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Clinical NLP Lab 26

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Ankle injuries account for 30 to 60 % of all parachuting injuries . This study was design ed to determine if outside-the-boot ankle braces could reduce ankle sprains during Army paratrooper training . METHODS The r and omized trial involved 777 volunteers from the U.S. Army Airborne School , Fort Benning , Ga. Of this group , 745 completed all study requirements ( 369 brace-wearers and 376 non-brace-wearers ) . Each volunteer made five parachute jumps , for a total of 3,674 jumps . RESULTS The incidence of inversion ankle sprains was 1.9 % in non-brace-wearers and 0.3 % in brace-wearers ( risk ratio , 6.9 ; p = 0.04 ) . Other injuries appeared unaffected by the brace . Overall , 5.3 % of the non-brace group and 4.6 % of the brace group experienced at least one injury . The risk ratio for injured individuals was 1.2:1 ( non-brace to brace groups ; p = 0.65 ) . CONCLUSION Inversion ankle sprains during parachute training can be significantly reduced by using an outside-the-boot ankle brace , with no increase in risk for other injuries To study the efficacy of an injury prevention program in a r and omized trial , 12 teams ( 180 players ) in a male senior soccer division were followed up for 6 months . The 12 teams were allocated at r and om to two groups of six teams , one being given a prophylactic program and the other serving as control . The program was based on previous studies of injury mechanisms . It comprised ( 1 ) correction of training , ( 2 ) provision of optimum equipment ; ( 3 ) prophylactic ankle taping ; ( 4 ) controlled rehabilitation ; ( 5 ) exclusion of players with grave knee instability ; ( 6 ) information about the impor tance of disciplined play and the increased risk of injury at training camps ; and ( 7 ) correction and supervision by doctor(s ) and physiotherapist(s ) . The injuries in the test teams were 75 % fewer than in the controls . The most common types of soccer injuries , sprains and strains to ankles and knees , were all significantly reduced . It is concluded that the pro posed prophylactic program , including close supervi sion and correction by doctors and physiotherapists , significantly reduces soccer injuries Ankle supports are commonly used in an attempt to decrease the risk of ankle injury during sport . However , their use may also impair postural control , which is an integral component of sports participation . The aim of this study was to investigate the effects of three different ankle supports ( tape , brace , and elastic b and age ) on postural control in 24 normal subjects with a mean age of 24.8 years ( + /- 4.4 ) . Two measures were used to evaluate postural control in one-legged stance with the eyes closed : variability of mediolateral ground reaction force ( acquired from a force platform ) and frequency of foot touchdowns by the nonsupport leg ( assumed to indicate ability of the subject to maintain one-legged stance posture ) . Both measures revealed a differential effect for ankle support on postural control . The use of an elastic b and age had no significant effect on postural control ( p > 0.05 ) , while the use of tape or a brace had a significant detrimental effect ( p < 0.05 ) . While wearing the tape or a brace , subjects were less steady and touched down more frequently . Restriction of ankle movement was offered as a possible explanation for the results , since postural control was impaired only by the ankle supports which limited ankle motion . These findings may have implication s regarding impaired athletic performance Young female players in European h and ball have a very high injury incidence , up to 50 injuries per 1000 hours of game . More than half of these injuries happen without any external cause . The aim of the study was to investigate the effect of an intervention programme design ed to reduce the number of injuries in young female players in European h and ball , with special emphasis on injuries in the lower extremities . The programme was created using elite athlete training programmes and those design ed for rehabilitation of injured athletes with functional instability of their ankles and rupture of the anterior cruciate ligament . It included the use of an ankle disk for 10 - 15 min at all practice sessions , for one 10-month season ( August 1995-May 1996 ) . Twenty-two teams participated in the study , and were r and omly assigned to the intervention or control group . Eleven teams with 111 players were r and omised to the intervention group and 11 teams with 126 players to the control group . Data were analysed using a t-test for continuous variables , chi2- analysis and Fisher 's exact test for dichotomous variables and multivariate methods to determine odds-ratios . The results indicated that using the intervention programme decreased the numbers of both traumatic and overuse injuries significantly . The differences in injuries between the groups were 80 % during games and 71 % during practice . In addition , the players in the control group had a 5.9 times higher risk of acquiring an injury than the players in the intervention group A study was undertaken to evaluate the effect of a semi rigid ankle orthosis ( Sport-Stirrup ) on the incidence of ankle sprains in soccer players during 1 playing season . Senior soccer players were divided into 2 groups : play ers with previous ankle sprains ( N = 258 ) and players without such history ( N = 246 ) . The players in these groups were each r and omly allocated to either a semi rigid orthosis or a control group at the start of the playing season . All subsequent injuries during the season and the total number of playing hours were documented . There was a significant reduction in the incidence of ankle sprains ( injuries/1 000 playing hours ) by ankles in the orthosis group with previous sprains ( 0.14 ) com pared with the nonbraced group with previous sprains ( 0.86 ) . The incidence of ankle sprains was significantly higher in the nonbraced group with previous sprains ( 0.86 ) compared with the nonbraced group without pre vious sprains ( 0.46 ) . Thus , in this study , a semirigid or thosis significantly reduced the incidence of recurrent ankle sprains in soccer players with previous history of ankle sprains The purpose of this study was to examine a young athletic population to up date the data regarding epidemiology and disability associated with ankle injuries . At the United States Military Academy , all cadets presenting with ankle injuries during a 2-month period were included in this prospect i ve observational study . The initial evaluation included an extensive question naire , physical examination , and radiographs . Ankle sprain treatment included a supervised rehabilitation program . Subjects were reevaluated at 6 weeks and 6 months with subjective assessment , physical examination , and functional testing . The mean age for all subjects was 20 years ( range , 17–24 years ) . There were 104 ankle injuries accounting for 23 % of all injuries seen . There were 96 sprains , 7 fractures , and 1 contusion . Of the 96 sprains , 4 were predominately medial injuries , 76 were lateral , and 16 were syndesmosis sprains . Ninety-five percent had returned to sports activities by 6 weeks ; however , 55 % of these subjects reported loss of function or presence of intermittent pain , and 23 % had a decrement of > 20 % in the lateral hop test when compared with the uninjured side . At 6 months , all subjects had returned to full activity ; however , 40 % reported residual symptoms and 2.5 % had a decrement of > 20 % on the lateral hop test . Neither previous injury nor ligament laxity was predictive of chronic symptomatology . Furthermore , chronic dysfunction could not be predicted by the grade of sprain ( grade I vs. II ) . The factor most predictive of residual symptoms was a syndesmosis sprain , regardless of grade . Syndesmosis sprains were most prevalent in collision sports . This study demonstrates that even though our knowledge and underst and ing of ankle sprains and rehabilitation of these injuries have progressed in the last 20 years , chronic ankle dysfunction continues to be a prevalent problem . The early return to sports occurs after almost every ankle sprain ; however , dysfunction persists in 40 % of patients for as long as 6 months after injury . Syndesmosis sprains are more common than previously thought , and this confirms that syndesmosis sprains are associated with prolonged disability The aim of this study was to investigate whether the number of patients with residual symptoms following ankle sprains could be reduced by training on a wobble board during a 12-week training recovery period . The effect of a 12-week training program was compared to no training . Forty-eight patients completed the study . In the follow-up period ( mean 230 days ) we found significantly fewer recurrent distorsions and fewer patients had functional instability in the study group compared to controls . There were no differences between the two groups concerning subjective complaints during the recovery period . Volumetric measurements revealed no difference in the speed of reduction of haematoma and oedema in the two groups . We conclude that training on a wobble board is effective in reducing residual symptoms following ankle sprains We evaluated the effect of different ankle support de vices on athletic performance . Thirty varsity college athletes were tested with both ankles supported by taping , Swede-O brace , Kallassy brace or left unsup ported . The athletes performed four events : broad jump , vertical leap , 10 yard shuttle run , and 40 yard sprint . The events and appliances were r and omized to prevent bias by fatigue . Compared to the results when no support was used , ankle taping result ed in a significant decreased perform ance in the vertical jump ( 4 % ) , shuttle run ( 1.6 % ) , and sprint ( 3.5 % ) ( P < 0.05 ) . Use of the Swede-O brace decreased performance in the vertical jump ( 4.6 % ) , broad jump ( 3.6 % ) , and time of the sprint ( 3.2 % ) . Re sults using the Kallassy brace showed a decrease in the vertical jump ( 3.4 % ) when compared to no support . The test results of the shuttle run with taping were slower than the Kallassy brace ( P < 0.05 ) . Wearing the Swede-O brace caused the athletes ' broad jump dis tance to decrease more than the Kallassy brace ( P < 0.05 ) . Subjective question naires supported the Kallassy brace as the most comfortable support and the one that decreased performance the least . Taping of the ankles is universally accepted for ankle prophylaxis . This study has shown a decrease in per formance when ankles are taped compared to ankles with no protection . Since the decreases in performance caused by ankle braces are minor , this should not be used as a criterion for selection of prophylactic support compared to taping This study investigated the relationship between exposure time and ankle sprains in soccer . Forty-one teams ( 639 players ) from four male senior soccer divisions at different levels of skill ( divisions I-VI ) were followed prospect ively for 1 year . The exposure to soccer and the number of injuries per player were higher in higher divisions , but the injury incidence , percentage of ankle injuries and incidence of ankle injuries were the same at different levels of skill . Of all injuries 17 to 20 % were ankle sprains and the incidence varied between 1.7 to 2.0 ankle injuries per 1000 hours of exposure . Since players with previous ankle problems run an increased risk of reinjury we suggest that these players receive preventive advice Ankle sprains are often complicated by functional instability and repeated sprains . Rehabilitation with wobble boards in patients with functional instability has been tested , and significant improvement has been found compared to no training . The aim of this study was to investigate whether the number of patients with residual symptoms following ankle sprains could be reduced by training on a wobble board during 12-week recovery period . In addition , the influence of training in the time course reduction of edema was investigated . We performed a prospect i ve study including 61 patients , all active in sports for more than 2 hours a week with primary ankle sprains . The effect of a 12-week training program with wobble board was compared with no training . Forty-eight patients completed the study . In the follow-up period ( mean X = 230 days ) , we found significantly fewer recurrent sprains , and significantly fewer patients in the training group had functional instability of the ankle compared with the no training group . There were no differences in the two groups in the time which elapsed before patients were painless at walking , during running , or at sports . Volumetric measurements revealed no difference in the speed of reduction of hematoma and edema of the ankle and foot between the two groups . We conclude that training on a wobble board early after primary stage 2 ankle sprains is effective in reducing residual symptoms following this lesion and that training does not seem to affect the time course reduction in edema This r and omized clinical study was design ed to pro spectively determine the efficacy of a semirigid ankle stabilizer in reducing the frequency and severity of acute ankle injuries in basketball . Athletic shoe , playing surface , athlete-exposure , ankle injury history , and brace assignment were either statistically or experimen tally controlled . Participants in the study were 1601 United States Military Academy cadets with no prepar ticipation , clinical , functional , or radiographic evidence of ankle instability . Subjects experienced a total of 13,430 athlete-exposures in the 199 \n Output:\n " }, { "from": "agent", "value": "There was no apparent difference in the severity of ankle sprains or any change to the incidence of other leg injuries .\nThe protective effect of ' high-top ' shoes remains to be established .\nThere was limited evidence for reduction in ankle sprain for those with previous ankle sprains who did ankle disk training exercises .\nREVIEW ER 'S CONCLUSIONS This review provides good evidence for the beneficial effect of ankle supports in the form of semi-rigid orthoses or air-cast braces to prevent ankle sprains during high-risk sporting activities ( e.g. soccer , basketball ) .\nParticipants with a history of previous sprain can be advised that wearing such supports may reduce the risk of incurring a future sprain ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background and purpose No prospect i ve surveillance systems have been available for monitoring the outcome of cruciate ligament surgery in Sc and inavia ( Denmark , Norway , and Sweden ) . In the present paper we describe the Sc and inavian ACL registries including their main function , similarities , and preliminary baseline results . Methods The Sc and inavian registries were established in 2004 ( Norway ) and 2005 ( Denmark and Sweden ) . The Danish and Swedish registries were originally based on the Norwegian registry , and there is no overriding difference between the three . In Denmark , all hospitals and clinics are legally bound to report to an approved national data base . In Norway and Sweden , the registries are based on voluntarily reporting by surgeons . Results The annual incidence of primary ACL reconstructions is higher in Denmark than in Norway , except in females younger than 20 years . Among Sc and inavian surgeons , there is a similar approach to the patients . Differences do , however , exist regarding choice of grafts , choice of implants , and choice of treatment of simultaneous meniscal and cartilage injuries ; the proportion of ACL reconstructions performed as outpatient surgery ; and the use of prophylactic anticoagulation . Clinical ly , the preoperative KOOS scores are not significantly different between the Sc and inavian registries , except that Denmark reports more symptoms both pre- and postoperatively . Interpretation The Sc and inavian national ACL registries will generate new data about ACL reconstructions . They will contribute important knowledge regarding ACL epidemiology . They will be the only source of data on the performance of a wide range of different implants and techniques . In addition , they will hopefully have an impact on the selection of methods for ACL reconstructions in Sc and inavia and elsewhere Background The choice of different graft types and surgical techniques used when reconstructing a torn anterior cruciate ligament may influence the long-term prevalence of osteoarthritis and functional outcomes . Hypothesis There are no differences in the prevalence of knee osteoarthritis or knee function in patients undergoing reconstruction of a torn anterior cruciate ligament with 4-str and hamstring autograft versus patellar tendon — bone autograft . Study Design R and omized controlled trial ; Level of evidence , 1 . Methods Seventy-two patients with subacute or chronic rupture of the anterior cruciate ligament were r and omly assigned to autograft reconstruction with 4-str and gracilis and semitendinosus tendon ( HAM ) ( N = 37 ) or with patellar tendon — bone ( PTB ) ( N = 35 ) from the ipsilateral side . Outcome measurements were the Cincinnati knee score , single-legged hop tests , isokinetic muscle strength tests , pain , knee joint laxity test ( KT-1000 arthrometer ) , and a radiologic evaluation ( Kellgren and Lawrence ) at 10-year follow-up . Results At 10 years , 57 patients ( 79 % ) were eligible for evaluation—29 in the HAM group and 28 in the PTB group . No differences were found between the 2 graft groups with respect to the Cincinnati knee score , the single-legged hop tests , pain , muscle strength measurements , or knee joint laxity . Fifty-five percent and 64 % of the patients had osteoarthritis corresponding to Kellgren and Lawrence grade 2 or more in the HAM and the PTB groups , respectively ( P = .27 ) . For the uninvolved knee , the corresponding numbers were 28 % and 22 % ( P = .62 ) . Conclusion At 10 years postoperatively , no statistically significant differences in clinical outcome between the 2 graft types were found . The prevalence of osteoarthritis was significantly higher in the operated leg than in the contralateral leg , but there were no significant differences between the 2 groups . The results indicate that the choice of graft type after an anterior cruciate ligament injury has minimal influence on the prevalence of osteoarthritis 10 years after surgery Seventy-two patients with subacute or chronic rupture of the anterior cruciate ligament were r and omly assigned to autograft reconstruction with four-str and gracilis and semitendinosus tendon ( N = 37 ) or with patellar tendon-bone ( N = 35 ) from the ipsilateral side . The groups were similar in terms of age , sex , level of activity , degree of laxity , meniscal lesions found surgically , and rehabilitation program . The follow-up was performed at another hospital by independent observers after 6 , 12 , and 24 months . Sixty-one patients ( 32 with hamstring tendon grafts and 29 with patellar tendon grafts ) complied with the follow-up routine for the full 24 months . No differences were found between the groups with respect to Cincinnati functional score , KT-1000 arthrometer measurements , or stairs hopple test results . The subjective result and the single-legged hop test result were better for the hamstring tendon group after 6 and 12 months , but no differences were found after 24 months . The hamstring tendon group showed better isokinetic knee extension strength than did the patellar tendon group after 6 months , but not after 12 and 24 months . There was a significant weakness in isokinetic knee flexion strength among the hamstring tendon group . Anterior knee pain was not significantly different between the groups , but kneeling pain was significantly less common in the hamstring tendon group after 24 months Background : R and omized controlled trials after anterior cruciate ligament reconstructions with long-term follow-up including assessment of health-related quality of life are rare . Purpose : To compare clinical outcome and health-related quality of life 8 years after anterior cruciate ligament reconstruction using 2 types of graft . Study Design : R and omized controlled trial ; Level of evidence , 1 . Methods : Long-term follow-up of 164 patients with anterior cruciate ligament injury r and omized to arthroscopic reconstruction with a quadrupled semitendinosus graft or a bone – patellar tendon – bone graft was undertaken . After a mean 8 years , 153 patients were available for follow-up , including instrumented laxity , 1-legged hop test , a knee-walking test , and assessment with International Knee Documentation Committee , Lysholm , Tegner , and patellofemoral pain score . Health-related quality of life was assessed with Knee Osteoarthritis Outcome Score and Short Form–36 . Results : Patients in both graft groups retained the same stability , knee function , and health-related quality of life . The patellofemoral pain score was similar for both groups ; the bone – patellar tendon – bone group had more donor site morbidity from kneeling and knee walking . In the bone – patellar tendon – bone group , 19 patients had no kneeling problems , 23 slight problems , 31 moderate problems , and 5 unable to kneel . Corresponding figures for the semitendinosus group were 25 , 32 , 16 , and 2 ( P < .001 ) . Patients with early reconstructions ( < 5 months ) had a lower risk for meniscal injuries ( 37 % ) than did later reconstructed ( 62 % , P = .008 ) . Health-related quality of life regarding physical functioning in Short Form–36 was better for the early-reconstructed patients than for the later reconstructed ( 92 vs 85 ; P = .014 ) . Patients without medial meniscal surgery had higher Knee Osteoarthritis Outcome Scores for all subscales than did patients with medial meniscal surgery , with most significant difference for sport and recreation ( 63 vs 75 , P = .008 ) . Conclusion : In the long term , the semitendinosus graft provided similar stability , knee function , and health-related quality of life but with less kneeling morbidity than did the bone – patellar tendon – bone graft Background No prospect i ve surveillance system exists for monitoring the outcome of cruciate ligament surgery . Purpose This article is intended to describe the development and procedures of the Norwegian National Knee Ligament Registry ( NKLR ) , including baseline results from the first 2 years of operation . Study Design Cohort study ( prevalence ) ; Level of evidence , 1 . Methods The NKLR was established on June 7 , 2004 to collect information prospect ively on all cases of cruciate ligament reconstruction surgery in Norway . Information on the details of surgery is gathered through a registration form completed by the surgeon postoperatively , and a vali date d knee outcome score form is completed by the patients preoperatively and at follow-ups on all patients at 2 , 5 , and 10 years postoperatively . Hospital compliance was examined in 2005 and 2006 . Results A total of 2793 primary cruciate ligament reconstruction surgeries were registered by 57 hospitals . This corresponds to an annual population incidence of primary anterior cruciate ligament reconstruction surgeries of 34 per 100 000 citizens ( 85 per 100 000 citizens in the main at-risk age group of 16–39 years ) . After 21 months of operation , the NKLR had an overall compliance of 97 % when compared with the hospital records . Conclusions A national population -based cruciate ligament registry has been developed , implemented , and maintained in Norway . The registry will each year enroll approximately 1500 primary cruciate ligament reconstruction cases . It is expected that inadequate procedures and devices can be identified , as well as prognostic factors associated with good and poor outcomes , at least for the most frequent categories In a two-centre study , 164 patients with unilateral instability of the anterior cruciate ligament were prospect ively r and omised to arthroscopic reconstruction with either a patellar tendon graft using interference screw fixation or a quadruple semitendinosus graft using an endobutton fixation technique . The same postoperative rehabilitation protocol was used for all patients and follow-up at a median of 31 months ( 24 to 59 ) was carried out by independent observers . Four patients ( 2 % ) were lost to follow-up . No significant differences were found between the groups regarding the Stryker laxity test , one-leg hop test , Tegner activity level , Lysholm score , patellofemoral pain score , International Knee Documentation Committee ( IKDC ) score or visual analogue scale , reflecting patient satisfaction and knee function . Slightly decreased extension , compared with the non-operated side , was found in the patellar tendon group ( p < 0.05 ) . Patients with associated meniscal injuries had lower IKDC , visual analogue ( p < 0.01 ) and Lysholm scores ( p < 0.05 ) than those without such injuries . Patients in whom reconstruction had been carried out less than five months after the injury had better final IKDC scores than the more chronic cases ( p < 0.05 ) . We conclude that patellar tendon and quadruple semitendinous tendon grafts have similar outcomes in the medium term . Associated meniscal pathology significantly affects the final outcome and early reconstruction seems to be beneficial Objective the aim of this study was to radiologically evaluate the femoral tunnel position in anterior cruciate ligament ( ACL ) reconstructions using the isometric and anatomical techniques . Methods a prospect i ve analytical study was conducted on patients undergoing ACL reconstruction by means of the isometric and anatomical techniques , using grafts from the knee flexor tendons or patellar tendon . Twenty-eight patients were recruited during the immediate postoperative period , at the knee surgery outpatient clinic of FCMMG-HUSJ . Radiographs of the operated knee were produced in anteroposterior ( AP ) view with the patient st and ing on both feet and in lateral view with 30 ° of flexion . The lines were traced out and the distances and angles were measured on the lateral radiograph to evaluate the sagittal plane . The distance from the center of the screw to the posterior cortical bone of the lateral condyle was measured and divided by the Blumensaat line . In relation to the height of the screw , the distance from the center of the screw to the joint surface of the lateral condyle of the knee was measured . On the AP radiograph , evaluating the coronal plane , the angle between the anatomical axis of the femur and a line traced at the center of the screw was measured . Results with regard to the p measurement ( posteriorization of the interference screw ) , the tests showed that the p-value ( 0.4213 ) was greater than the significance level used ( 0.05 ) ; the null hypothesis was not rejected and it could be stated that there was no statistically significant difference between the anatomical and isometric techniques . With regard to the H measurement ( height of the screw in relation to the lower cortical bone of the knee ) , the p-value observed ( 0.0006 ) was less than the significance level used ( 0.05 ) ; the null hypothesis was rejected and it could be stated that there was a statistically significant difference between the anatomical and isometric techniques . It can be concluded that the latter difference occurred because the isometric technique generated greater values for the H measurement than the anatomical technique . With regard to the MED variable ( position of the screw on the AP radiograph ) , the observed p-value ( 0.000 ) was less than the significance level ( 5 % ) ; the null hypothesis was rejected and it could be stated with 95 % confidence that there was a significant difference between the anatomical and isometric techniques . Conclusions there were statistically significant differences in the radiological evaluations of the femoral tunnel , both in the sagittal and in the coronal plane , between the ACL reconstruction techniques Radiographic tibial and femoral bone tunnel enlargement has been demonstrated following anterior cruciate ligament ( ACL ) reconstruction . This study investigated whether bone tunnel enlargement differs between four-str and hamstring \n Output:\n " }, { "from": "agent", "value": "We found significant differences in favor of the HT technique in the domains of anterior knee pain , kneeling pain , and restriction in the range of active extension ( \" extension deficit \" ) .\nWe found no differences between the PT and HT technique in terms of rerupture rate .\nThere were no clinical ly significant differences for the outcomes of Lysholm score and Tegner Activity Scale as well as the KT-1000 side-to-side at maximum manual force .\nContemporary 4-str and HT ACL reconstruction is comparable with the PT technique in terms of clinical stability and postoperative functional status across most parameters studied .\nThe HT technique carries lower risk of postoperative complications such as anterior knee pain , kneeling discomfort , and extension deficit .\nPrimary ACL reconstruction using the 4-str and HT technique achieves clinical results that are comparable with the PT technique with significantly less postoperative complications ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : The clinical course of ulcerative colitis ( UC ) is unpredictable . During recent years , the ability of fecal biomarkers to predict relapse in inflammatory bowel disease has been evaluated . The objective of this study was to assess fecal calprotectin ( FC ) as a predictor of disease recurrence in patients with new onset of UC . Methods : Sixty-nine patients were included . After the initial treatment , patients were followed up after 3 months and then yearly for 3 years . The prognostic role of FC 3 months after the initial therapy was evaluated . Results : The FC levels 3 months after the diagnosis were higher in patients experiencing a relapsing disease course compared with those with a mild disease course during 1 year ( median , 263 ; interquartile range [ IQR ] , 100–634 & mgr;g/g versus median , 102 ; IQR , 38–225 & mgr;g/g ; P = 0.009 ) and 3 years of follow-up ( median , 280 ; IQR , 102–622 & mgr;g/g versus median , 118 ; IQR , 39–219 & mgr;g/g ; P = 0.01 ) . The area under the receiver operating characteristic curves using calprotectin to predict a relapsing disease course during 1 year and 3 years were 0.69 ( 95 % confidence interval , 0.56–0.82 ) and 0.70 ( 95 % confidence interval , 0.57–0.83 ) , respectively . In the Kaplan – Meier survival analysis , a FC level > 262 & mgr;g/g was associated with an increased risk of a relapsing disease course during the study period ( P = 0.003 ) . In logistic regression analysis , only FC and age were found to be independent predictors of having a relapsing disease course . Conclusions : Levels of FC 3 months after the initial therapy in patients with new onset of UC predict the disease course over the following years , and they are of value in the clinical management of these patients Purpose This prospect i ve study was to evaluate the significance of fecal calprotectin and lactoferrin for the prediction of ulcerative colitis ( UC ) relapse . Methods Eighty UC patients in remission for ≥3 months on mesalamine as maintenance therapy were included . At entry , stool sample s were collected for the measurement of calprotectin and lactoferrin . All patients were followed up for the following 12 months . To identify predictive factors for relapse , time-dependent analyses using the Kaplan-Meier graphs and Cox 's proportional hazard model were applied . Results During the 12 months , 21 patients relapsed . Mean calprotectin and lactoferrin levels were significantly higher in patients with relapse than those in remission ( calprotectin—173.7 vs 135.5 μg/g , P = 0.02 ; lactoferrin—165.1 vs 130.7 μg/g , P = 0.03 ) . A cutoff value of 170 μg/g for calprotectin had a sensitivity of 76 % and a specificity of 76 % to predict relapse , while a cutoff value of 140 μg/g for lactoferrin had a sensitivity of 67 % and a specificity of 68 % . In a multivariate analysis , calprotectin ( ≥170 μg/g ) was a predictor of relapse ( hazard ratio , 7.23 ; P = 0.002 ) . None of the following parameters were significantly associated with relapse : age , gender , duration of UC , number of UC episode , severity of the previous episode , extent of UC , extraintestinal manifestation , and lactoferrin level . Conclusions Fecal calprotectin showed a higher sensitivity and specificity than fecal lactoferrin for predicting UC relapse . Fecal calprotectin level appeared to be a significant predictor of relapse in patients with quiescent UC on mesalamine as maintenance therapy Background Both faecal calprotectin [ Fcal ] and the faecal immunochemical test [ FIT ] are useful to predict clinical relapse of ulcerative colitis [ UC ] . However , the difference between Fcal and FIT in ability to predict relapse has scarcely been reported . Whether the combined use of these two faecal markers increases the predictability is also unknown . Methods UC patients in clinical remission who underwent colonoscopy were enrolled prospect ively , and the Fcal and FIT values were examined at enrolment . Their clinical course was observed for 2 years or until relapse . The correlation between the incidence of relapse and the values of the two markers was examined . Results A total of 113 patients were enrolled , and 48 [ 42 % ] relapsed . Fcal ≥ 75 μg/g and FIT ≥ 110 ng/mL were defined as Fcal-positive and FIT-positive , respectively , according to the receiver operating characteristic curves . Both Fcal-positive and FIT-positive statuses were independent predictive factors of clinical relapse ( hazard ratio [ HR ] 2.29 ; 95 % confidence interval [ CI ] , 1.23 - 4.49 ; p = 0.0086 , and HR 2.91 ; 95 % CI , 1.49 - 5.50 ; p = 0.0022 , respectively ) . Categorisation of patients into three groups according to the faecal marker status [ FIT-positive , FIT-negative and Fcal-positive , and both negative ] can efficiently stratify the risk of relapse with grade d increases in risk [ FIT-negative and Fcal-positive : HR 2.05 ; 95 % CI , 1.02 - 4.43 ; p = 0.0045 , and FIT-positive : HR 5.43 ; 95 % CI , 2.57 - 11.76 ; p < 0.0001 , compared with both negative ] . Conclusions Fcal vs FIT showed distinct properties regarding the prediction of relapse in UC . A risk assessment using both faecal markers could increase the predictability for relapse Background and Aims Endoscopic and histological healing are associated with improved clinical outcomes in ulcerative colitis [ UC ] . We aim ed to investigate the predictive value of faecal immunochemical test [ FIT ] for endoscopic and histological healing in UC . Methods We measured quantitative FIT and faecal calprotectin [ FC ] in 140 consecutive UC patients who underwent colonoscopy . We assessed the diagnostic accuracy of FIT for predicting endoscopic healing using the Mayo endoscopic subscore [ MES 0/1 ] and for histological healing using the Geboes score [ < 2.0 ] and Nancy index [ grade ≤ 1 ] . The predictive abilities of FIT were compared with those of FC . Results FIT had an area under the curve [ AUC ] of 0.77 ( 95 % confidence interval [ CI ] 0.67 - 0.86 , p < 0.001 ) for endoscopic healing , an AUC of 0.77 [ 95 % CI 0.67 - 0.86 , p < 0.001 ] using the Geboes score , and 0.77 [ 95 % CI 0.66 - 0.85 , p < 0.001 ] using the Nancy Index for histological healing . The AUC of FIT was comparable to that of FC for endoscopic healing [ p = 0.773 ] and histological healing [ p = 0.767 - 0.960 ] , and was comparable to colonoscopy for histological healing [ p = 0.384 - 0.673 ] . FIT < 50 ng/ml predicted endoscopic healing with a sensitivity , specificity , and positive predictive value [ PPV ] of 72 % , 68 % , and 82 % , respectively , and for histological healing with a sensitivity , specificity , and PPV of 73 - 75 % , 67 % , and 78 - 80 % , respectively . Combining FIT with FC led to a higher specificity [ 90 % ] for histological healing . Over 85 % of patients with FIT < 50 ng/ml and FC < 50 μg/g achieved histological healing . Conclusions FIT is highly sensitive and accurate to predict endoscopic and histological healing in UC . It represents a promising non-invasive tool for monitoring mucosal healing in UC Background : This study examined whether fecal calprotectin can be used in daily practice as a marker to monitor patients with ulcerative colitis ( UC ) receiving infliximab maintenance therapy . Methods : This prospect i ve multicenter study enrolled adult patients with UC in clinical remission under infliximab maintenance therapy . Fecal calprotectin levels were measured every 4 weeks . Sigmoidoscopies were performed at inclusion and at study end . Relapse was defined as a clinical need for change in treatment or an endoscopic Mayo subscore of ≥2 at week 52 . Sustained deep remission was defined as a partial Mayo score <3 at all points and an endoscopic Mayo score 0 at week 52 . Results : Full analysis was possible for 87 of 113 included patients with UC ( 77 % ) . Of these patients , 30 ( 34.4 % ) were considered to be in sustained deep remission and 13 ( 14.9 % ) to have relapsed . Calprotectin levels in patients with sustained deep remission remained very low ( median < 40 mg/kg at all time points ) . Patients who flared had significantly higher calprotectin levels ( median > 300 mg/kg ) already 3 months before the flare . Further receiver operator curve analysis suggested that a calprotectin level > 300 mg/kg had a reasonable sensitivity ( 58.3 % ) and specificity ( 93.3 % ) to model flare . Two consecutive calprotectin measurements of > 300 mg/kg with 1-month interval were identified as the best predictor of flare ( 61.5 % sensitivity and 100 % specificity ) . Conclusions : Fecal calprotectin can be used in daily practice to monitor patients with UC receiving infliximab maintenance therapy . Two consecutive measurements > 300 mg/kg is more specific than a single measurement for predicting relapse Background : The correlation between noninvasive markers with endoscopic activity according to the modified Baron Index in patients with ulcerative colitis ( UC ) is unknown . We aim ed to evaluate the correlation between endoscopic activity and fecal calprotectin ( FC ) , C-reactive protein ( CRP ) , hemoglobin , platelets , blood leukocytes , and the Lichtiger Index ( clinical score ) . Methods : UC patients undergoing complete colonoscopy were prospect ively enrolled and scored clinical ly and endoscopically . Sample s from feces and blood were analyzed in UC patients and controls . Results : We enrolled 228 UC patients and 52 healthy controls . Endoscopic disease activity correlated best with FC ( Spearman 's rank correlation coefficient r = 0.821 ) , followed by the Lichtiger Index ( r = 0.682 ) , CRP ( r = 0.556 ) , platelets ( r = 0.488 ) , blood leukocytes ( r = 0.401 ) , and hemoglobin ( r = −0.388 ) . FC was the only marker that could discriminate between different grade s of endoscopic activity ( grade 0 , 16 [ 10–30 ] & mgr;g/g ; grade 1 , 35 [ 25–48 ] & mgr;g/g ; grade 2 , 102 [ 44–159 ] & mgr;g/g ; grade 3 , 235 [ 176–319 ] & mgr;g/g ; grade 4 , 611 [ 406–868 ] & mgr;g/g ; P < 0.001 for discriminating the different grade s ) . FC with a cutoff of 57 & mgr;g/g had a sensitivity of 91 % and a specificity of 90 % to detect endoscopically active disease ( modified Baron Index ≥2 ) . Conclusions : FC correlated better with endoscopic disease activity than clinical activity , CRP , platelets , hemoglobin , and blood leukocytes . The strong correlation with endoscopic disease activity suggests that FC represents a useful biomarker for noninvasive monitoring of disease activity in UC patients Background : Fecal biomarkers are used increasingly to monitor Crohn 's disease ( CD ) . However , the relative accuracy of different markers in identifying inflammation has been poorly evaluated . We evaluated fecal calprotectin ( FC ) , lactoferrin ( FL ) , and S100A12 ( FS ) using endoscopic validation in a prospect i ve study of the progression of CD after intestinal resection . Methods : Data were collected from 135 participants in a prospect i ve , r and omized , controlled trial aim ed at preventing postoperative CD recurrence . Three hundred nineteen stool sample s were tested for FC , FL , and FS preoperatively and 6 , 12 , and 18 months after resection . Colonoscopy was performed at 6 and /or 18 months . Endoscopic recurrence was assessed blindly using the Rutgeerts score . C-reactive protein ( CRP ) and Crohn 's Disease Activity Index ( CDAI ) were assessed . Results : FC , FL , and FS concentrations were elevated preoperatively ( median : 1347 , \n Output:\n " }, { "from": "agent", "value": "Our meta- analysis has found that FIT is a simple , reliable non-invasive marker for predicting MH in UC patients" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: More than 25 % of the U.S. population aged ≥65 years has diabetes ( 1 ) , and the aging of the overall population is a significant driver of the diabetes epidemic . Although the burden of diabetes is often described in terms of its impact on working-age adults , diabetes in older adults is linked to higher mortality , reduced functional status , and increased risk of institutionalization ( 2 ) . Older adults with diabetes are at substantial risk for both acute and chronic microvascular and cardiovascular complications of the disease . Despite having the highest prevalence of diabetes of any age-group , older persons and /or those with multiple comorbidities have often been excluded from r and omized controlled trials of treatments— and treatment targets — for diabetes and its associated conditions . Heterogeneity of health status of older adults ( even within an age range ) and the dearth of evidence from clinical trials present challenges to determining st and ard intervention strategies that fit all older adults . To address these issues , the American Diabetes Association ( ADA ) convened a Consensus Development Conference on Diabetes and Older Adults ( defined as those aged ≥65 years ) in February 2012 . Following a series of scientific presentations by experts in the field , the writing group independently developed this consensus report to address the following questions : 1 . What is the epidemiology and pathogenesis of diabetes in older adults ? 2 . What is the evidence for preventing and treating diabetes and its common comorbidities in older adults ? 3 . What current guidelines exist for treating diabetes in older adults ? 4 . What issues need to be considered in individualizing treatment recommendations for older adults ? 5 . What are consensus recommendations for treating older adults with or at risk for diabetes ? 6 . How can gaps in the evidence best be filled ? According to the most recent surveillance data , the prevalence of diabetes among U.S. adults aged ≥65 years varies from 22 to 33 % , depending on the diagnostic criteria OBJECTIVE To evaluate the effectiveness of community periodontal care intervention in type 2 diabetic patients with chronic periodontitis who participated in community non-communicable diseases management service . METHODS The r and omized controlled and blinded community trial with a duration of six months was design ed to compare effects of \" periodontal initial therapy \" on group I(22 cases ) , of \" professional mechanical tooth cleaning ( PMTC ) , i.e. coronal scaling \" on group II(19 cases ) and of \" non- clinical therapy \" on the control group(25 cases ) . The clinical periodontal indexes , such as probing depth ( PD ) , attachment loss ( AL ) , modified bleeding index ( mBI ) , plaque index ( PLI ) were obtained with a Williams type periodontal probe ; Laboratory examinations including glycosylated haemoglobin A1(HbA1C ) , glucose assay , were conducted . RESULTS The reductions of PD in groups I and II were 0.71 and 0.70 mm , respectively , which was more significant than in control group ( 0.20 mm ) ; the reductions of AL in groups I , II , and control group were 0.86 , 0.57 , and 0.03 mm , respectively , which showed significance in all the three groups . The subjects of groups I and II had 0.56 % and 1.01 % reductions of HbA1C respectively , and the significance was observed in group II . In addition , the improvement of HbA1C values in group II was highly correlated with the decrease in gingivitis ( r=0.51 , P=0.03 ) . CONCLUSION The community periodontal care approaches implemented in the community health service centers have significantly improved periodontal health as well as reduced glycemic level , which could be regarded as basic health care strategies for the patients with diabetes Background 40 subjects with type 2 diabetes and moderate to severe CP were r and omly distributed to groups receiving either NSPT or OHI . Periodontal parameters , glycosylated haemoglobin ( HbA1c ) and high-sensitivity C-reactive protein ( hs-CRP ) were evaluated at baseline , 2- and 3-months intervals . Methods 40 subjects with type 2 diabetes and moderate to severe CP were r and omly distributed to groups receiving either NSPT or OHI . Periodontal parameters , glycosylated haemoglobin ( HbA1c ) and high-sensitivity C-reactive protein ( hs-CRP ) were evaluated at baseline , 2- and 3-months intervals . Results 15 subjects from NSPT group and 17 from OHI group completed the study . The difference in plaque index ( PI ) between NSPT and OHI groups were significant at 2 months recall ( p = 0.013 ) . There was no significant difference between NSPT and OHI group for all other clinical periodontal parameters , HbA1c and CRP levels . At 3 months post-therapy , periodontal parameters improved significantly in both groups with sites with probing pocket depth ( PPD ) < 4 mm reported as 98 ± 1.8 % in NSPT group and 92 ± 14.9 % in OHI group . Mean PPD and mean probing attachment loss ( PAL ) within the NSPT group reduced significantly from baseline ( 2.56 ± 0.57 mm , 3.35 ± 0.83 mm ) to final visit ( 1.94 ± 0.26 mm , 2.92 ± 0.72 mm ) ( p = 0.003 , p < 0.001 ) . For OHI group , improvements in mean PPD and mean PAL were also seen from baseline ( 2.29 ± 0.69 mm , 2.79 ± 0.96 mm ) to final visit ( 2.09 ± 0.72 mm , 2.62 ± 0.97 mm ) ( p < 0.001 for both ) . Similarly , HbA1c levels decreased in both groups with NSPT group recording statistically significant reduction ( p = 0.038 ) . Participants who demonstrated ≥ 50 % reduction in PPD showed significant reductions of HbA1c and hs-CRP levels ( p = 0.004 and p = 0.012 ) . Conclusion NSPT significantly reduced PI at 2 months post-therapy as compared to OHI . Both NSPT and OHI demonstrated improvements in other clinical parameters as well as HbA1c and CRP levels . Trial registration Clinical Trials.gov : NCT01951547 BACKGROUND AND OBJECTIVE Several studies have shown that periodontitis can complicate the severity of diabetes by worsening the degree of glycemic control . The purpose of this study was to determine the effect of full-mouth tooth extraction on glycemic control among type 2 diabetic patients . MATERIAL AND METHODS A total of 58 patients with type 2 diabetes mellitus and advanced periodontitis who were requiring extraction of all remaining teeth were r and omized consecutively into treatment ( full-mouth tooth extraction ) and control groups ( no treatment ) . Eight patients were lost to follow-up or reported use of antibiotics , leaving 50 patients to be included in the analysis . All patients had all their remaining teeth in a hopeless condition . Relevant data were collected , and glycosylated hemoglobin ( HbA(1c ) ) and fasting blood glucose levels were measured at baseline and at follow-up times of 3 and 6 mo . RESULTS At baseline , the mean ( SD ) HbA(1c ) level was 8.6 % ( 1.24 ) in the treatment group and 7.7 % ( 0.87 ) in the control group . In the treatment group , the mean HbA(1c ) level decreased significantly from 8.6 % at baseline to 7.4 % after 3 mo of denture treatment , and continued to decrease to 7.3 % after 6 mo . In the control group , the mean HbA(1c ) decreased from 7.7 % at baseline to 7.5 % after 3 mo , and remained almost the same after 6 mo . After adjusting for the baseline HbA(1c ) , the mean reduction in HbA(1c ) after 3 mo in the treatment group [ 1.23 % ( 0.79 ) ] was significantly higher than the mean reduction in the control group [ 0.28 % ( 0.87 ) ] . CONCLUSION Full-mouth tooth extraction result ed in an improvement in glycemic control among diabetic patients . Large-scale multicentre clinical trials are needed to confirm the current evidence The aim of this study was to evaluate changes in clinical parameters and levels of inflammatory biomarkers in plasma in periodontal patients with poorly controlled type 2 diabetes mellitus ( T2DM ) after non-surgical periodontal therapy . Twenty-eight poorly controlled T2DM patients were r and omly assigned to treatment with scaling and root planning ( SRP ) and SRP + subgingival minocycline administration . Clinical parameters , including the probing depth ( PD ) , bleeding on probing ( BOP ) , plaque score ( PS ) , clinical attachment level ( CAL ) , and plasma interleukin (IL)-6 , soluble receptor of advanced glycation end products ( sRAGE ) , chronic reactive protein ( CRP ) , and hemoglobin A1c ( HbA1c ) were measured before and after a 6-month treatment period . Significant changes in PD , BOP , PS , and CAL were found in both groups . The latent growth curve model showed an overall reduction in the log HbA1c level in the SRP group ( −0.082 , p = 0.033 ) . Small changes in the log sRAGE level and log CRP level in plasma were found in both groups . IL-6 in the plasma increased in the SRP group , but slightly decreased in the SRP+minocycline group ( 0.469 pg/ml , p = 0.172 ) . Non-surgical periodontal therapy with or without subgingival minocycline application may achieve significant periodontal improvement and moderate improvement in HbA1c , but had no significant effect on plasma levels of IL-6 , CRP , or sRAGE in patients with poorly controlled T2DM . For patients with both periodontal diseases and diabetes , non-surgical periodontal treatments may be helpful in their diabetic control OBJECTIVES We are conducting a clinical trial of the efficacy of periodontal therapy in the improvement of glycaemic control in veterans with poorly controlled diabetes . This report describes study design , recruitment and r and omization and compares baseline characteristics of the sample frame with those r and omized into study groups . METHODS Veterans with poorly controlled diabetes were r and omized in two groups : immediate periodontal therapy ( \" early treatment \" ) or usual care followed by periodontal therapy ( \" deferred treatment \" ) . Half of each group continued care for 12 months ; the other half returned to their usual care . We studied baseline patient characteristics , self-reported health measures , and clinical examination data . We examined means for continuous variables , frequencies for categorical variables and compared groups using t-tests and chi(2 ) tests ( alpha=0.05 for both ) . RESULTS The 193 r and omized participants were younger ( 58 years ) and had slightly higher HbA1c ( 10.2 % ) than the 2534 non-r and omized participants ( 64 years , HbA1c = 9.8 % ) . The deferred treatment group was more likely than the early treatment group to have a history of stroke , transient ischaemic attacks , and less likely to be current or former smokers . CONCLUSIONS The mechanism for r and omization was largely successful in this study IMPORTANCE Chronic periodontitis , a destructive inflammatory disorder of the supporting structures of the teeth , is prevalent in patients with diabetes . Limited evidence suggests that periodontal therapy may improve glycemic control . OBJECTIVE To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin ( HbA1c ) in persons with type 2 diabetes and moderate to advanced chronic periodontitis . DESIGN , SETTING , AND PARTICIPANTS The Diabetes and Periodontal Therapy Trial ( DPTT ) , a 6-month , single-masked , multicenter , r and omized clinical trial . Participants had type 2 diabetes , were taking stable doses of medications , had HbA1c levels between 7 % and less than 9 % , and untreated chronic periodontitis . Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers . INTERVENTIONS The treatment group ( n = 257 ) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months . The control group ( n = 257 ) received no treatment for 6 months . MAIN OUTCOMES AND MEASURES Difference in change in HbA1c level from baseline between groups at 6 months . Secondary outcomes included changes in probing pocket depths , clinical attachment loss , bleeding on probing , gingival index , fasting glucose level , and Homeostasis Model Assessment ( HOMA2 ) score . RESULTS Enrollment was stopped early because of futility . At 6 months , mean HbA1c levels in the periodontal therapy group increased 0.17 % ( SD , 1.0 ) , compared with 0.11 % ( SD , 1.0 ) in the control group , with no significant difference between groups based on a linear regression model adjusting for clinical site ( mean difference , -0.05 % [ 95 % CI , -0.23 % to 0.12 % ] ; P = .55 ) . Periodontal measures improved in the treatment \n Output:\n " }, { "from": "agent", "value": "Conclusion The evidence suggests a beneficial effect of receiving periodontal care on serum glycated hemoglobin and systemic biomarker levels in older persons with T2DM .\nSuch care would be considered a novel , safe , and acceptable adjunct to current medical management of T2DM in older individuals ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: 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 Stroke prevention in atrial fibrillation ( AF ) , most commonly with warfarin , requires maintenance of a narrow therapeutic target ( INR 2.0 to 3.0 ) and is often poorly controlled in practice . Poor patient-underst and ing surrounding AF and its treatment may contribute to the patient ’s willingness to adhere to recommendations . Method A theory-driven intervention , developed using patient interviews and focus groups , consisting of a one-off group session ( 1–6 patients ) utilising an “ expert-patient ” focussed DVD , educational booklet , self-monitoring diary and worksheet , was compared in a r and omised controlled trial ( IS RCT N93952605 ) against usual care , with patient postal follow-ups at 1 , 2 , 6 , and 12-months . Ninety-seven warfarin-naïve AF patients were r and omised to intervention ( n=46 , mean age ( SD ) 72.0 ( 8.2 ) , 67.4 % men ) , or usual care ( n=51 , mean age ( SD ) 73.7 ( 8.1 ) , 62.7 % men ) , stratified by age , sex , and recruitment centre . Primary endpoint was time within therapeutic range ( TTR ) ; secondary endpoints included knowledge , quality of life , anxiety/depression , beliefs about medication , and illness perceptions . Main Findings Intervention patients had significantly higher TTR than usual care at 6-months ( 76.2 % vs. 71.3 % ; p=0.035 ) ; at 12-months these differences were not significant ( 76.0 % vs. 70.0 % ; p=0.44 ) . Knowledge increased significantly across time ( F ( 3 , 47 ) = 6.4 ; p<0.01 ) , but there were no differences between groups ( F ( 1 , 47 ) = 3.3 ; p = 0.07 ) . At 6-months , knowledge scores predicted TTR ( r=0.245 ; p=0.04 ) . Patients ’ scores on subscales representing their perception of the general harm and overuse of medication , as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months . Conclusions A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months . Adverse clinical outcomes may potentially be reduced by improving patients ’ underst and ing of the necessity of warfarin and reducing their perception of treatment harm . Improving education provision for AF patients is essential to ensure efficacious and safe treatment . The trial is registered with Current Controlled Trials , IS RCT N93952605 , and details are available at www.controlled-trials.com/IS RCT N93952605 Background Effective and safe management of oral anticoagulant treatment ( OAT ) requires a high level of patient knowledge and adherence . The aim of this study was to assess patient knowledge about OAT and factors associated with patient knowledge . Methods This is a baseline survey of a cluster-r and omized controlled trial in 22 general practice s with an educational intervention for patients or their caregivers . We assessed knowledge about general information on OAT and key facts regarding nutrition , drug-interactions and other safety pre caution s of 345 patients at baseline . Results Participants rated their knowledge about OAT as excellent to good ( 56 % ) , moderate ( 36 % ) or poor ( 8 % ) . However , there was a discrepancy between self-rated knowledge and evaluated actual knowledge and we observed serious knowledge gaps . Half of the participants ( 49 % ) were unaware of dietary recommendations . The majority ( 80 % ) did not know which non-prescription analgesic is the safest and 73 % indicated they would not inform pharmacists about OAT . Many participants ( 35 - 75 % ) would not recognize important emergency situations . After adjustment in a multivariate analysis , older age and less than 10 years education remained significantly associated with lower overall score , but not with self-rated knowledge . Conclusions Patients have relevant knowledge gaps , potentially affecting safe and effective OAT . There is a need to assess patient knowledge and for structured education programs . Trial registration Deutsches Register Klinischer Studien ( German Clinical Trials Register ) : DRKS00000586.Universal Trial Number ( UTN U1111 - 1118 - 3464 ) BACKGROUND The knowledge of warning symptoms and risk factors for stroke has not been studied among patients with stroke in developing countries . AIMS We aim ed to assess the knowledge of stroke among patients with stroke and their relatives . SETTING S AND DESIGN Prospect i ve tertiary referral hospital-based study in Northwest India . MATERIAL S AND METHODS Trained nurses and medical interns interviewed patients with stroke and transient ischemic attack and their relatives about their knowledge of stroke symptoms and risk factors . STATISTICAL ANALYSIS Univariable and multivariable logistic regression were used . RESULTS Of the 147 subjects interviewed , 102 ( 69 % ) were patients and 45 ( 31 % ) were relatives . There were 99 ( 67 % ) men and 48 ( 33 % ) women and the mean age was 59.7+/-14.1 years . Sixty-two percent of respondents recognized paralysis of one side as a warning symptom and 54 % recognized hypertension as a risk factor for stroke . In the multivariable logistic regression analysis , higher education was associated with the knowledge of correct organ involvement in stroke ( OR 2.6 , CI 1.1- 6.1 , P = 0.02 ) , whereas younger age ( OR 2.7 , CI 1.1 - 7.0 , P = 0.04 ) and higher education ( OR 4.1 , CI 1.5 - 10.9 , P = 0.005 ) correlated with a better knowledge regarding warning symptoms of stroke . CONCLUSIONS In this study cohort , in general , there is lack of awareness of major warning symptoms , risk factors , organ involvement and self-recognition of stroke . However younger age and education status were associated with better knowledge . There is an urgent need for awareness programs about stroke in this study cohort OBJECTIVE Previous research has demonstrated that patients with atrial fibrillation ( AF ) possess very little knowledge of their disease , the consequences of AF and the benefits /risks of anti-coagulant therapy . The aim of this pilot study was to examine patient 's knowledge and perceptions of AF and their anticoagulant treatment before and after a brief educational intervention . MATERIAL S AND METHODS Ninety-three patients ( 47 male ; mean ( S.D. ) age 67.3 ( 11.6 ) years ) completed the baseline interview to assess their knowledge and perceptions of AF . All patients were given an information booklet which explained what AF was , associated symptoms , the possible causes and consequences of AF , treatment options and their benefits /risks , what the INR is and what factors may effect it . The booklet was explained to each patient by the research er and given to the patient to take away for reference . Thirty-three ( 35.5 % ) patients ( 12 men ; mean ( S.D. ) age 68.0 ( 13.6 ) years ) completed the follow-up assessment to re-assess their knowledge and perceptions of AF . RESULTS Only 49 % of patients could name their cardiac condition at baseline , although the majority were aware that AF was an arrhythmia ( 80 % baseline vs. 91 % follow-up ) . Only about half the patients perceived AF as a serious condition or were aware that AF predisposes to thromboembolism at baseline . Following the educational intervention there was a non-significant increase in patient knowledge of the risks associated with AF . Of those who completed both question naires , 52 % were aware that anticoagulants prevented blood clots , which increased to 70 % post-intervention . However , few patients were aware of the benefit of stroke prevention associated with anticoagulants at baseline ( 21 % ) or after the educational intervention ( 27 % ) . The intervention had little effect on increasing awareness of the bleeding risks associated with anticoagulants , although three in five people appeared to appreciate these risks . However , the educational intervention significantly improved patient 's knowledge of the target INR range and factors that may affect INR levels ( p=0.001 and p=0.014 , respectively ) for those who completed both question naires . CONCLUSIONS Most patients with AF possess very limited knowledge about their cardiac condition , its consequences , and how anticoagulant treatment can benefit them . This pilot study has demonstrated that a brief educational intervention with an information booklet can help to somewhat improve their knowledge about anticoagulation therapy for AF Of 125 patients aged 65 years or over , with atrial fibrillation taking warfarin for at least 12 months , with a st and ard deviation ( SD ) of prothrombin time , expressed as the International Normalized Ratio ( INR ) > 0·5 over the previous 6 months , 40 were r and omized to continue with usual clinic care and 85 to receive education about warfarin . Of these , 44 were r and omized to self‐monitor their INR and 41 returned to clinic . Compared with the previous 6 months there was a significant increase in percentage time within the therapeutic range for the 6 months following education [ 61·1 vs. 70·4 ; mean difference 8·8 ; 95 % confidence interval ( CI ) : −0·2–17·8 ; P = 0·054 ] and following education and self‐monitoring ( 57 vs. 71·1 ; mean difference 14·1 ; 95 % CI : 6·7–21·5 ; P < 0·001 ) , compared with those patients following usual clinic care ( 60·0 vs. 63·2 ; mean difference 3·2 ; 95 % CI : −7·3–13·7 ) . Using the same comparative periods , the INR SD fell by 0·24 ( P < 0·0001 ) in the group allocated to education and self‐monitoring , 0·26 ( P < 0·0001 ) in the group receiving education alone and 0·16 ( P = 0·003 ) in the control group . Inter‐group differences were not statistically significant ( intervention groups 0·26 ± 0·30 vs. control 0·16 ± 0·3 , P = 0·10 ) . Quality ‐of‐life measurements and health beliefs about warfarin were unchanged ( apart from emotional role limitation ) with education or education and self‐monitoring . Patient education regarding anticoagulation therapy could be a cost‐effective initiative and is worthy of further study \n Output:\n " }, { "from": "agent", "value": "Conclusion and Relevance : This systematic review identified several AF patient knowledge gaps about their condition and its treatment that can inform the development of AF patient education programs" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE We examined the effects of megestrol acetate versus placebo and progressive resistance physical exercise on weight , lean muscle mass , quality of life , ability to exercise , proinflammatory cytokines , and anti-inflammatory cytokines , and their correlations with one another . DESIGN We organized a prospect i ve 20-week , r and omized , double-blind , placebo-controlled pilot trial of hemodialysis patients . SETTING This study took place at the Outpatient Unit of the Northport Veteran Affairs Medical Center . SUBJECTS We studied nine male hemodialysis patients who had two or more of the following : albumin level < 4.0 g/dL , total cholesterol < 150 mg/dL , protein catabolic rate < 0.8 g/kg/day , and predialysis serum urea nitrogen < 60 mg/dL. Their ages were 50 to 83 years . Two were diabetic , and seven were nondiabetic . INTERVENTIONS Interventions included megestrol acetate ( MA ) or placebo 800 mg oral daily for 20 weeks , along with weight resistance physical therapy with weights twice a week before dialysis . Patients were followed prospect ively for an additional 4 weeks . MAIN OUTCOME MEASUREMENTS Weight , body composition , activities of daily living , ability to exercise , and plasma cytokine levels were measured . RESULTS At 24 weeks , the MA group had a statistically significant weight gain ( 11.1-pound increase vs. 1.5-pound decrease for the placebo group , P = .018 ) , body fat gain ( 6.2-pound increase vs. a 0.4-pound decrease for the placebo group , P = .044 ) and fat-free mass gain ( 5-pound increase vs. a 1.2-pound decrease in the placebo group ) . The MA group also had a greater tendency toward increased appetite and sense of well-being . The MA group showed a greater improvement in ability to exercise ( mean change in rate of perceived exertion ( RPE ) , 4.7 ) vs. the placebo group ( mean change in RPE vs. 0.5 , P = .02 ) . Elevated cytokine levels were evident at baseline in both groups . In all patients , increases in weight , fat-free mass , sense of well-being , appetite , and ability to exercise were negatively correlated with tumor necrosis factor receptor subunit p75 ( P < .05 ) . There was a trend toward all of these parameters to be negatively correlated with tumor necrosis factor receptor subunit p55 , although only sense of well-being was statistically significant ( P < .05 ) . CONCLUSION In a pilot trial in dialysis patients , MA showed significant benefits in improving weight and ability to exercise . Cytokine changes were correlated with weight gains and increases in fat-free mass BACKGROUND Malnutrition-inflammation complex syndrome and anorexia , common conditions in maintenance dialysis patients , are strongly associated with higher mortality and hospitalization and lower quality of life ( QoL ) in this population . Megestrol acetate , 800 mg/day , has been shown to increase appetite and food intake and to mitigate inflammation in cachectic AIDS and cancer patients , leading to weight gain , but it is also associated with side effects at this dose . METHODS We evaluated the efficacy of the oral solution of megestrol acetate in half of its conventional dose in improving the nutritional state and inflammation in 10 hypoalbuminemic dialysis patients ( albumin < 3.7 g/dL ) . Six women and 4 men , ages 60.2 years , took 400 mg of megestrol acetate solution daily for 16 weeks . Anthropometry , dual energy x-ray absorptiometry , 24-hour diet recalls , and biochemical measurements of nutrition and inflammation , including serum C-reactive protein and leptin , were performed . RESULTS At the end of the 16 weeks of intervention , weight and body mass index increased by 9 % , body fat proportion by 31 % , and triceps skinfold by 40 % ( P < .01 ) . Serum albumin increased from 3.0 to 3.3 g/dL and continued to increase significantly to 3.6 g/dL after 3 months postintervention ( P = .03 ) . Serum leptin increased from 5.2 to 10.7 ng/mL ( P = .09 ) . Daily protein and energy intake increased progressively up to 27 % to 42 % by the end of the trial ( P < or = .01 ) . In 8 patients without acute infection , serum C-reactive protein declined from 1.24 to 0.78 mg/L ( P = .06 ) . QoL and appetite were reported to be improved . No major side effects were observed , and all 10 patients completed the 16 weeks of daily intake of megestrol acetate without interruption . CONCLUSIONS Megestrol acetate oral solution in half of its conventional dose is safe and improves the nutritional state , inflammation , and anorexia in maintenance dialysis patients . Larger-scale placebo-controlled r and omized studies are needed to confirm the beneficial effects of 400 mg/day of megestrol acetate in dialysis patients Weight loss is known to impact survival among patients infected with human immunodeficiency virus ( HIV ) even in the era of highly active antiretroviral therapy ( HAART ) . In a r and omized trial , we compared the effects of 2 months of treatment with either megestrol acetate ( 800 mg every day ) or ox and rolone ( 10 mg twice per day ) on body weight and composition in patients with weight loss of > or = 5 kg who were receiving HAART . The mean weight was 66 kg , and the mean body mass index was 21 . Mean weight gain in the megestrol acetate and the ox and rolone arms were 2.8 kg ( 4.6 % of the baseline value ) and 2.5 kg ( 3.9 % of the baseline value ) , respectively ( P=.80 ) . Lean body mass accounted for 39 % of weight gain in the megestrol acetate arm and 56 % in the ox and rolone arm ( P=.38 ) . Seven patients in the megestrol acetate arm and 5 patients in the ox and rolone arm reported minor adverse events ( P=.74 ) . In conclusion , megestrol acetate therapy and ox and rolone therapy have similar effects on body weight and composition and are safe and well-tolerated during HAART Aim : N-3 fatty acids , especially eicosapentaenoic acid ( EPA ) , may possess anticachectic properties . This trial compared a protein and energy dense supplement enriched with n-3 fatty acids and antioxidants ( experimental : E ) with an isocaloric isonitrogenous control supplement ( C ) for their effects on weight , lean body mass ( LBM ) , dietary intake , and quality of life in cachectic patients with advanced pancreatic cancer . Methods : A total of 200 patients ( 95 E ; 105 C ) were r and omised to consume two cans/day of the E or C supplement ( 480 ml , 620 kcal , 32 g protein ± 2.2 g EPA ) for eight weeks in a multicentre , r and omised , double blind trial . Results : At enrolment , patients ’ mean rate of weight loss was 3.3 kg/month . Intake of the supplements ( E or C ) was below the recommended dose ( 2 cans/day ) and averaged 1.4 cans/day . Over eight weeks , patients in both groups stopped losing weight ( Δ weight E : −0.25 kg/month versus C : −0.37 kg/month ; p = 0.74 ) and LBM ( Δ LBM E : + 0.27 kg/month versus C : + 0.12 kg/month ; p = 0.88 ) to an equal degree ( change from baseline E and C , p<0.001 ) . In view of evident non-compliance in both E and C groups , correlation analyses were undertaken to examine for potential dose-response relationships . E patients demonstrated significant correlations between their supplement intake and weight gain ( r = 0.50 , p<0.001 ) and increase in LBM ( r = 0.33 , p = 0.036 ) . Such correlations were not statistically significant in C patients . The relationship of supplement intake with change in LBM was significantly different between E and C patients ( p = 0.043 ) . Increased plasma EPA levels in the E group were associated with weight and LBM gain ( r = 0.50 , p<0.001 ; r = 0.51 , p = 0.001 ) . Weight gain was associated with improved quality of life ( p<0.01 ) only in the E group . Conclusion : Intention to treat group comparisons indicated that at the mean dose taken , enrichment with n-3 fatty acids did not provide a therapeutic advantage and that both supplements were equally effective in arresting weight loss . Post hoc dose-response analysis suggests that if taken in sufficient quantity , only the n-3 fatty acid enriched energy and protein dense supplement results in net gain of weight , lean tissue , and improved quality of life . Further trials are required to examine the potential role of n-3 enriched supplements in the treatment of cancer cachexia CONTEXT Reduced energy intake is a primary factor in HIV-associated wasting . Megestrol acetate ( MA ) stimulates appetite and weight gain . However , much of the weight gained is fat , possibly as a result of MA-induced hypogonadism . OBJECTIVE The objective of the study was to determine whether coadministration of testosterone with MA could enhance lean body mass ( LBM ) accrual and evaluate the effects of MA , alone or combined with testosterone , on sexual functioning and the hypothalamic-pituitary-adrenal axis . DESIGN This was a r and omized , double-blind , placebo-controlled , multicenter trial . SETTING Fourteen AIDS Clinical Trials Units in the United States participated in the study . SUBJECTS Seventy-nine HIV-positive men with 5 % or more weight loss or body mass index less than 20 kg/m2 took part in the study . INTERVENTION Subjects were r and omized to receive MA ( 800 mg daily ) plus testosterone enanthate ( 200 mg ; MA/TE ; n = 41 ) or placebo ( MA/PL ; n = 38 ) biweekly for 12 wk . MAIN OUTCOME MEASURES Weight , body composition ( bioelectric impedance analysis ) , adrenal and gonadal hormones , and sexual functioning ( question naire ) were measured . RESULTS Both groups experienced robust increases in weight ( median 5.3 and 7.3 kg in MA/TE and MA/PL , respectively ) , LBM ( 3.3 and 3.3 kg ) , and fat ( 3.0 and 3.8 kg ) . There were no significant differences between groups in the magnitude or composition of weight gain ( P = 0.44 , 0.90 , and 0.11 for weight , LBM , and fat , respectively ) . Trough testosterone concentrations decreased to a greater extent in MA/PL ( -12.3 vs. -6.1 nmol/liter in MA/TE ; P = 0.04 ) . Cortisol levels became nearly undetectable in subjects with plasma MA levels greater than 150 ng/ml . Sexual functioning was preserved with MA/TE but worsened in MA/PL . CONCLUSIONS MA produced robust weight gain . Coadministration of testosterone preserved sexual functioning but did not enhance LBM accrual BACKGROUND We examined changes in total body weight ( TBW ) and health-related quality of life ( HRQL ) during prolonged combination weight-gaining therapy and dietary advice in HIV . DESIGN This was a cohort study of patients initially r and omized to single agent therapy for 2 months , megestrol acetate ( 800 mg daily ) , or ox and rolone ( 10 mg twice daily ) , followed by both agents and dietary advice for 5 months . METHODS Two community health clinics and 1 urban infectious disease clinic were included , as were HIV-positive adult patients receiving highly active antiretroviral therapy with documented 5 % weight loss . TBW and HRQL were measured after 7 months ( 7 m ) . RESULTS Twenty-nine of 39 participants completed 7 m. The average sample age was 40 years , 75 % were male , and 52 % were of color at enrollment . Baseline mean TBW and body mass index ( BMI ) were 62.5 kg and 21 kg/m(2 ) , respectively . Net gains in TBW , lean body mass , and fat during the 7 m were 5.3 kg ( 8.5 % of baseline ) , 2.1 kg , and 3.1 kg , respectively ( p < .01 for each ) . BMI increased to 23.1 kg/m(2 ) ( p < .01 ) . Dietary intake increased by 467 kcal/day ( p = .03 ) . Physical health improved by 5.7 ( 100-point scale , p < .01 ) , and mental health was unchanged ( -4.2 , p = .11 ) . In multivariable models , female gender ( p < .01 ) , lower baseline HIV viral load ( p = .03 ) , and increasing age ( p < .01 ) were associated with TBW gain . Injection drug use ( p < .01 ) and higher baseline HIV viral load ( p < .01 ) were associated with reduction in physical health . CONCLUSIONS Prolonged combination ther \n Output:\n " }, { "from": "agent", "value": "There was little evidence to show significant impact on LBM , and no trials looked at muscle strength .\nCurrent evidence does not support the use of progesterone therapies for non-cancer cachexia .\nThere may however be a limited role for its use as an appetite stimulant in a palliative context on a case-by-case basis" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This study attempted to determine the best method of treatment for patients with recurrent preterm labor : administration of terbutaline via an automated , programmable , subcutaneous infusion pump or oral terbutaline . In this retrospective , controlled study , 32 patients diagnosed with recurrent preterm labor , as determined by persistent uterine contractions with cervical change , were treated with a programmable infusion pump adjusted to control uterine contraction frequency to < or = 4 contractions per hour . Patients in this group were matched for age , race , parity , gestational age and cervical dilation at diagnosis of recurrent preterm labor in subjects taking oral terbutaline . The patients receiving oral terbutaline were given an average of 6.5 mg every four to six hours to maintain uterine quiescence , while those in the pump group were given basal rates of terbutaline and in addition received four to six boluses per day ( < 3 mg/d total dose ) to achieve this outcome . Patients using the pump were more likely to reach term and less likely to fail tocolytic therapy than were those taking oral terbutaline . The terbutaline pump appeared to be more successful in prolonging pregnancies to term after the diagnosis of recurrent preterm labor than did oral terbutaline PURPOSE To compare the clinical benefit and cost-effectiveness of utilizing continuous subcutaneous terbutaline versus oral tocolytics following recurrent preterm labor . DESIGN Retrospective , 1:1 matched cohort . METHODOLOGY From prospect ively collected data in a nationwide , perinatal data base of women receiving outpatient services , we identified singleton gestations having recurrent preterm labor , stabilized during hospitalization , and subsequently treated with oral tocolytics ( PO group ) or continuous subcutaneous terbutaline infusion ( SQ group ) . Those without medically indicated delivery were eligible for inclusion . Each woman in the PO group was matched 1:1 by gestational age at recurrent preterm labor to a woman in the SQ group . A st and ardized cost model was applied to compare total antepartum hospital , nursery , and outpatient charges . Wilcoxon Signed Rank , paired t , and McNemar 's C2 test statistics were used for comparisons . PRINCIPAL FINDINGS 558 women were studied ( 279 per group ) . The PO group had less gestational gain following recurrent preterm labor than the SQ group ( 28.4 + /- 19.8 days vs. 33.9 + /- 19.0 days , respectively , P < .001 ) . The SQ group had less per patient charges ( $ ) for antepartum hospitalization ( 3,986 + /- 6,895 vs. 5,495 + /- 7,131 , P = .009 ) , and nursery ( 7,143 + /- 20,048 vs. 15,050 + /- 32,648 , P < .001 ) . Outpatient charges were less for the PO group ( 1,390 + /- 1,152 vs. 5,520 + /- 3,292 , P < .001 ) . Overall costs for those in the SQ group were $ 5,286 less per pregnancy compared to the PO group . CONCLUSION In this population , continuous subcutaneous terbutaline infusion was both a clinical ly beneficial and cost-effective treatment following recurrent preterm labor OBJECTIVE Our hypothesis was that use of the subcutaneous terbutaline pump does not affect maternal glucose tolerance . STUDY DESIGN With the 1-hour glucose tolerance test , we examined the incidence of glucose intolerance in 37 patients using the pump compared with that of 54 patients receiving oral terbutaline and 634 control subjects without risk factors for gestational diabetes . The frequency of gestational diabetes and the need for insulin to maintain glycemic control were subjected to chi 2 analysis . RESULTS The incidence of gestational diabetes was 6 % in the control subjects , 5 % in patients using the pump ( p = 0.8 ) , and 11 % in those on the oral therapy regimen ( p = 0.4 ) . A total of 8 % of controls who had gestational diabetes required both insulin and diet , compared with 100 % using the pump ( p less than 0.01 ) and 50 % on the oral terbutaline regimen ( p = 0.03 ) . CONCLUSION The incidence of gestational diabetes is not increased in patients receiving terbutaline via the subcutaneous pump . The use of terbutaline by any route significantly increases the need for insulin to achieve glycemic control To determine the efficacy of the terbutaline pump for the prevention of preterm delivery , patients in preterm labor defined by progressive cervical change underwent intravenous magnesium sulfate tocolysis ( with or without oral indomethacin , as necessary ) , and once labor was arrested , were r and omized to one of three treatment arms : terbutaline by pump , saline by pump ( blinded ) , or oral terbutaline . If recurrent preterm labor occurred despite maximization of therapy , the treatment arm was determined and therapy was changed ; saline pump and oral terbutaline were switched to terbutaline pump , terbutaline pump was switched to oral terbutaline . Patients who continued to labor were readmitted for aggressive intravenous therapy . Women r and omized to the terbutaline pump ( n = 15 ) , saline pump ( n = 12 ) , and oral terbutaline ( n = 15 ) groups were similar in terms of gravidity , parity , days of tocolysis before study entry , gestational age at entry , and cervical dilatation at entry . The mean gestational age at delivery was the same in all three groups ( 35 weeks ) , as were neonatal outcomes . Terbutaline by pump , saline by pump , and oral terbutaline appear equivalent for the prevention of preterm delivery . The terbutaline pump should remain experimental We examined pregnancy outcomes in women receiving nifedipine tocolysis having recurrent preterm labor ( RPTL ) . Singleton gestations enrolled for outpatient nursing surveillance and prescribed nifedipine tocolysis were identified ( N = 4748 ) . Women hospitalized for RPTL at < 35 weeks then resuming outpatient surveillance were included ( N = 1366 ) . Pregnancy outcomes of women resuming nifedipine ( N = 830 ) were compared with those having an alteration in treatment to continuous subcutaneous terbutaline ( N = 536 ) . Overall , 56.7 % ( 2692/4748 ) experienced RPTL . Half ( 50.7 % ) were stabilized and resumed outpatient surveillance with nifedipine or continuous subcutaneous terbutaline . Infants from women resuming nifedipine versus those with alteration of treatment to terbutaline were more likely to deliver at < 35 weeks ( 28.0 % versus 13.8 % ) , weigh < 2500 g ( 32.9 % versus 20.3 % ) , and require a stay in the neonatal intensive care unit ( 34.0 % versus 23.1 % ) , all P < 0.001 . Alteration of tocolytic treatment following RPTL result ed in a decreased incidence of preterm birth and low birth weight , result ing in less admission to the neonatal intensive care unit and fewer nursery days \n Output:\n " }, { "from": "agent", "value": "The authors conclude that subcutaneous terbutaline pump is beneficial and safe for maintenance of tocolysis based on all the available evidence .\nAlthough we found that the pump was beneficial for some outcomes ( i.e. , neonatal death , incidence of delivery < 32 weeks and < 37 weeks , and prolonging pregnancy ) , importantly , these benefits were rated as having low strength of evidence , which means that we have low confidence that the evidence reflects the true effect [ 22 ] ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND A r and omised trial was performed on patients presenting to hospital with an exacerbation of chronic obstructive pulmonary disease ( COPD ) to compare outcomes in those managed at home with support with those admitted to hospital in the st and ard manner . METHODS Over an 18 month period all patients presenting to the Royal Infirmary of Edinburgh on weekdays ( n=718 ) with a diagnosis of an exacerbation of COPD were assessed for inclusion in the trial . Patients with impaired level of consciousness , acute confusion , acute changes on radiography , or an arterial pH of < 7.35 or with other serious medical or social reasons for admission were excluded . Patients r and omised to home support were discharged with an appropriate treatment package ( antibiotics , corticosteroids , nebulised bronchodilators and , if necessary , home oxygen ) . They were visited by a nurse the following day and thereafter at intervals of 2 - 3 days until recovery when they were discharged from follow up . Parallel observations were made on patients allocated to normal hospital admission up to the point of discharge . Patients in both groups were assessed at home eight weeks after the initial assessment . RESULTS Among weekday patients 353 ( 50 % ) were considered obligatory admissions , 140 ( 19 % ) were admitted because of co-morbidity , 17 ( 2 % ) because of poor social circumstances , and 24 ( 3 % ) did not consent to the trial . The remaining 184 ( 26 % ) were r and omised ( 2:1 ) either to home support or to a st and ard hospital admission . The median time to discharge was 7 days for the home support group and 5 days for the admitted group ( p<0.01 ) ; 25 % of the home support group and 34 % of the admitted group were readmitted before the final assessment at eight weeks ( p>0.05 ) . There were no significant differences between the groups in attendances by GPs and carers or in health status measured eight weeks after the initial assessment . Satisfaction with the service was good . The mean total health service cost per patient was estimated as 877 pounds sterling for the home support group and 1753 pounds sterling for the admitted group . CONCLUSIONS This study shows that home supported discharge is a well tolerated , safe , and economic alternative to hospital admission for a proportion of patients referred to hospital for admission for an exacerbation of COPD The aim of the present prospect i ve multicentric study was to develop a simple rule for the prediction of poor outcome in patients presenting to emergency departments with initially non-life threatening-chronic obstructive pulmonary disease ( COPD ) exacerbations in a real-life setting . All patients with an acute exacerbation of COPD visiting the emergency departments of 103 hospitals during a 3-month period were included , except those who immediately required intensive care unit admission and /or ventilatory support . The data collected included patient characteristics , in-hospital outcomes ( mortality and length of stay ) and mode of discharge ( unsupported or need for post-hospital assistance ) . The in-hospital mortality rate was 7.4 % ( 59 out of 794 ) . Independent prognostic factors were age , number of clinical signs of severity ( among cyanosis , impaired neurological status , lower limb oedema , asterixis and use of accessory inspiratory or expiratory muscles ) and dyspnoea grade in the stable state . The need for post-hospital support was also predicted by female sex . In order to construct and vali date a prediction score for mortality based on these items , patients were r and omly allocated to a derivation and a validation cohort . The prediction score showed good discrimination , with a c-statistic of 0.79 in the derivation cohort and 0.83 in the validation cohort . Thus simple purely clinical factors can reliably predict the risk of death and requirement for post-hospital support in an initially non-life threatening-acute exacerbation of chronic obstructive pulmonary disease . Their use needs to be prospect ively vali date Background Exacerbations of Chronic Obstructive Pulmonary Disease ( COPD ) are the main cause for hospitalisation . These hospitalisations result in a high pressure on hospital beds and high health care costs . Because of the increasing prevalence of COPD this will only become worse . Hospital at home is one of the alternatives that has been proved to be a safe alternative for hospitalisation in COPD . Most schemes are early assisted discharge schemes with specialised respiratory nurses providing care at home . Whether this type of service is cost-effective depends on the setting in which it is delivered and the way in which it is organised . Methods / Design GO AHEAD ( Assessment Of Going Home under Early Assisted Discharge ) is a 3-months , r and omised controlled , multi-centre clinical trial . Patients admitted to hospital for a COPD exacerbation are either discharged on the fourth day of admission and further treated at home , or receive usual inpatient hospital care . Home treatment is supervised by general nurses . Primary outcome is the effectiveness and cost effectiveness of an early assisted discharge intervention in comparison with usual inpatient hospital care for patients hospitalised with a COPD exacerbation . Secondary outcomes include effects on quality of life , primary informal caregiver burden and patient and primary caregiver satisfaction . Additionally , a discrete choice experiment is performed to provide insight in patient and informal caregiver preferences for different treatment characteristics . Measurements are performed on the first day of admission and 3 days , 7 days , 1 month and 3 months thereafter . Ethical approval has been obtained and the study has been registered . Discussion This article describes the study protocol of the GO AHEAD study . Early assisted discharge could be an effective and cost-effective method to reduce length of hospital stay in the Netherl and s which is beneficial for patients and society . If effectiveness and cost-effectiveness can be proven , implementation in the Dutch health care system should be considered . Trial registration Netherl and s Trial Register NTR1129 BACKGROUND We have previously reported the use of a hospital based respiratory nurse service ( Acute Respiratory Assessment Service , ARAS ) to support home treatment of patients with exacerbations of chronic obstructive pulmonary disease ( COPD ) . A controlled trial was undertaken to compare early discharge with home treatment supported by respiratory nurses with conventional hospital management of patients admitted with exacerbations of COPD . METHODS Patients with COPD admitted as emergencies were identified the next working day . They were eligible for inclusion in the study if the differential diagnosis included an exacerbation of COPD , but were excluded if other medical conditions or acidotic respiratory failure required inpatient investigation or management . Of 360 patients review ed , 209 were being assessed for other active medical problems and were excluded , 33 potential participants were already involved in research studies and so were ineligible , and 37 did not wish to participate in the study . Eighty one patients were r and omised to receive conventional inpatient care ( n=40 ) or to planned early discharge the next working day ( n=41 ) . Those discharged early continued treatment at home under the supervision of specialist respiratory nurses . Outcome measures were readmission , additional hospital days , and deaths within 60 days of initial admission . Process measures included number of visits , duration of follow up by the respiratory nurse , and additional treatment provided to support early discharge . RESULTS On an intention to treat basis , a policy of early discharge reduced inpatient stay from a mean of 6.1 ( range 1–13 ) days with conventional management to 3.2 ( 1–16 ) days with an early discharge policy . Twelve patients ( 30 % conventional management , 29.3 % early discharge ) were readmitted in each group giving a mean difference in readmission of 0.7 % ( 95 % CI of the difference –19.2 to 20.6 ) . In the conventional management group readmitted patients spent a mean of 8.75 additional days in hospital compared with 7.83 days in the early discharge group , giving a mean difference of 0.92 days ( 95 % CI of the difference –6.5 to 8.3 ) . There were two deaths ( 5 % ) in the conventional management group and one ( 2.4 % ) in the early discharge group , a mean difference of 2.6 % ( 95 % CI of the difference –5.7 to 10.8 ) . CONCLUSIONS Patients with acute exacerbations of COPD uncomplicated by acidotic respiratory failure or other medical problems can be discharged home earlier than is current practice with support by visiting respiratory nurses . No difference was found in the subsequent need for readmission It was postulated that home hospitalisation ( HH ) of selected chronic obstructive pulmonary disease ( COPD ) exacerbations admitted at the emergency room ( ER ) could facilitate a better outcome than conventional hospitalisation . To this end , 222 COPD patients ( 3.2 % female ; 71±10 yrs ( mean±sd ) ) were r and omly assigned to HH ( n=121 ) or conventional care ( n=101 ) . During HH , integrated care was delivered by a specialised nurse with the patient 's free-phone access to the nurse ensured for an 8‐week follow-up period . Mortality ( HH : 4.1 % ; controls : 6.9 % ) and hospital readmissions ( HH : 0.24±0.57 ; controls : 0.38±0.70 ) were similar in both groups . However , at the end of the follow-up period , HH patients showed : 1 ) a lower rate of ER visits ( 0.13±0.43 versus 0.31±0.62 ) ; and 2 ) a noticeable improvement of quality of life ( Δ St George 's Respiratory Question naire ( SGRQ ) , −6.9 versus −2.4 ) . Furthermore , a higher percentage of patients had a better knowledge of the disease ( 58 % versus 27 % ) , a better self-management of their condition ( 81 % versus 48 % ) , and the patient 's satisfaction was greater . The average overall direct cost per HH patient was 62 % of the costs of conventional care , essentially due to fewer days of inpatient hospitalisation ( 1.7±2.3 versus 4.2±4.1 days ) . A comprehensive home care intervention in selected chronic obstructive pulmonary disease exacerbations appears as cost effective . The home hospitalisation intervention generates better outcomes at lower costs than conventional care Objectives To determine the effectiveness of early assisted discharge for chronic obstructive pulmonary disease ( COPD ) exacerbations , with home care provided by generic community nurses , compared with usual hospital care . Design Prospect i ve , r and omised controlled and multicentre trial with 3-month follow-up . Setting Five hospitals and three home care organisations in the Netherl and s. Participants Patients admitted to the hospital with an exacerbation of COPD . Patients with no or limited improvement of respiratory symptoms and patients with severe unstable comorbidities , social problems or those unable to visit the toilet independently were excluded . Intervention Early discharge from hospital after 3 days inpatient treatment . Home visits by generic community nurses . Primary outcome measure was change in health status measured by the Clinical COPD Question naire ( CCQ ) . Treatment failures , readmissions , mortality and change in generic health-related quality of life ( HRQL ) were secondary outcome measures . Results 139 patients were r and omised . No difference between groups was found in change in CCQ score at day 7 ( difference in mean change 0.29 ( 95 % CI −0.03 to 0.61 ) ) or at 3 months ( difference in mean change 0.04 ( 95 % CI –0.40 to 0.49 ) ) . No difference was found in secondary outcomes . At day 7 there was a significant difference in change in generic HRQL , favouring usual hospital care . Conclusions While patients ’ disease-specific health status after 7-day treatment tended to be somewhat better in the usual hospital care group , the difference was small and not clinical ly relevant or statistically significant . After 3 months , the difference had disappeared . A significant difference in generic HRQL at the end of the treatment had disappeared after 3 months and there was no difference in treatment failures , readmissions or mortality . Early assisted discharge with community nursing is feasible and an alternative to usual hospital care for selected patients with an acute COPD exacerbation . Trial registration : Netherl and sTrialRegister NTR 1129 BACKGROUND The study was conducted to investigate the safety of \" hospital at home \" versus hospital care . MATERIAL S AND METHODS It was a prospect i ve r and omised controlled trial . Patients with an exacerbation of chronic obstructive pulmonary disease ( COPD ) were included and r and omised to supported discharge ( n = 22 ) or to conventional in-patient care ( n = 22 ) . Outcome measures were readmissions , complications , mortality within 60 days of initial admission . RESULTS 390 patients ( COPD ) were admitted and 44 patients ( 12 % ) were included in the study . In the home treatment period 2 patients ( 9 % ) were readmitted . One patient ( 4.5 % ) died 2 weeks after discharge from the home treatment . In the follow-up period 3 patients in the home treated group were readmitted 7 times ( 31.8 % ) , and 7 patients in the conventional in-patient group were readmitted 9 times ( 40.9 % ) . There were 14 complications ( 63.6 % ) in the home treated group and 15 complications ( 68.3 % ) in the conventional in-patient group . The length of hospital stays in the supported discharged group were shorter ( 1.3 ( std = 0.5 ) versus 3.7 ( std = 2.8 ) days , p = 0.002 ) . After discharge a respiratory nurse visited supported discharged patients at home during 5.1 days ( min \n Output:\n " }, { "from": "agent", "value": "Costs were lower for ESD/HAH than UC .\nESD/HAH is safe in selected patients with an AE COPD ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background and Purpose — Despite its high prevalence in stroke survivors , there is little clinical research on bowel dysfunction in this population . This is the first r and omized controlled trial to evaluate treatment of constipation and fecal incontinence in stroke survivors . Methods — Stroke patients with constipation or fecal incontinence were identified by screening question naire ( 122 community , 24 stroke rehabilitation in patients ) and r and omized to intervention or routine care ( 73 per group ) . The intervention consisted of a 1-off structured nurse assessment ( history and rectal examination ) , leading to targeted patient/carer education with booklet and provision of diagnostic summary and treatment recommendations ( after consultation with geriatrician ) to patient ’s general practitioner (GP)±ward physician . Results — Percentage of bowel movements ( BMs ) per week grade d as “ normal ” by participants in a prospect i ve 1-week stool diary was significantly higher in intervention versus control patients at 6 months ( 72 % versus 55 % ; P=0.027 ) , as was mean number of BMs per week ( 5.2 versus 3.6 ; P=0.005 ) . There was no significant reduction in fecal incontinence , although numbers were small . At 12 months , intervention patients were more likely to be modifying their diets ( odds ratio [ OR ] , 3.1 [ 1.2 to 8.0 ] ) and fluid intake ( OR , 4.2 [ 1.4 to 12.2 ] ) to control their bowels and to have visited their GP for their bowel problem ( OR , 5.0 [ 1.4 to 17.5 ] ) . GP prescribing of laxatives and suppositories was significantly influenced at 12 months . Conclusions — A single clinical /educational nurse intervention in stroke patients effectively improved symptoms of bowel dysfunction up to 6 months later , changed bowel-modifying lifestyle behaviors up to 12 months later , and influenced patient – GP interaction and physician prescribing patterns Objective : To investigate whether additional early physiotherapy after stroke improved functional recovery in stroke patients . Design : A prospect i ve , r and omized , controlled study . Setting : One stroke ward and an acute stroke unit in a large teaching hospital , southern China . Subjects : Patients with first-onset stroke consecutively admitted to the stroke centre . Interventions : One group ( n = 78 ) received additional early physiotherapy ( AEP ) for 45 minutes , five days a week for four weeks starting within the first week since stroke onset ; the routine therapy ( RT ) group ( n = 78 ) received no professional rehabilitation therapy . Main outcome measures : Glasgow Coma Scale , Mini-Mental State Examination , Fugl-Meyer Assessment of Motor Recovery , Clinical Neurological Deficit Scale and Modified Barthel Index ( MBI ) . Results : Patients from the AEP group had a high drop-out rate ( n = 28 ) , but those remaining made relatively better functional recovery at 30 days than those from the RT group if measured by MBI . Multiple linear regression analysis revealed that cognitive disturbance , aphasia , double incontinence , site of lesion and sensory impairment might affect functional recovery after stroke . Conclusions : Additional early physiotherapy might improve independence of patients after stroke but failed to show benefit in other aspects in our study . Cognitive disturbance , aphasia , double incontinence , site of lesion as well as sensory impairment might affect functional outcome after stroke OBJECTIVES To examine skin health outcomes of an exercise and incontinence intervention . DESIGN R and omized controlled trial with blinded assessment s of outcomes at three points over 8 months . SETTING Four nursing homes ( NHs ) . PARTICIPANTS One hundred ninety incontinent NH residents . INTERVENTION In the intervention group , research staff provided exercise and incontinence care every 2 hours from 8:00 a.m. to 4:30 p.m. ( total of four daily care episodes ) 5 days a week for 32 weeks . The control group received usual care from NH staff . MEASUREMENTS Perineal skin wetness and skin health outcomes ( primarily blanchable erythema and pressure ulcers ) as measured by direct assessment s by research staff , urinary and fecal incontinence frequency , and percentage of behavioral observations with resident engaged in st and ing or walking . RESULTS Intervention subjects were significantly better in urinary and fecal incontinence , physical activity , and skin wetness outcome measures than the control group . However , despite these improvements , differences in skin health measures were limited to the back distal perineal area , which included the sacral and trochanter regions . There was no difference between groups in the incidence rate of pressure ulcers as measured by research staff , even though those residents who improved the most on fecal incontinence showed improvement in pressure ulcers in one area . CONCLUSION A multifaceted intervention improved four risk factors related to skin health but did not translate into significant improvements in most measures of skin health . Even if they had adequate staffing re sources , NHs might not be able to improve skin health quality indicators significantly if they attempt to implement preventive interventions on all residents who are judged at risk because of their incontinence status The purpose of this study was to determine whether biofeedback benefits children with dyssynergic defecation and constipation/encopresis , and whether home biofeedback improves long-term outcomes . Thirty-six patients with chronic constipation who had failed at least 6 months of conventional treatment and demonstrated dyssynergic defecation at anorectal manometry were r and omized to biofeedback in the laboratory alone ( group 1 , n=24 ) or in the laboratory and at home ( group 2 , n=12 ) and followed up at 2 , 4 , and a mean of 44 months . Thirty patients were available for long-term follow-up . Bowel movements increased in all from a mean of 1.4/week to 5.1 , 5.8 , and 5.1 per week at 2 months , 4 months , and long-term , respectively ( p ≤0.001 ) . Soiling decreased in all from a mean of 5.5/week to 0.6 , 0.1 , and 1 per week at 2 months , 4 months , and long-term , respectively ( p ≤0.001 ) . Laxative use decreased from a mean of 4.1 days/week to 0.6 , 0.3 , and 0.7 per week at 2 months , 4 months , and long-term , respectively ( p ≤0.001 ) . Twenty-seven of 30 parents ranked their satisfaction a mean of 2.2 ( range 1-excellent to 3-good ) . There were no significant differences in outcomes between the laboratory alone group and the laboratory plus home group . Biofeedback is beneficial for some children with chronic constipation and dyssynergic defecation . Supplemental home biofeedback does not improve long-term outcomes Abstract BACKGROUND : A prospect i ve , three-armed , r and omized , controlled trial was performed to assess whether pelvic floor exercises with biofeedback using anal manometry or transanal ultrasound are superior to pelvic floor exercises with feedback from digital examination alone in terms of continence , quality of life , physiologic sphincter strength , and compliance . Its secondary objectives were to assess whether there are any differences in these outcomes between biofeedback with transanal ultrasound vs. anal manometry and to correlate the physiologic measures with clinical outcome . METHODS : One hundred twenty patients with mild to moderate fecal incontinence were r and omized into one of three treatment groups : biofeedback with anal manometry , biofeedback with transanal ultrasound , or pelvic floor exercises with feedback from digital examination alone . Commencing one week after an initial 45-minute assessment session , patients attended monthly treatments for a total of five sessions . Each session lasted 30 minutes and involved sphincter exercises with biofeedback that involved instrumentation or digital examination alone , and patients were encouraged to perform identical exercises twice per day between outpatient visits . RESULTS : One hundred two patients ( 85 percent ) completed the four-month treatment program . Across all treatment allocations , patients experienced modest but highly significant improvements in all nine outcome measures during treatment , with 70 percent of all patients perceiving improvement in symptom severity and 69 percent of patients reporting improved quality of life . With the possible exception of isotonic fatigue time , there were no significant differences between the three treatment groups in compliance , physiologic sphincter strength , and clinical or quality -of-life measures . Correlations between physiologic measures and clinical outcomes were much stronger with ultrasound-based measures than with manometry . CONCLUSIONS : Although patients in this study who completed pelvic floor exercises with feedback from digital examination achieved no additional benefit from biofeedback and measurement with transanal ultrasound or manometry , it may be that the guidance received through digital examination alone offered patients in the pelvic floor exercise group an effective biofeedback mechanism . Contrary to our hypothesis , the use of transanal ultrasound offered no benefit over manometry , but the use of ultrasound for isotonic fatigue time and isometric fatigue contractions provided potentially important physiologic measures that require further study . This study has confirmed , through a large sample of patients , that pelvic floor retraining programs are an effective treatment for improving physiologic , clinical , and quality -of-life parameters in the short term Background and aims Faecal incontinence is a distressing problem that is often not amenable to surgical correction . Chronic low-frequency electrical stimulation of damaged axons is thought to reduce synaptic resistance , increase the size of motor units by axonal sprouting and increase the rate of conduction of the pudendal nerve . The aim of this study was to prospect ively evaluate the effect of chronic low-frequency endo-anal electrical stimulation on faecal incontinence using a home-based unit and hospital-supervised therapy . Material s and methods Forty-eight patients with faecal incontinence completed a prospect i ve r and omised trial . Patients were allocated r and omly to one of two groups ; group 1 was exposed to endo-anal pudendal nerve stimulation daily at home with a portable home unit , group 2 attended the physiotherapy department for endo-anal electrical stimulation under supervision . Results Continence scores improved significantly after treatment in both groups ( p<0.001 ) . Both groups showed improved manometric scores , although only group 1 showed significant improvement in both resting and squeeze pressures ( mean total resting pressure 184–224 mmHg , p<0.001 ; mean total squeeze pressure 253–337 mmHg , p<0.001 ) . This was also reflected by an improvement in quality of life in both groups . Conclusions Low-frequency endo-anal electrical stimulation significantly improves continence scores and quality of life in patients with faecal incontinence not amenable to surgical correction . It leads to improved manometric values when carried out on a daily basis with a portable home unit Background : Prevalence studies of faecal incontinence in the general population are rare and the impact of faecal incontinence on quality of life has not been previously addressed . Aims : To establish the prevalence of faecal incontinence in adults in terms of frequency of leakage , degree of soiling , and level of impact on quality of life . Methods : In a cross sectional postal survey , 15 904 adults aged 40 years or more ( excluding residents of nursing and residential homes ) were selected r and omly by household from the Leicestershire Health Authority patient register . Participants were asked to complete a confidential health question naire . Major faecal incontinence was defined as soiling of underwear or worse with a frequency of several times a month or more . Respondents were also asked if bowel symptoms had an impact on their quality of life . Results : From a total sample of 10 116 respondents , 1.4 % reported major faecal incontinence and 0.7 % major faecal incontinence with bowel symptoms that had an impact on quality of life . Major faecal incontinence was significantly associated with a lot of impact on quality of life ( odds ratio 12.4 , 95 % confidence interval 7.5–20.6 ) . Incontinence was more prevalent and more severe in older people but there was no significant difference between men and women . Conclusions : This study has confirmed that faecal incontinence is a fairly common symptom , particularly in older people . Faecal incontinence in men has received little attention in the past and the results from this study indicate that it is as much of a problem in men as it is in women while the level of unmet need in this group is high . Estimates of need for health care for this symptom should be multidimensional and assess both the severity of symptoms and the impact it has on quality of life In order to evaluate the efficacy of biofeedback for childhood encopresis , 50 children with encopresis were prospect ively studied and r and omized to receive biofeedback ( B ) or mineral oil therapy ( M ) . Specificity of biofeedback was also evaluated by comparing outcomes of both regimens in children with normal ( n = 32 ) and abnormal ( n = 18 ) defecation patterns . Using a single blinded design , there were no significant differences in clinical outcomes between the 24 children receiving B and the 26 children receiving M at 3 , 6 , and 12 months . However , at 12 months six of nine children with abnormal defecation patterns were in remission or markedly improved after receiving B , compared to only three of nine children receiving M. In contrast , children with normal patterns appeared to respond better to M than did those receiving B ( 71 vs. 40 % at 12 months ) . Biofeedback appears to warrant further evaluation in children with encopresis and abnormal defecation patterns OBJECTIVE Abnormal defecation dynamics often are present in children with chronic constipation and encopresis . Patients who learned normal defecation dynamics with biofeedback treatment had improved short \n Output:\n " }, { "from": "agent", "value": "There are suggestions that rectal volume discrimination training improves continence more than sham training and that anal biofeedback combined with exercises and electrical stimulation provides more short-term benefits than vaginal biofeedback and exercises for women with obstetric-related faecal incontinence .\nThe limited number of identified trials together with their method ological weaknesses do not allow a definitive assessment of the possible role of anal sphincter exercises and biofeedback therapy in the management of people with faecal incontinence .\nWe found no evidence of biofeedback or exercises enhancing the outcome of treatment compared to other conservative management methods .\nWhile there is a suggestion that some elements of biofeedback therapy and sphincter exercises may have a therapeutic effect , this is not certain ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To evaluate the effectiveness of community periodontal care intervention in type 2 diabetic patients with chronic periodontitis who participated in community non-communicable diseases management service . METHODS The r and omized controlled and blinded community trial with a duration of six months was design ed to compare effects of \" periodontal initial therapy \" on group I(22 cases ) , of \" professional mechanical tooth cleaning ( PMTC ) , i.e. coronal scaling \" on group II(19 cases ) and of \" non- clinical therapy \" on the control group(25 cases ) . The clinical periodontal indexes , such as probing depth ( PD ) , attachment loss ( AL ) , modified bleeding index ( mBI ) , plaque index ( PLI ) were obtained with a Williams type periodontal probe ; Laboratory examinations including glycosylated haemoglobin A1(HbA1C ) , glucose assay , were conducted . RESULTS The reductions of PD in groups I and II were 0.71 and 0.70 mm , respectively , which was more significant than in control group ( 0.20 mm ) ; the reductions of AL in groups I , II , and control group were 0.86 , 0.57 , and 0.03 mm , respectively , which showed significance in all the three groups . The subjects of groups I and II had 0.56 % and 1.01 % reductions of HbA1C respectively , and the significance was observed in group II . In addition , the improvement of HbA1C values in group II was highly correlated with the decrease in gingivitis ( r=0.51 , P=0.03 ) . CONCLUSION The community periodontal care approaches implemented in the community health service centers have significantly improved periodontal health as well as reduced glycemic level , which could be regarded as basic health care strategies for the patients with diabetes AIM The aim of this r and omized controlled clinical trial was to evaluate the clinical effects of chlorhexidine ( CHX ) application in a full-mouth disinfection ( FMD ) protocol in poorly controlled type-2 diabetic subjects with generalized chronic periodontitis . MATERIAL AND METHODS Thirty-eight subjects were r and omly assigned into FMD group ( n=19 ) : full-mouth scaling and root planing ( FMSRP ) within 24 h + local application of CHX gel + CHX rinses for 60 days or Control group ( n = 19 ) : FMSRP within 24 h + local application of placebo gel + placebo rinses for 60 days . Clinical parameters , glycated haemoglobin and fasting plasma glucose were assessed at baseline , 3 , 6 and 12 months post-therapies . RESULTS All clinical parameters improved significantly at 3 , 6 and 12 months post-therapies for both groups ( p < 0.05 ) . There were no significant differences between groups for any clinical parameters , and glycemic condition at any time-point ( p > 0.05 ) . CONCLUSIONS The treatments did not differ with respect to clinical parameters , including the primary outcome variable ( i.e. changes in clinical attachment level in deep pockets ) , for up to 12 months post-treatments Background 40 subjects with type 2 diabetes and moderate to severe CP were r and omly distributed to groups receiving either NSPT or OHI . Periodontal parameters , glycosylated haemoglobin ( HbA1c ) and high-sensitivity C-reactive protein ( hs-CRP ) were evaluated at baseline , 2- and 3-months intervals . Methods 40 subjects with type 2 diabetes and moderate to severe CP were r and omly distributed to groups receiving either NSPT or OHI . Periodontal parameters , glycosylated haemoglobin ( HbA1c ) and high-sensitivity C-reactive protein ( hs-CRP ) were evaluated at baseline , 2- and 3-months intervals . Results 15 subjects from NSPT group and 17 from OHI group completed the study . The difference in plaque index ( PI ) between NSPT and OHI groups were significant at 2 months recall ( p = 0.013 ) . There was no significant difference between NSPT and OHI group for all other clinical periodontal parameters , HbA1c and CRP levels . At 3 months post-therapy , periodontal parameters improved significantly in both groups with sites with probing pocket depth ( PPD ) < 4 mm reported as 98 ± 1.8 % in NSPT group and 92 ± 14.9 % in OHI group . Mean PPD and mean probing attachment loss ( PAL ) within the NSPT group reduced significantly from baseline ( 2.56 ± 0.57 mm , 3.35 ± 0.83 mm ) to final visit ( 1.94 ± 0.26 mm , 2.92 ± 0.72 mm ) ( p = 0.003 , p < 0.001 ) . For OHI group , improvements in mean PPD and mean PAL were also seen from baseline ( 2.29 ± 0.69 mm , 2.79 ± 0.96 mm ) to final visit ( 2.09 ± 0.72 mm , 2.62 ± 0.97 mm ) ( p < 0.001 for both ) . Similarly , HbA1c levels decreased in both groups with NSPT group recording statistically significant reduction ( p = 0.038 ) . Participants who demonstrated ≥ 50 % reduction in PPD showed significant reductions of HbA1c and hs-CRP levels ( p = 0.004 and p = 0.012 ) . Conclusion NSPT significantly reduced PI at 2 months post-therapy as compared to OHI . Both NSPT and OHI demonstrated improvements in other clinical parameters as well as HbA1c and CRP levels . Trial registration Clinical Trials.gov : NCT01951547 Purpose Diabetes and periodontal disease are two common diseases with high prevalence rates . Recent evidence has shown a bidirectional relationship between diabetes and periodontitis . The aim of this study was to investigate the effects of nonsurgical periodontal therapy on glycemic control in type 2 diabetes mellitus patients . Methods Sixty subjects aged 35 - 45 years with blood sugar controlled by oral hypoglycaemic agents were r and omly divided equally among 3 groups : group A ( scaling , mouthwash , and brushing ) , group B ( mouthwash and brushing ) , and group C ( brushing only ) . Glycated haemoglobin ( HbA1c ) , fasting blood sugar ( FBS ) , probing pocket depth ( PPD ) , gingival index ( GI ) , plaque index ( PI ) , and the relevant drug history were recorded at baseline and after 3 months of intervention . Comparison of the mean difference among the variables was performed by parametric and nonparametric tests , which were further evaluated using multiple regression analysis . Results The mean differences between the PPD , FBS , HbA1c , GI , and PI in groups A and B were found to be statistically significant ( P<0.001 ) . Multiple regression analysis in group A showed that out of all the independent variables , GI and frequency of drug administration independently ( b=0.3761 and b=0.598 ) showed a significantly greater impact on HbA1c ( R2=0.832 , P<0.05 ) . Conclusions Nonsurgical periodontal therapy can effectively decrease HbA1c levels in type 2 diabetes mellitus patients on medication BACKGROUND AND OBJECTIVE Several studies have shown that periodontitis can complicate the severity of diabetes by worsening the degree of glycemic control . The purpose of this study was to determine the effect of full-mouth tooth extraction on glycemic control among type 2 diabetic patients . MATERIAL AND METHODS A total of 58 patients with type 2 diabetes mellitus and advanced periodontitis who were requiring extraction of all remaining teeth were r and omized consecutively into treatment ( full-mouth tooth extraction ) and control groups ( no treatment ) . Eight patients were lost to follow-up or reported use of antibiotics , leaving 50 patients to be included in the analysis . All patients had all their remaining teeth in a hopeless condition . Relevant data were collected , and glycosylated hemoglobin ( HbA(1c ) ) and fasting blood glucose levels were measured at baseline and at follow-up times of 3 and 6 mo . RESULTS At baseline , the mean ( SD ) HbA(1c ) level was 8.6 % ( 1.24 ) in the treatment group and 7.7 % ( 0.87 ) in the control group . In the treatment group , the mean HbA(1c ) level decreased significantly from 8.6 % at baseline to 7.4 % after 3 mo of denture treatment , and continued to decrease to 7.3 % after 6 mo . In the control group , the mean HbA(1c ) decreased from 7.7 % at baseline to 7.5 % after 3 mo , and remained almost the same after 6 mo . After adjusting for the baseline HbA(1c ) , the mean reduction in HbA(1c ) after 3 mo in the treatment group [ 1.23 % ( 0.79 ) ] was significantly higher than the mean reduction in the control group [ 0.28 % ( 0.87 ) ] . CONCLUSION Full-mouth tooth extraction result ed in an improvement in glycemic control among diabetic patients . Large-scale multicentre clinical trials are needed to confirm the current evidence The aim of this study was to evaluate changes in clinical parameters and levels of inflammatory biomarkers in plasma in periodontal patients with poorly controlled type 2 diabetes mellitus ( T2DM ) after non-surgical periodontal therapy . Twenty-eight poorly controlled T2DM patients were r and omly assigned to treatment with scaling and root planning ( SRP ) and SRP + subgingival minocycline administration . Clinical parameters , including the probing depth ( PD ) , bleeding on probing ( BOP ) , plaque score ( PS ) , clinical attachment level ( CAL ) , and plasma interleukin (IL)-6 , soluble receptor of advanced glycation end products ( sRAGE ) , chronic reactive protein ( CRP ) , and hemoglobin A1c ( HbA1c ) were measured before and after a 6-month treatment period . Significant changes in PD , BOP , PS , and CAL were found in both groups . The latent growth curve model showed an overall reduction in the log HbA1c level in the SRP group ( −0.082 , p = 0.033 ) . Small changes in the log sRAGE level and log CRP level in plasma were found in both groups . IL-6 in the plasma increased in the SRP group , but slightly decreased in the SRP+minocycline group ( 0.469 pg/ml , p = 0.172 ) . Non-surgical periodontal therapy with or without subgingival minocycline application may achieve significant periodontal improvement and moderate improvement in HbA1c , but had no significant effect on plasma levels of IL-6 , CRP , or sRAGE in patients with poorly controlled T2DM . For patients with both periodontal diseases and diabetes , non-surgical periodontal treatments may be helpful in their diabetic control IMPORTANCE Chronic periodontitis , a destructive inflammatory disorder of the supporting structures of the teeth , is prevalent in patients with diabetes . Limited evidence suggests that periodontal therapy may improve glycemic control . OBJECTIVE To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin ( HbA1c ) in persons with type 2 diabetes and moderate to advanced chronic periodontitis . DESIGN , SETTING , AND PARTICIPANTS The Diabetes and Periodontal Therapy Trial ( DPTT ) , a 6-month , single-masked , multicenter , r and omized clinical trial . Participants had type 2 diabetes , were taking stable doses of medications , had HbA1c levels between 7 % and less than 9 % , and untreated chronic periodontitis . Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers . INTERVENTIONS The treatment group ( n = 257 ) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months . The control group ( n = 257 ) received no treatment for 6 months . MAIN OUTCOMES AND MEASURES Difference in change in HbA1c level from baseline between groups at 6 months . Secondary outcomes included changes in probing pocket depths , clinical attachment loss , bleeding on probing , gingival index , fasting glucose level , and Homeostasis Model Assessment ( HOMA2 ) score . RESULTS Enrollment was stopped early because of futility . At 6 months , mean HbA1c levels in the periodontal therapy group increased 0.17 % ( SD , 1.0 ) , compared with 0.11 % ( SD , 1.0 ) in the control group , with no significant difference between groups based on a linear regression model adjusting for clinical site ( mean difference , -0.05 % [ 95 % CI , -0.23 % to 0.12 % ] ; P = .55 ) . Periodontal measures improved in the treatment group compared with the control group at 6 months , with adjusted between-group differences of 0.28 mm ( 95 % CI , 0.18 to 0.37 ) for probing depth , 0.25 mm ( 95 % CI , 0.14 to 0.36 ) for clinical attachment loss , 13.1 % ( 95 % CI , \n Output:\n " }, { "from": "agent", "value": "Highly heterogeneous short-term studies with small sample size suggest that periodontal treatment could help improve glycaemic control at 3 months in patients with type 2 diabetes and periodontitis .\nHowever , longer term studies having sufficient sample size do not provide evidence that periodontal therapy improves glycaemic control in these patients" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services . School-based dental screening could be a potential intervention that impacts uptake of dental services , and subsequently , dental caries ’ levels . The purpose of this study is to evaluate the effectiveness of two alternative approaches for school-based dental screening in promoting dental attendance and reducing untreated dental caries among primary schoolchildren . Methods This is a cluster r and omised controlled trial comparing referral of screened-positive children to a specific treatment facility ( King Saud University Dental College ) against conventional referral ( information letter advising parents to take their child to a dentist ) . A thous and and ten children in 16 schools in Riyadh , Saudi Arabia , will be recruited for the trial . Schools ( clusters ) will be r and omly selected and allocated to either group . Clinical assessment for dental caries will be conducted at baseline and after 12 months by dentists using the World Health Organisation ( WHO ) criteria . Data on sociodemographic , behavioural factors and children ’s dental visits will be collected through structured question naires at baseline and follow-up . The primary outcome is the change in number of teeth with untreated dental caries 12 months after referral . Secondary outcomes are the changes in the proportions of children having untreated caries and of those who visited the dentist over the trial period . Discussion This project should provide high level of evidence on the clinical benefits of school dental screening . The findings should potentially inform policies related to the continuation/implementation of school-based dental screening in Saudi Arabia . Trial registration Clinical Trials.gov , ID : NCT03345680 . Registered on 17 November 2017 OBJECTIVE To assess the impact of oral health promotion integrated with a health promoting school ( HPS ) initiative on the oral health outcomes of secondary school students . MATERIAL S AND METHOD Using an urban-rural stratified cluster r and omized approach , the intervention was applied to secondary school students in Arusha , Tanzania . In the urban , three control ( n = 315 ) and two intervention ( n = 214 ) schools performed oral clinical examination and question naires at baseline . In rural the corresponding figures at baseline were two ( n = 188 ) and three ( n = 360 ) schools . After 2 years , 374 and 358 students remained in the intervention and control arms . RESULTS Mean number of decayed teeth ( DT ) increased in the intervention ( mean score 1.0 vs 1.7 , p < 0.001 ) and control schools ( mean score 1.2 vs 1.7 , p < 0.001 ) . Mean number of teeth with plaque decreased significantly in intervention and control schools . No significant difference in caries increment and plaque decline scores was observed between groups . Mean number of teeth with bleeding decreased ( 0.5 vs 0.3 , p < 0.05 ) in intervention schools , whereas no change was observed in the control schools ( 0.4 vs 0.5 , p = 0.051 ) . Increment in mean number of DT between baseline and follow-up was largest and smallest in students who , respectively , deteriorated and improved their plaque and bleeding scores . CONCLUSION The intervention activities did not show any effect with respect to dental caries , calculus and plaque status among the students investigated . Compared with the control group , more favorable changes in the intervention group occurred with respect to bleeding on probing , suggesting a weak but positive effect on students ' oral hygiene status INTRODUCTION Many low-income parent/caregivers do not underst and the importance of cavity-free primary ( baby ) teeth and the chronic nature of dental caries ( tooth decay ) . As a consequence , dental preventive and treatment utilization is low even when children are screened in schools and referred for care . This study aims to test a referral letter and Dental Information Guide ( DIG ) design ed using the Common-Sense Model of Self-Regulation ( CSM ) framework to improve caregivers ' illness perception of dental caries and increase utilization of care by children with restorative dental needs . METHODS A multi-site r and omized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms : ( 1 ) CSM referral letter alone ; ( 2 ) CSM referral letter+DIG ; ( 3 ) reduced CSM referral letter alone ; ( 4 ) reduced CSM referral letter+DIG ; and ( 5 ) st and ard ( control ) referral . At baseline , children will be screened at school to determine restorative dental needs . If in need of treatment , caregivers will be r and omized to study arms and an intervention packet will be sent home . The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening ( ICDAS sealant codes 1 and 2 ; restoration codes 3 - 8 ; extraction ) . Enrollment commenced summer 2015 with results in summer 2016 . CONCLUSION This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers . If effective this simple intervention has broad applicability in clinical and community-based setting OBJECTIVES It has been suggested that changes in the distribution of dental caries mean that targeting high-risk groups can maximize the cost effectiveness of dental health programs . This study aim ed to assess the effectiveness of a targeted school-based dental screening program in terms of the proportion of children with dental care needs it identified . METHODS The target population was all children in junior and senior kindergarten and grade s 2 , 4 , 6 , and 8 who attended schools in four Ontario communities . The study was conducted in a r and om sample of 38 schools stratified according to caries risk . Universal screening was implemented in these schools . The parents of all children identified as having dental care needs were sent a short question naire to document the sociodemographic and family characteristics of these children . Children with needs were divided into two groups : those who would and who would not have been identified had the targeted program been implemented . The characteristics of the two groups were compared . RESULTS Overall , 21.0 percent of the target population were identified as needing dental care , with 7.4 percent needing urgent care . The targeted program would have identified 43.5 percent of those with dental care needs and 58.0 percent of those with urgent needs . There were substantial differences across the four communities in the proportions identified by the targeted program . Identification rates were lowest when the difference in prevalence of need between the high- and low-risk groups was small and where the low-risk group was large in relation to the high-risk group . The targeted program was more effective at identifying children from disadvantaged background s. Of those with needs who lived in households receiving government income support , 59.0 percent of those with needs and 80.1 percent of those with urgent needs would be identified . CONCLUSIONS The targeted program was most effective at identifying children with dental care needs from disadvantaged background s. However , any improvements in cost effectiveness achieved by targeting must be balanced against inequities in access to public health care re sources Objective To obtain consensus amongst a sample of primary care dentists in the North West of Engl and on a set of clinical criteria that should trigger referral following school dental screening . Design Delphi process . Setting Primary dental care , Engl and 2002 Method Primary care dentists in the North West of Engl and were r and omly selected to complete a two round ' Delphi exercise ' that included 10 potential referral criteria . The dentists were invited to express their level of support for the inclusion of each referral criterion . Main outcome measures Level of agreement for each referral criterion . Acceptance of any criterion was that the interquartile range should be no more than 3 scale points with the lower value being no less than 7 . Results Eighty-eight dentists , ( 72.7 % ) , completed the Delphi exercise . Six referral criteria met with the groups ' approval : Child with caries in permanent dentitionChild with darkened/discoloured permanent incisorsChild aged 9 - 10 years with overjet greater than 10 mmChild over six years with either gross plaque , calculus or swollen gumsChild with evidence of sepsisChild registered with a GDP with caries in permanent dentition . Conclusion It is possible for a representative sample of primary care dentists in the North West to agree referral criteria following school dental screening Background Recent studies have cast doubt on the effectiveness and efficiency of school based dental screening programmes in improving dental attendance or improving dental health . In 2002 the National Dental Inspection Programme was introduced in Scotl and which categorises children by their dental health and informs parents of the findings via a personalised letter home and encourages dental registration . In addition , epidemiological data for local and national planning purpose s is collected . This replaced an earlier school screening system in Lothian where a generic letter urging registration was sent to children who were identified as not being registered with a dentist . The objective of this study is to compare dental registration s rates among unregistered children in these two school inspection systems with a system where letters were sent home but no dental inspection was carried out . Methods The study was design ed as a single blinded , cluster r and omised , controlled trial involving 12,765 12–13-year-old children attending all 65 state Secondary schools in Lothian and Fife during the academic year 2003/4.After stratifying for school size and range of social deprivation , schools were r and omly allocated to one of four groups:1 . ' Traditional ' inspection , letter to unregistered children only,2 . Letter sent home to unregistered children only , no inspection,3 . National Dental Inspection Programme , letter to all children,4 . Control group in which the children were neither inspected nor sent a letter . Dental Registration status was compared at baseline and 3 months post inspection . Results The registration levels in both the ' Traditional ' screening and the NDIP inspection groups rose 3 months post inspection ( 14 % and 15.8 % respectively ) but were not significantly different from one another or the control group which rose by 15.8 % ( p > 0.05 ) . The group who were sent a letter home but were not inspected also has a rise in registration levels of 18.1 % which was not significantly different from either of the groups who were inspected or the control group ( p > 0.05 ) . The only significant predictors of registration were previous registration ( p < 0.05 ) and within those who previously registered , the length of time since last registration ( P < 0.001 ) . Conclusion Neither of the two dental inspection methods nor a letter home to unregistered children result ed in a significant rise in registration rates in 12–13-year-olds compared to a control group of children who received no intervention Background Poor response rates can jeopardise the validity of the findings of epidemiological surveys . The aim of this study was to undertake a r and omised controlled trial to determine the effectiveness of different strategies for maximizing parental consent rates for dental health surveys of young children . Methods The trial took place within the 2007/2008 NHS Epidemiological Dental Health Survey of 5-year-old children in the North West of Engl and . Schools were r and omised to one of five interventions : multiple letters to parents ; promoting the research by providing additional information to parents and children ; a financial incentive to the school ; a financial incentive to the school administrator plus direct mailing to parents ; and a control intervention comprising of usual practice , that is a single letter home to parents via the children . Results A total of 335 schools ( 11,088 children ) were recruited . The mean percentage consent rates ranged from 47 % ( financial incentive to school administrator plus direct mailing ) to 63 % ( multiple letters ) . Pair-wise comparisons indicated that the multiple letter group had a statistically significantly greater consent rate than the financial incentive to the school administrator plus direct mailing group and promoting the research by providing additional information group , but was not statistically significantly different from the financial incentive to the school group and the control group . Conclusions There was little evidence to show that any of the five interventions made a significant difference to consent rates when compared to the control group . Financial incentives to schools were less effective than multiple reminder letters to parents . Trials should be built into surveys to test different interventions , in different context s to exp and the evidence base for improving consent rates in health surveillance programmes Objective To determine dental attendance and treatment outcomes following two models of dental screening . Design An observational prospect i ve cohort study . Setting Infant , primary and junior schools in the North West of Engl and .Subjects Children aged six to nine years at the start of the study . Interventions Subjects received a screening examination according to either a ' Traditional model ' or ' New model ' of school dental screeningMain outcome measures Attendance at a dentist within four months of the intervention and treatment received by children referred via the ' New model ' with caries in their permanent teeth . Results In the ' New model ' of school dental screening 46 % of screened positive and 41 % of screened negative children attended a dentist during the study period . Some 44 % of children referred with caries in permanent teeth attended a dentist and 53 % of those attending received treatment for the referred condition . Larger proportions of children from disadvantaged background s were screened positive but higher proportions of children from more affluent background s attended the dentist and subsequently received treatment . Conclusion School dental screening has a minimal impact on dental attendance and only a small proportion of screened positive children receive appropriate treatment . The programme fails to reduce inequalities in utilisation of dental services One-hundred and twenty-five families in the Medicaid Early Periodic Screening , Diagnosis and Treatment Program were assigned to one of five treatments to encourage parents to obtain health care service following the dental screening of their children : ( a ) a control procedure , in which parents were given a dentist 's name ; ( b ) a multiple contact procedure , in which parents received a postcard and two telephone call reminders ; ( c ) a problem-solve procedure , in which a social worker aide conducted a brief session with \n Output:\n " }, { "from": "agent", "value": "We found very low certainty evidence that was insufficient to allow us to draw conclusions about whether there is a role for traditional school dental screening in improving dental attendance .