclusion : This systematic review found that moderate physical exercise improves cognition
MS2890	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: INTRODUCTION Perioperative blood loss is a frequent cause of complications in total hip replacement ( THR ) . The present prospect i ve study assessed the efficacy of tranexamic acid ( Exacyl ( ® ) ) in reducing blood loss in primary THR associated to rivaroxaban ( Xarelto ( ® ) ) thromboprophylaxis . HYPOTHESIS Tranexamic acid associated to rivaroxaban reduces blood loss . MATERIAL AND METHOD A prospect i ve case-control study included 70 primary cementless THRs performed by a single surgeon on a st and ardized technique , between September 2009 and September 2010 . Thirty-seven patients received perioperative tranexamic acid ; all patients received rivaroxaban thromboprophylaxis . RESULTS There was no significant difference between the two groups in terms of peroperative blood-loss volume or rates of thromboembolic or ischemic events or hematoma . Postoperative blood loss , D0 - 5 differential hemoglobinemia and real blood loss ( in mL 100 % hematocrit ) were significantly lower in the tranexamic acid group . No transfusions were required in the tranexamic acid group , versus four in the control group . DISCUSSION Tranexamic acid associated to direct anti-Xa ( antithrombin-independent ) oral anticoagulants was effective in reducing postoperative blood loss , improving hemoglobinemia at 5 days and reducing transfusion rates . The results also confirmed the efficacy of and tolerance for rivaroxaban thromboprophylaxis in primary THR , with no clinical thrombotic events induced by the association of tranexamic acid with rivaroxaban . CONCLUSIONS Tranexamic acid is a simple means of reducing postoperative blood loss in THR , without increased risk of thromboembolism when associated to rivaroxaban thromboprophylaxis . LEVEL OF EVIDENCE Level III prospect i ve case-control study OBJECTIVE Prevention of deep venous thrombosis ( DVT ) and associated pulmonary embolism following major orthopedic surgeries is challenging , and there is an increased interest in developing new treatment strategies . We compared 2 switch-therapy modalities-enoxaparin to rivaroxaban and enoxaparin to dabigatran- and enoxaparin monotherapy for preventing DVT after total knee arthroplasty ( TKA ) and total hip arthroplasty ( THA ) . METHODS This was a prospect i ve , non-blinded , r and omized controlled study . We selected 180 eligible patients out of 247 patients undergoing TKA or THA . During the preoperative checkup , patients were r and omized to receive either enoxaparin ( enoxaparin group ) or switch-therapy regimens , comprising enoxaparin during hospitalization and rivaroxaban ( rivaroxaban group ) or dabigatran ( dabigatran group ) during the outpatient period . All patients were evaluated for DVT using Doppler ultrasonography ( USG ) 6 weeks postoperatively . The primary efficacy outcome was the prevention of symptomatic or Doppler ultrasonography (USG)-proven DVT , whereas the primary safety outcome was the incidence of bleeding during the DVT-prophylaxis period . RESULTS Doppler USG at 6 weeks after surgery revealed no signs of DVT in any patient . During the hospitalization period , only 2 major bleeding events were reported ( 1 [ 1.6 % ] in the enoxaparin group and 1 [ 1.6 % ] in the dabigatran group ) . No major bleeding events were reported during the outpatient follow-up period in any group . Differences among the 3 groups regarding bleeding events were not statistically significant ( p>0.05 ) . CONCLUSION When using switch-therapy modalities , clinicians can take advantage of the safety of enoxaparin during the hospitalization period and ease of use of new oral anticoagulant drugs during the outpatient period Objective To examine the duration and magnitude of increased risk of venous thromboembolism after different types of surgery . Design Prospect i ve cohort study ( Million Women Study ) . Setting Question naire data from the Million Women Study linked with hospital admission and death records . Participants 947 454 middle aged women in the United Kingdom recruited in 1996 - 2001 and followed by record linkage to routinely collected NHS data on hospital admissions and deaths . During follow-up 239 614 admissions were for surgery ; 5419 women were admitted , and a further 270 died , from venous thromboembolism . Main outcome measures Adjusted relative risks and st and ardised incidence rates for hospital admission or death from venous thromboembolism ( pulmonary embolism or deep vein thrombosis ) , by time since and type of surgery . Results Compared with not having surgery , women were 70 times more likely to be admitted with venous thromboembolism in the first six weeks after an inpatient operation ( relative risk 69.1 , 95 % confidence interval 63.1 to 75.6 ) and 10 times more likely after a day case operation ( 9.6 , 8.0 to 11.5 ) . The risks were lower but still substantially increased 7 - 12 weeks after surgery ( 19.6 , 16.6 to 23.1 and 5.5 , 4.3 to 7.0 , respectively ) . This pattern of risk was similar for pulmonary embolism ( n=2487 ) and deep venous thrombosis ( n=3529 ) . The postoperative risks of venous thromboembolism varied considerably by surgery type , with highest relative risks after inpatient surgery for hip or knee replacement and for cancer—1 - 6 weeks after surgery the relative risks were , respectively , 220.6 ( 187.8 to 259.2 ) and 91.6 ( 73.9 to 113.4 ) . Conclusion The risk of deep vein thrombosis and pulmonary embolism after surgery is substantially increased in the first 12 postoperative weeks , and varies considerably by type of surgery . An estimated 1 in 140 middle aged women undergoing inpatient surgery in the UK will be admitted with venous thromboembolism during the 12 weeks after surgery ( 1 in 45 after hip or knee replacement and 1 in 85 after surgery for cancer ) , compared with 1 in 815 after day case surgery and only 1 in 6200 women during a 12 week period without surgery BACKGROUND This phase 3 trial compared the efficacy and safety of rivaroxaban , an oral direct inhibitor of factor Xa , with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty . METHODS In this r and omized , double-blind study , we assigned 4541 patients to receive either 10 mg of oral rivaroxaban once daily , beginning after surgery , or 40 mg of enoxaparin subcutaneously once daily , beginning the evening before surgery , plus a placebo tablet or injection . The primary efficacy outcome was the composite of deep-vein thrombosis ( either symptomatic or detected by bilateral venography if the patient was asymptomatic ) , nonfatal pulmonary embolism , or death from any cause at 36 days ( range , 30 to 42 ) . The main secondary efficacy outcome was major venous thromboembolism ( proximal deep-vein thrombosis , nonfatal pulmonary embolism , or death from venous thromboembolism ) . The primary safety outcome was major bleeding . RESULTS A total of 3153 patients were included in the superiority analysis ( after 1388 exclusions ) , and 4433 were included in the safety analysis ( after 108 exclusions ) . The primary efficacy outcome occurred in 18 of 1595 patients ( 1.1 % ) in the rivaroxaban group and in 58 of 1558 patients ( 3.7 % ) in the enoxaparin group ( absolute risk reduction , 2.6 % ; 95 % confidence interval [ CI ] , 1.5 to 3.7 ; P<0.001 ) . Major venous thromboembolism occurred in 4 of 1686 patients ( 0.2 % ) in the rivaroxaban group and in 33 of 1678 patients ( 2.0 % ) in the enoxaparin group ( absolute risk reduction , 1.7 % ; 95 % CI , 1.0 to 2.5 ; P<0.001 ) . Major bleeding occurred in 6 of 2209 patients ( 0.3 % ) in the rivaroxaban group and in 2 of 2224 patients ( 0.1 % ) in the enoxaparin group ( P=0.18 ) . CONCLUSIONS A once-daily , 10-mg oral dose of rivaroxaban was significantly more effective for extended thromboprophylaxis than a once-daily , 40-mg subcutaneous dose of enoxaparin in patients undergoing elective total hip arthroplasty . The two drugs had similar safety profiles . ( Clinical Trials.gov number , NCT00329628 . BACKGROUND The role of aspirin in thromboprophylaxis after total hip arthroplasty ( THA ) is controversial . OBJECTIVE To compare extended prophylaxis with aspirin and dalteparin for prevention of symptomatic venous thromboembolism ( VTE ) after THA . DESIGN Multicenter r and omized , controlled trial with a noninferiority design based on a minimal clinical ly important difference of 2.0 % . R and omization was electronically generated ; patients were assigned to a treatment group through a Web-based program . Patients , physicians , study coordinators , health care team members , outcome adjudicators , and data analysts were blinded to interventions . ( Current Controlled Trials : IS RCT N11902170 ) . SETTING 12 tertiary care orthopedic referral centers in Canada . PATIENTS 778 patients who had elective unilateral THA between 2007 and 2010 . INTERVENTION After an initial 10 days of dalteparin prophylaxis after elective THA , patients were r and omly assigned to 28 days of dalteparin ( n = 400 ) or aspirin ( n = 386 ) . MEASUREMENTS Symptomatic VTE confirmed by objective testing ( primary efficacy outcome ) and bleeding . RESULTS Five of 398 patients ( 1.3 % ) r and omly assigned to dalteparin and 1 of 380 ( 0.3 % ) r and omly assigned to aspirin had VTE ( absolute difference , 1.0 percentage point [ 95 % CI , -0.5 to 2.5 percentage points ] ) . Aspirin was noninferior ( P < 0.001 ) but not superior ( P = 0.22 ) to dalteparin . Clinical ly significant bleeding occurred in 5 patients ( 1.3 % ) receiving dalteparin and 2 ( 0.5 % ) receiving aspirin . The absolute between-group difference in a composite of all VTE and clinical ly significant bleeding events was 1.7 percentage points ( CI , -0.3 to 3.8 percentage points ; P = 0.091 ) in favor of aspirin . LIMITATION The study was halted prematurely because of difficulty with patient recruitment . CONCLUSION Extended prophylaxis for 28 days with aspirin was noninferior to and as safe as dalteparin for the prevention of VTE after THA in patients who initially received dalteparin for 10 days . Given its low cost and greater convenience , aspirin may be considered a reasonable alternative for extended thromboprophylaxis after THA . PRIMARY FUNDING SOURCE Canadian Institutes of Health Research Rivaroxaban demonstrated superior efficacy and a similar safety profile to enoxaparin for the prevention of venous thromboembolism in the phase III RECORD programme in patients undergoing elective hip or knee replacement surgery . The XAMOS study investigated adverse events , including bleeding and thromboembolic events , in patients receiving rivaroxaban for thromboprophylaxis in routine clinical practice . XAMOS was a non-interventional , open-label cohort study in patients undergoing major orthopaedic surgery of the hip or knee ( predominantly elective arthroplasty ) , in which rivaroxaban was compared with other pharmacological thromboprophylaxis . All adverse events were documented , including symptomatic thromboembolic and bleeding events . Crude and adjusted incidences based on propensity score subclasses were calculated and compared between the rivaroxaban and st and ard-of-care groups . A total of 17,701 patients were enrolled from 252 centres in 37 countries . Crude incidences of symptomatic thromboembolic events three months after surgery in the safety population were 0.89 % in the rivaroxaban group ( n=8,778 ) and 1.35 % in the st and ard-of-care group ( n=8,635 ; odds ratio [ OR ] 0.65 ; 95 % confidence interval [ CI ] 0.49 - 0.87 ) , and 0.91 % and 1.31 % ( weighted ) in the propensity score-adjusted analysis ( OR 0.69 ; 95 % CI 0.56 - 0.85 ) , respectively . Treatment-emergent major bleeding events ( as defined in the RECORD studies ) occurred in 0.40 % and 0.34 % Output:	The results of the studies showed some cases of pulmonary embolism , deep vein thrombosis , and bleeding ; even then , the NOACs were effective in preventing thromboembolic events . There is no consensus regarding the prophylaxis method for these events , which is why the challenge is to obtain high levels of prevention while minimizing the adverse effects .
