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cochrane-simplification-train-900
cochrane-simplification-train-900
One trial, involving 393 women undergoing either vacuum or forceps deliveries, was included. The trial compared the antibiotic intravenous cefotetan after cord clamping compared with no treatment. This trial reported only two out of the nine outcomes specified in this review. Seven women in the group given no antibiotics had endomyometritis and none in prophylactic antibiotic group, the risk reduction was 93% (risk ratio (RR) 0.07; 95% confidence interval (CI) 0.00 to 1.21; low-quality evidence). There was no difference in the length of hospital stay between the two groups (mean difference (MD) 0.09 days; 95% CI -0.23 to 0.41; low-quality evidence). Overall, the risk of bias was judged to be unclear. The quality of the evidence using GRADE was low for both endometritis and maternal length of stay. One small trial was identified reporting only two outcomes. Evidence from this single trial suggests that antibiotic prophylaxis may lead to little or no difference in endometritis or maternal length of stay. There were no data on any other outcomes to evaluate the impact of antibiotic prophylaxis after operative vaginal delivery. Future research on antibiotic prophylaxis for operative vaginal delivery is needed to conclude whether it is useful for reducing postpartum morbidity.
We searched for evidence in July 2017 and identified only one study published in 1989. The study included 393 women undergoing either vacuum or forceps delivery comparing those receiving the antibiotic cefotetan with those women who received no treatment. There were no differences between the two groups of women in terms of age, previous pregnancies and other important characteristics. The only two outcomes reported in the trial were infection of the uterus (endometritis) and length of hospital stay. The trial reported that seven women had an infection of the uterus (endometritis) in the group that did not receive any antibiotics. No woman in the antibiotic group was reported to have an infection. Giving antibiotics had no effect on length of hospital stay for the mother for either group. The quality of the evidence for these two outcomes was assessed as being low: the evidence comes from a single trial, which included a very small number of women and reported on only two outcomes. Evidence from this single trial suggests that antibiotic prophylaxis may lead to little or no difference in endometritis or maternal length of stay. There were no data on any other outcomes to evaluate the impact of antibiotics for preventing infection after operative vaginal delivery. Future research on antibiotic prophylaxis for operative vaginal delivery is needed to provide evidence on whether it is a useful intervention.
10.1002/14651858.CD004455.pub4
[ "We searched for evidence in July 2017 and identified only one study published in 1989. The study included 393 women undergoing either vacuum or forceps delivery comparing those receiving the antibiotic cefotetan with those women who received no treatment. There were no differences between the two groups of women in terms of age, previous pregnancies and other important characteristics. The only two outcomes reported in the trial were infection of the uterus (endometritis) and length of hospital stay. The trial reported that seven women had an infection of the uterus (endometritis) in the group that did not receive any antibiotics. No woman in the antibiotic group was reported to have an infection. Giving antibiotics had no effect on length of hospital stay for the mother for either group. The quality of the evidence for these two outcomes was assessed as being low: the evidence comes from a single trial, which included a very small number of women and reported on only two outcomes. Evidence from this single trial suggests that antibiotic prophylaxis may lead to little or no difference in endometritis or maternal length of stay. There were no data on any other outcomes to evaluate the impact of antibiotics for preventing infection after operative vaginal delivery. Future research on antibiotic prophylaxis for operative vaginal delivery is needed to provide evidence on whether it is a useful intervention." ]
cochrane-simplification-train-901
cochrane-simplification-train-901
Four trials involving 229 participants were included. The studies were clinically heterogeneous, which precluded a meta-analysis. One trial (48 participants with burn wounds undergoing split skin grafts) compared HBOT with usual care and reported a significantly higher complete graft survival associated with HBOT (95% healthy graft area risk ratio (RR) 3.50; 95% confidence interval (CI) 1.35 to 9.11). A second trial (10 participants in free flap surgery) reported no significant difference between graft survival (no data available). A third trial (36 participants with crush injuries) reported significantly more wounds healed (RR 1.70; 95% CI 1.11 to 2.61), and significantly less tissue necrosis (RR 0.13; 95% CI 0.02 to 0.90) with HBOT compared to sham HBOT. The fourth trial (135 people undergoing flap grafting) reported no significant differences in complete graft survival with HBOT compared with dexamethasone (RR 1.14; 95% CI 0.95 to 1.38) or heparin (RR 1.21; 95% CI 0.99 to 1.49). Many of the predefined secondary outcomes of the review were not reported. All four trials were at unclear or high risk of bias. There is a lack of high quality, valid research evidence regarding the effects of HBOT on wound healing. Whilst two small trials suggested that HBOT may improve the outcomes of skin grafting and trauma, these trials were at risk of bias. Further evaluation by means of high quality RCTs is needed.
This review did not find any high quality research evidence showing that HBOT is beneficial for wound healing. Two poor quality studies suggested benefits associated with HBOT. The first, in patients with crush injuries, showed improved wound healing and fewer adverse outcomes. The second reported improved survival of split skin grafts in people with burn wounds. Two trials reported no benefits associated with HBOT for either skin grafting or free flap surgery. Further, better quality research is needed to determine the effects of HBOT on wound healing.
10.1002/14651858.CD008059.pub3
[ "This review did not find any high quality research evidence showing that HBOT is beneficial for wound healing. Two poor quality studies suggested benefits associated with HBOT. The first, in patients with crush injuries, showed improved wound healing and fewer adverse outcomes. The second reported improved survival of split skin grafts in people with burn wounds. Two trials reported no benefits associated with HBOT for either skin grafting or free flap surgery. Further, better quality research is needed to determine the effects of HBOT on wound healing." ]
cochrane-simplification-train-902
cochrane-simplification-train-902
The updated review included data from 72 studies, comprising a total of 4378 participants. Of these, 2291 received some form of treatment and 2087 acted as controls. The interventions consisted most often of different pharmaceutical agents, such as dopamine and its analogues, diuretics, calcium channel blockers, ACE inhibitors, NAC, ANP, sodium bicarbonate, antioxidants and EPO or selected hydration fluids. Some clinical heterogeneity and varying risk of bias were noted amongst the studies, although we were able to meaningfully interpret the data. Results showed significant heterogeneity and indicated that most interventions provided no benefit. Data on perioperative mortality were reported in 41 studies and data on acute renal injury in 44 studies (all interventions combined). Because of considerable clinical heterogeneity (different clinical scenarios, as well as considerable methodological variability amongst the studies), we did not perform a meta-analysis on the combined data. Subgroup analysis of major interventions and surgical procedures showed no significant influence of interventions on reported mortality and acute renal injury. For the subgroup of participants who had pre-existing renal damage, the risk of mortality from 10 trials (959 participants) was estimated as odds ratio (OR) 0.76, 95% confidence interval (CI) 0.38 to 1.52; the risk of acute renal injury (as reported in the trials) was estimated from 11 trials (979 participants) as OR 0.43, 95% CI 0.23 to 0.80. Subgroup analysis of studies that were rated as having low risk of bias revealed that 19 studies reported mortality numbers (1604 participants); OR was 1.01, 95% CI 0.54 to 1.90. Fifteen studies reported data on acute renal injury (criteria chosen by the individual studies; 1600 participants); OR was 1.03, 95% CI 0.54 to 1.97. No reliable evidence from the available literature suggests that interventions during surgery can protect the kidneys from damage. However, the criteria used to diagnose acute renal damage varied in many of the older studies selected for inclusion in this review, many of which suffered from poor methodological quality such as insufficient participant numbers and poor definitions of end points such as acute renal failure and acute renal injury. Recent methods of detecting renal damage such as the use of specific biomarkers and better defined criteria for identifying renal damage (RIFLE (risk, injury, failure, loss of kidney function and end-stage renal failure) or AKI (acute kidney injury)) may have to be explored further to determine any possible benefit derived from interventions used to protect the kidneys during the perioperative period.
No clear evidence from available RCTs suggests that any of the measures used to protect the kidneys during the perioperative period are beneficial. These findings held true in 14 studies of patients with pre-existing renal damage and in 24 studies that were considered of good methodological quality. The primary outcomes of these studies were mortality and acute renal injury. Reported mortality in studies with low risk of bias was not different between intervention and control groups (odds ratio (OR) 1.01, 95% confidence interval (CI) 0.52 to 1.97) or for acute renal injury (OR 1.05, 95% CI 0.55 to 2.03). The summary of findings revealed a similar picture. So we conclude that evidence suggests that none of the interventions used currently are helpful in protecting the kidneys during the perioperative period, nor do they cause increased harm.
10.1002/14651858.CD003590.pub4
[ "No clear evidence from available RCTs suggests that any of the measures used to protect the kidneys during the perioperative period are beneficial. These findings held true in 14 studies of patients with pre-existing renal damage and in 24 studies that were considered of good methodological quality. The primary outcomes of these studies were mortality and acute renal injury. Reported mortality in studies with low risk of bias was not different between intervention and control groups (odds ratio (OR) 1.01, 95% confidence interval (CI) 0.52 to 1.97) or for acute renal injury (OR 1.05, 95% CI 0.55 to 2.03). The summary of findings revealed a similar picture. So we conclude that evidence suggests that none of the interventions used currently are helpful in protecting the kidneys during the perioperative period, nor do they cause increased harm." ]
cochrane-simplification-train-903
cochrane-simplification-train-903
Six studies involving over 1345 TBAs, more than 32,000 women and approximately 57,000 births that examined the effects of TBA training for trained versus untrained TBAs (one study) and additionally trained TBA training versus trained TBAs (five studies) are included in this review. These studies consist of individual randomised trials (two studies) and cluster-randomised trials (four studies). The primary outcomes across the sample of studies were perinatal deaths, stillbirths and neonatal deaths (early, late and overall). Trained TBAs versus untrained TBAs: one cluster-randomised trial found a significantly lower perinatal death rate in the trained versus untrained TBA clusters (adjusted odds ratio (OR) 0.70, 95% confidence interval (CI) 0.59 to 0.83), lower stillbirth rate (adjusted OR 0.69, 95% CI 0.57 to 0.83) and lower neonatal death rate (adjusted OR 0.71, 95% CI 0.61 to 0.82). This study also found the maternal death rate was lower but not significant (adjusted OR 0.74, 95% CI 0.45 to 1.22). Additionally trained TBAs versus trained TBAs: three large cluster-randomised trials compared TBAs who received additional training in initial steps of resuscitation, including bag-valve-mask ventilation, with TBAs who had received basic training in safe, clean delivery and immediate newborn care. Basic training included mouth-to-mouth resuscitation (two studies) or bag-valve-mask resuscitation (one study). There was no significant difference in the perinatal death rate between the intervention and control clusters (one study, adjusted OR 0.79, 95% CI 0.61 to 1.02) and no significant difference in late neonatal death rate between intervention and control clusters (one study, adjusted risk ratio (RR) 0.47, 95% CI 0.20 to 1.11). The neonatal death rate, however, was 45% lower in intervention compared with the control clusters (one study, 22.8% versus 40.2%, adjusted RR 0.54, 95% CI 0.32 to 0.92). We conducted a meta-analysis on two outcomes: stillbirths and early neonatal death. There was no significant difference between the additionally trained TBAs versus trained TBAs for stillbirths (two studies, mean weighted adjusted RR 0.99, 95% CI 0.76 to 1.28) or early neonatal death rate (three studies, mean weighted adjusted RR 0.83, 95% CI 0.68 to 1.01). The results are promising for some outcomes (perinatal death, stillbirth and neonatal death). However, most outcomes are reported in only one study. A lack of contrast in training in the intervention and control clusters may have contributed to the null result for stillbirths and an insufficient number of studies may have contributed to the failure to achieve significance for early neonatal deaths. Despite the additional studies included in this updated systematic review, there remains insufficient evidence to establish the potential of TBA training to improve peri-neonatal mortality.
This review included six studies involving over 1345 TBAs, more than 32,000 women and approximately 57,000 births and examined the effect of TBA training, or additional training, on TBA behaviour and on pregnancy outcomes. We conclude that while there are a few more studies meeting the inclusion criteria and the results are promising for some outcomes, more evidence is needed to establish the potential of TBA training to improve peri-neonatal mortality. A lack of contrast in training in the intervention and control clusters and an insufficient number of studies may have contributed to the lack of observed differences in maternal deaths and deaths of their babies (early neonatal deaths).
10.1002/14651858.CD005460.pub3
[ "This review included six studies involving over 1345 TBAs, more than 32,000 women and approximately 57,000 births and examined the effect of TBA training, or additional training, on TBA behaviour and on pregnancy outcomes. We conclude that while there are a few more studies meeting the inclusion criteria and the results are promising for some outcomes, more evidence is needed to establish the potential of TBA training to improve peri-neonatal mortality. A lack of contrast in training in the intervention and control clusters and an insufficient number of studies may have contributed to the lack of observed differences in maternal deaths and deaths of their babies (early neonatal deaths)." ]
cochrane-simplification-train-904
cochrane-simplification-train-904
Sixty-one observational studies were selected of varying quality. Despite methodological differences there was a remarkable consistency in results, particularly for death and head injury outcomes. Motorcycle helmets were found to reduce the risk of death and head injury in motorcyclists who crashed. From four higher quality studies helmets were estimated to reduce the risk of death by 42% (OR 0.58, 95% CI 0.50 to 0.68) and from six higher quality studies helmets were estimated to reduce the risk of head injury by 69% (OR 0.31, 95% CI 0.25 to 0.38). Insufficient evidence was found to estimate the effect of motorcycle helmets compared with no helmet on facial or neck injuries. However, studies of poorer quality suggest that helmets have no effect on the risk of neck injuries and are protective for facial injury. There was insufficient evidence to demonstrate whether differences in helmet type confer more or less advantage in injury reduction. Motorcycle helmets reduce the risk of death and head injury in motorcycle riders who crash. Further well-conducted research is required to determine the effects of helmets and different helmet types on mortality, head, neck and facial injuries. However, the findings suggest that global efforts to reduce road traffic injuries may be facilitated by increasing helmet use by motorcyclists.
A review of studies concluded that helmets reduce the risk of head injury by around 69% and death by around 42%. There is, so far, insufficient evidence to compare the effectiveness of different types of helmet. Some studies have suggested that helmets may protect against facial injury and that they have no effect on neck injury, but more research is required for a conclusive answer. The review supports the view that helmet use should be actively encouraged worldwide for rider safety.
10.1002/14651858.CD004333.pub3
[ "A review of studies concluded that helmets reduce the risk of head injury by around 69% and death by around 42%. There is, so far, insufficient evidence to compare the effectiveness of different types of helmet. Some studies have suggested that helmets may protect against facial injury and that they have no effect on neck injury, but more research is required for a conclusive answer. The review supports the view that helmet use should be actively encouraged worldwide for rider safety." ]
cochrane-simplification-train-905
cochrane-simplification-train-905
Twelve studies were included in the review. This update incorporated two new studies. One of the new trials was a large field-based trial that included 2377 participants, 1220 of whom were allocated stretching. All other 11 studies were small, with between 10 and 30 participants receiving the stretch condition. Ten studies were laboratory-based and other two were field-based. All studies were exposed to either a moderate or high risk of bias. The quality of evidence was low to moderate. There was a high degree of consistency of results across studies. The pooled estimate showed that pre-exercise stretching reduced soreness at one day after exercise by, on average, half a point on a 100-point scale (mean difference -0.52, 95% CI -11.30 to 10.26; 3 studies). Post-exercise stretching reduced soreness at one day after exercise by, on average, one point on a 100-point scale (mean difference -1.04, 95% CI -6.88 to 4.79; 4 studies). Similar effects were evident between half a day and three days after exercise. One large study showed that stretching before and after exercise reduced peak soreness over a one week period by, on average, four points on a 100-point scale (mean difference -3.80, 95% CI -5.17 to -2.43). This effect, though statistically significant, is very small. The evidence from randomised studies suggests that muscle stretching, whether conducted before, after, or before and after exercise, does not produce clinically important reductions in delayed-onset muscle soreness in healthy adults.
The review located 12 relevant randomised controlled studies looking at the effect of stretching before or after physical activity on muscle soreness. Eleven studies were small with between 10 to 30 people being allocated stretching exercises. In contrast, one study was large with 2337 participants, 1220 of whom were in the stretching group. Ten studies were conducted in laboratories using standardised exercises. The only two studies, which included the only large study, were so-called field-based studies. These examined the effect of stretching on muscle soreness associated with self-selected physical activity. The studies were of low to moderate quality. Some of the studies examined the effects of stretching before physical activity, some examined the effects of stretching after physical activity, and some examined effects of stretching both before and after physical activity. The studies produced very consistent findings. They showed there was little or no effect of stretching on the muscle soreness experienced in the week after the physical activity.
10.1002/14651858.CD004577.pub3
[ "The review located 12 relevant randomised controlled studies looking at the effect of stretching before or after physical activity on muscle soreness. Eleven studies were small with between 10 to 30 people being allocated stretching exercises. In contrast, one study was large with 2337 participants, 1220 of whom were in the stretching group. Ten studies were conducted in laboratories using standardised exercises. The only two studies, which included the only large study, were so-called field-based studies. These examined the effect of stretching on muscle soreness associated with self-selected physical activity. The studies were of low to moderate quality. Some of the studies examined the effects of stretching before physical activity, some examined the effects of stretching after physical activity, and some examined effects of stretching both before and after physical activity. The studies produced very consistent findings. They showed there was little or no effect of stretching on the muscle soreness experienced in the week after the physical activity." ]
cochrane-simplification-train-906
cochrane-simplification-train-906
One small, short-term trial was eligible for inclusion. We included this study of 25 adults with chronic lung disease (only 32% of people included in the trial had bronchiectasis), as the other conditions were linked to development of bronchiectasis, and all were characterised by chronic sputum production. We were not able to obtain separate data for people with a diagnosis of bronchiectasis. We judged that the study was at a high risk of selection bias. The primary outcome (mean difference in control of bronchiectasis severity, quality of life (Qol), cough scores) was not reported in the included study. The single trial in adults reported a significant reduction in sputum production over 14 days for the treatment group (inhaled indomethacin) compared with the placebo group (mean difference (MD) -75.00 g/day; 95% confidence interval (CI) -134.61 to -15.39) and a significant improvement in the Borg Dyspnoea Scale score (MD -1.90, 95% CI -3.15 to -0.65). We noted no significant differences between groups in lung function or blood indices and no reported adverse events. No new studies of adults or children have been conducted since the last version of this review was published. Therefore, final conclusions have not changed. Current evidence is insufficient to support or refute the use of inhaled NSAIDs for the management of bronchiectasis in adults or children. One small trial reported a reduction in sputum production and improved dyspnoea among adults with chronic lung disease who were treated with inhaled indomethacin, indicating that additional studies on the efficacy of NSAIDs for treatment of patients with bronchiectasis are warranted.
We included one small study on 25 people with chronic lung disease. Of those 25, only eight people had bronchiectasis. Other individuals had chronic bronchitis of diffuse panbronchiolitis and were at risk for bronchiectasis. However, we must remember when interpreting the results that not all study participants had bronchiectasis. Overall, the small study reported improvement in sputum production and dyspnoea (shortness of breath) in adults with chronic lung disease (chronic bronchitis, bronchiectasis or diffuse panbronchiolitis) who received inhaled indomethacin compared with placebo. Researchers observed no significant improvement in lung function (forced expiratory volume in one second (FEV1) and vital capacity (VC)) and reported no adverse events. Conclusions The small scale of this study and collective analysis of data from the three disease states made it difficult for review authors to draw solid conclusions on the benefit of using NSAIDs to treat adults with bronchiectasis. Review authors identified no studies examining the use of NSAIDs in children with bronchiectasis.
10.1002/14651858.CD007525.pub3
[ "We included one small study on 25 people with chronic lung disease. Of those 25, only eight people had bronchiectasis. Other individuals had chronic bronchitis of diffuse panbronchiolitis and were at risk for bronchiectasis. However, we must remember when interpreting the results that not all study participants had bronchiectasis. Overall, the small study reported improvement in sputum production and dyspnoea (shortness of breath) in adults with chronic lung disease (chronic bronchitis, bronchiectasis or diffuse panbronchiolitis) who received inhaled indomethacin compared with placebo. Researchers observed no significant improvement in lung function (forced expiratory volume in one second (FEV1) and vital capacity (VC)) and reported no adverse events. Conclusions The small scale of this study and collective analysis of data from the three disease states made it difficult for review authors to draw solid conclusions on the benefit of using NSAIDs to treat adults with bronchiectasis. Review authors identified no studies examining the use of NSAIDs in children with bronchiectasis." ]
cochrane-simplification-train-907
cochrane-simplification-train-907
We included six single-site trials in rehabilitation settings, involving 338 participants. Four trials included people with only stroke. All studies provided sensory stimulation, sometimes with another intervention. Sensory stimulation typically involved practising tasks that required visuo-perceptual processing with occupational therapist assistance. Repetition was never used and only one study included functional training. No trials provided data on longer term improvement in ADL scores. Only three trials provided any data suitable for analysis. Two of these trials compared active to placebo intervention. There was no evidence of a difference in ADL scores at the scheduled end of intervention: mean difference (95% confidence interval (CI)) was 0.9 (-1.6 to 3.5) points on a self-care ADL scale in one study and odds ratio (95% CI) was 1.3 (0.56 to 3.1) for passing a driving test in the other, both in favour of active intervention. The trial that compared two active interventions did not find evidence of difference in any of the review outcomes. There is insufficient evidence to support or refute the view that perceptual interventions are effective. Future studies should be sufficiently large, include a standard care comparison and measure longer term functional outcomes. People with impaired perception problems should continue to receive neurorehabilitation according to clinical guidelines.
We searched for all relevant research, found six studies and assessed the quality of each study. We pooled their results where possible to draw our overall conclusions. Some of the original researchers provided additional information beyond that in their published studies. However, most of the research was conducted more than 10 years ago and only the published work was available to us. We found that all six studies examined the therapy approach of practising perceptual activities (e.g. puzzles and tasks that involve processing sensory information) with stroke patients. No study examined whether the therapy provided benefits past six month in terms of the level of independence in undertaking everyday activities. On the basis of existing research evidence, the benefit or harm of therapy for adults who experience difficulty processing sensory information after stroke or brain injury remains unknown. People with perceptual problems should continue to be offered rehabilitation as recommended in guidelines intended for healthcare practitioners. Future studies should be large enough to be conclusive and should look at the longer-term effects of therapy, including independence in doing everyday activities, emotions, outcome for family caregivers and potential harmful effects.
10.1002/14651858.CD007039.pub2
[ "We searched for all relevant research, found six studies and assessed the quality of each study. We pooled their results where possible to draw our overall conclusions. Some of the original researchers provided additional information beyond that in their published studies. However, most of the research was conducted more than 10 years ago and only the published work was available to us. We found that all six studies examined the therapy approach of practising perceptual activities (e.g. puzzles and tasks that involve processing sensory information) with stroke patients. No study examined whether the therapy provided benefits past six month in terms of the level of independence in undertaking everyday activities. On the basis of existing research evidence, the benefit or harm of therapy for adults who experience difficulty processing sensory information after stroke or brain injury remains unknown. People with perceptual problems should continue to be offered rehabilitation as recommended in guidelines intended for healthcare practitioners. Future studies should be large enough to be conclusive and should look at the longer-term effects of therapy, including independence in doing everyday activities, emotions, outcome for family caregivers and potential harmful effects." ]
cochrane-simplification-train-908
cochrane-simplification-train-908
Thirty-eight studies fulfilled the inclusion criteria. Rectal 5-ASA was superior to placebo for inducing symptomatic, endoscopic and histological improvement and remission, with POR for symptomatic improvement 8.87 (8 trials, 95% CI: 5.30 to 14.83; P < 0.00001), endoscopic improvement 11.18 (5 trials, 95% CI 5.99 to 20.88; P < 0.00001), histologic improvement 7.69 (6 trials, 95% CI 3.26 to 18.12; P < 0.00001), symptomatic remission 8.30 (8 trials, 95% CI 4.28 to 16.12; P < 0.00001), endoscopic remission 5.31 (7 trials, 95% CI 3.15 to 8.92; P < 0.00001), and histologic remission 6.28 (5 trials, 95% CI 2.74 to 14.40; P < 0.0001). Rectal 5-ASA was superior to rectal corticosteroids for inducing symptomatic improvement and remission with POR 1.56 (6 trials, 95% CI 1.15 to 2.11; P = 0.004) and 1.65 (6 trials, 95% CI 1.11 to 2.45; P = 0.01), respectively. Rectal 5-ASA was not superior to oral 5-ASA for symptomatic improvement (POR 2.25; 95% CI 0.53 to 19.54; P = 0.27). Neither total daily dose nor 5-ASA formulation affected treatment response. Rectal 5-ASA should be considered a first-line therapy for patients with mild to moderately active distal UC. The optimal total daily dose and dose frequency of 5-ASA remain to be determined. Future research should define differences in efficacy among patient subgroups defined by proximal disease margin and disease activity. There is a strong need for consensus standardization of outcome measurements for clinical trials in ulcerative colitis.
A review of the literature was undertaken to determine how effective rectal 5-ASA (e.g. enemas, suppositories or foam) is for treating distal UC. Thirty-eight studies met the criteria for inclusion in the review. Pooled results from these studies show that rectal 5-ASA is superior to placebo (fake suppositories, enemas or foam) for improving symptoms, improving the appearance of the bowel lining at colonoscopy, and improving the appearance of biopsies of the bowel examined microscopically. Rectal 5-ASA is also superior to rectal steroids for improving symptoms. Side effects were generally mild in nature and included abdominal pain or distention, nausea and anal discomfort or irritation. From these results, it was concluded that rectal 5-ASA should be a first-line treatment for patients with mild to moderately active distal UC.
10.1002/14651858.CD004115.pub2
[ "A review of the literature was undertaken to determine how effective rectal 5-ASA (e.g. enemas, suppositories or foam) is for treating distal UC. Thirty-eight studies met the criteria for inclusion in the review. Pooled results from these studies show that rectal 5-ASA is superior to placebo (fake suppositories, enemas or foam) for improving symptoms, improving the appearance of the bowel lining at colonoscopy, and improving the appearance of biopsies of the bowel examined microscopically. Rectal 5-ASA is also superior to rectal steroids for improving symptoms. Side effects were generally mild in nature and included abdominal pain or distention, nausea and anal discomfort or irritation. From these results, it was concluded that rectal 5-ASA should be a first-line treatment for patients with mild to moderately active distal UC." ]
cochrane-simplification-train-909
cochrane-simplification-train-909
Twenty-one trials (n = 3286) were included in the review. Seventeen trials (n = 2617) were included in the meta-analysis. Antispasmodics used included valethamate bromide, hyoscine butyl-bromide, drotaverine hydrochloride, rociverine and camylofin dihydrochloride. Most studies included antispasmodics as part of their package of active management of labour. Overall, the quality of studies was poor, as only four trials were assessed as low risk of bias. Thirteen trials (n = 1995) reported on the duration of first stage of labour, which was significantly reduced by an average of 74.34 minutes when antispasmodics were administered (mean difference (MD) -74.34 minutes; 95% confidence Interval (CI) -98.76 to -49.93). Seven studies (n = 797) reported on the total duration of labour, which was significantly reduced by an average of 85.51 minutes (MD -85.51 minutes; 95% CI -121.81 to -49.20). Six studies (n = 820) had data for the outcome: rate of cervical dilatation. Administration of antispasmodics significantly increased the rate of cervical dilatation by an average of 0.61 cm/hour (MD 0.61 cm/hour; 95% CI 0.34 to 0.88). Antispasmodics did not affect the duration of second and third stage of labour. The rate of normal vertex deliveries was not affected either. Only one study explored pain relief following administration of antispasmodics and no conclusions can be drawn on this outcome. There was significant heterogeneity for most outcomes and therefore, we undertook random-effects meta-analysis. Subgroup analysis was undertaken to explore heterogeneity, but remained largely unexplained. Maternal and neonatal adverse events were reported inconsistently. The main maternal adverse event reported was tachycardia. No serious neonatal adverse events were reported. There is low quality evidence that antispasmodics reduce the duration of first stage of labour and increase the cervical dilatation rate. There is very low quality evidence that antispasmodics reduce the total duration of labour. There is moderate quality evidence that antispasmodics do not affect the rate of normal vertex deliveries. There is insufficient evidence to make any conclusions regarding the safety of these drugs for both mother and baby. Large, rigorous randomised controlled trials are needed to evaluate the effect of antispasmodics on prolonged labour and to evaluate their effect on labour in a context of expectant management of labour.
Twenty-one randomised controlled studies with a total of 3286 participants were included. The data were combined in an analysis to get an overall result. All types of antispasmodics were given at the beginning of established labour. They decreased the first stage of labour, the time from beginning of labour until the baby is about to be born, by 49 to 98 minutes, as well as the total duration of labour, from the beginning of labour until the delivery of the afterbirth, by 49 to 121 minutes. The drugs did not affect the number of women requiring emergency caesarean sections and did not have serious side effects for either mother or her baby. The most commonly reported adverse events for the mothers were fast heart rates and mouth dryness, but since both maternal and neonatal adverse events were poorly reported, more information is needed to make conclusions about the safety of these drugs during labour. The included studies were mostly of poor quality and good studies are needed to assess what happens when these drugs are given to women whose labour is already prolonged.
10.1002/14651858.CD009243.pub3
[ "Twenty-one randomised controlled studies with a total of 3286 participants were included. The data were combined in an analysis to get an overall result. All types of antispasmodics were given at the beginning of established labour. They decreased the first stage of labour, the time from beginning of labour until the baby is about to be born, by 49 to 98 minutes, as well as the total duration of labour, from the beginning of labour until the delivery of the afterbirth, by 49 to 121 minutes. The drugs did not affect the number of women requiring emergency caesarean sections and did not have serious side effects for either mother or her baby. The most commonly reported adverse events for the mothers were fast heart rates and mouth dryness, but since both maternal and neonatal adverse events were poorly reported, more information is needed to make conclusions about the safety of these drugs during labour. The included studies were mostly of poor quality and good studies are needed to assess what happens when these drugs are given to women whose labour is already prolonged." ]
cochrane-simplification-train-910
cochrane-simplification-train-910
Two studies with a combined total of 288 participants met the inclusion criteria for this review. One study compared low molecular weight heparin with unfractionated heparin and found no difference between the treatments in the prevention of DVT (odds ratio (OR) 1.23, 95% confidence interval (CI) 0.28 to 5.35). No bleeding events or deaths occurred. This study was open label and therefore at a high risk of performance bias. Additionally, the method of randomisation was not reported and therefore the risk of selection bias was unclear. In the second study heparin did not significantly improve prevention of pulmonary embolism (OR 1.02, 95% CI 0.44 to 2.37) when compared to placebo. Furthermore, when the level of amputation was considered, the incidence of pulmonary embolism was similar between the two treatment groups: above knee amputation (OR 0.79, 95% CI 0.31 to 1.97) and below knee amputation (OR 1.53, 95% CI 0.09 to 26.43). Ten participants died during the study; five underwent a post-mortem and three were found to have had a recent pulmonary embolism, all of whom had been on placebo. Bleeding events were reported in less than 10% of participants in both treatment groups but specific data were not presented. This study did not report the methods used to conceal allocation of treatment and therefore it was unclear if selection bias occurred. However, this study appeared to be free from all other sources of bias. No study looked at mechanical prophylaxis. As only two studies were included in this review, each comparing different interventions, there is insufficient evidence to make any conclusions regarding the most effective thromboprophylaxis regimen in patients undergoing lower limb amputation. Further large-scale studies that are of good quality are required.
After searching for relevant studies, we found two studies with a combined total of 288 participants to be included in this review of evidence. One study compared two forms of the anticoagulant heparin. Low molecular weight heparin offered no significant improvement over unfractionated heparin in the prevention of DVT. Furthermore neither drug caused bleeding. However, in this study both the participants and study personnel were aware of which treatment was being administered. This may have biased the results. It is unclear if other bias was introduced in the study because the process of randomly allocating treatment was not adequately described. The second study concluded that heparin was not more effective in preventing a PE than placebo whether the amputation was above or below the knee. Bleeding occurred in less than 10% of each treatment group but the study authors did not report specific numbers and therefore this could not be analysed. This study did not report the methods used to conceal how treatment was allocated but it was judged to be free from other sources of bias. This review found that there are too few trials to determine the most effective strategy in preventing VTE in people undergoing amputation of the lower limb. No study looked at mechanical forms of preventing VTE, such as compression devices, and therefore it is not possible to make any conclusions about these. Further good quality and large-scale studies are required.
10.1002/14651858.CD010525.pub2
[ "After searching for relevant studies, we found two studies with a combined total of 288 participants to be included in this review of evidence. One study compared two forms of the anticoagulant heparin. Low molecular weight heparin offered no significant improvement over unfractionated heparin in the prevention of DVT. Furthermore neither drug caused bleeding. However, in this study both the participants and study personnel were aware of which treatment was being administered. This may have biased the results. It is unclear if other bias was introduced in the study because the process of randomly allocating treatment was not adequately described. The second study concluded that heparin was not more effective in preventing a PE than placebo whether the amputation was above or below the knee. Bleeding occurred in less than 10% of each treatment group but the study authors did not report specific numbers and therefore this could not be analysed. This study did not report the methods used to conceal how treatment was allocated but it was judged to be free from other sources of bias. This review found that there are too few trials to determine the most effective strategy in preventing VTE in people undergoing amputation of the lower limb. No study looked at mechanical forms of preventing VTE, such as compression devices, and therefore it is not possible to make any conclusions about these. Further good quality and large-scale studies are required." ]
cochrane-simplification-train-911
cochrane-simplification-train-911
In this updated review, one new ongoing study was found but no new eligible completed studies were identified. This update was therefore conducted using the same four studies included in the original review. These studies included a total of 1219 participants, mean age 40 to 54 years. All included studies were reported as RCTs. Two were multicentred, together including a total of 1114 patients who underwent cerebral aneurysm clipping, and were judged to have an overall low risk of bias. The other two studies were single centred. One included 80 patients who had a craniotomy following severe traumatic brain injury and was judged to have an unclear or low risk of bias. The other study included 25 patients who underwent hemicranicectomy to relieve oedema following cerebral infarction and was judged to have an unclear or high risk of bias. All studies assessed hypothermia versus normothermia. Overall 608 participants received hypothermia with target temperatures ranging from 32.5 °C to 35 °C, and 611 were assigned to normothermia with the actual temperatures recorded in this group ranging form 36.5 °C to 38 °C. For those who were cooled, 556 had cooling commenced immediately after induction of anaesthesia that was continued until the surgical objective of aneurysm clipping was achieved, and 52 had cooling commenced immediately after surgery and continued for 48 to 96 hours. Pooled estimates of effect were calculated for the outcomes mortality during treatment or follow-up (ranging from in-hospital to one year); neurological outcome measured in terms of the Glasgow Outcome Score (GOS) of 3 or less; and adverse events of infections, myocardial infarction, ischaemic stroke and congestive cardiac failure. With regards to mortality, the risk of dying if allocated to hypothermia compared to normothermia was not statistically significantly different (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.59 to 1.27, P = 0.47). There was no indication that the time at which cooling was started affected the risk of dying (RR with intraoperative cooling 0.95, 95% CI 0.60 to 1.51, P = 0.83; RR for cooling postoperatively 0.67, 95% CI 0.34 to 1.35, P = 0.26). For the neurological outcome, the risk of having a poor outcome with a GOS of 3 or less was not statistically different in those who received hypothermia versus normothermia (RR 0.80, 95% CI 0.61 to 1.04, P = 0.09). Again there was no indication that the time at which cooling was started affected this result. Regarding adverse events, there was no statistically significant difference in the incidence in those allocated to hypothermia versus normothermia for risk of surgical infection (RR 1.20, 95% CI 0.73 to 1.97, P = 0.48), myocardial infarction (RR 1.86, 95% CI 0.69 to 4.98, P = 0.22), ischaemic stroke (RR 0.93, 95% CI 0.82 to 1.05, P = 0.24) or congestive heart failure (RR 0.85, 95% CI 0.60 to 1.21, P = 0.38). In contrast to other outcomes, where time of application of cooling did not change the statistical significance of the effect estimates, there was a weak statistically significant increased risk of infection in those who were cooled postoperatively versus those who were not cooled (RR 1.77, 95% CI 1.05 to 2.98, P = 0.03). Overall, as in the original review, no evidence was found that the use of induced hypothermia was either beneficial or harmful in patients undergoing neurosurgery. We found no evidence that the use of induced hypothermia was associated with a significant reduction in mortality or severe neurological disability, or an increase in harm in patients undergoing neurosurgery.
Studies in animals have shown that lowering the body temperature can help to protect the brain cells in circumstances when the blood supply to the cells is compromised. Similarly, studies in humans who have been resuscitated after their heart stopped beating have shown that lowering their body temperature helps to reduce brain damage. The purpose of this updated version of a previous review of the same title was to determine whether cooling patients who were having brain surgery reduced death and serious disability, or was associated with increased risk of harm. A detailed search of the available literature up until May 2014 identified four eligible studies that included a total of 1219 participants. Their results were combined to answer these questions. No evidence was found that cooling patients who are having brain operations reduced the risk of death or severe disability, or produced significant harm.
10.1002/14651858.CD006638.pub3
[ "Studies in animals have shown that lowering the body temperature can help to protect the brain cells in circumstances when the blood supply to the cells is compromised. Similarly, studies in humans who have been resuscitated after their heart stopped beating have shown that lowering their body temperature helps to reduce brain damage. The purpose of this updated version of a previous review of the same title was to determine whether cooling patients who were having brain surgery reduced death and serious disability, or was associated with increased risk of harm. A detailed search of the available literature up until May 2014 identified four eligible studies that included a total of 1219 participants. Their results were combined to answer these questions. No evidence was found that cooling patients who are having brain operations reduced the risk of death or severe disability, or produced significant harm." ]
cochrane-simplification-train-912
cochrane-simplification-train-912
The 2012 update identified 13 studies classified as ongoing or awaiting classification (yet to report allergy outcomes). Forty-three studies were excluded, primarily as no allergy data were reported, although none of these enrolled infants were at high risk of allergy. Four studies enrolling 1428 infants were eligible for inclusion. All studies were at high risk of attrition bias. Allergy outcomes were reported from four months to two years of age. Meta-analysis of two studies (226 infants) found no significant difference in infant asthma although significant heterogeneity was found between studies. Meta-analysis of four studies found a significant reduction in eczema (1218 infants, typical risk ratio 0.68, 95% CI 0.48 to 0.97; typical risk difference -0.04, 95% CI -0.07 to -0.00; number needed to treat to benefit (NNTB) 25, 95% CI 14 to > 100; P = 0.03). No statistically significant heterogeneity was found between studies. One study reported no significant difference in urticaria. No statistically significant subgroup differences were found according to infant risk of allergy or type of infant feed. However, individual studies reported a significant reduction in asthma and eczema from supplementation with a mixture of galacto- and fructo-oligosaccharide (GOS/FOS 9:1 ratio) (8 g/L) in infants at high risk of allergy; and in eczema from supplementation with GOS/FOS (9:1) (6.8 g/L) and acidic oligosacccharide (1.2 g/L) in infants not selected for allergy risk. Further research is needed before routine use of prebiotics can be recommended for prevention of allergy in formula fed infants. There is some evidence that a prebiotic supplement added to infant feeds may prevent eczema. It is unclear whether the use of prebiotic should be restricted to infants at high risk of allergy or may have an effect in low risk populations; or whether it may have an effect on other allergic diseases including asthma.
However, there is some concern about the reliability of the evidence due to not all trials reporting allergy outcomes and trials not reporting the outcome for all infants. Reactions to foods and allergies (including asthma, eczema and hay fever) are common and may be increasing. Many infants become sensitised to foods, including infant formula, through their gastrointestinal tract, a process that may be affected by the composition of the intestinal bacteria. Attempts to promote the growth of normal gastrointestinal bacteria and prevent sensitisation to foods have included the addition of prebiotic to infant formula. Prebiotics are nondigestible food components that help by selectively stimulating the growth or activity of 'healthy' bacteria in the colon. This review found some evidence that a prebiotic supplement added to infant feeds may prevent eczema in infants up to two years of age. It is unclear whether the use of prebiotic should be restricted to infants at high risk of allergy or may have an effect in low risk populations; or whether it may have an effect on other allergic diseases including asthma. However, further research is needed to confirm the findings before routine use of prebiotics can be recommended for prevention of allergy.
10.1002/14651858.CD006474.pub3
[ "However, there is some concern about the reliability of the evidence due to not all trials reporting allergy outcomes and trials not reporting the outcome for all infants. Reactions to foods and allergies (including asthma, eczema and hay fever) are common and may be increasing. Many infants become sensitised to foods, including infant formula, through their gastrointestinal tract, a process that may be affected by the composition of the intestinal bacteria. Attempts to promote the growth of normal gastrointestinal bacteria and prevent sensitisation to foods have included the addition of prebiotic to infant formula. Prebiotics are nondigestible food components that help by selectively stimulating the growth or activity of 'healthy' bacteria in the colon. This review found some evidence that a prebiotic supplement added to infant feeds may prevent eczema in infants up to two years of age. It is unclear whether the use of prebiotic should be restricted to infants at high risk of allergy or may have an effect in low risk populations; or whether it may have an effect on other allergic diseases including asthma. However, further research is needed to confirm the findings before routine use of prebiotics can be recommended for prevention of allergy." ]
cochrane-simplification-train-913
cochrane-simplification-train-913
We identified 10 published reports of nine original RCTs (one report was a long-term follow-up of the original trial) in over 1100 primary care doctors and around 492,000 patients. The main risk of bias came from participants in most studies knowing whether they had received the intervention or not, and we downgraded the rating of the quality of evidence because of this. We meta-analysed data using a random-effects model on the primary and key secondary outcomes and formally assessed heterogeneity. Remaining outcomes are presented narratively. There is moderate quality evidence that interventions that aim to facilitate shared decision making reduce antibiotic use for ARIs in primary care (immediately after or within six weeks of the consultation), compared with usual care, from 47% to 29%: risk ratio (RR) 0.61, 95% confidence interval (CI) 0.55 to 0.68. Reduction in antibiotic prescribing occurred without an increase in patient-initiated re-consultations (RR 0.87, 95% CI 0.74 to 1.03, moderate quality evidence) or a decrease in patient satisfaction with the consultation (OR 0.86, 95% CI 0.57 to 1.30, low quality evidence). There were insufficient data to assess the effects of the intervention on sustained reduction in antibiotic prescribing, adverse clinical outcomes (such as hospital admission, incidence of pneumonia and mortality), or measures of patient and caregiver involvement in shared decision making (such as satisfaction with the consultation; regret or conflict with the decision made; or treatment compliance following the decision). No studies assessed antibiotic resistance in colonising or infective organisms. Interventions that aim to facilitate shared decision making reduce antibiotic prescribing in primary care in the short term. Effects on longer-term rates of prescribing are uncertain and more evidence is needed to determine how any sustained reduction in antibiotic prescribing affects hospital admission, pneumonia and death.
We identified 10 studies (nine trials and one follow-up study) up to December 2014. In total, the studies involved over 1100 primary care doctors and around 492,000 patients. The intervention was different in each study. Six of the studies involved training clinicians (mostly primary care doctors) in communication skills that are needed to facilitate shared decision making. In three studies, as well as training doctors in these skills, patients were also given written information about antibiotics for acute respiratory infections. All included trials received funding from government sources. No studies declared a conflict of interest. Interventions that aim to facilitate shared decision making significantly reduce antibiotic prescribing for acute respiratory infections in primary care, without a decrease in patients' satisfaction with the consultation, or an increase in repeat consultations for the same illness. There was not enough information to decide whether shared decision making affects other clinically adverse secondary outcomes, measures of clinician and patient involvement in sharing decision making, or antibiotic resistance. We rated the quality of the evidence as moderate or low for all outcomes.
10.1002/14651858.CD010907.pub2
[ "We identified 10 studies (nine trials and one follow-up study) up to December 2014. In total, the studies involved over 1100 primary care doctors and around 492,000 patients. The intervention was different in each study. Six of the studies involved training clinicians (mostly primary care doctors) in communication skills that are needed to facilitate shared decision making. In three studies, as well as training doctors in these skills, patients were also given written information about antibiotics for acute respiratory infections. All included trials received funding from government sources. No studies declared a conflict of interest. Interventions that aim to facilitate shared decision making significantly reduce antibiotic prescribing for acute respiratory infections in primary care, without a decrease in patients' satisfaction with the consultation, or an increase in repeat consultations for the same illness. There was not enough information to decide whether shared decision making affects other clinically adverse secondary outcomes, measures of clinician and patient involvement in sharing decision making, or antibiotic resistance. We rated the quality of the evidence as moderate or low for all outcomes." ]
cochrane-simplification-train-914
cochrane-simplification-train-914
We included five RCTs with a total of 827 participants. Outcomes were available for 730 participants (384 participants randomised to continuous sutures and 346 participants to interrupted sutures). All the trials were of unclear or high risk of bias. The participants underwent abdominal or groin operations. The only outcomes reported in the trials were superficial surgical site infection, superficial wound dehiscence (breakdown) and length of hospital stay. Other important outcomes such as quality of life, long-term patient outcomes and use of healthcare resources were not reported in these trials. Overall, 6.5% (39/602 participants, four trials) developed superficial surgical site infections. There was no significant difference between the groups in the proportion of participants who developed superficial surgical site infections (RR 0.73; 95% CI 0.40 to 1.33). A total of 23 participants (23/625 (3.7%), four trials) developed superficial wound dehiscence. Twenty-two of the 23 participants belonged to the interrupted suture group.The proportion of participants who developed superficial wound dehiscence was statistically significantly lower in the continuous suture group compared to the interrupted suture group (RR 0.08; 95% CI 0.02 to 0.35). Most of these wound dehiscences were reported in two recent trials in which the continuous skin suture groups received absorbable subcuticular sutures while the interrupted skin suture groups received non-absorbable transcutaneous sutures. The non-absorbable sutures were removed seven to nine days after surgery in the interrupted sutures groups whilst sutures in the comparator groups were not removed, being absorbable. The continuous suture technique with absorbable suture does not require suture removal and provides support for the wound for a longer period of time. This may have contributed to the difference between the two groups in the proportion of participants who developed superficial wound dehiscence. There was no significant difference in the length of the hospital stay between the two groups (MD -1.40 days; 95% CI -7.14 to 4.34). Superficial wound dehiscence may be reduced by using continuous subcuticular sutures. However, there is uncertainty about this because of the quality of the evidence. Besides, the nature of the suture material used may have led to this observation, as the continuous suturing technique used suture material that did not need to be removed, whereas the comparator used interrupted (non-absorbable) sutures that did need to be removed. Differences in the methods of skin closure have the potential to affect patient outcomes and use of healthcare resources. Further well-designed trials at low risk of bias are necessary to determine which type of suturing is better.
We identified five RCTs with a total of 827 participants. Seven hundred thirty participants (384 received continuous sutures and 346 interrupted sutures) provided data for this review. Participants had abdominal or groin operations. The only outcomes reported were, superficial surgical site infection, superficial wound breakdown and length of hospital stay. No other important outcomes, including quality of life, long-term patient outcomes and use of healthcare resources, were reported. Approximately 6% of participants developed superficial surgical site infection, but there was no significant difference between the two groups in the proportion of participants who developed these. Approximately 4% of participants developed superficial wound breakdown. The proportion of participants with this problem in the continuous suture group was approximately one-tenth of that in the interrupted suture group. Most wound breakdowns occurred in two trials that used absorbable sutures for continuous suturing and non-absorbable sutures for interrupted suturing. Non-absorbable sutures are removed seven to nine days after surgery, but absorbable sutures are not removed, and so support the wound for longer - which may account for the difference in distribution of this problem between groups. There was no significant difference between groups for length of hospital stay. Superficial wound breakdown is reduced by continuous subcuticular suturing. However, the trials that contributed to this result had suture removal in only one group (interrupted sutures), which may have led to this observation. The number of participants included in this review was small and follow-up after surgery was short. The overall quality of evidence was very low. Levels of bias across the studies were mostly high or unclear, so there may have been flaws in trial organisation that could produce erroneous results. Further well-designed trials at low risk of bias are necessary.
10.1002/14651858.CD010365.pub2
[ "We identified five RCTs with a total of 827 participants. Seven hundred thirty participants (384 received continuous sutures and 346 interrupted sutures) provided data for this review. Participants had abdominal or groin operations. The only outcomes reported were, superficial surgical site infection, superficial wound breakdown and length of hospital stay. No other important outcomes, including quality of life, long-term patient outcomes and use of healthcare resources, were reported. Approximately 6% of participants developed superficial surgical site infection, but there was no significant difference between the two groups in the proportion of participants who developed these. Approximately 4% of participants developed superficial wound breakdown. The proportion of participants with this problem in the continuous suture group was approximately one-tenth of that in the interrupted suture group. Most wound breakdowns occurred in two trials that used absorbable sutures for continuous suturing and non-absorbable sutures for interrupted suturing. Non-absorbable sutures are removed seven to nine days after surgery, but absorbable sutures are not removed, and so support the wound for longer - which may account for the difference in distribution of this problem between groups. There was no significant difference between groups for length of hospital stay. Superficial wound breakdown is reduced by continuous subcuticular suturing. However, the trials that contributed to this result had suture removal in only one group (interrupted sutures), which may have led to this observation. The number of participants included in this review was small and follow-up after surgery was short. The overall quality of evidence was very low. Levels of bias across the studies were mostly high or unclear, so there may have been flaws in trial organisation that could produce erroneous results. Further well-designed trials at low risk of bias are necessary." ]
cochrane-simplification-train-915
cochrane-simplification-train-915
Six studies (271 patients) were included. Five studies investigated PGE1 with or without fosinopril/losartan versus fosinopril/losartan or no treatment and one compared PGE1 versus Xueshuantong (a Chinese medicinal herb). There was a significant decrease in urinary albumin excretion rate (UAER) in patients treated with PGE1 (MD -48.28 µg/min, 95% CI -75.29 to -21.28), other outcomes also showed a significant decrease in the patients with PGE1 (albuminuria: MD -143.66 mg/24 h, 95% CI -221.48 to -65.84; proteinuria: MD -300 g/24 h, 95% CI -518.34 to -81.66). PGE1 had a positive effect on albuminuria (MD -660 mg/24 h, 95% CI -867.07 to -452.93) in clinical DKD (CDN, III stage of DN) compared with Xueshuantong. No data on incidence of ESKD, all-cause mortality or quality of life were available. PGE1 may have positive effects on DKD by reducing UAER, decreasing albuminuria and lessening proteinuria, with no obvious serious adverse events. However, limited by the poor methodological quality of the included studies and the small number of participants, there is currently insufficient evidence for determining if PGE1 could be used for preventing the progression of DKD. Large, properly randomised, placebo-controlled, double-blind studies are urgently needed.