\nFor criteria -based screening , we found low-certainty evidence that it may improve dental attendance when compared to no screening .\nHowever , when compared to traditional screening there was no evidence of a difference in dental attendance ( very low-certainty evidence ) .We found low-certainty evidence to conclude that personalised or specific referral letters improve dental attendance when compared to non-specific counterparts .\nWe also found low-certainty evidence that screening supplemented with motivation ( oral health education and offer of free treatment ) improves dental attendance in comparison to screening alone .\nWe did not find any trials addressing cost-effectiveness and adverse effects of school dental screening" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The purpose of this study was to investigate the impact of nutritional labelling on energy intake , appetite perceptions and attitudes towards food . During a 10-d period , seventy normal-weight ( BMI < 25 kg/m2 ) and seventy-one obese women ( BMI ≥30 kg/m2 ) were given three meals per d under ad libitum conditions . Participants were r and omly assigned to one of three experimental labelling groups in which the only difference was the label posted on lunch meal entrée : ( 1 ) low-fat label , ( 2 ) energy label ( energy content of the entrée and average daily needs ) and ( 3 ) no label ( control ) . Average energy intake was calculated by weighing all foods before v. after daily consumption . Hunger and fullness perceptions were rated on visual analogue scales immediately before and after each meal . Satiety efficiency was assessed through the calculation of the satiety quotient ( SQ ) . The appreciation and perceived healthiness of the lunch entrées were rated on eight-point Likert scales . There was no difference in energy intake , SQ and attitudes towards food between the three labelling groups . Fasting hunger perception was higher in the low-fat label group compared with the two others groups ( P=0·0037 ) . No interactions between labelling groups and BMI categories were observed . In conclusion , although labelling does not seem to influence energy intake , a low-fat label may increase women 's fasting hunger perceptions compared with an energy label or no label 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 Numerous front-of-package ( FOP ) nutrition labeling systems exist , but it is unclear if such labels influence behavior . A single- summary label called Smart Choices ( SC ) appeared briefly on products in the United States in 2009 . The current study aim ed to evaluate ( 1 ) the influence the SC symbol has on the serving and consumption of cereal ; and ( 2 ) the impact of providing calorie and serving size information on a FOP label . Two hundred and sixteen adults were r and omized to a high-sugar breakfast cereal that had either ( 1 ) no label ; ( 2 ) the SC symbol ; or ( 3 ) a modified SC symbol with serving size information . Participants rated perceptions of healthfulness , taste , and purchase intent , estimated calories per serving and poured and ate the cereal for breakfast . Participants in the SC label conditions were better able to estimate calories per serving , but there were no differences across groups on perceptions of healthfulness , taste , purchase intent , and levels of vitamins , and sugar or amount of cereal poured or consumed . These results suggest that calories per serving information on FOP labels can increase knowledge , but the SC symbol had little impact on behavior . Studies examining FOP label influence on purchasing , consumption , and product reformulation are greatly needed to determine label utility Fitness cues on food packages are a common marketing practice in the food sector . This study aims to find out whether and how fitness cues influence food consumption . The results of two field studies show that , even though eating fitness-cued food does not help consumers become more fit , the cl aims on the packaging increase both serving size and actual food consumption . This effect is mediated by serving size inferences . Also , consumers feel less guilty and perceive themselves closer to desired fitness levels after having consumed the food . The findings show that packaging cues relating to energy expenditure can increase energy intake despite the fact that consumers are not engaged in any actual physical activity while eating the food OBJECTIVES The aim of this study was to investigate consumers ' willingness to pay ( WTP ) for cheeses bearing reduced-fat and low salt cl aims in Spain . STUDY DESIGN An experiment with 219 cheese consumers was conducted in the period March-May 2015 . We used different versions of cheese bearing reduced-fat and low salt cl aims . METHODS A choice experiment was used to estimate WTP for reduced-fat and /or low salt cheeses . Participants faced eight choice sets , each consisting of two packages of cheese with different combinations of two cl aims . Individuals chose one of the two packages of cheese in each choice set , or decided not to choose either . Moreover , to consider possible heterogeneity in WTP across consumers , a r and om parameters logit model ( RPL ) , a Chi-squared test , and analysis of variance tests were used . RESULTS Spanish cheese consumers were willing to pay a positive premium for packages of cheese with reduced-fat cl aims ( € 0.538/100 g ) , and for cheese with reduced-fat and low salt cl aims ( € 1.15/100 g ) . Conversely , consumers valued low-salt content cl aims negatively . They preferred to pay € 0.38/100 g for a conventional cheese rather than one low in salt content . As there was heterogeneity in consumers ' WTP , two different consumer segments were identified . Segment 1 consisted of normal weight and younger consumers with higher incomes and levels of education , who valued low salt cheese more negatively than those individuals in Segment 2 , predominantly comprising overweight and older consumers with low income and educational level . This means that individuals in Segment 1 would pay more for conventional cheese ( € 1/100 g ) than those in Segment 2 ( € 0.50/100 g ) . However , no difference between the two segments was found in WTP for reduced-fat cheese . CONCLUSIONS The findings suggest that consumers are willing to pay a price premium for a package of cheese with a reduced-fat cl aim or cheese with reduced-fat and low salt cl aims appearing together ; however , they are not willing to pay for a package of cheese with only a low salt cl aim . In comparison with overweight people , normal weight consumers would prefer to pay more for conventional cheese than low salt cheese . Finally , the results of this study contribute to insights in the promotion of healthier food choices among consumers . In this regard , outreach activities promoted by food companies could drive consumers to increase their knowledge of the benefits of eating reduced-fat and low salt food products in relation to their health status \n Output:\n " }, { "from": "agent", "value": "Conclusion Health-related cl aims have a substantial effect on dietary choices .\nHowever , this finding is based on research mostly conducted in artificial setting s. Findings from natural experiments have yielded smaller effects ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Evidence indicates that corticosteroid therapy might be beneficial for the primary treatment of severe Kawasaki disease . We assessed whether addition of prednisolone to intravenous immunoglobulin with aspirin would reduce the incidence of coronary artery abnormalities in patients with severe Kawasaki disease . METHODS We did a multicentre , prospect i ve , r and omised , open-label , blinded-endpoints trial at 74 hospitals in Japan between Sept 29 , 2008 , and Dec 2 , 2010 . Patients with severe Kawasaki disease were r and omly assigned by a minimisation method to receive either intravenous immunoglobulin ( 2 g/kg for 24 h and aspirin 30 mg/kg per day ) or intravenous immunoglobulin plus prednisolone ( the same intravenous immunoglobulin regimen as the intravenous immunoglobulin group plus prednisolone 2 mg/kg per day given over 15 days after concentrations of C-reactive protein normalised ) . Patients and treating physicians were unmasked to group allocation . The primary endpoint was incidence of coronary artery abnormalities during the study period . Analysis was by intention to treat . This trial is registered with the University Hospital Medical Information Network clinical trials registry , number UMIN000000940 . FINDINGS We r and omly assigned 125 patients to the intravenous immunoglobulin plus prednisolone group and 123 to the intravenous immunoglobulin group . Incidence of coronary artery abnormalities was significantly lower in the intravenous immunoglobulin plus prednisolone group than in the intravenous immunoglobulin group during the study period ( four patients [ 3 % ] vs 28 patients [ 23 % ] ; risk difference 0·20 , 95 % CI 0·12 - 0·28 , p<0·0001 ) . Serious adverse events were similar between both groups : two patients had high total cholesterol and one neutropenia in the intravenous immunoglobulin plus prednisolone group , and one had high total cholesterol and another non-occlusive thrombus in the intravenous immunoglobulin group . INTERPRETATION Addition of prednisolone to the st and ard regimen of intravenous immunoglobulin improves coronary artery outcomes in patients with severe Kawasaki disease in Japan . Further study of intensified primary treatment for this disease in a mixed ethnic population is warranted . FUNDING Japanese Ministry of Health , Labour and Welfare Prospect i ve evaluation of platelet activation and hypercoagulability was performed in 31 patients with Kawasaki syndrome . Most patients had elevated acute-phase reactants when studied during the first 3 weeks of their illness ; 17 of 25 ( 68 % ) patients had factor VIII activity greater than 150 % , 18 of 24 ( 75 % ) had fibrinogen greater than 400 mg/dl , and 17 of 31 ( 55 % ) had a platelet count greater than 450,000/mm3 . Antithrombin III was depressed initially in 17 of 25 ( 68 % ) patients . Depleted fibrinolytic activity , as measured by a euglobulin lysis time greater than 300 minutes , was documented in nine of 20 ( 45 % ) patients . Plasma beta-thromboglobulin ( BTG ) measured at 0 to 3 weeks was elevated ( greater than 43 ng/ml ) in seven of 24 ( 29 % ) patients . All patients with coronary artery aneurysms had elevated BTG values . The mean BTG in the group with aneurysms was 72.3 ng/ml when measured during the first 3 weeks after onset of fever , and 87.7 ng/ml at 4 to 7 weeks . The group without aneurysms had mean BTG values of 29.4 and 28.3 ng/ml at 0 to 3 and 4 to 7 weeks , respectively . The difference between the two groups was significant ( P less than 0.002 ) for both the initial and later values . An elevated BTG during the first 3 weeks after onset of fever was highly associated with aneurysm formation in our patients ( P less than 0.007 ) . No aneurysms occurred in patients with a normal BTG value BACKGROUND Little is known about the platelet dynamics and the effect of antiplatelet therapy in Kawasaki disease ( KD ) . The aim of this study was to clarify platelet activation dynamics in acute-phase KD patients by assaying platelet-derived microparticles ( PDMPs ) . METHODS AND RESULTS The PDMP level in 18 patients with acute KD was measured on ELISA . Of the 18 patients , 14 were receiving oral aspirin and i.v . immunoglobulin ( IVIG ) and 4 , oral aspirin alone . Blood sample s were drawn before , immediately after , and 10 - 14 days after IVIG infusion ; thereafter , at 1 , 2 , and 3 months after the onset of disease . PDMP level before aspirin treatment was significantly higher in acute-phase KD patients than in the control subjects with common febrile diseases ( P<0.01 ) . In the acute-phase KD patients , IVIG significantly decreased PDMP level ; the PDMP level was not lower on the similar day of KD in the patients who did not receive IVIG . Eight patients ' PDMP level rebounded after aspirin was discontinued . CONCLUSIONS Platelets are activated during acute-phase KD , which confirms the importance of antiplatelet therapy . In addition , platelet activation continues as long as 2 or 3 months after the acute phase , the time at which aspirin is commonly discontinued , and the timing of aspirin discontinuation should therefore be evaluated in each individual patient The comparative effectiveness of small-dose ( 30 mg/kg ) aspirin and highdose ( 150 mg/kg ) in Kawasaki disease was evaluated in clinical symptoms and platelet aggregation . Twenty-three patients with Kawasaki disease were entered in the r and omized study and devided into three groups . The duration s of fever were 14.8± 3.5 days in the control group , 11.3 ± 2.1 d. in the small-dose group and 8.7 ± 2.3 d. in the high-dose group . The high-dose group showed a significantly shorter duration of fever (P<.01).The platelet aggregation induced by ADP in the second week of illness were 82.4 ± 11.6 % in the control group , 66.8 ± 9.6 % in the small-dose group and 88.0 ± 10.7 % in the high-dose group ( 69.0 ± 5.0 % in healthy children ) . The control group and high-dose group showed significantly increased aggregation as compared with healthy children . The platelet aggregation in small-dose group was significantly lower than that in the control group ( P<.01 ) . SGOT and SGPT elevated in half of the patients treated with high dose of aspirin . In Kawasaki disease , 30 mg/kg/day of aspirin is recommended to prevent arterial thrombi Once-daily ( od ) , low-dose aspirin ( 75–100 mg ) is recommended to reduce the thrombotic risk of patients with essential thrombocytemia ( ET ) . This practice is based on data extrapolated from other high-risk patients and an aspirin trial in polycythemia vera , with the assumption of similar aspirin pharmacodynamics in the two setting s. However , the pharmacodynamics of low-dose aspirin is impaired in ET , reflecting accelerated renewal of platelet cyclooxygenase (COX)-1 . ARES is a parallel-arm , placebo-controlled , r and omized , dose-finding , phase II trial enrolling 300 ET patients to address two main questions . First , whether twice or three times 100 mg aspirin daily dosing is superior to the st and ard od regimen in inhibiting platelet thromboxane (TX)A2 production , without inhibiting vascular prostacyclin bio synthesis . Second , whether long-term persistence of superior biochemical efficacy can be safely maintained with multiple vs. single dosing aspirin regimen . Considering that the primary study end point is serum TXB2 , a surrogate biomarker of clinical efficacy , a preliminary exercise of reproducibility and validation of this biomarker across all the 11 participating centers was implemented . The results of this preliminary phase demonstrate the importance of controlling reproducibility of biomarkers in multicenter trials and the feasibility of using serum TXB2 as a reliable end point for dose-finding studies of novel aspirin regimens \n Output:\n " }, { "from": "agent", "value": "The groups with antiplatelet treatment tended to have a decreased platelet aggregation function .\nWhat is New:• This systematic review showed that the groups with antiplatelet treatment tended to have a decreased platelet aggregation function.• There is insufficient evidence for the effectiveness of antiplatelet therapy for Kawasaki disease" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Near-miss events are situations in which an action yields a negative result but is very close to being successful . They are known to influence behavior , especially in gambling scenarios . Previous neuroimaging studies have described an ' anomalous ' activity of brain reward areas following these events . The goal of the present research was to study electrophysiological correlates of near-misses in the expectation and outcome phases . Electroencephalography was recorded while participants were playing a simplified version of a slot machine . Four possible outcomes ( gain , near-miss , loss and no-information ) were presented in a pseudor and om order to ensure fixed proportions . Results from the time-frequency analysis for the theta ( 4 - 8 Hz ) , alpha ( 9 - 13 Hz ) , low beta ( 15 - 22 Hz ) and beta-gamma ( 25 - 35 Hz ) frequency-b and s presented larger power increases for wins and near-misses compared with losses . In the anticipation phase , power changes were lower than in the resolution phase . The current results are in agreement with previous studies showing that near-miss events recruit brain areas of the reward network . Likewise , the oscillatory activity in near-misses is very similar to the one elicited in the gain condition . In addition , present findings suggest that oscillatory activity in the expectation phase does not play a crucial role in near-miss events This study was conducted to examine the effects of the \" near miss , \" when a player almost wins , and the \" big win , \" a large early monetary gain , on persistence at slot machine gambling . One hundred eighty male and female undergraduates played a 4-wheel computerized slot machine . A 2 x 3 r and omized factorial design and an acquisition-extinction procedure were used . The dependent variable , persistence , was defined by the number of trials in the extinction phase . As hypothesized , the near miss had a statistically significant effect on the number of trials in extinction . An inverted U-shaped effect of the near miss showed that the 30 % near miss condition led to the greatest persistence , as compared to 45 % and 15 % near miss conditions . There was no statistically significant effect of the big win . Both cognitive and behavioral theories are discussed as explanations for effects of the near miss Problematic gambling is thought to be influenced by neurobiological mechanisms . However , the neuroendocrine response to gambling is largely unknown . Therefore , the effect of casino gambling on the sympathoadrenal system , the HPA-axis , and pituitary hormones were analyzed . Fourteen male problem gamblers and 15 non-problem gamblers were examined in a balanced cross-over design . In the experimental session , participants played blackjack in a casino wagering their own money . During the control session , subjects played cards for accumulation of points . Heart rate and endocrine measures were recorded at baseline , at 30 , 60 and 90 min during gambling/card playing , and after the game . Heart rate and norepinephrine levels increased with the onset of blackjack in both groups , with problem gamblers showing significantly higher levels across the entire gambling session . In addition , dopamine levels were significantly higher in problem gamblers during casino gambling compared to non-problem gamblers . Cortisol levels were transiently increased with the onset of blackjack in both groups . Casino gambling as a \" real life \" situation induces activation of the HPA-axis and the sympathoadrenergic system , with significantly more pronounced changes in problem gamblers . These findings may contribute to a better underst and ing of neuroendocrine disturbances in problem gambling A particularly rapid onset of pathological gambling ( PG-onset ) through the use of gambling machines has been widely alluded to , but this is the first study to empirically examine the phenomenon . This study compared the latency of PG-onset in those who gambled primarily on machines , compared to those who gambled primarily on more “ traditional ” forms of gambling at PG-onset . Subjects were 44 adult pathological gamblers ( PGs ) seeking outpatient treatment in Rhode Isl and ( 17 females ; mean age = 46.9 ) . Subjects completed question naires and a diagnostic interview including a complete history of gambling activities and the course of PG . The “ latency ” of PG-onset was defined as the time ( in years ) elapsed between the age of regular involvement in the primary form of gambling and the age at which DSM-IV criteria were first met . “ Machine ” PGs ( n = 25 ) had a significantly shorter latency of onset than did “ traditional ” PGs ( 1.08 years vs. 3.58 years ) . Females and machine PGs had a significantly older age of onset , but gender was not associated with latency of PG-onset . Lifetime comorbidity of either substance use disorders ( SUDS ) or depressive disorders ( DDS ) was also not associated with the latency of PG-onset . The results of the current study suggest that intrapersonal variables such as gender and comorbid disorders do not generally affect the speed with which people develop PG . Rather , the social , environmental , and stimulus features of mechanized gambling are implicated . Prospect i ve longitudinal studies on the onset and course of PG are needed , as well as more basic research on the features of machine gambling that may contribute to rapid onset Near-miss outcomes during gambling are non-win outcomes that fall close to a pay-out . While objective ly equivalent to an outright miss , near-misses motivate ongoing play and may therefore be implicated in the development of disordered gambling . Given naturalistic data showing increases in heart rate ( HR ) and electrodermal activity ( EDA ) during periods of real gambling play , we sought to explore the phasic impact of win , near-miss and full-miss outcomes on physiological arousal in a controlled laboratory environment . EDA and HR were monitored as healthy , student participants ( n = 33 ) played a simulated slot-machine task involving unpredictable monetary wins . A second gambling distortion , perceived personal control , was manipulated within the same task by allowing the participant to select the play icon on some trials , and having the computer automatically select the play icon on other trials . Near-misses were rated as less pleasant than full-misses . However , on trials that involved personal choice , near-misses produced higher ratings of ‘ continue to play ’ than full-misses . Winning outcomes were associated with phasic EDA responses that did not vary with personal choice . Compared to full-misses , near-miss outcomes also elicited an EDA increase , which was greater on personal choice trials . Near-misses were also associated with greater HR acceleration than other outcomes . Near-miss outcomes are capable of eliciting phasic changes in physiological arousal consistent with a state of subjective excitement , despite their objective non-win status Significance Gambling games are associated with a distorted psychological processing of r and om sequences ( the gambler ’s fallacy ) and unrewarded outcomes that fall close to a jackpot ( near misses ) . Problem gamblers appear more susceptible to these effects . Here , we show that these two gambling distortions are disrupted in patients with brain injury affecting the insula compared with patients with damage to the ventromedial prefrontal cortex or amygdala . In a roulette task ( red/black predictions ) , comparison groups chose either color less after longer runs of that color outcome . On a slot machine task , comparison groups rated higher motivation following near misses relative to full misses . Our results generate a clinical hypothesis that , in disordered gambling , these cognitions may be underpinned by excessive recruitment of insula circuitry . Gambling is a naturalistic example of risky decision-making . During gambling , players typically display an array of cognitive biases that create a distorted expectancy of winning . This study investigated brain regions underpinning gambling-related cognitive distortions , contrasting patients with focal brain lesions to the ventromedial prefrontal cortex ( vmPFC ) , insula , or amygdala ( “ target patients ” ) against healthy comparison participants and lesion comparison patients ( i.e. , with lesions that spare the target regions ) . A slot machine task was used to deliver near-miss outcomes ( i.e. , nonwins that fall spatially close to a jackpot ) , and a roulette game was used to examine the gambler ’s fallacy ( color decisions following outcome runs ) . Comparison groups displayed a heightened motivation to play following near misses ( compared with full misses ) , and manifested a classic gambler ’s fallacy effect . Both effects were also observed in patients with vmPFC and amygdala damage , but were absent in patients with insula damage . Our findings indicate that the distorted cognitive processing of near-miss outcomes and event sequences may be ordinarily supported by the recruitment of the insula . Interventions to reduce insula reactivity could show promise in the treatment of disordered gambling Responses to fear- and sadness-inducing films were assessed using a broad range of cardiovascular ( heart rate , T-wave amplitude , low- and high-frequency heart rate variability , stroke volume , preejection period , left-ventricular ejection time , Heather index , blood pressure , pulse amplitude and transit time , and finger temperature ) , electrodermal ( level , response rate , and response amplitude ) , and respiratory ( rate , tidal volume and its variability , inspiratory flow rate , duty cycle , and end-tidal pCO(2 ) ) measures . Subjective emotional experience and facial behavior ( Corrugator Supercilii and Zygomaticus Major EMG ) served as control measures . Results indicated robust differential physiological response patterns for fear , sadness , and neutral ( mean classification accuracy 85 % ) . Findings are discussed in terms of the fight-flight and conservation-withdrawal responses and possible limitations of a valence-arousal categorization of emotion in affective space \n Output:\n " }, { "from": "agent", "value": "The systematic review revealed that near misses motivate continued play , but have varying effects on the emotional state or betting behaviour of the player .\nNear miss events were also shown to be associated with elevated skin conductance levels and diffuse activity across the brain , most consistently in areas processing reinforcement and reward ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To establish whether an interactive booklet on respiratory tract infections in children reduces reconsultation for the same illness episode , reduces antibiotic use , and affects future consulting intentions , while maintaining parental satisfaction with care . Design Pragmatic cluster r and omised controlled trial . Setting 61 general practice s in Wales and Engl and . Participants 558 children ( 6 months to 14 years ) presenting to primary care with an acute respiratory tract infection ( 7 days or less ) . Children with suspected pneumonia , asthma or a serious concomitant illness , or needing immediate hospital admission were excluded . Three withdrew and 27 were lost to follow-up , leaving 528 ( 94.6 % ) with main outcome data . Interventions Clinicians in the intervention group were trained in the use of an interactive booklet on respiratory tract infections and asked to use the booklet during consultations with recruited patients ( and provide it as a take home re source ) . Clinicians in the control group conducted their consultations as usual . Main outcome measures The proportion of children who attended a face-to-face consultation about the same illness during the two week follow-up period . Secondary outcomes included antibiotic prescribing , antibiotic consumption , future consulting intentions , and parental satisfaction , reassurance , and enablement . Results Reconsultation occurred in 12.9 % of children in the intervention group and 16.2 % in the control group ( absolute risk reduction 3.3 % , 95 % confidence interval −2.7 % to 9.3 % , P=0.29 ) . Using multilevel modelling ( at the practice and individual level ) to account for clustering , no significant difference in reconsulting was noted ( odds ratio 0.75 ; 0.41 to 1.38 ) . Antibiotics were prescribed at the index consultation to 19.5 % of children in the intervention group and 40.8 % of children in the control group ( absolute risk reduction 21.3 % , 95 % confidence interval 13.7 to 28.9 ) , P<0.001 ) . A significant difference was still present after adjusting for clustering ( odds ratio 0.29 ; 0.14 to 0.60 ) . There was also a significant difference in the proportion of parents who said they would consult in the future if their child developed a similar illness ( odds ratio 0.34 ; 0.20 to 0.57 ) . Satisfaction , reassurance , and parental enablement scores were not significantly different between the two groups . Conclusions Use of a booklet on respiratory tract infections in children within primary care consultations led to important reductions in antibiotic prescribing and reduced intention to consult without reducing satisfaction with care . Trial registration Current Controlled Trials IS RCT Background To explore ways to reduce the overuse of antibiotics for acute respiratory infections ( ARIs ) , we conducted a pilot clustered r and omized controlled trial ( RCT ) to evaluate DECISION+ , a training program in shared decision making ( SDM ) for family physicians ( FPs ) . This pilot project demonstrated the feasibility of conducting a large clustered RCT and showed that DECISION+ reduced the proportion of patients who decided to use antibiotics immediately after consulting their physician . Consequently , the objective of this study is to evaluate , in patients consulting for ARIs , if exposure of physicians to a modified version of DECISION+ , DECISION+2 , would reduce the proportion of patients who decide to use antibiotics immediately after consulting their physician . Methods / design The study is a multi-center , two-arm , parallel clustered RCT . The 12 family practice teaching units ( FPTUs ) in the network of the Department of Family Medicine and Emergency Medicine of Université Laval will be r and omized to a DECISION+2 intervention group ( experimental group ) or to a no-intervention control group . These FPTUs will recruit patients consulting family physicians and residents in family medicine enrolled in the study . There will be two data collection periods : pre-intervention ( baseline ) including 175 patients with ARIs in each study arm , and post-intervention including 175 patients with ARIs in each study arm ( total n = 700 ) . The primary outcome will be the proportion of patients reporting a decision to use antibiotics immediately after consulting their physician . Secondary outcome measures include : 1 ) physicians and patients ' decisional conflict ; 2 ) the agreement between the parties ' decisional conflict scores ; and 3 ) perception of patients and physicians that SDM occurred . Also in patients , at 2 weeks follow-up , adherence to the decision , consultation for the same reason , decisional regret , and quality of life will be assessed . Finally , in both patients and physicians , intention to engage in SDM in future clinical encounters will be assessed . Intention-to-treat analyses will be applied and account for the nested design of the trial will be taken into consideration . Discussion DECISION+2 has the potential to reduce antibiotics use for ARIs by priming physicians and patients to share decisional process and empowering patients to make informed , value-based decisions . Trial Registration Clinical Trials.gov : OBJECTIVES . To determine whether we could increase adherence to the Centers for Disease Control and Prevention ( CDC ) recommendations with well-accepted approaches to improving quality of care and adherence to the CDC recommendations result ed in improved outcomes for acute otitis media ( AOM ) . METHODS . A cluster r and omization study was conducted in 12 pediatric practice s ( 6 intervention and 6 control sites ) . The main outcome measures were adherence to the CDC recommendations ( modified to include 2 additional antimicrobial agents ) and a subsequent antibiotic prescription for AOM within 30 days after diagnosis . RESULTS . Of 3152 patients referred to research assistants , 2584 ( 82 % ) were eligible . Of those eligible , 1368 ( 99 % ) of 1382 at the intervention sites and 1138 ( 99 % ) of 1146 at the control sites consented to participate . Rates of adherence to the CDC recommendations were not significantly higher at the intervention sites than at the control sites , for initial enrollment episodes ( 78.2 % vs 70.6 % ) or second episodes ( 62.6 % vs 59.9 % ) . After controlling for clustering according to site and covariates , children who were not treated in adherence to the CDC recommendations for both episodes had 1.60 times the odds of a subsequent prescription within 12 days , compared with those treated in adherence at both episodes . CONCLUSIONS . Despite using evidence -based approaches that are known to influence physician behavior , we were unable to increase adherence to the CDC recommendations for treatment of AOM . However , we did establish that prescription of antimicrobial therapy consistent with the CDC recommendations for a second episode of AOM was associated with improved outcomes , measured as the need for subsequent antibiotic prescription . Because of the selection of resistant otopathogens , adherence to the CDC recommendations is likely more important in subsequent episodes of AOM than in the initial episode Abstract Objective : To assess the medicalising effect of prescribing antibiotics for sore throat . Setting : 11 general practice s in Engl and . Design : R and omised trial of three approaches to sore throat : a 10 day prescription of antibiotics , no antibiotics , or a delayed prescription if the sore throat had not started to settle after three days . Patients : 716 patients aged 4 and over with sore throat and an abnormal physical sign : 84 % had tonsillitis or pharyngitis . Outcome measures : Number and rate of patients making a first return with sore throat , pharyngitis , or tonsillitis . Early returns ( within two weeks ) and complications ( otitis media , sinusitis , quinsy ) . Outcomes were documented in 675 subjects ( 94 % ) . Results : Mean follow up time was similar ( antibiotic group 1.07 years , other two groups 1.03 years ) . More of those initially prescribed antibiotics initially returned to the surgery with sore throat ( 38 % v 27 % , adjusted hazard ratio for return 1.39 , 95 % confidence interval 1.03 to 1.89 ) . Antibiotics prescribed for sore throat during the previous year had an additional effect ( hazard ratio 1.69 , 1.20 to 2.37 ) . Longer duration of illness ( > 5 days ) was associated with increased return within six weeks ( hazard ratio 2.90 , 1.70 to 4.92 ) . Prior attendance with upper respiratory conditions was also associated with increased reattendance . There was no difference between groups in early return ( 13/238 ( 5.5 % ) v 27/437 ( 6 % ) ) , or complications ( 2/236 ( 0.8 % ) v3/434 ( 0.7 % ) ) . Conclusions : Complications and early return result ing from no or delayed prescribing of antibiotics for sore throat are rare . Both current and previous prescribing for sore throat increase reattendance . To avoid medicalising a self limiting illness doctors should avoid antibiotics or offer a delayed prescription for most patients with sore throat . Key messages Sore throat is one of the commonest presentations of upper respiratory illness in primary care and attendence is increasing Complications are rare with no , or delayed , antibiotic prescription Prescribing antibiotics increases reattendance for future episodes Unless patients are very ill general practitioners should consider exploring concerns , explain the natural history , and avoid or delay prescribing CONTEXT Prescribing practice s for otitis media are not consistent with current evidence -based recommendations . OBJECTIVE To determine whether point-of-care evidence delivery regarding the use and duration of antibiotics for otitis media decreases the duration of therapy from 10 days and decreases the frequency of prescriptions written . DESIGN R and omized , controlled trial . SETTING Primary care pediatric clinic affiliated with university training program . Intervention . A point-of-care evidence -based message system presenting real time evidence to providers based on their prescribing practice for otitis media . MAIN OUTCOME MEASURES Proportion of prescriptions for otitis media that were for < 10 days and frequency with which antibiotics were prescribed . RESULTS Intervention providers had a 34 % greater reduction in the proportion of time they prescribed antibiotics for < 10 days . Intervention providers were less likely to prescribe antibiotics than were control providers . CONCLUSIONS A point-of-care information system integrated into outpatient pediatric care can significantly influence provider behavior for a common condition A r and omised controlled trial involving 54 general practitioners ( GPs ) was conducted in Canberra , Australian Capital Territory from September 1997 to November 1999 . In the first year of the study , 24 GPs , who constituted the active arm of the intervention group , were involved in the consideration of evidence and the development and implementation of a set of clinical guidelines for the treatment of acute respiratory infections . These guidelines were then endorsed in a meeting together with specialist colleagues . In the second year of the study the group of GPs who had been acting as controls , received a moderate intervention consisting of a brief educational event and distribution of the locally developed guidelines . We obtained data from January 1997 to December 1999 from the Health Insurance Commission on prescribing rates for 40 of the doctors in the study . The rate of prescribing was calculated as the number of antibiotic prescriptions per 100 Medicare services . The average yearly prescribing decreased significantly in the intensive intervention group and increased in the moderate intervention group , ( p=0.026 ) . A mixed effects longitudinal time series model was fitted to the data to account for seasonal variation of antibiotic prescribing and trends over time . The intensive intervention group significantly reduced their antibiotic prescribing over time compared to the moderate intervention group , ( p<0.001 ) . This study has shown that an intensive intervention in which general practitioners were actively engaged in development and consideration of the evidence base for the guidelines result ed in a significant fall in general antibiotic prescribing Objective To assess the effect of general practitioner testing for C reactive protein ( disease approach ) and receiving training in enhanced communication skills ( illness approach ) on antibiotic prescribing for lower respiratory tract infection . Design Pragmatic , 2 × 2 factorial , cluster r and omised controlled trial . Setting 20 general practice s in the Netherl and s. Participants 40 general practitioners from 20 practice s recruited 431 patients with lower respiratory tract infection . Main outcome measures The primary outcome was antibiotic prescribing at the index consultation . Secondary outcomes were antibiotic prescribing during 28 days ’ follow-up , reconsultation , clinical recovery , and patients ’ satisfaction and enablement . Interventions General practitioners ’ use of C reactive protein point of care testing and training in enhanced communication skills separately and combined , and usual care . Results General practitioners in the C reactive protein test group prescribed antibiotics to 31 % of patients compared with 53 % in the no test group ( P=0.02 ) . General practitioners trained in enhanced communication skills prescribed antibiotics to 27 % of patients compared with 54 % in the no training group ( P<0.01 ) . Both interventions showed a statistically significant effect on antibiotic prescribing at any point during the 28 days ’ follow-up . Clinicians in the combined intervention group prescribed antibiotics to 23 % of patients ( interaction term was non-significant ) . Patients ’ recovery and satisfaction were similar in all study groups . Conclusion Both general practitioners ’ use of point of care testing for C reactive protein and training in enhanced communication skills significantly reduced antibiotic prescribing for lower respiratory tract infection without compromising patients ’ recovery and satisfaction with \n Output:\n " }, { "from": "agent", "value": "Interventions that combined parent education with clinician behaviour change decreased antibiotic prescribing rates by between 6 - 21 % ; structuring the parent-clinician interaction during the consultation may further increase the effectiveness of these interventions .\nAutomatic computerised prescribing prompts increased prescribing appropriateness , while passive information , in the form of waiting room educational material s , yielded no benefit .\nConflicting evidence from the included studies found that interventions directed towards parents and /or clinicians can reduce rates of antibiotic prescribing .\nThe most effective interventions target both parents and clinicians during consultations , provide automatic prescribing prompts , and promote clinician leadership in the intervention design" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Child development delays can cause lower school performance , which in turn can lead to long-term poverty , developmental delays in offspring and a vicious cycle of loss of human potential ( 1 ) . Effective prevention strategies are vital . It is well known that effective early child development programmes should integrate health and education with family support , programme , but coverage is often low ( 1 ) . Cost-effective , high- quality programmes should therefore be considered . The Japanese Maternal and Child Health ( MCH ) h and book has been shown to provide cost-effective , high-level coverage that assists child development ( 2 ) . We evaluated the h and books effectiveness on child development in Mongolia . A threeyear follow-up of a cluster r and omised controlled trial ( RCT ) was conducted . All mothers provided written , informed consent and the institutional ethical boards in Japan and Mongolia approved the study . All women living in the Bulgan province of Mongolia who gave birth between March and August 2010 participated in the study and the three-year follow-up if they still lived in the area . There were 18 clusters in the trial , and a simple r and omisation method featuring sealed envelopes was used . Details of the r and omisation and intervention procedure have previously been published ( 3 ) . Healthcare professionals were trained to distribute the h and book , at the first antenatal visit from May 2009 to January 2010 and explain its use . Three years later , from July to October 2013 , we paid home visits and collected data on the mothers basic characteristics and use of the h and book , together with child anthropometric and developmental measurements . The primary study outcome was risk of developmental delay as assessed by the Mongolian Rapid Baby Scale ( 4 ) . We also analysed how the mothers used the h and book three years after distribution , which helped predict differences in the primary outcome . Univariate analyses were performed to determine the risk of delay in all developmental domains in the intervention group using the generalised estimating equations method and considering the cluster effect at the village level ( data not shown ) . This showed that the childrens cognitive development was likely to be associated with the h and book . Furthermore , multivariable analyses were conducted using generalised estimating equations with logit link , exchangeable correlation structure and robust variance to examine cluster differences . As a result , the odds ratio for the risk of cognitive developmental delay was calculated with an adjustment for the main influencing factor – distribution of the h and book – and adjusted for the following confounding covariates : maternal age , maternal education , marital status , wealth index , primigravidity , number of antenatal visits , miscarriage , second-h and smoke and drinking during pregnancy , risk of maternal depression symptoms , pregnancy complications , gestational week , birthweight , Apgar score , initiation of breastfeeding and living in an overcrowded home . The trial was registered at the UMIN Clinical Trial Registry ( UMIN000001748 ) . In the baseline trial , 253 and 248 women participated in the intervention and control groups , respectively , and three years later , we followed 386 ( 77 % ) participants : 214 ( 84.5 % ) in the intervention group and 172 ( 69.3 % ) in the control group . Participants were lost to follow-up because they moved to different parts of the country . Thus , attrition bias might have occurred due to participant losses in the follow-up study . However , no baseline difference was observed between dropouts and the remaining mothers . Dropouts occurred more often in the control group than the intervention group . Therefore , the effectiveness of the intervention for preventing child developmental delays might have been underestimated . To the best of our knowledge , this was the first longitudinal RCT assessment of the effectiveness of the h and book on child development . We found that the distribution of the h and book had a protective effect on the risk of cognitive delay ( Table 1 ) , but poor cognitive development was increased by higher maternal age , maternal depression one month after delivery and pregnancy complications ( Table 1 ) At an antenatal clinic in St. Thomas 's Hospital , London , 246 expectant mothers were r and omly allocated to hold either their own maternity case notes or the st and ard co-operation card . Information was collected on three occasions during their care on attitudes and health behaviour . Clinical outcomes were recorded and the effects of the two systems on clinic administration were observed . More of the notes group expressed satisfaction with most aspects of their care and delivery and significantly more of the notes group felt well informed and satisfied with their companion during labour . There were no differences in clinical outcomes between the two groups except that , for no identifiable systematic reason , there were more assisted deliveries among the notes group . A number of administrative advantages result ed from mothers holding their own notes and although initial reservations were found amongst professional staff interviewed at the start of the study , the results proved persuasive and the practice of giving mothers their own notes is now to be extended throughout the department Objective To assess the effectiveness of the Maternal and Child Health ( MCH ) h and book in Mongolia to increase antenatal clinic attendance , and to enhance health-seeking behaviors and other health outcomes . Methods A cluster r and omized trial was conducted using the translated MCH h and book in Bulgan , Mongolia to assess its effectiveness in promoting antenatal care attendance . Pregnant women were recruited from 18 r and omly allocated districts using shuffled , sealed envelopes . The h and book was implemented immediately for women at their first antenatal visit in the intervention group , and nine months later in the control group . The primary outcome was the number of antenatal care visits of all women residing in the selected districts . Cluster effects were adjusted for using generalized estimation equation . Masking was not possible among care providers , pregnant women and assessors . Findings Nine districts were allocated to the intervention group and the remainder to the control group . The intervention group ( 253 women ) attended antenatal clinics on average 6•9 times , while the control group ( 248 women ) attended 6•2 times . Socioeconomic status affected the frequency of clinic attendance : women of higher socioeconomic status visited antenatal clinics more often . Pregnancy complications were more likely to be detected among women using the h and book . Conclusion The MCH h and book promotes continuous care and showed an increase in antenatal visits among the intervention group . The intervention will help to identify maternal morbidities during pregnancy and promote health-seeking behaviors . Trial Registration UMIN Clinical Trial Registry Despite the widespread use of home based child health records of varying complexity in Engl and , there is a notable absence of their evaluation . Such a record booklet developed in the West Lambeth Health Authority has been used by parents , doctors , and community nurses to build up an independent chronological record of a child 's birth statistics , health , growth , immunisation , development checks , and contacts with health services . A r and omised controlled evaluation of the record , analyses of entries in it , and a survey of the views of mothers and health professionals using the record have been carried out . The need for such a record was confirmed by those question ed and analyses of entries in the booklet helped to modify and improve it . The evaluation was unable to show , however , any effect of the record on immunisation and developmental assessment service uptake . Its value in improving communication between the numerous health and other care agencies was dependent on its proper use In Pakistan during 2000 - 2004 , about 11 - 13 % of children who received the first dose of diphtheria-pertussis-tetanus ( DPT1 ) failed to complete its third dose ( DPT3 ) . We assessed the effect of a re design ed immunization card and center-based education to mothers on DPT3 completion . We enrolled 1500 mother-child units at DPT1 , r and omized them to three intervention and one st and ard care groups , and recorded their DPT3 visits during a 90-day follow-up . In multivariable analysis , a significant increase of 31 % ( adjusted RR=1.31 , 95 % CI=1.18 - 1.46 ) in DPT3 completion was estimated in the group that received both re design ed card and center-based education compared with the st and ard care group Background Maternal and Child Health ( MCH ) H and book , an integrated MCH home-based record , was piloted in four provinces of Vietnam ( Dien Bien , Hoa Binh , Thanh Hoa and An Giang ) . The study is aim ed at assessing the changes in pregnant women ’s behavior towards the frequencies of their antenatal care service utilizations and their subsequent breastfeeding practice s up to six months of age , through the MCH H and book intervention . This is because the levels of pregnant women ’s knowledge , attitude and practice s ( KAP ) towards their antenatal care service utilizations and exclusive breastfeeding practice s have been previously neither analyzed nor reported in relation to MCH home-based records in the country . Methods To compare pre-intervention baseline in 2011 , post-intervention data were collected in 2013 . Structured interviews were conducted with r and omly selected 810 mothers of children 6 - 18 months of age in the four provinces . A focus group discussion among mothers in each of four provinces was conducted . Results There was no significant difference in pregnant women ’s knowledge about the need for ≥3 antenatal care visits between pre- and post- interventions . Yet , the proportion of pregnant women who made ≥3 antenatal care visits in post-intervention was significantly higher than in pre-intervention . Thus , MCH H and book is likely to have contributed to practicing ≥3 antenatal care visits , by changing their attitude . The proportion of mothers who know the need for exclusive breastfeeding necessary during the initial six months significantly increased between pre- and post- interventions . The proportion of those practicing exclusive breastfeeding significantly increased between pre- and post- interventions , too . Thus , MCH H and book is likely to have contributed to the increase in both knowledge about and practice s of exclusive breastfeeding . Conclusion The results of study imply that MCH H and book contributed to the increase in pregnant women ’s practice s of ≥3 antenatal care visits and in their knowledge about and practice of exclusive breastfeeding . While there is room for improvement in the level of its data recording , the study confirmed that MCH H and book plays a catalytic role in ensuring a continuum of maternal , newborn and child care . Note that this study is the first study that attempted to estimate pregnant women ’s behavioral changes through MCH H and book intervention in Vietnam OBJECTIVE During pregnancy , the information needs of patients are high and effective information sharing between patients and health care providers is of particular importance . We conducted a r and omized controlled trial to evaluate the effect of providing pregnant women with secure access to their antenatal health records on their uptake of , and satisfaction with , relevant information . METHODS Women presenting to a primary care maternity centre before 28 weeks ' gestation were r and omized to receive access either to a secure website with links to general pregnancy health information alone ( GI group ) or to the same website with access to their own antenatal health record ( PI group ) . Primary outcomes included frequency of use , and satisfaction with and perceived usefulness of the web-based information . RESULTS We approached 199 women regarding participation in the study ; 193 agreed to participate , and 97 were r and omized to the PI group and 96 to the GI group . The mean number of log-ins to the website in the PI group subsequently was almost six times the number of log-ins in the GI group ( 10.4 + /- 17.8 vs. 1.8 + /- 1.4 ; P < 0.001 ) , and 84.2 % of log-ins in the PI group accessed the antenatal health record . The responses of participants to questions about the website 's ease of use and value in providing information about pregnancy indicated a high level of satisfaction , with no significant difference in responses between groups . CONCLUSION Pregnant patients are prepared to use a health information website and web-based health records . When personal information is provided there is greater use than when general pregnancy information alone is provided . Given the almost universal availability of the Internet , this option has the potential for wider application to patient-related outcomes To assess a policy of women holding and thus having constant access to their own obstetric records , 290 women attending a peripheral consultant clinic in Newbury , West Berkshire , were r and omly allocated to hold either their full case notes , or the more usual co‐operation card . Women holding their full records were significantly more likely to feel in control of their antenatal care ( rate ratio 1·45 ; 95 % confidence interval 1·08–1·95 ) and to feel it was easier to talk to doctors and midwives ( rate ratio 1·73 ; 95 % confidence interval 1·16‐2·59 ) . No other beneficial effects were detected . Asked about their preferences for any subsequent pregnancies , women holding their own records in the index pregnancy were more likely to say they would prefer to hold the same kind of record again in a subsequent pregnancy than were women holding a co‐operation card ( rate ratio 1·56 ; 95 % confidence interval 1·34–1·81 ) . There was no evidence of negative effects . In particular , women holding their case notes did not feel more anxious than co‐operation card holders . The policy of women holding their notes result ed in savings in elerical time , without evidence of an increase in the rate of lost notes OBJECTIVE A substantial dropout from the first dose of diphtheria-tetanus-pertussis ( DTP1 ) to the 3rd dose of DTP ( DTP3 ) immunization has been recorded in Pakistan . We conducted a r and omized controlled trial to assess the effects of providing a substantially re design ed immunization card , centre-based education , or both interventions together on DTP3 completion at six rural exp and ed programme on immunization ( EPI ) centres in Pakistan . METHODS Mother-child pairs were enrolled at DTP1 and r and omized to four study groups : re design ed card , centre-based education , combined intervention and st and ard care . Each child was followed up for 90 days to record the date s of DTP2 and DTP3 visits . The study outcome was DTP3 completion by the end of follow-up period in each study group . RESULTS We enrolled 378 mother-child pairs in re design ed card group , 376 in centre-based \n Output:\n " }, { "from": "agent", "value": "HBRs used during the life cycle of women and children in Indonesia showed benefits for continuity of care .\nThere were no significant effects on healthy pregnancy behaviors such as smoking and consumption of alcohol during pregnancy .\nThere were no statistically significant effects on newborn health outcomes .\nHBRs show modest but important health effects for women and children .\nThese effects with minimal-to-no harms , multiplied across a population , could play an important role in reducing health inequities in maternal , newborn , and child health" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction Return to work ( RTW ) of employees on sick leave for common mental disorders may require a multidisciplinary approach . This article aims to assess time to RTW after a psychiatric consultation providing treatment advice to the occupational physician ( OP ) for employees on sick leave for common mental disorders in the occupational health ( OH ) setting , compared to care as usual ( CAU ) . Methods Cluster r and omized clinical trial evaluating patients of 12 OPs receiving consultation by a psychiatrist , compared to CAU delivered by 12 OPs in the control group . 60 patients suffering from common mental disorders and ≥ six weeks sicklisted were included . Follow up three and six months after inclusion . Primary outcome measure was time to RTW . Intention- to-treat multilevel analysis and a survival analysis were performed to evaluate time to RTW in both groups . Results In CAU , referral was the main intervention . Both groups improved in terms of symptom severity and quality of life , but time to RTW was significantly shorter in the psychiatric consultation group . At three months follow up , 58 % of the psychiatric consultation group had full RTW versus 44 % of the control group , a significant finding ( P = 0.0093 ) . Survival analysis showed 68 days earlier RTW after intervention in the psychiatric consultation group ( P = 0.078 ) compared to CAU . Conclusion Psychiatric consultation for employees on sick leave in the OH setting improves time to RTW in patients with common mental disorders as compared to CAU . In further research , focus should be on early intervention in patients with common mental disorders on short sick leave duration . Psychiatric consultation might be particularly promising for improvement of RTW in those patients . Trial registration number IS RCT N : Background Since a higher level of self-efficacy in common mental disorders is associated with earlier return-to-work ( RTW ) , it is important to know if work related self-efficacy can be increased by occupational health care . The primary aim of this study was to evaluate whether an intervention to enhance guideline adherence of occupational physicians lead to an increase in RTW self-efficacy in workers three months later . The secondary aim was to evaluate whether the intervention modified the association between RTW self-efficacy and return-to-work three months later . Methods A total of 66 occupational physicians participated in the study . They were r and omized into two groups ; the intervention group received a training , the control group did not . The training aim ed to enhance adherence to a mental health guideline that contained strategies that are supposed to enhance RTW self-efficacy . In 128 sick-listed workers guided by these occupational physicians , RTW self-efficacy , RTW , and personal , health-related and work-related variables were measured at baseline and three months later . Generalized linear mixed models analysis and linear mixed models analysis were used for the evaluations . Results In workers whose occupational physicians had received the training RTW self-efficacy increased significantly more than in workers whose occupational physicians had participated in the control group ( t = −2.626 , p ≤ .05 ) . Higher baseline RTW self-efficacy scores were significantly more often associated with full RTW than with no RTW three months later ( OR 2.20 , 95 % CI 1.18–4.07 ) , but the intervention did not affect this association . Conclusions This study showed that a training to enhance guideline adherence of occupational physicians leads to increased RTW self-efficacy in workers sick-listed with common mental disorders during the first months of sickness absence in a real-life occupational health care setting . This insight is helpful for optimizing the recovery and RTW process , and for underst and ing the role of RTW self-efficacy in this process . Trial registration IS RCT Purpose Evidence -based guidelines in occupational health care improve the quality of care and may reduce sickness absence duration . Notwithst and ing that , guideline adherence of occupational physicians ( OPs ) is limited . Based on the literature on guideline implementation , an intervention was developed that was shown to effectively improve self-reported adherence in OPs . The aim of present study was to evaluate whether this intervention leads to earlier return to work ( RTW ) in workers with common mental disorders ( CMD ) . Methods In a two-armed cluster r and omized controlled trial , 66 OPs were r and omized . The trial included 3379 workers , with 1493 in the intervention group and 1886 in the control group . The outcome measures were : time to full RTW , time to first RTW , and total hours of sickness absence . Cox regression analyses and generalized linear mixed model analyses were used for the evaluations . Results The median time to RTW was 154 days among the 3228 workers with CMD . No significant differences occurred in ( time to ) full RTW between intervention and control group HR 0.96 ( 95 % CI 0.81–1.15 ) nor for first RTW HR 0.96 ( 95 % CI 0.80–1.15 ) . The mean total hours of sickness absence was 478 h in the intervention group and 483 h in the control group . Conclusions The intervention to enhance OPs ’ guideline adherence did not lead to earlier RTW in workers with CMD guided by the OPs . Possible explanations are the remaining external barriers for guideline use , and that perceived guideline adherence might not represent actual guideline adherence and improved care . Trail registration : IS RCT N86605310 R and omised controlled trial to evaluate the effectiveness of collaborative care in a Dutch occupational healthcare setting : 126 workers on sick leave with major depressive disorder were r and omised to usual care ( n = 61 ) or collaborative care ( n = 65 ) . After 3 months , collaborative care was more effective on the primary outcome measure of treatment response ( i.e. reduction in symptoms of ≥50 % ) on the Patient Health Question naire-9 ( PHQ-9 ) . However , the groups did not differ on the PHQ-9 as a continuous outcome measure . Implication s of these results are discussed Objective To examine the efficacy of structured early consultation among employees at high risk for future long-term sickness absence , in the prevention and /or reduction of sickness absence . The focus of the experiment was the timing of the intervention , that is , treatment before sickness absence actually occurs . Methods In the current prospect i ve r and omized controlled trial ( RCT ) , employees at high risk for long-term sickness absence were selected based on responses to a 34-item screening question naire including demographic , workplace , health and psychosocial factors associated with long-term sickness absence ( > 28 days ) . A total of 299 subjects at risk for future long-term sickness absence were r and omized in an experimental group ( n = 147 ) or in a control group ( n = 152 ) . Subjects in the experimental group received a structured early consult with their occupational physician ( OP ) , in some cases followed by targeted intervention . The control group received care as usual . Sickness absence was assessed objective ly through record linkage with the company registers on sickness absence over a 1 year follow-up period . Results Modified intention-to-treat analysis revealed substantial and statistically significant differences ( p = 0.007 ) in total sickness absence duration over 1 year follow-up between the experimental ( mean 18.98 ; SD 29.50 ) and control group ( mean 31.13 ; SD 55.47 ) . Per- protocol analysis additionally showed that the proportion of long-term sickness absence spells ( > 28 days ) over 1 year follow-up was significantly ( p = 0.048 ) lower in the experimental ( 9.1 % ) versus control group ( 18.3 % ) . Conclusions Structured early consultation with the OP among employees at high risk for future long-term sickness absence is successful in reducing total sickness absence OBJECTIVE The aim of the present study was to compare the effectiveness and acceptability of three interventions for occupational stress . METHODS / DESIGN A total of 90 National Health Service employees were r and omized to face-to-face counselling or telephone counselling or bibliotherapy . Outcomes were assessed at post-intervention and 4-month follow-up . Clinical Outcomes in Routine Evaluation ( CORE ) , General Health Question naire ( GHQ-12 ) , and Perceived Stress Scale ( PSS-10 ) were used to evaluate intervention outcomes . An intention-to-treat analyses was performed . RESULTS Repeated measures analysis revealed significant time effects on all measures with the exception of CORE Risk . No significant group effects were detected on all outcome measures . No time by group significant interaction effects were detected on any of the outcome measures with the exception of CORE Functioning and GHQ total . With regard to acceptability of interventions , participants expressed a preference for face-to-face counselling over the other two modalities . CONCLUSIONS Overall , it was concluded that the three intervention groups are equally effective . Given that bibliotherapy is the least costly of the three , results from the present study might be considered in relation to a stepped care approach to occupational stress management with bibliotherapy as the first line of intervention , followed by telephone and face-to-face counselling as required AIM This paper is a report of a study to test the effect of participating in a reflecting peer-support group on self-reported health , burnout and on perceived changes in work conditions . BACKGROUND Stress-related conditions are one of the most common causes for long-term sick-leave . There is limited evidence for the effectiveness of person-directed interventions aim ed at reducing stress levels in healthcare workers . Prior research in the relationship between support and burnout show somewhat inconsistent results . METHOD A r and omized controlled trial with peer-support groups as the intervention was conducted with 660 healthcare workers scoring above the 75th percentile on the exhaustion dimension of the Oldenburg Burnout Inventory . One hundred and fifty-one ( 22.9 % ) agreed to participate . The intervention started in 2002 with 51 participants ( 96.1 % were women ) , 80 of whom constituted the control group . Potential differences in outcome measures 12 months after the intervention were compared using ancova , and data collected was completed in 2004 . Qualitative content analyses were used to analyse reported experiences from group participation . RESULTS Statistically significant intervention effects were found for general health , perceived quantitative dem and s at work , participation and development opportunities at work and in support at work . Seven categories of experiences from participating were identified : talking to others in a similar situation , knowledge , sense of belonging , self-confidence , structure , relief of symptoms and behavioural change . CONCLUSION Peer-support groups using a problem-based method could be a useful and comparatively inexpensive tool in alleviating work-related stress and burnout OBJECTIVES Nurses are at elevated risk of burnout , anxiety and depressive disorders , and may then become less productive . This begs the question if a preventive intervention in the work setting might be cost-saving from a business perspective . MATERIAL AND METHODS A cost-benefit analysis was conducted to evaluate the balance between the costs of a preventive intervention among nurses at elevated risk of mental health complaints and the cost offsets stemming from improved productivity . This evaluation was conducted alongside a cluster-r and omized trial in a Dutch academic hospital . The control condition consisted of screening without feedback and unrestricted access to usual care ( N = 206 ) . In the experimental condition screen-positive nurses received personalized feedback and referral to the occupational physician ( N = 207 ) . RESULTS Subtracting intervention costs from the cost offsets due to reduced absenteeism and presenteeism result ed in net-savings of 244 euros per nurse when only absenteeism is regarded , and 651 euros when presenteeism is also taken into account . This corresponds to a return-on-investment of 5 euros up to 11 euros for every euro invested . CONCLUSIONS Within half a year , the cost of offering the preventive intervention was more than recouped . Offering the preventive intervention represents a favorable business case as seen from the employer 's perspective Objectives The aim of the present study was to investigate whether participation in a structured re source -enhancing group intervention at work would act as primary prevention against depression . The authors analysed whether the intervention result ed in universal , selected or indicated prevention . Methods A total of 566 persons participated in a prospect i ve , within-organisation , r and omly assigned field experimental study , which consisted of 34 workshops in 17 organisations . The participants filled in a question naire , were r and omly assigned to either intervention ( n=296 ) or comparison ( n=324 ) groups and returned another question naire 7 months later . The intervention , lasting four half-day sessions , was delivered by trainers from occupational health services and human re sources . The aim of the structured programme was to enhance participants ' career management preparedness by strengthening self-efficacy and inoculation against setbacks . The comparison group received a literature package . The authors measured depressive symptoms using the short version of the Beck Depression Inventory . A high number of depressive symptoms ( over 9 points ) were used as a proxy for depression . Results At follow-up , the odds of depression were lower in the intervention group ( OR=0.40 , 95 % CI 0.19 to 0.85 ) than in the comparison group when adjusted for baseline depressive symptoms , job strain and socio-demographics . In addition , the odds of depression among those with job strain ( OR=0.15 , 95 % CI 0.03–0.81 ) at baseline were lower after the intervention . The intervention had no statistically significant effect on those with depressive symptoms ( over 4 points ) at baseline . Conclusion The re source -enhancing group intervention appeared to be successful as universal and selective prevention of potential depression OBJECTIVES In case of long-term sick leave , gradually increasing workload appears to be an effective component of work-directed interventions to reduce sick leave due to common mental disorders ( CMD ) . CMD are defined as stress-related , adjustment , \n Output:\n " }, { "from": "agent", "value": "However , effect on return to full-time work was not consistent , and these interventions did not consistently improve CMD symptoms .\nInterventions at the workplace/organizational level were less common .\nReturn-to-work and improvement of CMD symptoms are poorly correlated and should be addressed simultaneously in future interventions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Several polymorphisms in DNA repair genes have been reported to be associated with lung cancer risk including XPA ( -4G/A ) , XPD ( Lys751Gln and Asp312Asn ) , XRCC1 ( Arg399Gln ) , APE1 ( Asp148Glu ) and XRCC3 ( Thr241Met ) . As there is little information on the combined effects of these variants , polymorphisms were analyzed in a case-control study including 463 lung cancer cases [ among them 204 adenocarcinoma and 212 squamous cell carcinoma ( SCC ) ] and 460 tumor-free hospital controls . Odds ratios ( OR ) adjusted for age , gender , smoking and occupational exposure were calculated for the variants alone and combinations thereof . For homozygous individuals carrying the Glu variant of APE1 , a protective effect was found ( OR = 0.77 , CI = 0.51 - 1.16 ) . Individuals homozygous for the variants XPA ( -4A ) ( OR = 1.53 , CI = 0.94 - 2.5 ) , XPD 751Gln ( OR = 1.39 , CI = 0.90 - 2.14 ) or XRCC3 241Met ( OR = 1.29 , CI = 0.85 - 1.98 ) showed a slightly higher risk for lung cancer overall . In the subgroup of adenocarcinoma cases , adjusted ORs were increased for individuals homozygous for XPA ( -4A ) ( OR = 1.62 , CI = 0.91 - 2.88 ) and XRCC3 241Met ( OR = 1.65 ; CI = 0.99 - 2.75 ) . When analyzing the combined effects of variant alleles , 54 patients and controls were identified that were homozygous for two or three of the potential risk alleles [ i.e. the variants in nucleotide excision repair , XPA ( -4A ) and XPD 751Gln , and in homologous recombination , XRCC3 - 241Met ] . ORs were significantly increased when all patients ( OR = 2.37 ; CI = 1.26 - 4.48 ) , patients with SCC ( OR = 2.83 ; CI = 1.17 - 6.85 ) and with adenocarcinoma ( OR = 3.05 ; CI = 1.49 - 6.23 ) were analyzed . Combinations of polymorphisms in genes involved in the same repair pathway ( XPA + XPD or XRCC1 + APE1 ) affected lung cancer risk only in patients with SCC . These results indicate that lung cancer risk is only moderately increased by single DNA repair gene variants investigated but it is considerably enhanced by specific combinations of variant alleles . Analyses of additional DNA repair gene interactions in larger population -based studies are warranted for identification of high-risk subjects Several single nucleotide polymorphisms ( SNPs ) affecting DNA repair capacity and modifying cancer susceptibility have been described . We evaluated the association of SNPs Arg194Trp , Arg280His , and Arg399Gln in the X-ray cross-complementing group 1 ( XRCC1 ) and Thr241Met in the X-ray cross-complementing group 3 ( XRCC3 ) DNA repair genes with the risk of brain tumors . The Caucasian study population consisted of 701 glioma ( including 320 glioblastoma ) cases , 524 meningioma cases , and 1,560 controls in a prospect i ve population -based case – control study conducted in Denmark , Finl and , Sweden , and the UK . The studied SNPs were not significantly associated with the risk of brain tumors . The highest odds ratios ( ORs ) for the associations were observed between the homozygous variant genotype XRCC1 Gln399Gln and the risk of glioma ( OR = 1.32 ; 95 % confidence interval , CI , 0.97–1.81 ) , glioblastoma ( OR = 1.48 ; 95 % CI , 0.98–2.24 ) , and meningioma ( OR = 1.34 ; 95 % CI , 0.96–1.86 ) . However , in pair-wise comparisons a few SNP combinations were associated with the risk of brain tumors : Among others , carriers of both homozygous variant genotypes , i.e. , XRCC1 Gln399Gln and XRCC3 Met241Met , were associated with a three-fold increased risk of glioma ( OR = 3.18 ; 95 % CI , 1.26–8.04 ) and meningioma ( OR = 2.99 ; 95 % CI , 1.16–7.72 ) . In conclusion , no significant association with brain tumors was found for any of the polymorphisms , when examined one by one . Our results indicated possible associations between combinations of XRCC1 and XRCC3 SNPs and the risk of brain tumors Environmental carcinogens contained in air pollution , such as polycyclic aromatic hydrocarbons , aromatic amines or N-nitroso compounds , predominantly form DNA adducts but can also generate interstr and cross-links and reactive oxygen species . If unrepaired , such lesions increase the risk of somatic mutations and cancer . Our study investigated the relationships between 22 polymorphisms ( and their haplotypes ) in 16 DNA repair genes belonging to different repair pathways in 1094 controls and 567 cancer cases ( bladder cancer , 131 ; lung cancer , 134 ; oral-pharyngeal cancer , 41 ; laryngeal cancer , 47 ; leukaemia , 179 ; death from emphysema and chronic obstructive pulmonary disease , 84 ) . The design was a case-control study nested within a prospect i ve investigation . Among the many comparisons , few polymorphisms were associated with the diseases at the univariate analysis : XRCC1 - 399 Gln/Gln variant homozygotes [ odds ratios ( OR ) = 2.20 , 95 % confidence intervals ( CI ) = 1.16 - 4.17 ] and XRCC3 - 241 Met/Met homozygotes ( OR = 0.51 , 95 % CI = 0.27 - 0.96 ) and leukaemia . The recessive model in the stepwise multivariate analysis revealed a possible protective effect of XRCC1 - 399Gln/Gln in lung cancer ( OR = 0.22 , 95 % CI = 0.05 - 0.98 ) , and confirmed an opposite effect ( OR = 2.47 , 95 % CI = 1.02 - 6.02 ) in the leukaemia group . Our results also suggest that the XPD/ERCC1-GAT haplotype may modulate leukaemia ( OR = 1.28 , 95 % CI = 1.02 - 1.61 ) , bladder cancer ( OR = 1.38 , 95 % CI = 1.06 - 1.79 ) and possibly other cancer risks . Further investigations of the combined effects of polymorphisms within these DNA repair genes , smoking and other risk factors may help to clarify the influence of genetic variation in the carcinogenic process \n Output:\n " }, { "from": "agent", "value": "Many of the reported SNPs had diverse association with specific human cancers .\nFor example , there was a positive association between the OGG1 Ser326Cys variant and gastric and lung cancer , while the XRCC1 Arg399Gln variant was associated with reduced cancer risk ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE A subset of fibromyalgia ( FM ) patients have a dysfunctional hypothalamic-pituitary-insulin-like growth factor 1 ( IGF-1 ) axis , as evidence d by low serum levels of IGF-1 and a reduced growth hormone ( GH ) response to physiologic stimuli . There is evidence that pyridostigmine ( PYD ) improves the acute response of GH to exercise in FM patients . The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms . METHODS FM patients were r and omized to 1 of the following 4 groups : PYD plus exercise , PYD plus diet recall but no exercise , placebo plus exercise , and placebo plus diet recall but no exercise . The primary outcome measures were the visual analog scale ( VAS ) score for pain , tender point count , and total myalgic score . Secondary outcome measures were the total score on the Fibromyalgia Impact Question naire ( FIQ ) and FIQ VAS scores for individual symptoms ( fatigue , poor sleep , stiffness , and anxiety ) , as well as quality of life ( QOL ) and physical fitness ( lower body strength/endurance , upper and lower body flexibility , balance , and time on the treadmill ) . RESULTS A total of 165 FM patients completed baseline measurements ; 154 ( 93.3 % ) completed the study . The combination of PYD and exercise did not improve pain scores . PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups . Compared with the nonexercise groups , the 2 exercise groups demonstrated improvement in fatigue and fitness . PYD was generally well tolerated . CONCLUSION Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms . However , PYD did improve anxiety and sleep , and exercise improved fatigue and fitness . We speculate that PYD may have improved vagal tone , thus benefiting sleep and anxiety ; this notion warrants further study A h and exerciser with an electronic counter and a visual display was used to measure compliance objective ly , to investigate the effects of visual feedback on compliance , and to assess the impact of exercise on seven mild and five moderate rheumatoid arthritis patients . A multiple time-series design varying the onset of the visual display was utilized . Compliance was assessed weekly over the 7 weeks of the study . Pretest and posttest measures of various indicators of h and functioning were taken by an occupational therapist . Visual display of the number of exercises completed decreased the number of noncompliant patients from six to two , with the maximum degree of noncompliance reduced from 44 to 5 % . Thus the use of visual display is effective in producing compliance to exercise regimens . In light of the small sample size , however , no definitive conclusions can be drawn regarding the effects of exercise on h and functioning Adjustments for making multiple comparisons in large bodies of data are recommended to avoid rejecting the null hypothesis too readily . Unfortunately , reducing the type I error for null associations increases the type II error for those associations that are not null . The theoretical basis for advocating a routine adjustment for multiple comparisons is the “ universal null hypothesis ” that “ chance ” serves as the first-order explanation for observed phenomena . This hypothesis undermines the basic premises of empirical research , which holds that nature hollows regular laws that may he studied through observations . A policy of not making adjustments for multiple comparisons is preferable because it will lead to fewer errors of interpretation when the data under evaluation are not r and om numbers but actual observations on nature . Furthermore , scientists should not he so reluctant to explore leads that may turn out to he wrong that they penalize themselves by missing possibly important findings OBJECTIVE To evaluate the feasibility of 8 months of supervised exercise therapy in warm water and its effects on the impact of fibromyalgia on physical and mental health and physical fitness in affected women . METHODS Thirty women with fibromyalgia were r and omly assigned to an exercise therapy group ( n = 15 ) or a control group ( inactive ) ( n = 15 ) . The impact of fibromyalgia on physical and mental health was assessed using the Fibromyalgia Impact Question naire and the anxiety state with State-Trait Anxiety Inventory . Physical fitness was measured using the following tests : Canadian Aerobic Fitness ; h and -grip dynamometry ; 10-metre walking ; 10-step stair-climbing and blind 1-leg stance . RESULTS After 8 months of training , the exercise therapy group improved compared with the control group in terms of physical function ( 20 % ) , pain ( 8 % ) , stiffness ( 53 % ) , anxiety ( 41 % ) , depression ( 27 % ) , Fibromyalgia Impact Question naire total scores ( 18 % ) , State-Trait Anxiety Inventory score ( 22 % ) , aerobic capacity ( 22 % ) , balance ( 30 % ) , functional capacity for walking ( 6 % ) , stair-climbing with no extra weight ( 14 % ) and stair-climbing 10 kg-weighted ( 25 % ) . CONCLUSION Eight months of supervised exercise in warm water was feasible and led to long-term improvements in physical and mental health in patients with fibromyalgia at a similar magnitude to those of shorter therapy programmes To compare the use of r and omized controls ( RCTs ) and historical controls ( HCTs ) for clinical trials , we search ed the literature for therapies studied by both methods . We found six therapies for which 50 RCTs and 56 HCTs were reported . Forty-four of 56 HCTs ( 79 percent ) found the therapy better than the control regimen , but only 10 of 50 RCTs ( 20 percent ) agreed . For each therapy , the treated patients in RCTs and HCTs of the same therapy was largely due to differences in outcome for the control groups , with HCT control patients generally doing worse than the RCT control groups . Adjustment of the outcomes of the HCTs for prognostic factors , when possible , did not appreciably change the results . The data suggest that biases in patient selection may irretrievably weight the outcome of HCts in favor of new therapies . RCTs may miss clinical ly important benefits because of inadequate attention to sample size . The predictive value of each might be improved by reconsidering the use of p less than 0.05 as the significance level for all types of clinical trials , and by the use of confidence intervals around estimates of treatment effects This study addressed a method ological gap by comparing psychological and social outcomes of exercise in green outdoors versus built indoors setting s , whilst rigorously controlling exercise mode and intensity . The hypotheses were that greater improvements or more desirable values for directed attention , mood , perceived exertion , social interaction time , intention for future exercise behaviour and enjoyment would be associated with outdoors compared to indoors exercise . Following a baseline session , paired participants completed two conditions of 15 min of cycling on an ergometer placed outside in a natural environment and inside in a laboratory setting in a r and omized , counter-balanced order . At pre- and post-exercise , directed attention was measured with the digit span backwards task , and mood was assessed with the Profile of Mood States . During the exercise session , visual and verbal interactions were recorded by means of experimenter observations . After each exercise session , participants provided self-reports of their enjoyment of the exercise , perceived exertion and intention for future exercise in the same environment . Social interaction time was significantly greater during outdoors exercise versus indoors ; on average , participants engaged in three minutes more social interaction during exercise outdoors compared to indoors . Social interaction time significantly predicted intention for future exercise in the outdoors condition , but did not in the indoor condition . There was a significant time by condition interaction for directed attention . Scores worsened in the indoors condition , but improved in the outdoors condition . There was no statistically-significant time by condition interaction for mood and no significant difference between conditions for either perceived exertion or intention . Taken together , these findings show that exercise in a natural environment may promote directed attention and social interactions , which may positively influence future exercise intentions BACKGROUND AND PURPOSE The purpose s of this study were : ( 1 ) to assess the effectiveness of a 16-week progressive program of home-based , videotape-based , low-impact aerobic exercise on physical function and signs and symptoms of fibromyalgia in previously sedentary women aged 20 to 55 years and ( 2 ) to compare the effects of 1 long exercise bout versus 2 short exercise bouts per training day ( fractionation ) on physical function , signs and symptoms of fibromyalgia , and exercise adherence . SUBJECTS One hundred forty-three sedentary women were r and omly assigned to 1 of 3 groups : a group who trained using a long bout of exercise ( LBE group , n=51 ) , a group who trained using short bouts of exercise ( SBE group , n=56 ) , and a group who performed no exercise ( NE group , n=36 ) . METHODS The SBE group exercised twice daily , and the LBE group worked out once daily . Both groups progressed in total daily training duration from 10 to 30 minutes , 3 to 5 times a week , for 16 weeks . Physical and psychological well-being , symptoms , and self-efficacy were evaluated using a multivariate analysis of variance . RESULTS Dropout rates for the NE , SBE , and LBE groups were 14 % , 38 % , and 29 % , respectively . The NE group differed from the LBE group in disease severity , self-efficacy , and psychological well-being ( midtest , efficacy analysis ) and from the SBE group in disease severity and self-efficacy ( posttest , efficacy analysis ) . Exercise adherence was greater for the LBE group than for the SBE group between weeks 5 and 8 of the training program . No other differences between exercise groups were found . DISCUSSION AND CONCLUSION Progressive , home-based , low-impact aerobics improved physical function and fibromyalgia symptoms minimally in participants who completed at least two thirds of the recommended exercise . Fractionation of exercise training provided no advantage in terms of exercise adherence , improvements in fibromyalgia symptoms or physical function . High attrition rates and problems with exercise adherence were experienced in both exercise groups OBJECTIVES To evaluate the effects of a 16-week exercise therapy in a chest-high pool of warm water through applicable tests in the clinical practice on the global symptomatology of women with fibromyalgia ( FM ) and to determine exercise adherence levels . DESIGN A r and omized controlled trial . SETTING Testing and training were completed at the university . PARTICIPANTS Middle-aged women with FM ( n=60 ) and healthy women ( n=25 ) . INTERVENTION A 16-week aquatic training program , including strength training , aerobic training , and relaxation exercises . MAIN OUTCOME MEASURES Tender point count ( syringe calibrated ) , health status ( Fibromyalgia Impact Question naire ) ; sleep quality ( Pittsburgh Sleep Quality Index ) ; physical ( endurance strength to low loads tests ) , psychologic ( State Anxiety Inventory ) , and cognitive function ( Paced Auditory Serial Addition Task ) ; and adherence 12 months after the completion of the study . RESULTS For all the measurements , the patients showed significant deficiencies compared with the healthy subjects . Efficacy analysis ( n=29 ) and intent-to-treat analysis ( n=34 ) of the exercise therapy was effective in decreasing the tender point count and improving sleep quality , cognitive function , and physical function . Anxiety remained unchanged during the follow-up . The exercise group had a significant improvement of health status , not associated exclusively with the exercise intervention . There were no changes in the control group . Twenty-three patients in the exercise group were exercising regularly 12 months after completing the program . CONCLUSIONS An exercise therapy 3 times a week for 16 weeks in a warm pool could improve most of the symptoms of FM and cause a high adherence to exercise in unfit women with heightened FM symptomatology . The therapeutic intervention 's effects can be assessed through applicable tests in the clinical practice OBJECTIVES To examine the effects of a supervised aerobic exercise programme on heart rate variability ( HRV ) parameters and symptom severity in women with fibromyalgia ( FM ) . METHODS Thirty-two women with FM were r and omly allocated to one of two groups : aerobic exercise ( AE ) or usual care control for 24 weeks . Women allocated to AE performed two aerobic exercise sessions per week of 45 - 60 min duration including 15 - 20 min of steady-state aerobic exercise at 60 - 65 % of predicted maximum heart rate ( HRmax ) and 15 min of interval training at 75 - 80 % HRmax ( six repetitions of 1.5 min , with 1 min interpolated rest intervals ) . Cardiac autonomic modulation was assessed using power spectral analysis of HRV . Symptom severity was assessed by a 10 cm visual analogue scale ( VAS ) for pain , sleep disturbances , stiffness , anxiety and depression . RESULTS After 24 weeks , the women in the exercise group showed an increase ( 4.8 ± 0.2 to 5.2 ± 0.2 ) in total power ( LnTP , p<0.001 ) , low frequency power ( LnLF , p<0.01 ) , high frequency power ( LnHF , p<0.001 ) , and the root-mean-square of successive R-R intervals ( rMSSD , p<0.001 ) . In addition , significant group-by-time interaction effects were observed for LnHF ( p=0.036 ) and LnLF/HF ( p=0.014 ) . Improvements in anxiety and depression were also observed in AE versus control patients . CONCLUSIONS These results show that a programme of aerobic exercise training induced changes in cardiac autonomic nervous system modulation in FM and that these changes in HRV parameters were accompanied by changes in anxiety \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS Exercise is associated with reductions in anxiety among adults with selected types of AORD ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Transcranial direct current stimulation ( tDCS ) of the human motor cortex results in polarity-specific shifts of cortical excitability during and after stimulation . Anodal tDCS enhances and cathodal stimulation reduces excitability . Animal experiments have demonstrated that the effect of anodal tDCS is caused by neuronal depolarisation , while cathodal tDCS hyperpolarises cortical neurones . However , not much is known about the ion channels and receptors involved in these effects . Thus , the impact of the sodium channel blocker carbamazepine , the calcium channel blocker flunarizine and the NMDA receptor antagonist dextromethorphane on tDCS-elicited motor cortical excitability changes of healthy human subjects were tested . tDCS- protocol s inducing excitability alterations ( 1 ) only during tDCS and ( 2 ) eliciting long-lasting after-effects were applied after drug administration . Carbamazepine selectively eliminated the excitability enhancement induced by anodal stimulation during and after tDCS . Flunarizine result ed in similar changes . Antagonising NMDA receptors did not alter current-generated excitability changes during a short stimulation , which elicits no after-effects , but prevented the induction of long-lasting after-effects independent of their direction . These results suggest that , like in other animals , cortical excitability shifts induced during tDCS in humans also depend on membrane polarisation , thus modulating the conductance of sodium and calcium channels . Moreover , they suggest that the after-effects may be NMDA receptor dependent . Since NMDA receptors are involved in neuroplastic changes , the results suggest a possible application of tDCS in the modulation or induction of these processes in a clinical setting . The selective elimination of tDCS-driven excitability enhancements by carbamazepine proposes a role for this drug in focussing the effects of cathodal tDCS , which may have important future clinical applications Summary Noninvasive brain stimulation has shown considerable promise for enhancing cognitive functions by the long-term manipulation of neuroplasticity [ 1–3 ] . However , the observation of such improvements has been focused at the behavioral level , and enhancements largely restricted to the performance of basic tasks . Here , we investigate whether transcranial r and om noise stimulation ( TRNS ) can improve learning and subsequent performance on complex arithmetic tasks . TRNS of the bilateral dorsolateral prefrontal cortex ( DLPFC ) , a key area in arithmetic [ 4 , 5 ] , was uniquely coupled with near-infrared spectroscopy ( NIRS ) to measure online hemodynamic responses within the prefrontal cortex . Five consecutive days of TRNS-accompanied cognitive training enhanced the speed of both calculation- and memory-recall-based arithmetic learning . These behavioral improvements were associated with defined hemodynamic responses consistent with more efficient neurovascular coupling within the left DLPFC . Testing 6 months after training revealed long-lasting behavioral and physiological modifications in the stimulated group relative to sham controls for trained and nontrained calculation material . These results demonstrate that , depending on the learning regime , TRNS can induce long-term enhancement of cognitive and brain functions . Such findings have significant implication s for basic and translational neuroscience , highlighting TRNS as a viable approach to enhancing learning and high-level cognition by the long-term modulation of neuroplasticity Computer-administered cognitive training ( CT ) tasks are a common component of cognitive remediation treatments . There is growing evidence that transcranial direct current stimulation ( tDCS ) , when given during cognitive tasks , improves performance . This r and omized , controlled trial explored the potential synergistic effects of CT combined with tDCS in healthy participants . Altogether , 60 healthy participants were r and omized to receive either active or sham tDCS administered during training on an adaptive CT task ( dual n-back task ) , or tDCS alone , over 10 daily sessions . Cognitive testing ( working memory , processing speed , executive function , reaction time ) was conducted at baseline , end of the 10 sessions , and at 4-wk follow-up to examine potential transfer effects to non-trained tasks . Altogether , 54 participants completed the study . Over the 10 ' online ' sessions , participants in the active tDCS+CT condition performed more accurately on the CT task than participants who received sham tDCS+CT . The performance enhancing effect , however , was present only during tDCS and did not result in greater learning ( i.e. improvement over sessions ) on the CT task . These results confirm prior reports of enhancement of cognitive function during tDCS stimulation . At follow-up , the active tDCS+CT group , but not the sham tDCS+CT group , showed greater gains on a non-trained test of attention and working memory than the tDCS-only group ( p < 0.01 ) . Although this gain can mainly be attributable to training , this result suggests that active tDCS may have a role in further enhancing outcomes The capacity for transcranial direct current stimulation ( tDCS ) to increase learning and cognition shows promise for the development of enhanced therapeutic interventions . One potential application is the combination of tDCS with cognitive training ( CT ) , a psychological intervention which aims to improve targeted cognitive abilities . We have previously shown that tDCS enhanced performance accuracy , but not skill acquisition , on a dual n-back working memory ( WM ) CT task over repeated sessions . In the current study , we investigated the optimal timing for combining tDCS with the same CT task to enhance within and between session performance outcomes across two daily CT sessions . Twenty healthy participants received in a r and omised order 30 min of anodal tDCS to the left dorsolateral prefrontal cortex immediately before ( ‘ offline ’ tDCS ) and during performance ( ‘ online ’ tDCS ) on a dual n-back WM CT task , in an intra-individual crossover design . Analyses examined within and between session consolidation effects of tDCS on CT performance outcomes . Results showed that ‘ online ’ tDCS was associated with better within session skill acquisition on the CT task , with a significant difference found between conditions the following day . These results suggest that ‘ online ’ tDCS is superior to ‘ offline ’ tDCS for enhancing skill acquisition when combining anodal tDCS with CT . This finding may assist with the development of enhanced protocol s involving the combination of tDCS with CT and other rehabilitation protocol The time-dependent effect of transcranial direct current stimulation ( tDCS ) on working memory was investigated by applying anodal stimulation over the left prefrontal cortex . This single-blind , sham-controlled crossover study recruited 15 healthy participants . A three-back verbal working-memory task was performed before , during , and 30 min after 1 mA anodal or sham tDCS . Anodal tDCS , compared with sham stimulation , significantly improved working-memory performance . Accuracy of response was significantly increased after 20 min of tDCS application , and was further enhanced after 30 min of stimulation . This effect was maintained for 30 min after the completion of stimulation . These results suggest that tDCS at 1 mA enhances working memory in a time-dependent manner for at least 30 min in healthy participants Weak transcranial direct current stimulation ( tDCS ) induces persisting excitability changes in the human motor cortex . These plastic excitability changes are selectively controlled by the polarity , duration and current strength of stimulation . To reveal the underlying mechanisms of direct current (DC)-induced neuroplasticity , we combined tDCS of the motor cortex with the application of Na(+)-channel-blocking carbamazepine ( CBZ ) and the N-methyl-D-aspartate (NMDA)-receptor antagonist dextromethorphan ( DMO ) . Monitored by transcranial magnetic stimulation ( TMS ) , motor cortical excitability changes of up to 40 % were achieved in the drug-free condition . Increase of cortical excitability could be selected by anodal stimulation , and decrease by cathodal stimulation . Both types of excitability change lasted several minutes after cessation of current stimulation . DMO suppressed the post-stimulation effects of both anodal and cathodal DC stimulation , strongly suggesting the involvement of NMDA receptors in both types of DC-induced neuroplasticity . In contrast , CBZ selectively eliminated anodal effects . Since CBZ stabilizes the membrane potential voltage-dependently , the results reveal that after-effects of anodal tDCS require a depolarization of membrane potentials . Similar to the induction of established types of short- or long-term neuroplasticity , a combination of glutamatergic and membrane mechanisms is necessary to induce the after-effects of tDCS . On the basis of these results , we suggest that polarity-driven alterations of resting membrane potentials represent the crucial mechanisms of the DC-induced after-effects , leading to both an alteration of spontaneous discharge rates and to a change in NMDA-receptor activation BACKGROUND Major depressive disorder ( MDD ) is frequently associated with underactivity of the dorsolateral prefrontal cortex ( DLPFC ) which has led to this brain region being identified as an important target for the development of neurobiological treatments . Transcranial direct current stimulation ( tDCS ) administered to the DLPFC has antidepressant efficacy , however the magnitude of antidepressant outcomes are limited . Concurrent cognitive activity has been shown to enhance tDCS induced stimulation effects . Cognitive control training ( CCT ) is a new cognitive therapy for MDD that aims to enhance DLPFC activity via behavioral methods . HYPOTHESIS We tested the hypothesis that co-administration of DLPFC tDCS and CCT would result in a greater reduction in depressive symptomology than administration of tDCS or CCT alone . METHODS 27 adult participants with MDD were r and omized into a three-arm sham-controlled between-groups pilot study comparing the efficacy of 2 mA tDCS + CCT , sham tDCS + CCT and sham CCT + 2 mA tDCS ( 5 sessions administered on consecutive working days ) . Blinded assessment s of depression severity and cognitive control were conducted at baseline , end of treatment and a three week follow up review . RESULTS All three treatment conditions were associated with a reduction in depression severity at the end of five treatment sessions . However , only administration of tDCS + CCT result ed in sustained antidepressant response at follow up , the magnitude of which was greater than that observed immediately following conclusion of the treatment course . CONCLUSIONS The results provide preliminary evidence that concurrent CCT enhances antidepressant outcomes from tDCS . In the current sample , participants receiving concurrent tDCS and CCT continued to improve following cessation of treatment . The clinical superiority of a combined therapeutic approach was apparent even in a small sample and following a relatively short treatment course Improvement in performance following cognitive training is known to be further enhanced when coupled with brain stimulation . Here we ask whether training-induced changes can be maintained long term and , crucially , whether they can extend to other related but untrained skills . We trained overall 40 human participants on a simple and well established paradigm assessing the ability to discriminate numerosity – or the number of items in a set – which is thought to rely on an “ approximate number sense ” ( ANS ) associated with parietal lobes . We coupled training with parietal stimulation in the form of transcranial r and om noise stimulation ( tRNS ) , a noninvasive technique that modulates neural activity . This yielded significantly better and longer lasting improvement ( up to 16 weeks post-training ) of the precision of the ANS compared with cognitive training in absence of stimulation , stimulation in absence of cognitive training , and cognitive training coupled to stimulation to a control site ( motor areas ) . Critically , only ANS improvement induced by parietal tRNS + Training transferred to proficiency in other parietal lobe-based quantity judgment , i.e. , time and space discrimination , but not to quantity-unrelated tasks measuring attention , executive functions , and visual pattern recognition . These results indicate that coupling intensive cognitive training with tRNS to critical brain regions result ed not only in the greatest and longer lasting improvement of numerosity discrimination , but importantly in this enhancement being transferable when trained and untrained abilities are carefully chosen to share common cognitive and neuronal components Non-invasive electrical stimulation of the human cortex by means of transcranial direct current stimulation ( tDCS ) has been instrumental in a number of important discoveries in the field of human cortical function and has become a well-established method for evaluating brain function in healthy human participants . Recently , transcranial alternating current stimulation ( tACS ) has been introduced to directly modulate the ongoing rhythmic brain activity by the application of oscillatory currents on the human scalp . Until now the efficiency of tACS in modulating rhythmic brain activity has been indicated only by inference from perceptual and behavioural consequences of electrical stimulation . No direct electrophysiological evidence of tACS has been reported . We delivered tACS over the occipital cortex of 10 healthy participants to entrain the neuronal oscillatory activity in their individual alpha frequency range and compared results with those from a separate group of participants receiving sham stimulation . The tACS but not the sham stimulation elevated the endogenous alpha power in parieto- central electrodes of the electroencephalogram . Additionally , in a network of spiking neurons , we simulated how tACS can be affected even after the end of stimulation . The results show that spike-timing-dependent plasticity ( STDP ) selectively modulates synapses depending on the resonance frequencies of the neural circuits that they belong to . Thus , tACS influences STDP which in turn results in aftereffects upon neural activity . The present findings are the first direct electrophysiological evidence of an interaction of tACS and ongoing oscillatory activity in the human cortex . The data demonstrate the ability of tACS to specifically modulate oscillatory brain activity and show its potential both at fostering knowledge on the functional significance of brain oscillations and for therapeutic application Perceptual learning is considered a manifestation of neural plasticity \n Output:\n " }, { "from": "agent", "value": "Findings indicated that tES + CT enhanced performance on the majority of CT tasks .\nThe effects on non-trained tasks were mixed , with some evidence for improvements in working memory , cognitive control , approximate number sense and arithmetic processing .\ntES + CT enhances performance on CT tasks across a range of cognitive functions .\nPreliminary evidence suggests that tES may also increase transfer effects to non-trained tasks in some domains ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The aim of this study was to assess the effectiveness of a 24-week exercise protocol carried out in geothermal spring water to improve overall physical function and muscle mass in a group of healthy elderly subjects . A further aim was to compare this water-based protocol with a l and -based protocol and a control group . For this purpose , 59 subjects were recruited and r and omly allocated to three groups : aquatic group ( AG ) , l and group ( LG ) , and control group ( CG ) . AG and LG followed a 6-month , twice-weekly , multimodality exercise intervention . AG underwent the protocol in hot-spring water ( 36 ° C ) while LG did it in a l and -based environment . After the intervention , knee-extension strength was maintained in AG and LG . The 8-foot up- and -go test showed a reduction in both exercise groups ( AG −19.3 % , P < 0.05 ; LG −12.6 % , P < 0.05 ) , with a significantly greater decrease in AG . The back-scratch test revealed an improvement only in AG ( 25.8 % ; P < 0.05 ) , while the sit- and -reach test improved in all groups . Finally , AG reduced fat mass by 4 % ( P < 0.05 ) , and dominant forearm fat decreased by 9.2 % ( P < 0.05 ) . In addition , calf muscle density increased by 1.8 % ( P < 0.05 ) . In summary , both water- and l and -based activities were beneficial in maintaining strength and in improving lower-body flexibility . Aquatic exercise appeared a better activity to improve dynamic balance . Thermal swimming pools and the use of rating of perceived exertion as a method of exercise monitoring should be considered potentially useful tools to enhance physical performance and body composition in healthy elderly The aim of the present study was to evaluate the effects of an AAG on BMD , osteocalcin and functional autonomy in older women . The sample consisted of eighty-two post-menopausal women with low BMD , r and omly divided into two groups : the Aquatic Aerobics Group [ AAG ; n=42 ; age : 66.8±4.2years ] , su bmi tted to two weekly sessions over eight months , and the Control Group ( GC ; n=42 ; age : 66.9±3.2years ) , which did not participate in regular exercise . BMD was measured by Dual Energy X-ray Absorptiometry [ DXA ] of the lumbar and femur , and serum osteocalcin was measured using electrochemiluminescence . A functional autonomy assessment protocol ( GDLAM , 2004 ) was also applied . Statistical analyses used were repeated measures ANOVA and Tukey 's post hoc tests . The results showed a significant improvement in tests following the GDLAM protocol : 10 meters walk ( 10mw ) -p=0.003 ; rising from a ventral decubitus position ( RVDP ) - Δ%=0.78 , p<0.001 ; rising from a chair and moving around the house ( RCMH ) -p<0.001 and autonomy index ( AI ) -p=0.007 , with more favorable results observed in the AAG when compared to the CG . The AAG achieved the best results for BMD ; however , no inter or intragroup statistical differences were recorded for total femur -p=0.975 and lumbar L(2)-L(4)p=0.597 . For serum osteocalcin , intra and intergroup statistical differences of p=0.042 and p=0.027 were observed in the AAG , respectively . This demonstrates that an eight-month aquatic aerobic exercise program can improve functional autonomy and osteocalcin levels , although training did not improve lumbar and total femur BMD in the older women BACKGROUND Fractures have been associated with subsequent increases in mortality , but it is unknown how long that increase persists . METHODS A total of 5580 women from a large community-based , multicenter US prospect i ve cohort of 9704 ( Study of Osteoporotic Fractures ) were observed prospect ively for almost 20 years . We age-matched 1116 hip fracture cases with 4 control participants ( n = 4464 ) . To examine the effect of health status , we examined a healthy older subset ( n = 960 ) 80 years or older who attended the 10-year follow-up examination and reported good or excellent health . Incident hip fractures were adjudicated from radiology reports by study physicians . Death was confirmed by death certificates . RESULTS Hip fracture cases had 2-fold increased mortality in the year after fracture compared with controls ( 16.9 % vs 8.4 % ; multivariable adjusted odds ratio [ OR ] , 2.4 ; 95 % CI , 1.9 - 3.1 ] . When examined by age and health status , short-term mortality was increased in those aged 65 to 69 years ( 16.3 % vs 3.7 % ; OR , 5.0 ; 95 % CI , 2.6 - 9.5 ) , 70 to 79 years ( 16.5 % vs 8.9 % ; OR , 2.4 ; 95 % CI , 1.8 - 3.3 ) , and only in those 80 years or older with good or excellent health ( 15.1 % vs 7.2 % ; multivariable adjusted OR , 2.8 ; 95 % CI , 1.5 - 5.2 ) . After the first year , survival of hip fracture cases and controls was similar except in those aged 65 to 69 years , who continued to have increased mortality . CONCLUSIONS Short-term mortality is increased after hip fracture in women aged 65 to 79 years and in exceptionally healthy women 80 years or older . Women 70 years or older return to previous risk levels after a year . Interventions are needed to decrease mortality in the year after hip fracture , when mortality risk is highest OBJECTIVE To analyze the effects of a water-based exercise program on peak torque ( PT ) and rate of torque development ( RTD ) during maximal voluntary ballistic isometric contractions of the lower limb muscles and the performance of a number of functional tests in the elderly . METHOD Thirty-seven elderly were r and omly assigned to water-based training ( 3 d/wk for 12 wk ) or a control group . Extensor and flexor PT and RTD of the ankle , knee , and hip joints and functional tests were evaluated before and after training . RESULTS PT increased after training for the hip flexors ( 18 % ) and extensors ( 40 % ) and the plantar-flexor ( 42 % ) muscles in the water-based group . RTD increased after training for the hip-extensor ( 10 % ) , knee-extensor ( 11 % ) , and ankle plantar-flexor ( 27 % ) muscles in the water-based group . Functional tests also improved after training in the water-based group ( p < .05 ) . CONCLUSION The water-based program improved PT and RTD and functional performance in the elderly Background and Purpose Aquatic physical therapy is frequently used in the management of patients with hip and knee osteoarthritis ( OA ) , yet there is little research establishing its efficacy for this population . The purpose of this study was to evaluate the effects of aquatic physical therapy on hip or knee OA . Subjects A total of 71 volunteers with symptomatic hip OA or knee OA participated in this study . Methods The study was design ed as a r and omized controlled trial in which participants r and omly received 6 weeks of aquatic physical therapy or no aquatic physical therapy . Outcome measures included pain , physical function , physical activity levels , quality of life , and muscle strength . Results The intervention result ed in less pain and joint stiffness and greater physical function , quality of life , and hip muscle strength . Totals of 72 % and 75 % of participants reported improvements in pain and function , respectively , compared with only 17 % ( each ) of control participants . Benefits were maintained 6 weeks after the completion of physical therapy , with 84 % of participants continuing independently . Discussion and Conclusion Compared with no intervention , a 6-week program of aquatic physical therapy result ed in significantly less pain and improved physical function , strength , and quality of life . It is unclear whether the benefits were attributable to intervention effects or a placebo response BACKGROUND Osteoporosis is a multifactorial progressive skeletal disorder characterized by reduced bone mass . Exercise is widely recommended to reduce osteoporosis , falls and related fragility fractures . The purpose of this study was to investigate the effects of l and exercise ( LE ) and aquatic exercise ( AE ) on physical function and bone mineral density ( BMD ) . MATERIAL AND METHODS Fifty-eight postmenopausal women , aged 50 - 70 years , diagnosed with osteoporosis according to BMD measures , enrolled in this study . The subjects were r and omly assigned to either the intervention group ( LE group ) or the control group ( AE group ) . Physical function and BMD were assessed in all subjects in both groups before and after 10 months of intervention . Muscle strength , flexibility , balance , gait time and pain were measured to assess physical function . Bone mineral density at the lumbar spine was measured by dual energy X-ray absorptiometry ( DEXA ) . RESULTS There were no significant differences between the two groups in the baseline anthropometric data . The two groups were similar with respect to age , weight , height , and body mass index ( p>0.05 ) . After the exercise program , muscle strength , flexibility , gait time , pain , and bone density ( p<0.001 ) improved significantly with LE compared to AE . There was no significant difference between the two groups with regard to balance at the 10-month follow-up . CONCLUSION Significant improvements in physical function and BMD suggest that LE is a possible alternative for postmenopausal women with OP Abstract . Osteoporosis is one of the most common skeletal disorders affecting postmenopausal women . The purpose of this study was to investigate whether a 24-week program of aerobic high-impact loading exercise was beneficial for enhancing physical fitness and bone mineral density ( BMD ) in osteopenic postmenopausal women . Forty-three postmenopausal women aged 48–65 years participated in this study . The BMD of the spine ( L2–L4 ) and right femoral neck of each woman was below 1 SD of the mean of premenopausal women , as examined by dual X-ray absorptiometry . The assignment of subjects into exercise or control group was not r and omized but based on each subject 's anticipated compliance to the 6-month long exercise program . Twenty-two subjects joined the exercise group and attended the training programs and 21 served as the control group . Exercise programs included treadmill walking at an intensity above 70 % of maximal oxygen consumption ( VO2max ) for 30 minutes , followed by 10 minutes of stepping exercise using a 20-cm-high bench . The program was conducted three times per week for 24 weeks . Physical fitness measurements included testing of flexibility , muscular strength and endurance , body composition , and cardiopulmonary fitness . The results showed that the quadriceps strength , muscular endurance , and VO2max in the exercise group had significant improvements , whereas no improvement was found in any of the physical fitness parameters in the control group . The BMD of the L2–L4 and the femoral neck in the exercise group increased 2.0 % ( P > 0.05 ) and 6.8 % ( P < 0.05 ) and those in the control group decreased 2.3 % ( P < 0.05 ) and 1.5 % ( P > 0.05 ) , respectively . In conclusion , aerobics combined with high-impact exercise at a moderate intensity was effective in off setting the decline in BMD in osteopenic postmenopausal women Summary In women aged 50 years or more who experienced a fracture , 81 % suffered a fragility fracture . Six to eight months after fragility fracture , 79 % had either not been investigated for osteoporosis or prescribed anti-fracture therapy . Despite fragility fractures being common in this population osteoporosis is under-diagnosed and under-treated . Introduction The objective of this study was to evaluate the diagnostic and treatment rates for osteoporosis six months following fragility fracture . Methods This prospect i ve cohort study was set in the general community from the Province of Quebec , Canada . Women at least 50 years of age who suffered a fracture were recruited during their initial visit to the hospital and had their fracture type classified as either fragility or traumatic . Six-to-eight months after fragility fracture , women were again contacted to evaluate the diagnostic and treatment rates of osteoporosis . Results Of the 2,075 women recruited over a 25 month period 1688 ( 81 % ) sustained a fragility fracture and 387 ( 19 % ) sustained a traumatic fracture . Nine hundred and three participants with a fragility fracture were again contacted six-to-eight months after fracture . For the 739 women not on treatment on the recruitment day , only 15.4 % initiated pharmacological therapy in the six-to-eight-month period following fracture and 79.0 % had either not been investigated for osteoporosis or prescribed anti-fracture treatment . Conclusions The proportion of fragility fractures to total fractures is higher than previously reported . Despite the availability of diagnostic modalities , effective treatments , and adequate health care assessment s , there is a substantial care gap in the management of osteoporosis PURPOSE The purpose of this study was to identify the effects of water-based exercises on the physical functions and quality of life ( QOL ) in community-dwelling elderly people with history of falling . MATERIAL S AND \n Output:\n " }, { "from": "agent", "value": "WBE may have benefits with respect to maintaining or improving bone health in postmenopausal women but less benefit when compared to LBE ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Oral contraceptive ( OC ) knowledge deficits may contribute to OC discontinuation . We examined the effect of an innovative educational intervention on young women 's OC knowledge . STUDY DESIGN As part of a r and omized trial evaluating the impact of text message reminders on OC continuation , we assessed OC knowledge in 659 women ages 13 - 25 years . Women received routine care or routine care plus 6 months of daily educational text messages . We administered a comprehensive 41-item OC knowledge survey at baseline and 6 months . RESULTS Mean OC knowledge scores improved over time for all women ( baseline 22.8 , 56 % correct versus 24.7 , 60 % at 6 months ) , including knowledge of OC 's mechanisms of action ( p=.004 ) , effectiveness ( p<.001 ) , side effects ( p=.03 ) and benefits ( p<.001 ) . Mean 6-month scores were greater in the intervention ( 25.5 ) than the control group (23.7)(p<.001 ) . In multivariable linear regression models , the text message intervention most strongly predicted OC knowledge ( β=1.6 , 95 % confidence interval 0.9 - 2.2 ) . CONCLUSION Daily educational text messages can modestly improve knowledge of OCs , which may promote successful contraceptive outcomes Objectives To compare two post-abortion family planning ( FP ) service packages on contraceptive use and repeat abortion rate among young women in three cities in China . Methods In this cluster-r and omized trial , one FP service package included provision of limited information and referral to existing FP services , and the other , more comprehensive , package consisted – in addition to the above simple package – of individual counselling , free provision of contraceptive material s , and involvement of the male partner . Eight matched pairs of hospitals were certified by central ized r and omization . Women undergoing abortion were followed up for six months , and data were collected in two rounds , before and after the intervention . Results We followed a total of 2336 women younger than 25 years ( 555 before and 555 after the simple intervention package ; 634 before and 592 after the comprehensive intervention package ) . Both packages increased use of any contraceptive method , but the comprehensive approach also increased use of more effective methods . Odds ratios for consistent and correct use of condoms were 2.32 ( 95 % confidence interval 1.55–3.46 ) and 2.78 ( 1.81–4.26 ) , respectively , compared with the simple package . The rates of unwanted pregnancies and repeat abortions were somewhat reduced for both packages , with no significant statistical difference between them . Conclusion Couples who received the comprehensive post-abortion FP service appear to use more effective contraceptive methods and show better compliance OBJECTIVE : To estimate whether women receiving daily text-message reminders have increased oral contraceptive pill adherence compared with women not receiving reminders . METHODS : This r and omized controlled trial estimated whether there was an effect of daily text-message reminders on oral contraceptive pill adherence of new oral contraceptive pill users . Pill-taking was tracked for 3 months by an electronic monitoring device with wireless data collection . During the study period , participants assigned the intervention received a daily reminder text message . Eighty-two women were assigned r and omly to detect a 1.6±2.0 pill difference ( 90 % power , 5 % & agr ; , 15 % dropout ) . RESULTS : Participants were 79 % white , non-Hispanic , 99 % high school graduates , and 99 % nulliparous with a mean age of 22 years . Most reported condom use with past coital activity , and more than half reported prior emergency contraception use . The mean number of missed pills per cycle did not differ significantly between the groups : 4.9±3.0 for the text-message group and 4.6±3.5 for the control group ( P=.60 ) . The number of missed pills per cycle increased over the course of the study , but this pattern did not increase differentially between the groups . Adherence recorded by the electronic monitoring device indicated much poorer adherence than that recorded by patient diaries . Despite poor pill-taking , there were no pregnancies . CONCLUSION : Daily text-message reminders did not improve oral contraceptive pill adherence . Although the lack of benefit may be attributed to the frequent use of alternative reminder systems in the control group , the rate of missed pills when measured objective ly was still very high in both groups . CLINICAL TRIAL REGISTRATION : Clinical trials.gov , www . clinical trials.gov , NCT00733707 . LEVEL OF EVIDENCE : OBJECTIVE : To estimate whether daily educational text messages affect oral contraceptive pill ( OCP ) continuation at 6 months . METHODS : We r and omized young women electing OCPs at an urban family planning health center to either routine care or routine care plus 180 days of daily educational text messages . Investigators masked to treatment allocation r and omized participants who were not masked to treatment . The primary outcome measure was self-reported OCP continuation through a telephone call at 6 months ( contacts between 5 and 8 months ) . RESULTS : We enrolled 962 participants ( 480 intervention and 482 routine care ) and obtained continuation data on 683 ( 346 and 337 , respectively ) . At the follow-up , 64 % of participants r and omized to the intervention were still OCP users compared with 54 % of the routine care group ( P=.005 ) . Continuation was highest in the intervention group if the interview took place while the intervention was ongoing ( 75 % compared with 54 % , P=.003 ) ; the effect of the intervention on continuation was less after the intervention ended ( 60 % compared with 54 % , P=.16 ) . Participants receiving the intervention were more likely to continue oral contraception than control participants at 6 months ( odds ratio 1.44 , 95 % confidence interval 1.03–2.00 ) in analyses adjusted for age , race or ethnicity , age at coitarche , pregnancy history , and OCP experience . CONCLUSION : The use of daily educational text messages improves OCP continuation at 6 months over routine care alone . Ten women would need to receive this simple intervention to improve continuation in one . This effect is strongest in the women whose follow-up took place while the text intervention was ongoing . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . Clinical Trials.gov , NCT00677703 . LEVEL OF EVIDENCE : CONTEXT Adolescent females often have questions or concerns about their contraceptive methods , and they may discontinue use if these questions are not answered . Little evidence exists on whether follow-up phone calls to address young women 's concerns can help sustain contraceptive use . METHODS Between 2005 and 2007 , a total of 805 females aged 14 - 18 attending a reproductive health clinic in San Francisco were r and omly assigned to receive either regular clinic services or regular clinic services plus nine follow-up phone calls over 12 months . The young women were surveyed at baseline and roughly six , 12 and 18 months later to measure condom and contraceptive use , rates of pregnancy and STDs , and other outcomes and mediators . Multiple linear and logistic regression repeated measures analyses were used to assess the program 's effects . RESULTS Clinic counselors completed only 2.7 calls per patient , and made 7.8 attempts for every completed call . Although contraceptive use increased from baseline to follow-up at six months in both groups , levels of condom and contraceptive use , and rates of pregnancy and STDs , did not differ between the intervention and control groups at any of the follow-up assessment s. Moreover , the intervention did not improve clinic utilization or satisfaction or have consistent positive effects on participants ' attitudes . CONCLUSIONS Reaching young women by phone after a clinic visit for contraception is challenging and does not appear to provide significant benefits beyond those provided by basic clinic services . More intensive interventions may be needed to markedly change adolescent sexual and contraceptive behavior Abstract Objective : To assess whether provision of educational leaflets or questions on contraception improves knowledge of contraception in women taking the combined contraceptive pill . Design : R and omisation of women into three groups according to type of educational leaflet on contraceptive information . These groups were subdivided into two on the basis of questions on contraception asked by the doctor or practice nurse . The women were followed up by postal question naire 3 months later . Setting : 15 general practice s in South and West region . Subjects : 636 women attending check up appointment for repeat prescription of the combined contraceptive pill . Main outcome measures : Knowledge of : factors causing pill failure , subsequent action , emergency contraception , and all the rules ( pill rules ) that apply to the contraceptive pill . Results : 523 women returned completed question naires ( response rate 82 % ) . Knowledge of contraception with no intervention was low with only 10 ( 12 % ) women knowing all the pill rules . Educational intervention had a highly significant effect on knowledge of : factors causing pill failure ( likelihood ratio χ2=22 ) ; subsequent action ( 21 ) ; emergency contraception ( 24 ) ; and all the pill rules ( 22 ) ( P<0.01 in all cases ) . Improvement in knowledge of all the pill rules occurred with provision of the summary leaflet ( 28 % knew all the rules , adjusted odds ratio 4.04 , 95 % confidence interval 1.68 to 9.75 ) , the Family Planning Association 's leaflet ( 27 % , 3.43 , 1.45 to 8.09 ) , and asking questions ( 26 % , 3.03 , 1.30 to 7.00 ) . Asking questions in addition to provision of leaflets improved knowledge of contraception further for the summary leaflet ( 39 % , 6.81 , 2.85 to 16.27 ) but not for the Family Planning Association leaflet ( 21 % , 2.58 , 1.07 to 6.18 ) . Conclusion : Women attending check ups for repeat prescriptions of the contraceptive pill should be provided with educational leaflets on contraception or asked relevant questions to help improve their knowledge of contraception . Asking questions in addition to providing a summary leaflet is time consuming , but results in the most knowledge gained . Key messages It is very important to most women who take the contraceptive pill to avoid pregnancy Poor knowledge of contraception is common in women taking the contraceptive pill and associated with unwanted pregnancy No r and omised trials have been conducted of educational interventions to improve knowledge of contraception Providing leaflets or asking questions both improve knowledge of contraception The largest effect on knowledge of contraception is from asking questions and providing a summary Background Emergency contraception ( EC ) can prevent unintended pregnancy . However , many women continue to lack information needed to use EC effectively and clinician time to counsel women about EC is limited . Objective To evaluate whether computer-assisted provision of EC can increase knowledge and use of EC among women able to access EC without a prescription . Design We conducted a r and omized controlled trial in which the intervention group received a 15-minute computerized educational session and 1 pack of EC . The control group received education about periconception folate supplementation , but no information about EC . Participants were contacted 7 months after enrollment . Participants Four hundred forty-six women recruited from 2 urgent care clinics in San Francisco in 2005 . Measurements Knowledge of EC , use of EC , and self-reported pregnancy . Results At follow-up , women in the intervention group answered an average of 2 more questions about EC correctly than they had at baseline , whereas women in the control group answered only 1 more item correctly ( 2.0 vs 1.2 , p < .001 ) . There was a trend toward more use of EC during the study period in the intervention group ( 10 % vs 4 % of women followed , p = .06 ; 6 % vs 3 % , p = .09 of women enrolled ) . Fewer women in the intervention group were pregnant at the time of follow-up ( 0.8 % vs 6.5 % , p = .01 of women followed ; 0.5 % vs 4.0 % , p = .01 of women enrolled ) . Conclusions Computer-assisted provision of EC in urgent care waiting areas increased knowledge of EC in a state where EC had been available without a prescription for 3 years Abstract Objective To assess the effect of a mobile phone-based intervention ( mHealth ) on post-abortion contraception use by women in Cambodia . Methods The Mobile Technology for Improved Family Planning ( MOTIF ) study involved women who sought safe abortion services at four Marie Stopes International clinics in Cambodia . We r and omly allocated 249 women to a mobile phone-based intervention , which comprised six automated , interactive voice messages with counsellor phone support , as required , whereas 251 women were allocated to a control group receiving st and ard care . The primary outcome was the self-reported use of an effective contraceptive method , 4 and 12 months after an abortion . Findings Data on effective contraceptive use were available for 431 ( 86 % ) participants at 4 months and 328 ( 66 % ) at 12 months . Significantly more women in the intervention than the control group reported effective contraception use at 4 months ( 64 % versus 46 % , respectively ; relative risk , RR : 1.39 ; 95 % confidence interval , CI : 1.17–1.66 ) but not at 12 months ( 50 % versus 43 % , respectively ; RR : 1.16 ; 95 % CI : 0.92–1.47 ) . However , significantly more women in the intervention group reported using a long-acting contraceptive method at both follow-up times . There was no significant difference between the \n Output:\n " }, { "from": "agent", "value": "Intensive counseling and reminders ( with or without educational information ) may be associated with improved continuation of shorter-term hormonal contraceptive methods when compared with usual family planning care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To monitor clinical , microbiological and host-derived alterations occurring around teeth and titanium implants during the development of experimental gingivitis/mucositis and their respective healing sequence in humans . MATERIAL AND METHODS Fifteen subjects with healthy or treated periodontal conditions and restored with dental implants underwent an experimental 3-week period of undisturbed plaque accumulation in the m and ible . Subsequently , a 3-week period with optimal plaque control was instituted . At Days 0 , 7 , 14 , 21 , 28 , 35 and 42 , the presence/absence of plaque deposits around teeth and implants was assessed , ( plaque index [ PlI ] ) and the gingival/mucosal conditions were evaluated ( gingival index[GI ] ) . Subgingival/submucosal plaque sample s and gingival/mucosal crevicular fluid ( CF ) sample s were collected from two pre-determined sites around each experimental unit . CF sample s were analyzed for matrix-metalloproteinase-8 ( MMP-8 ) and interleukin-1beta ( IL-1β ) . Microbial sample s were analyzed using DNA-DNA hybridization for 40 species . RESULTS During 3 weeks of plaque accumulation , the median PlI and GI increased significantly at implants and teeth . Implant sites yielded a greater increase in the median GI compared with tooth sites . Over the 6-week experimental period , the CF levels of MMP-8 were statistically significantly higher at implants compared with teeth ( P<0.05 ) . The CF IL-1β levels did not differ statistically significantly between teeth and implants ( P>0.05 ) . No differences in the total DNA counts between implant and tooth sites were found at any time points . No differences in the detection frequency were found for putative periodontal pathogens between implant and tooth sites . CONCLUSION Peri-implant soft tissues developed a stronger inflammatory response to experimental plaque accumulation when compared with that of their gingival counterparts . Experimental gingivitis and peri-implant mucositis were reversible at the biomarker level . Clinical ly , however , 3 weeks of resumed plaque control did not yield pre-experimental levels of gingival and peri-implant mucosal health indicating that longer healing periods are needed AIM To determine the incidence of peri-implantitis in individuals with mucositis in a 5-year follow-up study . MATERIAL AND METHODS A sample of 212 partially edentulous individuals , rehabilitated with dental implants , underwent periodontal and peri-implant clinical examinations in 2005 ( baseline ) . Five years later , 80 individuals who had been diagnosed with mucositis in the baseline examination were re-examined . These individuals were divided into two groups : one group with preventive maintenance during the study period ( GTP ; n = 39 ) , and another group without preventive maintenance ( GNTP ; n = 41 ) . The following parameters were clinical ly evaluated : plaque index , bleeding on periodontal and peri-implant probing , periodontal and peri-implant probing depth , suppuration and peri-implant bone loss . The influence of biological and behavioural risk variables associated with the occurrence of peri-implantitis was analysed using univariate and multivariate logistic regression analyses . RESULTS The incidence of peri-implantitis in the global sample was 31.2 % ( GNTP = 43.9 % and GTP = 18.0 % ) . CONCLUSION The absence of preventive maintenance in individuals with pre-existing peri-implant mucositis was associated with a high incidence of peri-implantitis . Clinical parameters , such as bleeding on peri-implant probing , periodontal probing depth and the presence of periodontitis were associated with a higher risk of developing peri-implantitis PURPOSE To evaluate the effect of irrigation with 0.06 % chlorhexidine ( PerioGard ) ( CHX ) using a powered oral irrigator ( Water Pik ) with a special subgingival irrigating tip ( Pik Pocket Subgingival Tip ) compared to rinsing with 0.12 % chlorhexidine gluconate once daily . MATERIAL S AND METHODS Following a prophylaxis , patients were r and omly assigned to an irrigation or a rinse group . The following clinical parameters were measured at baseline and at the 3-month end of the study : Modified Gingival Index ( MGI ) , Plaque Index ( PI ) , Bleeding Index ( BI ) , and Calculus Index ( CI ) . Also , a Stain Index ( SI ) was measured at 3 months . RESULTS Patients irrigating with diluted CHX showed a statistically significant reduction ( P < 0.05 ) from their baseline in the MGI , PI , BI , and CI scores at 3 months . In the rinse group both MGI and BI showed statistically significant reduction from their baseline ( P < 0.05 ) at 3 months . The rinse group showed a nonsignificant ( P > 0.05 ) increase from baseline in CI and a nonsignificant decrease in PI . Intergroup comparisons showed that CHX irrigation produced statistically significantly greater reductions than CHX rinsing in the PI , MGI , and SI . The irrigation group also showed a greater reduction in BI and CI than the rinsing group but these differences were not statistically significant ( P = 0.12 ) . The results of this study suggest that use of diluted 0.06 % CHX when used in a powered irrigator may be a valuable adjunct to oral health in patients with implants OBJECTIVES To evaluate clinical ly and radiographically immediate implants 5 years after insertion and to compare them with delayed-placed implants in the same subjects . MATERIAL AND METHODS Twenty-two consecutive patients that needed at least two implants for replacing hopeless teeth , one immediately upon extraction and the other in a delayed fashion ( at least 4 months post- extraction ) were selected in this prospect i ve cohort study . Post- extraction immediate implants ( II ) and delayed implants ( DI ) groups were defined . One and 5 years after implant loading , clinical and radiographical outcome variables were recorded and analysed both at site and at implant level . Intra-group and inter-group comparisons were performed . RESULTS The intergroup comparison did not show significant differences for plaque index , bleeding on probing and suppuration . These parameters worsen in both groups along the study . This trend was stronger for the plaque index in the group II , which increased from 15.6 % at 1 year to 25.9 % at 5 years ( P < 0.04 ) . One year after loading , the sites with probing depth ≥5 mm were higher for the group II compared to DI ( 2.5 % vs. 0 % ; P = 0.049 ) . At the end of the study , no significant statistical differences were found . Radiographically , bone crestal changes did not yield significant differences . During the follow-up period , 25 % of the implants ( 26.4 % in group II and 23.5 % in DI ) showed biological complications : mucositis ( 20 % ) and /or periimplantitis ( 5.8 % ) . No differences between groups were found . CONCLUSIONS Within the same patients , the implants placed with the immediate protocol demonstrated a higher tendency to crestal bone loss and to peri-implantitis , although these differences were not statistically significant AIM Supportive therapy to maintain dental implants is increasingly important . This study examined the effect of a 0.3 % triclosan/2 % copolymer dentifrice on oral biofilms and gingival inflammation ( GI ) on dental implants and peri-implant tissues . MATERIAL S AND METHODS One hundred and twenty adults with a dental implant and contra-lateral tooth were enrolled in this 6 month , double-blind , two-treatment , parallel group study . Sixty subjects were r and omly assigned to a triclosan/copolymer dentifrice test group and 60 subjects to a fluoride dentifrice control group and instructed to brush twice daily for 6 months . At baseline , 3 , and 6 months , a calibrated dentist assessed dental plaque , GI and collected supragingival dental plaque for microbiological analysis . RESULTS Subjects in the triclosan/copolymer group demonstrated significantly lower levels of dental plaque , gingivitis , and bleeding on probing at 3 and 6 months at both the implant and contra-lateral tooth compared with the fluoride group ( p<0.05 ) . There were significantly fewer Gram-negative anaerobes in the triclosan/copolymer group ( p<0.05 ) including > 90 % reductions in Aggregatibacter actinomycetemcomitans , Campylobacter rectus , Eubacterium saburreum , Fusobacterium nucleatum , Porphyromonas gingivalis , Prevotella melaninogenica , Solobacterium moorei , and Tannerella forsythia . CONCLUSIONS Twice daily use of a triclosan/copolymer dentifrice may enhance dental implant maintenance by reducing dental plaque and GI PURPOSE The aim of the present study was to investigate plaque levels following sonic-powered and manual toothbrushing in subjects with dental implants . MATERIAL S AND METHODS This study included 36 male and 47 female partially edentulous patients ( age range 45 - 78 years , mean age 59.8 years ) that were r and omly assigned to one of two treatment groups : the sonic toothbrush group ( n = 42 ; Philips Sonicare FlexCare ® toothbrush ) or the manual toothbrush group ( n = 41 ; Oral-B P40 ® ) . Clinical , microbiological and immunological examinations were performed blinded at baseline and after 3 , 6 , 9 and 12 months . Microbiological analyses were performed by real-time polymerase chain reaction . Immunological analyses ( prostagl and in E2 ) were performed by chromatography-electrospray spectrometry . RESULTS The plaque index difference between baseline and 12 months at implants showed no significant difference between sonic or manual toothbrushing in a two-sided Mann-Whitney test ( W = 773.5 , P = 0.426 , 95 % CI -0.64 to 0.20 ) . At the end of the study , there were no significant changes in plaque index , bleeding on probing , gingival index , pocket probing depth , gingival recession , clinical attachment level or the microbiological and immunological outcomes at implants or teeth in either group . CONCLUSIONS This study uncovered no significant difference between sonic and manual toothbrushing for plaque reduction at implants and teeth . Both toothbrushes maintain healthy peri-implant soft tissue PURPOSE This double-blind r and omized controlled trial assessed the effect of subgingival ozone ( O3 , gaseous ozone , HealOzone MK II , KaVo ) and /or hydrogen peroxide ( H2O2 ) on the development of peri-implant mucositis . MATERIAL S AND METHODS Twenty subjects ( mean age , 60 ± 7.7 years ) with 80 implants ( 4 implants each ) were recruited . First , a 2-week pretrial phase took place to achieve healthy gingiva . Subsequently , partial gum shields were constructed for the experimental area ( around the 4 implants ) ; subjects were asked to refrain from brushing in that area by wearing the gum shield . The following treatments were r and omly applied ( for 60 seconds ) to implant sites on days 0 , 7 , and 14 : ( 1 ) air ( O2 ) and saline ( 0.9 % NaCl ) ( control group ) , ( 2 ) O2 and H2O2 ( 3 % ) , ( 3 ) O3 and saline , and ( 4 ) O3 and H2O2 . Plaque , gingival , and bleeding indices were recorded on days 0 , 7 , 14 , and 21 . RESULTS Significant differences were seen among the treatments ( P < .01 ) in plaque ( F = 16.68 ) , modified gingival ( F = 7.86 ) , and bleeding ( F = 18.42 ) indices . O3 + saline and O3 + H2O2 produced optimum gingival health scores and were equally effective and the most effective in controlling bleeding ( mean score = 0.05 ) , while O2 + saline was the least effective ( mean score = 0.56 ) . CONCLUSION Ozone showed great potential for management of peri-implant mucositis OBJECTIVE The aim of this prospect i ve study was to assess the outcomes of an implant maintenance protocol for implants supporting a full-arch rehabilitation . MATERIAL S AND METHODS Sixty-one patients ( 28 women and 33 men ) treated with immediately loaded full-arch rehabilitation , both m and ibular and maxillary , supported by a combination of two tilted and two axial implants , were included in the study . Patients were scheduled for follow-up visits every 6 months for + 2 years , then yearly up to 4 years . Each patient received professional oral hygiene treatment and detailed oral hygiene instructions . During each visit , modified plaque index , bleeding index and probing depth were assessed . The presence of peri-implant tissue inflammation was also evaluated . RESULTS Mean observation time , considering both m and ible and maxilla , was 18.3 months ranging from 6 months to 5 years . Both plaque and bleeding indexes frequency decreased over time . Probing depth was stable ( 2.46 ± 0.5 mm at 4 years ) . Only three implants were lost due to peri-implantitis ( 1.4 % at 12 months ) , whereas the incidence of peri-implant \n Output:\n " }, { "from": "agent", "value": "The choice of control interventions showed great variability .\nTherapy of PM is a prerequisite for the prevention of peri-implantitis" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: : In recent years , skin grafting has evolved from the initial autograft and allograft preparations to biosynthetic and tissue-engineered living skin replacements . This review details the pioneering work of numerous investigators that led to the following precursors of tissue-engineered skin replacement : cultured autologous keratinocyte grafts , cultured allogeneic keratinocyte grafts , autologous/allogeneic composites , acellular collagen matrices , and cellular matrices . It also discusses the rationale for the development of the newer products and describes the technical advances leading to the development of Apligraf , a tissue-engineered human skin product BACKGROUND Burn-induced hypertrophic scars are disfiguring and can be associated with severe and intractable pruritus . No effective treatment modalities are currently available for symptomatic control of pruritus for most patients . We assessed the effect of the Antipruritic Hydrogel ( CQ-01 ) in the symptomatic treatment of severe and intractable pruritus associated with burn-induced hypertrophic scars in a prospect i ve , multicenter , controlled trial . METHODS A pilot study was conducted in healthy adult volunteers to identify the most appropriate hydrogel formulation . A selected preparation called Chongqing No. 1 ( CQ-01 ; a guar gum-based hydrogel impregnated with peppermint oil , menthol , and methyl salicylate by a nanoemulsion ) , showed an excellent symptomatic relief in an exploratory study in 2 patients with intractable pruritus . A statistically powered , prospect i ve , multicenter , controlled study was then conducted in 74 patients to evaluate the efficacy and safety of a 24-h application of CQ-01 compared to a gel control and a negative control on three separate areas in each patient . Symptom assessment was based on our visual analog JW scale ( ranging from 0 to 100 ) at baseline and various time points up to 7 days after application . Follow-up studies were conducted to determine the reproducibility of CQ-01 in repeated applications . RESULTS Of the 74 enrolled subjects , the only observed adverse event was skin irritation reported in 6 patients ( 8 % ) and resolved shortly after gel removal . Compared to the baseline , the gauze negative control had a mean JW score reduction of 7 ; while the gel control and CQ-01 had a drop of 18 ( p<0.001 ) and 36 ( p<0.001 ) , respectively . The CQ-01 clinical effect was significant for up to 3 days and waned slowly from 3 to 7 days . There was no statistical correlation between the treatment response and any of the demographic , patient or burn-related factors . Further studies showed a trend that repeated applications might be more effective , suggesting the absence of tachyphylaxis . CONCLUSIONS This prospect i ve , multicenter , controlled study showed that this novel hydrogel CQ-01 is safe and provides significant symptomatic relief for severe and intractable pruritus associated with hypertrophic scars , an unmet medical need for these patients . This effect is independent of the etiology of the burn trauma , extent of the scarring , and duration of the scar formation In a retrospective survey , 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987 , were studied for evidence of publication bias . As of May , 1990 , 285 of the studies had been analysed by the investigators , and 52 % of these had been published . Studies with statistically significant results were more likely to be published than those finding no difference between the study groups ( adjusted odds ratio [ OR ] 2.32 ; 95 % confidence interval [ Cl ] 1.25 - 4.28 ) . Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor . An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results , and with increasing sample size . The tendency towards publication bias was greater with observational and laboratory-based experimental studies ( OR = 3.79 ; 95 % Cl = 1.47 - 9.76 ) than with r and omised clinical trials ( OR = 0.84 ; 95 % Cl = 0.34 - 2.09 ) . We have confirmed the presence of publication bias in a cohort of clinical research studies . These findings suggest that conclusions based only on a review of published data should be interpreted cautiously , especially for observational studies . Improved strategies are needed to identify the results of unpublished as well as published studies \n Output:\n " }, { "from": "agent", "value": "Compared to the latter , hydrogel dressings associated with a significantly shortened healing time of degree II burn ( superficial and deep ) wounds , diabetic foot ulcers , traumatic skin injuries , radioactive skin injuries , dog bites , and body surface ulcers .\nIn addition , hydrogel dressing obviously increased the cure rate of diabetic foot ulcers , surgical wounds , dog bites , and body surface ulcers .\nMoreover , hydrogel dressing significantly relieved pain in degree II burn ( superficial and deep ) wounds , traumatic skin injuries , and laser treatment-induced wounds .\nHowever , no significant differences obtained between hydrogel and non-hydrogel dressings in the healing time of surgical wounds , the cure rate of in patients ' pressure ulcers , and phlebitis ulcers .\nThis comprehensive systematic review and meta- analysis of the available evidence reveals that the application of hydrogel dressings advances the healing of various wound types and effectively alleviates the pain with no severe adverse reactions .\nThese results strongly indicate that hydrogel products are effective and safe in wound management" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : To explore the effect of training on patient-actor perception of care during simulated obstetric emergencies . Method : A sub analysis from a prospect i ve r and omised controlled trial in six UK hospitals and the Bristol Medical Simulation Centre , UK . Midwives and doctors working in participating hospitals were eligible for inclusion . 140 participants ( 22 junior and 23 senior doctors , 47 junior and 48 senior midwives ) were r and omised to one of four obstetric emergency training interventions : 1-day course at local hospitals ; 1-day course at simulation centre ; 2-day course with teamwork training at local hospitals ; and 2-day course with teamwork training at simulation centre . Local training used patient-actors and low-fidelity part-task trainers whereas simulation centre training used full-bodied computerised manikins and high-fidelity part-task trainers . Three weeks before and after the training , the participants managed three simulated obstetric emergencies . Patient-actors scored their care after each simulation using a patient-actor perception score ( communication , safety , respect ) . Results : The following numbers of scores were awarded : 139 and 132 participant and 46 and 48 team scenarios , before and after training , respectively . There was a significant improvement in all scores in all scenarios after the training ( p = 0.017 to > 0.001 ) . Perception of safety and communication during postpartum haemorrhage was significantly improved following training with patient-actors compared with training with manikins ( safety p = 0.048 , communication p = 0.035 ) . Teamwork training offered no additional benefit to patient-actors ’ perception of their care . Conclusions : All multiprofessional training improved patient-actor perception of care . Training using a patient-actor may be better at improving perception of safety and communication than training with a computerised manikin simulator Objectives To determine the effect of training residents in interpersonal and communication skills on women ’s satisfaction with doctor – woman relationship in labour and delivery rooms . Design A stepped wedge cluster r and omised trial . Setting 4 tertiary care teaching maternity hospitals in Damascus , Syria . Participants 2000 women who gave birth to a living baby in the four study hospitals and consented to participate in the intervention took part in the study . Women with difficult labour and high-risk pregnancies were excluded . All were interviewed at home after discharge . Interventions A specially design ed training package in communication skills was delivered to all resident doctors at the four hospitals . Primary outcome measures The main outcome measure was women ’s satisfaction with interpersonal relationships in labour and delivery rooms measured via a series of questions on a Likert scale modified from the Medical Interview Satisfaction Scale . Results At the individual level , the mean for the average satisfaction score was 3.23 ( SD 0.72 ) of a possible score of 5 in the control group and 3.42 ( SD 0.73 ) in the intervention group . Using generalised linear mixed models , we were unable to detect a difference between the mean for the average satisfaction score of women in the intervention arm and that of women in the control arm ; the 95 % CI associated with the effect of the intervention ranged from –0.08 to 0.15 . Conclusions Despite slight changes in the observed residents ’ communication skills , the training package in communication skills does not seem to be associated with higher satisfaction scores of women . This raises the question of whether training individuals without further structural changes in the delivery of care and without further reinforcement of the training can have an impact on improving the quality of doctor – patient communication . Trial Registration Number IS RCT Background To assess the student perspective on acceptability , realism , and perceived effect of communication training with peer role play ( RP ) and st and ardised patients ( SP ) . Methods 69 prefinal year students from a large German medical faculty were r and omly assigned to one of two groups receiving communication training with RP ( N = 34 ) or SP ( N = 35 ) in the course of their paediatric rotation . In both groups , training addressed major medical and communication problems encountered in the exploration and counselling of parents of sick children . Acceptability and realism of the training as well as perceived effects and applicability for future parent-physician encounters were assessed using six-point Likert scales . Results Both forms of training were highly accepted ( RP 5.32 ± .41 , SP 5.51 ± .44 , n.s . ; 6 = very good , 1 = very poor ) and perceived to be highly realistic ( RP 5.60 ± .38 , SP 5.53 ± .36 , n.s . ; 6 = highly realistic , 1 = unrealistic ) . Regarding perceived effects , participation was seen to be significantly more worthwhile in the SP group ( RP 5.17 ± .37 , SP 5.50 ± .43 ; p < .003 ; 6 = totally agree , 1 = do n't agree at all ) . Both training methods were perceived as useful for training communication skills ( RP 5.01 ± .68 , SP 5.34 ± .47 ; 6 = totally agree ; 1 = do n't agree at all ) and were considered to be moderately applicable for future parent-physician encounters ( RP 4.29 ± 1.08 , SP 5.00 ± .89 ; 6 = well prepared , 1 = unprepared ) , with usefulness and applicability both being rated higher in the SP group ( p < .032 and p < .009 ) . Conclusions RP and SP represent comparably valuable tools for the training of specific communication skills from the student perspective . Both provide highly realistic training scenarios and warrant inclusion in medical curricula . Given the expense of SP , deciding which method to employ should be carefully weighed up . From the perspective of the students in our study , SP were seen as a more useful and more applicable tool than RP . We discuss the potential of RP to foster a greater empathic appreciation of the patient perspective \n Output:\n " }, { "from": "agent", "value": "The study from Syria reported that a communication skills training intervention for resident doctors was not associated with higher satisfaction reported by women .\nIn the UK study , patient-actors ' ( experienced midwives ) perceptions of safety and communication significantly improved for postpartum haemorrhage scenarios after training with patient-actors in local hospitals , compared with training using manikins in simulation centres , but no differences were identified for other scenarios .\nKEY CONCLUSIONS AND IMPLICATION S FOR PRACTICE the review identified a lack of evidence on impact of interventions to support effective communication between maternity care staff and healthy women during labour and birth .\nVery low quality evidence was found on effectiveness of communication training of maternity care staff ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Prospect i ve memory ( PM ) denotes the ability to remember to perform actions in the future . It has been argued that st and ard laboratory paradigms fail to capture core aspects of PM . Methodology /Principal Findings We combined functional MRI , virtual reality , eye-tracking and verbal reports to explore the dynamic allocation of neurocognitive processes during a naturalistic PM task where individuals performed err and s in a realistic model of their residential town . Based on eye movement data and verbal reports , we modeled PM as an iterative loop of five sustained and transient phases : intention maintenance before target detection ( TD ) , TD , intention maintenance after TD , action , and switching , the latter representing the activation of a new intention in mind . The fMRI analyses revealed continuous engagement of a top-down fronto-parietal network throughout the entire task , likely subserving goal maintenance in mind . In addition , a shift was observed from a perceptual ( occipital ) system while search ing for places to go , to a mnemonic ( temporo-parietal , fronto-hippocampal ) system for remembering what actions to perform after TD . Updating of the top-down fronto-parietal network occurred at both TD and switching , the latter likely also being characterized by frontopolar activity . Conclusion / Significance Taken together , these findings show how brain systems complementary interact during real-world PM , and support a more complete model of PM that can be applied to naturalistic PM tasks and that we named PROspect i ve MEmory DYnamic ( PROMEDY ) model because of its dynamics on both multi-phase iteration and the interactions of distinct neurocognitive networks Memories are of the past but for the future , enabling individuals to implement intended plans and actions at the appropriate time . Prospect i ve memory is the specific ability to remember and execute an intended behavior at some design ated point in the future . Although sleep is well-known to benefit the consolidation of memories for past events , its role for prospect i ve memory is still not well understood . Here , we show that sleep as compared to wakefulness after prospect i ve memory instruction enhanced the successful execution of prospect i ve memories two days later . We further show that sleep benefited both components of prospect i ve memory , i.e. to remember that something has to be done ( prospect i ve component ) and to remember what has to be done ( retrospective component ) . Finally , sleep enhanced prospect i ve remembering particularly when attentional re sources were reduced during task execution , suggesting that subjects after sleep were able to recruit additional spontaneous-associative retrieval processes to remember intentions successfully . Our findings indicate that sleep supports the maintenance of prospect i ve memory over time by strengthening intentional memory representations , thus favoring the spontaneous retrieval of the intended action at the appropriate time BACKGROUND Recent findings suggest that there may be a relationship between excessive daytime sleepiness ( EDS ) and cognitive deficits . This study aims to determine to what extent EDS is predictive of cognitive impairment in an elderly population . METHODS A total of 1026 individuals 60 years or older representative of the general population living in the metropolitan area of Paris , France , were interviewed by telephone using the Sleep-EVAL expert system . To find these individuals , 7010 r and omly selected households were called : 1269 had at least 1 household member in this age range ( participation rate , 80.9 % ) . In addition to Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , and International Classification of Sleep Disorders diagnoses , the system administered to participants the Psychological General Well-being Schedule , the Cognitive Difficulties Scale ( MacNair-R ) , and an independent living scale . RESULTS Excessive daytime sleepiness was reported by 13.6 % of the sample , with no significant difference among age groups . Compared with nonsleepy participants , those with EDS were at increased risk of cognitive impairment on all the dimensions of the MacNair-R scale after controlling for age , sex , physical activity , occupation , organic diseases , use of sleep or anxiety medication , sleep duration , and psychological well-being . The odd ratios were 2.1 for attention-concentration deficits , 1.7 for praxis , 2.0 for delayed recall , 2.5 for difficulties in orientation for persons , 2.2 for difficulties in temporal orientation , and 1.8 for prospect i ve memory . CONCLUSIONS Among elderly individuals in the general population , EDS is an important risk factor for cognitive impairment . A complaint of EDS by an elderly patient should signal the possibility of an underlying cognitive impairment in need of evaluation Time-based prospect i ve memory ( TBPM ) is required when it is necessary to remember to perform an action at a specific future point in time . This type of memory has been found to be particularly sensitive to ageing , probably because it requires a self-initiated response at a specific time . In this study , we sought to examine the involvement of temporal processes in the time monitoring strategy , which has been demonstrated to be a decisive factor in TBPM efficiency . We compared the performance of young and older adults in a TBPM task in which they had to press a response button every minute while categorising words . The design allowed participants to monitor time by checking a clock whenever they decided . Participants also completed a classic time-production task and several executive tasks assessing inhibition , updating and shifting processes . Our results confirm an age-related lack of accuracy in prospect i ve memory performance , which seems to be related to a deficient strategic use of time monitoring . This could in turn be partially explained by age-related temporal deficits , as evidence d in the duration production task . These findings suggest that studies design ed to investigate the age effect in TBPM tasks should consider the contribution of temporal mechanisms The aim of the present study was to deepen knowledge about the effect of a lowered vigilance state on time-based prospect i ve memory ( TBPM ) performance . For this purpose 2 TBPM tasks ( primary and interpolated ) , which shared a portion of the retention interval , and 3 reasoning tasks , as ongoing activities , were administered after total sleep deprivation and in a regular sleep condition . The results showed a detrimental effect of sleep deprivation on prospect i ve memory performance and a partial dissociation between clock-checking behavior and time estimation for prospect i ve compliance . This study clearly indicates that total sleep deprivation im- pairs the ability to complete multiple prospect i ve task assignments in a timely fashion . Results are discussed suggesting the existence of different mechanisms involved in time monitoring and other cognitive functions underlying TBPM performance Prospect i ve memory is defined as remembering to do something at a particular moment in the future and may be modulated by sleep . Here , we investigated whether multiple nights of partial sleep deprivation would affect the successful retrieval of intentions . Fifty-nine adolescents ( mean age ± SD : 16.1 ± 0.6 years ) were instructed to remember to press specific keys in response to the target words presented during a semantic categorization task in the future . Their memory was tested after five nights of either 5-h ( sleep restriction group ) or 9-h time-in-bed ( control group ) . The average percentage of target words correctly responded to was small and did not significantly differ between the two groups ( mean ± SEM for the sleep restriction group : 15.52 ± 6.61 % ; the control group : 23.33 ± 7.48 % , p = 0.44 ) . Thus , after the extended retention interval , prospect i ve remembering was poor and did not appear to be affected by post-learning sleep restriction . These findings suggest a temporal boundary beyond which intentions fall below requisite levels of activation , potentially masking any benefits for retrieval conferred by sleep OBJECTIVE The relationship between insomnia symptoms and cognitive performance is unclear , particularly at the population level . We conducted the largest examination of this association to date through analysis of the UK Biobank , a large population -based sample of adults aged 40 - 69 years . We also sought to determine associations between cognitive performance and self-reported chronotype , sleep medication use and sleep duration . METHODS This cross-sectional , population -based study involved 477,529 participants , comprising 133,314 patients with frequent insomnia symptoms ( age : 57.4 ± 7.7 years ; 62.1 % female ) and 344,215 controls without insomnia symptoms ( age : 56.1 ± 8.2 years ; 52.0 % female ) . Cognitive performance was assessed by a touchscreen test battery probing reasoning , basic reaction time , numeric memory , visual memory , and prospect i ve memory . Adjusted models included relevant demographic , clinical , and sleep variables . RESULTS Frequent insomnia symptoms were associated with cognitive impairment in unadjusted models ; however , these effects were reversed after full adjustment , leaving those with frequent insomnia symptoms showing statistically better cognitive performance over those without . Relative to intermediate chronotype , evening chronotype was associated with superior task performance , while morning chronotype was associated with the poorest performance . Sleep medication use and both long ( > 9 h ) and short ( < 7 h ) sleep duration s were associated with impaired performance . CONCLUSIONS Our results suggest that after adjustment for potential confounding variables , frequent insomnia symptoms may be associated with a small statistical advantage , which is unlikely to be clinical ly meaningful , on simple neurocognitive tasks . Further work is required to examine the mechanistic underpinnings of an apparent evening chronotype advantage in cognitive performance and the impairment associated with morning chronotype , sleep medication use , and sleep duration extremes Experimental data indicate a role for the prefrontal cortex in mediating normal sleep physiology , dreaming and sleep-deprivation phenomena . During nonr and om-eye-movement ( NREM ) sleep , frontal cortical activity is characterized by the highest voltage and the slowest brain waves compared to other cortical regions . The differences between the self-awareness experienced in waking and its diminution in dreaming can be explained by deactivation of the dorsolateral prefrontal cortex during REM sleep . Here , we propose that this deactivation results from a direct inhibition of the dorsolateral prefrontal cortical neurons by acetylcholine , the release of which is enhanced during REM sleep . Sleep deprivation influences frontal executive functions in particular , which further emphasizes the sensitivity of the prefrontal cortex to sleep In daily life , we often need to remember to perform an action after , or at , a specific period of time ( e.g. , take pizza out of oven in 15 minutes ) . Surprisingly , little is known about the neural mechanisms that support this form of memory , termed time-based prospect i ve memory ( PM ) . Here we pioneer an fMRI paradigm that enables examination of both sustained and transient processes engaged during time-based PM . Participants were scanned while performing a dem and ing on-going task ( n-back working memory ) , with and without an additional time-based PM dem and . During the PM condition participants could access a hidden clock with a specific button-press response , while in the control condition , pseudo-clocks r and omly appeared and were removed via the same response . Analyses tested for sustained activation associated with the PM condition , and also transient activation associated with clock-checks and the PM target response . Contrary to prior findings with event-based PM ( i.e. , remembering to perform a future action when a specific event occurs ) , no sustained PM-related activity was observed in anterior prefrontal cortex ( aPFC ) or elsewhere in the brain ; instead , transient clock-related activity was observed in this region . Critically , the activation was anticipatory , increasing before clock-check responses . Anticipatory activity prior to the PM target response was weaker in aPFC , but strong in pre-Supplementary Motor Area ( pre-SMA ; relative to clock-check responses ) , suggesting a functional double dissociation related to volitional decision-making . Together , the results suggest that aPFC-activity dynamics during time-based PM reflect a distinct transient monitoring process , enabling integration of the PM intention with current temporal information to facilitate scheduling of upcoming PM-related actions On a daily basis we form numerous intentions to perform specific actions . However , we often have to delay the execution of intended actions while engaging in other dem and ing activities . Previous research has shown that patterns of activity in human prefrontal cortex ( PFC ) can reveal our current intentions . However , two fundamental questions have remained unresolved : ( a ) how does the PFC encode information about future tasks while we are busy engaging in other activities , and ( b ) how does the PFC enable us to commence a stored task at the intended time ? Here we investigate how the brain stores and retrieves future intentions during occupied delays , i.e. while a person is busy performing a different task . For this purpose , we conducted a neuroimaging study with a time-based prospect i ve memory paradigm . Using multivariate pattern classification and fMRI we show that during an occupied delay , activity patterns in the anterior PFC encode the content of ' what ' subjects intend to do next , and ' when ' they intend to do it . Importantly , distinct anterior PFC regions store the ' what ' and ' when ' components of future intentions during occupied maintenance and self-initiated retrieval . These results show a role for anterior PFC activity patterns in storing future action plans and ensuring their timely retrieval STUDY OBJECTIVES To evaluate the effect of sleep deprivation on time-based prospect i ve memory performance , that is , realizing delayed intentions at an appropriate time in the future ( e.g. , to take a medicine in 30 minutes ) . DESIGN Between-subjects experimental design . The experimental group underwent 24 h of total sleep deprivation , and the control group had a regular sleep-wake cycle . Participants were tested at 08:00 . SETTING S Laboratory . PARTICIPANTS Fifty healthy young adults ( mean age 22 ± 2.1 , 31 female ) . INTERVENTIONS 24 h of total sleep deprivation . MEASUREMENTS AND RESULTS Participants were monitored by wrist actigraphy for 3 days before the experimental session . The following cognitive tasks were administered : one time-based prospect i ve memory task and 3 reasoning tasks as ongoing activity . Objective and subjective vigilance was assessed by the psychomotor vigilance task and a visual analog scale , respectively . To measure the time-based prospect i ve memory task we assessed compliance and clock checking behavior ( time monitoring ) . Sleep deprivation negatively affected time-based prospect i ve memory compliance ( P < 0.001 ) , objective vigil \n Output:\n " }, { "from": "agent", "value": "In contrast , the benefits of sleep are significantly greater when the likelihood of spontaneous retrieval is high ( d = 0.94 , CI95 = 0.44 - 1.44 ) versus low ( d = 0.45 , CI95 = -0.02 - 0.93 ) , suggesting that sleep may leverage on spontaneous retrieval processes to improve PM ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction Environmental stimulus , especially noise and light , is thought to disrupt sleep in patients in the intensive care unit ( ICU ) . This study aim ed to determine the physiological and psychological effects of ICU noise and light , and of earplugs and eye masks , used in these conditions in healthy subjects . Methods Fourteen subjects underwent polysomnography under four conditions : adaptation , baseline , exposure to recorded ICU noise and light ( NL ) , and NL plus use of earplugs and eye masks ( NLEE ) . Urine was analyzed for melatonin and cortisol levels . Subjects rated their perceived sleep quality , anxiety levels and perception of environmental stimuli . Results Subjects had poorer perceived sleep quality , more light sleep , longer rapid eye movement ( REM ) latency , less REM sleep when exposed to simulated ICU noise and light ( P < 0.05 ) . Nocturnal melatonin ( P = 0.007 ) and cortisol secretion levels ( P = 0.004 ) differed significantly by condition but anxiety levels did not ( P = 0.06 ) . Use of earplugs and eye masks result ed in more REM time , shorter REM latency , less arousal ( P < 0.05 ) and elevated melatonin levels ( P = 0.002 ) . Conclusions Earplugs and eye masks promote sleep and hormone balance in healthy subjects exposed to simulated ICU noise and light , making their promotion in ICU patients reasonable St and ardized diagnostic criteria determined by the International Restless Legs Syndrome Study Group were used to investigate the current prevalence of restless legs syndrome ( RLS ) . Possible associations between RLS and neuropsychiatric and somatic complaints were also investigated . A r and om sample of 4,000 men living in central Sweden were sent a question naire that included questions about sleep habits , symptoms of sleepiness , and somatic and neuropsychiatric complaints . Four symptom questions accepted as minimal diagnostic criteria for RLS were also included . Odds ( OR ) ratios and 95 % confidence interval ( CI ) for different variables were calculated by means of multivariate logistic regression ; 5.8 % of the men suffered from RLS . The prevalence of RLS increased with age . Sleep-related complaints were more frequent among the RLS sufferers . Complaints of headache at awakening and daytime headache were reported three to five times more frequently among RLS sufferers and there was a tendency toward reported social isolation related to RLS . Subjects with RLS more frequently reported depressed mood ( OR , 2.6 ; 95 % CI , 1.8 - 3.8 ) , and complained more often of reduced libido ( OR , 2.2 ; 95 % CI , 1.4 - 3.3 ) . RLS sufferers more frequently reported hypertension ( OR , 1.5 ; 95 % CI , 0.9 - 2.4 ) and heart problems ( OR , 2.5 ; 95 % CI , 1.4 - 4.3 ) . Results show that restless legs syndrome is common among men . It is hypothesized that RLS may be associated with several somatic and neuropsychiatric symptoms Objective : To evaluate if anger expression affects sleep quality in patients with coronary heart disease ( CHD ) . Research has indicated that poor sleep quality independently predicts adverse outcomes in patients with CHD . Risk factors for poor sleep quality include older age , socioeconomic factors , medical comorbidities , lack of exercise , and depression . Methods : We sought to examine the association of anger expression with sleep quality in 1020 out patients with CHD from the Heart and Soul Study . We assessed anger-in , anger-out , and anger temperament , using the Spielberger State-Trait Anger Expression Inventory 2 , and measured sleep quality , using items from the Cardiovascular Health Study and Pittsburgh Sleep Quality Index . We used multivariate analysis of variance to examine the association between anger expression and sleep quality , adjusting for potential confounding variables . Results : Each st and ard deviation ( SD ) increase in anger-in was associated with an 80 % greater odds of poor sleep quality ( odds ratio ( OR ) = 1.8 , 95 % Confidence Interval ( CI ) = 1.6–2.1 ; p < .0001 ) . This association remained strong after adjusting for demographics , comorbidities , lifestyle factors , medications , cardiac function , depressive symptoms , anger-out , and anger temperament ( adjusted OR = 1.4 , 95 % CI = 1.5–1.7 ; p = .001 ) . In the same model , each SD increase in anger-out was associated with a 21 % decreased odds of poor sleep quality ( OR = 0.79 , 95 % CI = 0.64–0.98 ; p = .03 ) . Anger temperament was not independently associated with sleep quality . Conclusions : Anger suppression is associated with poor sleep quality in patients with CHD . Whether modifying anger expression can improve sleep quality or reduce cardiovascular morbidity and mortality deserves further study . BMI = body mass index ; CHD = coronary heart disease ; DSM-IV-TR = Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision ; MI = myocardial infa rct ion ; REM = rapid eye movement ; STAXI-2 = Spielberger State-Trait Anger Expression Inventory 2 ; BP = blood pressure ; HR = heart rate ; SD = st and ard deviation ; ANOVA = analysis of variance ; CI = confidence interval ; OR = odds ratio ; PHQ = Patient Health Question naire ; COPD = chronic obstructive pulmonary disease AIM To evaluate the prevalence of Sleep Apnea-Hypopnea Syndrome ( SAHS ) in patients who were admitted with Acute Coronary Syndrome ( ACS ) to the Coronary Care Unit ( CCU ) and the clinical predictors of SAHS in patients with ACS and to compare the results of the simple sleep test ( SST ) with polysomnography ( PSG ) . METHODS This was a prospect i ve study that included patients who were admitted to the CCU with ACS , which was confirmed by coronary angiography . Demographic and anthropometric data , cardiovascular risk factors and measures on the Epworth Sleepiness Scale were collected . The SST was conducted with the ApneaLink(TM ) device during hospitalization or after discharge . Patients with an apnea-hypopnea index ( AHI ) ≥ 10/h were invited to participate in PSG . RESULTS Ninety-one patients with ACS were consecutively included over 4 months . Of the fifty-eight patients who completed the study 43 ( 74.1 % ) were male . The mean age was 61.7±12.2 years , and the mean body mass index was 27.4±3.5 kg/m(2 ) . The median time for SST performance was 17.5 days . This study was compatible with SAHS in 25 cases ( 43.1 % ) . Patients who had an AHI ≥ 10/h in the SST were su bmi tted to PSG and SST simultaneously . The median interval between the ACS and the execution of PSG was 30 days . PSG confirmed that all of the cases that were detected by SST were positive . CONCLUSION In our study , we found a high prevalence of SAHS in patients who were admitted to the CCU with ACS ( 43.1 % ) . These results support the need for SAHS screening in patients who are hospitalized with ACS . The SST may have a role in the screening of SAHS in this population To test the hypothesis that feelings of exhaustion are predictive of future coronary heart disease , a prospect i ve study was done among 3877 males , aged 39 - 65 . Feelings of exhaustion were assessed by the Maastricht Question naire . Among those who were free of coronary heart disease at screening , 59 subjects experienced a fatal or non-fatal myocardial infa rct ion during the 4.2 year follow-up period . A multiple logistic regression analysis revealed that feelings of exhaustion were predictive of future myocardial infa rct ion when controlling simultaneously for blood pressure , smoking , cholesterol , age and the use of antihypertensive drugs Background — Clinic-based observational studies in men have reported that obstructive sleep apnea is associated with an increased incidence of coronary heart disease . The objective of this study was to assess the relation of obstructive sleep apnea to incident coronary heart disease and heart failure in a general community sample of adult men and women . Methods and Results — A total of 1927 men and 2495 women ≥40 years of age and free of coronary heart disease and heart failure at the time of baseline polysomnography were followed up for a median of 8.7 years in this prospect i ve longitudinal epidemiological study . After adjustment for multiple risk factors , obstructive sleep apnea was a significant predictor of incident coronary heart disease ( myocardial infa rct ion , revascularization procedure , or coronary heart disease death ) only in men ≤70 years of age ( adjusted hazard ratio 1.10 [ 95 % confidence interval 1.00 to 1.21 ] per 10-unit increase in apnea-hypopnea index [ AHI ] ) but not in older men or in women of any age . Among men 40 to 70 years old , those with AHI ≥30 were 68 % more likely to develop coronary heart disease than those with AHI < 5 . Obstructive sleep apnea predicted incident heart failure in men but not in women ( adjusted hazard ratio 1.13 [ 95 % confidence interval 1.02 to 1.26 ] per 10-unit increase in AHI ) . Men with AHI ≥30 were 58 % more likely to develop heart failure than those with AHI < 5 . Conclusions — Obstructive sleep apnea is associated with an increased risk of incident heart failure in community-dwelling middle-aged and older men ; its association with incident coronary heart disease in this sample is equivocal BACKGROUND AND PURPOSE The aim of this study was to estimate the prevalence of restless legs syndrome ( RLS ) symptoms in the US adult population and to relate frequency of RLS symptoms to self-reported general health , depressive and anxiety symptoms , daytime sleepiness , and cardiovascular disease . PATIENTS AND METHODS Data were obtained from a survey , conducted in 2002 , of 2821 participants in the Wisconsin Sleep Cohort , a prospect i ve community-based epidemiology study . Classification of RLS symptoms was based on the following four symptoms at the 2002 survey : ' repeated urge to move your legs ' and ' strange and uncomfortable feelings in the legs ' , ' when sitting or lying down ' which occur at least weekly , ' get better when you get up and start walking ' and ' disrupt your sleep ' . RESULTS Prevalence of RLS symptoms occurring at least weekly was 10.6 % , with no statistical difference between males ( 9.9 % ) and females ( 11.2 % ) . Individuals with symptoms of RLS occurring at least weekly were older than those without such symptoms ( P<0.02 ) . Those with Daily RLS symptoms had statistically more frequent excessive daytime sleepiness , poorer self-reported general health , an elevation in depressive and anxiety symptoms , and an increased prevalence of cardiovascular disease compared to those with no RLS symptoms . All of these associations were stronger in subjects with Daily RLS symptoms than those with RLS symptoms 1 - 6 times per week . CONCLUSIONS RLS symptoms are associated with multiple physical and psychological indices of impaired health . Longitudinal studies are required to determine whether RLS symptoms are causally related to excessive daytime sleepiness , poor general health , elevated depression and anxiety symptoms , and cardiovascular disease BACKGROUND From a mechanistic st and point , obstructive sleep apnea ( OSA ) may further disturb cardiovascular homeostasis in the setting of acute coronary syndrome ( ACS ) . OBJECTIVE We sought to investigate if a st and ardized clinical diagnosis of OSA , in acute coronary syndrome patients , predicts the risk of cardiovascular events during hospitalization . METHODS In a prospect i ve cohort study , a group of 200 patients diagnosed with ACS between September 2005 and November 2007 were stratified by the Berlin Question naire ( BQ ) regarding the risk for OSA ( high or low risk ) . We tested if the subgroup of high risk for OSA was prone to a higher frequency of cardiovascular events . The primary endpoint evaluated was a composite outcome of cardiovascular death , recurrent cardiac ischemic events , acute pulmonary edema and stroke during hospitalization . RESULTS Ninety four ( 47 % ) patients assessed by the BQ were likely to have OSA . High risk for OSA was associated with a non-significant higher mortality ( 4.25 % vs 0.94 % ; p=0.189 ) , but a significant higher incidence of composite cardiovascular events ( 18.08 % vs 6.6 % ; p=0.016 ) . In the logistic regression model , multivariate predictors of composite cardiovascular events were age ( OR= 1.048 ; 95 % CI 1.008 to 1.090 ; p=0.019 ) , left ventricular ejection fraction ( OR= 0.954 ; 95 % CI 0.920 to 0.989 ; p=0.010 ) , and higher risk for OSA ( OR= 3.657 ; 95 % CI 1.216 to 10.996 ; p=0.021 ) . CONCLUSION The use of a simple and vali date d question naire ( BQ ) to identify patients with higher risk for OSA may help in the prediction of cardiovascular outcome during hospitalization . Moreover , our data suggests that OSA is very common in patients with ACS Abstract Little is known about the nature of the depressive symptomatology preceding myocard \n Output:\n " }, { "from": "agent", "value": "Factor analysis provided a question naire of 23 items on 5 dimensions of sleep disturbance in coronary patients : \" sleep onset and continuity disorder , \" \" disorder in daytime functioning , \" \" sleep disturbance caused by environmental factors , \" \" sleep disturbance as a result of cardiac diseases , \" and \" respiratory disorders during sleep ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background The effectiveness of bracing patients with IS has not yet been convincingly established due to a lack of RCTs . Some authors suggest that their results confirm that bracing is effective ; others conclude that the effectiveness of bracing is doubtful or recommend a RCT . The aim of this study was to establish whether bracing patients with idiopathic scoliosis ( IS ) in an early stage will result in at least 5 degrees less mean progression of the curvature compared to the control group after two years of follow-up . Methods A r and omized controlled trial was design ed . Eligible patients are girls and boys in the age group 8–15 years whose diagnosis of IS has been established by an orthopedic surgeon , who have not yet been treated by bracing or surgery , and for whom further growth of physical height is still expected based on medical examination and maturation characteristics ( Risser ≤ 2 ) . The Cobb angle of the eligible patient should either be minimally 22 and maximally 29 degrees with established progression of more than 5 degrees , or should be minimally 30 and maximally 35 degrees ; established progression for the latter is not necessary . A total of 100 patients will be included in this trial . The intervention group will be treated with full-time Boston brace wear ; the control group will not be braced . Every four months , each patient will have a physical and an X-ray examination . The main outcomes will be the Cobb angle two years after inclusion and health-related quality of life . Discussion The results of this trial will be of great importance for the discussion on early treatment for scoliosis . Furthermore , the result will also be important for screening for scoliosis policies . Trial registration Nederl and s Trialregister IS RCT Study Design . A consecutive series of female patients with adolescent idiopathic scoliosis treated between 1968 and 1977 , either with distraction and fusion using Harrington rods ( n = 145 ) or with a brace ( n = 122 ) , were followed for at least 20 years after completion of the treatment . Objectives . To determine the long-term outcomes of childbearing and sexual life in women treated for adolescent idiopathic scoliosis , as compared with matched control subjects who did not have scoliosis . Summary of Background Data . The effect of pregnancy on curve progression is not established , and results are contradictory . Few reports exist on the social life ( marriage , childbearing , and sexual function ) of formerly treated individuals with scoliosis . Methods . In this study , 136 surgically treated women ( 94 % ) and 111 brace-treated women ( 91 % ) completed the Scoliosis Research Society (SRS)/MODEM ’s question naire concerning childbearing and sexual life as a part of an unbiased personal follow-up examination . Of these , 129 surgically treated and 105 brace-treated women also underwent a radiographic examination . The Cobb method was used to measure curve size in present and earlier examinations . An age-matched control group of 90 women was r and omly selected and subjected to the same examinations . Results . The mean age for all the groups was 40 years . Of the surgically treated and brace-treated women , 85 % were or had been married , as compared with 82 % of the control women . In the total cohort , 628 pregnancies had occurred . No significant mean difference existed between the groups in the number of children born ( 1.8 for the surgically treated , 1.9 for the brace-treated , and 2 for the control women ) ( P = 0.25 ) . The patients in the brace-treated group had a significantly higher mean age at first pregnancy ( 28 years ) than the control subjects ( 25.9 years ) ( P = 0.011 ) , whereas the age for the surgically treated women ( 26.6 years ) did not differ significantly from that for the brace-treated women . There were no significant differences between the groups in rates for low back pain ( 35 % for the surgically treated , 43 % for the brace-treated , and 28 % for the control group ) or for cesarean section ( 19 % for the surgically treated , 14 % for the brace-treated , and 18 % for the control group ) during the first pregnancy . The rate of vacuum extraction s was higher in the surgically treated group ( 16 % ) than in thecontrol group ( 5 % ) ( P = 0.036 ) or the brace-treated group(8 % ) . Limitation of sexual function from the back was admitted by 33 % of the surgically treated , 28 % of the brace-treated , and 15 % of the control women : surgically treated vs control subjects ( P = 0.0042 ) , brace-treated vs control subjects ( P = 0.026 ) , and brace-treated vs surgically treated subjects ( P = 0.57 , a nonsignificant difference ) . These limitations were largely because of difficulties participating physically in activities or self-consciousness about appearance . Pain was a minor reason for limitation . There was no correlation between progression of the major or lumbar curve and number of pregnancies , or between curve progression and age at first pregnancy . Conclusions . Patients treated for adolescent idiopathic scoliosis appeared to function well with regard to marital status and number of children . The scoliotic curve did not seem to increase as a result of childbearing . Minor problems occurred during pregnancy and delivery . Some patients , however , experienced a slight negative effect in their sexual life Abstract In a 5-year prospect i ve study on idiopathic scoliosis , an attempt was made to eluci date the natural history of the disease and to determine which factors contribute to curve progression . A total of 85,622 children were examined for scoliosis in a prospect i ve school screening study carried out in northwestern and central Greece . Curve progression was studied in 839 of the 1,436 children with idiopathic scoliosis of at least 10 ° detected from the school screening program . Each child was followed clinical ly and roentgenographically for one to four follow-up visits for a mean of 3.2 years . Progression of the scoliotic curve was recorded in 14.7 % of the children . Spontaneous improvement of at least 5 ° was observed in 27.4 % of them , with 80 children ( 9.5 % ) demonstrating complete spontaneous resolution . Eighteen percent of the patients remained stable , while the remaining patients demonstrated nonsignificant changes of less than 5 ° in curve magnitude . A strong association was observed between the incidence of progression and the sex of the child , curve pattern , maturity , and to a lesser extent age and curve magnitude . More specifically , the following were associated with a high risk of curve progression : sex ( girls ) ; curve pattern ( right thoracic and double curves in girls , and right lumbar curves in boys ) ; maturity ( girls before the onset of menses ) ; age ( time of pubertal growth spurt ) ; and curve magnitude ( ≥ 30 ° ) . On the other h and , left thoracic curves showed a weak tendency for progression . In conclusion , the findings of the present study strongly suggest that only a small percentage of scoliotic curves will undergo progression . The pattern of the curve according to curve direction and sex of the child was found to be a key indicator of which curves will progress BACKGROUND CONTEXT The value of scoliosis screening has been recently shown in a multicenter r and omized controlled trial . However , the long-term sustainability of the clinical effectiveness of scoliosis screening as a routine health service remains unknown . PURPOSE The aim of this study was to assess the sustainability of the clinical effectiveness of school scoliosis screening . STUDY DESIGN / SETTING A large population -based cohort study with a 10-year follow-up was conducted . PATIENT SAMPLE A total of 394,401 students who were in the fifth grade during the five academic years from 1995/1996 to 1999/2000 formed five consecutive annual cohorts . The students were eligible for the Hong Kong scoliosis screening program , with their screening history and medical records until their nineteenth birthdays being assessed . OUTCOME MEASURES The outcome measures considered in the study were development of adolescent idiopathic scoliosis by the 19 years of age and the Cobb angle . METHODS The clinical effectiveness of scoliosis screening was assessed by referral rate for radiographic diagnosis , sensitivity , specificity , and predictive values . RESULTS A total of 306,144 students ( 78 % ) participated in scoliosis screening , which used a two-tier system . The prevalence of curves of 20 ° or greater was 1.8 % ( 95 % confidence interval [ CI ] , 1.7 - 1.8 % ) , whereas the referral rate for radiography , the sensitivity , and the positive predictive value ( PPV ) for curves of 20 ° or greater were 4.1 % ( 95 % CI , 4.0 - 4.2 % ) , 91 % ( 95 % CI , 90 - 92 % ) , and 40 % ( 95 % CI , 39 - 41 % ) , respectively . Across the five consecutive annual cohorts , the prevalence and sensitivity for curves of 20 ° or greater increased by 0.23 % ( 95 % CI , 0.21 - 0.25 % ; p<.001 ) and 0.76 % ( 95 % CI , 0.43 - 1.04 % ; p<.001 ) per year , respectively ; however , the PPV was reduced by 1.71 % ( 95 % CI , 1.09 - 2.33 % ; p<.001 ) per year . CONCLUSIONS This report describes the first large population -based study with a long-term follow-up indicating that a scoliosis screening program can have sustained clinical effectiveness in identifying patients with adolescent idiopathic scoliosis needing clinical observation . As the prevalence of adolescent idiopathic scoliosis increases , scoliosis screening should be continued as a routine health service in schools or by general practitioners if there is no scoliosis screening policy Abstract . No results on long-term outcome in terms of health-related quality of life ( HRQL ) have previously been presented for patients treated for adolescent idiopathic scoliosis . A consecutive series of patients with adolescent idiopathic scoliosis , treated between 1968 and 1977 before the age of 21 , either with distraction and fusion using Harrington rods [ surgical treatment group ( ST ) , n=156 ; 145 females and 11 males ] or with a brace [ brace treatment group ( BT ) , n=127 ; 122 females and 5 males ] were followed at least 20 years after completion of the treatment . Ninety-four percent of ST and 91 % of BT patients filled in a question naire comprising the SF-36 , Psychological General Well-Being Index ( PGWB ) , Oswestry Disability Back Pain Question naire , parts of SRS/MODEM 'S question naire and study -specific questions concerning the treatment , as a part of an unbiased personal follow-up examination including radiography and clinical examination . An age- and sex-matched control group of 100 persons was r and omly selected and subjected to the same examinations . The results showed no differences in terms of sociodemographic data between the groups . Both ST and BT patients had a slightly , but significantly , reduced physical function using the SF-36 subscales , SF-36/Physical Component Summary ( PCS ) score as well as the Oswestry Disability Back Pain Question naire compared to the controls . Neither the mental subscales and the Mental Component Summary ( MCS ) score of SF-36 nor the PGWB index showed any significant difference between the groups . Forty-nine percent of ST , 34 % of BT and 15 % of controls admitted limitation of social activities due to their back [ P<0.001 ST vs controls , P=0.0010 BT vs controls , and n.s . ( P=0.024 ) ST vs BT ] , mostly due to difficulties with physical participation in activities or self-consciousness about appearance . Pain was a minor reason for limitation . No correlation was found between the outcome scores and curve size after treatment , curve type , total treatment time or age at completed treatment . Patients treated for adolescent idiopathic scoliosis were found to have approximately the same HRQL as the general population . A minority of the patients ( 4 % ) had a severely decreased psychological well-being , and a few ( 1.5 % ) were severely physically disabled due to the back In a study conducted by the Scoliosis Research Society , 159 girls with a mean age of thirteen years ( range , ten to fifteen years ) who had adolescent idiopathic scoliosis were followed prospect ively until skeletal maturity or until the curve had increased 6 degrees or more . All patients had had an initial curve of 25 to 35 degrees and an apical level between the eighth thoracic and first lumbar vertebrae , inclusive . Of the 159 patients , 120 were observed without treatment and thirty-nine were managed with lateral electrical surface stimulation . The curve progressed at least 6 degrees in eighty patients . There was no apparent difference in the outcome between the patients who were managed with observation only and those who were given electrical stimulation . Logistic regression analysis was performed to determine which of eleven factors were predictive of progression of the scoliotic curve . A Risser sign of 0 or 1 , an apical level cephalad to the twelfth thoracic vertebra , and an imbalance of ten millimeters or less were found to be independently prognostic of progression of more than 6 degrees . A prognostic model that included these three factors and chronological age allowed correct classification of the curve as either progressive or non-progressive in 81 per cent of these patients who had a thoracic or thoracol \n Output:\n " }, { "from": "agent", "value": "There was no evidence on the effect of AIS screening on adult health outcomes .\nConclusions and Relevance Screening can detect AIS .\nBracing and possibly exercise treatment can interrupt or slow progression of curvature in adolescence .\nHowever , there is little or no evidence on long-term outcomes for AIS treated in adolescence , the association between curvature at skeletal maturity and adult health outcomes , the harms of AIS screening or treatment , or the effect of AIS screening on adult health outcomes" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Past efforts to promote family planning in Pakistan have been disappointing , but between 1990 - 91 and 2000 - 01 contraceptive use has more than doubled . This rise has coincided with a concerted effort on the part of the Pakistani government to increase access to contraceptive services , particularly in rural areas . The Lady Health Worker Programme ( LHWP ) , initiated under the Ministry of Health in the early 1990s , aim ed at integrating family planning into the doorstep provision of primary health care . This paper presents findings from the first national evaluation of this Programme . Data are analyzed from a r and om sample survey of 4277 women living in households served by the LHWP and those living in control areas . Logistic regression analysis was performed to determine the effect of the Programme on the uptake of modern reversible contraceptive methods , controlling for other independent variables . The data provide strong evidence that the LHWP has succeeded in increasing modern contraceptive use among rural women . Women served by Lady Health Workers are significantly more likely to use a modern reversible method than women in communities not served by the Programme ( OR=1.50 , 95 % CI=1.04 - 2.16 , p=0.031 ) , even after controlling for various household and individual characteristics . The model of providing doorstep services through community-based female workers should remain central to achieving universal access to safe family planning methods by the end of the decade -- the long-term objective of Pakistan 's most recent population policy adopted in 2002 This pilot study conducted in Muzaffarnagar district in the state of Uttar Pradesh , India , demonstrates the potential for using traditional medical practitioners in the delivery of family planning services after a brief training period . Practitioners participated continuously in the program for an intervention period of two years during which their services were accepted by the community . The impact of their involvement was reflected in increased knowledge of permanent as well as reversible contraceptive methods and in higher contraceptive use rates , especially of reversible methods adopted by women younger than 25 years ( from 8 percent to 37 percent ) , in the intervention villages , as compared with increased knowledge and use ( from 13 percent to 25 percent ) of permanent methods alone in the control villages In response to the concept that a good postpartum program should begin prenatally , this study was design ed to determine whether the provision of expert contraceptive counseling during the antenatal period would have an impact on contraceptive uptake , patterns of contraceptive usage , and pregnancy rates during the first year after childbirth . Over 500 women attending antenatal clinics in each of three centers ( Edinburgh , Scotl and ; Shanghai , People 's Republic of China ; Cape Town , South Africa ) were r and omized to receive expert contraceptive advice ( participants , n = 771 ) or the st and ard advice routinely given in that setting ( controls , n = 866 ) . Follow-up was by postal or interviewer-administered question naires at 16 and 52 weeks after childbirth . There were no significant differences in the prevalence of contraceptive use at one year ( over 79 % in all centers ) between participants and controls . In Edinburgh , participants were more likely to undergo sterilization ( p < 0.01 ) than controls , otherwise there were no differences among Edinburgh , Shanghai , or Cape Town in either the methods of contraception chosen or in the methods used over time . Contraceptive counseling delivered antenatally appeared to have no impact on the pregnancy rate during the first year after childbirth . In Shanghai , over 11 % of women in both groups underwent termination of pregnancy in the year of follow-up . In conclusion , although women in all centers said they found the opportunity to discuss contraception antenatally was useful , it had very little effect on contraceptive use or on subsequent pregnancy rates Objectives To assess the profile of long-acting reversible contraceptives ( LARCs ) users in Europe . Methods A r and om sample of women aged 15–49 years in 14 European countries ( Germany , France , UK , Spain , Italy , Russian Federation , Estonia , Latvia , Lithuania , Austria , Czech Republic , Denmark , Norway , and Sweden ) underwent web-based or computer-aided face-to-face interviews in June 2006 . In this paper data pertaining to a subgroup of women using LARCs are presented . Results A total of 11,490 women participated in the full study . Of these , 1,188 ( 10 % ) women were LARC ( hormonal implant , injectables , levonorgestrel-releasing intrauterine system [ LNG-IUS ] , copper intrauterine device [ Cu-IUD ] ) users . The age of the LARC users exceeded 30 years for 57–91 % of them . Furthermore , more than half of them found convenience an extremely important factor when selecting the LARC as a contraceptive method . As compared to those wearing a Cu-IUD , women using hormonal LARCs experienced fewer physical and emotional symptoms that appeared or worsened during menstruation . Conclusions LARCs have their place in the contraceptive market in Europe . The most popular LARCs among European women were the LNG-IUS and the Cu-IUD ; both were mainly used by women who had children and had no wish to have more in the future BACKGROUND The study was conducted to determine the impact of counseling and educational leaflets on contraceptive practice s of couples . STUDY DESIGN R and omization of 600 women was done in two groups matched for age , parity and socioeconomic status at the Department of Obstetrics and Gynaecology , Shifa Foundation Community Health Centre , Shifa International Hospital , Islamabad , Pakistan . In Group A , the intervention group was exposed to contraceptive counseling and educational leaflets in the postnatal ward after delivery , whereas in Group B , the nonintervention group was not given any formal contraceptive advice . Later on , both groups were assessed regarding their contraceptive practice s. RESULTS At their follow-up visit ( 8 - 12 weeks ) postpartum , 19 ( 6.3 % ) women in the nonintervention group had started contraceptive use , whereas 153 ( 50.8 % ) had decided to start contraception in the next 6 months , and 129 ( 42.8 % ) women were still undecided . The main contraceptive user was the male partner ( n=117 , 38.8 % ) , and the most common method used was coitus interruptus ( n=62 , 36.3 % ) . In the intervention group , 170 women ( 56.9 % ) had started using contraceptives , whereas 129 ( 43.1 % ) had decided to start contraceptive use in the next 6 months . The predominant contraceptive user was the females ( n=212 - 70.9 % ) , and the most popular method chosen was oral contraceptive pills ( n=111 , 37.1 % ) . CONCLUSION There is a definite increase in contraceptive uptake in women provided with educational leaflets and counseling session with a shift toward use of more reliable contraceptive methods BACKGROUND Brazilian women who have undergone abortion use contraceptive methods ; however , their use of contraceptive methods is inconsistent and /or inappropriate . STUDY DESIGN This r and omized trial evaluated the effectiveness of a personalized counseling on contraceptive acceptability and its use for postabortion women in the northeast of Brazil . It was conducted in July 2008 to September 2009 , enrolling 246 women r and omly distributed in intervention ( n=123 ) and control ( n=123 ) groups . An intention-to-treat analysis was performed . RESULTS In the follow-up , 98.4 % women in the intervention group were using contraceptive methods compared with 70.6 % women in the control group ( p<.001 ) . The probability of adherence and of the use of any kind of contraceptive method 6 months after the abortion was 41 % greater in the intervention group . CONCLUSIONS The strategy on individualized contraceptive counseling increased the acceptance and the use of contraceptive methods and increased the adequate use of the methods Objective Despite the availability of free contraception from family planning clinics , the rate of unwanted pregnancy in Iran is still high . The effectiveness of other methods for contraceptive supply should , therefore , be evaluated . The aim of this study was to determine the effects of community-based distribution ( CBD ) on contraceptive usage in Iran . Methods This controlled field trial study involved 297 individuals ( 100 subjects in the CBD group and 197 subjects in the control group ) from four major remote areas of Hamedan , Iran . Stratified r and om sampling was used . Results Data analysis suggested that using CBD has four major effects : ( 1 ) it increases the level of contraceptive knowledge ( p<0.0001 ) , ( 2 ) it enhances correct contraceptive choice by couples ( p<0.0001 ) , ( 3 ) it improves contraceptive usage ( p<0.0001 ) and ( 4 ) it improves contraceptive continuation rates ( p<0.0001 ) . Conclusions CBD facilitates better knowledge , proper choice , and correct and continuous usage of contraception . This method should , therefore , be adopted for family planning services in remote areas of Iran The impact of antenatal counselling on couples ' knowledge and practice of contraception was investigated . An interview question naire was used before and after conducting counselling sessions with 200 pregnant women and 100 spouses . The participants were followed up immediately after delivery and 3 months later . Both the control and study groups displayed a lack of knowledge of contraception . Counselling sessions improved the couples ' knowledge and practice in the study group . Involving husb and s in family planning counselling sessions led to joint decisions being made and encouraged women 's use of contraception . The majority of couples retained most of the information given . Integrating family planning counselling into antenatal care in all facilities and involving the husb and are recommended OBJECTIVE Early postpartum home visiting is universal in many Western countries . Studies from developing countries on the effects of home visits are rare . In Syria , where the postpartum period is rather ignored , this study aim ed to assess whether a community-based intervention of postnatal home visits has an effect on maternal postpartum morbidities ; infant morbidity ; uptake of postpartum care ; use of contraceptive methods ; and on selected neonatal health practice s. DESIGN A r and omized controlled trial was carried out in Damascus . Three groups of new mothers were r and omly allocated to receive either 4 postnatal home visits ( A ) , one visit ( B ) , or no visit ( C ) . SAMPLE A total of 876 women were allocated and followed up . INTERVENTION Registered midwives with special training made a one or a series of home visits providing information , educating , and supporting women . RESULTS A significantly higher proportion of mothers in Groups A and B reported exclusively breastfeeding their infants ( 28.5 % and 30 % , respectively ) as compared with Group C ( 20 % ) , who received no visits . There were no reported differences between groups in other outcomes . CONCLUSIONS While postpartum home visits significantly increased exclusive breastfeeding , other outcomes did not change . Further studies framed in a nonbiomedical context are needed . Other innovative approaches to improve postnatal care in Syria are needed \n Output:\n " }, { "from": "agent", "value": "Community-based interventions and antenatal contraceptive counselling improved uptake of copper-IUD in studies mainly conducted in developing counties ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Humans are able to use nonverbal behavior to make fast , reliable judgments of both emotional states and personality traits . Whereas a sizeable body of research has identified neural structures critical for emotion recognition , the neural substrates of personality trait attribution have not been explored in detail . In the present study , we investigated the neural systems involved in emotion and personality trait judgments . We used a type of visual stimulus that is known to convey both emotion and personality information , namely , point-light walkers . We compared the emotion and personality trait judgments made by subjects with brain damage to those made by neurologically normal subjects and then conducted a lesion overlap analysis to identify neural regions critical for these two tasks . Impairments on the two tasks dissociated : Some subjects were impaired at emotion recognition , but judged personality normally ; other subjects were impaired on the personality task , but normal at emotion recognition . Moreover , these dissociations in performance were associated with damage to specific neural regions : Right somatosensory cortices were a primary focus of lesion overlap in subjects impaired on the emotion task , whereas left frontal opercular cortices were a primary focus of lesion overlap in subjects impaired on the personality task . These findings suggest that attributions of emotional states and personality traits are accomplished by partially dissociable neural systems The psychometric properties of 4 paradigms adapted from the social neuroscience literature were evaluated to determine their suitability for use in clinical trials of schizophrenia . This 2-site study ( University of California , Los Angeles and University of North Carolina ) included 173 clinical ly stable schizophrenia out patients and 88 healthy controls . The social cognition battery was administered twice to the schizophrenia group ( baseline , 4-week retest ) and once to the control group . The 4 paradigms included 2 that assess perception of nonverbal social and action cues ( basic biological motion and emotion in biological motion ) and 2 that involve higher level inferences about self and others ' mental states ( self-referential memory and empathic accuracy ) . Each paradigm was evaluated on ( 1 ) patient vs healthy control group differences , ( 2 ) test-retest reliability , ( 3 ) utility as a repeated measure , and ( 4 ) tolerability . Of the 4 paradigms , empathic accuracy demonstrated the strongest characteristics , including large between-group differences , adequate test-retest reliability ( .72 ) , negligible practice effects , and good tolerability ratings . The other paradigms showed weaker psychometric characteristics in their current forms . These findings highlight challenges in adapting social neuroscience paradigms for use in clinical trials Previous research has shown that motion processing is significantly impaired in both autistic and schizophrenic patients . One specific area of motion perception that is affected by both disorders is the processing of biological motion . Stimuli that are often used to investigate biological motion perception are point-light walkers ( PLW ) , for which point-lights are attached to the joints of a moving person , which alone are enough to perceive the human figure . PLWs are useful stimuli to investigate biological motion perception , because they contain the local motion information of each dot , and in addition , by grouping the local elements of the walkers into a global form , they have a high-level interpretation of a moving person ( normal walker ) . By scrambling the positions of the points on the screen , the local motion of each dot is preserved while obscuring the underlying form ( scrambled walker ) . Similarly , by r and omizing the position of the dots along the underlying skeleton each frame of the moving sequence , the local image motion is lost , whereas the global form of the walker is preserved ( r and om-position walker ) . Also inverting the walker in a way that it appears to be walking on the ceiling can obscure the global form of the walker ( inverted walker ) . Using these four kinds of walkers , it is possible to investigate the relative contribution of form and motion information to biological motion perception using one single paradigm . We have successfully used these walkers before to investigate biological motion perception in ageing . Here , we tested differences in biological motion processing in healthy young people with different schizotypic ( N=38 ) and autistic traits ( N=35 ) . We asked participants to perform a biological motion direction discrimination task for normal , inverted , scrambled and r and om-position walkers . In addition , they had to complete question naires on autistic and schizotypic traits . Using both reaction time and accuracy measures we found differences for processing local motion and global form information between participants with high or low scores on both question naires People with schizophrenia ( SCZ ) are impaired in several domains of visual processing , including the discrimination and detection of biological motion . However , the mechanisms underlying SCZ-related biological motion processing deficits are unknown . Moreover , whether these impairments are specific to biological motion or represent a more widespread visual motion processing deficit is unclear . In the current study , three experiments were conducted to investigate the contribution of global coherent motion processing to biological motion perception among patients with SCZ . In Experiments 1 and 2 , participants with SCZ ( n = 33 ) and healthy controls ( n = 33 ) were asked to discriminate the direction of motion from upright and inverted point-light walkers in the presence and absence of a noise mask . Additionally , participants discriminated the direction of non-biological global coherent motion . In Experiment 3 , participants discriminated the direction of motion from upright scrambled walkers ( which contained only local motion information ) and upright r and om position walkers ( which contained only global form information ) . Consistent with previous research , results from Experiment 1 and 2 showed that people with SCZ exhibited deficits in the direction discrimination of point-light walkers ; however , this impairment was accounted for by decreased performance in the coherent motion control task . Furthermore , results from Experiment 3 demonstrated similar performance in the discrimination of scrambled and r and om position point-light walkers BACKGROUND Motion perception deficits have been suggested to be an important feature of schizophrenia but the behavioral consequences of such deficits are unknown . Biological motion refers to the movements generated by living beings . The human visual system rapidly and effortlessly detects and extracts socially relevant information from biological motion . A deficit in biological motion perception may have significant consequences for detecting and interpreting social information . METHODS Schizophrenia patients and matched healthy controls were tested on two visual tasks : recognition of human activity portrayed in point-light animations ( biological motion task ) and a perceptual control task involving detection of a grouped figure against the background noise ( global-form task ) . Both tasks required detection of a global form against background noise but only the biological motion task required the extraction of motion-related information . RESULTS Schizophrenia patients performed as well as the controls in the global-form task , but were significantly impaired on the biological motion task . In addition , deficits in biological motion perception correlated with impaired social functioning as measured by the Zigler social competence scale [ Zigler , E. , Levine , J. ( 1981 ) . Premorbid competence in schizophrenia : what is being measured ? Journal of Consulting and Clinical Psychology , 49 , 96 - 105 . ] . CONCLUSION The deficit in biological motion processing , which may be related to the previously documented deficit in global motion processing , could contribute to abnormal social functioning in schizophrenia Obsessive‐compulsive disorder ( OCD ) is associated with a variety of well‐documented cognitive deficits such as deficits in memory and executive functioning , but little is known about basic perceptual concomitants of OCD . This study investigated global , configural processing in OCD using dynamic ( moving ) and static stimuli with minimal dem and s on cognitive function . Twenty OCD patients and 16 age‐ and education‐matched healthy control subjects were tested on four perceptual tasks : two motion tasks involved detection and discrimination of human activity portrayed by point‐light animations ( “ biological ” motion ) . The other two tasks involved detection of coherent , translational motion defined by r and om‐dot cinematograms and detection of static global shape defined by spatially distributed contours . OCD patients exhibited impaired performance on biological motion tasks ; in contrast , their performance on tasks of coherent motion detection and global form perception were comparable to those of healthy controls . These results indicate that OCD patients have a specific deficit in perceiving biological motion signals , whereas their perception of non‐biological coherent motion and static global shape is intact . Because efficient social interactions depend on accurate and rapid perception of subtle socially relevant cues , deficits in biological motion perception may compromise social functioning in people with OCD . Depression and Anxiety 0:1–11 , 2007 . Published 2007 Wiley‐Liss , Dysregulation of the Mirror Neuron System ( MNS ) in schizophrenia ( SCZ ) may underlie the cognitive and behavioral manifestations of social dysfunction associated with that disorder . In healthy subjects intranasal ( IN ) oxytocin ( OT ) improves neural processing in the MNS and is associated with improved social cognition . OT 's brain effects can be measured through its modulation of the MNS by suppressing EEG mu-b and electrical activity ( 8 - 13Hz ) in response to motion perception . Although IN OT 's effects on social cognition have been tested in SCZ , OT 's impact on the MNS has not been evaluated to date . Therefore , we design ed a study to investigate the effects of two different OT doses on biological motion-induced mu suppression in SCZ and healthy subjects . EEG recordings were taken after each subject received a single IN administration of placebo , OT-24IU and OT-48IU in r and omized order in a double-blind crossover design . The results provide support for OT 's regulation of the MNS in both healthy and SCZ subjects , with the optimal dose dependent on diagnostic group and sex of subject . A statistically significant response was seen in SCZ males only , indicating a heightened sensitivity to those effects , although sex hormone related effects can not be ruled out . In general , OT appears to have positive effects on neural circuitry that supports social cognition and socially adaptive behaviors \n Output:\n " }, { "from": "agent", "value": "The findings from our meta- analysis highlight abnormalities in general and specific domains of biological motion perception in schizophrenia patients as compared with healthy controls" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background —Insulin-like growth factor I ( IGF-I ) has been suggested to be involved in the pathogenesis of atherosclerosis . We hypothesize that low IGF-I and high IGFBP-3 levels might be associated with increased risk of ischemic heart disease ( IHD ) . Methods and Results —We conducted a nested case-control study within a large prospect i ve study on cardiovascular epidemiology ( DAN-MONICA ) . We measured IGF-I and IGFBP-3 in serum from 231 individuals who had a diagnosis of IHD 7.63 years after blood sampling and among 374 control subjects matched for age , sex , and calendar time . At baseline when all individuals were free of disease , subjects in the low IGF-I quartile had significantly higher risk of IHD during the 15-year follow-up period , with a relative risk ( RR ) of 1.94 ( 95 % CI , 1.03 to 3.66 ) of IHD compared with the high IGF-I quartile group , when IGFBP-3 , body mass index , smoking , menopause , diabetes , and use of antihypertensives were controlled for . Conversely , individuals in the high IGFBP-3 quartile group had an adjusted RR of 2.16 ( 95 % CI , 1.18 to 3.95 ) of having IHD . Identification of a high-risk population with low IGF-I and high IGFBP-3 levels result ed in markedly higher risk of IHD ( RR 4.07 ; 95 % CI , 1.48 to 11.22 ) compared with the index group . Conclusions —Individuals without IHD but with low circulating IGF-I levels and high IGFBP-3 levels have significantly increased risk of developing IHD during a 15-year follow-up period . Our findings suggest that IGF-I may be involved in the pathogenesis of IHD Background : Some studies suggest that elevated serum insulin-like growth factor (IGF)-I concentrations are associated with an increased risk of prostate cancer and , in particular , with an increased risk of advanced-stage prostate cancer . Methods : We analyzed the association between prediagnostic serum concentrations of IGF-I and IGF-binding protein-3 ( IGFBP-3 ) and prostate cancer risk in a case-control study nested in the European Prospect i ve Investigation into Cancer and Nutrition . This study includes 630 incident prostate cancer cases and 630 matched control subjects . Odds ratios and their 95 % confidence intervals ( 95 % CI ) were calculated for prostate cancer risk associated with increasing IGF-I and IGFBP-3 concentrations using conditional logistic regression . Results : The risk of total prostate cancer in the highest versus the lowest third of serum peptide concentration was 1.35 ( 95 % CI , 0.99 - 1.82 ; Ptrend = 0.08 ) for IGF-I , 1.39 ( 95 % CI , 1.02 - 1.89 ; Ptrend = 0.12 ) for the IGF-I residuals after adjusting for IGFBP-3 , 1.22 ( 95 % CI , 0.92 - 1.64 ; Ptrend = 0.38 ) for IGFBP-3 , and 1.01 ( 95 % CI , 0.74 - 1.37 ; Ptrend = 0.75 ) for the IGFBP-3 residuals after adjusting for IGF-I. There was no significant difference in the association of peptide hormones and prostate cancer by stage of disease , although the association of serum IGF-I concentration with risk was slightly stronger for advanced-stage disease ; the odds ratio for the highest versus the lowest third was 1.65 ( 95 % CI , 0.88 - 3.08 ; Ptrend = 0.21 ) for IGF-I and 1.76 ( 95 % CI , 0.92 - 3.40 ; Ptrend = 0.11 ) for IGF-I adjusted for IGFBP-3 . Conclusions : In this large nested case-control study , serum IGF-I concentration is not strongly associated with prostate cancer risk , although the results are compatible with a small increase in risk , particularly for advanced-stage disease ; no association for IGFBP-3 was observed . ( Cancer Epidemiol Biomarkers Prev 2007;16(6):1121–7 A major problem in review ing the published results of different epidemiologic studies of the relation between a quantitative variable and the risk of disease is that the results are presented in many different ways . The purpose of this paper is to exemplify methods by which results expressed either as risks ( or rates ) according to quantlle groups of the quantitative variable or as results derived from a logistic regression analysis can be reexpressed in a uniform manner , as a mean difference in the quantitative variable between the cases of disease and the other subjects in the study . An important assumption of the methods is that the quantitative variable has an approximately normal distribution , and a way of investigating the appropriateness of this assumption is given . The methods can be applied to both prospect i ve and case-control studies and are exemplified by a number of studies of serum albumin concentrations and mortality . In some applications , these methods can be used as a precursor to formal meta- analysis , for example , when differential control of potential confounding factors is not a problem . At the least , the methods can be useful either in quantitatively review ing published studies before undertaking new research or in putting the results of a new study into the context of previously published ones Several epidemiologic studies have examined with diverging results the relationships between circulating levels of insulin-like growth factors ( IGF ) and of IGF-binding proteins ( IGFBP ) and prostate cancer risk . We assessed the association of prediagnostic plasma levels of IGF-I , IGF-II , IGFBP-2 , and IGFBP-3 and subsequent occurrence of prostate cancer in a case-control study nested in the SU.VI.MAX trial . The SU.VI.MAX study was a primary prevention trial testing a daily supplementation with low-dose antioxidant vitamins and minerals in male and female middle-aged volunteers in France . One hundred prostate cancer cases were diagnosed among 4,855 SU.VI.MAX participants over a 9-year follow-up period . For each case , four age-matched controls were selected r and omly . Frozen baseline plasma sample s were used to measure IGF-I , IGF-II , IGFBP-2 , and IGFBP-3 . Conditional logistic regression was used to assess the association between these four biochemical markers and prostate cancer risk . After controlling for the intervention group in the trial and the other IGF axis variables , the odds ratios and 95 % confidence interval ( 95 % CI ) comparing the upper quartile to the baseline quartile were 1.83 ( 95 % CI , 0.85 - 3.95 ) , 1.05 ( 95 % CI , 0.35 - 3.18 ) , 0.79 ( 95 % CI , 0.39 - 1.58 ) , and 0.42 ( 95 % CI , 0.12 - 1.52 ) for IGF-I , IGF-II , IGFBP-2 , and IGFBP-3 , respectively . More suggestive associations for IGF-I and IGFBP-3 were observed with advanced and aggressive cancers . Our results are consistent with those of some previous prospect i ve studies and suggest that IGF axis variables are not long-term predictors of the occurrence of prostate cancer OBJECTIVE To quantify the level of insulin-like growth factor ( IGF-1 ) in serum and investigate its role in the diagnosis of prostate cancer . METHODS IGF-1 immunoradiometric assay ( IRMA ) was set up and used to determine serum IGF-1 level in patients with prostate cancer ( n = 81 ) , benign prostate hyperplasia ( BPH , n = 55 ) , uroepithelial tumor ( n = 32 ) and healthy male controls ( n = 84 ) . Furthermore , the levels of IGF-1 and prostate-specific antigen ( PSA ) in 38 patients with BPH were determined every three months for one year . RESULTS Linearity was well demonstrated for IGF-1 in the range of 8 - 1000 ng ( r = 0.98 ) , the lowest limit for detecting IGF-1 being 2 mg/L and the mean recovery for detecting IGF-1 being 94.5 % . The within-replicate coefficient of variance ( CV ) of IGF-1 detection was 7.2 % for a higher level ( 382.4 mg/L ) and 4.2 % for a low level ( 32.5 mg/L ) of IGF-1 . Insulin , growth factor or IGF-2 did not interfere with the detection of IGF-1 ( < 3 ml/L ) . There was high level of IGF-1 in patients with prostate cancer than in healthy controls , patients with BPH and uroepithelial tumor ( P < 0.05 ) ; the odds ratio and its 95 % confidence intervals were 2.86 and 1.38 - 5.34 , respectively ; the specificity and sensitivity of IGF-1 determination were 0.68 and 0.58 , respectively ; furthermore , the level of IGF-1 was increased during the development of prostate cancer . CONCLUSIONS These findings demonstrate that IGF-1 may serve prospect ively as an important tumor marker in the diagnosis and prediction of prostate cancer Some recent epidemiologic studies have failed to confirm positive associations between insulin-like growth factor-I ( IGF-I ) and the risk of prostate cancer observed in earlier studies but have reported suggestive evidence for a positive association between IGF-binding protein-3 ( IGFBP-3 ) and prostate cancer risk , a result contradicting the earlier assumption that high levels of IGFBP-3 would be protective against prostate cancer . We tested the association between IGF-I and IGFBP-3 and prostate cancer risk by measuring the two peptides in plasma sample s collected at baseline in a prospect i ve cohort study of 17,049 men . We used a case-cohort design , including 524 cases diagnosed during a mean of 8.7 years follow-up and a r and omly sample d subcohort of 1,826 men . The association between each peptide level and prostate cancer risk was tested using Cox models adjusted for country of birth and alcohol consumption . The risk of prostate cancer was not associated with baseline levels of IGF-I or the molar ratio IGF-I/IGFBP-3 ( all odds ratios are between 0.82 and 1.08 ; Ptrend ≥ 0.2 ) , whereas the risk increased with baseline levels of IGFBP-3 ( Ptrend = 0.008 ) , the hazard ratio ( HR ) associated with a doubling of the concentration of IGFBP-3 being 1.70 ( 95 % confidence interval , 1.15 - 2.52 ) . The HR for quartile 4 relative to quartile 1 of IGFBP-3 was 1.49 ( 95 % confidence interval , 1.11 - 2.00 ) . The HRs did not differ by tumor aggressiveness or age at onset ( all Ps ≥ 0.4 ) . In our study , high levels of IGFBP-3 but not IGF-I were associated with an increased risk of prostate cancer . ( Cancer Epidemiol Biomarkers Prev 2006;15(6):1137–41 Insulin-like growth factors ( IGFs ) have potent mitogenic and antiapoptotic effects on prostate epithelial cells . Through modulation of IGF bioactivity and other mechanisms , IGF-binding proteins ( IGFBPs ) also have growth-regulatory effects on prostate cells . Recently , IGF-I and IGFBP-3 have been implicated in prostate cancer risk among Western population s. To assess whether IGF-I , IGF-II , IGFBP-1 , or IGFBP-3 are also associated with prostate cancer in a low-risk population , we measured plasma levels of these factors among 128 newly diagnosed prostate cancer cases and 306 r and omly selected population controls in Shanghai , China . Relative to the lowest quartile of IGF-I levels , men in the highest quartile had a 2.6-fold higher prostate cancer risk , with a significant trend [ odds ratio ( OR ) = 2.63 ; 95 % confidence interval ( 95 % CI ) = 1.19 - 5.79 ; P(trend ) = 0.01 ] . In contrast , men in the highest quartile of IGFBP-3 levels had a 46 % decreased risk relative to the lowest quartile ( OR = 0.54 ; 95 % CI = 0.26 - 1.15 ; P(trend ) = 0.08 ) . A similar but less distinct result was observed for IGFBP-1 ( OR = 0.60 ; 95 % CI = 0.31 - 1.17 ; P(trend ) = 0.25 ) . Men in the highest quartile for the IGF-I : IGFBP-3 molar ratio ( an indirect measure of free IGF-I ) had a 2.5-fold higher risk compared with the lowest quartile ( OR = 2.51 ; 95 % CI = 1.32 - 4.75 , P(trend ) < 0.001 ) . These associations were more pronounced after adjustment for serum 5alpha- and rostane-3alpha,17beta-diol glucuronide \n Output:\n " }, { "from": "agent", "value": "For all exposures , there was substantial heterogeneity ( all I(2 ) > 75 % ) , partly explained by study design : the magnitude of associations was smaller in prospect i ve vs. retrospective studies , and for IGFBP-3 , the inverse association with prostate cancer risk was seen in retrospective but not prospect i ve studies .\nThere was weak evidence that associations of IGF-I and IGFBP-3 with prostate cancer were stronger for advanced disease .\nOur meta- analysis confirms that raised circulating lGF-I is positively associated with prostate cancer risk .\nAssociations between IGFBP-3 and prostate cancer were inconsistent , and there was little evidence for a role of IGF-II , IGFBP-1 or IGFBP-2 in prostate cancer risk" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective Cancer cachexia is a paraneoplastic syndrome comprising involuntary weight loss and muscle depletion ( sarcopenia ) . Although weight loss has been associated with poor clinical outcome , there is only limited information on the prevalence and prognostic impact of sarcopenia in ovarian cancer so far . Methods Total skeletal muscle mass was determined by computed tomography image analysis of the third lumbar skeletal muscle cross-sectional area in 128 patients with advanced serous ovarian cancer . Longitudinal change of muscle mass was studied in 209 consecutive computed tomography scans from 43 patients . Association with survival was determined using Cox proportional hazards model . Results The prevalence of sarcopenia at first diagnosis was 11 % ( 12/105 ; 95 % confidence interval [ CI ] , 6%–20 % ) . Sarcopenic patients had a significantly reduced progression-free ( hazard ratio , 2.64 ; 95 % CI , 1.24–5.64 ; P = 0.012 ) and overall survival ( hazard ratio , 3.17 ; 95 % CI , 1.29–7.80 ; P = 0.012 ) . On multivariable analysis , these prognostic effects remained significant after adjustment for age , International Federation of Gynecology and Obstetrics stage , and postsurgical residual disease . Longitudinal analyses identified both patients with loss and gain of muscle mass . However , change in muscle mass over time was not associated with survival . Conclusions Baseline sarcopenia is a prognostic factor in advanced serous ovarian cancer . Identification of sarcopenic patients and early enrollment in physical or nutritional education programs might thus be a feasible way to improve outcome and should be further evaluated in prospect i ve clinical trials Abstract Background Malnutrition , weight loss , and muscle wasting ( sarcopenia ) are common among women with advanced ovarian cancer and have been associated with adverse clinical outcomes and survival . Our objective is to investigate overall survival ( OS ) related to changes in skeletal muscle ( SM ) for patients with advanced ovarian cancer treated with neoadjuvant chemotherapy and interval debulking . Methods Ovarian cancer patients ( n = 123 ) treated with neoadjuvant chemotherapy and interval debulking in the area of Maastricht ( the Netherl and s ) between 2000 and 2014 were included retrospectively . Surface areas of SM and adipose tissue were defined on computed tomography at the level of the third lumbar vertebra . Low SM at baseline and SM changes during chemotherapy were compared with Kaplan Meier curves , and Cox‐regression models were applied to test predictors of OS . Results Median OS for patients who lost SM ( n = 83 ) was 916 ± 99 days , which was significantly different from median OS for patients who maintained or gained SM ( n = 40 ) , which was 1431 ± 470 days ( P = 0.004 ) . Loss of SM was also a significant predictor of OS in multivariable Cox‐regression analysis ( hazard ratio 1.773 ( 95%CI : 1.018–3.088 ) , P = 0.043 ) . Low baseline SM did not influence survival . Conclusions Patients with ovarian cancer have a worse survival when they lose SM during neoadjuvant chemotherapy . Evaluation of low SM at a specific time point is not prognostic for OS . External and prospect i ve validation of these findings is imperative . Nutritional , pharmacological , and /or physical intervention studies are necessary to establish whether SM impairment can be prevented to prolong ovarian cancer survival OBJECTIVE To prospect ively examine body weight changes in women with newly diagnosed ovarian cancer receiving surgery and adjuvant chemotherapy . Body composition was examined in a subset of these women . METHODS Body weight ( BW ) and body composition , using bioelectrical impedance ( RJL Systems Inc. ) , were prospect ively measured pre- and post-operatively , and at 3 , 6 , and 12 months . RESULTS Mean age of 42 women was 59 years and did not differ by stage of disease . Nine women with early stage disease did not receive adjuvant chemotherapy . Mean BW of 33 patients receiving chemotherapy decreased from the pre- to post-operative visit and then returned to baseline levels by 12 months ( F = 8.70 , P = 0.003 ) . Nine patients who did not receive chemotherapy demonstrated a similar pattern ( F = 7.0 , P = 0.002 ) . Women receiving chemotherapy with stage I/II cancer had a 2.8 + /- 2.0 kg weight gain over the year , and women with stage III/IV cancer had a 1.5 + /- 1.5 kg weight loss ( t = 1.72 , P = 0.096 ) . A subset of women with stage I/II ( n = 6 ) and stage III/IV ( n = 6 ) ovarian cancer receiving chemotherapy had body composition measured at three time points . Absolute body fat changes paralleled changes in BW ( F = 9.95 , P = 0.002 ) . CONCLUSIONS Our study is the first prospect i ve evaluation of body weight and composition in women undergoing surgery and chemotherapy for ovarian cancer . These results demonstrate that women undergoing surgery for ovarian cancer lost weight following surgery and regained it slowly over the following year . Further investigations of weight changes during adjuvant chemotherapy are indicated to assess potential changes in different stages of disease BACKGROUND Sarcopenia , severe skeletal muscle loss , has been identified as a prognostic factor in various malignancies . This study aims to investigate whether sarcopenia is associated with overall survival ( OS ) and surgical complications in patients with advanced ovarian cancer undergoing primary debulking surgery ( PDS ) . METHODS Ovarian cancer patients ( n = 216 ) treated with PDS were enrolled retrospectively . Total skeletal muscle surface area was measured on axial computed tomography at the level of the third lumbar vertebra . Optimum stratification was used to find the optimal skeletal muscle index cut-off to define sarcopenia ( ≤38.73 cm2/m2 ) . Cox-regression and Kaplan-Meier analysis were used to analyse the relationship between sarcopenia and OS . The effect of sarcopenia on the development of major surgical complications was studied with logistic regression . RESULTS Kaplan-Meier analysis showed a significant survival disadvantage for patients with sarcopenia compared to patients without sarcopenia ( p = 0.010 ) . Sarcopenia univariably predicted OS ( HR 1.536 ( 95 % CI 1.105 - 2.134 ) , p = 0.011 ) but was not significant in multivariable Cox-regression analysis ( HR 1.362 ( 95 % CI 0.968 - 1.916 ) , p = 0.076 ) . Significant predictors for OS in multivariable Cox-regression analysis were complete PDS , treatment in a specialised centre and the development of major complications . Sarcopenia was not predictive of major complications . CONCLUSION Sarcopenia was not predictive of OS or major complications in ovarian cancer patients undergoing primary debulking surgery . However a strong trend towards a survival disadvantage for patients with sarcopenia was seen . Future prospect i ve studies should focus on interventions to prevent or reverse sarcopenia and possibly increase ovarian cancer survival . Complete cytoreduction remains the strongest predictor of ovarian cancer survival Emerging research suggests that body composition can predict toxicity of certain chemotherapeutic agents . We used data from a clinical study to investigate associations between body composition and combined DOXIL ( pegylated liposomal doxorubicin ; PLD ) and trabectedin ( Yondelis ) treatment , an effective treatment for ovarian cancer that shows high interpatient variation in toxicity profile . Patients ( n = 74 ) participating in a phase III r and omized trial of relapsed advanced ovarian cancer receiving PLD ( 30 mg/m(2 ) ) and trabectedin ( 1.1 mg/m(2 ) ) were included . Muscle tissue was measured by analysis of computerized tomography images , and an extrapolation of muscle and adipose tissue to lean body mass ( LBM ) and fat mass ( FM ) were employed . Toxicity profile after cycle 1 was used and grade d according to the National Cancer Institute Common Toxicity Criteria ( version 3 ) . Patients presented with a wide range of body composition . In overweight and obese patients ( body mass index ( BMI ) ≥ 25 kg/m(2 ) , n = 48 ) toxicity was more prevalent in those with lower BMI ( p = 0.028 ) and a lower FM ( n = 43 , p = 0.034 ) . Although LBM alone was not predictive of toxicity , a lower FM/LBM ratio was the most powerful variable associated with toxicity ( p = 0.006 ) . A different pattern emerged among normal weight patients ( n = 26 ) where toxicity was rare among patients with smaller BMI ( < 21 kg/m(2 ) ) . A clear association between both FM and LBM ( primarily driven by FM ) in explaining PLD plus trabectedin toxicity emerged , but only in individuals with excess body weight , with a lower ratio predicting higher exposure and risk for toxicity OBJECTIVE To investigate whether patients ' altered body composition ( measured with bioimpedentiometry ) , due to a poor nutritional status , predicts the incidence of no residual disease at primary debulking and the risk of complications in patients with newly-diagnosed advanced epithelial ovarian cancer ( EOC ) . METHODS Data regarding patients with newly-diagnosed stage IIIC-IV EOC undergoing elective nutritional assessment between December 2016 and March 2017 , were prospect ively collected . Bioelectrical impedance analysis ( BIA ) with measurement of BIA-derived phase angle [ PhA ] at 50KHz , was accomplished . Only patients with disease which was considered resectable at staging laparoscopy were su bmi tted to open primary cytoreduction . The rate of residual tumor (RT)=0 and the incidence of complications were assessed . RESULTS Seventy patients were included . Fifty-two of them were su bmi tted to primary cytoreduction ( 74.3 % ) and 48 ( 68.6 % of the entire cohort , 92.3 % of those who underwent primary debulking ) had RT=0 at the end of surgery . Median values of PhA were significantly lower in patients with RT > vs . = 0 ( 4.7 , range : 3.6 - 5.8 vs. 5.3 , range : 4.2 - 6.8 ; p=0.001 ) . Twenty-four ( out of the 52 operated ) patients ( 46.2 % ) developed at least one complication . PhA was significantly lower in patients with vs. without complications ( 5 , range : 3.6 - 6.4 , vs. 5.4 , range 4.5 - 6.8 ; p=0.03 ) . After multivariable analysis , Fagotti score and PhA were the only independent predictors of residual disease ( OR:13.56 ; 95%CI:1.33 - 137.6 ; p=0.027 and 9.24 ; 1.16 - 73.43 ; p=0.036 , respectively ) and of any complication ( OR:4.9;95%CI:1.17 - 20.6 ; p=0.03 and 7.27 ; 1.45 - 36.4 ; p=0.01 , respectively ) . CONCLUSIONS Derangement of body composition ( likely due to disease-related malnutrition ) expressed as a low phase angle , is an independent predictor of residual disease and peri-operative complications at the time of upfront cytoreduction for advanced EOC INTRODUCTION Ovarian cancer is the leading cause of death among gynecological malignancies . Its usual clinical manifestation is at advanced stages , with nutritional impairment , weight loss , and a consequent decline in skeletal muscle mass and strength ( defined as sarcopenia ) . The relationship between sarcopenia and decreased survival was demonstrated not only in ovarian cancer but also in other cancer types , such as hepatocellular , pancreatic , lung , colon , cervical , metastatic breast , and renal cancer . The aim of this study is to review the current evidence regarding the relationship between sarcopenia and the surgical and oncological outcomes in ovarian cancer patients . METHODS The systematic search was performed according to the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRSIMA ) statement . The terms \" SARCOPENIA \" AND \" OVARIAN CANCER \" were systematic ally used to search PubMed and Scopus data bases . Original reports in English language were identified , with the purpose to include all relevant papers regarding the role of sarcopenia and indicators of skeletal muscle quality assessment in gynecological ovarian cancer . RESULTS A total of 9 studies were considered eligible for the present review . The strength of recommendation was moderate and the level of evidence was low in all selected articles . No prospect i ve studies were conducted and most of the papers were case-control series comparing ovarian cancer sarcopenic population vs. non sarcopenic population . CONCLUSIONS Sarcopenia appears to have an important role in oncological outcomes of ovarian cancer patients . However , sarcopenia occurrence during disease history and mechanisms underlying the possible impairment in prognosis should be better investigated . Prospect i ve trials are awaited in order to obtain a better insight in this topic OBJECTIVE Adiposity has been hypothesized to interfere with the activity of bevacizum \n Output:\n " }, { "from": "agent", "value": "Moreover , the heterogeneity between studies precluded the possibility of performing a meta- analysis and reaching conclusions for progression free survival , disease free survival , surgical complications , and chemotoxicity .\nCONCLUSIONS This work suggested that the measurement of skeletal muscle radiodensity by routine CT scan at diagnosis , with st and ardization of diagnostic criteria , could be a reliable tool to select at risk patients and to individualize effective nutritional strategies ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract This prospect i ve study evaluated the viability of telbivudine for blocking mother-to-child transmission ( MTCT ) of hepatitis B virus ( HBV ) infection . Pregnant women positive for the hepatitis B surface antigen began telbivudine treatment before 14 weeks of gestation ( i.e. , early ) , between 14 and 28 weeks of gestation ( late ) , or not at all ( control ) . In the late-treatment group , 55 women terminated telbivudine therapy within puerperium . All neonates underwent routine hepatitis B immunoglobulin plus vaccination . Mothers and infants were followed for 7 months after birth . Pregnancy outcomes were similar among the 3 groups . HBV MTCT rates in the early and late treatment and control groups were 0 , 0 , and 4.69 % , respectively . The rates of infant vaccination success among the 3 groups were similar , as were neonatal outcomes including birth weights , asphyxia , hyperbilirubinemia , Apgar score , birth defects , and weight and height at 7 months . Puerperal discontinuation of telbivudine did not increase the alanine transaminase value at 7 months after birth , but increased serum HBV DNA levels , and rates of positive hepatitis Be-antigen . Telbivudine treatment in HBV-infected pregnant women was associated with lower serum HBV DNA levels and reduced rates of HBV MTCT ; there were no associated changes in pregnancy or neonatal outcomes at birth or 7 months after birth , or in the rate of infant vaccination success . Puerperal drug withdrawal after short-term antiviral therapy will not influence hepatic function , but may increase virus replication This r and omized , double-blind , placebo-controlled study evaluated whether lamivudine given during late pregnancy can reduce hepatitis B virus ( HBV ) perinatal transmission in highly viraemic mothers . Mothers were r and omized to either lamivudine 100 mg or placebo from week 32 of gestation to week 4 postpartum . At birth , infants received recombinant HBV vaccine with or without HBIg and were followed until week 52 . One hundred and fifty mothers , with a gestational age of 26 - 30 weeks and serum HBV DNA > 1000 MEq/mL ( bDNA assay ) , were treated . A total of 141 infants received immunoprophylaxis at birth . In lamivudine-treated mothers , 56 infants received vaccine + HBIg ( lamivudine + vaccine + HBIg ) and 26 infants received vaccine ( lamivudine + vaccine ) . In placebo-treated mothers , 59 infants received vaccine + HBIg ( placebo + vaccine + HBIg ) . At week 52 , in the primary analyses where missing data was counted as failures , infants in the lamivudine + vaccine + HBIg group had a significant decrease in incidence of HBsAg seropositivity ( 10/56 , 18%vs 23/59 , 39 % ; P = 0.014 ) and in detectable HBV DNA ( 11/56 , 20%vs 27/59 , 46 % ; P = 0.003 ) compared to infants in the placebo + vaccine + HBIg group . Sensitivity analyses to evaluate the impact of missing data at week 52 result ing from a high dropout rate ( 13 % in the lamivudine + vaccine + HBIg group and 31 % in the placebo + vaccine + HBIg group ) remained consistent with the primary analysis in that lower transmission rates were still observed in the infants of lamivudine-treated mothers , but the differences were not statistically significant . No safety concerns were noted in the lamivudine-treated mothers or their infants . Results of this study suggest that lamivudine reduced HBV transmission from highly viraemic mothers to their infants who received passive/active immunization Background To evaluate the efficacy and safety of treating HBV-positive mothers with telbivudine in early and middle pregnancy to prevent mother-to-infant HBV transmission . Methods The subject population comprised pregnant women with chronic hepatitis B ( CHB ; n = 188 ) from January 2013 to June 2015 , with HBV DNA ≥1.0 × 107copies/mL and increased alanine aminotransferase levels . Groups A ( n = 62 ) and B ( n = 61 ) were treated with telbivudine starting at 12 weeks or 20–28 weeks after gestation , respectively . Telbivudine was discontinued at postpartum 12 weeks . Group C ( n = 65 ) received no antiviral . All infants were vaccinated with hepatitis B immunoglobulin ( 200 IU ) and HBV vaccine ( 20 with hepatitis B The maternal HBV DNA levels of the groups were compared . Mother-to-infant transmission of HBV was indicated by the presence of HBsAg in infants 7 months after birth . Results Before treatment , the HBV DNA levels of the 3 groups were similar . Before delivery and 12 weeks after delivery , the HBV DNA levels of groups A and B were similar , but both were significantly lower than that of group C ( P < 0.01 , all ) . No infants in groups A and B were HBsAg-positive , but the infection rate of group C was 18.4 % ( P < 0.01 ) . The HBV infection rate of infants was positively associated with the HBV DNA levels of the pregnant mothers . Conclusion Administration of telbivudine to HBV-infected mothers , started during early and middle pregnancy , completely blocked mother-to-infant HBV transmission . Trial registration The study was registered retrospectively on Janurary 25 in 2016 at Chinese Clinical Trial Registry ( ChiCTR-OPC-16007899 ) Infection of hepatitis B virus ( HBV ) occurs in ~10 % of infants of HBV-infected mothers with positive hepatitis B e antigen ( HBeAg ) after immunoprophylaxis . We aim ed to evaluate the safety and efficacy of telbivudine used during late pregnancy for preventing mother-to-child transmission of HBV . We conducted a multicenter prospect i ve cohort study in 5 hospitals from 2012 to 2014 , which enrolled HBV-infected singleton pregnant women with positive HBeAg . By their choice , women were divided into therapy ( telbivudine 600 mg/day , from gestation 28 - 32 weeks to 3 - 4 weeks postpartum ) and control ( no antiviral agent ) groups . Infants received passive-active immunoprophylaxis and follow-up at the age of 7 - 14 months . Totally , 328 pregnant women were included : 149 in the telbivudine group and 179 in the control group . Baseline HBV DNA levels were similar in the 2 groups ( 7.43 vs 7.37 log10 IU/mL , P = .711 ) . At delivery , HBV DNA levels in the telbivudine and control groups were 3.80 and 7.26 log10 IU/mL , respectively ( P < .0001 ) . Of the infants , 128 ( 85.9 % ) in the telbivudine group and 156 ( 87.2 % ) in the control group were followed up . No infant in the telbivudine group had chronic infection , while 2 ( 1.28 % ) infants in the control group did ( P = .503 ) . Three ( 2.34 % ) infants in the telbivudine group , but none in the control group , had severe congenital or developmental abnormalities ( P = .090 ) . The data indicate that telbivudine may block perinatal HBV transmission . However , larger studies are required to clarify whether anti-HBV therapy in pregnancy is associated with severe adverse effects in the foetuses and infants BACKGROUND Pregnant women with an elevated viral load of hepatitis B virus ( HBV ) have a risk of transmitting infection to their infants , despite the infants ' receiving hepatitis B immune globulin . METHODS In this multicenter , double‐blind clinical trial performed in Thail and , we r and omly assigned hepatitis B e antigen (HBeAg)–positive pregnant women with an alanine aminotransferase level of 60 IU or less per liter to receive tenofovir disoproxil fumarate ( TDF ) or placebo from 28 weeks of gestation to 2 months post partum . Infants received hepatitis B immune globulin at birth and hepatitis B vaccine at birth and at 1 , 2 , 4 , and 6 months . The primary end point was a hepatitis B surface antigen (HBsAg)–positive status in the infant , confirmed by the HBV DNA level at 6 months of age . We calculated that a sample of 328 women would provide the trial with 90 % power to detect a difference of at least 9 percentage points in the transmission rate ( expected rate , 3 % in the TDF group vs. 12 % in the placebo group ) . RESULTS From January 2013 to August 2015 , we enrolled 331 women ; 168 women were r and omly assigned to the TDF group and 163 to the placebo group . At enrollment , the median gestational age was 28.3 weeks , and the median HBV DNA level was 8.0 log10 IU per milliliter . Among 322 deliveries ( 97 % of the participants ) , there were 319 singleton births , two twin pairs , and one stillborn infant . The median time from birth to administration of hepatitis B immune globulin was 1.3 hours , and the median time from birth to administration of hepatitis B vaccine was 1.2 hours . In the primary analysis , none of the 147 infants ( 0 % ; 95 % confidence interval [ CI ] , 0 to 2 ) in the TDF group were infected , as compared with 3 of 147 ( 2 % ; 95 % CI , 0 to 6 ) in the placebo group ( P=0.12 ) . The rate of adverse events did not differ significantly between groups . The incidence of a maternal alanine aminotransferase level of more than 300 IU per liter after discontinuation of the trial regimen was 6 % in the TDF group and 3 % in the placebo group ( P=0.29 ) . CONCLUSIONS In a setting in which the rate of mother‐to‐child HBV transmission was low with the administration of hepatitis B immune globulin and hepatitis B vaccine in infants born to HBeAg‐positive mothers , the additional maternal use of TDF did not result in a significantly lower rate of transmission . ( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development ; Clinical Trials.gov number , NCT01745822 . OBJECTIVE To investigate the efficacy of telbivudine on intrauterine hepatitis B virus ( HBV ) infection during the last stage of pregnancy . METHODS 61 pregnant chronic hepatitis B ( CHB ) patients were enrolled and 31 patients were treated by telbivudine 600 mg once daily , 30 patients in the control group were not received antiviral treatment . Maternal HBV DNA level and the HBsAg positive rate in newborns were investigated . RESULTS The levels of serum HBV DNA in patients treated with Telbivudine were significantly reduced ( t = 19.09 , P less than 0.01 ) . Compared with the control group , serum HBV DNA levels were significantly lower in telbivudine treated patients than those in the control group before parturition ( t = 23.64 , P less than 0.01 ) . The infection rate of 7-month newborns were 0 and 13.33 % ( 4/30 ) , in telbivudine group and control group , respectively ( x2 = 4.29 , probability value less than 0.05 ) . CONCLUSIONS Telbivudine treatment can block intrauterine infection in pregnant chronic hepatitis B patients OBJECTIVE To investigate the effect of high viral loads ( HBV DNA concentration in blood > 2.0 copy/ml ) on the vertical transmission of hepatitis B virus in mothers with HBV DNA positivity . METHOD Forty pregnant women with HBV DNA positivity were divided r and omly , double-blindly into 2 groups : at 28 weeks of pregnancy , one group received oral lamivudine ( 100 mg/d ) and the other received oral placebo . The serum HBV DNA loads were tested at 28 and 40 weeks ' gestation in mothers , and serum HBV DNA , HBsAg , HBeAg and anti-HBs were examined in infants at 12 month follow up . RESULT Thirty-nine infants finished ( one twins ) the follow up , and 2 infants lost ( 5 % ) . Among them 4 infants were confirmed to be HBV infection ( 10 % , 4/39 ) , 2 in the treatment group ( 10 % , 2/20 ) and 2 in the control group ( 11 % , 2/19 ) ( P > 0.05 ) . The serum HBV DNA levels of 40 weeks ' gestation in the treatment group , compared with \n Output:\n " }, { "from": "agent", "value": "Using network analysis , any antiviral agent interrupted HBV vertical transmission much more effectively than placebo .\nNo agent showed significant efficacy different from others , but a strong trend toward significance was found in telbivudine and tenofovir , of which had the highest probability of being ranked the first- or second-best treatment for reducing MTCT of HBV .\nThe treatment applied in the first and second trimester had a similar efficacy in preventing MTCT .\nCompared with the initiation during the third trimester , lower rate of MTCT was revealed when antiviral therapy was administrated before third trimester , ( RR = 0.045 , 95 % CI 0.0053 to 0.20 ) ; a similar effect at delivery on suppressing maternal HBV DNA level and converting serum HBeAg were achieved if the timing of antiviral treatment started prior , but an obvious improvement of normalizing ALT flare was calculated out ; no statistically differences among maternal and fetal safety outcomes were found if mothers received antiviral agents before pregnant 28 weeks .