MS2891	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The objectives of the Prostate , Lung , Colorectal and Ovarian Cancer Screening Trial are to determine in screenees ages 55 - 74 at entry whether screening with flexible sigmoidoscopy ( 60-cm sigmoidoscope ) can reduce mortality from colorectal cancer , whether screening with chest X-ray can reduce mortality from lung cancer , whether screening men with digital rectal examination ( DRE ) plus serum prostate-specific antigen ( PSA ) can reduce mortality from prostate cancer , and whether screening women with CA125 and transvaginal ultrasound ( TVU ) can reduce mortality from ovarian cancer . Secondary objectives are to assess screening variables other than mortality for each of the interventions including sensitivity , specificity , and positive predictive value ; to assess incidence , stage , and survival of cancer cases ; and to investigate biologic and /or prognostic characterizations of tumor tissue and biochemical products as intermediate endpoints . The design is a multicenter , two-armed , r and omized trial with 37,000 females and 37,000 males in each of the two arms . In the intervention arm , the PSA and CA125 tests are performed at entry , then annually for 5 years . The DRE , TVU , and chest X-ray exams are performed at entry and then annually for 3 years . Sigmoidoscopy is performed at entry and then at the 5-year point . Participants in the control arm follow their usual medical care practice s. Participants will be followed for at least 13 years from r and omization to ascertain all cancers of the prostate , lung , colorectum , and ovary , as well as deaths from all causes . A pilot phase was undertaken to assess the r and omization , screening , and data collection procedures of the trial and to estimate design parameters such as compliance and contamination levels . This paper describes eligibility , consent , and other design features of the trial , r and omization and screening procedures , and an outline of the follow-up procedures . Sample -size calculations are reported , and a data analysis plan is presented BACKGROUND Prostate cancer is one of the leading causes of death from malignant disease among men in the developed world . One strategy to decrease the risk of death from this disease is screening with prostate-specific antigen ( PSA ) ; however , the extent of benefit and harm with such screening is under continuous debate . METHODS In December , 1994 , 20,000 men born between 1930 and 1944 , r and omly sample d from the population register , were r and omised by computer in a 1:1 ratio to either a screening group invited for PSA testing every 2 years ( n=10,000 ) or to a control group not invited ( n=10,000 ) . Men in the screening group were invited up to the upper age limit ( median 69 , range 67 - 71 years ) and only men with raised PSA concentrations were offered additional tests such as digital rectal examination and prostate biopsies . The primary endpoint was prostate-cancer specific mortality , analysed according to the intention-to-screen principle . The study is ongoing , with men who have not reached the upper age limit invited for PSA testing . This is the first planned report on cumulative prostate-cancer incidence and mortality calculated up to Dec 31 , 2008 . This study is registered as an International St and ard R and omised Controlled Trial IS RCT N54449243 . FINDINGS In each group , 48 men were excluded from the analysis because of death or emigration before the r and omisation date , or prevalent prostate cancer . In men r and omised to screening , 7578 ( 76 % ) of 9952 attended at least once . During a median follow-up of 14 years , 1138 men in the screening group and 718 in the control group were diagnosed with prostate cancer , result ing in a cumulative prostate-cancer incidence of 12.7 % in the screening group and 8.2 % in the control group ( hazard ratio 1.64 ; 95 % CI 1.50 - 1.80 ; p<0.0001 ) . The absolute cumulative risk reduction of death from prostate cancer at 14 years was 0.40 % ( 95 % CI 0.17 - 0.64 ) , from 0.90 % in the control group to 0.50 % in the screening group . The rate ratio for death from prostate cancer was 0.56 ( 95 % CI 0.39 - 0.82 ; p=0.002 ) in the screening compared with the control group . The rate ratio of death from prostate cancer for attendees compared with the control group was 0.44 ( 95 % CI 0.28 - 0.68 ; p=0.0002 ) . Overall , 293 ( 95 % CI 177 - 799 ) men needed to be invited for screening and 12 to be diagnosed to prevent one prostate cancer death . INTERPRETATION This study shows that prostate cancer mortality was reduced almost by half over 14 years . However , the risk of over-diagnosis is substantial and the number needed to treat is at least as high as in breast-cancer screening programmes . The benefit of prostate-cancer screening compares favourably to other cancer screening programs . FUNDING The Swedish Cancer Society , the Swedish Research Council , and the National Cancer Institute BACKGROUND The effect of screening with prostate-specific-antigen ( PSA ) testing and digital rectal examination on the rate of death from prostate cancer is unknown . This is the first report from the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial on prostate-cancer mortality . METHODS From 1993 through 2001 , we r and omly assigned 76,693 men at 10 U.S. study centers to receive either annual screening ( 38,343 subjects ) or usual care as the control ( 38,350 subjects ) . Men in the screening group were offered annual PSA testing for 6 years and digital rectal examination for 4 years . The subjects and health care providers received the results and decided on the type of follow-up evaluation . Usual care sometimes included screening , as some organizations have recommended . The numbers of all cancers and deaths and causes of death were ascertained . RESULTS In the screening group , rates of compliance were 85 % for PSA testing and 86 % for digital rectal examination . Rates of screening in the control group increased from 40 % in the first year to 52 % in the sixth year for PSA testing and ranged from 41 to 46 % for digital rectal examination . After 7 years of follow-up , the incidence of prostate cancer per 10,000 person-years was 116 ( 2820 cancers ) in the screening group and 95 ( 2322 cancers ) in the control group ( rate ratio , 1.22 ; 95 % confidence interval [ CI ] , 1.16 to 1.29 ) . The incidence of death per 10,000 person-years was 2.0 ( 50 deaths ) in the screening group and 1.7 ( 44 deaths ) in the control group ( rate ratio , 1.13 ; 95 % CI , 0.75 to 1.70 ) . The data at 10 years were 67 % complete and consistent with these overall findings . CONCLUSIONS After 7 to 10 years of follow-up , the rate of death from prostate cancer was very low and did not differ significantly between the two study groups . ( Clinical Trials.gov number , NCT00002540 . BACKGROUND Screening for prostate cancer advances the time of diagnosis ( lead time ) and detects cancers that would not have been diagnosed in the absence of screening ( overdetection ) . Both consequences have considerable impact on the net benefits of screening . METHODS We developed simulation models based on results of the Rotterdam section of the European R and omized Study of Screening for Prostate Cancer ( ERSPC ) , which enrolled 42,376 men and in which 1498 cases of prostate cancer were identified , and on baseline prostate cancer incidence and stage distribution data . The models were used to predict mean lead times , overdetection rates , and ranges ( corresponding to approximate 95 % confidence intervals ) associated with different screening programs . RESULTS Mean lead times and rates of overdetection depended on a man 's age at screening . For a single screening test at age 55 , the estimated mean lead time was 12.3 years ( range = 11.6 - 14.1 years ) and the overdetection rate was 27 % ( range = 24%-37 % ) ; at age 75 , the estimates were 6.0 years ( range = 5.8 - 6.3 years ) and 56 % ( range = 53%-61 % ) , respectively . For a screening program with a 4-year screening interval from age 55 to 67 , the estimated mean lead time was 11.2 years ( range = 10.8 - 12.1 years ) , and the overdetection rate was 48 % ( range = 44%-55 % ) . This screening program raised the lifetime risk of a prostate cancer diagnosis from 6.4 % to 10.6 % , a relative increase of 65 % ( range = 56%-87 % ) . In annual screening from age 55 to 67 , the estimated overdetection rate was 50 % ( range = 46%-57 % ) and the lifetime prostate cancer risk was increased by 80 % ( range = 69%-116 % ) . Extending annual or quadrennial screening to the age of 75 would result in at least two cases of overdetection for every clinical ly relevant cancer detected . CONCLUSIONS These model-based lead-time estimates support a prostate cancer screening interval of more than 1 year BACKGROUND In 2008 , we reported that radical prostatectomy , as compared with watchful waiting , reduces the rate of death from prostate cancer . After an additional 3 years of follow-up , we now report estimated 15-year results . METHODS From October 1989 through February 1999 , we r and omly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy . Follow-up was complete through December 2009 , with histopathological review of biopsy and radical-prostatectomy specimens and blinded evaluation of causes of death . Relative risks , with 95 % confidence intervals , were estimated with the use of a Cox proportional-hazards model . RESULTS During a median of 12.8 years , 166 of the 347 men in the radical-prostatectomy group and 201 of the 348 in the watchful-waiting group died ( P=0.007 ) . In the case of 55 men assigned to surgery and 81 men assigned to watchful waiting , death was due to prostate cancer . This yielded a cumulative incidence of death from prostate cancer at 15 years of 14.6 % and 20.7 % , respectively ( a difference of 6.1 percentage points ; 95 % confidence interval [ CI ] , 0.2 to 12.0 ) , and a relative risk with surgery of 0.62 ( 95 % CI , 0.44 to 0.87 ; P=0.01 ) . The survival benefit was similar before and after 9 years of follow-up , was observed also among men with low-risk prostate cancer , and was confined to men younger than 65 years of age . The number needed to treat to avert one death was 15 overall and 7 for men younger than 65 years of age . Among men who underwent radical prostatectomy , those with extracapsular tumor growth had a risk of death from prostate cancer that was 7 times that of men without extracapsular tumor growth ( relative risk , 6.9 ; 95 % CI , 2.6 to 18.4 ) . CONCLUSIONS Radical prostatectomy was associated with a reduction in the rate of death from prostate cancer . Men with extracapsular tumor growth may benefit from adjuvant local or systemic treatment . ( Funded by the Swedish Cancer Society and the National Institutes of Health . ) PURPOSE This clinical trial is aim ed at evaluating the impact of prostate cancer screening on cancer-specific mortality . SUBJECTS AND METHODS Forty-six thous and four hundred and eighty-six ( 46,486 ) men aged 45 - 80 years registered in the electoral roll of the Quebec city area were r and omized in 1988 between screening and no screening . Screening included measurement of serum prostatic specific antigen ( PSA ) using 3.0 ng/ml as upper limit of normal and digital rectal examination ( DRE ) at first visit . At follow-up visits , serum PSA only was used . RESULTS Seventy-four ( 74 ) deaths from prostate cancer occurred in the 14,231 unscreened controls while 10 deaths were observed in the screened group of 7,348 men during the first 11 years following r and omization . Median follow-up of screened men was 7.93 years . A Cox proportional hazards model of the age at death from prostate cancer shows a 62 % reduction ( P < 0.002 , Fisher 's exact test ) of cause-specific mortality in the screened men ( P = 0.005 ) . These results are in agreement with the continuous decrease of prostate cancer mortality observed in North America Of 9,026 males aged 50 - 69 years , 1,494 were r and omly selected and invited to participate in a programme including two screenings for carcinoma of the prostate by digital rectal examination performed in 19 Output:	Sub-group analyses indicated that prostate cancer-specific mortality was not affected by age at which participants were screened . •Harms of screening included high rates of false-positive results for the PSA test , over-diagnosis and adverse events associated with transrectal ultrasonography guided biopsies such as infection , bleeding and pain . •Any benefits from prostate cancer screening may take > 10 years to accrue ; therefore , men who have a life expectancy of < 10 - 15 years should be informed that screening for prostate cancer is not beneficial and has harms
MS2892	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE This study aim ed to explore effects of adjunctive N-acetylcysteine ( NAC ) treatment on inflammatory and neurogenesis markers in unipolar depression . METHODS We embarked on a 12-week clinical trial of NAC ( 2000 mg/day compared with placebo ) as an adjunctive treatment for unipolar depression . A follow-up visit was conducted 4 weeks following the completion of treatment . We collected serum sample s at baseline and the end of the treatment phase ( week 12 ) to determine changes in interleukin-6 ( IL6 ) , C-reactive protein ( CRP ) and brain-derived neurotrophic factor ( BDNF ) following NAC treatment . RESULTS NAC treatment significantly improved depressive symptoms on the Montgomery-Asberg Depression Rating Scale ( MADRS ) over 16 weeks of the trial . Serum levels of IL6 were associated with reductions of MADRS scores independent of treatment response . However , we found no significant changes in IL6 , CRP and BDNF levels following NAC treatment . CONCLUSION Overall , this suggests that our results failed to support the hypothesis that IL6 , CRP and BDNF are directly involved in the therapeutic mechanism of NAC in depression . IL6 may be a useful marker for future exploration of treatment response Given evidence of chronic inflammation in bipolar disorder ( BD ) , we tested the efficacy of aspirin and minocycline as augmentation therapy for bipolar depression . Ninety-nine depressed out patients with BD were enrolled in a 6 week , double-blind , placebo-controlled trial , and r and omized to one of four groups : active minocycline ( 100 mg b.i.d . ) + active aspirin ( 81 mg b.i.d . ) ( M + A ) ; active minocycline + placebo aspirin ( M + P ) ; placebo-minocycline + active aspirin ( A + P ) ; and placebo-minocycline + placebo aspirin ( P + P ) . A blinded interim analysis mid-way through the study led to the dropping of the M + P and A + P arms from further enrollment giving numbers per group who were included in the final analysis of : 30 ( M + A ) , 18 ( M + P ) , 19 ( A + P ) , and 28 ( P + P ) . When the study started , there were three primary outcome measures . Based on the results of the interim analysis , the primary outcome variable , response to treatment as defined by > 50 % decrease in Montgomery – Äsberg Depression Rating Scale ( MADRS ) score was maintained . The other two ( i.e. , the change in mean MADRS score from baseline to end of study and the remission rate , with remission being defined as a score of < 11 on the MADRS ) were reduced to exploratory outcome measures because the interim analysis indicated that the study was adequately powered to test differences in response rate but not the mean change in MADRS scores or remission rates . CRP and IL-6 were assayed to measure inflammation . Urinary thromboxane B2 ( 11-D-TXB2 ) concentrations , which were significantly increased at baseline in the combined BD sample ( n = 90 ) vs. a healthy control group ( n = 27 ) , served as an indirect marker of cyclooxygenase ( COX ) activity . In a two-group analysis , the M + A group showed a greater response rate than the P + P group ( p(one-tailed ) = 0.034 , OR = 2.93 , NNT = 4.7 ) . When all four arms were included in the analysis , there was a main effect of aspirin on treatment response that was driven by both the M + A and the A + P groups ( p(two-tailed ) = 0.019 , OR = 3.67 , NNT = 4.0 ) . Additionally , there was a significant 3-way interaction between aspirin , minocycline , and IL-6 , indicating that response to minocycline was significantly greater in participants in the M + P