This review identified six studies (271 participants) comparing PGE1 with or without ACEi/ARB versus ACEi/ARB, no treatment or Xueshuantong (a Chinese medicinal herb). The results suggest that PGE1 may have a positive effect on DKD by reducing urinary albumin excretion rate (UAER), microalbuminuria and proteinuria. No serious adverse events or allergic responses were reported. All studies were methodologically poor and there is no strong evidence for recommending PGE1 for preventing the progression of DKD as a routine therapeutic measure. More high-quality research is needed.
10.1002/14651858.CD006872.pub2
[ "This review identified six studies (271 participants) comparing PGE1 with or without ACEi/ARB versus ACEi/ARB, no treatment or Xueshuantong (a Chinese medicinal herb). The results suggest that PGE1 may have a positive effect on DKD by reducing urinary albumin excretion rate (UAER), microalbuminuria and proteinuria. No serious adverse events or allergic responses were reported. All studies were methodologically poor and there is no strong evidence for recommending PGE1 for preventing the progression of DKD as a routine therapeutic measure. More high-quality research is needed." ]
cochrane-simplification-train-916
cochrane-simplification-train-916
The search found 17 studies that assessed the effect of higher versus lower intake of PUFAs on allergic outcomes in infants. Only nine studies enrolling 2704 infants reported allergy outcomes that could be used in meta-analyses. Of these, there were methodological concerns for eight. In infants up to two years of age, meta-analyses found no difference in incidence of all allergy (1 study, 323 infants; RR 0.96, 95% CI 0.73 to 1.26; risk difference (RD) -0.02, 95% CI -0.12 to 0.09; heterogeneity not applicable), asthma (3 studies, 1162 infants; RR 1.04, 95% CI 0.80 to 1.35, I2 = 0%; RD 0.01, 95% CI -0.04 to 0.05, I2 = 0%), dermatitis/eczema (7 studies, 1906 infants; RR 0.93, 95% CI 0.82 to 1.06, I2 = 0%; RD -0.02, 95% CI -0.06 to 0.02, I2 = 0%) or food allergy (3 studies, 915 infants; RR 0.81, 95% CI 0.56 to 1.19, I2 = 63%; RD -0.02, 95% CI -0.06 to 0.02, I2 = 74%). There was a reduction in allergic rhinitis (2 studies, 594 infants; RR 0.47, 95% CI 0.23 to 0.96, I2 = 6%; RD -0.04, 95% CI -0.08 to -0.00, I2 = 54%; number needed to treat for an additional beneficial outcome (NNTB) 25, 95% CI 13 to ∞). In children aged two to five years, meta-analysis found no difference in incidence of all allergic disease (2 studies, 154 infants; RR 0.69, 95% CI 0.47 to 1.02, I2 = 43%; RD -0.16, 95% CI -0.31 to -0.00, I2 = 63%; NNTB 6, 95% CI 3 to ∞), asthma (1 study, 89 infants; RR 0.45, 95% CI 0.20 to 1.02; RD -0.20, 95% CI -0.37 to -0.02; heterogeneity not applicable; NNTB 5, 95% CI 3 to 50), dermatitis/eczema (2 studies, 154 infants; RR 0.65, 95% CI 0.34 to 1.24, I2 = 0%; RD -0.09 95% CI -0.22 to 0.04, I2 = 24%) or food allergy (1 study, 65 infants; RR 2.27, 95% CI 0.25 to 20.68; RD 0.05, 95% CI -0.07 to 0.16; heterogeneity not applicable). In children aged two to five years, meta-analysis found no difference in prevalence of all allergic disease (2 studies, 633 infants; RR 0.98, 95% CI 0.81 to 1.19, I2 = 36%; RD -0.01, 95% CI -0.08 to 0.07, I2 = 0%), asthma (2 studies, 635 infants; RR 1.12, 95% CI 0.82 to 1.53, I2 = 0%; RD 0.02, 95% CI -0.04 to 0.09, I2 = 0%), dermatitis/eczema (2 studies, 635 infants; RR 0.81, 95% CI 0.59 to 1.09, I2 = 0%; RD -0.04 95% CI -0.11 to 0.02, I2 = 0%), allergic rhinitis (2 studies, 635 infants; RR 1.02, 95% CI 0.83 to 1.25, I2 = 0%; RD 0.01, 95% CI -0.06 to 0.08, I2 = 0%) or food allergy (1 study, 119 infants; RR 0.27, 95% CI 0.06 to 1.19; RD -0.10, 95% CI -0.20 to -0.00; heterogeneity not applicable; NNTB 10, 95% CI 5 to ∞). There is no evidence that PUFA supplementation in infancy has an effect on infant or childhood allergy, asthma, dermatitis/eczema or food allergy. However, the quality of evidence was very low. There was insufficient evidence to determine an effect on allergic rhinitis.
This review found 100 studies that assessed the effect of higher versus lower intake of PUFAs in infants through searches of medical databases up to September 2015. However, only nine of these studies enrolling 2704 infants reported allergy outcomes (measures). Of these nine studies, we considered only one to be high quality. Five studies reported all allergy as an outcome measure; four studies reported asthma; all nine studies reported dermatitis/eczema; two studies reported allergic rhinitis and four studies reported food allergy. PUFA supplementation in infancy did not affect the risk of infant (aged up to two years of age) or childhood (aged up to 10 years of age) allergy, asthma, dermatitis/eczema and food allergy. There was a reduction in the risk of allergic rhinitis during infancy, however, there was no effect on the risk of childhood allergic rhinitis. There is insufficient evidence to determine an effect on allergic rhinitis. We graded the evidence for no effect on infant incidence, childhood incidence and childhood prevalence of all allergy as very low; the reduction in infant incidence of allergic rhinitis as very low; and the evidence for no effect on infant incidence, childhood incidence and childhood prevalence of all other allergic outcomes as very low to low. Further high quality studies are needed before we can determine an effect of higher PUFA intake in infants on the risk of allergic disease.
10.1002/14651858.CD010112.pub2
[ "This review found 100 studies that assessed the effect of higher versus lower intake of PUFAs in infants through searches of medical databases up to September 2015. However, only nine of these studies enrolling 2704 infants reported allergy outcomes (measures). Of these nine studies, we considered only one to be high quality. Five studies reported all allergy as an outcome measure; four studies reported asthma; all nine studies reported dermatitis/eczema; two studies reported allergic rhinitis and four studies reported food allergy. PUFA supplementation in infancy did not affect the risk of infant (aged up to two years of age) or childhood (aged up to 10 years of age) allergy, asthma, dermatitis/eczema and food allergy. There was a reduction in the risk of allergic rhinitis during infancy, however, there was no effect on the risk of childhood allergic rhinitis. There is insufficient evidence to determine an effect on allergic rhinitis. We graded the evidence for no effect on infant incidence, childhood incidence and childhood prevalence of all allergy as very low; the reduction in infant incidence of allergic rhinitis as very low; and the evidence for no effect on infant incidence, childhood incidence and childhood prevalence of all other allergic outcomes as very low to low. Further high quality studies are needed before we can determine an effect of higher PUFA intake in infants on the risk of allergic disease." ]
cochrane-simplification-train-917
cochrane-simplification-train-917
We identified 12 studies of patients commencing warfarin for inclusion in the review. The overall risk of bias was found to be variable, with most studies reporting adequate methods for randomisation but only two studies reporting adequate data on allocation concealment. Four studies (355 patients) compared 5 mg versus 10 mg loading doses. All four studies reported INR in-range by day five. Although there was notable heterogeneity, pooling of these four studies showed no overall difference between 5 mg versus 10 mg loading doses (RR 1.17, 95% CI 0.77 to 1.77, P = 0.46, I2 = 83%). Two of these studies used two consecutive INRs in-range as the outcome and showed no difference between a 5 mg and 10 mg dose by day five (RR 0.86, 95% CI 0.62 to 1.19, P = 0.37, I2 = 22%); two other studies used a single INR in-range as the outcome and showed a benefit for the 10 mg initiation dose by day 5 (RR 1.49, 95% CI 1.01 to 2.21, P = 0.05, I2 = 72%). Two studies compared a 5 mg dose to other doses: a 2.5 mg initiation dose took longer to achieve the therapeutic range (2.7 versus 2.0 days; P < 0.0001), but those receiving a calculated initiation dose achieved a target range quicker (4.2 days versus 5 days, P = 0.007). Two studies compared age adjusted doses to 10 mg initiation doses. More elderly patients receiving an age adjusted dose achieved a stable INR compared to those receiving a 10 mg initial dose (and Fennerty regimen). Four studies used genotype guided dosing in one arm of each trial. Three studies reported no overall differences; the fourth study, which reported that the genotype group spent significantly more time in-range (P < 0.001), had a control group whose INRs were significantly lower than expected. No clear impacts from adverse events were found in either arm to make an overall conclusion. The studies in this review compared loading doses in several different situations. There is still considerable uncertainty between the use of a 5 mg and a 10 mg loading dose for the initiation of warfarin. In the elderly, there is some evidence that lower initiation doses or age adjusted doses are more appropriate, leading to fewer high INRs. However, there is insufficient evidence to warrant genotype guided initiation.
Warfarin is commonly prescribed to prevent blot clots in patients with medical conditions such as atrial fibrillation, heart valve replacement or previous blood clots. Warfarin is an effective treatment which has been used for many years but needs to be closely monitored, especially at the beginning of treatment, as there is a wide variation in response to dose. Monitoring of the response to dose is done using an International Normalized Ratio (INR) and it is important that patients remain within a narrow range (typically 2 to 3 INR) due to the need to balance the goal of preventing blood clots with the risk of causing excessive bleeding. This review included 12 randomised controlled trials comparing different warfarin doses given to patients beginning warfarin treatment. Most of the studies had a high risk of bias so the results were interpreted with caution. Those trials that were included compared loading doses in several different situations. The review authors divided the trials into four categories, 5 mg versus 10 mg initial doses (four studies), 5 mg versus other doses (two studies), 5 mg or 10 mg versus age adjusted doses (two studies), 5 mg or 10 mg versus genotype adjusted doses (four studies). The review authors concluded that there is still considerable uncertainty between the use of a 5 mg and a 10 mg loading dose for the initiation of warfarin. In the elderly, there is some evidence that lower initiation doses or age adjusted doses are more appropriate. However, there is insufficient evidence to warrant genotype adjusted dosing. We also found no data to suggest that any one method was safer than another.
10.1002/14651858.CD008685.pub2
[ "Warfarin is commonly prescribed to prevent blot clots in patients with medical conditions such as atrial fibrillation, heart valve replacement or previous blood clots. Warfarin is an effective treatment which has been used for many years but needs to be closely monitored, especially at the beginning of treatment, as there is a wide variation in response to dose. Monitoring of the response to dose is done using an International Normalized Ratio (INR) and it is important that patients remain within a narrow range (typically 2 to 3 INR) due to the need to balance the goal of preventing blood clots with the risk of causing excessive bleeding. This review included 12 randomised controlled trials comparing different warfarin doses given to patients beginning warfarin treatment. Most of the studies had a high risk of bias so the results were interpreted with caution. Those trials that were included compared loading doses in several different situations. The review authors divided the trials into four categories, 5 mg versus 10 mg initial doses (four studies), 5 mg versus other doses (two studies), 5 mg or 10 mg versus age adjusted doses (two studies), 5 mg or 10 mg versus genotype adjusted doses (four studies). The review authors concluded that there is still considerable uncertainty between the use of a 5 mg and a 10 mg loading dose for the initiation of warfarin. In the elderly, there is some evidence that lower initiation doses or age adjusted doses are more appropriate. However, there is insufficient evidence to warrant genotype adjusted dosing. We also found no data to suggest that any one method was safer than another." ]
cochrane-simplification-train-918
cochrane-simplification-train-918
This review includes two studies. The previous review included one RCT with a parallel-group design, which was conducted in a dental hospital setting in the United Kingdom; our new search for this update identified one prospective cohort study conducted in the private sector in the USA. Primary outcome No eligible studies in this review reported the effects of removal compared with retention of asymptomatic disease-free impacted wisdom teeth on health-related quality of life Secondary outcomes We found only low to very low quality evidence of the effects of removal compared with retention of asymptomatic disease-free impacted wisdom teeth for a limited number of secondary outcome measures. One prospective cohort study, reporting data from a subgroup of 416 healthy male participants, aged 24 to 84 years, compared the effect of the absence (previous removal or agenesis) against the presence of asymptomatic disease-free impacted wisdom teeth on periodontitis and caries associated with the distal of the adjacent second molar during a follow-up period of three to over 25 years. Very low quality evidence suggests that the presence of asymptomatic disease-free impacted wisdom teeth may be associated with increased risk of periodontitis affecting the adjacent second molar in the long term. In the same study, which is at serious risk of bias, there is insufficient evidence to demonstrate a difference in caries risk associated with the presence or absence of impacted wisdom teeth. One RCT with 164 randomised and 77 analysed adolescent participants compared the effect of extraction with retention of asymptomatic disease-free impacted wisdom teeth on dimensional changes in the dental arch after five years. Participants (55% female) had previously undergone orthodontic treatment and had 'crowded' wisdom teeth. No evidence from this study, which was at high risk of bias, was found to suggest that removal of asymptomatic disease-free impacted wisdom teeth has a clinically significant effect on dimensional changes in the dental arch. The included studies did not measure our other secondary outcomes: costs, other adverse events associated with retention of asymptomatic disease-free impacted wisdom teeth (pericoronitis, root resorption, cyst formation, tumour formation, inflammation/infection) and adverse effects associated with their removal (alveolar osteitis/postoperative infection, nerve injury, damage to adjacent teeth during surgery, bleeding, osteonecrosis related to medication/radiotherapy, inflammation/infection). Insufficient evidence is available to determine whether or not asymptomatic disease-free impacted wisdom teeth should be removed. Although asymptomatic disease-free impacted wisdom teeth may be associated with increased risk of periodontitis affecting adjacent second molars in the long term, the evidence is of very low quality. Well-designed RCTs investigating long-term and rare effects of retention and removal of asymptomatic disease-free impacted wisdom teeth, in a representative group of individuals, are unlikely to be feasible. In their continuing absence, high quality, long-term prospective cohort studies may provide valuable evidence in the future. Given the lack of available evidence, patient values should be considered and clinical expertise used to guide shared decision making with patients who have asymptomatic disease-free impacted wisdom teeth. If the decision is made to retain asymptomatic disease-free impacted wisdom teeth, clinical assessment at regular intervals to prevent undesirable outcomes is advisable.
We searched the medical literature up to May 2016 and found one randomised controlled trial (RCT) and one prospective cohort study to include in this review. These studies involved 493 participants in total. The RCT conducted at a dental hospital in the UK included 77 adolescent male and female participants, and the cohort study conducted at a private dental clinic in the USA involved 416 men aged 24 to 84 years. Available evidence is insufficient to show whether or not asymptomatic disease-free impacted wisdom teeth should be removed. One study at serious risk of bias provided very low quality evidence suggesting that the presence of asymptomatic disease-free impacted wisdom teeth is associated with increased risk of periodontitis (infection of the gums) affecting the adjacent second molar (teeth directly in front of the wisdom teeth) in the long term. In the same study, no evidence was found to suggest that the presence of asymptomatic disease-free impacted wisdom teeth increases the risk of caries affecting the adjacent second molar. Another study, also at high risk of bias, found no evidence to suggest that removal of asymptomatic disease-free impacted wisdom teeth has an effect on crowding in the dental arch. The included studies did not measure our primary outcome - health-related quality of life. Nor did they measure our secondary outcomes - costs, other adverse events associated with retention of asymptomatic disease-free impacted wisdom teeth (pericoronitis, root resorption, cyst formation, tumour formation, inflammation/infection) and adverse effects associated with their removal (alveolar osteitis/postoperative infection, nerve injury, damage to adjacent teeth during surgery, bleeding, osteonecrosis related to medication/radiotherapy, inflammation/infection). Evidence provided by the two studies included in this review is of low to very low quality, so we cannot rely on these findings. High-quality research is urgently needed to support clinical practice in this area. In light of the lack of available evidence, patient values should be considered and clinical expertise used when treatment decisions are made with patients who have asymptomatic disease-free impacted wisdom teeth. If the decision is made to retain asymptomatic disease-free impacted wisdom teeth, clinical assessment at regular intervals is advisable to prevent undesirable outcomes.
10.1002/14651858.CD003879.pub4
[ "We searched the medical literature up to May 2016 and found one randomised controlled trial (RCT) and one prospective cohort study to include in this review. These studies involved 493 participants in total. The RCT conducted at a dental hospital in the UK included 77 adolescent male and female participants, and the cohort study conducted at a private dental clinic in the USA involved 416 men aged 24 to 84 years. Available evidence is insufficient to show whether or not asymptomatic disease-free impacted wisdom teeth should be removed. One study at serious risk of bias provided very low quality evidence suggesting that the presence of asymptomatic disease-free impacted wisdom teeth is associated with increased risk of periodontitis (infection of the gums) affecting the adjacent second molar (teeth directly in front of the wisdom teeth) in the long term. In the same study, no evidence was found to suggest that the presence of asymptomatic disease-free impacted wisdom teeth increases the risk of caries affecting the adjacent second molar. Another study, also at high risk of bias, found no evidence to suggest that removal of asymptomatic disease-free impacted wisdom teeth has an effect on crowding in the dental arch. The included studies did not measure our primary outcome - health-related quality of life. Nor did they measure our secondary outcomes - costs, other adverse events associated with retention of asymptomatic disease-free impacted wisdom teeth (pericoronitis, root resorption, cyst formation, tumour formation, inflammation/infection) and adverse effects associated with their removal (alveolar osteitis/postoperative infection, nerve injury, damage to adjacent teeth during surgery, bleeding, osteonecrosis related to medication/radiotherapy, inflammation/infection). Evidence provided by the two studies included in this review is of low to very low quality, so we cannot rely on these findings. High-quality research is urgently needed to support clinical practice in this area. In light of the lack of available evidence, patient values should be considered and clinical expertise used when treatment decisions are made with patients who have asymptomatic disease-free impacted wisdom teeth. If the decision is made to retain asymptomatic disease-free impacted wisdom teeth, clinical assessment at regular intervals is advisable to prevent undesirable outcomes." ]
cochrane-simplification-train-919
cochrane-simplification-train-919
We included 32 studies involving a total of 748 participants aged above 18 with acute, postacute or chronic ischaemic or haemorrhagic stroke. We also identified 55 ongoing studies. The risk of bias did not differ substantially for different comparisons and outcomes. We found nine studies with 396 participants examining the effects of tDCS versus sham tDCS (or any other passive intervention) on our primary outcome measure, ADLs after stroke. We found evidence of effect regarding ADL performance at the end of the intervention period (standardised mean difference (SMD) 0.24, 95% confidence interval (CI) 0.03 to 0.44; inverse variance method with random-effects model; moderate quality evidence). Six studies with 269 participants assessed the effects of tDCS on ADLs at the end of follow-up, and found improved ADL performance (SMD 0.31, 95% CI 0.01 to 0.62; inverse variance method with random-effects model; moderate quality evidence). However, the results did not persist in a sensitivity analysis including only trials of good methodological quality. One of our secondary outcome measures was upper extremity function: 12 trials with a total of 431 participants measured upper extremity function at the end of the intervention period, revealing no evidence of an effect in favour of tDCS (SMD 0.01, 95% CI -0.48 to 0.50 for studies presenting absolute values (low quality evidence) and SMD 0.32, 95% CI -0.51 to 1.15 (low quality evidence) for studies presenting change values; inverse variance method with random-effects model). Regarding the effects of tDCS on upper extremity function at the end of follow-up, we identified four studies with a total of 187 participants (absolute values) that showed no evidence of an effect (SMD 0.01, 95% CI -0.48 to 0.50; inverse variance method with random-effects model; low quality evidence). Ten studies with 313 participants reported outcome data for muscle strength at the end of the intervention period, but in the corresponding meta-analysis there was no evidence of an effect. Three studies with 156 participants reported outcome data on muscle strength at follow-up, but there was no evidence of an effect. In six of 23 studies (26%), dropouts, adverse events or deaths that occurred during the intervention period were reported, and the proportions of dropouts and adverse events were comparable between groups (risk difference (RD) 0.01, 95% CI -0.02 to 0.03; Mantel-Haenszel method with random-effects model; low quality evidence; analysis based only on studies that reported either on dropouts, or on adverse events, or on both). However, this effect may be underestimated due to reporting bias. At the moment, evidence of very low to moderate quality is available on the effectiveness of tDCS (anodal/cathodal/dual) versus control (sham/any other intervention) for improving ADL performance after stroke. However, there are many ongoing randomised trials that could change the quality of evidence in the future. Future studies should particularly engage those who may benefit most from tDCS after stroke and in the effects of tDCS on upper and lower limb function, muscle strength and cognitive abilities (including spatial neglect). Dropouts and adverse events should be routinely monitored and presented as secondary outcomes. They should also address methodological issues by adhering to the Consolidated Standards of Reporting Trials (CONSORT) statement.
We included 32 studies involving a total of 748 participants aged above 18 with acute, postacute or chronic ischaemic or haemorrhagic stroke. The mean age in the experimental groups ranged from 43 years up to 70 years and from 45 years up to 75 years in the control groups. The level of participants' impairment ranged from severe to moderate. The majority of studies were conducted in an inpatient setting. Different stimulation types (anodal, cathodal, dual) of tDCS with different stimulation durations and dosages were administered and compared with sham tDCS or an active control intervention. Sham tDCS means that the stimulation is switched off covertly in the first minute of the intervention. This review found that tDCS might enhance ADLs, but it is still uncertain if arm and leg function, muscle strength and cognitive abilities may be improved. Proportions of adverse events and people discontinuing the treatment were comparable between groups. Included studies differed in terms of type, location and duration of stimulation, amount of current delivered, electrode size and positioning as well as type and location of stroke. Future research is needed in this area to foster the evidence base of these findings, especially regarding arm and leg function, muscle strength and cognitive abilities (including spatial neglect). The quality of evidence for tDCS for improving ADLs was very low to moderate. It was low for upper extremity function and low for adverse events and people discontinuing the treatment.
10.1002/14651858.CD009645.pub3
[ "We included 32 studies involving a total of 748 participants aged above 18 with acute, postacute or chronic ischaemic or haemorrhagic stroke. The mean age in the experimental groups ranged from 43 years up to 70 years and from 45 years up to 75 years in the control groups. The level of participants' impairment ranged from severe to moderate. The majority of studies were conducted in an inpatient setting. Different stimulation types (anodal, cathodal, dual) of tDCS with different stimulation durations and dosages were administered and compared with sham tDCS or an active control intervention. Sham tDCS means that the stimulation is switched off covertly in the first minute of the intervention. This review found that tDCS might enhance ADLs, but it is still uncertain if arm and leg function, muscle strength and cognitive abilities may be improved. Proportions of adverse events and people discontinuing the treatment were comparable between groups. Included studies differed in terms of type, location and duration of stimulation, amount of current delivered, electrode size and positioning as well as type and location of stroke. Future research is needed in this area to foster the evidence base of these findings, especially regarding arm and leg function, muscle strength and cognitive abilities (including spatial neglect). The quality of evidence for tDCS for improving ADLs was very low to moderate. It was low for upper extremity function and low for adverse events and people discontinuing the treatment." ]
cochrane-simplification-train-920
cochrane-simplification-train-920
Thirteen studies (2032 participants) were included. Six studies (654 patients) reported symptomatic UTI and eight studies (796 patients) reported bacteriuria. Overall, study quality was mixed. The overall pooled estimates for the major outcome measures were not interpretable because of underlying heterogeneity. Subgroup analyses suggested that methenamine hippurate may have some benefit in patients without renal tract abnormalities (symptomatic UTI: RR 0.24, 95% CI 0.07 to 0.89; bacteriuria: RR 0.56, 95% CI 0.37 to 0.83), but not in patients with known renal tract abnormalities (symptomatic UTI: RR 1.54, 95% CI 0.38 to 6.20; bacteriuria: RR 1.29, 95% CI 0.54 to 3.07). For short-term treatment duration (1 week or less) there was a significant reduction in symptomatic UTI in those without renal tract abnormalities (RR 0.14, 95% CI 0.05 to 0.38). The rate of adverse events was low. Methenamine hippurate may be effective for preventing UTI in patients without renal tract abnormalities, particularly when used for short-term prophylaxis. It does not appear to work in patients with neuropathic bladder or in patients who have renal tract abnormalities. The rate of adverse events was low, but poorly described. There is a need for further large well-conducted RCTs to clarify this question, particularly for longer term use for people without neuropathic bladder.
This review identified 13 studies (2032 participants). Methenamine hippurate may be effective in preventing UTI in patients without renal tract abnormalities particularly when used for short term prophylaxis. It does not appear to be effective for long term prophylaxis in patients who have neuropathic bladder. There were few adverse effects.Additional well controlled randomised controlled trials are necessary in particular to clarify effectiveness for longer term prophylaxis in those without neuropathic bladder.
10.1002/14651858.CD003265.pub3
[ "This review identified 13 studies (2032 participants). Methenamine hippurate may be effective in preventing UTI in patients without renal tract abnormalities particularly when used for short term prophylaxis. It does not appear to be effective for long term prophylaxis in patients who have neuropathic bladder. There were few adverse effects.Additional well controlled randomised controlled trials are necessary in particular to clarify effectiveness for longer term prophylaxis in those without neuropathic bladder." ]
cochrane-simplification-train-921
cochrane-simplification-train-921
All three studies fulfilling the entry criteria had limitations, including possible or definite bias. There was substantial heterogeneity among studies. Furosemide administration did not significantly increase the risk of failure of ductal closure; however, sample size was insufficient to rule out even a 31% increase. In the subset with initial BUN/creatinine ratio > 20 mg/mg, two of 18 patients receiving furosemide could not complete a three-dose course of indomethacin because of toxicity. Minimal or no information was available about any of the other main outcome variables. Furosemide increased urine output regardless of the initial BUN/creatinine ratio, leading to a 5% weight loss during a three-dose course, an undesired effect in patients with initial BUN/creatinine ratio > 20 mg/mg. Furosemide increased creatinine clearance only in patients with initial BUN/creatinine ratio < 20 mg/mg. There is not enough evidence to support the administration of furosemide to premature infants treated with indomethacin for symptomatic patent ductus arteriosus. Furosemide appears to be contraindicated in the presence of dehydration in those infants.
This review analyzed the effects of furosemide on preterm babies receiving indomethacin to close the ductus arteriosus. The review of trials found not enough evidence to recommend routine use of furosemide in preterm infants who receive indomethacin for closing a ductus arteriosus.
10.1002/14651858.CD001148
[ "This review analyzed the effects of furosemide on preterm babies receiving indomethacin to close the ductus arteriosus. The review of trials found not enough evidence to recommend routine use of furosemide in preterm infants who receive indomethacin for closing a ductus arteriosus." ]
cochrane-simplification-train-922
cochrane-simplification-train-922
All 61 included studies were observational studies with some methodological limitations; randomized trials were absent. The studies presented data on 15,077 women with a wide range of risk factors for breast cancer, who underwent RRM. Twenty-one BRRM studies looking at the incidence of breast cancer or disease-specific mortality, or both, reported reductions after BRRM, particularly for those women with BRCA1/2 mutations. Twenty-six CRRM studies consistently reported reductions in incidence of contralateral breast cancer but were inconsistent about improvements in disease-specific survival. Seven studies attempted to control for multiple differences between intervention groups and showed no overall survival advantage for CRRM. Another study showed significantly improved survival following CRRM, but after adjusting for bilateral risk-reducing salpingo-oophorectomy (BRRSO), the CRRM effect on all-cause mortality was no longer significant. Twenty studies assessed psychosocial measures; most reported high levels of satisfaction with the decision to have RRM but greater variation in satisfaction with cosmetic results. Worry over breast cancer was significantly reduced after BRRM when compared both to baseline worry levels and to the groups who opted for surveillance rather than BRRM, but there was diminished satisfaction with body image and sexual feelings. Seventeen case series reporting on adverse events from RRM with or without reconstruction reported rates of unanticipated reoperations from 4% in those without reconstruction to 64% in participants with reconstruction. In women who have had cancer in one breast, removing the other breast may reduce the incidence of cancer in that other breast, but there is insufficient evidence that this improves survival because of the continuing risk of recurrence or metastases from the original cancer. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention, when considering RRM. While published observational studies demonstrated that BRRM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies are suggested. BRRM should be considered only among those at high risk of disease, for example, BRCA1/2 carriers. CRRM was shown to reduce the incidence of contralateral breast cancer, but there is insufficient evidence that CRRM improves survival, and studies that control for multiple confounding variables are recommended. It is possible that selection bias in terms of healthier, younger women being recommended for or choosing CRRM produces better overall survival numbers for CRRM. Given the number of women who may be over-treated with BRRM/CRRM, it is critical that women and clinicians understand the true risk for each individual woman before considering surgery. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention when considering RRM.
Sixty-one studies presented data on 15,077 women with a wide range of risk factors for developing breast cancer, who underwent RRM. Risk-reducing mastectomy could include either surgically removing both breasts to prevent breast cancer (bilateral risk-reducing mastectomy or BRRM), or removing the disease-free breast in women who have had breast cancer in one breast to reduce the incidence of breast cancer in the other breast (contralateral risk-reducing mastectomy or CRRM). The evidence is current to July 2016. The BRRM studies reported that it reduced the incidence of breast cancer or the number of deaths or both, but many of the studies have methodological limitations. After BRRM, most women are satisfied with their decision, but reported less satisfaction with cosmetic results, body image, and sexual feelings. One of the complications of RRM was the need for additional unanticipated surgeries, particularly in women undergoing reconstruction after RRM. However, most women also experienced reduced worry of developing and dying from breast cancer along with diminished satisfaction with body image and sexual feelings In women who have had cancer in one breast, removing the other breast (CRRM) may reduce the incidence of cancer in that other breast, but there is insufficient evidence that this improves survival because of the continuing risk of recurrence or metastases from the original cancer. While published observational studies demonstrated that BRRM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies are suggested. BRRM should be considered only among those at high risk of disease, for example, carriers of mutations in the breast cancer genes, BRCA1 and BRCA2. CRRM was shown to reduce the incidence of contralateral breast cancer (CBC), but there is insufficient evidence that CRRM improves survival, and studies that control for multiple variables that can affect results are recommended. It is possible that selection bias in terms of healthier, younger women being recommended for or choosing CRRM produces better overall survival numbers for CRRM. Just over half of the studies were found to have a low risk of selection bias, that is, studies adjusting for systematic differences in prognosis or treatment responsiveness between the groups, and similarly, 60% had a low risk of detection bias, that is, studies considered systematic differences in the ways the outcomes were measured and detected. The primary cause for both selection bias and detection bias was not controlling for all major confounding factors, e.g., risk factors or having bilateral risk-reducing salpingo-oophorectomy (BRRSO - surgery to remove fallopian tubes and ovaries) in the subject and control groups. Performance bias (validation of the risk-reducing mastectomy) was not problematic, as most studies were based on surgical reports; three relied on self-reports and eight were unclear because of multiple sources of data and/or broad timeframe. Attrition bias was at high risk or unclear in approximately 13% of the studies. The mean or median follow-up period reported was from 1 - 22 years. Given the number of women who may be over-treated with BRRM/CRRM, it is critical that women and clinicians understand the true risk for each individual woman before considering surgery. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention, when considering RRM.
10.1002/14651858.CD002748.pub4
[ "Sixty-one studies presented data on 15,077 women with a wide range of risk factors for developing breast cancer, who underwent RRM. Risk-reducing mastectomy could include either surgically removing both breasts to prevent breast cancer (bilateral risk-reducing mastectomy or BRRM), or removing the disease-free breast in women who have had breast cancer in one breast to reduce the incidence of breast cancer in the other breast (contralateral risk-reducing mastectomy or CRRM). The evidence is current to July 2016. The BRRM studies reported that it reduced the incidence of breast cancer or the number of deaths or both, but many of the studies have methodological limitations. After BRRM, most women are satisfied with their decision, but reported less satisfaction with cosmetic results, body image, and sexual feelings. One of the complications of RRM was the need for additional unanticipated surgeries, particularly in women undergoing reconstruction after RRM. However, most women also experienced reduced worry of developing and dying from breast cancer along with diminished satisfaction with body image and sexual feelings In women who have had cancer in one breast, removing the other breast (CRRM) may reduce the incidence of cancer in that other breast, but there is insufficient evidence that this improves survival because of the continuing risk of recurrence or metastases from the original cancer. While published observational studies demonstrated that BRRM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies are suggested. BRRM should be considered only among those at high risk of disease, for example, carriers of mutations in the breast cancer genes, BRCA1 and BRCA2. CRRM was shown to reduce the incidence of contralateral breast cancer (CBC), but there is insufficient evidence that CRRM improves survival, and studies that control for multiple variables that can affect results are recommended. It is possible that selection bias in terms of healthier, younger women being recommended for or choosing CRRM produces better overall survival numbers for CRRM. Just over half of the studies were found to have a low risk of selection bias, that is, studies adjusting for systematic differences in prognosis or treatment responsiveness between the groups, and similarly, 60% had a low risk of detection bias, that is, studies considered systematic differences in the ways the outcomes were measured and detected. The primary cause for both selection bias and detection bias was not controlling for all major confounding factors, e.g., risk factors or having bilateral risk-reducing salpingo-oophorectomy (BRRSO - surgery to remove fallopian tubes and ovaries) in the subject and control groups. Performance bias (validation of the risk-reducing mastectomy) was not problematic, as most studies were based on surgical reports; three relied on self-reports and eight were unclear because of multiple sources of data and/or broad timeframe. Attrition bias was at high risk or unclear in approximately 13% of the studies. The mean or median follow-up period reported was from 1 - 22 years. Given the number of women who may be over-treated with BRRM/CRRM, it is critical that women and clinicians understand the true risk for each individual woman before considering surgery. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention, when considering RRM." ]
cochrane-simplification-train-923
cochrane-simplification-train-923
We included and analysed 140 studies for this review. In the main analyses, a total of 108 comparisons from 70 studies compared any intervention in which audit and feedback was a core, essential component to usual care and evaluated effects on professional practice. After excluding studies at high risk of bias, there were 82 comparisons from 49 studies featuring dichotomous outcomes, and the weighted median adjusted RD was a 4.3% (interquartile range (IQR) 0.5% to 16%) absolute increase in healthcare professionals' compliance with desired practice. Across 26 comparisons from 21 studies with continuous outcomes, the weighted median adjusted percent change relative to control was 1.3% (IQR = 1.3% to 28.9%). For patient outcomes, the weighted median RD was -0.4% (IQR -1.3% to 1.6%) for 12 comparisons from six studies reporting dichotomous outcomes and the weighted median percentage change was 17% (IQR 1.5% to 17%) for eight comparisons from five studies reporting continuous outcomes. Multivariable meta-regression indicated that feedback may be more effective when baseline performance is low, the source is a supervisor or colleague, it is provided more than once, it is delivered in both verbal and written formats, and when it includes both explicit targets and an action plan. In addition, the effect size varied based on the clinical behaviour targeted by the intervention. Audit and feedback generally leads to small but potentially important improvements in professional practice. The effectiveness of audit and feedback seems to depend on baseline performance and how the feedback is provided. Future studies of audit and feedback should directly compare different ways of providing feedback.
In some studies, health professionals were simply given information about their performance and how this compared to professional standards or targets. In other studies, health professionals were also given a specific target that they personally were expected to reach, or were given an action plan with suggestions or advice about how to improve their performance. What happens when health professionals are given audit and feedback? The effect of using audit and feedback varied widely across the included studies. Overall, the review shows that: The effect of audit and feedback on professional behaviour and on patient outcomes ranges from little or no effect to a substantial effect. The quality of the evidence is moderate. Audit and feedback may be most effective when: 1. the health professionals are not performing well to start out with; 2. the person responsible for the audit and feedback is a supervisor or colleague; 3. it is provided more than once; 4. it is given both verbally and in writing; 5. it includes clear targets and an action plan. In addition, the effect of audit and feedback may be influenced by the type of behaviour it is targeting. It is uncertain whether audit and feedback is more effective when combined with other interventions.
10.1002/14651858.CD000259.pub3
[ "In some studies, health professionals were simply given information about their performance and how this compared to professional standards or targets. In other studies, health professionals were also given a specific target that they personally were expected to reach, or were given an action plan with suggestions or advice about how to improve their performance. What happens when health professionals are given audit and feedback? The effect of using audit and feedback varied widely across the included studies. Overall, the review shows that: The effect of audit and feedback on professional behaviour and on patient outcomes ranges from little or no effect to a substantial effect. The quality of the evidence is moderate. Audit and feedback may be most effective when: 1. the health professionals are not performing well to start out with; 2. the person responsible for the audit and feedback is a supervisor or colleague; 3. it is provided more than once; 4. it is given both verbally and in writing; 5. it includes clear targets and an action plan. In addition, the effect of audit and feedback may be influenced by the type of behaviour it is targeting. It is uncertain whether audit and feedback is more effective when combined with other interventions." ]
cochrane-simplification-train-924
cochrane-simplification-train-924
Combining data from 425 reports (307,028 abstracts) resulted in an overall full publication proportion of 37.3% (95% confidence interval (CI), 35.3% to 39.3%) with varying lengths of follow-up. This is significantly lower than that found in our 2007 review (44.5%. 95% CI, 43.9% to 45.1%). Using a survival analyses to estimate the proportion of abstracts that would be published in full by 10 years produced proportions of 46.4% for all studies; 68.7% for randomized and controlled trials and 44.9% for other studies. Three hundred and fifty-three reports were at high risk of bias on one or more items, but only 32 reports were considered at high risk of bias overall. Forty-five reports (15,783 abstracts) with 'positive' results (defined as any 'significant' result) showed an association with full publication (RR = 1.31; 95% CI 1.23 to 1.40), as did 'positive' results defined as a result favoring the experimental treatment (RR =1.17; 95% CI 1.07 to 1.28) in 34 reports (8794 abstracts). Results emanating from randomized or controlled trials showed the same pattern for both definitions (RR = 1.21; 95% CI 1.10 to 1.32 (15 reports and 2616 abstracts) and RR = 1.17; 95% CI, 1.04 to 1.32 (13 reports and 2307 abstracts), respectively. Other factors associated with full publication include oral presentation (RR = 1.46; 95% CI 1.40 to 1.52; studied in 143 reports with 115,910 abstracts); acceptance for meeting presentation (RR = 1.65; 95% CI 1.48 to 1.85; 22 reports with 22,319 abstracts); randomized trial design (RR = 1.51; 95% CI 1.36 to 1.67; 47 reports with 28,928 abstracts); and basic research (RR = 0.78; 95% CI 0.74 to 0.82; 92 reports with 97,372 abstracts). Abstracts originating at an academic setting were associated with full publication (RR = 1.60; 95% CI 1.34 to 1.92; 34 reports with 16,913 abstracts), as were those considered to be of higher quality (RR = 1.46; 95% CI 1.23 to 1.73; 12 reports with 3364 abstracts), or having high impact (RR = 1.60; 95% CI 1.41 to 1.82; 11 reports with 6982 abstracts). Sensitivity analyses excluding reports that were abstracts themselves or classified as having a high risk of bias did not change these findings in any important way. In considering the reports of the methodology research that we included in this review, we found that reports published in English or from a native English-speaking country found significantly higher proportions of studies published in full, but that there was no association with year of report publication. The findings correspond to a proportion of abstracts published in full of 31.9% for all reports, 40.5% for reports in English, 42.9% for reports from native English-speaking countries, and 52.2% for both these covariates combined. More than half of results from abstracts, and almost a third of randomized trial results initially presented as abstracts fail to be published in full and this problem does not appear to be decreasing over time. Publication bias is present in that 'positive' results were more frequently published than 'not positive' results. Reports of methodology research written in English showed that a higher proportion of abstracts had been published in full, as did those from native English-speaking countries, suggesting that studies from non-native English-speaking countries may be underrepresented in the scientific literature. After the considerable work involved in adding in the more than 300 additional studies found by the February 2016 searches, we chose not to update the search again because additional searches are unlikely to change these overall conclusions in any important way.
We included 425 research reports described in 551 articles, which had studied the subsequent full publication of 307,028 abstracts from a variety of biomedical and social sciences. Fifty-four reports included data from abstracts describing randomized or controlled trials. Of the 425 reports, 376 were published in English, and 49 in other languages. 1. Less than half of all studies, and about two-thirds of randomized trials, initially presented as summaries or abstracts at meetings, are published as journal articles in the 10 years after presentation. 2. Studies with positive results are more likely to be published. 3. Studies with larger sample sizes are more likely to be published. 4. Studies with abstracts presented orally are more likely to be published than those presented as posters. 5. Studies accepted for presentation at a meeting are more likely to be published than those not accepted. 6. Studies describing basic science are more likely to be published that those describing clinical research. 7. Studies describing randomized trials are more likely to be published than those describing other types of studies. 8. Studies that took place in multiple centers are more likely to be published than those at a single center. 9. Studies classified as ‘high quality’ are more likely to be published than ‘low quality’ studies. 10. Studies with authors from an academic setting are more likely to be published than those with authors from other settings. 11. Studies considered by the report authors to have a high impact are more likely to be published than other studies. 12. Studies with funding source reported are more likely to be published than those not reporting funding. 13. Studies originating in North America or Europe are more likely to be published than those originating elsewhere. 14. Studies from English-speaking countries are more likely to be published than studies originating elsewhere. We have confidence in our findings. We considered five criteria to constitute a risk of bias in the included reports, including methods to identify and match full publications to abstracts, and methods to determine whether a factor was associated with full publication. Overall, 7.5% (32/425) of the reports were scored as having an overall high risk of bias, 83.1% (353/425) had at least one criterion at high risk of bias, and 6.1% (26/425) had all criteria at low risk of bias. Our search updated our 2007 review and is current to February 2016. After the considerable work involved in including more than 300 additional studies from the February 2016 searches, we chose not to update the search again because additional searches are unlikely to change our overall conclusions in any important way.
10.1002/14651858.MR000005.pub4
[ "We included 425 research reports described in 551 articles, which had studied the subsequent full publication of 307,028 abstracts from a variety of biomedical and social sciences. Fifty-four reports included data from abstracts describing randomized or controlled trials. Of the 425 reports, 376 were published in English, and 49 in other languages. 1. Less than half of all studies, and about two-thirds of randomized trials, initially presented as summaries or abstracts at meetings, are published as journal articles in the 10 years after presentation. 2. Studies with positive results are more likely to be published. 3. Studies with larger sample sizes are more likely to be published. 4. Studies with abstracts presented orally are more likely to be published than those presented as posters. 5. Studies accepted for presentation at a meeting are more likely to be published than those not accepted. 6. Studies describing basic science are more likely to be published that those describing clinical research. 7. Studies describing randomized trials are more likely to be published than those describing other types of studies. 8. Studies that took place in multiple centers are more likely to be published than those at a single center. 9. Studies classified as ‘high quality’ are more likely to be published than ‘low quality’ studies. 10. Studies with authors from an academic setting are more likely to be published than those with authors from other settings. 11. Studies considered by the report authors to have a high impact are more likely to be published than other studies. 12. Studies with funding source reported are more likely to be published than those not reporting funding. 13. Studies originating in North America or Europe are more likely to be published than those originating elsewhere. 14. Studies from English-speaking countries are more likely to be published than studies originating elsewhere. We have confidence in our findings. We considered five criteria to constitute a risk of bias in the included reports, including methods to identify and match full publications to abstracts, and methods to determine whether a factor was associated with full publication. Overall, 7.5% (32/425) of the reports were scored as having an overall high risk of bias, 83.1% (353/425) had at least one criterion at high risk of bias, and 6.1% (26/425) had all criteria at low risk of bias. Our search updated our 2007 review and is current to February 2016. After the considerable work involved in including more than 300 additional studies from the February 2016 searches, we chose not to update the search again because additional searches are unlikely to change our overall conclusions in any important way." ]
cochrane-simplification-train-925
cochrane-simplification-train-925
We included one RCT (56 eyes of 55 participants) in this review. The study compared two types of topical biguanides for the treatment of AK: chlorhexidine 0.02% and polyhexamethylene biguanide (PHMB) 0.02%. All participants were contact lens wearers with a median age of 31 years. Treatment duration ranged from 51 to 145 days. The study, conducted in the UK, was well-designed and had low risk of bias overall. Outcome data were available for 51 (91%) of 56 eyes. Follow-up times for outcome measurements in the study were not reported. Resolution of infection, defined as control of ocular inflammation, relief of pain and photosensitivity, and recovery of vision, was 86% in the chlorhexidine group compared with 78% in the PHMB group (relative risk (RR) 1.10, 95% confidence intervals (CI) 0.84 to 1.42). In the chlorhexidine group, 20 of 28 eyes (71%) had better visual acuity compared with 13 of 23 eyes (57%) in the PHMB group at final follow-up (RR 1.26, 95% CI 0.82 to 1.94). Five participants required therapeutic keratoplasty: 2 in the chlorhexidine group compared with 3 in the PHMB group (RR 0.55, 95% CI 0.10 to 3.00). No serious adverse event related to drug toxicity was observed in the study. There is insufficient evidence to evaluate the relative effectiveness and safety of medical therapy for the treatment of AK. Results from the one included study yielded no difference with respect to outcomes reported between chlorhexidine and PHMB. However, the sample size was inadequate to detect clinically meaningful differences between the two groups as indicated by the wide confidence intervals of effect estimates.
We found one eligible study of 55 participants from the UK. All participants in the study had a history of contact lens wear. The study randomly assigned people with AK to one of two medical treatment options: chlorhexidine eye drops or polyhexamethylene biguanide (PHMB) eye drops. Participants in the study were treated for 51 to 145 days. In the one study identified, similar results were seen between the chlorhexidine and PHMB groups in terms of resolution of infection, changes in vision, or need for surgery. However, the number of participants in the study was small and the results uncertain; thus, we cannot be confident that there are really no differences between these treatments. No serious side effect was observed with either treatment in the study. Although the study was well-designed with no suggestion of bias, the results must be interpreted carefully because of the small number of participants.
10.1002/14651858.CD010792.pub2
[ "We found one eligible study of 55 participants from the UK. All participants in the study had a history of contact lens wear. The study randomly assigned people with AK to one of two medical treatment options: chlorhexidine eye drops or polyhexamethylene biguanide (PHMB) eye drops. Participants in the study were treated for 51 to 145 days. In the one study identified, similar results were seen between the chlorhexidine and PHMB groups in terms of resolution of infection, changes in vision, or need for surgery. However, the number of participants in the study was small and the results uncertain; thus, we cannot be confident that there are really no differences between these treatments. No serious side effect was observed with either treatment in the study. Although the study was well-designed with no suggestion of bias, the results must be interpreted carefully because of the small number of participants." ]
cochrane-simplification-train-926
cochrane-simplification-train-926
We identified one study, which was set in Australia, that met the inclusion criteria. This was a randomised, double-blind, placebo-controlled, cross-over trial in 16 children (10 boys and 6 girls) with predominant dystonic cerebral palsy and a mean age of 9 years (standard deviation 4.3 years, range 2 to 17 years). We considered the trial to be at low risk of selection, performance, detection, attrition, reporting and other sources of bias. We rated the GRADE quality of the evidence as low. We found no difference in mean follow-up scores for change in dystonia as measured by the Barry Albright Dystonia Scale (BADS), which assesses eight body regions for dystonia on a 5-point scale (0 = none to 4 = severe), resulting in a total score of 0 to 32. The BADS score was 2.67 points higher (95% confidence interval (CI) −2.55 to 7.90; low-quality evidence), that is, worse dystonia, in the treated group. Trihexyphenidyl may be associated with an increased risk of adverse effects (risk ratio 2.54, 95% CI 1.38 to 4.67; low-quality evidence). There was no difference in mean follow-up scores for upper limb function as measured by the Quality of Upper Extremity Skills Test, which has four domains that collectively assess 36 items (each scored 1 or 2) and produces a total score of 0 to 100. The score in the treated group was 4.62 points lower (95% CI −10.98 to 20.22; low-quality evidence), corresponding to worse function, than in the control group. We found low-quality evidence for improved participation (as represented by higher scores) in the treated group in activities of daily living, as measured by three tools: 18.86 points higher (95% CI 5.68 to 32.03) for the Goal Attainment Scale (up to five functional goals scored on 5-point scale (−2 = much less than expected to +2 = much more than expected)), 2.91 points higher (95% CI 1.01 to 4.82) for the satisfaction subscale of the Canadian Occupational Performance Measure (COPM; satisfaction with performance in up to five problem areas scored on a 10-point scale (1 = not satisfied at all to 10 = extremely satisfied)), and 2.24 points higher (95% CI 0.64 to 3.84) for performance subscale of the COPM (performance in up to five problem areas scored on a 10-point scale (1 = not able to do to; 10 = able to do extremely well)). The study did not report on pain or quality of life. At present, there is insufficient evidence regarding the effectiveness of trihexyphenidyl for people with cerebral palsy for the outcomes of: change in dystonia, adverse effects, increased upper limb function and improved participation in activities of daily living. The study did not measure pain or quality of life. There is a need for larger randomised, controlled, multicentre trials that also examine the effect on pain and quality of life in order to determine the effectiveness of trihexyphenidyl for people with cerebral palsy.