\nThis network meta- analysis recommended the earlier use of telbivudine or tenofovir , tends to be better to prevent MTCT of HBV in pregnancy with no increased adverse maternal or fetal outcomes" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Cross-sectional studies have reported an association between lead ( Pb ) levels in bone and delinquent behavior in later childhood and adolescence . This is the first prospect i ve longitudinal study of Pb and child development to address this question with comprehensive assessment s of toxicant exposure and other developmental cofactors . A prospect i ve longitudinal birth cohort of 195 urban , inner-city adolescents recruited between 1979 and 1985 was examined . Relationships between prenatal and postnatal exposure to Pb ( serial blood Pb determinations ) and antisocial and delinquent behaviors ( self- and parental reports ) were examined . Prenatal exposure to Pb was significantly associated with a covariate-adjusted increase in the frequency of parent-reported delinquent and antisocial behaviors , while prenatal and postnatal exposure to Pb was significantly associated with a covariate-adjusted increase in frequency of self-reported delinquent and antisocial behaviors , including marijuana use . Use of marijuana itself by Cincinnati Lead Study ( CLS ) teens was strongly associated with all measures of delinquent and antisocial behavior . This prospect i ve longitudinal study confirmed earlier clinical observations and recent retrospective studies that have linked Pb exposure with antisocial behavior in children and adolescents . Both prenatal and postnatal exposure to Pb were associated with reported antisocial acts and may play a measurable role in the epigenesis of behavioral problems independent of the other social and biomedical cofactors assessed in this study OBJECTIVE To evaluate the direct effects of prenatal cocaine exposure and prenatal opiate exposure on infant mental , motor , and behavioral outcomes longitudinally between 1 and 3 years old . METHODS As part of a prospect i ve , longitudinal , multisite study , the Bayley Scales of Infant Development II were administered to 1227 infants who were exposed to cocaine ( n = 474 ) , opiates ( n = 50 ) , cocaine and opiates ( n = 48 ) , and neither substance ( n = 655 ) at 1 , 2 , and 3 years of corrected age by certified , masked examiners . Hierarchic linear modeling of the 1- , 2- , and 3-year scores was conducted using cocaine and opiate exposure as predictors with and without controlling for covariates . RESULTS Overall retention was 88.4 % and did not differ by cocaine or opiate exposure . Overall ( at 1 , 2 , and 3 years ) , cocaine-exposed infants scored 1.6 Mental Development Index points below infants who were not exposed to cocaine . Opiate-exposed infants scored 3.8 Psychomotor Development Index points below infants who were not exposed to opiates . Neither the cocaine nor the opiate effect remained significant after controlling for covariates . Neither cocaine nor opiate exposure was associated with the Behavioral Record Score during the examination . Low birth weight and indices of nonoptimal caregiving were associated with lower Mental Development Index , Psychomotor Development Index , and Behavioral Record Score scores for all groups of infants . CONCLUSIONS In the largest at-risk sample observed longitudinally to date , infant prenatal exposure to cocaine and to opiates was not associated with mental , motor , or behavioral deficits after controlling for birth weight and environmental risks Abstract .This paper reports on a prospect i ve , longitudinal study of children prenatally exposed to poly-substances , who were reared under minimal postnatal risk conditions . The aim of the study was to examine whether the substance-exposed group exhibited a higher level of attention-related problems than a group of age-matched , nonexposed children . The substance-exposed children ( n = 42 ) evinced significant elevated levels of impulsivity and attention problems on the CBCL and on the ADHD rating scale at ages 2 and 4 1/2 as compared to the non-exposed peers ( n = 50 ) . The severity of the attention problems in the substance-exposed group was related to dysfunction in the area of perceptual performance and motor abilities assessed on the McCarthy scales . This finding lends support to the hypothesis of a neurological basis of the behavioral problems . The combination of attention problems and specific cognitive deficits indicates that the children exposed to poly-substances in utero had symptoms associated with ADHD/DAMP . The study suggests that even if children experience adequate care after birth , the accumulation of risk factors associated with prenatal substance exposure is still a potential contributor to impulsivity and attention-related problems in preschool children A cohort of 1022 consecutive singleton births was generated during 1986 - 1987 in the Faroe Isl and s. Increased methylmercury exposure from maternal consumption of pilot whale meat was indicated by mercury concentrations in cord blood and maternal hair . At approximately 7 years of age , 917 of the children underwent detailed neurobehavioral examination . Neuropsychological tests included Finger Tapping ; H and -Eye Coordination ; reaction time on a Continuous Performance Test ; Wechsler Intelligence Scale for Children-Revised Digit Spans , Similarities , and Block Design s ; Bender Visual Motor Gestalt Test ; Boston Naming Test ; and California Verbal Learning Test ( Children ) . Clinical examination and neurophysiological testing did not reveal any clear-cut mercury-related abnormalities . However , mercury-related neuropsychological dysfunctions were most pronounced in the domains of language , attention , and memory , and to a lesser extent in visuospatial and motor functions . These associations remained after adjustment for covariates and after exclusion of children with maternal hair mercury concentrations above 10 microgram(s ) ( 50 nmol/g ) . The effects on brain function associated with prenatal methylmercury exposure therefore appear widespread , and early dysfunction is detectable at exposure levels currently considered safe In Amsterdam a longitudinal , prospect i ve and multidisciplinary study on the development of infants of drug‐dependent mothers ( IDDM ) was started in 1983 : 35 IDDM and 35 reference infants were originally enrolled . The drug‐dependent women had used combinations of methadone , heroin , cocaine and other drugs during pregnancy . Of the IDDM , 80 % had to be treated pharmaceutically for neonatal abstinence symptoms ( NAS ) . Physical , neurological , cognitive and the socio – emotional development of the children were studied regularly from birth until 5.5 years of age . Differences between the reference group and the IDDM were found most clearly in cognitive development . The IDDM also had more behavioural problems at some of the ages studied . No group differences were seen in motor development . So far the results of the study show that IDDM and their caregivers need extra support in order to improve early communication and the children 's cognitive development OBJECTIVE To examine the relation of prenatal polychlorinated biphenyl ( PCB ) exposure to child performance on neuropsychological tests of attention and information processing . Study design In this prospect i ve , longitudinal study , assessment of prenatal PCB exposure was based on umbilical cord serum and maternal serum and milk concentrations . The children were tested in their homes at age 11 years . Multiple regression was used to examine the relation of this exposure to performance on 15 neuropsychological tests after controlling for a broad range of potential confounding variables . RESULTS Adverse effects were seen primarily in children who had not been breast fed . Among these children , prenatal PCB exposure was associated with greater impulsivity , poorer concentration , and poorer verbal , pictorial , and auditory working memory . There was no evidence of visual-spatial deficit or increased hyperactivity . CONCLUSIONS These findings are consistent with earlier reports of greater vulnerability to prenatal PCB exposure in children who were not breast fed . It is not clear whether the protection offered by breast-feeding is caused by nutrients in breast milk or better quality of intellectual stimulation often provided by breast-feeding mothers ABSTRACT . This article presents a Norwegian prospect i ve , longitudinal study of children prenatally exposed to opiates and other substances under conditions of minimal postnatal social risk . Outcome at 4½ years of age is presented . The study reports on the prediction of later intellectual performance , on the basis of the children ’s prenatal , perinatal , and early developmental status , as well as the foster or adoptive parents ’ socioeconomic level . Significant differences were found between the substance-exposed group and the comparison group on the Bayley Scales at age 1 year and on the McCarthy Scales at age 4½ years . The findings showed that although the mean cognitive scores were within normal limits at age 4½ years , a special weakness in the area of visual-motor and perceptual abilities was detected among the substance-exposed children . It is indicated that these areas of performance are especially sensitive to the effect of prenatal adversity . A special vulnerability among the substance-exposed boys , detected at an earlier age , persisted at 4½ years . The study indicates that even if children experience adequate caregiving , the accumulation of biomedical risk factors associated with prenatal substance exposure is still a potential determinant of developmental problems , especially in the area of perceptual-performance functions . The study also hints at differential influences of biomedical and environmental variables on outcome at age 4½ years The association between early lead exposure and later problem behaviors was evaluated prospect ively in a cohort of 8-year-old children born during a 12-month period at one hospital . Lead levels in umbilical cord blood ( means = 6.8 micrograms/dl , SD = 3.1 ) and the dentin of a shed deciduous tooth ( means = 3.4 micrograms/g , SD = 2.4 ) provided measures of prenatal and postnatal exposure , respectively . Ratings on the Teacher Report Form of the Child Behavior Profile provided information about children 's problem behaviors . Cord blood lead level was not associated with the overall prevalence or nature of problem behaviors . In both crude and adjusted analyses , tooth lead level was significantly associated with total problem behavior scores ( approximately 2 points in T score per log unit increase in tooth lead ) . Significant tooth lead-associated increases in both internalizing and externalizing scores were also observed ( approximately 1.5 points in T score per log unit increase ) . Weaker associations were noted between tooth lead level and the prevalence of \" extreme \" problem behavior scores . The extent to which these associations reflect residual confounding is uncertain . These data suggest , however , that social and emotional dysfunctions are correlates and may be expressions of increased lead exposure OBJECTIVE This study was undertaken to determine the effects of repeated courses of antenatal corticosteroids on childhood behavior and disabilities , including cognitive delay and cerebral palsy . STUDY DESIGN Nonr and omized regional cohort of 541 very preterm infants born in Western Australia from singleton pregnancies and alive at 3 years were included in the study . MAIN OUTCOME MEASURES Physical , cognitive , and psychological assessment s up to 6 years . RESULTS Increasing numbers of antenatal corticosteroid courses were associated with a reduction in the rate of cerebral palsy . Three or more courses were also associated with increased rates of aggressive/destructive , distractible , and hyperkinetic behavior and these effects were present at both ages 3 and 6 years . Measures of internalizing behavior and intelligence quotient were unaffected by antenatal corticosteroid use . CONCLUSION Repeated antenatal courses of corticosteroids may protect against cerebral palsy but are associated with hyperactivity later in childhood Prenatally irradiated children ( n = 544 ) , who were born between 26 April 1986 and 26 February 1987 , in regions of the Ukraine which were radioactively contaminated as a result of the Chernobyl disaster , their mothers and teachers have been examined with psychometric tests . The control group of relevant children ( n = 759 ) , their mothers and teachers , were living at the radioecological ' clear ' regions ( Kharkov and Kharkov Region ) . Further , we r and omly selected 50 prenatally irradiated children whose mothers were evacuated from the Chernobyl exclusion zone and 50 age- and -gender-matched non-exposed children . At this phase clinical examinations , psychometric tests , computerized EEG , thyroid function assessment and dosimetric reconstruction were used . We found a significant increase in mental retardation ( IQ < 70 ) and of borderline and low range IQ , as well as emotional and behavioral disorders and a decrease in high IQ ( IQ > 110 ) in children irradiated in utero as a result of the Chernobyl disaster , in comparison with the controls . One important biological mechanism in the genesis of mental disorders in prenatally irradiated children is the radiation-induced malfunction of the thyroid-pituitary system with the effect threshold of 0.30 Sv of thyroid exposure dose . We hypothesize that the cerebral basis of mental disorders in the prenatally irradiated children is the malfunction of the left hemisphere limbic-reticular structures , particularly in those exposed at the most critical period of cerebrogenesis ( 8 - 25 weeks of gestation ) . The data obtained reveal mental disorders in prenatally irradiated children and obviously reflect developmental abnormalities of brain structure and function as a result of the interaction of prenatal and post-natal factors where it is possible to assume radiation effects on the developing brain . A follow-up study of the children irradiated in utero , who may be at risk for schizophrenia , is proposed because of its particular importance to clinical medicine and neuroscience Abstract Objective : To examine the association between environmental exposure to lead and children 's intelligence at age 11 - 13 years , and to assess the implication s of exposure in the first seven years of life for later childhood development . Design : Prospect i ve cohort study . Subjects : 375 children born in or around the lead smel \n Output:\n " }, { "from": "agent", "value": "However , some findings are consistent .\nLead and PCB ’s have a general effect on brain development , whilst marijuana and alcohol appear to have long-term effects specifically on attentional skills .\nThe effects of alcohol increase with maternal age and binge drinking is more important than average intake .\nThe effects of cocaine diminish with age and are largely mediated through psychosocial factors , whilst the relation between smoking and later delinquency is largely mediated by genetically inherited factors .\nExposure to toxins during pregnancy may constitute an important but relatively unacknowledged cause of child psychiatric morbidity" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Screening for colorectal cancer is widely recommended , but the preferred strategy remains unidentified . We aim ed to compare participation and diagnostic yield between screening with colonoscopy and with non-cathartic CT colonography . METHODS Members of the general population , aged 50 - 75 years , and living in the regions of Amsterdam or Rotterdam , identified via the registries of the regional municipal administration , were r and omly allocated ( 2:1 ) to be invited for primary screening for colorectal cancer by colonoscopy or by CT colonography . R and omisation was done per household with a minimisation algorithm based on age , sex , and socioeconomic status . Invitations were sent between June 8 , 2009 , and Aug 16 , 2010 . Participants assigned to CT colonography who were found to have one or more large lesions ( ≥10 mm ) were offered colonoscopy ; those with 6 - 9 mm lesions were offered surveillance CT colonography . The primary outcome was the participation rate , defined as number of invitees undergoing the examination relative to the total number of invitees . Diagnostic yield was calculated as number of participants with advanced neoplasia relative to the total number of invitees . Invitees and screening centre employees were not masked to allocation . This trial is registered in the Dutch trial register , number NTR1829 . FINDINGS 1276 ( 22 % ) of 5924 colonoscopy invitees participated , compared with 982 ( 34 % ) of 2920 CT colonography invitees ( relative risk [ RR ] 1·56 , 95 % CI 1·46 - 1·68 ; p<0·0001 ) . Of the participants in the colonoscopy group , 111 ( 9 % ) had advanced neoplasia of whom seven ( < 1 % ) had a carcinoma . Of CT colonography participants , 84 ( 9 % ) were offered colonoscopy , of whom 60 ( 6 % ) had advanced neoplasia of whom five ( < 1 % ) had a carcinoma ; 82 ( 8 % ) were offered surveillance . The diagnostic yield for all advanced neoplasia was 8·7 per 100 participants for colonoscopy versus 6·1 per 100 for CT colonography ( RR 1·46 , 95 % CI 1·06 - 2·03 ; p=0·02 ) and 1·9 per 100 invitees for colonoscopy and 2·1 per 100 invitees for CT colonography ( RR 0·91 , 0·66 - 2·03 ; p=0·56 ) . The diagnostic yield for advanced neoplasia of 10 mm or more was 1·5 per 100 invitees for colonoscopy and 2·0 per 100 invitees for CT colonography , respectively ( RR 0·74 , 95 % CI 0·53 - 1·03 ; p=0·07 ) . Serious adverse events related to the screening procedure were post-polypectomy bleedings : two in the colonoscopy group and three in the CT colonography group . INTERPRETATION Participation in colorectal cancer screening with CT colonography was significantly better than with colonoscopy , but colonoscopy identified significantly more advanced neoplasia per 100 participants than did CT colonography . The diagnostic yield for advanced neoplasia per 100 invitees was similar for both strategies , indicating that both techniques can be used for population -based screening for colorectal cancer . Other factors such as cost-effectiveness and perceived burden should be taken into account when deciding which technique is preferable . FUNDING Netherl and s Organisation for Health Research and Development , Centre for Translational Molecular Medicine , and the Nuts Ohra Foundation BACKGROUND & AIMS Data from r and omized controlled trials on the effects of screening colonoscopies on colorectal cancer ( CRC ) incidence and mortality are not available . Observational studies have suggested that colonoscopies strongly reduce the risk of CRC , but there is little specific evidence on the effects of screening colonoscopies . METHODS We performed a population -based case-control study of 3148 patients with a first diagnosis of CRC ( cases ) and 3274 subjects without CRC ( controls ) from the Rhine-Neckar region of Germany from 2003 to 2010 . Detailed information on previous colonoscopy and potential confounding factors was collected by st and ardized personal interviews . Self-reported information on colonoscopies and their indications was vali date d by medical records . We used multiple logistic regression to assess the association between colonoscopy conducted for specific indications within the past 10 years and risk of CRC . RESULTS A history of colonoscopy was associated with a reduced subsequent risk of CRC , independently of the indication for the examination . However , somewhat stronger associations were found for examinations with screening indications ( adjusted odds ratio [ OR ] 0.09 , 95 % confidence interval [ CI ] 0.07 - 0.13 ) than for examinations with diagnostic indications , such as positive fecal occult blood test result ( OR , 0.33 ; 95 % CI , 0.19 - 0.57 ) , surveillance after a preceding colonoscopy ( OR , 0.33 ; 95 % CI , 0.24 - 0.45 ) , rectal bleeding ( OR , 0.28 ; 95 % CI , 0.20 - 0.40 ) , abdominal symptoms ( OR , 0.15 ; 95 % CI , 0.10 - 0.21 ) , or other ( OR , 0.21 ; 95 % CI , 0.14 - 0.30 ) . Colonoscopy was also associated with a reduced risk of cancer in the right colon , regardless of the indication , although to a smaller extent than for other areas of the colon ( OR for screening colonoscopy , 0.22 ; 95 % CI , 0.14 - 0.33 ) . CONCLUSIONS In a population -based case-control study , the risk of CRC was strongly reduced up to 10 years after colonoscopy for any indication . Risk was particularly low after screening colonoscopy , even for cancer in the right colon BACKGROUND In r and omized trials , fecal occult-blood testing reduces mortality from colorectal cancer . However , the duration of the benefit is unknown , as are the effects specific to age and sex . METHODS In the Minnesota Colon Cancer Control Study , 46,551 participants , 50 to 80 years of age , were r and omly assigned to usual care ( control ) or to annual or biennial screening with fecal occult-blood testing . Screening was performed from 1976 through 1982 and from 1986 through 1992 . We used the National Death Index to obtain up date d information on the vital status of participants and to determine causes of death through 2008 . RESULTS Through 30 years of follow-up , 33,020 participants ( 70.9 % ) died . A total of 732 deaths were attributed to colorectal cancer : 200 of the 11,072 deaths ( 1.8 % ) in the annual-screening group , 237 of the 11,004 deaths ( 2.2 % ) in the biennial-screening group , and 295 of the 10,944 deaths ( 2.7 % ) in the control group . Screening reduced colorectal-cancer mortality ( relative risk with annual screening , 0.68 ; 95 % confidence interval [ CI ] , 0.56 to 0.82 ; relative risk with biennial screening , 0.78 ; 95 % CI , 0.65 to 0.93 ) through 30 years of follow-up . No reduction was observed in all-cause mortality ( relative risk with annual screening , 1.00 ; 95 % CI , 0.99 to 1.01 ; relative risk with biennial screening , 0.99 ; 95 % CI , 0.98 to 1.01 ) . The reduction in colorectal-cancer mortality was larger for men than for women in the biennial-screening group ( P=0.04 for interaction ) . CONCLUSIONS The effect of screening with fecal occult-blood testing on colorectal-cancer mortality persists after 30 years but does not influence all-cause mortality . The sustained reduction in colorectal-cancer mortality supports the effect of polypectomy . ( Funded by the Veterans Affairs Merit Review Award Program and others . ) Introduction : We conducted a cluster-r and omized trial aim ed at assessing the effect of the type of faecal occult blood , guaiac or immunochemical test on screening compliance . Methods : We sample d 130 general practitioners ( GPs ) who consented to participate in the trial . We r and omly allocated half of them to the guaiac ( Hemo-Fec ) and half to the immunochemical test ( OC-Hemodia ) . We sample d 2/10 of the GPs ' 50–75-year-old patients ( n=7332 ) and r and omly divided this population into half . One half was invited to be screened at the GP 's office and the other to the nearest gastroenterology ward . The principal outcome was the percentage of returned tests . Results : The immunochemical test had a compliance of 35.8 % and the guaiac of 30.4 % ( relative risk [ RR ] 1.20 ; 95 % confidence interval [ CI ] 1.02–1.44 ) . The difference was mostly due to a higher probability of returning the sample : 93.8 % and 88.6 % for immunochemical and guaiac , respectively ( RR 1.06 ; 95 % CI 1.02–1.10 ) . The guaiac test had a higher prevalence of positives ( 10.3 % versus 6.3 % , RR 0.603 ; 95 % CI 0.433–0.837 ) . There was a higher variability in the results obtained with the guaiac test compared with the immunochemical ( F[1 , 12 ] = 16.25 ; P=0.0017 ) . Conclusions : Compliance is more likely with the immunochemical than the guaiac test , independent of the provider . Guaiac tests show a higher variability of the results among centres . The successful implementation of a screening programme requires a period of st and ardization of the test reading in order to avoid unexpected work overload for colonscopy services BACKGROUND Data on the adherence rate to screening colonoscopy ( OC ) in the average-risk general population are limited and variable . Aim of this study was to compare the uptake of OC screening with that of fecal occult blood ( FOBT ) . METHODS A nationwide , population -based , multicentre , r and omized trial comparing attendance to OC with that to FOBT was performed . Sixty-four general practitioners ( GPs ) , overall including in their lists 9889 average-risk subjects aged 55 - 64 years , were r and omized between OC and FOBT screening programs . Eligible subjects were mailed a personal invitation letter co-signed by their GP and the coordinator of the area-reference GI centre . Attendance rate and detection rate for advanced neoplasia ( colorectal cancer , adenoma > 10 mm or with villous histology or high- grade dysplasia ) for each arm of the study were assessed . RESULTS The overall attendance rate was 18.7 % ( 1563/8378 eligible subjects ) . It was markedly lower in the OC than in the FOBT strategy ( 10 % vs. 27.1 % ; OR 0.28 , 95 % CI : 0.25 - 0.32 ; P<0.0001 ) . In particular , participation in OC screening arm was extremely low in South Italy ( 2.8 % ) , whilst it was higher in North- Central Italy ( 12.4 % ; P<0.0001 ) . Compliance to colonoscopy in those with a positive FOBT was only 58 % . Advanced neoplasia was detected in 28 ( 6.8 % ) patients in the OC arm and in 6 ( 18 % ) in those with a positive FOBT su bmi tted to OC . CONCLUSIONS The results of our study underline the difficulties and barriers to implement a OC population screening in Italy , at least through primary care . Although attendance to FOBT was higher , it was disappointingly less than 30 % . Significant actions to improve awareness amongst GPs and the population are a high priority BACKGROUND : The role of screening colonoscopy for colorectal ( CR ) neoplasia in average-risk population , remains to be determined . OBJECTIVES : To evaluate the prevalence and anatomic location of CR adenoma and carcinoma and the morbidity of colonoscopy in individuals at average risk for CR cancer ( CRC ) . METHODS : A retrospective prevalence study of subjects aged 40–80 yr , with no cancer-related symptoms , personal or family history of CR neoplasia , who underwent a colonoscopy . RESULTS : Enrolled were 1,177 persons ; 183 aged 40–49 yr ( young ) , 917 aged 50–75 yr , and 77 aged 76–80 yr ( elderly ) . The prevalence of overall CR neoplasia , advanced neoplasia , and cancer was 20.9 % , 6.3 % , and 1.1 % , respectively . In the 50–75 age group , the prevalence of overall adenoma , advanced ne \n Output:\n " }, { "from": "agent", "value": "Flexible sigmoidoscopy ( FS ) prevented CRC and led to the largest reduction in CRC mortality with a smaller but significant reduction in CRC mortality with the use of guaiac fecal occult blood tests ( gFOBTs ) .\nThere was insufficient or low quality evidence to support the use of other screening tests , including colonoscopy , as well as changing the ages of initiation and cessation for CRC screening with gFOBTs in Ontario .\nEither annual or biennial screening using gFOBT reduces CRC-related mortality .\nConclusion .\nThe evidentiary base supports the use of FS or FOBT ( either annual or biennial ) to screen patients at average risk for CRC ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background / Aims : We investigated whether urinary podocytes are present in septic patients with methicillin-resistant Staphylococcus aureus (MRSA)-associated glomerulonephritis and whether polymyxin B-immobilized fiber ( PMX-F ) treatment affects proteinuria and urinary podocyte excretion in these patients . Methods : Twenty septic patients with MRSA-associated glomerulonephritis ( mean age : 63.7 years ) and 80 septic patients whose MRSA infection was not followed by glomerulonephritis ( mean age : 60.5 years ) were included in this study . All septic patients were treated with fosfomycin sodium , β-lactams , arbekacin sulfate , and teicoplanin , or a combination of these . Twenty septic patients with MRSA-associated glomerulonephritis were r and omly assigned to one of two treatments : PMX-F treatment ( group A , n = 10 ) and conventional treatment ( group B , n = 10 ) . PMX-F treatment was repeated twice . Results : Urinary podocytes and urinary protein excretion were not detected in MRSA septic patients without glomerulonephritis . However , urinary podocytes ( 1.7 ± 0.6 cells/ml ) and proteinuria ( 2.6 ± 0.6 g/d ) were detected in the 20 septic patients with MRSA-associated glomerulonephritis . Plasma endotoxin levels were decreased from 13.6 ± 4.6 pg/ml to 6.6 ± 2.2 pg/ml ( p < 0.05 ) in group A. Levels in group B , however , showed little difference after treatment . Urinary podocytes were reduced in group A ( from 1.8 ± 0.6 cells/ml to 0.4 ± 0.2 cells/ml , p < 0.01 ) as was urinary protein excretion ( from 3.0 ± 0.5 g/d to 0.8 ± 0.4 g/d , p < 0.01 ) but urinary podocytes and protein excretion levels showed little difference after treatment in group B. Conclusion : PMX-F treatment may be effective in reducing urinary protein and urinary podocyte excretion in septic patients with MRSA-associated glomerulonephritis Introduction The objective of this study was to clarify the efficacy and mechanism of action of direct hemoperfusion with an immobilized polymyxin B fiber column ( DHP-PMX ) in patients with acute lung injury or acute respiratory distress syndrome caused by sepsis . Method Thirty-six patients with sepsis were included . In each patient a thermodilution catheter was inserted , and the oxygen delivery index and oxygen consumption index were measured . DHP-PMX was performed in patients with a normal oxygen delivery index and oxygen consumption index ( > 500 ml/minute per m2 and > 120 ml/minute per m2 , respectively ) . The Acute Physiology and Chronic Health Evaluation II score was used as an index of the severity of sepsis , and survival was assessed after 1 month . The humoral mediators measured were the chemokine IL-8 , plasminogen activator inhibitor-1 , and neutrophil elastase ( NE ) . These mediators were measured before DHP-PMX treatment , and at 24 , 48 , and 78 hours after the start of treatment . The arterial oxygen tension (PaO2)/fractional inspired oxygen ( FiO2 ) ratio was measured before DHP-PMX treatment and at 24 , 48 , 72 , 92 , and 120 hours after the start of treatment . Results All patients remained alive after 1 month . Before DHP-PMX treatment , the Acute Physiology and Chronic Health Evaluation II score was 24 ± 2.0 , the IL-8 level was 54 ± 15.8 pg/ml , plasminogen activator inhibitor-1 was 133 ± 28.1 ng/ml , and NE was 418 ± 72.1 μg/l . These three humoral mediators began to decrease from 24 hours after DHP-PMX treatment , and the decline became significant from 48 hours onward . The PaO2/FiO2 ratio was 244 ± 26.3 before DHP-PMX treatment but improved significantly from 96 hours onward . There were significant negative correlations between the PaO2/FiO2 ratio and blood levels of NE and IL-8 . Conclusion The mechanism of action of DHP-PMX is still not fully understood , but we report the following findings . The mean blood levels of plasminogen activator inhibitor-1 , NE , and IL-8 were significantly decreased from 48 hours after DHP-PMX treatment . The mean PaO2/FiO2 ratio was significantly improved from 96 hours after DHP-PMX treatment . Improvement in the PaO2/FiO2 ratio appeared to be related to the decreases in blood NE and IL-8 levels OBJECTIVE the aim of the present study was to determine whether serum neopterin and soluble interleukin (IL)-2 receptor levels were related to the development of septic shock and whether polymyxin B-immobilized fibre ( PMX-F ) treatment affects these levels . METHODS we examined 24 patients admitted to our intensive care unit with Gram-negative septic shock . Serum neopterin and soluble IL-2 receptor levels were measured using commercially available test kits . Patients were treated with direct hemoperfusion using PMX-F columns . RESULTS fifteen out of 24 patients ( 63 % ) survived and were discharged from our hospitals within 30 days after PMX-F treatment . Blood endotoxin levels decreased significantly from 49.2+/-8.6 pg/ml to 13.2+/-4.4 pg/ml after PMX-F treatment . The pretreatment serum concentrations of neopterin and IL-2 receptor were significantly higher in the nine non-surviving patients with septic shock than in the 15 surviving patients ( P<0.01 ) and 20 control subjects ( P<0.001 ) . Serum concentrations of neopterin and IL-2 receptor in patients with septic shock decreased significantly after PMX-F treatment ( P<0.01 ) . CONCLUSIONS these data suggest that serum neopterin and IL-2 receptor concentrations may be prognostic indicators in patients with septic shock . PMX-F treatment may be effective for reducing serum neopterin and IL-2 receptor concentrations Endotoxin plays an important role in the pathogenesis of septic shock . Exposure of endothelial cells to endotoxin activates endothelial cells and increases the surface expression of adhesion molecules , markers of endothelial damage in organ dysfunction . Endotoxin adsorption therapy by polymyxin B-immobilized fiber column ( PMX ) hemoperfusion has been used for the treatment of septic shock patients . In this study , we measured plasma concentrations of endotoxin and soluble adhesion molecules in septic shock patients before and after the PMX treatment then observed on the relationships between actual duration of use and various outcomes . Sixteen patients with septic shock were studied . The 28-day mortality rate was 50 % . The elevated plasma concentrations of endotoxin decreased after the PMX treatment in the survivors but not in the nonsurvivors . The norepinephrine dose and plasma concentrations of soluble endothelial leukocyte adhesion molecule 1 and soluble intercellular adhesion molecule 1 significantly ( P < 0.05 ) decreased in the PMX greater-than-2-h ( prolonged ) group than in the PMX 2-h ( conventional ) group ( −17.8 ± 14.6 vs. −1.8 ± 2.7 & mgr;g/min , −143.0 ± 111.0 vs. 0 ± 2.8 ng/mL , and −126.2 ± 144.9 vs. 16.5 ± 108.1 ng/mL , respectively ) . Changes in the PaO2-FiO2 ratio and the Sequential Organ Failure Assessment score were significantly ( P < 0.05 ) more improved in the PMX greater-than-2-h group than in the PMX 2-h group ( 75.4 ± 80.7 vs. 1.2 ± 49.2 and −0.8 ± 1.8 vs. 2.2 ± 1.9 torr , respectively ) . We thus suggest that a longer duration of PMX treatment may improve the pulmonary oxygenation associated with decreased adhesion molecules in septic shock Background : CD16 + CD14 + monocytes dramatically increase in number in patients with severe infection . Hemoperfusion with PMX-F ( direct hemoperfusion with polymyxin B immobilized fibers ) has been reported to be a safe and effective treatment for patients with septic shock , although the molecular mechanism that accounts for its effectiveness is still unclear . The purpose of this study was to quantify the number of CD16+CD14 + monocytes in patients with an intra-abdominal infection and to evaluate the effects of PMX-F treatment on clinical parameters and leukocyte surface antigen expression in these patients . Material s and Methods : Seventeen septic patients who had an intra-abdominal infection were enrolled in this study ; 7 of these patients received PMX-F treatment . Peripheral blood sample s were obtained immediately after admission , and were also collected from the above 7 patients before , during , and immediately after their PMX-F treatment . The expression of CD14 , CD16 , and Toll-like receptor (TLR)-4 on these patients ' monocytes was evaluated using flow cytometry . In addition , lipopolysaccharide (LPS)-induced production of TNF-α and IL-1β by these cells was measured by ELISA . Results : Monocytic expression of CD16 and TLR-4 was significantly greater in septic patients than in healthy controls , and their proportion of CD16+CD14 + monocytes was similarly elevated . LPSinduced production of TNF-α and IL-1β by peripheral blood mononuclear cells ( P BMC s ) of septic patients was significantly reduced compared to controls . Furthermore , there was a reduction in the proportion of CD 16+CD 14 + monocytes during PMX-F treatment , and in the expression of TLR-4 on monocytes after PMX-F treatment . Conclusions : These results showed that the number of peripheral blood CD16+CD14 + monocytes and monocytic TLR-4 expression were markedly increased , and the production of pro-inflammatory cytokines in response to LPS significantly reduced in patients with sepsis . PMX-F treatment was found to be effective in reducing the number of CD 16+CD 14 + monocytes and in decreasing the monocytic expression of TLR-4 in patients with septic shock Objective : To determine the impact of a thyroid hormone infusion ( T4 ) on the vasopressor requirements in children with cessation of neurologic function ( i.e. , brain death ) during evaluation for organ recovery Design : Retrospective cohort study . Setting : The 1998–2002 data base of a regional organ recovery program . Patients : Children ≤18 yrs with cessation of neurologic function during evaluation for organ recovery ( n = 171 ) were included . The treated group ( n = 91 ) received a weight-based bolus and continuous infusion of T4 according to the organ procurement agency protocol . All other children ( n = 80 ) were considered untreated . Interventions : T4 was administered at the clinician ’s discretion . All children ( treated and untreated ) had identical goals for fluids , blood pressure , and organ function criteria . Vasopressor score ( [ dopamine × 1 ] + [ dobutamine × 1 ] + [ epinephrine × 100 ] + [ norepinephrine × 100 ] + [ phenylephrine × 100 ] ) at the time of the program ’s involvement ( T0 ) and at organ recovery ( TOR ) were recorded . The Wilcoxon rank sum and Student ’s two- sample t-test were used to compare the average vasopressor score at T0 vs. TOR . The Wilcoxon signed rank test was used to analyze the difference in median vasopressor score at T0 vs. TOR . Multivariable linear regression was used to assess the impact of T4 on the ability to wean vasopressor support while accounting for the effects of several potential confounders . Measurements and Main Results : One hundred seventy-one subjects were included in the final analysis . T4 administration was associated with an unadjusted decrease in the vasopressor score of 32 ( 95 % confidence interval , 12–53 ; p = .002 ) . After adjusting for steroid administration , fluid balance , and baseline vasopressor score , T4 administration was associated with a decrease in vasopressor score of 24 ( 95 % confidence interval , 6–43 ; p = .011 ) . Conclusions : T4 reduced vasopressor needs in children with cessation of neurologic function and hemodynamic instability . A prospect i ve study of T4 in critically ill and hemodynamically unstable children appears warranted Objective To analyze the effects of polymyxin B-immobilized fiber ( PMX-F ) on bone resorption in septic patients . Design and setting Observational prospect i ve study in intensive care units of a general hospital . Patients and participants 25 patients with severe sepsis and 20 healthy controls . Measurements and results Septic patients were r and omly assigned to two groups : PMX-F treatment group ( n=15 ) and conventional treatment group ( n=10 ) . Total pyridinium crosslink pyridinoline ( PYD ) and deoxypyridinoline ( DPD ) in urine were determined by \n Output:\n " }, { "from": "agent", "value": "This systematic review found positive effects of PMX-DHP on mean arterial pressure and dopamine/ dobutamine use , PaO2/FiO2 ratio , endotoxin removal , and mortality .\nThe EUPHAS study , a multicenter RCT performed in ten Italian intensive care units in 2009 , found that PMX-DHP improved 28-day survival , blood pressure , vasopressor requirement , and degree of organ failure ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The kidney is one of the organs most prominently affected by aging . This can be seen by a loss of renal mass which is caused by a decrease in the number of nephrons result ing in hyperfiltration , hypertrophy and elevations in glomerular pressure . The factors influencing aging of the kidney are not fully eluci date d. Epidemiological , experimental and interventional studies result ed in inconsistent results and have not firmly established whether uric acid levels affect progression of Chronic Kidney Disease ( CKD ) . Therefore , we analyzed whether uric acid levels predict the progression of CKD in the Mild to Moderate Kidney Disease Study comprising at baseline 227 Caucasian patients aged 18 - 65 years with primary non-diabetic CKD of various degrees of renal impairment . Of them , 177 completed a prospect i ve follow-up of 7 years . Primary endpoint was progression of CKD defined as doubling of baseline serum creatinine and /or terminal renal failure . Patients who reached a progression endpoint ( n = 6 5 ) were significantly older , had higher baseline serum creatinine and protein excretion rates as well as lower Glomerular Filtration Rate ( GFR ) . Uric acid levels were only higher in patients with progression of disease when patients with uric acid-lowering drugs were excluded from the analysis . Cox regression analysis revealed that increasing uric acid levels predict disease progression only when the analysis was not adjusted for baseline kidney function parameters . As soon as we adjusted the analysis for GFR and proteinuria this association completely vanished . In summary , our prospect i ve 7 year follow-up study in patients with non-diabetic primary CKD did not support uric acid as an independent predictor for CKD progression Background : Endothelial dysfunction is an important risk factor for cardiovascular diseases to occur in end-stage renal disease patients . Febuxostat , being a novel xanthine oxidase inhibitor , is apparently having a beneficial role in improving the endothelial dysfunction ; however , data among hemodialysis patients are still limited . Methods : A prospect i ve , placebo-controlled , block-r and omized , double-blinded study was carried out to evaluate the effect of oral febuxostat on the endothelial dysfunction in hemodialysis patients . Fifty-seven eligible hemodialysis patients were r and omly assigned to either the drug group ( 40 mg thrice weekly ) or the placebo group . Serum Asymmetric dimethylarginine ( ADMA ) , Serum uric acid ( UA ) , and serum high sensitivity C-reactive protein ( hsCRP ) were measured at baseline and at the end of a 2-month study . Serum alanine aminotransferase ( ALT ) , serum aspartate aminotransferase ( AST ) , and the occurrence of pancytopenia were tested as safety parameters at baseline and at the end of study . Results : Serum UA significantly decreased from 7.5 ± 0.8 to 5.1 ± 1.2 mg/dL in the febuxostat group , while it did not change significantly in the placebo group . Treatment with febuxostat result ed in a significant decrease in the serum ADMA level from 1.027 ± 0.116 to 0.944 ± 0.104 µmol/L and the serum hsCRP level from 12.5 ± 1.65 to 12.1 ± 1.70 mg/L. Testing of serum ALT , serum AST , and pancytopenia revealed no significant difference in both groups . Conclusion : Febuxostat appears to improve hyperuricemia and endothelial dysfunction and ameliorate inflammation in hemodialysis patients with no safety concerns Introduction The purpose of this study was to compare urate-lowering ( UL ) efficacy and safety of daily febuxostat and allopurinol in subjects with gout and serum urate ( sUA ) ≥ 8.0 mg/dL in a six-month trial . Methods Subjects ( n = 2,269 ) were r and omized to febuxostat 40 mg or 80 mg , or allopurinol 300 mg ( 200 mg in moderate renal impairment ) . Endpoints included the proportion of all subjects with sUA < 6.0 mg/dL and the proportion of subjects with mild/moderate renal impairment and sUA < 6.0 mg/dL. Safety assessment s included blinded adjudication of each cardiovascular ( CV ) adverse event ( AE ) and death . Results Comorbidities included : renal impairment ( 65 % ) ; obesity ( 64 % ) ; hyperlipidemia ( 42 % ) ; and hypertension ( 53 % ) . In febuxostat 40 mg , febuxostat 80 mg , and allopurinol groups , primary endpoint was achieved in 45 % , 67 % , and 42 % , respectively . Febuxostat 40 mg UL was statistically non-inferior to allopurinol , but febuxostat 80 mg was superior to both ( P < 0.001 ) . Achievement of target sUA in subjects with renal impairment was also superior with febuxostat 80 mg ( 72 % ; P < 0.001 ) compared with febuxostat 40 mg ( 50 % ) or allopurinol ( 42 % ) , but febuxostat 40 mg showed greater efficacy than allopurinol ( P = 0.021 ) . Rates of AEs did not differ across treatment groups . Adjudicated ( APTC ) CV event rates were 0.0 % for febuxostat 40 mg and 0.4 % for both febuxostat 80 mg and allopurinol . One death occurred in each febuxostat group and three in the allopurinol group . Conclusions Urate-lowering efficacy of febuxostat 80 mg exceeded that of febuxostat 40 mg and allopurinol ( 300/200 mg ) , which were comparable . In subjects with mild/moderate renal impairment , both febuxostat doses were more efficacious than allopurinol and equally safe . At the doses tested , safety of febuxostat and allopurinol was comparable . Clinical Trial Registration The aim of the present study was to determine the influence of severe renal dysfunction ( estimated glomerular filtration rate < 30 ml/min/1.73 m2 , including hemodialysis ) on the pharmacokinetics and therapeutic effects of febuxostat using a population pharmacokinetic analysis . This study recruited patients with hyperuricemia who were initially treated with allopurinol , but were switched to febuxostat , and it consists of 2 sub- studies : a pharmacokinetic study ( 26 patients ) and retrospective efficacy evaluation study ( 51 patients ) . The demographic and clinical data of patients were collected from electronic medical records . Plasma febuxostat concentrations were obtained at each hospital visit . Population pharmacokinetic modeling was performed with NONMEM version 7.2 . A total of 128 plasma febuxostat concentrations from 26 patients were used in the population pharmacokinetic analysis . The data were best described by a 1-compartment model with first order absorption . Covariate analysis revealed that renal function did not influence the pharmacokinetics of febuxostat , whereas actual body weight significantly influenced apparent clearance and apparent volume of distribution . The retrospective efficacy analysis showed the favorable therapeutic response of febuxostat switched from allopurinol in patients with moderate to severe renal impairment . No serious adverse event associated with febuxostat was observed irrespective of renal function . The population pharmacokinetic analysis and therapeutic analysis of febuxostat revealed that severe renal dysfunction had no influence on the pharmacokinetic parameters of febuxostat . These results suggest that febuxostat is tolerated well by patients with severe renal impairment Background Hyperuricemia is associated with the onset of chronic kidney disease ( CKD ) and renal disease progression . Febuxostat , a novel , non-purine , selective xanthine oxidase inhibitor , has been reported to have a stronger effect on hyperuricemia than conventional therapy with allopurinol . However , few data are available regarding the clinical effect of febuxostat in patients with CKD . Methods A prospect i ve , r and omized , open-label , parallel-group trial was conducted in hyperuricemic patients with stage 3 CKD . Patients were r and omly assigned to treatment with febuxostat ( n = 21 ) or to continue conventional therapy ( n = 19 ) . Treatment was continued for 12 weeks . The efficacy of febuxostat was determined by monitoring serum uric acid ( UA ) levels , blood pressures , renal function , and urinary protein levels . In addition , urinary liver-type fatty acid-binding protein ( L-FABP ) , urinary albumin , urinary beta 2 microglobulin ( β2MG ) , and serum high sensitivity C-reactive protein were measured before and 12 weeks after febuxostat was added to the treatment . Results Febuxostat result ed in a significantly greater reduction in serum UA ( −2.2 mg/dL ) than conventional therapy ( −0.3 mg/dL , P < 0.001 ) . Serum creatinine and estimated glomerular filtration rate changed little during the study period in each group . However , treatment with febuxostat for 12 weeks reduced the urinary levels of L-FABP , albumin , and β2MG , whereas the levels of these markers did not change in the control group . Conclusion Febuxostat reduced serum UA levels more effectively than conventional therapy and might have a renoprotective effect in hyperuricemic patients with CKD . Further studies should clarify whether febuxostat prevents the progression of renal disease and improves the prognosis of CKD BACKGROUND Hyperuricemia is associated strongly with the development of hypertension , renal disease , and progression . Allopurinol decreases serum uric acid levels by inhibiting the enzyme xanthine oxidase . We hypothesized that administrating allopurinol to decrease serum uric acid levels to the normal range in hyperuricemic patients with chronic kidney disease may be of benefit in decreasing blood pressure and slowing the rate of renal disease progression in these patients . METHODS We conducted a prospect i ve , r and omized , controlled trial of 54 hyperuricemic patients with chronic kidney disease . Patients were r and omly assigned to treatment with allopurinol , 100 to 300 mg/d , or to continue the usual therapy for 12 months . Clinical , hematologic , and biochemical parameters were measured at baseline and 3 , 6 , and 12 months of treatment . We define our study end points as : ( 1 ) stable kidney function with less than 40 % increase in serum creatinine level , ( 2 ) impaired renal function with creatinine level increase greater than 40 % of baseline value , ( 3 ) initiation of dialysis therapy , and ( 4 ) death . RESULTS One patient in the treatment group dropped out because of skin allergy to allopurinol . Serum uric acid levels were significantly decreased in subjects treated with allopurinol , from 9.75 + /- 1.18 mg/dL ( 0.58 + /- 0.07 mmol/L ) to 5.88 + /- 1.01 mg/dL ( 0.35 + /- 0.06 mmol/L ; P < 0.001 ) . There were no significant differences in systolic or diastolic blood pressure at the end of the study comparing the 2 groups . There was a trend toward a lower serum creatinine level in the treatment group compared with controls after 12 months of therapy , although it did not reach statistical significance ( P = 0.08 ) . Overall , 4 of 25 patients ( 16 % ) in the allopurinol group reached the combined end points of significant deterioration in renal function and dialysis dependence compared with 12 of 26 patients ( 46.1 % ) in the control group ( P = 0.015 ) . CONCLUSION Allopurinol therapy significantly decreases serum uric acid levels in hyperuricemic patients with mild to moderate chronic kidney disease . Its use is safe and helps preserve kidney function during 12 months of therapy compared with controls . Results of this study need to be confirmed with an additional prospect i ve trial involving a larger cohort of patients to determine the long-term efficacy of allopurinol therapy and in specific chronic kidney disease sub population Recent epidemiologic studies suggest that uric acid predicts the development of new-onset kidney disease , but it is unclear whether uric acid is an independent risk factor . In this study , data from 21,475 healthy volunteers who were followed prospect ively for a median of 7 yr were analyzed to examine the association between uric acid level and incident kidney disease ( estimated GFR [ eGFR ] < 60 ml/min per 1.73 m(2 ) ) . After adjustment for baseline eGFR , a slightly elevated uric acid level ( 7.0 to 8.9 mg/dl ) was associated with a nearly doubled risk for incident kidney disease ( odds ratio 1.74 ; 95 % confidence interval 1.45 to 2.09 ) , and an elevated uric acid ( > or = 9.0 mg/dl ) was associated with a tripled risk ( odds ratio 3.12 ; 95 % confidence interval \n Output:\n " }, { "from": "agent", "value": "The meta- analysis showed that other than its urate-lowering effect , febuxostat presented a reno-protective effect in CKD patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Little is known about the optimal duration of antibiotic therapy for diabetic foot osteomyelitis ( DFO ) . This study sought to compare the effectiveness of 6 versus 12 weeks of antibiotic therapy in patients with DFO treated nonsurgically ( i.e. , antibiotics alone ) . RESEARCH DESIGN AND METHODS This was a prospect i ve r and omized trial comparing 6- versus 12-week duration of antibiotic treatment . Remission of osteomyelitis during the monitoring period was defined as complete and persistent ( > 4 weeks ) healing of the wound ( if present initially ) , absence of recurrent infection at the initial site or that of adjacent rays , and no need for surgical bone resection or amputation at the end of a follow-up period of at least 12 months after completion of antibiotic treatment . RESULTS Forty patients followed at five French general hospitals were r and omized between January 2007 and January 2009 , with 20 treated for 6 weeks and 20 treated for 12 weeks with antibiotics . The two groups were comparable for all variables recorded at inclusion in the study . Remission was obtained in 26 ( 65 % ) patients , with no significant differences between patients treated for 6 versus 12 weeks ( 12/20 vs. 14/20 , respectively ; P = 0.50 ) . We did not identify any significant parameters associated with patient outcome . Fewer patients treated for 6 weeks experienced gastrointestinal adverse events related to antimicrobial therapy compared with patients treated for 12 weeks ( respectively , 15 vs. 45 % ; P = 0.04 ) . CONCLUSIONS The present multicenter prospect i ve r and omized study provides data suggesting that 6-week duration of antibiotic therapy may be sufficient in patients with DFO for whom nonsurgical treatment is considered A phase 3 , r and omized , double-blind trial was conducted in subjects with diabetic foot infections without osteomyelitis ( primary study ) or with osteomyelitis ( sub study ) to determine the efficacy and safety of parenteral ( intravenous [ iv ] ) tigecycline ( 150 mg once-daily ) versus 1 g once-daily iv ertapenem ± vancomycin . Among 944 subjects in the primary study who received ≥1 dose of study drug , > 85 % had type 2 diabetes ; ~90 % had Perfusion , Extent , Depth/tissue loss , Infection , and Sensation infection grade 2 or 3 ; and ~20 % reported prior antibiotic failure . For the clinical ly evaluable population at test-of-cure , 77.5 % of tigecycline- and 82.5 % of ertapenem ± vancomycin-treated subjects were cured . Corresponding rates for the clinical modified intent-to-treat population were 71.4 % and 77.9 % , respectively . Clinical cure rates in the sub study were low ( < 36 % ) for a subset of tigecycline-treated subjects with osteomyelitis . Nausea and vomiting occurred significantly more often after tigecycline treatment ( P = 0.003 and P < 0.001 , respectively ) , result ing in significantly higher discontinuation rates in the primary study ( nausea P = 0.007 , vomiting P < 0.001 ) . In the primary study , tigecycline did not meet criteria for noninferiority compared with ertapenem ± vancomycin in the treatment of subjects with diabetic foot infections BACKGROUND This r and omized , prospect i ve , multicenter , open-label study was design ed to test whether a topical , electrolyzed , superoxidized solution ( Microcyn Rx ) is a safe and effective treatment for mildly infected diabetic foot ulcers . METHODS Sixty-seven patients with ulcers were r and omized into three groups . Patients with wounds irrigated with Microcyn Rx alone were compared with patients treated with oral levofloxacin plus normal saline wound irrigation and with patients treated with oral levofloxacin plus Microcyn Rx wound irrigation . Patients were evaluated on day 3 , at the end of treatment on day 10 ( visit 3 ) , and 14 days after completion of therapy for test of cure ( visit 4 ) . RESULTS In the intention-to-treat sample at visit 3 , the clinical success rate was higher in the Microcyn Rx alone group ( 75.0 % ) than in the saline plus levofloxacin group ( 57.1 % ) or in the Microcyn Rx plus levofloxacin group ( 64.0 % ) . Results at visit 4 were similar . In the clinical ly evaluable population , the clinical success rate at visit 3 ( end of treatment ) for patients treated with Microcyn Rx alone was 77.8 % versus 61.1 % for the levofloxacin group . The clinical success rate at visit 4 ( test of cure ) for patients treated with Microcyn Rx alone was 93.3 % versus 56.3 % for levofloxacin plus saline-treated patients . This study was not statistically powered , but the high clinical success rate ( 93.3 % ) and the P value ( P = .033 ) suggest that the difference is meaningfully positive for Microcyn Rx-treated patients . CONCLUSIONS Microcyn Rx is safe and at least as effective as oral levofloxacin for mild diabetic foot infections Abstract Aims /hypothesis . To re-evaluate the use of Granulocyte-Colony Stimulating Factor ( G-CSF ) in the treatment of infected diabetic foot ulcers . Methods . Thirty-seven diabetic subjects were r and omised to Granulocyte-Colony Stimulating Factor ( G-CSF ) ( n=20 ) or placebo ( n=17 ) . The primary endpoint was resolution of cellulitis , which was evaluated clinical ly and with an infection summary score . Patients were hospitalised for 10 days and received subcutaneously either 5 µg/kg G-CSF or placebo daily . Ulcers were treated with a st and ard wound protocol and the patients were instructed to stay in bed . All subjects received antibiotics ( clindamycin and ciprofloxacin ) intravenously until the inflammation had subsided . Results . Patients who received G-CSF did not have an earlier resolution of clinical ly defined cellulitis ( p=0.57 ) . The infection summary score declined , but comparably , in both groups ( G-CSF : 29.5±18.4 to 6.7±6.3 p<0.001 , placebo : 24.2±16.9 to 8.9±7.2 p<0.001 ) . The ulcer volume , which was not greater among placebo patients , was reduced by 59 % in G-CSF and by 35 % in placebo patients . Conclusion /interpretation . We conclude that antibiotic and non weight-bearing therapy ( bed rest ) accelerated the resolution of cellulitis in infected foot ulcers . Additional treatment with G-CSF had no further beneficial effect This study tested whether levofloxacin , at a new high dose of 750 mg , was effective for the treatment of complicated skin and skin-structure infections ( SSSIs ) . Patients with complicated SSSIs ( n=399 ) were r and omly assigned in a ratio of 1:1 to 2 treatment arms : levofloxacin ( 750 mg given once per day intravenously [ iv ] , orally , or iv/orally ) or ticarcillin-clavulanate ( TC ; 3.1 g given iv every 4 - 6 hours ) followed , at the investigator 's discretion , by amoxicillin-clavulanate ( AC ; 875 mg given orally every 12 hours ) . In the clinical ly evaluable population , therapeutic equivalence was demonstrated between the levofloxacin and TC/AC regimens ( success rates of 84.1 % and 80.3 % , respectively ) . In the microbiologically evaluable population , the overall rate of eradication was 83.7 % in the levofloxacin treatment group and 71.4 % in the TC/AC treatment group ( 95 % confidence interval , -24.3 to -0.2 ) . Both levofloxacin and TC/AC were well tolerated . These data demonstrate that levofloxacin ( 750 mg once per day ) is safe and at least as effective as TC/AC for complicated SSSIs OBJECTIVE To investigate the change of bacterial load applied with iodophors and rivanol of diabetic foot ulcers ( DFUs ) , furthermore to evaluate the effect of both in removing superficial microbes of DFUs . METHODS From March 2006 to March 2007 , 30 patients were r and omly divided into control group ( group A , n = 10 ) , iodophor group ( group B , n = 10 ) and rivanol group ( group C , n = 10 ) . There were 18 males and 12 females with an average age of 59.8 years ( range 46 - 78 years ) . The wound size ranged from 3 cm x 2 cm to 15 cm x 10 cm . The disease course was 6 weeks to 6 months ( mean 2.1 months ) . Each wound was debrided and irrigated before process , then drug was compressed on the wound for 5 minutes , and irrigated again . The sample s gained for three times , before , immediately and 24 hours after the process . Each sample was diluted before cultivation , the bacteria of wound were counted and compared among 3 groups . RESULTS The cultures of specimens showed that the load decreased in every group , each cultured colony of specimen grew well , and there were no significant differences between 3 groups immediately after procedure ( P > 0.05 ) . There were significant differences between group B and groups A , C ( P < 0.05 ) , but there were no significant difference between group A and group C 24 hours after treatment ( P > 0.05 ) . CONCLUSION Both iodophors and rivanol could remove the bacteria on the surface of wound . Topical germicide could reduced bacterial load in the wound of diabetic foot , the role of sterilizing and bacteriostasis of iodophors were better than that of rivanol Background Chronic foot ulcers in diabetes are serious , costly and frequently difficult to heal . Recent guidelines conclude that new dressings and treatments generally fail to show superiority compared with st and ard of care . Several mechanisms are probably responsible for impaired healing of chronic foot ulcers , including inflammation and infection . Chloramines have presumed antiseptic and antibacterial properties , and have shown to be a useful treatment in odontology . Methods In an explorative open r and omised controlled multi-centre study , we compared chloramine-based treatment with current st and ard of care for 12 weeks and follow-up for 24 weeks . Seventeen patients in each group , mean age about 70 , duration of diabetes > 20 years and foot ulcers about 1.5 years , completed the 12 weeks study . Results After 5 weeks , the difference between the groups in relative reduction in ulcer area was statistically significant ( p=0.016 ) . Absolute change in ulcer area was first statistically significant within the chloraminetreated group after 2 weeks ( p=0.026 ) , after 8 weeks in the control group ( p=0.0023 ) , with significant difference between groups after 5 weeks ( p=0.024 ) . The approximate relative decrease per week was 19.4 % ( 95%CI 12.2 , 26.0 ; p<0.0001 ) in the chloramine-treated group and 11.7 % ( 95%CI 6.4 , 16.7 ; p<0.0001 ; between-group difference p=0.083 ) . After 9 weeks 7 patients had healed in the chloraminetreated group , but only one in the control group ( p=0.039 ) . There were no statistically significant differences in wound healing at 12 or 24 weeks , and no marked differences in signs of infection , pain , quality of life ( EQ-5D ) , or incidence of adverse events . Conclusions Chloramine-based treatment seems to be efficacious , particularly in the early phase of the care of infected diabetic foot ulcers . It is safe and easy to use , and could prove to be a valuable addition in the treatment arsenal , providing non-surgical debridement . Future studies will evaluate its role in wound care BACKGROUND The aim of this pilot study was to determine the safety and potential benefit of adding a topical gentamicin-collagen sponge to st and ard of care ( systemic antibiotic therapy plus st and ard diabetic wound management ) for treating diabetic foot infections of moderate severity . METHODS We r and omized 56 patients with moderately infected diabetic foot ulcers in a 2:1 ratio to receive st and ard of care plus the gentamicin-collagen sponge ( treatment group , n = 38 ) or st and ard of care only ( control group , n = 18 ) for up to 28 days of treatment . Investigators performed clinical , microbiological , and safety assessment s at regularly scheduled intervals and collected pharmacokinetic sample s from patients treated with the gentamicin-collagen sponge . Test of cure was clinical ly assessed 14 days after all antibiotic therapy was stopped . RESULTS On treatment day 7 , we noted clinical cure in no treatment patients and three control patients ( P = .0 \n Output:\n " }, { "from": "agent", "value": "Thus , our systematic review revealed little evidence upon which to make recommendations for treatment of DFIs ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The purpose of this study was to evaluate crestal bone loss around 282 two-piece implants with straight ( n = 193 ) and platform-switched ( n = 89 ) abutment connections after placement at various crestal levels . Implants were assigned into two groups according to straight and platform-switched abutment connections . Each group was further subdivided into three groups depending on the location ( supracrestal , crestal , or subcrestal ) of the implant cervical platform . Linear measurements of bone resorption were made from the implant 's platform to the first point of bone-to-implant contact at the time of implant placement and 2 years postrestoration . Data were statistically analyzed . Statistically significant differences were found between subgroups in both straight and platform-switched categories . The only nonstatistically significant difference ( P = .341 ) arose when comparing the supra- and subcrestal locations in the straight abutment connection group . The platform-switched group exhibited significantly less bone loss ( P = .046 ) only in subcrestal locations . The platform-switched concept was not beneficial during the overall comparison , but it was for the subcrestal location of the abutment connection . Crestal placement of the implant-abutment connection result ed in higher marginal bone resorption in both straight and platform-switched abutments BACKGROUND The purpose of this study is to assess the influence of the placement level of implants with a laser-microtextured collar design on the outcomes of crestal bone and soft tissue levels . In addition , we assessed the vertical and horizontal defect fill and identified factors that influenced clinical outcomes of immediate implant placement . METHODS Twenty-four patients , each with a hopeless tooth ( anterior or premolar region ) , were recruited to receive dental implants . Patients were r and omly assigned to have the implant placed at the palatal crest or 1 mm subcrestally . Clinical parameters including the keratinized gingival ( KG ) width , KG thickness , horizontal defect depth ( HDD ) , facial and interproximal marginal bone levels ( MBLs ) , facial threads exposed , tissue-implant horizontal distance , gingival index ( GI ) , and plaque index ( PI ) were assessed at baseline and 4 months after surgery . In addition , soft tissue profile measurements including the papilla index , papilla height ( PH ) , and gingival level ( GL ) were assessed after crown placement at 6 and 12 months post-surgery . RESULTS The overall 4-month implant success rate was 95.8 % ( one implant failed ) . A total of 20 of 24 patients completed the study . At baseline , there were no significant differences between crestal and subcrestal groups in all clinical parameters except for the facial MBL ( P = 0.035 ) . At 4 months , the subcrestal group had significantly more tissue thickness gain ( keratinized tissue ) than the crestal group compared to baseline . Other clinical parameters ( papilla index , PH , GL , PI , and GI ) showed no significant differences between groups at any time . A facial plate thickness ≤1.5 mm and HDD ≥2 mm were strongly correlated with the facial marginal bone loss . A facial plate thickness ≤2 mm and HDD ≥3 were strongly correlated with horizontal dimensional changes . CONCLUSIONS The use of immediate implants was a predictable surgical approach ( 96 % survival rate ) , and the level of placement did not influence horizontal and vertical bone and soft tissue changes . This study suggests that a thick facial plate , small gaps , and premolar sites were more favorable for successful implant clinical outcomes in immediate implant placement The medium-long term success of osseointegrated dental implants is evaluated on the basis of the degree of osseointegration over time , assessed by radiographic or instrumental analysis ( ISQ ) . Over the years , the question has always been which surgical technique can provide a better performance in the medium-long term and , thanks to literature studies , it has been evidence d that there are no differences between \" one stage \" and \" two stage \" interventions . The purpose of this study is to evaluate clinical and radiographic parameters , referring to interventions for the insertion of dental implants characterized by a new kind of implant surface ( Synthegra ® GEASS , Udine ) . The prospect i ve study , not r and omized and controlled , referred to the insertion of 18 implants on 9 patients with mono or bilateral edentulism , with measurements at 1 , 3 , 6 and 12 months and an overall follow-up at 3 years , in order to evaluate the different degree of crestal bone resorption using the submerged and transmucosal surgical technique . The results of our study show that there are no differences in the resorption of the two surgical techniques , with an average bone resorption of 2,05±0,16 mm , comparable with values reported in literature BACKGROUND It has been reported in many articles that marginal bone resorptions are prevented by platform-switching design . However , what occurs when these implants are placed in the apical position is not completely known . PURPOSE This report describes a r and omized controlled clinical trial study that aims to test the hypothesis that less resorption will occur when platform-switching implants are placed 1 mm below bone level . MATERIAL S AND METHODS A total of 56 r and omly selected implants were inserted bilaterally , either 1 mm below bone level ( test group , 28 implants ) or at bone level ( control group , 28 implants ) of the patients ' posterior regions . Marginal bone resorptions were examined through periapical radiographies taken with the parallel technique at the time of crown cementation and the third , sixth , 12th , and 36th months after prosthetic loading . The modified plaque index , gingival index , bleeding on probing , and probing depths were used for follow-up periodontal care of the implants . RESULTS After 3 years , the mean radiographic vertical bone loss in the control group was significantly lower than in the test group ( 0.56 ± 0.35 mm and 1.21 ± 1.05 mm , respectively ) ( p < .01 ) . In terms of periodontal indexes , there were no statistically significant differences between the two groups ( p > .05 ) . No peri-implantitis or peri-implant mucositis was observed around the test or control implants . CONCLUSIONS More marginal bone resorptions occurred after the third year of loading in implants placed 1 mm below bone level . However , the resorptions did not reach the implants thread . In the control group , the first bone implant contact was placed under the level of the first threads . Therefore , the present r and omized clinical trial confirmed the hypothesis that placing platform-switching implants 1 mm below bone level reduced marginal bone loss . It can be noted that to reduce resorption , platform-switching implants should be placed below bone level OBJECTIVES To assess the impact of microgrooved abutments and the insertion depth on crestal bone changes at titanium implants with platform switch . MATERIAL S AND METHODS A total of n = 3 titanium implants ( conical abutment connection ) were inserted in each hemim and ible of n = 6 foxhounds with the implant shoulder ( IS ) located at either epicrestal , supracrestal ( + 1 mm ) , or subcrestal ( -1 mm ) positions and r and omly ( split-mouth design ) connected with machined or partially microgrooved healing abutments . At 20 weeks , tissue biopsies were processed for histological ( primary outcome : net bone loss - NET ) analyses . RESULTS Subcrestal positioning of IS tended to be associated with higher mean NET values ( mm ) at both machined ( subcrestal [ -0.72 ± 0.32 ] > epicrestal [ -0.34 ± 0.21 ] > supracrestal [ + 0.20 ± 0.64 ] ) and microgrooved ( subcrestal [ -0.48 ± 0.25 ] > epicrestal [ -0.13 ± 0.54 ] > supracrestal [ + 0.33 ± 0.58 ] ) abutments . However , these differences failed to reach statistical significance . CONCLUSIONS The insertion depth may have a direct influence on crestal bone-level changes at both types of abutments investigated OBJECTIVE This prospect i ve r and omized match-paired controlled trial aim ed to evaluate the impact of implant platform diameter on marginal bone level around implants restored according to the platform switching ( PS ) concept . MATERIAL AND METHODS A total of 24 implants were examined in 12 patients . All patients received two adjacent implants inserted at the crestal level : 4.3 mm ( control group ) and 4.8 mm ( test group ) in diameter . Mesio-distal implant position was r and omly performed . According to the PS concept , for restoration , a 3.8 and 4.3 mm diameter abutment was used , respectively in the control and test groups , result ing , in both groups , with 0.25 mm of implant/abutment mismatching . Implant restorations were splinted . Eighteen months after final restoration , periapical st and ardized digital radiographs were taken to evaluate marginal bone level alterations after loading . The Wilcoxon Signed-Rank Test was selected to identify differences between groups . RESULTS At the last follow-up , control implants exhibited a mean bone loss value of 1.10 mm ( SD : 0.47 mm ) ; the test group showed a mean value of 1.09 mm ( SD : 0.08 mm ) . No statistically significant differences were found between test and control groups . CONCLUSIONS Within the limits of this study , the present results suggest that bone resorption is mostly related to biologic ( biologic width re-establishment ) rather than to biomechanical factors ( implant platform diameter ) . Furthermore long-term studies with a wider sample size are needed to confirm the platform diameter influence on hard tissue response around implants restored according to the PS concept PURPOSE Submerged and nonsubmerged ITI solid-screw titanium implants were followed retrospectively from 1989 to 1993 and prospect ively from 1994 on to analyze long-term prognosis in partially and fully edentulous patients . MATERIAL AND METHODS A total of 468 implants were consecutively inserted in 191 patients from 1989 to 1998 . Two hundred twenty-eight successfully integrated fixed-restoration implants and 238 with removable restorations were restored following a healing period of 4 to 6 months ( 9 months in sinus floor elevation sites ) . From 1994 on all implants inserted were documented annually up to 9 years . During examination the clinical status of the implants was analyzed and evaluated according to predefined criteria of success and this allowed the calculation of 10-year cumulative survival and success rates for 468 implants . RESULTS Two implants ( 0.43 % ) did not successfully integrate during the healing period , and 8 implants ( 1.7 % ) were classified as failures during follow-up ( 1 late failure under load , 7 with a progressive bone loss from 1 to 3 threads ) . Including 68 implants in subjects who dropped out ( with a dropout rate of 14.4 % ) , the 10-year cumulative survival and success rates were 99.2 % and 96.4 % , respectively . DISCUSSION Over the course of this long-term study , osseointegrated implants , once used as a last possible solution , became nearly st and ard in cases of single-tooth implants because of the high rate of long-term success . Life table analysis not only determines whether an implant is functioning , it also makes a statement about its clinical status according to strict success criteria . CONCLUSION The study demonstrated that ITI solid-screw titanium implants achieved success rates above 95 % in a clinical center for an observation period of up to 10 years BACKGROUND Today , implants are placed using both non-submerged and submerged approaches , and in 1- and 2-piece configurations . Previous work has demonstrated that peri-implant crestal bone reactions differ radiographically under such conditions and are dependent on a rough/smooth implant border in 1-piece implants and on the location of the interface ( microgap ) between the implant and abutment/restoration in 2-piece configurations . The purpose of this investigation was to examine histometrically crestal bone changes around unloaded non-submerged and submerged 1- and 2-piece titanium implants in a side-by-side comparison . METHODS A total of 59 titanium implants were r and omly placed in edentulous m and ibular areas of 5 foxhounds , forming 6 different implant subgroups ( types A-F ) . In general , all implants had a relatively smooth , machined coronal portion as well as a rough , s and blasted and acid-etched ( SLA ) apical portion . Implant types A-C were placed in a non-submerged approach , while types D-F were inserted in a submerged fashion . Type A and B implants were 1-piece implants with the rough/smooth border ( r/s ) at the alveolar crest ( type A ) or 1.0 mm below ( type B ) . Type C implants had an abutment placed at the time of surgery with the interface located at the bone crest level . In the submerged group , types D-F , the interface was located either at the bone crest level ( type D ) , 1 mm above ( type E ) , or 1 mm below ( type F ) . Three months after implant placement , abutment connection was performed in the submerged implant groups . At 6 months , all animals were sacrificed . Non-decalcified histology was analyzed by evaluating peri-implant crestal bone levels . RESULTS For types A and B \n Output:\n " }, { "from": "agent", "value": "No significant difference in CBL was found around submerged and nonsubmerged dental implants" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background and aims : Specialised intestinal metaplasia and its dysplastic transformation , which precedes cancer in Barrett ’s oesophagus can not be differentiated in st and ard gastroscopy . The aim of this study was to investigate whether laser induced protoporphyrin IX fluorescence permits the detection of specialised intestinal metaplasia and dysplasia during endoscopy and to take biopsy specimens in a guided rather than r and om manner . Methods : In 53 patients with Barrett ’s oesophagus 5-aminolaevulinic acid was sprayed on the mucosa . Approximately 60 to 120 minutes later , biopsy specimens were taken based on point-like measurements of delayed fluorescence intensity ratios of protoporphyrin IX in vivo . Two independent pathologists examined the 596 biopsy specimens taken , 168 of which were selected to be investigated by a third pathologist . Among these specimens only those ( n=141 ) with a consensus diagnosis by at least two pathologists and p53 expression as additional marker were included in the analysis . Results : The median of normalised fluorescence intensity ( ratio of delayed PpIX fluorescence intensity to immediate autofluorescence intensity ) in non-dysplastic specialised intestinal metaplasia ( 0.51 , 68 % CI 0.09 to 1.92 ) and low grade dysplasia ( 1.89 , 68 % CI 0.55 to 3.92 ) differed significantly ( p<0.005 ) . Dysplasia was detected at a rate 2.8-fold higher compared with screening endoscopy despite taking fewer specimens . In addition , three early cancers were detected for the first time . Moreover , this method permitted differentiation of specialised intestinal metaplasia from junctional or gastric-fundic type epithelium ( p<0.013 ) . Conclusions : For the first time it was possible to differentiate low grade dysplasia from non-dysplastic Barrett ’s mucosa during endoscopy based on delayed laser induced fluorescence endoscopy of PpIX . Furthermore , the method helps to detect specialised intestinal metaplasia in short Barrett ’s oesophagus BACKGROUND AND AIMS Photodynamic therapy ( PDT ) is a treatment in which cell damage is achieved by the action of light on a photosensitising agent . We have assessed the potential use of PDT in the ablation of Barrett 's oesophagus . METHODS Thirty six patients with dysplastic Barrett 's oesophagus receiving acid suppression medication with omeprazole were r and omised to receive oral 5-aminolaevulinic acid ( ALA ) 30 mg/kg or placebo , followed four hours later by laser endoscopy . Follow up endoscopy was performed at one , six , 12 , and 24 months . RESULTS Of 18 patients in the ALA group , a response was seen in 16 ( median decrease in area in the treated region 30 % ; range 0–60 % ) . In the placebo group , a decrease in area of 10 % was observed in two patients with no change in 16 ( median 0 % ; range 0–10 % ; treatment vplacebo , p<0.001 ) . No dysplasia was seen in the columnar epithelium within the treatment area of any patient in the PDT group . However , in the placebo group , persistent low grade dysplasia was found in 12 patients ( p<0.001 ) . There were no short or long term major side effects . The effects of treatment were maintained for up to 24 months . CONCLUSIONS This is the first r and omised controlled trial of PDT for Barrett 's oesophagus . It demonstrates that ALA induced PDT can provide safe and effective ablation of low grade dysplastic epithelium Barrett 's oesophagus is a major risk factor for developing oesophageal adenocarcinoma . Ablation by argon plasma coagulation ( APC ) and photodynamic therapy ( PDT ) is currently under investigation for the removal of metaplastic and dysplastic Barrett 's oesophagus . This study examined the effect of ablative therapy on Barrett 's oesophagus at cell-cycle and genetic levels . The premalignant potential of residual or recurring Barrett 's oesophagus was assessed by p53 immunohistochemistry , Ki67-related proliferative capacity , and DNA ploidy status ( ie an abnormal chromosome 1 number ) as measured by interphase in situ hybridization . Twenty-nine patients with Barrett 's oesophagus ( 23 male and 6 female , mean age 58 years , mean length of Barrett 's oesophagus 4 cm ) were treated with APC or PDT . Intestinal metaplasia without dysplasia was present in 16 patients , low- grade dysplasia in five , and high- grade dysplasia in eight patients . Biopsy sample s were obtained at regular intervals ( mean follow-up 20 months , range 6 - 36 months ) . One month after the first ablation , Barrett 's oesophagus was no longer identified , either endoscopically or histologically , in nine patients ( 32 % ) . At this time point , significant down-grading was achieved for abnormal chromosome 1 numbers ( p = 0.020 ) and Ki67-defined proliferation ( p = 0.002 ) . Patients with residual Barrett 's oesophagus were additionally treated with APC , result ing in the elimination of Barrett 's oesophagus in 76 % of all patients . However , at the last follow-up endoscopy , metaplasia without dysplasia was still present in five patients , and low- and high- grade dysplasia were each present in one patient . An abnormal chromosome 1 number and p53 protein overexpression were detected only in the high- grade dysplastic lesion , but increased proliferation was still present in the majority of these persisting cases . Although endoscopic removal of Barrett 's oesophagus by ablative therapies is possible in the majority of patients , histologically complete elimination can not be achieved in all cases . Persistent Barrett 's oesophagus may still harbour molecular aberrations and must therefore be considered still to be at risk of progression to adenocarcinoma INTRODUCTION Acid suppression therapy and surgical antireflux procedures have not consistently led to regression of Barrett 's epithelium . We reasoned that laser photocoagulation in combination with powerful acid suppression might destroy the metaplastic columnar epithelium and allow the area to be replaced by normal squamous mucosa . PATIENTS AND METHODS Eight patients with endoscopic and histologically proven Barrett 's oesophagus were recruited into the study . Four patients were r and omized to receive omeprazole 40 mg daily and four patients received the same medical therapy plus repeated laser photocoagulation administered at 4 - 6 weekly intervals . Endoscopies were performed on entry and at 6 months . The extent of Barrett 's epithelium was assessed and mapped on to a grid system and histological changes were assessed in blinded manner by a single histopathologist . One new quadrant of Barrett 's segment was irradiated per treatment . RESULTS Laser therapy was well tolerated and no complications occurred . After 6 months , the extent of Barrett 's epithelium was unchanged in both groups . There was no appearance of squamous isl and s either endoscopically or microscopically in areas treated with laser . CONCLUSION Nd-YAG laser is ineffective in ablating Barrett 's epithelium Background : Many modalities have been used to ablate Barrett ’s oesophagus ( BO ) . However , long term results and comparative effectiveness are unknown . Aims : Our aim was to compare the long term efficacy of achieving complete reversal ( endoscopic and histological ) between multipolar electrocoagulation ( MPEC ) and argon plasma coagulation ( APC ) in BO patients and assess factors influencing successful ablation . Methods : Patients with BO , 2–6 cm long , underwent 24 hour pH testing on proton pump inhibitor ( PPI ) therapy . Patients were then r and omised by BO length to undergo ablation with MPEC or APC every 4–8 weeks until endoscopic reversal or maximal of six treatment sessions . Results : Thirty five BO patients have been followed for at least two years following endoscopic ablation , 16 treated with MPEC and 19 with APC . There was complete reversal of BO in 24 patients ( 69 % ) ; 75 % with MPEC and 63 % with APC ( p = 0.49 ) . There was no difference in the number of sessions required in the two groups . There was no difference in age , pH results , BO length , PPI dose , or hiatal hernia size between patients with and without complete reversal . One patient developed an oesophageal stricture but there were no major complications such as bleeding or perforation . Conclusions : In BO patients treated with MPEC or APC in combination with acid suppression , at long term follow up , complete reversal of BO can be maintained in approximately 70 % of patients , irrespective of the technique . There are no predictors associated with achieving complete reversal of BO . Continued surveillance is still indicated in the post ablative setting . As yet , these techniques are not ready for clinical application ( other than for high grade dysplasia or early oesophageal adenocarcinoma ) and can not be offered outside the research arena BACKGROUND Selective inhibition of cyclooxygenase-2 ( COX-2 ) may be associated with an increased risk of thrombotic events , but only limited long-term data have been available for analysis . We report on the cardiovascular outcomes associated with the use of the selective COX-2 inhibitor rofecoxib in a long-term , multicenter , r and omized , placebo-controlled , double-blind trial design ed to determine the effect of three years of treatment with rofecoxib on the risk of recurrent neoplastic polyps of the large bowel in patients with a history of colorectal adenomas . METHODS A total of 2586 patients with a history of colorectal adenomas underwent r and omization : 1287 were assigned to receive 25 mg of rofecoxib daily , and 1299 to receive placebo . All investigator-reported serious adverse events that represented potential thrombotic cardiovascular events were adjudicated in a blinded fashion by an external committee . RESULTS A total of 46 patients in the rofecoxib group had a confirmed thrombotic event during 3059 patient-years of follow-up ( 1.50 events per 100 patient-years ) , as compared with 26 patients in the placebo group during 3327 patient-years of follow-up ( 0.78 event per 100 patient-years ) ; the corresponding relative risk was 1.92 ( 95 percent confidence interval , 1.19 to 3.11 ; P=0.008 ) . The increased relative risk became apparent after 18 months of treatment ; during the first 18 months , the event rates were similar in the two groups . The results primarily reflect a greater number of myocardial infa rct ions and ischemic cerebrovascular events in the rofecoxib group . There was earlier separation ( at approximately five months ) between groups in the incidence of nonadjudicated investigator-reported congestive heart failure , pulmonary edema , or cardiac failure ( hazard ratio for the comparison of the rofecoxib group with the placebo group , 4.61 ; 95 percent confidence interval , 1.50 to 18.83 ) . Overall and cardiovascular mortality was similar in the two groups . CONCLUSIONS Among patients with a history of colorectal adenomas , the use of rofecoxib was associated with an increased cardiovascular risk Background : Barrett 's esopagus ( BE ) is considered a risk factor for the development of esophageal carcinoma . Recently , partial restoration of squamous mucosa after ablation of BE with endoscopic techniques has been described . Methods : From November 1996 to November 1999 , 23 patients with histologically proven BE have been treated by endoscopic argon plasma coagulation ( APC ) following suppression of gastro-esophageal reflux by laparoscopic fundoplication . Histological follow-up after completed ablation ranged from 16 to 45 months ( mean , 31.9 months ) . Results : Histologically , complete squamous reepithelialization was observed in 20/23 patients , whereas a regrowth of a mixed squamous and gastric type mucosa was observed in 1 patient . Small isl and s of intestinal metaplasia were observed under the neosquamous epithelium in two patients ( 9 % ) during follow-up . Conclusion : The success rate of APC ablation following laparoscopic antireflux surgery in our series may be as high as 91 % . Nevertheless , small isl and s of intestinal metaplasia under the new squamous epithelium may persist in some patients . In these circumstances , the authors recommend that endoscopic ablation of BE should be confined to controlled clinical trials The guidelines for the diagnosis , surveillance and therapy of Barrett ’s esophagus were originally published by the American College of Gastroenterology in 1998 and up date d in 2002 . These and other guidelines undergo periodic review . Significant advances have occurred in the area of Barrett ’s esophagus over the past four years leading to another revision of the prior guidelines . These advances include the potential use \n Output:\n " }, { "from": "agent", "value": "Medical and surgical interventions to reduce symptoms and sequelae of gastro-oesophageal reflux disease ( GORD ) did not induce significant eradication of Barrett 's oesophagus or dysplasia .\nEndoscopic therapies ( photodynamic therapy ( PDT with aminolevulinic acid or porfimer sodium ) , argon plasma coagulation ( APC ) and radiofrequency ablation ( RFA ) ) all induced regression of Barrett 's oesophagus and dysplasia .\nThe variation in photodynamic therapy eradication rates for dysplasia was dependent on the drug , source and dose of light .\nAblative therapies have an increasing role in the management of dysplasia within Barrett 's and current data would favour the use of radiofrequency ablation compared with photodynamic therapy .\nRadiofrequency ablation has been shown to yield significantly fewer complications than photodynamic therapy and is very efficacious at eradicating both dysplasia and Barrett 's itself ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The objective of this study was to determine acceptability and feasibility of patient-based partner referral ( PBPR ) and patient-delivered partner medication ( PDPM ) among female sexually transmitted infection ( STI ) patients in a community-based STI screening study . Women were r and omized to STI screening at home or at a clinic . STI patients could choose between PBPR and PDPM . Six-week follow-up interviews , and in-depth interviews , were conducted . STI prevalence was high . Most of the 106 women with an STI chose PDPM , mainly because partners would not have time or would not want to attend a clinic , and to ensure that partners received treatment . Nearly all partners reportedly took medication ( 94 ; 89 % took it in front of the woman ) or went to a clinic for treatment ( 92 % ) . No adverse events were reported . Good communication emerged as the key to successful partner notification . In conclusion , PDPM could be used as a strategy to improve STI treatment coverage Objective : To measure quality of sexually transmitted disease ( STD ) syndromic case management and aspects of health-seeking behaviour at baseline in an intervention trial . Setting : Ten rural primary care clinics , Hlabisa district , South Africa . Design : Simulated patients ( fieldworkers trained to present with STD syndromes ) made a total of 44 clinic visits ; 49 STD patients were interviewed when exiting clinics ; facilities were assessed for availability of necessary equipment and drugs ; 10 focus group discussion s were held with staff ; and STD syndrome surveillance was performed in all 10 clinics . Results : A total of 9 % of simulated patients were correctly managed ( given correct drugs , plus condoms and partner notification cards ) , recommended drug treatment was given in only 41 % of visits , and appropriate counselling was given in 48 % of visits . Among patients leaving the clinic , although 39 % waited over an hour to be seen and only 37 % were consulted in private , all reported staff attitudes as satisfactory or good . Only six clinics had syndromic management protocol s available , three reported intermittent drug shortages , and seven lacked partner notification cards . Focus group discussion s revealed good staff knowledge about STD , but showed lack of training in syndromic management and low morale . Surveillance data showed that while 75 % of those presenting for care did so within 1 week of symptom onset , 27 % had been treated for an STD in the preceding 3 months , and only 6 % of those treated were contacts . Conclusions : Quality of STD case management was poor despite good staff knowledge and availability of most essential re sources . An intervention comprising staff training and STD syndrome packets has been design ed to improve quality of case management Objectives : To describe important details of the design and operational features of the Mwanza sexually transmitted diseases ( STD ) control programme . To assess the feasibility of the intervention , the distribution of STD syndromes observed , the clinical effectiveness of syndromic STD case management , the utilisation of STD services by the population , and the quality of syndromic STD services delivered at rural health units . Methods : The intervention was integrated into rural primary healthcare ( PHC ) units . It comprised improved STD case management using the syndromic approach , facilitated by a regional programme office which ensured the training of health workers , a reliable supply of effective drugs , and regular support supervision . Five studies were performed to evaluate operational performance : ( i ) a survey of register books to collect data on patients presenting with STDs and reproductive tract infections ( RTIs ) to rural health units with improved STD services , ( ii ) a survey of register books from health units in communities without improved services , ( iii ) a survey of register books from referral clinics , ( iv ) a home based cross sectional study of STD patients who did not return to the intervention health units for follow up , ( v ) a cross sectional survey of reported STD treatment seeking behaviour in a r and om cohort of 8845 adults served by rural health units . Results : During the 2 years of the Mwanza trial , 12 895 STD syndromes were treated at the 25 intervention health units . The most common syndromes were urethral discharge ( 67 % ) and genital ulcers ( 26 % ) in men and vaginal discharge ( 50 % ) , lower abdominal tenderness ( 33 % ) , and genital ulcers ( 13 % ) in women . Clinical treatment effectiveness was high in patients from whom complete follow up data were available , reaching between 81 % and 98 % after first line treatment and 97%–99 % after first , second , and third line treatment . Only 26 % of patients referred to higher levels of health care had presented to their referral institutions . During the trial period , data from the cohort showed that 12.8 % of men and 8.6 % of women in the intervention communities experienced at least one STD syndrome . Based on various approaches , utilisation of the improved health units by symptomatic STD patients in these communities was estimated at between 50 % and 75 % . During the first 6 months of intervention attendance at intervention units increased by 53 % . Thereafter , the average attendance rate was about 25 % higher than in comparison communities . Home visits to 367 non-returners revealed that 89 % had been free of symptoms after treatment , but 28 % became symptomatic again within 3 months of treatment . 100 % of these patients reported that they had received treatment , but only 74 % had been examined , only 57 % had been given health education , and only 30 % were offered condoms . Patients did not fully recall which treatment they had been given , but possibly only 63 % had been treated exactly according to guidelines . Conclusions : This study demonstrated that it is feasible to integrate effective STD services into the existing PHC structure of a developing country . Improved services attract more patients , but additional educational efforts are needed to further improve treatment seeking behaviour . Furthermore , clear treatment guidelines , a reliable drug supply system , and regular supervision are critical . All efforts should be made to treat patients on the spot , without delay , as referral to higher levels of care led to a high number of dropouts . The syndromic approach to STD control should be supported by at least one reference clinic and laboratory per country to ensure monitoring of prevalent aetiologies , of the development of bacterial resistance , and of the effectiveness of the syndromic algorithms in use STUDY OBJECTIVE To assess quality of care of sexually transmitted diseases ( STDs ) and evaluate interactive training methods aim ed at improving providers ' performance . DESIGN AND SETTING This comparative study , with a baseline , intervention , and evaluation phases was conducted at two urban health centers in Zambia . The personnel at one health center were trained in STD management using interactive training methods . The other health center acted as a control . SUBJECTS AND METHODS Two-hundred patients with STD were interviewed and their interaction with health care providers observed before and after the training . Another 200 interviews and observations were conducted at the control health center . RESULTS The proportion of patients being examined , given health education and informed about partner notification increased significantly after the intervention . The proportion of patients who had complaints about the health care did not decrease . Long waiting time and lack of time to discuss the disease were the main complaints . CONCLUSION The training solved some , but not all , problems of poor case management . This indicates the need for a more process-oriented approach for improving quality of care Objective : To explore the role of primary health centers in provision of voluntary counseling and testing ( VCT ) in Kenya . Design and Setting : Prospect i ve service evaluation at 3 ( 1 urban and 2 rural ) government health centers . Subjects : Consecutive adult clients . Main Outcome Measures : Uptake of services , user characteristics , quality of service . Results : Counseling services received 2315 new clients over 26 months . The last quarter averaged 101 clients per clinic . More than 80 % of clients lived locally . Overall 93 % opted to test , 91 % receiving results , 82 % on the same day . Most clients tested HIV negative ( 81 % ) . Youth and men were well represented . Few couples ( 10 % ) attended . Seventeen percent of women were pregnant . Self-referral was common and illness was an uncommon reason for testing ( < 20 % ) . Thirty-one percent of clients were referred from VCT to other health center services . Counseling was perceived as high quality by users and providers . Validation of the test algorithm showed a sensitivity of 98.0 % and specificity of 98.7 % . Conclusion : Government health centers in Kenya can be appropriate providers of VCT . This pilot helped initiate a new strategy of health center-based VCT in Kenya and this has facilitated rapid expansion and more equitable provision for Kenyans Unlike contact-tracing procedures for syphilis and gonorrhea , field follow-up to locate and treat patients with Chlamydia trachomatis infections has not been extensively applied in the United States . We implemented two studies to assess the efficiency and cost-effectiveness of using field follow-up for contact of two groups : patients with chlamydial infection detected as part of a screening program and women who were sexual partners of men with nongonococcal urethritis ( NGU ) . Of the 142 patients with chlamydial infection who had not been treated empirically , 112 ( 79 % ) returned for treatment when a reminder system was used , as compared with a return rate of 97 % ( 259/266 ) achieved by field follow-up ( P less than 0.0001 ) . Among the 678 men with NGU enrolled in a r and omized trial of field follow-up vs. two self-referral methods , field follow-up yielded over three times as many partners returning to the clinic for treatment as did either of the other two methods ( P less than 0.001 ) . Analyses using the estimated costs of the intervention strategies and the medical costs associated with an untreated chlamydial infection showed that field follow-up by trained investigators proved to be not only the most efficient method for locating patients with chlamydial infection and /or patients who were at risk for it , but also the most cost-effective in terms of total health-care dollars spent BACKGROUND Treatment of sexually-transmitted infections ( STIs ) and behavioural interventions are the main methods to prevent HIV in developing countries . We aim ed to assess the effect of these interventions on incidence of HIV-1 and other sexually-transmitted infections . METHODS We r and omly allocated all adults living in 18 communities in rural Ug and a to receive behavioural interventions alone ( group A ) , behavioural and STI interventions ( group B ) , or routine government health services and community development activities ( group C ) . The primary outcome was HIV-1 incidence . Secondary outcomes were incidence of herpes simplex virus type 2 ( HSV2 ) and active syphilis and prevalence of gonorrhoea , chlamydia , reported genital ulcers , reported genital discharge , and markers of behavioural change . Analysis was per protocol . FINDINGS Compared with group C , the incidence rate ratio of HIV-1 was 0.94 ( 0.60 - 1.45 , p=0.72 ) in group A and 1.00 ( 0.63 - 1.58 , p=0.98 ) in group B , and the prevalence ratio of use of condoms with last casual partner was 1.12 ( 95 % CI 0.99 - 1.25 ) in group A and 1.27 ( 1.02 - 1.56 ) in group B. Incidence of HSV2 was lower in group A than in group C ( incidence rate ratio 0.65 , 0.53 - 0.80 ) and incidence of active syphilis for high rapid plasma reagent test titre and prevalence of gonorrhoea were both lower in group B than in group C ( active syphilis incidence rate ratio , 0.52 , 0.27 - 0.98 ; gonorrhoea prevalence ratio , 0.25 , 0.10 - 0.64 ) . INTERPRETATION The interventions we used were insufficient to reduce HIV-1 incidence in rural Ug and a , where secular changes are occurring . More effective STI and behavioural interventions need to be developed for HIV control in mature epidemics Background Patient-based partner referral ( PBPR ) , which is the main method for treating sexual partners of patients with sexually transmitted diseases ( STDs ) , has limited effectiveness . Goal The authors compared the efficacy of PBPR with patient-delivered partner medication ( PDPM ) among patients attending the Mulago STD clinic in Kampala , Ug and a. Study Design A total of 383 patients ( 187 women , 196 men ) with STDs were r and omized to the PBPR or PDPM group . The proportion of sexual partners treated in either group was compared using the chi-square statistic by intention to treat for partners whose follow-up status was unknown . Results The two groups had similar background characteristics . Of the 237 partners elicited , 176 ( 74 % ) were reported treated in the PDPM group . In the PBPR group , in which 234 partners were elicited , 79 ( 34 % ) were referred to the treatment clinic . This difference was statistically significant ( risk ratio [ RR ] , 2.44 ; 95 % CI , 1.95–3.07;P < 0.001 ) . Furthermore , PDPM was more effective than PBPR for women and for casual partners for whom PBPR is considered difficult . For women , 86 of 103 partners in the PDPM group were reported treated , compared with 23 of 104 partners in the PBPR group ( RR , 4.55 ; 95 % CI , 2.92–7.08;P < 0.001 ) . For casual partners , 18 of 51 ( 34 % ) were reported treated in the PDPM group , compared with only three of 45 partners ( 7 % ) who were \n Output:\n " }, { "from": "agent", "value": "Reported barriers included sociocultural factors such as stigma , fear of abuse for having an STI , and infrastructural factors related to the limited number of STD clinics , and trained providers and reliable diagnostic methods .\nClient-oriented counselling was found to be effective in improving partner referral outcomes .\nConclusions STD clinics can improve PN with client-oriented counselling , which should help clients to overcome perceived barriers ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This study was design ed to evaluate the effects of enriching an essential amino acid ( EAA ) mixture with leucine on muscle protein metabolism in elderly and young individuals . Four ( 2 elderly and 2 young ) groups were studied before and after ingestion of 6.7 g of EAAs . EAAs were based on the composition of whey protein [ 26 % leucine ( 26 % Leu ) ] or were enriched in leucine [ 41 % leucine ( 41 % Leu ) ] . A primed , continuous infusion of L-[ring-2H5]phenylalanine was used together with vastus lateralis muscle biopsies and leg arteriovenous blood sample s for the determinations of fractional synthetic rate ( FSR ) and balance of muscle protein . FSR increased following amino acid ingestion in both the 26 % ( basal : 0.048 + /- 0.005%/h ; post-EAA : 0.063 + /- 0.007%/h ) and the 41 % ( basal : 0.036 + /- 0.004%/h ; post-EAA : 0.051 + /- 0.007%/h ) Leu young groups ( P < 0.05 ) . In contrast , in the elderly , FSR did not increase following ingestion of 26 % Leu EAA ( basal : 0.044 + /- 0.003%/h ; post-EAA : 0.049 + /- 0.006%/h ; P > 0.05 ) but did increase following ingestion of 41 % Leu EAA ( basal : 0.038 + /- 0.007%/h ; post-EAA : 0.056 + /- 0.008%/h ; P < 0.05 ) . Similar to the FSR responses , the mean response of muscle phenylalanine net balance , a reflection of muscle protein balance , was improved ( P < 0.05 ) in all groups , with the exception of the 26 % Leu elderly group . We conclude that increasing the proportion of leucine in a mixture of EAA can reverse an attenuated response of muscle protein synthesis in elderly but does not result in further stimulation of muscle protein synthesis in young subjects Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity BACKGROUND To describe the prevalence of sarcopenia in ambulatory patients with heart failure with preserved ejection fraction ( HFpEF ) and its relation to reduced exercise capacity , muscle strength , and quality of life ( QoL ) . METHODS AND RESULTS A total of 117 symptomatic out patients with HFpEF were prospect ively enrolled in Germany , Engl and , and Slovenia as part of the Studies Investigating Co-morbidities Aggravating Heart Failure ( SICA-HF ) . Appendicular skeletal muscle ( ASM ) mass ( the sum of muscle mass in both arms and legs ) was assessed by DEXA . Echocardiography , 6-minute walk testing ( 6-MWT ) , muscle strength assessment , spiroergometry and QoL evaluation using EQ-5D Question naire were performed . Sarcopenia was defined as ASM 2 st and ard deviations below the mean of a healthy reference group aged 18 - 40years . Patients were divided into 3 groups according to the E/e ' value : ≤8 , 9 - 14 , and ≥15 . Sarcopenia was detected in 19.7 % of all patients . These patients performed worse during 6-MWT ( 404±116 vs. 307±145 m , p=0.003 ) and showed lower absolute peak oxygen consumption ( 1579±474 vs. 1211±442mL/min , p<0.05 ) . Both ASM and muscle strength were lowest in patients with E/e ' > 15 ( p<0.05 ) . Higher values of muscle strength/ASM were associated with a better QoL ( r=0.5 , p<0.0005 ) . Logistic regression showed ASM to be independently associated with reduced distance walked during the 6-MWT adjusted for NYHA , height , left atrium diameter , ferritin and forced expiratory volume in 1s ( FEV1 ) ( odds ratio 1.2 , p=0.02 ) . CONCLUSION Sarcopenia affects a clinical ly relevant proportion of patients with HFpEF . Low ASM is strongly linked to reduced muscle strength , exercise capacity and QoL in these 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 AIMS To assess the prevalence and clinical impact of reductions in the skeletal muscle mass of patients with chronic heart failure ( HF ) . Chronic HF is accompanied by co-morbidities that influence the quality of life and outcomes . METHODS AND RESULTS We prospect ively enrolled 200 patients with chronic HF . The appendicular skeletal muscle mass of the arms and the legs combined , was assessed by dual energy X-ray absorptiometry . We analysed the muscle strength in arms and legs , and all patients underwent a 6-min walk test , a 4-m walk test , and spiroergometry testing . Muscle wasting was defined as the appendicular muscle mass 2 SD below the mean of a healthy reference group of adults aged 18 - 40 years , as suggested for the diagnosis of muscle wasting in healthy ageing ( sarcopenia ) . Muscle wasting was detected in 39 ( 19.5 % ) subjects . Patients with muscle wasting had significantly lower values for h and grip and quadriceps strength as well as lower total peak oxygen consumption ( peakVO2 , 1173 ± 433 vs. 1622 ± 456 mL/min ) , lower exercise time ( 7.7 ± 3.8 vs. 10.22 ± 3.0 min , both P < 0.001 ) , and lower left ventricular ejection fraction ( LVEF , P = 0.05 ) than patients without . The distance walked during 6 min and the gait speed during the 4-m walk were lower in patients with muscle wasting ( both P < 0.05 ) . Serum levels of interleukin-6 were significantly elevated in patients with muscle wasting ( P = 0.001 ) . Logistic regression showed muscle wasting to be independently associated with reduced peak VO2 adjusted for age , sex , New York Heart Association class , haemoglobin , LVEF , distance walked in 6 minutes , and the number of co-morbidities ( odds ratio 6.53 , p = 0.01 ) . CONCLUSION Muscle wasting is a frequent co-morbidity among patients with chronic HF . Patients with muscle wasting present with reduced exercise capacity and muscle strength , and advanced disease Background —Skeletal muscle dysfunction and exercise intolerance are clinical hallmarks of patients with heart failure . These have been linked to a progressive catabolic state , skeletal muscle inflammation , and impaired oxidative metabolism . Previous studies suggest beneficial effects of & ohgr;-3 polyunsaturated fatty acids and glutamine on exercise performance and muscle protein balance . Methods and Results —In a r and omized double-blind , placebo-controlled trial , 31 patients with heart failure were r and omized to either L-alanyl-L-glutamine ( 8 g/d ) and polyunsaturated fatty acid ( 6.5 g/d ) or placebo ( safflower oil and milk powder ) for 3 months . Cardiopulmonary exercise testing , dual-energy x-ray absorptiometry , 6-minute walk test , h and grip strength , functional muscle testing , echocardiography , and quality of life and lateral quadriceps muscle biopsy were performed at baseline and at follow-up . Oxidative capacity and metabolic gene expression were analyzed on muscle biopsies . No differences in muscle function , echocardiography , 6-minute walk test , or h and grip strength and a nonsignificant increase in peak VO2 in the treatment group were found . Lean body mass increased and quality of life improved in the active treatment group . Molecular analysis revealed no differences in muscle fiber composition , fiber cross-sectional area , gene expression of metabolic marker genes ( PGC1&agr ; , CPT1 , PDK4 , and GLUT4 ) , and skeletal muscle oxidative capacity . Conclusions —The combined supplementation of L-alanyl-L-glutamine and polyunsaturated fatty acid did not improve exercise performance or muscle function but increased lean body mass and quality of life in patients with chronic stable heart failure . These findings suggest potentially beneficial effects of high-dose nutritional polyunsaturated fatty acids and amino acid supplementations in patients with chronic stable heart failure . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT01534663 BACKGROUND & AIMS Heart Failure ( HF ) is a complex syndrome , which can include the physiological , neural hormonal and metabolic complications known as \" Cardiac Cachexia \" ( CC ) . In the development of CC there is a release of catabolic cytokines ( Tumor Necrosis Factor-α , interleukins 1 and 6 ) that cause a decrease of fat free mass and fat mass . These changes in body composition might be reversed with a therapeutic combination of resistance exercise and branched chain amino acid supplementation ( BCAA ) . AIM Evaluate changes in body composition after a resistance exercise program and BCAA supplementation in patients with HF . METHODS In a r and omized clinical trial with 3 month of follow-up anthropometric body composition analysis and stress tests were evaluated at the beginning and in the end of the study . Patients were divided into two groups ; the experimental group performed the resistance exercise program and received 10 g/day BCAA supplementation , and the control group only performed the resistance exercise program . Both groups were provided with individualized diets and conventional medical treatment . RESULTS Changes were found in hip circumference between the groups ( p = 0.02 ) , and muscle strength was increased in the experimental group ( 8 % ) and the control group ( 11.4 % ) with no difference between them . METS and VO2Max also increased in experimental and control groups ( 16.6 % and 50.1 % respectively ) . Regarding changes in symptoms , improvements in fatigue ( 45.4 % ) , decubitus intolerance ( 21.8 % ) and dyspnea ( 25.4 % ) were observed in the overall sample . CONCLUSION Improvements in physical and functional capacities are attributed to resistance exercise program but not to the BCAA supplementation . CLINICAL TRIALS IDENTIFIER NCT02240511 \n Output:\n " }, { "from": "agent", "value": "Data from 167 patients with CHF suggest that protein and /or EAA supplementation does not improve strength , but may increase six-minute walk test distance , muscle mass and QoL. The limited quality of the studies makes firm conclusions difficult , however protein and /or EAA supplementation may improve important outcome measures related to sarcopenia ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Obese women with the polycystic ovary syndrome are relatively unresponsive to the induction of ovulation by clomiphene . We hypothesized that reducing insulin secretion by administering metformin would increase the ovulatory response to clomiphene . METHODS We performed oral glucose-tolerance tests before and after the administration of 500 mg of metformin or placebo three times daily for 35 days in 61 obese women with the polycystic ovary syndrome . Women who did not ovulate spontaneously were then given 50 mg of clomiphene daily for five days while continuing to take metformin or placebo . Serum progesterone was measured on days 14 , 28 , 35 , 44 , and 53 , and ovulation was presumed to have occurred if the concentration exceeded 8 ng per milliliter ( 26 nmol per liter ) on any of these days . RESULTS Twenty-one women in the metformin group and 25 women in the placebo group were given clomiphene because they did not ovulate spontaneously during the first phase of the study . Among the 21 women given metformin plus clomiphene , the mean ( + /-SE ) area under the serum insulin curve after oral glucose administration decreased from 6745+/-2021 to 3479+/-455 microU per milliliter per minute ( 40.5+/-12.1 to 20.9+/-2.7 nmol per liter per minute , P=0.03 ) , but it did not change significantly in the 25 women given placebo plus clomiphene . Nineteen of the 21 women ( 90 percent ) who received metformin plus clomiphene ovulated ( mean peak serum progesterone concentration , 23.8+/-3.4 ng per milliliter [ 7.6+/-10.9 nmol per liter ] ) . Two of the 25 women ( 8 percent ) who received placebo plus clomiphene ovulated ( P<0.001 ) . Overall , 31 of the 35 women ( 89 percent ) treated with metformin ovulated spontaneously or in response to clomiphene , as compared with 3 of the 26 women ( 12 percent ) treated with placebo . CONCLUSIONS The ovulatory response to clomiphene can be increased in obese women with the polycystic ovary syndrome by decreasing insulin secretion with metformin Abdominal obesity and hyperinsulinemia play a key role in the development of the polycystic ovary syndrome ( PCOS ) . Dietary-induced weight loss and the administration of insulin-lowering drugs , such as metformin , are usually followed by improved hyper and rogenism and related clinical abnormalities . This study was carried out to evaluate the effects of combined hypocaloric diet and metformin on body weight , fat distribution , the glucose-insulin system , and hormones in a group of 20 obese PCOS women [ body mass index ( BMI ) > 28 kg/m2 ] with the abdominal phenotype ( waist to hip ratio > 0.80 ) , and an appropriate control group of 20 obese women who were comparable for age and pattern of body fat distribution but without PCOS . At baseline , we measured sex hormone , sex hormone-binding globulin ( SHBG ) , and leptin blood concentrations and performed an oral glucose tolerance test and computerized tomography ( CT ) at the L4-L5 level , to measure sc adipose tissue area ( SAT ) and visceral adipose tissue area . All women were then given a low-calorie diet ( 1,200 - 1,400 kcal/day ) alone for one month , after which anthropometric parameters and CT scan were newly measured . While continuing dietary treatment , PCOS women and obese controls were subsequently placed , in a r and om order , on metformin ( 850 mg/os , twice daily ) ( 12 and 8 , respectively ) or placebo ( 8 and 12 , respectively ) , according to a double-blind design , for the following 6 months . Blood tests and the CT scan were performed in each woman at the end of the study while they were still on treatment . During the treatment period , 3 women of the control group ( all treated with placebo ) were excluded because of noncompliance ; and 2 PCOS women , both treated with metformin , were also excluded because they became pregnant . Therefore , the women cohort available for final statistical analysis included 18 PCOS ( 10 treated with metformin and 8 with placebo ) and 17 control women ( 8 treated with metformin and 9 with placebo ) . The treatment was well tolerated . In the PCOS group , metformin therapy improved hirsutism and menstrual cycles significantly more than placebo . Baseline anthropometric and CT parameters were similar in all groups . Hypocaloric dieting for 1 month similarly reduced BMI values and the waist circumference in both PCOS and control groups , without any significant effect on CT scan parameters . In both PCOS and control women , however , metformin treatment reduced body weight and BMI significantly more than placebo . Changes in the waist-to-hip ratio values were similar in PCOS women and controls , regardless of pharmacological treatment . Metformin treatment significantly decreased SAT values in both PCOS and control groups , although only in the latter group were SAT changes significantly greater than those observed during the placebo treatment . On the contrary , visceral adipose tissue area values significantly decreased during metformin treatment in both PCOS and control groups , but only in the former was the effect of metformin treatment significantly higher than that of placebo . Fasting insulin significantly decreased in both PCOS women and controls , regardless of treatment , whereas glucose-stimulated insulin significantly decreased only in PCOS women and controls treated with metformin . Neither metformin or placebo significantly modified the levels of LH , FSH , dehydroepi and rosterone sulphate , and progesterone in any group , whereas testosterone concentrations decreased only in PCOS women treated with metformin . SHBG concentrations remained unchanged in all PCOS women ; whereas in the control group , they significantly increased after both metformin and placebo . Leptin levels decreased only during metformin treatment in both PCOS and control groups . ( ABSTRACT TRUNCATED BACKGROUND Insulin resistance and increased ovarian cytochrome P450c17 alpha activity are both features of the polycystic ovary syndrome . P450c17 alpha , which is involved in and rogen bio synthesis , has both 17 alpha-hydroxylase and 17,20-lyase activities . Increased activity of this enzyme results in exaggerated conversion of progesterone to 17 alpha-hydroxyprogesterone in response to stimulation by gonadotrophin . We hypothesized that hyperinsulinemia stimulates ovarian P450c17 alpha activity . METHODS We measured fasting serum steroid concentrations and the response of serum 17 alpha-hydroxyprogesterone to leuprolide , a gonadotrophin-releasing hormone agonist , and performed oral glucose-tolerance tests before and after oral administration of either metformin ( 500 mg three times daily ) or placebo for four to eight weeks in 24 obese women with the polycystic ovary syndrome . RESULTS In the 11 women given metformin , the mean ( + /- SE ) area under the serum insulin curve after oral glucose administration decreased from 9303 + /- 1603 to 4982 + /- 911 microU per milliliter per minute ( 56 + /- 10 to 30 + /- 6 nmol per liter per minute ) ( P = 0.004 ) . This decrease was associated with a reduction in the basal serum 17 alpha-hydroxyprogesterone concentration from 135 + /- 21 to 66 + /- 7 ng per deciliter ( 4.1 + /- 0.6 to 2.0 + /- 0.2 nmol per liter ) ( P = 0.01 ) and a reduction in the leuprolide-stimulated peak serum 17 alpha-hydroxyprogesterone concentration from 455 + /- 54 to 281 + /- 52 ng per deciliter ( 13.7 + /- 1.6 to 8.5 + /- 1.6 nmol per liter ) ( P = 0.01 ) . The serum 17 alpha-hydroxyprogesterone values increased slightly in the placebo group . In the metformin group , the basal serum luteinizing hormone concentration decreased from 8.5 + /- 2.2 to 2.8 + /- 0.5 mlU per milliliter ( P = 0.01 ) , the serum free testosterone concentration decreased from 0.34 + /- 0.07 to 0.19 + /- 0.05 ng per deciliter ( 12 + /- 3 to 7 + /- 2 pmol per liter ) ( P = 0.009 ) , and the serum sex hormone-binding globulin concentration increased from 0.8 + /- 0.2 to 2.3 + /- 0.6 microgram per deciliter ( 29 + /- 7 to 80 + /- 21 nmol per liter ) ( P < 0.001 ) . None of these values changed significantly in the placebo group . CONCLUSIONS In obese women with the polycystic ovary syndrome , decreasing serum insulin concentrations with metformin reduces ovarian cytochrome P450c17 alpha activity and ameliorates hyper and rogenism BACKGROUND This study aims to evaluate the impact of metformin on ovarian response when co-administered during recombinant (r)FSH using the low-dose step-up protocol in clomiphene citrate-resistant polycystic ovarian syndrome ( PCOS ) patients with normal glucose tolerance . METHODS AND RESULTS Thirty-two patients were r and omized to metformin ( n = 16 ) and placebo ( n = 16 ) groups . Hormonal assessment , a 75 g oral glucose tolerance test ( OGTT ) and a frequently sample d i.v . glucose tolerance test ( FSIGTT ) were performed before and after oral administration of metformin ( 850 mg twice daily ) or placebo for 6 weeks . Recombinant FSH treatment was undertaken , thereafter , in women who did not ovulate on metformin ( n = 10 ) or placebo ( n = 15 ) . There was no significant change in all insulin sensitivity indices in both groups . The only change noted was a decline in mean serum free testosterone concentration in the metformin group ( P = 0.049 ) . One patient on placebo and six patients on metformin ovulated spontaneously ( P < 0.05 ) . All parameters of ovarian response were comparable between the two groups during rFSH treatment . Combining the 6 week placebo or metformin-only period with a single rFSH treatment cycle , the overall ovulation rates were 75 and 94 % in the placebo and metformin groups respectively ( P > 0.05 ) . The respective figures for pregnancy were 6.3 and 31.3 % ( P > 0.05 ) . CONCLUSIONS Metformin may restore ovulation with no improvement on insulin resistance in clomiphene citrate-resistant PCOS patients with normal glucose tolerance , but has no significant effect on ovarian response during rFSH treatment OBJECTIVE To evaluate the effect of metformin therapy on hyper and rogenism , insulin resistance , cervical scores , ovulation , and pregnancy rates in clomiphene citrate-resistant women with polycystic ovary syndrome ( PCOS ) . DESIGN Prospect i ve , r and omized , double-blind , placebo-controlled study . SETTING Infertility clinic of a tertiary referral center . PATIENT(S ) Fifty-six women with clomiphene citrate-resistant PCOS . INTERVENTION(S ) Two cycles of oral metformin therapy ( 850 mg , twice daily ) in group I and placebo therapy ( twice daily ) in group II . Clomiphene citrate ( 100 mg/day ) on cycle days 3 - 7 of the second cycle in both groups . MAIN OUTCOME MEASURE(S ) Insulin , T , DHEAS , FSH , LH , body mass index ( BMI ) , waist-to-hip ratio , endometrial thickness , cervical score , ovulation , and pregnancy rates in clomiphene-induced cycles after metformin therapy . RESULT ( S ) Metformin therapy result ed in a significant decrease in total T , LH level , LH/FSH ratio , insulin resistance , and mean BMI . No difference in waist-to-hip ratio , DHEAS level , and fasting insulin level was observed . Clomiphene citrate induction result ed in higher ovulation rates and thicker endometrium in the metformin group than in the placebo group . There was higher cumulative pregnancy rate in the metformin group ; however , there was no significant difference in the pregnancy rate between the two groups . CONCLUSION ( S ) Metformin therapy not only decreases hyper and rogenism and insulin resistance but also improves ovulation rates , cervical scores , and pregnancy rates in clomiphene citrate-resistant women with PCOS We hypothesized that hyperinsulinemia contributes to early pregnancy loss in the polycystic ovary syndrome by adversely affecting endometrial function and environment . Serum glycodelin , a \n Output:\n " }, { "from": "agent", "value": "Metformin has an effect in reducing fasting insulin concentrations , blood pressure , and low density lipoprotein cholesterol .\nWe found no evidence of any effect on body mass index or waist : hip ratio .\nMetformin was associated with a higher incidence of nausea , vomiting , and other gastrointestinal disturbance .\nCONCLUSIONS Metformin is an effective treatment for anovulation in women with polycystic ovary syndrome .\nNo data are available regarding the safety of metformin in long term use in young women and only limited data on its safety in early pregnancy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE The purpose of this study was to evaluate the effect of hormone replacement therapy ( HRT ) on the acute and chronic hormonal responses to resistance exercise in post-menopausal women . METHODS Thirty-two post-menopausal women were recruited for this study ; 16 who were currently using HRT and 16 who were not using HRT . Subjects in both the HRT and NHRT groups were r and omly assigned to either a resistance training group ( N = 16 ; 8 HRT and 8 NHRT ) or a control group ( N = 16 ; 8 HRT and 8 NHRT ) . The training group completed a supervised resistance training program three times a week for 12 weeks . To evaluate changes in hormone levels , resting blood sample s were drawn at weeks 0 , 4 , and 13 of the program . In addition , at weeks 0 and 13 , post-exercise blood sample s were drawn in order to examine the hormone response to an acute bout of resistance exercise . Sample s were analyzed for serum growth hormone ( GH ) , insulin-like growth factor-1 ( IGF-1 ) , testosterone , estradiol , dehydroepi and rosterone ( DHEA ) , and cortisol . RESULTS There were no significant changes in resting hormone levels between weeks 0 , 4 , and 13 of the training program . There was a significant week-by-group interaction for DHEA ( P < 0.05 ) and cortisol ( P < 0.05 ) with the NHRT-training group having a greater post-exercise increase in DHEA and cortisol after training . Overall , the post-exercise GH levels were significantly greater than pre-exercise ( P < 0.05 ) or recovery levels ( P < 0.01 ) . There were no significant differences between HRT and NHRT groups in the acute hormone response to exercise . CONCLUSION These results indicate that HRT will not have an effect on the acute or chronic hormone response to a recreational resistance training program in post-menopausal women Elevated circulating estrogens and a sedentary lifestyle increase risk for breast cancer . The effect of exercise on circulating estrogens in sedentary postmenopausal women is unknown . The objective of this study was to examine the effects of a 12-month moderate-intensity exercise intervention on serum estrogens . We r and omly assigned 173 sedentary , overweight ( body mass index > 24.0 kg/m(2 ) , body fat > 33 % ) , postmenopausal women , ages 50 - 75 years , not using hormone therapy , living in the Seattle , Washington , area for the next year , and willing to be r and omly assigned to an exercise intervention or stretching control group . The exercise intervention included facility and home-based exercise ( 45 min , 5 days/week moderate intensity sports/recreational exercise ) . A total of 170 ( 98.3 % ) women completed the study with exercisers averaging 171 min/week of exercise . After 3 months , exercisers experienced declines in estrone , estradiol , and free estradiol of 3.8 , 7.7 , and 8.2 % , respectively , versus no change or increased concentrations in controls ( P = 0.03 , 0.07 , and 0.02 , respectively ) . At 12 months , the direction of effect remained the same , although the differences were no longer statistically significant . The effect was limited to women who lost body fat : women whose percentage of body fat [ by dual energy x-ray absortiometry ( DEXA ) ] decreased by > /== \" BORDER=\"0\">2 % had statistically significant ( comparing exercisers versus controls ) decreases at 12 months of 11.9 , 13.7 , and 16.7 % for serum estrone , estradiol , and free estradiol , respectively . We concluded that a 12-month moderate-intensity exercise intervention in postmenopausal women result ed in significant decreases in serum estrogens . The association between increased physical activity and reduced risk for postmenopausal breast cancer may be partly explained by effects on serum estrogens BACKGROUND Women with polycystic ovary syndrome ( PCOS ) present with vascular abnormalities , including elevated markers of endothelial dysfunction . There is limited evidence for the effect of lifestyle modification and weight loss on these markers . The aim of this study was to determine if 20 weeks of a high-protein energy-restricted diet with or without exercise in women with PCOS could improve endothelial function . METHODS This is a secondary analysis of a subset of 50 overweight/obese women with PCOS ( age : 30.3 ± 6.3 years ; BMI : 36.5 ± 5.7 kg/m(2 ) ) from a previous study . Participants were r and omly assigned by computer generation to one of three 20-week interventions : diet only ( DO ; n = 14 , ≈ 6000 kJ/day ) , diet and aerobic exercise ( DA ; n = 16 , ≈ 6000 kJ/day and five walking sessions/week ) and diet and combined aerobic-resistance exercise ( DC ; n = 20 , ≈ 6000 kJ/day , three walking and two strength sessions/week ) . At Weeks 0 and 20 , weight , markers of endothelial function [ vascular cell adhesion molecule-1 ( sVCAM-1 ) , inter-cellular adhesion molecule-1 ( sICAM-1 ) , plasminogen activator inhibitor-1 ( PAI-1 ) and asymmetric dimethylarginine ( ADMA ) ] , insulin resistance and hormonal profile were assessed . RESULTS All three treatments result ed in significant weight loss ( DO 7.9 ± 1.2 % , DA 11.0 ± 1.6 % , DC 8.8 ± 1.1 ; P < 0.001 for time ; P = 0.6 time × treatment ) . sVCAM-1 , sICAM-1 and PAI-1 levels decreased with weight loss ( P≤ 0.01 ) , with no differences between treatments ( P ≥ 0.4 ) . ADMA levels did not change significantly ( P = 0.06 ) . Testosterone , sex hormone-binding globulin and the free and rogen index ( FAI ) and insulin resistance also improved ( P < 0.001 ) with no differences between treatments ( P ≥ 0.2 ) . Reductions in sVCAM-1 were correlated to reductions in testosterone ( r = 0.32 , P = 0.03 ) and FAI ( r = 0.33 , P = 0.02 ) as well as weight loss ( r= 0.44 , P = 0.002 ) . Weight loss was also associated with reductions in sICAM-1 ( r= 0.37 , P = 0.008 ) . CONCLUSIONS Exercise training provided no additional benefit to following a high-protein , hypocaloric diet on markers of endothelial function in overweight/obese women with PCOS Polycystic ovary syndrome ( PCOS ) , the most common endocrine disorder in women of reproductive age , is characterized by hyper and rogenism , oligo/amenorrhea , and polycystic ovaries . We aim ed to determine whether low-frequency electro-acupuncture ( EA ) would decrease hyper and rogenism and improve oligo/amenorrhea more effectively than physical exercise or no intervention . We r and omized 84 women with PCOS , aged 18 - 37 yr , to 16 wk of low-frequency EA , physical exercise , or no intervention . The primary outcome measure changes in the concentration of total testosterone ( T ) at week 16 determined by gas and liquid chromatography-mass spectrometry was analyzed by intention to treat . Secondary outcome measures were changes in menstrual frequency ; concentrations of and rogens , estrogens , and rogen precursors , and glucuroni date d and rogen metabolites ; and acne and hirsutism . Outcomes were assessed at baseline , after 16 wk of intervention , and after a 16-wk follow-up . After 16 wk of intervention , circulating T decreased by -25 % , and rosterone glucuronide by -30 % , and and rostane-3α,17β-diol-3-glucuronide by -28 % in the EA group ( P = 0.038 , 0.030 , and 0.047 , respectively vs. exercise ) ; menstrual frequency increased to 0.69/month from 0.28 at baseline in the EA group ( P = 0.018 vs. exercise ) . After the 16-wk follow-up , the acne score decreased by -32 % in the EA group ( P = 0.006 vs. exercise ) . Both EA and exercise improved menstrual frequency and decreased the levels of several sex steroids at week 16 and at the 16-wk follow-up compared with no intervention . Low-frequency EA and physical exercise improved hyper and rogenism and menstrual frequency more effectively than no intervention in women with PCOS . Low-frequency EA was superior to physical exercise and may be useful for treating hyper and rogenism and oligo/amenorrhea Background : It is hypothesized that exercise can lead to a decrease in breast cancer risk through several hormonal and nonhormonal mechanisms . The WISER ( Women In Steady Exercise Research ) study investigated the effects of aerobic exercise on premenopausal sex hormone levels . Methods : Three hundred ninety-one sedentary , healthy , young eumenorrheic women were r and omized either into an exercise intervention of 30 minutes of aerobic exercise 5 times a week for approximately 16 weeks ( n = 212 ) or into a control group ( n = 179 ) . Serum levels of estradiol , estrone sulfate , testosterone , and sex hormone – binding globulin ( SHBG ) , all in the midfollicular phase , and of progesterone , in the midluteal phase , were measured at baseline and at the end of the 16-week period . Results : Compared with the controls ( n = 153 ) , exercisers ( n = 166 ) experienced significant increases in aerobic fitness , lean body mass , and decreases in percent body fat . There were no significant changes in body weight and menstrual cycle length between or within groups . Progesterone decreased significantly in exercisers ; however , this reduction was similar to that of the control group . No significant changes between or within groups were found for any of the other sex hormones or SHBG . Conclusions : In premenopausal women , 16 weeks of 150 minutes per week of moderate aerobic exercise in young women did not significantly alter sex hormone or SHBG levels . Impact : Any favorable effects that moderate aerobic exercise without an associated weight change may have on breast cancer risk in premenopausal women are unlikely to be a consequence of changes in levels of sex hormones or SHBG . Cancer Epidemiol Biomarkers Prev ; 20(6 ) ; 1098–106 . © 2011 AACR Physical activity has been proposed as one strategy to enhance bone mineral acquisition ; however , the basic mechanisms of this effect are not fully understood . The purpose of this study was to investigate the effect of 12 weeks of resistance training on hormones of bone formation in young sedentary women . Twenty sedentary females ( aged 25.3 ± 3.2 years ; ±SD ) volunteered to participate in this study . The subjects were r and omly assigned to a training group ( n = 10 ) or control group ( n = 10 ) . Subjects executed eight resistance exercises selected to stress the major muscle groups in the following order : chest press , leg extension , shoulder press , leg curls , latissimus pull down , leg press , arm curls , and triceps extension . Resistance training consisted of 50–60 min of circuit weight training per day , 3 days a week , for 12 weeks . This training was circularly performed in eight stations and included two to four sets with 8–12 maximal repetitions at 65–80 % of one-repetition maximum in each station . After 12 weeks , the training group had a significant increase ( P < 0.05 ) in the growth hormone , estrogen , parathyroid hormone and testosterone compared to the control group . The results showed that insulin-like growth factor I levels did not change significantly in response to resistance training . In conclusion , the results suggest that resistance training with specific intensity and duration utilized in this study increases the hormones of bone formation in young sedentary women CONTEXT Polycystic ovary syndrome ( PCOS ) presents in adolescence , and obesity is a common finding . The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear . OBJECTIVE We investigated the effects of metformin , oral contraceptives ( OCs ) , and /or lifestyle modification in obese adolescent women with PCOS . DESIGN Two small , r and omized , placebo-controlled clinical trials were performed . PATIENTS AND PARTICIPANTS A total of 79 obese adolescent women with PCOS participated . INTERVENTIONS In the single treatment trial , subjects were r and omized to metformin , placebo , a lifestyle modification program , or OC . In the combined treatment trial , all subjects received lifestyle modification and OC and were r and omized to metformin or placebo . MAIN OUTCOME MEASURES Serum concentrations of and rogens and lipids were measured . RESULTS Lifestyle modification alone result ed in a 59 % reduction in free and rogen index with a 122 % increase in SHB \n Output:\n " }, { "from": "agent", "value": "Subgroup analyses suggest that this effect is independent of menopausal status and is more noticeable for non-obese women and for high intensity exercise .