group with higher IL-6 concentrations . Further , participants in the M + P group who responded to treatment had significantly greater decreases in IL-6 levels between baseline and visit 7 vs. non-responders . Regarding the exploratory outcomes , there was a main effect for aspirin on the remission rate ( χ12 = 4.14 , p(2 t ) = 0.04 , OR = 2.52 , NNT = 8.0 ) . There was no significant main effect of aspirin or minocycline on the mean change in MADRS score across visits . Aspirin and minocycline may be efficacious adjunctive treatments for bipolar depression . Given their potential import , additional studies to confirm and extend these findings are warranted Background : Evidence suggests that anti-inflammatory medication may be effective in the treatment of depressive symptoms . In this study , we aim ed to investigate whether minocycline added to treatment as usual ( TAU ) for 3 months in patients with treatment-resistant depression will lead to an improvement in depressive symptoms . Methods : Multi-site , 12-week , double-blind , placebo-controlled , pilot trial of minocycline added to TAU for patients suffering from DSM-5 major depressive disorder , whose current episode has failed to respond to at least two antidepressants . The primary outcome measure was mean change in Hamilton Depression Rating Scale ( HAMD-17 ) scores from baseline to week 12 . Secondary measures were the Clinical Global Impression scale ( CGI ) , Patient Health Question naire-9 ( PHQ-9 ) , the Generalised Anxiety Disorder scale ( GAD-7 ) and EuroQoL ( EQ-5D ) quality -of-life question naire . Side-effect checklists were also used . Minocycline was started at 100 mg once daily ( OD ) and increased to 200 mg after 2 weeks . Results : A total of 41 participants were r and omised , with 21 in the minocycline group and 20 in the placebo group . A large decrease in HAMD scores was observed in the minocycline group compared to the placebo group ( st and ardised effect size ( ES ) –1.21 , p < 0.001 ) . CGI scores in the minocycline group also showed a large improvement compared with placebo ( odds ratio ( OR ) : 17.6 , p < 0.001 ) . PHQ-9 , GAD-7 and EQ-5D total showed more moderate improvements ( ES ~ 0.4–0.5 ) . Conclusion : The findings indicate that adjunctive minocycline leads to improvement in symptoms of treatment-resistant depression . However , our findings require replication in a larger sample . Trial Registration : Clinical Trials.gov identifier : NCT02263872 , registered October 2014 There is increasing evidence that both immune and neurochemical alterations are involved in the pathogenesis of bipolar disorder ; however , their precise role remains unclear . In this study , we aim ed to evaluate neuro‐immune changes in a prospect i ve study on children of patients with bipolar disorder Major depressive disorder ( MDD ) in general , and anxious-depression in particular , are characterized by poor rates of remission with first-line treatments , contributing to the chronic illness burden suffered by many patients . Prospect i ve research is needed to identify the biomarkers predicting nonremission prior to treatment initiation . We collected blood sample s from a discovery cohort of 34 adult MDD patients with co-occurring anxiety and 33 matched , nondepressed controls at baseline and after 12 weeks ( of citalopram plus psychotherapy treatment for the depressed cohort ) . Sample s were processed on gene arrays and group differences in gene expression were investigated . Exploratory analyses suggest that at pretreatment baseline , nonremitting patients differ from controls with gene function and transcription factor analyses potentially related to elevated inflammation and immune activation . In a second phase , we applied an unbiased machine learning prediction model and corrected for model- selection bias . Results show that baseline gene expression predicted nonremission with 79.4 % corrected accuracy with a 13-gene model . The same gene-only model predicted nonremission after 8 weeks of citalopram treatment with 76 % corrected accuracy in an independent validation cohort of 63 MDD patients treated with citalopram at another institution . Together , these results demonstrate the potential , but also the limitations , of baseline peripheral blood-based gene expression to predict nonremission after citalopram treatment . These results not only support their use in future prediction tools but also suggest that increased accuracy may be obtained with the inclusion of additional predictors ( eg , genetics and clinical scales ) OBJECTIVE Major depressive disorder has been linked with inflammatory processes , but it is unclear whether individual differences in levels of inflammatory biomarkers could help match patients to treatments that are most likely to be beneficial . The authors tested the hypothesis that C-reactive protein ( CRP ) , a commonly available marker of systemic inflammation , predicts differential response to escitalopram ( a serotonin reuptake inhibitor ) and nortriptyline ( a norepinephrine reuptake inhibitor ) . METHOD The hypothesis was tested in the Genome-Based Therapeutic Drugs for Depression ( GENDEP ) study , a multicenter open-label r and omized clinical trial . CRP was measured with a high-sensitivity method in serum sample s from 241 adult men and women with major depressive disorder r and omly allocated to 12-week treatment with escitalopram ( N=115 ) or nortriptyline ( N=126 ) . The primary outcome measure was the score on the Montgomery-Åsberg Depression Rating Scale ( MADRS ) , administered weekly . RESULTS CRP level at baseline differentially predicted treatment outcome with the two antidepressants ( CRP-drug interaction : β=3.27 , 95 % CI=1.65 , 4.89 ) . For patients with low levels of CRP ( < 1 mg/L ) , improvement on the MADRS score was 3 points higher with escitalopram than with nortriptyline . For patients with higher CRP levels , improvement on the MADRS score was 3 points higher with nortriptyline than with escitalopram . CRP and its interaction with medication explained more than 10 % of individual-level variance in treatment outcome . CONCLUSIONS An easily accessible peripheral blood biomarker may contribute to improvement in outcomes of major depressive disorder by personalizing treatment choice Although stress-induced increases in inflammation have been implicated in several major disorders , including cardiovascular disease and depression , the neurocognitive pathways that underlie inflammatory responses to stress remain largely unknown . To examine these processes , we recruited 124 healthy young adult participants to complete a laboratory-based social stressor while markers of inflammatory activity were obtained from oral fluids . A subset of participants ( n = 31 ) later completed an fMRI session in which their neural responses to social rejection were assessed . As predicted , exposure to the laboratory-based social stressor was associated with significant increases in two markers of inflammatory activity , namely a soluble receptor for tumor necrosis factor-α ( sTNFαRII ) and interleukin-6 ( IL-6 ) . In the neuroimaging sub sample , greater increases in sTNFαRII ( but not IL-6 ) were associated with greater activity in the dorsal anterior cingulate cortex and anterior insula , brain regions that have previously been associated with processing rejection-related distress and negative affect . These data thus eluci date a neurocognitive pathway that may be involved in potentiated inflammatory responses to acute social stress . As such , they have implication s for underst and ing how social stressors may promote susceptibility to diseases with an inflammatory component OBJECTIVE To compare the efficacy of plasma level-targeted dose imipramine and high-dose venlafaxine in depressed in patients in a r and omized double-blind study . METHODS The study included 85 patients with a diagnosis of major depressive episode according to the DSM IV criteria and a 17-item Hamilton Rating Scale for Depression ( HAM-D ) score ≥ 17 . Patients were r and omized to imipramine or venlafaxine . The dose of imipramine was adjusted for each patient to a predefined blood level of 200 - 300 ng/ml . The dose of venlafaxine was increased gradually to 300 - 375 mg/day . Efficacy was evaluated after 7 weeks of treatment . RESULTS The mean age of the study group was 54.5 ( range 29 - 82 ) years . There was no significant difference according to the primary outcome criterion of a ≥50 % reduction on the HAM-D score : 17 of 43 ( 39.5 % ) patients on imipramine were responders compared to 21 of 42 ( 50 % ) patients on venlafaxine . When considering remission as outcome criterion ( HAM-D score ≤ 7 ) , 10 of 43 ( 23.3 % ) patients on imipramine were remitters compared to 15 of 42 ( 35.7 % ) patients on venlafaxine ; again , no significant difference . When analysing a sub population of patients without psychotic features , with remission as outcome criterion , a significant difference was found : 5 of 34 ( 14.7 % ) patients on imipramine were remitters compared to 12 of 31 ( 38.7 % ) patients on venlafaxine . CONCLUSIONS The present study used optimal doses in depressed in patients and showed that venlafaxine is at least equal in efficacy to imipramine . The results in the subgroup without psychotic features indicate a possible superiority of venlafaxine Background Research ers turn to citation tracking to find the most influential articles for a particular topic Output:	Results : Collectively , the literature and original data showed that : 1 ) raised serum levels of pro-inflammatory compounds ( in particular of CRP/IL-6 ) characterize an inflammatory form of MDD with poor responsiveness to predominately serotonergic agents , but a better responsiveness to antidepressant regimens with a ) ( add-on ) noradrenergic , dopaminergic , or glutamatergic action or b ) ( add-on ) anti-inflammatory agents such as infliximab , minocycline , or eicosapentaenoic acid , showing — next to anti-inflammatory — dopaminergic or lipid corrective action ; 2 ) these successful anti-inflammatory ( add-on ) agents , when used in patients with low serum levels of CRP/IL-6 , decreased response rates in comparison to placebo . Add-on aspirin , in contrast , improved responsiveness in such “ non-inflammatory ” patients ; 3 ) patients with increased inflammatory gene expression in circulating leukocytes had a poor responsiveness to serotonergic/noradrenergic agents . However , at present , insufficient data exist to design protocol s with reliable inflammation parameter cutoff points to guide such therapies , the more since detrimental outcomes are possible of anti-inflammatory agents in “ non-inflamed ” patients
MS2893	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND / AIMS The frequency of colorectal adenomas , the precursor lesions for most cases of colorectal carcinoma , has been generally measured as prevalence rates of adenomas at autopsy or colonoscopy . The aim of this study was to estimate the incidence rate of adenomas and compare it with the adenoma recurrence rate . METHODS Data on colonoscopies performed in three New York City practice s were collected prospect ively . The cumulative rate of adenoma diagnosis on repeat colonoscopy was calculated for patients with no abnormalities on index colonoscopy ( " incidence " rate ) and for patients with adenomas on the index colonoscopy ( " recurrence " rate ) . RESULTS The cumulative incidence rate of adenomas at 36 months was 16 % , and the cumulative recurrence rate at 36 months was 42 % ( P < 0.004 ) . The recurrence rate was higher in patients with multiple adenomas than in those with a single adenoma on index colonoscopy , although the increase was not statistically significant . CONCLUSIONS Although the recurrence rate has always been assumed to be elevated , this study is the first to compare the recurrence rate of adenomas with the incidence rate directly and to show that the recurrence rate is indeed elevated The National Polyp Study ( NPS ) , a r and omized clinical trial to evaluate effective surveillance of patients discovered to have one or more colorectal adenomas , was the framework for this statistical analysis which used a multiple logistic model to assess the independent risk factors of patient and polyp characteristics associated with high- grade dysplasia in adenomas . The data base included 3371 adenomas from 1867 patients . Adenoma size and the extent of the villous component were found to be the major independent polyp risk factors associated with high- grade dysplasia ( p less than 0.0001 ) . The adjusted odds ratios were 3.3 for medium-sized adenomas and 7.7 for large adenomas relative to small adenomas and 2.7 for villous A adenomas , 3.4 for villous B adenomas , and 8.1 for villous C and D adenomas relative to tubular adenomas . Increased frequency of high- grade dysplasia in adenomas located distal to the splenic flexure was attributable mainly to increased size and villous component rather than to location per se . The adjusted odds ratio was 1.4 ( p less than 0.11 ) for left-sided location . Multiplicity of adenomas affected the risk for high- grade dysplasia in patients but was dependent on adenoma size and villous component and was not an independent factor . The adjusted odds ratio was 1.3 ( p less than 0.17 ) for multiplicity . Increasing age was associated with risk for high- grade dysplasia in patients , and this effect was independent of the effect of adenoma size and histological type . The adjusted odds ratio was 1.8 ( p less than 0.0016 ) for age greater than or equal to 60 yr . Gender was not associated with high- grade dysplasia . The adjusted odds ratio was 1.0 ( p less than 0.95 ) for men . The size of the patient series , the prospect i ve nature of the data collection , the completeness of information on all patients , the requirements of complete examination of the entire colon and pathological examination of all lesions encountered , and the exclusion of patients with previously diagnosed adenomas are , collectively , features unique to this study . The detailed model provided by the analysis integrates multiple patient and adenoma factors associated with high- grade dysplasia in colorectal adenomas BACKGROUND & AIMS Outcomes of colon surveillance after colorectal cancer screening with colonoscopy are uncertain . We conducted a prospect i ve study to measure incidence of advanced neoplasia in patients within 5.5 years of screening colonoscopy . METHODS Three thous and one hundred twenty-one asymptomatic subjects , age 50 to 75 years , had screening colonoscopy between 1994 and 1997 in the Department of Veterans Affairs . One thous and one hundred seventy-one subjects with neoplasia and 501 neoplasia-free controls were assigned to colonoscopic surveillance over 5 years . Cohorts were defined by baseline findings . Relative risks for advanced neoplasia within 5.5 years were calculated . Advanced neoplasia was defined as tubular adenoma greater than > or = 10 mm , adenoma with villous histology , adenoma with high- grade dysplasia , or invasive cancer . RESULTS Eight hundred ninety-five ( 76.4 % ) patients with neoplasia and 298 subjects ( 59.5 % ) without neoplasia at baseline had colonoscopy within 5.5 years ; 2.4 % of patients with no neoplasia had interval advanced neoplasia . The relative risk in patients with baseline neoplasia was 1.92 ( 95 % CI : 0.83 - 4.42 ) with 1 or 2 tubular adenomas < 10 mm , 5.01 ( 95 % CI : 2.10 - 11.96 ) with 3 or more tubular adenomas < 10 mm , 6.40 ( 95 % CI : 2.74 - 14.94 ) with tubular adenoma > or = 10 mm , 6.05 ( 95 % CI : 2.48 - 14.71 ) for villous adenoma , and 6.87 ( 95 % CI : 2.61 - 18.07 ) for adenoma with high- grade dysplasia . CONCLUSIONS There is a strong association between results of baseline screening colonoscopy and rate of serious incident lesions during 5.5 years of surveillance . Patients with 1 or 2 tubular adenomas less than 10 mm represent a low-risk group compared with other patients with colon neoplasia Output:	6 Gimeno-Garcı́a AZ , Ramı́rez F , Gonzalo V , Belaguer F , Petit A , Pellisé M , Llach J , Bordas JM , Piqué JM , Castells A. High- grade dysplasia as a risk factor of metachronous advanced neoplasms in patients with advanced adenomas . Ongoing colorectal cancer risk despite surveillance colonoscopy : the Polyp Prevention Trial Continued Follow-up Study .