In May 2017 we searched for all clinical trials that investigated the effectiveness of trihexyphenidyl for people with dystonic cerebral palsy. We included one Australian trial that involved 16 children (10 boys, 6 girls) with cerebral palsy and dystonia. They had an average age of nine years. The children were divided into two different groups. Both groups took 12 weeks of trihexyphenidyl and 12 weeks of a placebo (something that looks the same as trihexyphenidyl but with no active ingredient), with a 4-week break in between during which they received neither. The only difference between the groups was that one group started with trihexyphenidyl and then had placebo, and the other group started with placebo and then had trihexyphenidyl. We found no evidence that trihexyphenidyl was effective for reducing dystonia or improving upper arm function in children with cerebral palsy and dystonia. Trihexyphenidyl may be associated with an increased risk of side effects (agitation, constipation, dry mouth and poor sleep). There was some evidence that trihexyphenidyl may improve individual goals set by the child and family around improved participation in activities of daily living. The study did not measure pain or quality of life. We rated the quality of the evidence as low because the one study included a small number of children and there are no other studies to support the findings. Therefore, we are uncertain about the effectiveness of trihexyphenidyl in reducing dystonia or improving arm function and participation in everyday activities of people with cerebral palsy and dystonia.
10.1002/14651858.CD012430.pub2
[ "In May 2017 we searched for all clinical trials that investigated the effectiveness of trihexyphenidyl for people with dystonic cerebral palsy. We included one Australian trial that involved 16 children (10 boys, 6 girls) with cerebral palsy and dystonia. They had an average age of nine years. The children were divided into two different groups. Both groups took 12 weeks of trihexyphenidyl and 12 weeks of a placebo (something that looks the same as trihexyphenidyl but with no active ingredient), with a 4-week break in between during which they received neither. The only difference between the groups was that one group started with trihexyphenidyl and then had placebo, and the other group started with placebo and then had trihexyphenidyl. We found no evidence that trihexyphenidyl was effective for reducing dystonia or improving upper arm function in children with cerebral palsy and dystonia. Trihexyphenidyl may be associated with an increased risk of side effects (agitation, constipation, dry mouth and poor sleep). There was some evidence that trihexyphenidyl may improve individual goals set by the child and family around improved participation in activities of daily living. The study did not measure pain or quality of life. We rated the quality of the evidence as low because the one study included a small number of children and there are no other studies to support the findings. Therefore, we are uncertain about the effectiveness of trihexyphenidyl in reducing dystonia or improving arm function and participation in everyday activities of people with cerebral palsy and dystonia." ]
cochrane-simplification-train-927
cochrane-simplification-train-927
One new trial was identified and included in this update bringing the total to eight trials involving 787 women. Three small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Four trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. One trial compared three groups: a mechanical device alone, behavioural therapy (pelvic floor muscle training) alone and behavioural therapy combined with a mechanical device. While at three months there were more withdrawals from the device-only group, at 12 months differences between the groups were not sustained on any measure. The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and large well-conducted trials are required for clarification. There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment.
This review of trials found that using mechanical devices might be better than no treatment but the evidence is weak. There was not enough evidence to recommend any specific type of device or to show whether mechanical devices are better than other forms of treatment such as pelvic floor muscle training.
10.1002/14651858.CD001756.pub6
[ "This review of trials found that using mechanical devices might be better than no treatment but the evidence is weak. There was not enough evidence to recommend any specific type of device or to show whether mechanical devices are better than other forms of treatment such as pelvic floor muscle training." ]
cochrane-simplification-train-928
cochrane-simplification-train-928
We included four studies (152 participants), with a follow-up duration ranging from three months to 12 months. In two studies patients acted as self-controls, i.e. one side of the nose underwent debridement and the other side did not ('split-nose' studies). The risk of bias in all studies was high, mostly due to the inability to blind the patients to the debridement procedure. Primary outcomes Disease-specific health-related quality of life scores Only one study (58 participants) provided data for disease-specific health-related quality of life. At six months follow-up, lower disease-specific health-related quality of life scores, measured using the Sino-Nasal Outcome Test-22 (SNOT-22, range 0 to 110), were noted in the debridement group but the difference was not statistically significant (9.7 in the debridement group versus 10.3 in the control group, P = 0.47) (low-quality evidence). Disease severity (patient-reported symptom score) Only one study (60 participants) provided data for disease severity measured by visual analogue scale (VAS) score. No significant differences in total symptom score were observed between groups postoperatively (low-quality evidence). Significant adverse effects Significant adverse effects related to the debridement procedure were not reported in any of the included studies, however it is not clear whether data regarding adverse effects were not collected or if none were indeed observed in any of the included studies. Secondary outcomes All four studies assessed thepostoperative endoscopic appearance of the sinonasal cavities using the Lund-Kennedy score (range 0 to 10). A pooled analysis of endoscopic scores in the two non 'split-nose' studies revealed better endoscopic scores in the debridement group, however this was not a statistically significant difference (mean difference -0.31, 95% confidence interval (CI) -1.35 to 0.72; I² = 0%; two studies; 118 participants) (low-quality evidence). A sub-analysis of the adhesion formation component of the endoscopic score was available for all four studies and revealed a significantly lower adhesion rate in the debridement group (risk ratio 0.43, 95% CI 0.28 to 0.68; I² = 29%; four studies; 152 participants). Analysis of the number needed to treat to benefit revealed that for every three patients undergoing debridement, the endoscopic score would be decreased by one point in one patient. For every five patients undergoing debridement adhesion formation would be prevented in one patient. Use of postoperative medical treatment was reported in all studies, all of which recommended nasal douching. Steroids (systemic or nasal) were administered in two studies. However, the data were very limited and heterogeneous, therefore we could not analyse the impact of concomitant postoperative medical treatment. The rate of revision surgery was not reported in any of the included studies, however it is not clear whether these data were not recorded or if there were no revision surgeries in any of the included studies. We are uncertain about the effects of postoperative sinonasal debridement due to high risk of bias in the included studies and the low quality of the evidence. Sinonasal debridement may make little or no difference to disease-specific health-related quality of life or disease severity. Low-quality evidence suggests that postoperative debridement is associated with a significantly lower risk of adhesions at three months follow-up. Whether this has any impact on longer-term outcomes is unknown.
We included four studies with a total of 152 adult participants. These studies were conducted in several countries (Norway, the United Kingdom and Canada). All of them compared debridement to no debridement after endoscopic sinus surgery. The minimum follow-up time in the studies ranged from 3 to 12 months. Only one study reported health-related quality of life scores and only one reported disease severity scores. However, all four studies reported scores for the appearance of the sinonasal cavities viewed through an endoscope. Adverse effects of this procedure and rates of revision surgery were not reported in any of these studies. Health-related quality of life and disease severity scores were not significantly different between those patients who underwent debridement and those who did not. All four studies demonstrated better post-surgical endoscopic appearance in the debridement group, although the size of improvement was not statistically significant. A lower rate of intranasal scarring was noted in the patient group that underwent debridement. Nonetheless, the overall evidence for all of these outcomes is of low quality. We identified several problems or potential problems in these studies. The most important was that in each study a different protocol was used for the number of debridement interventions performed per patient and the time interval between each such intervention. In addition, the numbers of patients in the study groups were relatively small. We therefore determined the overall quality of the evidence to be low for all outcomes. The evidence in this review is up to date to May 2018.
10.1002/14651858.CD011988.pub2
[ "We included four studies with a total of 152 adult participants. These studies were conducted in several countries (Norway, the United Kingdom and Canada). All of them compared debridement to no debridement after endoscopic sinus surgery. The minimum follow-up time in the studies ranged from 3 to 12 months. Only one study reported health-related quality of life scores and only one reported disease severity scores. However, all four studies reported scores for the appearance of the sinonasal cavities viewed through an endoscope. Adverse effects of this procedure and rates of revision surgery were not reported in any of these studies. Health-related quality of life and disease severity scores were not significantly different between those patients who underwent debridement and those who did not. All four studies demonstrated better post-surgical endoscopic appearance in the debridement group, although the size of improvement was not statistically significant. A lower rate of intranasal scarring was noted in the patient group that underwent debridement. Nonetheless, the overall evidence for all of these outcomes is of low quality. We identified several problems or potential problems in these studies. The most important was that in each study a different protocol was used for the number of debridement interventions performed per patient and the time interval between each such intervention. In addition, the numbers of patients in the study groups were relatively small. We therefore determined the overall quality of the evidence to be low for all outcomes. The evidence in this review is up to date to May 2018." ]
cochrane-simplification-train-929
cochrane-simplification-train-929
We reviewed 106 reports of 35 trials, published between 1931 and 2015. We included 19 trials including over 310,000 women, excluded 15 trials and one is ongoing. Overall, seven trials were judged to be of low risk of bias, three were high risk of bias and for nine it was unclear. 1) Vitamin A alone versus placebo or no treatment Overall, when trial results are pooled, vitamin A supplementation does not affect the risk of maternal mortality (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.65 to 1.20; four trials Ghana, Nepal, Bangladesh, UK, high quality evidence), perinatal mortality (RR 1.01, 95% CI 0.95 to 1.07; one study, high quality evidence), neonatal mortality, stillbirth, neonatal anaemia, preterm birth (RR 0.98, 95% CI 0.94 to 1.01, five studies, high quality evidence), or the risk of having a low birthweight baby. Vitamin A supplementation reduces the risk of maternal night blindness (RR 0.79, 95% CI 0.64 to 0.98; two trials). There is evidence that vitamin A supplements may reduce maternal clinical infection (RR 0.45, 95% CI 0.20 to 0.99, five trials; South Africa, Nepal, Indonesia, Tanzania, UK, low quality evidence) and maternal anaemia (RR 0.64, 95% CI 0.43 to 0.94; three studies, moderate quality evidence). 2) Vitamin A alone versus micronutrient supplements without vitamin A Vitamin A alone compared to micronutrient supplements without vitamin A does not decrease maternal clinical infection (RR 0.99, 95% CI 0.83 to 1.18, two trials, 591 women). No other primary or secondary outcomes were reported 3) Vitamin A with other micronutrients versus micronutrient supplements without vitamin A Vitamin A supplementation (with other micronutrients) does not decrease perinatal mortality (RR 0.51, 95% CI 0.10 to 2.69; one study, low quality evidence), maternal anaemia (RR 0.86, 95% CI 0.68 to 1.09; three studies, low quality evidence), maternal clinical infection (RR 0.95, 95% CI 0.80 to 1.13; I² = 45%, two studies, low quality evidence) or preterm birth (RR 0.39, 95% CI 0.08 to 1.93; one study, low quality evidence). In HIV-positive women vitamin A supplementation given with other micronutrients was associated with fewer low birthweight babies (< 2.5 kg) in the supplemented group in one study (RR 0.67, 95% CI 0.47 to 0.96; one study, 594 women). The pooled results of three large trials in Nepal, Ghana and Bangladesh (with over 153,500 women) do not currently suggest a role for antenatal vitamin A supplementation to reduce maternal or perinatal mortality. However, the populations studied were probably different with regard to baseline vitamin A status and there were problems with follow-up of women. There is good evidence that antenatal vitamin A supplementation reduces maternal night blindness, maternal anaemia for women who live in areas where vitamin A deficiency is common or who are HIV-positive. In addition the available evidence suggests a reduction in maternal infection, but these data are not of a high quality.
This review included 19 studies involving over 310,000 women. Seven trials were conducted in Africa, six in Indonesia, two in Bangladesh, and one each in Nepal, China, India, UK and USA. Most of the trials were conducted in populations considered to be vitamin A deficient (except USA and UK). The overall risk of bias was low to unclear in most of the trials, and the body of evidence was moderate to high quality. The findings indicate that routine supplementation with vitamin A (either alone or in combination with other supplements) during pregnancy did not reduce mother or newborn baby deaths. There is good evidence that antenatal vitamin A supplementation does reduce maternal anaemia in women who live in areas where vitamin A deficiency is common or who are HIV-positive. The trials published so far did not report any side effects or adverse events. The available evidence suggests a reduction in maternal infection but these data are not of a high quality and further trials would be needed to confirm or refute this. Taking vitamin A supplements during pregnancy does not help to prevent maternal deaths (related to pregnancy) or perinatal or newborn baby deaths. Taking vitamin A supplements during pregnancy does not help to prevent other problems that can occur such as stillbirth, preterm birth, low birthweight of babies or newborn babies with anaemia. However, the risk of maternal anaemia, maternal infection and maternal night blindness is reduced.
10.1002/14651858.CD008666.pub3
[ "This review included 19 studies involving over 310,000 women. Seven trials were conducted in Africa, six in Indonesia, two in Bangladesh, and one each in Nepal, China, India, UK and USA. Most of the trials were conducted in populations considered to be vitamin A deficient (except USA and UK). The overall risk of bias was low to unclear in most of the trials, and the body of evidence was moderate to high quality. The findings indicate that routine supplementation with vitamin A (either alone or in combination with other supplements) during pregnancy did not reduce mother or newborn baby deaths. There is good evidence that antenatal vitamin A supplementation does reduce maternal anaemia in women who live in areas where vitamin A deficiency is common or who are HIV-positive. The trials published so far did not report any side effects or adverse events. The available evidence suggests a reduction in maternal infection but these data are not of a high quality and further trials would be needed to confirm or refute this. Taking vitamin A supplements during pregnancy does not help to prevent maternal deaths (related to pregnancy) or perinatal or newborn baby deaths. Taking vitamin A supplements during pregnancy does not help to prevent other problems that can occur such as stillbirth, preterm birth, low birthweight of babies or newborn babies with anaemia. However, the risk of maternal anaemia, maternal infection and maternal night blindness is reduced." ]
cochrane-simplification-train-930
cochrane-simplification-train-930
We identified seven studies that met inclusion criteria for this review. Three were recorded as completed (or terminated) but no results were published. Of the remaining four studies (299 participants): two investigated liposomal bupivacaine transversus abdominis plane (TAP) block, one liposomal bupivacaine dorsal penile nerve block, and one ankle block. The study investigating liposomal bupivacaine ankle block was a Phase II dose-escalating/de-escalating trial presenting pooled data that we could not use in our analysis. The studies did not report our primary outcome, cumulative pain score between 0 and 72 hours, and secondary outcomes, mean pain score at 12, 24, 48, 72, or 96 hours. One study reported no difference in mean pain score during the first, second, and third postoperative 24-hour periods in participants receiving liposomal bupivacaine TAP block compared to no TAP block. Two studies, both in people undergoing laparoscopic surgery under TAP block, investigated cumulative postoperative opioid dose, reported opposing findings. One found a lower cumulative opioid consumption between 0 and 72 hours compared to bupivacaine hydrochloride TAP block and one found no difference during the first, second, and third postoperative 24-hour periods compared to no TAP block. No studies reported time to first postoperative opioid or percentage not requiring opioids over the initial 72 hours. No studies reported a health economic analysis or patient-reported outcome measures (outside of pain). The review authors sought data regarding adverse events but none were available, however there were no withdrawals reported to be due to adverse events. Using GRADE, we considered the quality of evidence to be very low with any estimate of effect very uncertain and further research very likely to have an important impact on our confidence in the estimate of effect. All studies were at high risk of bias due to their small sample size (fewer than 50 participants per arm) leading to uncertainty around effect estimates. Additionally, inconsistency of results and sparseness of data resulted in further downgrading of the quality of the data. A lack of evidence has prevented an assessment of the efficacy of liposomal bupivacaine administered as a peripheral nerve block. At present there is a lack of data to support or refute the use of liposomal bupivacaine administered as a peripheral nerve block for the management of postoperative pain. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
In January 2016, we found seven studies that assessed liposomal bupivacaine nerve block. Three studies were listed as completed but had not reported results. This left four studies involving 299 participants for this review. Two studies investigated liposomal bupivacaine given between two of the layers of abdominal muscles to block the nerves supplying sensation to that area (known as a transversus abdominus plane (TAP) block); one study investigated liposomal bupivacaine given around the nerves that supply sensation to the penis (dorsal penile nerve block); and one study investigated the ankle (ankle block). We did not identify any studies that reported our primary outcome cumulative pain score between 0 and 72 hours or pain-centred secondary outcomes. Two studies reported cumulative opioid (a strong painkiller) use with inconsistent results. We looked for results about side effects but none were reported, however no participants dropped out of the studies due to side effects. Overall, the lack of evidence, due to the small number of trials each reporting different outcomes, prevented a full assessment of the role of liposomal bupivacaine administered as a nerve block for the management of pain after surgery in adults. Due to the small number of trials, and small number of participants in these trials, the quality of evidence was very low. As such, further research is required to evaluate the role of liposomal bupivacaine as a nerve block to treat pain after surgery.
10.1002/14651858.CD011476.pub2
[ "In January 2016, we found seven studies that assessed liposomal bupivacaine nerve block. Three studies were listed as completed but had not reported results. This left four studies involving 299 participants for this review. Two studies investigated liposomal bupivacaine given between two of the layers of abdominal muscles to block the nerves supplying sensation to that area (known as a transversus abdominus plane (TAP) block); one study investigated liposomal bupivacaine given around the nerves that supply sensation to the penis (dorsal penile nerve block); and one study investigated the ankle (ankle block). We did not identify any studies that reported our primary outcome cumulative pain score between 0 and 72 hours or pain-centred secondary outcomes. Two studies reported cumulative opioid (a strong painkiller) use with inconsistent results. We looked for results about side effects but none were reported, however no participants dropped out of the studies due to side effects. Overall, the lack of evidence, due to the small number of trials each reporting different outcomes, prevented a full assessment of the role of liposomal bupivacaine administered as a nerve block for the management of pain after surgery in adults. Due to the small number of trials, and small number of participants in these trials, the quality of evidence was very low. As such, further research is required to evaluate the role of liposomal bupivacaine as a nerve block to treat pain after surgery." ]
cochrane-simplification-train-931
cochrane-simplification-train-931
Two studies (67 participants) were included in the review. Based on the published reports, both studies had potential for bias in several domains. There is some evidence that long intravenous lines are superior to short intravenous lines. One study of 20 participants found that the lifespan of a long intravenous line is longer than that of a short intravenous line, and that participants preferred the long intravenous lines to short intravenous lines. A further study of 47 participants found no difference in lifespan, or participant preference when comparing two different long intravenous lines (the Hydrocath and Vygon EC). Neither study was powered to detect differences in serious complications of the devices. There is some evidence to support the use of long intravenous lines rather than short intravenous lines, in terms of lifespan of the line and patient satisfaction. There is no evidence to suggest that any one type of long intravenous line is superior, and currently choice of line should be determined by operator and patient preference. There are numerous devices available which are used in cystic fibrosis. Further research is required to identify clinically important differences between these devices.
We have found two trials comparing these devices and including 67 participants in total. The studies compared different devices, so we could not pool the information from the two studies. However, one study showed that long intravenous lines last for longer than short intravenous lines (thus reducing the number of procedures which a participant has to undergo for a course of antibiotics). Patient satisfaction was higher with long intravenous lines compared to short intravenous lines. The study comparing two different types of long intravenous line did not show that one type was clearly better than another. Neither study was large enough to show differences in complications for the different devices. Neither study reported on important outcomes, such as the number of attempts required to insert the device. We recommend further research to compare different types of percutaneous long intravenous line.
10.1002/14651858.CD008243.pub2
[ "We have found two trials comparing these devices and including 67 participants in total. The studies compared different devices, so we could not pool the information from the two studies. However, one study showed that long intravenous lines last for longer than short intravenous lines (thus reducing the number of procedures which a participant has to undergo for a course of antibiotics). Patient satisfaction was higher with long intravenous lines compared to short intravenous lines. The study comparing two different types of long intravenous line did not show that one type was clearly better than another. Neither study was large enough to show differences in complications for the different devices. Neither study reported on important outcomes, such as the number of attempts required to insert the device. We recommend further research to compare different types of percutaneous long intravenous line." ]
cochrane-simplification-train-932
cochrane-simplification-train-932
We included in the review seven trials with 542 participants. One trial randomised limbs to undergo PTA alone or PTA with stent placement, and the remaining studies randomised participants. Five trials with 476 participants show that the technical success rate was greater in the stent group than in the angioplasty group (odds ratio (OR) 3.00, 95% confidence interval (CI) 1.14 to 7.93; 476 lesions; 5 studies; I² = 23%). Meta-analysis of three eligible trials with 456 participants did not show a clear difference in short-term (within six months) patency between infrapopliteal arterial lesions treated with PTA and those treated with PTA and stenting (OR 0.88, 95% CI 0.37 to 2.11; 456 lesions; 3 studies; I² = 77%). Results also did not show clear differences between treatment groups in procedure complication rate (OR 0.87, 95% CI 0.01 to 53.60; 360 participants; 5 studies; I² = 85%), rate of major amputations at 12 months (OR 1.34, 95% CI 0.56 to 3.22; 306 participants; 4 studies; I² = 0%), and rate of mortality at 12 months (OR 0.71, 95% CI 0.43 to 1.17; 497 participants; 6 studies; I² = 0%). Heterogeneity between studies was high for the outcomes procedure complications and primary patency. The overall methodological quality of the trials included in this review was moderate due to selection and performance bias. Studies used different regimens for pretreatment and post-treatment antiplatelet/anticoagulant medication. We downgraded the certainty of the overall evidence for all outcomes by one level to moderate due to inconsistency of results across studies and large confidence intervals (small numbers of trials and participants). Trials show that the immediate technical success rate of restoring luminal patency is higher in the stent group but reveal no clear differences in short-term patency at six months between infrapopliteal arterial lesions treated with PTA with stenting versus those treated with PTA without stenting. We ascertained no clear differences between groups in periprocedural complications, major amputation, and mortality. However, use of different regimens for pretreatment and post-treatment antiplatelet/anticoagulant medication and the duration of its use within and between trials may have influenced the outcomes. Limited currently available data suggest that high-quality evidence is insufficient to show that PTA with stent insertion is superior to use of standard PTA alone without stenting for treatment of infrapopliteal arterial lesions. Further studies should standardise the use of antiplatelets/anticoagulants before and after the intervention to improve the comparability of the two treatments.
We identified seven trials with a combined total of 542 participants comparing percutaneous transluminal angioplasty (PTA) alone versus PTA with stent placement (current until June 2018). One trial randomised limbs to PTA alone or PTA with stent placement, and the remaining studies randomised participants. Full analysis of five trials shows that the technical success rate of re-opening the narrowed artery was higher in the stent group than in the PTA group. However, we noted no clear differences in patency (opened vessel remaining open) of the treated vessel at six months. The complication rate of the procedure, the number of major amputations at 12 months, and the number of deaths at 12 months also did not differ greatly between treatment groups. The overall certainty of evidence provided by the trials included in this review was moderate. Trials differed in their methods. Two studies reported poorly on the methods used to generate random numbers and to allocate participants to different groups. All studies were unblinded. All included studies were rated as direct in their relevance to the review question. Overall, we downgraded the certainty of evidence for all outcomes by one level to moderate due to inconsistency of results across studies and the small numbers of studies and participants. PTA with stent placement is better than PTA alone for restoring vessel patency immediately; however we found no clear difference in short-term patency at six months between the two groups. Trials show no clear differences between groups in complications at or around the time of the procedure, major amputation, and death. Currently available data suggest that high-certainty evidence is insufficient to show that PTA with stent placement is superior to PTA alone for treatment of infrapopliteal arterial lesions. Further studies should standardise the use of blood-thinning drugs (antiplatelets/anticoagulants) before and after both interventions to improve the comparability of the two treatments.
10.1002/14651858.CD009195.pub2
[ "We identified seven trials with a combined total of 542 participants comparing percutaneous transluminal angioplasty (PTA) alone versus PTA with stent placement (current until June 2018). One trial randomised limbs to PTA alone or PTA with stent placement, and the remaining studies randomised participants. Full analysis of five trials shows that the technical success rate of re-opening the narrowed artery was higher in the stent group than in the PTA group. However, we noted no clear differences in patency (opened vessel remaining open) of the treated vessel at six months. The complication rate of the procedure, the number of major amputations at 12 months, and the number of deaths at 12 months also did not differ greatly between treatment groups. The overall certainty of evidence provided by the trials included in this review was moderate. Trials differed in their methods. Two studies reported poorly on the methods used to generate random numbers and to allocate participants to different groups. All studies were unblinded. All included studies were rated as direct in their relevance to the review question. Overall, we downgraded the certainty of evidence for all outcomes by one level to moderate due to inconsistency of results across studies and the small numbers of studies and participants. PTA with stent placement is better than PTA alone for restoring vessel patency immediately; however we found no clear difference in short-term patency at six months between the two groups. Trials show no clear differences between groups in complications at or around the time of the procedure, major amputation, and death. Currently available data suggest that high-certainty evidence is insufficient to show that PTA with stent placement is superior to PTA alone for treatment of infrapopliteal arterial lesions. Further studies should standardise the use of blood-thinning drugs (antiplatelets/anticoagulants) before and after both interventions to improve the comparability of the two treatments." ]
cochrane-simplification-train-933
cochrane-simplification-train-933
We included nine studies randomising 4514 women for meta-analysis and review. Overall results for the primary endpoint of PFS indicated that women receiving fulvestrant did at least as well as the control groups (hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.89 to 1.02; P = 0.18, I2= 56%, 4258 women, 9 studies, high-quality evidence). In the one high-quality study that tested fulvestrant at the currently approved and now standard dose of 500 mg against anastrozole, women treated with fulvestrant 500 mg did better than anastrozole, with a HR for TTP of 0.66 (95% CI 0.47 to 0.93; 205 women) and a HR for overall survival of 0.70 (95% CI 0.50 to 0.98; 205 women). There was no difference in PFS whether fulvestrant was used in combination with another endocrine therapy or in the first- or second-line setting, when compared to control treatments: for monotherapy HR 0.97 (95% CI 0.90 to 1.04) versus HR 0.87 (95% CI 0.77 to 0.99) for combination therapy when compared to control, and HR 0.93 (95% CI 0.84 to 1.03) in the first-line setting and HR 0.96 (95% CI 0.88 to 1.04) in the second-line setting. Overall, there was no difference between fulvestrant and control treatments in clinical benefit rate (risk ratio (RR) 1.03, 95% CI 0.97 to 1.10; P = 0.29, I2 = 24%, 4105 women, 9 studies, high-quality evidence) or overall survival (HR 0.97, 95% CI 0.87 to 1.09, P = 0.62, I2 = 66%, 2480 women, 5 studies, high-quality evidence). There was no significant difference in vasomotor toxicity (RR 1.02, 95% CI 0.89 to 1.18, 3544 women, 8 studies, high-quality evidence), arthralgia (RR 0.96, 95% CI 0.86 to 1.09, 3244 women, 7 studies, high-quality evidence), and gynaecological toxicities (RR 1.22, 95% CI 0.94 to 1.57, 2848 women, 6 studies, high-quality evidence). Four studies reported quality of life, none of which reported a difference between the fulvestrant and control arms, though specific data were not presented. For postmenopausal women with advanced hormone-sensitive breast cancer, fulvestrant is at least as effective and safe as the comparator endocrine therapies in the included studies. However, fulvestrant may be potentially more effective than current therapies when given at 500 mg, though this higher dosage was used in only one of the nine studies included in the review. We saw no advantage with combination therapy, and fulvestrant was equally as effective as control therapies in both the first- and second-line setting. Our review demonstrates that fulvestrant is a safe and effective systemic therapy and can be considered as a valid option in the sequence of treatments for postmenopausal women with hormone-sensitive advanced breast cancer.
The evidence is current to 7 July 2015. Our review identified nine clinical trials that compared the effectiveness and safety of fulvestrant against other standard treatments for advanced hormone-sensitive breast cancer and pooled the data from these trials to analyse all the data together. Three different endocrine therapies were analysed as comparator drugs against fulvestrant. Two of these drugs were the aromatase inhibitors anastrozole and exemestane, which lower oestrogen levels in postmenopausal women, and the third was tamoxifen, which works by blocking oestrogen. Four of the studies were in the first-line setting, meaning that fulvestrant was tested against these endocrine therapies as the initial treatment for advanced disease. Five of the studies tested fulvestrant in the second-line or more setting, meaning after the women had progressed on a prior initial treatment for advanced disease. Two studies examined fulvestrant in combination with anastrozole against anastrozole alone, and the other seven studies compared fulvestrant alone with other comparator drugs. We found that fulvestrant was at least as effective as the other three standard endocrine therapies used in the treatment of advanced hormone-sensitive breast cancer and is possibly more effective at the new standard dose of 500 mg, rather than the lower dose of 250 mg, which was previously used and tested in all but one of the included studies. We also found that combining fulvestrant with an aromatase inhibitor did not improve effectiveness, and neither was effectiveness influenced by whether fulvestrant was used as the first treatment upon diagnosis of advanced disease or after another endocrine therapy. This was evident in the pooled data analysis for both survival time without progression of cancer and the rate of tumour shrinkage or stabilisation due to fulvestrant as compared with the other endocrine therapies. In addition, fulvestrant-treated women did not experience worse side effects than those receiving the comparator endocrine therapies, and quality of life was equivalent in both fulvestrant-treated women and women treated with the other endocrine therapies. Fulvestrant can therefore be considered an effective and safe treatment for postmenopausal women with advanced hormone-sensitive breast cancer, when treatment with endocrine therapy is indicated. All studies were of high quality.
10.1002/14651858.CD011093.pub2
[ "The evidence is current to 7 July 2015. Our review identified nine clinical trials that compared the effectiveness and safety of fulvestrant against other standard treatments for advanced hormone-sensitive breast cancer and pooled the data from these trials to analyse all the data together. Three different endocrine therapies were analysed as comparator drugs against fulvestrant. Two of these drugs were the aromatase inhibitors anastrozole and exemestane, which lower oestrogen levels in postmenopausal women, and the third was tamoxifen, which works by blocking oestrogen. Four of the studies were in the first-line setting, meaning that fulvestrant was tested against these endocrine therapies as the initial treatment for advanced disease. Five of the studies tested fulvestrant in the second-line or more setting, meaning after the women had progressed on a prior initial treatment for advanced disease. Two studies examined fulvestrant in combination with anastrozole against anastrozole alone, and the other seven studies compared fulvestrant alone with other comparator drugs. We found that fulvestrant was at least as effective as the other three standard endocrine therapies used in the treatment of advanced hormone-sensitive breast cancer and is possibly more effective at the new standard dose of 500 mg, rather than the lower dose of 250 mg, which was previously used and tested in all but one of the included studies. We also found that combining fulvestrant with an aromatase inhibitor did not improve effectiveness, and neither was effectiveness influenced by whether fulvestrant was used as the first treatment upon diagnosis of advanced disease or after another endocrine therapy. This was evident in the pooled data analysis for both survival time without progression of cancer and the rate of tumour shrinkage or stabilisation due to fulvestrant as compared with the other endocrine therapies. In addition, fulvestrant-treated women did not experience worse side effects than those receiving the comparator endocrine therapies, and quality of life was equivalent in both fulvestrant-treated women and women treated with the other endocrine therapies. Fulvestrant can therefore be considered an effective and safe treatment for postmenopausal women with advanced hormone-sensitive breast cancer, when treatment with endocrine therapy is indicated. All studies were of high quality." ]
cochrane-simplification-train-934
cochrane-simplification-train-934
Seven small studies were identified and varied according to probiotics tested, methodological quality and medication regimen. No studies were pooled for statistical analysis. There was no statistically significant benefit of E. coli Nissle for reducing the risk of relapse compared to placebo (RR 0.43, 95% CI 0.15 to 1.20), or Lactobacillus GG after surgically-induced remission (RR 1.58, 95% CI 0.30 to 8.40) or medically-induced remission (RR 0.83, 95% CI 0.25 to 2.80). There was no statistically significant benefit of probiotics for reducing the risk of relapse compared to maintenance therapy employing aminosalicylates or azathioprine (RR 0.67, 95% CI 0.13 to 3.30), and in this study the probiotic Lactobacillus GG was associated with adverse events. In children, there was there was no statistically significant difference between Lactobacillus GG and placebo for reducing the risk of relapse (RR 1.85, 95% CI 0.77 to 4.40). A small study using the yeast Saccharomyces boulardii demonstrated a difference that was not statistically significant in favour of probiotic combined with a reduced level of maintenance therapy over standard maintenance treatment alone (RR 0.17, 95% CI 0.02 to 1.23). There is no evidence to suggest that probiotics are beneficial for the maintenance of remission in CD. All of the included studies enrolled small numbers of patients and may have lacked statistical power to show differences should they exist. Larger trials are required to determine if probiotics are of benefit in Crohn's disease.
Seven small studies of variable quality were reviewed. The studies tested the effect of maintenance treatment with probiotics (e.g. Lactobacilli GG, Escherichia coli strain Nissle 1917, VSL#3, Saccharomyces boulardii) among patients with Crohn's disease in remission. Remission was induced by medical or surgical treatment. The studies lasted for 6 months to a year. The studies did not demonstrate any benefit for probiotic treatment. Probiotics were generally well tolerated and few side effects were reported. Reported side effects include bloating, diarrhoea, constipation, nausea and epigastric pain. Currently, there is no evidence to support the use of probiotics for the maintenance treatment of Crohn's disease. It is possible that larger studies might show that this approach to treatment is effective.
10.1002/14651858.CD004826.pub2
[ "Seven small studies of variable quality were reviewed. The studies tested the effect of maintenance treatment with probiotics (e.g. Lactobacilli GG, Escherichia coli strain Nissle 1917, VSL#3, Saccharomyces boulardii) among patients with Crohn's disease in remission. Remission was induced by medical or surgical treatment. The studies lasted for 6 months to a year. The studies did not demonstrate any benefit for probiotic treatment. Probiotics were generally well tolerated and few side effects were reported. Reported side effects include bloating, diarrhoea, constipation, nausea and epigastric pain. Currently, there is no evidence to support the use of probiotics for the maintenance treatment of Crohn's disease. It is possible that larger studies might show that this approach to treatment is effective." ]
cochrane-simplification-train-935
cochrane-simplification-train-935
We included three randomised controlled trials (RCTs) with 175 women. The three published RCTs compared NTG alone versus placebo. The detachment status of retained placenta was unknown in all three RCTs. Collectively, among the three included trials, two were judged to be at low risk of bias and the third trial was judged to be at high risk of bias for two domains: incomplete outcome data and selective reporting. The three trials reported seven out of 23 of the review's pre-specified outcomes. The primary outcome "manual removal of the placenta" was reported in all three studies. No differences were seen between NTG and placebo for manual removal of the placenta (average risk ratio (RR) 0.83, 95% confidence interval (CI) 0.47 to 1.46; women = 175; I² = 81%). A random-effects model was used because of evidence of substantial heterogeneity in the analysis. There were also no differences between groups for risk of severe postpartum haemorrhage (RR 0.93, 95% CI 0.62 to 1.39; women = 150; studies = two; I² = 0%). Blood transfusion was only reported in one study (40 women) and again there was no difference between groups (RR 1.00, 95% CI 0.07 to 14.90; women = 40; I² = 0%). Mean blood loss (mL) was reported in the three studies and no differences were observed (mean difference (MD) -115.31, 95% CI -306.25 to 75.63; women = 169; I² = 83%). Nitroglycerin administration was not associated with an increase in headaches (RR 1.09, 95% CI 0.80 to 1.47; women = 174; studies = three; I² = 0%). However, nitroglycerin administration was associated with a significant, though mild, decrease in systolic and diastolic blood pressure and a significant increase in pulse rate (MD -3.75, 95% CI -7.47 to -0.03) for systolic blood pressure, and (MD 6.00, 95% CI 3.07 to 8.93) for pulse rate (beats per minute) respectively (reported by only one study including 24 participants). Maternal mortality and addition of therapeutic uterotonics were not reported in any study. In cases of retained placenta, currently available data showed that the use of NTG alone did not reduce the need for manual removal of placenta. This intervention did not increase the incidence of severe postpartum haemorrhage nor the need for blood transfusion. Haemodynamically, NTG had a significant though mild effect on both pulse rate and blood pressure.
This review included three trials that randomly assigned 175 women with the placenta remaining undelivered more than 15 minutes after delivery to either a placebo or the tocolytic nitroglycerin. Both groups received oxytocin to stimulate contractions of the uterus. Combined administration of nitroglycerin and oxytocin did not reduce the need for manual removal of placenta, blood loss, nor the incidence of severe postpartum haemorrhage. Nitroglycerin administration did not cause headache but resulted in a mild drop in blood pressure and a related increase in heart rate. Two out of the three trials had low risk of bias but this result needs confirmation in larger trials with adequate sample sizes to verify the role of nitroglycerin and other tocolytic drugs in managing different subtypes of retained placenta. The trials in this review did not specify the type of retained placenta. We have included an explanation of some of the scientific terms that are used in this review in a glossary (see Appendix 1).
10.1002/14651858.CD007708.pub3
[ "This review included three trials that randomly assigned 175 women with the placenta remaining undelivered more than 15 minutes after delivery to either a placebo or the tocolytic nitroglycerin. Both groups received oxytocin to stimulate contractions of the uterus. Combined administration of nitroglycerin and oxytocin did not reduce the need for manual removal of placenta, blood loss, nor the incidence of severe postpartum haemorrhage. Nitroglycerin administration did not cause headache but resulted in a mild drop in blood pressure and a related increase in heart rate. Two out of the three trials had low risk of bias but this result needs confirmation in larger trials with adequate sample sizes to verify the role of nitroglycerin and other tocolytic drugs in managing different subtypes of retained placenta. The trials in this review did not specify the type of retained placenta. We have included an explanation of some of the scientific terms that are used in this review in a glossary (see Appendix 1)." ]
cochrane-simplification-train-936
cochrane-simplification-train-936
Twelve trials were eligible. All had high risk of bias and reporting was inconsistent. Hepatitis B vaccine did not show a clear effect on the risk of developing HBsAg (RR 0.96, 95% CI 0.89 to 1.03, 4 trials, 1230 participants) and anti-HBc (RR 0.81, 95% CI 0.61 to 1.07; 4 trials, 1230 participants, random-effects) when data were analysed using intention-to-treat analysis assuming an unfavourable event for missing data. Analysis based on data of available participants showed reduced risk of developing HBsAg (RR 0.12, 95% CI 0.03 to 0.44, 4 trials, 576 participants) and anti-HBc (RR 0.36, 95% CI 0.17 to 0.76, 4 trials, 576 participants, random-effects). Intention-to-treat analysis assuming favourable outcome for missing data showed similar reduction in risk. Hepatitis B vaccination had an unclear effect on the risk of lacking protective antibody levels (RR 0.57, 95% CI 0.26 to 1.27, 3 trials, 1210 participants, random-effects). Development of adverse events was sparsely reported. In people not previously exposed to hepatitis B, vaccination has unclear effect on the risk of developing infection, as compared to no vaccination. The risk of lacking protective antibody levels as well as serious and non-serious adverse events appear comparable among recipients and non-recipients of hepatitis B vaccine.
Twelve randomised clinical trials fulfilled the inclusion criteria of this review. Primary analysis of the data based on criteria described beforehand (intention-to-treat model assigning unfavourable outcome for missing data) showed that hepatitis B vaccination has an unclear effect on the risk of developing hepatitis B infection. Analysis of data of available participants in the various trials showed that as compared to not vaccinating, hepatitis B vaccination reduces the risk of developing hepatitis B infection; by 88% for hepatitis B surface antigen marker and 62% for anti-core antibody marker. One should note, that these findings are based on only four randomised clinical trials of poor methodological quality involving 1230 participants. When compared with other vaccines or placebo, hepatitis B vaccination results in comparable risk of developing adverse events. This includes serious adverse events such as admission to hospital and convulsions, as well as less serious events such as fever, local redness, and pain. This shows that the risk of developing these adverse events is not more than with other vaccinations. There was not enough data to draw definite conclusions on the effect of hepatitis B vaccination on compliance and cost-effectiveness.
10.1002/14651858.CD006481.pub2
[ "Twelve randomised clinical trials fulfilled the inclusion criteria of this review. Primary analysis of the data based on criteria described beforehand (intention-to-treat model assigning unfavourable outcome for missing data) showed that hepatitis B vaccination has an unclear effect on the risk of developing hepatitis B infection. Analysis of data of available participants in the various trials showed that as compared to not vaccinating, hepatitis B vaccination reduces the risk of developing hepatitis B infection; by 88% for hepatitis B surface antigen marker and 62% for anti-core antibody marker. One should note, that these findings are based on only four randomised clinical trials of poor methodological quality involving 1230 participants. When compared with other vaccines or placebo, hepatitis B vaccination results in comparable risk of developing adverse events. This includes serious adverse events such as admission to hospital and convulsions, as well as less serious events such as fever, local redness, and pain. This shows that the risk of developing these adverse events is not more than with other vaccinations. There was not enough data to draw definite conclusions on the effect of hepatitis B vaccination on compliance and cost-effectiveness." ]
cochrane-simplification-train-937
cochrane-simplification-train-937
We retrieved a total of 10 studies (885 participants), seven of which contributed to the meta-analysis for the primary outcome. Four of these compared antidepressants and placebo, two compared two antidepressants, and one three-armed study compared two antidepressants and placebo. In this update we included one additional unpublished study. These new data contributed to the secondary analysis, while the results of the primary analysis remained unchanged. For acute-phase treatment response (6 to 12 weeks), we found no difference between antidepressants as a class and placebo on symptoms of depression measured both as a continuous outcome (standardised mean difference (SMD) −0.45, 95% confidence interval (CI) −1.01 to 0.11, five RCTs, 266 participants; very low certainty evidence) and as a proportion of people who had depression at the end of the study (risk ratio (RR) 0.82, 95% CI 0.62 to 1.08, five RCTs, 417 participants; very low certainty evidence). No trials reported data on follow-up response (more than 12 weeks). In head-to-head comparisons we only retrieved data for selective serotonin reuptake inhibitors (SSRIs) versus tricyclic antidepressants, showing no difference between these two classes (SMD −0.08, 95% CI −0.34 to 0.18, three RCTs, 237 participants; very low certainty evidence). No clear evidence of a beneficial effect of antidepressants versus either placebo or other antidepressants emerged from our analyses of the secondary efficacy outcomes (dichotomous outcome, response at 6 to 12 weeks, very low certainty evidence). In terms of dropouts due to any cause, we found no difference between antidepressants as a class compared with placebo (RR 0.85, 95% CI 0.52 to 1.38, seven RCTs, 479 participants; very low certainty evidence), and between SSRIs and tricyclic antidepressants (RR 0.83, 95% CI 0.53 to 1.30, three RCTs, 237 participants). We downgraded the certainty (quality) of the evidence because the included studies were at an unclear or high risk of bias due to poor reporting, imprecision arising from small sample sizes and wide confidence intervals, and inconsistency due to statistical or clinical heterogeneity. Despite the impact of depression on people with cancer, the available studies were very few and of low quality. This review found very low certainty evidence for the effects of these drugs compared with placebo. On the basis of these results, clear implications for practice cannot be deduced. The use of antidepressants in people with cancer should be considered on an individual basis and, considering the lack of head-to-head data, the choice of which agent to prescribe may be based on the data on antidepressant efficacy in the general population of individuals with major depression, also taking into account that data on medically ill patients suggest a positive safety profile for the SSRIs. To better inform clinical practice, there is an urgent need for large, simple, randomised, pragmatic trials comparing commonly used antidepressants versus placebo in people with cancer who have depressive symptoms, with or without a formal diagnosis of a depressive disorder.
We systematically reviewed ten studies assessing the efficacy of antidepressants, for a total of 885 participants. The evidence is current to 3 July 2017. Due to the small number of people in the studies, and issues with how the studies reported what was done, there is uncertainty over whether antidepressants were better than placebo in terms of depressive symptoms after 6 to 12 weeks of treatment. We did not have enough evidence to determine how well antidepressants were tolerated in comparison with placebo. Our results did not show whether any particular antidepressant was better than any other in terms of both beneficial and harmful effects. To better inform clinical practice, we need large studies which randomly assign people to different treatments. Currently, we cannot draw reliable conclusions about the effects of antidepressants on depression in people with cancer. The certainty of the evidence was very low because of a lack of information about how the studies were designed, low numbers of people in the analysis of results, and differences between the characteristics of the studies and their results. Despite the impact of depression on people with cancer, the available studies were very few and of low quality. This review found very low certainty evidence for the effects of these drugs compared with placebo.
10.1002/14651858.CD011006.pub3
[ "We systematically reviewed ten studies assessing the efficacy of antidepressants, for a total of 885 participants. The evidence is current to 3 July 2017. Due to the small number of people in the studies, and issues with how the studies reported what was done, there is uncertainty over whether antidepressants were better than placebo in terms of depressive symptoms after 6 to 12 weeks of treatment. We did not have enough evidence to determine how well antidepressants were tolerated in comparison with placebo. Our results did not show whether any particular antidepressant was better than any other in terms of both beneficial and harmful effects. To better inform clinical practice, we need large studies which randomly assign people to different treatments. Currently, we cannot draw reliable conclusions about the effects of antidepressants on depression in people with cancer. The certainty of the evidence was very low because of a lack of information about how the studies were designed, low numbers of people in the analysis of results, and differences between the characteristics of the studies and their results. Despite the impact of depression on people with cancer, the available studies were very few and of low quality. This review found very low certainty evidence for the effects of these drugs compared with placebo." ]
cochrane-simplification-train-938
cochrane-simplification-train-938
Of the nine hundred and seventy titles initially identified through the search strategy, eight trials met the inclusion criteria. A total of 749 children and their families were randomised to receive a family and parenting intervention or to be in a control group. In seven of these studies the participants were juvenile delinquents and their families and in only one the participants were children/adolescents with conduct disorder who had not yet had contact with the juvenile justice system. At follow up, family and parenting interventions significantly reduced the time spent by juvenile delinquents in institutions (WMD 51.34 days, 95%CI 72.52 to 30.16). There was also a significant reduction in the risk of a juvenile delinquent being re arrested (RR 0.66, 95%CI 0.44 to 0.98) and in their rate of subsequent arrests at 1-3 years (SMD -0.56, 95% CI -1.100 to - 0.03). For both of these outcomes there was substantial heterogeneity in the results suggesting a need for caution in interpretation. At present there is insufficient evidence that family and parenting interventions reduce the risk of being incarcerated (RR=0.50, 95% CI 0.20 to 1.21). No significant difference was found for psychosocial outcomes such as family functioning, and child/adolescent behaviour. The evidence suggests that family and parenting interventions for juvenile delinquents and their families have beneficial effects on reducing time spent in institutions. This has an obvious benefit to the participant and their family and may result in a cost saving for society. These interventions may also reduce rates of subsequent arrest but at present these results need to be interpreted with caution due to the heterogeneity of the results.
The aim of this review was to determine if these interventions are effective in the management of conduct disorder and delinquency in children and adolescents, aged 10-17. Current evidence suggests that family and parenting interventions for juvenile delinquents and their families have beneficial effects on reducing time spent in institutions. This has an obvious benefit to the participant and their family and may result in a cost saving for society. These interventions may also reduce rates of later arrest, but at present these results need to be interpreted with caution, because of diversity in the results of studies.
10.1002/14651858.CD003015
[ "The aim of this review was to determine if these interventions are effective in the management of conduct disorder and delinquency in children and adolescents, aged 10-17. Current evidence suggests that family and parenting interventions for juvenile delinquents and their families have beneficial effects on reducing time spent in institutions. This has an obvious benefit to the participant and their family and may result in a cost saving for society. These interventions may also reduce rates of later arrest, but at present these results need to be interpreted with caution, because of diversity in the results of studies." ]
cochrane-simplification-train-939
cochrane-simplification-train-939
We identified 10 studies (545 participants and 560 tube insertions) which met our inclusion criteria. No study was assigned low risk of bias or low concern in every QUADAS-2 domain. We judged only three (30%) studies to have low risk of bias in the participant selection domain because they performed ultrasound after they confirmed correct position by other methods. Few data (43 participants) were available for misplacement detection (specificity) due to the low incidence of misplacement. We did not perform a meta-analysis because of considerable heterogeneity of the index test such as the difference of echo window, the combination of ultrasound with other confirmation methods (e.g. saline flush visualization by ultrasound) and ultrasound during the insertion of the tube. For all settings, sensitivity estimates for individual studies ranged from 0.50 to 1.00 and specificity estimates from 0.17 to 1.00. For settings where X-ray was not readily available and participants underwent gastric tube insertion for drainage (four studies, 305 participants), sensitivity estimates of ultrasound in combination with other confirmatory tests ranged from 0.86 to 0.98 and specificity estimates of 1.00 with wide confidence intervals. For the studies using ultrasound alone (four studies, 314 participants), sensitivity estimates ranged from 0.91 to 0.98 and specificity estimates from 0.67 to 1.00. Of 10 studies that assessed the diagnostic accuracy of gastric tube placement, few studies had a low risk of bias. Based on limited evidence, ultrasound does not have sufficient accuracy as a single test to confirm gastric tube placement. However, in settings where X-ray is not readily available, ultrasound may be useful to detect misplaced gastric tubes. Larger studies are needed to determine the possibility of adverse events when ultrasound is used to confirm tube placement.