\nMeta- analysis for secondary outcomes found that physical activity induces a statistically significant decline of free testosterone , and rostenedione , dehydroepi and rosterone – sulfate and adiposity markers , while a significant increase of SHBG was observed .\nConclusions Although the effect is relatively modest , physical activity induces a decrease in circulating sex hormones and this effect is not entirely explained by weight loss .\nThe findings emphasize the benefits of physical activity for women" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We identified patients who experienced ovarian hyperstimulation syndrome ( OHSS ) ( n = 16 ) and compared their baseline pretreatment levels of müllerian-inhibiting substance ( MIS ) to age- and weight-matched patients with normal responses to gonadotropins ( n = 14 ) . Baseline serum MIS in patients with OHSS were sixfold higher than those seen in normal controls ( 3.62 + /- 0.87 vs. 0.63 + /- 0.09 ng/mL ; P=.0036 ) , indicating that MIS could potentially serve as a useful marker for identifying patients at risk for OHSS BACKGROUND Anti-Müllerian hormone ( AMH ) is produced by the granulosa cells of preantral and small antral follicles and its levels can be assessed in serum . Since the number of ovarian follicles declines with increasing age , AMH levels might be used as a marker for ovarian ageing . Therefore , we studied the relationship between AMH levels and ovarian response during ovarian stimulation for IVF . METHODS A total of 130 patients undergoing their first IVF treatment cycle using a long protocol with GnRH agonist was prospect ively included . Blood withdrawal was performed and the number of antral follicles was assessed by ultrasound on day 3 of a spontaneous cycle . Poor response and the number of oocytes were used as primary outcome measures . In a r and om subset of 23 patients a GnRH agonist stimulation test was performed to investigate whether a rise in FSH and LH would affect AMH levels . RESULTS The data of 119 patients were analysed . Serum AMH levels were highly correlated with the number of antral follicles ( r = 0.77 ; P < 0.01 ) and the number of oocytes retrieved ( r = 0.57 , P < 0.01 ) . A negative association was found between AMH levels and poor ovarian response ( fewer than 4 oocytes or cycle cancellation ; OR 0.82 , 95 % CI 0.75 - 0.90 , P < 0.01 ) . Inclusion of inhibin B and FSH concentrations to AMH in a multivariate model improved the prediction of ovarian response . The post GnRH agonist rise in FSH and LH levels did not influence AMH values . CONCLUSIONS Poor response in IVF , indicative of a diminished ovarian reserve , is associated with reduced baseline serum AMH concentrations . In line with recent observations it appears that AMH can be used as a marker for ovarian ageing BACKGROUND To test whether ovarian stimulation for in-vitro fertilization ( IVF ) affects oocyte quality and thus chromosome segregation behaviour during meiosis and early embryo development , preimplantation genetic screening of embryos was employed in a prospect i ve , r and omized controlled trial , comparing two ovarian stimulation regimens . METHODS Infertile patients under 38 years of age were r and omly assigned to undergo a mild stimulation regimen using gonadotrophin-releasing hormone ( GnRH ) antagonist co-treatment ( 67 patients ) , which does not disrupt secondary follicle recruitment , or a conventional high-dose exogenous gonadotrophin regimen and GnRH agonist co-treatment ( 44 patients ) . Following IVF , embryos were biopsied at the eight-cell stage and the copy number of 10 chromosomes was analysed in 1 or 2 blastomeres . RESULTS The study was terminated prematurely , after an unplanned interim analysis ( which included 61 % of the planned number of patients ) found a lower embryo aneuploidy rate following mild stimulation . Compared with conventional stimulation , significantly fewer oocytes and embryos were obtained following mild stimulation ( P < 0.01 and < 0.05 , respectively ) . Consequently , both regimens generated on average a similar number ( 1.8 ) of chromosomally normal embryos . Differences in rates of mosaic embryos suggest an effect of ovarian stimulation on mitotic segregation errors . CONCLUSIONS Future ovarian stimulation strategies should avoid maximizing oocyte yield , but aim at generating a sufficient number of chromosomally normal embryos by reduced interference with ovarian physiology Purpose To evaluate the predictive value of basal serum anti-müllerian hormone level and small antral follicle count for high ovarian response to controlled ovarian hyperstimulation . Methods A total of 159 patients were prospect ively included . Basal serum anti-müllerian hormone and small antral follicle count ( 2–6 mm ) were measured . Results Small antral follicle count and anti-müllerian hormone have similar predictive accuracy for high ovarian response with area under curve of 0.961 and 0.922 , respectively . The sensitivity and specificity for prediction of high ovarian response were 89 % and 92 % for small antral follicle count and 93 % and 78 % for anti-müllerian hormone at the cutoff values of ≥ 16 and ≥ 34.5 pmol/l , respectively . Conclusions Small antral follicle count and anti-müllerian hormone are equally accurate predictors of high ovarian response and facilitate determination of the optimal strategy for controlled ovarian hyperstimulation The effect of 100 and 200 IU per day recombinant FSH ( rFSH ) on numbers of oocytes retrieved and the total dose used in ovarian stimulation before intracytoplasmic sperm injection was investigated in a double-blind , r and omized multicentre trial . A total of 91 women was treated with a low-dose protocol and 88 with a high-dose regimen at five centres . For each started cycle , significantly more oocytes were retrieved in the 200 IU group than in 100 IU group ( 12.0 versus 5.7 , P < 0.001 ) ; total rFSH consumption was 1121 and 1875 IU in the low- and high-dose groups respectively . Significant variations were noted between centres with regard to numbers of oocytes collected per started cycle , ranging from 2.8 to 7.2 in the 100 IU group and from 9.0 to 19.1 in the high-dose group . Exploratory analyses of secondary outcomes suggested there were no differences in vital pregnancy rates per started cycle ( 19.2 versus 16.9 % ) and per embryo transfer ( 26.2 versus 19.3 % ) in the low- and high dose groups respectively . There were four hospitalizations due to ovarian hyperstimulation syndrome , all in the 200 IU group 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 BACKGROUND Serum anti-Müllerian hormone ( AMH ) levels provide a powerful means for predicting ovarian response , which is reflected not only by the size of the primordial follicle pool but also by the quality of the oocytes . Considering a mutual interdependence between AMH-expressing somatic cells and gametes , this prospect i ve morphological study was set up to evaluate whether extreme AMH levels represent diminished oocyte quality and developmental incompetence . METHODS A total of 141 consecutive ICSI patients were subdivided into three groups using the 25th and 75th percentiles of the serum AMH levels ( cycle day 3 ) . In these three groups , morphology of all oocytes and fertilization rate , embryo quality and blastocyst formation were evaluated , and FSH , LH and estradiol ( E(2 ) ) levels were also measured . RESULTS Cycle cancellation rate was correlated with AMH levels ( P < 0.05 ) . AMH groups 1 ( < 1.66 ng/ml ) and 3 ( > 4.52 ng/ml ) showed oocytes of lower quality [ dark central granulation , aggregation of smooth endoplasmic reticulum ( sER ) ] compared with the median group 2 ( 1.66 - 4.52 ng/ml ) . Basal serum FSH did not allow for adequate prognosis in terms of gamete appearance . Fertilization and further cleavage up to blastocyst stage was not affected by AMH levels . CONCLUSIONS AMH seems to be superior to FSH in predicting both oocyte number and quality 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 . SETTING The study was conducted at a university hospital . MAIN OUTCOME MEASURES AMH , FSH , LH , and estradiol measurements were allocated to one of seven cycle phases , and a multilevel analysis was performed . Consistent fluctuation patterns were tested by fitting sine patterns to the data . Finally , the frequency in which r and omly selected individual sample s would remain in one of five preset level categories ( quintiles ) for each of the variables was studied . RESULTS A sine pattern fitted to the AMH data was not statistically significant ( P = 0.40 ) . In contrast , sine patterns for FSH , LH , and estradiol were highly significant . Comparing the seven cycle phases , no significant differences could be observed between phase-specific AMH levels ( P = 0.06 ) . Repeated selection of AMH sample s for each individual showed that in 71.5 % of selection s , AMH values remained in the same quintile , whereas in 27.9 % values fell in an adjacent quintile . CONCLUSIONS AMH levels measured through a full menstrual cycle did not show consistent fluctuation patterns in contrast to levels of FSH , LH , and estradiol . Furthermore , r and om fluctuations were small , indicating that AMH can be relied on as a cycle-independent marker for ovarian reserve BACKGROUND Mild in-vitro fertilisation ( IVF ) treatment might lessen both patients ' discomfort and multiple births , with their associated risks . We aim ed to test the hypothesis that mild IVF treatment can achieve the same chance of a pregnancy result ing in term livebirth within 1 year compared with st and ard treatment , and can also reduce patients ' discomfort , multiple pregnancies , and costs . METHODS We did a r and omised , non-inferiority effectiveness trial . 404 patients were r and omly assigned to undergo either mild treatment ( mild ovarian stimulation with gonadotropin-releasing hormone [ GnRH ] antagonist co-treatment combined with single embryo transfer ) or a st and ard treatment ( stimulation with a GnRH agonist long- protocol and transfer of two embryos ) . Primary endpoints were proportion of cumulative pregnancies leading to term livebirth within 1 year after r and omisation ( with a non-inferiority threshold of -12.5 % ) , total costs per couple up to 6 weeks after expected date of delivery , and overall discomfort for patients . Analysis was by intention to treat . This trial is registered as an International St and ard R and omised Clinical Trial , number IS RCT N35766970 . FINDINGS The proportions of cumulative pregnancies that result ed in term livebirth after 1 year were 43.4 % with mild treatment and 44.7 % with st and ard treatment ( absolute number of patients = 86 for both groups ) . The lower limit of the one-sided 95 % CI was -9.8 % . The proportion of couples with multiple pregnancy outcomes was 0.5 % with mild IVF treatment versus 13.1 % ( p<0.0001 ) with st and ard treatment , and mean total costs were 8333 euros and 10745 euros , respectively ( difference 2412 euros , 95 % CI 703 - 4131 ) . There were no significant differences between the groups in the anxiety , depression , physical discomfort , or sleep quality of the mother . INTERPRETATION Over 1 year of treatment , cumulative rates of term livebirths and patients ' discomfort are much the same for mild ovarian stimulation with single embryos transferred and for \n Output:\n " }, { "from": "agent", "value": "Both AMH and AFC are accurate predictors of excessive response to ovarian hyperstimulation .\nMoreover , both tests appear to have clinical value ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The psychological response to breast cancer , such as a fighting spirit or an attitude of helplessness and hopelessness toward the disease , has been suggested as a prognostic factor with an influence on survival . We have investigated the effect of psychological response on disease outcome in a large cohort of women with early-stage breast cancer . METHODS 578 women with early-stage breast cancer were enrolled in a prospect i ve survival study . Psychological response was measured by the mental adjustment to cancer ( MAC ) scale , the Courtauld emotional control ( CEC ) scale , and the hospital anxiety and depression ( HAD ) scale 4 - 12 weeks and 12 months after diagnosis . The women were followed up for at least 5 years . Cox 's proportional-hazards regression was used to obtain the hazard ratios for the measures of psychological response , with adjustment for known clinical factors associated with survival . FINDINGS At 5 years , 395 women were alive and without relapse , 50 were alive with relapse , and 133 had died . There was a significantly increased risk of death from all causes by 5 years in women with a high score on the HAD scale category of depression ( hazard ratio 3.59 [ 95 % CI 1.39 - 9.24 ] ) . There was a significantly increased risk of relapse or death at 5 years in women with high scores on the helplessness and hopelessness category of the MAC scale compared with those with a low score in this category ( 1.55 [ 1.07 - 2.25 ] ) . There were no significant results found for the category of \" fighting spirit \" . INTERPRETATION For 5-year event-free survival a high helplessness/hopelessness score has a moderate but detrimental effect . A high score for depression is linked to a significantly reduced chance of survival ; however , this result is based on a small number of patients and should be interpreted with caution Little has been done to study the effectiveness of antidepressants in controlling anxiety/depression in a population of cancer patients . A double‐blind placebo‐controlled study was therefore design ed to assess the effectiveness of 20 mg fluoxetine . Of 115 cancer patients who fulfilled entry criteria for levels of distress , 45 patients were r and omized to a fluoxetine treatment group ( FA ) and 46 patients to a placebo group ( PA ) after a 1‐week placebo period design ed to exclude placebo responders . The Montgomery and Asberg Depression Scale ( MADRS ) , the Hamilton Anxiety Scale ( HAS ) , the Hospital Anxiety and Depression Scale ( HADS ) , the Revised Symptom Checklist ( SCL90‐R ) and the Spitzer Quality of Life Index ( SQOLI ) were used to assess the efficacy of fluoxetine . The response rate , defined by a HADS score lower than 8 after 5 weeks of treatment , was not significantly higher in the FA group ( 11 % ) compared to the PA group ( 7 % ) . Compared to the PA group , patients in the FA group showed a significantly greater decrease in SCL90‐R mean total score after 5 weeks , but not a greater decrease in HADS mean score . No difference between the two groups was found in observer‐reported assessment s ( MADRS , HAS and SQOLI ) . Significantly more drop‐outs were observed in the FA group ( n=15 ) than in the PA group ( n=7 ) , although the frequencies of side‐effects were not significantly different Cancer patients diagnosed with solid tumors and undergoing a first course of chemotherapy were r and omized to either conventional care or a 10 contact 20 week cognitive behavioral intervention design ed to reduce emotional distress . Three hypotheses were tested . First , a test for a group effect found that patients in the intervention who entered the trial with higher symptom severity reported significantly lower depression at 10 but not 20 weeks . Patients in the experimental group who entered with higher depression were more depressed at 10 weeks than patients in the control group . The second hypothesis compared the intervention in two sub-indices of symptom severity ; one comprised of symptoms with a depressive component , the other of symptoms not associated with depression . The intervention was more effective in lowering depression at 10 weeks through an interaction with the non-depressive symptom sub-index . At 20 weeks , a significant main effect for the intervention on depression was observed . No interaction with either sub-index was observed . The third hypothesis found no main or interaction effect between psychotropic drugs and the intervention . In conclusion , behavioral interventions may influence depression differently over time . Initially , the intervention lowered depression through certain symptoms and only later did it effect depression directly . Symptoms with an affective component are relatively unaffected by the intervention which was independent of the presence of psychotropic medications Summary Background . Fatigue can significantly interfere with a cancer patient ’s ability to fulfill daily responsibilities and enjoy life . It commonly co-exists with depression in patients undergoing chemotherapy , suggesting that administration of an antidepressant that alleviates symptoms of depression could also reduce fatigue . Methods . We report on a double-blind clinical trial of 94 female breast cancer patients receiving at least four cycles of chemotherapy r and omly assigned to receive either 20 mg of the selective serotonin re-uptake inhibitor ( SSRI ) paroxetine ( Paxil ® , SmithKline Beecham Pharmaceuticals ) or an identical-appearing placebo . Patients began their study medication seven days following their first on- study treatment and continued until seven days following their fourth on- study treatment . Seven days after each treatment , participants completed question naires measuring fatigue ( Multidimensional Assessment of Fatigue , Profile of Mood States-Fatigue/Inertia subscale and Fatigue Symptom Checklist ) and depression ( Profile of Mood States-Depression subscale [ POMS-DD ] and Center for Epidemiologic Studies -Depression [ CES-D ] ) . Results . Repeated- measures ANOVAs , after controlling for baseline measures , showed that paroxetine was more effective than placebo in reducing depression during chemotherapy as measured by the CES-D ( p=0.006 ) and the POMS-DD ( p=0.07 ) but not in reducing fatigue ( all measures , ps > 0.27 ) . Conclusions . Although depression was significantly reduced in the 44 patients receiving paroxetine compared to the 50 patients receiving placebo , indicating that a biologically active dose was used , no significant differences between groups on any of the measures of fatigued were observed . Results suggest that modulation of serotonin may not be a primary mechanism of fatigue related to cancer treatment Abstract Objective : To determine the efficacy of adjuvant psychological therapy in patients with testicular cancer and to compare the characteristics and psychosocial outcomes of men who agreed to participate with those who declined to participate in a r and omised trial of psychological intervention . Design : Newly diagnosed patients were asked to participate in a r and omised trial of psychological support compared with st and ard medical care . Participants and non- participants completed self assessment question naires at baseline and at 2 , 4 and 12 months . Setting : Testicular Tumour Unit of the Royal Marsden Hospital . Subjects : 73 of 184 ( 40 % ) eligible patients agreed to enter the r and omised trial ( participants ) and 81 ( 44 % ) declined to participate but agreed to complete further assessment s ( non- participants ) . 30 patients wanted no further contact with the research ers . Outcome measures : Hospital anxiety and depression scale , psychosocial adjustment to illness scale , Rotterdam symptom checklist , mental adjustment to cancer scale . Only scores on the hospital anxiety and depression scale are reported for evaluating treatment efficacy . Results : 111 of 184 ( 60 % ) eligible men declined to participate in the trial . Patients with stage I disease were most likely to refuse to participate . A patient was less likely to participate if he had low volume disease and was receiving no further treatment . Likelihood of participation was associated with stage of disease and with type of primary treatment ( P<0.001 for heterogeneity ) . Patients with early stage disease ( P<0.001 ) and fewer physical symptoms ( P<0.001 ) were less likely to participate . Psychosocial factors associated with participation included anxious preoccupation regarding disease ( P=0.01 ) . There were no differences in outcome between participants and non- participants during follow up . Patients seemed to gain little benefit from adjuvant psychological therapy . At 2 months change from baseline favoured the treated group in the anxiety subscale ( mean difference between groups −1.41 ( 95 % confidence interval −2.86 to 0.03 ) ) . This was not sustained when adjusted for factors related to the disease . By 12 months change from baseline seemed to favour the control group ( mean difference between groups 1.66 ( −0.18 to 3.50 ) ) . Conclusions : Patients with testicular cancer seem to have considerable coping abilities . Those who declined to participate in the trial differed from those who participated . Those who agreed to participate may comprise the clinical group who perceive a need for psychological support . No evidence was found to indicate a need for routinely offering adjuvant psychological therapy . Key messages Counselling for patients with cancer is widely advocated , although its effectiveness has not been fully evaluated No study of patients with cancer has evaluated a psychological intervention in young men or in a group of patients with a disease with an excellent prognosis Most patients with testicular cancer declined to participate in this r and omised trial of adjuvant psychological therapy , and those who participated had more psychosocial dysfunction No evidence of benefit was observed after treatment with adjuvant psychological therapy in this group of patients There were no consistently significant differences in psychosocial outcome over one year between those who agreed to participate and those who declined to BACKGROUND We conducted a r and omised , controlled trial of cognitive-existential group therapy ( CEGT ) for women with early stage breast cancer receiving adjuvant chemotherapy with the aim of improving mood and mental attitude to cancer . METHODS Women were r and omised to 20 sessions of weekly group therapy plus 3 relaxation classes or to a control arm receiving 3 relaxation classes . Assessment s , independently done at baseline , 6 and 12 months , included a structured psychiatric interview and vali date d question naires covering mood , attitudes to cancer , family relationships , and satisfaction with therapy . RESULTS Three hundred and three of 491 ( 62 % ) eligible patients participated over 3 years . Distress was high pre-intervention : 10 % were diagnosed as suffering from major depression , 27 % from minor depression and 9 % from anxiety disorders . On an intention-to-treat analysis , there was a trend for those receiving group therapy ( n=154 ) to have reduced anxiety ( p=0.05 , 2-sided ) compared to controls ( n=149 ) . Women in group therapy also showed a trend towards improved family functioning compared to controls ( p=0.07 , 2-sided ) . The women in the groups reported greater satisfaction with their therapy ( p<0.001 , 2-sided ) , appreciating the support and citing better coping , self-growth and increased knowledge about cancer and its treatment . They valued the CEGT therapy . Overall effect size for the group intervention was small ( d=0.25 ) , with cancer recurrence having a deleterious effect in three of the 19 therapy groups . Psychologists as a discipline achieved a moderate mean effect size ( d=0.52 ) . CONCLUSION CEGT is a useful adjuvant psychological therapy for women with early stage breast cancer . Interaction effects between group members and therapists are relevant to outcome . Group-as-a-whole effects are powerful , but the training and experience of the therapist is especially critical to an efficacious outcome Urinary and sexual dysfunctions are side effects of radical prostatectomy ( RP ) for prostate cancer ( PC ) that contribute to depression . Despite the effectiveness of support groups at reducing depression in cancer patients , men typically do not participate in them . The purpose of this pilot study was to test the effects of a dyadic intervention ( one-to-one support ) on social support ( Modified Inventory of Socially Supportive Behaviors ) , self-efficacy ( Stanford Inventory of Cancer Patient Adjustment ) , and depression ( Geriatric Depression Scale ) . Subjects were r and omized to group . Controls ( N=15 ; Mage=59.7 ) received usual care . Experimentals were paired with long-term survivors ( LTS ) who had RP and who had treatment side effects in common . Experimentals ( N=15 ; Mage=57.5 ) met with a LTS 8 times in 8 weeks to discuss concerns associated with survivorship . No significant differences were detected on social support , but after 4 weeks , significant differences were present on depression between controls and experimentals , however these differences were not seen at 8 weeks . After 8 weeks , there were also significant differences on self-efficacy between controls and experimentals . Weekly anecdotal data supported the feasibility and acceptance of the intervention that was a low cost strategy effective at reducing depression and increasing self-efficacy in men treated by RP . Future research directions and clinical application is presented Women with breast carcinoma commonly experience psychologic distress following their diagnosis . Women who participate in breast cancer support groups have reported significant reduction in their psychologic distress and pain and improvement in the quality of their lives . Web‐based breast cancer social support groups are widely used , but little is known of their effectiveness . Preliminary evidence suggests that women benefit from their participation in web‐based support groups Increasing numbers of women with breast cancer are seeking alternatives to st and ard group support in coping with their illness . This study examines outcomes for 181 women with breast cancer r and omized to either a 12-week st and ard group support or a 12-week complementary and alternative medicine ( CAM ) support intervention . Participants in the CAM group were taught the use of meditation , affirmation , imagery and ritual . The st and ard group combined cognitive-behavioral approaches with group sharing and \n Output:\n " }, { "from": "agent", "value": "Contrary to previous review s that failed to distinguish between depressive symptoms and depression , this review found very little data from clinical trials ( without the possibility of confounding factors ) to demonstrate that psychotherapeutic interventions are effective in reducing depression in cancer patients .\nA number of small-scale , single-centre trials indicated that psychotherapeutic interventions ( especially cognitive behavioural therapy ) can have effects on depressive symptoms in cancer patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective . Gastroesophageal reflux disease has been reported to be a common burden on health-care re sources in the Western world , but its manifestations in the general population are as yet unclear . The aim of this study was to estimate the prevalence of , and to identify the risk factors for gastroesophageal reflux symptoms ( GERS ) and erosive esophagitis ( EE ) in the adult population of two Swedish municipalities . Material and methods . A r and om sample ( n=3000 ) of the adult population ( 20–81 years of age ) of two Swedish municipalities ( n=21,610 ) was surveyed using a vali date d postal question naire assessing gastrointestinal symptoms . The response rate was 74 % . A sub sample ( n=1000 ) of the responders was subsequently invited , in r and om order , for esophago-gastro-duodenoscopy with evaluation of GERS , risk factors and tests for Helicobacter pylori . Results . GERS were reported by 40.0 % and EE was found in 15.5 % of the population that had undergone endoscopy . Of those with GERS , 24.5 % had EE while 36.8 % of those with EE reported no GERS . Hiatus hernia and obesity remained significant risk factors for GERS and /or EE , with or without symptoms in a main effect model ( OR up to 14 at EE ) . Those with active H. pylori infection had a higher risk of GERS without EE than those without H. pylori infection ( OR=1.71 ( 1.23–2.38 ) ) . Conclusions . GERS and EE ( of which one-third is asymptomatic ) are highly prevalent in the Swedish adult population . H. pylori infection seems to play a role in the manifestations of gastroesophageal reflux AIM To clarify the association between physical activity and gastroesophageal reflux disease ( GERD ) in non-obese and obese people . METHODS A Swedish population -based cross-sectional survey was conducted . Participants aged 40 - 79 years were r and omly selected from the Swedish Registry of the Total Population . Data on physical activity , GERD , body mass index ( BMI ) and the covariates age , gender , comorbidity , education , sleeping problems , and tobacco smoking were obtained using vali date d question naires . GERD was self-reported and defined as heartburn or regurgitation at least once weekly , and having at least moderate problems from such symptoms . Frequency of physical activity was categorized into three groups : ( 1 ) \" high \" ( several times/week ) ; ( 2 ) \" intermediate \" ( approximately once weekly ) ; and ( 3 ) \" low \" ( 1 - 3 times/mo or less ) . Analyses were stratified for participants with \" normal weight \" ( BMI < 25 kg/m² ) , \" overweight \" ( BMI 25 to ≤ 30 kg/m² ) and \" obese \" ( BMI > 30 kg/m² ) . Multivariate logistic regression was used to calculate odds ratios ( ORs ) with 95 % confidence intervals ( CIs ) , adjusted for potential confounding by covariates . RESULTS Of 6969 eligible and r and omly selected individuals , 4910 ( 70.5 % ) participated . High frequency of physical activity was reported by 2463 ( 50 % ) participants , GERD was identified in 472 ( 10 % ) participants , and obesity was found in 680 ( 14 % ) . There were 226 ( 5 % ) individuals with missing information about BMI . Normal weight , overweight and obese participants were similar regarding distribution of gender and tobacco smoking status , while obese participants were on average slightly older , had fewer years of education , more comorbidity , slightly more sleeping problems , lower frequency of physical activity , and higher occurrence of GERD . Among the 2146 normal-weight participants , crude point estimates indicated a decreased risk of GERD among individuals with high frequency of physical activity ( OR : 0.59 , 95 % CI : 0.39 - 0.89 ) , compared to low frequency of physical activity . However , after adjustment for potential confounding factors , neither intermediate ( OR : 1.30 , 95 % CI : 0.75 - 2.26 ) nor high ( OR : 0.99 , 95 % CI : 0.62 - 1.60 ) frequency of physical activity was followed by decreased risk of GERD . Sleeping problems and high comorbidity were identified as potential confounders . Among the 1859 overweight participants , crude point estimates indicated no increased or decreased risk of GERD among individuals with intermediate or high frequency of physical activity , compared to low frequency . After adjustment for confounding , neither intermediate ( OR : 0.75 , 95 % CI : 0.46 - 1.22 ) nor high frequency of physical activity were followed by increased or decreased risk of GERD compared to low frequency among nonobese participants . Sleeping problems and high comorbidity were identified as potential confounders for overweight participants . In obese individuals , crude ORs were similar to the adjusted ORs and no particular confounding factors were identified . Intermediate frequency of physical activity was associated with a decreased occurrence of GERD compared to low frequency of physical activity ( adjusted OR : 0.41 , 95 % CI : 0.22 - 0.77 ) . CONCLUSION Intermediate frequency of physical activity might decrease the risk of GERD among obese individuals , while no influence of physical activity on GERD was found in non-obese people BACKGROUND Two types of reflux episodes have been identified : upright or daytime and supine or nocturnal . The population -based prevalence of symptoms of nocturnal gastroesophageal reflux disease ( GERD ) and the impact of those symptoms on health-related quality of life ( HRQL ) have not been established . METHODS A national r and om- sample telephone survey was conducted to estimate the prevalence of frequent GERD and nocturnal GERD-like symptoms and to assess the relationship between HRQL , GERD , and nocturnal GERD symptoms . Respondents were classified as controls , subjects with symptomatic nonnocturnal GERD , and subjects with symptomatic nocturnal GERD . The HRQL was assessed using the Medical Outcomes Study Short-Form 36 Health Survey ( SF-36 ) . RESULTS The prevalence of frequent GERD was 14 % , with an overall prevalence of nocturnal GERD of 10 % . Seventy-four percent of those with frequent GERD symptoms reported nocturnal GERD symptoms . Subjects with nonnocturnal GERD had significant decrements on the SF-36 physical and mental component summary scores compared with the US general population . Subjects reporting nocturnal GERD symptoms were significantly more impaired than subjects reporting nonnocturnal GERD symptoms on both the physical component summary ( 38.94 vs 41 . 52 ; P<.001 ) and mental component summary ( 46.78 vs 49.51 ; P<.001 ) and all 8 subscales of the SF-36 ( P<.001 ) . Subjects with nocturnal GERD demonstrated considerable impairment compared with the US general population and chronic disease population s. Subjects with nocturnal GERD had significantly more pain than those with hypertension and diabetes ( P<.001 ) and similar pain compared with those with angina and congestive heart failure . CONCLUSIONS Nocturnal symptoms are commonly experienced by individuals who report frequent GERD symptoms . In addition , HRQL is significantly impaired in those persons who report frequent GERD symptoms , and HRQL impairment is exacerbated in those who report nocturnal GERD symptoms Symptoms suggestive of gastro-oesophageal reflux disease are very common . The aim of the study was to assess the prevalence of these symptoms and factors influencing them in an unselected adult population . A question naire was mailed to a r and om sample of 2500 people aged > or = 20 years . The questions concerned heartburn , regurgitation , dysphagia , chest and upper abdominal pain , as well as medication and medical consultations for these symptoms . Of the 1700 ( 68 % ) responders , 9 % had experienced heartburn on the day of response and 15 % , 21 % and 27 % during the preceding week , month and year , respectively . The corresponding figures for regurgitation were 5 , 15 , 29 and 45 % . During the past year 43 % of the study group had had no such symptoms . Age , overweight , pregnancy and cigarette smoking significantly influenced the prevalence of symptoms . Using daily heartburn and /or regurgitation as dominant indicators 10.3 % ( 95 % CI 12 - 11.7 ) of the responders had gastro-oesophageal reflux disease . Medication ( most commonly antacids ) was used by only 16 % of the symptomatic people , and only 5.5 % had sought medical advice for symptoms during the past year . Thus , despite commonness of symptoms suggestive of gastro-oesophageal reflux disease only a minority of the individuals suffering from such symptoms use medication or have medical consultation BACKGROUND The prevalence of gastroesophageal reflux disease ( GERD ) in Asian population s is reported to be lower than that in the West . Population -based data on the prevalence and symptom profile of GERD in developing Caucasian countries is lacking . Our objective was to determine the prevalence of gastrointestinal symptoms and clinical spectrum of GERD in Tehran , northern Iran and their association with patient characteristics . METHODS One thous and seven hundred telephone numbers were r and omly selected from Tehran telephone directory using a simple r and om method . A two-step screening telephone survey was then performed . In each answered call a second rapid survey was done to select a subject 18 - 65 years old from that household . A vali date d question naire was then filled out for that individual . Patient characteristics ( age , education , and gender ) and history of acid regurgitation and heartburn during the last week , as well as the previous three months were inquired about . RESULTS Of the 1,700 selected numbers , 278 either did not answer or did not have an eligible case ; 220 refused to participate . A total of 1,202 subjects ( 42 % males , mean age : 36 years , range : 18 - 65 yr ) were surveyed . The prevalence of heartburn occurring monthly , weekly , and daily was 4.7 % ( CI95 % : 3.5 - 6.0 % ) , 1.6 % ( CI95 % : 1.0 - 2.5 % ) , and 0.6 % ( CI95 % : 0.3 - 1.3 % ) , respectively . The corresponding figures for acid regurgitation were 15.6 % ( CI95 % : 13.6 - 17.7 % ) , 5.7 % ( CI95 % : 4.4 - 7.1 % ) and 1.5 % ( CI95 % : 0.9 - 2.4 % ) , respectively . The prevalence of GERD , defined as heartburn and /or acid regurgitation experienced daily , weekly and monthly was 1.9 % ( CI95 % : 1.2 - 2.9 % ) , 6.8 % ( CI95 % : 5.4 - 8.3 % ) , and 18.4 % ( CI95 % : 16.2 - 20.6 % ) . There was no relationship between the prevalence of GERD and either gender , age , or education . CONCLUSION Monthly GERD symptoms occur in 18.4 % of the general population in Tehran . Acid regurgitation is more common ( 4 - 5 times ) than heartburn . Gender , age , and level of education do not affect the prevalence of GERD symptoms in the community studied Background We aim ed to determine the prevalence of gastroesophageal reflux disease ( GERD ) and associated risk factors , and assess quality of life ( QoL ) in relation to the frequency and severity of reflux symptoms . Methods A r and om sample of 1000 residents of Western Sydney were mailed a vali date d self-report question naire . GERD symptoms , risk factors , psychologic distress , QoL , and demographics were measured . Results The response rate was 73 % ( n=672 ; mean age , 46 y ; 52 % female ) . A total of 78 [ 12 % , 95 % confidence interval ( CI ) : 9 - 14 ] had GERD ( at least weekly heartburn and /or acid regurgitation ) . Independent risk factors for GERD were high cholesterol [ odds ratio ( OR ) = 3.28 , 95 % CI : 1.42 - 7.57 , P=0.005 ] and current smoker ( OR=2.47 , 95 % CI : 1.07 - 5.70 , P=0.03 ) . Anxiety , depression , and neuroticism were not risk factors . Worse physical functioning was the only QoL domain associated with GERD ( OR=0.98 , 95 % CI : 0.97 - 0.99 , P=0.006 ) . QoL was significantly impaired regardless of the severity of GERD for the QoL domains physical function , body pain , vitality , and social function . The frequency of heartburn and acid regurgitation were not associated with significantly reduced QoL domain scores . Conclusions Cardiac risk factors ( high cholesterol and smoking ) were independently associated with GERD . Increasing GERD symptom severity is associated with worse Q \n Output:\n " }, { "from": "agent", "value": "Conclusions The prevalence of gastro-oesophageal reflux symptoms varied strikingly among countries , even when similar definitions were used to define their presence .\nPrevalence was significantly higher in subjects ≥50 years , smokers , NSAID users and obese individuals , although these associations were modest" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The purpose of the present study was to examine the duration of caffeine 's ergogenic effect and whether it differs between users and nonusers of the drug . Twenty-one subjects ( 13 caffeine users and 8 nonusers ) completed six r and omized exercise rides to exhaustion at 80 % of maximal oxygen consumption after ingesting either a placebo or 5 mg/kg of caffeine . Exercise to exhaustion was completed once per week at either 1 , 3 , or 6 h after placebo or drug ingestion . Exercise time to exhaustion differed between users and nonusers with the ergogenic effect being greater and lasting longer in nonusers . For the nonusers , exercise times 1 , 3 , and 6 h after caffeine ingestion were 32.7 + /- 8.4 , 32.1 + /- 8.6 , and 31.7 + /- 12.0 min , respectively , and these values were each significantly greater than the corresponding placebo values of 24.2 + /- 6.4 , 25.8 + /- 9.0 , and 23.2 + /- 7.1 min . For caffeine users , exercise times 1 , 3 , and 6 h after caffeine ingestion were 27.4 + /- 7.2 , 28.1 + /- 7.8 , and 24.5 + /- 7.6 min , respectively . Only exercise times 1 and 3 h after drug ingestion were significantly greater than the respective placebo trials of 23.3 + /- 6.5 , 23.2 + /- 7.1 , and 23.5 + /- 5.7 min . In conclusion , both the duration and magnitude of the ergogenic effect that followed a 5 mg/kg dose of caffeine were greater in the nonusers compared with the users We investigated the effects of caffeine ingestion on skeletal muscle glucose uptake , glycogen synthase ( GS ) activity , and insulin signaling intermediates during a 100-min euglycemic-hyperinsulinemic ( 100 microU/ml ) clamp . On two occasions , seven men performed 1-h one-legged knee extensor exercise at 3 h before the clamp . Caffeine ( 5 mg/kg ) or placebo was administered in a r and omized , double-blind fashion 1 h before the clamp . During the clamp , whole-body glucose disposal was reduced ( P < 0.05 ) in caffeine ( 37.5 + /- 3.1 micromol x min(-1 ) x kg(-1 ) ) vs. placebo ( 54.1 + /- 2.9 micromol x min(-1 ) x kg(-1 ) ) . In accordance , the total area under the curve over 100 min ( AUC(0 - -100 min ) ) for insulin-stimulated glucose uptake in caffeine was reduced ( P < 0.05 ) by approximately 50 % in rested and exercised muscle . Caffeine also reduced ( P < 0.05 ) GS activity before and during insulin infusion in both legs . Exercise increased insulin sensitivity of leg glucose uptake in both caffeine and placebo . Insulin increased insulin receptor tyrosine kinase ( IRTK ) , insulin receptor substrate 1-associated phosphatidylinositol ( PI ) 3-kinase activities , and Ser(473 ) phosphorylation of protein kinase B (PKB)/Akt significantly but similarly in rested and exercised legs . Furthermore , insulin significantly decreased glycogen synthase kinase-3alpha ( GSK-3alpha ) activity equally in both legs . Caffeine did not alter insulin signaling in either leg . Plasma epinephrine and muscle cAMP concentrations were increased in caffeine . We conclude that 1 ) caffeine impairs insulin-stimulated glucose uptake and GS activity in rested and exercised human skeletal muscle ; 2 ) caffeine-induced impairment of insulin-stimulated muscle glucose uptake and downregulation of GS activity are not accompanied by alterations in IRTK , PI 3-kinase , PKB/Akt , or GSK-3alpha but may be associated with increases in epinephrine and intramuscular cAMP concentrations ; and 3 ) exercise reduces the detrimental effects of caffeine on insulin action in muscle Objectives The aim of this study was to evaluate the effects of caffeine on physiological responses to submaximal exercise , with a focus on blood lactate concentration ( [ BLa ] ) . Methods Using a r and omised , single-blind , crossover design ; 16 endurance-trained , male cyclists ( age : 38 ± 8 years ; height : 1.80 ± 0.05 m ; body mass : 76.6 ± 7.8 kg ; V˙O2max : 4.3 ± 0.6 L∙min-1 ) completed four trials on an electromagnetically-braked cycle ergometer . Each trial consisted of a six-stage incremental test ( 3 minute stages ) followed by 30 minutes of passive recovery . One hour before trials 2–4 , participants ingested a capsule containing 5 mg∙kg-1 of either caffeine or placebo ( maltodextrin ) . Trials 2 and 3 were design ed to evaluate the effects of caffeine on various physiological responses during exercise and recovery . In contrast , Trial 4 was design ed to evaluate the effects of caffeine on [ BLa ] during passive recovery from an end-exercise concentration of 4 mmol∙L-1 . Results Relative to placebo , caffeine increased [ BLa ] during exercise , independent of exercise intensity ( mean difference : 0.33 ± 0.41 mmol∙L-1 ; 95 % likely range : 0.11 to 0.55 mmol∙L-1 ) , but did not affect the time-course of [ BLa ] during recovery ( p = 0.604 ) . Caffeine reduced ratings of perceived exertion ( mean difference : 0.5 ± 0.7 ; 95 % likely range : 0.1 to 0.9 ) and heart rate ( mean difference : 3.6 ± 4.2 b∙min-1 ; 95 % likely range : 1.3 to 5.8 b∙min-1 ) during exercise , with the effect on the latter dissipating as exercise intensity increased . Supplement × exercise intensity interactions were observed for respiratory exchange ratio ( p = 0.004 ) and minute ventilation ( p = 0.034 ) . Conclusions The results of the present study illustrate the clear , though often subtle , effects of caffeine on physiological responses to submaximal exercise . Research ers should be aware of these responses , particularly when evaluating the physiological effects of various experimental interventions This study examined the acute effects of caffeine on the cardiovascular system during dynamic leg exercise . Ten trained , caffeine-naive cyclists ( 7 women and 3 men ) were studied at rest and during bicycle ergometry before and after the ingestion of 6 mg/kg caffeine or 6 mg/kg fructose ( placebo ) with 250 ml of water . After consumption of caffeine or placebo , subjects either rested for 100 min ( rest protocol ) or rested for 45 min followed by 55 min of cycle ergometry at 65 % of maximal oxygen consumption ( exercise protocol ) . Measurement of mean arterial pressure ( MAP ) , forearm blood flow ( FBF ) , heart rate , skin temperature , and rectal temperature and calculation of forearm vascular conductance ( FVC ) were made at baseline and at 20-min intervals . Plasma ANG II was measured at baseline and at 60 min postingestion in the two exercise protocol s. Before exercise , caffeine increased both systolic blood pressure ( 17 % ) and MAP ( 11 % ) without affecting FBF or FVC . During dynamic exercise , caffeine attenuated the increase in FBF ( 53 % ) and FVC ( 50 % ) and accentuated exercise-induced increases in ANG II ( 44 % ) . Systolic blood pressure and MAP were also higher during exercise plus caffeine ; however , these increases were secondary to the effects of caffeine on resting blood pressure . No significant differences were observed in heart rate , skin temperature , or rectal temperature . These findings indicate that caffeine can alter the cardiovascular response to dynamic exercise in a manner that may modify regional blood flow and conductance This study analyzed the effects of caffeine intake on whole-body substrate metabolism and exercise tolerance during cycling by using a more individualized intensity for merging the subjects into homogeneous metabolic responses ( the workload associated with the maximal lactate steady state — MLSS ) . MLSS was firstly determined in eight active males ( 25 ± 4 years , 176 ± 7 cm , 77 ± 11 kg ) using from two to four constant-load tests of 30 min . On two following occasions , participants performed a test until exhaustion at the MLSS workload 1 h after taking either 6 mg/kg of body mass of caffeine or placebo ( dextrose ) , in a r and omized , double-blinded manner . Respiratory exchange ratio was calculated from gas exchange measurements . There was an improvement of 22.7 % in time to exhaustion at MLSS workload following caffeine ingestion ( 95 % confidence limits of ±10.3 % , p = 0.002 ) , which was accompanied by decrease in respiratory exchange ratio ( p = 0.001 ) . These results reinforce findings indicating that sparing of the endogenous carbohydrate stores could be one of the several physiological effects of caffeine during submaximal performance around 1 PURPOSE Performance improvements after caffeine ( CAF ) ingestion are well documented when using a 1-d protocol . In numerous competitions such as the Tour de France , Tour de Ski , world championships , and National College Athletic Association championships , athletes compete for several days in a row . To date , no studies have investigated the effects of CAF when competing for consecutive days in a row . This study aim ed to investigate the effects of placebo ( PLA ) and two different CAF doses ( 3 and 4.5 mg·kg body mass ) on performance in a 10-min all-out , cross-country , double poling ergometer test ( C-PT ) 2 d in a row . METHOD Eight highly trained male cross-country skiers ( V˙O2max-run , 78.5 ± 1.6 mL·kg·min ) participated in the study , which was a r and omized , double-blind , PLA-controlled , crossover design . Performance was assessed as distance covered during a 10-min all-out C-PT . Oral ingestion of CAF or PLA was consumed 75 min before the all-out C-PT . RESULTS Poling distance was improved after CAF ingestions compared with that after PLA on both days . The improvements on day 1 were 4.0 % ( 90 % confidence limits , ±3.3 ) and 4.0 % ± 2.9 % for both CAF doses , respectively ( P < 0.05 ) , whereas improvements on day 2 were 5.0 % ± 3.6 % and 5.1 % ± 2.8 % for CAF3 and CAF4.5 , respectively , compared with those for PLA . Improved performance was associated with increased HR , adrenaline concentration , blood lactate concentration , and V˙O2 consumption after CAF ingestion . Furthermore , performance was elevated despite higher creatine kinase concentration and muscular pain at arrival on day 2 for both CAF doses . CONCLUSIONS Both CAF doses improved performance in the 10-min all-out C-PT compared with PLA over two consecutive days . Therefore , CAF seems useful for athletes competing over consecutive days despite higher muscle damage occurring after enhanced performance on the first day Abstract The aim of this study was to investigate the effects of caffeine supplementation on peak anaerobic power output ( Wmax ) . Using a counterbalanced , r and omised , double-blind , placebo-controlled design , 14 well-trained men completed three trials of a protocol consisting of a series of 6-s cycle ergometer sprints , separated by 5-min passive recovery periods . Sprints were performed at progressively increasing torque factors to determine the peak power/torque relationship and Wmax . Apart from Trial 1 ( familiarisation ) , participants ingested a capsule containing 5 mg·kg−1 of caffeine or placebo , one hour before each trial . The effects of caffeine on blood lactate were investigated using capillary sample s taken after each sprint . The torque factor which produced Wmax was not significantly different ( p ≥ 0.05 ) between the caffeine ( 1.15 ± 0.08 N·m·kg−1 ) and placebo ( 1.13 ± 0.10 N·m·kg−1 ) trials . There was , however , a significant effect ( p < 0.05 ) of supplementation on Wmax , with caffeine producing a higher value ( 1885 ± 303 W ) than placebo ( 1835 ± 290 W ) . Analysis of the blood lactate data revealed a significant ( p < 0.05 ) torque factor × supplement interaction with values being significantly higher from the sixth sprint ( torque factor 1.0 N·m·kg−1 ) onwards following caffeine supplementation . The results of this study confirm previous reports that caffeine supplementation significantly increases blood lactate and Wmax . These findings may explain why the majority of previous studies , which have used fixed-torque factors of around 0.75 N·m·kg−1 and thereby failing to elicit Wmax , \n Output:\n " }, { "from": "agent", "value": "This meta- analysis has revealed clear effects of caffeine on various physiological responses during submaximal exercise , which may help explain its ergogenic action" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Regular review and support for asthma self-management is promoted in guidelines . A r and omised controlled trial suggested that unscheduled health care usage was similar when patients were offered self management support by a lay-trainer or practice nurses . Methods Following the RCT , a costing study was undertaken using the trial data to account for the cost of delivery of the service under both strategies and the result ing impact on unscheduled healthcare ( measure of effectiveness ) in this trial . Results One year data ( n = 418 ) showed that 29 % ( 61/205 ) of the nurse group required unscheduled healthcare ( 177 events ) compared with 30.5 % ( 65/213 ) for lay-trainers ( 178 events).The training costs for the lay-trainers were greater than nurses ( £ 36 versus £ 18 respectively per patient , p<0.001 ) , however , the consultation cost for lay-trainers were lower than nurses ( £ 6 per patient versus £ 24 , p<0.001 ) . If the cost of unscheduled healthcare are accounted for then the costs of nurses is £ 161 , and £ 135 for lay-trainers ( mean difference £ 25 , [ 95 % CI = −£97 , £ 149 , p = 0.681 ] ) . The total costs ( delivery and unscheduled healthcare ) were £ 202 per patient for nurses versus £ 178 for lay-trainers , ( mean difference £ 24 , [ 95%CI = −£100 , £ 147 , p = 0.707 ] ) . Conclusions There were no significant differences in the cost of training and healthcare delivery between nurse and lay trainers , and no significant difference in the cost of unscheduled health care use 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 determine whether a parent-youth teamwork intervention improved medication adherence and related outcomes among youth with asthma . METHODS We used a r and omized clinical trial with 48 youth ( aged 9 - 15 years ) assigned to 1 of 3 groups : Teamwork Intervention ( TI ) , Asthma Education ( AE ) , or St and ard Care ( SC ) . Treatment occurred across 2 months , with a 3-month follow-up assessment . Adherence to inhaled corticosteroids was assessed via the MDILog-II . Parent-adolescent conflict , asthma functional severity , and spirometry assessment s were obtained pre-treatment , post-treatment , and on follow-up . Mixed linear model analysis was used to evaluate group and time effects for outcome measures . RESULTS TI group had significantly higher adherence and lower functional severity scores than AE or SC conditions , and lower parent-reported conflict and a trend for higher spirometry values compared with the SC group . CONCLUSIONS Results suggest support for the efficacy of TI for improving medication adherence as youth acquire more responsibility for their asthma management BACKGROUND Poor adherence to inhaled corticosteroids ( ICS ) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents . OBJECTIVE This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS . METHODS Low-income African American and /or Hispanic adolescents , ages 11 - 16 years old , with persistent asthma , and poor ( ≤ 48 % ) adherence to prescription ICS during the 3-week run-in were r and omized to intervention or attention control groups ( ATG ) for the 10-week treatment . During treatment , the intervention arm subjects participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages that promoted adherence . The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 physician-recorded asthma messages . Adherence was measured by using self-report and the Doser CT , an electronic dose counter . The primary outcome was the difference in adherence at 10 weeks between the 2 arms . RESULTS Thirty-four subjects were r and omized to each arm . At 10 weeks , no statistical difference in objective ly measured adherence could be detected between the 2 arms when adjusting for baseline adherence ( P = .929 ) . Adherence declined in both groups over the course of the active treatment period . In both study arms , self-reported adherence by participants was significantly higher than their objective ly measured adherence at week 10 ( P < .0001 ) . CONCLUSION Improving medication adherence in longitudinal studies is challenging . Peer support and mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes One hundred subjects with arthritis were r and omized into lay-taught , or professional-taught 12-h arthritis self-management courses , or a control group . Outcomes , knowledge , exercise , relaxation , disability , pain , and number of physician visits were measured aat baseline and 4 months . Professional-taught groups demonstrated greater knowledge gain while lay-taught groups had greater changes in relaxation ( p less than .01 ) and a tendency toward less disability . Although it is impossible to draw definitive conclusions , this study suggests that lay leaders can teach arthritis self-management courses with results similar to those achieved by professionals Background Estimates of asthma incidence and its possible determinants in adolescent population s have rarely been obtained using prospect i ve design s. We sought to identify socio-demographic and other patterns in the incidence of asthma among Canadian adolescents and to examine possible behavioural and environmental determinants of asthma incidence using longitudinal analyses . Methods We used data from the National Population Health Survey ( NPHS ) , a nationally representative longitudinal survey of Canadians . All persons aged 12–18 years without asthma at baseline were followed up to a maximum of 12 years . The outcome was a reported diagnosis of asthma during the follow-up period . Analyses were weighted to the population and bootstrapping procedures were used to estimate variances . Results Participants ( n = 956 ) represented 2,038,890 adolescents of whom 293,450 ( 14.4 % ) developed asthma over the 21,274,890 person-years of follow-up . Overall , the incidence of asthma was 10.2 per 1000 person-years . In adjusted Cox regression analysis , being female ( HR = 2.13 , 95 % CI = 1.26 - 3.62 , p = 0.005 ) and being exposed to passive smoking ( HR = 2.06 , 95 % CI = 1.27 - 3.34 , p = 0.003 ) were associated with the development of asthma while no statistically significant associations were identified for rural residence , being overweight , and other health behaviours . There was also an apparent cohort effect among girls where girls who were older at baseline reported being diagnosed with asthma more over the follow-up than their younger counterparts . This was not observed among males . Conclusions Asthma prevention initiatives for adolescents should target girls and focus on smoking exposures . The role that differential diagnostic patterns play in these observations should be investigated to more accurately assess the incidence of asthma 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 OBJECTIVES We examined whether a home-based educational and environmental intervention delivered by lay health educators would improve asthma symptom control in inner-city children with asthma . METHODS Children 2 to 16 years of age with diagnosed asthma and at least 1 asthma-related hospitalization or 2 emergency visits in the prior year were r and omly assigned into 2 groups ( immediate and delayed intervention ) in a crossover study . Each group participated in the active phase ( intervention ) and the inactive phase . Outcomes included asthma symptoms , albuterol use , emergency department visits , hospitalizations , and trigger reduction . RESULTS A total of 264 primarily Black ( 94 % ) children were enrolled . The mean number of emergency visits decreased by 30 % and inpatient visits decreased by 53 % ( P < .001 ) after the intervention . Reductions were seen in pests , presence of carpets in bedrooms , and dust . Nighttime wheezing was significantly reduced after the intervention in both groups ( P < .001 ) . CONCLUSIONS Lay health educators effectively reduced asthma triggers and increased caregiver asthma knowledge , which result ed in reduced emergency department visits , hospitalizations , and asthma symptoms . The relationships formed between the caregivers and the lay health educators appeared to positively impact asthma outcomes in this disadvantaged population Abstract Objective : To determine the effect of a peer led programme for asthma education on quality of life and related morbidity in adolescents with asthma . Design : Cluster r and omised controlled trial . Setting : Six high schools in rural Australia . Participants : 272 students with recent wheeze , recruited from a cohort of 1515 students from two school years ( mean age 12.5 and 15.5 years ) ; 251 ( 92.3 % ) completed the study . Intervention : A structured education programme for peers comprising three steps ( the “ Triple A Program ” ) . Main outcome measures : Quality of life , school absenteeism , asthma attacks , and lung function . Results : When adjusted for year and sex , mean total quality of life scores showed significant improvement in the intervention than control group . Clinical ly important improvement in quality of life ( > 0.5 units ) occurred in 25 % of students with asthma in the intervention group compared with 12 % in the control group ( P=0.01 ) . The number needed to treat was 8 ( 95 % confidence interval 4.5 to 35.7 ) . \n Output:\n " }, { "from": "agent", "value": "Effects on asthma control favoured the intervention but findings were not statistically significant .\nResults from two studies with high levels of baseline smoking showed some promise for self-efficacy to stop smoking , but overall nicotine dependence and smoking-related knowledge were not significantly better in the intervention group .\nInvestigators did not report adverse events .\nAlthough weak evidence suggests that lay-led and peer support interventions could lead to a small improvement in asthma-related quality of life for adolescents , benefits for asthma control , exacerbations and medication adherence remain unproven .\nCurrent evidence is insufficient to reveal whether routine use of lay-led or peer support programmes is beneficial for adolescents receiving asthma care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To evaluate the effect of aquatic exercise and education on fall risk factors in older adults with hip osteoarthritis ( OA ) . METHOD Seventy-nine adults , 65 years of age or older with hip OA and at least 1 fall risk factor , were r and omly assigned to 1 of 3 groups : aquatics and education ( AE ; aquatic exercise twice a wk with once-a-wk group education ) , aquatics only ( A ; 2 wk aquatic exercise ) and control ( C ; usual activity ) . Balance , falls efficacy , dual-task function , functional performance ( chair st and s ) , and walking performance were measured pre- and postintervention or control period . RESULTS There was a significant improvement in fall risk factors ( full-factorial MANCOVA , baseline values as covariates ; p = .038 ) ; AE improved in falls efficacy compared with C and in functional performance compared with A and C. CONCLUSION The combination of aquatic exercise and education was effective in improving fall risk factors in older adults with arthritis OBJECTIVE To examine effects of activity strategy training ( AST ) , a structured rehabilitation program taught by occupational therapists and design ed to teach adaptive strategies for symptom control and engagement in physical activity ( PA ) . METHODS A r and omized controlled pilot trial was conducted at 4 sites ( 3 senior housing facilities and 1 senior center ) in southeastern , lower Michigan . Fifty-four older adults with hip or knee osteoarthritis ( mean + /- SD age 75.3+/-7.1 years ) participated . At each site , older adults were r and omly assigned to 1 of 2 programs : exercise plus AST ( Ex + AST ) or exercise plus health education ( Ex + Ed ) . The programs involved 8 sessions over 4 weeks with 2 followup sessions over a 6-month period , and were conducted concurrently within each site . Pain , total PA and PA intensity ( measured objective ly by actigraphy and subjectively by the Community Healthy Activities Model Program for Seniors question naire ) , arthritis self-efficacy , and physical function were assessed at baseline and posttest . RESULTS At posttest , participants who received Ex + AST had significantly higher levels of objective peak PA ( P=0.02 ) compared with participants who received Ex + Ed . Although not statistically significant , participants in Ex + AST tended to have larger pain decreases , increased total objective and subjective PA , and increased physical function . No effects were found for arthritis self-efficacy . CONCLUSION Although participants were involved in identical exercise programs , participants who received AST tended to have larger increases in PA at posttest compared with participants who received health education . Future studies will be needed to examine larger sample s and long-term effects of AST OBJECTIVE The Arthritis , Diet , and Activity Promotion Trial ( ADAPT ) was a r and omized , single-blind clinical trial lasting 18 months that was design ed to determine whether long-term exercise and dietary weight loss are more effective , either separately or in combination , than usual care in improving physical function , pain , and mobility in older overweight and obese adults with knee osteoarthritis ( OA ) . METHODS Three hundred sixteen community-dwelling overweight and obese adults ages 60 years and older , with a body mass index of > or = 28 kg/m(2 ) , knee pain , radiographic evidence of knee OA , and self-reported physical disability , were r and omized into healthy lifestyle ( control ) , diet only , exercise only , and diet plus exercise groups . The primary outcome was self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Secondary outcomes included weight loss , 6-minute walk distance , stair-climb time , WOMAC pain and stiffness scores , and joint space width . RESULTS Of the 316 r and omized participants , 252 ( 80 % ) completed the study . Adherence was as follows : for healthy lifestyle , 73 % ; for diet only , 72 % ; for exercise only , 60 % ; and for diet plus exercise , 64 % . In the diet plus exercise group , significant improvements in self-reported physical function ( P < 0.05 ) , 6-minute walk distance ( P < 0.05 ) , stair-climb time ( P < 0.05 ) , and knee pain ( P < 0.05 ) relative to the healthy lifestyle group were observed . In the exercise group , a significant improvement in the 6-minute walk distance ( P < 0.05 ) was observed . The diet-only group was not significantly different from the healthy lifestyle group for any of the functional or mobility measures . The weight-loss groups lost significantly ( P < 0.05 ) more body weight ( for diet , 4.9 % ; for diet plus exercise , 5.7 % ) than did the healthy lifestyle group ( 1.2 % ) . Finally , changes in joint space width were not different between the groups . CONCLUSION The combination of modest weight loss plus moderate exercise provides better overall improvements in self-reported measures of function and pain and in performance measures of mobility in older overweight and obese adults with knee OA compared with either intervention alone OBJECTIVE To evaluate the effects of st and ardized western acupuncture and physiotherapy on pain and functional ability in patients with severe osteoarthritic knee pain awaiting knee arthroplasty . METHODS Three-arm , assessor-blind , r and omized controlled trial . PARTICIPANTS 181 patients awaiting knee arthroplasty . INTERVENTIONS acupuncture for 6 weeks ; physiotherapy for 6 weeks ; st and ardized advice . MAIN OUTCOME MEASURES Oxford Knee Score question naire ( OKS ) ( primary ) ; 50 m timed walk , and duration of hospital stay following knee arthroplasty . RESULTS There was no baseline difference between groups . At 7 weeks , there was a 10 % reduction in OKS in the acupuncture group which was a significant difference between the acupuncture and the control group : Mean ( s.d . ) acupuncture 36.8 ( 7.20 ) ; physiotherapy 39.2 ( 8.22 ) ; control 40.3 ( 8.48 ) ( P = 0.0497 ) . These effects were no longer present at 12 weeks . There was a trend ( P = 0.0984 ) towards a shorter in-patient stay of 1 day for the physiotherapy group [ mean 6.50 days ( s.d . 2.0 ) ] compared with the acupuncture group [ mean 7.77 days ( s.d . 3.96 ) ] . CONCLUSIONS We have demonstrated that patients with severe knee osteoarthritis can achieve a short-term reduction in OKS when treated with acupuncture . However , we failed to demonstrate any other clinical ly or statically significant effects between the groups . Both interventions can be delivered effectively in an out-patient group setting at a district general hospital . Further study is needed to evaluate the combined effects of these treatments BACKGROUND Although weight loss reduces risk for comorbid diseases , many observational studies suggest that weight loss is associated with increased mortality risk , leading to reluctance by clinicians to consider weight reduction as a strategy to maintain health and independence in older adults . However , whether the observed weight loss is intentional is difficult to determine and may not accurately represent the mortality risk associated with intentional weight reduction . Data from the Arthritis , Diet , and Activity Promotion Trial ( ADAPT ) were used to determine whether r and omization to a weight reduction program was associated with total mortality in overweight/obese older adults . METHODS ADAPT ( n = 318 ; mean age 69 + /- 6 years , body mass index 34 + /- 5 kg/m2 , 72 % female ) assessed the influence of weight loss ( achieved through dietary counseling and lifestyle modification ) and /or exercise on function in overweight/obese older adults with knee osteoarthritis . ADAPT ended in December 1999 . Participant vital was ascertained status through December 2006 using the National Death and Social Security Indexes . RESULTS The mortality rate for those r and omized to the 18-month weight loss intervention ( n = 159 , mean weight loss = -4.8 kg , 15 deaths ) was lower than that for those not r and omized to the weight loss intervention ( n = 159 , mean weight loss = -1.4 kg , 30 deaths ; hazard rate ratio = 0.5 , 95 % confidence interval 0.3 - 1.0 ) . Results were not appreciably changed when analyses were stratified by age , gender , baseline weight status , or magnitude of weight loss . CONCLUSIONS In older adults , intentional weight loss was not associated with increased total mortality and may reduce mortality risk . Observational studies of weight loss , especially when intentionality can not be rigorously established , may be misleading with respect to the effect of weight loss on mortality PURPOSE This study assessed the impact of a low cost , multicomponent physical activity intervention for older adults with lower extremity osteoarthritis . DESIGN AND METHODS A r and omized controlled trial compared the effects of a facility-based multiple-component training program followed by home-based adherence ( n = 80 ) to a wait list control group ( n = 70 ) . Assessment s were conducted at baseline and at 2 and 6 months following r and omization . The training program consisted of range of motion , resistance training , aerobic walking , and education-group problem solving regarding self-efficacy for exercise and exercise adherence . All training group participants developed individualized plans for posttraining adherence . RESULTS Relative to the persons in the control group , individuals who participated in the exercise program experienced a statistically significant improvement in exercise efficacy , a 48.5 % increase in exercise adherence , and a 13.3 % increase in 6-min distance walk that were accompanied by significant decreases in lower extremity stiffness at 2 and 6 months . Program participants also experienced a significant decrease in lower extremity pain and a borderline significant improvement in efficacy to adhere to exercise over time at 6 months ( p = .052 ) . In contrast , persons in the control group deteriorated over time on the efficacy and adherence measures and showed no change on the other measures . No adverse health effects were encountered . IMPLICATION S These benefits indicate that this low-cost intervention may hold great promise as one of a growing number of public health intervention strategies for older adults in the United States with osteoarthritis OBJECTIVE To compare the preoperative effects of multidimensional l and -based and pool-based exercise programs for people awaiting joint replacement surgery of the hip or knee . DESIGN R and omized , single-blind , before-after trial . SETTING Physiotherapy gymnasium and hydrotherapy pool . PARTICIPANTS Patients awaiting elective hip or knee joint replacement surgery . INTERVENTIONS L and -based ( n=40 ) or pool-based exercise program ( n=42 ) . Each 6-week program included an education session , twice-weekly exercise classes , and an occupational therapy home assessment . MAIN OUTCOME MEASURES Participants were assessed immediately before and after the 6-week intervention , then 8 weeks later . Primary outcomes were pain and self-reported function ( Western Ontario and McMaster Universities Osteoarthritis Index ) and patient global assessment . Secondary outcomes were performance-based measures ( timed walk and chair st and ) and psychosocial status ( Medical Outcomes Study 36-Item Short-Form Health Survey mental component score ) . Pain was also measured before and after each exercise class on a 7-point verbal rating scale . RESULTS Although both interventions were effective in reducing pain and improving function , there were no postintervention differences between the groups for the primary and secondary outcomes . However , the pool-based group had less pain immediately after the exercise classes . CONCLUSIONS While our multidimensional exercise-based interventions appeared to be effective in reducing disability in those awaiting joint replacement surgery of the hip or knee , there were no large differences in the postintervention effects of the interventions . However , pool-based exercise appeared to have a more favorable effect on pain immediately after the exercise classes BACKGROUND People with osteoarthritis ( OA ) of the knee experience pain and deconditioning that lead to disability . This study challenged the clinical belief that repetitive lower extremity exercise is not indicated in persons with knee OA . The effects of high-intensity and low-intensity stationary cycling on functional status , gait , overall and acute pain , and aerobic capacity were examined . METHODS Thirty-nine adults ( 71+/-6.9 years old ) with complaints of knee pain and diagnosis of OA were r and omized to either a high-intensity ( 70 % heart rate reserve [ HRR ] ) or low-intensity ( 40 % HRR ) exercise group for 10 weeks of stationary cycling . Participants cycled for 25 minutes , 3 times per week . Before and after the exercise intervention they completed the Arthritis Impact Measurement Scale 2 for overall pain assessment , underwent timed chair rise , 6-minute walk test , gait , and grade d exercise treadmill tests . Acute pain was reported daily with a visual analog scale and the Western Ontario and McMaster Universities Osteoarthritis Index scale . RESULTS Analysis of variance revealed that participants in both groups significantly improved in the timed chair rise , in the 6-minute walk test , in the range of walking speeds , in the amount of overall pain relief , and in aerobic capacity . No differences between groups were found . Daily pain reports suggested that cycling did not increase acute pain in either group . CONCLUSIONS Cycling may be considered as an alternative exercise modality for patients with knee OA . Low-intensity cycling was as effective as high-intensity cycling in improving function and gait , decreasing pain , and increasing aerobic capacity Lifestyle interventions \n Output:\n " }, { "from": "agent", "value": "Our systematic review confirms that international recommendations on exercise for knee osteoarthritis also apply to subjects aged 70 - 80 years ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Sixty patients meeting Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . : American Psychiatric Association , 1994 ) criteria for generalized social phobia were assigned to cognitive therapy ( CT ) , fluoxetine plus self-exposure ( FLU + SE ) , or placebo plus self-exposure ( PLA + SE ) . At posttreatment ( 16 weeks ) , the medication blind was broken . CT and FLU + SE patients then entered a 3-month booster phase . Assessment s were at pretreatment , midtreatment , posttreatment , end of booster phase , and 12-month follow-up . Significant improvements were observed on most measures in all 3 treatments . On measures of social phobia , CT was superior to FLU + SE and PLA + SE at midtreatment and at posttreatment . FLU + SE and PLA + SE did not differ . CT remained superior to FLU + SE at the end of the booster period and at 12-month follow-up . On general mood measures , there were few differences between the Behavioral inhibition ( BI ) and maternal over-control are early risk factors for later childhood internalizing problems , particularly social anxiety disorder ( SAD ) . Consistently high BI across childhood appears to confer risk for the onset of SAD by adolescence . However , no prior studies have prospect ively examined observed maternal over-control as a risk factor for adolescent social anxiety ( SA ) among children initially selected for BI . The present prospect i ve longitudinal study examines the direct and indirect relations between these early risk factors and adolescent SA symptoms and SAD , using a multi- method approach . The sample consisted of 176 participants initially recruited as infants and assessed for temperamental reactivity to novel stimuli at age 4 months . BI was measured via observations and parent-report across multiple assessment s between the ages of 14 months and 7 years . Maternal over-control was assessed observationally during parent – child interaction tasks at 7 years . Adolescents ( ages 14–17 years ) and parents provided independent reports of adolescent SA symptoms . Results indicated that higher maternal over-control at 7 years predicted higher SA symptoms and lifetime rates of SAD during adolescence . Additionally , there was a significant interaction between consistently high BI and maternal over-control , such that patterns of consistently high BI predicted higher adolescent SA symptoms in the presence of high maternal over-control . High BI across childhood was not significantly associated with adolescent SA symptoms when children experienced low maternal over-control . These findings have the potential to inform prevention and early intervention programs by indentifying particularly at-risk youth and specific targets of treatment Two experiments were conducted to examine the link between safety behaviors and social judgments in social anxiety disorder ( SAD ) . Safety behaviors were manipulated in the context of a controlled laboratory-based social interaction , and subsequent effects of the manipulation on the social judgments of socially anxious participants ( N = 50 , Study 1 ) and individuals meeting diagnostic criteria for generalized SAD ( N = 80 , Study 2 ) were examined . Participants were r and omly assigned to either a safety behavior reduction plus exposure condition ( SB + EXP ) or a graduated exposure ( EXP ) control condition , and then took part in a conversation with a trained experimental confederate . Results revealed across both studies that participants in the SB + EXP group were less negative and more accurate in judgments of their performance following safety behavior reduction relative to EXP participants . Study 2 also demonstrated that participants in the SB + EXP group displayed lower judgments about the likelihood of negative outcomes in a subsequent social event compared to controls . Moreover , reduction in safety behaviors mediated change in participant self-judgments and future social predictions . The current findings are consistent with cognitive theories of anxiety , and support the causal role of safety behaviors in the persistence of negative social judgments in SAD OBJECTIVE Behavioral inhibition ( BI ) , a temperamental style identifiable in early childhood , is considered a risk factor for the development of anxiety disorders , particularly social anxiety disorder ( SAD ) . However , few studies examining this question have evaluated the stability of BI across multiple developmental time points and followed participants into adolescence-the developmental period during which risk for SAD onset is at its peak . The current study used a prospect i ve longitudinal design to determine whether stable early BI predicted the presence of psychiatric disorders and continuous levels of social anxiety in adolescents . It was hypothesized that stable BI would predict the presence of adolescent psychiatric diagnoses , specifically SAD . METHOD Participants included 126 adolescents aged 14 to 16 years who were first recruited at 4 months of age from hospital birth records . Temperament was measured at multiple time points between the ages of 14 months and 7 years . In adolescence , diagnostic interviews were conducted with parents and adolescents , and continuous measures of adolescent- and parent-reported social anxiety were collected . RESULTS Stable maternal-reported early BI was associated with 3.79 times increased odds of a lifetime SAD diagnosis , but not other diagnoses , during adolescence ( 95 % confidence interval 1.18 - 12.12 ) . Stable maternal-reported early BI also predicted independent adolescent and parent ratings of ongoing social anxiety symptoms . CONCLUSIONS Findings suggesting that stable maternal-reported early BI predicts lifetime SAD have important implication s for the early identification and prevention of SAD Recent theoretical models of social phobia suggest that targeting several specific cognitive factors in treatment should enhance treatment efficacy over that of more traditional skills-based treatment programs . In the current study , 195 people with social phobia were r and omly allocated to 1 of 3 treatments : st and ard cognitive restructuring plus in vivo exposure , an \" enhanced \" treatment that augmented the st and ard program with several additional treatment techniques ( e.g. , performance feedback , attention retraining ) , and a nonspecific ( stress management ) treatment . The enhanced treatment demonstrated significantly greater effects on diagnoses , diagnostic severity , and anxiety during a speech . The specific treatments failed to differ significantly on self-report measures of social anxiety symptoms and life interference , although they were both significantly better than the nonspecific treatment . The enhanced treatment also showed significantly greater effects than st and ard treatment on 2 putative process measures : cost of negative evaluation and negative views of one 's skills and appearance . Changes on these process variables mediated differences between the treatments on changes in diagnostic severity This study used a 2-month prospect i ve research design to examine the bi-directional interplay between peer victimization and social anxiety among adolescents . Participants included 228 adolescents ( 58 % female ) in grade s 10–12 . Three types of peer victimization were examined : overt ( physical aggression or verbal threats ) , relational ( malicious manipulation of a relationship , such as by friendship withdrawal ) , and reputational ( damaging another ’s peer relationships , such as through rumor spreading ) . Adolescents ’ self-reported feelings of social anxiety and peer victimization experiences were assessed at two time points , in November and January of the same school year . Peer victimization was strongly related to adolescents ’ social anxiety , and relational victimization explained additional unique variance . Moreover , peer victimization was both a predictor and consequence of social anxiety over time , with the most robust results found for relational victimization . Limited support was obtained for gender as a moderating variable . Findings highlight the deleterious effects of peer victimization , especially relational victimization , and suggest avenues for future research and clinical intervention for adolescents experiencing such victimization The study investigated the relationship between self-focused attention ( SFA ) and post-event processing ( PEP ) in social anxiety . SFA is the process of directing attention to internal stimuli during a social interaction . PEP is a detailed review of performance following an interaction . Highly socially anxious students ( N = 82 ) were r and omly assigned to a high SFA ( n = 40 ) or low SFA condition ( n = 42 ) and completed baseline measures of social anxiety , depression , trait SFA , and trait rumination . After SFA was manipulated via instructions , participants engaged in a 5-min unstructured conversation with a confederate , followed by a manipulation check . PEP was assessed the next day online . The high SFA group reported a similar amount of positive PEP but more frequent negative PEP over the 24-h period compared to the low SFA group . These results provide support for a causal relationship between SFA and PEP and have important applications for the development of effective cognitive-behavioural interventions CONTEXT Epidemiological findings demonstrating an increased risk for individuals with social anxiety disorder ( SAD ) to develop depression have been challenged by discrepant findings from prospect i ve longitudinal examinations in childhood and early adolescence . OBJECTIVES To examine patterns of SAD incidence , the consistency of associations of SAD with subsequent depression , and distal and proximal predictors for subsequent depression . DESIGN Face-to-face , 10-year prospect i ve longitudinal and family study of up to 4 waves . The DSM-IV Munich-Composite International Diagnostic Interview was administered by clinical ly trained interviewers . SETTING Community sample in Munich . PARTICIPANTS Three thous and twenty-one individuals aged 14 to 24 years at baseline and 21 to 34 years at follow-up . MAIN OUTCOME MEASURES Cumulative incidence of SAD and depression ( major depressive episode or dysthymia ) . RESULTS Cumulative incidence for SAD was 11.0 % ; for depression , 27.0 % . St and ardized person-years of incidence for SAD were highest for those aged 10 to 19 years ( 0.72 % ) and were low before ( 0.20 % ) and after ( 0.19 % ) that age range . Depression incidence was different , characterized by delayed and continued high rates . Social anxiety disorder was consistently associated with subsequent depression , independent of age at onset for SAD ( relative risk range , 1.49 - 1.85 , controlling for age and sex ) . Crude Cox regressions showed significant distal ( eg , parental anxiety or depression , behavioral inhibition ) and proximal SAD characteristics ( eg , severity measures , persistence ) as predictors . Most associations were attenuated in multiple models , leaving behavioral inhibition ( hazard ratio , 1.30 [ 95 % confidence interval , 1.04 - 1.62 ; P = .02 ] ) and , less consistently , panic ( hazard ratio , 1.85 [ 95 % confidence interval , 1.08 - 3.18 ; P = .03 ] ) as the remaining significant predictors . CONCLUSIONS Social anxiety disorder is an early , adolescent-onset disorder related to a substantially and consistently increased risk for subsequent depression . The demonstration of proximal and particularly distal predictors for increased depression risks requires further exploration to identify their moderator or mediator role . Along with previous evidence that comorbid SAD is associated with a more malignant course and character of depression , these results call for targeted prevention with the aim of reducing the burden of SAD and its consequences The current study investigated the mechanism through which safety behaviors perpetuate perceived and actual negative social outcomes hypothesized to maintain social anxiety disorder ( SAD ) . Eighty individuals diagnosed with generalized SAD took part in a \" getting acquainted \" conversation with a trained experimental confederate . Participants were then r and omly assigned to either a safety behavior reduction plus exposure condition ( SB + EXP ) or a graduated exposure ( EXP ) control condition and completed a 2nd conversation with the same interaction partner . Mediation analyses revealed that participants instructed to reduce their idiosyncratic safety behaviors displayed significantly greater increases in both perceived and actual positive interpersonal outcomes relative to the EXP group . However , whereas the safety behavior manipulation influenced participants ' appraisal s of their partner 's reaction to them through reducing self-judgments about the visibility of anxiety-related behaviors , in reality , the SB + EXP group elicited more positive partner reactions because they displayed a greater increase in social approach behavior . Thus , although both parties recognized positive changes in the social exchange following the safety behavior manipulation , different sources of social information accounted for participant versus partner interpersonal judgments . The current findings point to the potential value of considering both the intra and interpersonal consequences of safety behaviors in SAD The present study investigated whether post-event processing ( PEP ) involving mental imagery about a past speech is particularly detrimental for socially anxious individuals who are currently anticipating giving a speech . One hundred fourteen high and low socially anxious participants were told they would give a 5 min impromptu speech at the end of the experimental session . They were r and omly assigned to one of three manipulation conditions : post-event processing about a past speech incorporating imagery ( PEP-Imagery ) , semantic post-event processing about a past speech ( PEP-Semantic ) , or a control condition , ( n=19 per experimental group , per condition [ high vs low socially anxious ] ) . After the condition inductions , individuals ' anxiety , their predictions of performance in the anticipated speech , and their interpretations of other ambiguous social events were measured . Consistent with predictions , high socially anxious individuals in the PEP-Imagery condition displayed greater anxiety than individuals in the other conditions immediately following the induction and before the anticipated speech task . They also interpreted ambiguous social scenarios in a more socially anxious manner than socially anxious individuals in the control condition . High socially anxious individuals made more negative predictions about their upcoming speech performance than low anxious participants in all conditions . The impact of imagery during post-event processing in social anxiety and its implication s are discussed BACKGROUND Childhood shyness can pre date social anxiety disorder and may be associated with biased discrimination of facial expressions of emotions . OBJECTIVE To determine whether childhood shyness , or the serotonin transporter promoter polymorphism genotype , can predict participants ' visual event-related potentials in response to expressions of children of similar ages . DESIGN Study group drawn from an inception cohort of 149 subjects characterized 1 year before the present study by their degree of shyness . SETTING Third- \n Output:\n " }, { "from": "agent", "value": "On balance , there is empirical evidence for the association of each of the factors in the IAM model with social anxiety or SAD , providing preliminary support for the model ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract OBJECTIVE : To determine if a simple educational intervention can increase resident physician literature search activity . DESIGN : R and omized controlled trial . SETTING : University hospital-based internal medicine training program . PATIENTS / PARTICIPANTS : Forty-eight medical residents rotating on the general internal medicine service . INTERVENTIONS : One-hour didactic session , the use of well-built clinical question cards , and practical sessions in clinical question building . MEASUREMENTS AND MAIN RESULTS : Objective data from the library information system that included the number of log-ons to MEDLINE , search ing volume , abstract s viewed , full-text articles viewed , and time spent search ing . Median search activity as measured per person per week ( control vs intervention ) : number of log-ons to MEDLINE ( 2.1 vs 4.4 , P<.001 ) ; total number of search sets ( 24.0 vs 74.2 , P<.001 ) ; abstract s viewed ( 5.8 vs 17.7 , P=.001 ) ; articles viewed ( 1.0 vs 2.6 , P=.005 ) ; and hours spent search ing ( 0.8 vs 2.4 , P<.001 ) . CONCLUSIONS : A simple educational intervention can markedly increase resident search ing activity 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 PURPOSE The study assesses potential for improving residents ' evidence -based medicine search ing skills in MEDLINE through real-time librarian instruction . SUBJECTS Ten residents on a rotation in a neonatal intensive care unit participated . METHODOLOGY Residents were r and omized into an instruction and a non-instruction group . Residents generated questions from rounds and search ed MEDLINE for answers . Data were collected through observation , search strategy analysis , and surveys . Librarians observed search es and collected data on questions , search ing skills , search problems , and the test group 's instruction topics . Participants performed st and ardized search es before , after , and six-months after intervention and were scored using a search strategy analysis tool ( 1 representing highest score and 5 representing lowest score ) . Residents completed pre- and post-intervention surveys to measure opinions about MEDLINE and search satisfaction . RESULTS Post-intervention , the test group formulated better questions , used limits more effectively , and reported greater confidence in using MEDLINE . The control group expressed less satisfaction with retrieval and demonstrated more errors when limiting . The test and control groups had the following average search scores respectively : 3.0 and 3.5 ( pre-intervention ) , 3.3 and 3.4 ( post-intervention ) , and 2.0 and 3.8 ( six-month post-intervention ) . CONCLUSION Data suggest that measurable learning outcomes were achieved . Residents receiving instruction improved and retained search ing skills six-months after intervention Background Previous studies have shown that Norwegian public health physicians do not systematic ally and explicitly use scientific evidence in their practice . They work in an environment that does not encourage the integration of this information in decision-making . In this study we investigate whether a theoretically grounded tailored intervention to diffuse evidence -based public health practice increases the physicians ' use of research information . Methods 148 self-selected public health physicians were r and omised to an intervention group ( n = 73 ) and a control group ( n = 75 ) . The intervention group received a multifaceted intervention while the control group received a letter declaring that they had access to library services . Baseline assessment s before the intervention and post-testing immediately at the end of a 1.5-year intervention period were conducted . The intervention was theoretically based and consisted of a workshop in evidence -based public health , a newsletter , access to a specially design ed information service , to relevant data bases , and to an electronic discussion list . The main outcome measure was behaviour as measured by the use of research in different documents . Results The intervention did not demonstrate any evidence of effects on the objective behaviour outcomes . We found , however , a statistical significant difference between the two groups for both knowledge scores : Mean difference of 0.4 ( 95 % CI : 0.2–0.6 ) in the score for knowledge about EBM-re sources and mean difference of 0.2 ( 95 % CI : 0.0–0.3 ) in the score for conceptual knowledge of importance for critical appraisal . There were no statistical significant differences in attitude- , self-efficacy- , decision-to-adopt- or job-satisfaction scales . There were no significant differences in Cochrane library search ing after controlling for baseline values and characteristics . Conclusion Though demonstrating effect on knowledge the study failed to provide support for the hypothesis that a theory-based multifaceted intervention targeted at identified barriers will change professional behaviour OBJECTIVE : To evaluate an educational intervention in evidence -based ethics ( emphasizing clinical knowledge , epidemiologic skills , and recognition of ethical issues ) administered to house staff before rotating through our neonatal intensive care unit . STUDY DESIGN : A controlled trial of 64 pediatric house staff assigned to alternating control and intervention rotations . Question naires were administered at the end of the rotation . RESULTS : Some benefits of the intervention were observed . However , a large percentage of intervention and control house staff substantially overestimated ( > 1.25 correct value ) predischarge mortality ( 23 % vs. 55 % of house staff ; p<0.02 ) , mortality or major morbidity ( 74 % vs. 46 % of house staff ; p=0.04 ) , and cerebral palsy rates ( 70 % vs. 87 % ; p=0.12 ) . Neither group cited many method ological criteria for evaluating follow-up studies ( 3.3 vs. 2.4 criteria ; p=0.05 ) or ethical issues considered in treatment recommendations for extremely premature infants ( 3.1 vs. 2.8 issues ; p=0.35 ) . CONCLUSION : Improved house staff training in evidence -based ethics is needed Objective An intervention existing of an evidence -based medicine ( EBM ) course in combination with case method learning sessions ( CMLSs ) was design ed to enhance the professional performance , self-efficacy and job satisfaction of occupational physicians . Methods A cluster r and omized controlled trial was set up and data were collected through question naires at baseline ( T0 ) , directly after the intervention ( T1 ) and 7 months after baseline ( T2 ) . The data of the intervention group [ T0 ( n = 49 ) , T1 ( n = 31 ) , T2 ( n = 29 ) ] and control group [ T0 ( n = 49 ) , T1 ( n = 28 ) , T2 ( n = 28 ) ] were analysed in mixed model analyses . Mean scores of the perceived value of the CMLS were calculated in the intervention group . Results The overall effect of the intervention over time comparing the intervention with the control group was statistically significant for professional performance ( p < 0.001 ) . Job satisfaction and self-efficacy changes were small and not statistically significant between the groups . The perceived value of the CMLS to gain new insights and to improve the quality of their performance increased with the number of sessions followed . Conclusion An EBM course in combination with case method learning sessions is perceived as valuable and offers evidence to enhance the professional performance of occupational physicians . However , it does not seem to influence their self-efficacy and job satisfaction Background To evaluate the educational effects of a clinical ly integrated e-learning course for teaching basic evidence -based medicine ( EBM ) among postgraduates compared to a traditional lecture-based course of equivalent content . Methods We conducted a cluster r and omised controlled trial in the Netherl and s and the UK involving postgraduate trainees in six obstetrics and gynaecology departments . Outcomes ( knowledge gain and change in attitude towards EBM ) were compared between the clinical ly integrated e-learning course ( intervention ) and the traditional lecture based course ( control ) . We measured change from pre- to post-intervention scores using a vali date d question naire assessing knowledge ( primary outcome ) and attitudes ( secondary outcome ) . Results There were six clusters involving teaching of 61 postgraduate trainees ( 28 in the intervention and 33 in the control group ) . The intervention group achieved slightly higher scores for knowledge gain compared to the control , but these results were not statistically significant ( difference in knowledge gain : 3.5 points , 95 % CI -2.7 to 9.8 , p = 0.27 ) . The attitudinal changes were similar for both groups . Conclusion A clinical ly integrated e-learning course was at least as effective as a traditional lecture based course and was well accepted . Being less costly than traditional teaching and allowing for more independent learning through material s that can be easily up date d , there is a place for incorporating e-learning into postgraduate EBM curricula that offer on-the-job training for just-in-time learning . Trial registration Trial registration number : ACTRN12609000022268 Summary Aim To evaluate the educational effectiveness of a clinical ly integrated e-learning course for teaching basic evidence -based medicine ( EBM ) among postgraduate medical trainees compared to a traditional lecture-based course of equivalent content . Methods We conducted a cluster r and omized controlled trial to compare a clinical ly integrated e-learning EBM course ( intervention ) to a lecture-based course ( control ) among postgraduate trainees at foundation or internship level in seven teaching hospitals in the UK West Midl and s region . Knowledge gain among participants was measured with a vali date d instrument using multiple choice questions . Change in knowledge was compared between groups taking into account the cluster design and adjusted for covariates at baseline using generalized estimating equations ( GEE ) model . Results There were seven clusters involving teaching of 237 trainees ( 122 in the intervention and 115 in the control group ) . The total number of postgraduate trainees who completed the course was 88 in the intervention group and 72 in the control group . After adjusting for baseline knowledge , there was no difference in the amount of improvement in knowledge of EBM between the two groups . The adjusted post course difference between the intervention group and the control group was only 0.1 scoring points ( 95 % CI −1.2–1.4 ) . Conclusion An e-learning course in EBM was as effective in improving knowledge as a st and ard lecture-based course . The benefits of an e-learning approach need to be considered when planning EBM curricula as it allows st and ardization of teaching material s and is a potential cost-effective alternative to st and ard lecture-based teaching Abstract Objective : To evaluate the READER model for critical reading by comparing it with a free appraisal , and to explore what factors influence different components of the model . Design : A r and omised controlled trial in which two groups of general practitioners assessed three papers from the general practice section of the BMJ . Setting : Northern Irel and . Subjects : 243 general practitioners . Main outcome measures : Scores given using the READER model ( Relevance , Education , Applicability , Discrimination , overall Evaluation ) and scores given using a free appraisal for scientific quality and an overall total . Results : The hierarchical order for the three papers was different for the two groups , according to the total scores . Participants using the READER method ( intervention group ) gave a significantly lower total score ( P⩽0.01 ) and a lower score for the scientific quality ( P⩽0.0001 ) for all three papers . Overall more than one in five ( 22 % ) , and more men than women , read more than 5 articles a month ( P⩽0.05 ) . Those who were trainers tended to read more articles ( P⩽0.05 ) , and no trainers admitted to reading none . Overall , 58 % ( 135/234 ) ( 68 % ( 76/112 ) of the intervention group ) believed that taking part in the exercise would encourage them to be more critical of published articles in the future ( P⩽0.01 ) . Conclusion : Participants using the READER model gave a consistently lower overall score and applied a more appropriate appraisal to the methodology of the studies . The method was both accurate and repeatable . No intrinsic factors influenced the scores , so the model is appropriate for use by all general practitioners regardless of their seniority , location , \n Output:\n " }, { "from": "agent", "value": "Conclusion This systematic review demonstrates inconsistencies in describing educational interventions for EBP in r and omised and non-r and omised trials ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To assess the subjective health status , quality of life , and functional ability of patients whose intensive care stay was prolonged and to compare their quality of life with that of the general population . DESIGN Inception cohort study . SETTING Twenty-three-bed multidisciplinary intensive care unit ( ICU ) in a tertiary care center . PATIENTS A consecutive sample of 718 patients aged > or = 18 yrs who required intensive care > or = 4 days . INTERVENTIONS None . MEASUREMENTS AND MAIN RESULTS The Nottingham Health Profile was used to compare the ICU patients with a r and om sample ( n = 2,595 ) of the general population . The quality of life and functional ability of 368 respondents ( 78.3 % of 470 survivors ) were assessed at 6 months after ICU admission . The length of the ICU stay was 13.6+/-11.8 ( median , 9 ; maximum , 81 ) days . The quality of life and its various dimensions were influenced by the diagnosis for ICU admission and age . Although problems in physical mobility and energy were prevalent among all patient groups , only a small proportion was dependent on others for the management of daily activities . Patients with trauma or respiratory failure experienced the most limitations . The quality of life of elderly patients and patients who had undergone cardiac surgery was comparable with the general population regarding emotional reactions , social isolation , and pain . CONCLUSIONS The quality of life of survivors after a prolonged intensive care stay is fairly good , although not comparable with that of the general population . The psychosocial aspects of the quality of life are restored more rapidly than physical performance A system has been constructed to evaluate the design , implementation , and analysis of r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials OBJECTIVES Few studies have examined the effects of caregiving on the caregivers of chronically critically ill ( CCI ) patients , and no one has examined the impact of a disease management program ( DMP ) on physical and psychological outcomes for the caregivers of CCI patients . The purpose s of this study of caregivers of CCI patients were as follows : ( 1 ) to describe the characteristics of CCI patients and caregivers and to examine the frequency of depression , subjective burden , and physical health ; ( 2 ) to examine factors related to depression after hospital discharge ; and ( 3 ) to examine the effects of a DMP on the physical health , depression , and burden of caregivers 2 months post-hospital discharge . DESIGN Prospect i ve experimental design . SETTING AND PARTICIPANTS Caregivers of 290 patients who had received > 3 days of mechanical ventilation while in the ICU of a university medical center . MEASUREMENTS Sociodemographics , caregiver burden , physical health status , and depression were measured using established tools . RESULTS Interviews of caregivers were conducted at hospital discharge and 2 months later . Seventy-three percent of patients survived , completed the study period , and required caregiving 2 months later . Caregivers of patients residing in an institution reported higher depression ( p = 0.0001 ) , higher burden ( ie , disrupted schedule , p = 0.0001 ; lack of family support , p = 0.036 ) , and greater health problem scores ( p = 0.0001 ) than did caregivers of patients residing at home . The DMP did not have a statistically significant impact on any of the outcome variables . However , by 2 months , 54 % of caregivers in the experimental group had no depression or mild depression compared with 34.5 % of the control group . CONCLUSION Two months after hospital discharge , approximately 25 % of caregivers were classified as depressed with 16.7 % of the depressed group classified as moderately or severely depressed . The caregivers of CCI patients are at risk for post-hospital discharge depression , and the caregivers of institutionalized CCI patients are at highest risk of long-term negative effects from caregiving OBJECTIVE Although oral bisphosphonates are effective treatments for postmenopausal women with osteoporosis , oral dosing may be unsuitable for some patients . An efficacious intravenously administered bisphosphonate could be beneficial for such patients . Ib and ronate , a potent nitrogen-containing bisphosphonate , can be administered using extended dosing intervals , either orally or by rapid intravenous injection . The aim of this study was to identify the optimal intravenous dosing regimen for ib and ronate in postmenopausal women with osteoporosis . METHODS In a r and omized , double-blind , double-dummy , phase III , noninferiority study , we compared 2 regimens of intermittent intravenous injections of ib and ronate ( 2 mg every 2 months and 3 mg every 3 months ) with a regimen of 2.5 mg of oral ib and ronate daily , the latter of which has proven antifracture efficacy . The study group comprised 1,395 women ( ages 55 - 80 years ) who were at least 5 years postmenopausal . All patients had osteoporosis ( lumbar spine [ L2-L4 ] bone mineral density [ BMD ] T score less than -2.5 ) . Participants also received daily calcium ( 500 mg ) and vitamin D ( 400 IU ) . The primary end point was change from baseline in lumbar spine BMD at 1 year . Changes in hip BMD and in the level of serum C-telopeptide of type I collagen ( CTX ) were also measured , as were safety and tolerability . RESULTS At 1 year , mean lumbar spine BMD increases were as follows : 5.1 % among 353 patients receiving 2 mg of ib and ronate every 2 months , 4.8 % among 365 patients receiving 3 mg of ib and ronate every 3 months , and 3.8 % among 377 patients receiving 2.5 mg of oral ib and ronate daily . Both of the intravenous regimens not only were noninferior , but also were superior ( P < 0.001 ) to the oral regimen . Hip BMD increases ( at all sites ) were also greater in the groups receiving medication intravenously than in the group receiving ib and ronate orally . Robust decreases in the serum CTX level were observed in all arms of the study . Both of the intravenous regimens were well tolerated and did not compromise renal function . CONCLUSION As assessed by BMD , intravenous injections of ib and ronate ( 2 mg every 2 months or 3 mg every 3 months ) are at least as effective as the regimen of 2.5 mg orally daily , which has proven antifracture efficacy , and are well tolerated Quality of life is often thought to be poor before and after intensive care unit admission . The aim of this study was to investigate changes in quality of life before and after intensive care . A prospect i ve cohort study of 300 consecutive patients admitted to intensive care was performed in a Scottish Teaching Hospital . Quality of life was assessed premorbidly and 3 , 6 and 12 months after intensive care admission for surviving patients using SF‐36 as well as EQ‐5D scores at 12 months . The median value for age was 60.5 years and for APACHE II score , 18 . The mean length of stay was 6.7 days . SF‐36 physical component scores decreased from premorbid values at 3 months ( p = 0.05 ) and then returned to premorbid values at 12 months ( p < 0.001 ) . The mean physical scores were below the population norm at all time points but the mean mental scores were similar or higher than these population norms . Patients who died after intensive care discharge had lower quality of life scores than did survivors ( all p < 0.01 ) . Poor premorbid quality of life was demonstrated and appears to reduce after ICU discharge . For survivors there was a slow increase in physical quality of life to premorbid levels by the end of the first year but these remained lower than in the general population . ICU patients experience a considerable longer‐term burden of ill health OBJECTIVE To evaluate the long-term mortality and morbidity of critically ill elderly patients requiring intensive care . DESIGN Prospect i ve comparison of outcome of critically ill patients aged 75 years and older with patients aged 65 to 74 years . PATIENTS Critically ill patients aged 65 years and older who required intensive care and who were recruited during a 3-month period . MAIN OUTCOME MEASURES Duration of hospitalization , hospital charges , procedures used in the intensive care unit , mortality in the hospital and during the follow-up period , and quality of life of survivors during the follow-up period . RESULTS Ninety-seven patients were included in the study ; 54 were 75 years or older and 43 were aged 65 to 74 years . No significant difference was noted between the two groups for length of stay in the hospital , hospital charges , or mortality at 1 year . Severity of illness , as assessed by Acute Physiology and Chronic Health Evaluation score at the time of intensive care unit admission , was a better predictor of survival than age . Quality of life , as assessed by activities of daily living , perceived quality of life , and Center for Epidemiologic Studies -Depression score , were not significantly different in either group at 1 , 6 , and 12 months after discharge from the hospital . Most patients in both groups described their quality of life as adequate and were willing to receive intensive care again , if necessary . CONCLUSION Age alone is not an adequate predictor of long-term survival and quality of life in critically ill elderly patients Objective : Patients who remain critically ill for prolonged periods and require tracheotomy , defined as chronic critical illness ( CCI ) , display elevated levels of bone resorption . The measurement of bone turnover markers reveals that osteoclastic bone resorption is not only enhanced but also uncoupled from osteoblastic bone formation . We examine the effect of ib and ronate on bone turnover in patients with CCI . Methods : This study is a prospect i ve , double-blind , placebo-controlled trial , in which 20 postmenopausal female participants with CCI were followed for an 11-day period after the administration of a single intravenous dose of ib and ronate ( 3 mg ) . All participants were treated with ergocalciferol ( 2000 IU daily ) , calcium carbonate ( 1250 mg daily ) , and calcitriol ( 0.25 μg daily ) . Results : The ib and ronate group showed a 34 % decrease in serum C-telopeptide ( CTX ) levels ( a marker of osteoclastic activity ) on day 6 , while the placebo group showed a 13 % increase ( P = .01 ) . By day 11 , CTX levels in ib and ronate group were not significantly different than baseline or from the placebo group . Osteocalcin ( OCN ) levels ( a marker of osteoblast activity ) increased by 78 % compared to baseline in the ib and ronate group ( P = .01 ) and by 42 % in the placebo group ( P = .05 ) . There were no significant differences in OCN between the 2 groups throughout the study . Parathyroid hormone levels remained constant throughout the study . No adverse events were observed . Conclusion : A single dose of intravenous ib and ronate causes a significant but transient reduction in osteoclast activity in patients with CCI , which persists over a 6-day period UNLABELLED Osteoporotic fractures are associated with accelerated bone turnover and excess mortality . In a prospect i ve study of 1112 frail subjects ( 79 % female ; mean age , 86 years ) , high bone turnover was an independent predictor of all-cause mortality . This association seemed to be mainly manifested in deaths from cardiovascular causes . INTRODUCTION Osteoporotic fractures are associated with accelerated bone turnover and excess mortality . In a prospect i ve cohort study of elderly men and women , we assessed whether the rate of bone turnover measured by markers of bone remodeling is a direct predictor of mortality . MATERIAL S AND METHODS We measured serum concentrations of the aminoterminal propeptide of type I collagen ( PINP ) , a marker of bone formation , and of the carboxyterminal telopeptide of type I collagen ( CTX-I ) , a marker of bone resorption , along with serum PTH and 25-hydroxyvitamin D [ 25(OH)D ] levels in 1112 subjects ( 79 % female ; mean age , 86 years ) living in residential care . Co-morbidity was measured using the Implicit Illness Severity Scale . Fracture data were vali date d by a radiology report . Mortality and causes of death were ascertained from death certificates . RESULTS Over a median follow-up of 817 days , 559 ( 50.3 % ) subjects died . In univariate analyses , time to death from all causes was significantly ( p < 0.01 ) associated with age ( HR \n Output:\n " }, { "from": "agent", "value": "This systematic review found moderate evidence for a positive association between critical illness and increased bone turnover .\nFindings were consistent across studies , and best- evidence analysis result ed in a conclusion that moderate evidence exists for an association between critical illness requiring admission to intensive care and altered bone turnover ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Objective : To compare chemotherapy given at home with outpatient treatment in terms of colorectal cancer patients ' safety , compliance , use of health services , quality of life , and satisfaction with treatment . Design : R and omised controlled trial . Setting : Large teaching hospital . Participants : 87 patients receiving adjuvant or palliative chemotherapy for colorectal cancer . Interventions : Treatment with fluorouracil ( with or without folinic acid or levamisole ) at outpatient clinic or at home . Main outcome measures : Treatment toxicity ; patients ' compliance with treatment , quality of life , satisfaction with care , and use of health re sources . Results : 42 patients were treated at outpatient clinic and 45 at home . The two groups were balanced in terms of age , sex , site of cancer , and disease stage . Treatment related toxicity was similar in the two groups ( difference 7 % ( 95 % confidence interval −12 % to 26 % ) ) , but there were more voluntary withdrawals from treatment in the outpatient group than in the home group ( 14 % v 2 % , difference 12 % ( 1 % to 24 % ) ) . There were no differences between groups in terms of quality of life scores during and after treatment . Levels of patient satisfaction were higher in the home treatment group , specifically with regard to information received and nursing care . There were no significant differences in use of health services . Conclusions : Home chemotherapy seemed an acceptable and safe alternative to hospital treatment for patients with colorectal cancer that may improve compliance and satisfaction with treatment . What is already known on this topic Home chemotherapy programmes have been proposed as an alternative to hospital treatment However , they are more costly , and there is little evidence on their impact on outcomes such as compliance , quality of life , or use of other health services What this study adds Home chemotherapy was not associated with an increased use of health services such as primary care or emergency departments Home chemotherapy had no effect on patients ' quality of life but increased their compliance with treatment and satisfaction , particularly with regard to nursing care Home chemotherapy seems an acceptable and safe alternative to outpatient treatment that may improve compliance with Background : Care closer to home is being explored as a means of improving patient experience as well as efficiency in terms of cost savings . Evidence that community cancer services improve care quality and /or generate cost savings is currently limited . A r and omised study was undertaken to compare delivery of cancer treatment in the hospital with two different community setting s. Methods : Ninety-seven patients being offered outpatient-based cancer treatment were r and omised to treatment delivered in a hospital day unit , at the patient ’s home or in local general practice ( GP ) surgeries . The primary outcome was patient-perceived benefits , using the emotional function domain of the EORTC quality of life ( QOL ) QLQC30 question naire evaluated after 12 weeks . Secondary outcomes included additional QOL measures , patient satisfaction , safety and health economics . Results : There was no statistically significant QOL difference between treatment in the combined community locations relative to hospital ( difference of −7.2 , 95 % confidence interval : −19·5 to + 5·2 , P=0.25 ) . There was a significant difference between the two community locations in favour of home ( + 15·2 , 1·3 to 29·1 , P=0.033 ) . Hospital anxiety and depression scale scores were consistent with the primary outcome measure . There was no evidence that community treatment compromised patient safety and no significant difference between treatment arms in terms of overall costs or Quality Adjusted Life Year . Seventy-eight percent of patients expressed satisfaction with their treatment whatever their location , whereas 57 % of patients preferred future treatment to continue at the hospital , 81 % at GP surgeries and 90 % at home . Although initial pre-trial interviews revealed concerns among health-care professionals and some patients regarding community treatment , opinions were largely more favourable in post-trial interviews . Interpretation : Patient QOL favours delivering cancer treatment in the home rather than GP surgeries . Nevertheless , both community setting s were acceptable to and preferred by patients compared with hospital , were safe , with no detrimental impact on overall health-care costs OBJECTIVES To evaluate the feasibility and adherence to home delivery ( HD ) of pemetrexed maintenance treatment in patients with advanced non-squamous non-small cell lung cancer ( nsqNSCLC ) . MATERIAL S AND METHODS Exploratory , prospect i ve , single-arm , Phase II study in advanced nsqNSCLC patients , with an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0/1 that did not progress after 4 first-line induction cycles of a platinum doublet . The first cycle of pemetrexed ( 500mg/m(2 ) ) was hospital administered , further cycles were HD until progressive disease or discontinuation . Feasibility was assessed by the adherence rate to HD ( probability of reversion to hospital administration or treatment discontinuation due to HD ) as primary endpoint , and by health-related quality -of-life ( HRQoL : EQ-5D , lung cancer symptom scale [ LCSS ] ) , satisfaction with HD , overall survival ( OS ) , and safety . RESULTS 52 patients ( UK & Sweden ) received a median of 4 ( range 1 - 19 ) pemetrexed maintenance cycles . Adherence rate up to Cycle 6 was 98.0 % ( 95 % confidence interval [ CI ] : 86.4 % , 99.7 % ) . All but 2 patients remained on HD . 1 patient discontinued after Cycle 1 ( patient decision ) , and 1 after Cycle 6 ( non-compliance with oral dexamethasone ) . 87 % ( 33/38 ) of the patients preferred home to hospital treatment and in 90 % ( 28/31 ) of cases , physicians were satisfied with distant management of patients . During HD Cycles 2 - 4 mean change from baseline ranged from 3.0 to 7.7 for EQ-5D visual analog scale . The 6-month OS rate was 73 % ( 95 % CI : 58 % , 83 % ) . 1 patient had an HD-related adverse event ( device-related infection , Grade 2 ) and 1 patient died after Cycle 1 , before HD , due to a possibly drug-related atypical pneumonia . CONCLUSION HD of pemetrexed maintenance treatment in patients with advanced nsqNSCLC was feasible , safe , and preferred by patients , while maintaining HRQoL. Physicians were satisfied with distant patient management Although primary treatment for cancer has been associated with psychosocial distress , less research has focused on patients with advanced disease . Traditionally , the outcomes of treatment have been assessed using biomedical criteria , including tumour regression , progression and survival . It is argued that these data are inadequate to underst and the impact of cancer upon the patient . Instead , quality of life considerations are crucial when treatments are aversive , especially when the aims are palliative rather than curative . Fifty-three patients with advanced breast cancer or ovarian cancer were studied prospect ively for 6 months to assess whether the site and method of chemotherapy administration influenced their quality of life . Patients received palliative chemotherapy either at home or in hospital . Quality of life was operationalized as measurement of anxiety , depression , self-esteem , health locus of control , physical performance and symptoms . In addition , semi-structured interviews explored social roles , relationships , and perceptions of treatment . Hospital administered chemotherapy was perceived to be most distressing . Regression analysis indicated that anxiety and depression accounted for most of the variance in quality of life . Patients who died during the study 13 ( 24 % ) experienced considerable psychological and physical morbidity . Women over 60 years , experienced less psychological and physical distress . Quality of life broadens the criteria by which cancer treatments are evaluated , to include the experience of the patient A prospect i ve comparative analysis of home and hospital comprehensive treatment for advanced non-ambulatory cancer patients was conducted . Patients were assigned to hospital ( group A ) and home ( group B ) treatment groups based on geographic location . Home treatment was provided by the Don Monti Home Oncology Medical Extension ( HOME ) program . A multidisciplinary health team , including an oncologist , oncology nurse , social worker , dietitian , and medical technologist , was transported to the home in a medically equipped van . Services included physical examinations , pain control , psychosocial interventions , chemotherapy and blood transfusions , nutrition consultation , and bereavement counseling . One hundred seventy-four patients were treated at home and 44 in the hospital . Pretreatment characteristics were similar for both groups , with the exception that age under 50 years was more frequent in the hospital group , and home patients were more likely to have gastrointestinal ( GI ) cancer . Medical benefits for home treatment included decreased narcotic analgesic requirements , decreased hospitalization and length of stay , and improved measurements of fat stores for female patients . Improved survival for home patients was related to Karnofsky performance status , since there was no difference in survival for sicker patients with lower performance status whether they received home or hospital treatment . Patient and family acceptance of home treatment was excellent . Comprehensive home treatment provided by a multispecialty oncology team is an effective alternative to hospitalization for terminal cancer patients Context Hospital care for older people often means iatrogenic complications and a decline in function . Home hospital care might reduce these adverse outcomes . Content Patients were 65 years of age or older and required hospital care for pneumonia , heart failure , chronic obstructive pulmonary disease , or cellulitis . In phase I , they were hospitalized . In phase II , they could choose home hospital care ( continuous nursing care followed by at least daily visits from a nurse and a physician ) . Sixty percent of patients chose home hospital care . Patients who received this type of care had shorter stays ; fewer procedures , consultations , and indwelling devices ; less delirium ; greater satisfaction ; and similar functional outcomes . Caution s The study was nonr and omized , and data were missing . Conclusion Home hospital care may be a good alternative for selected patients . The Editors Although the acute care hospital is the st and ard venue for providing acute medical care , it is expensive and may be hazardous for older persons , who commonly experience functional decline , iatrogenic illness , and other adverse events during care ( 1 - 3 ) . Providing acute hospital-level care in a patient 's home is an alternative to hospital care ( 4 , 5 ) . Although several hospital-at-home models have been studied , there is controversy regarding the effectiveness of this method . In part , this reflects heterogeneity among hospital-at-home models ( 6 ) . A recent Cochrane review examined surgical and medical early hospital discharge models , terminal care , and admission avoidance , that is , substitutive models . Overall , no differences were found in health outcomes . Patients , but not caregivers , had increased satisfaction with hospital-at-home care , and there was some evidence that substitutive models may be cost-effective ( 7 ) . However , with some exceptions ( 8) , most of these models would be difficult to distinguish from augmented skilled nursing services , community-based long-term care , or home-based primary care services in the United States . In addition , most studies have been done in countries with single-payer national health insurance systems ( 7 - 14 ) . Previous research in the United States has been limited to a pilot study of a physician-led substitutive hospital-at-home model for older persons with acute medical illness ( 15 ) . The aim of our study was to evaluate the safety , efficacy , clinical and functional outcomes , patient and caregiver satisfaction , and costs of providing acute hospital-level care in a hospital at home that substituted entirely for admission to an acute care hospital for older persons . Methods Patients The target sample was community-dwelling persons , age 65 years and older , who lived in a catchment area and who , in the opinion of a physician not involved in the study , required admission to an acute care hospital for 1 of 4 target illnesses : community-acquired pneumonia , exacerbation of chronic heart failure , exacerbation of chronic obstructive pulmonary disease , or cellulitis . Patients were required to meet vali date d criteria of medical eligibility for hospital-at-home care ( 16 ) , which were design ed to identify patients who would be medically suitable for this type of treatment . The most common reasons for medical in eligibility were uncorrectable hypoxemia ( oxygen saturation < 90 % ) , suspected myocardial ischemia , and presence of an acute illness , other than the target illness , for which the patient was required to be hospitalized . Study Design This study was a prospect i ve quasi-experiment conducted in 2 consecutive 11-month phases . During the acute care hospital observation phase ( 1 November 1990 to 30 September 2001 ) , eligible patients were identified and followed through usual hospital care . Study coordinators verified the patient 's eligibility for hospital-at-home care using a st and ard protocol at the time of enrollment . During this observation phase of the study , most patients were identified the morning after admission . These patients made up the acute hospital observation comparison group . During the intervention phase ( 1 November 2001 to 30 September 2002 ) , eligible patients were identified at the time of admission and were offered the option of receiving their care in hospital at home rather than in the acute care hospital . Patients who chose hospital-at-home treatment were never admitted to the acute care hospital but received treatment , after initial evaluation ( usually in the emergency department ) , in their home . The intervention group comprised all patients eligible for hospital-at-home care , irrespective of where they were treated . Approval The institutional review boards from each study site , the coordinating center , and officials at the Center for Health Plans and Providers at the Centers for Medicare & Medicaid Services ( CMS ) gave their approval for the study . All participants provided informed written consent . Study Sites The study was conducted in 3 Medicare managed care ( Medicare + Choice ) plans at 2 sites and at a Veterans Administration medical center . Univera Health and Independent Health , in Buffalo , New York , are Medicare + Choice plans that operate in an independent practice association model . These 2 plans collaborated to provide hospital-at-home care and made up 1 study site ( \n Output:\n " }, { "from": "agent", "value": "Despite heterogeneity , majority of reported models for oncological home-hospitalization demonstrated that this is a safe , equivalent and acceptable alternative to ambulatory hospital care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND In the ESSENCE trial , subcutaneous low-molecular-weight heparin ( enoxaparin ) reduced the 30-day incidence of death , myocardial infa rct ion , and recurrent angina relative to intravenous unfractionated heparin in 3171 patients with acute coronary syndrome ( unstable angina or non-Q-wave myocardial infa rct ion ) . No increase in major bleeding was seen . METHODS AND RESULTS Of the 936 ESSENCE patients r and omized in the United States , 655 had hospital billing data collected . For the remainder , hospital costs were imputed with a multivariable linear regression model ( R2=.86 ) . Physician fees were estimated from the Medicare Fee Schedule . During the initial hospitalization , major re source use was reduced for enoxaparin patients , with the largest effect seen with coronary angioplasty ( 15 % versus 20 % for heparin , P=.04 ) . At 30 days , these effects persisted , with the largest reductions seen in diagnostic catheterization ( 57 % versus 63 % for heparin , P=.04 ) and coronary angioplasty ( 18 % versus 22 % , P=.08 ) . All re source use trends seen in the US cohort were also evident in the overall ESSENCE study population . In the United States , the mean cost of a course of enoxaparin therapy was $ 155 , whereas that for heparin was $ 80 . The total medical costs ( hospital , physician , drug ) for the initial hospitalization were $ 11 857 for enoxaparin and $ 12620 for heparin , a cost advantage for the enoxaparin arm of $ 763 ( P=.18 ) . At the end of 30 days , the cumulative cost savings associated with enoxaparin was $ 1172 ( P=.04 ) . In 200 bootstrap sample s of the 30-day data , 94 % of the sample s showed a cost advantage for enoxaparin . CONCLUSIONS In patients with acute coronary syndrome , low-molecular-weight heparin ( enoxaparin ) both improves important clinical outcomes and saves money relative to therapy with st and ard unfractionated heparin BACKGROUND Despite the use of aspirin , there is still a risk of ischaemic events after percutaneous coronary intervention ( PCI ) . We aim ed to find out whether , in addition to aspirin , pretreatment with clopidogrel followed by long-term therapy after PCI is superior to a strategy of no pretreatment and short-term therapy for only 4 weeks after PCI . METHODS 2658 patients with non-ST-elevation acute coronary syndrome undergoing PCI in the CURE study had been r and omly assigned double-blind treatment with clopidogrel ( n=1313 ) or placebo ( n=1345 ) . Patients were pretreated with aspirin and study drug for a median of 6 days before PCI during the initial hospital admission , and for a median of 10 days overall . After PCI , most patients ( > 80 % ) in both groups received open-label thienopyridine for about 4 weeks , after which study drug was restarted for a mean of 8 months . The primary endpoint was a composite of cardiovascular death , myocardial infa rct ion , or urgent target-vessel revascularisation within 30 days of PCI . The main analysis was by intention to treat . FINDINGS There were no drop-outs . 