GEM/cochrane-simplification huggingface dataset:
Abstract: Of the 908 participants enrolled (three RCTs), 454 were allocated for drainage and 454 for no drainage. We found no new RCTs for this review update. Two trials reported the primary outcome measure of anastomotic dehiscence. There was no statistically significant difference in anastomotic dehiscence in participants treated with intra-abdominal drainage routinely compared to no treatment (risk ratio (RR) 1.40, 95% confidence intervals (CI) 0.45 to 4.40; I2 = 0%; 2 RCTs; 809 participants). There was no statistically significant difference in mortality (RR 0.77, 95% CI 0.41 to 1.45; I2 = 0%; 3 RCTs; 908 participants); surgical re-intervention (RR 1.11, 95% CI 0.67 to 1.82; I2 = 29%; 3 RCTs; 908 participants); radiological dehiscence (RR 0.85, 95% CI 0.39 to 1.83; I2 = 0%; 2 RCTs; 809 participants) and wound infection (RR 0.82, 95% CI 0.45 to 1.51; I2 = 0%; 3 RCTs; 908 participants) in participants treated with routine prophylactic drainage compared to no treatment undergoing elective colorectal surgery. The quality of evidence was low according to GRADE method assessment. There was insufficient evidence for the use of prophylactic drains after elective colorectal anastomoses. The conclusions of this review were limited due to the nature of the available clinical data; The three included RCTs performed different interventions with relatively small sample sizes of eligible participants.

Plain-language summary: We included three clinical trials involving 908 participants. The trials were conducted in Germany and France. All trials compared routine anastomotic drainage versus no anastomotic drainage after elective colorectal surgery. The evidence was current to February 2015. This review showed no apparent difference in anastomotic leak, death, radiological (x-ray) evidence of anastomotic leak, wound infection or need for re-operation. We found insufficient evidence to support the use of routine prophylactic drains after elective colorectal anastomosis. We based our conclusion on limited evidence with relatively small numbers of participants; this means that it is difficult to detect differences between treatment groups that may be present. The quality of the evidence was low, making it impossible to draw firm conclusions about the use of routine prophylactic drains after elective colorectal anastomosis. Additional studies are needed to strengthen the conclusion drawn by this systematic review and to provide further analysis using modern colorectal surgery. We found no new evidence since the previous version of our systematic review of 2004.
Abstract: The search identified one new RCT, making a total of 10 included RCTs (442 participants, 42% women). The median number of participants per RCT was 29 (range 10 to 117). Four RCTs recruited people with a range of chronic wounds; three RCTs recruited people with venous leg ulcers, and three RCTs considered foot ulcers in people with diabetes. The median length of treatment was 12 weeks (range 8 to 40 weeks). It is unclear whether autologous PRP improves the healing of chronic wounds generally compared with standard treatment (with or without placebo) (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.95 to 1.50; I2 = 27%, low quality evidence, 8 RCTs, 391 participants). Autologous PRP may increase the healing of foot ulcers in people with diabetes compared with standard care (with or without placebo) (RR 1.22, 95% CI 1.01 to 1.49; I2 = 0%, low quality evidence, 2 RCTs, 189 participants). It is unclear if autologous PRP affects the healing of venous leg ulcers (RR 1.02, 95% CI 0.81 to 1.27; I2 = 0% ). It is unclear if there is a difference in the risk of adverse events in people treated with PRP or standard care (RR 1.05, 95% CI 0.29 to 3.88; I2 = 0%, low quality evidence from 3 trials, 102 participants). PRP may improve the healing of foot ulcers associated with diabetes, but this conclusion is based on low quality evidence from two small RCTs. It is unclear whether PRP influences the healing of other chronic wounds. The overall quality of evidence of autologous PRP for treating chronic wounds is low. There are very few RCTs evaluating PRP, they are underpowered to detect treatment effects, if they exist, and are generally at high or unclear risk of bias. Well designed and adequately powered clinical trials are needed.