Studies included in this review are current to March 2016. We included 10 studies involving 545 participants for evaluation of the diagnostic accuracy of ultrasound for confirmation of gastric tube placement. Most studies showed good performance for correct placement of the tube. However, few data were available for incorrect placement of the tube and the possible complications of a misplaced tube. Among the included studies, only 43 participants had a misplaced tube. None of the studies reported complications during ultrasound use. Three methods of ultrasound were reported: neck approach, upper abdominal (tummy) approach and a combination of both. No included studies indicated that ultrasound had sufficient accuracy as a single test for the confirmation of gastric tube placement for feeding. In contrast, ultrasound combined with other tests (e.g. saline flush visualization (pushing salt solution through the tube and seeing it inside the stomach by ultrasound)) might be useful for the confirmation of tubes used for gastric drainage. Generally, the studies were of low or unclear methodological quality. We considered only three (30%) of the 10 included studies to be representative of patients in practice because they performed ultrasound after they confirmed correct position by other methods. The studies reported a variety of results for incorrect tube placement. Larger studies are needed to investigate whether ultrasound could replace X-rays for confirming gastric tube placement, as well as whether ultrasound could decrease severe complications, such as pneumonia, from a misplaced tube.
10.1002/14651858.CD012083.pub2
[ "Studies included in this review are current to March 2016. We included 10 studies involving 545 participants for evaluation of the diagnostic accuracy of ultrasound for confirmation of gastric tube placement. Most studies showed good performance for correct placement of the tube. However, few data were available for incorrect placement of the tube and the possible complications of a misplaced tube. Among the included studies, only 43 participants had a misplaced tube. None of the studies reported complications during ultrasound use. Three methods of ultrasound were reported: neck approach, upper abdominal (tummy) approach and a combination of both. No included studies indicated that ultrasound had sufficient accuracy as a single test for the confirmation of gastric tube placement for feeding. In contrast, ultrasound combined with other tests (e.g. saline flush visualization (pushing salt solution through the tube and seeing it inside the stomach by ultrasound)) might be useful for the confirmation of tubes used for gastric drainage. Generally, the studies were of low or unclear methodological quality. We considered only three (30%) of the 10 included studies to be representative of patients in practice because they performed ultrasound after they confirmed correct position by other methods. The studies reported a variety of results for incorrect tube placement. Larger studies are needed to investigate whether ultrasound could replace X-rays for confirming gastric tube placement, as well as whether ultrasound could decrease severe complications, such as pneumonia, from a misplaced tube." ]
cochrane-simplification-train-940
cochrane-simplification-train-940
The review included four studies with 820 women. The included studies were of overall low risk of bias. Using GRADE methodology, we assessed the quality of evidence for the primary outcomes of this review to be very low- to low-quality evidence. Evidence was downgraded for imprecision as it was based on single, small trials with wide confidence intervals (CI). We were able to include data from three of the four included studies. In one study of women with both subclinical hypothyroidism and positive or negative anti-TPO antibodies (autoimmune disease), the evidence suggested that thyroxine replacement may have improved live birth rate (RR 2.13, 95% CI 1.07 to 4.21; 1 RCT, n = 64; low-quality evidence) and it may have led to similar miscarriage rates (RR 0.11, 95% CI 0.01 to 1.98; 1 RCT, n = 64; low-quality evidence). The evidence suggested that women with both subclinical hypothyroidism and positive or negative anti-TPO antibodies would have a 25% chance of a live birth with placebo or no treatment, and that the chance of a live birth in these women using thyroxine would be between 27% and 100%. In women with normal thyroid function and thyroid autoimmunity (euthyroid ATD), treatment with thyroxine replacement compared with placebo or no treatment may have led to similar live birth rates (risk ratio (RR) 1.04, 95% CI 0.83 to 1.29; 2 RCTs, number of participants (n) = 686; I2 = 46%; low-quality evidence) and miscarriage rates (RR 0.83, 95% CI 0.47 to 1.46, 2 RCTs, n = 686, I2 = 0%; low-quality evidence). The evidence suggested that women with normal thyroid function and thyroid autoimmunity would have a 31% chance of a live birth with placebo or no treatment, and that the chance of a live birth in these women using thyroxine would be between 26% and 40%. Adverse events were rarely reported. One RCT reported 0/32 in the thyroxine replacement group and 1/32 preterm births in the control group in women diagnosed with subclinical hypothyroidism and positive or negative anti-TPO antibodies. One RCT reported 21/300 preterm births in the thyroxine replacement group and 19/300 preterm births in the control group in women diagnosed with positive anti-TPO antibodies. None of the RCTs reported on other maternal pregnancy complications, foetal complications or adverse effects of thyroxine. We could draw no clear conclusions in this systematic review due to the very low to low quality of the evidence reported.
Cochrane authors performed a comprehensive literature search of the standard medical databases to 8 April 2019 in consultation with the Cochrane Gynaecology and Fertility Group Information Specialist, for randomised clinical trials (RCTs: clinical studies where people are randomly put into one of two or more treatment groups) investigating the effect of thyroid hormones (levothyroxine) for women diagnosed with ATD or mildly underactive thyroid who were planning to undergo assisted reproduction. Two authors independently selected studies, evaluated them, extracted data and attempted to contact the authors where data were missing. We found four RCTs (with 820 women) that met our inclusion requirements. The thyroid hormones were administered in a range of doses to women diagnosed with mildly underactive thyroid or presence of thyroid antibodies (ATD). In women with mild thyroid hormone imbalance and unknown thyroid autoimmunity status, we were uncertain whether thyroxine replacement had an effect on live birth or miscarriage rates (very low-quality evidence from one study involving 70 women). In women with mildly underactive thyroids (with or without ATD), the evidence suggested that thyroxine replacement may have improved live birth rates (low-quality evidence from one study involving 64 women) and it may have led to similar miscarriage rates (low-quality evidence from one study involving 64 women). The evidence suggested that women with mildly underactive thyroid (with or without ATD) would have a 25% chance of a live birth with placebo or no treatment, and 27% to 100% with thyroxine. In women with ATD and normal thyroid function, treatment with thyroxine replacement compared with placebo or no treatment may have led to similar live birth rates (low-quality evidence from two studies involving 686 women) and miscarriage rates (low quality evidence from two studies involving 686 women). The evidence suggested that women with ATD and normal thyroid function would have a 31% chance of a live birth with placebo or no treatment, and 26% to 40% with thyroxine. Side effects were rarely reported. One study reported none out of 32 preterm births in the thyroxine replacement group and one out of 32 preterm births in the control group in women diagnosed with mildly underactive thyroid (with or without ATD). One study reported 21 out of 300 preterm births in the thyroxine replacement group and 19 out of 300 preterm births in the control group in women diagnosed with ATD and normal thyroid function. None of the studies reported on other maternal pregnancy complications, foetal complications or side effects of thyroxine. The evidence was of very low to low quality. We downgraded the evidence as it was based on single, small trials with widely variable results.
10.1002/14651858.CD011009.pub2
[ "Cochrane authors performed a comprehensive literature search of the standard medical databases to 8 April 2019 in consultation with the Cochrane Gynaecology and Fertility Group Information Specialist, for randomised clinical trials (RCTs: clinical studies where people are randomly put into one of two or more treatment groups) investigating the effect of thyroid hormones (levothyroxine) for women diagnosed with ATD or mildly underactive thyroid who were planning to undergo assisted reproduction. Two authors independently selected studies, evaluated them, extracted data and attempted to contact the authors where data were missing. We found four RCTs (with 820 women) that met our inclusion requirements. The thyroid hormones were administered in a range of doses to women diagnosed with mildly underactive thyroid or presence of thyroid antibodies (ATD). In women with mild thyroid hormone imbalance and unknown thyroid autoimmunity status, we were uncertain whether thyroxine replacement had an effect on live birth or miscarriage rates (very low-quality evidence from one study involving 70 women). In women with mildly underactive thyroids (with or without ATD), the evidence suggested that thyroxine replacement may have improved live birth rates (low-quality evidence from one study involving 64 women) and it may have led to similar miscarriage rates (low-quality evidence from one study involving 64 women). The evidence suggested that women with mildly underactive thyroid (with or without ATD) would have a 25% chance of a live birth with placebo or no treatment, and 27% to 100% with thyroxine. In women with ATD and normal thyroid function, treatment with thyroxine replacement compared with placebo or no treatment may have led to similar live birth rates (low-quality evidence from two studies involving 686 women) and miscarriage rates (low quality evidence from two studies involving 686 women). The evidence suggested that women with ATD and normal thyroid function would have a 31% chance of a live birth with placebo or no treatment, and 26% to 40% with thyroxine. Side effects were rarely reported. One study reported none out of 32 preterm births in the thyroxine replacement group and one out of 32 preterm births in the control group in women diagnosed with mildly underactive thyroid (with or without ATD). One study reported 21 out of 300 preterm births in the thyroxine replacement group and 19 out of 300 preterm births in the control group in women diagnosed with ATD and normal thyroid function. None of the studies reported on other maternal pregnancy complications, foetal complications or side effects of thyroxine. The evidence was of very low to low quality. We downgraded the evidence as it was based on single, small trials with widely variable results." ]
cochrane-simplification-train-941
cochrane-simplification-train-941
We included one trial with relevant and available data (n=56, duration 2 years) comparing compliance therapy with non-specific counseling. The primary outcome 'non-compliance with treatment' showed no significant difference between compliance therapy and non-specific counseling (n=56, RR 1.23 CI 0.74 to 2.05). The compliance therapy did not substantially effect attitudes to treatment (n=50, WMD DAI score -2.10 CI -6.11 to 1.91). Very few people (˜10%) left the study by one year (n=56, RR 0.5 CI 0.1 to 2.51). Mental state seemed unaffected by the therapy (n=50, WMD PANSS score 6.1 CI -4.54 to 16.74) as was insight (n=50, WMD SAI -0.5 CI -2.43 to 1.43), global functioning (n=50, WMD GAF -4.20 CI -16.42 to 8.02) and quality of life (n=50, WMD QLS -3.40 CI -16.25 to 9.45). At both one and two years the average number of days in hospital was non-significantly reduced for those allocated to the compliance therapy. There is no clear evidence to suggest that compliance therapy is beneficial for people with schizophrenia and related syndromes but more randomised studies are justified and needed in order for this intervention to be fully examined.
We only found one reasonably good but small trial. It did not show that compliance therapy really effected compliance with medication, psychotic symptoms, or quality of life but it was always too small really to show this for certain. The study did, however, suggest that the compliance therapy may help people spend shorter times in hospital across a two year period, when compared with standard care. There is a need for more studies and we have proposed a design that could be conducted within the confines of routine care for outcomes of interest to everyone involved.
10.1002/14651858.CD003442.pub2
[ "We only found one reasonably good but small trial. It did not show that compliance therapy really effected compliance with medication, psychotic symptoms, or quality of life but it was always too small really to show this for certain. The study did, however, suggest that the compliance therapy may help people spend shorter times in hospital across a two year period, when compared with standard care. There is a need for more studies and we have proposed a design that could be conducted within the confines of routine care for outcomes of interest to everyone involved." ]
cochrane-simplification-train-942
cochrane-simplification-train-942
One randomised controlled trial of 100 IBD patients receiving a specialist nurse delivered counselling package (n = 50) or routine outpatient clinic follow-up (n = 50), with assessments at entry and six and 12 months, was included in this review. This study was of low methodological quality. Disease remission, patient compliance, clinical improvement, utilisation of nurse-led services, patient satisfaction, hospital admission, outpatient attendance, progression to surgery, length of hospital stay and cost effectiveness data were not reported. Pooled mean mental health scores at 6 months were higher in patients who received nurse-led counselling compared to patients who received routine follow-up. However, this difference was not statistically significant (WMD 3.67; 95% CI -0.44 to 7.77; P = 0.08). Other pooled assessments of physical and psychological well-being showed no statistically significant differences. Although specialist nurse counselling interventions might provide benefit for IBD patients the one included study was of low quality and the results of this study should be interpreted with caution. Higher quality trials of gastroenterology and IBD specialist nursing interventions are needed to assess the impact of specialist nursing interventions on the care and management of patients with inflammatory bowel disease.
This review included one low quality trial of a specialist nurse counselling intervention compared with routine outpatient clinic follow up. No data were reported on remission outcomes. Counselling by a specialist nurse might improve mental health related quality of life for some IBD patients in the short term. However, the poor quality of the one included study does not allow for any definitive conclusions regarding the impact of the nurse-led counselling program. Better designed studies are needed to assess the impact of specialist nursing interventions on the care and management of patients with inflammatory bowel disease.
10.1002/14651858.CD006597.pub2
[ "This review included one low quality trial of a specialist nurse counselling intervention compared with routine outpatient clinic follow up. No data were reported on remission outcomes. Counselling by a specialist nurse might improve mental health related quality of life for some IBD patients in the short term. However, the poor quality of the one included study does not allow for any definitive conclusions regarding the impact of the nurse-led counselling program. Better designed studies are needed to assess the impact of specialist nursing interventions on the care and management of patients with inflammatory bowel disease." ]
cochrane-simplification-train-943
cochrane-simplification-train-943
Our initial search yielded 4406 unique references. Fifteen reviews met our inclusion criteria; 14 of which were included in the quantitative analysis. The included reviews analyzed data from 1583 meta-analyses that covered 228 different medical conditions. The mean number of included studies per paper was 178 (range 19 to 530). Eleven (73%) reviews had low risk of bias for explicit criteria for study selection, nine (60%) were low risk of bias for investigators' agreement for study selection, five (33%) included a complete sample of studies, seven (47%) assessed the risk of bias of their included studies, Seven (47%) reviews controlled for methodological differences between studies, Eight (53%) reviews controlled for heterogeneity among studies, nine (60%) analyzed similar outcome measures, and four (27%) were judged to be at low risk of reporting bias. Our primary quantitative analysis, including 14 reviews, showed that the pooled ROR comparing effects from RCTs with effects from observational studies was 1.08 (95% confidence interval (CI) 0.96 to 1.22). Of 14 reviews included in this analysis, 11 (79%) found no significant difference between observational studies and RCTs. One review suggested observational studies had larger effects of interest, and two reviews suggested observational studies had smaller effects of interest. Similar to the effect across all included reviews, effects from reviews comparing RCTs with cohort studies had a pooled ROR of 1.04 (95% CI 0.89 to 1.21), with substantial heterogeneity (I2 = 68%). Three reviews compared effects of RCTs and case-control designs (pooled ROR: 1.11 (95% CI 0.91 to 1.35)). No significant difference in point estimates across heterogeneity, pharmacological intervention, or propensity score adjustment subgroups were noted. No reviews had compared RCTs with observational studies that used two of the most common causal inference methods, instrumental variables and marginal structural models. Our results across all reviews (pooled ROR 1.08) are very similar to results reported by similarly conducted reviews. As such, we have reached similar conclusions; on average, there is little evidence for significant effect estimate differences between observational studies and RCTs, regardless of specific observational study design, heterogeneity, or inclusion of studies of pharmacological interventions. Factors other than study design per se need to be considered when exploring reasons for a lack of agreement between results of RCTs and observational studies. Our results underscore that it is important for review authors to consider not only study design, but the level of heterogeneity in meta-analyses of RCTs or observational studies. A better understanding of how these factors influence study effects might yield estimates reflective of true effectiveness.
Researchers and organizations often use evidence from randomized controlled trials (RCTs) to determine the efficacy of a treatment or intervention under ideal conditions, while studies of observational designs are used to measure the effectiveness of an intervention in non-experimental, 'real world' scenarios. Sometimes, the results of RCTs and observational studies addressing the same question may have different results. This review explores the questions of whether these differences in results are related to the study design itself, or other study characteristics. This review summarizes the results of methodological reviews that compare the outcomes of observational studies with randomized trials addressing the same question, as well as methodological reviews that compare the outcomes of different types of observational studies. The main objectives of the review are to assess the impact of study design--to include RCTs versus observational study designs (e.g. cohort versus case-control designs) on the effect measures estimated, and to explore methodological variables that might explain any differences. We searched multiple electronic databases and reference lists of relevant articles to identify systematic reviews that were designed as methodological reviews to compare quantitative effect size estimates measuring efficacy or effectiveness of interventions of trials with observational studies or different designs of observational studies. We assessed the risks of bias of the included reviews. Our results provide little evidence for significant effect estimate differences between observational studies and RCTs, regardless of specific observational study design, heterogeneity, inclusion of pharmacological studies, or use of propensity score adjustment. Factors other than study design per se need to be considered when exploring reasons for a lack of agreement between results of RCTs and observational studies.
10.1002/14651858.MR000034.pub2
[ "Researchers and organizations often use evidence from randomized controlled trials (RCTs) to determine the efficacy of a treatment or intervention under ideal conditions, while studies of observational designs are used to measure the effectiveness of an intervention in non-experimental, 'real world' scenarios. Sometimes, the results of RCTs and observational studies addressing the same question may have different results. This review explores the questions of whether these differences in results are related to the study design itself, or other study characteristics. This review summarizes the results of methodological reviews that compare the outcomes of observational studies with randomized trials addressing the same question, as well as methodological reviews that compare the outcomes of different types of observational studies. The main objectives of the review are to assess the impact of study design--to include RCTs versus observational study designs (e.g. cohort versus case-control designs) on the effect measures estimated, and to explore methodological variables that might explain any differences. We searched multiple electronic databases and reference lists of relevant articles to identify systematic reviews that were designed as methodological reviews to compare quantitative effect size estimates measuring efficacy or effectiveness of interventions of trials with observational studies or different designs of observational studies. We assessed the risks of bias of the included reviews. Our results provide little evidence for significant effect estimate differences between observational studies and RCTs, regardless of specific observational study design, heterogeneity, inclusion of pharmacological studies, or use of propensity score adjustment. Factors other than study design per se need to be considered when exploring reasons for a lack of agreement between results of RCTs and observational studies." ]
cochrane-simplification-train-944
cochrane-simplification-train-944
This review included two randomised controlled trials. The first trial included 200 women who were randomised to receive uterine massage or no massage following delivery of the placenta, after active management of the third stage of labour including use of oxytocin. The numbers of women with blood loss more than 500 mL was small, with no statistically significant difference (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.16 to 1.67). There were no cases of retained placenta in either group. The mean blood loss was significantly less in the uterine massage group at 30 minutes (mean difference (MD) -41.60 mL, 95% CI -75.16 to -8.04) and 60 minutes after trial entry (MD -77.40 mL, 95% CI -118.71 to -36.09). The need for additional uterotonics was significantly reduced in the uterine massage group (RR 0.20, 95% CI 0.08 to 0.50). For use of uterine massage before and after delivery of the placenta, one trial recruited 1964 women in Egypt and South Africa. Women were assigned to receive oxytocin, uterine massage or both after delivery of the baby but before delivery of the placenta. There was no added benefit for uterine massage plus oxytocin over oxytocin alone as regards blood loss greater than or equal to 500 mL (average RR 1.56, 95% CI 0.44, 5.49; random-effects) or need for additional use of uterotonics (RR 1.02, 95% CI 0.56 to 1.85). The two trials were combined to examine the effect of uterine massage commenced either before or after delivery of the placenta. There was substantial heterogeneity with respect to the blood loss 500 mL or more after trial entry. The average effect using a random-effects model found no statistically significant differences between groups (average RR 1.14, 95% CI 0.39 to 3.32; random-effects). The results of this review are inconclusive, and should not be interpreted as a reason to change current practice. Due to the limitations of the included trials, more trials with sufficient numbers of women are needed in order to estimate the effects of sustained uterine massage. All the women compared in this review received oxytocin as part of the active management of labour. Recent research suggests that once an oxytocic has been given, there is limited scope for further reduction in postpartum blood loss. Trials of uterine massage in settings where uterotonics are not available, and which measure women's experience of the procedure, are needed.
In one trial involving 200 women, uterine massage was given every 10 minutes for 60 minutes after delivery of the placenta effectively reduced blood loss, and the need for additional uterotonics, by some 80%. The numbers of women losing more than 500 mL of blood were too small for meaningful comparison. Two women in the control group and none in the uterine massage group needed blood transfusions. The second trial involved 1964 women who were assigned to receive oxytocin, uterine massage or both after delivery of the baby and before delivery of the placenta. There was no added benefit for uterine massage when oxytocin was used. The results of this review are inconclusive. The methodological quality of the two included trials was high but it is possible that there were differences in the procedures used in the study sites. Disadvantages of uterine massage include the use of staff time, and discomfort caused to women. The findings should not change the recommended practice. It is likely that any reduction in blood loss was limited with the use of oxytocin in these trials. Uterine massage may also have increased apparent blood loss by pressing pooled blood out from the uterine cavity. There is a need for more trials, especially in settings where uterotonics are not available. Uterine massage could be a simple inexpensive intervention if proved effective.
10.1002/14651858.CD006431.pub3
[ "In one trial involving 200 women, uterine massage was given every 10 minutes for 60 minutes after delivery of the placenta effectively reduced blood loss, and the need for additional uterotonics, by some 80%. The numbers of women losing more than 500 mL of blood were too small for meaningful comparison. Two women in the control group and none in the uterine massage group needed blood transfusions. The second trial involved 1964 women who were assigned to receive oxytocin, uterine massage or both after delivery of the baby and before delivery of the placenta. There was no added benefit for uterine massage when oxytocin was used. The results of this review are inconclusive. The methodological quality of the two included trials was high but it is possible that there were differences in the procedures used in the study sites. Disadvantages of uterine massage include the use of staff time, and discomfort caused to women. The findings should not change the recommended practice. It is likely that any reduction in blood loss was limited with the use of oxytocin in these trials. Uterine massage may also have increased apparent blood loss by pressing pooled blood out from the uterine cavity. There is a need for more trials, especially in settings where uterotonics are not available. Uterine massage could be a simple inexpensive intervention if proved effective." ]
cochrane-simplification-train-945
cochrane-simplification-train-945
Eleven studies met the inclusion criteria. Six studies (440 participants) compared dextropropoxyphene with placebo, four studies (325 participants) and one individual patient meta-analysis (638 participant) compared dextropropoxyphene plus paracetamol 650 mg with placebo. For a single dose of dextropropoxyphene 65 mg in postoperative pain the NNT for at least 50% pain relief was 7.7 (95% confidence interval (CI) 4.6 to 22) when compared with placebo over four to six hours. There was no significant difference between the proportion of participants remedicating within four to eight hours with dextroporpoxyphene 65 mg (35%) and placebo (43%), relative risk 0.8 (0.7 to 1.03). For the equivalent dose of dextropropoxyphene combined with paracetamol 650 mg the NNT was 4.4 (3.5 to 5.6) when compared with placebo. These results were compared with those for other analgesics obtained from equivalent systematic reviews. Significantly fewer participants remedicated within four to eight hours with dextropropoxyphene 65 mg combined with paracetamol 650 mg (34%) than with placebo (57%), relative risk 0.7 (0.5 to 0.8). Pooled data showed increased incidence of central nervous system adverse effects for dextropropoxyphene plus paracetamol compared with placebo. Since the last version of this review no new relevant studies have been identified. The combination of dextropropoxyphene 65 mg with paracetamol 650 mg shows similar efficacy to tramadol 100 mg for single dose studies in postoperative pain but with a lower incidence of adverse effects. The same dose of paracetamol combined with 60 mg codeine appears more effective but, with the slight overlap in the 95% CI, this conclusion is not robust. Adverse effects of both combinations were similar. Ibuprofen 400 mg has a lower (better) NNT than both dextropropoxyphene 65 mg plus paracetamol 650 mg and tramadol 100 mg.
This review assessed the analgesic efficacy and adverse effects that single dose oral dextropropoxyphene taken alone or in combination with paracetamol had in treating moderate to severe postoperative pain. The combination of dextropropoxyphene 65 mg with paracetamol 650 mg showed similar efficacy to that of tramadol 100 mg for single dose studies in postoperative pain but with a lower incidence of side effects. This review also highlighted that Ibuprofen 400 mg was yet more effective than both tramadol 100 mg and dextropropoxyphene 65 mg.
10.1002/14651858.CD001440
[ "This review assessed the analgesic efficacy and adverse effects that single dose oral dextropropoxyphene taken alone or in combination with paracetamol had in treating moderate to severe postoperative pain. The combination of dextropropoxyphene 65 mg with paracetamol 650 mg showed similar efficacy to that of tramadol 100 mg for single dose studies in postoperative pain but with a lower incidence of side effects. This review also highlighted that Ibuprofen 400 mg was yet more effective than both tramadol 100 mg and dextropropoxyphene 65 mg." ]
cochrane-simplification-train-946
cochrane-simplification-train-946
Eleven trials that randomized 1838 participants met the study inclusion criteria. Seven of the trials included femoropopliteal arterial lesions, three included tibial arterial lesions, and one included both. The trials were carried out in Europe and in the USA and all used the taxane drug paclitaxel in the DEB arm. Nine of the 11 trials were industry-sponsored. Four companies manufactured the DEB devices (Bard, Bavaria Medizin, Biotronik, and Medtronic). The trials examined both anatomic and clinical endpoints. There was heterogeneity in the frequency of stent deployment and the type and duration of antiplatelet therapy between trials. Using GRADE assessment criteria, the quality of the evidence presented was moderate for the outcomes of target lesion revascularization and change in Rutherford category, and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (ABI). Most participants were followed up for 12 months, but one trial reported outcomes at five years. There were better outcomes for DEBs for up to two years in primary vessel patency (odds ratio (OR) 1.47, 95% confidence interval (CI) 0.22 to 9.57 at six months; OR 1.92, 95% CI 1.45 to 2.56 at 12 months; OR 3.51, 95% CI 2.26 to 5.46 at two years) and at six months and two years for late lumen loss (mean difference (MD) -0.64 mm, 95% CI -1.00 to -0.28 at six months; MD -0.80 mm, 95% CI -1.44 to -0.16 at two years). DEB were also superior to uncoated balloon angioplasty for up to five years in target lesion revascularization (OR 0.28, 95% CI 0.17 to 0.47 at six months; OR 0.40, 95% CI 0.31 to 0.51 at 12 months; OR 0.28, 95% CI 0.18 to 0.44 at two years; OR 0.21, 95% CI 0.09 to 0.51 at five years) and binary restenosis rate (OR 0.44, 95% CI 0.29 to 0.67 at six months; OR 0.38, 95% CI 0.15 to 0.98 at 12 months; OR 0.26, 95% CI 0.10 to 0.66 at two years; OR 0.12, 95% CI 0.05 to 0.30 at five years). There was no significant difference between DEB and uncoated angioplasty in amputation, death, change in ABI, change in Rutherford category and quality of life (QoL) scores, or functional walking ability, although none of the trials were powered to detect a significant difference in these clinical endpoints. We carried out two subgroup analyses to examine outcomes in femoropopliteal and tibial interventions as well as in people with CLI (4 or greater Rutherford class), and showed no advantage for DEBs in tibial vessels at six and 12 months compared with uncoated balloon angioplasty. There was also no advantage for DEBs in CLI compared with uncoated balloon angioplasty at 12 months. Based on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified.
Our review included 11 clinical trials that randomized 1838 participants (current until December 2015). The trials included thigh and leg arteries above and below the knee. The trials were carried out in Europe and the USA, and all used DEBs that contained paclitaxel. Four companies manufactured the DEB devices: Bard, Bavaria Medizin, Biotronik, and Medtronic. Most participants were followed for 12 or more months (called follow-up). At six and 12 months of follow-up, DEBs were associated with improved primary vessel patency, which is an indicator of whether a vessel is still patent without any further interventions (blood flowing well), late lumen loss, which is the difference in millimeters between the angioplastied segment and how narrow it is on follow-up, target lesion revascularization, which is an indicator of whether a person received more than one treatment to the same artery during the period covered by the study, and binary restenosis, which occurs when a treated artery becomes narrowed again after being previously treated. Unfortunately, early anatomic (structural) advantages of DEBs were not accompanied by improvements in quality of life, functional walking ability, or in the occurrence of amputation or death. When we specifically examined arteries below the knee and people who had very advanced PAD, we found no clinical or angiographic advantage for DEBs at 12 months of follow-up compared with uncoated balloon angioplasty. In summary, DEBs have several anatomic advantages over uncoated balloons for the treatment of lower limb PAD for up to 12 months after undergoing the procedure. However, more data are needed to assess the long-term results of this treatment option adequately. All the trials had differences in the way in which they inserted the balloons, and in the type and duration of additional antiplatelet (anticlotting) therapy, leading to downgrading of the quality of the evidence. The quality of the evidence presented was moderate for target lesion revascularization and change in Rutherford category (a way of classifying PAD), and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (which is used to predict the severity of PAD).
10.1002/14651858.CD011319.pub2
[ "Our review included 11 clinical trials that randomized 1838 participants (current until December 2015). The trials included thigh and leg arteries above and below the knee. The trials were carried out in Europe and the USA, and all used DEBs that contained paclitaxel. Four companies manufactured the DEB devices: Bard, Bavaria Medizin, Biotronik, and Medtronic. Most participants were followed for 12 or more months (called follow-up). At six and 12 months of follow-up, DEBs were associated with improved primary vessel patency, which is an indicator of whether a vessel is still patent without any further interventions (blood flowing well), late lumen loss, which is the difference in millimeters between the angioplastied segment and how narrow it is on follow-up, target lesion revascularization, which is an indicator of whether a person received more than one treatment to the same artery during the period covered by the study, and binary restenosis, which occurs when a treated artery becomes narrowed again after being previously treated. Unfortunately, early anatomic (structural) advantages of DEBs were not accompanied by improvements in quality of life, functional walking ability, or in the occurrence of amputation or death. When we specifically examined arteries below the knee and people who had very advanced PAD, we found no clinical or angiographic advantage for DEBs at 12 months of follow-up compared with uncoated balloon angioplasty. In summary, DEBs have several anatomic advantages over uncoated balloons for the treatment of lower limb PAD for up to 12 months after undergoing the procedure. However, more data are needed to assess the long-term results of this treatment option adequately. All the trials had differences in the way in which they inserted the balloons, and in the type and duration of additional antiplatelet (anticlotting) therapy, leading to downgrading of the quality of the evidence. The quality of the evidence presented was moderate for target lesion revascularization and change in Rutherford category (a way of classifying PAD), and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (which is used to predict the severity of PAD)." ]
cochrane-simplification-train-947
cochrane-simplification-train-947
24 RCTs with 6915 participants fulfilled the criteria of inclusion and were included in the review. Compared to placebo, acamprosate was shown to significantly reduce the risk of any drinking RR 0.86 (95% CI 0.81 to 0.91); NNT 9.09 (95% CI 6.66 to 14.28) and to significantly increase the cumulative abstinence duration MD 10.94 (95% CI 5.08 to 16.81), while secondary outcomes (gamma-glutamyltransferase, heavy drinking) did not reach statistical significance. Diarrhea was the only side effect that was more frequently reported under acamprosate than placebo RD 0.11 (95% 0.09 to 0.13); NNTB 9.09 (95% CI 7.69 to 11.11). Effects of industry-sponsored trials RR 0.88 (95% 0.80 to 0.97) did not significantly differ from those of non-profit funded trials RR 0.88 (95% CI 0.81 to 0.96). In addition, the linear regression test did not indicate a significant risk of publication bias (p = 0.861). Acamprosate appears to be an effective and safe treatment strategy for supporting continuous abstinence after detoxification in alcohol dependent patients. Even though the sizes of treatment effects appear to be rather moderate in their magnitude, they should be valued against the background of the relapsing nature of alcoholism and the limited therapeutic options currently available for its treatment.
These conclusions are based on 24 randomised controlled trials with 6915 participants who were treated as outpatients in all but one trial that involved adolescent inpatients. The majority of participants were men, median age 42 years. Most studies were conducted in Europe; two studies were conducted in the United States and one study in each of South Korea,Australia and Brazil. The effects of acamprosate did not differ in industry-sponsored and non-profit funded trials. Three trials compared acamprosate and naltrexone and did not indicate a superiority of one or the other drug on return to any drinking, return to heavy drinking and cumulative abstinence duration.
10.1002/14651858.CD004332.pub2
[ "These conclusions are based on 24 randomised controlled trials with 6915 participants who were treated as outpatients in all but one trial that involved adolescent inpatients. The majority of participants were men, median age 42 years. Most studies were conducted in Europe; two studies were conducted in the United States and one study in each of South Korea,Australia and Brazil. The effects of acamprosate did not differ in industry-sponsored and non-profit funded trials. Three trials compared acamprosate and naltrexone and did not indicate a superiority of one or the other drug on return to any drinking, return to heavy drinking and cumulative abstinence duration." ]
cochrane-simplification-train-948
cochrane-simplification-train-948
We included 67 studies including randomised controlled trials and observational studies with a mixed risk of bias. A total number of participants is not included as the total would be made up of a heterogenous set of observations (participant people, observations on participants and countries (object of some studies)). The risk of bias for five RCTs and most cluster-RCTs was high. Observational studies were of mixed quality. Only case-control data were sufficiently homogeneous to allow meta-analysis. The highest quality cluster-RCTs suggest respiratory virus spread can be prevented by hygienic measures, such as handwashing, especially around younger children. Benefit from reduced transmission from children to household members is broadly supported also in other study designs where the potential for confounding is greater. Nine case-control studies suggested implementing transmission barriers, isolation and hygienic measures are effective at containing respiratory virus epidemics. Surgical masks or N95 respirators were the most consistent and comprehensive supportive measures. N95 respirators were non-inferior to simple surgical masks but more expensive, uncomfortable and irritating to skin. Adding virucidals or antiseptics to normal handwashing to decrease respiratory disease transmission remains uncertain. Global measures, such as screening at entry ports, led to a non-significant marginal delay in spread. There was limited evidence that social distancing was effective, especially if related to the risk of exposure. Simple and low-cost interventions would be useful for reducing transmission of epidemic respiratory viruses. Routine long-term implementation of some measures assessed might be difficult without the threat of an epidemic.
We included 67 studies including randomised controlled trials and observational studies with a mixed risk of bias. A total number of participants is not included as the total would be made up of a varied set of observations: participant people and observations on participants and countries (the object of some studies). Any total figure would therefore be misleading. Respiratory virus spread can be reduced by hygienic measures (such as handwashing), especially around younger children. Frequent handwashing can also reduce transmission from children to other household members. Implementing barriers to transmission, such as isolation, and hygienic measures (wearing masks, gloves and gowns) can be effective in containing respiratory virus epidemics or in hospital wards. We found no evidence that the more expensive, irritating and uncomfortable N95 respirators were superior to simple surgical masks. It is unclear if adding virucidals or antiseptics to normal handwashing with soap is more effective. There is insufficient evidence to support screening at entry ports and social distancing (spatial separation of at least one metre between those infected and those non-infected) as a method to reduce spread during epidemics.
10.1002/14651858.CD006207.pub4
[ "We included 67 studies including randomised controlled trials and observational studies with a mixed risk of bias. A total number of participants is not included as the total would be made up of a varied set of observations: participant people and observations on participants and countries (the object of some studies). Any total figure would therefore be misleading. Respiratory virus spread can be reduced by hygienic measures (such as handwashing), especially around younger children. Frequent handwashing can also reduce transmission from children to other household members. Implementing barriers to transmission, such as isolation, and hygienic measures (wearing masks, gloves and gowns) can be effective in containing respiratory virus epidemics or in hospital wards. We found no evidence that the more expensive, irritating and uncomfortable N95 respirators were superior to simple surgical masks. It is unclear if adding virucidals or antiseptics to normal handwashing with soap is more effective. There is insufficient evidence to support screening at entry ports and social distancing (spatial separation of at least one metre between those infected and those non-infected) as a method to reduce spread during epidemics." ]
cochrane-simplification-train-949
cochrane-simplification-train-949
We included 23 studies that involved a total of 2724 enrolled participants. Most studies were rated at unclear or high risk of bias. Overall, participants receiving combination inhaled therapy were less likely to be hospitalised (RR 0.72, 95% CI 0.59 to 0.87; participants = 2120; studies = 16; I² = 12%; moderate quality of evidence). An estimated 65 fewer patients per 1000 would require hospitalisation after receiving combination therapy (95% 30 to 95), compared to 231 per 1000 patients receiving SABA alone. Although combination inhaled therapy was more effective than SABA treatment alone in reducing hospitalisation in participants with severe asthma exacerbations, this was not found for participants with mild or moderate exacerbations (test for difference between subgroups P = 0.02). Participants receiving combination therapy were more likely to experience improved forced expiratory volume in one second (FEV₁) (MD 0.25 L, 95% CI 0.02 to 0.48; participants = 687; studies = 6; I² = 70%; low quality of evidence), peak expiratory flow (PEF) (MD 36.58 L/min, 95% CI 23.07 to 50.09; participants = 1056; studies = 12; I² = 25%; very low quality of evidence), increased percent change in PEF from baseline (MD 24.88, 95% CI 14.83 to 34.93; participants = 551; studies = 7; I² = 23%; moderate quality of evidence), and were less likely to return to the ED for additional care (RR 0.80, 95% CI 0.66 to 0.98; participants = 1180; studies = 5; I² = 0%; moderate quality of evidence) than participants receiving SABA alone. Participants receiving combination inhaled therapy were more likely to experience adverse events than those treated with SABA agents alone (OR 2.03, 95% CI 1.28 to 3.20; participants = 1392; studies = 11; I² = 14%; moderate quality of evidence). Among patients receiving combination therapy, 103 per 1000 were likely to report adverse events (95% 31 to 195 more) compared to 131 per 1000 patients receiving SABA alone. Overall, combination inhaled therapy with SAAC and SABA reduced hospitalisation and improved pulmonary function in adults presenting to the ED with acute asthma. In particular, combination inhaled therapy was more effective in preventing hospitalisation in adults with severe asthma exacerbations who are at increased risk of hospitalisation, compared to those with mild-moderate exacerbations, who were at a lower risk to be hospitalised. A single dose of combination therapy and multiple doses both showed reductions in the risk of hospitalisation among adults with acute asthma. However, adults receiving combination therapy were more likely to experience adverse events, such as tremor, agitation, and palpitations, compared to patients receiving SABA alone.
We included 23 studies that compared the effectiveness of combined treatment with beta-agonists and anticholinergics versus treatment with beta-agonists alone. A total of 2724 adult participants were enrolled in the studies. Salbutamol (also called albuterol) was the most common beta-agonist investigated and ipratropium bromide was the most common anticholinergic assessed. We found that most studies did not report sources of funding (14 studies); one study was supported by a hospital; another received support from a pharmaceutical company, but indicated that there was no involvement from the company in conducting or reporting research. Two studies were part-funded and four were funded by pharmaceutical companies. Patients with severe asthma who received combined treatment of beta-agonists and anticholinergics were less likely to be admitted to hospital. An estimated 65 fewer patients per 1000 would require hospital admission after receiving combined inhaled therapy in the emergency department. Among patients with mild -to-moderate asthma, combined inhaled therapy was less effective in preventing admission to hospital compared with people with severe asthma. Patients receiving combined treatment were less likely to return to the emergency department with worsening asthma symptoms and had better outcomes in most lung function tests. On the other hand, 103 more participants per 1000 who receive combined inhaled therapy would experience side effects compared to people who receive beta-agonists alone. Quality of the evidence that combination inhaled therapy can improve health outcomes compared to treatment with beta-agonists alone ranged from very low to moderate. Our confidence about the effects of combination inhaled therapy on hospital admissions, peak expiratory flow, percent change in peak expiratory flow from baseline, and relapse was moderate because of the overall risk of bias among included studies. Factors associated with inconsistency and imprecision were additional aspects that reduced the quality of the evidence for forced expiratory volume in one second, and percent predicted peak expiratory flow.
10.1002/14651858.CD001284.pub2
[ "We included 23 studies that compared the effectiveness of combined treatment with beta-agonists and anticholinergics versus treatment with beta-agonists alone. A total of 2724 adult participants were enrolled in the studies. Salbutamol (also called albuterol) was the most common beta-agonist investigated and ipratropium bromide was the most common anticholinergic assessed. We found that most studies did not report sources of funding (14 studies); one study was supported by a hospital; another received support from a pharmaceutical company, but indicated that there was no involvement from the company in conducting or reporting research. Two studies were part-funded and four were funded by pharmaceutical companies. Patients with severe asthma who received combined treatment of beta-agonists and anticholinergics were less likely to be admitted to hospital. An estimated 65 fewer patients per 1000 would require hospital admission after receiving combined inhaled therapy in the emergency department. Among patients with mild -to-moderate asthma, combined inhaled therapy was less effective in preventing admission to hospital compared with people with severe asthma. Patients receiving combined treatment were less likely to return to the emergency department with worsening asthma symptoms and had better outcomes in most lung function tests. On the other hand, 103 more participants per 1000 who receive combined inhaled therapy would experience side effects compared to people who receive beta-agonists alone. Quality of the evidence that combination inhaled therapy can improve health outcomes compared to treatment with beta-agonists alone ranged from very low to moderate. Our confidence about the effects of combination inhaled therapy on hospital admissions, peak expiratory flow, percent change in peak expiratory flow from baseline, and relapse was moderate because of the overall risk of bias among included studies. Factors associated with inconsistency and imprecision were additional aspects that reduced the quality of the evidence for forced expiratory volume in one second, and percent predicted peak expiratory flow." ]
cochrane-simplification-train-950
cochrane-simplification-train-950
Fifty-three studies (8548 patients) were included. The majority of included studies were rated as low risk of bias. 5-ASA was significantly superior to placebo with regard to all measured outcome variables. Seventy-one per cent of 5-ASA patients failed to enter clinical remission compared to 83% of placebo patients (RR 0.86, 95% CI 0.82 to 0.89). A dose-response trend for 5-ASA was also observed. No statistically significant differences in efficacy were found between 5-ASA and SASP. Fifty-four per cent of 5-ASA patients failed to enter remission compared to 58% of SASP patients (RR 0.90, 95% CI 0.77 to 1.04). No statistically significant differences in efficacy or adherence were found between once daily and conventionally dosed 5-ASA. Forty-five per cent of once daily patients failed to enter clinical remission compared to 48% of conventionally dosed patients (RR 0.94, 95% CI 0.83 to 1.07). Eight per cent of patients dosed once daily failed to adhere to their medication regimen compared to 6% of conventionally dosed patients (RR 1.36, 95% CI 0.64 to 2.86). There does not appear to be any difference in efficacy among the various 5-ASA formulations. Fifty per cent of patients in the 5-ASA group failed to enter remission compared to 52% of patients in the 5-ASA comparator group (RR 0.94, 95% CI 0.86 to 1.02). A pooled analysis of 3 studies (n = 1459 patients) studies found no statistically significant difference in clinical improvement between Asacol 4.8 g/day and 2.4 g/day used for the treatment of moderately active ulcerative colitis. Thirty-seven per cent of patients in the 4.8 g/day group failed to improve clinically compared to 41% of patients in the 2.4 g/day group (RR 0.89; 95% CI 0.78 to 1.01). Subgroup analysis indicated that patients with moderate disease may benefit from the higher dose of 4.8 g/day. One study compared (n = 123 patients) Pentasa 4 g/day to 2.25 g/day in patients with moderate disease. Twenty-five per cent of patients in the 4 g/day group failed to improve clinically compared to 57% of patients in the 2.25 g/day group (RR 0.44; 95% CI 0.27 to 0.71). A pooled analysis of two studies comparing MMX mesalamine 4.8 g/day to 2.4 g/day found no statistically significant difference in efficacy (RR 1.03, 95% CI 0.82 to 1.29). There were no statistically significant differences in the incidence of adverse events between 5-ASA and placebo, once daily and conventionally dosed 5-ASA, 5-ASA and comparator 5-ASA formulation and 5-ASA dose ranging (high dose versus low dose) studies. Common adverse events included flatulence, abdominal pain, nausea, diarrhea, headache and worsening ulcerative colitis. SASP was not as well tolerated as 5-ASA. Twenty-nine percent of SASP patients experienced an adverse event compared to 15% of 5-ASA patients (RR 0.48, 95% CI 0.37 to 0.63). 5-ASA was superior to placebo and no more effective than SASP. Considering their relative costs, a clinical advantage to using oral 5-ASA in place of SASP appears unlikely. 5-ASA dosed once daily appears to be as efficacious and safe as conventionally dosed 5-ASA. Adherence does not appear to be enhanced by once daily dosing in the clinical trial setting. It is unknown if once daily dosing of 5-ASA improves adherence in a community-based setting. There do not appear to be any differences in efficacy or safety among the various 5-ASA formulations. A daily dosage of 2.4 g appears to be a safe and effective induction therapy for patients with mild to moderately active ulcerative colitis. Patients with moderate disease may benefit from an initial dose of 4.8 g/day.
This review includes 53 randomized trials with a total of 8548 participants. Oral 5-ASA was found to be more effective than placebo (fake drug). Although oral 5-ASA drugs are effective for treating active ulcerative colitis, they are no more effective than SASP therapy. Patients taking 5-ASA are less likely to experience side effects than patients taking SASP. Side effects associated with 5-ASA are generally mild in nature, and common side effects include gastrointestinal symptoms (e.g. flatulence, abdominal pain, nausea, and diarrhea), headache and worsening ulcerative colitis. Male infertility is associated with SASP and not with 5-ASA, so 5-ASA may be preferred for patients concerned about fertility. 5-ASA compounds are more expensive than SASP, so SASP may be the preferred option where cost is an important factor. 5-ASA dosed once daily appears to be as effective and safe as conventionally dosed (two or three times daily) 5-ASA. There do not appear to be any differences in effectiveness or safety among the various 5-ASA formulations. A daily dosage of 2.4 g appears to be a safe and effective therapy for patients with mild to moderately active ulcerative colitis. Patients with moderate disease may benefit from an initial dose of 4.8 g/day.
10.1002/14651858.CD000543.pub4
[ "This review includes 53 randomized trials with a total of 8548 participants. Oral 5-ASA was found to be more effective than placebo (fake drug). Although oral 5-ASA drugs are effective for treating active ulcerative colitis, they are no more effective than SASP therapy. Patients taking 5-ASA are less likely to experience side effects than patients taking SASP. Side effects associated with 5-ASA are generally mild in nature, and common side effects include gastrointestinal symptoms (e.g. flatulence, abdominal pain, nausea, and diarrhea), headache and worsening ulcerative colitis. Male infertility is associated with SASP and not with 5-ASA, so 5-ASA may be preferred for patients concerned about fertility. 5-ASA compounds are more expensive than SASP, so SASP may be the preferred option where cost is an important factor. 5-ASA dosed once daily appears to be as effective and safe as conventionally dosed (two or three times daily) 5-ASA. There do not appear to be any differences in effectiveness or safety among the various 5-ASA formulations. A daily dosage of 2.4 g appears to be a safe and effective therapy for patients with mild to moderately active ulcerative colitis. Patients with moderate disease may benefit from an initial dose of 4.8 g/day." ]
cochrane-simplification-train-951
cochrane-simplification-train-951
The search identified one study of 125 children (72 boys and 53 girls) with calcium-containing idiopathic nephrolithiasis and normal renal morphology following initial treatment with shockwave lithotripsy (SWL). Patients were randomized to oral potassium citrate 1 mEq/kg per day for 12 months versus no specific medication or preventive measure with results reported for a total of 96 patients (48 per group). This included children who were stone-free (n = 52) or had residual stone fragments (n = 44) following SWL. Primary outcomes: Medical therapy may lower rates of stone recurrence with a risk ratio (RR) of 0.19 (95% confidence interval (CI) 0.06 to 0.60; low quality evidence). This corresponds to 270 fewer stone recurrences per 1000 (133 fewer to 313 fewer) children. We downgraded the quality of evidence by two levels for very serious study limitations related to unclear allocation concealment (selection bias) and a high risk of performance, detection and attrition bias. While the data for adverse events were incomplete, they reported that six of 48 (12.5%) children receiving potassium citrate left the trial because of adverse effects. This corresponds to a RR of 13.0 (95% CI 0.75 to 224.53; very low quality evidence); an absolute effect size estimate could not be generated. We downgraded the quality of evidence for study limitations and imprecision. We found no information on retreatment rates. Secondary outcomes: We found no evidence on serum electrolytes, 24-hour urine collection parameters or time to new stone formation. We were unable to perform any preplanned secondary analyses. Oral potassium citrate supplementation may reduce recurrent calcium urinary stone formation in children following SWL; however, our confidence in this finding is limited. A substantial number of children stopped the medication due to adverse events. There is no trial evidence on retreatment rates. There is a critical need for additional well-designed trials in children with nephrolithiasis.
We examined research published up to 14 February 2017. We looked for studies of boys and girls from age one to 18 years who sometime before had problems with kidney stones and who were assigned to a different diet or a medicine (or both) to stop the stones from coming back for at least 12 months. We were most interested in whether the stones returned, how many side effects there were and if children had to have more treatments for kidney stones. We only found one small study with 125 children (72 boys and 53 girls) who had been treated with waves similar to those that carry sound, so-called shock waves to treat their kidney stones. These children formed kidney stones for unknown reasons and had otherwise normal kidneys. Fifty-two children had no more stones and 44 children still had small stone pieces left when they started the study. One group was given a medicine by mouth called potassium citrate; the other group was given no special medicine. The children were on this study for about two years. The study reported on the findings in 96 children; 48 in each group. Based on this study, we found that this medicine may result in stones coming back less often. However, we are not sure about this finding because the study was not of good quality and small. One in eight patients stopped the medicine because of side effects. We did not find any information on how often children had to be treated for stones again. The evidence quality for stones coming back less often was low and that for side effects very low. We found no evidence on how often children had to be treated for stones again.