MS2894	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE This study aim ed to quantify the costs of complete denture fabrication by a simplified method compared with a conventional protocol . MATERIAL S AND METHODS A sample of edentulous patients needing conventional maxillary and m and ibular complete dentures was r and omly divided into group S , which received dentures fabricated by a simplified method , and group C , which received conventionally fabricated dentures . We calculated direct and indirect costs for each participant including unscheduled procedures . This study assessed 19 and 20 participants allocated into groups S and C , respectively , and comparisons between groups were conducted by the Mann-Whitney and Student 's t-test ( α = 0.05 ) . RESULTS Complete denture fabrication dem and ed median time periods of 173.2 and 284.5 minutes from the operator for groups S and C respectively , and 46.6 and 61.7 minutes from the dental assistant ( significant differences , p < 0.05 ) . There was no difference between groups regarding postinsertion adjustments . Group S showed lower values for costs with material s and time spent by patients than group C during the fabrication stage , but not during adjustments . CONCLUSIONS The median direct cost of complete denture treatment was 34.9 % lower for the simplified method . It can be concluded that the simplified method is less costly for patients and the health system when compared with a conventional protocol for the rehabilitation of edentulous patients Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Previous papers in this series on evidence -based dentistry have discussed the first 2 steps in seeking answers to clinical problems formulating a clear question and strategically search ing for evidence . The next step , critical appraisal of the evidence , is made easier if one underst and s the basic concepts of clinical research design . The strongest design , especially for questions related to therapeutic or preventive interventions , is the r and omized , controlled trial . Questions relating to diagnosis , prognosis and causation are often studied with observational , rather than experimental , research design s. The strongest study design should be used whenever possible . Rules have been established to grade research evidence . This paper , the fourth in the series , presents an overview of research methodology most commonly used in the dental literature OBJECTIVES To compare subjective and objective outcomes of complete dentures fabricated with st and ard clinical protocol s , but omitted selected steps during the laboratory phase . MATERIAL S AND METHODS Forty-three edentulous patients ( mean age 58.1 years , SD 9.9 , range 35 - 78 ) , were consecutively recruited and r and omly assigned to one of four groups according to selected variations of laboratory steps : Group 1 ( n=10 ) , omission of secondary casts obtained from impressions in border moulded custom trays ; Group 2 ( n=10 ) , omission of secondary casts and face-bow articulator mounting ; Group 3 ( n=10 ) , omission of face-bow mounting ; Group 4 ( n=13 ) , no steps omitted ( control ) . Clinical procedures for all groups were identical , and performed by senior dental students under supervision of prosthodontists , all of whom were blinded to the Group . At 1- , 4- and 12-weeks after delivery , patients rated their overall satisfaction , as well as a range of functional factors using visual analogue scales . An independent blinded prosthodontist similarly rated four domains of denture quality at the 1-week follow-up . RESULTS No significant differences were noted among the groups in all aspects of patients ' assessment s at all the time points ( P>0.1 ) . There were no significant differences in prosthodontists ' ratings of denture quality in any of the domains examined ( P>0.1 ) . CONCLUSION Selected omissions of steps ( face-bow mounting and /or secondary casts ) during the laboratory phase of complete denture fabrication has only a minor role , if any , in subjective and objective outcomes , contrasting with the common belief that such omissions will adversely affect outcomes . CLINICAL SIGNIFICANCE General practitioners provide most complete dentures . Many do not follow all the procedures they were taught at dental school . Our finding that omitting frequently advocated steps made no difference to patient satisfaction or to denture quality suggests that cost-effectiveness through simplifications be considered in practice and in education OBJECTIVES To compare a simplified method to a conventional protocol for complete denture fabrication regarding masticatory performance and ability . METHODS A sample was formed by edentulous patients requesting treatment with maxillary and m and ibular complete dentures . Participants were r and omly divided into two groups : Group S , which received dentures fabricated by a simplified method , and Group C ( n=21 each ) , which received conventionally fabricated dentures . After three months following insertion , masticatory performance was evaluated by a colorimetric assay based on chewing two capsules as test food during twenty and forty cycles . Masticatory ability was assessed by a question naire with binary answers and a single question answered by means of a 0 - 10 scale . A third group ( DN ) formed by seventeen dentate volunteers served as an external comparator . Groups were compared by statistical tests suitable for data distribution ( α=0.05 ) . RESULTS Thirty-nine participants were assessed for three months ( twenty from Group C and nineteen from Group S ) . Groups C and S presented similar masticatory performance which corresponded to approximately 30 % of Group DN . Results for masticatory ability showed similarity between S and C , regardless of the assessment method , although an isolate question naire item showed more favourable results for the first group . CONCLUSIONS The simplified method for complete denture fabrication is able to restore masticatory function to a level comparable to a conventional protocol , both physiologically and according to patient 's perceptions . CLINICAL SIGNIFICANCE Although masticatory function is impaired by the loss of natural teeth and dentures can restore only a fraction of such function , patients can benefit from a simplified protocol for complete denture fabrication to the same extent they would by conventional techniques PURPOSE Conventional dentures will remain the only treatment available to most edentulous people for the foreseeable future . In this study , we compared the efficiency of two methods of making complete conventional dentures-the traditional academic st and ard ( T ) and a simplified technique ( S ) used in private practice . We have previously shown that they produce similar levels of patient satisfaction and denture quality . MATERIAL S AND METHODS Data were gathered during a r and omized controlled clinical trial of 122 subjects from initial examination until 6-month follow-up . For this report , the direct costs of providing one set of conventional complete dentures by T or S techniques were estimated . All material s used were recorded and their cost was calculated in Canadian dollars ( CAN$ ) . The costs of fabrication in an outside laboratory were added . Clinician 's labor time was recorded for every procedure . Between-group comparisons for each clinical procedure were carried out with independent t-tests . The number of patients in each group who needed postdelivery treatment was compared with Chi-square tests . The effect of group assignment and of treatment difficulty on outcomes was analyzed with multiple regression analysis . RESULTS The mean total cost of the T method was significantly greater than S ( CAN$166.3 ; p < 0.001 ) , and clinicians spent 90 minutes longer ( p < 0.001 ) on clinical care . The difficulty of the case had no significant influence on outcomes . CONCLUSIONS The results indicate that the S method is the more cost-efficient method and that there are no negative consequences that detract from the cost savings OBJECTIVES The objective of this r and omised controlled clinical trial study was to compare the effectiveness of a traditional and a simplified protocol for construction of conventional CD . BACKGROUND The replacement of conventional dentures can result in potential functional and aesthetic benefits to the patient . Previous studies suggest that simplified procedures for complete dentures ( CD ) construction achieve results similar to the traditional methods . MATERIAL S AND METHODS Fifty patients were r and omly divided into two equal groups , traditional protocol ( T group ) and simplified protocol ( S group ) . Treatment outcomes were assessed before the insertion of the new dentures and 30 days and 6 months after the last adjustment . It included measurements of quality of life related to oral conditions measured by the Brazilian version of OHIP-Edentulous scale and patients ' satisfaction with the upper and lower dentures using a visual analogue scale ( VAS ) , which combines the patient 's perception in relation to overall satisfaction with the comfort , stability , ability to chew , ability to talk and aesthetics . RESULTS The results showed significant reduction in negative impacts of oral conditions on quality of life and improved satisfaction with the upper and lower dentures ( p < 0.001 ) at the 30-day and 6-month follow-up . Quality of life improvement occurred in all dimensions of the OHIP-Edentulous ( p < 0.001 ) . Despite the significant reduction in quality of life impacts and significant increase in patients ' satisfaction with the dentures , there were no differences between the traditional and simplified protocol s ( p > 0.05 ) . CONCLUSIONS It was concluded that the simplified protocol results in patent 's perception of treatment outcomes similar to the traditional protocol OBJECTIVES To compare the quality of conventional complete dentures fabricated with two different techniques . A r and omized controlled clinical trial was conducted to compare traditional ( T ) and simplified ( S ) methods of making complete conventional dentures on patients ' ratings of satisfaction , comfort and function at 3 and 6 months following delivery . The quality of the prostheses was rated by prosthodontists at 6 months . MATERIAL S AND METHODS One hundred twenty-two male and female edentulous individuals , aged 45 - 75 years , were r and omly allocated into groups that received dentures made with either T or S methods . Following delivery , patients ' ratings of several denture-related factors were measured using 100 mm visual analogue scales , and denture quality was assessed by blinded prosthodontists using ratings on a vali date d quantitative scale . RESULTS There were no significant differences between the two groups in patient ratings for overall satisfaction ( 3 months : mean T = 83 mm , mean S = 83 mm , P = 0.97 ; 6 months : mean T = 79 mm , mean S = 79 mm , P = 0.96 ) or in prosthodontists ' ratings of denture quality ( T = 66 , S = 63 ; P = 0.38 ) . CONCLUSION These results show that the quality of complete dentures does not suffer when manufacturing techniques are simplified to save time and material s. Dental educators should consider these findings when re- design ing prosthodontic training programs Output:	The clinical studies considered for this review suggest that a two-step impression procedure may not be m and atory for the success of conventional complete denture fabrication regarding a variety of clinical aspects of denture quality and patients ' perceptions of the treatment