Plain-language summary: We included 10 randomised clinical trials, with a total of 442 participants (mean age 61 years and 42% women). Four included studies recruited people with a range of chronic wounds; three studies enrolled people with venous leg ulcers; and the other three studies included people with diabetes who had foot ulcers. The median length of treatment was 12 weeks. All but three trials reported the sources of funding. Four of the studies received financial support from companies manufacturing PRP devices. The results were non-conclusive as to whether autologous PRP improves the healing of chronic wounds generally compared with standard treatment. Autologous PRP may increase the healing of foot ulcers in people with diabetes compared with standard care, but it is unclear if autologous PRP has an effect on other types of chronic wound. Three studies reported wound complications such as infection or dermatitis, but results showed no difference in the risk of adverse events in people treated with PRP or standard care. These findings are based on low quality evidence due to the small number of studies and patients included, and their poor methodological quality. This Plain Language Summary is up to date as of 16 June 2015.
Abstract: Two cluster-randomised control trials were included: one randomised at hospital level (23 hospitals in Australia) and one at ward level (16 wards in the UK). The primary outcome in the Australian trial (a composite score comprising incidence of unexpected cardiac arrests, unexpected deaths and unplanned ICU admissions) showed no statistical significant difference between control and medical emergency team (MET) hospitals (adjusted P value 0.640; adjusted odds ratio (OR) 0.98; 95% confidence interval (CI) 0.83 to 1.16). The UK-based trial found that outreach reduced in-hospital mortality (adjusted OR 0.52; 95% CI 0.32 to 0.85) compared with the control group. The evidence from this review highlights the diversity and poor methodological quality of most studies investigating outreach. The results of the two included studies showed either no evidence of the effectiveness of outreach or a reduction in overall mortality in patients receiving outreach. The lack of evidence on outreach requires further multi-site RCT's to determine potential effectiveness.

Plain-language summary: This summary of a Cochrane review presents what we know from research about the effect of outreach services for patients on general hospital wards. The review found two studies which were of good quality. One study compared 12 hospitals with outreach services to 11 that did not. Another study compared 16 wards with outreach to general wards without outreach. One of the studies showed that outreach reduced the number of hospital deaths, while the other study found no differences between hospitals with outreach and those with no outreach. It is not clear whether outreach reduces hospital deaths or ICU admissions. High quality research is needed to determine the effect of outreach services.
Abstract: We included six trials that enrolled 794 women and their babies and all assessed nifedipine as calcium channel blocker maintenance therapy. The six trials were judged to be at a moderate risk of bias overall. No differences in the incidence of preterm birth (risk ratio (RR) 0.97; 95% confidence interval (CI) 0.87 to 1.09; five trials, 681 women), birth within 48 hours of treatment (RR 0.46; 95% CI 0.07 to 3.00; two trials, 128 women) or neonatal mortality (average RR 0.75; 95% CI 0.05 to 11.76; two trials, 133 infants) were seen when nifedipine maintenance therapy was compared with placebo or no treatment. No stillbirths were reported in the one trial that provided data for this outcome. No trials reported on longer-term follow-up of infants. Women receiving nifedipine maintenance therapy were significantly more likely to have their pregnancy prolonged (mean difference (MD) 5.35 days; 95% CI 0.49 to 10.21; four trials, 275 women); however, no differences between groups were shown for birth at less than 34 weeks' gestation, birth at less than 28 weeks' gestation, birth within seven days of treatment, or gestational age at birth. No significant differences were shown between the nifedipine and control groups for any of the secondary neonatal morbidities reported. Similarly, no significant differences were seen for the outcomes relating to the use of health services, except for in one trial, where infants whose mothers received nifedipine were significantly more likely to have a longer length of hospital stay as compared with infants born to mothers who received a placebo (MD 14.00 days; 95% CI 4.21 to 23.79; 60 infants). Based on the current available evidence, maintenance treatment with a calcium channel blocker after threatened preterm labour does not prevent preterm birth or improve maternal or infant outcomes.

Plain-language summary: We identified six randomised controlled trials involving a total of 794 women and their babies for this review. The trials were of moderate risk of bias overall. The trials did not demonstrate differences between calcium channel blocker maintenance therapy and placebo or no treatment in the prevention of preterm birth or perinatal death (fetal or neonatal deaths). None of the trials included any follow-up of the infants to assess longer-term development. Calcium channel blocker maintenance therapy (with a drug called nifedipine) was more likely than placebo or no treatment to prolong pregnancy, however the infants of these mothers were more likely to have a longer hospital stay. Based on the current studies, we found no convincing evidence that calcium channel blocker maintenance therapy prevents preterm birth for women after threatened preterm labour, or that it improves outcomes for babies.
Abstract: We identified eight studies with a total of 204 participants and a mean sample size of 25. All trials were single-centre trials, and participants seen on an outpatient basis. Seven studies compared medication and placebo (n = 184); one study compared medication and another active agent (n = 13). Duration of the studies was six to twelve weeks. Meta-analysis was not undertaken because of the methodological heterogeneity of the trials. The studies did not employ intention-to-treat analyses and were at a high risk of attrition bias. Adverse events were not well-documented in the studies. None of the three studies of selective serotonin reuptake inhibitors (SSRIs) demonstrated strong evidence of a treatment effect on any of the outcomes of interest. The unpublished naltrexone study did not provide strong evidence of a treatment effect. Two studies, an olanzapine study and a N-acetylcysteine (NAC) study, reported statistically significant treatment effects. One study of clomipramine demonstrated a treatment effect on two out of three measures of response to treatment. No particular medication class definitively demonstrates efficacy in the treatment of trichotillomania. Preliminary evidence suggests treatment effects of clomipramine, NAC and olanzapine based on three individual trials, albeit with very small sample sizes.