10.1002/14651858.CD011252.pub2
[ "We examined research published up to 14 February 2017. We looked for studies of boys and girls from age one to 18 years who sometime before had problems with kidney stones and who were assigned to a different diet or a medicine (or both) to stop the stones from coming back for at least 12 months. We were most interested in whether the stones returned, how many side effects there were and if children had to have more treatments for kidney stones. We only found one small study with 125 children (72 boys and 53 girls) who had been treated with waves similar to those that carry sound, so-called shock waves to treat their kidney stones. These children formed kidney stones for unknown reasons and had otherwise normal kidneys. Fifty-two children had no more stones and 44 children still had small stone pieces left when they started the study. One group was given a medicine by mouth called potassium citrate; the other group was given no special medicine. The children were on this study for about two years. The study reported on the findings in 96 children; 48 in each group. Based on this study, we found that this medicine may result in stones coming back less often. However, we are not sure about this finding because the study was not of good quality and small. One in eight patients stopped the medicine because of side effects. We did not find any information on how often children had to be treated for stones again. The evidence quality for stones coming back less often was low and that for side effects very low. We found no evidence on how often children had to be treated for stones again." ]
cochrane-simplification-train-952
cochrane-simplification-train-952
We included four RCTs (a total of 690 participants), in this review. Participants were adults who were mechanically ventilated in a general, medical or surgical ICU, with mean or median age in the studies ranging from 56 to 62 years. Admitting diagnoses in three of the four studies were indicative of critical illness, while participants in the fourth study had undergone cardiac surgery. Three studies included range-of-motion exercises, bed mobility activities, transfers and ambulation. The fourth study involved only upper limb exercises. Included studies were at high risk of performance bias, as they were not blinded to participants and personnel, and two of four did not blind outcome assessors. Three of four studies reported only on those participants who completed the study, with high rates of dropout. The description of intervention type, dose, intensity and frequency in the standard care control group was poor in two of four studies. Three studies (a total of 454 participants) reported at least one measure of physical function. One study (104 participants) reported low-quality evidence of beneficial effects in the intervention group on return to independent functional status at hospital discharge (59% versus 35%, risk ratio (RR) 1.71, 95% confidence interval (CI) 1.11 to 2.64); the absolute effect is that 246 more people (95% CI 38 to 567) per 1000 would attain independent functional status when provided with early mobilization. The effects on physical functioning are uncertain for a range measures: Barthel Index scores (early mobilization: median 75 control: versus 55, low quality evidence), number of ADLs achieved at ICU (median of 3 versus 0, low quality evidence) or at hospital discharge (median of 6 versus 4, low quality evidence). The effects of early mobilization on physical function measured at ICU discharge are uncertain, as measured by the Acute Care Index of Function (ACIF) (early mobilization mean: 61.1 versus control: 55, mean difference (MD) 6.10, 95% CI -11.85 to 24.05, low quality evidence) and the Physical Function ICU Test (PFIT) score (5.6 versus 5.4, MD 0.20, 95% CI -0.98 to 1.38, low quality evidence). There is low quality evidence that early mobilization may have little or no effect on physical function measured by the Short Physical Performance Battery score at ICU discharge from one study of 184 participants (mean 1.6 in the intervention group versus 1.9 in usual care, MD -0.30, 95% CI -1.10 to 0.50), or at hospital discharge (MD 0, 95% CI -1.00 to 0.90). The fourth study, which examined postoperative cardiac surgery patients did not measure physical function as an outcome. Adverse effects were reported across the four studies but we could not combine the data. Our certainty in the risk of adverse events with either mobilization strategy is low due to the low rate of events. One study reported that in the intervention group one out of 49 participants (2%) experienced oxygen desaturation less than 80% and one of 49 (2%) had accidental dislodgement of the radial catheter. This study also found cessation of therapy due to participant instability occurred in 19 of 498 (4%) of the intervention sessions. In another study five of 101 (5%) participants in the intervention group and five of 109 (4.6%) participants in the control group had postoperative pulmonary complications deemed to be unrelated to intervention. A third study found one of 150 participants in the intervention group had an episode of asymptomatic bradycardia, but completed the exercise session. The fourth study reported no adverse events. There is insufficient evidence on the effect of early mobilization of critically ill people in the ICU on physical function or performance, adverse events, muscle strength and health-related quality of life at this time. The four studies awaiting classification, and the three ongoing studies may alter the conclusions of the review once these results are available. We assessed that there is currently low-quality evidence for the effect of early mobilization of critically ill adults in the ICU due to small sample sizes, lack of blinding of participants and personnel, variation in the interventions and outcomes used to measure their effect and inadequate descriptions of the interventions delivered as usual care in the studies included in this Cochrane Review.
We found four studies that included a total of 690 adults who had been in the ICU. Patients were randomized to receive exercises and assistance to move early in their stay in the ICU or to usual care. All participants had been on a breathing machine at some point during their time in the ICU. Three studies included adults with critical illness involving severe disease of the lungs or severe body response to infection and one study involved adults who had undergone cardiac surgery. One study was funded by the Intensive Care Foundation, Royal Brisbane and Women's Hospital, Australia and the investigator was supported by a Postgraduate Award from Singapore. We were unable to determine whether early movement or exercise of critically ill people in the ICU improves their ability to do daily activities, muscle strength, or quality of life. There were mixed results on the effect of early movement or exercise on physical function. One study found that on some measures of physical function, participants who received the intervention could get out of bed earlier and walk greater distances. However, the same study found no differences in the number of daily activities they could do when leaving ICU. Early movement or exercise appears safe as the number of adverse events was very low. There was no difference between groups in time spent in hospital, muscle strength or death rates. Overall there was low-quality evidence from these studies. The main reasons were that only a small number of studies have examined this intervention. Most studies included only a small number of participants, and participants and study staff were aware of group assignment. In addition, in two studies, staff assessing outcomes were aware of group assignment. There were also differences in participant diagnoses, interventions and the way that outcomes were measured. The four studies awaiting classification, and the three ongoing studies may alter the conclusions of the review once these results are available. Evidence in this review is current to August 2017.
10.1002/14651858.CD010754.pub2
[ "We found four studies that included a total of 690 adults who had been in the ICU. Patients were randomized to receive exercises and assistance to move early in their stay in the ICU or to usual care. All participants had been on a breathing machine at some point during their time in the ICU. Three studies included adults with critical illness involving severe disease of the lungs or severe body response to infection and one study involved adults who had undergone cardiac surgery. One study was funded by the Intensive Care Foundation, Royal Brisbane and Women's Hospital, Australia and the investigator was supported by a Postgraduate Award from Singapore. We were unable to determine whether early movement or exercise of critically ill people in the ICU improves their ability to do daily activities, muscle strength, or quality of life. There were mixed results on the effect of early movement or exercise on physical function. One study found that on some measures of physical function, participants who received the intervention could get out of bed earlier and walk greater distances. However, the same study found no differences in the number of daily activities they could do when leaving ICU. Early movement or exercise appears safe as the number of adverse events was very low. There was no difference between groups in time spent in hospital, muscle strength or death rates. Overall there was low-quality evidence from these studies. The main reasons were that only a small number of studies have examined this intervention. Most studies included only a small number of participants, and participants and study staff were aware of group assignment. In addition, in two studies, staff assessing outcomes were aware of group assignment. There were also differences in participant diagnoses, interventions and the way that outcomes were measured. The four studies awaiting classification, and the three ongoing studies may alter the conclusions of the review once these results are available. Evidence in this review is current to August 2017." ]
cochrane-simplification-train-953
cochrane-simplification-train-953
We included nine studies involving 1118 women. We identified four comparisons. One comparison included six studies (which randomised 394 women) comparing umbilical vein injection of normal saline plus oxytocin versus that of normal saline, as well as three other comparisons, each of which includes one study. Comparing intraumbilical injection of normal saline plus oxytocin with intraumbilical injection of saline only, there was no evidence of difference in any of the relevant outcomes reported namely the number of women who required blood transfusion, the incidence of manual removal of placenta, blood loss, and length of the third stage of labour. Subgroup analyses by both total amount of solution administered and dose of oxytocin showed no evidence of difference. Other comparisons included only one study for each, and there was no relevant information available. Routine use of oxytocin or any other uterotonics with normal saline via umbilical vein injection is not recommended until new evidence is available. Further research should be conducted to show effectiveness of oxytocin with normal saline via umbilical vein injection.
This review included nine randomised controlled trials involving 1118 women and assessed six of these studies (involving 394 women) comparing umbilical vein injection of normal saline with or without oxytocin. Other comparisons did not provide the required information. With umbilical vein injection of saline solution plus oxytocin versus umbilical vein injection of saline solution there was no evidence of a difference in the amount of blood lost, duration of the third stage of labour or need for manual removal of a retained placenta. routine use of umbilical injection after childbirth to deliver any infusion, though the combined results of the small number of relevant studies showed no evidence of effect and further research is needed to make a conclusion. There is a need for training in the technique and a possible higher cost of materials.
10.1002/14651858.CD006176.pub2
[ "This review included nine randomised controlled trials involving 1118 women and assessed six of these studies (involving 394 women) comparing umbilical vein injection of normal saline with or without oxytocin. Other comparisons did not provide the required information. With umbilical vein injection of saline solution plus oxytocin versus umbilical vein injection of saline solution there was no evidence of a difference in the amount of blood lost, duration of the third stage of labour or need for manual removal of a retained placenta. routine use of umbilical injection after childbirth to deliver any infusion, though the combined results of the small number of relevant studies showed no evidence of effect and further research is needed to make a conclusion. There is a need for training in the technique and a possible higher cost of materials." ]
cochrane-simplification-train-954
cochrane-simplification-train-954
Forty-four eligible trials, involving 8436 participants were identified. Compared to placebo, adjuvant therapy significantly reduced off-time (-1.05 hours/day, 95% confidence interval (CI) -1.19 to -0.90; P<0.00001), the required levodopa dose (-55.65 mg/day, CI -62.67 to -48.62; P<0.00001) and improved UPDRS scores (UPDRS ADL score: -1.31 points, CI -1.62 to -0.99; P<0.00001; UPDRS motor score: -2.84 points, CI -3.36 to -2.32; P<0.00001; UPDRS total score: -3.26 points, CI -4.52 to -2.00; P<0.00001). However, dyskinesia (odds ratio (OR) 2.50, CI 2.21 to 2.84; P<0.00001) and side-effects including constipation (OR 3.19, CI 2.17 to 4.68; P<0.00001), dizziness (OR 1.57, CI 1.30 to 1.90; P<0.00001), dry mouth (OR 2.33, CI 1.22 to 4.47; P=0.01), hallucinations (OR 2.16, CI 1.70 to 2.74; P<0.00001), hypotension (OR 1.47, CI 1.18 to 1.83; P=0.0007), insomnia (OR 1.38, CI 1.09 to 1.74; P=0.007), nausea (OR 1.78, CI 1.53 to 2.07; P<0.00001), somnolence (OR 1.87, CI 1.40 to 2.51; P<0.0001) and vomiting (OR 2.56, CI 1.67 to 3.93; P<0.0001) were all increased with adjuvant therapy. Indirect comparisons of the three drug classes suggested that dopamine agonists were more efficacious in reducing off-time (dopamine agonist: -1.54 hours/day; COMTI: -0.83 hours/day; MAOBI: -0.93 hours/day; test for heterogeneity between drug classes P=0.0003) and levodopa dose (dopamine agonist: -116 mg/day; COMTI: -52 mg/day; MAOBI: -29 mg/day; test for heterogeneity between drug classes P<0.00001). UPDRS scores also improved more with dopamine agonists than with COMTI or MAOBI (UPDRS total scores - dopamine agonist: -10.01 points versus COMTI: -1.46 points versus MAOBI: -2.20 points; test for heterogeneity between drug classes P<0.00001), although more dyskinesia were seen with dopamine agonists (OR 2.70) and COMTI (OR 2.50) than with MAOBI (OR 0.94) (test for heterogeneity between drug classes P=0.009). Although the increase in the overall incidence of side-effects was generally more marked with dopamine agonists (OR 1.52) and COMTI (OR 2.0) than with MAOBI (OR 1.32), heterogeneity between drug classes was only of borderline significance (P=0.07). Compared to placebo, adjuvant therapy reduces off-time, levodopa dose, and improves UPDRS scores in PD patients who develop motor complications on levodopa therapy. However, this is at the expense of increased dyskinesia and numerous other side-effects. Indirect comparisons suggest that dopamine agonist therapy may be more effective than COMTI and MAOBI therapy, which have comparable efficacy. However, as indirect comparisons should be interpreted with caution, direct head-to-head randomised trials assessing the impact of these different drug classes on overall patient-rated quality of life are needed.
This review assesses data from randomised trials of the three classes of drugs commonly used as add-on (adjuvant) treatment to levodopa therapy in people with PD who have motor complications. Forty-four randomised trials, involving 8436 participants were identified as suitable for this review. The review confirms reports from individual trials that, compared to placebo, add-on therapy (on a background of levodopa) significantly reduces patient off-time, reduces the required levodopa dose and improves overall disability scores (measured on the Unified Parkinson's Disease Rating Scale - UPDRS). However, dyskinesia and other side-effects such as constipation, hallucinations and vomiting are increased with adjuvant therapy. Indirect comparisons of the three drug classes (dopamine agonists, COMTIs and MAOBIs) suggest that dopamine agonists may provide more effective symptomatic control than COMTI and MAOBI therapy. COMTI and MAOBI have comparable efficacy. There was no significant evidence of differences in efficacy between individual drugs within the drug classes, other than tolcapone appearing more effective than entacapone. However these observations are based on indirect comparisons between trials, so could be due to other factors, e.g. differences in the types of people included in the trials, and so should to be interpreted with caution. This review highlights the need for large randomised studies that directly compare the different drug classes with patient-rated overall quality of life and health economic measures as the primary outcomes.
10.1002/14651858.CD007166.pub2
[ "This review assesses data from randomised trials of the three classes of drugs commonly used as add-on (adjuvant) treatment to levodopa therapy in people with PD who have motor complications. Forty-four randomised trials, involving 8436 participants were identified as suitable for this review. The review confirms reports from individual trials that, compared to placebo, add-on therapy (on a background of levodopa) significantly reduces patient off-time, reduces the required levodopa dose and improves overall disability scores (measured on the Unified Parkinson's Disease Rating Scale - UPDRS). However, dyskinesia and other side-effects such as constipation, hallucinations and vomiting are increased with adjuvant therapy. Indirect comparisons of the three drug classes (dopamine agonists, COMTIs and MAOBIs) suggest that dopamine agonists may provide more effective symptomatic control than COMTI and MAOBI therapy. COMTI and MAOBI have comparable efficacy. There was no significant evidence of differences in efficacy between individual drugs within the drug classes, other than tolcapone appearing more effective than entacapone. However these observations are based on indirect comparisons between trials, so could be due to other factors, e.g. differences in the types of people included in the trials, and so should to be interpreted with caution. This review highlights the need for large randomised studies that directly compare the different drug classes with patient-rated overall quality of life and health economic measures as the primary outcomes." ]
cochrane-simplification-train-955
cochrane-simplification-train-955
Our search identified 1999 titles, of which 53 trials (57 articles) fulfilled our inclusion criteria. The 53 included studies enrolled a total of 4671 participants with critical illness or undergoing elective major surgery. We analysed seven domains of potential risk of bias. In 10 studies the risk of bias was evaluated as low in all of the domains. Thirty-three trials (2303 patients) provided data on nosocomial infectious complications; pooling of these data suggested that glutamine supplementation reduced the infectious complications rate in adults with critical illness or undergoing elective major surgery (RR 0.79, 95% CI 0.71 to 0.87, P < 0.00001, I² = 8%, moderate quality evidence). Thirty-six studies reported short-term (hospital or less than one month) mortality. The combined rate of mortality from these studies was not statistically different between the groups receiving glutamine supplement and those receiving no supplement (RR 0.89, 95% CI 0.78 to 1.02, P = 0.10, I² = 22%, low quality evidence). Eleven studies reported long-term (more than six months) mortality; meta-analysis of these studies (2277 participants) yielded a RR of 1.00 (95% CI 0.89 to 1.12, P = 0.94, I² = 30%, moderate quality evidence). Subgroup analysis of infectious complications and mortality outcomes did not find any statistically significant differences between the predefined groups. Hospital length of stay was reported in 36 studies. We found that the length of hospital stay was shorter in the intervention group than in the control group (MD -3.46 days, 95% CI -4.61 to -2.32, P < 0.0001, I² = 63%, low quality evidence). Slightly prolonged intensive care unit (ICU) stay was found in the glutamine supplemented group from 22 studies (2285 participants) (MD 0.18 days, 95% CI 0.07 to 0.29, P = 0.002, I² = 11%, moderate quality evidence). Days on mechanical ventilation (14 studies, 1297 participants) was found to be slightly shorter in the intervention group than in the control group (MD - 0.69 days, 95% CI -1.37 to -0.02, P = 0.04, I² = 18%, moderate quality evidence). There was no clear evidence of a difference between the groups for side effects and quality of life, however results were imprecise for serious adverse events and few studies reported on quality of life. Sensitivity analysis including only low risk of bias studies found that glutamine supplementation had beneficial effects in reducing the length of hospital stay (MD -2.9 days, 95% CI -5.3 to -0.5, P = 0.02, I² = 58%, eight studies) while there was no statistically significant difference between the groups for all of the other outcomes. This review found moderate evidence that glutamine supplementation reduced the infection rate and days on mechanical ventilation, and low quality evidence that glutamine supplementation reduced length of hospital stay in critically ill or surgical patients. It seems to have little or no effect on the risk of mortality and length of ICU stay, however. The effects on the risk of serious side effects were imprecise. The strength of evidence in this review was impaired by a high risk of overall bias, suspected publication bias, and moderate to substantial heterogeneity within the included studies.
Glutamine is a non-essential amino acid which is abundant in the healthy human body. There are studies reporting that muscle and plasma glutamine levels are reduced in patients with critical illness, or following major surgery, suggesting that the body's demand for glutamine is increased in these situations. In the past decade, several clinical trials have examined the effects of glutamine supplementation in patients with critical illness or receiving surgery, and a systematic review of this clinical evidence suggested that giving glutamine to these patients may reduce infection and mortality rates. However, two recent large-scale clinical trials, published in 2011 and 2013, did not find any beneficial effects of glutamine supplementation in patients with critical illness. In this review, we searched the available literature until May 2013 and included studies which compared the outcomes with glutamine supplementation and without in adults with a critical illness or undergoing elective major surgery. We included 57 articles from 53 randomized controlled studies in this review. These 53 studies enrolled a total of 4671 patients with critical illness or undergoing elective major surgery. The risk of mortality, length of intensive care unit stay and the incidence of side effects were not significantly different between those given glutamine and those who were not. However, our findings showed that the risk of infectious complications in patients who were given glutamine was 79% of the risk for those who were not. In other words, 12 patients need to be supplemented with glutamine to prevent one case of infection. This result needs to be interpreted cautiously as the quality of evidence for infectious complications was moderate. The funnel plot for this outcome suggested that smaller studies with outcomes favouring non-supplemented patients have not been published, and further research is likely to have an impact on the estimate of effect for this outcome. The findings from this review also suggested that the average length of hospital stay in critically ill or surgical patients supplemented with glutamine was 3.46 days shorter than for patients without glutamine supplementation. This result should also be treated with care as there was substantial heterogeneity between these studies. We found in this review that the mean number of days on mechanical ventilation was 0.69 days shorter in patients with glutamine supplementation than for patients without glutamine supplementation.
10.1002/14651858.CD010050.pub2
[ "Glutamine is a non-essential amino acid which is abundant in the healthy human body. There are studies reporting that muscle and plasma glutamine levels are reduced in patients with critical illness, or following major surgery, suggesting that the body's demand for glutamine is increased in these situations. In the past decade, several clinical trials have examined the effects of glutamine supplementation in patients with critical illness or receiving surgery, and a systematic review of this clinical evidence suggested that giving glutamine to these patients may reduce infection and mortality rates. However, two recent large-scale clinical trials, published in 2011 and 2013, did not find any beneficial effects of glutamine supplementation in patients with critical illness. In this review, we searched the available literature until May 2013 and included studies which compared the outcomes with glutamine supplementation and without in adults with a critical illness or undergoing elective major surgery. We included 57 articles from 53 randomized controlled studies in this review. These 53 studies enrolled a total of 4671 patients with critical illness or undergoing elective major surgery. The risk of mortality, length of intensive care unit stay and the incidence of side effects were not significantly different between those given glutamine and those who were not. However, our findings showed that the risk of infectious complications in patients who were given glutamine was 79% of the risk for those who were not. In other words, 12 patients need to be supplemented with glutamine to prevent one case of infection. This result needs to be interpreted cautiously as the quality of evidence for infectious complications was moderate. The funnel plot for this outcome suggested that smaller studies with outcomes favouring non-supplemented patients have not been published, and further research is likely to have an impact on the estimate of effect for this outcome. The findings from this review also suggested that the average length of hospital stay in critically ill or surgical patients supplemented with glutamine was 3.46 days shorter than for patients without glutamine supplementation. This result should also be treated with care as there was substantial heterogeneity between these studies. We found in this review that the mean number of days on mechanical ventilation was 0.69 days shorter in patients with glutamine supplementation than for patients without glutamine supplementation." ]
cochrane-simplification-train-956
cochrane-simplification-train-956
We identified 15 studies for inclusion in the review. The studies differed in the interventions compared (nasal continuous positive airway pressure (CPAP), nasal intermittent positive pressure ventilation (NIPPV), non-humidified HFNC, models for delivering HFNC), the gas flows used and the indications for respiratory support (primary support from soon after birth, post-extubation support, weaning from CPAP support). When used as primary respiratory support after birth compared to CPAP (4 studies, 439 infants), there were no differences in the primary outcomes of death (typical risk ratio (RR) 0.36, 95% CI 0.01 to 8.73; 4 studies, 439 infants) or chronic lung disease (CLD) (typical RR 2.07, 95% CI 0.64 to 6.64; 4 studies, 439 infants). HFNC use resulted in longer duration of respiratory support, but there were no differences in other secondary outcomes. One study (75 infants) showed no differences between HFNC and NIPPV as primary support. Following extubation (total 6 studies, 934 infants), there were no differences between HFNC and CPAP in the primary outcomes of death (typical RR 0.77, 95% CI 0.43 to 1.36; 5 studies, 896 infants) or CLD (typical RR 0.96, 95% CI 0.78 to 1.18; 5 studies, 893 infants). There was no difference in the rate of treatment failure (typical RR 1.21, 95% CI 0.95 to 1.55; 5 studies, 786 infants) or reintubation (typical RR 0.91, 95% CI 0.68 to 1.20; 6 studies, 934 infants). Infants randomised to HFNC had reduced nasal trauma (typical RR 0.64, 95% CI 0.51 to 0.79; typical risk difference (RD) −0.14, 95% CI −0.20 to −0.08; 4 studies, 645 infants). There was a small reduction in the rate of pneumothorax (typical RR 0.35, 95% CI 0.11 to 1.06; typical RD −0.02, 95% CI −0.03 to −0.00; 5 studies 896 infants) in infants treated with HFNC. Subgroup analysis found no difference in the rate of the primary outcomes between HFNC and CPAP in preterm infants in different gestational age subgroups, though there were only small numbers of extremely preterm and late preterm infants. One trial (28 infants) found similar rates of reintubation for humidified and non-humidified HFNC, and two other trials (100 infants) found no difference between different models of equipment used to deliver humidified HFNC. For infants weaning from non-invasive respiratory support (CPAP), two studies (149 infants) found that preterm infants randomised to HFNC had a reduced duration of hospitalisation compared with infants who remained on CPAP. HFNC has similar rates of efficacy to other forms of non-invasive respiratory support in preterm infants for preventing treatment failure, death and CLD. Most evidence is available for the use of HFNC as post-extubation support. Following extubation, HFNC is associated with less nasal trauma, and may be associated with reduced pneumothorax compared with nasal CPAP. Further adequately powered randomised controlled trials should be undertaken in preterm infants comparing HFNC with other forms of primary non-invasive support after birth and for weaning from non-invasive support. Further evidence is also required for evaluating the safety and efficacy of HFNC in extremely preterm and mildly preterm subgroups, and for comparing different HFNC devices.
This review found 15 randomised studies that compared HFNC with other non-invasive ways of supporting babies' breathing. The studies differed in the interventions that were compared, the gas flows used and the reasons for respiratory support. When HFNC was used as first-line respiratory support after birth compared to CPAP (4 studies, 439 infants), there were no differences in the rates of death or chronic lung disease (CLD). HFNC use resulted in longer duration of respiratory support, but there were no differences in other outcomes. One study (75 infants) showed no differences between HFNC and NIPPV as breathing support after birth. When HFNC were used after a period of mechanical ventilation (total 6 studies, 934 infants), there were no differences between HFNC and CPAP in the rates of death or CLD. There was no difference in the rate of treatment failure or reintubation. Infants randomised to HFNC had less trauma to the infant's nose. There was a small reduction in the rate of pneumothorax in infants treated with HFNC. We found no difference between the effect of HFNC compared with CPAP in preterm infants in different gestational age subgroups, though there were only small numbers of extremely preterm and late preterm infants. One trial (28 infants) found similar rates of reintubation for humidified and non-humidified HFNC, and two other trials (100 infants) found no difference between different models of equipment used to deliver humidified HFNC. For infants weaning from non-invasive respiratory support (CPAP), two studies (149 infants) found that preterm infants randomised to HFNC had a reduced duration of hospitalisation compared with infants who remained on CPAP. HFNC use has similar rates of efficacy to other forms of non-invasive respiratory support in preterm infants for preventing treatment failure, death and CLD. Most evidence is available for the use of HFNC as post-extubation support. Following extubation, use of HFNC is associated with less nasal trauma, and may be associated with reduced pneumothorax compared with nasal CPAP. Further adequately powered randomised controlled trials should be undertaken in preterm infants comparing HFNC with other forms of primary non-invasive support after birth and for weaning from non-invasive support. Further evidence is also required for evaluating the safety and efficacy of HFNC in extremely preterm and mildly preterm subgroups, and for comparing different HFNC devices.
10.1002/14651858.CD006405.pub3
[ "This review found 15 randomised studies that compared HFNC with other non-invasive ways of supporting babies' breathing. The studies differed in the interventions that were compared, the gas flows used and the reasons for respiratory support. When HFNC was used as first-line respiratory support after birth compared to CPAP (4 studies, 439 infants), there were no differences in the rates of death or chronic lung disease (CLD). HFNC use resulted in longer duration of respiratory support, but there were no differences in other outcomes. One study (75 infants) showed no differences between HFNC and NIPPV as breathing support after birth. When HFNC were used after a period of mechanical ventilation (total 6 studies, 934 infants), there were no differences between HFNC and CPAP in the rates of death or CLD. There was no difference in the rate of treatment failure or reintubation. Infants randomised to HFNC had less trauma to the infant's nose. There was a small reduction in the rate of pneumothorax in infants treated with HFNC. We found no difference between the effect of HFNC compared with CPAP in preterm infants in different gestational age subgroups, though there were only small numbers of extremely preterm and late preterm infants. One trial (28 infants) found similar rates of reintubation for humidified and non-humidified HFNC, and two other trials (100 infants) found no difference between different models of equipment used to deliver humidified HFNC. For infants weaning from non-invasive respiratory support (CPAP), two studies (149 infants) found that preterm infants randomised to HFNC had a reduced duration of hospitalisation compared with infants who remained on CPAP. HFNC use has similar rates of efficacy to other forms of non-invasive respiratory support in preterm infants for preventing treatment failure, death and CLD. Most evidence is available for the use of HFNC as post-extubation support. Following extubation, use of HFNC is associated with less nasal trauma, and may be associated with reduced pneumothorax compared with nasal CPAP. Further adequately powered randomised controlled trials should be undertaken in preterm infants comparing HFNC with other forms of primary non-invasive support after birth and for weaning from non-invasive support. Further evidence is also required for evaluating the safety and efficacy of HFNC in extremely preterm and mildly preterm subgroups, and for comparing different HFNC devices." ]
cochrane-simplification-train-957
cochrane-simplification-train-957
A total of 30 RCTs are included in this review. Overall both the quality of trial reporting and trial conduct were generally poor and meta analysis was largely precluded due to study heterogeneity or poor data reporting. In the context of this poor quality evidence, silver sulphadiazine (SSD) was consistently associated with poorer healing outcomes than biosynthetic (skin substitute) dressings, silver-containing dressings and silicon-coated dressings. Burns treated with hydrogel dressings appear to heal more quickly than those treated with usual care. There is a paucity of high-quality evidence regarding the effect of different dressings on the healing of superficial and partial thickness burn injuries. The studies summarised in this review evaluated a variety of interventions, comparators and clinical endpoints and all were at risk of bias. It is impossible to draw firm and confident conclusions about the effectiveness of specific dressings, however silver sulphadiazine was consistently associated with poorer healing outcomes than biosynthetic, silicon-coated and silver dressings whilst hydrogel-treated burns had better healing outcomes than those treated with usual care.
Evidence from poor quality, small trials, suggests that superficial and partial thickness burns heal more quickly with silicon-coated nylon, silver containing dressings and biosynthetic dressings than with silver sulphadiazine cream. Burns treated with hydrogel dressings healed more quickly than those treated with usual care.
10.1002/14651858.CD002106.pub4
[ "Evidence from poor quality, small trials, suggests that superficial and partial thickness burns heal more quickly with silicon-coated nylon, silver containing dressings and biosynthetic dressings than with silver sulphadiazine cream. Burns treated with hydrogel dressings healed more quickly than those treated with usual care." ]
cochrane-simplification-train-958
cochrane-simplification-train-958
Thirty-nine trials (2326 participants) fulfilled our inclusion criteria, of which 37 provided data for meta-analyses. There were multiple sources of bias in many of the trials; randomisation was adequately concealed in 14 studies, 15 used intention-to-treat analyses and 12 used blinded outcome assessors. For the 35 trials (1356 participants) comparing exercise with no treatment or a control intervention, the pooled SMD for the primary outcome of depression at the end of treatment was -0.62 (95% confidence interval (CI) -0.81 to -0.42), indicating a moderate clinical effect. There was moderate heterogeneity (I² = 63%). When we included only the six trials (464 participants) with adequate allocation concealment, intention-to-treat analysis and blinded outcome assessment, the pooled SMD for this outcome was not statistically significant (-0.18, 95% CI -0.47 to 0.11). Pooled data from the eight trials (377 participants) providing long-term follow-up data on mood found a small effect in favour of exercise (SMD -0.33, 95% CI -0.63 to -0.03). Twenty-nine trials reported acceptability of treatment, three trials reported quality of life, none reported cost, and six reported adverse events. For acceptability of treatment (assessed by number of drop-outs during the intervention), the risk ratio was 1.00 (95% CI 0.97 to 1.04). Seven trials compared exercise with psychological therapy (189 participants), and found no significant difference (SMD -0.03, 95% CI -0.32 to 0.26). Four trials (n = 300) compared exercise with pharmacological treatment and found no significant difference (SMD -0.11, -0.34, 0.12). One trial (n = 18) reported that exercise was more effective than bright light therapy (MD -6.40, 95% CI -10.20 to -2.60). For each trial that was included, two authors independently assessed for sources of bias in accordance with the Cochrane Collaboration 'Risk of bias' tool. In exercise trials, there are inherent difficulties in blinding both those receiving the intervention and those delivering the intervention. Many trials used participant self-report rating scales as a method for post-intervention analysis, which also has the potential to bias findings. Exercise is moderately more effective than a control intervention for reducing symptoms of depression, but analysis of methodologically robust trials only shows a smaller effect in favour of exercise. When compared to psychological or pharmacological therapies, exercise appears to be no more effective, though this conclusion is based on a few small trials.
Exercise is moderately more effective than no therapy for reducing symptoms of depression. Exercise is no more effective than antidepressants for reducing symptoms of depression, although this conclusion is based on a small number of studies. Exercise is no more effective than psychological therapies for reducing symptoms of depression, although this conclusion is based on small number of studies. The reviewers also note that when only high-quality studies were included, the difference between exercise and no therapy is less conclusive. Attendance rates for exercise treatments ranged from 50% to 100%. The evidence about whether exercise for depression improves quality of life is inconclusive. The reviewers recommend that future research should look in more detail at what types of exercise could most benefit people with depression, and the number and duration of sessions which are of most benefit. Further larger trials are needed to find out whether exercise is as effective as antidepressants or psychological treatments.
10.1002/14651858.CD004366.pub6
[ "Exercise is moderately more effective than no therapy for reducing symptoms of depression. Exercise is no more effective than antidepressants for reducing symptoms of depression, although this conclusion is based on a small number of studies. Exercise is no more effective than psychological therapies for reducing symptoms of depression, although this conclusion is based on small number of studies. The reviewers also note that when only high-quality studies were included, the difference between exercise and no therapy is less conclusive. Attendance rates for exercise treatments ranged from 50% to 100%. The evidence about whether exercise for depression improves quality of life is inconclusive. The reviewers recommend that future research should look in more detail at what types of exercise could most benefit people with depression, and the number and duration of sessions which are of most benefit. Further larger trials are needed to find out whether exercise is as effective as antidepressants or psychological treatments." ]
cochrane-simplification-train-959
cochrane-simplification-train-959
We included nine studies in this review which involved 134 participants with TBI. Only five studies reported between-group differences, yielding outcome data for 105 participants with TBI. These five studies assessed the effects of a range of pharmacological (baclofen, botulinum toxin A) and non-pharmacological (casting, physiotherapy, splints, tilt table standing and electrical stimulation) interventions, often in combination. The studies which tested the effect of baclofen and tizanidine did not report their results adequately. Where outcome data were available, spasticity and adverse events were reported, in addition to some secondary outcome measures. Of the five studies with results, three were funded by governments, charities or health services and two were funded by a pharmaceutical or medical technology company. The four studies without useable results were funded by pharmaceutical or medical technology companies. It was difficult to draw conclusions about the effectiveness of these interventions due to poor reporting, small study size and the fact that participants with TBI were usually only a proportion of the overall total. Meta-analysis was not feasible due to the paucity of data and heterogeneity of interventions and comparator groups. Some studies concluded that the intervention they tested had beneficial effects on spasticity, and others found no difference between certain treatments. The most common adverse event was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all outcomes. The very low quality and limited amount of evidence about the management of spasticity in people with TBI means that we are uncertain about the effectiveness or harms of these interventions. Well-designed and adequately powered studies using functional outcome measures to test the interventions used in clinical practice are needed.
We included nine studies in this review which involved 134 participants with TBI. Only five studies, including 105 people provided usable results. These studies tested the effects of a range of treatments, including medicines (baclofen or botulinum toxin A), casting, physiotherapy, splints, a table that moves people from the lying position to standing and electrical stimulation (where electrical impulses are delivered to the muscles). Studies inadequately reporting results had tested the effect of medicines (baclofen or tizanidine). Of the five studies with results, three were funded by governments, charities or health services and two were funded by a drug manufacturer and medical technology company. The other four studies without useable results were funded by drug manufacturer or medical technology companies. This evidence is current to June 2017. Interpreting the results of the studies was difficult because of a lack of information and concerns about the quality of the evidence. For spasticity, some studies concluded that the treatment they tested made an improvement, and others found no difference between treatments. The most common side effect was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all measurements. The quality of this evidence was very low; we only had five studies with results and none of the studies were large or comparable with one another. We also had concerns about how they were conducted or analysed. Because of this, we cannot draw any firm conclusions about the benefits and harms of different treatments for spasticity in people with TBI.
10.1002/14651858.CD008929.pub2
[ "We included nine studies in this review which involved 134 participants with TBI. Only five studies, including 105 people provided usable results. These studies tested the effects of a range of treatments, including medicines (baclofen or botulinum toxin A), casting, physiotherapy, splints, a table that moves people from the lying position to standing and electrical stimulation (where electrical impulses are delivered to the muscles). Studies inadequately reporting results had tested the effect of medicines (baclofen or tizanidine). Of the five studies with results, three were funded by governments, charities or health services and two were funded by a drug manufacturer and medical technology company. The other four studies without useable results were funded by drug manufacturer or medical technology companies. This evidence is current to June 2017. Interpreting the results of the studies was difficult because of a lack of information and concerns about the quality of the evidence. For spasticity, some studies concluded that the treatment they tested made an improvement, and others found no difference between treatments. The most common side effect was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all measurements. The quality of this evidence was very low; we only had five studies with results and none of the studies were large or comparable with one another. We also had concerns about how they were conducted or analysed. Because of this, we cannot draw any firm conclusions about the benefits and harms of different treatments for spasticity in people with TBI." ]
cochrane-simplification-train-960
cochrane-simplification-train-960
Five small trials comparing dynamic compression plates with locked intramedullary nailing were included in this review. These involved a total of 260 participants undergoing surgery for either acute fractures or after early failure of conservative treatment. All five trials had methodological flaws, such as the lack of assessor blinding, that could have influenced their findings. There was no significant difference in fracture union between plating and nailing (five trials, RR 1.05; 95% CI 0.97 to 1.13). There was a statistically significant increase in shoulder impingement following nailing when compared with plating (five trials, RR 0.12; 95% CI 0.04 to 0.38). Intramedullary nails were removed significantly more frequently than plates (three trials, RR 0.17; 95% CI 0.04 to 0.76). There was no statistically significant difference between plating and nailing in operating time, blood loss during surgery, iatrogenic radial nerve injury, return to pre-injury occupation by six months or American Shoulder and Elbow Surgeons (ASES) scores. Two further small trials are awaiting classification. The available evidence shows that intramedullary nailing is associated with an increased risk of shoulder impingement, with a related increase in restriction of shoulder movement and need for removal of metalwork. There was insufficient evidence to determine if there were any other important differences, including in functional outcome, between dynamic compression plating and locked intramedullary nailing for humeral shaft fractures.
Five poor quality trials were included in this review. These involved a total of 260 participants who were randomly assigned to having their humerus fractures fixed with either a plate or a nail. Both nailing and plating had similar fracture union rates. Compared with plating, nailing was associated with an increased risk of shoulder impingement involving shoulder pain and restrictions in shoulder range of movement. Usually because of impingement, nails had to be removed more frequently than plates. The limited available evidence did not show important differences between the two surgical methods in the other outcomes reported by one or more trials. These outcomes included nerve injury, infection, healing time, operating time, blood loss and return to pre-injury occupation.
10.1002/14651858.CD005959.pub2
[ "Five poor quality trials were included in this review. These involved a total of 260 participants who were randomly assigned to having their humerus fractures fixed with either a plate or a nail. Both nailing and plating had similar fracture union rates. Compared with plating, nailing was associated with an increased risk of shoulder impingement involving shoulder pain and restrictions in shoulder range of movement. Usually because of impingement, nails had to be removed more frequently than plates. The limited available evidence did not show important differences between the two surgical methods in the other outcomes reported by one or more trials. These outcomes included nerve injury, infection, healing time, operating time, blood loss and return to pre-injury occupation." ]
cochrane-simplification-train-961
cochrane-simplification-train-961
We included 30 trials (35 data sets) representing 1992 infants with bronchiolitis. In 11 inpatient and 10 outpatient studies, oxygen saturation did not improve with bronchodilators (mean difference (MD) -0.43, 95% confidence interval (CI) -0.92 to 0.06, n = 1242). Outpatient bronchodilator treatment did not reduce the rate of hospitalization (11.9% in bronchodilator group versus 15.9% in placebo group, odds ratio (OR) 0.75, 95% CI 0.46 to 1.21, n = 710). Inpatient bronchodilator treatment did not reduce the duration of hospitalization (MD 0.06, 95% CI -0.27 to 0.39, n = 349). Effect estimates for inpatients (MD -0.62, 95% CI -1.40 to 0.16) were slightly larger than for outpatients (MD -0.25, 95% CI -0.61 to 0.11) for oximetry. Oximetry outcomes showed significant heterogeneity (I2 statistic = 81%). Including only studies with low risk of bias had little impact on the overall effect size of oximetry (MD -0.38, 95% CI -0.75 to 0.00) but results were close to statistical significance. In eight inpatient studies, there was no change in average clinical score (standardized MD (SMD) -0.14, 95% CI -0.41 to 0.12) with bronchodilators. In nine outpatient studies, the average clinical score decreased slightly with bronchodilators (SMD -0.42, 95% CI -0.79 to -0.06), a statistically significant finding of questionable clinical importance. The clinical score outcome showed significant heterogeneity (I2 statistic = 73%). Including only studies with low risk of bias reduced the heterogeneity but had little impact on the overall effect size of average clinical score (SMD -0.22, 95% CI -0.41 to -0.03). Sub-analyses limited to nebulized albuterol or salbutamol among outpatients (nine studies) showed no effect on oxygen saturation (MD -0.19, 95% CI -0.59 to 0.21, n = 572), average clinical score (SMD -0.36, 95% CI -0.83 to 0.11, n = 532) or hospital admission after treatment (OR 0.77, 95% CI 0.44 to 1.33, n = 404). Adverse effects included tachycardia, oxygen desaturation and tremors. Bronchodilators such as albuterol or salbutamol do not improve oxygen saturation, do not reduce hospital admission after outpatient treatment, do not shorten the duration of hospitalization and do not reduce the time to resolution of illness at home. Given the adverse side effects and the expense associated with these treatments, bronchodilators are not effective in the routine management of bronchiolitis. This meta-analysis continues to be limited by the small sample sizes and the lack of standardized study design and validated outcomes across the studies. Future trials with large sample sizes, standardized methodology across clinical sites and consistent assessment methods are needed to answer completely the question of efficacy.
We reviewed the evidence about the effect of bronchodilators in infants with bronchiolitis. We found 30 trials that included a total of 1922 infants, in several countries. The evidence is current up to January 2014. We analyzed studies done in outpatient and inpatient settings separately. All bronchodilators were included in the review except for epinephrine because it is reviewed in another Cochrane review. Albuterol (otherwise known as salbutamol) is commonly used in studies, so we also reviewed this bronchodilator as a subgroup. We found no effect of bronchodilators on oxygen saturation. Infants hospitalized for bronchiolitis showed no significant benefit of bronchodilator treatment. This review also found that bronchodilators do not reduce the need for hospitalization, do not shorten the length of stay in hospital and do not shorten the length of the illness at home. Reviewing the subgroup of studies using albuterol (salbutamol), we found no effect of this bronchodilator on oxygen saturation or clinical scores. Side effects of bronchodilators include rapid heart beat, decrease in oxygen and shakiness. Given these side effects, little evidence that they are effective and the expense associated with these treatments, bronchodilators are not helpful in the management of bronchiolitis. This review is limited by the small number of studies that use the same measures and methods. For example, only 22 studies included only infants wheezing for the first time. Older studies included children who had wheezed before and may have had asthma. Thus these older studies favor the use of bronchodilators. Newer studies that excluded infants with prior wheezing and had a better study design do not show a benefit of bronchodilators. This review is also limited by the small number of infants included in each study. Lastly, clinical scores used to measure the effect of the bronchodilators in some studies may vary from one observer to the next, making this measure unreliable. Studies that include more infants, use better measures and have a stronger study design are needed to define the effectiveness of these medications.
10.1002/14651858.CD001266.pub4
[ "We reviewed the evidence about the effect of bronchodilators in infants with bronchiolitis. We found 30 trials that included a total of 1922 infants, in several countries. The evidence is current up to January 2014. We analyzed studies done in outpatient and inpatient settings separately. All bronchodilators were included in the review except for epinephrine because it is reviewed in another Cochrane review. Albuterol (otherwise known as salbutamol) is commonly used in studies, so we also reviewed this bronchodilator as a subgroup. We found no effect of bronchodilators on oxygen saturation. Infants hospitalized for bronchiolitis showed no significant benefit of bronchodilator treatment. This review also found that bronchodilators do not reduce the need for hospitalization, do not shorten the length of stay in hospital and do not shorten the length of the illness at home. Reviewing the subgroup of studies using albuterol (salbutamol), we found no effect of this bronchodilator on oxygen saturation or clinical scores. Side effects of bronchodilators include rapid heart beat, decrease in oxygen and shakiness. Given these side effects, little evidence that they are effective and the expense associated with these treatments, bronchodilators are not helpful in the management of bronchiolitis. This review is limited by the small number of studies that use the same measures and methods. For example, only 22 studies included only infants wheezing for the first time. Older studies included children who had wheezed before and may have had asthma. Thus these older studies favor the use of bronchodilators. Newer studies that excluded infants with prior wheezing and had a better study design do not show a benefit of bronchodilators. This review is also limited by the small number of infants included in each study. Lastly, clinical scores used to measure the effect of the bronchodilators in some studies may vary from one observer to the next, making this measure unreliable. Studies that include more infants, use better measures and have a stronger study design are needed to define the effectiveness of these medications." ]
cochrane-simplification-train-962
cochrane-simplification-train-962
One small trial at high risk of bias met the inclusion criteria. The trial randomised 49 participants, most of whom had cancer. It compared standard care (defined as surgery, antibiotics and oral rinses at the discretion of the oral-maxillofacial surgeon) to standard care plus hyperbaric oxygen therapy (2 atmospheres twice a day for 40 treatments). The trial measured the percentage of participants who improved or healed at three, six, 12 and 18 months and last contact. It also measured mean weekly pain scores. At three months, the study found that the participants in intervention group were more likely to have an improvement in their osteonecrosis than the standard care group participants (risk ratio (RR) 1.94, 95% confidence interval (CI) 1.01 to 3.74). There was no clear difference between the groups for the outcome 'healed' at three months (RR 3.60, 95% CI 0.87 to 14.82). There was no clear difference between the groups for improvement or healing when they were evaluated at six, 12 and 18 months and last contact. The study did not give any information on adverse events. Although the findings suggest adjunctive hyperbaric oxygen improved BRONJ, the quality of the evidence is very low since the only study was underpowered and was at high risk of bias due to lack of blinding, cross-over of participants between groups and very high attrition (50% at 12 months and 80% at 18 months in this study, which was designed for an intended follow-up of 24 months). There is a lack of evidence from randomised controlled trials to guide treatment of bisphosphonate-related osteonecrosis of the jaw (BRONJ). One small trial at high risk of bias evaluated hyperbaric oxygen therapy (HBO) as an adjunct to "standard" care and could not confirm or refute the effectiveness of HBO. There are two ongoing trials of teriparatide treatment for BRONJ. We found no randomised controlled trials of any other BRONJ treatments. High quality randomised controlled trials are needed. We provide recommendations for their focus and design.
Review authors, working with the Cochrane Oral Health Group, carried out a thorough search up to 15 December 2015 for studies that randomly allocated participants to different treatments for BRONJ (or to a 'placebo' condition that has no active treatment). This type of study design is known as a 'randomised controlled trial'. We only found one relevant completed study and two ongoing studies. The completed study compared people with BRONJ being treated with surgery, antibiotics and mouth rinses to people receiving the same 'standard care' with an add-on treatment called hyperbaric oxygen therapy, which is thought to increase bone renewal. There were 49 participants, most of whom had cancer. The study found that the participants in intervention group were more likely than the standard care group participants to have an improvement in their osteonecrosis at three months, but there was no clear difference between the groups when they were evaluated at six, 12 and 18 months and last contact. There was no clear difference between the groups at any time point for complete healing. These results are not reliable as the quality of the evidence is very low. The study did not assess whether there were any side effects of the treatment. The study had several important flaws: for example, there was a very small number of participants, some participants changed groups during the study and there was a loss of participants during the study. There is insufficient evidence to conclude whether hyperbaric oxygen therapy is a useful add-on to standard care in the treatment of BRONJ. There are two ongoing trials of teriparatide, a hormonal treatment for BRONJ. We found no randomised controlled trials of any other treatments for BRONJ. As there is a lack of good quality scientific evidence to decide how best to treat BRONJ, high quality trials are needed.