59 ( 4.5 % ) patients in the clopidogrel group had the primary endpoint , compared with 86 ( 6.4 % ) in the placebo group ( relative risk 0.70 [ 95 % CI 0.50 - 0.97 ] , p=0.03 ) . Long-term administration of clopidogrel after PCI was associated with a lower rate of cardiovascular death , myocardial infa rct ion , or any revascularisation ( p=0.03 ) , and of cardiovascular death or myocardial infa rct ion ( p=0.047 ) . Overall ( including events before and after PCI ) there was a 31 % reduction cardiovascular death or myocardial infa rct ion ( p=0.002 ) . There was less use of glycoprotein IIb/IIIa inhibitor in the clopidogrel group ( p=0.001 ) . At follow-up , there was no significant difference in major bleeding between the groups ( p=0.64 ) . INTERPRETATION In patients with acute coronary syndrome receiving aspirin , a strategy of clopidogrel pretreatment followed by long-term therapy is beneficial in reducing major cardiovascular events , compared with placebo OBJECTIVES The aim of this study was to determine the economic impact of several anticoagulation strategies for moderate- and high-risk non-ST-segment elevation acute coronary syndrome ( NSTE-ACS ) patients managed invasively . BACKGROUND The ACUITY ( Acute Catheterization and Urgent Intervention Triage Strategy ) trial demonstrated that bivalirudin monotherapy yields similar rates of ischemic complications and less bleeding than regimens incorporating glycoprotein IIb/IIIa receptor inhibitors ( GPI ) for moderate- and high-risk NSTE-ACS . METHODS In ACUITY , 7,851 U.S. patients were r and omized to : 1 ) heparin ( unfractionated or enoxaparin ) + GPI ; 2 ) bivalirudin + GPI ; or 3 ) bivalirudin monotherapy . Patients assigned to GPI were also r and omized to upstream GPI before catheterization or selective GPI only with percutaneous coronary intervention . Re source use data were collected prospect ively through 30-day follow-up . Costs were estimated with st and ard methods including re source -based accounting , hospital billing data , and the Medicare fee schedule . RESULTS At 30 days , ischemic events were similar for all groups . Major bleeding was reduced with bivalirudin monotherapy compared with heparin + GPI or bivalirudin + GPI ( p < 0.001 ) . Length of stay was lowest with bivalirudin monotherapy or bivalirudin + catheterization laboratory GPI ( p = 0.02 ) . Despite higher drug costs , aggregate hospital stay costs were lowest with bivalirudin monotherapy ( mean difference range : $ 184 to $ 1,081 , p < 0.001 for overall comparison ) and at 30 days ( mean difference range : $ 123 to $ 938 , p = 0.005 ) . Regression modeling demonstrated that hospital savings were primarily due to less major and minor bleeding with bivalirudin ( $ 8,658/event and $ 2,282/event , respectively ) . CONCLUSIONS Among U.S. patients in the ACUITY trial , bivalirudin monotherapy compared with heparin + GPI result ed in similar protection from ischemic events , reduced bleeding , and shorter length of stay . Despite higher drug costs , aggregate hospital and 30-day costs were lowest with bivalirudin monotherapy . Thus bivalirudin monotherapy seems to be an economically attractive alternative to heparin + GPI for patients with moderate- and high-risk NSTE-ACS . ( Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ ACS ] ; NCT00093158 ) Background The CURE study demonstrated that clopidogrel prevents a range of ischaemic cardiovascular events in patients with Acute Coronary Syndromes ( unstable angina or non-ST-segment elevation MI ) . Design We undertook an economic analysis of the use of clopidogrel in the UK , USA , Sweden , France and Canada based on the CURE study . Methods The costs of hospitalization , study drug and other medications were calculated , based on re source utilization for all patients in CURE . Unit costs were obtained for all re source items for each country , and are reported in local currencies in 2001 prices . Results While hospitalization costs were lower in the clopidogrel group , when the acquisition cost of clopidogrel for 9 months is included , the average cost per patient is higher in the clopidogrel group than the placebo group in all countries [ difference in costs ( with 95 % CI ) UK £ 208 ( 119 , 297 ) , US$ 451 ( 58 , 845 ) , SKr 2571 ( 728 , 4412 ) , Fr ∊325 ( 85 , 565 ) , C$ 161 ( −185 , 506 ) ] . The absolute reduction in the number of total primary events was 2.0 % , result ing in an incremental cost-effectiveness ratio ( ICER ) of £ 10,366 in the UK , $ 22,484 in the USA , SKr 127,951 in Sweden , ∊16,186 in France , and C$ 7973 in Canada per primary event avoided with clopidogrel . Conclusions Clopidogrel in CURE reduced hospitalization costs but the acquisition cost of clopidogrel creates an overall increase in direct health care costs over 9 months . Nevertheless , the cost-effectiveness is in a range comparable to other therapies currently utilized for acute coronary syndromes BACKGROUND In the PURSUIT trial , eptifibatide significantly reduced the 30-day incidence of death and myocardial infa rct ion relative to placebo in 9461 patients with an acute coronary syndrome ( unstable angina or non-Q-wave myocardial infa rct ion ) . METHODS AND RESULTS We conducted a 2-part prospect i ve economic sub study of the 3522 US patients enrolled in PURSUIT : ( 1 ) an empirical intention-to-treat comparison of medical costs ( hospital plus physician ) up to 6 months after hospitalization and ( 2 ) a lifetime cost-effectiveness analysis . The base-case cost-effectiveness ratio was expressed as the 1996 US dollars required to add 1 life-year with eptifibatide therapy . The 2 treatment arms had equivalent re source consumption and medical costs ( exclusive of the cost of the eptifibatide regimen ) during the index ( enrollment ) hospitalization ( P=0.78 ) and up to 6 months afterward ( P=0.60 ) . The average wholesale price of the eptifibatide regimen was $ 1217 , but a typical hospital discounted price was $ 1014 . The estimated life expectancy from r and omization in the US patients was 15.96 years for eptifibatide and 15.85 years for placebo , an incremental difference of 0.111 . The incremental cost-effectiveness ratio for eptifibatide therapy in US PURSUIT patients was $ 16 491 per year of life saved . This result was robust through a wide range of sensitivity analyses . The cost-utility ratio for eptifibatide ( using time trade-off defined utilities ) was $ 19 693 per added quality -adjusted life-year . CONCLUSIONS Based on the results observed in the US PURSUIT patients , the routine addition of eptifibatide to st and ard care for non-ST-elevation acute coronary syndrome patients is economically attractive by conventional st and ards AIMS To assess the direct medical costs and cost effectiveness of routine eptifibatide use amongst patients with unstable angina and myocardial infa rct ion without persistent ST-segment elevation in the Western European subgroup of the PURSUIT trial . METHODS AND RESULTS Health care re sources were collected for the Western European PURSUIT trial patients ( n=3697 ) . Unit costs for major re sources were developed within six countries using a consistent bottom-up methodology . Re source consumption from the Western European population was used to calculate the average direct medical costs per patient in the eptifibatide and placebo arms of the trial . Eptifibatide was estimated to cost 524 Euros per treatment . Long-term survival estimated from the 6-month trial survival data and combined with the cost data was used to calculate cost-effectiveness ratios . Additionally , cost per death and non-fatal myocardial infa rct ion at 30 days was calculated . Sensitivity analyses were conducted on the discount rate and re source consumption . Cost-effectiveness ratios ranged from 9603 Euros to 18 115 Euros per year of life saved with 3 % discount . Using re source consumption based on countries with low coronary arteriography rates , the cost per year of life saved was between 3329 Euros and 10 079 Euros . Using re source consumption based on high coronary arteriography rate countries , the cost per year of life saved was between 17 089 Euros and 24 099 Euros . Assuming no difference in treatment costs except for the addition of eptifibatide , the incremental cost per year of life saved was 23 818 Euros . CONCLUSIONS Routine eptifibatide use was associated with a reduction in the combined end-point of death and myocardial infa rct ion at 30 days , which was sustained at 6 months . Long-term projections indicate a modest increase in survival in eptifibatide patients . These data translate into cost-effectiveness ratios that compare favourably with other new technologies that are currently in use BACKGROUND Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention . METHODS To compare prasugrel , a new th \n Output:\n " }, { "from": "agent", "value": "Conclusions Evidence from the present systematic review suggests that the majority of the available treatments represent either cost-saving or cost-effective options for NSTE-ACS patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Sixty‐four patients with chronic bronchitis with a history of recurrent respiratory tract infections were admitted to a double‐blind r and omised controlled study in which the efficacy of an oral vaccine containing killed Haemophilus influenzae in preventing acute exacerbations of chronic bronchitis was compared with placebo . Patients given vaccine developed fewer acute infective episodes . Although the numbers of patients who required antibiotic therapy in the two groups were not significantly different , the number of antibiotic prescriptions given to the vaccinated group of patients was significantly less than that required by the control group . A reduction in colonisation with Haemophilus influenzae occurred in the active group , which was maximal 14 weeks after the onset of the study . ( Aust NZ J Med 1991 ; 21 : 427–432 . Subjects prone to recurrent acute bronchitis were admitted to a six-month double-blind clinical study , in which the value of oral immunization with a preparation of killed Haemophilus influenzae was tested . Most subjects had early smoking-related chronic lung disease , unrecognized by either the patient or his/her doctor . Subjects taking the active agent had a 41 % reduction in the total number of episodes of acute bronchitis ( P = 0.16 ) , a 60 % reduction in the number of episodes of acute wheezy bronchitis ( P = 0.02 ) and a 58 % reduction in antibiotic use ( P = 0.07 ) . The power of analysis was restricted by the small study group . Parameters of episode severity favoured the test group , suggesting that individual episodes of acute bronchitis in subjects taking an oral preparation of killed H. influenzae were less severe than in those taking placebo tablets . Oral immunization with H. influenzae selectively reduced the increase in colonization of the oropharynx with H. influenzae which occurred in the group taking placebo . This is the first demonstration that the common mucosal system can be activated to modify a colonization pattern at a distant site BACKGROUND Acute exacerbations adversely affect patients with chronic obstructive pulmonary disease ( COPD ) . Macrolide antibiotics benefit patients with a variety of inflammatory airway diseases . METHODS We performed a r and omized trial to determine whether azithromycin decreased the frequency of exacerbations in participants with COPD who had an increased risk of exacerbations but no hearing impairment , resting tachycardia , or apparent risk of prolongation of the corrected QT interval . RESULTS A total of 1577 subjects were screened ; 1142 ( 72 % ) were r and omly assigned to receive azithromycin , at a dose of 250 mg daily ( 570 participants ) , or placebo ( 572 participants ) for 1 year in addition to their usual care . The rate of 1-year follow-up was 89 % in the azithromycin group and 90 % in the placebo group . The median time to the first exacerbation was 266 days ( 95 % confidence interval [ CI ] , 227 to 313 ) among participants receiving azithromycin , as compared with 174 days ( 95 % CI , 143 to 215 ) among participants receiving placebo ( P<0.001 ) . The frequency of exacerbations was 1.48 exacerbations per patient-year in the azithromycin group , as compared with 1.83 per patient-year in the placebo group ( P=0.01 ) , and the hazard ratio for having an acute exacerbation of COPD per patient-year in the azithromycin group was 0.73 ( 95 % CI , 0.63 to 0.84 ; P<0.001 ) . The scores on the St. George 's Respiratory Question naire ( on a scale of 0 to 100 , with lower scores indicating better functioning ) improved more in the azithromycin group than in the placebo group ( a mean [ ±SD ] decrease of 2.8±12.8 vs. 0.6±11.4 , P=0.004 ) ; the percentage of participants with more than the minimal clinical ly important difference of -4 units was 43 % in the azithromycin group , as compared with 36 % in the placebo group ( P=0.03 ) . Hearing decrements were more common in the azithromycin group than in the placebo group ( 25 % vs. 20 % , P=0.04 ) . CONCLUSIONS Among selected subjects with COPD , azithromycin taken daily for 1 year , when added to usual treatment , decreased the frequency of exacerbations and improved quality of life but caused hearing decrements in a small percentage of subjects . Although this intervention could change microbial resistance patterns , the effect of this change is not known . ( Funded by the National Institutes of Health ; Clinical Trials.gov number , NCT00325897 . ) The PARI-IS Study is a double-blind placebo-controlled r and omized clinical trial to study the effect of an immunostimulating agent to prevent acute respiratory exacerbation in patients with COPD . Three hundred eighty-one ambulatory patients ( 190 placebo and 191 immunostimulant ) were followed at home for 6 mo by experienced research nurses . The risk of having at least one episode of acute exacerbation ( primary outcome ) was similar in the two groups ( p = 0.872 ) . In contrast , the total number of days of hospitalization for a respiratory problem was 55 % less in the group treated with OM-85 BV ( 287 d ) than in the group treated with placebo ( 642 d ) . Patients treated with OM-85 BV spent an average of 1.5 d in hospital compared with 3.4 d for patients treated with placebo ( p = 0.037 ) . The risk of being hospitalized for a respiratory problem was 30 % lower in the treated group ( 16.2 % ) than in the placebo group ( 23.2 % ) ; p = 0.089 . Eight deaths were observed : two in patients treated with OM-85 BV and six in patients treated with placebo ( p = 0.153 ) . During the course of the study dyspnea improved slightly in patients treated with OM-85 BV , whereas it deteriorated slightly in patients receiving placebo ( p = 0.028 ) . These results suggest that this immunostimulating agent may be beneficial for patients with COPD by reducing the likelihood of severe respiratory events leading to hospitalization Following the administration of a st and ardized question naire , 62 adult patients with chronic bronchitis were enrolled into a double-blind controlled trial of an oral killed Haemophilus influenzae vaccine in the highl and s of Papua New Guinea . A 3-day course of vaccine or placebo was given monthly for 3 consecutive months . Participants were monitored weekly over 12 months for acute exacerbations ; early morning sputum specimens were collected monthly and during acute exacerbations . Density of colonization by H. influenzae and H. parainfluenzae was determined by st and ard quantitative and semiquantitative techniques , and the latter method ( quadrant score ) was used to determine the density of growth of pneumococci . A total of 30 patients received vaccine and 32 placebo . The incidence rate of acute bronchitis in the vaccine group ( 0.011 episodes/person-weeks ) was significantly lower than that in the placebo group ( 0.021 episodes/person-weeks ) , but there was no difference between the two groups in the incidence rates of more severe disease . Vaccine efficacy was maximal at times of peak incidence of disease . There was no evidence of a decline in vaccine efficacy for acute bronchitis over the 12-month follow-up period . The number of viable H. influenzae in the sputum declined in both vaccine and placebo groups over the 12-month follow-up period . The average concentration of H. influenzae in the vaccine group fell below that in the placebo group within 1 to 2 months after first immunization and remained so for 12 months , although the difference between the two groups narrowed during the follow-up period . ( ABSTRACT TRUNCATED AT 250 WORDS Oral immunotherapy with inactivated non‐typeable Haemophilus influenzae ( NTHi ) prevents exacerbations of chronic obstructive pulmonary disease , but the mechanism is unclear . The aim of this study was to determine the mechanism of protection . This was a placebo versus active prospect i ve study over 3 months in 64 smokers . The active treatment was three courses of oral NTHi given at monthly intervals , followed by measurement of bacteriological and immunological parameters . The results can be summarized : ( i ) NTHi‐specific T cells increased in the placebo treatment group over time ( P < 0·05 ) ; ( ii ) the T cell response in the oral NTHi group started earlier than that in the placebo group ( P < 0·05 ) ; and ( iii ) serum NTHi‐specific immunoglobulin (Ig)G had significantly greater variation in the placebo group ( P < 0·0001 ) . The increase in antibody in placebos over time correlated with exposure to live H. influenzae ( P < 0·05 ) determined from culture of gargles ; ( iv ) reduction in saliva lysozyme over time ( P < 0·05 ) was detected only in the oral NTHi treatment group . These data are consistent with T cell priming of gut lymphoid tissue by aspiration of bronchus content into the gut , with oral immunotherapy augmenting this process leading to enhanced bronchus protection . The evidence for protection was a stable IgG antibody level through the study in the oral NTHi treatment group , contrasting with an increase in antibody correlating with exposure of the airways to H. influenzae in the placebo group . Saliva lysozyme was a useful biomarker of mucosal inflammation , falling after oral NTHi consistent with a reduction in the level of intralumenal inflammation Fifty patients with chronic obstructive lung disease were r and omly allocated to three groups , to assess whether an oral vaccine containing non-typable Haemophilus influenzae protected against acute bronchitis . The double-blind prospect i ve study over a three-month winter period included two placebo groups and one test group . Oral immunisation with H influenzae induced a tenfold reduction in the incidence of infection ( p less than 0.001 ) . During the subsequent winter , without further immunisation , protection by the vaccine was no longer statistically significant . There was no clear correlation between clinical protection and either carriage of H influenzae or the level of antibody to H influenzae antigen in saliva BACKGROUND Acute exacerbations of COPD reflect in part an inappropriate host response to abnormal bacterial colonization . Orally administered inactivated nontypeable Haemophilus influenzae ( NTHi ) can drive a specific T-cell response that by promoting intrabronchial phagocytosis down-regulates bronchus inflammation . METHODS Subjects with recurrent exacerbations of COPD were studied in a r and omized , multicenter , double-blind , placebo-controlled trial , to test efficacy of an NTHi oral immunotherapeutic ( HI-164OV ) . This report describes the outcome in 38 subjects with severe COPD defined as having an FEV(1 ) < or = 50 % of predicted normal . RESULTS Exacerbations defined as an increase in volume and purulence of sputum were reduced by 16 % ( not significant ) in the active group . However , moderate-to-severe exacerbations ( defined as requiring corticosteroid therapy ) were reduced by 63 % ( P = .05 ) . The proportion with any acute exacerbation was little changed with treatment , but the proportion with episodes requiring corticosteroid therapy was reduced by 56 % ( P = .07 ) . The mean duration of episodes was reduced by 37 % ( P = .01 ) and prescribed courses of antibiotics were reduced by 56 % ( P = .03 ) following therapy . Exacerbations requiring admission into hospital were reduced by 90 % ( P = .04 ) in the active group . No specific adverse effect was detected . CONCLUSIONS Treatment of severe COPD with frequent exacerbations with HI-164OV was safe and effective , especially with respect to reduction in parameters of severity . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry , www.anzctr.org.au ; identifier : ACTRN012606000074594 \n Output:\n " }, { "from": "agent", "value": "Analyses demonstrate that NTHi oral vaccination of people with recurrent exacerbations of chronic bronchitis or COPD does not yield a significant reduction in the number and severity of exacerbations .\nEvidence was mixed , and the individual trials that showed a significant benefit of the vaccine are too small to advocate widespread oral vaccination of people with COPD" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : An inadequate response to initial empirical treatment of community acquired pneumonia ( CAP ) represents a challenge for clinicians and requires early identification and intervention . A study was undertaken to quantify the incidence of failure of empirical treatment in CAP , to identify risk factors for treatment failure , and to determine the implication s of treatment failure on the outcome . Methods : A prospect i ve multicentre cohort study was performed in 1424 hospitalised patients from 15 hospitals . Early treatment failure ( < 72 hours ) , late treatment failure , and in-hospital mortality were recorded . Results : Treatment failure occurred in 215 patients ( 15.1 % ) : 134 early failure ( 62.3 % ) and 81 late failure ( 37.7 % ) . The causes were infectious in 86 patients ( 40 % ) , non-infectious in 34 ( 15.8 % ) , and undetermined in 95 . The independent risk factors associated with treatment failure in a stepwise logistic regression analysis were liver disease , pneumonia risk class , leucopenia , multilobar CAP , pleural effusion , and radiological signs of cavitation . Independent factors associated with a lower risk of treatment failure were influenza vaccination , initial treatment with fluoroquinolones , and chronic obstructive pulmonary disease ( COPD ) . Mortality was significantly higher in patients with treatment failure ( 25 % v 2 % ) . Failure of empirical treatment increased the mortality of CAP 11-fold after adjustment for risk class . Conclusions : Although these findings need to be confirmed by r and omised studies , they suggest possible interventions to decrease mortality due to CAP BACKGROUND Clinical trials yielded conflicting data about the benefit of adding systemic corticosteroids for treatment of community-acquired pneumonia . We assessed whether short-term corticosteroid treatment reduces time to clinical stability in patients admitted to hospital for community-acquired pneumonia . METHODS In this double-blind , multicentre , r and omised , placebo-controlled trial , we recruited patients aged 18 years or older with community-acquired pneumonia from seven tertiary care hospitals in Switzerl and within 24 h of presentation . Patients were r and omly assigned ( 1:1 ratio ) to receive either prednisone 50 mg daily for 7 days or placebo . The computer-generated r and omisation was done with variable block sizes of four to six and stratified by study centre . The primary endpoint was time to clinical stability defined as time ( days ) until stable vital signs for at least 24 h , and analysed by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00973154 . FINDINGS From Dec 1 , 2009 , to May 21 , 2014 , of 2911 patients assessed for eligibility , 785 patients were r and omly assigned to either the prednisone group ( n=392 ) or the placebo group ( n=393 ) . Median time to clinical stability was shorter in the prednisone group ( 3·0 days , IQR 2·5 - 3·4 ) than in the placebo group ( 4·4 days , 4·0 - 5·0 ; hazard ratio [ HR ] 1·33 , 95 % CI 1·15 - 1·50 , p<0·0001 ) . Pneumonia-associated complications until day 30 did not differ between groups ( 11 [ 3 % ] in the prednisone group and 22 [ 6 % ] in the placebo group ; odds ratio [ OR ] 0·49 [ 95 % CI 0·23 - 1·02 ] ; p=0·056 ) . The prednisone group had a higher incidence of in-hospital hyperglycaemia needing insulin treatment ( 76 [ 19 % ] vs 43 [ 11 % ] ; OR 1·96 , 95 % CI 1·31 - 2·93 , p=0·0010 ) . Other adverse events compatible with corticosteroid use were rare and similar in both groups . INTERPRETATION Prednisone treatment for 7 days in patients with community-acquired pneumonia admitted to hospital shortens time to clinical stability without an increase in complications . This finding is relevant from a patient perspective and an important determinant of hospital costs and efficiency . FUNDING Swiss National Science Foundation , Viollier AG , Nora van Meeuwen Haefliger Stiftung , Julia und Gottfried Bangerter-Rhyner Stiftung Objectives It has been suggested that statins have an effect on the modulation of the cytokine cascade and on the outcome of patients with community-acquired pneumonia ( CAP ) . The aim of this prospect i ve , r and omised , double-blind , placebo-controlled trial was to determine whether statin therapy given to hospitalised patients with CAP improves clinical outcomes and reduces the concentration of inflammatory cytokines . Setting A tertiary teaching hospital in Barcelona , Spain . Participants Thirty-four patients were r and omly assigned and included in an intention-to-treat analysis ( 19 to the simvastatin group and 15 to the placebo group ) . Intervention Patients were r and omly assigned to receive 20 mg of simvastatin or placebo administered in the first 24 h of hospital admission and once daily thereafter for 4 days . Outcome Primary end point was the time from hospital admission to clinical stability . The secondary end points were serum concentrations of inflammatory cytokines and partial pressure of arterial oxygen/fractional inspired oxygen ( PaO2/FiO2 ) at 48 h after treatment administration . Results The trial was stopped because enrolment was much slower than originally anticipated . The baseline characteristics of the patients and cytokine concentrations at the time of enrolment were similar in the two groups . No significant differences in the time from hospital admission to clinical stability were found between study groups ( median 3 days , IQR 2–5 vs 3 days , IQR 2–5 ; p=0.47 ) . No significant differences in PaO2/FiO2 ( p=0.37 ) , C reactive protein ( p=0.23 ) , tumour necrosis factor-α ( p=0.58 ) , interleukin 6 ( IL-6 ; p=0.64 ) , and IL-10 ( p=0.61 ) levels at 48 h of hospitalisation were found between simvastatin and placebo groups . Similarly , transaminase and total creatine kinase levels were similar between study groups at 48 h of hospitalisation ( p=0.19 , 0.08 and 0.53 , respectively ) . Conclusions Our results suggest that the use of simvastatin , 20 mg once daily for 4 days , since hospital admission did not reduce the time to clinical stability and the levels of inflammatory cytokines in hospitalised patients with CAP . Trial registration number IS RCT N91327214 Background : In the assessment of severity in community acquired pneumonia ( CAP ) , the modified British Thoracic Society ( mBTS ) rule identifies patients with severe pneumonia but not patients who might be suitable for home management . A multicentre study was conducted to derive and vali date a practical severity assessment model for stratifying adults hospitalised with CAP into different management groups . Methods : Data from three prospect i ve studies of CAP conducted in the UK , New Zeal and , and the Netherl and s were combined . A derivation cohort comprising 80 % of the data was used to develop the model . Prognostic variables were identified using multiple logistic regression with 30 day mortality as the outcome measure . The final model was tested against the validation cohort . Results : 1068 patients were studied ( mean age 64 years , 51.5 % male , 30 day mortality 9 % ) . Age ⩾65 years ( OR 3.5 , 95 % CI 1.6 to 8.0 ) and albumin < 30 g/dl ( OR 4.7 , 95 % CI 2.5 to 8.7 ) were independently associated with mortality over and above the mBTS rule ( OR 5.2 , 95 % CI 2.7 to 10 ) . A six point score , one point for each of Confusion , Urea > 7 mmol/l , Respiratory rate ⩾30/min , low systolic(<90 mm Hg ) or diastolic ( ⩽60 mm Hg ) Blood pressure ) , age ⩾65 years ( CURB-65 score ) based on information available at initial hospital assessment , enabled patients to be stratified according to increasing risk of mortality : score 0 , 0.7 % ; score 1 , 3.2 % ; score 2 , 3 % ; score 3 , 17 % ; score 4 , 41.5 % and score 5 , 57 % . The validation cohort confirmed a similar pattern . Conclusions : A simple six point score based on confusion , urea , respiratory rate , blood pressure , and age can be used to stratify patients with CAP into different management groups Background Community-acquired pneumonia ( CAP ) is generally considered a major cause of morbidity and mortality in the elderly . However , population -based data are very limited and its overall burden is unclear . This study assessed incidence and mortality from CAP among Spanish community-dwelling elderly . Methods Prospect i ve cohort study that included 11,240 individuals aged 65 years or older , who were followed from January 2002 until April 2005 . Primary endpoints were all-cause CAP ( hospitalised and outpatient ) and 30-day mortality after the diagnosis . All cases were radiographically proved and vali date d by checking clinical records . Results Incidence rate of overall CAP was 14 cases per 1,000 person-year ( 95 % confidence interval : 12.7 to 15.3 ) . Incidence increased dramatically by age ( 9.9 in people 65–74 years vs 29.4 in people 85 years or older ) , and it was almost double in men than in women ( 19.3 vs 10.1 ) . Hospitalisation rate was 75.1 % , with a mean length-stay of 10.4 days . Overall 30-days case-fatality rate was 13 % ( 15 % in hospitalised and 2 % in outpatient cases ) . Conclusion CAP remains as a major health problem in older adults . Incidence rates in this study are comparable with rates described in Northern Europe and America , but they largely doubled prior rates reported in other Southern European regions Objective To determine differences in aetiologies , initial antimicrobial treatment choices and outcomes in patients with nursing-home-acquired pneumonia ( NHAP ) compared with patients with community-acquired pneumonia ( CAP ) , which is a controversial issue . Methods Data from the prospect i ve multicentre Competence Network for Community-acquired pneumonia ( CAPNETZ ) data base were analysed for hospitalised patients aged ≥65 years with CAP or NHAP . Potential differences in baseline characteristics , comorbidities , physical examination findings , severity at presentation , initial laboratory investigations , blood gases , microbial investigations , aetiologies , antimicrobial treatment and outcomes were determined between the two groups . Results Patients with NHAP presented with more severe pneumonia as assessed by CRB-65 ( confusion , respiratory rate , blood pressure , 65 years and older ) score than patients with CAP but received the same frequency of mechanical ventilation and less antimicrobial combination treatment . There were no clinical ly relevant differences in aetiology , with Streptococcus pneumoniae the most important pathogen in both groups , and potential multidrug-resistant pathogens were very rare ( < 5 % ) . Only Staphylococcus aureus was more frequent in the NHAP group ( n=12 , 2.3 % of the total population , 3.1 % of those with microbial sampling compared with 0.7 % and 0.8 % in the CAP group , respectively ) . Short-term and long-term mortality in the NHAP group was higher than in the CAP group for patients aged ≥65 years ( 26.6 % vs 7.2 % and 43.8 % vs 14.6 % , respectively ) . However , there was no association between excess mortality and potential multidrug-resistant pathogens . Conclusions Excess mortality in patients with NHAP can not be attributed to a different microbial pattern but appears to result from increased comorbidities , and consequently , pneumonia is frequently considered and managed as a terminal event Background Age-related alterations in the clinical characteristics and performance of severity scoring systems for community-acquired pneumonia ( CAP ) are unknown . Methods Consecutive patients with CAP presenting to the emergency department were prospect ively studied . Patients were classified as younger adults ( age 18–64 years ) , elderly ( age 65–84 years ) and very old subjects ( age ≥85 years ) . Clinical characteristics , complications , outcomes and validity of the pneumonia severity index ( PSI ) and CURB-65 categories were compared across these three age categories . Results Analysis involved 348 ( 35.3 % ) younger adult patients , 438 ( 44.3 % ) elderly patients and 201 ( 20.0 % ) very old patients . Compared with younger adults , elderly and very old patients had a higher burden of comorbidities and a higher incidence of CAP-related complications . The 30-day mortality rate was 5.2 % in younger adults , 7.1 % in elderly patients and 9.5 % in very old patients . The area under the ROC curve ( AUCs ) for PSI were 0.87 ( 95 % CI 0.77 to 0.97 ) , 0.85 ( 95 % CI 0.803 to 0.897 ) and 0.69 ( 95 % CI 0.597 to 0.787 ) and \n Output:\n " }, { "from": "agent", "value": "Pneumococcal and influenza vaccination comprise one of the most important preventive approaches for CAP in the elderly" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : MicroRNAs ( miRNAs ) are a key factor in epigenetic regulation of gene expression , but miRNA responses to fine particulate matter ( PM2.5 ) air pollution and their potential contribution to cardiovascular effects of PM2.5 are unknown . Objective : We explored the potential influence of PM2.5 on the expression of selected cytokines relevant to systemic inflammation , coagulation , and vasoconstriction , and on miRNAs that may regulate their expression . Methods : We design ed a double-blind , r and omized crossover study in which true and sham air purifiers were used to expose 55 healthy young adult students in Shanghai , China , to reduced or ambient levels of indoor PM2.5 during two-week periods , and we measured the expression ( mRNA and protein ) of 10 serum cytokines , and miRNAs that target them , after each intervention period . We used linear mixed-effect models to estimate associations of the intervention , and time-weighted personal PM2.5 exposures , with the cytokines , mRNA , and miRNAs ; we also explored potential mediation by miRNAs . Results : The findings were generally consistent for associations with the intervention and for associations with an interquartile range increase in time-weighted PM2.5 . Specifically , higher PM2.5 exposure was positively associated with the expression ( mRNA , protein , or both ) of interleukin-1 ( encoded by IL1 ) , IL6 , tumor necrosis factor ( encoded by TNF ) , toll-like receptor 2 ( encoded by TLR2 ) , coagulation factor 3 ( encoded by F3 ) , and endothelin 1 ( encoded by EDN1 ) , and was negatively associated with miRNAs ( miR-21 - 5p , miR-187 - 3p , miR-146a-5p , miR-1 - 3p , and miR-199a-5p ) predicted to target mRNAs of IL1 , TNF , TLR2 , and EDN1 . Conclusions : Our findings require confirmation but suggest that effects of PM2.5 on cardiovascular diseases may be related to acute effects on cytokine expression , which may be partly mediated through effects of PM2.5 on miRNAs that regulate cytokine expression . BACKGROUND Short-term exposure to fine particulate matter ( PM2.5 ) air pollution has been associated with altered DNA methylation in observational studies , but it remains unclear whether this change mediates the effects on cardiovascular biomarkers . OBJECTIVE To examine the impact of ambient PM2.5 on gene-specific DNA methylation and its potential mediation in the acute effects of PM2.5 on cardiovascular biomarkers . METHODS We design ed a r and omized , double-blind crossover trial using true or sham air purifiers for 48h among 35 healthy college students in Shanghai , China , in 2014 . We measured blood global methylation estimated in long interspersed nucleotide element-1 ( LINE‑1 ) and Alu repetitive elements , methylation in ten specific genes , and ten cardiovascular biomarkers . We used linear mixed-effect models to examine the associations between PM2.5 and methylation . We also performed causal mediation analyses to evaluate the potential mediation of methylation in the associations between PM2.5 and biomarkers . RESULTS Air purification increased DNA methylation in repetitive elements and all c and i date genes . An IQR increase ( 64μg/m(3 ) ) in PM2.5 was significantly associated with reduction of methylation in LINE-1 ( 1.44 % ) , one pro-inflammatory gene ( CD40LG , 9.13 % ) , two pro-coagulant genes ( F3 , 15.20 % ; SERPINE1 , 3.69 % ) , and two pro-vasoconstriction genes ( ACE , 4.64 % ; EDN1 , 9.74 % ) . There was a significant mediated effect ( 17.82 % , P=0.03 ) of PM2.5 on sCD40L protein through CD40LG hypomethylation . Hypomethylation in other c and i date genes generally showed positive but non-significant mediation . CONCLUSIONS This intervention study provided robust human evidence that ambient PM2.5 could induce rapid decreases in DNA methylation and consequently partly mediate its effects on cardiovascular biomarkers Objective The objective of the study was to analyze the effect of environmental factors on the differential expression of microRNAs in the peripheral blood of migratory and local patients in northern People ’s Republic of China and on clinical symptoms of local patients in northern People ’s Republic of China with COPD . Methods A total of 118 patients in the northern region and 8 migratory patients were enrolled in this prospect i ve study . We collected general information . Blood sample s were collected from 9 patients in the Beijing group , from 8 patients in the migratory group and from 9 healthy control subjects . After extracting the total RNA from these 3 groups , serum miRNA was identified by Solexa sequencing . We collected COPD assessment test ( CAT ) and Modified British Medical Research Council ( mMRC ) scores at different levels of air pollution and also collected the number of exacerbations over the year prior to the baseline and in the year preceding the follow-up . Results In total 9 miRNAs were differentially expressed . When air quality index ( AQI ) > 100 , the CAT and mMRC scores at baseline were significantly higher than those when the AQI ≤100 ( P<0.001 ) . When AQI > 100 , the follow-up CAT and mMRC scores were significantly higher than those when AQI ≤100 ( P<0.001 ) . Follow-up mMRC scores were significantly higher than baseline scores ( P=0.04 ) . When AQI ≤100 , the baseline CAT score of the group with fewer symptoms was 6.50 ( 4.00–8.75 ) . However , when AQI > 100 , the baseline CAT score of this fewer symptoms group was 10.00 ( 6.25–12.00 ) . The median CAT score was close to 10 . When AQI ≤100 , the follow-up CAT score of the fewer symptoms group was 8.00 ( 4.25–12.00 ) . However , when AQI > 100 , the follow-up CAT score of the fewer symptoms group was 9.50 ( 6.00–16.75 ) . The median CAT score was close to 10 . Conclusion Environmental factors may cause differential expression of miRNAs in the peripheral blood of migratory and local patients in northern People ’s Republic of China . Air pollution may aggravate clinical symptoms of patients with COPD Background : Epidemiological studies have reported associations between particulate matter ( PM ) concentrations and cancer and respiratory and cardiovascular diseases . DNA methylation has been identified as a possible link but so far it has only been analyzed in c and i date sites . Objectives : We studied the association between DNA methylation and short- and mid-term air pollution exposure using genome-wide data and identified potential biological pathways for additional investigation . Methods : We collected whole blood sample s from three independent studies —KORA F3 ( 2004–2005 ) and F4 ( 2006–2008 ) in Germany , and the Normative Aging Study ( 1999–2007 ) in the United States— and measured genome-wide DNA methylation proportions with the Illumina 450k BeadChip . PM concentration was measured daily at fixed monitoring stations and three different trailing averages were considered and regressed against DNA methylation : 2-day , 7-day and 28-day . Meta- analysis was performed to pool the study -specific results . Results : R and om-effect meta- analysis revealed 12 CpG ( cytosine-guanine dinucleotide ) sites as associated with PM concentration ( 1 for 2-day average , 1 for 7-day , and 10 for 28-day ) at a genome-wide Bonferroni significance level ( p ≤ 7.5E-8 ) ; 9 out of these 12 sites expressed increased methylation . Through estimation of I2 for homogeneity assessment across the studies , 4 of these sites ( annotated in NSMAF , C1orf212 , MSGN1 , NXN ) showed p > 0.05 and I2 < 0.5 : the site from the 7-day average results and 3 for the 28-day average . Applying false discovery rate , p-value < 0.05 was observed in 8 and 1,819 additional CpGs at 7- and 28-day average PM2.5 exposure respectively . Conclusion : The PM-related CpG sites found in our study suggest novel plausible systemic pathways linking ambient PM exposure to adverse health effect through variations in DNA methylation . Citation : Panni T , Mehta AJ , Schwartz JD , Baccarelli AA , Just AC , Wolf K , Wahl S , Cyrys J , Kunze S , Strauch K , Waldenberger M , Peters A. 2016 . A genome-wide analysis of DNA methylation and fine particulate matter air pollution in three study population s : KORA F3 , KORA F4 , and the Normative Aging Study . Environ Health Perspect 124:983–990 ; Background Air pollution from particulate matter ( PM ) has been linked to cardiovascular morbidity and mortality ; however the underlying biological mechanisms remain to be uncovered . Gene regulation by microRNAs ( miRNAs ) that are transferred between cells by extracellular vesicles ( EVs ) may play an important role in PM-induced cardiovascular risk . This study sought to determine if ambient PM2.5 levels are associated with expression of EV-encapsulated miRNAs ( evmiRNAs ) , and to investigate the participation of such evmiRNAs in pathways related to cardiovascular disease ( CVD ) . Methods We estimated the short- ( 1-day ) , intermediate- ( 1-week and 1-month ) and long-term ( 3-month , 6-month , and 1-year ) moving averages of ambient PM2.5 levels at participants ’ addresses using a vali date d hybrid spatio-temporal l and -use regression model . We collected 42 serum sample s from 22 r and omly selected participants in the Normative Aging Study cohort and screened for 800 miRNAs using the NanoString nCounter ® platform . Mixed effects regression models , adjusted for potential confounders were used to assess the association between ambient PM2.5 levels and evmiRNAs . All p-values were adjusted for multiple comparisons . In-silico Ingenuity Pathway Analysis ( IPA ) was performed to identify biological pathways that are regulated by PM-associated evmiRNAs . Results We found a significant association between long-term ambient PM2.5 exposures and levels of multiple evmiRNAs circulating in serum . In the 6-month window , ambient PM2.5 exposures were associated with increased levels of miR-126 - 3p ( 0.74 ± 0.21 ; p = 0.02 ) , miR-19b-3p ( 0.52 ± 0.15 ; p = 0.02 ) , miR-93 - 5p ( 0.78 ± 0.22 ; p = 0.02 ) , miR-223 - 3p ( 0.74 ± 0.22 ; p = 0.02 ) , and miR-142 - 3p ( 0.81 ± 0.21 ; p = 0.03 ) . Similarly , in the 1-year window , ambient PM2.5 levels were associated with increased levels of miR-23a-3p ( 0.83 ± 0.23 ; p = 0.02 ) , miR-150 - 5p ( 0.90 ± 0.24 ; p = 0.02 ) , miR-15a-5p ( 0.70 ± 0.21 ; p = 0.02 ) , miR-191 - 5p ( 1.20 ± 0.35 ; p = 0.02 ) , and let-7a-5p ( 1.42 ± 0.39 ; p = 0.02 ) . In silico pathway analysis on PM2.5-associated evmiRNAs identified several key CVD-related pathways including oxidative stress , inflammation , and atherosclerosis . Conclusions We found an association between long-term ambient PM2.5 levels and increased levels of evmiRNAs circulating in serum . Further observational studies are warranted to confirm and extend these important findings in larger and more diverse population s , and experimental studies are needed to eluci date the exact roles of evmiRNAs in PM-induced CVD Air pollution is associated with a broad range of adverse health effects , including mortality and morbidity due to cardio‐ and cerebrovascular diseases ( CCVD ) , but the molecular mechanisms involved are not entirely understood . This study aims to investigate the involvement of oxidative stress and inflammation in the causal chain , and to identify intermediate biomarkers that are associated retrospectively with the exposure and prospect ively with the disease . We design ed a case‐control study on CCVD nested in a cohort of 18,982 individuals from the EPIC‐Italy study . We measured air pollution , inflammatory biomarkers , and whole‐genome DNA methylation in blood collected up to 17 years before the diagnosis . The study sample includes \n Output:\n " }, { "from": "agent", "value": "Panel and experimental studies revealed a relatively large number of significant methylome alterations , though based on smaller sample sizes .\nParticulate matter levels were positively associated in several studies with global or LINE-1 hypomethylation , a hallmark of several diseases , and with decondensed chromatin structure .\nSeveral air pollution species altered the DNA methylation clock , inducing accelerated biological aging .\nThe causal nature of identified associations is not clear , however , especially that most originate from countries with low air pollution levels ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To do an indirect comparison analysis of apixaban against dabigatran etexilate ( 2 doses ) and rivaroxaban ( 1 dose ) , as well as of rivaroxaban against dabigatranetexilate ( 2 doses ) , for their relative efficacy and safety against each other , with particular focus on the secondary prevention population for stroke prevention in atrial fibrillation . A secondary objective was to do the same analysis in the primary prevention cohort . Design Indirect treatment comparisons of phase III clinical trials of stroke prevention in atrial fibrillation , with a focus on the secondary prevention cohorts . A secondary analysis was done on the primary prevention cohort . Data sources Medline and Central ( up to June 2012 ) , clinical trials registers , conference proceedings , and websites of regulatory agencies . Study selection R and omised controlled trials of rivaroxaban , dabigatran , or apixaban compared with warfarin for stroke prevention in atrial fibrillation . Results In the secondary prevention ( previous stroke ) subgroup , when apixaban was compared with dabigatran ( 110 mg and 150 mg twice daily ) for efficacy and safety endpoints , the only significant difference seen was less myocardial infa rct ion ( hazard ratio 0.39 , 95 % confidence interval 0.16 to 0.95 ) with apixaban compared with dabigatran 150 mg twice daily . No significant differences were seen in efficacy and most safety endpoints between apixaban or dabigatran 150 mg twice daily versus rivaroxaban . Less haemorrhagic stroke ( hazard ratio 0.15 , 0.03 to 0.66 ) , vascular death ( 0.64 , 0.42 to 0.99 ) , major bleeding ( 0.68 , 0.47 to 0.99 ) , and intracranial bleeding ( 0.27 , 0.10 to 0.73 ) were seen with dabigatran 110 mg twice daily versus rivaroxaban . In the primary prevention ( no previous stroke ) subgroup , apixaban was superior to dabigatran 110 mg twice daily for disabling or fatal stroke ( hazard ratio 0.59 , 0.36 to 0.97 ) . Compared with dabigatran 150 mg twice daily , apixaban was associated with more stroke ( hazard ratio 1.45 , 1.01 to 2.08 ) and with less major bleeding ( 0.75 , 0.60 to 0.94 ) , gastrointestinal bleeding ( 0.61 , 0.42 to 0.89 ) , and other location bleeding ( 0.74 , 0.58 to 0.94 ) . Compared with rivaroxaban , dabigatran 110 mg twice daily was associated with more myocardial infa rct ion events . No significant differences were seen for the main efficacy and safety endpoints between dabigatran 150 mg twice daily and rivaroxaban , or in efficacy endpoints between apixaban and rivaroxaban . Apixaban was associated with less major bleeding ( hazard ratio 0.61 , 0.48 to 0.78 ) than rivaroxaban . Conclusions For secondary prevention , apixaban , rivaroxaban , and dabigatran had broadly similar efficacy for the main endpoints , although the endpoints of haemorrhagic stroke , vascular death , major bleeding , and intracranial bleeding were less common with dabigatran 110 mg twice daily than with rivaroxaban . For primary prevention , the three drugs showed some differences in relation to efficacy and bleeding . These results are hypothesis generating and should be confirmed in a head to head r and omised trial The primary objective of this study was to compare the safety of four fixed-dose regimens of edoxaban with warfarin in patients with non-valvular atrial fibrillation ( AF ) . In this 12-week , parallel-group , multicentre , multinational study , 1,146 patients with AF and risk of stroke were r and omised to edoxaban 30 mg qd , 30 mg bid , 60 mg qd , or 60 mg bid or warfarin dose-adjusted to a target international normalised ratio of 2.0 - 3.0 . The study was double-blind to edoxaban dose , but open-label to warfarin . Primary outcomes were occurrence of major and /or clinical ly relevant non-major bleeding and elevated hepatic enzymes and /or bilirubin . Mean age was 65 + /- 8.7 years and 64.4 % were warfarin-naïve . Whereas major plus clinical ly relevant non-major bleeding occurred in 3.2 % of patients r and omised to warfarin , the incidence of bleeding was significantly higher with the edoxaban 60 mg bid ( 10.6 % ; p=0.002 ) and 30 mg bid regimens ( 7.8 % ; p=0.029 ) , but not with the edoxaban 60 mg qd ( 3.8 % ) or 30 mg qd regimens ( 3.0 % ) . For the same total daily dose of 60 mg , both bleeding frequency and trough edoxaban concentrations were higher in the 30-mg bid group than in the 60-mg qd group . There were no significant differences in hepatic enzyme elevations or bilirubin values among the groups . The safety profiles of edoxaban 30 and 60 mg qd in patients with AF were similar to warfarin . In contrast , the edoxaban bid regimens were associated with more bleeding than warfarin . These results suggest that in this three-month study , edoxaban 30 or 60 mg qd are safe and well-tolerated BACKGROUND Atrial fibrillation is an important cause of morbidity and mortality worldwide , but scant data are available for long-term outcomes in individuals outside North America or Europe , especially in primary care setting s. METHODS We did a cohort study using a prospect i ve registry of patients in 47 countries who presented to a hospital emergency department with atrial fibrillation or atrial flutter as a primary or secondary diagnosis . 15 400 individuals were enrolled to determine the occurrence of death and strokes ( the primary outcomes ) in this cohort over eight geographical regions ( North America , western Europe , and Australia ; South America ; eastern Europe ; the Middle East and Mediterranean crescent ; sub-Saharan Africa ; India ; China ; and southeast Asia ) 1 year after attending the emergency department . Patients from North America , western Europe , and Australia were used as the reference population , and compared with patients from the other seven regions FINDINGS Between Dec 24 , 2007 , and Oct 21 , 2011 , we enrolled 15 400 individuals to the registry . Follow-up was complete for 15 361 ( 99·7 % ) , of whom 1758 ( 11 % ) died within 1 year . Fewer deaths occurred among patients presenting to the emergency department with a primary diagnosis of atrial fibrillation compared with patients who had atrial fibrillation as a secondary diagnosis ( 377 [ 6 % ] of 6825 patients vs 1381 [ 16 % ] of 8536 , p<0·0001 ) . Twice as many patients had died by 1 year in South America ( 192 [ 17 % ] of 1132 ) and Africa ( 225 [ 20 % ] of 1137 ) compared with North America , western Europe , and Australia ( 366 [ 10 % ] of 3800 , p<0·0001 ) . Heart failure was the most common cause of death ( 519 [ 30 % ] of 1758 ) ; stroke caused 148 ( 8 % ) deaths . 604 ( 4 % ) of 15361 patients had had a stroke by 1 year ; 170 ( 3 % ) of 6825 for whom atrial fibrillation was a primary diagnosis and 434 ( 5 % ) of 8536 for whom it was a secondary diagnosis ( p<0·0001 ) . The highest number of strokes occurred in patients in Africa ( 89 [ 8 % ] of 1137 ) , China ( 143 [ 7 % ] of 2023 ) , and southeast Asia ( 88 [ 7 % ] of 1331 ) and the lowest occurred in India ( 20 [ < 1 % ] of 2536 ) . 94 ( 3 % ) of 3800 patients in North America , western Europe , and Australia had a stroke . INTERPRETATION Marked unexplained inter-regional variations in the occurrence of stroke and mortality suggest that factors other than clinical variables might be important . Prevention of death from heart failure should be a major priority in the treatment of atrial fibrillation . FUNDING Boehringer Ingelheim Edoxaban is an oral , reversible , direct factor Xa inhibitor in phase III clinical development for the prevention of stroke in atrial fibrillation ( AF ) . A phase II study was undertaken to evaluate the safety and efficacy of edoxaban in Asian patients with non-valvular AF with CHADS2 score ≥1 . In a multicentre , active-controlled , double-blind edoxaban and open-label warfarin , parallel-group study , a total of 235 patients from four Asian countries were r and omly assigned to edoxaban 30 mg qd , 60 mg qd or warfarin dose adjusted to international normalised ratio of 2 - 3 for three months . The primary endpoint was the incidence of central ly adjudicated all bleeding events ( major , clinical ly relevant non-major and minor ) . Secondary endpoints included thromboembolic events , biomarkers of thrombus formation and all adverse events ( AEs ) . The incidence of all bleeding events ( 95 % CI ) was 20.3 % ( 12.9 , 30.4 ) for edoxaban 30 mg , 23.8 % ( 15.8 , 34.1 ) for edoxaban 60 mg , and 29.3 % ( 20.2 , 40.4 ) for warfarin . A subgroup analysis suggested low body weight ( ≤60 kg ) may affect the incidence of bleeding events with edoxaban . The incidence of study drug-related AEs was 22 % for edoxaban 30 mg , 29 % for edoxaban 60 mg and 33 % for warfarin . No thromboembolic events occurred in any treatment group . In conclusion , this phase II study found a trend for a reduction in the incidence of all bleeding events in Asian AF patients with edoxaban 30 mg and 60 mg compared with warfarin . Adverse events were similar between the edoxaban 60-mg and warfarin groups and were lower with the edoxaban 30-mg group 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 investigate whether warfarin is more effective and superior to aspirin for the prevention of thromboembolism in nonvalvular atrial fibrillation in Chinese . METHODS In a multicenter r and omized trial , the patients diagnosed as nonvalvular atrial fibrillation were r and omized to receive aspirin 150 mg - 160 mg once daily or adjusted-dose warfarin ( international normalized ratio , 2.0 - 3.0 ) . We compared the effect of the two therapy on the primary end point of ischemic stroke or death from any cause and on the combined end-point ( stroke , death , peripheral arteries embolism , TIA , acute myocardial infa rct ion , serious bleeding ) during a median follow-up period of 19 months . RESULTS Of the 704 patients , 420 ( 59.7 % ) were male . The average patient age was ( 63.3 + /- 9.9 ) years . The median follow-up period is 19 months . The mean dose of warfarin was ( 3.2 + /- 0.7 ) mg . Compared with aspirin , the primary end point of death or ischemic stroke was reduced by warfarin ( 2.7 % vs 6.0 % , P = 0.03 , OR 0.44 , 95 % CI 0.198 - 0.960 ) and the relative risk decreased by 56 % . The thromboembolism event in the aspirin group was significantly higher than that in warfarin group ( 10.6 % vs 5.4 % , P = 0.01 , OR 0.48 , 95 % CI 0.269 - 0.858 ) . There was no significant differences of the mortality rate between the two groups ( 1.2 % vs 2.2 % , P > 0.05 ) . The secondary end point was nonsignificantly reduced in warfarin group than that in aspirin group , while the combined end point is statistically decreased by adjusted-dose warfarin ( 8.4 % vs 13.0 % , P = 0.047 ) . Warfarin treatment was associated with increased bleeding rate compared to aspirin ( 6.9 % vs 2.4 % , P < 0.05 ) , although the major bleeding rate is rather low ( 1.5 % ) . All the major bleeding events occurred with INR above 3.0 . CONCLUSIONS R and omized control study demonstrated that anticoagulation with adjusted- \n Output:\n " }, { "from": "agent", "value": "The risk of all‐cause mortality was lower with all DOACs than with warfarin .\nThe risk of intracranial bleeding was substantially lower for most DOACs compared with warfarin , whereas the risk of gastrointestinal bleeding was higher with some DOACs than warfarin .\nApixaban 5 mg twice daily was ranked the highest for most outcomes , and was cost effective compared with warfarin .\nThe network meta‐ analysis informs the choice of DOACs for prevention of stroke in patients with atrial fibrillation .\nSeveral DOACs are of net benefit compared with warfarin ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The current evidence -based practice ( EBP ) movement in healthcare emphasizes that clinical decision making should be based on the \" best evidence \" available , preferably the findings of r and omized clinical trials . Within this context qualitative research findings are considered to have little value and the old debate in nursing has been re-ignited related to whether qualitative versus quantitative research findings provides the best empirical evidence for nursing practice . In response to this crisis qualitative scholars have been called upon by leaders in the field to clarify for outsiders what qualitative research is and to be more explicit in pointing out the utility of qualitative research findings . In addition , attention to \" quality \" in qualitative research has been identified as an area worthy of renewed focus . Within this paper two key problems related to addressing these issues are review ed : disagreement not only among \" outsiders \" but also some nursing scholars related to the definition of \" qualitative research \" , and a lack of consensus related how to best address \" rigor \" in this type of inquiry . Based on this review a set of st and ard requirements for qualitative research published in nursing journals is proposed that reflects a uniform definition of qualitative research and an enlarged yet clearly articulated conceptualization of quality . The approach suggested provides a framework for developing and evaluating qualitative research that would have both defensible scholarly merit and heuristic value . This will help solidify the argument in favor of incorporating qualitative research findings as part of the empirical \" evidence \" upon which evidence -based nursing is founded This is a prospect i ve study of clinical questions generated in primary care consultations and a comparison of two approaches to answering those clinical questions . Twenty-one doctors in a university-based primary care clinic su bmi tted 78 clinical questions arising from patient consultations during 24 clinic days ( 0.01 question per patient encounter ) . These doctors subsequently found answers to 40 % of their questions but were satisfied with only 67 % of these answers . The investigators were able to provide answers for 95 % of the questions asked and the doctors rated these answers as satisfactory in 86 % of instances . Answers obtained by investigators had significantly higher satisfaction score than those obtained by doctors ' search ( p = 0.002 ) . The two main findings of this study are ( 1 ) almost all questions arising in clinic setting could be answered by intensive search ; ( 2 ) answers found by intensive search es were judged to be more satisfactory than those found routinely by doctors . Provision of an information retrieval service in addition to training in the search ing and appraisal of medical literature are possible solutions to the information needs of busy clinicians BACKGROUND No professional society or group recommends routine ovarian cancer screening , yet physicians ' enthusiasm for several cancer screening tests before benefit has been proven suggests that some women may be exposed to potential harms . OBJECTIVE To provide nationally representative estimates of physicians ' reported nonadherence to recommendations against ovarian cancer screening . DESIGN Cross-sectional survey of physicians offering women 's primary care . The 12-page question naire contained a woman 's annual examination vignette and questions about offers or orders for transvaginal ultrasonography ( TVU ) and cancer antigen 125 ( CA-125 ) . SETTING United States . PARTICIPANTS 3200 physicians r and omly sample d equally from the 2008 American Medical Association Physician Masterfile lists of family physicians , general internists , and obstetrician-gynecologists ; 61.7 % responded . After exclusions , 1088 respondents were included ; their responses were weighted to represent the specialty distribution of practicing U.S. physicians nationally . MEASUREMENTS Reported nonadherence to screening recommendations ( defined as sometimes or almost always ordering screening TVU or CA-125 or both ) . RESULTS Twenty-eight percent ( 95 % CI , 24.5 % to 32.9 % ) of physicians reported nonadherence to screening recommendations for women at low risk for ovarian cancer ; 65.4 % ( CI , 61.1 % to 69.4 % ) did so for women at medium risk for ovarian cancer . Six percent ( CI , 4.4 % to 8.9 % ) reported routinely ordering or offering ovarian cancer screening for low-risk women , as did 24.0 % ( CI , 20.5 % to 28.0 % ) for medium-risk women ( P ≤ 0.001 ) . Thirty-three percent believed TVU or CA-125 was an effective screening test . In adjusted analysis , actual and physician-perceived patient risk , patient request for ovarian cancer screening , and physician belief that TVU or CA-125 was an effective screening test were the strongest predictors of physician-reported nonadherence to published recommendations . LIMITATION The results are limited by their reliance on survey methods ; there may be respondent-nonrespondent bias . CONCLUSION One in 3 physicians believed that ovarian cancer screening was effective , despite evidence to the contrary . Substantial proportions of physicians reported routinely offering or ordering ovarian cancer screening , thereby exposing women to the documented risks of these tests . PRIMARY FUNDING SOURCE Centers for Disease Control and Prevention and the National Cancer Institute BACKGROUND Unlike reduced mortality rates , improved survival rates and increased early detection do not prove that cancer screening tests save lives . Nevertheless , these 2 statistics are often used to promote screening . OBJECTIVE To learn whether primary care physicians underst and which statistics provide evidence about whether screening saves lives . DESIGN Parallel-group , r and omized trial ( r and omization controlled for order effect only ) , conducted by Internet survey . ( Clinical Trials.gov registration number : NCT00981019 ) SETTING National sample of U.S. primary care physicians from a research panel maintained by Harris Interactive ( 79 % cooperation rate ) . PARTICIPANTS 297 physicians who practice d both inpatient and outpatient medicine were surveyed in 2010 , and 115 physicians who practice d exclusively outpatient medicine were surveyed in 2011 . INTERVENTION Physicians received scenarios about the effect of 2 hypothetical screening tests : The effect was described as improved 5-year survival and increased early detection in one scenario and as decreased cancer mortality and increased incidence in the other . MEASUREMENTS Physicians ' recommendation of screening and perception of its benefit in the scenarios and general knowledge of screening statistics . RESULTS Primary care physicians were more enthusiastic about the screening test supported by irrelevant evidence ( 5-year survival increased from 68 % to 99 % ) than about the test supported by relevant evidence ( cancer mortality reduced from 2 to 1.6 in 1000 persons ) . When presented with irrelevant evidence , 69 % of physicians recommended the test , compared with 23 % when presented with relevant evidence ( P < 0.001 ) . When asked general knowledge questions about screening statistics , many physicians did not distinguish between irrelevant and relevant screening evidence ; 76 % versus 81 % , respectively , stated that each of these statistics proves that screening saves lives ( P = 0.39 ) . About one half ( 47 % ) of the physicians incorrectly said that finding more cases of cancer in screened as opposed to unscreened population s \" proves that screening saves lives . \" LIMITATION Physicians ' recommendations for screening were based on hypothetical scenarios , not actual practice . CONCLUSION Most primary care physicians mistakenly interpreted improved survival and increased detection with screening as evidence that screening saves lives . Few correctly recognized that only reduced mortality in a r and omized trial constitutes evidence of the benefit of screening . PRIMARY FUNDING SOURCE Harding Center for Risk Literacy , Max Planck Institute for Human Development OBJECTIVE Usage of computer re sources at the point of care has a positive effect on physician decision making . Pediatricians ' information-seeking behaviors are not well characterized . The goal of this study was to characterize quantitatively the information-seeking behaviors of general pediatricians and specifically compare their use of computers , including digital libraries , before and after an educational intervention . METHODS General pediatric residents and faculty at a US Midwest children 's hospital participated . A control ( year 1 ) versus intervention group ( year 2 ) research design was implemented . Eligible pediatrician pools overlapped , such that some participated first in the control group and later as part of the intervention . The intervention group received a 10-minute individual training session and h and out on how to use a pediatric digital library to answer professional questions . A general medical digital library was also available . Pediatricians in both the control and the intervention groups were surveyed using the critical incident technique during 2 6-month time periods . Both groups were telephoned for 1- to 2-minute interviews and were asked , \" What pediatric question ( s ) did you have that you needed additional information to answer ? \" The main outcome measures were the differences between the proportion of pediatricians who use computers and digital libraries and a comparison of the number of times that pediatricians use these re sources before and after intervention . RESULTS A total of 58 pediatricians were eligible , and 52 participated ( 89.6 % ) . Participant demographics between control ( N = 41 ; 89.1 % ) and intervention ( N = 31 ; 70.4 % ) were not statistically different . Twenty pediatricians were in both groups . Pediatricians were slightly less likely to pursue answers after the intervention ( 94.7 % vs 89.2 % ) ; the primary reason cited for both groups was a lack of time . The pediatricians were as successful in finding answers in each group ( 95.7 % vs 92.7 % ) , but the intervention group took significantly less time ( 8.3 minutes vs 19.6 minutes ) . After the intervention , pediatricians used computers and digital libraries more to answer their questions and spent less time using them . CONCLUSION This study showed higher rates of physician questions pursued and answered and higher rates of computer use at baseline and after intervention compared with previous studies . Pediatricians who seek answers at the point of care therefore should begin to shift their information-seeking behaviors toward computer re sources , as they are as effective but more time-efficient OBJECTIVE To measure the effects of a summary -of- findings ( SoF ) table on user satisfaction , underst and ing , and time spent finding key results in a Cochrane review . STUDY DESIGN AND SETTING We r and omized participants in an evidence -based practice workshop ( r and omized controlled trial [ RCT ] I ) and a Cochrane Collaboration entities meeting ( RCT II ) to receive a Cochrane review with or without an SoF table . In RCT I , we measured user satisfaction . In RCT II , we measured correct comprehension and time spent finding key results . RESULTS RCT I : Participants with the SoF table ( n=47 ) were more likely to \" agree \" or \" strongly agree \" that it was easy to find results for important outcomes than ( n=25 ) participants without the SoF table-68 % vs. 40 % ( P=0.021 ) . RCT II : Participants with the SoF table ( n=18 ) were more likely to correctly answer two questions regarding results than ( n=15 ) those without the SoF table : 93 % vs. 44 % ( P=0.003 ) and 87 % vs. 11 % ( P<0.001 ) . Participants with the SoF table spent an average of 90 seconds to find key information compared with 4 minutes for participants without the SoF table ( P=0.002 ) . CONCLUSION In two small trials , we found that inclusion of an SoF table in a review improved underst and ing and rapid retrieval of key findings compared with review s with no SoF table RATIONALE AND AIM Over the past 12 years , thous and s of authors working with the Cochrane Collaboration around the world have produced systematic review s to reduce uncertainty in health care decision making . We evaluated the conclusions from Cochrane systematic review s of r and omized controlled trials in terms of their recommendations for clinical practice and research . METHODS In our cross-sectional study of systematic review s published in the Cochrane Library , we r and omly selected and analysed completed systematic review s published across all 50 Cochrane Collaborative Review Groups . RESULTS We analysed 1016 completed systematic review s. Of these , 44 % concluded that the interventions studied were likely to be beneficial , of which 1 % recommended no further research and 43 % recommended additional research . Also , 7 % of the review s concluded that the interventions were likely to be harmful , of which 2 % did not recommend further studies and 5 % recommended additional studies . In total , 49 % of the review s reported that the evidence did not support either benefit or harm , of which 1 % did not recommend further studies and 48 % recommended additional studies . Overall , 96 % of the review s recommended further research . CONCLUSIONS Cochrane systematic review s were about evenly split between those in which the authors concluded that at least one of the interventions was beneficial and those in which the evidence neither supported nor refuted the intervention tested . The Cochrane Collaboration needs to include clinical trial protocol summaries with a study design optimized to answer the relevant research questions \n Output:\n " }, { "from": "agent", "value": "Finding information relating to the number of studies in the meta- analysis , and locating the number of studies in the entire systematic review were revealed as areas needing attention during the usability evaluation .\nIterative testing combined with a multifaceted approach to usability testing offered essential insight into aspects of the prototypes that required modifications ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background —Recovery of function is possible in patients with ischemic cardiomyopathy when left ventricular dysfunction is caused by stunning or hibernation . It is plausible that recovery of function after revascularization may take a longer time in hibernating myocardium compared with stunned myocardium . Accordingly , the time courses of functional recovery in hibernating and stunned myocardium were compared . Methods and Results — Patients ( n=26 ) with ischemic cardiomyopathy undergoing surgical revascularization were studied ; regional perfusion ( resting 201Tl single-photon emission CT ) , glucose utilization ( 18F-2-deoxyglucose single-photon emission CT ) , and contractile function ( 2D echocardiography ) were assessed before revascularization . Dysfunctional segments with normal perfusion/glucose utilization were considered to be stunned , and dysfunctional segments with reduced perfusion/preserved glucose utilization were considered to be hibernating . Contractile function was reevaluated 3 months ( early ) and 14 months ( late ) after revascularization . Of the 266 dysfunctional segments , 57 ( 22 % ) were stunned , 62 ( 23 % ) were hibernating , and 147 ( 55 % ) were scar tissue . In stunned myocardium , contractile function improved significantly at 3 months , without further improvement at 14 months ; 61 % of the stunned segments improved at 3 months , and 9 % improved at 14 months . In hibernating myocardium , contractile function improved at 3 months , with a further improvement at 14 months ; 31 % of the hibernating segments improved at 3 months , and 61 % showed ( additional ) recovery at 14 months . Conclusions —Stunned myocardium is likely to demonstrate early recovery of function , whereas hibernating myocardium may take a longer time to ( fully ) recover in function after revascularization BACKGROUND In 10 % to 15 % of patients with ST-segment elevation myocardial infa rct ion ( STEMI ) , concurrent coronary chronic total occlusion ( CTO ) in a non-infa rct -related artery is present and is associated with increased morbidity and mortality . OBJECTIVES The EXPLORE ( Evaluating Xience and Left Ventricular Function in Percutaneous Coronary Intervention on Occlusions After ST-Elevation Myocardial Infa rct ion ) trial evaluated whether patients with STEMI and concurrent CTO in a non-infa rct -related artery benefit from additional percutaneous coronary intervention ( PCI ) of CTO shortly after primary PCI . METHODS From November 2007 through April 2015 , we enrolled 304 patients with acute STEMI who underwent primary PCI and had concurrent CTO in 14 centers in Europe and Canada . A total of 150 patients were r and omly assigned to early PCI of the CTO ( CTO PCI ) , and 154 patients were assigned to conservative treatment without PCI of the CTO ( no CTO PCI ) . Primary outcomes were left ventricular ejection fraction ( LVEF ) and left ventricular end diastolic volume ( LVEDV ) on cardiac magnetic resonance imaging after 4 months . RESULTS The investigator-reported procedural success rate in the CTO PCI arm of the trial was 77 % , and the adjudicated success rate was 73 % . At 4 months , mean LVEF did not differ between the 2 groups ( 44.1 ± 12.2 % vs. 44.8 ± 11.9 % , respectively ; p = 0.60 ) . Mean LVEDV at 4 months was 215.6 ± 62.5 ml in the CTO PCI arm versus 212.8 ± 60.3 ml in the no-CTO PCI arm ( p = 0.70 ) . Subgroup analysis revealed that patients with CTO located in the left anterior descending coronary artery who were r and omized to the CTO PCI strategy had significantly higher LVEF compared with patients r and omized to the no-CTO PCI strategy ( 47.2 ± 12.3 % vs. 40.4 ± 11.9 % ; p = 0.02 ) . There were no differences in terms of 4-month major adverse coronary events ( 5.4 % vs. 2.6 % ; p = 0.25 ) . CONCLUSIONS Additional CTO PCI within 1 week after primary PCI for STEMI was feasible and safe . In patients with STEMI and concurrent CTO , we did not find an overall benefit for CTO PCI in terms of LVEF or LVEDV . The finding that early CTO PCI in the left anterior descending coronary artery subgroup was beneficial warrants further investigation . ( Evaluating Xience and Left Ventricular Function in Percutaneous Coronary Intervention on Occlusions After ST-Segment Elevation Myocardial Infa rct ion ; NTR1108 ) OBJECTIVES This study explored whether cardiac magnetic resonance ( CMR ) could help select patients who could benefit from revascularization by identifying inducible myocardial ischemia and viability in the perfusion territory of the artery with chronic total occlusion ( CTO ) . BACKGROUND The benefit of revascularization using percutaneous coronary intervention ( PCI ) in CTO is controversial . CMR offers incomparable left ventricular ( LV ) systolic function assessment in addition to potent ischemic burden quantification and reliable myocardial viability analysis . Whether CMR guided CTO revascularization would be helpful to such patients has not yet been explored fully . METHODS A prospect i ve study of 50 consecutive CTO patients was conducted . Of 50 patients undergoing baseline stress CMR , 32 ( 64 % ) were selected for recanalization based on the presence of significant inducible perfusion deficit and myocardial viability within the CTO arterial territory . Patients were rescanned 3 months after successful CTO recanalization . RESULTS At baseline , myocardial perfusion reserve ( MPR ) in the CTO territory was significantly reduced compared with the remote region ( 1.8 ± 0.72 vs. 2.2 ± 0.7 ; p = 0.01 ) . MPR in the CTO region improved significantly after PCI ( to 2.3 ± 0.9 ; p = 0.02 vs. baseline ) with complete or near-complete resolution of CTO related perfusion defect in 90 % of patients . Remote territory MPR was unchanged after PCI ( 2.5 ± 1.2 ; p = NS vs. baseline ) . The LV ejection fraction increased from 63 ± 13 % to 67 ± 12 % ( p < 0.0001 ) and end-systolic volume decreased from 65 ± 38 to 56 ± 38 ml ( p < 0.001 ) 3 months after CTO PCI . Importantly , despite minimal post-procedural infa rct ion due to distal embolization and side branch occlusion in 8 of 32 patients ( 25 % ) , the total Seattle Angina Question naire score improved from a median of 54 ( range 45 to 74 ) at baseline to 89 ( range 77 to 98 ) after CTO recanalization ( p < 0.0001 ) . CONCLUSIONS In this small group of patients showing CMR evidence of significant myocardial inducible perfusion defect and viability , CTO recanalization reduces ischemic burden , favors reverse remodeling , and ameliorates quality of life AIMS The aim of the present study was to investigate the effects of successful PCI CTO on absolute myocardial blood flow ( MBF ) and functional recovery . METHODS AND RESULTS Patients with a documented CTO were prospect ively examined for ischaemia and viability with [15O]H2O positron emission tomography ( PET ) and late gadolinium enhancement cardiac magnetic resonance imaging ( LGE-CMR ) . Sixty-nine consecutive patients , in whom PCI was successful , underwent follow-up PET and CMR after approximately 12 weeks to evaluate potential improvement of MBF as well as systolic function . After PCI , stress MBF in the CTO area increased from 1.22±0.36 to 2.40±0.90 mL·min-1·g-1 ( p<0.001 ) , whilst stress MBF in the remote area also increased significantly between baseline and follow-up PET ( 2.58±0.68 to 2.77±0.77 mL·min-1·g-1 , p=0.01 ) . The ratio of stress MBF between CTO and remote area was 0.49±0.13 at baseline and increased to 0.87±0.24 at follow-up ( p<0.001 ) . The MBF defect size of the CTO area decreased from 5.12±1.69 to 1.91±1.75 myocardial segments after PCI ( p<0.001 ) . Left ventricular ejection fraction ( LVEF ) increased significantly ( 46.4±11.0 vs. 47.5±11.4 % , p=0.01 ) at follow-up . CONCLUSIONS The vast majority of CTO patients with documented ischaemia and viability showed significant improvement in stress MBF and a reduction of ischaemic burden after successful percutaneous revascularisation with only minimal effect on LVEF The present study aim ed to assess the mechanisms of effects of percutaneous coronary intervention ( PCI ) for chronic total occlusion ( CTO ) from two different aspects : left ventricular ( LV ) systolic function assessed by two-dimensional speckle tracking echocardiography ( 2D-STE ) and electrical stability evaluated by late potential on signal-averaged electrocardiogram ( SAECG ) . We conducted a prospect i ve observational study with consecutive CTO-PCI patients . 2D-STE and SAECG were performed before PCI , and after 1-day and 3-months of procedure . 2D-STE computed global longitudinal strain ( GLS ) and regional longitudinal strain ( RLS ) in CTO area , collateral blood-supplying donor artery area , and non-CTO/non-donor area . A total of 37 patients ( 66 ± 11 years , 78 % male ) were analyzed . RLS in CTO and donor areas and GLS were significantly improved 1-day after the procedure , but these improvements diminished during 3 months . The improvement of RLS in donor area remained significant after 3-months the index procedure ( pre-PCI −13.4 ± 4.8 % vs. post-3 M −15.1 ± 4.5 % , P = 0.034 ) . RLS in non-CTO/non-donor area and LV ejection fraction were not influenced . Mitral annulus velocity was improved at 3-month follow-up ( 5.0 ± 1.4 vs. 5.6 ± 1.7 cm/s , P = 0.049 ) . Before the procedure , 12 patients ( 35 % ) had a late potential . All components of the late potential ( filtered QRS duration , root-mean-square voltage in the terminal 40 ms , and duration of the low amplitude signal < 40 μV ) were not improved . CTO-PCI improved RLS in the donor area at 3-month follow-up without changes of LV ejection fraction . Although higher prevalence of late potential in the current population compared to healthy population was observed , late potential as a surrogate of arrhythmogenic substrate was not influenced by CTO-PCI Background In congestive heart failure patients , a single measurement of left ventricular ejection fraction ( LVEF ) provides important prognostic information . The importance , if any , of improvement or worsening in serial LVEF has not been defined . The Department of Veterans Affairs Cooperative Vasodilator-Heart Failure Trials ( V-HeFT ) data base was analyzed to determine the prognostic importance of LVEF changes . Methods and Results The data bases for V-HeFT I ( n = 642 ) and V-HeFT II ( n=804 ) were analyzed . All patients had heart failure with documented exercise intolerance and abnormal LVEF or cardiac dilatation by chest x-ray or echocardiography . Radionuclide LVEF was obtained at baseline , within 6 months , and at least yearly after r and omization to treatment . Cumulative survival subsequent to LVEF follow-up measurements was calculated for strata defined by LVEF change from baseline . In V-HeFT I , patients treated with hydralazine/isosorbide dinitrate ( H-I ) experienced a significant ( P < O.OOl ) increase in LVEF and a survival advantage over those treated with placebo and prazosin . In V-HeFT II , both treatment groups showed significant improvements in LVEF , with the increase with H-I greater than that with enalapril , and enalapril provided a significant survival advantage overH-L. Change ( > 5 ) in LVEF from baseline at 6 months ( V-HeFT I ) and 1 year ( V-HeFT II ) were the strongest predictors of mortality among the serial measurements and were significant after adjustment for therapy and baseline LVEF . Baseline clinical variables were not helpfulin predicting the patients who would experience an improvement in LVEF . Conclusions In patients with heart failure , serial measurements of LVEF provide additional important prognostic information . Vasodilator therapy with H-I is associated with an improvement in LVEF and prognosis . Vasodilator therapy with enalapril improves LVEF less than H-I but provides an additional survival benefit In recent years , several clinical trials conducted on selected middle-aged patients have documented the positive effects of new pharm \n Output:\n " }, { "from": "agent", "value": "Successful CTO PCI is associated with a statistically significant improvement in LV ejection fraction and decrease in LV end-systolic volume , that may reflect a beneficial effect of CTO recanalization on LV remodeling ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size Summary The pharmacokinetics of aspirin ( ASA ) in acute migraine attacks , and the influence of metoclopramide on ASA disposition , were studied in 32 attacks in 30 patients . An intergroup comparison was made between normal volunteers , and the migraineurs , who were assigned at r and om to one of three treatment groups : a ) oral ASA only ( 900 mg ) ; b ) 10 mg oral metoclopramide + oral ASA 900 mg ; c ) 10 mg i. m. metoclopramide + oral ASA 900 mg . Plasma ASA and SA levels were measured serially over 2 h , and the result ant data evaluated pharmacokinetically . Metoclopramide plasma levels were also determined over 2 h , and the results compared with a second group of normal volunteers . The rates of oral ASA absorption and elimination were unaffected by migraine . Mean absorption rate constants of 14.15±9.48 h−1 ( normals ) , 7.91±3.42 h−1 ( ASA only ) , 6.74±3.26 h−1 ( ASA + oral metoclopramide ) and 8.12±2.82 h−1 ( ASA + i. m. metoclopramide ) were calculated . Mean elimination rate constants ranged from 2.56 h−1 to 3.37 h−1 , and did not differ significantly between controls and migrainous patients . Values for absorption lag time , however , were higher in migraine patients treated with ASA alone than in any other group . The amount of ASA absorbed unhydrolysed was also lower in this group . SA levels appeared unaffected either by the migraine attack , or by metoclopramide administration , over the period of study . Metoclopramide plasma levels were significantly lower during migraine attacks , and the amount of drug absorbed up to 2 h from dosing was also reduced , as compared with non-migrainous subjects . It was concluded that acute migraine caused a delay in orally administered ASA reaching its absorption sites , probably as a result of gastric stasis , and may have decreased the amount of ASA absorbed . The prior administration of metoclopramide , either orally or intramuscularly , reduced the absorption lag time , and thus promoted the early absorption of ASA , probably by restoring alimentary tract motility Objective : To estimate the 1-year prevalences of primary headache disorders and identify their principal risk factors in the general population of Russia . Methods : A countrywide population -based r and om sample of 2725 biologically unrelated adults in 35 cities and nine rural areas were interviewed in a door-to-door survey using a previously vali date d diagnostic question naire . Results : Of the 2725 eligible adults contacted , 2025 ( 74.3 % ) responded ( females 52.6 % , mean age 39.5 ± 13.4 years ) . Of these , 1273 ( 62.9 % ) reported headache ‘ not related to flu , hangover , cold , head injury ’ occurring at least once in the previous year . The gender- and age-st and ardized 1-year prevalence of migraine was 20.8 % . Female gender ( odds ratio ( OR ) = 3.8 ; 95 % confidence interval ( CI ) 2.8–5.1 ) and obesity ( OR = 1.5 ; 1.1–2.1 ) were positively associated with this type of headache . The gender- and age-st and ardized 1-year prevalence of tension-type headache ( TTH ) was 30.8 % . TTH was more prevalent in urban than in rural areas ( OR = 1.6 ; 1.3–2.0 ) . Headache on ≥15 days/month was reported by 213 ( 10.5 % ) respondents ( gender- and age-st and ardized prevalence 10.4 % ) , and associated with low socioeconomic status ( OR = 3.4 ; 2.4–4.9 ) , obesity ( OR = 3.0 ; 2.1–4.3 ) , female gender ( OR = 2.9 ; 2.1–4.1 ) and age over 40 years ( OR = 2.6 ; 1.9–3.6 ) . The majority of these respondents ( 68.1 % ) overused acute headache medications . Conclusion : The study demonstrated a high prevalence of migraine and a very high prevalence of headache on ≥15 days/month , and revealed unmet health-care needs of people with headache in Russia 1 The absorption of effervescent aspirin was studied in two groups of patients during attacks of migraine . The first group received effervescent aspirin alone whilst the second group received intramuscular metoclopramide before effervescent aspirin . 2 After effervescent aspirin alone there was significant impairment in the rate of aspirin absorption during migraine attacks compared with the rate of aspirin absorption in normal volunteers and in the same patients when headache-free . 3 When metoclopramide was given before effervescent aspirin the rate of aspirin absorption during migraine attacks was not significantly different from that obtained in normal volunteers given effervescent aspirin alone or from that obtained in the patients themselves when given both metoclopramide and effervescent aspirin when headache-free . 4 It is concluded that the impairment of absorption of effervescent aspirin during migraine attacks is related to impaired gastro-intestinal motility with delayed gastric emptying and that this impaired motility can be overcome by parenteral metoclopramide & NA ; A data base of r and omised clinical trials ( RCTs ) in pain research published from 1950 to 1990 was created following an extensive literature search . By applying a refined MEDLINE search strategy from 1966 to 1990 and by h and ‐ search ing more than 1 000 000 pages of a total of 40 biomedical journals published during the period 1950–1990 , more than 8000 RCTs were identified . The RCTs were published in more than 800 journals and over 85 % appeared between 1976 and 1990 . If the trend of the last 15 years persists , a total of more than 15 000 RCTs will be published in pain relief by the year 2000 . A detailed description of methods to ensure efficient use of re sources during the identification , retrieval and management of the information in pain relief and other fields is given . Emphasis is made on the importance of refining MEDLINE search strategies , on the use of volunteers to h and ‐ search journals and on careful monitoring of each of the steps of the process . The potential uses of the data base to guide clinical and research decisions are discussed Abstract One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity . The usual criterion is at least moderate pain on a categorical pain intensity scale . When visual analogue scales ( VAS ) are the only pain measure in trials we need to know what point on a VAS represents moderate pain , so that these trials can be included in meta‐ analysis when baseline pain of at least moderate intensity is an inclusion criterion . To investigate this we used individual patient data from 1080 patients from r and omised controlled trials of various analgesics . Baseline pain was measured using a 4‐point categorical pain intensity scale and a pain intensity VAS under identical conditions . The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for 344 reporting severe pain . The VAS scores corresponding to moderate or severe pain were also examined by gender . Baseline VAS scores recorded by patients reporting moderate pain were significantly different from those of patients reporting severe pain . Of the patients reporting moderate pain 85 % scored over 30 mm on the corresponding VAS , with a mean score of 49 mm . For those reporting severe pain 85 % scored over 54 mm with a mean score of 75 mm . There was no difference between the corresponding VAS scores of men and women . Our results indicate that if a patient records a baseline VAS score in excess of 30 mm they would probably have recorded at least moderate pain on a 4‐point categorical scale \n Output:\n " }, { "from": "agent", "value": "Aspirin 1000 mg is an effective treatment for acute migraine headaches , similar to sumatriptan 50 mg or 100 mg .\nAddition of metoclopramide 10 mg improves relief of nausea and vomiting .\nAdverse events were mainly mild and transient , and were slightly more common with aspirin than placebo , but less common than with sumatriptan 100 mg" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The management of depression in patients with poor prognosis cancers , such as lung cancer , creates specific challenges . We aim ed to assess the efficacy of an integrated treatment programme for major depression in patients with lung cancer compared with usual care . METHODS Symptom Management Research Trials ( SMaRT ) Oncology-3 is a parallel-group , multicentre , r and omised controlled trial . We enrolled patients with lung cancer and major depression from three cancer centres and their associated clinics in Scotl and , UK . Participants were r and omly assigned in a 1:1 ratio to the depression care for people with lung cancer treatment programme or usual care by a data base software algorithm that used stratification ( by trial centre ) and minimisation ( by age , sex , and cancer type ) with allocation concealment . Depression care for people with lung cancer is a manualised , multicomponent collaborative care treatment that is systematic ally delivered by a team of cancer nurses and psychiatrists in collaboration with primary care physicians . Usual care is provided by primary care physicians . The primary outcome was depression severity ( on the Symptom Checklist Depression Scale [ SCL-20 ] , range 0 - 4 ) averaged over the patient 's time in the trial ( up to a maximum of 32 weeks ) . Trial statisticians and data collection staff were masked to treatment allocation , but patients and clinicians could not be masked to the allocations . Analyses were by intention to treat . This trial is registered with Current Controlled Trials , number IS RCT N75905964 . FINDINGS 142 participants were recruited between Jan 5 , 2009 , and Sept 9 , 2011 ; 68 were r and omly allocated to depression care for people with lung cancer and 74 to usual care . 43 ( 30 % ) of 142 patients had died by 32 weeks , all of which were cancer-related deaths . No intervention-related serious adverse events occurred . 131 ( 92 % ) of 142 patients provided outcome data ( 59 in the depression care for people with lung cancer group and 72 in the usual care group ) and were included in the intention-to-treat primary analysis . Average depression severity was significantly lower in patients allocated to depression care for people with lung cancer ( mean score on the SCL-20 1·24 [ SD 0·64 ] ) than in those allocated to usual care ( mean score 1·61 [ SD 0·58 ] ) ; difference -0·38 ( 95 % CI -0·58 to -0·18 ) ; st and ardised mean difference -0·62 ( 95 % CI -0·94 to -0·29 ) . Self-rated depression improvement , anxiety , quality of life , role functioning , perceived quality of care , and proportion of patients achieving a 12-week treatment response were also significantly better in the depression care for people with lung cancer group than in the usual care group . INTERPRETATION Our findings suggest that major depression can be treated effectively in patients with a poor prognosis cancer ; integrated depression care for people with lung cancer was substantially more efficacious than was usual care . Larger trials are now needed to estimate the effectiveness and cost-effectiveness of this care programme in this patient population , and further adaptation of the treatment will be necessary to address the unmet needs of patients with major depression and even shorter life expectancy . FUNDING Cancer Research UK and Chief Scientist Office of the Scottish Government BACKGROUND Depression is a highly prevalent , often recurring or persistent disorder . The majority of patients are initially seen and treated in primary care . Effective treatments are available , but possibilities for providing adequate follow-up care are often limited in this setting . This study assesses the effectiveness of primary -care-based enhanced treatment modalities on short-term patient outcomes . METHOD In a r and omized controlled trial we evaluated a psycho-educational self-management intervention . We included 267 adult patients meeting criteria for a DSM-IV diagnosis of major depressive disorder , assessed by a structured psychiatric interview . Patients were r and omly assigned to : the Depression Recurrence Prevention ( DRP ) program ( n=112 ) ; a combination of the DRP program with psychiatric consultation ( PC+DRP , n=39 ) ; a combination with brief cognitive behavior therapy ( CBT+DRP , n=44 ) ; and care as usual ( CAU , n=72 ) . Follow-up assessment s were made at 3 months ( response 90 % ) and 6 months ( 85 % ) . RESULTS Patient acceptance of enhanced care was good . The mean duration of the index episode was 11 weeks ( S.D.=9.78 ) and similar in CAU and enhanced care . Recovery rate after 6 months was 67 % overall ; 17 % of all participants remained depressed for the entire 6-month period . CONCLUSION Enhanced care did not result in better short-term outcomes . We found no evidence that the DRP program was more effective than CAU and no indications for added beneficial effects of either the psychiatric evaluation or the CBT treatment to the basic format of the DRP program . Observed depression treatment rates in CAU were high Background Depression is common in primary care and is often unrecognized and untreated . Studies are needed to demonstrate the feasibility of implementing evidence -based depression care provided by primary health care workers ( PHCWs ) in sub-Saharan Africa . We carried out a pilot two-parallel arm cluster r and omized controlled trial of a package of care for depression in primary care . Methods Six primary health care centers ( PHCC ) in two Local Government Areas of Oyo State , South West Nigeria were r and omized into 3 intervention and 3 control clinics . Three PHCWs were selected for training from each of the participating clinics . The PHCWs from the intervention clinics were trained to deliver a manualized multicomponent stepped care intervention package for depression consisting of psychoeducation , activity scheduling , problem solving treatment and medication for severe depression . Providers from the control clinics delivered care as usual , enhanced by a refresher training on depression diagnosis and management . Outcome measures Patient ’s Health Question naire ( PHQ-9 ) , WHO quality of Life instrument ( WHOQOL-Bref ) and the WHO disability assessment schedule ( WHODAS ) were administered in the participants ’ home at baseline , 3 and 6 months . Results About 98 % of the consecutive attendees to the clinics agreed to have the screening interview . Of those screened , 284 ( 22.7 % ) were positive ( PHQ-9 score ≥ 8) and 234 gave consent for inclusion in the study : 165 from intervention and 69 from control clinics . The rates of eligible and consenting participants were similar in the control and intervention arms . In all 85.9 % ( 92.8 % in intervention and 83 % in control ) of the participants were successfully administered outcome assessment s at 6 months . The PHCWs had little difficulty in delivering the intervention package . At 6 months follow up , depression symptoms had improved in 73.0 % from the intervention arm compared to 51.6 % control . Compared to the mean scores at baseline , there was improvement in the mean scores on all outcome measures in both arms at six months . Conclusion The results provide support for the feasibility of conducting a fully-powered r and omized study in this setting and suggest that the instruments used may have the potential to detect differences between the arms . Trial registration numberIS RCT N46754188 ( ISRTCN registry at isrtcn.com ) ; registered 23 September 2013 , details of the pilot study added 12/02/2015 Background Evidence -based practice s design ed for large urban clinics are not necessarily portable into smaller isolated clinics . Implementing practice -based collaborative care for depression in smaller primary care clinics presents unique challenges because it is often not feasible to employ on-site psychiatrists . Objective The purpose of the Telemedicine Enhanced Antidepressant Management ( TEAM ) study was to evaluate a telemedicine-based collaborative care model adapted for small clinics without on-site psychiatrists . Design Matched sites were r and omized to the intervention or usual care . Participants Small VA Community-based outpatient clinics with no on-site psychiatrists , but access to telepsychiatrists . In 2003–2004 , 395 primary care patients with PHQ9 depression severity scores ≥12 were enrolled , and followed for 12 months . Patients with serious mental illness and current substance dependence were excluded . Measures Medication adherence , treatment response , remission , health status , health-related quality of life , and treatment satisfaction . Results The sample comprised mostly elderly , white , males with substantial physical and behavioral health comorbidity . At baseline , subjects had moderate depression severity ( Hopkins Symptom Checklist , SCL-20 = 1.8 ) , 3.7 prior depression episodes , and 67 % had received prior depression treatment . Multivariate analyses indicated that intervention patients were more likely to be adherent at both 6 ( odds ratio [ OR ] = 2.1 , p = .04 ) and 12 months ( OR = 2.7 , p = .01 ) . Intervention patients were more likely to respond by 6 months ( OR = 2.0 , p = .02 ) , and remit by 12 months ( OR = 2.4 , p = .02 ) . Intervention patients reported larger gains in mental health status and health-related quality of life , and reported higher satisfaction . Conclusions Collaborative care can be successfully adapted for primary care clinics without on-site psychiatrists using telemedicine technologies Background People with chronic depression are frequently lost from effective care , with result ing psychological , physical and social morbidity and considerable social and financial societal costs . This r and omised controlled trial will evaluate whether regular structured practice nurse review s lead to better mental health and social outcomes for these patients and will assess the cost-effectiveness of the structured review s compared to usual care . The hypothesis is that structured , pro-active care of patients with chronic depression in primary care will lead to a cost-effective improvement in medical and social outcomes when compared with usual general practitioner ( GP ) care . Methods / Design Participants were recruited from 42 general practice s throughout the United Kingdom . Eligible participants had to have a history of chronic major depression , recurrent major depression or chronic dsythymia confirmed using the Composite International Diagnostic Interview ( CIDI ) . They also needed to score 14 or above on the Beck Depression Inventory ( BDI-II ) at recruitment . Once consented , participants were r and omised to treatment as usual from their general practice ( controls ) or the practice nurse led intervention . The intervention includes a specially prepared education booklet and a comprehensive baseline assessment of participants ' mood and any associated physical and psycho-social factors , followed by regular 3 monthly review s by the nurse over the 2 year study period . At these appointments intervention participants ' mood will be review ed , together with their current pharmacological and psychological treatments and any relevant social factors , with the nurse suggesting possible amendments according to evidence based guidelines . This is a chronic disease management model , similar to that used for other long-term conditions in primary care . The primary outcome is the BDI-II , measured at baseline and 6 monthly by self-complete postal question naire . Secondary outcomes collected by self-complete question naire at baseline and 2 years include social functioning , quality of life and data for the economic analyses . Health service data will be collected from GP notes for the 24 months before recruitment and the 24 months of the study . Discussion 558 participants were recruited , 282 to the intervention and 276 to the control arm . The majority were recruited via practice data base search es using relevant READ codes . Trial registration IS RCT IMPORTANCE It is often difficult for members of the US military to access high- quality care for posttraumatic stress disorder ( PTSD ) and depression . OBJECTIVE To determine effectiveness of a central ly assisted collaborative telecare ( CACT ) intervention for PTSD and depression in military primary care . DESIGN , SETTING , AND PARTICIPANTS The STEPS-UP study ( Stepped Enhancement of PTSD Services Using Primary Care ) is a r and omized trial comparing CACT with usual integrated mental health care for PTSD or depression . Patients , mostly men in their 20s , were enrolled from 18 primary care clinics at 6 military installations from February 2012 to August 2013 with 12-month follow-up completed in October 2014 . INTERVENTIONS R and omization was to CACT ( n = 332 ) or usual care ( n = 334 ) . The CACT patients received 12 months of stepped psychosocial and pharmacologic treatment with nurse telecare management of caseloads , symptoms , and treatment . MAIN OUTCOMES AND MEASURES Primary outcomes were severity scores on the PTSD Diagnostic Scale ( PDS ; scored 0 - 51 ) and Symptom Checklist depression items ( SCL-20 ; scored 0 - 4 ) . Secondary outcomes were somatic symptoms , pain severity , health-related function , and mental health service use . RESULTS Of 666 patients , 81 % were male and the mean ( SD ) age was 31.1 ( 7.7 ) years . The CACT and usual care patients had similar baseline mean ( SD ) PDS PTSD ( 29.4 [ 9.4 ] vs 28.9 [ 8.9 ] ) and SCL-20 depression ( 2.1 [ 0.6 ] vs 2.0 [ 0.7 ] ) scores . Compared with usual care , CACT patients reported significantly greater mean ( SE ) 12-month decrease in PDS PTSD scores ( -6.07 [ 0.68 ] vs -3.54 [ 0.72 ] ) and SCL-20 depression scores -0.56 [ 0.05 ] vs -0.31 [ 0.05 ] ) . In the \n Output:\n " }, { "from": "agent", "value": "Relapse is a significant risk amongst people treated for depression and interventions are needed that specifically address and minimise this risk ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND AND OBJECTIVES Lanthanum carbonate ( LC ) is a nonaluminum , noncalcium phosphate binder that is effective for hyperphosphatemia in dialysis patients . However , its efficacy and cost-effectiveness as second-line therapy have not been fully examined . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS We first conducted a multicenter , open-label , 16-week clinical trial to examine the effect of additive LC in 116 hemodialysis patients who had uncontrolled hyperphosphatemia with conventional phosphorus-lowering therapy alone . Based on these clinical data , a state transition model was developed to evaluate the benefits and costs associated with LC as second-line therapy . Reduced risks for cardiovascular morbidity and mortality among patients treated with LC arise through more of the population achieving the target phosphorus levels . Uncertainty was explored through sensitivity analysis . RESULTS After 16 weeks of additive LC treatment , mean serum phosphorus levels decreased from 7.30 ± 0.90 to 5.71 ± 1.32 mg/dl , without significant changes in serum calcium or intact parathyroid hormone levels . A subsequent cost-effectiveness analysis showed that compared with conventional treatment , additive LC incurred an average additional lifetime cost of $ 22,054 per person and conferred an additional 0.632 quality -adjusted life years ( QALYs ) . This result ed in an incremental cost-effectiveness ratio of $ 34,896 per QALY gained . Applying a cost-effectiveness threshold of $ 50,000 per QALY , a probabilistic sensitivity analysis showed that additive LC had a 97.4 % probability of being cost-effective compared with conventional treatment . CONCLUSIONS Our results indicate that the use of LC as second-line therapy would be cost-effective among hemodialysis patients with uncontrolled hyperphosphatemia in Japan Vascular calcification ( VC ) contributes to cardiovascular disease in hemodialysis ( HD ) patients , especially with diabetes mellitus ( DM ) complications . No r and omized studies have been published regarding the effect of lanthanum carbonate ( LC ) on VC progression in DM patients . The aim of this study was to evaluate the effects of lanthanum carbonate on the progression of VC in HD patients with type 2 DM . We conducted a r and omized controlled trial comparing LC with calcium carbonate ( CC ) in 43 HD patients at a single dialysis center . Estimations of aortic calcification index ( ACI ) by abdominal computed tomography were performed twice for each patient ( at baseline and 12 months ) . Forty-one patients completed the study ( 19 LC , 22 CC ) . When ACI at baseline was ≦0.48 ( median of baseline ACI ) , median change in ACI ( Δ%ACI ) was 20.44 ( 11.50 - 36.80 % ) in the LC group , and 40.00 ( 33.30 - 92.60 % ) in the CC group ( P = 0.026 ) . On the other h and , when ACI at baseline was > 0.48 , the median change in ACI ( Δ%ACI ) was 6.42 ( 3.13 - 24.40 % ) in the LC group , and 8.08 ( 5.68 - 12.20 % ) in the CC group ( P = 1.000 ) . Serum markers of chronic kidney disease-mineral and bone disorder ( CKD-MBD ) , HbA1c , dose of vitamin D analogues , and side-effects of medications did not change in either group throughout the study except int-PTH increased in the LC group . This study indicated that administration of LC inhibited the progression of VC in patients receiving HD for type 2 DM , only in cases of slight VC compared with CC BACKGROUND Lanthanum carbonate ( LC ) is a non-calcium-containing phosphate binder and shows a comparable effect with other phosphate binders on hyperphosphatemia in dialysis patients . LC also contributes to a reduced oral calcium load compared with calcium carbonate ( CaC ) treatment . However , no crossover studies which compare the influence on serum calcium level between treatments with LC and CaC in hemodialysis ( HD ) patients have been carried out . METHODS After washout for 2 weeks , 50 patients on HD were r and omized ( 1 : 1 ) to receive LC or CaC for 3 months . Thereafter , patients underwent a second 2-week washout period and were switched to the alternative binder for the next 3 months . Mineral and bone metabolism markers were measured with the changes of vitamin D doses . RESULTS The serum phosphate level showed a similar decrease from baseline to 3 months in both groups . During the study periods , hypercalcemia was observed only in patients taking CaC. The dose of vitamin D analogue was increased more frequently in the patients of the LC group compared with LC group . The iPTH level showed a significant decrease in the CaC group , but not in the LC group . Serum levels of BAP , TRAP5b , and ALP were significantly elevated in the LC group , whereas the FGF-23 level showed a significant decrease . CONCLUSION LC effectively reduced the serum phosphate level ( like CaC ) and allowed the vitamin D analogue dosage to be increased without hypercalcemia in HD patients . LC is one of the useful phosphate binders without hypercalcemia . ( UMIN-CTR registration number : UMIN000002331 ) Treating hyperphosphatemia without increasing the calcium load in chronic kidney disease patients on dialysis is important , as conventional treatment frequently results in ectopic calcification . Sevelamer , a monotherapy for hyperphosphatemia is frequently associated with gastrointestinal disorders , often result ing in discontinuation of treatment . Lanthanum carbonate is a novel non-calcium-based phosphate binder for the treatment of chronic kidney disease . Here , its clinical efficacy and safety were assessed in Japanese dialysis patients . A placebo-controlled , r and omized , double-blind , parallel group , multicenter study was performed in Japanese dialysis patients . Patients were treated with various dosages of lanthanum carbonate or a placebo daily for six weeks . The primary efficacy endpoint was the change in serum phosphate level from the baseline . Secondary endpoints included achievement rates to target serum phosphate levels and changes in serum calcium levels . Safety was evaluated by the incidence of drug-related and treatment-emergent adverse events . A significant reduction in serum phosphate level was demonstrated for all dosages from Week 1 . This dose-dependent effect was also observed in the changes in serum calcium x phosphate product , yet there was no notable difference in serum calcium or serum intact parathyroid hormone levels . The incidence of drug-related adverse events was dose-dependent , with the most common being gastrointestinal symptoms . Lanthanum carbonate effectively controls serum phosphate levels and is generally tolerable to Japanese chronic kidney disease patients on dialysis , as reported for the Caucasian population . The optimal dosage in Japanese patients needs to be confirmed using a flexible-dose titration schedule BACKGROUND Lanthanum carbonate ( LC ) has been proposed as a new phosphate binder . Presented here are the results from one centre that participated in a multicentre trial to assess the effect of treatment with LC and calcium carbonate ( CC ) on the evolution of renal osteodystrophy in dialysis patients . Bone biopsies were performed at baseline , after 1 year of treatment and after a further 2-year follow-up period to assess the lanthanum concentration in bone and plasma . METHODS Twenty new dialysis patients were r and omized to receive LC ( median dose 1250 mg ) for 1 year ( n = 10 ) , followed by 2 years of CC treatment or CC ( n = 10 ) during the whole study period ( 3 years ) . RESULTS After 36 weeks of treatment , steady state was reached with plasma lanthanum levels varying around 0.6 ng/ml . Six weeks after cessation of 1 year of treatment , the plasma lanthanum levels declined to a value of 0.17 + /- 0.12 ng/ml ( P < 0.05 ) and after 2 years to 0.09 + /- 0.03 ng/ml . Plasma and bone lanthanum levels did not correlate with the average lanthanum dose at any time point . The mean bone concentration in patients receiving LC increased from 0.05 + /- 0.03 to 2.3 + /- 1.6 microg/g ( P < 0.05 ) after 1 year and slightly decreased at the end of the study to 1.9 + /- 1.6 microg/g ( P < 0.05 ) . CONCLUSIONS Bone deposition after 1 year of treatment with LC is low ( highest concentration : 5.5 microg/g ) . There is a slow release of lanthanum from its bone deposits 2 years after the discontinuation of the treatment and no association with aluminium-like bone toxicity BACKGROUND Renal osteodystrophy is a common complication of end-stage renal disease ( ESRD ) and is a major cause of morbidity in patients with ESRD . High serum levels of phosphorus , calcium and parathyroid hormone are associated with the development of this disease . The effects on bone of treatment with lanthanum carbonate , a new phosphate binder , and calcium carbonate were assessed in patients with ESRD . METHODS This was an open-label , multicenter , parallel-group study . Patients were recruited within 12 weeks of commencing dialysis . Following screening , phosphate binder administration was stopped , tetracycline labeling administered and a transiliac bone biopsy taken . After r and omization to lanthanum carbonate or calcium carbonate , patients were titrated to an optimum dose for 8 weeks and maintained at this dose for 44 weeks . The bone was then labeled and a second biopsy taken . Biopsy sample s were analyzed histomorphometrically . RESULTS Paired bone biopsies from 33 lanthanum carbonate- and 30 calcium carbonate-treated patients were suitable for analysis . None of the patients on either treatment developed osteomalacia . Assessment of activation frequency changes showed that 41 % of biopsies from lanthanum carbonate-treated patients moved towards normal ( observed values at the follow-up biopsy were closer to expected values than were the baseline values , so patients were considered to be improved ) compared with 23 % of calcium carbonate-treated patients ( p = 0.15 ) . CONCLUSIONS This study indicates that there was no evidence of aluminum-like toxicity with lanthanum carbonate after 1 year of treatment in ESRD patients commencing dialysis , and there appeared to be a beneficial effect on bone-cell function and activity compared with calcium carbonate BACKGROUND Abnormalities in serum calcium , phosphorus , and parathyroid hormone ( PTH ) concentrations are common in patients with chronic kidney disease and have been associated with increased morbidity and mortality . No clinical trials have been conducted to clearly identify categories of calcium , phosphorus , and PTH levels associated with the lowest mortality risk . Current clinical practice guidelines are based largely on expert opinions , and clinical ly relevant differences exist among guidelines across countries . We sought to describe international trends in calcium , phosphorus , and PTH levels during 10 years and identify mortality risk categories in the Dialysis Outcomes and Practice Patterns Study ( DOPPS ) , an international study of hemodialysis practice s and associated outcomes . STUDY DESIGN Prospect i ve cohort study . PARTICIPANTS 25,588 patients with end-stage renal disease on hemodialysis therapy for longer than 180 days at 925 facilities in DOPPS I ( 1996 - 2001 ) , DOPPS II ( 2002 - 2004 ) , or DOPPS III ( 2005 - 2007 ) . PREDICTORS Serum calcium , albumin-corrected calcium ( Ca(Alb ) ) , phosphorus , and PTH levels . OUTCOMES Adjusted hazard ratios for all-cause and cardiovascular mortality calculated using Cox models . RESULTS Distributions of mineral metabolism markers differed across DOPPS countries and phases , with lower calcium and phosphorus levels observed in the most recent phase of DOPPS . Survival models identified categories with the lowest mortality risk for calcium ( 8.6 to 10.0 mg/dL ) , Ca(Alb ) ( 7.6 to 9.5 mg/dL ) , phosphorus ( 3.6 to 5.0 mg/dL ) , and PTH ( 101 to 300 pg/mL ) . The greatest risk of mortality was found for calcium or Ca(Alb ) levels greater than 10.0 mg/dL , phosphorus levels greater than 7.0 mg/dL , and PTH levels greater than 600 pg/mL and in patients with combinations of high-risk categories of calcium , phosphorus , and PTH . LIMITATIONS Because of the observational nature of DOPPS , this study can only indicate an association between mineral metabolism categories and mortality . CONCLUSIONS Our results provide important information about mineral metabolism trends in hemodialysis patients in 12 countries during a decade . The risk categories identified in the DOPPS cohort may be relevant to efforts at international harmonization of existing clinical guidelines for mineral metabolism BACKGROUND The efficacy of lanth \n Output:\n " }, { "from": "agent", "value": "Lanthanum carbonate appeared to be associated with a significant reduction in progression of vascular calcification and a beneficial effect on bone outcomes without aluminum-like toxicity .\nLanthanum carbonate was associated with significantly lower serum calcium , similar serum Ca × P product and higher serum iPTH compared with calcium salts in patients with chronic kidney disease .\nConclusion Lanthanum carbonate could delay the progression of vascular calcification and benefit chronic kidney disease patients on bone outcomes .\nLanthanum carbonate could achieve similar proportion of phosphate-controlled patients as calcium-based phosphate binders with lower incidence of hypercalcemia" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: An examination of test manuals and published research indicates that widely used memory tests ( e.g. , Verbal Paired Associates and Word List tests of the Wechsler Memory Scale , Rey Auditory Verbal Learning Test , and California Verbal Learning Test ) are afflicted by severe ceiling effects . In the present study , the true extent of memory ability in healthy young adults was tested by giving 208 college undergraduates verbal paired-associate and verbal learning tests of various lengths ; the findings demonstrate that healthy adults can remember much more than is suggested by the normative data for the memory tests just mentioned . The findings highlight the adverse effects of low ceilings in memory assessment and underscore the severe consequences of ceiling effects on score distributions , means , st and ard deviations , and all variability-dependent indices , such as reliability , validity , and correlations with other tests . The article discusses the optimal test lengths for verbal paired-associate and verbal list-learning tests , shows how to identify ceiling-afflicted data in published research , and explains how proper attention to this phenomenon can improve future research and clinical practice Objective Our aim was to evaluate the association between adherence to the Mediterranean Diet ( MedDiet ) and cognitive function in 823 participants ( 62 ± 6 years at baseline ) from a Spanish prospect i ve cohort ( SUN project ) . Method A vali date d 136-item food frequency question naire was used to assess the adherence to the MedDiet at baseline . The 10-point ( 0 to 9 ) MedDiet Score was used to categorize adherence to MedDiet . Cognitive function was assessed twice at follow-up with a mean follow-up time between exposure and outcome assessment of 6 and 8y using the Telephone Interview of Cognitive Status-modified ( TICS-m , range 0 to 54 points ) . ANCOVA models were used to assess the association between adherence to the MedDiet and cognitive decline . Results In the multivariable-adjusted analysis of 2-year changes , a higher cognitive decline was observed among participants with low or moderate baseline adherence to the MedDiet than among those with better adherence ( adjusted difference = −0.56 points in TICS-m , 95 % CI = −0.99 to −0.13 ) . Conclusion A higher adherence to the MedDiet might be associated with better cognitive function . However , observed differences were of small magnitude and further studies are needed to confirm this finding OBJECTIVE To determine the validity and reliability of a rapidly administered neurocognitive screening battery consisting of 4 brief tests ( Enhanced Cued Recall , Temporal Orientation , Verbal Fluency , and Clock Drawing ) to distinguish between patients with probable Alzheimer 's disease ( AD ) and healthy control subjects . SUBJECTS Sixty successive referrals to the Memory Disorders Clinic at Southwestern Vermont Medical Center , Bennington , who were diagnosed as having probable AD and 60 community-dwelling volunteers of comparable age , sex distribution , and education . DESIGN Interrater and test-retest reliability , intergroup comparisons between patients with AD and control subjects on the 4 individual tests , and determination of probability of dementia for patients with AD and control subjects using the entire battery of tests . SETTING Outpatient care . MAIN OUTCOME MEASURE Comparison of the probability of dementia on the 7 Minute Screen with the criterion st and ard of clinical diagnosis established by examination and laboratory studies . SECONDARY OUTCOME MEASURES Test-retest and interrater reliability ( correlation coefficients ) , time for administration . RESULTS Mean time of administration was 7 minutes 42 seconds . Mean scores for patients with AD and control subjects on all 4 individual tests were significantly different ( for each , P<.001 ) . When the 4 tests were combined in a logistic regression , the battery had a sensitivity of 100 % and a specificity of 100 % . A series of 1000 repeated r and om sample s of 30 patients with AD and 30 control subjects taken from the overall sample of 60 patients with AD and 60 control subjects had a mean sensitivity of 92 % and a mean specificity of 96 % . The battery was equally sensitive to patients with mild AD as demonstrated by correctly classifying all 13 patients with AD using Mini-Mental State Examination scores of 24 or higher . Neither age nor education was a statistically significant factor when added as a covariate . Test-retest reliabilities for individual tests ranged from 0.83 to 0.93 . Test-retest reliability for the entire battery was 0.91 . Interrater reliability for the entire battery was 0.92 . CONCLUSIONS The 7 Minute Screen appears highly sensitive to AD and may be useful in helping to make initial distinctions between patients experiencing cognitive changes related to the normal aging process and those experiencing cognitive deficits related to dementing disorders such as AD . It has reasonable interrater and test-retest reliability , can be administered in a brief period , and requires no clinical judgment and minimal training BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality CONTEXT Higher adherence to a Mediterranean-type diet is linked to lower risk for mortality and chronic diseases , but its association with cognitive decline is unclear . OBJECTIVE To investigate the association of a Mediterranean diet with change in cognitive performance and risk for dementia in elderly French persons . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 1410 adults ( > or = 65 years ) from Bordeaux , France , included in the Three-City cohort in 2001 - 2002 and reexamined at least once over 5 years . Adherence to a Mediterranean diet ( scored as 0 to 9 ) was computed from a food frequency question naire and 24-hour recall . MAIN OUTCOME MEASURES Cognitive performance was assessed on 4 neuropsychological tests : the Mini-Mental State Examination ( MMSE ) , Isaacs Set Test ( IST ) , Benton Visual Retention Test ( BVRT ) , and Free and Cued Selective Reminding Test ( FCSRT ) . Incident cases of dementia ( n = 99 ) were vali date d by an independent expert committee of neurologists . RESULTS Adjusting for age , sex , education , marital status , energy intake , physical activity , depressive symptomatology , taking 5 medications/d or more , apolipoprotein E genotype , cardiovascular risk factors , and stroke , higher Mediterranean diet score was associated with fewer MMSE errors ( beta = -0.006 ; 95 % confidence interval [ CI ] , -0.01 to -0.0003 ; P = .04 for 1 point of the Mediterranean diet score ) . Performance on the IST , BVRT , or FCSRT over time was not significantly associated with Mediterranean diet adherence . Greater adherence as a categorical variable ( score 6 - 9 ) was not significantly associated with fewer MMSE errors and better FCSRT scores in the entire cohort , but among individuals who remained free from dementia over 5 years , the association for the highest compared with the lowest group was significant ( adjusted for all factors , for MMSE : beta = -0.03 ; 95 % CI , -0.05 to -0.001 ; P = .04 ; for FCSRT : beta = 0.21 ; 95 % CI , 0.008 to 0.41 ; P = .04 ) . Mediterranean diet adherence was not associated with the risk for incident dementia ( fully adjusted model : hazard ratio , 1.12 ; 95 % CI , 0.60 to 2.10 ; P = .72 ) , although power to detect a difference was limited . CONCLUSIONS Higher adherence to a Mediterranean diet was associated with slower MMSE cognitive decline but not consistently with other cognitive tests . Higher adherence was not associated with risk for incident dementia To examine the association between dietary habits , cognitive functioning and brain volumes in older individuals , data from 194 cognitively healthy individuals who participated in the Prospect i ve Investigation of the Vasculature in Uppsala Seniors cohort were used . At age 70 , participants kept diaries of their food intake for 1week . These records were used to calculate a Mediterranean diet ( MeDi ) score ( comprising dietary habits traditionally found in Mediterranean countries , e.g. high intake of fruits and low intake of meat ) , with higher scores indicating more pronounced MeDi-like dietary habits . Five years later , participants ' cognitive capabilities were examined by the seven minute screening ( 7MS ) ( a cognitive test battery used by clinicians to screen for dementia ) , and their brain volumes were measured by volumetric magnetic resonance imaging . Multivariate linear regression analyses were constructed to examine the association between the total MeDi score and cognitive functioning and brain volumes . In addition , possible associations between MeDi 's eight dietary features and cognitive functioning and brain volumes were investigated . From the eight dietary features included in the MeDi score , pertaining to a low consumption of meat and meat products was linked to a better performance on the 7MS test ( P=0.001 ) and greater total brain volume ( i.e. the sum of white and gray matter , P=0.03 ) when controlling for potential confounders ( e.g. BMI ) in the analysis . Integrating all dietary features into the total MeDi score explained less variance in cognitive functioning and brain volumes than its single dietary component meat intake . These observational findings suggest that keeping to a low meat intake could prove to be an impact-driven public health policy to support healthy cognitive aging , when confirmed by longitudinal studies . Further , they suggest that the MeDi score is a construct that may mask possible associations of single MeDi features with brain health domains in elderly population Background : We previously reported that the Mediterranean diet ( MeDi ) is related to lower risk for Alzheimer disease ( AD ) . Whether MeDi is associated with subsequent AD course and outcomes has not been investigated . Objectives : To examine the association between MeDi and mortality in patients with AD . Methods : A total of 192 community-based individuals in New York who were diagnosed with AD were prospect ively followed every 1.5 years . Adherence to the MeDi ( 0- to 9-point scale with higher scores indicating higher adherence ) was the main predictor of mortality in Cox models that were adjusted for period of recruitment , age , gender , ethnicity , education , APOE genotype , caloric intake , smoking , and body mass index . Results : Eighty-five patients with AD ( 44 % ) died during the course of 4.4 ( ±3.6 , 0.2 to 13.6 ) years of follow-up . In unadjusted models , higher adherence to MeDi was associated with lower mortality risk ( for each additional MeDi point hazard ratio 0.79 ; 95 % CI 0.69 to 0.91 ; p = 0.001 ) . This result remained significant after controlling for all covariates ( 0.76 ; 0.65 to 0.89 ; p = 0.001 ) . In adjusted models , as compared with AD patients at the lowest MeDi adherence tertile , those at the middle tertile had lower mortality risk ( 0.65 ; 0.38 to 1.09 ; 1.33 years ' longer survival ) , whereas subjects at the highest tertile had an even lower risk ( 0.27 ; 0.10 to 0.69 ; 3.91 years ' longer survival ; p for trend = 0.003 ) . Conclusion : Adherence to the Mediterranean diet ( MeDi ) may affect not only risk for Alzheimer disease ( AD ) but also subsequent disease course : Higher adherence to the MeDi is associated with lower mortality in AD . The gradual reduction in mortality risk for higher MeDi adherence tertiles suggests a possible dose-response effect Observational longitudinal research is particularly useful for assessing etiology and prognosis and for providing evidence for clinical decision making . However , there are no structured reporting requirements for studies of this design to assist authors , editors , and readers . The authors developed and tested a checklist of criteria related to threats to the internal \n Output:\n " }, { "from": "agent", "value": "Among this group of studies , conflicting results and conclusions regarding the efficacy of the MedDiet as a therapeutic approach for age-related cognitive function were found .