Plain-language summary: This systematic review of randomised controlled trials (RCTs) set out to review the evidence for medication in treating TTM. The findings are based on eight studies (which included a total of 204 people). Not enough evidence was found to conclude definitively that any particular medication is effective in the treatment of TTM. Furthermore, side effects related to medications were not well-documented in the majority of the studies. Because of differences in the way the included studies were carried out, we were unable to combine their results to draw more conclusive evidence. However, an early trial found some evidence for the efficacy of clomipramine, and two recent trials reported statistically significant treatment outcomes with olanzapine and N-acetylcysteine. More research is needed to find an optimal treatment for TTM.
Abstract: Nine studies (1265 participants) met the inclusion criteria of the review. Two studies were conducted in children. Study reporting quality was fair, but all studies were of short duration (three to twelve weeks). Lung function was not significantly different between extrafine BDP and FP when compared at the same dose in parallel studies, change in FEV1: 0.04 litres (95% CI -0.03 to 0.11 litres; three studies, 659 adults); change in FEV1 predicted: -2.18% (95% CI -4.62 to 0.26; three studies, 334 adults); change in am PEF: -0.69 litres (95% CI -11.21 to 9.83 litres; two studies, 364 adults). Individual studies reported non-significant findings in symptom scores and quality of life questionnaires. There was no significant difference between FP and extrafine HFA-BDP in the risk of study withdrawal, dysphonia or when data were reported as any adverse event. There was no significant difference between FP and extrafine HFA-BDP on FEV1 or peak flow at a dose ratio of 1:1. However, the number of studies and width of the confidence intervals in the analyses do not exclude a clinically meaningful difference between these two drugs. Difficulty in the successful manipulation of the devices studied may be a barrier to the widespread use of MDIs. Only two small paediatric studies were included in the review, so extrapolation of the findings of this review to children is limited. Further longer term studies in adults and children with moderate and severe asthma are required.

Plain-language summary: The review of studies found that there was a limited amount of evidence to show that the newer extra-fine form of BDP was similar to FP at the same dose. More research should be done in children and in people with more severe asthma to help answer the question of what the relative effects of these two steroids are. Some people may not be particularly good at using certain inhaler types and the findings of the review may only really apply to people who are competent in using metered-dose inhalers (MDIs). Studies should consider introducing spacers where people find these easier to use.
Abstract: Twelve randomized controlled trials met our inclusion criteria. Study findings were similar between 28-day and extended or continuous regimens in regard to contraceptive efficacy (i.e., pregnancy rates) and safety profiles. When compliance was reported, no difference between 28-day and extended or continuous cycles was found. Participants reported high satisfaction with both dosing regimens, but this was not an outcome universally studied. Overall discontinuation and discontinuation for bleeding problems were not uniformly higher in either group. The studies that reported menstrual symptoms found that the extended or continuous group fared better in terms of headaches, genital irritation, tiredness, bloating, and menstrual pain. Eleven out of the twelve studies found that bleeding patterns were either equivalent between groups or improved with extended or continuous cycles over time. Endometrial lining assessments by ultrasound and/or endometrial biopsy were done in some participants and were all normal after cyclic or extended CHC use. The 2014 update yielded four additional trials but unchanged conclusions. Evidence from existing randomized control trials comparing continuous or extended-cycle CHCs (greater than 28 days of active combined hormones) to traditional cyclic dosing (21 days of active hormone and 7 days of placebo, or 24 days of active hormone and 4 days of placebo) is of good quality. However, the variations in type of hormones and time length for extended-cycle dosing make a formal meta-analysis impossible. Future studies should choose a previously described type of CHC and dosing regimen. More attention needs to be directed towards participant satisfaction, continuation, and menstruation-associated symptoms.