10.1002/14651858.CD008455.pub2
[ "Review authors, working with the Cochrane Oral Health Group, carried out a thorough search up to 15 December 2015 for studies that randomly allocated participants to different treatments for BRONJ (or to a 'placebo' condition that has no active treatment). This type of study design is known as a 'randomised controlled trial'. We only found one relevant completed study and two ongoing studies. The completed study compared people with BRONJ being treated with surgery, antibiotics and mouth rinses to people receiving the same 'standard care' with an add-on treatment called hyperbaric oxygen therapy, which is thought to increase bone renewal. There were 49 participants, most of whom had cancer. The study found that the participants in intervention group were more likely than the standard care group participants to have an improvement in their osteonecrosis at three months, but there was no clear difference between the groups when they were evaluated at six, 12 and 18 months and last contact. There was no clear difference between the groups at any time point for complete healing. These results are not reliable as the quality of the evidence is very low. The study did not assess whether there were any side effects of the treatment. The study had several important flaws: for example, there was a very small number of participants, some participants changed groups during the study and there was a loss of participants during the study. There is insufficient evidence to conclude whether hyperbaric oxygen therapy is a useful add-on to standard care in the treatment of BRONJ. There are two ongoing trials of teriparatide, a hormonal treatment for BRONJ. We found no randomised controlled trials of any other treatments for BRONJ. As there is a lack of good quality scientific evidence to decide how best to treat BRONJ, high quality trials are needed." ]
cochrane-simplification-train-963
cochrane-simplification-train-963
Two randomised controlled trials recruiting a total of 413 patients met the criteria for inclusion in our review; one study had a low risk of bias and the other study had a high risk of bias. Ear plugs versus control One study recruited 201 children (aged six months to six years) who underwent myringotomy and ventilation tube insertion. The study compared an intervention group who were instructed to swim and bathe with ear plugs with a control group; the participants were followed up at one-month intervals for one year. This study, with low risk of bias, showed that the use of ear plugs results in a small but statistically significant reduction in the rate of otorrhoea from 1.2 episodes to 0.84 episodes in the year of follow-up (mean difference (MD) -0.36 episodes per year, 95% confidence interval (CI) -0.45 to -0.27). There was no significant difference in ventilation tube extrusion or hearing outcomes between the two study arms. No child required surgical intervention to remove ventilation tubes and no adverse events were reported. Water avoidance versus control Another study recruited 212 children (aged three months to 12 years) who underwent myringotomy and ventilation tube insertion. The study compared an intervention group who were instructed not to swim or submerge their heads while bathing with a control group; the participants were followed up at three-month intervals for one year. This study, with high risk of bias, did not show any evidence of a reduction or increase in the rate of otorrhoea (1.17 episodes per year in both groups; MD 0 episodes, 95% CI -0.14 to 0.14). No other outcomes were reported for this study and no adverse events were reported. Quality of evidence The overall quality (GRADE) of the body of evidence for the effect of ear plugs on the rate of otorrhoea and the effect of water avoidance on the rate of otorrhoea are low and very low respectively. The baseline rate of ventilation tube otorrhoea and the morbidity associated with it is usually low and therefore careful prior consideration must be given to the efficacy, costs and burdens of any intervention aimed at reducing this rate. While there is some evidence to suggest that wearing ear plugs reduces the rate of otorrhoea in children with ventilation tubes, clinicians and parents should understand that the absolute reduction in the number of episodes of otorrhoea appears to be very small and is unlikely to be clinically significant. Based on the data available, an average child would have to wear ear plugs for 2.8 years to prevent one episode of otorrhoea. Some evidence suggests that advising children to avoid swimming or head immersion during bathing does not affect rates of otorrhoea, although good quality data are lacking in this area. Currently, consensus guidelines therefore recommend against the routine use of water precautions on the basis that the limited clinical benefit is outweighed by the associated cost, inconvenience and anxiety. Future high-quality studies could be undertaken but may not be thought necessary. It is uncertain whether further trials in this area would change the findings of this review or have an impact on practice. Any future high-quality research should focus on determining whether particular groups of children benefit more from water precautions than others, as well as on developing clinical guidelines and their implementation.
We included two studies, recruiting a total of 413 patients. One study looked at 201 children between six months and six years who had ventilation tubes inserted to treat glue ear or recurrent infections. Children were divided into two groups: one group was allowed to swim and bathe freely, the other group was instructed to wear ear plugs while swimming or bathing. Another study looked at 212 children between three months and 12 years who had ventilation tubes inserted (we do not know precisely what for). These children were divided into two groups: one group was allowed to swim and bathe freely, the other group was instructed not to swim and told to avoid putting their head under water when bathing. Children in both studies were followed for about one year to see how many ear infections they had and if there were any other problems. We do not have any reason to be concerned about who funded these studies. The main result we looked for was the effect that keeping ears dry had on ear infections, specifically ear discharge. One study showed that there was a small reduction in the likelihood of getting an ear infection in children who protected their ears from water with ear plugs when swimming or bathing. The effect of wearing ear plugs was to reduce the number of infections a child would have every year (on average) from 1.2 to 0.84. We think the results from this study are quite reliable. Another study showed that there was no difference in the likelihood of children getting ear infections whether they were told to avoid swimming and putting their head under water, or whether they took no precautions at all. We are uncertain whether the results from this study are reliable. Neither study showed any other important differences between the children who got their ears wet and those who kept them dry. There was no effect on how long the tubes stayed in place or on hearing (although these results were only measured in one study). No harm to any participant was reported in either study. The evidence is current to September 2015. We graded the quality of evidence for the use of ear plugs as low, which means that "further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate". We have graded the quality of evidence relating to water avoidance as very low ("we are very uncertain about the estimate"). The difference that wearing ear plugs makes appears to be very small and a child would have to wear them on average for almost three years to prevent one infection resulting in ear discharge. It may be that telling children to avoid swimming and putting their head under water makes no difference to whether or not they get ear infections, but this is very uncertain. Current expert guidelines for clinicians therefore recommend against routinely using water precautions because the limited clinical benefit is outweighed by the associated cost, inconvenience and anxiety. Future high-quality studies could be undertaken but may not be thought necessary. It is uncertain whether further trials in this area would change the findings of this review or have an impact on practice. Any future high-quality research should focus on determining whether particular groups of children benefit more from water precautions than others, as well as on developing clinical guidelines and their implementation.
10.1002/14651858.CD010375.pub2
[ "We included two studies, recruiting a total of 413 patients. One study looked at 201 children between six months and six years who had ventilation tubes inserted to treat glue ear or recurrent infections. Children were divided into two groups: one group was allowed to swim and bathe freely, the other group was instructed to wear ear plugs while swimming or bathing. Another study looked at 212 children between three months and 12 years who had ventilation tubes inserted (we do not know precisely what for). These children were divided into two groups: one group was allowed to swim and bathe freely, the other group was instructed not to swim and told to avoid putting their head under water when bathing. Children in both studies were followed for about one year to see how many ear infections they had and if there were any other problems. We do not have any reason to be concerned about who funded these studies. The main result we looked for was the effect that keeping ears dry had on ear infections, specifically ear discharge. One study showed that there was a small reduction in the likelihood of getting an ear infection in children who protected their ears from water with ear plugs when swimming or bathing. The effect of wearing ear plugs was to reduce the number of infections a child would have every year (on average) from 1.2 to 0.84. We think the results from this study are quite reliable. Another study showed that there was no difference in the likelihood of children getting ear infections whether they were told to avoid swimming and putting their head under water, or whether they took no precautions at all. We are uncertain whether the results from this study are reliable. Neither study showed any other important differences between the children who got their ears wet and those who kept them dry. There was no effect on how long the tubes stayed in place or on hearing (although these results were only measured in one study). No harm to any participant was reported in either study. The evidence is current to September 2015. We graded the quality of evidence for the use of ear plugs as low, which means that \"further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate\". We have graded the quality of evidence relating to water avoidance as very low (\"we are very uncertain about the estimate\"). The difference that wearing ear plugs makes appears to be very small and a child would have to wear them on average for almost three years to prevent one infection resulting in ear discharge. It may be that telling children to avoid swimming and putting their head under water makes no difference to whether or not they get ear infections, but this is very uncertain. Current expert guidelines for clinicians therefore recommend against routinely using water precautions because the limited clinical benefit is outweighed by the associated cost, inconvenience and anxiety. Future high-quality studies could be undertaken but may not be thought necessary. It is uncertain whether further trials in this area would change the findings of this review or have an impact on practice. Any future high-quality research should focus on determining whether particular groups of children benefit more from water precautions than others, as well as on developing clinical guidelines and their implementation." ]
cochrane-simplification-train-964
cochrane-simplification-train-964
We identified no studies for inclusion in the original review or for this update. However, we felt that some studies that were excluded warranted discussion. These included one randomised trial (RCT), which showed no improvement in sexual scores associated with encouraging women to practise dilation therapy; a recent small RCT that did not show any advantage to dilation over vibration therapy during radiotherapy; two non-randomised comparative studies; and five correlation studies. One of these showed that objective measurements of vaginal elasticity and length were not linked to dilation during radiotherapy, but the study lacked power. One study showed that women who dilated tolerated a larger dilator, but the risk of objectivity and bias with historical controls was high. Another study showed that the vaginal measurements increased in length by a mean of 3 cm after dilation was introduced 6 to 10 weeks after radiotherapy, but there was no control group; another case series showed the opposite. Three recent studies showed less stenosis associated with prophylactic dilation after radiotherapy. One small case series suggested that dilation years after radiotherapy might restore the vagina to a functional length. There is no reliable evidence to show that routine, regular vaginal dilation during radiotherapy treatment prevents stenosis or improves quality of life. Several observational studies have examined the effect of dilation therapy after radiotherapy. They suggest that frequent dilation practice is associated with lower rates of self reported stenosis. This could be because dilation is effective or because women with a healthy vagina are more likely to comply with dilation therapy instructions compared to women with strictures. We would normally suggest that a RCT is needed to distinguish between a casual and causative link, but pilot studies highlight many reasons why RCT methodology is challenging in this area.
Women who want to preserve the length of their vagina after radiotherapy should consider dilation. There are limited data from observational studies that suggest regular stretching of the vagina, once radiotherapy treatment is completed, might reduce the risk of scaring by a small amount. There is no evidence to support dilation therapy during radiotherapy. There are also case reports and one case series suggesting that dilation months or years after radiotherapy might help restore vaginal length. Randomised trial design has not, and may never, obtain high-quality evidence to assess vaginal dilation therapy. The available studies suggest, but cannot prove, that dilation works. However, this only applies once the radiotherapy has finished. There is an association between vaginal dilation after radiotherapy and less vaginal stenosis, but this is not proof that the benefit is due to dilation. The link between dilation and less stenosis could either be due to a beneficial effect of dilation or because women with stenosis (or who self report stenosis) are less able to use the dilator.
10.1002/14651858.CD007291.pub3
[ "Women who want to preserve the length of their vagina after radiotherapy should consider dilation. There are limited data from observational studies that suggest regular stretching of the vagina, once radiotherapy treatment is completed, might reduce the risk of scaring by a small amount. There is no evidence to support dilation therapy during radiotherapy. There are also case reports and one case series suggesting that dilation months or years after radiotherapy might help restore vaginal length. Randomised trial design has not, and may never, obtain high-quality evidence to assess vaginal dilation therapy. The available studies suggest, but cannot prove, that dilation works. However, this only applies once the radiotherapy has finished. There is an association between vaginal dilation after radiotherapy and less vaginal stenosis, but this is not proof that the benefit is due to dilation. The link between dilation and less stenosis could either be due to a beneficial effect of dilation or because women with stenosis (or who self report stenosis) are less able to use the dilator." ]
cochrane-simplification-train-965
cochrane-simplification-train-965
We included eight studies (490 adult participants). The presence of nasal polyps on examination was an inclusion criterion in three studies, an exclusion criterion in one study and the remaining studies included a mixed population. No studies specifically investigated the effect of antifungals in patients with AFRS. Topical antifungal treatment versus placebo or no intervention We included seven studies (437 participants) that used amphotericin B (six studies; 383 participants) and one that used fluconazole (54 participants). Different delivery methods, volumes and concentrations were used. Four studies reported disease-specific health-related quality of life using a range of instruments. We did not meta-analyse the results due to differences in the instruments used, and measurement and reporting methods. At the end of treatment (one to six months) none of the studies reported statistically significant differences between the groups (low-quality evidence - we are uncertain about the result). Two studies reported disease severity using patient-reported symptom scores. Meta-analysis was not possible. At the end of treatment (8 to 13 weeks) one study showed no difference and the second found that patients in the placebo group had less severe symptoms (very low-quality evidence - we are very uncertain about the result). In terms of adverse effects , topical antifungals may lead to more local irritation compared with placebo (risk ratio (RR) 2.29, 95% confidence interval (CI) 0.61 to 8.62; 312 participants; 5 studies; low-quality evidence) but little or no difference in epistaxis (RR 0.97, 95% CI 0.14 to 6.63; 225 participants; 4 studies, low-quality evidence) or headache (RR 1.26, 95% CI 0.60 to 2.63; 195 participants; 3 studies; very low-quality evidence). None of the studies found a difference in generic health-related quality of life (one study) or endoscopic score (five studies) between the treatment groups. Three studies investigated CT scan ; two found no difference between the groups and one found a significant decrease in the mean percentage of air space occluded, favouring the antifungal group. Systemic antifungal treatment versus placebo or no treatment One study (53 participants) comparing terbinafine tablets against placebo reported that there may be little or no difference between the groups in disease-specific health-related quality of life or disease severity score (both low-quality evidence). Systemic antifungals may lead to more hepatic toxicity events (RR 3.35, 95% CI 0.14 to 78.60) but fewer gastrointestinal disturbances (RR 0.37, 95% CI 0.04 to 3.36), compared to placebo, although the evidence was of low quality. This study did not find a difference in CT scan score between the groups. Generic health-related quality of life and endoscopic score were not measured. Other comparisons We found no studies that compared antifungal agents against other treatments for chronic rhinosinusitis. Due to the very low quality of the evidence, it is uncertain whether or not the use of topical or systemic antifungals has an impact on patient outcomes in adults with chronic rhinosinusitis compared with placebo or no treatment. Studies including specific subgroups (i.e. AFRS) are lacking.
We included eight studies (490 adult participants). Seven studies (437 participants) investigated topical antifungals (nasal sprays or irrigations) and one study (53 participants) investigated systemic antifungals (tablets). All studies compared antifungals to placebo or no treatment. Most studies were well conducted and there was a mix of patients with chronic rhinosinusitis both with, and without, nasal polyps. At the end of at least four weeks treatment, none of the studies found that patients using antifungals (topical or systemic) had a better quality of life or less severe symptoms than patients who used placebo or had no treatment. Not many participants in the studies reported having adverse effects. Topical antifungals may lead to more nasal irritation compared with placebo. It is uncertain if patients taking topical antifungals have more headaches or nosebleeds than with placebo. For systemic antifungals, it is uncertain if patients using antifungals have more problems with their liver (hepatic toxicity) than with placebo. Systemic antifungals may lead to fewer patients with gastrointestinal disturbances compared to placebo. We found no studies that compared antifungal treatment with other treatments for chronic rhinosinusitis. We assessed the quality of the evidence as either low (further research is very likely to have an important impact on our confidence in the result) or very low (any estimate of the result is very uncertain), as some of the results are only from one or two studies, which do not have a lot of participants. Moreover, the different studies reported outcomes using different measurement scales making it difficult to draw conclusions. Due to the very low quality of the evidence, it is uncertain whether or not the use of topical or systemic antifungals has an impact on patient outcomes in adults with chronic rhinosinusitis compared with placebo or no treatment. More trials are needed to assess well-defined patient populations (such as the AFRS subgroup) and to evaluate other antifungals that have not been assessed in randomised controlled trials.
10.1002/14651858.CD012453.pub2
[ "We included eight studies (490 adult participants). Seven studies (437 participants) investigated topical antifungals (nasal sprays or irrigations) and one study (53 participants) investigated systemic antifungals (tablets). All studies compared antifungals to placebo or no treatment. Most studies were well conducted and there was a mix of patients with chronic rhinosinusitis both with, and without, nasal polyps. At the end of at least four weeks treatment, none of the studies found that patients using antifungals (topical or systemic) had a better quality of life or less severe symptoms than patients who used placebo or had no treatment. Not many participants in the studies reported having adverse effects. Topical antifungals may lead to more nasal irritation compared with placebo. It is uncertain if patients taking topical antifungals have more headaches or nosebleeds than with placebo. For systemic antifungals, it is uncertain if patients using antifungals have more problems with their liver (hepatic toxicity) than with placebo. Systemic antifungals may lead to fewer patients with gastrointestinal disturbances compared to placebo. We found no studies that compared antifungal treatment with other treatments for chronic rhinosinusitis. We assessed the quality of the evidence as either low (further research is very likely to have an important impact on our confidence in the result) or very low (any estimate of the result is very uncertain), as some of the results are only from one or two studies, which do not have a lot of participants. Moreover, the different studies reported outcomes using different measurement scales making it difficult to draw conclusions. Due to the very low quality of the evidence, it is uncertain whether or not the use of topical or systemic antifungals has an impact on patient outcomes in adults with chronic rhinosinusitis compared with placebo or no treatment. More trials are needed to assess well-defined patient populations (such as the AFRS subgroup) and to evaluate other antifungals that have not been assessed in randomised controlled trials." ]
cochrane-simplification-train-966
cochrane-simplification-train-966
In this updated review, we included seven completed RCTs with 401 participants. All tested adult human non-neural stem cells; cells were transplanted during the acute, subacute, or chronic phase of ischemic stroke; administered intravenously, intra-arterially, intracerebrally, or into the lumbar subarachnoid space. Follow-up ranged from six months to seven years. Efficacy outcomes were measured with the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), or Barthel Index (BI). Safety outcomes included case fatality, and were measured at the end of the trial. Overall, stem cell transplantation was associated with a better clinical outcome when measured with the NIHSS (mean difference [MD] -1.49, 95% confidence interval [CI] -2.65 to -0.33; five studies, 319 participants; low-certainty evidence), but not with the mRS (MD -0.42, 95% CI -0.86 to 0.02; six studies, 371 participants; very low-certainty evidence), or the BI (MD 14.09, 95% CI -1.94 to 30.13; three studies, 170 participants; very low-certainty evidence). The studies in favor of stem cell transplantation had, on average, a higher risk of bias, and a sample size of 32 or fewer participants. No significant safety concerns associated with stem cell transplantation were raised with respect to death (risk ratio [RR] 0.66, 95% CI 0.39 to 1.14; six studies, participants; low-certainty evidence). We were not able to perform the sensitivity analysis according to the quality of studies, because all of them were at high risk of bias. Overall, in participants with ischemic stroke, stem cell transplantation was associated with a reduced neurological impairment, but not with a better functional outcome. No obvious safety concerns were raised. However, these conclusions came mostly from small RCTs with high risk of bias, and the certainty of the evidence ranged from low to very low. More well-designed trials are needed.
We included randomized trials that recruited adults with ischemic stroke, at any time after onset. We included any kind of stem cell or method of administration. We identified seven randomized trials, involving 401 participants. Overall, stem cell transplantation was associated with a reduced neurological impairment, but not with a better functional outcome. No safety concerns were raised. The certainty of the evidence ranged from low to very low because of the risk of bias in the included studies, the lack of precision of the results, and different designs. More well-designed randomized controlled trials are needed.
10.1002/14651858.CD007231.pub3
[ "We included randomized trials that recruited adults with ischemic stroke, at any time after onset. We included any kind of stem cell or method of administration. We identified seven randomized trials, involving 401 participants. Overall, stem cell transplantation was associated with a reduced neurological impairment, but not with a better functional outcome. No safety concerns were raised. The certainty of the evidence ranged from low to very low because of the risk of bias in the included studies, the lack of precision of the results, and different designs. More well-designed randomized controlled trials are needed." ]
cochrane-simplification-train-967
cochrane-simplification-train-967
We included a total of 27 reviews in this overview. The reviews were generally of high quality according to AMSTAR ratings, and included studies provided evidence that ranged from very low to high in quality. Ten reviews had not been updated in the past three years. Seven reviews described interventions that provided a beneficial effect in reducing OHSS rates, and we categorised one additional review as 'promising'. Of the effective interventions, all except one had no detrimental effect on pregnancy outcomes. Evidence of at least moderate quality indicates that clinicians should consider the following interventions in ART cycles to reduce OHSS rates. • Metformin treatment before and during an ART cycle for women with PCOS (moderate-quality evidence). • Gonadotrophin-releasing hormone (GnRH) antagonist protocol in ART cycles (moderate-quality evidence). • GnRH agonist (GnRHa) trigger in donor oocyte or 'freeze-all' programmes (moderate-quality evidence). Evidence of low or very low quality suggests that clinicians should consider the following interventions in ART cycles to reduce OHSS rates. • Clomiphene citrate for controlled ovarian stimulation in ART cycles (low-quality evidence). • Cabergoline around the time of human chorionic gonadotrophin (hCG) administration or oocyte pickup in ART cycles (low-quality evidence). • Intravenous fluids (plasma expanders) around the time of hCG administration or oocyte pickup in ART cycles (very low-quality evidence). • Progesterone for luteal phase support in ART cycles (low-quality evidence). • Coasting (withholding gonadotrophins) - a promising intervention that needs to be researched further for reduction of OHSS. On the basis of this overview, we must conclude that evidence is currently insufficient to support the widespread practice of embryo cryopreservation. Currently, 27 reviews in the Cochrane Library were conducted to report on or to try to report on OHSS in ART cycles. We identified four review protocols but no new registered titles that can potentially be included in this overview in the future. This overview provides the most up-to-date evidence on prevention of OHSS in ART cycles from all currently published Cochrane reviews on ART. Clinicians can use the evidence summarised in this overview to choose the best treatment regimen for individual patients - a regimen that not only reduces the chance of developing OHSS but does not compromise other outcomes such as pregnancy or live birth rate. Review results, however, are limited by the lack of recent primary studies or updated reviews. Furthermore, this overview can be used by policymakers in developing local and regional protocols or guidelines and can reveal knowledge gaps for future research.
We found a total of 27 Cochrane ART reviews of high quality that could be included for this overview. These reviews aimed to report on OHSS in cycles of IVF or ICSI. We did not include reviews of intrauterine insemination and ovulation induction. The evidence is current to 12 December 2016. Of the 27 reviews included in this overview, 10 reviews had not been updated in the past three years. Seven reviews described interventions that provided a beneficial effect in reducing OHSS rates, and we categorised one additional review as 'promising'. Of the effective interventions, all except one had no detrimental effect on pregnancy outcomes. Evidence of at least moderate quality evidence indicates that clinicians should consider the following interventions in ART cycles to reduce OHSS rates. • Metformin treatment before and during an ART cycle in women with PCOS (moderate-quality evidence). • Gonadotrophin-releasing hormone (GnRH) antagonist protocol in ART cycles (moderate-quality evidence). • GnRH agonist (GnRHa) trigger in donor oocyte or 'freeze-all' programmes (moderate-quality evidence). Evidence of low or very low quality evidence suggests that clinicians should consider the following interventions in ART cycles to reduce OHSS rates. • Clomiphene citrate for controlled ovarian stimulation in ART cycles (low-quality evidence). • Cabergoline around the time of human chorionic gonadotrophin (hCG) administration or oocyte pickup in ART cycles (low-quality evidence). • Intravenous fluids (blood plasma expanders) around the time of hCG administration or egg pickup in ART cycles (very low-quality evidence). • Progesterone for luteal phase support in ART cycles (low-quality evidence). A promising intervention that needs to be researched further is coasting (withholding gonadotrophins) for reduction of OHSS. On the basis of this overview, we must conclude that evidence is currently insufficient to support the widespread practice of freezing all embryos and replacing them at a later time when OHSS has dissolved. Clinicians can use the evidence summarised in this overview to choose the best treatment regimen for individual patients - a regimen that not only reduces the chance of developing OHSS but does not compromise pregnancy outcomes. However, results of this overview are limited by the lack of recent primary studies or updated reviews. Furthermore, this overview can be used by policymakers in developing local and regional protocols or guidelines and can reveal knowledge gaps for future research.
10.1002/14651858.CD012103.pub2
[ "We found a total of 27 Cochrane ART reviews of high quality that could be included for this overview. These reviews aimed to report on OHSS in cycles of IVF or ICSI. We did not include reviews of intrauterine insemination and ovulation induction. The evidence is current to 12 December 2016. Of the 27 reviews included in this overview, 10 reviews had not been updated in the past three years. Seven reviews described interventions that provided a beneficial effect in reducing OHSS rates, and we categorised one additional review as 'promising'. Of the effective interventions, all except one had no detrimental effect on pregnancy outcomes. Evidence of at least moderate quality evidence indicates that clinicians should consider the following interventions in ART cycles to reduce OHSS rates. • Metformin treatment before and during an ART cycle in women with PCOS (moderate-quality evidence). • Gonadotrophin-releasing hormone (GnRH) antagonist protocol in ART cycles (moderate-quality evidence). • GnRH agonist (GnRHa) trigger in donor oocyte or 'freeze-all' programmes (moderate-quality evidence). Evidence of low or very low quality evidence suggests that clinicians should consider the following interventions in ART cycles to reduce OHSS rates. • Clomiphene citrate for controlled ovarian stimulation in ART cycles (low-quality evidence). • Cabergoline around the time of human chorionic gonadotrophin (hCG) administration or oocyte pickup in ART cycles (low-quality evidence). • Intravenous fluids (blood plasma expanders) around the time of hCG administration or egg pickup in ART cycles (very low-quality evidence). • Progesterone for luteal phase support in ART cycles (low-quality evidence). A promising intervention that needs to be researched further is coasting (withholding gonadotrophins) for reduction of OHSS. On the basis of this overview, we must conclude that evidence is currently insufficient to support the widespread practice of freezing all embryos and replacing them at a later time when OHSS has dissolved. Clinicians can use the evidence summarised in this overview to choose the best treatment regimen for individual patients - a regimen that not only reduces the chance of developing OHSS but does not compromise pregnancy outcomes. However, results of this overview are limited by the lack of recent primary studies or updated reviews. Furthermore, this overview can be used by policymakers in developing local and regional protocols or guidelines and can reveal knowledge gaps for future research." ]
cochrane-simplification-train-968
cochrane-simplification-train-968
We identified no new studies from the updated searches. We included in this review two RCTs for a total of 630 participants. Both RCTs included participants with an established diagnosis of polycythaemia vera and with no clear indication or contraindication to aspirin therapy. We judged both studies to be of moderate quality. Published data from both studies were insufficient for a time-to-event data analysis and for some of the primary and secondary outcomes that we planned. The use of low-dose aspirin, compared with placebo, was associated with a lower risk of fatal thrombotic events (although this benefit was not statistically significant (OR 0.20, 95% CI 0.03 to 1.14; P = 0.07). No data on mortality from bleeding episodes were available. A non-significant benefit of aspirin was shown for all-cause mortality (OR 0.46, 95% CI 0.21 to 1.01; P = 0.05). No increase in the risk of major bleeding was reported in participants taking aspirin compared with those given placebo (OR 0.99, 95% CI 0.23 to 4.36; P = 0.99), and a non-significant increase with aspirin treatment was shown for minor bleeding (OR 1.85, 95% CI 0.90 to 3.79; P = 0.09). No published studies have reported findings in participants with essential thrombocythaemia or in the study of other antiplatelet drugs. For patients with polycythaemia vera who have no clear indication or contraindication to aspirin therapy, available evidence suggests that the use of low-dose aspirin, when compared with no treatment, is associated with a statistically non-significant reduction in the risk of fatal thrombotic events and all-cause mortality, without an increased risk of major bleeding.
Evidence from this review of 630 people in two trials suggests that, in patients with polycythaemia vera and with no clear indication or contraindication to aspirin therapy, low-dose aspirin may reduce the risk of thrombotic and all-cause mortality. No data were provided on mortality from bleeding episodes. No studies in participants with essential thrombocythaemia and with antiplatelet therapy other than aspirin have been published.
10.1002/14651858.CD006503.pub3
[ "Evidence from this review of 630 people in two trials suggests that, in patients with polycythaemia vera and with no clear indication or contraindication to aspirin therapy, low-dose aspirin may reduce the risk of thrombotic and all-cause mortality. No data were provided on mortality from bleeding episodes. No studies in participants with essential thrombocythaemia and with antiplatelet therapy other than aspirin have been published." ]
cochrane-simplification-train-969
cochrane-simplification-train-969
We found only one RCT meeting the selection criteria for the second objective (therapeutic potential) of this review. This study recruited nine participants. It compared the use of gastrografin versus placebo in adult patients with MBO with no indication for further intervention (surgery, endoscopy) apart from standardised conservative management. The overall risk of bias for the study was high due to issues with low numbers of participants, selective reporting of outcomes and a high attrition rate for the intervention arm. Primary outcomes The included trial was a pilot study whose primary outcome was to test the feasibility for a large study. The authors reported specifically on the number of patients screened, the number recruited and reasons for exclusion; this was not the focus of our review. Due to the low number of participants, the authors of the study decided not to report on our primary outcome of assessing the ability of OWSC to predict the likelihood of malignant small bowel obstruction resolving with conservative treatment alone (diagnostic effect). It also did not report on our primary outcome of rate of resolution of MBO in patients receiving OWSC compared with those not receiving it (therapeutic effect). The study reported that no issues regarding safety or tolerability of either gastrografin or placebo were identified. The overall quality of the evidence for the incidence of adverse events with OWSC was very low, downgraded twice for serious limitations to study quality (high risk of selective reporting and attrition bias) and downgraded once for imprecision (sparse data). Secondary outcomes The study planned to report on this review’s secondary outcome measures of length of hospital stay and time from administration of OWSC to resolution of MBO. However the authors of the study decided not to do so due to the low numbers of patients recruited. The study did not report on our secondary outcome measure of survival times from onset of inoperable MBO until death. There is insufficient evidence from RCTs to determine the place of OWSC in predicting which patients with inoperable MBO will respond with conservative treatment alone. There is also insufficient evidence from RCTs to determine the therapeutic effects and safety of OWSC in patients with malignant small bowel obstruction.
We searched for evidence that OWSC could be used to identify which patients with inoperable MBO would recover with conservative management. We also wanted to know if OWSC increased the likelihood of recovery from MBO, reduced hospital stay or improved prognosis. Finally, we wished to know what side effects OWSC might cause for patients with MBO. We conducted the search in June 2017 and found one study. It only recruited nine participants and did not fully report on the outcomes of using OWSC in MBO. We found insufficient evidence that OWSC can identify which patients with MBO will recover with conservative management. We found insufficient evidence that patients with MBO benefit from OWSC in terms of length of hospital stay, recovery time or survival. No conclusions could be made about side effects from OWSC. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. We rated the quality of the evidence as very low due to the lack of studies reporting on the benefits of using OWSC in MBO and the only study we found reporting on side effects recruited very few participants (nine). The low quality of the evidence means that we are very uncertain about the use of OWSC in the management of MBO and cannot confirm its benefits or harms in patients with this condition.
10.1002/14651858.CD012014.pub2
[ "We searched for evidence that OWSC could be used to identify which patients with inoperable MBO would recover with conservative management. We also wanted to know if OWSC increased the likelihood of recovery from MBO, reduced hospital stay or improved prognosis. Finally, we wished to know what side effects OWSC might cause for patients with MBO. We conducted the search in June 2017 and found one study. It only recruited nine participants and did not fully report on the outcomes of using OWSC in MBO. We found insufficient evidence that OWSC can identify which patients with MBO will recover with conservative management. We found insufficient evidence that patients with MBO benefit from OWSC in terms of length of hospital stay, recovery time or survival. No conclusions could be made about side effects from OWSC. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. We rated the quality of the evidence as very low due to the lack of studies reporting on the benefits of using OWSC in MBO and the only study we found reporting on side effects recruited very few participants (nine). The low quality of the evidence means that we are very uncertain about the use of OWSC in the management of MBO and cannot confirm its benefits or harms in patients with this condition." ]
cochrane-simplification-train-970
cochrane-simplification-train-970
We included 14 studies investigating the use of cholinergic drugs compared with placebo published between 1976 and 2014. All studies involved small numbers of participants (five to 60 people). Three studies that investigated the new cholinergic Alzheimer drugs for the treatment of TD are new to this update. Overall, the risk of bias in the included studies was unclear, mainly due to poor reporting; allocation concealment was not described, generation of the sequence was not explicit, studies were not clearly blinded, we are unsure if data are incomplete, and data were often poorly or selectively reported. We are uncertain about the effect of new or old cholinergic drugs on no clinically important improvement in TD symptoms when compared with placebo; the quality of evidence was very low (RR 0.89, 95% CI 0.65 to 1.23; 27 people, 4 RCTs). Eight trials found that cholinergic drugs may make little or no difference to deterioration of TD symptoms (low-quality evidence, RR 1.11, 95% CI 0.55 to 2.24; 147 people). Again, due to very low-quality evidence, we are uncertain about the effects on mental state (RR 0.50, 95% CI 0.10 to 2.61; 77 people, 5 RCTs), adverse events (RR 0.56, 95% CI 0.15 to 2.14; 106 people, 4 RCTs), and leaving the study early (RR 1.09,95% CI 0.56 to 2.10; 288 people 12 RCTs). No study reported on social confidence, social inclusion, social networks, or personalised quality of life. TD remains a major public health problem. The clinical effects of both older cholinergic drugs and new cholinergic agents, now used for treating Alzheimer's disease, are unclear, as too few, too small studies leave many questions unanswered. Cholinergic drugs should remain of interest to researchers and currently have little place in routine clinical work. However, with the advent of new cholinergic agents now used for treating Alzheimer's disease, scope exists for more informative trials. If these new cholinergic agents are to be investigated for treating people with TD, their effects should be demonstrated in large well-designed, conducted and reported randomised trials.
. We searched for trials in July 2015 and April 2017, using the Cochrane Schizophrenia Group's register of trials. The review includes 14 studies investigating the use of cholinergic drugs compared with placebo. All studies randomised small numbers of participants (five to 60 people) with schizophrenia or other chronic mental illnesses who had also developed antipsychotic-induced tardive dyskinesia. . We found the effects of both older and newer cholinergic drugs to be unclear as too few and too small studies are available and do not yield great evidence and leave many questions unanswered. . The available evidence is weak, limited, and small scale. It is not possible to recommend these drugs as a treatment for tardive dyskinesia based on our findings. To fully investigate whether the use of cholinergic drugs have any positive effects for people with tardive dyskinesia, there would have to be well-designed, larger, longer-term studies, particularly on new cholinergic drugs currently being used for treating Alzheimer’s disease. Ben Gray, Senior Peer Researcher, McPin Foundation. http://mcpin.org/
10.1002/14651858.CD000207.pub2
[ ". We searched for trials in July 2015 and April 2017, using the Cochrane Schizophrenia Group's register of trials. The review includes 14 studies investigating the use of cholinergic drugs compared with placebo. All studies randomised small numbers of participants (five to 60 people) with schizophrenia or other chronic mental illnesses who had also developed antipsychotic-induced tardive dyskinesia. . We found the effects of both older and newer cholinergic drugs to be unclear as too few and too small studies are available and do not yield great evidence and leave many questions unanswered. . The available evidence is weak, limited, and small scale. It is not possible to recommend these drugs as a treatment for tardive dyskinesia based on our findings. To fully investigate whether the use of cholinergic drugs have any positive effects for people with tardive dyskinesia, there would have to be well-designed, larger, longer-term studies, particularly on new cholinergic drugs currently being used for treating Alzheimer’s disease. Ben Gray, Senior Peer Researcher, McPin Foundation. http://mcpin.org/" ]
cochrane-simplification-train-971
cochrane-simplification-train-971
Out of 14 717 citations, 11 RCTs met the inclusion criteria (1381 participants). Six studies addressed outcomes relating to medication adherence, and there was some evidence from two studies that telephone interventions can improve adherence. A meta-analysis of three studies for which there was sufficient data showed no significant benefit (SMD 0.49, 95% CI -1.12 to 2.11). There was some evidence from a study of young substance abusing HIV positive persons of the efficacy of telephone interventions for reducing risky sexual behaviour, while a trial of older persons found no benefit. Three RCTs addressed virologic outcomes, and there is very little evidence that telephone interventions improved virologic outcomes. Five RCTs addressed outcomes relating to depressive and psychiatric symptoms, and showed some evidence that telephone interventions can be of benefit. Three of these studies which focussed on depressive symptoms were combined in a meta-analysis, which showed no significant benefit (SMD 0.02, 95% CI -0.18 to 0.21 95% CI). Telephone voice interventions may have a role in improving medication adherence, reducing risky sexual behaviour, and reducing depressive and psychiatric symptoms, but current evidence is sparse, and further research is needed.
The aim of this review was to assess the effectiveness of using the telephone to deliver interventions to improve the health of PLHIV compared to standard care. A comprehensive search of various scientific databases and other resources found 11 relevant studies. All of the studies were performed in the United States, and so the results may not apply to other countries, particularly developing countries. Some studies were aimed at any HIV positive person in the area in which the study was carried out, and others focused on specific groups of people, such as young substance using PLHIV, or older PLHIV. There were a lot of differences in the types of telephone interventions used in each study. There was some evidence that telephone interventions can improve medication adherence, reduce risky sexual behaviour, and reduce symptoms of depression in PLHIV. However, there were also a number of studies that suggested that telephone interventions were no more effective than usual care alone. We need more studies conducted in different settings to assess the effectiveness of telephone interventions for improving the health of PLHIV.
10.1002/14651858.CD009189.pub2
[ "The aim of this review was to assess the effectiveness of using the telephone to deliver interventions to improve the health of PLHIV compared to standard care. A comprehensive search of various scientific databases and other resources found 11 relevant studies. All of the studies were performed in the United States, and so the results may not apply to other countries, particularly developing countries. Some studies were aimed at any HIV positive person in the area in which the study was carried out, and others focused on specific groups of people, such as young substance using PLHIV, or older PLHIV. There were a lot of differences in the types of telephone interventions used in each study. There was some evidence that telephone interventions can improve medication adherence, reduce risky sexual behaviour, and reduce symptoms of depression in PLHIV. However, there were also a number of studies that suggested that telephone interventions were no more effective than usual care alone. We need more studies conducted in different settings to assess the effectiveness of telephone interventions for improving the health of PLHIV." ]
cochrane-simplification-train-972
cochrane-simplification-train-972
The updated search resulted in the inclusion of one new study. This review now includes five RCTs with 366 participants. There were more female than male participants (70% were female); their ages ranged from 14 to 53 years. All trials involved ACL reconstructions performed by experienced surgeons. Assessing the studies' risk of bias was hampered by poor reporting of trial methods, and consequently several studies were judged to be 'unclear' for several types of bias. One trial presenting primary outcome data was at high risk of detection bias from lack of clinician blinding and attrition bias from an unaccounted loss to follow-up at two years. We found moderate quality evidence (three trials, 193 participants) of no clinically relevant difference between CAS and conventional surgery in International Knee Documentation Committee (IKDC) subjective scores (self-reported measure of knee function; scale of 0 to 100 where 100 was best function). Pooled data from two of these trials (120 participants) showed a small, but clinically irrelevant difference favouring CAS (MD 2.05, 95% CI -2.16 to 6.25). A third trial (73 participants) also found minimal difference in IKDC subjective scores (reported MD 0.2). We found low quality evidence (two trials, 120 participants) showing no difference between the two groups in Lysholm scores, also measured on a scale 0 to 100 where 100 is best function (MD 0.25, 95% CI -3.75 to 4.25). We found very low quality evidence (one trial, 40 participants) showing no difference between the two groups in Tegner scores. We found low quality evidence (three trials, 173 participants) showing the majority of participants in both groups were assessed as having normal or nearly normal knee function (86/87 with CAS versus 84/86 with no CAS; RR 1.01, 95% CI 0.96 to 1.06). Similarly, no differences were found for our secondary outcome measures of knee stability, loss in range of motion and tunnel placement. None of the trials reported on re-operation. No adverse post-surgical events were reported in two trials (133 participants); this outcome was not reported by the other three trials. CAS use was associated with longer operating times compared with conventional operating techniques: the mean difference in operating times reported in the studies ranged between 9 and 27 minutes. From the available evidence, we are unable to demonstrate or refute a favourable effect of CAS for cruciate ligament reconstructions of the knee compared with conventional reconstructions. However, the currently available evidence does not indicate that CAS in knee ligament reconstruction improves outcome. There is a need for improved reporting of future studies of this technology.
We conducted a comprehensive search of medical literature up to 5 July 2013 to find randomized controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) and quasi-randomized controlled trials (e.g. allocation by hospital record number or date of birth) comparing computer-assisted surgery (CAS) of the ACL or PCL with conventional operating techniques not involving CAS in adults. We found five studies for inclusion in this review. These studies involved 366 participants, mainly female (70%), aged 14 to 53 years. All five trials involved ACL reconstruction. We were uncertain about the reliability of study findings due to poor reporting of trial methods and, sometimes, results. Our assessment of the quality of the evidence available for individual outcomes ranged from 'moderate' quality (which means further research may change the estimate) to 'very low' quality (which means we are very uncertain about the estimate). The trials provided some moderate quality evidence that there was no difference between computer-assisted surgery and conventional surgery for patient-reported knee function. There was low quality evidence of no difference between the two groups in self-reported function score and very low quality evidence of no difference in a score measuring activity levels. There was low quality evidence of no difference between the two treatment groups in the number of people assessed by clinicians as having a normal or nearly normal knee function at the final follow-up time. No adverse post-surgical events were reported in two trials; this outcome was not reported by the other three trials. CAS took longer to do than conventional surgery (from 9 to 27 minutes longer). Overall, the currently available evidence does not indicate that CAS in knee ligament reconstruction improves outcome compared with conventional surgery.
10.1002/14651858.CD007601.pub4
[ "We conducted a comprehensive search of medical literature up to 5 July 2013 to find randomized controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) and quasi-randomized controlled trials (e.g. allocation by hospital record number or date of birth) comparing computer-assisted surgery (CAS) of the ACL or PCL with conventional operating techniques not involving CAS in adults. We found five studies for inclusion in this review. These studies involved 366 participants, mainly female (70%), aged 14 to 53 years. All five trials involved ACL reconstruction. We were uncertain about the reliability of study findings due to poor reporting of trial methods and, sometimes, results. Our assessment of the quality of the evidence available for individual outcomes ranged from 'moderate' quality (which means further research may change the estimate) to 'very low' quality (which means we are very uncertain about the estimate). The trials provided some moderate quality evidence that there was no difference between computer-assisted surgery and conventional surgery for patient-reported knee function. There was low quality evidence of no difference between the two groups in self-reported function score and very low quality evidence of no difference in a score measuring activity levels. There was low quality evidence of no difference between the two treatment groups in the number of people assessed by clinicians as having a normal or nearly normal knee function at the final follow-up time. No adverse post-surgical events were reported in two trials; this outcome was not reported by the other three trials. CAS took longer to do than conventional surgery (from 9 to 27 minutes longer). Overall, the currently available evidence does not indicate that CAS in knee ligament reconstruction improves outcome compared with conventional surgery." ]
cochrane-simplification-train-973
cochrane-simplification-train-973
We included two cluster-RCTs, which provided data from 2447 participants. Both trials were conducted in areas endemic to trachoma: Northern Australia and Tanzania. The follow-up period was three months in one trial and 12 months in the other; both trials had about 90% participant follow-up at final visit. Overall the quality of the evidence is uncertain due to the trials not reporting many design methods and the differences in outcomes reported between trials. Face washing combined with topical tetracycline was compared with topical tetracycline alone in three pairs of villages in one trial. The trial found that face washing combined with topical tetracycline reduced 'severe' active trachoma compared with topical tetracycline alone at 12 months (adjusted odds ratio (OR) 0.62, 95% confidence interval (CI) 0.40 to 0.97); however, the trial did not find any important difference between the intervention and control villages in reducing other types of active trachoma (adjusted OR 0.81, 95% CI 0.42 to 1.59). Intervention villages had a higher prevalence of clean faces than the control villages among children with severe trachoma (adjusted OR 0.35, 95% CI 0.21 to 0.59) and any trachoma (adjusted OR 0.58, 95% CI 0.47 to 0.72) at 12 months follow-up. The second trial compared eye washing to no treatment or to topical tetracycline alone or to a combination of eye washing and tetracycline drops in children with follicular trachoma. At three months, the trial found no evidence of benefit of eye washing alone or in combination with tetracycline eye drops in reducing follicular trachoma amongst children with follicular trachoma (risk ratio (RR) 1.03, 95% CI 0.96 to 1.11; one trial, 1143 participants). There is evidence from one trial that face washing combined with topical tetracycline may be effective in reducing severe active trachoma and in increasing the prevalence of clean faces at one year follow-up. Current evidence is inconclusive as to the effectiveness of face washing alone or in combination with topical tetracycline in reducing active or severe trachoma.
We included two randomized controlled trials with a total of 2560 participants set in Australia and Tanzania. One trial compared a combined strategy of face washing plus tetracycline (an antibiotic) ointment with tetracycline ointment alone for up to one year. The second trial compared four intervention groups for three months in children who already had follicular trachoma: a combined strategy of face washing plus tetracycline eye drops, face washing alone, tetracycline eye drops alone, and no treatment. The evidence is current to January 2015. Both trials reported the number of children with active trachoma as an outcome measure; one trial also reported the number of children with severe trachoma and the percentage of clean faces after one year. One trial reported that face washing was effective in increasing facial cleanliness and in reducing severe trachoma at one year; the second trial did not show that eye washing alone or in combination with tetracycline eye drops reduced follicular trachoma amongst children who had follicular trachoma at time of enrollment. The two included trials were of uncertain risk of bias due to not reporting many aspects of the trial designs.
10.1002/14651858.CD003659.pub4
[ "We included two randomized controlled trials with a total of 2560 participants set in Australia and Tanzania. One trial compared a combined strategy of face washing plus tetracycline (an antibiotic) ointment with tetracycline ointment alone for up to one year. The second trial compared four intervention groups for three months in children who already had follicular trachoma: a combined strategy of face washing plus tetracycline eye drops, face washing alone, tetracycline eye drops alone, and no treatment. The evidence is current to January 2015. Both trials reported the number of children with active trachoma as an outcome measure; one trial also reported the number of children with severe trachoma and the percentage of clean faces after one year. One trial reported that face washing was effective in increasing facial cleanliness and in reducing severe trachoma at one year; the second trial did not show that eye washing alone or in combination with tetracycline eye drops reduced follicular trachoma amongst children who had follicular trachoma at time of enrollment. The two included trials were of uncertain risk of bias due to not reporting many aspects of the trial designs." ]
cochrane-simplification-train-974
cochrane-simplification-train-974
One hundred and thirty-four studies involving 428,293 participants met the inclusion criteria. Some studies provided data for more than one group. Pure Prevention cohorts (Group 1) included 49 studies (N = 142,447). Pooled results at follow-up at one year or less found no overall effect of intervention curricula versus control (odds ratio (OR) 0.94, 95% confidence interval (CI) 0.85 to 1.05). In a subgroup analysis, the combined social competence and social influences curricula (six RCTs) showed a statistically significant effect in preventing the onset of smoking (OR 0.49, 95% CI 0.28 to 0.87; seven arms); whereas significant effects were not detected in programmes involving information only (OR 0.12, 95% CI 0.00 to 14.87; one study), social influences only (OR 1.00, 95% CI 0.88 to 1.13; 25 studies), or multimodal interventions (OR 0.89, 95% CI 0.73 to 1.08; five studies). In contrast, pooled results at longest follow-up showed an overall significant effect favouring the intervention (OR 0.88, 95% CI 0.82 to 0.96). Subgroup analyses detected significant effects in programmes with social competence curricula (OR 0.52, 95% CI 0.30 to 0.88), and the combined social competence and social influences curricula (OR 0.50, 95% CI 0.28 to 0.87), but not in those programmes with information only, social influence only, and multimodal programmes. Change in Smoking Behaviour over time (Group 2) included 15 studies (N = 45,555). At one year or less there was a small but statistically significant effect favouring controls (standardised mean difference (SMD) 0.04, 95% CI 0.02 to 0.06). For follow-up longer than one year there was a statistically nonsignificant effect (SMD 0.02, 95% CI -0.00 to 0.02). Twenty-five studies reported data on the Point Prevalence of Smoking (Group 3), though heterogeneity in this group was too high for data to be pooled. We were unable to analyse data for 49 studies (N = 152,544). Subgroup analyses (Pure Prevention cohorts only) demonstrated that at longest follow-up for all curricula combined, there was a significant effect favouring adult presenters (OR 0.88, 95% CI 0.81 to 0.96). There were no differences between tobacco-only and multifocal interventions. For curricula with booster sessions there was a significant effect only for combined social competence and social influences interventions with follow-up of one year or less (OR 0.50, 95% CI 0.26 to 0.96) and at longest follow-up (OR 0.51, 95% CI 0.27 to 0.96). Limited data on gender differences suggested no overall effect, although one study found an effect of multimodal intervention at one year for male students. Sensitivity analyses for Pure Prevention cohorts and Change in Smoking Behaviour over time outcomes suggested that neither selection nor attrition bias affected the results. Pure Prevention cohorts showed a significant effect at longest follow-up, with an average 12% reduction in starting smoking compared to the control groups. However, no overall effect was detected at one year or less. The combined social competence and social influences interventions showed a significant effect at one year and at longest follow-up. Studies that deployed a social influences programme showed no overall effect at any time point; multimodal interventions and those with an information-only approach were similarly ineffective. Studies reporting Change in Smoking Behaviour over time did not show an overall effect, but at an intervention level there were positive findings for social competence and combined social competence and social influences interventions.
We identified 49 randomised controlled trials (over 140,000 school children) of interventions aiming to prevent children who had never smoked from becoming smokers. At longer than one year, there was a significant effect of the interventions in preventing young people from starting smoking. Programmes that used a social competence approach and those that combined a social competence with a social influence approach were found to be more effective than other programmes. However, at one year or less there was no overall effect, except for programmes which taught young people to be socially competent and to resist social influences. A smaller group of trials reported on the smoking status of all people in the class, whether or not they smoked at the start of the study. In these trials with follow-up of one year or less there was an overall small but significant effect favouring the controls. This continued after a year; for trials with follow-up longer than one year, those in the intervention groups smoked more than those in the control groups. When trials at low risk of bias from randomisation, or from losing participants, were examined separately, the conclusions remained the same. Programmes led by adults may be more effective than those led by young people. There is no evidence that delivering extra sessions makes the intervention more effective.