MS2895	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To compare the surgical management and follow-up of patients with endometriomas managed by endoscopic surgery versus laparotomy using a retrospective case control format . DESIGN Endoscopic oophorocystectomies were performed on 36 patients . Chart review of laparotomy oophorocystectomies from 21 patients was conducted . Six-week and 12-month follow-up for evaluation of symptoms , evidence of recurrence , and fertility was available on all subjects . RESULTS In the endoscopy group , 39 patients had screening laparoscopy for possible endoscopic surgery . Three of this group required laparotomy and 36 patients underwent endoscopic surgery . Chart review identified 21 patients who had undergone primary laparotomy for endometriomas . Patient groups were matched for age , severity of disease , presence of other infertility factors , and absence of perioperative medical suppression . Outcome parameters for each group were : operating time -- endoscopy 2.8 hours ( + /- 1.2 ) , laparotomy 3.1 hours ( + /- 1.8 ) ; estimated blood loss -- endoscopy 40 cc ( + /- 45 ) ; laparotomy , 240 cc ( + /- 107 ) ; recovery time -- endoscopy , 6.2 days ( + /- 2.5 ) , laparotomy 30 days ( + /- 6.8 ) ; endometrioma recurrence rate -- endoscopy 11.1 % , laparotomy 19 % ; and pregnancy rate -- endoscopy 42.8 % , laparotomy 46.6 % . CONCLUSION A high percentage of patients with endometriomas associated with advanced endometriosis can be managed effectively by endoscopic surgery OBJECTIVE To evaluate the efficacy of laparoscopic ovarian cystectomy and to compare the surgical course , post-surgical course and particularly post-surgical pain of the laparoscopic and laparotomic methods . STUDY DESIGN We conducted a surgical study on dermoid cysts at the Gynecology Department of Siena University between 1 January 1992 and 31 December 1996 . The selected cases were r and omized into two groups based on surgical approach : via laparotomy ( n=22 ) or laparoscopy ( n=22 ) . Surgical times , estimated blood loss , post-surgical pain , time in hospital , speed of recovery and complications were compared . RESULTS Mean blood loss was significantly less for laparoscopy ( 58.64+/-30.17 ml versus 103.84+/-38.45 ml , P<0.05 ) . Mean hospitalization was 6.32+/-1.09 days for laparotomy and 3.18+/-0.39 days for laparoscopy ( P<0.05 ) . Post-surgical pain was significantly less in laparoscopy patients ( P<0.05 ) . The laparoscopic technique had fewer post-surgical complications . CONCLUSIONS The laparoscopic approach had many advantages . Laparoscopy should be the elective treatment for women with dermoid cysts , because it has many advantages for the patient and lower costs for the national health system OBJECTIVES Our purpose was to evaluate the efficacy of laparoscopic ovarian dermoid cystectomy and to compare the operative course , postoperative course , and complications between the laparoscopy and the laparotomy techniques . STUDY DESIGN The safety and efficacy of laparoscopic ovarian dermoid cystectomy were evaluated in 40 women . Twenty-nine of 40 patients underwent laparoscopic excision of a solitary dermoid cyst without any additional procedure . The operative course , the postoperative course , and complications among these 29 women were compared with those of 26 other women who underwent a similar procedure by laparotomy . RESULTS Spillage of the cyst 's content did not lead to any complication . The operating time in the laparoscopy group was 73.5 + /- 4.7 minutes and in the laparotomy group it was 41.4 + /- 2.9 minutes . The duration of hospitalization was significantly shorter in the laparoscopy group ( 0.7 + /- 0.2 days ) than in the laparotomy group ( 3.8 + /- 0.1 days ) . CONCLUSIONS Although ovarian dermoid cystectomy by laparoscopy is associated with a longer operating time than by laparotomy , the duration of hospitalization is shorter and recovery is faster . Spillage of the contents of the dermoid cyst does not lead to any complication ; perhaps this is due to the liberal irrigation of the peritoneal cavity STUDY OBJECTIVE To compare the outcome of laparoscopic treatment of adnexal masses with treatment by laparotomy . The procedures , their duration , and associated complications also were evaluated . DESIGN Women were r and omized to undergo either procedure based on the ward to which they were admitted . SETTING A university teaching hospital . PATIENTS The 192 patients were admitted with a preoperative diagnosis of adnexal mass . INTERVENTIONS Surgical procedures were cystectomy , salpingectomy , oophorectomy , and unilateral or bilateral salpingo-oophorectomy . Organ-preserving techniques were used wherever possible . All tissue specimens were examined histologically . MEASUREMENTS AND MAIN RESULTS The mean duration of surgery was statistically not significantly different between the groups , 96.8 minutes for minimally invasive surgery , and 116 minutes for laparotomy . Organ preservation did reach statistical significance at 65.7 % and 17.2 % respectively ( p < 0.001 ) . Postoperative morbidity was statistically lower in patients undergoing minimally invasive procedures . Preoperative tumor marker levels did not correlate well with postoperative histology . One woman in the laparotomy group had histologically proved ovarian cancer . Minimally invasive surgery was converted to laparotomy in three patients in whom malignancy was suspected at the start of operation . CONCLUSIONS Laparoscopic management of adnexal masses has definite advantages over laparotomy , for example , lower postoperative morbidity . In addition , intraoperative endoscopic diagnosis is highly accurate , and the frequency of unnecessary procedures is lower OBJECTIVE To analyze clinical results and financial costs of salpingo-oophorectomy performed by laparoscopy versus laparotomy . STUDY DESIGN Comparison of laparoscopic salpingo-oophorectomy with procedures performed by laparotomy . SETTING St. Vincent 's Hospital and Fallon Clinic in Worcester , Massachusetts . PATIENTS Twenty women in both groups . INTERVENTIONS Salpingo-oophorectomies performed by laparoscopy and laparotomy . MEASUREMENTS AND MAIN RESULTS Women undergoing laparotomy had a 25 % rate of postoperative complications compared with 0 % of those having laparoscopy . The duration of the procedures and hospital charges were similar for both groups . Length of hospital stay and time to return to work were significantly less after laparoscopy than laparotomy . CONCLUSIONS Laparoscopic salpingo-oophorectomy was associated with significantly fewer complications than the operations performed by laparotomy . Although women in the laparoscopy group had a shorter hospital stay , their higher charges were attributed to costly disposable instruments . Patients benefit from early return to work and other activities after laparoscopy OBJECTIVE Our purpose was to compare the newer technique of laparoscopic adnexal excision with conventional laparotomy . DESIGN With the same entry criteria , a retrospective , consecutive series of 26 women who underwent adnexectomy by laparotomy was compared with a later prospect i ve consecutive series of 64 women who had laparoscopic adnexectomy in a university referral practice . The two groups were similar in all characteristics examined . The ages of the women ranged from 18 to 70 years , but only two women were postmenopausal . Pelvic pain with or without an ovarian cystic mass was the surgical indication in 91 % to 92 % of the women . Seven women had a persistent adnexal cystic mass and one woman had a unilateral and rogen-secreting ovary . Bipolar coagulation was the laparoscopic method used . RESULTS Median operating time ( 88 vs 107 minutes ) , blood loss ( 72 vs 222 ml ) , days in the hospital ( 1 day vs 3 days ) , total costs ( $ 4573 vs $ 6044 ) , and recovery time ( 1 week vs 4 weeks ) were significantly less with laparoscopic adnexectomy . There were no differences between the two techniques in major complications ( one in each group ) , blood transfusions , adhesion formation , or the proportion of women noting improvement of pain symptoms . CONCLUSION In this preliminary assessment of laparoscopic adnexectomy , this surgical procedure offers significant advantages to laparotomy in selected patients when performed by a laparoscopist experienced in advanced techniques The aim of our study was to compare laparoscopy with laparotomy for the removal of ovarian dermoid cysts . Thirty-eight women with benign ovarian dermoid cyst were allocated for either laparoscopy ( 18 patients ) or laparotomy ( 20 patients ) . The two groups were compared for operative and hospitalization times and postoperative course . Operating time was longer ( 93.6 + /- 23.8 min ) and hospitalization time significantly shorter ( 22.4 + /- 6.6 h ) in the laparoscopy group . No complications were reported in either group . We conclude that operative laparoscopy is a safe procedure for the removal of dermoid ovarian cysts and is as effective as laparotomy OBJECTIVES The aim of the study is to specify the place , modalities and results of operative laparoscopy when adnexectomy is indicated in a patient presenting with an adnexal mass . STUDY DESIGN A retrospective analysis of the 186 patients who underwent adnexectomy for an adnexal mass between January 1 , 1989 and December 31 , 1994 . RESULTS The operation took place via laparotomy in 34.9 % of cases ( 65 patients ) and by laparoscopic surgery in 65.1 % of cases ( 121 patients ) . All the patients presenting a malignant ovarian lesion ( 15 cases ) were operated by laparotomy . For these patients the laparotomy was decided from the outset in 7 cases and there was a conversion to laparotomy decided during the diagnostic phase of laparoscopy in 8 cases . The preoperative workup ( clinical examination , study of past history , trans vaginal ultrasonography , doppler , tumoral markers etc . ) together with the diagnostic phase of laparoscopy provide 100 % sensitivity , a positive predictive value of 50 % and a negative predictive value of 100 % for diagnosis of malignancy . CONCLUSION These results demonstrate that provided a strict selection system is used , it is possible to carry out adnexectomy using laparoscopic surgery in 70.8 % of cases ( 121/171 ) for patients with benign adnexal mass OBJECTIVE Our purpose was to compare the results of laparoscopy with laparotomy in the management of ovarian masses not suspected to be malignant . STUDY DESIGN In a prospect i ve r and omized study 102 patients requiring surgical management of ovarian masses were r and omly assigned to laparoscopy ( 52 ) or laparotomy ( 50 ) in a teaching hospital from July 1994 to September 1995 . Inclusion criteria was tumor not suspected to be malignant with a diameter of < or = 10 cm as measured by ultrasonography . All operations were performed by trainees under the supervision of an experienced surgeon . Statistical analysis included t tests and chi2 tests . RESULTS There were no differences in demographic characteristics between the two groups nor any difference in the size of ovarian masses , adnexal adhesion score , or frequency of bilateral disease . All the ovarian masses were benign . Endometriotic cysts and dermoid cysts were the most common disorder in the two groups . Cystectomy was performed in > 70 % of cases in each group . Operating time was not increased with the laparoscopic approach , and the frequency of inadvertent rupture of the ovarian masses was just as high as in laparotomy . The laparoscopic approach was associated with a significant reduction in operative morbidity ( odds ratio 0.34 , 95 % confidence interval 0.13 to 0.88 ) , postoperative pain and analgesic requirement , hospital stay , and recovery period . Patients in general were satisfied with the operation , but significantly more patients were satisfied with the laparoscopy scar . CONCLUSION Operative laparoscopy should replace laparotomy in the management of benign ovarian masses Objective To compare laparoscopy and laparotomy in the management of benign adnexal cysts , with particular attention to postoperative convalescence . Methods Forty premenopausal , nonpregnant women , 18–40 years of age and without acute pelvic symptoms , were scheduled to undergo surgical management of anechoic , unilateral , unilocular , persistent adnexal cysts from January 1993 through June 1994 at the Department of Obstetrics and Gynecology of the University of Cagliari , Cagliari , Italy . After ultrasonographic examination , followed by the completion of 6 months ' expectant management with repeat ultrasonographic evaluations , subjects were r and omized to undergo operative laparoscopy ( n = 20 ) or laparotomy ( n = 20 ) . The patients Output:	Laparoscopy is associated with a reduction in the following : febrile morbidity , urinary tract infection , postoperative complications , postoperative pain , days in hospital , and total cost .