\nThis type of endeavor will enable the ability to vali date with greater confidence , whether or not adherence to a MedDiet does promote benefit for age-related cognitive function" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The aim of this study was to evaluate prevalence of obstructive sleep apnea among patients undergoing bariatric surgery and the predictive value of various clinical parameters : body mass index ( BMI ) , neck circumference ( NC ) and the Epworth Sleepiness Scale ( ESS ) . We performed a prospect i ve , multidisciplinary , single-center observational study including all patients on the waiting list for bariatric surgery between June 2009 and June 2010 , irrespective of history or clinical findings . Patients visited our ENT outpatient clinic for patient history , ENT and general examination and underwent a full night polysomnography , unless performed previously . As much as 69.9 % of the patients fulfilled the criteria for OSA ( mean BMI 44.2 ± SD 6.4 kg/m2 ) ; 40.4 % of the patients met the criteria for severe OSA . The regression models found BMI to be the best clinical predictor , while the ROC curve found the NC to be the most accurate predictor of the presence of OSA . The discrepancy of the results and the poor statistical power suggest that all three clinical parameters are inadequate predictors of OSA . In conclusion , in this large patient series , 69.9 % of patients undergoing BS meet the criteria for OSA . More than 40 % of these patients have severe OSA . A mere 13.3 % of the patients were diagnosed with OSA before being placed on the waiting list for BS . On statistical analysis , increased neck circumference , BMI and the ESS were found to be insufficient predictors of the presence of OSA . Polysomnography is an essential component of the preoperative workup of patients undergoing BS . When OSA is found , specific perioperative measures are indicated BACKGROUND Limited data have suggested that sleep-disordered breathing , a condition of repeated episodes of apnea and hypopnea during sleep , is prevalent among adults . Data from the Wisconsin Sleep Cohort Study , a longitudinal study of the natural history of cardiopulmonary disorders of sleep , were used to estimate the prevalence of undiagnosed sleep-disordered breathing among adults and address its importance to the public health . METHODS A r and om sample of 602 employed men and women 30 to 60 years old were studied by overnight polysomnography to determine the frequency of episodes of apnea and hypopnea per hour of sleep ( the apnea-hypopnea score ) . We measured the age- and sex-specific prevalence of sleep-disordered breathing in this group using three cutoff points for the apnea-hypopnea score ( > or = 5 , > or = 10 , and > or = 15 ) ; we used logistic regression to investigate risk factors . RESULTS The estimated prevalence of sleep-disordered breathing , defined as an apnea-hypopnea score of 5 or higher , was 9 percent for women and 24 percent for men . We estimated that 2 percent of women and 4 percent of men in the middle-aged work force meet the minimal diagnostic criteria for the sleep apnea syndrome ( an apnea-hypopnea score of 5 or higher and daytime hypersomnolence ) . Male sex and obesity were strongly associated with the presence of sleep-disordered breathing . Habitual snorers , both men and women , tended to have a higher prevalence of apnea-hypopnea scores of 15 or higher . CONCLUSIONS The prevalence of undiagnosed sleep-disordered breathing is high among men and is much higher than previously suspected among women . Undiagnosed sleep-disordered breathing is associated with daytime hypersomnolence CONTEXT Excess body weight is positively associated with sleep-disordered breathing ( SDB ) , a prevalent condition in the US general population . No large study has been conducted of the longitudinal association between SDB and change in weight . OBJECTIVE To measure the independent longitudinal association between weight change and change in SDB severity . DESIGN Population -based , prospect i ve cohort study conducted from July 1989 to January 2000 . SETTING AND PARTICIPANTS Six hundred ninety r and omly selected employed Wisconsin residents ( mean age at baseline , 46 years ; 56 % male ) who were evaluated twice at 4-year intervals for SDB . MAIN OUTCOME MEASURES Percentage change in the apnea-hypopnea index ( AHI ; apnea events + hypopnea events per hour of sleep ) and odds of developing moderate-to-severe SDB ( defined by an AHI > or = 15 events per hour of sleep ) , with respect to change in weight . RESULTS Relative to stable weight , a 10 % weight gain predicted an approximate 32 % ( 95 % confidence interval [ CI ] , 20%-45 % ) increase in the AHI . A 10 % weight loss predicted a 26 % ( 95 % CI , 18%-34 % ) decrease in the AHI . A 10 % increase in weight predicted a 6-fold ( 95 % CI , 2.2 - 17.0 ) increase in the odds of developing moderate-to-severe SDB . CONCLUSIONS Our data indicate that clinical and public health programs that result in even modest weight control are likely to be effective in managing SDB and reducing new occurrence of SDB Daytime sleepiness , impaired cognitive performance and dysphoric mood are often present in patients with obstructive sleep apnoea syndrome ( SAS ) . This prospect i ve controlled study evaluates the effects of treatment with continuous positive airway pressure ( CPAP ) during 1 yr on daytime functioning in a large group of patients with SAS . The authors studied 80 patients ( mean+/-sem 49+/-1 yrs ) with SAS with a mean apnoea-hypopnoea index of 60+/-2 h-1 , and 80 healthy control subjects matched for sex and age ( 46+/-1 yrs . ) . Measurements were obtained at the beginning of the study and 12+/-1 months later , and included : daytime sleepiness ( Epworth scale ) , depression and anxiety ( Beck tests ) , vigilance ( Steer-Clear ) and reaction time ( Psychometer Vigilance Test 192 ) . Drug , coffee and alcohol intake , as well as the sleep schedule , were also recorded . Results showed that , before treatment , patients were more somnolent ( p<0.001 ) , anxious ( p<0.01 ) and depressed ( p<0.001 ) than control subjects . Also , they had a longer reaction time ( p<0.05 ) and poorer vigilance ( p<0.01 ) . The use of CPAP improved significantly the levels of somnolence ( p<0.0001 ) and vigilance ( p<0.01 ) , but failed to modify anxiety and depression . Reaction time changes were minor . Variables with a potential confounding effect did not change during the study . These results provide firm evidence to substantiate the use of continuous positive airway pressure in patients with sleep apnoea syndrome BACKGROUND Results of clinical studies suggest that there may be a relationship between breathing-related sleep disorders and depressive disorders . This study aims to assess the impact of breathing-related sleep disorder on major depressive disorder in the general population . METHOD A cross-sectional telephone survey was carried out between 1994 and 1999 in the general population of the United Kingdom , Germany , Italy , Portugal , and Spain . A total of 18,980 r and omly selected subjects aged 15 to 100 years and representative of the general population of their respective countries participated in the study . The question naire included a series of questions about sleep quality , breathing-related sleep disorder symptoms , mental disorders , and medical conditions . Data are presented using point prevalence . RESULTS 2.1 % of the subjects were found with obstructive sleep apnea syndrome at the time of the interview , and 2.5 % had some other type of DSM-IV breathing-related sleep disorder diagnosis . The association of DSM-IV breathing-related sleep disorder diagnosis and major depressive disorder diagnosis was found in 0.8 % of the sample . As many as 18 % of individuals with a major depressive disorder diagnosis also have a DSM-IV breathing-related sleep disorders diagnosis , and 17.6 % of subjects with a DSM-IV breathing-related sleep disorders diagnosis have a major depressive disorder diagnosis . Multivariate models showed that even after controlling for obesity and hypertension , the odds of having a DSM-IV breathing-related sleep disorders diagnosis was 5.26 for individuals with a major depressive disorder diagnosis . CONCLUSION About 800 of 100,000 individuals have both a breathing-related sleep disorder and a major depressive disorder . The identification of 1 of these 2 disorders should prompt the investigation of the other disorder since nearly a fifth of them have the other disorder \n Output:\n " }, { "from": "agent", "value": "People with SMI ( particularly MDD ) have a high prevalence of OSA ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Active participation in the medical consultation has been demonstrated to benefit aspects of patients ’ subsequent psychological well-being . We investigated two interventions promoting patient question -asking behaviour . The first was a question prompt sheet provided before the consultation , which was endorsed and worked through by the clinician . The second was a face to face coaching session exploring the benefits of , and barriers to , question -asking , followed by coaching in question -asking behaviour employing rehearsal techniques . Sixty patients with heterogeneous cancers , seeing two medical oncologists for the first time , were r and omly assigned to one of three groups : two intervention groups and one control group . Sociodemographic variables and anxiety were assessed prior to the intervention which preceded the consultation . The consultations were audiotaped and subsequently analysed for question -asking behaviour . Anxiety was assessed again immediately following the consultation . Question naires to assess patient satisfaction , anxiety and psychological adjustment were sent by mail 2 weeks following the consultation . Presentation and discussion of the prompt sheet significantly increased the total number of questions asked and the number of questions asked regarding tests and treatment . Coaching did not add significantly to the effects of the prompt sheet . Psychological outcomes were not different among the groups . We conclude that a question prompt sheet addressed by the doctor is a simple , inexpensive and effective means of promoting patient question asking in the cancer consultation Patient participation in medical consultations has been demonstrated to benefit their subsequent psychological well being . Question asking is one way in which patients can be active . We investigated 2 means of promoting cancer patient question asking . One was the provision of a question prompt sheet to patients prior to their initial consultation with their oncologist . The second was the active endorsement and systematic review of the question prompt sheet by their oncologist . 318 patients with heterogeneous cancers , seeing one of 5 medical and 4 radiation oncologists for the first time , were r and omised to either receive or not receive a question prompt sheet . Doctors were r and omised to either proactively address or passively respond to the question prompt sheet in the subsequent consultation . Anxiety was assessed prior to the consultation . Consultations were audiotaped and content analysed . Anxiety was assessed again immediately following the consultation . Within the next 10 days patients completed question naires assessing information needs , anxiety and satisfaction and were given a structured telephone interview assessing information recall . Patients provided with a question prompt sheet asked more questions about prognosis compared with controls and oncologists gave significantly more prognostic information to these patients . Provision of the question prompt sheet prolonged consultations and increased patient anxiety ; however , when oncologists specifically addressed the prompt sheet , anxiety levels were significantly reduced , consultation duration was decreased and recall was significantly improved . A patient question prompt sheet , used proactively by the doctor , is a powerful addition to the oncology consultation . © 2001 Cancer Research Campaign BACKGROUND The aims of this study were to ( i ) conceptualize dimensions of a good death in Japanese cancer care , ( ii ) clarify the relative importance of each component of a good death and ( iii ) explore factors related to an individual 's perception of the domains of a good death . METHODS The general population was sample d using a stratified r and om sampling method ( n = 2548 ; response rate , 51 % ) and bereaved families from 12 certified palliative care units were surveyed as well ( n = 513 ; 70 % ) . We asked the subjects about the relative importance of 57 components of a good death . RESULTS Explanatory factor analysis demonstrated 18 domains contributing to a good death . Ten domains were classified as ' consistently important domains ' , including ' physical and psychological comfort ' , ' dying in a favorite place ' , ' good relationship with medical staff ' , ' maintaining hope and pleasure ' , ' not being a burden to others ' , ' good relationship with family ' , ' physical and cognitive control ' , ' environmental comfort ' , ' being respected as an individual ' and ' life completion ' . CONCLUSIONS We quantitatively identified 18 important domains that contribute to a good death in Japanese cancer care . The next step of our work should be to conduct a national survey to identify what is required to achieve a good death BACKGROUND Active participation and asking questions are important ways in which patients can ensure they underst and what the doctor has said . This study evaluated a question prompt sheet design ed to encourage patients to ask questions in the cancer consultation . PATIENTS AND METHODS Patients ( n = 142 ) were r and omised to receive ( i ) a question prompt sheet or ( ii ) a general sheet informing patients of services available through the regional Cancer Council . Recall of information was assessed in a structured interview 4 - 20 days after the consultation . Question naires to assess patient satisfaction and adjustment to cancer were sent by mail . RESULTS The question prompt sheet had a significant effect in one content area : prognosis . Thirty-five percent of patients who received the question h and out asked questions about prognosis compared to 16 % of those receiving the information h and out . The prompt sheet did not increase the mean number of questions asked overall . Age , in/out-patient status , gender and involvement preference were predictive of both number and duration of patient questions . CONCLUSIONS A question prompt sheet has a limited but important effect on patient question asking behaviour in the cancer consultation PURPOSE This study evaluated a cancer consultation preparation package ( CCPP ) design ed to facilitate patient involvement in the oncology consultation . PATIENTS AND METHODS A total of 164 cancer patients ( 67 % response rate ) were r and omly assigned to receive the CCPP or a control booklet at least 48 hours before their first oncology appointment . The CCPP included a question prompt sheet , booklets on clinical decision making and patient rights , and an introduction to the clinic . The control booklet contained only the introduction to the clinic . Physicians were blinded to which intervention patients received . Patients completed question naires immediately after the consultation and 1 month later . Consultations were audiotaped , transcribed verbatim , and coded . RESULTS All but one patient read the information . Before the consultation , intervention patients were significantly more anxious than were controls ( mean , 42 v 38 ; P = .04 ) ; however anxiety was equivalent at follow-up . The CCPP was reported as being significantly more useful to family members than the control booklet ( P = .004 ) . Patients receiving the intervention asked significantly more questions ( 11 v seven questions ; P = .005 ) , tended to interrupt the physician more ( 1.01 v 0.71 interruptions ; P = .08 ) , and challenged information significantly more often ( twice v once ; P = .05 ) . Patients receiving the CCPP were less likely to achieve their preferred decision making style ( 22 % ) than were controls ( 35 % ; P = .06 ) . CONCLUSION This CCPP influences patients ' consultation behavior and does not increase anxiety in the long-term . However , this intervention , without physician endorsement , reduced the percentage of patients whose preferred involvement in decision making was achieved \n Output:\n " }, { "from": "agent", "value": "The findings in this review suggest that patient preferences with regard to the communication of bad news by physicians consist of four components : setting , manner of communicating bad news , what and how much information is provided and emotional support , and that patients ' preferences are associated with demographic factors .\nYounger patients , female patients and more highly educated patients consistently expressed a desire to receive as much detailed information as possible and to receive emotional support .\nAsian patients were shown to prefer that relatives be present when receiving bad news more than Westerners do and to prefer to discuss their life expectancy less than Westerners ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To identify predictors of success for physiotherapy treatment in women with persistent postpartum stress urinary incontinence ( SUI ) . DESIGN Secondary analysis of data from a single-blind r and omized controlled trial comparing 2 physiotherapy intervention programs for persistent SUI in postpartum women . SETTING Obstetric clinic of a mother and children 's university hospital . PARTICIPANTS Women , ages 23 to 39 ( N=57 ) , were r and omized to 1 of 2 pelvic floor muscle ( PFM ) training programs , 1 with and 1 without abdominal muscle training . INTERVENTION Over 8 weeks , participants in each group followed a specific home exercise program once a day , 5 days a week . In addition , participants attended individual weekly physiotherapy sessions throughout the 8-week program . MAIN OUTCOME MEASURES Treatment success was defined as a pad weight gain of less than 2 g on a 20-minute pad test with st and ardized bladder volume after 8 weeks ' treatment . The relationship between potential predictive PFM function variables as measured by a PFM dynamometer and success of physiotherapy was studied using forward stepwise multivariate logistic regression analyses . RESULTS Forty-two women ( 74 % ) were classified as treatment successes , and 15 ( 26 % ) were not . Treatment success was associated with lower pretreatment PFM passive force and greater PFM endurance pretreatment , but the latter association was barely statistically significant . This model explained between 23 % ( Cox and Snell R(2 ) ) and 34 % ( Nagelkerke R(2 ) ) of the outcome variability . CONCLUSIONS The results contribute new information on predictors of success for physiotherapy treatment in women with persistent postpartum SUI Objective To assess the effect of pelvic floor education after vaginal delivery on pelvic floor characteristics in nulliparous women . Methods We examined 107 nulliparas during pregnancy and at 9 weeks and 10 months after vaginal delivery . Methods used included a question naire , clinical examination , perineosonography , urethral pressure profiles , and intravaginal and intra-anal pressure recordings during pelvic floor contraction . After the second examination , the women were assigned in alternating manner to either 12 sessions of pelvic floor exercises with biofeedback and electrostimulation ( n = 51 ) or no training ( n = 56 ) . The two groups were compared at the third examination . Results Stress urinary incontinence incidence decreased in 2 % of control subjects compared with 19 % of women who underwent pelvic floor education ( P = .002 ) , whereas the incidence of fecal incontinence ( 5 % versus 4 % , P = 1 ) and the percentage of women who recovered predelivery pelvic floor contraction strength ( 33 % versus 41 % , P = .4 ) were no different . We observed no significant differences in bladder neck position and mobility , urethral functional length , maximal urethral closure pressure , pressure transmission ratio , residual area of continence at stress st and ing , or intravaginal or intra-anal pressures during pelvic floor contraction between groups at the third examination . Conclusion Pelvic floor education , begun 2 months postpartum , significantly reduced the incidence of stress urinary incontinence , but not fecal incontinence or weak pelvic floor . Similarly , bladder neck behavior , urodynamic characteristics , intravaginal or intra-anal pressures during pelvic floor squeezing also were not modified Background Both maternal pre-pregnancy obesity and excessive gestational weight gain are increasing in prevalence and associated with a number of adverse pregnancy outcomes for both mother and child . Observational studies regarding physical activity in pregnancy have found reduced weight gain in active mothers , as well as reduced risk of adverse pregnancy outcomes . There is however a lack of high quality , r and omized controlled trials on the effects of regular exercise training in pregnancy , especially those with a pre-pregnancy body mass index ( BMI ) at or above 30 kg/m2 . Methods We are conducting a r and omised , controlled trial in Norway with two parallel arms ; one intervention group and one control group . We will enroll 150 previously sedentary , pregnant women with a pre-pregnancy BMI at or above 30 kg/m2 . The intervention group will meet for organized exercise training three times per week , starting in gestation week 14 ( range 12 - 16 ) . The control group will get st and ard antenatal care . The main outcome measure will be weight gain from baseline to delivery . Among the secondary outcome measures are changes in exercise capacity , endothelial function , physical activity level , body composition , serum markers of cardiovascular risk , incontinence , lumbopelvic pain and cardiac function from baseline to gestation week 37 ( range 36 - 38 ) . Offspring outcome measures include anthropometric variables at birth , Apgar score , as well as serum markers of inflammation and metabolism in cord blood . Discussion The results of this trial will provide knowledge about effects of regular exercise training in previously sedentary , obese pregnant women . If the program proves effective in reducing gestational weight gain and adverse pregnancy outcomes , such programs should be considered as part of routine pregnancy care for obese women . Trial Registration Clinical Trials.gov : A physiotherapist-delivered continence promotion program was recently implemented with postpartum women in Australia . A previous r and omised controlled trial demonstrated that the program was effective in promoting pelvic floor exercises and continence at 3 months postpartum . The present study compares pelvic floor exercise frequency and continence status for women in the intervention and ‘ usual care ’ control groups at 12 months postpartum . While there was no significant difference in continence status , women in the intervention group were more likely than those in the control group to be practising pelvic floor exercises at adequate frequencies . In turn , continued adherence to pelvic floor exercises at 12 months was predictive of continence at that time . Potential strategies for enhancing women ’s adherence to pelvic floor exercise regimes during and beyond the postpartum year are discussed OBJECTIVE : The long-term prevalence of anal incontinence after vaginal delivery is unknown . The aim of the present study was to evaluate the prevalence of anal incontinence in primiparous women 5 years after their first delivery and to evaluate the influence of subsequent childbirth . METHODS : A total of 349 nulliparous women were prospect ively followed up with question naires before pregnancy , at 5 and 9 months , and 5 years after delivery . A total of 242 women completed all question naires . Women with sphincter tear at their first delivery were compared with women without such injury . Risk factors for development of anal incontinence were also analyzed . RESULTS : Anal incontinence increased significantly during the study period . Among women with sphincter tears , 44 % reported anal incontinence at 9 months and 53 % at 5 years ( P = .002 ) . Twenty-five percent of women without a sphincter tear reported anal incontinence at 9 months and 32 % had symptoms at 5 years ( P < .001 ) . Risk factors for anal incontinence at 5 years were age ( odds ratio [ OR ] 1.1 ; 95 % confidence interval [ CI ] 1.0–1.2 ) , sphincter tear ( OR 2.3 ; 95 % CI 1.1–5.0 ) , and subsequent childbirth ( OR 2.4 ; 95 % CI 1.1–5.6 ) . As a predictor of anal incontinence at 5 years after the first delivery , anal incontinence at both 5 months ( OR 3.8 ; 95 % CI 2.0–7.3 ) and 9 months ( OR 4.3 ; 95 % CI 2.2–8.2 ) was identified . Among women with symptoms , the majority had infrequent incontinence to flatus , whereas fecal incontinence was rare . CONCLUSION : Anal incontinence among primiparous women increases over time and is affected by further childbirth . Anal incontinence at 9 months postpartum is an important predictor of persisting symptoms Introduction and hypothesisThe objective was to examine the relationship between maternal and perinatal factors and the occurrence of stress ( SUI ) or mixed ( MUI ) urinary incontinence ( UI ) 1 year after the first vaginal delivery in primiparous women . Methods Participants in this prospect i ve cohort were recruited consecutively from June 2003 to July 2005 from all eligible women who delivered in the department . A vali date d question naire , the International Consultation of Incontinence Question naire Short Form ( ICIQ-SF ) was completed by all participants 2–3 days after delivery , and a similar second question naire was filled out 1 year later . Additional data were obtained from the medical records . The first question naire was completed by 1,018 women ( 63 % ) and the second by 859 women ( 84 % ) . The study group comprised the 575 women without any UI before the pregnancy and who had a vaginal delivery . The primary analysis comprised 117 women with either SUI or MUI 1 year after the vaginal delivery and 403 women without any UI . Results In univariate analyses , the following factors were associated with SUI or MUI : prepregnancy body mass index ( BMI ) ≥ 30 ( p < 0.05 ) , UI during the pregnancy ( p < 0.05 ) , perineal lesions ( p < 0.05 ) , and anal sphincter tears ( p = 0.05 ) . Logistic regression analysis showed that SUI or MUI was strongly associated with UI during the pregnancy [ adjusted odds ratio ( OR ) 4.7 , 95 % confidence interval ( CI ) 2.9–7.7 ) and inversely associated with oxytocin augmentation ( adjusted OR 0.5 , 95 % CI 0.3–0.9 ) . Conclusions SUI or MUI 1 year after the first vaginal delivery was strongly associated with UI during the pregnancy and inversely associated with oxytocin augmentation OBJECTIVE The purpose of this study was to determine the effects of extracorporeal magnetic innervation ( ExMI ) on pelvic muscle strength of primiparous patients . STUDY DESIGN Primigravid patients were r and omized to receive either active or sham ExMI postpartum treatments for 8 weeks . The main outcome measure was pelvic muscle strength measured by perineometry at baseline ( midtrimester ) , 6 weeks ( before treatments ) , 14 weeks , 6 months , and 12 months postpartum . Mixed r and omized-repeated measures ANOVA was used to analyze the mean perineometry values between the 2 groups and across all 5 time periods . RESULTS Fifty-one patients enrolled , and 18 were lost to attrition . There were no differences in demographics or delivery characteristics between the active and sham groups . There was an overall time effect , F(3,85 ) = 3.1 , P = .049 , but no group , F(1,31 ) = 0.007 , P = .94 , or (group)(time ) interaction , F(3,85 ) = 1.8 , P = .15 . CONCLUSION We found no differences in pelvic muscle strength between patients receiving active or sham ExMI treatments in the early postpartum period Objective : To investigate the effect of supervised and unsupervised pelvic floor muscle exercises utilizing trunk stabilization for treating postpartum urinary incontinence and to compare the outcomes . Design : R and omized , single-blind controlled study . Setting : Outpatient rehabilitation hospital . Subjects : Eighteen subjects with postpartum urinary incontinence . Interventions : Subjects were r and omized to either a supervised training group with verbal instruction from a physiotherapist , or an unsupervised training group after undergoing a supervised demonstration session . Main measures : Bristol Female Lower Urinary Tract Symptom question naire ( urinary symptoms and quality of life ) and vaginal function test ( maximal vaginal squeeze pressure and holding time ) using a perineometer . Results : The change values for urinary symptoms ( −27.22 ± 6.20 versus −18.22 ± 5.49 ) , quality of life ( −5.33 ± 2.96 versus −1.78 ± 3.93 ) , total score ( −32.56 ± 8.17 versus −20.00 ± 6.67 ) , maximal vaginal squeeze pressure ( 18.96 ± 9.08 versus 2.67 ± 3.64 mmHg ) , and holding time ( 11.32 ± 3.17 versus 5.72 ± 2.29 seconds ) were more improved in the supervised group than in the unsupervised group ( P < 0.05 ) . In the supervised group , significant differences were found for all variables between pre- and post-test values ( P < 0.01 ) , whereas the unsupervised group showed significant differences for urinary symptom score , total score and holding time between the pre- and post-test results ( P < 0.05 ) . Conclusions : These findings suggest that exercising the pelvic floor muscles by utilizing trunk stabilization under physiotherapist supervision may be beneficial for the management of postpartum urinary incontinence A r and omized controlled trial was carried out to evaluate the extent to which a program of reinforced pelvic floor muscle exercises ( PFME ) reduces urinary incontinence 1 year after delivery . Two hundred and thirty women who were incontinent 3 months postpartum were r and omized to either a control group doing st and ard postnatal pelvic floor muscle exercises ( n=117 ) or to an intervention group ( n=113 ) who saw a physiother \n Output:\n " }, { "from": "agent", "value": "It seemed that the more intensive the programme the greater the treatment effect .\nIt is possible that mixed prevention and treatment approaches might be effective when the intervention is intensive enough .\nThere was little evidence about long-term effects for either urinary or faecal incontinence .\nAUTHORS ' CONCLUSIONS There is some evidence that for women having their first baby , PFMT can prevent urinary incontinence up to six months after delivery .\nThere is support for the widespread recommendation that PFMT is an appropriate treatment for women with persistent postpartum urinary incontinence ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Risk of knee osteoarthritis ( OA ) associated with constitutional factors , history of joint injuries , and occupational factors was assessed in a case-control study among women in Japan . Results were contrasted with a comparable study in Britain . METHODS The study covered 3 health districts in Japan . Cases were women aged > /= 45 years old , diagnosed with knee OA by orthopedic physicians utilizing radiography . No cases displayed established causes of secondary OA . Controls selected r and omly from the general population were individually matched to each case for age , sex , and residential district . Subjects were interviewed using structured question naires to determine medical history , including history of joint injury , physical activity , socioeconomic factors , and occupation . Height and weight were measured . RESULTS Interviews were obtained from 101 female cases and controls . The highest third of heaviest body weight in the past [ high ( > 62.0 kg ) vs low ( < 55 kg ) odds ratio = 4.42 , 95 % confidence interval 1.17 - 16.64 ] , previous injury to the knee ( OR 7.11 , 95 % CI 2.40 - 21.09 ) , sedentary work during initial employment ( OR 0.35 , 95 % CI 0.15 - 0.84 ) , and total working years ( OR 1.05 , 95 % CI 1.01 - 1.08 ) represented independent factors associated with knee OA , after controlling for other potential risk factors . CONCLUSION Heavy weight in the past appears to represent a risk factor for knee OA among women in Japan , as reported in Britain . Constitutional factors may represent important determinants for knee OA , regardless of race . Previous injury to the knee and occupational factors are also associated with knee OA in both Britain and Japan , although characteristic activities for work vary Although treatments for osteoarthritis of the knee are often directed at relieving pain , pain may cause patients to alter how they perform activities to decrease the loads on the joints . The knee-adduction moment is a major determinant of the load distribution between the medial and lateral plateaus . Therefore , the interrelationship between pain and the external knee-adduction moment during walking may be especially important for underst and ing mechanical factors related to the progression of medial tibiofemoral osteoarthritis . Fifty-three subjects with symptomatic radiographic evidence of osteoarthritis of the knee were studied . These subjects were a subset of those enrolled in a double-blind study in which gait analysis and radiographic and clinical evaluations were performed after a 2-week washout of anti-inflammatory and analgesic treatment . The subjects then took a nonsteroidal anti-inflammatory drug , acetaminophen , or placebo for 2 weeks , and the gait and clinical evaluations were repeated . The change in the peak external adduction moment between the two evaluations was inversely correlated with the change in pain ( R = 0.48 , p < 0.001 ) and was significantly different between those whose pain increased ( n = 7 ) , decreased ( n = 18 ) , or remained unchanged ( n = 28 ) ( p = 0.009 ) . Those with increased pain had a significant decrease in the peak external adduction ( p = 0.005 ) and flexion moments ( p = 0.023 ) . In contrast , the subjects with decreased pain tended to have an increase in the peak external adduction moment ( p = 0.095 ) and had a significant increase in the peak external extension moment ( p = 0.017 ) . The subjects whose pain was unchanged had no significant change in the peak external adduction ( p = 0.757 ) , flexion ( p = 0.234 ) , or extension ( p = 0.465 ) moments . Thus , decreases in pain among patients with medial tibiofemoral osteoarthritis were related to increased loading of the degenerative portion of the joints . Additional long-term prospect i ve studies are needed to determine whether increased loading during walking actually results in accelerated progression of the disease This study tested whether the peak external knee adduction moments during walking in subjects with knee osteoarthritis ( OA ) were correlated with the mechanical axis of the leg , radiographic measures of OA severity , toe out angle or clinical assessment s of pain , stiffness or function . Gait analysis was performed on 62 subjects with knee OA and 49 asymptomatic control subjects ( normal subjects ) . The subjects with OA walked with a greater than normal peak adduction moment during early stance ( p = 0.027 ) . In the OA group , the mechanical axis was the best single predictor of the peak adduction moment during both early and late stance ( R = 0.74 , p < 0.001 ) . The radiographic measures of OA severity in the medial compartment were also predictive of both peak adduction moments ( R = 0.43 to 0.48 , p < 0.001 ) along with the sum of the WOMAC subscales ( R = -0.33 to -0.31 , p < 0.017 ) . The toe out angle was predictive of the peak adduction moment only during late stance ( R = -0.45 , p < 0.001 ) . Once mechanical axis was accounted for , other factors only increased the ability to predict the peak knee adduction moments by 10 18 % . While the mechanical axis was indicative of the peak adduction moments , it only accounted for about 50 % of its variation , emphasizing the need for a dynamic evaluation of the knee joint loading environment . Underst and ing which clinical measures of OA are most closely associated with the dynamic knee joint loads may ultimately result in a better underst and ing of the disease process and the development of therapeutic interventions OBJECTIVE The adduction moment at the knee during gait is the primary determinant of medial-to-lateral load distribution . If the adduction moment contributes to progression of osteoarthritis ( OA ) , then patients with advanced medial tibiofemoral OA should have higher adduction moments . The present study was undertaken to investigate the hypothesis that the adduction moment normalized for weight and height is associated with medial tibiofemoral OA disease severity after controlling for age , sex , and pain level , and to examine the correlation of serum hyaluronan ( HA ) level with disease severity and with the adduction moment in a subset of patients . METHODS Fifty-four patients with medial tibiofemoral OA underwent gait analysis and radiographic evaluation . Disease severity was assessed using the Kellgren-Lawrence ( K-L ) grade and medial joint space width . In a subset of 23 patients with available sera , HA was quantified by s and wich enzyme-linked immunosorbent assay . Pearson correlations , a r and om effects model , and multivariate regression models were used . RESULTS The adduction moment correlated with the K-L grade in the left and right knees ( r = 0.68 and r = 0.60 , respectively ) , and with joint space width in the left and right knees ( r = -0.45 and r = -0.47 , respectively ) . The relationship persisted after controlling for age , sex , and severity of pain . The partial correlation between K-L grade and adduction moment was 0.71 in the left knees and 0.61 in the right knees . For every 1.0-unit increase in adduction moment , there was a 0.63-mm decrease in joint space width . In the subset of patients in whom serum HA levels were measured , HA levels correlated with medial joint space width ( r = -0.55 ) , but not with the adduction moment . CONCLUSION There is a significant relationship between the adduction moment and OA disease severity . Serum HA levels correlate with joint space width but not with the adduction moment . Longitudinal studies will be necessary to determine the contribution of the adduction moment , and its contribution in conjunction with metabolic markers , to progression of medial tibiofemoral OA OBJECTIVE To determine the relationship between change in body mass and knee-joint moments and forces during walking in overweight and obese older adults with knee osteoarthritis ( OA ) following an 18-month clinical trial of diet and exercise . METHODS Data were obtained from 142 sedentary , overweight , and obese older adults with self-reported disability and radiographic evidence of knee OA who underwent 3-dimensional gait analysis . Gait kinetic outcome variables included peak knee-joint forces and peak internal knee-joint moments . Mixed regression models were created to predict followup kinetic values , using followup body mass as the primary explanatory variable . Baseline body mass was used as a covariate , and thus followup body mass was a surrogate measure for change in body mass ( i.e. , weight loss ) . RESULTS There was a significant direct association between followup body mass and peak followup values of compressive force ( P = 0.001 ) , result ant force ( P = 0.002 ) , abduction moment ( P = 0.03 ) , and medial rotation moment ( P = 0.02 ) . A weight reduction of 9.8 N ( 1 kg ) was associated with reductions of 40.6 N and 38.7 N in compressive and result ant forces , respectively . Thus , each weight-loss unit was associated with an approximately 4-unit reduction in knee-joint forces . In addition , a reduction in body weight of 9.8 N ( 1 kg ) was associated with a 1.4 % reduction ( 0.496 Nm ) in knee abduction moment . CONCLUSION Our results indicate that each pound of weight lost will result in a 4-fold reduction in the load exerted on the knee per step during daily activities . Accumulated over thous and s of steps per day , a reduction of this magnitude would appear to be clinical ly meaningful Elderly subjects with and without knee pain walked at a comfortable pace during gait analysis . Comparison of peak hip and knee internal extensor generalized muscle moments ( GMMs ) during loading response was made between groups . Walking velocity , peak hip internal extensor GMM , and knee range of motion ( ROM ) were significantly less for the group with knee pain than for the group without pain . Peak hip internal extensor GMM was strongly correlated with velocity , but peak knee internal extensor GMM was not . Knee ROM limitations may account for the increased peak knee internal extensor GMM in the knee pain group \n Output:\n " }, { "from": "agent", "value": "RESULTS The magnitude and time course of KAM during gait appeared to be consistent across laboratories and computational methods .\nKnee adduction moment increased with OA severity and was directly proportional to varus malalignment .\nClassifying the patients on the basis of disease severity decreased the group variability , permitting the differences to be more detectable .\nBiomechanical variables such as varus malalignment are associated with KAM and therefore may affect the disease process ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES It has been suggested that changes in the distribution of dental caries mean that targeting high-risk groups can maximize the cost effectiveness of dental health programs . This study aim ed to assess the effectiveness of a targeted school-based dental screening program in terms of the proportion of children with dental care needs it identified . METHODS The target population was all children in junior and senior kindergarten and grade s 2 , 4 , 6 , and 8 who attended schools in four Ontario communities . The study was conducted in a r and om sample of 38 schools stratified according to caries risk . Universal screening was implemented in these schools . The parents of all children identified as having dental care needs were sent a short question naire to document the sociodemographic and family characteristics of these children . Children with needs were divided into two groups : those who would and who would not have been identified had the targeted program been implemented . The characteristics of the two groups were compared . RESULTS Overall , 21.0 percent of the target population were identified as needing dental care , with 7.4 percent needing urgent care . The targeted program would have identified 43.5 percent of those with dental care needs and 58.0 percent of those with urgent needs . There were substantial differences across the four communities in the proportions identified by the targeted program . Identification rates were lowest when the difference in prevalence of need between the high- and low-risk groups was small and where the low-risk group was large in relation to the high-risk group . The targeted program was more effective at identifying children from disadvantaged background s. Of those with needs who lived in households receiving government income support , 59.0 percent of those with needs and 80.1 percent of those with urgent needs would be identified . CONCLUSIONS The targeted program was most effective at identifying children with dental care needs from disadvantaged background s. However , any improvements in cost effectiveness achieved by targeting must be balanced against inequities in access to public health care re sources Objective To obtain consensus amongst a sample of primary care dentists in the North West of Engl and on a set of clinical criteria that should trigger referral following school dental screening . Design Delphi process . Setting Primary dental care , Engl and 2002 Method Primary care dentists in the North West of Engl and were r and omly selected to complete a two round ' Delphi exercise ' that included 10 potential referral criteria . The dentists were invited to express their level of support for the inclusion of each referral criterion . Main outcome measures Level of agreement for each referral criterion . Acceptance of any criterion was that the interquartile range should be no more than 3 scale points with the lower value being no less than 7 . Results Eighty-eight dentists , ( 72.7 % ) , completed the Delphi exercise . Six referral criteria met with the groups ' approval : Child with caries in permanent dentitionChild with darkened/discoloured permanent incisorsChild aged 9 - 10 years with overjet greater than 10 mmChild over six years with either gross plaque , calculus or swollen gumsChild with evidence of sepsisChild registered with a GDP with caries in permanent dentition . Conclusion It is possible for a representative sample of primary care dentists in the North West to agree referral criteria following school dental screening Background Recent studies have cast doubt on the effectiveness and efficiency of school based dental screening programmes in improving dental attendance or improving dental health . In 2002 the National Dental Inspection Programme was introduced in Scotl and which categorises children by their dental health and informs parents of the findings via a personalised letter home and encourages dental registration . In addition , epidemiological data for local and national planning purpose s is collected . This replaced an earlier school screening system in Lothian where a generic letter urging registration was sent to children who were identified as not being registered with a dentist . The objective of this study is to compare dental registration s rates among unregistered children in these two school inspection systems with a system where letters were sent home but no dental inspection was carried out . Methods The study was design ed as a single blinded , cluster r and omised , controlled trial involving 12,765 12–13-year-old children attending all 65 state Secondary schools in Lothian and Fife during the academic year 2003/4.After stratifying for school size and range of social deprivation , schools were r and omly allocated to one of four groups:1 . ' Traditional ' inspection , letter to unregistered children only,2 . Letter sent home to unregistered children only , no inspection,3 . National Dental Inspection Programme , letter to all children,4 . Control group in which the children were neither inspected nor sent a letter . Dental Registration status was compared at baseline and 3 months post inspection . Results The registration levels in both the ' Traditional ' screening and the NDIP inspection groups rose 3 months post inspection ( 14 % and 15.8 % respectively ) but were not significantly different from one another or the control group which rose by 15.8 % ( p > 0.05 ) . The group who were sent a letter home but were not inspected also has a rise in registration levels of 18.1 % which was not significantly different from either of the groups who were inspected or the control group ( p > 0.05 ) . The only significant predictors of registration were previous registration ( p < 0.05 ) and within those who previously registered , the length of time since last registration ( P < 0.001 ) . Conclusion Neither of the two dental inspection methods nor a letter home to unregistered children result ed in a significant rise in registration rates in 12–13-year-olds compared to a control group of children who received no intervention The aim of this study was to assess the prevalence of condition-specific impacts on daily performances attributed to malocclusion in British adolescents . Two hundred 16- to 17-year-old adolescents were r and omly selected from 957 children attending a public college in London , UK . During interviews , participants provided information about demographic variables and socio-dental impacts on quality of life attributed to malocclusions , using the Condition-Specific form of the Oral Impacts on Daily Performances ( CS-OIDP ) index . Adolescents were also clinical ly examined using the Index of Orthodontic Treatment Need . Statistical comparison by covariates was performed using chi-squared test and chi-squared test for trends . The prevalence of oral impacts on daily performances attributed to any oral condition was 26.5 % whereas the prevalence of CS-OIDP attributed to malocclusion was 21.5 % . There was no statistically significant difference by sex , age , ethnicity or orthodontic treatment status of schoolchildren in the prevalence of CS-OIDP attributed to malocclusion ( P > /= 0.243 for all cases ) . However , there was a linear trend for the prevalence of CS-OIDP attributed to malocclusion , by level of normative orthodontic treatment need ( P = 0.042 ) . The prevalence of such impacts increased from 16.8 % for adolescents with no/slight need for orthodontic treatment , to 31.7 % for those with definite need for orthodontic treatment . Although findings support the idea that malocclusion has physical , psychological and social effects on quality of life of these adolescents , the inconsistencies in findings between the self-reports of impacts of malocclusion and the assessment of normative needs highlight the shortcomings of using only clinical indexes to estimate orthodontic treatment needs Objective To determine dental attendance and treatment outcomes following two models of dental screening . Design An observational prospect i ve cohort study . Setting Infant , primary and junior schools in the North West of Engl and .Subjects Children aged six to nine years at the start of the study . Interventions Subjects received a screening examination according to either a ' Traditional model ' or ' New model ' of school dental screeningMain outcome measures Attendance at a dentist within four months of the intervention and treatment received by children referred via the ' New model ' with caries in their permanent teeth . Results In the ' New model ' of school dental screening 46 % of screened positive and 41 % of screened negative children attended a dentist during the study period . Some 44 % of children referred with caries in permanent teeth attended a dentist and 53 % of those attending received treatment for the referred condition . Larger proportions of children from disadvantaged background s were screened positive but higher proportions of children from more affluent background s attended the dentist and subsequently received treatment . Conclusion School dental screening has a minimal impact on dental attendance and only a small proportion of screened positive children receive appropriate treatment . The programme fails to reduce inequalities in utilisation of dental services The aim of this study was to determine the effectiveness of a school dental screening in encouraging school children aged 4 to 6 years to visit a dentist . One thous and five hundred and sixty-two children attending the 13 primary schools in Wallasey . Merseyside , were examined by a single trained examiner ; those with urgent treatment needs or evidence of recent treatment were excluded . The remaining 528 children with signs of dental caries were entered into the study . Children within each school were stratified by age , sex and number of carious teeth and then allocated at r and om to test and control groups . Parents of children in the test group were advised by letter that their child would benefit from a more detailed clinical examination . A reply slip was attached to the letter and non-responders were carefully followed up . The control group received no such interventions . After 4 months , data on dental visits by both test and control group children were extracted from clinical records . Attendance data were obtained for 262 children ( 97 per cent ) in the test group and 243 children ( 94 per cent ) in the control group . Seventy-three per cent of the test group and 42 per cent of the control group visited the dentist over the review period ; the difference of 31 per cent favour of the test group was statistically significant . Attendances at both general dental practitioners and community dental clinics were increased . The effect of the screening procedure was seen particularly in areas of lower socio-economic status . ( ABSTRACT TRUNCATED AT 250 WORDS Dental screening of children in schools is undertaken in many countries . There is no evidence that this activity is effective . The objective of our study was to determine if school dental screening of children reduces untreated disease or improves attendance at the population level . A four-arm cluster-r and omized controlled trial was undertaken in the northwest of Engl and . In total , 16,864 children aged 6–9 years in 168 schools were r and omly allocated to 3 test groups , which received screening according to different models , and a control , which received no intervention . There were no significant differences in caries increment in the primary and secondary dentitions or in the proportions of children attending a dentist after screening between the control group and the 3 intervention arms . School dental screening delivered according to 3 different models was not effective at reducing levels of active caries and increasing attendance in the population under study The purpose of this study was to evaluate the effectiveness of a screening program and referral system in stimulating dental attendance of children in need of treatment at Bapuji Dental College and Hospital of Davangere , India . A total of fourteen schools in the Davangere area were selected r and omly and divided into two groups : seven schools that had a dental screening program ( study group , n=2100 children ) , and seven schools that did not have one ( control group , n=2400 children ) . The attendance rate by members of the study group was determined during the three-month period from the date of initiating the school screening program . During this same period the students who visited the college from the control group underwent a dental examination . Chi-square tests were used to test the difference between different variables . The response rate for seeking treatment was 31 percent for the study group ( 34.2 percent for males ; 26.2 percent for females ) and 10 percent for the control group ( 9.6 percent for males ; 10.5 percent for females ) . In both the groups , the treatment need was highest for dental caries ( study group=36.3 percent , control group=11.1 percent ) and least for fluorosis ( study group=21.2 percent , control group=1.2 percent ) . The study demonstrated that screening and motivation significantly improved the percentage of school children who sought dental care UNLABELLED The school dental screening programme has been in existence from the beginning of the 20th century yet its value in encouraging attendance among children with a dental health need is not fully established . OBJECTIVE To evaluate the effectiveness of school dental screening in promoting dental attendance among children with a treatment need and to examine the relative importance of screening , social class and other factors in dental attendance . METHODS Sixty-four participating schools were assigned to study and control groups using a stratified , blocked r and omisation technique . The study group children received the st and ard school dental screening and the dental attendance of those with a positive screening result was assessed after 2 months by means of a question naire issued to the children 's parents . The control group children were not , at this stage , screened , yet their parents received the same question naire assessing dental attendance over the 2-month period . However , only question naires from control group children who had a positive result at a subsequent screening were retained for analysis . RESULTS A total of 2,321 children were screened , with 980 having a positive result . The mean dmft of those screening positive was 4.85 . In all , 664 completed question naires were returned , giving a response rate of 67.8 % . Dental attendance was reported among 45.5 % of the study group ( n=352 ) in the 2 months following screening . In the same period , 27.6 % of the control group ( n=312 ) cl aim ed attendance . The effect was found to be significant among the high employed group ( P<0.01 ) and the unemployed group ( P<0.05 ) . CONCLUSION School dental screening was capable of stimulating dental attendance . The strong effect among the lowest socio-economic group shows that school dental screening may be used to decrease dental health inequalities \n Output:\n " }, { "from": "agent", "value": "There is currently no evidence to support or refute the clinical benefits or harms of dental screening .\nCLINICAL SIGNIFICANCE Evidence from the review ed trials suggests no clinical benefit from school-based screening in improving children 's oral health ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE This study examined the prevalence and psychological sequelae of childhood sexual and physical abuse in adults from the general population . METHOD A national sampling service generated a geographically stratified , r and om sample of 1,442 subjects from the United States . Subjects were mailed a question naire that included the Traumatic Events Survey ( TES ) [ Traumatic Events Survey , Unpublished Psychological Test , Harbor-UCLA Medical Center , Los Angeles ] and the Trauma Symptom Inventory ( TSI ) [ Trauma Symptom Inventory Professional Manual , Psychological Assessment Re sources , Odessa , FL ] . Of all potential subjects , 935 ( 64.8 % ) returned substantially completed surveys . RESULTS Sixty-six men and 152 women ( 14.2 % and 32.3 % , respectively ) reported childhood experiences that satisfied criteria for sexual abuse , and 103 males and 92 females ( 22.2 % and 19.5 % , respectively ) met criteria for physical abuse . Twenty-one percent of subjects with one type of abuse also had experienced the other type , and both types were associated with subsequent adult victimization . After controlling for demographics , adult history of interpersonal violence , and other child abuse , childhood sexual abuse was associated with all 10 scales of the TSI , and physical abuse was related to all TSI scales except those tapping sexual issues . Sexual abuse predicted more symptom variance than did physical abuse or adult interpersonal victimization . Various aspects of both physical and sexual abuse experiences were predictive of TSI scores . Abuser sex , however , both alone and in interaction with victim sex , was not associated with additional TSI symptomatology . CONCLUSIONS Childhood sexual and physical abuse is relatively common in the general population , and is associated with a wide variety of psychological symptoms . These relationships remain even after controlling for relevant background variables OBJECTIVE To examine the long-term effects of an intervention combining teacher training , parent education , and social competence training for children during the elementary grade s on adolescent health-risk behaviors at age 18 years . DESIGN Nonr and omized controlled trial with follow-up 6 years after intervention . SETTING Public elementary schools serving high-crime areas in Seattle , Wash. PARTICIPANTS Of the fifth- grade students enrolled in participating schools , 643 ( 76 % ) were given written parental consent for the longitudinal study and 598 ( 93 % ) were followed up and interviewed at age 18 years . INTERVENTIONS A full intervention provided in grade s 1 through 6 of 5 days of in-service training for teachers each intervention year , developmentally appropriate parenting classes offered to parents when children were in grade s 1 through 3 and 5 through 6 , and developmentally adjusted social competence training for children in grade s 1 and 6 . A late intervention , provided in grade s 5 and 6 only , paralleled the full intervention at these grade s. MAIN OUTCOME MEASURES Self-reported violent and nonviolent crime , substance use , sexual activity , pregnancy , bonding to school , school achievement , grade repetition and school dropout , suspension and /or expulsion , and school misbehavior ; delinquency charges from court records ; grade point average ; California Achievement Test scores : and disciplinary action reports from school records . RESULTS Fewer students receiving full intervention than control students reported violent delinquent acts ( 48.3 % vs 59.7 % ; P=.04 ) , heavy drinking ( 15.4 % vs 25.6 % ; P=.04 ) , sexual intercourse ( 72.1 % vs 83.0 % ; P=.02 ) , having multiple sex partners ( 49.7 % vs 61.5 % ; P=.04 ) , and pregnancy or causing pregnancy ( 17.1 % vs 26.4 % ; P=.06 ) by age 18 years . The full intervention student group reported more commitment ( P=.03 ) and attachment ( P=.006 ) to school , better academic achievement ( P=.01 ) , and less school misbehavior ( P=.02 ) than control students . Late intervention in grade s 5 and 6 only did not significantly affect health-risk behaviors in adolescence . CONCLUSIONS A package of interventions with teachers , parents , and children provided throughout the elementary grade s can have enduring effects in reducing violent behavior , heavy drinking , and sexual intercourse by age 18 years among multiethnic urban children . Results are consistent with the theoretical model guiding the intervention and support efforts to reduce health-risk behaviors through universal interventions in selected communities or schools serving high-crime neighborhoods This study examined whether childhood victimization increases risk for drug abuse using prospect i ve and retrospective victimization information . Substantiated cases of child abuse/neglect from 1967 to 1971 were matched on gender , age , race , and approximate social class with nonabused/nonneglected children and followed prospect ively into young adulthood . Between 1989 and 1995 , 1,196 participants ( 676 abused/neglected and 520 control ) were administered a 2-hr interview , including measures of self-reported childhood victimization and drug use/abuse ( the National Institute of Mental Health Diagnostic Interview Schedule -- Version III -- Revised ) . Prospect ively , abused/neglected individuals were not at increased risk for drug abuse . In contrast , retrospective self-reports of childhood victimization were associated with robust and significant increases in risk for drug abuse . The relationship between childhood victimization and subsequent drug problems is more complex than originally anticipated OBJECTIVE This study examines whether child abuse ; child neglect ; demographic , family and social , behavioral , economic , and neighborhood risk ; and protective factors predict different drug-use patterns into middle adulthood . METHOD Using a prospect i ve cohort design , individuals with documented cases of childhood physical and sexual abuse and neglect ( processed during 1967 - 1971 ) and a matched control group were followed into middle adulthood . Participants completed in-person interviews in 1989 - 1995 ( average age 29 ) , 2000 - 2002 ( average age 39.5 ) , and 2003 - 2004 ( average age 41 ) . The sample for this study included 374 women and 332 men . RESULTS Four patterns of drug use were revealed : ( a ) abstinence and low use ( 34 % ) , ( b ) adolescent and young adult limited use ( 31 % ) , ( c ) chronic-persistent use ( 29 % ) , and ( d ) late use ( 7 % ) . The chronic-persistent pattern was associated with being male , parental substance-use problems , involvement in crime , and neighborhood problems . The late-use pattern was significantly associated with childhood neglect and being Black , when other risk factors were controlled ; bivariate analyses also indicated associations with female gender , lower income , and greater neighborhood disadvantage . CONCLUSIONS This study revealed two patterns of drug use involving substance use and substance-related problems in middle adulthood that are associated with different sets of risk factors . Further research is needed to underst and the late-drug-use pattern , which appears to disproportionately involve low-income Black women with histories of childhood neglect . These individuals may be missed in efforts to prevent or reduce drug use among youths OBJECTIVE To determine whether child physical maltreatment early in life has long-term effects on psychological , behavioral , and academic problems independent of other characteristics associated with maltreatment . DESIGN Prospect i ve longitudinal study with data collected annually from 1987 through 1999 . SETTING AND PARTICIPANTS R and omly selected , community-based sample s of 585 children from the ongoing Child Development Project were recruited the summer before children entered kindergarten in 3 geographic sites . Seventy-nine percent continued to participate in grade 11 . The initial in-home interviews revealed that 69 children ( 11.8 % ) had experienced physical maltreatment prior to kindergarten matriculation . MAIN OUTCOME MEASURES Adolescent assessment of school grade s , st and ardized test scores , absences , suspensions , aggression , anxiety/depression , other psychological problems , drug use , trouble with police , pregnancy , running away , gang membership , and educational aspirations . RESULTS Adolescents maltreated early in life were absent from school more than 1.5 as many days , were less likely to anticipate attending college compared with nonmaltreated adolescents , and had levels of aggression , anxiety/depression , dissociation , posttraumatic stress disorder symptoms , social problems , thought problems , and social withdrawal that were on average more than three quarters of an SD higher than those of their nonmaltreated counterparts . The findings held after controlling for family and child characteristics correlated with maltreatment . CONCLUSIONS Early physical maltreatment predicts adolescent psychological and behavioral problems , beyond the effects of other factors associated with maltreatment . Undetected early physical maltreatment in community population s represents a major problem worthy of prevention Prospect i ve longitudinal data from 585 families were used to examine parents ’ reports of child physical abuse in the first 5 years of life as a predictor of substance use at ages 12 , 16 , and 24 . Path analyses revealed that physical abuse in the first 5 years of life predicted subsequent substance use for females but not males . We found a direct effect of early physical abuse on girls ’ substance use at age 12 and indirect effects on substance use at age 16 and age 24 through substance use at age 12 . For boys , age 12 substance use predicted age 16 substance use , and age 16 substance use predicted age 24 substance use , but physical abuse in the first 5 years of life was unrelated to subsequent substance use . These findings suggest that for females , a mechanism of influence of early physical abuse on substance use into early adulthood appears to be through precocious initiation of substance use in early adolescence AIMS The purpose of this study was to examine differences in the clinical presentation and treatment outcomes of older adults with a diagnosis of alcohol dependence compared to middle-aged adults . DESIGN The study is a prospect i ve naturalistic study . Participants included 1358 patients admitted to a residential rehabilitation program for alcohol dependence . RESULTS Older adults entering an alcohol rehabilitation program are less impaired on a number measures of psychiatric distress and addiction severity but more impaired in somatic health . While there were no significantly different outcomes in abstinence rates at 1 month , older adults engaged in formal post-discharge aftercare less than middle-aged adults . CONCLUSIONS These results confirm impressions that older adults seeking alcohol treatment may have a lower severity of alcohol dependence compared to those at younger ages . However , results suggest that traditional outpatient substance abuse care is not accepted at the same rates as middle-aged adults . The low rates of engagement suggest the need for age appropriate treatment options and are potentially of concern if treatment is necessary to maintain short-term success Background Adverse childhood experiences ( ACEs ) have been consistently linked to psychiatric difficulties in children and adults . However , the long-term effects of ACEs on mental health during the early adult years have been understudied . In addition , many studies are method ologically limited by use of non-representative sample s , and few studies have investigated gender and racial differences . The current study relates self-reported lifetime exposure to a range of ACEs in a community sample of high school seniors to three mental health outcomes –depressive symptoms , drug abuse , and antisocial behavior – two years later during the transition to adulthood . Methods The study has a two-wave , prospect i ve design . A systematic probability sample of high school seniors ( N = 1093 ) was taken from communities of diverse socioeconomic status . They were interviewed in person in 1998 and over the telephone two years later . Gender and racial differences in ACE prevalence were tested with chi-square tests . Each mental health outcome was regressed on one ACE , controlling for gender , race/ethnicity , and SES to obtain partially st and ardized regression coefficients . Results Most ACEs were strongly associated with all three outcomes . The cumulative effect of ACEs was significant and of similar magnitude for all three outcomes . Except for sex abuse/assault , significant gender differences in the effects of single ACEs on depression and drug use were not observed . However , boys who experienced ACEs were more likely to engage in antisocial behavior early in young adulthood than girls who experienced similar ACEs . Where racial/ethnic differences existed , the adverse mental health impact of ACEs on Whites was consistently greater than on Blacks and Hispanics . Conclusion Our sample of young adults from urban , socio-economically disadvantaged communities reported high rates of adverse childhood experiences . The public health impact of childhood adversity is evident in the very strong association between childhood adversity and depressive symptoms , antisocial behavior , and drug use during the early transition to adulthood . These findings , coupled with evidence that the impact of major childhood adversities persists well into adulthood , indicate the critical need for prevention and intervention strategies targeting early adverse experiences and their mental health consequences OBJECTIVE To examine : ( a ) child maltreatment 's association with young adult daily cigarette smoking , ( b ) variations in this association by gender , and ( c ) mediators of this association . METHODS For all study participants ( N = 1,125 , 94 % African American ) , data from multiple sources ( e.g. , child welfare records ) were collected prospect ively at child , adolescent , and young adult time points . Authors enlisted multivariate probit regression for objectives a and b versus exploratory and confirmatory mediation strategies for objective c. RESULTS Maltreatment was significantly associated with daily cigarette smoking . Although not moderated by gender , this relation was fully mediated by adolescent indicators of family support/stability , social adjustment , and cognitive/school performance along with \n Output:\n " }, { "from": "agent", "value": "When studies that found no gender effects were compared with studies that did identify gender effects , differences in measurement , sample composition , and developmental timing of outcomes were identified ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: New treatments are needed for B-cell malignancies persisting after allogeneic hematopoietic stem cell transplantation ( alloHSCT ) . We conducted a clinical trial of allogeneic T cells genetically modified to express a chimeric antigen receptor ( CAR ) targeting the B-cell antigen CD19 . T cells for genetic modification were obtained from each patient 's alloHSCT donor . All patients had malignancy that persisted after alloHSCT and st and ard donor lymphocyte infusions ( DLIs ) . Patients did not receive chemotherapy prior to the CAR T-cell infusions and were not lymphocyte depleted at the time of the infusions . The 10 treated patients received a single infusion of allogeneic anti-CD19-CAR T cells . Three patients had regressions of their malignancies . One patient with chronic lymphocytic leukemia ( CLL ) obtained an ongoing complete remission after treatment with allogeneic anti-CD19-CAR T cells , another CLL patient had tumor lysis syndrome as his leukemia dramatically regressed , and a patient with mantle cell lymphoma obtained an ongoing partial remission . None of the 10 patients developed graft-versus-host disease ( GVHD ) . Toxicities included transient hypotension and fever . We detected cells containing the anti-CD19-CAR gene in the blood of 8 of 10 patients . These results show for the first time that donor-derived allogeneic anti-CD19-CAR T cells can cause regression of B-cell malignancies resistant to st and ard DLIs without causing GVHD We conducted a clinical trial to assess adoptive transfer of T cells genetically modified to express an anti-CD19 chimeric Ag receptor ( CAR ) . Our clinical protocol consisted of chemotherapy followed by an infusion of anti-CD19-CAR-transduced T cells and a course of IL-2 . Six of the 8 patients treated on our protocol obtained remissions of their advanced , progressive B-cell malignancies . Four of the 8 patients treated on the protocol had long-term depletion of normal polyclonal CD19(+ ) B-lineage cells . Cells containing the anti-CD19 CAR gene were detected in the blood of all patients . Four of the 8 treated patients had prominent elevations in serum levels of the inflammatory cytokines IFNγ and TNF . The severity of acute toxicities experienced by the patients correlated with serum IFNγ and TNF levels . The infused anti-CD19-CAR-transduced T cells were a possible source of these inflammatory cytokines because we demonstrated peripheral blood T cells that produced TNF and IFNγ ex vivo in a CD19-specific manner after anti-CD19-CAR-transduced T-cell infusions . Anti-CD19-CAR-transduced T cells have great promise to improve the treatment of B-cell malignancies because of a potent ability to eradicate CD19(+ ) cells in vivo ; however , reversible cytokine-associated toxicities occurred after CAR-transduced T-cell infusions Outcomes for patients with refractory diffuse large B cell lymphoma ( DLBCL ) are poor . In the multicenter ZUMA-1 phase 1 study , we evaluated KTE-C19 , an autologous CD3ζ/CD28-based chimeric antigen receptor ( CAR ) T cell therapy , in patients with refractory DLBCL . Patients received low-dose conditioning chemotherapy with concurrent cyclophosphamide ( 500 mg/m2 ) and fludarabine ( 30 mg/m2 ) for 3 days followed by KTE-C19 at a target dose of 2 × 106 CAR T cells/kg . The incidence of dose-limiting toxicity ( DLT ) was the primary endpoint . Seven patients were treated with KTE-C19 and one patient experienced a DLT of grade 4 cytokine release syndrome ( CRS ) and neurotoxicity . Grade ≥3 CRS and neurotoxicity were observed in 14 % ( n = 1/7 ) and 57 % ( n = 4/7 ) of patients , respectively . All other KTE-C19-related grade ≥3 events resolved within 1 month . The overall response rate was 71 % ( n = 5/7 ) and complete response ( CR ) rate was 57 % ( n = 4/7 ) . Three patients have ongoing CR ( all at 12 + months ) . CAR T cells demonstrated peak expansion within 2 weeks and continued to be detectable at 12 + months in patients with ongoing CR . This regimen of KTE-C19 was safe for further study in phase 2 and induced durable remissions in patients with refractory DLBCL PURPOSE Salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation ( ASCT ) is the st and ard treatment for relapsed diffuse large B-cell lymphoma ( DLBCL ) . Salvage regimens have never been compared ; their efficacy in the rituximab era is unknown . PATIENTS AND METHODS Patients with CD20(+ ) DLBCL in first relapse or who were refractory after first-line therapy were r and omly assigned to either rituximab , ifosfamide , etoposide , and carboplatin ( R-ICE ) or rituximab , dexamethasone , high-dose cytarabine , and cisplatin ( R-DHAP ) . Responding patients received high-dose chemotherapy and ASCT . RESULTS The median age of the 396 patients enrolled ( R-ICE , n = 202 ; R-DHAP , n = 194 ) was 55 years . Similar response rates were observed after three cycles of R-ICE ( 63.5 % ; 95 % CI , 56 % to 70 % ) and R-DHAP ( 62.8 % ; 95 CI , 55 % to 69 % ) . Factors affecting response rates ( P < .001 ) were refractory disease/relapse less than versus more than 12 months after diagnosis ( 46 % v 88 % , respectively ) , International Prognostic Index ( IPI ) of more than 1 versus 0 to 1 ( 52 % v 71 % , respectively ) , and prior rituximab treatment versus no prior rituximab ( 51 % v 83 % , respectively ) . There was no significant difference between R-ICE and R-DHAP for 3-year event-free survival ( EFS ) or overall survival . Three-year EFS was affected by prior rituximab treatment versus no rituximab ( 21 % v 47 % , respectively ) , relapse less than versus more than 12 months after diagnosis ( 20 % v 45 % , respectively ) , and IPI of 2 to 3 versus 0 to 1 ( 18 % v 40 % , respectively ) . In the Cox model , these parameters were significant ( P < .001 ) . CONCLUSION In patients who experience relapse more than 12 months after diagnosis , prior rituximab treatment does not affect EFS . Patients with early relapses after rituximab-containing first-line therapy have a poor prognosis , with no difference between the effects of R-ICE and R-DHAP BACKGROUND Treatment of B cell malignancies with adoptive transfer of T cells with a CD19-specific chimeric antigen receptor ( CAR ) shows remarkable clinical efficacy . However , long-term persistence of T cells targeting CD19 , a pan-B cell marker , also depletes normal B cells and causes severe hypogammaglobulinemia . Here , we developed a strategy to target B cell malignancies more selectively by taking advantage of B cell light Ig chain restriction . We generated a CAR that is specific for the κ light chain ( κ . CAR ) and therefore recognizes κ-restricted cells and spares the normal B cells expressing the nontargeted λ light chain , thus potentially minimizing humoral immunity impairment . METHODS We conducted a phase 1 clinical trial and treated 16 patients with relapsed or refractory κ+ non-Hodgkin lymphoma/chronic lymphocytic leukemia ( NHL/CLL ) or multiple myeloma ( MM ) with autologous T cells genetically modified to express κ . CAR ( κ . CARTs ) . Other treatments were discontinued in 11 of the 16 patients at least 4 weeks prior to T cell infusion . Six patients without lymphopenia received 12.5 mg/kg cyclophosphamide 4 days before κ . CART infusion ( 0.2 × 108 to 2 × 108 κ . CARTs/m2 ) . No other lymphodepletion was used . RESULTS κ . CART expansion peaked 1 - 2 weeks after infusion , and cells remained detectable for more than 6 weeks . Of 9 patients with relapsed NHL or CLL , 2 entered complete remission after 2 and 3 infusions of κ . CARTs , and 1 had a partial response . Of 7 patients with MM , 4 had stable disease lasting 2 - 17 months . No toxicities attributable to κ . CARTs were observed . CONCLUSION κ . CART infusion is feasible and safe and can lead to complete clinical responses . TRIAL REGISTRATION Clinical Trials.gov NCT00881920 . FUNDING National Cancer Institute ( NCI ) grants 3P50CA126752 and 5P30CA125123 and Leukemia and Lymphoma Society ( LLS ) Specialized Centers of Research ( SCOR ) grant 7018 Immunotherapeutic ablation of lymphoma is a conceptually attractive treatment strategy that is the subject of intense translational research . Cytotoxic T lymphocytes ( CTLs ) that are genetically modified to express CD19- or CD20-specific , single-chain antibody-derived chimeric antigen receptors ( CARs ) display HLA-independent antigen-specific recognition/killing of lymphoma targets . Here , we describe our initial experience in applying CAR-redirected autologous CTL adoptive therapy to patients with recurrent lymphoma . Using plasmid vector electrotransfer/drug selection systems , cloned and polyclonal CAR(+ ) CTLs were generated from autologous peripheral blood mononuclear cells and exp and ed in vitro to cell numbers sufficient for clinical use . In 2 FDA -authorized trials , patients with recurrent diffuse large cell lymphoma were treated with cloned CD8(+ ) CTLs expressing a CD20-specific CAR ( along with NeoR ) after autologous hematopoietic stem cell transplantation , and patients with refractory follicular lymphoma were treated with polyclonal T cell preparations expressing a CD19-specific CAR ( along with HyTK , a fusion of hygromycin resistance and HSV-1 thymidine kinase suicide genes ) and low-dose s.c . recombinant human interleukin-2 . A total of 15 infusions were administered ( 5 at 10(8)cells/m(2 ) , 7 at 10(9)cells/m(2 ) , and 3 at 2 x 10(9)cells/m(2 ) ) to 4 patients . Overt toxicities attributable to CTL administration were not observed ; however , detection of transferred CTLs in the circulation , as measured by quantitative polymerase chain reaction , was short ( 24 hours to 7 days ) , and cellular antitransgene immune rejection responses were noted in 2 patients . These studies reveal the primary barrier to therapeutic efficacy is limited persistence , and provide the rationale to prospect ively define T cell population s intrinsically programmed for survival after adoptive transfer and to modulate the immune status of recipients to prevent/delay antitransgene rejection responses Myeloablative autologous hematopoietic stem cell transplantation ( HSCT ) is a mainstay of therapy for relapsed intermediate- grade B-cell non-Hodgkin lymphoma ( NHL ) ; however , relapse rates are high . In phase 1 studies design ed to improve long-term remission rates , we administered adoptive T-cell immunotherapy after HSCT , using ex vivo-exp and ed autologous central memory-enriched T cells ( TCM ) transduced with lentivirus expressing CD19-specific chimeric antigen receptors ( CARs ) . We present results from 2 safety/feasibility studies , NHL1 and NHL2 , investigating different T-cell population s and CAR constructs . Engineered TCM-derived CD19 CAR T cells were infused 2 days after HSCT at doses of 25 to 200 × 10(6 ) in a single infusion . In NHL1 , 8 patients safely received T-cell products engineered from enriched CD8(+ ) TCM subsets , expressing a first-generation CD19 CAR containing only the CD3ζ endodomain ( CD19R : ζ ) . Four of 8 patients ( 50 % ; 95 % confidence interval [ CI ] : 16 - 84 % ) were progression free at both 1 and 2 years . In NHL2 , 8 patients safely received T-cell products engineered from enriched CD4(+ ) and CD8(+ ) TCM subsets and expressing a second-generation CD19 CAR containing the CD28 and CD3ζ endodomains ( CD19R:28ζ ) . Six of 8 patients ( 75 % ; 95 % CI : 35 - 97 % ) were progression free at 1 year . The CD4(+)/CD8(+ ) TCM-derived CD19 CAR T \n Output:\n " }, { "from": "agent", "value": "Although the CRS and neurotoxicity incidences were high , most were reversible with minimal risk of death ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults , but it is not known which results in better clinical outcomes . METHODS In a pragmatic , cluster‐r and omized , multiple‐crossover trial conducted in five intensive care units at an academic center , we assigned 15,802 adults to receive saline ( 0.9 % sodium chloride ) or balanced crystalloids ( lactated Ringer 's solution or Plasma‐Lyte A ) according to the r and omization of the unit to which they were admitted . The primary outcome was a major adverse kidney event within 30 days — a composite of death from any cause , new renal‐replacement therapy , or persistent renal dysfunction ( defined as an elevation of the creatinine level to ≥200 % of baseline ) — all censored at hospital discharge or 30 days , whichever occurred first . RESULTS Among the 7942 patients in the balanced‐crystalloids group , 1139 ( 14.3 % ) had a major adverse kidney event , as compared with 1211 of 7860 patients ( 15.4 % ) in the saline group ( marginal odds ratio , 0.91 ; 95 % confidence interval [ CI ] , 0.84 to 0.99 ; conditional odds ratio , 0.90 ; 95 % CI , 0.82 to 0.99 ; P=0.04 ) . In‐hospital mortality at 30 days was 10.3 % in the balanced‐crystalloids group and 11.1 % in the saline group ( P=0.06 ) . The incidence of new renal‐replacement therapy was 2.5 % and 2.9 % , respectively ( P=0.08 ) , and the incidence of persistent renal dysfunction was 6.4 % and 6.6 % , respectively ( P=0.60 ) . CONCLUSIONS Among critically ill adults , the use of balanced crystalloids for intravenous fluid administration result ed in a lower rate of the composite outcome of death from any cause , new renal‐replacement therapy , or persistent renal dysfunction than the use of saline . ( Funded by the V and erbilt Institute for Clinical and Translational Research and others ; SMART‐MED and SMART‐SURG Clinical Trials.gov numbers , NCT02444988 and NCT02547779 . BACKGROUND Normal saline ( NS ) is the most commonly used crystalloid solution worldwide but contains an excess of chloride and may cause metabolic acidosis and hyperchloraemia . Such abnormalities may be attenuated by the use of a balanced solution such as Plasma-Lyte 148 ( PL-148 ) . OBJECTIVE To assess the feasibility , safety and biochemical and physiological effects of resuscitation with NS versus PL-148 in critically ill patients . DESIGN , SETTING AND PARTICIPANTS An exploratory , multicentre , doubleblind , r and omised controlled trial involving patients aged ≥ 18 years who were prescribed crystalloid fluid resuscitation by the treating clinician between 16 July and 22 October 2015 , in three multidisciplinary intensive care units in Melbourne , Victoria , Australia . METHODS R and om allocation of NS or PL-148 was concealed , and all fluids were delivered in indistinguishable bags . INTERVENTION NS or PL-148 was administered for all fluid resuscitation and for all subsequent crystalloid fluid therapy until Day 4 of ICU admission . The treating intensivist determined the rate and frequency of fluid administration . MAIN OUTCOME MEASURES Primary outcome was daily base excess ( BE ) . Relevant secondary outcomes included the incidence of acute kidney injury ( AKI ) , change in serum creatinine and serum chloride levels , and mortality . RESULTS Seventy patients were recruited , with 34 in the NS group and 33 in the PL-148 group available for analysis . Baseline characteristics of study patients were well balanced ; the mean ages were 64 and 62 years , respectively , and nearly two-thirds of the patients in each group were men . The median Acute Physiology and Chronic Health Evaluation III scores were 64 for the NS group ( interquartile range [ IQR ] , 48 - 73 ) and 55 for the PL-148 group ( IQR , 44 - 81 ) . After treatment , there was no significant difference in the worst ( most negative ) median BE between the NS and PL-148 groups ( -4 mEq/L [ IQR , -7 to -2 mEq/L ] v -3 mEq/L [ IQR , -7 to 2 mEq/L ] ; P = 0.42 ) . Chloride levels were significantly higher with NS therapy ( median , 111 mmol/L [ IQR , 108 - 116 mmol/L ] v 108 mmol/L [ IQR , 106 - 110 mmol/L ] ; P = 0.01 ) . There was no significant difference in the incidence of AKI ( P = 0.48 ) , peak creatinine levels ( P = 0.92 ) or ICU or hospital mortality between the two groups . CONCLUSIONS In our exploratory , double-blind , r and omised controlled trial , when compared with NS , PL-148 did not significantly increase BE values in critically ill patients requiring fluid resuscitation , but decreased peak chloride concentrations BACKGROUND It remains uncertain whether the choice of resuscitation fluid for patients in intensive care units ( ICUs ) affects survival . We conducted a multicenter , r and omized , double-blind trial to compare the effect of fluid resuscitation with albumin or saline on mortality in a heterogeneous population of patients in the ICU . METHODS We r and omly assigned patients who had been admitted to the ICU to receive either 4 percent albumin or normal saline for intravascular-fluid resuscitation during the next 28 days . The primary outcome measure was death from any cause during the 28-day period after r and omization . RESULTS Of the 6997 patients who underwent r and omization , 3497 were assigned to receive albumin and 3500 to receive saline ; the two groups had similar baseline characteristics . There were 726 deaths in the albumin group , as compared with 729 deaths in the saline group ( relative risk of death , 0.99 ; 95 percent confidence interval , 0.91 to 1.09 ; P=0.87 ) . The proportion of patients with new single-organ and multiple-organ failure was similar in the two groups ( P=0.85 ) . There were no significant differences between the groups in the mean ( + /-SD ) numbers of days spent in the ICU ( 6.5+/-6.6 in the albumin group and 6.2+/-6.2 in the saline group , P=0.44 ) , days spent in the hospital ( 15.3+/-9.6 and 15.6+/-9.6 , respectively ; P=0.30 ) , days of mechanical ventilation ( 4.5+/-6.1 and 4.3+/-5.7 , respectively ; P=0.74 ) , or days of renal-replacement therapy ( 0.5+/-2.3 and 0.4+/-2.0 , respectively ; P=0.41 ) . CONCLUSIONS In patients in the ICU , use of either 4 percent albumin or normal saline for fluid resuscitation results in similar outcomes at 28 days The high chloride content of 0.9 % saline leads to adverse pathophysiological effects in both animals and healthy human volunteers , changes not seen after balanced crystalloids . Small r and omized trials confirm that the hyperchloremic acidosis induced by saline also occurs in patients , but no clinical outcome benefit was demonstrable when compared with balanced crystalloids , perhaps due to a type II error . A strong signal is emerging from recent large propensity-matched and cohort studies for the adverse effects that 0.9 % saline has on the clinical outcome in surgical and critically ill patients when compared with balanced crystalloids . Major complications are the increased incidence of acute kidney injury and the need for renal replacement therapy , and that pathological hyperchloremia may increase postoperative mortality . However , there are no large-scale r and omized trials comparing 0.9 % saline with balanced crystalloids . Some balanced crystalloids are hypo-osmolar and may not be suitable for neurosurgical patients because of their propensity to cause brain edema . Saline may be the solution of choice used for the resuscitation of patients with alkalosis and hypochloremia . Nevertheless , there is evidence to suggest that balanced crystalloids cause less detriment to renal function than 0.9 % saline , with perhaps better clinical outcome . Hence , we argue that chloride-rich crystalloids such as 0.9 % saline should be replaced with balanced crystalloids as the mainstay of fluid resuscitation to prevent ‘ pre-renal ' acute kidney injury Metabolic acidosis and changes in serum osmolarity are consequences of 0.9 % normal saline ( NS ) solution administration . We sought to determine if these physiologic changes influence patient outcome . Patients undergoing aortic reconstructive surgery were enrolled and were r and omly assigned to receive lactated Ringer ’s ( LR ) solution ( n = 33 ) or NS ( n = 33 ) in a double-blinded fashion . Anesthetic and fluid management were st and ardized . Multiple measures of outcome were monitored . The NS patients developed a hyperchloremic acidosis and received more bicarbonate therapy ( 30 ± 62 mL in the NS group versus 4 ± 16 mL in the LR group ; mean ± sd ) , which was given if the base deficit was greater than −5 mEq/L. The NS patients also received a larger volume of platelet transfusion ( 478 ± 302 mL in the NS group versus 223 ± 24 mL in the LR group ; mean ± sd ) . When all blood products were summed , the NS group received significantly more blood products ( P = 0.02 ) . There were no differences in duration of mechanical ventilation , intensive care unit stay , hospital stay , and incidence of complications . When NS was used as the primary intraoperative solution , significantly more acidosis was seen on completion of surgery . This acidosis result ed in no apparent change in outcome but required larger amounts of bicarbonate to achieve predetermined measurements of base deficit and was associated with the use of larger amounts of blood products . These changes should be considered when choosing fluids for surgical procedures involving extensive blood loss and requiring extensive fluid administration 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 Saline versus Albumin Fluid Evaluation study suggested that patients with traumatic brain injury resuscitated with albumin had a higher mortality rate than those resuscitated with saline . We conducted a post hoc follow-up study of patients with traumatic brain injury who were enrolled in the study . METHODS For patients with traumatic brain injury ( i.e. , a history of trauma , evidence of head trauma on a computed tomographic [ CT ] scan , and a score of < or = 13 on the Glasgow Coma Scale [ GCS ] ) , we recorded baseline characteristics from case-report forms , clinical records , and CT scans and determined vital status and functional neurologic outcomes 24 months after r and omization . RESULTS We followed 460 patients , of whom 231 ( 50.2 % ) received albumin and 229 ( 49.8 % ) received saline . The subgroup of patients with GCS scores of 3 to 8 were classified as having severe brain injury ( 160 [ 69.3 % ] in the albumin group and 158 [ 69.0 % ] in the saline group ) . Demographic characteristics and indexes of severity of brain injury were similar at baseline . At 24 months , 71 of 214 patients in the albumin group ( 33.2 % ) had died , as compared with 42 of 206 in the saline group ( 20.4 % ) ( relative risk , 1.63 ; 95 % confidence interval [ CI ] , 1.17 to 2.26 ; P=0.003 ) . Among patients with severe brain injury , 61 of 146 patients in the albumin group ( 41.8 % ) died , as compared with 32 of 144 in the saline group ( 22.2 % ) ( relative risk , 1.88 ; 95 % CI , 1.31 to 2.70 ; P<0.001 ) ; among patients with GCS scores of 9 to 12 , death occurred in 8 of 50 patients in the albumin group ( 16.0 % ) and 8 of 37 in the saline group ( 21.6 % ) ( relative risk , 0.74 ; 95 % CI , 0.31 to 1.79 ; P=0.50 ) . CONCLUSIONS In this post hoc study of critically ill patients with traumatic brain injury , fluid resuscitation with albumin was associated with higher mortality rates than was resuscitation with saline . ( Current Controlled Trials number , IS RCT N76588266 [ controlled-trials.com ] . ) OBJECTIVE To determine if Ringer 's lactate is superior to 0.9 % sodium chloride solution for resolution of acidosis in the management of diab \n Output:\n " }, { "from": "agent", "value": "Conclusions Limited evidence supported statistical survival benefit with balanced crystalloid solutions , while it benefited in reducing organ support duration and fluctuations in serum electrolyte and base excess and was associated with decreased in-hospital mortality in sub population with sepsis and non-TBI ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : Due to high rates of undiagnosed and untreated HIV infection in Africa , we compared HIV counseling and testing ( VCT ) uptake among household members of patients receiving antiretroviral therapy . Methods : HIV-infected persons attending an AIDS clinic were r and omized to a home-based or clinic-based antiretroviral therapy program including VCT for household members . Clinic arm participants were given free VCT vouchers and encouraged to invite their household members to the clinic for VCT . Home arm participants were visited , and their household members offered VCT using a 3-test rapid finger-stick testing algorithm . VCT uptake and HIV prevalence were compared . Findings : Of 7184 household members , 3974 ( 55.3 % ) were female and 4798 ( 66.8 % ) were in the home arm . Home arm household members were more likely to receive VCT than those from the clinic arm ( 55.8 % vs. 10.9 % , odds ratio : 10.41 , 95 % confidence interval : 7.89 to 13.73 ; P < 0.001 ) , although the proportion of HIV-infected household members was higher in the clinic arm ( 17.3 % vs. 7.1 % , odds ratio : 2.76 , 95 % confidence interval : 1.97 to 3.86 , P < 0.001 ) . HIV prevalence among all household members tested in the home arm was 56 % compared with 27 % in the clinic arm . Of 148 spouses of HIV-infected patients , 69 ( 46.6 % ) were uninfected . Persons aged 15 - 24 were less likely to test than other age groups , and in the home arm , women were more likely to test than men . Conclusions : Home-based VCT for household members of HIV-infected persons was feasible , associated with lower prevalence , higher uptake , and increased identification of HIV-infected persons than clinic-based provision OBJECTIVE Patient satisfaction with HIV screening is crucial for sustainable implementation of the Centers for Disease Control and Prevention ( CDC ) HIV testing recommendations . This investigation assesses patient satisfaction with rapid HIV testing in the emergency department ( ED ) of an urban tertiary academic medical center . METHODS After receiving HIV test results , participants in the Universal Screening for HIV Infection in the Emergency Room ( USHER ) r and omized controlled trial were offered a patient satisfaction survey . Questions concerned overall satisfaction with ED visit , time spent on primary medical problem , time spent on HIV testing , and test provider 's ability to answer HIV-related questions . Responses were reported on a 4-point Likert scale , ranging from very dissatisfied to very satisfied ( defined as optimal satisfaction ) . RESULTS Of 4,860 USHER participants , 2,025 completed testing and were offered the survey : 1,616 ( 79.8 % ) completed the survey . Overall , 1,478 ( 91.5 % ) were very satisfied . Satisfaction was less than optimal for 34.5 % ( 10 of 29 ) of participants with reactive results and for 7.5 % ( 115 of 1,542 ) with nonreactive results . The independent factors associated with less than optimal satisfaction were reactive test result , aged 60 years or older , black race , Hispanic/Latino ethnicity , and testing by ED provider instead of HIV counselor . CONCLUSION Most participants were very satisfied with the ED-based rapid HIV testing program . Identification of independent factors that correlate with patient satisfaction will help guide best practice s as EDs implement CDC recommendations . It is critical to better underst and whether patients with reactive results were negatively affected by their results or truly had concerns about the testing process Background Routine HIV screening in emergency department ( ED ) setting s may require dedicated personnel . We evaluated the outcomes , costs and cost-effectiveness of HIV screening when offered by either a member of the ED staff or by an HIV counselor . Methods We employed a mathematical model to extend data obtained from a r and omized clinical trial of provider- vs. counselor-based HIV screening in the ED . We compared the downstream survival , costs , and cost-effectiveness of three HIV screening modalities : 1 ) no screening program ; 2 ) an ED provider-based program ; and 3 ) an HIV counselor-based program . Trial arm-specific data were used for test offer and acceptance rates ( provider offer 36 % , acceptance 75 % ; counselor offer 80 % , acceptance 71 % ) . Undiagnosed HIV prevalence ( 0.4 % ) and linkage to care rates ( 80 % ) were assumed to be equal between the screening modalities . Personnel costs were derived from trial-based re source utilization data . We examined the generalizability of results by conducting sensitivity analyses on offer and acceptance rates , undetected HIV prevalence , and costs . Results Estimated HIV screening costs in the provider and counselor arms averaged $ 8.10 and $ 31.00 per result received . The Provider strategy ( compared to no screening ) had an incremental cost-effectiveness ratio of $ 58,700/ quality -adjusted life year ( QALY ) and the Counselor strategy ( compared to the Provider strategy ) had an incremental cost-effectiveness ratio of $ 64,500/QALY . Results were sensitive to the relative offer and acceptance rates by strategy and the capacity of providers to target-screen , but were robust to changes in undiagnosed HIV prevalence and programmatic costs . Conclusions The cost-effectiveness of provider-based HIV screening in an emergency department setting compares favorably to other US screening programs . Despite its additional cost , counselor-based screening delivers just as much return on investment as provider based-screening . Investment in dedicated HIV screening personnel is justified in situations where ED staff re sources may be insufficient to provide comprehensive , sustainable screening services Introduction Lack of universal , annual testing for human immunodeficiency virus ( HIV ) in health facilities suggests that expansion of HIV testing and counselling ( HTC ) to non- clinical setting s is critical to the achievement of national goals for prevention , care and treatment . Consideration should be given to the ability of lay counsellors to perform home-based HTC in community setting s. Methods We implemented a community cluster r and omized controlled trial of home-based HTC in Sisonke District , South Africa . Trained lay counsellors conducted door-to-door HIV testing using the same rapid tests used by the local health department at the time of the study ( SD Bioline and Sensa ) . To monitor testing quality and counsellor skill , additional dry blood spots were taken and sent for laboratory-based enzyme-linked immunosorbent assay ( ELISA ) testing . Sensitivity and specificity were calculated using the laboratory result as the gold st and ard . Results and discussion From 3986 sample s , the counsellor and laboratory results matched in all but 23 cases . In 18 cases , the counsellor judged the result as indeterminate , whereas the laboratory judged 10 positive , eight negative and three indeterminate , indicating that the counsellor may have erred on the side of caution . Sensitivity was 98.0 % ( 95 % CI : 96.3–98.9 % ) , and specificity 99.6 % ( 95 % CI : 99.4–99.7 % ) , for the lay counsellor field-based rapid tests . Both measures are high , and the lower confidence bound for specificity meets the international st and ard for assessing HIV rapid tests . Conclusions These findings indicate that adequately trained lay counsellors are capable of safely conducting high- quality rapid HIV tests and interpreting the results as per the kit guidelines . These findings are important given the likely expansion of community and home-based testing models and the shortage of clinical ly trained professional staff Home-based voluntary HIV counselling and testing ( HB-VCT ) has been reported to have a high uptake , but it has not been rigorously evaluated . We design ed a model for HB-VCT appropriate for wider scale-up , and investigated the acceptance of home-based counselling and testing , equity in uptake and negative life events with a cluster-r and omized trial . Thirty six rural clusters in southern Zambia were pair-matched based on baseline data and r and omly assigned to the intervention or the control arm . Both arms had access to st and ard HIV testing services . Adults in the intervention clusters were offered HB-VCT by local lay counsellors . Effects were first analysed among those participating in the baseline and post-intervention surveys and then as intention-to-treat analysis . The study was registered with www.controlled-trials.com , number IS RCT N53353725 . A total of 836 and 858 adults were assigned to the intervention and control clusters , respectively . In the intervention arm , counselling was accepted by 85 % and 66 % were tested ( n = 686 ) . Among counselled respondents who were cohabiting with the partner , 62 % were counselled together with the partner . At follow-up eight months later , the proportion of adults reporting to have been tested the year prior to follow-up was 82 % in the intervention arm and 52 % in the control arm ( Relative Risk ( RR ) 1.6 , 95 % CI 1.4 - 1.8 ) , whereas the RR was 1.7 ( 1.4 - 2.0 ) according to the intention-to-treat analysis . At baseline the likelihood of being tested was higher for women vs. men and for more educated people . At follow-up these differences were found only in the control communities . Measured negative life events following HIV testing were similar in both groups . In conclusion , this HB-VCT model was found to be feasible , with a very high acceptance and to have important equity effects . The high couple counselling acceptance suggests that the home-based approach has a particularly high HIV prevention potential HIV-related stigma continues to be a prominent barrier to testing , treatment and care . However , few studies have investigated changes in stigma over time and the factors contributing to these changes , and there is no evidence of the impact of HIV testing and counselling on stigma . This study was nested within a pair-matched cluster-r and omized trial on the acceptance of home-based voluntary HIV counselling and testing conducted in a rural district in Zambia between 2009 and 2011 , and investigated changes in stigma over time and the impact of HIV testing and counselling on stigma . Data from a baseline survey ( n = 1500 ) and a follow-up survey ( n = 1107 ) were used to evaluate changes in stigma . There was an overall reduction of seven per cent in stigma from baseline to follow-up . This was mainly due to a reduction in individual stigmatizing attitudes but not in perceived stigma . The reduction did not differ between the trial arms ( β = -0.22 , p = 0.423 ) . Being tested for HIV was associated with a reduction in stigma ( β = -0.57 , p = 0.030 ) , and there was a trend towards home-based Voluntary Counselling and Testing having a larger impact on stigma than other testing approaches ( β = -0.78 , p = 0.080 vs. β = -0.37 , p = 0.551 ) , possibly explained by a strong focus on counselling and the safe environment of the home . The reduction observed in both arms may give reason to be optimistic as it may have consequences for disclosure , treatment access and adherence . Yet , the change in stigma may have been affected by social desirability bias , as extensive community mobilization was carried out in both arms . The study underscores the challenges in measuring and monitoring HIV-related stigma . Adjustment for social desirability bias and inclusion of qualitative methods are recommended for further studies on the impact of HIV testing on stigma HIV testing and counselling is a critical gateway to prevention and treatment . Yet , coverage remains insufficient , few couples are tested together and gender differences in access exist . We used an embedded mixed methods approach to investigate possible explanations for the high acceptance of home-based voluntary HIV counselling and testing ( HB-VCT ) in a pair-matched cluster-r and omized trial in Zambia . A baseline survey included 1694 individuals in 36 clusters . Adults in 18 intervention clusters were offered HB-VCT by lay counsellors . St and ard testing services were available in both trial arms . After the completion of the intervention , a follow-up survey was conducted in all trial clusters . In addition , 21 in-depth interviews and one focus group discussion were conducted with home-based VCT clients in the intervention arm . Informants favoured the convenience , confidentiality and credibility of HB-VCT . Counsellors were perceived as trustworthy owing to their closeness and conduct , and the consent process was experienced as convincing . Couple testing was selected by 70 % of cohabiting couples and was experienced as beneficial by both genders . Levels of first-time testing ( 68 % vs. 29 % , p < 0.0001 ) and re-testing ( 94 % vs. 74 % , p < 0.0001 ) were higher in the intervention than in the control arm . Acceptance of HIV testing and counselling is dependent on stigma , trust and gender . The confidentiality of home-based VCT was essential for overcoming stigma-related barriers , and the selection of local counsellors was important to ensure trust in the services . The high level of couple counselling within HB-VCT may contribute to closing the gender gap in HIV testing , and has benefits for both genders and potentially for prevention of HIV transmission . The study demonstrates the feasibility of achieving high test coverage with an opt-in consent approach . The embedded qualitative component confirmed the high satisfaction with HB-VCT reported in the quantitative survey and was crucial to fully under \n Output:\n " }, { "from": "agent", "value": "Values and preferences studies generally found support for lay providers conducting HTS , particularly in non-hypothetical scenarios .\nUptake of this recommendation could exp and HIV testing to more people globally" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The prophylactic administration of injectable tilmicosin for pneumonia in weaned beef calves was investigated in 1,806 animals . Comparisons were made among calves receiving an \" on-arrival \" injection of tilmicosin , calves receiving a single injection of long-acting oxytetracycline , and calves receiving no prophylaxis . Morbidity and mortality attributable to pneumonia , morbidity and mortality attributable to all causes , and case fatality were significantly lower in the group of calves that received tilmicosin , compared with calves that received long-acting oxytetracycline and calves that received no prophylactic antibiotic . Mean time to initial pneumonia treatment was significantly extended in calves that received prophylaxis , compared with those that received no antibiotic on arrival at the feedlot . Calves that received tilmicosin gained significantly more weight than calves that received oxytetracycline . Calves that were not treated for pneumonia during the trial period gained significantly more weight than did those calves that were treated for pneumonia regardless of experimental group . The majority of mortalities were attributable to fibrinous pneumonia ( 31/34 ) . Important bacterial isolates ( Pasteurella spp , Haemophilus somnus , Actinomyces pyogenes ) obtained at necropsy did not have resistance to tilmicosin in association with administration of tilmicosin as prophylaxis for pneumonia . However , bacterial resistance to trimethoprim/sulfonamide and to oxytetracycline were commonly found in these postmortem isolates The objectives of this study were to determine ( i ) whether an association exists between individual pharmacokinetic parameters and treatment outcome when feeder cattle were diagnosed with bovine respiratory disease ( BRD ) and treated with gamithromycin ( Zactran ( ® ) ) at the label dose and ( ii ) whether there was a stronger association between treatment outcome and gamithromycin concentration in plasma or in the pulmonary epithelial lining fluid ( PELF ) effect compartment . The study design was a prospect i ve , blinded , r and omized clinical trial utilizing three groups of 60 ( 362 - 592 lb ) steers/bulls r and omly allocated within origin to sham injection or gamithromycin mass medication . Cattle were evaluated daily for signs of BRD by a veterinarian blinded to treatment . Animals meeting the BRD case definition were enrolled and allocated to a sample collection scheme consisting of sample s for bacterial isolation ( bronchoalveolar lavage fluid and nasopharyngeal swabs ) and gamithromycin concentration determination ( PELF and plasma ) . Gamithromycin susceptibility of M. haemolytica ( n = 287 ) and P. multocida ( n = 257 ) were determined using broth microdilution with frozen panels containing gamithromycin at concentrations from 0.03 to 16 μg/mL. A two-compartment plasma pharmacokinetic model with an additional compartment for gamithromycin in PELF was developed using rich data sets from published and unpublished studies . The sparse data from our study were then fit to this model using nonlinear mixed effects modeling to estimate individual parameter values . The result ing parameter estimates were used to simulate full time-concentration profiles for each animal in this study . These profiles were analyzed using noncompartmental methods so that PK/PD indices ( AUC24 /MIC , AUC∞ /MIC , CMAX /MIC ) could be calculated for plasma and PELF ( also T > MIC ) for each individual . The calculated PK/PD indices were indicative that for both M. haemolytica and P. multocida a higher drug exposure in terms of concentration , and duration of exposure relative to the MIC of the target pathogen , was favorable to a successful case outcome . A significant association was found between treatment success and PELF AUC0 - 24 /MIC for P. multocida . The calves in this study demonstrated an increased clearance and volume of distribution in plasma as compared to the healthy calves in two previously published reports . Ultimately , the findings from this study indicate that higher PK/PD indices were predictive of positive treatment outcomes Three studies were conducted to determine and confirm the effective dosage rate of ceftiofur crystalline-free acid sterile suspension ( CCFA-SS , 200 mg ceftiofur equivalents [CE]/ml ) , a long-acting ceftiofur formulation , for control and treatment of bovine respiratory disease ( BRD ) . In each study , CCFA-SS was administered once by subcutaneous ( SC ) injection in the middle third of the posterior aspect of the ear . Study 1 was conducted using an intratracheal challenge with Mannheimia ( formerly Pasteurella ) haemolytica and dosages ranging from 0 to 8.8 mg CE/kg to select a dosage for further field testing . In Study 2 , a single dose of CCFA-SS at 0.0 , 4.4 , or 6.6 mg CE/kg was administered when uniform clinical signs of BRD were present in feedlot cattle . Study 3 was conducted in several feedlots to evaluate the efficacy , practicality , and safety of CCFA-SS at 4.4 or 6.6 mg CE/kg compared with a placebo control or tilmicosin for preemptive control of BRD . In Study 1 , the effective dose was determined to be 5.35 mg CE/kg ; therefore , 4.4 and 6.6 mg CE/kg were selected as the dosages for further field testing . Administration of CCFA-SS at 4.4 or 6.6 mg CE/kg improved treatment success compared with negative controls ( P < or = .05 for both doses ) in Study 2 . In Study 3 , a single administration of 4.4 or 6.6 mg CE/kg was comparable to tilmicosin ( P < .001 ) and was significantly better than placebo ( P < .001 ) for the control of BRD . Using the ear as an administration site was acceptable under field conditions and was well tolerated by all animals . These studies demonstrated that a single administration of CCFA-SS by SC injection in the middle third of the posterior aspect of the ear at 4.4 or 6.6 mg CE/kg is effective , safe , and practical for preemptive control and treatment of the bacterial component of BRD in feedlot cattle . Administration in an inedible tissue results in a short withdrawal time and no injection-site trimming at slaughter Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed Three studies conducted at feedlots in Colorado , Idaho , and Texas examined the comparative efficacy of tulathromycin injectable solution for the treatment of cattle at high risk of developing undifferentiated bovine respiratory disease ( BRD ) . Each study r and omly allocated 250 calves to receive tulathromycin at 2.5 mg/kg and 250 calves to receive either tilmicosin at 10 mg/kg ( Colorado site ) or florfenicol at 40 mg/kg ( Idaho and Texas sites ) on arrival at the feedlot . Calves were housed by treatment group in pens with 50 calves/pen . Beginning 3 days after antimicrobial treatment , cattle were observed for signs of BRD daily until harvest . In all three studies , the treatment success rates at 28 days after treatment and at harvest were significantly higher ( P < or = .013 ) for cattle treated with tulathromycin than for cattle treated with either tilmicosin or florfenicol . Fewer tulathromycin-treated cattle were removed from the group as \" chronics \" or \" mortalities \" at 28 days posttreatment ( P < or = .014 ) in all three studies . Tulathromycin demonstrated superior efficacy compared with tilmicosin and florfenicol when treating groups of high-risk cattle before the onset of signs of BRD OBJECTIVES To evaluate effects of tilmicosin when used in fever-based and metaphylactic treatment programs to attenuate acute undifferentiated bovine respiratory disease ( BRD ) in cattle that recently arrived at feedlots , and to evaluate the effects of tilmicosin for the treatment of BRD . DESIGN R and omized-block controlled study . ANIMALS 1,639 calves from livestock auctions . PROCEDURES Cattle were assigned to 3 groups . Cattle in the nonmedicated ( control ) group were not given antibiotics during processing . Cattle in the fever-based treatment group were given tilmicosin ( 10 mg/kg [ 4.5 mg/lb ] of body weight , s.c . ) during processing when their rectal temperature was > or = 40 C ( 104 F ) . All cattle in the metaphylactic treatment group were given tilmicosin ( 10 mg/kg , s.c . ) during processing . Calves with BRD were treated with tilmicosin ( 10 mg/kg , s.c . ) . RESULTS Morbidity rates in the metaphylactic ( 30.4 % ) and fever-based ( 44.7 % ) treatment groups were less than that for the nonmedicated group ( 54.8 % ) . Mortality rate for the metaphylactic group during the first 28 days ( 1.1 % ) and during the entire study ( 1.7 % ) was less than that for the nonmedicated group ( 3.3 and 4.6 % , respectively ) . Differences were not observed in therapeutic response rates among calves with BRD that were treated . CLINICAL IMPLICATION S Fever-based and metaphylactic treatment programs that used tilmicosin decreased the prevalence of BRD and improved growth of calves . Metaphylactic treatment decreased the number of fatalities caused by BRD in high-risk calves . Fever-based treatment was less effective than metaphylactic treatment for decreasing the prevalence of BRD in newly arrived cattle Feedlot calves ( n = 3784 ) were systematic ally r and omized and allocated in a 2 × 2 factorial study to receive metaphylactic oxytetracycline ( OTC ) on arrival or no antimicrobial , as well as florfenicol once subcutaneously or twice intramuscularly ( 48 h apart ) if diagnosed with bovine respiratory disease ( BRD ) . Calves of different treatment groups were comingled and followed from placement to re-implantation ( ~100 days ) . Animals receiving OTC had a reduced risk of BRD , an increased risk of arthritis , and no significant differences in average daily gain , BRD relapse , overall mortality , or BRD mortality . There were no significant differences between treatment protocol s. Deep nasal swabs ( n = 233 ) taken at arrival ( n = 122 ) , treatment ( n = 77 ) , and swabs from lungs and joints at postmortem ( n = 34 ) were cultured for Mycoplasma bovis from 61 animals ill or dying of chronic pneumonia and arthritis and from 61 healthy calves . There was significant variation in diversity among isolates ( n = 51 ) between study years and different cattle . Metaphylaxis or antimicrobial treatment did not affect the diversity of isolates . Except for tilmicosin , isolates were largely susceptible to tested antimicrobials R and omized controlled trials ( RCTs ) are the gold st and ard for evaluating efficacy of treatments under real world conditions and , as such , it is important that they are conducted with method ological rigour to prevent biased results . Many medical journals have adopted a st and ard checklist for reporting of RCTs , the CONSORT statement . The objective of this study was to evaluate clinical trials in livestock population s to assess method ological quality and completeness of reporting and to investigate the association between these criteria and treatment effects . A total of 100 clinical trials published between 2006 and 2008 in the English language were r and omly selected . For each trial , 2 review ers independently completed a checklist based on the CONSORT statement and a different 2 review ers completed a st and ard template describing the outcomes used and the statistical significance of all reported treatment effects . Disagreements among review ers were resolved by consensus . The results showed that there were substantive deficiencies in the reporting of many of trial features , both related to method ological quality and completeness of reporting . Details on key features such as r and omization , double blinding , and the number of subjects lost to follow-up were reported in only 67 , 4 , and 62 % of trials , respectively . Reporting of r and om allocation to treatment group was associated with a lower proportion of positive treatments effects within trials , as was reporting of inclusion /exclusion criteria for study subjects , details on the intervention , animal signalment , significance tests of baseline differences for at least one variable , and the methods used to measure all outcomes . The results suggest that there are deficiencies in the current reporting of important features of RCTs conducted in livestock species and that these deficiencies may be associated with biased treatment effects . The creation and adoption of \n Output:\n " }, { "from": "agent", "value": "The results suggest that macrolides are the most effective antibiotics for the reduction of BRD incidence .\nInjectable oxytetracycline effectively controlled BRD compared with no antibiotics ; however , it was less effective than macrolide treatment .\nBecause oxytetracycline is already commonly used to prevent , control , and treat BRD in groups of feedlot cattle , the use of injectable oxytetracycline for BRD control might have advantages from an antibiotic stewardship perspective" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: 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 PURPOSE For patients with small-cell lung cancer ( SCLC ) , further chemotherapy is routinely considered at relapse after first-line therapy . However , proof of clinical benefit has not been documented . PATIENTS AND METHODS This study r and omly assigned patients with relapsed SCLC not considered as c and i date s for st and ard intravenous therapy to best supportive care ( BSC ) alone ( n = 70 ) or oral topotecan ( 2.3 mg/m2/d , days 1 through 5 , every 21 days ) plus BSC ( topotecan ; n = 71 ) . RESULTS In the intent-to-treat population , survival ( primary end point ) was prolonged in the topotecan group ( log-rank P = .0104 ) . Median survival with BSC was 13.9 weeks ( 95 % CI , 11.1 to 18.6 ) and with topotecan , 25.9 weeks ( 95 % CI , 18.3 to 31.6 ) . Statistical significance for survival was maintained in a subgroup of patients with a short treatment-free interval ( < or = 60 days ) . Response to topotecan was 7 % partial and 44 % stable disease . Patients on topotecan had slower quality of life deterioration and greater symptom control . Principal toxicities with topotecan were hematological : grade 4 neutropenia , 33 % ; grade 4 thrombocytopenia , 7 % ; and grade 3/4 anemia , 25 % . Comparing topotecan with BSC , infection grade 2 was 14 % versus 12 % and sepsis 4 % versus 1 % ; other grade 3/4 events included vomiting 3 % versus 0 , diarrhea 6 % versus 0 , dyspnea 3 % versus 9 % , and pain 3 % versus 6 % . Toxic deaths occurred in four patients ( 6 % ) in the topotecan arm . All cause mortality within 30 days of r and om assignment was 13 % on BSC and 7 % on topotecan . CONCLUSION Chemotherapy with oral topotecan is associated with prolongation of survival and quality of life benefit in patients with relapsed SCLC PURPOSE This phase II study evaluated the safety and efficacy of single-agent amrubicin versus topotecan in patients with small-cell lung cancer ( SCLC ) sensitive to first-line platinum-based chemotherapy . PATIENTS AND METHODS Patients were r and omly assigned 2:1 to amrubicin ( 40 mg/m(2)/d in a 5-minute intravenous [ IV ] infusion , days 1 through 3 , every 21 days ) or topotecan ( 1.5 mg/m(2)/d in a 30-minute IV infusion , days 1 through 5 , every 21 days ) . The primary efficacy end point was overall response rate ( ORR ) for amrubicin . Secondary end points included time to progression , median progression-free survival ( PFS ) , and median overall survival ( OS ) . RESULTS Of 76 patients enrolled , 50 patients were r and omly assigned to amrubicin , and 26 patients were r and omly assigned to topotecan . Amrubicin treatment result ed in a significantly higher ORR than topotecan ( 44 % v 15 % ; P = .021 ) . Median PFS and median OS were 4.5 months and 9.2 months with amrubicin and 3.3 months and 7.6 months with topotecan , respectively . Tolerability was similar with both agents . However , grade 3 or worse neutropenia and thrombocytopenia seemed to be more frequent in the topotecan group as compared with the amrubicin group ( 78 % and 61 % v 61 % and 39 % , respectively ) . CONCLUSION Amrubicin shows promising activity , with an ORR of 44 % compared with an ORR of 15 % for topotecan as second-line treatment in patients with SCLC sensitive to first-line platinum-based chemotherapy . In addition , the safety profiles were comparable ; however , a trend was noted for more frequent grade 3 or worse neutropenia and thrombocytopenia in the topotecan group as compared with the amrubicin group . Additional studies are ongoing OBJECTIVES We conducted an open-label , multicenter , single-arm study to confirm the efficacy and safety of amrubicin ( AMR ) , a topoisomerase II inhibitor , for treating refractory small-cell lung cancer ( SCLC ) . PATIENTS AND METHODS Patients with chemotherapy-refractory SCLC received 40 mg/m(2 ) AMR for 3 consecutive days , every 21 days . The primary endpoint was the overall response rate ( ORR ) and the secondary endpoints were progression-free survival ( PFS ) , overall survival ( OS ) , and safety . RESULTS Between November 2009 and February 2011 , 82 patients were enrolled . Each patient received a median of four treatment cycles ( range , 1 - 22 cycles ) . ORR was 32.9 % [ P<0.0001 by the exact binomial test for the null hypothesis that ORR ≤ 10 % ; 95 % confidence interval ( CI ) , 22.9 - 44.2 % ] . The median PFS and OS periods were 3.5 months ( 95 % CI , 3.0 - 4.3 months ) and 8.9 months ( 95 % CI , 7.6 - 11.3 months ) , respectively . Significant differences in ORR ( 21.4 % v 45.0 % ; P=0.034 ) , PFS ( median , 2.9 v 5.1 months ; P=0.0009 ) , and OS ( median , 7.9 v 13.1 months ; P=0.0128 ) were observed between patients previously treated with etoposide and others . Neutropenia was the most common grade 3 or 4 adverse events ( 93.9 % ) , and febrile neutropenia developed in 26.8 % patients . No treatment-related death occurred . CONCLUSIONS AMR monotherapy can be considered an effective and safe treatment option for refractory SCLC . Previous chemotherapy with etoposide may influence AMR efficacy PURPOSE Amrubicin , a third-generation anthracycline and potent topoisomerase II inhibitor , showed promising activity in small-cell lung cancer ( SCLC ) in phase II trials . This phase III trial compared the safety and efficacy of amrubicin versus topotecan as second-line treatment for SCLC . PATIENTS AND METHODS A total of 637 patients with refractory or sensitive SCLC were r and omly assigned at a ratio of 2:1 to 21-day cycles of amrubicin 40 mg/m(2 ) intravenously ( IV ) on days 1 to 3 or topotecan 1.5 mg/m(2 ) IV on days 1 to 5 . Primary end point was overall survival ( OS ) ; secondary end points included overall response rate ( ORR ) , progression-free survival ( PFS ) , and safety . RESULTS Median OS was 7.5 months with amrubicin versus 7.8 months with topotecan ( hazard ratio [ HR ] , 0.880 ; P = .170 ) ; in refractory patients , median OS was 6.2 and 5.7 months , respectively ( HR , 0.77 ; P = .047 ) . Median PFS was 4.1 months with amrubicin and 3.5 months with topotecan ( HR , 0.802 ; P = .018 ) . ORR was 31.1 % with amrubicin and 16.9 % with topotecan ( odds ratio , 2.223 ; P < .001 ) . Grade ≥ 3 treatment-emergent adverse events in the amrubicin and topotecan arms were : neutropenia ( 41 % v 54 % ; P = .004 ) , thrombocytopenia ( 21 % v 54 % ; P < .001 ) , anemia ( 16 % v 31 % ; P < .001 ) , infections ( 16 % v 10 % ; P = .043 ) , febrile neutropenia ( 10 % v 3 % ; P = .003 ) , and cardiac disorders ( 5 % v 5 % ; P = .759 ) ; transfusion rates were 32 % and 53 % ( P < .001 ) , respectively . NQO1 polymorphisms did not influence safety outcomes . CONCLUSION Amrubicin did not improve survival when compared with topotecan in the second-line treatment of patients with SCLC . OS did not differ significantly between treatment groups , although an improvement in OS was noted in patients with refractory disease treated with amrubicin PURPOSE Amrubicin and re-challenge of platinum doublet are both effective treatments for sensitive-relapsed small-cell lung cancer ( SCLC ) . However , no comparative study of these treatments has been reported . This r and omized study was conducted to select the most suitable regimen for future evaluation . PATIENTS AND METHODS SCLC patients who had relapsed more than 90 days after their first-line platinum-doublet regimen were r and omized to receive amrubicin ( 40mg/m(2 ) , days 1 - 3 ) or re-challenge with platinum doublet . Primary endpoint was objective response rate ( ORR ) , with secondary endpoints of progression-free survival ( PFS ) , overall survival and toxicity profiles . We assumed that an ORR of 50 % indicates potential usefulness , while that of 30 % would constitute the lower limit of interest ( alpha 0.1 ; beta 0.1 ) . Initial estimated accrual was 28 patients to each arm . RESULTS From February 2008 to June 2013 , 60 patients were enrolled and 57 patients ( 27 amrubicin and 30 re-challenge ) were found to be evaluable for efficacy and safety . The ORR and PFS were 67 % ( 90 % confidence interval , 52 - 82 ) and 5.4 months in the amrubicin group , and 43 % ( 90 % confidence interval , 28 - 58 ) and 5.1 months in the re-challenge group , respectively . Although grade 3 febrile neutropenia was observed in 19 % of patients in the amrubicin group , these episodes were transient and manageable . Non-hematological toxicities were generally moderate and no treatment-related death was observed in either group . CONCLUSION Only amrubicin met the primary endpoint . Moreover , amrubicin demonstrated superior efficacy over re-challenge of platinum with acceptable levels of toxicity . Further evaluation of amrubicin \n Output:\n " }, { "from": "agent", "value": "Amrubicin seemed much more beneficial for Japanese patients .\nHowever , compared to the efficacy of topotecan presented in a previous meta- analysis , amrubicin may be a better treatment option than topotecan for both Japanese and Euro-American .