10.1002/14651858.CD001293.pub3
[ "We identified 49 randomised controlled trials (over 140,000 school children) of interventions aiming to prevent children who had never smoked from becoming smokers. At longer than one year, there was a significant effect of the interventions in preventing young people from starting smoking. Programmes that used a social competence approach and those that combined a social competence with a social influence approach were found to be more effective than other programmes. However, at one year or less there was no overall effect, except for programmes which taught young people to be socially competent and to resist social influences. A smaller group of trials reported on the smoking status of all people in the class, whether or not they smoked at the start of the study. In these trials with follow-up of one year or less there was an overall small but significant effect favouring the controls. This continued after a year; for trials with follow-up longer than one year, those in the intervention groups smoked more than those in the control groups. When trials at low risk of bias from randomisation, or from losing participants, were examined separately, the conclusions remained the same. Programmes led by adults may be more effective than those led by young people. There is no evidence that delivering extra sessions makes the intervention more effective." ]
cochrane-simplification-train-975
cochrane-simplification-train-975
We included 24 studies (2664 participants) of adult participants (older than 18 years of age) with respiratory distress due to ACPE, not requiring immediate mechanical ventilation. People with ACPE presented either to an Emergency Department or were inpatients. ACPE treatment was provided in an intensive care or Emergency Department setting. There was a median follow-up of 13 days for hospital mortality, one day for endotracheal intubation, and three days for acute myocardial infarction. Compared with SMC, NPPV may reduce hospital mortality (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.51 to 0.82; participants = 2484; studies = 21; I2 = 6%; low quality of evidence) with a number needed to treat for an additional beneficial outcome (NNTB) of 17 (NNTB 12 to 32). NPPV probably reduces endotracheal intubation rates (RR 0.49, 95% CI 0.38 to 0.62; participants = 2449; studies = 20; I2 = 0%; moderate quality of evidence) with a NNTB of 13 (NNTB 11 to 18). There is probably little or no difference in acute myocardial infarction (AMI) incidence with NPPV compared to SMC for ACPE (RR 1.03, 95% CI 0.91 to 1.16; participants = 1313; studies = 5; I2 = 0%; moderate quality of evidence). We are uncertain as to whether NPPV increases hospital length of stay (mean difference (MD) −0.31 days, 95% CI −1.23 to 0.61; participants = 1714; studies = 11; I2 = 55%; very low quality of evidence). Adverse events were generally similar between NPPV and SMC groups, but evidence was of low quality. Our review provides support for continued clinical application of NPPV for ACPE, to improve outcomes such as hospital mortality and intubation rates. NPPV is a safe intervention with similar adverse event rates to SMC alone. Additional research is needed to determine if specific subgroups of people with ACPE have greater benefit of NPPV compared to SMC. Future research should explore the benefit of NPPV for ACPE patients with hypercapnia.
Randomised controlled studies compare treatments to find out if they are truly effective. We searched for randomised studies comparing non-invasive ventilation to routine care for adults with acute cardiogenic pulmonary oedema. We compared studies treating people with non-invasive ventilation versus medical care. Medical care includes therapies such as providing extra oxygen and water pills to patients. The evidence upon which this review is based is current to September 2018. We sought to address if non-invasive ventilation in adults with acute cardiogenic pulmonary oedema reduces rates of deaths, the need for a breathing tube, and heart attacks. We found 24 studies with 2664 participants comparing non-invasive ventilation to medical care alone. Non-invasive ventilation may decrease the chances of dying in hospital. The quality of results for studies reporting death in hospital was low. Studies were poorly conducted, and results were not similar across studies. In addition, non-invasive ventilation probably reduces the chances of needing a breathing tube. The quality of results for studies reporting breathing tube rates was moderate. Studies evaluating breathing tube rates were poorly conducted. Non-invasive ventilation probably has little or no effect on getting a heart attack. The quality of results for studies reporting heart attack rates was moderate, and studies had inconsistent results for this outcome. We are unsure if the length of hospital stay is improved with non-invasive ventilation. The quality of results for studies reporting hospital length of stay was very low, which was due to poor study conduct and inconsistent results. Finally, non-invasive ventilation may make little or no difference to adverse events (complications), compared to medical care. The quality of results for studies reporting adverse events was low. Studies evaluating adverse events were poorly conducted and had inconsistent results.
10.1002/14651858.CD005351.pub4
[ "Randomised controlled studies compare treatments to find out if they are truly effective. We searched for randomised studies comparing non-invasive ventilation to routine care for adults with acute cardiogenic pulmonary oedema. We compared studies treating people with non-invasive ventilation versus medical care. Medical care includes therapies such as providing extra oxygen and water pills to patients. The evidence upon which this review is based is current to September 2018. We sought to address if non-invasive ventilation in adults with acute cardiogenic pulmonary oedema reduces rates of deaths, the need for a breathing tube, and heart attacks. We found 24 studies with 2664 participants comparing non-invasive ventilation to medical care alone. Non-invasive ventilation may decrease the chances of dying in hospital. The quality of results for studies reporting death in hospital was low. Studies were poorly conducted, and results were not similar across studies. In addition, non-invasive ventilation probably reduces the chances of needing a breathing tube. The quality of results for studies reporting breathing tube rates was moderate. Studies evaluating breathing tube rates were poorly conducted. Non-invasive ventilation probably has little or no effect on getting a heart attack. The quality of results for studies reporting heart attack rates was moderate, and studies had inconsistent results for this outcome. We are unsure if the length of hospital stay is improved with non-invasive ventilation. The quality of results for studies reporting hospital length of stay was very low, which was due to poor study conduct and inconsistent results. Finally, non-invasive ventilation may make little or no difference to adverse events (complications), compared to medical care. The quality of results for studies reporting adverse events was low. Studies evaluating adverse events were poorly conducted and had inconsistent results." ]
cochrane-simplification-train-976
cochrane-simplification-train-976
A single trial containing 22 patients, with a low risk of bias was included. This trial found that after 24 months, compared with placebo, the use of intratympanic dexamethasone demonstrated a statistically significant improvement in vertigo as defined by a respective improvement in functional level (90% versus 42%), class (82% versus 57%), change in Dizziness Handicap Inventory scores (60.4 versus 41.3) and mean vertigo subjective improvement (90% versus 57%). The treatment regime described by the authors involved daily injections of dexamethasone solution 4 mg/ml for five consecutive days. These results were clinically significant. No complications were reported. The results of a single trial provide limited evidence to support the effectiveness of intratympanic steroids in patients with Ménière's disease. This trial demonstrated a statistically and clinically significant improvement of the frequency and severity of vertigo measured 24 months after the treatment was administered. It is important to note that there were a few aspects of the study which we were unable to clarify with the study authors.
We looked for studies which compared steroid injections in the ear with placebo in patients with Ménière's disease or syndrome. Only one study satisfied the prespecified inclusion criteria for this review. This study demonstrated a benefit of this treatment for patients with Ménière's disease; at 24 months the patients in the treatment group had far fewer episodes of vertigo. The results of this review are encouraging, however as it is based solely on the results of a single study, further research is required.
10.1002/14651858.CD008514.pub2
[ "We looked for studies which compared steroid injections in the ear with placebo in patients with Ménière's disease or syndrome. Only one study satisfied the prespecified inclusion criteria for this review. This study demonstrated a benefit of this treatment for patients with Ménière's disease; at 24 months the patients in the treatment group had far fewer episodes of vertigo. The results of this review are encouraging, however as it is based solely on the results of a single study, further research is required." ]
cochrane-simplification-train-977
cochrane-simplification-train-977
Fifty trials met the inclusion criteria, 45 in men after radical prostatectomy, four trials after TURP and one trial after either operation. The trials included 4717 men of whom 2736 had an active conservative intervention. There was considerable variation in the interventions, populations and outcome measures. Data were not available for many of the pre-stated outcomes. Men's symptoms improved over time irrespective of management. There was no evidence from eight trials that pelvic floor muscle training with or without biofeedback was better than control for men who had urinary incontinence up to 12 months after radical prostatectomy; the quality of the evidence was judged to be moderate (for example 57% with urinary incontinence in the intervention group versus 62% in the control group, risk ratio (RR) for incontinence after 12 months 0.85, 95% confidence interval (CI) 0.60 to 1.22). One large multi-centre trial of one-to-one therapy showed no difference in any urinary or quality of life outcome measures and had narrow CIs. It seems unlikely that men benefit from one-to-one PFMT therapy after TURP. Individual small trials provided data to suggest that electrical stimulation, external magnetic innervation, or combinations of treatments might be beneficial but the evidence was limited. Amongst trials of conservative treatment for all men after radical prostatectomy, aimed at both treatment and prevention, there was moderate evidence of an overall benefit from pelvic floor muscle training versus control management in terms of reduction of urinary incontinence (for example 10% with urinary incontinence after one year in the intervention groups versus 32% in the control groups, RR for urinary incontinence 0.32, 95% CI 0.20 to 0.51). However, this finding was not supported by other data from pad tests. The findings should be treated with caution because the risk of bias assessment showed methodological limitations. Men in one trial were more satisfied with one type of external compression device, which had the lowest urine loss, compared to two others or no treatment. The effect of other conservative interventions such as lifestyle changes remained undetermined as no trials involving these interventions were identified. The value of the various approaches to conservative management of postprostatectomy incontinence after radical prostatectomy remains uncertain. The evidence is conflicting and therefore rigorous, adequately powered randomised controlled trials (RCTs) which abide by the principles and recommendations of the CONSORT statement are still needed to obtain a definitive answer. The trials should be robustly designed to answer specific well constructed research questions and include outcomes which are important from the patient's perspective in decision making and are also relevant to the healthcare professionals. Long-term incontinence may be managed by an external penile clamp, but there are safety problems.
The review of trials found that there was conflicting evidence about the benefit of therapists teaching men to contract their pelvic floor muscles for either prevention or treatment of urine leakage after radical prostate surgery for cancer. However, information from one large trial suggested that men do not benefit from seeing a therapist to receive pelvic floor muscle training after transurethral resection (TURP) for benign prostatic enlargement. Overall, there was insufficient evidence to demonstrate a beneficial effect from pelvic floor muscle training. Of three external compression devices tested, one penile clamp seemed to be better than the others. This one penile clamp needed to be used cautiously because of safety risks. In future updates it may be worth considering two separate reviews, looking separately at 'treatment' and 'prevention' trials. More research that is of better quality is also needed to assess conservative management.
10.1002/14651858.CD001843.pub5
[ "The review of trials found that there was conflicting evidence about the benefit of therapists teaching men to contract their pelvic floor muscles for either prevention or treatment of urine leakage after radical prostate surgery for cancer. However, information from one large trial suggested that men do not benefit from seeing a therapist to receive pelvic floor muscle training after transurethral resection (TURP) for benign prostatic enlargement. Overall, there was insufficient evidence to demonstrate a beneficial effect from pelvic floor muscle training. Of three external compression devices tested, one penile clamp seemed to be better than the others. This one penile clamp needed to be used cautiously because of safety risks. In future updates it may be worth considering two separate reviews, looking separately at 'treatment' and 'prevention' trials. More research that is of better quality is also needed to assess conservative management." ]
cochrane-simplification-train-978
cochrane-simplification-train-978
One trial involving 76 women who planned to have their babies delivered by caesarean section met the inclusion criteria, but data were available for only 64 women. This trial was of low quality with unclear allocation concealment and only a few main clinical outcomes reported for the women. The trial did not report any infant outcomes. It appears that music added to standard care during caesarean section under regional anaesthesia had some impact on pulse rate at the end of maternal contact with the neonate in the intra-operative period (MD -7.50 fewer beats per minute, 95% CI -14.08 to -0.92) and after completion of skin suture for the caesarean section (MD -7.37 fewer beats per minute, 95% CI -13.37 to -1.37). There was also an improvement in the birth satisfaction score (maximum possible score of 35) (MD of 3.38, 95%CI 1.59 to 5.17). Effects on other outcomes were either not significant or not reported in the one included trial. The findings indicate that music during planned caesarean section under regional anaesthesia may improve pulse rate and birth satisfaction score. However, the magnitude of these benefits is small and the methodological quality of the one included trial is questionable. Therefore, the clinical significance of music is unclear. More research is needed to investigate the effects of music during caesarean section under regional anaesthesia on both maternal and infant outcomes, in various ethnic pregnant women, and with adequate sample sizes.
The review findings indicate that listening to music during planned caesarean section under regional anaesthesia may improve pulse rates and birth satisfaction scores, although the effect sizes were not large enough to indicate a clinically beneficial effect. The review authors identified one controlled trial that randomly assigned 76 women who listened to their preferred music through earphones, or to standard care, but data were available for only 64 women. The music was provided from the beginning of anaesthesia to the end of surgery. The women's heart rates were reduced by some seven beats/minute when measured at the end of contact with the newborn during the intra-operative period and after the surgeon had completed skin suture. Birth satisfaction scores were increased by a mean of 3.4 points on a 35-point scale when women listened to music. Respiration rates were no different for the two groups and neither were levels of anxiety, which decreased at the end of contact with the newborn and again after closing the skin, with no clear difference with or without music. The trial was from Taiwan and reporting of trial methodology was poor.
10.1002/14651858.CD006914.pub2
[ "The review findings indicate that listening to music during planned caesarean section under regional anaesthesia may improve pulse rates and birth satisfaction scores, although the effect sizes were not large enough to indicate a clinically beneficial effect. The review authors identified one controlled trial that randomly assigned 76 women who listened to their preferred music through earphones, or to standard care, but data were available for only 64 women. The music was provided from the beginning of anaesthesia to the end of surgery. The women's heart rates were reduced by some seven beats/minute when measured at the end of contact with the newborn during the intra-operative period and after the surgeon had completed skin suture. Birth satisfaction scores were increased by a mean of 3.4 points on a 35-point scale when women listened to music. Respiration rates were no different for the two groups and neither were levels of anxiety, which decreased at the end of contact with the newborn and again after closing the skin, with no clear difference with or without music. The trial was from Taiwan and reporting of trial methodology was poor." ]
cochrane-simplification-train-979
cochrane-simplification-train-979
Two randomised controlled trials comparing elective birth at 37 weeks for women with an uncomplicated twin pregnancy, with expectant management were included, involving 271 women and 542 infants. One trial was at an overall low risk of bias, and one trial was at unclear risk of selection bias, performance bias and detection bias. There were no statistically significant differences identified between a policy of elective birth at 37 weeks' gestation and expectant management with regards to birth by caesarean section (two studies; 271 participants; risk ratio (RR) 1.05; 95% confidence interval (CI) 0.83 to 1.32); perinatal death or serious perinatal morbidity (two studies; 542 infants; RR 0.34; 95% CI 0.01 to 8.35); or maternal death or serious maternal morbidity (one study; 235 women; RR 0.29; 95% CI 0.06 to 1.38). There were no statistically significant differences identified for the pre-specified secondary maternal and infant review outcomes reported by these two trials between the two treatment policies (including for: haemorrhage requiring blood transfusion; instrumental vaginal birth; meconium-stained liquor; Apgar score less than seven at five minutes; admission to neonatal intensive care; birthweight less than 2500 g; neonatal encephalopathy; and respiratory distress syndrome). While not a pre-specified review outcome, elective birth at 37 weeks, compared with expectant management, was shown to significantly reduce the risk of infants being born with a birthweight less than the third centile (one study; 470 infants; RR 0.30; 95% CI 0.13 to 0.68). Early birth at 37 weeks' gestation compared with ongoing expectant management for women with an uncomplicated twin pregnancy does not appear to be associated with an increased risk of harms, findings which are consistent with the United Kingdom's National Institute for Health and Care Excellence (NICE) recommendations which advocate birth for women with a dichorionic twin pregnancy at 37 + 0 weeks' gestation. It is unlikely that sufficient clinical equipoise exists to allow for the randomisation of women to a later gestational age at birth.
Two randomised controlled trials were included in this review involving a total of 271 women with twin pregnancies at 37 weeks' gestation. One of the two trials (involving 235 women) was of high quality, and the quality of the second trial (involving 36 women) was unclear. There were no differences shown between the group of women who had an elective birth at 37 weeks' gestation and the group of women who waited for labour to start spontaneously for the outcomes: birth by caesarean section, perinatal (fetal or neonatal) death or serious perinatal morbidity, or maternal death or serious maternal morbidity. No other differences between the two groups of women were shown for other pregnancy and birth complications or for complications for the infant. Elective birth at 37 weeks' gestation compared with ongoing expectant management for women with uncomplicated twin pregnancies does not appear be associated with an increased risk of harms.
10.1002/14651858.CD003582.pub2
[ "Two randomised controlled trials were included in this review involving a total of 271 women with twin pregnancies at 37 weeks' gestation. One of the two trials (involving 235 women) was of high quality, and the quality of the second trial (involving 36 women) was unclear. There were no differences shown between the group of women who had an elective birth at 37 weeks' gestation and the group of women who waited for labour to start spontaneously for the outcomes: birth by caesarean section, perinatal (fetal or neonatal) death or serious perinatal morbidity, or maternal death or serious maternal morbidity. No other differences between the two groups of women were shown for other pregnancy and birth complications or for complications for the infant. Elective birth at 37 weeks' gestation compared with ongoing expectant management for women with uncomplicated twin pregnancies does not appear be associated with an increased risk of harms." ]
cochrane-simplification-train-980
cochrane-simplification-train-980
We found one small RCT, judged to be at low risk of bias, that enrolled 28 children aged 1 to 16 years with evidence of sensitisation to peanut and a clinical history of reaction to peanut within 60 minutes of exposure. The study did not include children who had moderate to severe asthma or who had a history of severe peanut anaphylaxis. Randomisation was in a 2:1 ratio resulting in 19 children being randomised to the intervention arm and nine to the placebo arm. Intervention arm children received OIT with peanut flour and control arm participants received placebo comprising of oat flour. The primary outcome was assessed using a double-blind, placebo controlled oral food challenge (OFC) at approximately one year. No data were available on longer term outcomes beyond the OFC conducted at the end of the study. Because of adverse events, three patients withdrew from the intervention arm before the completion of the study. Therefore, only 16 participants received the full course of peanut OIT, whereas all nine patients receiving placebo completed the trial. The per-protocol analysis found a significant increase in the threshold dose of peanut allergen required to trigger a reaction in those in the intervention arm with all 16 participants able to ingest the maximum cumulative dose of 5000 mg of peanut protein (which the authors equate as being equivalent to approximately 20 peanuts) without developing symptoms, whereas in the placebo group they were able to ingest a median cumulative dose of 280 mg (range: 0 to 1900 mg, P < 0.001) before experiencing symptoms.  Per-protocol analyses also demonstrated that peanut OIT resulted in reductions in skin prick test size (P < 0.001), interleukin-5 (P = 0.01), interleukin-13 (P = 0.02) and an increase in peanut-specific immunoglobulin G4 (IgG4) (P < 0.01). Children in the intervention arm experienced more adverse events during treatment than those in the placebo arm. In the initial day escalation phase, nine (47%) of the 19 participants initially enrolled in the OIT arm experienced clinically-relevant adverse events which required treatment with H1-antihistamines, two of which required additional treatment with epinephrine (adrenaline). The one small RCT we found showed that allergen-specific peanut OIT can result in desensitisation in children, and that this is associated with evidence of underlying immune-modulation. However, this treatment approach was associated with a substantial risk of adverse events, although the majority of these were mild.  In view of the risk of adverse events and the lack of evidence of long-term benefits, allergen-specific peanut OIT cannot currently be recommended as a treatment for the management of patients with IgE-mediated peanut allergy.  Larger RCTs are needed to investigate the acceptability, long-term effectiveness and cost-effectiveness of safer treatment regimens, particularly in relation to the induction of clinical and immunological tolerance.
We found one small trial undertaken in 28 children aged 1 to 16 years with confirmed peanut allergy. The study did not include children who had moderate to severe asthma or who had had severe anaphylaxis (a severe allergic reaction that may result in death) because of their peanut allergy. The authors randomised children to intervention or placebo in a 2:1 ratio. Intervention arm children received peanut flour whereas control arm participants received oat flour. The 48-week trial showed that treatment with peanut OIT enabled children receiving OIT to substantially increase the amount of peanut flour they ate in comparison with those in the placebo arm without having an allergic reaction.  However, almost half of the children (nine out of 19) receiving OIT had an allergic reaction due to the OIT which required antihistamines, and two had more serious reactions to the treatment which required adrenaline (epinephrine). Although promising, based on the findings of this one small trial, we cannot recommend that peanut OIT be used routinely for people with peanut allergy. There is a need for further larger studies investigating safer OIT regimens and establishing the long-term effectiveness of OIT after treatment is stopped.
10.1002/14651858.CD009014.pub2
[ "We found one small trial undertaken in 28 children aged 1 to 16 years with confirmed peanut allergy. The study did not include children who had moderate to severe asthma or who had had severe anaphylaxis (a severe allergic reaction that may result in death) because of their peanut allergy. The authors randomised children to intervention or placebo in a 2:1 ratio. Intervention arm children received peanut flour whereas control arm participants received oat flour. The 48-week trial showed that treatment with peanut OIT enabled children receiving OIT to substantially increase the amount of peanut flour they ate in comparison with those in the placebo arm without having an allergic reaction.  However, almost half of the children (nine out of 19) receiving OIT had an allergic reaction due to the OIT which required antihistamines, and two had more serious reactions to the treatment which required adrenaline (epinephrine). Although promising, based on the findings of this one small trial, we cannot recommend that peanut OIT be used routinely for people with peanut allergy. There is a need for further larger studies investigating safer OIT regimens and establishing the long-term effectiveness of OIT after treatment is stopped." ]
cochrane-simplification-train-981
cochrane-simplification-train-981
Four trials were included in the review. Of these, two were randomised parallel studies, one was a crossover study and the other had a sequential design. A total of 84 patients were involved. Study quality was mixed and the studies were short (typically two weeks). All studies showed a similar direction and size of effect. In the randomised parallel studies, acetazolamide caused a metabolic acidosis and produced a non-significant fall in PCO2 (MD -0.41 kPa; 95% CI -0.91, 0.09; N=2) and a significant rise in PO2 (MD 1.54 kPa; 95% CI 0.97, 2.11; N=2). One study reported an improvement in sleep but there were no data concerning outcomes such as health status, symptoms, exacerbation rate, hospital admissions or deaths. Side effects were reported infrequently. An update search conducted in October 2005 did not identify any further studies. Acetazolamide can produce a small increase in arterial PO2 and fall in PCO2. These conclusions are drawn from a few small short studies that were not all of high quality. It is not known whether this physiological improvement is associated with clinical benefit.
The review of trials found that a few days of using acetazolamide can improve the level of oxygen in the blood of people with COPD. It is not clear if this leads to better outcomes, so more research is needed. Not enough data were reported on the safety of the drug.
10.1002/14651858.CD002881
[ "The review of trials found that a few days of using acetazolamide can improve the level of oxygen in the blood of people with COPD. It is not clear if this leads to better outcomes, so more research is needed. Not enough data were reported on the safety of the drug." ]
cochrane-simplification-train-982
cochrane-simplification-train-982
The evidence favoured five active strategies for inviting women into community breast cancer screening services: letter of invitation (OR 1.66, 95% CI 1.43 to 1.92), mailed educational material (Odds Ratio(OR) 2.81, 95% Confidence Interval (CI) 1.96 to 4.02), letter of invitation plus phone call (OR 2.53, 95% CI 2.02 to 3.18), phone call (OR 1.94, 95% CI 1.70 to 2.23), and training activities plus direct reminders for the women (OR 2.46, 95% CI 1.72 to 3.50). Home visits did not prove to be effective (OR 1.06, 95 % CI 0.80 to 1.40) and letters of invitation to multiple examinations plus educational material favoured the control group (OR 0.62, 95 % CI 0.32 to 1.20). Most active recruitment strategies for breast cancer screening programs examined in this review were more effective than no intervention. Combinations of effective interventions can have an important effect. Some costly strategies, as a home visit and a letter of invitation to multiple screening examinations plus educational material, were not effective. Further reviews comparing the effective interventions and studies that include cost-effectiveness, women's satisfaction and equity issues are needed.
The review of trials found that a letter of invitation, mailed educational material, a phone call and some combined actions (such as a letter of invitation plus a phone call and training activities plus reminders) all seem to increase numbers of women participating. However it is not known which of these work better. Other interventions (such as a home visit) have not been proven to work.
10.1002/14651858.CD002943
[ "The review of trials found that a letter of invitation, mailed educational material, a phone call and some combined actions (such as a letter of invitation plus a phone call and training activities plus reminders) all seem to increase numbers of women participating. However it is not known which of these work better. Other interventions (such as a home visit) have not been proven to work." ]
cochrane-simplification-train-983
cochrane-simplification-train-983
We included 13 trials that recruited 14,959 women from diverse healthcare settings (antenatal clinics, women's health clinics, emergency departments, primary care) predominantly located in high-income countries and urban settings. The majority of studies minimised selection bias; performance bias was the greatest threat to validity. The overall quality of the body of evidence was low to moderate, mainly due to heterogeneity, risk of bias, and imprecision. We excluded five of 13 studies from the primary analysis as they either did not report identification data, or the way in which they did was not consistent with clinical identification by healthcare providers. In the remaining eight studies (n = 10,074), screening increased clinical identification of victims/survivors (OR 2.95, 95% CI 1.79 to 4.87, moderate quality evidence). Subgroup analyses suggested increases in identification in antenatal care (OR 4.53, 95% CI 1.82 to 11.27, two studies, n = 663, moderate quality evidence); maternal health services (OR 2.36, 95% CI 1.14 to 4.87, one study, n = 829, moderate quality evidence); and emergency departments (OR 2.72, 95% CI 1.03 to 7.19, three studies, n = 2608, moderate quality evidence); but not in hospital-based primary care (OR 1.53, 95% CI 0.79 to 2.94, one study, n = 293, moderate quality evidence). Only two studies (n = 1298) measured referrals to domestic violence support services following clinical identification. We detected no evidence of an effect on referrals (OR 2.24, 95% CI 0.64 to 7.86, low quality evidence). Four of 13 studies (n = 2765) investigated prevalence (excluded from main analysis as rates were not clinically recorded); detection of IPV did not differ between face-to-face screening and computer/written-based assessment (OR 1.12, 95% CI 0.53 to 2.36, moderate quality evidence). Only two studies measured women's experience of violence (three to 18 months after screening) and found no evidence that screening decreased IPV. Only one study reported on women's health with no differences observable at 18 months. Although no study reported adverse effects from screening interventions, harm outcomes were only measured immediately afterwards and only one study reported outcomes at three months. There was insufficient evidence on which to judge whether screening increases uptake of specialist services, and no studies included an economic evaluation. The evidence shows that screening increases the identification of women experiencing IPV in healthcare settings. Overall, however, rates were low relative to best estimates of prevalence of IPV in women seeking healthcare. Pregnant women in antenatal settings may be more likely to disclose IPV when screened, however, rigorous research is needed to confirm this. There was no evidence of an effect for other outcomes (referral, re-exposure to violence, health measures, harm arising from screening). Thus, while screening increases identification, there is insufficient evidence to justify screening in healthcare settings. Furthermore, there remains a need for studies comparing universal screening to case-finding (with or without advocacy or therapeutic interventions) for women's long-term wellbeing in order to inform IPV identification policies in healthcare settings.
We examined research up to 17 February 2015. We included research studies that had women over 16 years of age attending any healthcare setting. Our search generated 12,369 studies and we eventually included 13 studies that met the criteria described above. In all, 14,959 women had agreed to be in those studies. Studies were in different healthcare settings (antenatal clinics, women's health/maternity services, emergency departments, and primary care centres). They were conducted in mainly urban settings, in high-income countries with domestic violence legislation and developed support services to which healthcare professionals could refer. Each of the included studies was funded by an external source. The majority of the funding came from government departments and research councils, with a small number of grants/support coming from trusts and universities. Eight studies with 10,074 women looked at whether healthcare professionals asked about abuse, discussed it, and/or documented abuse in participating women's records. There was a twofold increase in the number of women identified in this way compared to the comparison group. The quality of this evidence was moderate. We looked at smaller groups within the overall group, and found, for example, that pregnant women were four times as likely to be identified by a screening intervention as pregnant women in a comparison group. We did not see an increase in referral behaviours of healthcare professionals but only two studies measured referrals in the same way and there were some shortcomings to these studies. We could not tell if screening increased uptake of specialist services and no studies examined if it is cost-effective to screen. We also looked to see if different methods were better at picking up abuse, for example, you might expect that women would be more willing to disclose to a computer, but we did not find one method to be better than another. We found an absence overall of studies examining the recurrence of violence (only two studies looked at this, and saw no effect) and women's health (only one study looked at this, and found no difference 18 months later). Finally, many studies included some short-term assessment of adverse outcomes, but reported none. There is a mismatch between the increased numbers of women picked up through screening by healthcare professionals and the high numbers of women attending healthcare settings actually affected by domestic violence. We would need more evidence to show screening actually increases referring and women's engagement with support services, and/or reduces violence and positively impacts on their health and wellbeing. On this basis, we concluded that there is insufficient evidence to recommend asking all women about abuse in healthcare settings. It may be more effective at this time to train healthcare professionals to ask women who show signs of abuse or those in high-risk groups, and provide them with a supportive response and information, and plan with them for their safety.
10.1002/14651858.CD007007.pub3
[ "We examined research up to 17 February 2015. We included research studies that had women over 16 years of age attending any healthcare setting. Our search generated 12,369 studies and we eventually included 13 studies that met the criteria described above. In all, 14,959 women had agreed to be in those studies. Studies were in different healthcare settings (antenatal clinics, women's health/maternity services, emergency departments, and primary care centres). They were conducted in mainly urban settings, in high-income countries with domestic violence legislation and developed support services to which healthcare professionals could refer. Each of the included studies was funded by an external source. The majority of the funding came from government departments and research councils, with a small number of grants/support coming from trusts and universities. Eight studies with 10,074 women looked at whether healthcare professionals asked about abuse, discussed it, and/or documented abuse in participating women's records. There was a twofold increase in the number of women identified in this way compared to the comparison group. The quality of this evidence was moderate. We looked at smaller groups within the overall group, and found, for example, that pregnant women were four times as likely to be identified by a screening intervention as pregnant women in a comparison group. We did not see an increase in referral behaviours of healthcare professionals but only two studies measured referrals in the same way and there were some shortcomings to these studies. We could not tell if screening increased uptake of specialist services and no studies examined if it is cost-effective to screen. We also looked to see if different methods were better at picking up abuse, for example, you might expect that women would be more willing to disclose to a computer, but we did not find one method to be better than another. We found an absence overall of studies examining the recurrence of violence (only two studies looked at this, and saw no effect) and women's health (only one study looked at this, and found no difference 18 months later). Finally, many studies included some short-term assessment of adverse outcomes, but reported none. There is a mismatch between the increased numbers of women picked up through screening by healthcare professionals and the high numbers of women attending healthcare settings actually affected by domestic violence. We would need more evidence to show screening actually increases referring and women's engagement with support services, and/or reduces violence and positively impacts on their health and wellbeing. On this basis, we concluded that there is insufficient evidence to recommend asking all women about abuse in healthcare settings. It may be more effective at this time to train healthcare professionals to ask women who show signs of abuse or those in high-risk groups, and provide them with a supportive response and information, and plan with them for their safety." ]
cochrane-simplification-train-984
cochrane-simplification-train-984
Only one trial (89 patients) fulfilled the inclusion criteria. This trial randomized 45 patients to curcumin and 44 patients to placebo. All patients received treatment with sulfasalazine or mesalamine. The study was rated as low risk of bias. Curcumin was administered orally in a dose of 2 g/day for six months. Fewer patients relapsed in the curcumin group than the placebo group at six months. Four per cent of patients in the curcumin group relapsed at six months compared to 18% of patients in the placebo group (RR 0.24, 95% CI 0.05 to 1.09; P = 0.06). There was no statistically significant difference in relapse rates at 12 months. Twenty-two per cent of curcumin patients relapsed at 12 months compared to 32% of placebo patients (RR 0.70, 95% CI 0.35 to 1.40; P = 0.31). A total of nine adverse events were reported in seven patients. These adverse events included sensation of abdominal bulging, nausea, transient hypertension, and transient increase in the number of stools. The authors did not report which treatment group the patients who experienced adverse events belonged to. The clinical activity index (CAI) at six months was significantly lower in the curcumin group compared to the placebo group (1.0 + 2.0 versus 2.2 + 2.3; MD -1.20, 95% CI -2.14 to -0.26). The endoscopic index (EI) at six months was significantly lower in the curcumin group than in the placebo group (0.8 + 0.6 versus 1.6 + 1.6; MD -0.80, 95% CI -1.33 to -0.27). Curcumin may be a safe and effective therapy for maintenance of remission in quiescent UC when given as adjunctive therapy along with mesalamine or sulfasalazine. However, further research in the form of a large scale methodologically rigorous randomized controlled trial is needed to confirm any possible benefit of curcumin in quiescent UC.
The purpose of this systematic review was to examine the effectiveness and safety of curcumin therapy for the maintenance of remission in patients with ulcerative colitis (UC), a chronic inflammatory condition of the colon. Currently available agents for the management of this condition have been reported to result side effects, particularly when used for prolonged periods. This review includes one randomized trial with a total of 89 participants. All patients received treatment with sulfasalazine or mesalamine (drugs containing 5-aminosalicylic acid). Fewer patients in the curcumin group relapsed at six months compared to patients who received placebo (e.g. fake drug). However, this result was not statistically significant. Patients in the curcumin group had significantly lower disease activity index and endoscopic index scores at six months than patients in the placebo group. No serious side effects were reported. A total of nine mild side effects were reported in seven patients. These side effects included a sensation of abdominal bulging, nausea, a brief increase in blood pressure, and a brief increase in the number of stools. The results of this systematic review suggest that curcumin may be a safe and effective therapy for maintenance of remission in ulcerative colitis when given as additional therapy with mesalamine or sulfasalazine. Further research is needed to confirm any possible benefit of curcumin for maintenance therapy in ulcerative colitis.
10.1002/14651858.CD008424.pub2
[ "The purpose of this systematic review was to examine the effectiveness and safety of curcumin therapy for the maintenance of remission in patients with ulcerative colitis (UC), a chronic inflammatory condition of the colon. Currently available agents for the management of this condition have been reported to result side effects, particularly when used for prolonged periods. This review includes one randomized trial with a total of 89 participants. All patients received treatment with sulfasalazine or mesalamine (drugs containing 5-aminosalicylic acid). Fewer patients in the curcumin group relapsed at six months compared to patients who received placebo (e.g. fake drug). However, this result was not statistically significant. Patients in the curcumin group had significantly lower disease activity index and endoscopic index scores at six months than patients in the placebo group. No serious side effects were reported. A total of nine mild side effects were reported in seven patients. These side effects included a sensation of abdominal bulging, nausea, a brief increase in blood pressure, and a brief increase in the number of stools. The results of this systematic review suggest that curcumin may be a safe and effective therapy for maintenance of remission in ulcerative colitis when given as additional therapy with mesalamine or sulfasalazine. Further research is needed to confirm any possible benefit of curcumin for maintenance therapy in ulcerative colitis." ]
cochrane-simplification-train-985
cochrane-simplification-train-985
The review found seven trials, involving 1497 patients, which met the criteria to be included. The trials were generally of moderate methodological quality; two studies have not published their results on overall survival so the presence of selective outcome reporting bias cannot be ruled out. None of the studies used blinding to treatment allocation, though this is unlikely to have biased the results for overall survival. Studies varied in terms of co-administered regimen and in terms of treatment line. In four studies, trastuzumab was administered with a chemotherapy, such as a taxane-containing, anthracycline-containing or capecitabine-containing regimen. Two studies considered postmenopausal women and administered trastuzumab with hormone-blocking medications, such as an aromatase inhibitor. One study administered trastuzumab in addition to lapatinib. Five studies out of seven included women treated with trastuzumab administered until progression as first-line treatment and two studies considered trastuzumab beyond progression. The combined HRs for overall survival and progression-free survival favoured the trastuzumab-containing regimens (HR 0.82, 95% confidence interval (CI) 0.71 to 0.94, P = 0.004; and HR 0.61, 95% CI 0.54 to 0.70, P < 0.00001, respectively; moderate-quality evidence). Trastuzumab increased the risk of congestive heart failure (RR 3.49, 90% CI 1.88 to 6.47, P = 0.0009; moderate-quality evidence) and left ventricular ejection fraction (LVEF) decline (RR 2.65, 90% CI 1.48 to 4.74, P = 0.006). For haematological toxicities, such as neutropenic fever and anaemia, there was no clear evidence that risks differed between groups, while trastuzumab seemed to raise the risk of neutropenia. The overall survival improvement was maintained when considering patients treated as first-line or patients receiving taxane-based regimens. The progression-free survival improvement was maintained when considering patients receiving taxane-based regimens, and patients treated as first-line or subsequent lines. Few data were collected on central nervous system progression. Similarly, few studies reported on quality of life and treatment-related deaths. Trastuzumab improved overall survival and progression-free survival in HER2-positive women with metastatic breast cancer, but it also increased the risk of cardiac toxicities, such as congestive heart failure and LVEF decline. The available subgroup analyses are limited by the small number of studies. Studies that administered trastuzumab as first-line treatment, or along with a taxane-based regimen, improved mortality outcomes. The evidence to support the use of trastuzumab beyond progression is limited. The recruitment in three out of seven studies was stopped early and in three trials more than 50% of patients in the control groups were permitted to switch to the trastuzumab arms at progression, making it more difficult to understand the real net benefit of trastuzumab. Trastuzumab is generally used for women with HER2-positive early breast cancer in clinical practice, while women enrolled in most of the trials in the metastatic setting were naive to trastuzumab. The effectiveness of trastuzumab for women relapsing after adjuvant trastuzumab is therefore still an open issue, although it is likely that the majority are being offered it again.
We included seven trials with 1497 women who had HER2-positive metastatic breast cancer in this review. They were assigned by chance to receive trastuzumab with or without chemotherapy (taxane, anthracycline or capecitabine in four studies), hormonal therapy (aromatase inhibitors including letrozole or anastrozole in two studies) or targeted therapy (lapatinib in one study). Women treated with trastuzumab were followed up until disease progression in five studies and beyond disease progression in two studies. The length of trastuzumab administration varied between 8.7 and 30 months, and follow-up averaged two years after starting trastuzumab. All studies found that trastuzumab extends time to disease progression, with gains varying between two and 11 months, and in five studies it extended time to death by between five and eight months. However, some patients develop severe heart toxicity (congestive heart failure) during treatment. While trastuzumab reduces breast cancer mortality by one-fifth, the risk of heart toxicity is between three and four times more likely. If 1000 women were given standard therapy alone (with no trastuzumab) about 300 would survive and 10 would have heart toxicities. With the addition of trastuzumab to this treatment, an additional 73 would have their lives prolonged, and an additional 25 would have severe heart toxicity. Omitting the anthracycline-trastuzumab arms (which would not be regarded as standard of care) 21 patients would have severe heart toxicity (11 more than the chemotherapy alone group). These heart toxicities are often reversible if the treatment is stopped once heart disease is discovered. Women with advanced disease might choose to accept this risk. On balance, this review shows that with trastuzumab the time to disease progression and survival benefits outweigh the risk of heart harm. Trastuzumab does not increase the risk of haematological toxicities, such as neutropenic fever and anaemia; however, it seems to raise the risk of neutropenia. There were insufficient data on the impact of trastuzumab on quality of life, treatment-related deaths and brain metastases to reach a conclusion for these outcomes. We rated the overall quality of the evidence as moderate, with the main weaknesses being the fact that all studies included were open-label (not blinded), which may have affected the outcome assessments for time to disease progression and toxicities, and that two studies have not published their results for mortality. Furthermore, the recruitment in three out of seven studies was stopped early and in three trials more than 50% of patients in the control groups were permitted to switch to the trastuzumab arms at disease progression, making it more difficult to understand the real net benefit of trastuzumab on mortality. The evidence to support the use of trastuzumab beyond disease progression is limited. It is important to highlight that, although trastuzumab is used for women with HER2-positive early breast cancer, the women enrolled in these metastatic trials were not previously treated with trastuzumab. The effectiveness of trastuzumab for women relapsing after adjuvant trastuzumab is still an open issue, although it is likely that it is offered to the majority of them.
10.1002/14651858.CD006242.pub2
[ "We included seven trials with 1497 women who had HER2-positive metastatic breast cancer in this review. They were assigned by chance to receive trastuzumab with or without chemotherapy (taxane, anthracycline or capecitabine in four studies), hormonal therapy (aromatase inhibitors including letrozole or anastrozole in two studies) or targeted therapy (lapatinib in one study). Women treated with trastuzumab were followed up until disease progression in five studies and beyond disease progression in two studies. The length of trastuzumab administration varied between 8.7 and 30 months, and follow-up averaged two years after starting trastuzumab. All studies found that trastuzumab extends time to disease progression, with gains varying between two and 11 months, and in five studies it extended time to death by between five and eight months. However, some patients develop severe heart toxicity (congestive heart failure) during treatment. While trastuzumab reduces breast cancer mortality by one-fifth, the risk of heart toxicity is between three and four times more likely. If 1000 women were given standard therapy alone (with no trastuzumab) about 300 would survive and 10 would have heart toxicities. With the addition of trastuzumab to this treatment, an additional 73 would have their lives prolonged, and an additional 25 would have severe heart toxicity. Omitting the anthracycline-trastuzumab arms (which would not be regarded as standard of care) 21 patients would have severe heart toxicity (11 more than the chemotherapy alone group). These heart toxicities are often reversible if the treatment is stopped once heart disease is discovered. Women with advanced disease might choose to accept this risk. On balance, this review shows that with trastuzumab the time to disease progression and survival benefits outweigh the risk of heart harm. Trastuzumab does not increase the risk of haematological toxicities, such as neutropenic fever and anaemia; however, it seems to raise the risk of neutropenia. There were insufficient data on the impact of trastuzumab on quality of life, treatment-related deaths and brain metastases to reach a conclusion for these outcomes. We rated the overall quality of the evidence as moderate, with the main weaknesses being the fact that all studies included were open-label (not blinded), which may have affected the outcome assessments for time to disease progression and toxicities, and that two studies have not published their results for mortality. Furthermore, the recruitment in three out of seven studies was stopped early and in three trials more than 50% of patients in the control groups were permitted to switch to the trastuzumab arms at disease progression, making it more difficult to understand the real net benefit of trastuzumab on mortality. The evidence to support the use of trastuzumab beyond disease progression is limited. It is important to highlight that, although trastuzumab is used for women with HER2-positive early breast cancer, the women enrolled in these metastatic trials were not previously treated with trastuzumab. The effectiveness of trastuzumab for women relapsing after adjuvant trastuzumab is still an open issue, although it is likely that it is offered to the majority of them." ]
cochrane-simplification-train-986
cochrane-simplification-train-986
Fourteen studies (1805 patients) were included: Nine (779 patients) compared budesonide to conventional corticosteroids, three (535 patients) were placebo-controlled, and two (491 patients) compared budesonide to mesalamine. Ten studies were judged to be at low risk of bias. Three studies were judged to be at high risk of bias due to open label design. One study was judged to be at high risk of bias due to selective reporting. After eight weeks of treatment, 9 mg budesonide was significantly more effective than placebo for induction of clinical remission. Forty-seven per cent (115/246) of budesonide patients achieved remission at 8 weeks compared to 22% (29/133) of placebo patients (RR 1.93, 95% CI 1.37 to 2.73; 3 studies, 379 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was moderate due to sparse data (144 events). Budesonide was significantly less effective than conventional steroids for induction of remission at eight weeks. Fifty-two per cent of budesonide patients achieved remission at week 8 compared to 61% of patients who received conventional steroids (RR 0.85, 95% CI 0.75 to 0.97; 8 studies, 750 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was moderate due to risk of bias. Budesonide was significantly less effective than conventional steroids among patients with severe disease (CDAI > 300) (RR 0.52, 95% CI 0.28 to 0.95). Studies comparing budesonide to mesalamine were not pooled due to heterogeneity (I2 = 81%). One study (n = 182) found budesonide to be superior to mesalamine for induction of remission at 8 weeks. Sixty-eight per cent (63/93) of budesonide patients were in remission at 8 weeks compared to 42% (37/89) of mesalamine patients (RR 1.63, 95% CI 1.23 to 2.16). The other study found no statistically significant difference in remission rates at eight weeks. Sixty-nine per cent (107/154) of budesonide patients were in remission at 8 weeks compared to 62% (132/242) of mesalamine patients (RR 1.12, 95% CI 0.95 to 1.32). Fewer adverse events occurred in those treated with budesonide compared to conventional steroids (RR 0.64, 95% CI 0.54 to 0.76) and budesonide was better than conventional steroids in preserving adrenal function (RR for abnormal ACTH test 0.65, 95% CI 0.55 to 0.78). Budesonide is more effective than placebo for induction of remission in Crohn's disease. Although short-term efficacy with budesonide is less than with conventional steroids, particularly in those with severe disease or more extensive colonic involvement, the likelihood of adverse events and adrenal suppression with budesonide is lower. The current evidence does not allow for a firm conclusion on the relative efficacy of budesonide compared to 5-ASA products.
The researchers identified 14 studies that included a total of 1805 participants. Nine studies (779 participants) compared budesonide to conventional corticosteroids, three studies (535 participants) compared budesonide to a placebo (e.g. a sugar pill), and two studies (491 participants) compared budesonide to mesalamine (an anti-inflammatory drug composed of 5-aminosalicylic acid). Ten studies were judged to be of high quality. Four studies were judged to be of low quality. Budesonide was superior to placebo for induction of remission. An increase in side effects was not seen with budesonide compared to placebo. Withdrawals due to disease worsening were similar in budesonide and placebo groups. Budesonide patients were more likely than placebo patients to experience adrenal suppression a condition in which the adrenal glands do not produce adequate amounts of steroid hormones. Budesonide was significantly less effective than conventional steroids for induction of remission in people with Crohn's disease. However, fewer side effects occurred in those treated with budesonide compared to conventional steroids and budesonide was better than conventional steroids in preserving adrenal function. One study (n = 182) found budesonide to be superior to mesalamine for induction of remission in patients with Crohn's disease whereas another study found no difference in remission rates. The current evidence does not allow for a firm conclusion on the relative efficacy of budesonide compared to 5-aminosalicylic products. Budesonide is more effective than placebo for induction of remission in Crohn's disease. Although budesonide is less effective than conventional steroids for induction of remission the likelihood of side effects and adrenal suppression is lower than with conventional steroids.
10.1002/14651858.CD000296.pub4
[ "The researchers identified 14 studies that included a total of 1805 participants. Nine studies (779 participants) compared budesonide to conventional corticosteroids, three studies (535 participants) compared budesonide to a placebo (e.g. a sugar pill), and two studies (491 participants) compared budesonide to mesalamine (an anti-inflammatory drug composed of 5-aminosalicylic acid). Ten studies were judged to be of high quality. Four studies were judged to be of low quality. Budesonide was superior to placebo for induction of remission. An increase in side effects was not seen with budesonide compared to placebo. Withdrawals due to disease worsening were similar in budesonide and placebo groups. Budesonide patients were more likely than placebo patients to experience adrenal suppression a condition in which the adrenal glands do not produce adequate amounts of steroid hormones. Budesonide was significantly less effective than conventional steroids for induction of remission in people with Crohn's disease. However, fewer side effects occurred in those treated with budesonide compared to conventional steroids and budesonide was better than conventional steroids in preserving adrenal function. One study (n = 182) found budesonide to be superior to mesalamine for induction of remission in patients with Crohn's disease whereas another study found no difference in remission rates. The current evidence does not allow for a firm conclusion on the relative efficacy of budesonide compared to 5-aminosalicylic products. Budesonide is more effective than placebo for induction of remission in Crohn's disease. Although budesonide is less effective than conventional steroids for induction of remission the likelihood of side effects and adrenal suppression is lower than with conventional steroids." ]
cochrane-simplification-train-987
cochrane-simplification-train-987
We identified 15 studies (1550 patients). CRRT did not differ from IRRT with respect to in-hospital mortality (RR 1.01, 95% CI 0.92 to 1.12), ICU mortality (RR 1.06, 95% CI 0.90 to 1.26), number of surviving patients not requiring RRT (RR 0.99, 95% CI 0.92 to 1.07), haemodynamic instability (RR 0.48, 95% CI 0.10 to 2.28) or hypotension (RR 0.92, 95% CI 0.72 to 1.16) and need for escalation of pressor therapy (RR 0.53, 95% CI 0.26 to 1.08). Patients on CRRT were likely to have significantly higher mean arterial pressure (MAP) (MD 5.35, 95% CI 1.41 to 9.29) and higher risk of clotting dialysis filters (RR, 95% CI 8.50 CI 1.14 to 63.33). In patients who are haemodynamically stable, the RRT modality does not appear to influence important patient outcomes, and therefore the preference for CRRT over IRRT in such patients does not appear justified in the light of available evidence. CRRT was shown to achieve better haemodynamic parameters such as MAP. Future research should focus on factors such as the dose of dialysis and evaluation of newer promising hybrid technologies such as SLED. Triallists should follow the recommendations regarding clinical endpoints assessment in RCTs in ARF made by the Working Group of the Acute Dialysis Quality Initiative Working Group.
Our systematic review identified 15 randomised studies with 1550 patients comparing CRRT with IRRT. We did not find any difference between CRRT and IRRT with respect to mortality, renal recovery, and risk of haemodynamic instability or hypotension episodes.