MS2896	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Please cite this paper as : MacIntyre et al. ( 2011 ) A cluster r and omized clinical trial comparing fit‐tested and non‐fit‐tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers . Influenza and Other Respiratory Viruses DOI : 10.1111/j.1750‐2659.2010.00198.x . Background We compared the efficacy of medical masks , N95 respirators ( fit tested and non fit tested ) , in health care workers ( HCWs ) . Methods A cluster r and omized clinical trial ( RCT ) of 1441 HCWs in 15 Beijing hospitals was performed during the 2008/2009 winter . Participants wore masks or respirators during the entire work shift for 4 weeks . Outcomes included clinical respiratory illness ( CRI ) , influenza‐like illness ( ILI ) , laboratory‐confirmed respiratory virus infection and influenza . A convenience no‐mask/respirator group of 481 health workers from nine hospitals was compared . Findings The rates of CRI ( 3·9 % versus 6·7 % ) , ILI ( 0·3 % versus 0·6 % ) , laboratory‐confirmed respiratory virus ( 1·4 % versus 2·6 % ) and influenza ( 0·3 % versus 1 % ) infection were consistently lower for the N95 group compared to medical masks . By intention‐to‐treat analysis , when P values were adjusted for clustering , non‐fit‐tested N95 respirators were significantly more protective than medical masks against CRI , but no other outcomes were significant . The rates of all outcomes were higher in the convenience no‐mask group compared to the intervention arms . There was no significant difference in outcomes between the N95 arms with and without fit testing . Rates of fit test failure were low . In a post hoc analysis adjusted for potential confounders , N95 masks and hospital level were significant , but medical masks , vaccination , h and washing and high‐risk procedures were not . Interpretation Rates of infection in the medical mask group were double that in the N95 group . A benefit of respirators is suggested but would need to be confirmed by a larger trial , as this study may have been underpowered . The finding on fit testing is specific to the type of respirator used in the study and can not be generalized to other respirators . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) , ACTRN : ACTRN12609000257268 ( http://www.anzctr.org.au ) BACKGROUND During the influenza A(H1N1 ) p and emic , antiviral prescribing was limited , vaccines were not available early , and the effectiveness of nonpharmaceutical interventions ( NPIs ) was uncertain . Our study examined whether use of face masks and h and hygiene reduced the incidence of influenza-like illness ( ILI ) . METHODS A r and omized intervention trial involving 1437 young adults living in university residence halls during the 2006 - 2007 influenza season was design ed . Residence halls were r and omly assigned to 1 of 3 groups-face mask use , face masks with h and hygiene , or control- for 6 weeks . Generalized models estimated rate ratios for clinical ly diagnosed or survey-reported ILI weekly and cumulatively . RESULTS We observed significant reductions in ILI during weeks 4 - 6 in the mask and h and hygiene group , compared with the control group , ranging from 35 % ( confidence interval [ CI ] , 9%-53 % ) to 51 % ( CI , 13%-73 % ) , after adjusting for vaccination and other covariates . Face mask use alone showed a similar reduction in ILI compared with the control group , but adjusted estimates were not statistically significant . Neither face mask use and h and hygiene nor face mask use alone was associated with a significant reduction in the rate of ILI cumulatively . CONCLUSIONS These findings suggest that face masks and h and hygiene may reduce respiratory illnesses in shared living setting s and mitigate the impact of the influenza A(H1N1 ) p and emic . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00490633 BACKGROUND Health care workers outside surgical suites in Asia use surgical-type face masks commonly . Prevention of upper respiratory infection is one reason given , although evidence of effectiveness is lacking . METHODS Health care workers in a tertiary care hospital in Japan were r and omized into 2 groups : 1 that wore face masks and 1 that did not . They provided information about demographics , health habits , and quality of life . Participants recorded symptoms daily for 77 consecutive days , starting in January 2008 . Presence of a cold was determined based on a previously vali date d measure of self-reported symptoms . The number of colds between groups was compared , as were risk factors for experiencing cold symptoms . RESULTS Thirty-two health care workers completed the study , result ing in 2464 subject days . There were 2 colds during this time period , 1 in each group . Of the 8 symptoms recorded daily , subjects in the mask group were significantly more likely to experience headache during the study period ( P < .05 ) . Subjects living with children were more likely to have high cold severity scores over the course of the study . CONCLUSION Face mask use in health care workers has not been demonstrated to provide benefit in terms of cold symptoms or getting colds . A larger study is needed to definitively establish noninferiority of no mask use Background There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza . We implemented a study of the feasibility and efficacy of face masks and h and hygiene to reduce influenza transmission among Hong Kong household members . Methodology /Principal Findings We conducted a cluster r and omized controlled trial of households ( composed of at least 3 members ) where an index subject presented with influenza-like-illness of < 48 hours duration . After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test , the household of the index subject was r and omized to 1 ) control or 2 ) surgical face masks or 3 ) h and hygiene . Households were visited within 36 hours , and 3 , 6 and 9 days later . Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture . The primary outcome measure was laboratory culture confirmed influenza in a household contact ; the secondary outcome was clinical ly diagnosed influenza ( by self-reported symptoms ) . We r and omized 198 households and completed follow up home visits in 128 ; the index cases in 122 of those households had laboratory-confirmed influenza . There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6 % . Clinical secondary attack ratios varied from 5 % to 18 % depending on case definitions . The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms . Adherence to interventions was variable . Conclusions / Significance The secondary attack ratios were lower than anticipated , and lower than reported in other countries , perhaps due to differing patterns of susceptibility , lack of significant antigenic drift in circulating influenza virus strains recently , and /or issues related to the symptomatic recruitment design . Lessons learnt from this pilot have informed changes for the main study in 2008 . Trial Registration Clinical Trials.gov NCT00425893 HK Clinical Trials.com CONTEXT Data about the effectiveness of the surgical mask compared with the N95 respirator for protecting health care workers against influenza are sparse . Given the likelihood that N95 respirators will be in short supply during a p and emic and not available in many countries , knowing the effectiveness of the surgical mask is of public health importance . OBJECTIVE To compare the surgical mask with the N95 respirator in protecting health care workers against influenza . DESIGN , SETTING , AND PARTICIPANTS Noninferiority r and omized controlled trial of 446 nurses in emergency departments , medical units , and pediatric units in 8 tertiary care Ontario hospitals . INTERVENTION Assignment to either a fit-tested N95 respirator or a surgical mask when providing care to patients with febrile respiratory illness during the 2008 - 2009 influenza season . MAIN OUTCOME MEASURES The primary outcome was laboratory-confirmed influenza measured by polymerase chain reaction or a 4-fold rise in hemagglutinin titers . Effectiveness of the surgical mask was assessed as noninferiority of the surgical mask compared with the N95 respirator . The criterion for noninferiority was met if the lower limit of the 95 % confidence interval ( CI ) for the reduction in incidence ( N95 respirator minus surgical group ) was greater than -9 % . RESULTS Between September 23 , 2008 , and December 8 , 2008 , 478 nurses were assessed for eligibility and 446 nurses were enrolled and r and omly assigned the intervention ; 225 were allocated to receive surgical masks and 221 to N95 respirators . Influenza infection occurred in 50 nurses ( 23.6 % ) in the surgical mask group and in 48 ( 22.9 % ) in the N95 respirator group ( absolute risk difference , -0.73 % ; 95 % CI , -8.8 % to 7.3 % ; P = .86 ) , the lower confidence limit being inside the noninferiority limit of -9 % . CONCLUSION Among nurses in Ontario tertiary care hospitals , use of a surgical mask compared with an N95 respirator result ed in noninferior rates of laboratory-confirmed influenza . TRIAL REGISTRATION clinical trials.gov Identifier : Output:	None of the studies established a conclusive relationship between mask/respirator use and protection against influenza infection . Some evidence suggests that mask use is best undertaken as part of a package of personal protection especially h and hygiene . The effectiveness of masks and respirators is likely linked to early , consistent and correct usage
MS2897	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract Objectives : To determine whether earlier clinical intervention by a medical emergency team prompted by clinical instability in a patient could reduce the incidence of and mortality from unexpected cardiac arrest in hospital . Design : A non-r and omised , population based study before ( 1996 ) and after ( 1999 ) introduction of the medical emergency team . Setting : 300 bed tertiary referral teaching hospital . Participants : All patients admitted to the hospital in 1996 ( n=19 317 ) and 1999 ( n=22 847 ) . Interventions : Medical emergency team ( two doctors and one senior intensive care nurse ) attended clinical ly unstable patients immediately with resuscitation drugs , fluid , and equipment . Response activated by the bedside nurse or doctor according to predefined criteria . Main outcome measures : Incidence and outcome of unexpected cardiac arrest . Results : The incidence of unexpected cardiac arrest was 3.77 per 1000 hospital admissions ( 73 cases ) in 1996 ( before intervention ) and 2.05 per 1000 admissions ( 47 cases ) in 1999 ( after intervention ) , with mortality being 77 % ( 56 patients ) and 55 % ( 26 patients ) , respectively . After adjustment for case mix the intervention was associated with a 50 % reduction in the incidence of unexpected cardiac arrest ( odds ratio 0.50 , 95 % confidence interval 0.35 to 0.73 ) . Conclusions : In clinical ly unstable in patients early intervention by a medical emergency team significantly reduces the incidence of and mortality from unexpected cardiac arrest in hospital . What is already known on this topic In most studies mortality from unexpected cardiac arrest in hospital exceeds 50 % Such events are usually preceded by signs of clinical deterioration in the hours before cardiac arrest What this paper adds Early intervention by a medical emergency team significantly reduced the incidence of and mortality from unexpected cardiac arrest in BACKGROUND Patients with cardiac arrests or who die in general wards have often received delayed or inadequate care . We investigated whether the medical emergency team ( MET ) system could reduce the incidence of cardiac arrests , unplanned admissions to intensive care units ( ICU ) , and deaths . METHODS We r and omised 23 hospitals in Australia to continue functioning as usual ( n=11 ) or to introduce a MET system ( n=12 ) . The primary outcome was the composite of cardiac arrest , unexpected death , or unplanned ICU admission during the 6-month study period after MET activation . Analysis was by intention to treat . FINDINGS Introduction of the MET increased the overall calling incidence for an emergency team ( 3.1 vs 8.7 per 1000 admissions , p=0.0001 ) . The MET was called to 30 % of patients who fulfilled the calling criteria and who were subsequently admitted to the ICU . During the study , we recorded similar incidence of the composite primary outcome in the control and MET hospitals ( 5.86 vs 5.31 per 1000 admissions , p=0.640 ) , as well as of the individual secondary outcomes ( cardiac arrests , 1.64 vs 1.31 , p=0.736 ; unplanned ICU admissions , 4.68 vs 4.19 , p=0.599 ; and unexpected deaths , 1.18 vs 1.06 , p=0.752 ) . A reduction in the rate of cardiac arrests ( p=0.003 ) and unexpected deaths ( p=0.01 ) was seen from baseline to the study period for both groups combined . INTERPRETATION The MET system greatly increases emergency team calling , but does not substantially affect the incidence of cardiac arrest , unplanned ICU admissions , or unexpected death Objective To determine whether the introduction of an intensive care unit-based medical emergency team , responding to hospital-wide preset criteria of physiologic instability , would decrease the rate of predefined adverse outcomes in patients having major surgery . Design Prospect i ve , controlled before- and -after trial . Setting University-affiliated hospital . Patients Consecutive patients admitted to hospital for major surgery during a 4-month control phase and during a 4-month intervention phase . Interventions Introduction of a hospital-wide intensive care unit-based medical emergency team to evaluate and treat in- patients deemed at risk of developing an adverse outcome by nursing , paramedical , and /or medical staff . Measurements and Main Results We measured incidence of serious adverse events , mortality after major surgery , and mean duration of hospital stay . There were 1,369 operations in 1,116 patients during the control period and 1,313 in 1,067 patients during the medical emergency team intervention period . In the control period , there were 336 adverse outcomes in 190 patients ( 301 outcomes /1,000 surgical admissions ) , which decreased to 136 in 105 patients ( 127 outcomes /1,000 surgical admissions ) during the intervention period ( relative risk reduction , 57.8 % ; p < .0001 ) . These changes were due to significant decreases in the number of cases of respiratory failure ( relative risk reduction , 79.1 % ; p < .0001 ) , stroke ( relative risk reduction , 78.2 % ; p = .0026 ) , severe sepsis ( relative risk reduction , 74.3 % ; p = .0044 ) , and acute renal failure requiring renal replacement therapy ( relative risk reduction , 88.5 % ; p < .0001 ) . Emergency intensive care unit admissions were also reduced ( relative risk reduction , 44.4 % ; p = .001 ) . The introduction of the medical emergency team was also associated with a significant decrease in the number of postoperative deaths ( relative risk reduction , 36.6 % ; p = .0178 ) . Duration of hospital stay after major surgery decreased from a mean of 23.8 days to 19.8 days ( p = .0092 ) . Conclusions The introduction of an intensive care unit-based medical emergency team in a teaching hospital was associated with a reduced incidence of postoperative adverse outcomes , postoperative mortality rate , and mean duration of hospital stay INTRODUCTION Atrial fibrillation ( AF ) in hospitalized patients may lead to activation of the medical emergency team ( MET ) . We sought to assess the baseline characteristics and outcomes of the patients presenting AF as a cause of MET call activation . METHODS Using a prospect ively constructed MET data base , we retrospectively review ed all patients with AF as a trigger for MET activation between August 2005 and April 2010 . Demographics , principal diagnostic and outcome of these patients were compared with those of a control group of patients matched for age , sex and ward of origin , r and omly selected from the data base . RESULTS We studied 5431 MET calls of which 557 ( 10.3 % ) , in 458 patients were triggered by AF . Mean age for AF patients was 74.8 years , 230 ( 50.2 % ) were female and 271 ( 59.1 % ) were in a surgical ward . 92 ( 20.1 % ) AF patients died in hospital compared with 131 ( 28.6 % ) in the control group . Among the 336 patients without limitations of medical therapy ( LOMT ) , 46 ( 13.7 % ) died in hospital . In total , 46 ( 13.7 % ) patients were transferred to a higher level care ward while 290 ( 86.3 % ) remained on the ward . Only 2 ( 4.3 % ) of these patients died compared with 44 ( 15.2 % ) among those who remained in the general ward ( p=0.03 ) . CONCLUSIONS In our hospital , AF triggers one tenth of MET activations and mortality associated with it is high even when issues of LOMT are excluded . The decreased mortality among patients admitted to a higher level ward suggests that some of these deaths may be avoidable OBJECTIVE To examine NFR orders in relation to adverse events and emergency team calls in hospitals with or without a Medical Emergency Team ( MET ) system during the MERIT study . METHOD Within a cluster r and omized controlled trial ( the MERIT study ) , examining the effect of introducing a MET system , we recorded NFR orders in relation to adverse events and emergency team calls . We compared the proportion and rate of NFR orders issued in relation to " adverse events " and " adverse event-free emergency team calls " in hospitals with or without a MET system . RESULTS Information on NFR orders was available for 3650 patients who died , 1466 patients who had an unplanned ICU admission , 574 patients who suffered a cardiac arrest and 1529 patients who had a adverse event-free emergency team call . Close to 90 % of deaths occurred in patients with a previously documented NFR order . Only approximately 4 % of cardiac arrests had a previously documented NFR order . In patients with unplanned ICU admission , NFR orders were present in approximately 3 % of cases . An NFR order was issued at the time of an " event " in 3.85 % of cases in MET hospitals compared with 1.72 % in control hospitals ( OR=2.29 ; 95 % CI : 1.31 - 4.01 ; p=0.005 ) . This difference was mostly due to a greater proportion of patients being made NFR in MET hospitals at the time of a " adverse event-free " emergency team call ( 7.96 % vs. 3.05 % ; OR=2.75 ; 95 % CI : 0.97 - 7.80 ; p=0.048 ) . The number of NFR orders issued at the time of a serious adverse event-free emergency team call was 10 times higher in MET hospitals ( 0.398 vs. 0.041 per 1000 admissions ; weighted absolute risk difference : 0.49 ( 95 % CI : 0.20 - 0.78 ; p=0.002 ) . Multivariate models could only account for less than 50 % of the variance in the issuing of NFR orders . CONCLUSIONS In a cohort of Australian hospitals , most deaths occurred in patients with a previously documented NFR order but NFR orders were uncommon before cardiac arrest calls or unplanned ICU admissions . During the conduct of a cluster r and omised controlled trial , more NFR orders were issued by emergency teams in those hospitals that implemented a MET system than in control hospitals . MET allocation , teaching hospital status , number of hospital beds and metropolitan location could only explain less than 50 % of variance in NFR orders CONTEXT Rapid response teams have been shown in adult in patients to decrease cardiopulmonary arrest ( code ) rates outside of the intensive care unit ( ICU ) . Because a primary action of rapid response teams is to transfer patients to the ICU , their ability to reduce hospital-wide code rates and mortality remains unknown . OBJECTIVE To determine rates of hospital-wide codes and mortality before and after implementation of a long-term rapid response team intervention . DESIGN , SETTING , AND PATIENTS A prospect i ve cohort design of adult in patients admitted between January 1 , 2004 , and August 31 , 2007 , at Saint Luke 's Hospital , a 404-bed tertiary care academic hospital in Kansas City , Missouri . Rapid response team education and program rollout occurred from September 1 to December 31 , 2005 . A total of 24 193 patient admissions were evaluated prior to the intervention ( January 1 , 2004 , to August 31 , 2005 ) , and 24 978 admissions were evaluated after the intervention ( January 1 , 2006 , to August 31 , 2007 ) . INTERVENTION Using st and ard activation criteria , a 3-member rapid response team composed of experienced ICU staff and a respiratory therapist performed the evaluation , treatment , and triage of in patients with evidence of acute physiological decline . MAIN OUTCOME MEASURES Hospital-wide code rates and mortality , adjusted for preintervention trends . RESULTS There were a total of 376 rapid response team activations . After rapid response team implementation , mean hospital-wide code rates decreased from 11.2 to 7.5 per 1000 admissions . This was not associated with a reduction in the primary end point of hospital-wide code rates ( adjusted odds ratio [ AOR ] , 0.76 [ 95 % confidence interval { CI } , 0.57 - 1.01 ] ; P = .06 ) , although lower rates of non-ICU codes were observed ( non-ICU AOR , 0.59 [ 95 % CI , 0.40 - 0.89 ] vs ICU AOR , 0.95 [ 95 % CI , 0.64 - 1.43 ] ; P = .03 for interaction ) . Similarly , hospital-wide mortality did not differ between the preintervention and postintervention periods ( 3.22 vs 3.09 per 100 admissions ; AOR , 0.95 [ 95 % CI , 0.81 - 1.11 ] ; P = .52 ) . Secondary analyses revealed few instances of rapid response team undertreatment or underuse that may have affected the mortality findings . CONCLUSION In this large single-institution study , rapid response team implementation was not associated with reductions in hospital-wide code rates or mortality Problem : Advance cardiac life support ( ACLS ) training does not address coordination of team re sources to improve the ability of teams to deliver needed treatments reliably and rapidly . Our objective was to use a human simulation training educational environment to develop multidisciplinary team skills and improve medical emergency team ( MET ) performance . We report findings of a crisis team training course that is focused on organization . Setting : Lar Output:	Discussion s regarding LOMT were frequently performed more commonly than resuscitation interventions such as endotracheal intubation .