\nAdverse effects by amrubicin were almost exclusively observed to be hematological ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: STUDY OBJECTIVE We sought to develop and vali date st and ardized clinical criteria to identify patients presenting to the emergency department whose care may be safely deferred to a later date in a nonemergency setting . METHODS Using a modified Delphi process , a 17-member multidisciplinary physician panel developed explicit , st and ardized , deferred-care criteria . In a prospect i ve cohort design , emergency nurses at a tertiary care Veterans Administration ( VA ) Medical Center , using the criteria , screened 1,187 consecutive ambulatory adult patients presenting with abdominal pain , musculoskeletal symptoms , or respiratory infection symptoms . Patients meeting deferred-care criteria were offered the option of an appointment within 1 week in the ambulatory care clinic at the study site ; all other patients were offered same-day care . As outcome measures , we assessed nonelective hospitalizations for related conditions occurring within 7 days of evaluation at our facility or any other VA facility within a 300-mile radius , and we assessed 30-day all-cause mortality . RESULTS Two hundred twenty-six ( 19 % ) patients met screening criteria for deferred care . Patients meeting deferred-care criteria experienced zero ( 95 % confidence interval , 0 % to 1.2 % ) related nonelective VA hospitalizations within 7 days of evaluation , and none died within 30 days . By contrast , 68 ( 7 % ) of 961 ( 95 % confidence interval , 5.5 % to 8.9 % ) patients who did not meet deferred-care criteria were hospitalized nonelectively for related conditions , and 5 ( 0.5 % ) died . CONCLUSION By using hospitalization and 30-day mortality as safety gauges , st and ardized clinical criteria can identify , at presentation , VA ED users who may be safely cared for at a later date in a nonemergency setting . These guidelines apply to a significant proportion of VA ED users with common ambulatory conditions . These criteria deserve testing in other ED setting Objective To evaluate effectiveness , safety and cost-effectiveness of Computerised Clinical Decision Support ( CCDS ) for paramedics attending older people who fall . Design Cluster trial r and omised by paramedic ; modelling . Setting 13 ambulance stations in two UK emergency ambulance services . Participants 42 of 409 eligible paramedics , who attended 779 older patients for a reported fall . Interventions Intervention paramedics received CCDS on Tablet computers to guide patient care . Control paramedics provided care as usual . One service had already installed electronic data capture . Main Outcome Measures Effectiveness : patients referred to falls service , patient reported quality of life and satisfaction , processes of care . Safety Further emergency contacts or death within one month . Cost-Effectiveness Costs and quality of life . We used findings from published Community Falls Prevention Trial to model cost-effectiveness . Results 17 intervention paramedics used CCDS for 54 ( 12.4 % ) of 436 participants . They referred 42 ( 9.6 % ) to falls services , compared with 17 ( 5.0 % ) of 343 participants seen by 19 control paramedics [ Odds ratio ( OR ) 2.04 , 95 % CI 1.12 to 3.72 ] . No adverse events were related to the intervention . Non-significant differences between groups included : subsequent emergency contacts ( 34.6 % versus 29.1 % ; OR 1.27 , 95 % CI 0.93 to 1.72 ) ; quality of life ( mean SF12 differences : MCS −0.74 , 95 % CI −2.83 to + 1.28 ; PCS −0.13 , 95 % CI −1.65 to + 1.39 ) and non-conveyance ( 42.0 % versus 36.7 % ; OR 1.13 , 95 % CI 0.84 to 1.52 ) . However ambulance job cycle time was 8.9 minutes longer for intervention patients ( 95 % CI 2.3 to 15.3 ) . Average net cost of implementing CCDS was £ 208 per patient with existing electronic data capture , and £ 308 without . Modelling estimated cost per quality -adjusted life-year at £ 15,000 with existing electronic data capture ; and £ 22,200 without . Conclusions Intervention paramedics referred twice as many participants to falls services with no difference in safety . CCDS is potentially cost-effective , especially with existing electronic data capture . Trial Registration IS RCT N Register IS RCT Objective : To investigate the potential impact for ambulance services of telephone assessment and triage for callers who present with non-serious problems ( Category C calls ) as classified by ambulance service call takers . Design : Pragmatic controlled trial . Calls identified using priority dispatch protocol s as non-serious were allocated to intervention and control groups according to time of call . Ambulance dispatch occurred according to existing procedures . During intervention sessions , nurses or paramedics within the control room used a computerised decision support system to provide telephone assessment , triage and , if appropriate , offer advice to permit estimation of the potential impact on ambulance dispatch . Setting : Ambulance services in London and the West Midl and s. Subjects : Patients for whom emergency calls were made to the ambulance services between April 1998 and May 1999 during four hour sessions sample d across all days of the week between 0700 and 2300 . Main outcome measures : Triage decision , ambulance cancellation , attendance at an emergency department . Results : In total , there were 635 intervention calls and 611 controls . Of those in the intervention group , 330 ( 52.0 % ) were triaged as not requiring an emergency ambulance , and 119 ( 36.6 % ) of these did not attend an emergency department . This compares with 55 ( 18.1 % ) of those triaged by a nurse or paramedic as requiring an ambulance ( odds ratio 2.62 ; 95 % CI 1.78 to 3.85 ) . Patients triaged as not requiring an emergency ambulance were less likely to be admitted to an inpatient bed ( odds ratio 0.55 ; 95 % CI 0.33 to 0.93 ) , but even so 30 ( 9.2 % ) were admitted . Nurses were more likely than paramedics to triage calls into the groups classified as not requiring an ambulance . After controlling for age , case mix , time of day , day of week , season , and ambulance service , the results of a logistic regression analysis revealed that this difference was significant with an odds ratio for nurses : paramedics of 1.28 ( 95 % CI 1.12 to 1.47 ) . Conclusions : The findings indicate that telephone assessment of Category C calls identifies patients who are less likely to require emergency department care and that this could have a significant impact on emergency ambulance dispatch rates . Nurses were more likely than paramedics to assess calls as requiring an alternative response to emergency ambulance despatch , but the extent to which this relates to aspects of training and professional perspective is unclear . However , consideration should be given to the acceptability , reliability , and cost consequences of this intervention before it can be recommended for full evaluation STUDY OBJECTIVE Our objective is to determine whether a point-of-care intervention that navigates willing , low-acuity patients from the emergency department ( ED ) to a Primary Care Clinic will increase future primary care follow-up . METHODS We conducted a quasi-experimental trial at an urban safety net hospital . Adults presenting to the ED for select low-acuity problems were eligible . Patients were excluded if arriving by emergency medical services , if febrile , or if the triage nurse believed they required ED care . We enrolled 965 patients . Navigators escorted a subset of willing participants to the Primary Care Clinic ( in the same hospital complex ) , where they were assigned a personal physician , were given an overview of clinic services , and received same-day clinic care . The primary outcome was Primary Care Clinic follow-up within 1 year of the index ED visit among patients having no previous primary care provider . RESULTS In the bivariate intention-to-treat analysis , 50.3 % of intervention group patients versus 36.9 % of control group patients with no previous primary care provider had at least 1 Primary Care Clinic follow-up visit in the year after the intervention . In the multivariable analysis , the absolute difference in having at least 1 Primary Care Clinic follow-up for the intervention group compared with the control group was 9.3 % ( 95 % confidence interval 2.2 % to 16.3 % ) . There was no significant difference in the number of future ED visits . CONCLUSION A point-of-care intervention offering low-acuity ED patients the opportunity to alternatively be treated at the hospital 's Primary Care Clinic result ed in increased future primary care follow-up compared with st and ard ED referral practice 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 Aims Overcrowding at pediatric emergency departments ( EDs ) may result in delayed clinical management and higher risks of medical error . This study was design ed to prospect ively evaluate what parents of sick children seek emergency care for and how these patients are being assessed and managed . Methods Patients aged 0 to 17 years seeking ED care at an urban Swedish university hospital , from 8 AM to 9 PM on 25 consecutive days , were included . Clinical urgency and further level of medical care were determined by experienced nurses based on individual clinical signs and vital parameters . Information on presenting problem , medical priority , gender , age , waiting time , day of week , time of day , and further management was recorded . Results Among 1057 included children , two thirds were assessed by physicians , whereas one third were referred directly by nurses for other ED ( n = 54 ) or primary care ( n = 114 ) , or sent home with medical advice ( n = 176 ) , more often during evenings and weekends . Of primarily referred patients , 7.6 % returned within 72 hours , and three of them were admitted . Young infants , patients with respiratory or neurological problems , and sicker patients with fever or infections were mainly assessed by physicians , within desired priority time . Discussion More than one fourth of pediatric ED patients might rapidly , appropriately , and safely be referred for primary care or sent home by experienced pediatric nurses soon after arrival , thereby facilitating management of urgent and more appropriate patients . Evaluations by physicians were primarily required in young infants and for urgent medical conditions dem and ing qualified pediatric skills 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 Objective . To examine the effects of transferring nonurgent 911 calls to a telephone consulting nurse . It was hypothesized that the telephone referral program would result in fewer basic life \n Output:\n " }, { "from": "agent", "value": "Conclusion There was no conclusive evidence regarding the impact of diversion strategies on ED utilisation and subsequent healthcare utilisation ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Aims and Background Amitriptyline is the most common analgesic adjuvant used in cancer patients with neuropathic pain , even though no specific studies have demonstrated a benefit . A r and omized placebo-controlled , double-blind crossover study was design ed to evidence the effects of amitriptyline in patients with neuropathic cancer pain . Methods Sixteen advanced cancer patients with neuropathic pain on systemic morphine therapy , no longer receiving oncologic treatment , presenting moderate pain ( about 4 or more , but less than 7 , on a numerical scale of 0 - 10 ) in the last week , and given a stable morphine dose in the last 2 days were admitted to the study . During the first week of study , patients were administered 25 mg of amitriptyline or equivalent drops of placebo at night for 3 days and 50 mg for the following 4 days . Doses for patients aged more than 65 years were 15 mg ( first 3 days ) and 30 mg ( 3 days after ) . After a week , a crossover took place for the second week , with the other treatment at an inverse sequence . Opioid consumption , pain intensity , symptoms and adverse effects , mood , sleep , patient 's preference , quality of life before starting the study , the first week after and the second week after were recorded . Results No significant benefits in analgesia were found in the global pain intensity of the previous week of treatment , the least pain intensity or the pain evaluated just after a week of treatment , at the moment of the visit , when amitriptyline was compared with placebo . A significant difference was evidence d for the worst pain ( P < 0.035 ) . No differences in opioid doses during the period of study were found . Drowsiness , confusion and dry mouth were significantly more intense with amitriptyline than with placebo ( P < 0.036 , 0.003 , and 0.034 , respectively ) . There were no substantial differences between the two treatments in Spitzer 's quality of life score and for each item . No differences in patients ' preference for the two treatment periods were found . The analgesic effects of amitriptyline were slight and associated with adverse effects . Conclusions In light of the results obtained in the study , the extensive use of the drug for cancer pain should be question ed Abstract Objective To evaluate the effect of the oral synthetic δ-9-tetrahydrocannabinol dronabinol on central neuropathic pain in patients with multiple sclerosis . Design R and omised double blind placebo controlled crossovertrial . Setting Outpatient clinic , University Hospital of Aarhus , Denmark . Participants 24 patients aged between 23 and 55 years with multiple sclerosis and central pain . Intervention Orally administered dronabinol at a maximum doseof 10 mg daily or corresponding placebo for three weeks ( 15 - 21days ) , separated by a three week washout period . Main outcome measure Median spontaneous pain intensity ( numericalrating scale ) in the last week of treatment . Results Median spontaneous pain intensity was significantlylower during dronabinol treatment than during placebo treatment(4.0 ( 25th to 75th centiles 2.3 to 6.0 ) v 5.0 ( 4.0 to 6.4),P = 0.02 ) , and median pain relief score ( numerical rating scale)was higher ( 3.0 ( 0 to 6.7 ) v > 0 ( 0 to 2.3 ) , P = 0.035 ) . Thenumber needed to treat for 50 % pain relief was 3.5 ( 95 % confidenceinterval 1.9 to 24.8 ) . On the SF-36 quality of life scale , thetwo items bodily pain and mental health indicated benefits fromactive treatment compared with placebo . The number of patients with adverse events was higher during active treatment , especiallyin the first week of treatment . The functional ability of themultiple sclerosis patients did not change . Conclusions Dronabinol has a modest but clinical ly relevantanalgesic effect on central pain in patients with multiple sclerosis . Adverse events , including dizziness , were more frequent withdronabinol than with placebo during the first week of treatment Substance P is one of the neurotransmitters released by primary nociceptive neurons in the dorsal horn of the spinal cord and it binds postsynaptically to NK1‐receptors . This receptor is therefore an obvious target for analgesic drugs . The aim of this multicenter , r and omised , double‐blind , placebo‐controlled and parallel‐group study was to test if the non‐peptide NK1‐receptor antagonist TKA731 would relieve painful diabetic polyneuropathy . Eighty‐seven patients completed a treatment period of 2 weeks ' duration with TKA731 ( 150 mg daily ) or placebo preceded by one week for baseline observations . There was no significant difference between TKA731 and placebo in change in pain rating from baseline to study end neither for rating of total pain ( mean −13.4 mm vs. −11.6 mm , p = 0.664 ) nor for change in ratings of different pain symptoms ( touch‐ or pressure‐evoked pain , pain paroxysms , steady burning or deep aching pain ) ( p = 0.169‐0.834 ) Objective Oral amitriptyline , a tricyclic antidepressant , is effective for treating neuropathic pain . We conducted a double-blind , r and omized , placebo-controlled crossover study to evaluate the efficacy of topical 5 % amitriptyline and 5 % lidocaine in treating patients with neuropathic pain . Methods Thirty-five patients with postsurgical neuropathic pain , postherpetic neuralgia , or diabetic neuropathy with allodynia or hyperalgesia were assigned to receive 3 topical creams ( 5 % amitriptyline , 5 % lidocaine , or placebo ) in r and om sequence . The primary outcome measure was change in pain intensity ( baseline vs. posttreatment average pain ) using a 0 to 100 mm Visual Analog Scale . Secondary outcome measures included the McGill Pain Question naire , requirement for rescue medication , and patient satisfaction . Primary statistical comparisons were made with paired t tests or signed-rank tests . Results A reduction in pain intensity was observed with topical lidocaine ( P<0.05 ) . No significant change in pain intensity was found with topical amitriptyline or placebo . In pairwise comparison of treatments , topical lidocaine and placebo each reduced pain more than topical amitriptyline ( P<0.05 ) . Discussion This r and omized , placebo-controlled crossover study examining topical 5 % amitriptyline and 5 % lidocaine in the treatment of neuropathic pain showed that topical lidocaine reduced pain intensity but the clinical improvement is minimal and that topical 5 % amitriptyline was not effective Idiopathic , painful , small fiber predominant peripheral neuropathy is resistant to symptomatic treatment . Previous treatments have not been directed toward repairing the underlying deficit . Growth factors hold promise as agents to encourage axonal regrowth . In vitro , insulin-like growth factor-I ( IGF-I ) has been shown to prevent neuronal apoptosis , to increase axonal growth , and to support myelination . Using a double-blind , placebo-controlled design , 40 patients were r and omized to treatment with recombinant human IGF-I ( 0.05 mg/kg twice daily by subcutaneous injection ) or placebo for 6 months . There were no significant adverse events and minor adverse events occurred equally in both groups . The primary outcome measure was change in score on an analog pain scale . Secondary endpoints included quantitative sensory testing , quantitative autonomic testing , neuropathy impairment score , nerve conduction studies , and neuropathy symptom and change score . There was no significant difference in the primary endpoint between the two groups . Analysis of secondary endpoints and a global impression of improvement by patients and physicians did not show consistent differences between the groups . IGF-I was safe , but did not improve symptoms in this 6-month trial & NA ; Levodopa has been used to treat some painful conditions and found to be effective in neuropathic pain due to herpes zoster in a double‐blind study . From our anecdotal observations about the efficacy of levodopa on diabetic neuropathic pain , we design ed a double‐blind placebo‐controlled study to test levodopa in painful diabetic neuropathy . Twenty‐five out‐ patients with painful symmetrical diabetic polyneuropathy were admitted to the study . Fourteen patients were given 100 mg levodopa plus 25 mg benserazide to be taken three times per day for 28 days . Eleven patients were given identical placebo capsules . A blinded neurologist evaluated the patients clinical ly and performed Visual Analogue Scale ( VAS ) measurement every week from day 0 to day 28 . The results seemed promising and levodopa may be a choice for the control of pain in neuropathy for which we do not have many alternative treatments OBJECTIVE To assess the efficacy of Sativex , a cannabis-based medicinal extract , as adjuvant treatment in painful diabetic peripheral neuropathy ( DPN ) . RESEARCH DESIGN AND METHODS In this r and omized controlled trial , 30 subjects with painful DPN received daily Sativex or placebo . The primary outcome measure was change in mean daily pain scores , and secondary outcome measures included quality -of-life assessment s. RESULTS There was significant improvement in pain scores in both groups , but mean change between groups was not significant . There were no significant differences in secondary outcome measures . Patients with depression had significantly greater baseline pain scores that improved regardless of intervention . CONCLUSIONS This first-ever trial assessing the efficacy of cannabis has shown it to be no more efficacious than placebo in painful DPN . Depression was a major confounder and may have important implication s for future trials on painful DPN Distal sensory polyneuropathy ( DSP ) is the most frequent neurological complication of HIV infection . Neuropathic symptoms vary from mild paresthesias to severe pain that respond only partially to symptomatic treatment . Forty-five subjects with human immunodeficiency virus (HIV)-associated symptomatic DSP ( SDSP ) were enrolled in a r and omized , multicenter , 16-week placebo-controlled study of memantine , an N-methyl-d-aspartate ( NMDA ) uncompetitive antagonist . Although memantine was well tolerated , no trend toward clinical benefit was observed . Results were similar to those of other pilot studies of memantine for neuropathic pain unrelated to HIV , suggesting that memantine is ineffective for the symptomatic treatment of HIV-associated SDSP Abstract We sought to develop an enrichment crossover study design that would allow us to efficiently evaluate and compare promising c and i date neuropathic pain drugs . We evaluated the efficacy of gabapentin or tramadol vs. active placebo ( diphenhydramine ) in subjects with biopsy‐proven painful idiopathic small fiber neuropathy ( SFN ) who were self‐reported gabapentin responders . Eligible subjects entered two single blind run‐in phases . In the first phase ( Period A ) , subjects were treated with single blinded gabapentin at their pre study dose followed by a second run‐in phase ( Period B ) in which they were treated with diphenhydramine active placebo . Subjects with ⩾3 pain and a ⩾30 % increase in pain intensity in Period B compared to Period A were then r and omized to a double‐blind three period cross over trial of gabapentin at pre study dosage , tramadol 50 mg QID and diphenhydramine 50 mg qhs . Of the 59 subjects enrolled , 41 subjects were excluded : Twenty‐three had an insufficient rise in pain intensity in Period B ; eight had skin biopsies that did not confirm SFN . Eighteen subjects were r and omized into the double‐blind , crossover phase . There was a significant treatment effect of gabapentin vs. diphenhydramine ( p = 0.001 ) and tramadol vs. diphenhydramine ( p = 0.018 ) by the before‐bed daily pain score averaged over the final 7 days of each treatment period . We conclude that gabapentin and tramadol were effective in the treatment of painful SFN and that this experimental enrichment paradigm is attractive to screen potential neuropathic pain compounds for efficacy in proof‐of‐concept studies Objective : To evaluate the efficacy and tolerability of lamotrigine ( LTG ) for the treatment of pain in HIV-associated sensory neuropathies . Methods : In a r and omized , double-blind study , patients with HIV-associated distal sensory polyneuropathy ( DSP ) received LTG or placebo during a 7-week dose escalation phase followed by a 4-week maintenance phase . R and omization was stratified according to whether or not patients were currently using neurotoxic antiretroviral therapy ( ART ) . Results : The number of patients r and omized was 92 ( 62 LTG , 30 placebo ) in the stratum receiving neurotoxic ART and 135 ( 88 LTG , 47 placebo ) in the stratum not receiving neurotoxic ART . Mean change from baseline in Gracely Pain Scale score for average pain was not different between LTG and placebo at the end of the maintenance phase in either stratum , but the slope of the change in Gracely Pain Scale score for average pain reflected greater improvement with LTG than with placebo in the stratum receiving neurotoxic ART ( p = 0.004 ) , as did the mean change from baseline scores on the Visual Analogue Scale for Pain Intensity and the McGill Pain Assessment Scale and patient and clinician ratings of global impression of change in pain ( p ≤ 0.02 ) . The incidence of adverse events , including r \n Output:\n " }, { "from": "agent", "value": "After controlling for potential confounders ( e.g. , subject characteristics , study design characteristics ) , the placebo response was found to be large and varied with the pain syndrome .\nThe type of treatment in the active arm also influenced the placebo response .\nCONCLUSIONS Placebo response is influenced by the pain syndrome evaluated ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND We studied the effect on tumour response to neoadjuvant therapy of the substitution of lapatinib for trastuzumab in combination with weekly paclitaxel after doxorubicin plus cyclophosphamide treatment , and of the addition of lapatinib and trastuzumab combined after doxorubicin plus cyclophosphamide treatment in patients with HER2-positive operable breast cancer to determine whether there would be a benefit of dual HER2 blockade in these patients . METHODS For this open-label , r and omised phase 3 trial we recruited women aged 18 years or older with an ECOG performance status of 0 or 1 with operable HER2-positive breast cancer . Each received four cycles of st and ard doxorubicin 60 mg/m(2 ) and cyclophosphamide 600 mg/m(2 ) intravenously on day 1 every 3 weeks followed by four cycles of weekly paclitaxel ( 80 mg/m(2 ) ) intravenously on days 1 , 8 , and 15 , every 4 weeks . Concurrently with weekly paclitaxel , patients received either trastuzumab ( 4 mg/kg load , then 2 mg/kg intravenously ) weekly until surgery , lapatinib ( 1250 mg orally ) daily until surgery , or weekly trastuzumab plus lapatinib ( 750 mg orally ) daily until surgery . After surgery , all patients received trastuzumab to complete 52 weeks of HER2-targeted therapy . R and omisation ( ratio 1:1:1 ) was done central ly with stratification by clinical tumour size , clinical nodal status , hormone-receptor status , and age . The primary endpoint was the pathological complete response in the breast , and analysis was performed on an intention-to-treat population . FINDINGS Patient accrual started on July 16 , 2007 , and was completed on June 30 , 2011 ; 529 women were enrolled in the trial . 519 patients had their pathological response determined . Breast pathological complete response was noted in 93 ( 52·5 % , 95 % CI 44·9 - 59·5 ) of 177 patients in the trastuzumab group , 91 ( 53·2 % , 45·4 - 60·3 ) of 171 patients in the lapatinib group ( p=0·9852 ) ; and 106 ( 62·0 % , 54·3 - 68·8 ) of 171 patients in the combination group ( p=0·095 ) . The most common grade 3 and 4 toxic effects were neutropenia ( 29 [ 16 % ] patients in the trastuzumab group [ grade 4 in five patients ( 3 % ) , 28 [ 16 % ] in the lapatinib group [ grade 4 in eight patients ( 5 % ) ] , and 29 [ 17 % ] in the combination group [ grade 4 in nine patients ( 5 % ) ] ) and grade 3 diarrhoea ( four [ 2 % ] patients in the trastuzumab group , 35 [ 20 % ] in the lapatinib group , and 46 [ 27 % ] in the combination group ; p<0·0001 ) . Symptomatic congestive heart failure defined as New York Heart Association Class III or IV events occurred in seven ( 4 % ) patients in the trastuzumab group , seven ( 4 % ) in the lapatinib group , and one ( < 1 % ) in the combination group ; p=0·185 ) . INTERPRETATION Substitution of lapatinib for trastuzumab in combination with chemotherapy result ed in similar high percentages of pathological complete response . Combined HER2-targeted therapy produced a numerically but insignificantly higher pathological complete response percentage than single-agent HER2-directed therapy ; these findings are consistent with results from other studies . Trials are being undertaken to further assess these findings in the adjuvant setting BACKGROUND In metastatic breast cancer , nab-paclitaxel has been shown to significantly increase progression-free survival compared with solvent-based paclitaxel . The GeparSepto ( GBG 69 ) trial assessed whether weekly nab-paclitaxel could increase the proportion of patients achieving pathological complete response compared with weekly solvent-based paclitaxel , both followed by epirubicin plus cyclophosphamide as neoadjuvant treatment . METHOD In a phase 3 r and omised trial , we enrolled patients with previously untreated unilateral or bilateral primary invasive breast cancer and r and omly assigned them in a 1:1 ratio using dynamic allocation and Pocock minimisation by breast cancer subtype , Ki67 and SPARC expression . Patients were treated for 12 weeks with either intravenous nab-paclitaxel 150 mg/m(2 ) ( after study amendment , 125 mg/m(2 ) ) on days 1 , 8 , and 15 for four 3-week cycles , or solvent-based intravenous paclitaxel 80 mg/m(2 ) on days 1 , 8 , and 15 for four 3-week cycles . Taxane treatment was followed in both groups by intravenous epirubicin 90 mg/m(2 ) plus intravenous cyclophosphamide 600 mg/m(2 ) on day 1 for four 3-week cycles . Patients with HER2-positive tumours received concurrent trastuzumab 6 mg/kg ( loading dose 8 mg/kg ) and pertuzumab 420 mg ( loading dose 840 mg ) on day 1 of every 3-week cycle . Trastuzumab and pertuzumab were given every 3 weeks concomitantly with chemotherapy for all cycles . This report is the final analysis of the primary endpoint , pathological complete response ( ypT0 ypN0 ) , analysed for all patients who started treatment ( modified intention to treat ) . We used a closed test procedure to test for non-inferiority , with the nab-paclitaxel group calculated as non-inferior to the solvent-based paclitaxel group if the lower 95 % CI for the OR was above 0·858 ( OR equivalent to pathological complete response [ 33 % ] minus a 10 % non-inferiority margin [ 3·3 % ] ; 29·7 % ) . We planned to test for superiority only in case of a positive non-inferiority test , using an α of 0·05 . Safety was assessed in all patients who received study drug . The trial is registered with Clinical Trials.gov , number NCT01583426 . FINDINGS Between July 30 , 2012 , and Dec 23 , 2013 , we r and omly assigned 1229 women , of whom 1206 started treatment ( 606 with nab-paclitaxel and 600 with solvent-based paclitaxel ) . The nab-paclitaxel dose was reduced after enrolment of 464 participants to 125 mg/m(2 ) due to increased treatment discontinuation and sensory neuropathy in this group . Pathological complete response occurred more frequently in the nab-paclitaxel group ( 233 [ 38 % , 95 % CI 35 - 42 ] patients ) than in the solvent-based paclitaxel group ( 174 [ 29 % , 25 - 33 ] patients ; OR 1·53 , 95 % CI 1·20 - 1·95 ; unadjusted p=0·00065 ) . The incidence of grade 3 - 4 anaemia ( 13 [ 2 % ] of 605 patients in the nab-paclitaxel group vs four [ 1 % ] of patients in the solvent-based paclitaxel group ; p=0·048 ) and peripheral sensory neuropathy grade 3 - 4 ( 63 [ 10 % ] patients receiving any nab-paclitaxel dose ; 31 [ 8 % ] of patients starting with 125 mg/m(2 ) and 32 [ 15 % ] of patients starting with 150 mg/m(2 ) ; vs 16 [ 3 % ] in the solvent-based paclitaxel group , p<0·001 ) was significantly higher for nab-paclitaxel than for solvent-based paclitaxel . Overall , 283 ( 23 % ) patients were noted to have at least one serious adverse event ( based on study drug received ) , 156 ( 26 % ) in the nab-paclitaxel group and 127 ( 21 % ) in the solvent-based paclitaxel group ( p=0·057 ) . There were three deaths ( during epirubicin plus cyclophosphamide treatment ) in the nab-paclitaxel group ( due to sepsis , diarrhoea , and accident unrelated to the trial ) versus one in the solvent-based paclitaxel group ( during paclitaxel treatment ; cardiac failure ) . INTERPRETATION Substituting solvent-based paclitaxel with nab-paclitaxel significantly increases the proportion of patients achieving a pathological complete response rate after anthracycline-based chemotherapy . These results might lead to an exchange of the preferred taxane , solvent-based paclitaxel , for nab-paclitaxel in therapy for primary breast cancer . FUNDING Celgene , Roche BACKGROUND Pertuzumab ( P ) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer . We assessed the tolerability , with particular focus on cardiac safety , of H and P with chemotherapy in the neoadjuvant treatment of HER2-positive early breast cancer . PATIENTS AND METHODS In this multicenter , open-label phase II study , patients with operable , locally advanced , or inflammatory breast cancer were r and omized 1 : 1 : 1 to receive six neoadjuvant cycles q3w ( Arm A : 5-fluorouracil , epirubicin , cyclophosphamide [ FEC ] + H + P ×3 → docetaxel [ T ] + H + P ×3 ; Arm B : FEC ×3 → T + H + P ×3 ; Arm C : T + carboplatin + H [TCH]+P ×6 ) . pCR was assessed at surgery and adjuvant therapy given to complete 1 year of H. RESULTS Two hundred twenty-five patients were r and omized . During neoadjuvant treatment , two patients ( 2.7 % ; Arm B ) experienced symptomatic left ventricular systolic dysfunction ( LVSD ) and 11 patients ( Arm A : 4 [ 5.6 % ] ; Arm B : 4 [ 5.3 % ] ; Arm C : 3 [ 3.9 % ] ) had declines in left ventricular ejection fraction of ≥10 % points from baseline to < 50 % . Diarrhea was the most common adverse event . pCR ( ypT0/is ) was reported for 61.6 % ( Arm A ) , 57.3 % ( Arm B ) , and 66.2 % ( Arm C ) of patients . CONCLUSION The combination of P with H and st and ard chemotherapy result ed in low rates of symptomatic LVSD BACKGROUND If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node , axillary lymph node dissection is the present st and ard . Although axillary lymph node dissection provides excellent regional control , it is associated with harmful side-effects . We aim ed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects . METHODS Patients with T1 - 2 primary breast cancer and no palpable lymphadenopathy were enrolled in the r and omised , multicentre , open-label , phase 3 non-inferiority EORTC 10981 - 22023 AMAROS trial . Patients were r and omly assigned ( 1:1 ) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node , stratified by institution . The primary endpoint was non-inferiority of 5-year axillary recurrence , considered to be not more than 4 % for the axillary radiotherapy group compared with an expected 2 % in the axillary lymph node dissection group . Analyses were by intention to treat and per protocol . The AMAROS trial is registered with Clinical Trials.gov , number NCT00014612 . FINDINGS Between Feb 19 , 2001 , and April 29 , 2010 , 4823 patients were enrolled at 34 centres from nine European countries , of whom 4806 were eligible for r and omisation . 2402 patients were r and omly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy . Of the 1425 patients with a positive sentinel node , 744 had been r and omly assigned to axillary lymph node dissection and 681 to axillary radiotherapy ; these patients constituted the intention-to-treat population . Median follow-up was 6·1 years ( IQR 4·1 - 8·0 ) for the patients with positive sentinel lymph nodes . In the axillary lymph node dissection group , 220 ( 33 % ) of 672 patients who underwent axillary lymph node dissection had additional positive nodes . Axillary recurrence occurred in four of 744 patients in the axillary \n Output:\n " }, { "from": "agent", "value": "Breast surgery performed after NAT does not reflect tumour response , result ing in potentially unnecessary radical surgery , especially mastectomy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Pain control after thoracotomy prevents postsurgical complications and improves respiratory function . The gold st and ard for post-thoracotomy analgesia is the epidural catheter . The aim of this study was to compare it with a new technique that involves placement of a catheter in the paravertebral space at the end of surgery under a surgeon 's direct vision . METHODS From November 2011 to June 2012 , 52 patients were r and omized into 2 groups depending on catheter placement : an epidural catheter for group A and a paravertebral catheter for group B. At 12 , 24 , 48 , and 72 hours after surgery , the following parameters were recorded : ( 1 ) pain control using the patient 's completion of a visual analog scale module , ( 2 ) respiratory function using forced expiratory volume in 1 second and ambient air saturation , and ( 3 ) blood cortisol values as an index of systemic reaction to pain . RESULTS Statistically significant differences ( P < .05 ) were found in favor of group B for both cough and rest pain control ( P = .002 and .002 , respectively ) and respiratory function in terms of forced expiratory volume in 1 second and ambient air saturation levels ( P = .023 and .001 , respectively ) . No statistically significant differences were found in blood cortisol trends between the 2 groups ( P > .05 ) . Collateral effects such as vomiting , nausea , low pressure , or urinary retention were observed only in group A. No collateral effects were recorded in the paravertebral group . CONCLUSIONS According to our data , drugs administered through a paravertebral catheter are very effective . Moreover , it does not present contraindications to its positioning or collateral effects . More studies are necessary to confirm data we collected AIM Epidural analgesia is considered to be the best method of pain relief after major surgery despite its side-effects , which include hypotension , respiratory depression , urinary retention , incomplete or failed block , and , in rare cases , paraplegia . Paravertebral block is an alternative technique that may offer a comparable analgesic effect and a better side-effect profile . This study measured postoperative pain and respiratory function in patients r and omized to receive either paravertebral block or epidural analgesia for pain control after thoracic surgery . METHODS Twenty-four adult patients undergoing thoracic surgery were enrolled in a prospect i ve and r and omized clinical study . Patients were r and omly allocated to receive either postoperative continuous paravertebral analgesia ( N=12 ) or epidural analgesia ( N=12 ) starting at pleura closure . Postoperative use of morphine , visual analogue scores , and spirometer data were collected for 72 hours after surgery as markers of pain relief . RESULTS There was a statistically significant ( P=0.003 ) increase in median ( 25th-75th percentiles ) patient-controlled use of morphine , with values of 36 ( 22 - 42 ) mg in the paravertebral group vs. 9 ( 2 - 22 ) mg in the epidural group . This increase in morphine usage in the paravertebral group was statistically significant at 6 , 24 , 48 , and 72 hours after surgery . Postoperative pain measured with the visual analogue score was not significantly different in the two groups . Spirometer values at 72 h were better in the epidural group than in the paravertebral group ( P=0.03 ) . CONCLUSIONS Epidural analgesia is more efficient than paravertebral continuous block at reducing pain after thoracic surgery DESIGN A prospect i ve , r and omized , open study . The regional technique used was not blinded . SETTING A university teaching hospital . PARTICIPANTS Forty-eight patients undergoing video-assisted thoracoscopic surgery ( VATS ) for tumor resection . INTERVENTIONS Patients received either continuous extrapleural block or continuous epidural block using ropivacaine for a period of 60 hours after surgery . MEASUREMENTS AND MAIN RESULTS To evaluate postoperative pain control , the primary and secondary endpoints were the visual analog scale ( VAS ) on movement and the amount of rescue analgesia , respectively . There were no significant differences between the extrapleural and epidural block groups with regard to VAS at rest and during movement assessed at 4 , 12 , 24 , 36 , and 48 hours after surgery , dosage of intravenous morphine ( extrapleural : 12.9 ± 11.3 , epidural : 10.2 ± 6.9 mg ) , supplemental nonsteroidal anti-inflammatory drugs , incidence of postoperative nausea and vomiting ( extrapleural : 12/20 , epidural : 11/20 ) , postoperative ambulation ( extrapleural : 18 at postoperative day [ POD ] 1 and 20 at POD 2 , epidural : 19 at POD 1 and 20 at POD 2 ) and hospital stay after surgery ( extrapleural : 12.7 ± 6.3 , epidural : 12.6 ± 4.7 days ) . CONCLUSIONS Although this study did not show the superiority of continuous extrapleural block relative to continuous epidural in VATS patients , the results suggest that both methods provided effective analgesia with a relatively small dose of rescue morphine . Although the analgesic effects of these techniques were comparable , extrapleural block has the advantage of safety and precise placement of the catheter and can be considered an alternative to epidural block in VATS patients Background : Relevant discharge information about the use of analgesic medication and other strategies may help patients to manage their pain more effectively and prevent postoperative persistent pain . Aims : To examine patients ’ pain characteristics , analgesic intake and the impact of an educational pain management booklet intervention on postoperative pain control after cardiac surgery . Concerns about pain and pain medication prior to surgery will also be described . Methods : From March 2012 to September 2013 , 416 participants ( 23 % women ) were consecutively enrolled in a r and omized controlled trial . The intervention group received usual care plus an educational booklet at discharge with supportive telephone follow-up on postoperative day 10 , and the control group received only usual care . The primary outcome was worst pain intensity ( The Brief Pain Inventory – Short Form ) . Data about pain characteristics and analgesic use were collected at 2 weeks and at 1 , 3 , 6 and 12 months post-surgery . General linear mixed models were used to determine between-group differences over time . Results : Twenty-nine percent of participants reported surgically related pain at rest and 9 % reported moderate to severe pain at 12 months post-surgery . Many participants had concerns about pain and pain medication , and analgesic intake was insufficient post-discharge . No statistically significant differences between the groups were observed in terms of the outcome measures following surgery . Conclusion : Postoperative pain and inadequate analgesic use were problems for many participants regardless of group allocation , and the current intervention did not reduce worst pain intensity compared with control . Further examination of supportive follow-up monitoring and /or self-management strategies post-discharge is required OBJECTIVE To compare the results of continuous epidural bupivacaine analgesia with and without hydromorphone to continuous paravertebral analgesia with bupivcaine in patients with post-thoracotomy pain . DESIGN A prospect i ve , r and omized , double-blinded trial . SETTING A teaching hospital . PARTICIPANTS Patients at a tertiary care teaching hospital undergoing throracotomy for lung cancer . INTERVENTIONS Subjects were assigned r and omly to receive a continuous thoracic epidural or paravertebral infusion . Patients in the epidural group were r and omized to receive either bupivacaine alone or in combination with hydromorphone . Visual analog scores as well as incentive spirometery results were obtained before and after thoracotomy . METHODS AND MAIN RESULTS Seventy-five consecutive patients presenting for thoracotomy were enrolled in this institutional review board-approved study . On the morning of surgery , subjects were r and omized to either an epidural group receiving bupvicaine with and without hydromorphone or a paravertebral catheter-infused bupvicaine . Postoperative visual analog scores and incentive spirometry data were measured in the postanesthesia care unit , the evening of the first operative day , and daily thereafter until postoperative day 4 . Analgesia on all postoperative days was superior in the thoracic epidural group receiving bupivacaine plus hydromorphone . Analgesia was similar in the epidural and continuous paravertebral groups receiving bupivacaine alone . No significant improvement was noted by combining the continuous infusion of bupivacaine via the paravertebral and epidural routes . Incentive spirometry goals were best achieved in the epidural bupivacaine and hydromorphone group and equal in the group receiving bupivacaine alone either via epidural or continuous paravertebral infusion . CONCLUSIONS The current study provided data that fill gaps in the current literature in 3 important areas . First , this study found that thoracic epidural analgesia ( TEA ) with bupivacaine and a hydrophilic opioid , hydromorphone , may provide enhanced analgesia over TEA or continuous paravertebral infusion ( CPI ) with bupivacaine alone . Second , in the bupivacaine-alone group , the increased basal rates required to achieve analgesia result ed in hypotension more frequently than in the bupivacaine/hydromorphone combination group , underscoring the benefit of the synergistic activity . Finally , in agreement with previous retrospective studies , the current data suggest that CPI of local anesthetic appears to provide acceptable analgesia for post-thoracotomy pain Background : The aim of this prospect i ve , r and omized , blinded study was to compare analgesic efficacy of continuous paravertebral and epidural analgesia for post‐thoracotomy pain . Methods : Forty‐two ASA physical status II – III patients undergoing lung resection surgery were r and omly allocated to receive post‐thoracotomy analgesia with either a thoracic epidural ( group EPI , n = 21 ) or paravertebral ( group PVB , n = 21 ) infusion of 0.2 % ropivacaine ( infusion rate : 5–10 mL h−1 ) . The degree of pain at rest and during coughing , haemodynamic variables and blood gas analysis were recorded every 12 h for the first 48 h. Results : The area under the curve of the visual analogue pain score during coughing over time was 192 ( 60–444 ) cm h−1 in group EPI and 228 ( 72–456 ) cm h−1 in group PVB ( P = 0.29 ) . Rescue morphine analgesia was required in four patients of group EPI ( 19 % ) and five patients of group PVB ( 23 % ) ( P = 0.99 ) . The PaO2/FiO2 ratio reduced significantly from baseline values in both groups without between‐group differences . The median ( range ) percentage reduction of systolic arterial pressure from baseline was −9 ( 0 to −9)% in group PVB and −17 ( 0 to −38)% in group EPI ( P = 0.02 ) ; while clinical ly relevant hypotension ( systolic arterial pressure decrease > 30 % of baseline ) was observed in four patients of group EPI only ( 19 % ) ( P = 0.04 ) . Patient satisfaction with the analgesia technique was 8.5 ( 8–9.8 ) cm in group EPI and 9 ( 7.5–10 ) cm in group PVB ( P = 0.65 ) . Conclusions : Continuous thoracic paravertebral analgesia is as effective as epidural blockade in controlling post‐thoracotomy pain , but is associated with less haemodynamic effects OBJECTIVES Paravertebral block is an effective alternative to epidural analgesia in the management of post-thoracotomy pain , however , there are no established guidelines regarding what is the most suitable strategy when varying drugs and dosages between different groups . Our objective was to evaluate the effectiveness of paravertebral block comparing the most frequently employed drugs in this procedure ( bupivacaine vs ropivacaine ) . METHODS Prospect i ve r and omized study of 70 patients su bmi tted to thoracotomy . Patients were divided in two independent groups ( anterior thoracotomy ( AT ) and posterolateral thoracotomy ( PT ) ) . At the end of surgery a catheter was inserted under direct vision in the thoracic paravertebral space at the level of incision . In each group ( AT or PT ) patients were r and omized to receive a bolus of 15 ml of bupivacaine 0.5 % or 20 ml of ropivacaine 0.2 % before closing the thoracotomy . They postoperatively received 10 ml of bupivacaine or 15 ml of ropivacaine every 6h combined with methamizol ( every 6h ) . Subcutaneous meperidine was employed as rescue drug . The level of pain was measured with the visual analogic scale ( VAS ) at 1 , 6 , 24 , 48 and 72 h after surgery . The need of meperidine as rescue drug and secondary effects was also recorded . RESULTS We did not register secondary effects in relation to the paravertebral catheter ( paravertebral or cutaneous bleeding or hematoma , respiratory depression ( respiratory rate < 8 breaths per minute ) , cardiotoxicity , confusion , sedation , urinary retention , nausea , vomiting and pruritus ) . Eleven patients ( 1 \n Output:\n " }, { "from": "agent", "value": "No statistically significant difference in pain relief was reported .\nThe continuous paravertebral block has equivalent analgesic effects to epidural analgesia , wound infiltration and st and ard care , but is associated with a lower incidence of nausea and vomiting , hypotension and urinary retention than epidural analgesia" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The Mediterranean diet has been suggested to play a beneficial role for health and longevity . However , to our knowledge , no prospect i ve US study has investigated the Mediterranean dietary pattern in relation to mortality . METHODS Study participants included 214,284 men and 166,012 women in the National Institutes of Health (NIH)-AARP ( formerly known as the American Association of Retired Persons ) Diet and Health Study . During follow-up for all-cause mortality ( 1995 - 2005 ) , 27,799 deaths were documented . In the first 5 years of follow-up , 5,985 cancer deaths and 3,451 cardiovascular disease ( CVD ) deaths were reported . We used a 9-point score to assess conformity with the Mediterranean dietary pattern ( components included vegetables , legumes , fruits , nuts , whole grains , fish , monounsaturated fat-saturated fat ratio , alcohol , and meat ) . We calculated hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) using age- and multivariate-adjusted Cox models . RESULTS The Mediterranean diet was associated with reduced all-cause and cause-specific mortality . In men , the multivariate HRs comparing high to low conformity for all-cause , CVD , and cancer mortality were 0.79 ( 95 % CI , 0.76 - 0.83 ) , 0.78 ( 95 % CI , 0.69 - 0.87 ) , and 0.83 ( 95 % CI , 0.76 - 0.91 ) , respectively . In women , an inverse association was seen with high conformity with this pattern : decreased risks that ranged from 12 % for cancer mortality to 20 % for all-cause mortality ( P = .04 and P < .001 , respectively , for the trend ) . When we restricted our analyses to never smokers , associations were virtually unchanged . CONCLUSION These results provide strong evidence for a beneficial effect of higher conformity with the Mediterranean dietary pattern on risk of death from all causes , including deaths due to CVD and cancer , in a US population The Healthy Eating Index-2005 ( HEI-2005 ) measures adherence to the 2005 Dietary Guidelines for Americans , but the association between the HEI-2005 and risk of chronic disease is not known . The Alternative Healthy Eating Index ( AHEI ) , which is based on foods and nutrients predictive of chronic disease risk , was associated inversely with chronic disease risk previously . We up date d the AHEI , including additional dietary factors involved in the development of chronic disease , and assessed the associations between the AHEI-2010 and the HEI-2005 and risk of major chronic disease prospect ively among 71,495 women from the Nurses ' Health Study and 41,029 men from the Health Professionals Follow-Up Study who were free of chronic disease at baseline . During ≥24 y of follow-up , we documented 26,759 and 15,558 incident chronic diseases ( cardiovascular disease , diabetes , cancer , or nontrauma death ) among women and men , respectively . The RR ( 95 % CI ) of chronic disease comparing the highest with the lowest quintile was 0.84 ( 0.81 , 0.87 ) for the HEI-2005 and 0.81 ( 0.77 , 0.85 ) for the AHEI-2010 . The AHEI-2010 and HEI-2005 were most strongly associated with coronary heart disease ( CHD ) and diabetes , and for both outcomes the AHEI-2010 was more strongly associated with risk than the HEI-2005 ( P-difference = 0.002 and < 0.001 , respectively ) . The 2 indices were similarly associated with risk of stroke and cancer . These findings suggest that closer adherence to the 2005 Dietary Guidelines may lower risk of major chronic disease . However , the AHEI-2010 , which included additional dietary information , was more strongly associated with chronic disease risk , particularly CHD and diabetes BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality Pancreatic cancer is the fourth most common cause of cancer death worldwide with large geographical variation , which implies the contribution of diet and lifestyle in its etiology . We examined the association of meat and fish consumption with risk of pancreatic cancer in the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) . A total of 477,202 EPIC participants from 10 European countries recruited between 1992 and 2000 were included in our analysis . Until 2008 , 865 nonendocrine pancreatic cancer cases have been observed . Calibrated relative risks ( RRs ) and 95 % confidence intervals ( CIs ) were computed using multivariable-adjusted Cox hazard regression models . The consumption of red meat ( RR per 50 g increase per day = 1.03 , 95 % CI = 0.93 - 1.14 ) and processed meat ( RR per 50 g increase per day = 0.93 , 95 % CI = 0.71 - 1.23 ) were not associated with an increased pancreatic cancer risk . Poultry consumption tended to be associated with an increased pancreatic cancer risk ( RR per 50 g increase per day = 1.72 , 95 % CI = 1.04 - 2.84 ) ; however , there was no association with fish consumption ( RR per 50 g increase per day = 1.22 , 95 % CI = 0.92 - 1.62 ) . Our results do not support the conclusion of the World Cancer Research Fund that red or processed meat consumption may possibly increase the risk of pancreatic cancer . The positive association of poultry consumption with pancreatic cancer might be a chance finding as it contradicts most previous findings BACKGROUND Advanced glycation end products ( AGEs ) are a heterogeneous group of compounds present in uncooked foods as well as in foods cooked at high temperatures . AGEs have been associated with insulin resistance , oxidative stress , and chronic inflammation in patients with diabetes . Dietary AGEs are an important contributor to the AGE pool in the body . N(ϵ)-(carboxymethyl)lysine ( CML ) AGE is one of the major biologically and chemically well-characterized AGE markers . The consumption of red meat , which is CML-AGE rich , has been positively associated with pancreatic cancer in men . OBJECTIVES With the use of a published food CML-AGE data base , we estimated the consumption of CML AGE in the prospect i ve NIH-AARP Diet and Health Study and evaluated the association between CML-AGE consumption and pancreatic cancer and the mediating effect of CML AGE on the association between red meat consumption and pancreatic cancer . DESIGN Multivariate Cox proportional hazard regression models were used to estimate HRs and 95 % CIs for pancreatic cancer . RESULTS During an average of 10.5 y of follow-up , we identified 2193 pancreatic cancer cases ( 1407 men and 786 women ) from 528,251 subjects . With the comparison of subjects in the fifth and the first quintiles of CML-AGE consumption , we observed increased pancreatic cancer risk in men ( HR : 1.43 ; 95 % CI : 1.06 , 1.93 , P-trend = 0.003 ) but not women ( HR : 1.14 ; 95 % CI : 0.76 , 1.72 , P-trend = 0.42 ) . Men in the highest quintile of red meat consumption had higher risk of pancreatic cancer ( HR : 1.35 ; 95 % CI : 1.07 , 1.70 ) , which attenuated after adjustment for CML-AGE consumption ( HR : 1.20 ; 95 % CI : 0.95 , 1.53 ) . CONCLUSION Dietary CML-AGE consumption was associated with modestly increased risk of pancreatic cancer in men and may partially explain the positive association between red meat and pancreatic cancer BACKGROUND & AIMS Diet could affect risk for esophageal and gastric cancers , but associations have been inconsistent . The diet is complex , so studies of dietary patterns , rather than studies of individual foods , might be more likely to identify cancer risk factors . There is limited research on index-based dietary patterns and esophageal and gastric cancers . We prospect ively evaluated associations between the Healthy Eating Index-2005 ( HEI-2005 ) and alternate Mediterranean Diet ( aMED ) scores and risk of esophageal and gastric cancers . METHODS We analyzed data from 494,968 participants in the National Institutes of Health-AARP Diet and Health study , in which AARP members ( age , 51 - 70 y ) completed a self-administered baseline food frequency question naire between 1995 and 1996 . Their answers were used to estimate scores for each index . RESULTS During the follow-up period ( 1995 - 2006 ) , participants developed 215 esophageal squamous cell carcinomas ( ESCCs ) , 633 esophageal adenocarcinomas ( EACs ) , 453 gastric cardia adenocarcinomas , and 501 gastric noncardia adenocarcinomas . Higher scores from the HEI-2005 were associated with a reduced risk of ESCC ( comparing the highest quintile with the lowest quintile : hazard ratio , 0.51 ; 95 % confidence interval , 0.31 - 0.86 ; Ptrend = .001 ) and EAC ( hazard ratio , 0.75 ; 95 % confidence interval , 0.57 - 0.98 ; Ptrend = .01 ) . We observed an inverse association between ESCC , but not EAC , and a higher aMED score ( meaning a higher- quality diet ) . HEI-2005 and aMED scores were not associated significantly with gastric cardia or noncardia adenocarcinomas . CONCLUSIONS By using data collected from 1995 through 2006 from the National Institutes of Health-AARP Diet and Health Study , HEI-2005 and aMED scores were associated inversely with risk for esophageal cancers , particularly ESCC . Adherence to dietary recommendations might help prevent esophageal cancers Epidemiological data investigating the relation between fruit and vegetable consumption and pancreatic cancer risk have shown inconsistent results so far . Most case-control studies observed an inverse association with total fruit and vegetable consumption , whereas results from most cohort studies have largely been null . We examined prospect ively the relation between pancreatic cancer risk and intake of vegetables , fruits , carotenoids and vitamins C and E. The Netherl and s Cohort Study consisted of 120,852 men and women who completed a question naire at baseline in 1986 , including a vali date d 150-item food-frequency question naire . After 16.3 years of follow-up , 423 cases were available for analysis . Total vegetable and total fruit consumption were not associated with pancreatic cancer risk ( highest vs. lowest quintile , multivariable-adjusted hazard rate ratio = 1.23 , 95 % confidence interval : 0.86 - 1.75 and multivariable-adjusted hazard rate ratio = 0.90 , 95 % confidence interval : 0.66 - 1.24 , respectively ) . Also , for cooked vegetables , raw vegetables and vegetables and fruits classified into subgroups , no associations were observed . Dietary carotenoids , vitamin C and E intake and supplements containing vitamin C or E were not associated with pancreatic cancer risk . The results were not \n Output:\n " }, { "from": "agent", "value": "Conclusions Better diet quality is associated with reduced risk of pancreatic cancer .\nThe associations between dietary patterns and pancreatic cancer were stronger in case-control studies than in cohort studies and were stronger among men than among women" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES : Difficult diagnoses and a lack of effective therapy complicate biliary tract malignancies . Interleukin-6 ( IL-6 ) is a human bile duct epithelium growth factor correlated with tumor burden . We evaluated the usefulness of serum IL-6 in the diagnosis of primary BDC and measured changes in serum IL-6 levels following photodynamic therapy ( PDT ) . METHODS : We prospect ively measured serum IL-6 levels in patients with BDC ( N = 26 : 14 patients treated with PDT , 12 with biliary drainage alone ) , hepatocelluar carcinoma ( HCC , N = 26 ) , and healthy adults ( N = 23 ) . Serum IL-6 levels were measured by an enzyme-linked immunosorbent assay . Patients with clinical conditions known to increase IL-6 levels were excluded . RESULTS : IL-6 was detected in all patients with BDC and HCC , and in 6 of 23 healthy adults . Median and mean levels of IL-6 were higher in patients with BDC than in both other groups ( P < 0.001 ) . Using a 25.8 pg/mL cutoff , IL-6 provided a diagnostic sensitivity of 73 % and a specificity of 92 % ; positive and negative predictive values were 83 % and 87 % , respectively . Serum levels of IL-6 were correlated with tumor burden in BDC patients . One month after treatment of BDC with PDT , the mean IL-6 level decreased significantly from 282.1 ± 121.8 to 38.2 ± 9.9 pg/mL ( P = 0.008 ) . CONCLUSIONS : Serum IL-6 concentration is a useful addition to the available tests for the differential diagnosis of BDC , and serves as a marker for monitoring the response to treatment of BDC with PDT AIM Serum alpha-fetoprotein ( AFP ) is the most important tumor marker for hepatocellular carcinoma ( HCC ) . Previous reports indicated that HCC was also associated with increased levels of interleukin (IL)-6 , IL-10 and hepatocyte growth factor ( HGF ) . This study investigated the role of these cytokines as tumor markers for HCC . METHOD A total of 128 adults were prospect ively enrolled and categorized into four groups : normal subjects ( n=29 ) , chronic hepatitis B or C ( n=50 ) , non-HCC tumors ( n=23 ) and HCC ( n=26 ) . Serum AFP , IL-6 , IL-10 and HGF levels were determined in all subjects . RESULTS The expression of IL-6 or IL-10 ( > or =3 pg/ml ) , or high level of HGF ( > 1000 pg/ml ) or AFP ( > 20 ng/ml ) was observed in only 0 - 3 % of normal subjects . Patients with HCC more frequently had higher IL-6 and IL-10 levels ( p<0.05 ) , whereas HGF levels in HCC patients were not significantly elevated compared to patients with chronic hepatitis or non-HCC tumors . Among patients with low ( < 20 ng/ml ) AFP level , IL-6 or IL-10 expression was significantly associated with the existence of HCC ( p<0.05 ) . Patients with large ( > 5 cm ) HCC more often had increased IL-6 , IL-10 or AFP levels ( p values all < 0.05 ) . CONCLUSIONS Serum levels of IL-6 and IL-10 are frequently elevated in patients with HCC but not in benign liver disease or non-HCC tumors . IL-6 and IL-10 may help identify a subset of HCC patients with low AFP level , and may serve as complementary tumor markers in these patients Interleukin-6 ( IL-6 ) is a promising tumor marker for hepatocellular carcinoma ; HCC . IL-6 may help to identify a subset of HCC patients with low alpha-fetoprotein ( AFP ) level , and may serve as complementary tumor marker , however , this has to be clarified . This study assesses the value of measuring serum level of interleukin-6 in patients with chronic liver disease and HCC , and evaluates its sensitivity and specificity in comparison to AFP in early diagnosis of HCC . Seventy five patients with chronic liver disease ( CLD ) with or without HCC and 25 healthy controls were included . Patients were divided into Group I : 25 patients with CLD but no evidence of HCC . Group II : 25 patients with HCC on top of post-viral hepatitic with elevation in AFP ( > 200 ng ) ; and Group III : 25 patients with HCC on top of post-viral hepatitic but without elevation in AFP ( < 200 ng ) . Analysis of the mean serum IL-6 levels revealed a statistically significant difference between all groups ( P < 0.01 ) . A significant positive correlation was found between mean levels of IL- 6 & AFP in HCC ( P < 0.05 ) , the mean IL-6 levels in patients with Child classification C was higher than in those with Child A and B.After adjustment using multiple logistic regressions , only loss of weight and AFP were found to be significantly associated with HCC ( P < 0.05 ) . It is concluded that the diagnostic value of IL-6 increased when it is associated with AFP measurement . Combining the two markers can provide a new perspective in the diagnosis of HCC \n Output:\n " }, { "from": "agent", "value": "Conclusions The elevated IL-6 levels in HCC patients compared with hepatitis and cirrhosis patients and healthy controls may show a significant association of this cytokine with increased risk of HCC and its potential as a diagnostic marker for HCC in future diagnostic and therapeutic strategies" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Whiplash‐associated disorders are common and incur considerable expense in social and economic terms . There are no known effective treatments for those people whose pain and disability persist beyond 3 months . We conducted a r and omized , assessor‐blinded , controlled trial at two centres in Australia . All participants received 3 advice sessions . In addition the experimental group participated in 12 exercise sessions over 6 weeks . Primary outcomes were pain intensity , pain bothersomeness and function measured at 6 weeks and 12 months . Exercise and advice was more effective than advice alone at 6 weeks for all primary outcomes but not at 12 months . The effect of exercise on the 0–10 pain intensity scale was −1.1 ( 95%CI −1.8 to −0.3 , p = 0.005 ) at 6 weeks and −0.2 ( 0.6 to −1.0 , p = 0.59 ) at 12 months ; on the bothersomeness scale the effect was −1.0 ( −1.9 to −0.2 , p = 0.003 ) at 6 weeks and 0.3 ( −0.6 to 1.3 , p = 0.48 ) at 12 months . The effect on function was 0.9 ( 0.3 to 1.6 , p = 0.006 ) at 6 weeks and 0.6 ( −0.1 to 1.4 , p = 0.10 ) at 12 months . High levels of baseline pain intensity were associated with greater treatment effects at 6 weeks and high levels of baseline disability were associated with greater treatment effects at 12 months . In the short‐term exercise and advice is slightly more effective than advice alone for people with persisting pain and disability following whiplash . Exercise is more effective for subjects with higher baseline pain and disability BACKGROUND AND OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review OBJECTIVE To compare the effects of manual therapy and stretching exercise on neck pain and disability . DESIGN An examiner-blinded r and omized cross-over trial . PATIENTS A total of 125 women with non-specific neck pain . METHODS PATIENTS were r and omized into 2 groups . Group 1 received manual therapy twice weekly and Group 2 performed stretching exercises 5 times a week . After 4 weeks the treatments were changed . The follow-up times were after 4 and 12 weeks . Neck pain ( visual analogue scale ) and disability indices were measured . RESULTS Mean value ( st and ard deviation ) for neck pain was 50 mm ( 22 ) and 49 mm ( 19 ) at baseline in Group 1 and Group 2 , respectively , and decreased during the first 4 weeks by 26 mm ( 95 % Confidence Interval 20 - 33 ) and 19 mm ( 12 - 27 ) , respectively . There was no significant difference between groups . Neck and shoulder pain and disability index decreased significantly more in Group 1 after manual therapy ( p=0.01 ) as well as neck stiffness ( p=0.01 ) . CONCLUSION Both stretching exercise and manual therapy considerably decreased neck pain and disability in women with non-specific neck pain . The difference in effectiveness between the 2 treatments was minor . Low-cost stretching exercises can be recommended in the first instance as an appropriate therapy intervention to relieve pain , at least in the short-term OBJECTIVE --To assess the long term effect of early mobilisation exercises in patients with acute sprains of the neck after road accidents . DESIGN --Single blind r and omised prospect i ve study of patients receiving physiotherapy , advice on mobilisation , or on an initial period of rest followed up after two years by postal question naire . SETTING --Accident and emergency department in urban hospital . PATIENTS --247 Consecutive patients ( mean age at injury 30.6 years ) presenting within 48 hours after injury with no pre-existing disease of the neck or serious skeletal injury . Of these , 167 patients responded to the question naire ; 77 who responded but had not completed their treatment or review course were included in the analysis as a fourth group ( non-attenders ) . MAIN OUTCOME MEASURE -- Presence of symptoms after two years . RESULTS --Of the 167 patients ( 68 % ) responding , the percentage of patients still with symptoms was not significantly different in those receiving rest or physiotherapy ( 46 % , 12/26 v 44 % , 24/54 ) , but that in those receiving advice on early mobilisation was significantly lower ( 23 % , 11/48 , p = 0.02 ) . Of the 104 patients without symptoms , 94 ( 90 % ) recovered within six months and 62 ( 60 % ) within three months . Patients without symptoms who received advice or physiotherapy wore a collar for a significantly shorter time than those with persistent symptoms ( mean duration 1.4 ( SD 0.7 ) months v 2.8 ( 1.6 ) months , p = 0.005 and 1.6 ( 1.1 ) months v 1.8 ( 1.3 ) months , p = 0.006 respectively ) . CONCLUSIONS --Advice to mobilise in the early phase after neck injury reduces the number of patients with symptoms at two years and is superior to manipulative physiotherapy . Prolonged wearing of a collar is associated with persistence of symptoms Abstract Objectives Firstly , to compare the effectiveness of a brief physiotherapy intervention with “ usual ” physiotherapy for patients with neck pain . Secondly , to evaluate the effect of patients ' preferences on outcome . Design Non-inferiority r and omised controlled trial eliciting preferences independently of r and omisation . Setting Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire . Participants 268 patients ( mean age 48 years ) with subacute and chronic neck pain , who were referred by their general practitioner and r and omly assigned to a brief physiotherapy intervention ( one to three sessions ) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy , at the discretion of the physiotherapist concerned . Main outcome measures The Northwick Park neck pain question naire ( NPQ ) , a specific measure of functional disability result ing from neck pain . Also , the short form 36 ( SF-36 ) question naire , a generic , health related , quality of life measure ; and the Tampa scale for kinesophobia , a measure of fear and avoidance of movement . Results At 12 months , patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group ( mean difference 1.99 , 95 % confidence interval 0.45 to 3.52 ; P = 0.01 ) . Although the result shows a significant inferiority of the intervention , the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention ( below 1.2 points of NPQ score ) . Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy . Conclusions Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain . Patients with a preference for the brief intervention may do at least as well with this approach . Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further Study Design . A single‐blinded , r and omized treatment study with a follow‐up period of 6 months . Objective . To study the long‐term consequences of whiplash neck sprain injuries in patients treated with two different regimes during the first 14 days after the car accident . Patients in the first group were encouraged to act as usual , i.e. , continue to engage in their normal , pre‐injury activities ; that group was compared with another group of patients who were given time off from work and who were immobilized using a soft neck collar . The end point of the comparison was the evaluation of subjective symptoms 6 months after the accident . Summary of Background Data . Few r and omized treatment studies have been performed to evaluate the clinical outcome for patients with neck sprain . Method . Patients who participated in the study were recruited from the Emergency Clinic at the University Hospital in Trondheim , Norway . The study group included 201 patients ( 47 % of the study group ) with neck sprain that result ed from a car accident . Neck and shoulder movements and subjective symptoms , which were assessed using several different measurements , were assessed during the follow‐up period . Results . There was a significant reduction of symptoms from the time of intake to 24 weeks after the treatment period in both groups . There was a significantly better outcome for the act‐as‐usual group in terms of subjective symptoms , including pain localization , pain during daily activities , neck stiffness , memory , and concentration , and in terms of visual analog scale measurements of neck pain and headache . Conclusions . The outcome was better for patients who were encouraged to continue engaging in their normal , pre‐injury activities as usual than for patients who took sick leave from work and who were immobilized during the first 14 days after the neck sprain injury Objective : To evaluate the effects of a physical training programme which is supervised and tailored to meet the needs of patients with subacute whiplash-associated disorders . Design : A r and omized controlled trial with follow-up at three and nine months after r and omization . Setting : An interdisciplinary rehabilitation centre . Subjects : Forty-seven patients with subacute disorders following a whiplash trauma . Interventions : Patients were r and omized to a supervised training group or a self-administered home training group . Main measures : Primary outcome measures were the Self-Efficacy Scale , the Tampa Scale for Kinesiophobia and the Pain Disability Index . Secondary outcome measures were neck pain intensity , sensory and affective dimensions of pain , pain location and duration , muscle tenderness , grip strength , cervical mobility , sick leave and analgesic consumption . Results : Forty patients ( 85 % ) completed the intervention period , and the drop-outs were followed up by intention-to-treat . The results showed that supervised training was significantly more favourable than home training , with a more rapid improvement in self-efficacy ( P=0.03 ) , fear of movement/(re)injury ( P=0.03 ) and pain disability ( P=0.03 ) at three months . Further , supervised training significantly reduced the frequency of analgesic consumption ( P=0.03 ) . The improvements were partly maintained at nine months , even though there was no amelioration in pain and physical disorders . Despite the favourable outcome , supervised intervention did not reduce sick leave . Conclusions : The findings indicate a treatment approach that is feasible in the rehabilitation of patients with subacute whiplash-associated disorders in the short term , but additional research is needed to extend these findings and eluci date treatment strategies that also are cost effective Objectives The authors ' goals were to compare the effectiveness of manual therapy ( MT ; mainly spinal mobilization ) , physical therapy ( PT ; mainly exercise therapy ) , and continued care by the general practitioner ( GP ; analgesics , counseling and education ) over a period of 1 year . Methods One hundred eighty-three patients suffering for at least 2 weeks from nonspecific neck pain were r and omized to receive a 6-week treatment strategy of MT once a week , PT twice a week , or GP care once every 2 weeks . The primary outcome measures were perceived recovery , severity of physical dysfunctioning , pain intensity , and functional disability . Results The differences between groups considered over 1 year were statistically significant ( repeated measurements analyses P<0.001 to P=0.02 ) for all outcomes but borderline for the Neck Disability Index ( P=0.06 ) . Higher improvement scores were observed for MT for all outcomes , followed by PT and GP care . The success rate , based on perceived recovery after 13 weeks , was 72 % for MT , which was significantly higher than the success rate for continued GP care ( 42 % , P=0.001 ) but not significantly higher compared with PT treatment ( 59 % , P=0.16 ) . The difference between PT and GP approached statistical significance ( P=0.06 ) . After 1 year the success rates were 75 % , 63 % , and 56 % , respectively , and no longer significantly different . Conclusions Short-term results ( at 7 weeks ) have shown that MT speeded recovery compared with GP care and , to a lesser extent , also compared with PT . In the long-term , GP treatment and PT caught up with MT , and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up Study Design . R and omized clinical trial . Objective . To compare the effectiveness of education and advice given by general practitioners ( GPs ) with education , \n Output:\n " }, { "from": "agent", "value": "With the exception of one trial , this review has not shown effectiveness for educational interventions , including advice to activate , advice on stress-coping skills , workplace ergonomics and self-care strategies ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To determine whether dexamethasone prevents postextubation airway obstruction in young children . DESIGN Prospect i ve , r and omized , double-blind , placebo-controlled study . SETTING Pediatric intensive care unit of a university teaching hospital . PATIENTS Sixty-six children , < 5 yrs of age , intubated and mechanically ventilated for > 48 hrs . INTERVENTIONS Patients were r and omized to receive intravenous dexamethasone ( 0.5 mg/kg , maximum dose 10 mg ) or saline , every 6 hrs for six doses , beginning 6 to 12 hrs before elective extubation . MEASUREMENTS AND MAIN RESULTS Dependent variables included the presence of stridor , Croup Score , and pulsus paradoxus at 10 mins , 6 , 12 , and 24 hrs after extubation ; need for aerosolized racemic epinephrine and reintubation . The dexamethasone and placebo groups were similar in age ( median 3 months [ range 1 to 57 ] vs. 4 months [ range 1 to 59 ] , p = .6 ) , frequency of underlying airway anomalies ( 3/33 vs. 3/33 , p = 1.0 ) , and duration of mechanical ventilation ( median 3.3 days [ range 2.1 to 39 ] vs. 3.5 days [ range 2.1 to 15 ] , p = .7 ) . The dexamethasone group had a lower frequency of stridor , Croup Score , and pulsus paradoxus measurement at 10 mins and at 6 and 12 hrs after extubation . Fewer dexamethasone-treated patients required epinephrine aerosol ( 4/31 vs. 22/32 , p < .0001 ) and reintubation ( 0/31 vs. 7/32 , p < .01 ) . Three patients exited the study early-one patient in the dexamethasone group had occult gastrointestinal hemorrhage and one patient in each group had hypertension . CONCLUSION Pretreatment with dexamethasone decreases the frequency of postextubation airway obstruction in children STUDY OBJECTIVE To identify patients with croup who after treatment with nebulized racemic epinephrine , oral dexamethasone , and mist may be safely discharged home after a period of observation . DESIGN Prospect i ve interventional . SETTING Urban children 's hospital emergency department . PARTICIPANTS Children with croup who received racemic epinephrine for the treatment of stridor at rest . INTERVENTIONS After treatment with .5 mL racemic epinephrine , .6 mg/kg dexamethasone PO , and mist , patients who were assessed as being safe for discharge after 3 hours of observation were discharged home and contacted for 48-hour follow-up . RESULTS Fifty-five patients with croup were treated with racemic epinephrine . Thirty patients ( 55 % ) had sustained responses and were discharged home after 3 hours of observation . No recurrence of respiratory distress and no return visits for medical care were reported ( 95 % confidence interval , 0 % to 8.0 % ) . CONCLUSION Patients with croup who are treated with racemic epinephrine , oral dexamethasone , and mist may be safely discharged home if the patient is assessed as ready for discharge after 3 hours of observation BACKGROUND Although previous studies have shown that dexamethasone is useful in croup , the optimal dosage has not been clarified yet . The aim of this study was to investigate the effectiveness of dexamethasone 0.15 mg/kg single dose compared with the recommended dose of 0.6 mg/kg for treatment of hospitalized children with moderate to severe croup . METHOD Forty-one children aged 6 months to 5 years admitted from March 2001 to October 2003 at the pediatric ward of Hatyai Hospital with moderate to severe croup were recruited for the study . After r and om allocation , each child received a single intravenous injection of either dexamethasone 0.6 mg/kg ( maximum dose 12 mg ) or 0.15 mg/kg ( maximum dose 3 mg ) . All children were given a single dose of epinephrine nebulization at the beginning of the study . The croup scores were measured at 0 , 1 , 2 , 3 , 4 , 6 , 8 , 10 and 12 h after the dexamethasone injection . RESULTS One hour following the injection , the mean croup scores were significantly reduced from baseline values in both groups ( p<0.01 ) . There was no difference in the mean croup scores between the two groups at any time . Median times to croup scores equal or less than two in both high- and low-dose groups were 8 and 7.9 h , respectively . No patient required intubation or was removed from the study because of a rising croup score after enrollment . There was no significant adverse reaction from dexamethasone treatment in either group . CONCLUSION Dexamethasone 0.15 and 0.6 mg/kg are equally effective in the treatment of moderate to severe croup Abstract Objective : To assess the efficacy of a single dose of oral dexamethasone 0.15 mg/kg in children with mild croup not admitted to hospital . Design : Double blind , r and omised , placebo controlled clinical trial . Setting : The emergency department of a tertiary paediatric hospital . Subjects : 100 children aged 4 - 122 months presenting with mild croup . Intervention : A single oral dose of dexamethasone 0.15 mg/kg or placebo . Main outcome measure : Return to medical care with ongoing croup . Results : Baseline characteristics of the two treatment groups were similar . Eight children ( all from the placebo group ) returned to medical care with ongoing croup , one being admitted . There was no reported difference in duration of croup symptoms , duration of viral symptoms , or rate of return to medical care for other reasons . Conclusion : Oral dexamethasone in a dose of 0.15 mg/kg is effective in reducing return to medical care with ongoing croup in children with mild croup . Key messages The benefits of steroids for children admitted to hospital are now well estab- lished Most children with croup may be sent home , though up to one fifth may return with croup A small single dose of oral dexamethasone ( 0.15 mg/kg ) dramatically reduces the chance of reattending All children presenting with croup should be considered for The objective of this study was to compare the efficacy of a single dose of oral dexamethasone of varying sizes in 120 children hospitalized with croup in two sequential double blind , r and omized , controlled clinical trials ( Trials A and B ) . The study was conducted in the Emergency Department Observation Ward of a tertiary pediatric hospital . One hundred and twenty children ( age range 6 to 160 months ) hospitalized with croup participated . Baseline characteristics for the two groups in each trial were similar . In Trial A 60 children received either 0.6 or 0.3 mg/kg dexamethasone syrup ; in Trial B 60 children received either 0.3 or 0.15 mg/ kg dexamethasone syrup . Duration of hospitalization , reduction in croup scores , and adrenaline usage were evaluated . Median duration of hospitalization was similar for children in Trial A ( 7 and 8 hr ) , and in Trial B ( 9 and 9 hr ) . Croup scores following treatment did not differ and were significantly lower than initial scores for all groups and in each trial . Other outcome measures were similar for the two groups in each trial , including need for nebulized adrenaline , numbers of patients admitted to intensive care , rate of return to medical care with reoccurrence of croup , and readmission to hospital with croup following discharge from hospital . We conclude that oral dexamethasone in a dose of 0.15 mg/kg is as effective as 0.3 or 0.6 mg/kg in relieving symptoms and results in a similar duration of hospitalization in children with croup Objective : To evaluate the effect of adding inhaled budesonide ( 2 mg ) to oral dexamethasone 0.15 mg/kg in children hospitalized with croup . Setting : Observation ward of a Tertiary Paediatric Hospital Emergency Department . Subjects : Seventy-two children ( age range 3 to 126 months ) hospitalized with croup . Intervention : Children r and omized to receive either 2 mg of nebulized budesonide or placebo , with all children receiving a single oral dose of 0.15 mg/kg dexamethasone . Outcome measures : Primary outcome was duration of hospital stay . Other measures included croup scores from 0 to 12 hours , use of nebulized epinephrine , duration of croup symptoms , duration of viral symptoms , and return to medical care for croup or for any other reason following discharge from hospital . Results : Baseline characteristics for the 2 groups were similar . There was no difference in time to discharge for the 2 groups or for other outcome measures with a risk ratio of 1.3 ( 95 % confidence intervals of 0.82 and 2.1 ) . Conclusions : The addition of inhaled budesonide ( 2 mg ) to oral dexamethasone ( 0.15 mg/kg ) offers no advantage in the treatment of children hospitalized with croup OBJECTIVE To investigate the efficacy and tolerance of 12-hourly dosing with 2 mg 4 mL-1 of inhaled budesonide versus placebo in patients admitted to hospital with moderate/severe croup . METHOD Eighty-two children hospitalised with croup received either 2 mg 4 mL-1 of budesonide or placebo 12 hourly ( maximum four doses ) via Ventstream nebuliser in a r and omised , double-blind manner . Croup scores were performed at 0 , 2 , 6 , 12 , 24 , 36 and 48 h from initial nebulisation whilst the patient remained hospitalised . Follow-up assessment s were made 1 and 3 days after discharge . RESULTS Improvement was observed in the budesonide group over the 12-h dosing interval when compared to placebo ( P = 0.04 ) . Time to attain a significant clinical improvement was superior in the budesonide group ( P = 0.01 ) . Three days after discharge seven of 32 placebo-treated patients and one of 34 budesonide-treated patients had sought further medical follow-up ( P = 0.02 ) . CONCLUSION Twelve-hourly dosing with inhaled budesonide significantly improved symptoms of croup as well as decreased relapse rates when compared with placebo OBJECTIVES Croup or acute laryngotracheobronchitis is the most common cause of the upper airway obstruction . Cool mist , nebulized racemic epinephrine and steroids are commonly used for therapy . Although steroid treatment can be applied orally , in nebulized form , or parenterally , no study has compared these three regimens yet . In this study , the efficacy of nebulized budesonide , and oral and intramuscular dexamethasone are compared for treatment of croup . STUDY DESIGN Sixty children aged 6 - 36 months were r and omly allocated into four groups . The first three study groups ( 15 children in each ) took nebulized budesonide , oral dexamethasone and intramuscular dexamethasone , respectively , in addition to salbutamol and other supportive measures and these were compared with the placebo group . All patients were evaluated with \" Westley Croup Score \" on admission to pediatric emergency department ( 0h ) and at 24 , 48 and 72h . RESULTS At the end of the study , the croup scores of all steroid treatment groups were significantly lower than the placebo group , but there was no statistical difference among them . CONCLUSIONS Nebulized budesonide , oral and parenteral dexamethasone have the same effectiveness for treatment of croup and the choice depends on conditions of the patient and the physician ABSTRACT . Seventy‐two children hospitalized for croup received on admission a single dose of either 0.6 mg/kg dexamethasone or an equivalent placebo intramuscularly from r and omized ampules ; subsequently the same patients were r and omized to receive either nebulized racemic epinephrine or saline by intermittent positive pressure breathing . Of the four treatment groups those receiving a placebo injection and nebulized saline had the slowest recovery by all criteria . Dexamethasone and nebulized epinephrine reduced the symptoms and hastened recovery , but dexamethasone was more effective by clinical evaluation at 6 and 12 hours post admission . The patients given dexamethasone had a significantly shorter hospital stay than those receiving placebo . We conclude that a single injection of a potent corticosteroid is beneficial in acute spasmodic croup . Nebulized racemic epinephrine given with an appropriate device is also effective , but the effect of epinephrine is less remarkable in patients treated with dexamethasone This prospect i ve cohort study evaluated the effectiveness and safety of a selective discharge policy for patients treated with racemic epinephrine ( RE ) and intramuscular ( IM ) dexamethasone ( DEX ) in the emergency department ( ED ) . Children younger than 13 years of age presenting to the ED with croup who were treated with RE and IM DEX and discharged home were enrolled in the study . Patients were discharged home if they were free of intercostal retractions and stridor at rest , following a 2 h observation period . Telephone follow up determined whether further \n Output:\n " }, { "from": "agent", "value": "Dexamethasone and budesonide are effective in relieving the symptoms of croup as early as six hours after treatment .\nFewer return visits and /or (re)admissions are required and the length of time spent in hospital is decreased ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Finasteride , an inhibitor of type 2 5alpha-reductase , decreases serum and scalp dihydrotestosterone ( DHT ) by inhibiting conversion of testosterone to DHT and has been shown to be effective in men with and rogenetic alopecia ( AGA ) . The effects of finasteride in women with AGA have not been evaluated . OBJECTIVE The purpose of this study was to evaluate the efficacy of finasteride in postmenopausal women with AGA . METHODS In this 1-year , double-blind , placebo-controlled , r and omized , multicenter trial , 137 postmenopausal women ( 41 - 60 years of age ) with AGA received finasteride 1 mg/day or placebo . Efficacy was evaluated by scalp hair counts , patient and investigator assessment s , assessment of global photographs by a blinded expert panel , and histologic analysis of scalp biopsy specimens . RESULTS After 1 year of therapy , there was no significant difference in the change in hair count between the finasteride and placebo groups . Both treatment groups had significant decreases in hair count in the frontal/parietal ( anterior/mid ) scalp during the 1-year study period . Similarly , patient , investigator , and photographic assessment s as well as scalp biopsy analysis did not demonstrate any improvement in slowing hair thinning , increasing hair growth , or improving the appearance of the hair in finasteride-treated subjects compared with the placebo group . Finasteride was generally well tolerated . CONCLUSION In postmenopausal women with AGA , finasteride 1 mg/day taken for 12 months did not not increase hair growth or slow the progression of hair thinning The aim of this study was to assess the usefulness of ketoconazole as a therapeutic alternative to polycystic ovary syndrome . The study group comprised 37 women with signs of hyper and rogenism ( hirsutism , acne ) and oligomenorrhea . A low dose ( 400 mg/day ) of ketoconazole was tested in a 9-month prospect i ve clinical study . Clinical response ( Ferriman & Gallway score , acne ) and modifications in hormone pattern ( luteinizing hormone , follicle-stimulating hormone , estradiol , testosterone , prolactin , 17-hydroxy-progesterone , and rostenedione , steroid hormone-binding globulin , dehydroepi and rosterone sulfate , cortisol , adrenocorticotropin ( ACTH ) and free testesterone index ) were measured , and ACTH stimulation tests were performed . Tolerance and side-effect also were assessed . After 9 months of ketoconazole treatment , the patients ' Ferriman & Gallway scores ( 18.26 + /- 4.6 vs 12.4 + /- 4.1 ; p < 0.001 ) and acne had improved markedly . Hormone patterns also became more favorable , with decreases in and rogenic steroids ( testosterone , and rostenedione , free testosterone index and dehydroepi and rosterone sulfate ; p < 0.01 ) and increases in estradiol ( p < 0.01 ) . Basal cortisol levels and cortisol after ACTH stimulation were not changed significantly , remaining within the reference range . Increases in ACTH were observed only in the 3rd month ( p < 0.01 ) . Initial levels of and rogenic steroids were correlated inversely with their percentage decrease in successive samplings . Decreases in adrenal and rogenic steroids were associated with an increase in steroid hormone-binding globulin . The side-effects of treatment , although not severe , caused some discomfort and led to a high drop-out rate ( 30 % ) . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Topical minoxidil and oral finasteride have been used to treat men with and rogenetic alopecia ( AGA ) . There are concerns about side effects of oral finasteride especially erectile dysfunction . OBJECTIVE To compare the efficacy and safety of the 24 weeks application of 3 % minoxidil lotion ( MNX ) versus combined 3 % minoxidil and 0.1 % finasteride lotion ( MFX ) in men with AGA . MATERIAL AND METHOD Forty men with AGA were r and omized treated with MNX or MFX . Efficacy was evaluated by hair counts and global photographic assessment . Safety assessment was performed by history and physical examination . RESULTS At week 24 , hair counts were increased from baseline in both groups . However paired t-test revealed statistical difference only in MFX group ( p = 0.044 ) . Unpaired t-test revealed no statistical difference between two groups with respect to change of hair counts at 24 weeks from baseline ( p = 0.503 ) . MFX showed significantly higher efficacy than MNX by global photographic assessment ( p = 0.003 ) . There was no significant difference in side effects between both groups . CONCLUSION Although change of hair counts was not statistically different between two groups , global photographic assessment showed significantly greater improvement in the MFX group than the MNX group . There was no sexual side effect . MFX may be a safe and effective treatment option OBJECTIVE To determine the effectiveness of various anti and rogens for the treatment of premenopausal women with hyper and rogenic alopecia . DESIGN R and omized , unmasked trial of three treatments in 36 hyper and rogenic women with alopecia and observation , without treatment , in 12 other similar patients . SETTING Endocrinologic outpatient practice in Italy . PARTICIPANT(S ) A total of 48 hyper and rogenic women with alopecia and 30 age- and weight-matched controls for the assessment of and rogen levels . INTERVENTION(S ) R and omization to cyproterone acetate ( 50 mg ) with ethinyl estradiol ( EE ) in a reverse sequential regimen ; flutamide ( 250 mg ) or finasteride ( 5 mg ) daily ; all for 1 year . Twelve similar patients were observed without treatment for 1 year . MAIN OUTCOME MEASURE(S ) Ludwig scores for hair thinning as well as patient and investigator assessment s of treatment effectiveness . RESULT ( S ) Flutamide result ed in a reduction of 21 % in Ludwig scores ( 2.3 + /- 0.2 to 1.8 + /- 0.1 ) . The other treatment effects were not statistically significant . Patient and investigator assessment s showed a similar trend . CONCLUSION ( S ) Flutamide at a dose of 250 mg daily induced a modest improvement in alopecia after 1 year , whereas cyproterone acetate and finasteride were not effective . Treatment for more than 1 year may be required for better results Background : The pathogenesis of and rogenic alopecia is not fully understood . A microbial-driven inflammatory reaction abutting on the hair follicles might participate in the hair status anomaly . Objective : The aim of our study was to determine if ketoconazole ( KCZ ) which is active against the scalp microflora and shows some intrinsic anti-inflammatory activity might improve alopecia . Method : The effect of 2 % KCZ shampoo was compared to that of an unmedicated shampoo used in combination with or without 2 % minoxidil therapy . Results : Hair density and size and proportion of anagen follicles were improved almost similarly by both KCZ and minoxidil regimens . The sebum casual level appeared to be decreased by KCZ . Conclusion : Comparative data suggest that there may be a significant action of KCZ upon the course of and rogenic alopecia and that Malassezia spp . may play a role in the inflammatory reaction . The clinical significance of the results awaits further controlled study in a larger group of subjects BACKGROUND Finasteride , a type II-selective 5alpha-reductase inhibitor , as a causative agent of decreasing dihydroxy testosterone ( DHT ) level , is effective in the treatment of male and rogenic alopecia . AIM We compared the local and oral finasteride in the treatment of and rogenic alopecia . METHOD This is a double blind , r and omized clinical trial study of 45 male patients , who were referred with alopecia to the private clinics and departments in Boo-Ali Sina Hospital , in Sari . Patients with male and rogenic alopecia were selected according to the history and physical examinations . The patients were r and omly divided into two : topical finasteride ( A ) and oral finasteride ( B ) groups . Topical finasteride group ( A ) received a topical gel of 1 % finasteride and placebo tablets , while the oral finasteride group ( B ) received finasteride tablets ( 1 mg ) and gel base ( without drug ) as placebo for 6 months . The patients were followed by clinical observation and recording of side effects prior to the treatment and at the end of first week , and then by a monthly follow-up . The size of bald area , total hair count , and terminal hair were studied . Data were analyzed by descriptive and Chi-square statistical test . RESULTS The mean duration of hair loss was 18.8+/-23.10 months . Each month the terminal hair , size of bald area and hair count between the two groups were compared . There were no significant differences between the two groups as a viewpoint of hair thickness , hair counts and the size of bald area . Serial measurements indicated a significant increase in hair counts and terminal hair counts between the two groups . CONCLUSIONS The results of this study showed that the therapeutic effects of both finasteride gel and finasteride tablet were relatively similar to each other OBJECTIVE The effects on scalp and serum dihydrotestosterone ( DHT ) of different doses of a novel topical solution of 0.25 % finasteride ( P-3074 ) , a type 2 5α-reductase , were investigated in men with and rogenetic alopecia . METHODS Two r and omized , parallel-group studies were conducted . Study I : 18 men received 1 mL ( 2.275 mg ) P-3074 , applied to the scalp once a day ( o.d . ) or twice a day ( b.i.d ) , or 1 mg oral tablet o.d . for 1 week . Study II : 32 men received P-3074 at the dose of 100 ( 0.2275 mg ) , 200 ( 0.455 mg ) , 300 ( 0.6285 mg ) , or 400 ( 0.91 mg ) μL or the vehicle o.d . for 1 week . Scalp and serum DHT and serum testosterone were evaluated at baseline and treatment end . RESULTS Change from baseline in scalp DHT was -70 % for P-3074 o.d . and approx . -50 % for P-3074 b.i.d . and the tablet . Serum DHT decreased by 60 - 70 % . The doses of 100 and 200 μL P-3074 result ed in a -47/-52 % scalp DHT reduction , similar to the 300 and 400 μL doses ( i.e. , -37/-54 % ) . A -5.6 % inhibition was observed for the vehicle . Serum DHT was reduced by only -24/-26 % with 100 and 200 μL P-3074 and by -44/-48 % with 300 and 400 μL P-3074 . No relevant changes occurred for serum testosterone . CONCLUSIONS The novel finasteride 0.25 % solution applied o.d . at the doses of 100 and 200 μL results in an appropriate inhibition of scalp DHT potentially minimizing the untoward sexual side-effects linked to a systemic DHT reduction BACKGROUND The synergism of combined use between oral finasteride and topical minoxidil has been established in treating and rogenetic alopecia among men . However , the concern regarding adverse effects of finasteride use has been rising . OBJECTIVE To compare the efficacy and safety of topical solution of 0.25 % finasteride admixed with 3 % minoxidil vs. 3 % minoxidil solution in men with and rogenetic alopecia . METHODS Forty men aged 18 - 60 years with and rogenetic alopecia were r and omized to 24 weeks of treatment with a finasteride/minoxidil or minoxidil solution twice daily . Primary efficacy endpoint was the change from baseline in hair density and hair diameter at week 24 . Secondary endpoints included global photographic assessment by treatment-blinded investigators and subjects . Changes in plasma dihydrotestosterone levels and adverse events were recorded . RESULTS At week 24 , the combined solution of finasteride and minoxidil was significantly superior to minoxidil alone in improvements of hair density , hair diameter and global photographic assessment ( all P < 0.05 ) . About 90 % of patients treated with the combined solution experienced moderate to marked improvement . The combined solution also had minimal effect on plasma dihydrotestosterone levels , approximately 5 % reduction . There were also no systemic adverse events reported by patients in both groups . CONCLUSION Treatment with topical solution of 0.25 % finasteride admixed with 3 % minoxidil was significantly superior to 3 % minoxidil solution for promoting hair growth in male and rogenetic alopecia , and well tolerated Background The relationship between female pattern hair loss ( FPHL ) and and rogenic hormones is not well established , but some evidence indicates oral finasteride may be efficacious in FPHL . Use of a topical formulation has been \n Output:\n " }, { "from": "agent", "value": "The results demonstrated that topical formulations of finasteride , ketoconazole , and C17P are promising treatments for male pattern hair loss , especially topical finasteride in combination with topical minoxidil .\nLimited studies have shown C17P to have potential in treating acne vulgaris in both males and females .\nMinimal adverse effects have been reported in clinical trials for all topical therapies , although topical finasteride is still contraindicated in pregnancy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The mechanisms underlying the skin blood flow ( SkBF ) response to local heating are complex and poorly understood . Our goal was to examine the role of axon reflexes and nitric oxide ( NO ) in the SkBF response to a local heating protocol . We performed 40 experiments following a st and ardized heating protocol with different interventions , including blockade of the axon reflex ( EMLA cream ) , antebrachial nerve blockade ( 0.5 % bupivacaine injection ) , and NO synthase ( NOS ) inhibition ( > or = 10 mM N(G)-nitro-L-arginine methyl ester ; microdialysis ) . Appropriate controls were performed to verify the efficacy of the various blocks . Values are expressed as a percentage of maximal SkBF ( SkBF(max ) ; 50 mM sodium nitroprusside ) . At the initiation of local heating , SkBF rose to an initial peak , followed by a brief nadir , and a secondary , progressive rise to a plateau . Axon reflex block decreased the initial peak from 75 + 3 to 32 + /- 2 % SkBF(max ) ( P < 0.01 vs. control ) but did not affect the plateau . NOS inhibition before and throughout local heating reduced the initial peak from 75 + /- 3 to 56 + /- 3 % SkBF(max ) ( P < 0.01 ) and the plateau from 87 + /- 4 to 40 + /- 5 % . NOS inhibition during axon reflex block did not further reduce the initial SkBF peak compared with axon reflex block alone . Antebrachial nerve block did not affect the local heating SkBF response . The primary finding of these studies is that there are at least two independent mechanisms contributing to the rise in SkBF during nonpainful local heating : a fast-responding vasodilator system mediated by the axon reflexes and a more slowly responding vasodilator system that relies on local production of NO 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 OBJECTIVE To evaluate the vasodilation induced by topical application of methyl nicotinate ( MN ) and to compare it with the vasodilatory response to acetylcholine ( ACh ) and sodium nitroprusside ( SNP ) in healthy subjects and diabetic neuropathic patients . RESEARCH DESIGN AND METHODS Ten diabetic patients with peripheral neuropathy ( DN ) and 10 age- and sex-matched healthy control subjects ( C ) were enrolled . The vasodilatory response to topical application of 1 % MN and a placebo emulsion at the forearm and dorsum of the foot skin at 5 , 15 , 30 , 60 and 120 min was measured using Laser Doppler Perfusion Imaging . The vasodilatory response to iontophoresis of 1 % ACh and 1 % SNP solutions was also evaluated . RESULTS The maximal vasodilatory response to ACh , SNP and MN was similar at the forearm and foot level in the diabetic patients . In the control group , the responses to MN , ACh and SNP were similar on the forearm but in the foot , the MN vasodilatory response was higher when compared to the ACh and SNP responses . MN-related vasodilation was present 5 min after the application , reached its peak at 15 - 30 min and declined to pre-application levels 120 min afterward . CONCLUSIONS Topical application of MN at the forearm and foot levels of diabetic neuropathic patients results in skin vasodilation that is comparable to the maximal vasodilation that can be induced by iontophoresis of ACh or SNP and lasts for less than 2 h. Further studies will be required to explore the potential of MN to increase blood flow and to prevent diabetic foot problems in clinical practice The aim of the present study was to examine the relationship among water diuresis-induced changes in renal oxygenation , endothelial function , and various metabolic parameters in type 2 diabetic patients and healthy subjects at risk of type 2 diabetes . Thirty-eight subjects with type 2 diabetes ( D : age , 54 + /- 10 years , mean + /- SD , 24 men ) and 7 healthy subjects with parental history of type 2 diabetes or with impaired glucose tolerance ( IGT ) ( relatives [ R ] : age 46 + /- 11 years , 4 men ) were included . Laser Doppler imaging scanning was used to measure vasodilatation in the forearm skin in response to iontophoresis of 1 % acetylcholine ( Ach ) and 1 % sodium nitroprusside ( SNP ) , and ultrasound was used to measure the flow-mediated dilation ( FMD ) and nitroglycerin-induced dilation ( NID ) in the brachial artery . Renal oxygenation was assessed by magnetic resonance imaging ( MRI ) before and during water diuresis . A decrease in the magnetic parameter R2 * implies an increase in oxygenation . Renal medullary oxygenation did not improve with diuresis in either group ( D : -0.5 + /- 1.9 , R : -0.4 + /- 2.1 , P = not significant [ NS ] ) . The renal cortical oxygenation showed a small , but statistically significant , improvement after diuresis in the 2 groups ( D : -0.6 + /- 1.1 , R : -0.5 + /- 0.5 , P < .05 ) . There were no correlations between the change in cortical R2 * ( R2 * post-minus R2 * prewater diuresis ) and the micro- and macrovascular reactivity . The postdiuresis renal cortical R2 * was negatively correlated with both the Ach- and SNP-induced skin vasodilation ( % change over baseline)(r = -.40 , P < .01 and r = -.39 , P < .05 , respectively ) , while no correlation existed with the FMD and NID . The baseline renal cortical oxygenation was also negatively correlated with the SNP-induced skin vasodilation ( r = -.36 , P < .05 ) and positively correlated with the fasting plasma glucose , total cholesterol , and vascular cell adhesion molecule ( VCAM ) concentrations ( r = .34 , P < .05 , r = .31 , P < .05 and r = .37 , P < .05 , respectively ) . These preliminary findings suggest an association between the kidney cortical oxygenation and the skin microvascular reactivity , glycemia , and lipidemia . Water diuresis failed to produce an improvement in renal medullary oxygenation in both patients with diabetes and subjects at risk for diabetes OBJECTIVES Capillary rarefaction is a hallmark of untreated hypertension . Recent data indicate that rarefaction may be reversed by antihypertensive treatment in nondiabetic hypertensive patients . Despite the frequent association of diabetes with hypertension , nothing is known on the capillary density of treated diabetic patients with hypertension . METHODS We enrolled 21 normotensive healthy , 25 hypertensive only , and 21 diabetic ( type 2 ) hypertensive subjects . All hypertensive patients were treated with a blocker of the renin-angiotensin system , and a majority had a home blood pressure ≤135/85 mmHg . Capillary density was assessed with videomicroscopy on dorsal finger skin and with laser Doppler imaging on forearm skin ( maximal vasodilation elicited by local heating ) . RESULTS There was no difference between any of the study groups in either dorsal finger skin capillary density ( controls 101 ± 11 capillaries/mm(2 ) , nondiabetic hypertensive 99 ± 16 , diabetic hypertensive 96 ± 18 , p > 0.5 ) or maximal blood flow in forearm skin ( controls 666 ± 114 perfusion units , nondiabetic hypertensive 612 ± 126 , diabetic hypertensive 620 ± 103 , p > 0.5 ) . CONCLUSIONS Irrespective of the presence or not of type 2 diabetes , capillary density is normal in hypertensive patients with reasonable control of blood pressure achieved with a blocker of the renin-angiotensin system OBJECTIVE To examine the effect of a 12-week daily treatment with 160 mg of valsartan , an angiotensin II receptor blocker , on the microcirculation and macrocirculation of type 2 diabetic patients ( T2DM ) and healthy subjects . METHODS This was a prospect i ve , r and omized , double-blind , placebo-controlled crossover study . Thirteen T2DM with no severe complications and 13 healthy subjects completed the trial . RESULTS Treatment with valsartan in T2DM improved the resting forearm skin blood flow and increased the resting brachial artery diameter but had no effects on arterial blood pressure , large vessel vascular reactivity , or carotid intima-media thickness . Resting skin blood flow increased by 60 % ( 2%-90 % ; median and 25th-75th percentiles ) during valsartan treatment and by only 2 % ( -22 % to 27 % ) during placebo treatment ( P < .05 ) . No changes were observed in the nondiabetic subjects . Immunostaining studies of forearm skin biopsy sample s from T2DM and healthy subjects showed that valsartan reduced poly(adenosine diphosphate-ribose ) polymerase ( PARP ) activity in 50 % ( 6/12 ) of the subjects . PARP activity remained unchanged in placebo-treated subjects ( P < .02 ) . In addition , valsartan treatment increased CD31 staining in 33 % ( 4/12 ) of the subjects , whereas no change was noted in sequential skin biopsy sample s of placebo-treated subjects ( P = .057 ) . Valsartan had no effect on the biochemical markers of endothelial cell activation and other cytokines , including CAMs , interleukin 6 , tumor necrosis factor alpha , C-reactive protein , adiponectin , and plasma activator inhibitor 1 . CONCLUSIONS Valsartan increases the resting skin blood flow in T2DM , likely through reduction of PARP activity We have investigated the effect of atorvastatin on the endothelial function of patients with diabetes and subjects at risk for type 2 diabetes in a 12-wk , prospect i ve , r and omized , placebo-controlled , double-blind clinical trial . The flow- mediated dilation ( FMD ; endothelium dependent ) and nitroglycerin-induced dilation ( endothelium independent ) in the brachial artery and the vascular reactivity at the forearm skin were measured . FMD improved in the atorvastatin-treated , at-risk subjects [ median ( 25 - 75 percentile ) , 7.2 % ( 2.9 - 9.6 % ) at exit visit vs. 6.6 % ( 2.9 - 9.5 % ) at baseline ; P < 0.05 ] . A similar improvement of FMD was found in atorvastatin-treated diabetic patients [ median ( 25 - 75 percentile ) , 5.6 ( 3.9 - 7.9 ) at exit visit vs. 4.2 ( 3.2 - 7.2 ) at baseline ; P = 0.07 ] . No changes were observed in nitroglycerin-induced dilation and the microcirculation reactivity measurements in either group . In the at-risk group , there was a decrease in the C-reactive protein [ median ( \n Output:\n " }, { "from": "agent", "value": "However , subgroup analysis revealed no difference between the type and duration of diabetes and other health related factors , indicating that diabetes per se causes the microvascular dysfunction .\nConclusion Our meta- analysis shows that diabetes is associated with a large reduction of dermal microvascular function in diabetic patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Morbidity and mortality are high in young children with medulloblastoma who receive craniospinal radiotherapy . We aim ed to assess whether adjuvant treatment with protracted chemotherapy alone could replace radiotherapy . METHODS We enrolled 79 children aged younger than 5 years who had had surgical resection of medulloblastoma onto a multicentre trial . Patients were treated with combination chemotherapy , which did not include methotrexate , for more than 16 months irrespective of the extent of disease . Early postoperative imaging defined three groups : R0M0 ( no residual disease , no metastasis ) , R1M0 ( radiological residual disease alone ) , and RXM+ ( presence of metastases ) . Patients who did not relapse did not receive radiotherapy . Patients who relapsed or had disease progression received salvage treatment , which consisted of high-dose chemotherapy and stem-cell transplantation followed by local or craniospinal radiotherapy . For children classified as R0M0 , the primary endpoint was 5-year overall survival and the secondary endpoint was 5-year progression-free survival . For children classified as R1M0 or RXM+ , the primary endpoint was best radiological response and the secondary endpoints were 5-year overall survival and 5-year progression-free survival . Analyses were done by intention to treat . FINDINGS Two of 15 patients classified as RXM+ and four of 17 patients classified as R1M0 had a complete radiological response . 5-year progression-free survival was 29 % ( 95 % CI 18 - 44 ) in the R0M0 group , 6 % ( 1 - 27 ) in the R1M0 group , and 13 % ( 4 - 38 ) in the RXM+ group . 5-year overall survival was 73 % ( 59 - 84 ) in the R0M0 group , 41 % ( 22 - 64 ) in the R1M0 group , and 13 % ( 4 - 38 ) in the RXM+ group . In the R0M0 group , 5-year progression-free survival was 41 % ( 26 - 58 ) for the 34 patients who underwent gross total resection compared with 0 % for the 13 patients who had subtotal resection ( relative risk 2.7 [ 1.3 - 5.6 ] , p=0.0065 ) . INTERPRETATION Conventional chemotherapy alone can be used to cure children with non-metastatic medulloblastoma who have gross total resection confirmed by early radiological assessment , but is not sufficient for treatment of those with metastatic or incompletely resected medulloblastoma . Salvage treatment followed by posterior-fossa radiotherapy can effectively treat local relapses or progression This paper describes some of the statistical considerations in the intent-to-treat design and analysis of clinical trials . The pivotal property of a clinical trial is the assignment of treatments to patients at r and om . R and omization alone , however , is not sufficient to provide an unbiased comparison of therapies . An additional requirement is that the set of patients contributing to an analysis provides an unbiased assessment of treatment effects , or that any missing data are ignorable . A sufficient condition to provide an unbiased comparison is to obtain complete data on all r and omized subjects . This can be achieved by an intent-to-treat design wherein all patients are followed until death or the end of the trial , or until the outcome event is reached in a time-to-event trial , irrespective of whether the patient is still receiving or complying with the assigned treatment . The properties of this strategy are contrasted with those of an efficacy subset analysis in which patients and observable patient data are excluded from the analysis on the basis of information obtained postr and omization . I describe the potential bias that can be introduced by such postr and omization exclusions and the pursuant effects on type I error probabilities . Especially in a large study , the inflation in type I error probability can be severe , 0.50 or higher , even when the null hypothesis is true . St and ard statistical methods for the analysis of censored or incomplete observations all require the assumption of missing at r and om to some degree , and none of these methods adjust for the potential bias introduced by post hoc subset selection . Nor is such adjustment possible unless one posits a model that relates the missing observations to other observed information for each subject-models that are inherently untestable . Further , the subset selection bias is confounded with the subset-specific treatment effect , and the two components are not identifiable without additional untestable assumptions . Methods for sensitivity analysis to assess the impact of bias in the efficacy subset analysis are described . It is generally believed that the efficacy subset analysis has greater power than the intent-to-treat analysis . However , even when the efficacy subset analysis is assumed to be unbiased , or have a true type I error probability equal to the desired level alpha , situations are described where the intent-to-treat analysis in fact has greater power than the efficacy subset analysis . The intent-to-treat design , wherein all possible patients continue to be followed , is especially powerful when an effective treatment arrests progression of disease during its administration . Thus , a patient benefits long after the patient becomes noncompliant or the treatment is terminated . In such cases , a l and mark analysis using the observations from the last patient evaluation is likely to prove more powerful than life-table or longitudinal analyses . Examples are described PURPOSE AND EXPERIMENTAL DESIGN Cerebellar primitive neuroectodermal tumors/medulloblastomas ( PNET/MB ) are the most common malignant brain tumors in childhood . To identify PNET/MB biological prognostic factors that define a patient group with a sufficiently good prognosis to permit a reduction in treatment intensity , we determined the expression levels of MYC mRNA in fresh frozen tumor sample s from 26 PNET/MB patients using semiquantitative reverse transcription-PCR . RESULTS MYC mRNA expression levels in primary PNET/MB showed a wide range with a 22-fold difference between the highest and lowest values and did not correlate with MYC gene amplification . MYC mRNA expression was an independent significant prognostic factor for progression-free survival outcome and was more predictive than st and ard clinical factors . The combination of low MYC mRNA expression and high TrkC mRNA expression identified a good outcome group of PNET/MB patients ( n = 7 ) with 100 % progression-free survival after a median follow-up time of 55 months ( range , 15 - 91 months ) . Three of these seven good outcome patients survived without radiotherapy . CONCLUSIONS Low MYC mRNA expression is a powerful independent predictor of favorable clinical outcome in PNET/MB . Assessment of MYC mRNA levels is feasible and may be incorporated in prospect i ve PNET/MB clinical trials to aid in treatment planning for patients with PNET/MB on confirmation of our results in larger studies PURPOSE To identify biologic prognostic factors in childhood primitive neuroectodermal tumors ( PNET ) , including medulloblastoma , that accurately define patient groups with sufficiently good prognosis to permit a reduction in treatment intensity . PATIENTS AND METHODS We determined expression levels of the neurotrophin receptor TrkC mRNA in formalin-fixed tumor sample s from 87 well characterized PNET patients using in situ hybridization . Comparison of TrkC mRNA expression levels with clinical and other laboratory variables was performed using univariate and multivariate Cox regression analysis . RESULTS High TrkC mRNA expression was found to be associated more with higher 5-year cumulative survival rate than was low TrkC mRNA expression ( 89 % v 46 % , respectively ) . When compared with established clinical prognostic factors and laboratory variables of potential prognostic significance , TrkC mRNA expression , by univariate analysis , was found to be the single most powerful predictor of outcome ( hazards ratio , 4.81 ; P < .00005 ) , exceeding all clinical prognostic factors . In multivariate analysis , the hazards ratio remained significant ( P < .00005 ) . CONCLUSION High TrkC mRNA expression in PNET is a powerful independent predictor of favorable clinical outcome . Assessment of TrkC mRNA levels may aid in treatment planning for patients with PNETs and should be incorporated prospect ively into PNET clinical trials PURPOSE To analyze the impact of radiotherapy ( RT ) parameters on outcome in a r and omized study of pre-RT chemotherapy for M0-M1 medulloblastoma . METHODS AND MATERIAL S Patients were r and omized to RT alone or RT preceded by chemotherapy with vincristine , etoposide , carboplatin , and cyclophosphamide . RT consisted of craniospinal RT , 35 Gy in 21 fractions , followed by a posterior fossa ( PF ) boost of 20 Gy in 12 fractions . The accuracy of cribriform fossa , skull base , and PF field placement was assessed . RESULTS Between 1992 and 2000 , 217 patients were r and omized , of whom 179 were eligible for analysis . At a median follow-up of 5.4 years , the 3- and 5-year overall survival rate was 79.5 % and 70.7 % , respectively . The 3- and 5-year event-free survival ( EFS ) rate was 71.6 % and 67.0 % , respectively . EFS was significantly better for the chemotherapy plus RT group ( 3-year EFS rate 78.5 % vs. 64.8 % , p = 0.0366 ) . Overall survival and EFS were significantly better for patients completing RT within 50 days compared with those taking > 50 days to complete RT ( 3-year overall survival rate 84.1 % vs. 70.9 % , p = 0.0356 , 3-year EFS rate 78.5 % vs. 53.7 % , p = 0.0092 ) . Multivariate analysis identified the use of chemotherapy ( p = 0.0248 ) and RT duration ( p = 0.0100 ) as predictive of better EFS . Planning films were review ed for 131 ( 74.4 % ) of 176 patients . Sixty-five ( 49.6 % ) had no targeting deviations and 58 ( 44.3 % ) had one or more deviations . PF recurrence occurred in 11 ( 34.4 % ) of 32 with a PF targeting deviation compared with 13 ( 16.3 % ) of 80 without ( p = 0.043 ) . No statistically significant impact of other targeting deviations on recurrence risk or EFS were found . CONCLUSION The results of this study have confirmed the importance of the duration of RT for medulloblastoma . Also , attention to detail when planning RT is important , as illustrated in the case of PF field placement BACKGROUND Current treatment for medulloblastoma , which includes postoperative radiotherapy and 1 year of chemotherapy , does not cure many children with high-risk disease . We aim ed to investigate the effectiveness of risk-adapted radiotherapy followed by a shortened period of dose-intense chemotherapy in children with medulloblastoma . METHODS After resection , patients were classified as having average-risk medulloblastoma ( < or = 1.5 cm2 residual tumour and no metastatic disease ) or high-risk medulloblastoma ( > 1.5 cm2 residual disease or metastatic disease localised to neuraxis ) medulloblastoma . All patients received risk-adapted craniospinal radiotherapy ( 23.4 Gy for average-risk disease and 36.0 - 39.6 Gy for high-risk disease ) followed by four cycles of cyclophosphamide-based , dose-intensive chemotherapy . Patients were assessed regularly for disease status and treatment side-effects . The primary endpoint was 5-year event-free survival ; we also measured overall survival . This study is registered with Clinical Trials.gov , number NCT00003211 . FINDINGS Of 134 children with medulloblastoma who underwent treatment ( 86 average-risk , 48 high-risk ) , 119 ( 89 % ) completed the planned protocol . No treatment-related deaths occurred . 5-year overall survival was 85 % ( 95 % CI 75 - 94 ) in patients in the average-risk group and 70 % ( 54 - 84 ) in those in the high-risk group ( p=0.04 ) ; 5-year event-free survival was 83 % ( 73 - 93 ) and 70 % ( 55 - 85 ) , respectively ( p=0.046 ) . For the 116 patients whose histology was review ed central ly , histological subtype correlated with 5-year event-free survival ( p=0.04 ) : 84 % ( 74 - 95 ) for classic histology , 77 % ( 49 - 100 ) for desmoplastic tumours , and 57 % ( 33 - 80 ) for large-cell anaplastic tumours . INTERPRETATION Risk-adapted radiotherapy followed by a shortened schedule of dose-intensive chemotherapy can be used to improve the outcome of patients with high-risk medulloblastoma This international , prospect i ve , r and omised therapeutic study is based on previous , separate studies of the two societies . The study asks two principal questions : ( 1 ) Is it possible to improve the results of therapy by inserting , between surgery and post-operative irradiation , an intensive course of chemotherapy consisting of vincristine , procarbazine and methotrexate , followed by citrovorum factor rescue ? ( 2 ) In “ low risk ” patients ( i.e. those with macroscopically “ complete ” resection and absence of met \n Output:\n " }, { "from": "agent", "value": "Based on the evidence identified in this systematic review , a benefit of chemotherapy can not be excluded , but at this moment we are unable to draw a definitive conclusion regarding treatment with or without chemotherapy .\nThis systematic review only allowed a conclusion on the concept of treatment , not on the best strategy regarding specific chemotherapeutic agents and radiation dose ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The aim of this study was to assess whether a combination of gemcitabine ( GEM ) with either paclitaxel ( PTX ) or vinorelbine ( VNR ) could be more effective than GEM or PTX alone in elderly or unfit advanced non-small-cell lung cancer ( NSCLC ) patients . A total of 264 NSCLC patients aged > 70 years with ECOG performance status (PS)⩽2 , or younger with PS=2 , were r and omly treated with : GEM 1200 mg m−2 on days 1 , 8 and 15 every 28 days ; PTX 100 mg m−2 on days 1 , 8 and 15 every 28 days ; GEM 1000 mg m−2 plus PTX 80 mg m−2 ( GT ) on days 1 and 8 every 21 days ; GEM 1000 mg m−2 plus VNR 25 mg m−2 ( GV ) on days 1 and 8 every 21 days . In all arms , an intra- patients dose escalation was applied over the first three courses , provided that no toxicity of WHO grade ⩾2 had previously occurred . At present time , 217 ( 82 % ) patients had died . The median ( months ) and 1-year survival probability were 5.1 and 29 % for GEM , 6.4 and 25 % for PTX , 9.2 and 44 % for GT , and 9.7 and 32 % for GV . Multivariate analysis showed that PS⩽1 ( hazard ratio (HR)=0.67 ; 95 % CI 0.51–0.90 ) , and doublet treatments ( HR=0.76 ; 95 % CI 0.59–0.99 ) were significantly associated with longer survival . Doublets produced no more toxicity than single agents . GT should be considered a reference regimen for elderly NSCLC patients with PS⩽1 PURPOSE Sufficient data are currently unavailable to assist in defining suitable regimens for patients ≥ 70 years with advanced non-small cell lung cancer ( NSCLC ) . METHODS Chemonaïve patients with a performance status ( PS ) of 0 or 1 and stage IIIB or IV NSCLC were r and omized to gemcitabine 1000mg/m(2 ) on days 1 and 8 plus carboplatin area under the curve ( AUC ) 5.5 on day 1 ; the same schedule of gemcitabine plus paclitaxel 200mg/m(2 ) on day 1 ; or paclitaxel 225mg/m(2 ) on day 1 plus carboplatin AUC 6.0 on day 1 . Cycles were every 21 days up to 6 . Efficacy and toxicity results were compared by age groups . RESULTS Overall survival ( OS ) between patients < 70 years ( 8.6 months , 95 % CI : 7.9 , 9.5 ) and ≥ 70 years ( 7.9 months , 95 % CI : 7.1 , 9.5 ) was similar . OS was 8.8 months ( 95 % CI : 7.5 , 10.3 ) among patients 70 - 74 years , 6.5 months ( 95 % CI : 5.6 , 9.3 ) among patients 75 - 79 years , and 7.9 months ( 95 % CI : 6.3 , 10.3 ) among patients ≥ 80 years . OS was lower among patients 75 - 79 years compared with patients 70 - 74 years ( P=0.04 ) . Compared with patients < 70 years , patients ≥ 70 years experienced similar rates of myelosuppresion , but younger patients experienced more vomiting and nausea . There was no clear pattern with respect to differences in efficacy by treatments across age groups . CONCLUSIONS Based on the similarity of patient outcomes across age groups , doublet chemotherapy is feasible among carefully selected elderly patients with good PS The toxicity and therapeutic activity , including the effect on quality of life , of the carboplatin-oral etoposide combination , given with an intrapatient dose escalation , was tested in 38 non-small cell lung cancer ( NSCLC ) patients aged over 70 years , and in 8 younger patients with a performance status of 2 . In the absence of grade 3 - 4 toxicity , doses were escalated as follows : first course ( carboplatin AUC 4 ; etoposide 50 mg twice daily orally days 1 - 14 ) ; second course ( carboplatin AUC 5 ; etoposide 50 mg twice daily orally days 1 - 14 ) ; third course ( carboplatin AUC 5 ; etoposide 50 mg twice daily orally days 1 - 21 ) . A total of 141 chemotherapy cycles were delivered . The treatment was , in general , well tolerated and no toxic deaths occurred . More than 60 % of patients received 100 % of the planned dose intensity . Transient grade 4 neutropenia or thrombocytopenia occurred in 6 and 2 patients , respectively , but only 2 patients had to be hospitalised because of fever . All patients were evaluated for activity on an ' intention to treat basis ' . Ten partial responses and 20 stable disease were recorded , for an overall response rate of 22 % ( 95 % confidence interval ( CI ) = 11 - 36 ) . 9/38 ( 24 % ; 95 % CI = 12 - 41 ) elderly patients obtained a partial response . The median response duration was 4 months . A quality of life improvement was observed in 19 of the 46 enrolled patients ( 41 % ; 95 % CI = 27 - 57 ) , and 15/46 ( 33 % ; 95 % CI = 19 - 48 ) showed a performance status improvement . The quality of life score improved in 17/38 ( 45 % ) elderly patients . 8/10 responders and 11/20 patients with stable disease showed a concomitant improvement in quality of life . At a median potential follow-up of 16 months ( range 2 - 21 ) , 31 patients had had progression of disease and 23 had died , for a median time to progression ( TTP ) and overall survival ( OS ) of 5 and 10 months , respectively . The median survival time was 11 months in the elderly patients . The median time to subjective impairment ( TSI ) was 6 months ( 7 months in the elderly group ) . One-year estimated TTP , TSI and OS rates were 22 , 29 and 41 % , respectively . At multivariate Cox analysis , a > 25 % improvement in the quality of life score was more predictive of a better survival outcome than the response achievement The optimal treatment strategy for elderly patients with advanced nonsmall cell lung carcinoma has not been defined to date . The authors performed a retrospective analysis of a Phase III trial that treated patients who had Stage IIIB or IV nonsmall cell lung carcinoma with carboplatin and paclitaxel and analyzed the impact of age on response rate , survival , toxicity , and quality of life The aim of this study was to compare the efficacy of single‐agent weekly docetaxel with the combination of docetaxel and gemcitabine in elderly and /or poor performance status patients with advanced nonsmall cell lung cancer ( NSCLC ) BACKGROUND Platinum-based doublet chemotherapy is recommended to treat advanced non-small-cell lung cancer ( NSCLC ) in fit , non-elderly adults , but monotherapy is recommended for patients older than 70 years . We compared a carboplatin and paclitaxel doublet chemotherapy regimen with monotherapy in elderly patients with advanced NSCLC . METHODS In this multicentre , open-label , phase 3 , r and omised trial we recruited patients aged 70 - 89 years with locally advanced or metastatic NSCLC and WHO performance status scores of 0 - 2 . Patients received either four cycles ( 3 weeks on treatment , 1 week off treatment ) of carboplatin ( on day 1 ) plus paclitaxel ( on days 1 , 8 , and 15 ) or five cycles ( 2 weeks on treatment , 1 week off treatment ) of vinorelbine or gemcitabine monotherapy . R and omisation was done central ly with the minimisation method . The primary endpoint was overall survival , and analysis was done by intention to treat . This trial is registered , number NCT00298415 . FINDINGS 451 patients were enrolled . 226 were r and omly assigned monotherapy and 225 doublet chemotherapy . Median age was 77 years and median follow-up was 30.3 months ( range 8.6 - 45.2 ) . Median overall survival was 10.3 months for doublet chemotherapy and 6.2 months for monotherapy ( hazard ratio 0.64 , 95 % CI 0.52 - 0.78 ; p<0.0001 ) ; 1-year survival was 44.5 % ( 95 % CI 37.9 - 50.9 ) and 25.4 % ( 19.9 - 31.3 ) , respectively . Toxic effects were more frequent in the doublet chemotherapy group than in the monotherapy group ( most frequent , decreased neutrophil count ( 108 [ 48.4 % ] vs 28 [ 12.4 % ] ; asthenia 23 [ 10.3 % ] vs 13 [ 5.8 % ] ) . INTERPRETATION Despite increased toxic effects , platinum-based doublet chemotherapy was associated with survival benefits compared with vinorelbine or gemcitabine monotherapy in elderly patients with NSCLC . We feel that the current treatment paradigm for these patients should be reconsidered . FUNDING Intergroupe Francophone de Cancérologie Thoracique , Institut National du Cancer INTRODUCTION Elderly cancer patients are a very heterogeneous population . A comprehensive geriatric assessment ( CGA ) shall help to identify more precisely those patients who are fit , compared to those who are vulnerable or frail , when deciding on chemotherapeutical treatment . METHODS In a prospect i ve trial , 200 cancer patients treated in an out-patient setting were judged by their physician for their fitness for chemotherapy as fit , vulnerable or frail . A CGA was performed thereafter . We determined the feasibility of a CGA in an out-patient setting and the frequency of changes within the different assessment tools and compared physicians ' judgement with the CGA results . RESULTS Physicians judged 64.3 % of their patients as fit , 32.4 % as vulnerable , and 3.2 % as frail . A CGA was completed by 97.5 % of patients and lasted 20min per patients ( range : 9 - 47min ) . 26.5 % of all patients had no deficits in the CGA . The CGA identified a mean of 1.7 problems per patient , 1.3 in patients judged as fit , 2.3 in those judged as vulnerable , and 4.2 in those judged as frail . A CGA is more sensitive in classifying patients as fit compared to vulnerable or frail than physicians ' judgement . CONCLUSION A CGA is feasible and detects more elderly cancer patients as being unfit for chemotherapy than physicians ' judgement . Further trials including disease and treatment related end-points are needed BACKGROUND Vinorelbine prolongs survival and improves quality of life in elderly patients with advanced non-small-cell lung cancer ( NSCLC ) . Some studies have also suggested that gemcitabine is well tolerated and effective in such patients . We compared the effectiveness and toxicity of the combination of vinorelbine plus gemcitabine with those of each drug given alone in an open-label , r and omized phase III trial in elderly patients with advanced NSCLC . METHODS Patients aged 70 years and older , enrolled between December 1997 and November 2000 , were r and omly assigned to receive intravenous vinorelbine ( 30 mg/m(2 ) of body surface area ) , gemcitabine ( 1200 mg/m(2 ) ) , or vinorelbine ( 25 mg/m(2 ) ) plus gemcitabine ( 1000 mg/m(2 ) ) . All treatments were delivered on days 1 and 8 every 3 weeks for a maximum of six cycles . The primary endpoint was survival . Survival curves were drawn using the Kaplan-Meier method and analyzed by the Mantel-Haenszel test . Secondary endpoints were quality of life and toxicity . RESULTS Of 698 patients available for intention-to-treat analysis , 233 were assigned to receive vinorelbine , 233 to gemcitabine , and 232 to vinorelbine plus gemcitabine . Compared with each single drug , the combination treatment did not improve survival . The hazard ratio of death for patients receiving the combination treatment was 1.17 ( 95 % confidence interval [ CI ] = 0.95 to 1.44 ) that of patients receiving vinorelbine and 1.06 ( 95 % CI = 0.86 to 1.29 ) that of patients receiving gemcitabine . Although quality of life was similar across the three treatment arms , the combination treatment was more toxic than the two drugs given singly . CONCLUSION The combination of vinorelbine plus gemcitabine is not more effective than single-agent vinorelbine or gemcitabine in the treatment of elderly patients with advanced NSCLC BACKGROUND Older patients , even if fit , are often considered incapable of tolerating platinum-based systemic therapy . We performed a retrospective analysis of Eastern Cooperative Oncology Group ( ECOG ) 5592 , a phase III r and omized trial of platinum-based chemotherapy regimens \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS Doublets appear to be more effective and tolerable than single-agent therapy for treating elderly advanced NSCLC patients , and therefore could be considered as a treatment option for elderly population s with good physical status" } ]