10.1002/14651858.CD003773.pub3
[ "Our systematic review identified 15 randomised studies with 1550 patients comparing CRRT with IRRT. We did not find any difference between CRRT and IRRT with respect to mortality, renal recovery, and risk of haemodynamic instability or hypotension episodes." ]
cochrane-simplification-train-988
cochrane-simplification-train-988
Four trials appeared to meet the inclusion criteria, but one was excluded because of poor methodology. The three remaining trials compared testosterone treatment with placebo in a total of 109 subjects with intermittent claudication or critical leg ischaemia. The most recent trial to meet the inclusion criteria dated from 1971. No trials were available which investigated the potentially beneficial effects of oestrogenic hormones in women with lower limb atherosclerosis. Testosterone therapy produced no significant improvement in tests of walking distance or in a variety of other objective tests for peripheral arterial disease, including venous filling time, muscle blood flow and plethysmography. The relative risk for subjective improvement in symptoms using the combined trial results was also non-significant (relative risk (RR) 1.10, 95% confidence interval (CI) 0.81 to 1.48). There is no evidence to date that short-term testosterone treatment is beneficial in subjects with lower limb atherosclerosis. However, this might reflect limited data rather than the lack of a real effect.
Although four randomised controlled trials met the inclusion criteria, one was excluded because of poor methodology. The three remaining trials compared testosterone treatment with placebo in a total of 109 middle-aged to elderly people, predominantly men. The participants had symptoms of lower limb atherosclerosis, predominantly intermittent claudication. The trials were published from 1967 to 1971 and all took place in Denmark. Testosterone did not provide any clear improvement in the symptoms reported by the participants, walking distance or other objective tests for peripheral arterial disease including leg muscle blood flow. The dose of testosterone in the trials varied between 300 mg taken by mouth every two weeks for three months to a lower (100 mg) oral dose taken more often and 200 mg given by intramuscular injection, first weekly then every two weeks for six months. Side effects were poorly reported except for subjective sexual functioning, which did seem to improve with testosterone treatment. No trials investigated oestrogens in women with lower limb atherosclerosis. Trials by the Women's Health Initiative (published in 2004) have shown that oestrogen and progestin does not confer any protection against peripheral arterial disease in healthy postmenopausal women or reduce the risk of coronary events in postmenopausal women with coronary heart disease.
10.1002/14651858.CD000188.pub2
[ "Although four randomised controlled trials met the inclusion criteria, one was excluded because of poor methodology. The three remaining trials compared testosterone treatment with placebo in a total of 109 middle-aged to elderly people, predominantly men. The participants had symptoms of lower limb atherosclerosis, predominantly intermittent claudication. The trials were published from 1967 to 1971 and all took place in Denmark. Testosterone did not provide any clear improvement in the symptoms reported by the participants, walking distance or other objective tests for peripheral arterial disease including leg muscle blood flow. The dose of testosterone in the trials varied between 300 mg taken by mouth every two weeks for three months to a lower (100 mg) oral dose taken more often and 200 mg given by intramuscular injection, first weekly then every two weeks for six months. Side effects were poorly reported except for subjective sexual functioning, which did seem to improve with testosterone treatment. No trials investigated oestrogens in women with lower limb atherosclerosis. Trials by the Women's Health Initiative (published in 2004) have shown that oestrogen and progestin does not confer any protection against peripheral arterial disease in healthy postmenopausal women or reduce the risk of coronary events in postmenopausal women with coronary heart disease." ]
cochrane-simplification-train-989
cochrane-simplification-train-989
We included two RCTs with 297 participants comparing PUL to sham surgery or TURP. The mean age was 65.6 years and mean International Prostate Symptom Score was 22.7. Mean prostate volume was 42.2 mL. We considered review outcomes measured up to and including 12 months after randomization as short-term and later than 12 months as long-term. For patient-reported outcomes, lower scores indicate more urological symptom improvement and higher quality of life. In contrast, higher scores refers to better erectile and ejaculatory function. PUL versus sham: based on one study of 206 randomized participants with short follow-up (up to three months), PUL may lead to a clinically important improvement in urological symptom scores (mean difference (MD) –5.20, 95% confidence interval (CI) –7.44 to –2.96; low-certainty evidence) and likely improves quality of life (MD –1.20, 95% CI –1.67 to –0.73; moderate-certainty evidence). We are uncertain whether PUL increases major adverse events (very low-certainty evidence). There were no retreatments reported in either study group by three months. PUL likely results in little to no difference in erectile function (MD –1.40, 95% CI –3.24 to 0.44; moderate-certainty evidence) and ejaculatory function (MD 0.50, 95% CI –0.38 to 1.38; moderate-certainty evidence). PUL versus TURP: based on one study of 91 randomized participants with a short follow-up (up to 12 months), PUL may result in a substantially lesser improvement in urological symptom scores than TURP (MD 4.50, 95% CI 1.10 to 7.90; low-certainty evidence). PUL may result in a slightly reduced or similar quality of life (MD 0.30, 95% CI –0.49 to 1.09; low-certainty evidence). We are very uncertain whether PUL may cause fewer major adverse events but increased retreatments (both very low-certainty evidence). PUL probably results in little to no difference in erectile function (MD 0.80, 95% CI –1.50 to 3.10; moderate-certainty evidence), but probably results in substantially better ejaculatory function (MD 5.00, 95% CI 3.08 to 6.92; moderate-certainty evidence). With regards to longer term follow-up (up to 24 months) based on one study of 91 randomized participants, PUL may result in a substantially lesser improvement in urological symptom score (MD 6.10, 95% CI 2.16 to 10.04; low-certainty evidence) and result in little worse to no difference in quality of life (MD 0.80, 95% CI 0.00 to 1.60; low-certainty evidence). The study did not report on major adverse events. We are very uncertain whether PUL increases retreatment (very low-certainty evidence). PUL likely results in little to no difference in erectile function (MD 1.60, 95% CI –0.80 to 4.00; moderate-certainty evidence), but may result in substantially better ejaculatory function (MD 4.30, 95% CI 2.17 to 6.43; low-certainty evidence). We were unable to perform any of the predefined secondary analyses for either comparison. We found no evidence for other comparisons such as PUL versus laser ablation or enucleation. PUL appears less effective than TURP in improving urological symptoms both short-term and long term, while quality of life outcomes may be similar. The effect on erectile function appears similar but ejaculatory function may be better. We are uncertain about major adverse events short-term and found no long-term information. We are very uncertain about retreatment rates both short-term and long-term. We were unable to assess the effects of PUL in subgroups based on age, prostate size, or symptom severity and also could not assess how PUL compared to other surgical management approaches. Given the large numbers of alternative treatment modalities to treat men with LUTS secondary to BPH, this represents important information that should be shared with men considering surgical treatment.
We included two randomized controlled studies (clinical trials where people are randomly put into one of two or more treatment groups) with 297 men comparing PUL to sham surgery (participants are made to believe they received treatment, while in reality they did not) or transurethral resection of prostate (TURP: removing the excess prostate growth using a camera and an electrically activated resecting loop inserted via the penis). The average age of the participants was 65.6 years. Compared to sham surgery up to three months, PUL may improve urinary symptoms and likely improves quality of life without additional unwanted side effects after surgery. In the short term, there were no additional surgeries because PUL did not work. PUL likely does not make erections or ejaculation worse. Compared to TURP up to 24 months, PUL may be less effective in relieving urinary symptoms, but result in similar quality of life. PUL may preserve ejaculation, but may have less unwanted effects on erections than TURP. However, we are either very uncertain or have no evidence about serious unwanted side effects or the need for additional treatment after surgery. Findings of this review are up-to-date until 31 January, 2019. The certainty of evidence for most outcomes was low. This means that the true effect may be substantially different from what this review shows.
10.1002/14651858.CD012832.pub2
[ "We included two randomized controlled studies (clinical trials where people are randomly put into one of two or more treatment groups) with 297 men comparing PUL to sham surgery (participants are made to believe they received treatment, while in reality they did not) or transurethral resection of prostate (TURP: removing the excess prostate growth using a camera and an electrically activated resecting loop inserted via the penis). The average age of the participants was 65.6 years. Compared to sham surgery up to three months, PUL may improve urinary symptoms and likely improves quality of life without additional unwanted side effects after surgery. In the short term, there were no additional surgeries because PUL did not work. PUL likely does not make erections or ejaculation worse. Compared to TURP up to 24 months, PUL may be less effective in relieving urinary symptoms, but result in similar quality of life. PUL may preserve ejaculation, but may have less unwanted effects on erections than TURP. However, we are either very uncertain or have no evidence about serious unwanted side effects or the need for additional treatment after surgery. Findings of this review are up-to-date until 31 January, 2019. The certainty of evidence for most outcomes was low. This means that the true effect may be substantially different from what this review shows." ]
cochrane-simplification-train-990
cochrane-simplification-train-990
In this update, no new trials were identified (08/2002). Only one trial with 54 men lasting 240 days (with 330 days of follow up) met study inclusion criteria. There was a statistically significant change favoring allopurinol in patient-reported discomfort between the study and control groups at follow up. Between days 45 to 225, the mean score was -0.95 (SD 0.19) for the allopurinol group (seven men), compared with -0.47 (SD 0.21) for the placebo group (seven men). The weighted mean difference (WMD) was -0.48 (95% CI -0.690 to -0.270). The mean score between days 45-135 was -1.08 (SD 1.29) for the 25 men in the allopurinol group, compared with -0.21 (SD 0.97) for the 14 men in the control group. The WMD was -0.87 (95%CI -1.587 to -0.153). The allopurinol group had significantly less investigator graded prostate pain and had lower levels of serum urate, urine urate, and expressed prostatic secretion urate and xanthine. No significant differences between the two groups regarding leukocyte counts were found. No patient receiving allopurinol had any significant side effects. Three patients in the placebo group dropped out because of side effects. One small trial of allopurinol for treating chronic prostatitis showed improvements in patient-reported symptom improvement, investigator-graded prostate pain, and biochemical parameters. However, the data provided, the measures used, and the statistics presented do not make these findings convincing that changes in urine and prostatic secretion composition regarding purine and pyrimidine bases resulted in the relief of symptoms. Further studies of allopurinol treatment using standardized and validated outcomes measures and analyses are necessary to determine whether allopurinol is effective.
Only one small randomized trial of 54 men was included in this review. Based on the results of this trial, which used non-valid ways to measure symptom improvements, allopurinol cannot be recommended. Further studies of allopurinol treatment, enrolling larger numbers of men and using standard and validated measures to measure symptom improvements, are necessary to determine whether allopurinol is an effective treatment for chronic prostatitis.
10.1002/14651858.CD001041
[ "Only one small randomized trial of 54 men was included in this review. Based on the results of this trial, which used non-valid ways to measure symptom improvements, allopurinol cannot be recommended. Further studies of allopurinol treatment, enrolling larger numbers of men and using standard and validated measures to measure symptom improvements, are necessary to determine whether allopurinol is an effective treatment for chronic prostatitis." ]
cochrane-simplification-train-991
cochrane-simplification-train-991
Based on a single trial and moderate-quality evidence, alvimopan reduced the time to reach a composite endpoint of tolerance of solid food and documented bowel movements (hazard ratio (HR) 1.77, 95% confidence interval (CI) 1.41 to 2.23). This represents 165 more patients (109 more to 207 more) per 1000 meeting this endpoint within 10 days of surgery. Based on moderate-quality evidence, alvimopan reduced the time to hospital discharge (HR 1.67, 95% CI 1.38 to 2.01). This represents 138 more patients (82 more to 198 more) per 1000 being discharged within 10 days of surgery. Also based on moderate-quality evidence, alvimopan was associated with a reduced risk of major adverse events (risk ratio (RR) 0.28, 95% CI 0.18 to 0.44) representing 355 fewer patients (404 fewer to 276 fewer) with major adverse events per 1000. We downgraded this outcome for indirectness as it included adverse events that we did not consider major. In terms of secondary outcomes, alvimopan did not appear to alter the rate of readmission (RR 0.89, 95% CI 0.59 to 1.33), change the rate of any cardiovascular event (RR 0.54, 95% CI 0.27 to 1.05) or alter the mean narcotic pain medication use (mean difference 0, 95% CI 14.08 fewer to 14.08 more morphine equivalents). The quality of evidence was moderate for all three outcomes. Based on high-quality evidence, alvimopan reduced the rate of nasogastric tube replacement (RR 0.31, 95% CI 0.16 to 0.59). We did not find evidence for the drug's impact on rates of parenteral nutrition. All outcomes were short term and limited to a 30-day time horizon. Based on the existence of only one trial, we were unable to perform any subgroup or sensitivity analyses. In patients undergoing radical cystectomy and urinary diversion, the use of alvimopan administered as part of an enhanced recovery pathway for a limited duration (up to 15 doses for up to seven days) probably reduces the time to tolerance of solid food, time to hospital discharge and rates of major adverse events. Readmission rates, rates of cardiovascular events and narcotic pain requirements are probably similar. The need for reinsertion of nasogastric tubes is reduced. We found no evidence for the impact on rates of parenteral nutrition within 30 postoperative days.
We performed a comprehensive literature search for randomized controlled trials and found one study that addressed our question. This study was a randomized trial of adults undergoing surgery to remove their bladder. They received either 12 mg alvimopan of up to 15 doses over seven days (143 patients) or placebo (137 patients). This study was conducted at centres that did many of these operations (at least 50 per year), had experienced surgeons and also used other measures such as asking patients to get out of bed soon after surgery to hasten bowel recovery. We found that patients who receive alvimopan short-term probably tolerate solid food faster, are discharged from the hospital more quickly and have fewer major adverse events. We did not find any differences with regards to these patients' need to be readmitted to hospital, their risk of heart problems or their need for narcotic pain medications. Patients taking alvimopan were less likely to have a tube placed back into their stomach. The quality of evidence was rated as at least moderate as per GRADE for all primary outcomes. This means that our estimates of how well alvimopan works is likely close to how well it really works although there is a possibility that it may be different.
10.1002/14651858.CD012111.pub2
[ "We performed a comprehensive literature search for randomized controlled trials and found one study that addressed our question. This study was a randomized trial of adults undergoing surgery to remove their bladder. They received either 12 mg alvimopan of up to 15 doses over seven days (143 patients) or placebo (137 patients). This study was conducted at centres that did many of these operations (at least 50 per year), had experienced surgeons and also used other measures such as asking patients to get out of bed soon after surgery to hasten bowel recovery. We found that patients who receive alvimopan short-term probably tolerate solid food faster, are discharged from the hospital more quickly and have fewer major adverse events. We did not find any differences with regards to these patients' need to be readmitted to hospital, their risk of heart problems or their need for narcotic pain medications. Patients taking alvimopan were less likely to have a tube placed back into their stomach. The quality of evidence was rated as at least moderate as per GRADE for all primary outcomes. This means that our estimates of how well alvimopan works is likely close to how well it really works although there is a possibility that it may be different." ]
cochrane-simplification-train-992
cochrane-simplification-train-992
We included 26 trials involving 17,011 participants (8497 participants were assigned active therapy and 8514 participants received placebo/control). Not all trials contributed to each outcome. Most data came from trials that had a wide time window for recruitment; four trials gave treatment within six hours and one trial within eight hours. The trials tested alpha-2 adrenergic agonists (A2AA), angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor antagonists (ARA), calcium channel blockers (CCBs), nitric oxide (NO) donors, thiazide-like diuretics, and target-driven blood pressure lowering. One trial tested phenylephrine. At 24 hours after randomisation oral ACEIs reduced systolic blood pressure (SBP, mean difference (MD) -8 mmHg, 95% confidence interval (CI) -17 to 1) and diastolic blood pressure (DBP, MD -3 mmHg, 95% CI -9 to 2), sublingual ACEIs reduced SBP (MD -12.00 mm Hg, 95% CI -26 to 2) and DBP (MD -2, 95%CI -10 to 6), oral ARA reduced SBP (MD -1 mm Hg, 95% CI -3 to 2) and DBP (MD -1 mm Hg, 95% CI -3 to 1), oral beta blockers reduced SBP (MD -14 mm Hg; 95% CI -27 to -1) and DBP (MD -1 mm Hg, 95% CI -9 to 7), intravenous (iv) beta blockers reduced SBP (MD -5 mm Hg, 95% CI -18 to 8) and DBP (-5 mm Hg, 95% CI -13 to 3), oral CCBs reduced SBP (MD -13 mmHg, 95% CI -43 to 17) and DBP (MD -6 mmHg, 95% CI -14 to 2), iv CCBs reduced SBP (MD -32 mmHg, 95% CI -65 to 1) and DBP (MD -13, 95% CI -31 to 6), NO donors reduced SBP (MD -12 mmHg, 95% CI -19 to -5) and DBP (MD -3, 95% CI -4 to -2) while phenylephrine, non-significantly increased SBP (MD 21 mmHg, 95% CI -13 to 55) and DBP (MD 1 mmHg, 95% CI -15 to 16). Blood pressure lowering did not reduce death or dependency either by drug class (OR 0.98, 95% CI 0.92 to 1.05), stroke type (OR 0.98, 95% CI 0.92 to 1.05) or time to treatment (OR 0.98, 95% CI 0.92 to 1.05). Treatment within six hours of stroke appeared effective in reducing death or dependency (OR 0.86, 95% CI 0.76 to 0.99) but not death (OR 0.70, 95% CI 0.38 to 1.26) at the end of the trial. Although death or dependency did not differ between people who continued pre-stroke antihypertensive treatment versus those who stopped it temporarily (worse outcome with continuing treatment, OR 1.06, 95% CI 0.91 to 1.24), disability scores at the end of the trial were worse in participants randomised to continue treatment (Barthel Index, MD -3.2, 95% CI -5.8, -0.6). There is insufficient evidence that lowering blood pressure during the acute phase of stroke improves functional outcome. It is reasonable to withhold blood pressure-lowering drugs until patients are medically and neurologically stable, and have suitable oral or enteral access, after which drugs can than be reintroduced. In people with acute stroke, CCBs, ACEI, ARA, beta blockers and NO donors each lower blood pressure while phenylephrine probably increases blood pressure. Further trials are needed to identify which people are most likely to benefit from early treatment, in particular whether treatment started very early is beneficial.
This review is up-to-date to May 2014. We included 26 trials involving 17,011 participants: 24 trials assessed lowering blood pressure, one trial tested raising blood pressure, and two trials assessed what to do with drugs taken before stroke. All studies took place in hospitals that were used to treating people with stroke. Not all trials contributed information to all outcomes, and we have used data that were available in publications. There is insufficient evidence to say that lowering blood pressure saves lives or reduces disability in people with acute stroke. Immediately restarting blood pressure-lowering drugs taken before the stroke may increase disability. More research is needed to identify those people who are most likely to benefit from altering blood pressure in acute stroke, the time window in which the treatment is likely to be of benefit, what types of stroke are likely to respond favourably, and the environment in which such treatment may be best given in routine practice.
10.1002/14651858.CD000039.pub3
[ "This review is up-to-date to May 2014. We included 26 trials involving 17,011 participants: 24 trials assessed lowering blood pressure, one trial tested raising blood pressure, and two trials assessed what to do with drugs taken before stroke. All studies took place in hospitals that were used to treating people with stroke. Not all trials contributed information to all outcomes, and we have used data that were available in publications. There is insufficient evidence to say that lowering blood pressure saves lives or reduces disability in people with acute stroke. Immediately restarting blood pressure-lowering drugs taken before the stroke may increase disability. More research is needed to identify those people who are most likely to benefit from altering blood pressure in acute stroke, the time window in which the treatment is likely to be of benefit, what types of stroke are likely to respond favourably, and the environment in which such treatment may be best given in routine practice." ]
cochrane-simplification-train-993
cochrane-simplification-train-993
Two studies, involving a total of 147 participants with TransAtlantic Inter-Society Consensus (TASC)-II D femoropopliteal lesions, met our inclusion criteria and were included in the review. Both studies were small but otherwise of high methodological quality. However, the treatment techniques and control groups of the two studies differed, precluding the combining of study results and resulting in the evidence being less applicable. We therefore considered the quality of the evidence to be low. In one study, participants with TASC-II D lesions were randomized to receive either SIA with stenting of the superficial femoral artery or remote endarterectomy (RE) with stenting of the superficial femoral artery. Three-year follow-up results showed a Rutherford classification improvement of 64% in the SIA group compared to 80% in the RE group (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.61 to 1.03; 95 participants; P = 0.079). Postexercise ankle brachial index improvements (defined as an increased value of 0.2) were reported in 70% of participants in the SIA group compared to 82% in the RE group (RR 0.86, 95% CI 0.68 to 1.08; 95 participants; P = 0.18). The study reported the technical success rate was 93% for the SIA group and 96% for the RE group (RR 0.97, 95% CI 0.88 to 1.07; 95 participants; P = 0.91). Primary patency at 12 months was 59.1% in the SIA group compared to 78.4% in the RE group (RR 0.75, 95% CI 0.57 to 1.00; 95 participants; P = 0.05). Primary patency at 24 months was 56.8% in the SIA group compared to 76.5% in the RE group (RR 0.74, 95% CI 0.55 to 1.00; 95 participants; P = 0.05) and 47.7% in the SIA group and 62.7% in the RE group at 36 months (RR 0.76, 95% CI 0.52 to 1.11; 95 participants; P = 0.15). Assisted primary patency was 52.3% in the SIA group compared to 70.6% in the RE group (P = 0.01) at 36 months. Secondary patency was better for the RE group (P = 0.03) at 36 months. Limb salvage at three years' follow-up was 95% in the SIA group and 98% in the RE group (RR 0.97, 95% CI 0.90 to 1.05; 95 participants; P = 0.4). There were no perioperative deaths, but complications occurred in two SIA participants (femoral pseudoaneurysm and pulmonary edema) and in three RE participants (seroma, femoral pseudoaneurysm, superficial femoral artery acute occlusion). In the second study, the effects of the SIA OUTBACK re-entry catheter device in people affected by TASC-II D superficial femoral artery chronic total occlusion were compared with the SIA manual re-entry technique. This study did not report clinical improvement and limb salvage. Technical success was achieved in all cases in both the OUTBACK device and manual groups. The primary 6-month patency rate was 100% in the OUTBACK group (26 of 26 participants) compared to 96.2% in the manual group (25 of 26 participants) (RR 1.04, 95% CI 0.94 to 1.15). The primary 12-month patency rate was 92.3% in the OUTBACK group (24 of 26 participants) compared to 84.6% in the manual group (22 of 26 participants) (RR 1.09, 95% CI 0.90 to 1.33). Patency rates at 24 and 36 months were not reported. The study reported that there were no complications. Using the GRADE approach, we classified the quality of the evidence presented by both studies in this review as low due to small study size and the small number of studies. In addition, the two included trials differed from each other in the techniques and control used, and we were therefore unable to combine the data. Consequently there is currently insufficient evidence to support SIA over other techniques. Evidence from more randomized controlled trials is needed to assess the role of SIA in people with chronic lower limb arterial total occlusions.
We identified two randomized controlled trials involving a total of 147 participants (current until January 2016). Due to differences in the techniques and outcomes measured, we were unable to combine the data from these studies. In one study, participants were randomized to receive either subintimal angioplasty (SIA) with stenting or remote endarterectomy (RE) (a surgical procedure to unblock the artery) with stenting. This study showed significantly better vessel patency (no obstruction) with RE compared to SIA. Three-year follow-up results showed clinical improvement measured by a Rutherford classification improvement in 64% of participants in the SIA group compared to 80% of participants in the RE group. Postexercise ankle brachial index improvements (0.2) were reported in 70% of SIA participants compared to 82% of RE participants. The technical success rate was 93% for SIA participants and 96% for RE participants. Primary patency was 56.8% in SIA compared to 76.5% in RE at 24 months, and 47.7% in SIA and 62.7% in RE at 36 months. Assisted primary patency was 52.3% in SIA compared to 70.6% in RE at 36 months. Secondary patency favored RE at 36 months. Limb salvage at three years' follow-up was 95% in the SIA group and 98% in the RE group. There were no deaths during or around the time of the procedure, but complications occurred in two SIA participants and three RE participants. The other study, which compared the SIA OUTBACK device with a manual re-entry technique, reported that technical success was achieved in all cases but did not report on clinical improvement. The primary 6-month patency rate was 100% in the OUTBACK group (26 of 26 participants) compared to 96.2% in the manual re-entry group (25 of 26 participants). The primary 12-month patency rate was 92.3% in the OUTBACK group (24 of 26 participants) compared to 84.6% in manual group (22 of 26 participants). Patency rates at 24 and 36 months were not reported. Limb salvage rates at 36 months were not reported. No complications were reported. Both studies were at an overall low risk of methodological bias, but the quality of the evidence is low due to small study size and the small number of studies. Moreover, the two included trials differed from each other in the techniques and control used, preventing the combining of trial results. Since we included only two small studies, we doubt the completeness and applicability of the evidence presented in this review. Further studies are needed to reach a definitive conclusion.
10.1002/14651858.CD009418.pub3
[ "We identified two randomized controlled trials involving a total of 147 participants (current until January 2016). Due to differences in the techniques and outcomes measured, we were unable to combine the data from these studies. In one study, participants were randomized to receive either subintimal angioplasty (SIA) with stenting or remote endarterectomy (RE) (a surgical procedure to unblock the artery) with stenting. This study showed significantly better vessel patency (no obstruction) with RE compared to SIA. Three-year follow-up results showed clinical improvement measured by a Rutherford classification improvement in 64% of participants in the SIA group compared to 80% of participants in the RE group. Postexercise ankle brachial index improvements (0.2) were reported in 70% of SIA participants compared to 82% of RE participants. The technical success rate was 93% for SIA participants and 96% for RE participants. Primary patency was 56.8% in SIA compared to 76.5% in RE at 24 months, and 47.7% in SIA and 62.7% in RE at 36 months. Assisted primary patency was 52.3% in SIA compared to 70.6% in RE at 36 months. Secondary patency favored RE at 36 months. Limb salvage at three years' follow-up was 95% in the SIA group and 98% in the RE group. There were no deaths during or around the time of the procedure, but complications occurred in two SIA participants and three RE participants. The other study, which compared the SIA OUTBACK device with a manual re-entry technique, reported that technical success was achieved in all cases but did not report on clinical improvement. The primary 6-month patency rate was 100% in the OUTBACK group (26 of 26 participants) compared to 96.2% in the manual re-entry group (25 of 26 participants). The primary 12-month patency rate was 92.3% in the OUTBACK group (24 of 26 participants) compared to 84.6% in manual group (22 of 26 participants). Patency rates at 24 and 36 months were not reported. Limb salvage rates at 36 months were not reported. No complications were reported. Both studies were at an overall low risk of methodological bias, but the quality of the evidence is low due to small study size and the small number of studies. Moreover, the two included trials differed from each other in the techniques and control used, preventing the combining of trial results. Since we included only two small studies, we doubt the completeness and applicability of the evidence presented in this review. Further studies are needed to reach a definitive conclusion." ]
cochrane-simplification-train-994
cochrane-simplification-train-994
We have included data from 27 randomised trials involving 12,256 women. All of the trials examined telephone support versus usual care (no additional telephone support). We did not identify any trials comparing different modes of telephone support (for example, text messaging versus one-to-one calls). All but one of the trials were carried out in high-resource settings. The majority of studies examined support provided via telephone conversations between women and health professionals although a small number of trials included telephone support from peers. In two trials women received automated text messages. Many of the interventions aimed to address specific health problems and collected data on behavioural outcomes such as smoking cessation and relapse (seven trials) or breastfeeding continuation (seven trials). Other studies examined support interventions aimed at women at high risk of postnatal depression (two trials) or preterm birth (two trials); the rest of the interventions were designed to offer women more general support and advice. For most of our pre-specified outcomes few studies contributed data, and many of the results described in the review are based on findings from only one or two studies. Overall, results were inconsistent and inconclusive although there was some evidence that telephone support may be a promising intervention. Results suggest that telephone support may increase women's overall satisfaction with their care during pregnancy and the postnatal period, although results for both periods were derived from only two studies. There was no consistent evidence confirming that telephone support reduces maternal anxiety during pregnancy or after the birth of the baby, although results on anxiety outcomes were not easy to interpret as data were collected at different time points using a variety of measurement tools. There was evidence from two trials that women at high risk of depression who received support had lower mean depression scores in the postnatal period, although there was no clear evidence that women who received support were less likely to have a diagnosis of depression. Results from trials offering breastfeeding telephone support were also inconsistent, although the evidence suggests that telephone support may increase the duration of breastfeeding. There was no strong evidence that women receiving telephone support were less likely to be smoking at the end of pregnancy or during the postnatal period. For infant outcomes, such as preterm birth and infant birthweight, overall, there was little evidence. Where evidence was available, there were no clear differences between groups. Results from two trials suggest that babies whose mothers received support may have been less likely to have been admitted to a neonatal intensive care unit (NICU), although it is not easy to understand the mechanisms underpinning this finding. Despite some encouraging findings, there is insufficient evidence to recommend routine telephone support for women accessing maternity services, as the evidence from included trials is neither strong nor consistent. Although benefits were found in terms of reduced depression scores, breastfeeding duration and increased overall satisfaction, the current trials do not provide strong enough evidence to warrant investment in resources.
In this review we have included results from 27 randomised trials with more than 12,000 women. All of the trials examined telephone support versus usual care (no additional telephone support). In two trials women received automated text messages. We did not identify any trials comparing different types of telephone support (for example, text messaging versus one-to-one calls). All but one of the trials were carried out in high-resource settings. The majority of studies examined support provided via telephone conversations between women and health professionals although a small number of trials included telephone support from peers. Many of the results described in the review are based on findings from only one or two studies. Overall, results were inconsistent and inconclusive. Telephone support may increase women's overall satisfaction with their care during pregnancy and the postnatal period; although results for both periods were from only two studies. There was no consistent evidence confirming that telephone support reduces anxiety during pregnancy or after the birth of the baby. Evidence from two trials showed that women who received support had lower average depression scores in the postnatal period but without clear evidence that women who were supported were less likely to have a diagnosis of depression. Results from trials encouraging breastfeeding through telephone support were also inconsistent, although there was some evidence that telephone support may increase the duration of breastfeeding. There was no strong evidence that women receiving telephone support were less likely to be smoking at the end of pregnancy or during the postnatal period. For infant outcomes, such as preterm birth and infant birthweight, overall, there was little evidence. Where evidence was available, there were no clear differences between groups. There remains uncertainty regarding the benefit of telephone support and despite some encouraging findings, there is insufficient evidence to recommend routine telephone support for women accessing maternity services.
10.1002/14651858.CD009338.pub2
[ "In this review we have included results from 27 randomised trials with more than 12,000 women. All of the trials examined telephone support versus usual care (no additional telephone support). In two trials women received automated text messages. We did not identify any trials comparing different types of telephone support (for example, text messaging versus one-to-one calls). All but one of the trials were carried out in high-resource settings. The majority of studies examined support provided via telephone conversations between women and health professionals although a small number of trials included telephone support from peers. Many of the results described in the review are based on findings from only one or two studies. Overall, results were inconsistent and inconclusive. Telephone support may increase women's overall satisfaction with their care during pregnancy and the postnatal period; although results for both periods were from only two studies. There was no consistent evidence confirming that telephone support reduces anxiety during pregnancy or after the birth of the baby. Evidence from two trials showed that women who received support had lower average depression scores in the postnatal period but without clear evidence that women who were supported were less likely to have a diagnosis of depression. Results from trials encouraging breastfeeding through telephone support were also inconsistent, although there was some evidence that telephone support may increase the duration of breastfeeding. There was no strong evidence that women receiving telephone support were less likely to be smoking at the end of pregnancy or during the postnatal period. For infant outcomes, such as preterm birth and infant birthweight, overall, there was little evidence. Where evidence was available, there were no clear differences between groups. There remains uncertainty regarding the benefit of telephone support and despite some encouraging findings, there is insufficient evidence to recommend routine telephone support for women accessing maternity services." ]
cochrane-simplification-train-995
cochrane-simplification-train-995
Ten studies met the inclusion criteria. Nine of them were RCTs. All studies involved physicians as participants (including postgraduate trainees), and one study also included other participants. Only two studies measured patient outcomes. Searching skills and/or frequency of use of electronic databases, mainly MEDLINE, were targeted in eight studies. Use of Internet for audit and feedback, and email for provider-patient communication, were targeted in two studies. Four studies showed small to moderate positive effects of the intervention on ICT adoption. Four studies were unable to demonstrate significant positive effects, and the two others showed mixed effects. No studies looked at the long-term effect or sustainability of the intervention. There is very limited evidence on effective interventions promoting the adoption of ICTs by healthcare professionals. Small effects have been reported for interventions targeting the use of electronic databases and digital libraries. The effectiveness of interventions to promote ICT adoption in healthcare settings remains uncertain, and more well designed trials are needed.
Information and communication technologies (ICTs) are technologies that help gather, store, process and share information electronically.  Examples of ICTs are electronic medical records, medical journals and databases on the internet, videoconferencing for doctor appointments, or systems on the internet to give feedback to doctors so they can improve the care they provide.  ICTs have the potential to improve health care and the health of patients.  But even though computers are being used more and more in hospitals, not all health care professionals use ICTs.   For this reason, there are many strategies to try and promote the use of ICTs.  Strategies can include training groups of health care professionals to use a specific ICT, or teaching someone one-on-one to use an ICT, or simply providing training materials. A review of the effects of different strategies to promote the use of ICTs was conducted.  After searching for all relevant studies, 10 studies were found.  The evidence shows that some ways, such as group training, or one-on-one training sessions, or providing training materials, may improve the use of ICTs.  But overall, it is still uncertain whether some strategies are effective.  More research is needed.
10.1002/14651858.CD006093.pub2
[ "Information and communication technologies (ICTs) are technologies that help gather, store, process and share information electronically.  Examples of ICTs are electronic medical records, medical journals and databases on the internet, videoconferencing for doctor appointments, or systems on the internet to give feedback to doctors so they can improve the care they provide.  ICTs have the potential to improve health care and the health of patients.  But even though computers are being used more and more in hospitals, not all health care professionals use ICTs.   For this reason, there are many strategies to try and promote the use of ICTs.  Strategies can include training groups of health care professionals to use a specific ICT, or teaching someone one-on-one to use an ICT, or simply providing training materials. A review of the effects of different strategies to promote the use of ICTs was conducted.  After searching for all relevant studies, 10 studies were found.  The evidence shows that some ways, such as group training, or one-on-one training sessions, or providing training materials, may improve the use of ICTs.  But overall, it is still uncertain whether some strategies are effective.  More research is needed." ]
cochrane-simplification-train-996
cochrane-simplification-train-996
Nine randomised and two quasi-randomised clinical trials, involving a total of 2093 participants with 2123 fractures, were included. The evidence was dominated by one large multicentre trial of 1319 participants. Both quasi-randomised trials were at high risk of selection bias. Otherwise, the trials were generally at low or unclear risk of bias. There were very few data on functional outcomes; and often incomplete data on re-operations. The trials evaluated five different comparisons of interventions: reamed versus unreamed intramedullary nailing (six trials); Ender nail versus interlocking nail (two trials); expandable nail versus interlocking nail (one trial); interlocking nail with one distal screw versus with two distal screws (one trial); and closed nailing via the transtendinous approach versus the paratendinous approach (one trial). No statistically significant differences were found between the reamed and unreamed nailing groups in 'major' re-operations (66/789 versus 72/756; risk ratio (RR) 0.88, 95% confidence interval (CI) 0.64 to 1.21; 5 trials), or in the secondary outcomes of nonunion, pain, deep infection, malunion and compartment syndrome. While inconclusive, the evidence from a subgroup analysis suggests that reamed nailing is more likely to reduce the incidence of major re-operations related to non-union in closed fractures than in open fractures. Implant failure, such as broken screws, occurred less often in the reamed nailing group (35/789 versus 79/756; RR 0.42, 95% CI 0.28 to 0.61). There was insufficient evidence established to determine the effects of interlocking nail with one distal screw versus with two distal screws, interlocking nail versus expandable nail and paratendinous approach versus transtendinous approach for treating tibial shaft fractures in adults. Ender nails when compared with an interlocking nail in two trials resulted in a higher re-operation rate (12/110 versus 3/128; RR 4.43, 95% CI 1.37 to 14.32) and more malunions. There were no statistically significant differences between the two devices in the other reported secondary outcomes of nonunion, deep infection, and implant failure. One trial found a lower re-operation rate for an expandable nail when compared with an interlocking nail (1/27 versus 9/26; RR 0.11, 95% CI 0.01 to 0.79). The differences between the two nails in the incidence of deep infection or neurological defects were not statistically significant. The trial comparing one distal screw versus two distal screws found no statistically significant difference in nonunion between the two groups. However, it found significantly more implant failures in the one distal screw group (13/22 versus 1/20; RR 11.82, 95% CI 1.70 to 82.38). One trial found no statistically significant differences in functional outcomes or anterior knee pain at three year follow-up between the transtendinous approach and the paratendinous approach for nail insertion. Overall, there is insufficient evidence to draw definitive conclusions on the best type of, or technique for, intramedullary nailing for tibial shaft fractures in adults. 'Moderate' quality evidence suggests that there is no clear difference in the rate of major re-operations and complications between reamed and unreamed intramedullary nailing. Reamed intramedullary nailing has, however, a lower incidence of implant failure than unreamed nailing. 'Low' quality evidence suggests that reamed nailing may reduce the incidence of major re-operations related to non-union in closed fractures rather than in open fractures. 'Low' quality evidence suggests that the Ender nail has poorer results in terms of re-operation and malunion than an interlocking nail.
Eleven studies involving a total of 2093 participants were included. The evidence was dominated by one large multicentre trial of 1319 participants. The methods of two studies were flawed such that their results were likely to be biased. The remaining studies were at a lower risk of bias. The trials evaluated five different comparisons of interventions. Only the two comparisons tested by more than one trial are reported here. These were reamed versus unreamed intramedullary nailing (six trials) and Ender nail versus interlocking nail (two trials). The review found no evidence of a significant difference between reamed and unreamed intramedullary nailing in re-operations for complications, nor in various complications such as nonunion (where the bone fails to heal). However, reamed nailing was more associated with a lower implant failure, such as broken screws, than unreamed nailing. Moreover, there was some weak evidence that reamed nailing may be associated with fewer major re-operations for non-union when used for closed fractures (where the skin remains intact) compared with open (where the skin is broken) fractures. The review also found that the Ender nail resulted in more re-operations and deformity (malunion) than an interlocking nail. The review concluded that there is insufficient evidence to draw definitive conclusions on the best type of, or technique for, intramedullary nailing for tibial shaft fractures in adults.
10.1002/14651858.CD008241.pub2
[ "Eleven studies involving a total of 2093 participants were included. The evidence was dominated by one large multicentre trial of 1319 participants. The methods of two studies were flawed such that their results were likely to be biased. The remaining studies were at a lower risk of bias. The trials evaluated five different comparisons of interventions. Only the two comparisons tested by more than one trial are reported here. These were reamed versus unreamed intramedullary nailing (six trials) and Ender nail versus interlocking nail (two trials). The review found no evidence of a significant difference between reamed and unreamed intramedullary nailing in re-operations for complications, nor in various complications such as nonunion (where the bone fails to heal). However, reamed nailing was more associated with a lower implant failure, such as broken screws, than unreamed nailing. Moreover, there was some weak evidence that reamed nailing may be associated with fewer major re-operations for non-union when used for closed fractures (where the skin remains intact) compared with open (where the skin is broken) fractures. The review also found that the Ender nail resulted in more re-operations and deformity (malunion) than an interlocking nail. The review concluded that there is insufficient evidence to draw definitive conclusions on the best type of, or technique for, intramedullary nailing for tibial shaft fractures in adults." ]
cochrane-simplification-train-997
cochrane-simplification-train-997
According to GRADE the quality of the studies was moderate. Three additional trials are included in this update. The present review includes data analyses based on 10 qualifying trials that enrolled 1644 neonates. There was no significant difference in the incidence of CLD at 36 weeks' PMA in the inhaled steroid versus the placebo group (5 trials, 429 neonates) among all randomised (typical RR 0.97, 95% CI 0.62 to 1.52; typical RD −0.00, 95% CI −0.07 to 0.06). There was no heterogeneity for this outcome (typical RR I² = 11%; typical RD I² = 0%). There was a significant reduction in the incidence of CLD at 36 weeks' PMA among survivors (6 trials, 1088 neonates) (typical RR 0.76, 95% CI 0.63 to 0.93; typical RD −0.07, 95% CI −0.13 to −0.02; NNTB 14, 95% CI 8 to 50). There was a significant reduction in the combined outcome of death or CLD at 36 weeks' PMA among all randomised neonates (6 trials, 1285 neonates) (typical RR 0.86, 95% CI 0.75 to 0.99; typical RD −0.06, 95% CI −0.11 to −0.00) (P = 0.04); NNTB 17, 95% CI 9 to infinity). There was no significant heterogeneity for any of these analyses (I² = 0%). A lower rate of reintubation was noted in the inhaled steroid group compared with the control group in one study. There were no statistically significant differences in short-term complications between groups and no differences in adverse events at long-term follow-up reported. Long-term follow-up of infants enrolled in the study by Bassler 2015 is ongoing. Based on this updated review, there is increasing evidence from the trials reviewed that early administration of inhaled steroids to VLBW neonates is effective in reducing the incidence of death or CLD at 36 weeks' PMA among either all randomised infants or among survivors. Even though there is statistical significance, the clinical relevance is of question as the upper CI limit for the outcome of death or CLD at 36 weeks' PMA is infinity. The long-term follow-up results of the Bassler 2015 study may affect the conclusions of this review. Further studies are needed to identify the risk/benefit ratio of different delivery techniques and dosing schedules for the administration of these medications. Studies need to address both the short- and long-term benefits and adverse effects of inhaled steroids with particular attention to neurodevelopmental outcome.
From literature searches updated to 5 January 2016, 10 randomised controlled trials that enrolled 1644 infants were included. We are not aware of any financial support from the industry for the included studies. In this update of the review there was no significant reduction in the rate of chronic lung disease at 36 weeks' postmenstrual age. A significant reduction in the combined outcome of death or chronic lung disease at 36 weeks' postmenstrual age among all randomised neonates and among survivors was noted. Even though the results were significant, the upper confidence interval was infinity (i.e. we would have to treat every baby with inhaled steroid to prevent one baby dying or developing chronic lung disease at 36 weeks' postmenstrual age). This would not be acceptable in clinical practice. A lower rate of reintubation (the need for the insertion of a tube into the airway) was noted in the steroid group compared with the control group in one large study. There were no statistically significant differences in short- and long-term complications between groups. The results of the long-term follow-up of one large study is awaited. In general the quality of the studies was good.
10.1002/14651858.CD001969.pub4
[ "From literature searches updated to 5 January 2016, 10 randomised controlled trials that enrolled 1644 infants were included. We are not aware of any financial support from the industry for the included studies. In this update of the review there was no significant reduction in the rate of chronic lung disease at 36 weeks' postmenstrual age. A significant reduction in the combined outcome of death or chronic lung disease at 36 weeks' postmenstrual age among all randomised neonates and among survivors was noted. Even though the results were significant, the upper confidence interval was infinity (i.e. we would have to treat every baby with inhaled steroid to prevent one baby dying or developing chronic lung disease at 36 weeks' postmenstrual age). This would not be acceptable in clinical practice. A lower rate of reintubation (the need for the insertion of a tube into the airway) was noted in the steroid group compared with the control group in one large study. There were no statistically significant differences in short- and long-term complications between groups. The results of the long-term follow-up of one large study is awaited. In general the quality of the studies was good." ]
cochrane-simplification-train-998
cochrane-simplification-train-998
The search of four standard electronic databases yielded 119 potentially relevant studies but only 18 RCTs involving 1252 people were found suitable for statistical analysis. There was significant heterogeneity among trials and the majority of trials were of poor quality. The use of FG under skin flaps following breast and axillary surgery failed to reduce the incidence of postoperative seroma (risk ratio (RR) 1.02; 95% Confidence Interval (CI) 0.90 to 1.16, P value = 0.73), mean volume of seroma (standardised mean difference (SMD) -0.25; 95% CI -0.92 to 0.42, P value = 0.46), wound infection (RR 1.05; 95% CI 0.63 to 1.77, P value = 0.84), postoperative complications (RR 1.13; 95% CI 0.63 to 2.04, P value = 0.68) and length of hospital stay (SMD -0.2; 95% CI -0.78 to 0.39, P value = 0.51). FG reduced the total volume of drained seroma (SMD -0.75, 95% CI -1.24 to -0.26, P value = 0.003) and duration of persistent seromas requiring frequent aspirations (SMD -0.59; CI 95% -0.95 to -0.23, P value = 0.001). FG did not influence the incidence of postoperative seroma, the mean volume of seroma, wound infections, complications and the length of hospital stays in people undergoing breast cancer surgery. Due to significant methodological and clinical diversity among the included studies this conclusion may be considered weak and biased. Therefore, a major multicentre and high-quality RCT is required to validate these findings.
We systematically analysed the published trials comparing the usefulness of FG as a small-vessel sealing agent. Eighteen randomised controlled trials on 1252 people were retrieved following bibliographic searches on standard medical databases. There were significant clinical and methodological differences among the included trials. The use of FG following breast and axillary surgery did not reduce the incidence of postoperative seroma, mean volume of seroma, wound infections, postoperative complications and the length of hospital stays. FG reduced the total volume of drained seroma and the duration of persistent seroma requiring frequent aspirations. This review showed no overall benefit of using FG. Although this conclusion is based on the combined analysis of 18 trials, the majority of these were of poor quality due to flaws in trial methods. Therefore, this conclusion should be taken cautiously and a major, multicentre, high-quality randomised controlled trial on people undergoing breast and axillary surgery for breast cancer is required to corroborate this conclusion.
10.1002/14651858.CD009557.pub2
[ "We systematically analysed the published trials comparing the usefulness of FG as a small-vessel sealing agent. Eighteen randomised controlled trials on 1252 people were retrieved following bibliographic searches on standard medical databases. There were significant clinical and methodological differences among the included trials. The use of FG following breast and axillary surgery did not reduce the incidence of postoperative seroma, mean volume of seroma, wound infections, postoperative complications and the length of hospital stays. FG reduced the total volume of drained seroma and the duration of persistent seroma requiring frequent aspirations. This review showed no overall benefit of using FG. Although this conclusion is based on the combined analysis of 18 trials, the majority of these were of poor quality due to flaws in trial methods. Therefore, this conclusion should be taken cautiously and a major, multicentre, high-quality randomised controlled trial on people undergoing breast and axillary surgery for breast cancer is required to corroborate this conclusion." ]
cochrane-simplification-train-999
cochrane-simplification-train-999
Cabergoline has been compared with placebo in two phase II (6 - 12 weeks) and one phase III randomised controlled trials (24 weeks). These were double-blind, parallel group, multicentre studies including 268 patients with Parkinson's disease and motor complications. The reduction of 1.14 hours (WMD; 95% CI -0.06, 2.33; p = 0.06) in off time in favour of cabergoline was not statistically significant. Inadequate data on dyskinesia was collected either on rating scales or as adverse event reporting to allow a conclusion to be drawn. A small but statistically significant advantage of cabergoline over placebo was seen in one study for UPDRS ADL (part II) score and UPDRS motor score. No such advantage was seen in one other study due to small numbers of patients and the comparatively low doses of cabergoline used. No significant differences in Schwab and England scale were seen in two studies. Levodopa dose reduction was significantly greater with cabergoline (WMD 149.6 mg/d; 95% CI 94.1, 205.1; p < 0.00001). There was a trend towards more dopaminergic adverse events with cabergoline but this did not reach statistical significance at the p < 0.01 level. However, there was a trend towards fewer withdrawals from cabergoline. In the management of the motor complications seen in Parkinson's disease, cabergoline can be used to reduce levodopa dose and modestly improve motor impairment and disability with an acceptable adverse event profile. These conclusions are based on, at best, medium term evidence.
Cabergoline has been compared with inactive placebo in two smaller and shorter (6 - 12 weeks) studies and one larger, medium term trial (24 weeks). These trials included 268 patients with Parkinson's disease and motor complications. The average reduction in the time patients spent in the immobile off state was 1.1 hours greater with cabergoline compared with placebo, although this was not statistically significant. Inadequate data on dyskinesia was collected to allow a conclusion to be drawn. A small but significant advantage of cabergoline over placebo was seen in one study for activities of daily living and physical functioning. No such advantage was seen in one other study due to small numbers of patients and the comparatively low doses of cabergoline used. Levodopa dose reduction was greater with cabergoline by 145 mg per day. There was a trend towards more side effects with cabergoline but towards fewer withdrawals from cabergoline treatment. In the management of the motor complications seen in Parkinson's disease, cabergoline can be used to reduce levodopa dose and modestly improve motor function and activities of daily living with an acceptable side effect profile. This is based on, at best, medium term evidence. Further long term trials are required to compare the newer with the older dopamine agonists, particularly in terms of quality of life and cost.
10.1002/14651858.CD001518
[ "Cabergoline has been compared with inactive placebo in two smaller and shorter (6 - 12 weeks) studies and one larger, medium term trial (24 weeks). These trials included 268 patients with Parkinson's disease and motor complications. The average reduction in the time patients spent in the immobile off state was 1.1 hours greater with cabergoline compared with placebo, although this was not statistically significant. Inadequate data on dyskinesia was collected to allow a conclusion to be drawn. A small but significant advantage of cabergoline over placebo was seen in one study for activities of daily living and physical functioning. No such advantage was seen in one other study due to small numbers of patients and the comparatively low doses of cabergoline used. Levodopa dose reduction was greater with cabergoline by 145 mg per day. There was a trend towards more side effects with cabergoline but towards fewer withdrawals from cabergoline treatment. In the management of the motor complications seen in Parkinson's disease, cabergoline can be used to reduce levodopa dose and modestly improve motor function and activities of daily living with an acceptable side effect profile. This is based on, at best, medium term evidence. Further long term trials are required to compare the newer with the older dopamine agonists, particularly in terms of quality of life and cost." ]