MS2898	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A retrospective analysis of insurance data was made of 600 individuals cl aim ing compensation for whiplash following motor vehicle accidents . Three hundred r and omly selected cl aim ants who had settled their injury cl aims within 9 months of the accident were compared with 300 who had settled more than 24 months after the accident . We compared the two groups to identify possible risk factors for prolonged recovery , for which settlement time greater than 24 months was a marker . Variables considered included demographic factors , type of collision , degree of vehicle damage , workers compensation , prior cl aim or neck disability , treatment and time to settlement . Consulting a solicitor was associated with a highly significant , four-fold increase of late settlement of the cl aim . A concurrent workers ’ compensation cl aim , prior neck disability and undergoing physiotherapy or chiropractic treatment were weakly associated with late settlement . The degree of damage to the vehicle ( as indicated by cost of repairs ) was not a significant predictor of late settlement . Late settlement may be the direct effect of legal intervention , independent of the severity of the injury . Whilst the financial benefit to the cl aim ant of consulting a solicitor is apparent , the benefit of prolonged disability is not . It may be to the advantage of both insurers and cl aim ants if those likely to proceed to late settlement could be recognised early and their cl aims settled expeditiously We performed a prospect i ve study of patients with a whiplash trauma to the cervical spine to describe the incidence of these injuries and to evaluate prognostic factors for disability and recovery . A total of 356 patients were enrolled in the study . All the patients received a comprehensive question naire after the injury , and 296 cases responded to the follow-up protocol more than 1 year after the accident . Disability related to the whiplash trauma was used as the outcome variable for the assessment of prognostic factors . The annual incidence of acute whiplash trauma in the catchment area was 4.2 per 1,000 inhabitants and 3.2 per 1,000 for whiplash-associated disorder grade s 1–3 . Thirty-two percent reported persisting disability at follow-up . The following factors were significantly associated with a poor prognosis : pretraumatic neck pain , low educational level , female gender , and whiplash-associated disorder grade s 2–3 Ninety-three cases with a car-accident soft-tissue injury of the cervical spine were studied prospect ively . Neck pain and stiffness were the main initial symptoms , while 4 cases had abnormal neurologic signs . At follow-up , on an average 2 years after the accident , 42 percent had recovered completely , 15 percent had minor discomfort , and 43 percent had discomfort sufficient to interfere with their capacity for work . The statistical analysis of 17 factors , including acute symptoms and physical findings , as well as the forces and directions of impact , head rests , radiographs , length , and sex , did not reveal any factor of prognostic importance Hypersensitivity to a variety of sensory stimuli is a feature of persistent whiplash associated disorders ( WAD ) . However , little is known about sensory disturbances from the time of injury until transition to either recovery or symptom persistence . Quantitative sensory testing ( pressure and thermal pain thresholds , the brachial plexus provocation test ) , the sympathetic vasoconstrictor reflex and psychological distress ( GHQ‐28 ) were prospect ively measured in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . Sensory and sympathetic nervous system tests were also measured in 20 control subjects . All whiplash groups demonstrated local mechanical hyperalgesia in the cervical spine at 1 month post‐injury . This hyperalgesia persisted in those with moderate/severe symptoms at 6 months but resolved by 2 months in those who had recovered or reported persistent mild symptoms . Only those with persistent moderate/severe symptoms at 6 months demonstrated generalised hypersensitivity to all sensory tests . These changes occurred within 1 month of injury and remained unchanged throughout the study period . Whilst no significant group differences were evident for the sympathetic vasoconstrictor response , the moderate/severe group showed a tendency for diminished sympathetic reactivity . GHQ‐28 scores of the moderate/severe group were higher than those of the other two groups . The differences in GHQ‐28 did not impact on any of the sensory measures . These findings suggest that those with persistent moderate/severe symptoms at 6 months display , soon after injury , generalised hypersensitivity suggestive of changes in central pain processing mechanisms . This phenomenon did not occur in those who recover or those with persistent mild symptoms The present study aim ed to establish criteria for delayed recovery after whiplash injury using a 1-year prospect i ve cohort study . 117 whiplash patients referred from primary care and 16 whiplash patients recruited from the insurance company . At baseline all patients underwent neurological , radiological and psychosocial factors assessment and testing of personality traits , well-being , cognitive ability and cognitive functioning . According to the logistic regression in patients referred from primary care the following initial variables are in significant relationship with poor outcome at 1 year : impaired neck movement , history of pretraumatic headache , history of head trauma , higher age , initial neck pain intensity , initial headache intensity , nervousness score , neuroticism score and test score on focused attention . Employing these variables , correct prediction of outcome at 1 year was found in 88 % of patients recruited from the insurance company . Authors conclude that a comprehensive assessment of whiplash patients early after trauma enables physicians to identify patients at risk of delayed recovery & NA ; Dysfunction in the motor system is a feature of persistent whiplash associated disorders . Little is known about motor dysfunction in the early stages following injury and of its progress in those persons who recover and those who develop persistent symptoms . This study measured prospect ively , motor system function ( cervical range of movement ( ROM ) , joint position error ( JPE ) and activity of the superficial neck flexors ( EMG ) during a test of cranio‐cervical flexion ) as well as a measure of fear of re‐injury ( TAMPA ) in 66 whiplash subjects within 1 month of injury and then 2 and 3 months post injury . Subjects were classified at 3 months post injury using scores on the neck disability index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . Motor system function was also measured in 20 control subjects . All whiplash groups demonstrated decreased ROM and increased EMG ( compared to controls ) at 1 month post injury . This deficit persisted in the group with moderate/severe symptoms but returned to within normal limits in those who had recovered or reported persistent mild pain at 3 months . Increased EMG persisted for 3 months in all whiplash groups . Only the moderate/severe group showed greater JPE , within 1 month of injury , which remained unchanged at 3 months . TAMPA scores of the moderate/severe group were higher than those of the other two groups . The differences in TAMPA did not impact on ROM , EMG or JPE . This study identifies , for the first time , deficits in the motor system , as early as 1 month post whiplash injury , that persisted not only in those reporting moderate/severe symptoms at 3 months but also in subjects who recovered and those with persistent mild symptoms Abstract . Outcome following whiplash injury of the cervical spine is variable , and the pathology of those with prolonged symptoms is uncertain . We undertook a prospect i ve study in 25 patients to identify whether those with prolonged symptoms following whiplash injury exhibit a rise in serum creatine kinase consistent with significant muscle damage at the time of injury . Transient rise in creatine kinase level was seen in only 2 of 25 patients , neither of whom complained of prolonged symptoms . Of the 8 patients who developed chronic symptoms following whiplash injury , none demonstrated a serum creatine kinase rise . Prolonged symptoms following whiplash injury can not be explained by biochemically measurable muscle damage OBJECTIVE An earlier pilot study suggested that the late whiplash syndrome is uncommon in Greece . The purpose of the present study is to extend the evaluation to a larger sample , and include the prevalence of specific symptoms in the evaluation . METHODS In a prospect i ve , cohort study , a total of 180 accident victims were consecutively recruited following Emergency ward presentation . A st and ard question naire asked about neck pain , headache , shoulder pain , limb numbness or pain , and dizziness . Accident victims were followed for 6 months . RESULTS In the initial 4 weeks after the accident , accident victims reported neck pain , headache , shoulder pain , arm numbness or pain , and dizziness , but at 4 weeks more than 90 % had recovered from these , the remainder of the subjects having minor symptoms ( not requiring therapy ) , and returning to their pre-accident state of health ( which included minor symptoms ) . There were no cases of chronic disability . CONCLUSION In Greece , symptoms after an acute whiplash injury are self-limiting , brief , and do not appear to evolve into the so-called late whiplash syndrome One hundred and seventeen r and omly selected patients were assessed for different psychological variables ( personality traits , wellbeing , and cognitive ability ) in relation to somatic symptoms after common whiplash . Patients were investigated at an average of 7.4 ( SD 4.2 ) days after trauma and again at three and six months . The course of recovery could not be explained by the patients ' disposition . The results indicated that improvement in wellbeing was associated with recovery from somatic symptoms . There was , however , cognitive impairment in patients who suffered from symptoms . These findings support the view that the psychological and cognitive problems of patients with common whiplash are mainly related to somatic symptoms It is generally accepted that the incidence of whiplash associated disorders is increasing in all industrialised countries , despite the almost universal fitment of head restraints in at least the front seats of cars . This is usually attributed to the fact that few people can be observed to follow the st and ard recommendations as regards head restraint positioning , that is , level with the head vertically and as close to the head as possible horizontally . This study set out to determine whether any other factors , in addition to head restraint adjustment , could be found which would influence the severity of whiplash injury . This was done by linking medical assessment of real-world accident victims with engineering assessment of the accident vehicles . A r and om sample of road accident victims suffering from whiplash associated disorder was studied . The vehicles they had been travelling in were examined to assess impact severity and , where possible , measurements were made of seat and head restraint adjustment with the subject sitting in the vehicle . All subjects were interviewed to assess the disability result ing from their injuries , and their progress was followed for 12 months . The results were subjected to statistical analysis to try to determine relationships between severity of injury ( as measured by result ant disability ) and a number of occupant- and vehicle-related factors . A significant proportion of the sample had suffered lumbar strain injury in addition to whiplash , and these were excluded from the present analysis . Frontal impact victims suffered symptoms indistinguishable from those of rear impact victims . The beneficial effects of good head restraint adjustment could not be clearly demonstrated , and some trends , especially in rear impacts , where the benefits of a well-adjusted restraint should have been very clear , indicated that larger distances from head to restraint were associated with lower disability . The paper discusses these counter-intuitive results and their implication Background : Exposure to a whiplash injury implies a risk for development of chronic disability and h and icap , with reported frequencies ranging from 0 % to 50 % in follow-up studies . The exact risk for development of chronic whiplash syndrome is not known . Objective : To prospect ively determine the sensitivity and specificity of five possible predictors for h and icap following a whiplash injury . Methods : In a 1-year prospect i ve study of persons with acute whiplash injury ( n = 141 ) and control subjects who had acute ankle distortion ( n = 40 ) , pain intensity , number of nonpainful neurologic complaints , cervical mobility , workload during extension and flexion of the neck , and results of psychometric assessment were recorded . The consecutively sample d injured persons were assessed with structured and semistructured question naires , and underwent neurologic examination after 1 week and 1 , 3 , 6 , and 12 months . After 3 to 4 years , participants with whiplash injury were question ed about legal issues . Results : After 1 year , 11 ( 7.8 % ) persons with whiplash injury had not returned to usual level of activity or work . The best single estimator of h and icap was the cervical range-of-motion test , which had a sensitivity of 73 % and a specificity of 91 % ( p < 0.01 , Cox regression analysis ) . Accuracy and specificity increased to 94 % and 99 % when combined with pain intensity and other complaints . This increase was gained at the expense of a reduced sensitivity . Initiation of lawsuit within first month after injury did not influence recovery . Conclusion : The cervical range-of-motion test has a high sensitivity in prediction of h and icap after acute whiplash injury . The value of cervical range-of-motion test is further improved by additional recording of symptoms and pain intensity & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury Output:	These data suggest that recovery occurs for a substantial proportion of subjects in the initial 3 months after the accident but after this time recovery rates level off . Pain and disability symptoms also reduce rapidly in the initial months after the accident but show little improvement after 3 months have elapsed .
MS2899	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Recent r and omized trials and meta-analyses demonstrated that a complete revascularization of significant non culprit lesions in patients with ST elevation myocardial infa rct ion ( STEMI ) is superior to a culprit only revascularization approach in reducing major adverse cardiac events ( MACE ) , however the proportion of diabetic patients was low in these trials . OBJECTIVES To investigate whether a complete revascularization approach is associated with better outcomes in diabetic patients with STEMI and multi-vessel disease . METHODS One hundred diabetic patients with acute STEMI with at least one non-culprit lesion were r and omized to either complete revascularization ( n = 50 ) or culprit-only treatment ( n = 50 ) . Complete revascularization was performed either at the time of primary percutaneous coronary intervention ( PCI ) or within 72 hours during hospitalization . The primary endpoint was the composite of all-cause mortality , recurrent MI , and ischemia-driven revascularization at 6 months . RESULTS A complete revascularization approach was significantly associated with a reduction in the primary outcome ( 6 % vs. 24 % , P = 0.01 ) , primarily due to reduction in ischemia driven revascularization in the complete revascularization group ( 2 % vs. 12 % ; P = 0.047 ) . There was no significant reduction in death or MI ( 2 % vs. 8 % ; P = 0.17 ) and ( 2 % vs. 4 % ; P = 0.56 ) respectively , or in the safety endpoints of major or minor bleeding , contrast-induced nephropathy , or stroke between the groups . CONCLUSIONS In diabetic patients with multi-vessel coronary artery disease undergoing PPCI , complete revascularization is associated with significantly reduced risk of adverse cardiovascular events , as compared with culprit vessel only PCI . ( J Interven Cardiol 2016;29:241 - 247 ) Background There are conflicting data regarding optimal treatment of non-culprit lesions detected during primary percutaneous coronary intervention ( PCI ) in patients with ST-elevation myocardial infa rct ion ( STEMI ) and multi-vessel disease ( MVD ) . We aim ed to investigate whether ischaemia-driven early invasive treatment improves the long-term outcome and prevents major adverse cardiac events ( MACE ) . Methods 121 patients with at least one non-culprit lesion were r and omised in a 2:1 manner , 80 were r and omised to early fractional flow reserve (FFR)-guided PCI ( invasive group ) , and 41 to medical treatment ( conservative group ) . The primary endpoint was MACE at 3 years . Results Three-year follow-up was available in 119 patients ( 98.3 % ) . There was no significant difference in all-cause mortality between the invasive and conservative strategy , 4 patients ( 3.4 % ) died , all in the invasive group ( P = 0.29 ) . Re-infa rct ion occurred in 14 patients ( 11.8 % ) in the invasive group versus none in the conservative group ( p = 0.002 ) . Re-PCI was performed in 7 patients ( 8.9 % ) in the invasive group and in 13 patients ( 32.5 % ) in the conservative group ( P = 0.001 ) . There was no difference in MACE between these two strategies ( 35.4 vs 35.0 % , p = 0.96 ) . Conclusions In STEMI patients with MVD , early FFR-guided additional revascularisation of the non-culprit lesion did not reduce MACE at three-year follow-up compared with a more conservative strategy . The rate of MACE in the invasive group was predominantly driven by death and re-infa rct ion , whereas in the conservative group the rate of MACE was only driven by repeat interventions Results of recent studies have suggested that routine cardiac catheterization may be unnecessary after reperfusion therapy for acute myocardial infa rct ion . Therefore to better define the short-term prognostic value of early coronary angiography , and specifically the prognostic significance of multivessel coronary artery disease , the angiographic findings of 855 patients consecutively enrolled in five phases of the TAMI study were correlated with their in-hospital outcome . All patients received intravenous thrombolytic therapy ( tissue plasminogen activator , urokinase , or both agents ) and underwent cardiac catheterization within 90 minutes of the initiation of therapy . Multivessel disease , defined as the presence of greater than or equal to 75 % luminal diameter stenosis in two or more major epicardial arteries , was documented in 236 patients . When compared with the group of patients without multivessel disease , this group had a higher prevalence of coronary risk factors and more frequently had a history of antecedent ischemic chest pain . Although the severity of the infa rct zone dysfunction was similar in the two groups ( -2.77 + /- 1.00 vs -2.50 + /- 1.09 SD/chord , p = NS ) , global left ventricular ejection fraction was lower in the group with multivessel disease ( 48.6 + /- 12.4 % vs 51.8 + /- 10.6 % , p less than 0.01 ) . This was associated with a significant difference in the function of the noninfa rct zone . Whereas this region was hyperkinetic in the group with minimal or single-vessel disease , it was hypocontractile or dyskinetic in those with multivessel disease ( + 0.66 + /- 1.53 vs -0.52 + /- 1.73 SD/chord , p = 0.0001 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Background : In the Preventive Angioplasty in Myocardial Infa rct ion trial ( PRAMI ; IS RCT N73028481 ) , immediate multivessel PCI ( MV-PCI ) of non-IRA ( infa rct related artery ) lesions in patients with acute ST elevation myocardial infa rct ion ( STEMI ) and multivessel coronary disease ( MVD ) improved long term prognosis . We assessed infa rct distribution and size in a pre-specified cardiac magnetic resonance ( CMR ) sub- study . Methods : In this single centre prospect i ve sub- study , PRAMI participants were invited to undergo 1.5 Tesla CMR 1 week and 1 year after primary PCI . The CMR scans were analysed using semi-automated software by a clinician blinded to treatment group assignment and clinical outcomes . The presence and extent of infa rct ion were assessed quantitatively with late gadolinium enhancement ( LGE ) imaging ( Gadovist , 0.1 mmol/kg ) . The infa rct was delineated as an area of myocardial enhancement ( cm2 ) using a signal intensity threshold of > 5SDs above a remote region , and expressed as a % of total LV mass . The incidence of new LGE in non-infa rct related artery territories at baseline and 1 year were assessed . Data were analysed by an independent statistician . Results : Of 465 r and omised trial participants in 6 UK hospitals , 138 ( 30 % ) were enrolled in Glasgow . Of these 80 patients underwent CMR 1 week post primary PCI of whom 41 ( 51 % ) were in the multi-vessel PCI group and 39 ( 49 % ) were in the IRA-only group . At 1 year , 69 ( 86 % ) patients had a follow up CMR scan . Infa rct size and distribution are described in Table 1 BACKGROUND In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infa rct ion , ischemic postconditioning has been shown to reduce infa rct size , but the effect on clinical outcome has not been tested in a large r and omized trial . In addition , deferring stent implantation in the infa rct -related lesion 1 to 3 days after acute opening of the infa rct -related artery could have protective effects , by reducing the risk of injury caused by distal embolization and microvascular obstruction . Finally , a considerable fraction of patients present with lesions in other coronary artery branches than the infa rct -related artery . Whether a strategy of complete or partial revascularization of these patients should be preferred remains uncertain . STUDY DESIGN The DANAMI 3 trial program was design ed to investigate 3 different r and omized treatment strategies in patients with ST-segment elevation myocardial infa rct ion : ( 1 ) ischemic postconditioning versus conventional treatment with a primary end point of death and hospitalization for heart failure ; ( 2 ) deferring stent implantation in the infa rct -related lesion versus conventional treatment with a primary end point of death , hospitalization for heart failure , reinfa rct ion , and repeat revascularization ; and ( 3 ) treatment of the culprit lesion only versus fractional flow reserve-guided complete revascularization in patients with multivessel disease , with a primary end point of death , reinfa rct ion , and repeat revascularization . SUMMARY The DANAMI 3 trial program will determine whether either of 2 approaches to reduce reperfusion injury and distal microvascular obstruction with postconditioning or deferred stent implantation will translate into improved clinical outcome and whether patients with multivessel disease undergoing primary percutaneous coronary intervention will benefit from a strategy of complete or partial revascularization Background Few reports described outcomes of complete compared with infa rct -related artery (IRA)-only revascularisation in patients with ST-elevation myocardial infa rct ion ( STEMI ) and multivessel coronary artery disease ( CAD ) . Moreover , no studies have compared the simultaneous treatment of non-IRA with the IRA treatment followed by an elective procedure for the other lesions ( staged revascularisation ) . Methods The outcomes of 214 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty were studied . Before the first angioplasty patients were r and omly assigned to three different strategies : culprit vessel angioplasty-only ( COR group ) ; staged revascularisation ( SR group ) and simultaneous treatment of non-IRA ( CR group ) . Results During a mean follow-up of 2.5 years , 42 ( 50.0 % ) patients in the COR group experienced at least one major adverse cardiac event ( MACE ) , 13 ( 20.0 % ) in the SR group and 15 ( 23.1 % ) in the CR group , p<0.001 . Inhospital death , repeat revascularisation and re-hospitalisation occurred more frequently in the COR group ( all p<0.05 ) , whereas there was no significant difference in re-infa rct ion among the three groups . Survival free of MACE was significantly reduced in the COR group but was similar in the CR and SR groups . Conclusions Culprit vessel-only angioplasty was associated with the highest rate of long-term MACE compared with multivessel treatment . Patients scheduled for staged revascularisation experienced a similar rate of MACE to patients undergoing complete simultaneous treatment of non-IRA AIMS To examine the incidence of and propensity for non-culprit interventions performed at the time of the primary percutaneous coronary intervention ( PCI ) and its association with 90-day outcomes . METHODS AND RESULTS We examined the incidence , propensity for , and associated 90-day outcomes following non-culprit interventions performed at the time of primary PCI among ST-elevation myocardial infa rct ion patients with multi-vessel coronary artery disease ( MVD ) . Of the 5373 patients who underwent primary PCI in the APEX-AMI trial , 2201 had MVD . Of those , 217 ( 9.9 % ) underwent non-infa rct -related arteries ( IRA ) PCI , whereas 1984 ( 90.1 % ) underwent PCI of the IRA alone . Ninety-day death and death/CHF/shock were higher in the non-IRA group compared with the IRA-only PCI group ( 12.5 vs. 5.6 % , P ( log-rank ) < 0.001 and 17.4 vs. 12.0 % , P ( log-rank ) = 0.020 , respectively ) . After adjusting for patient and procedural characteristics as well as propensity for performing non-IRA PCI , this procedure remained independently associated with an increased hazard of 90-day mortality [ adjusted hazard ratio 2.44 , 95 % CI ( 1.55 - 3.83 ) , P < 0.001 ] . CONCLUSION Non-culprit coronary interventions were performed at the time of primary PCI in 10 % of MVD patients and were significantly associated with increased mortality . Our data support current guideline recommendations discouraging the performance of such procedures in stable primary PCI patients . Prospect i ve r and omized study of this issue may be warranted BACKGROUND Rapid recanalization of infa rct -related artery ( IRA ) has become the major target during primary percutaneous coronary intervention ( PCI ) for patients with ST-elevation myocardial infa rct ion ( MI ) , but strategy for treatment of non-IRA lesions in this setting remains unclear . This study aim ed to compare long-term effects between PCI for IRA only and that for both IRA and non-IRA in ST-elevation MI patients with multi-vessel disease . METHODS A total of 242 eligible patients with ST-elevation MI and at least two diseased coronary arteries ( luminal narrowing > or = 70 % ) undergoing primary PCI were included Output:	TSA of long-term all-cause mortality , long-term cardiovascular mortality , and long-term non-fatal myocardial infa rct ion showed that more RCTs are needed to reach more conclusive results on these outcomes . Regarding long-term repeat revascularisation more RCTs may not change our present result . TSA also supports the need for more RCTs in order to draw stronger conclusions regarding the effects of complete revascularisation on long-term all-cause mortality , long-term cardiovascular mortality , and long-term non-fatal myocardial infa rct ion

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