Plain-language summary: Delaying or eliminating the break in hormone use has become a popular way for women to avoid monthly bleeding, so we performed this review to compare these newer regimens to traditional CHC dosing regimens. We searched for all randomized controlled trials on this question in any language; we found twelve that met our criteria. The continuous or extended-cycle and traditional regimens appeared similar, as judged by bleeding, discontinuation rates, and reported satisfaction. The studies were too small to address efficacy, rare adverse events, and safety. Extended-cycle (for more than 28 days) or continuous dosing appears to be a reasonable approach to CHC use.
Abstract: A total of 798 studies were identified following the initial search. No published or unpublished randomised controlled trials comparing primary tumour resection versus no resection in asymptomatic patients with unresectable stage IV colorectal cancer who were treated with chemo/radiotherapy were identified. Seven non-randomised studies, potentially eligible for inclusion, were identified: 2 case-matched studies, 2 CCTs and 3 retrospective cohort studies. Overall, these trials included 1.086 patients (722 patients treated with primary tumour resection, and 364 patients managed first with chemotherapy and/or radiotherapy). Resection of the primary tumour in asymptomatic patients with unresectable stage IV colorectal cancer who are managed with chemo/radiotherapy is not associated with a consistent improvement in overall survival. In addition, resection does not significantly reduce the risk of complications from the primary tumour (i.e.  obstruction, perforation or bleeding). Yet there is enough doubt with regard to the published literature to justify further clinical trials in this area. The results from an ongoing high quality randomised controlled trial will help to answer this question.

Plain-language summary: Some studies have suggested that resecting the primary cancer can prolong survival and prevent complication arising from the cancer, such as obstruction or bleeding. This review addresses the question of whether surgically removing the primary cancer is beneficial to patients with advanced and unresectable colorectal cancer. No randomised controlled trials were identified.
Abstract: A total of 14 relevant trials were identified, consisting of a total of 3157 patients. There was a statistically significant overall survival advantage in favor of the donor versus no donor group (HR 0.86; 95% CI 0.77 to 0.97; P = 0.01), as well as significant improvement in disease-free survival in the donor group(HR 0.82; 95% CI 0.72 to 0.94; P = 0.004). Those in the donor group had significant reduction in primary disease relapse(RR 0.53; 95% CI 0.37 to 0.76; P = 0.0004) and significant increase in non-relapse mortality(RR 2.8; 95% CI 1.66 to 4.73; P = 0.001). Significant heterogeneity was detected in analysis of relapse (Chi2 40.51, df = 6, P < 0.00001; I2 = 85%). In regard to methodologic quality, the majority of included studies were free of selective reporting, and performed analyses according to intention to treat. Conversely, few reported sample size calculation that informed the study design. While blinding was considered as an important domain of methodological quality, none of the studies reported on whether any of the study personnel were blinded (e.g. subjects, personnel, outcome assessors, data analysts etc). Therefore, we did not consider blinding further in the analysis of methodological quality in this review. The results of this systematic review and meta-analysis support matched sibling donor allogeneic hematopoietic cell transplantation as the optimal post-remission therapy in ALL patients aged 15 years or over. This therapy offers superior overall survival and disease-free survival, and significantly reduces the risk of disease relapse, but does impose an increased risk of non-relapse mortality. Importantly these data are based on adult ALL treated with largely total body irradiation-based myeloablative conditioning and sibling donor transplantation and, therefore, cannot be generalized to pediatric ALL, alternative donors including HLA (human leukocyte antigen) mismatched or unrelated donors, or reduced toxicity or non-myeloablative conditioning regimens.

Plain-language summary: Clinical trials have come to different conclusions about the best approach. We conducted a systematic review and meta-analysis to synthesize available clinical research studies that have examined outcome according to donor vs. no donor status, or genetic randomization. This is a method of analysis for assessing the effect of transplantation in this disease condition. Our analysis supports matched sibling donor allogeneic hematopoeitic cell transplantation as the approach which offers the best long-term outcomes, specifically providing optimal survival and reduced risk for ALL relapse.
Abstract: Thirty eight randomised controlled comparisons (made within 22 trials) were identified. Most were based on 'healthy' adult participants who were not considered to be at increased risk of regurgitation or aspiration during anaesthesia. Few trials reported the incidence of aspiration/regurgitation or related morbidity but relied on indirect measures of patient safety i.e. intra-operative gastric volume and pH. There was no evidence that the volume or pH of participants' gastric contents differed significantly depending on whether the groups were permitted a shortened preoperative fluid fast or continued a standard fast. Fluids evaluated included water, coffee, fruit juice, clear fluids and other drinks (e.g. isotonic drink, carbohydrate drink). Participants given a drink of water preoperatively were found to have a significantly lower volume of gastric contents than the groups that followed a standard fasting regimen. This difference was modest and clinically insignificant. There was no indication that the volume of fluid permitted during the preoperative period (i.e. low or high) resulted in a difference in outcomes from those participants that followed a standard fast. Few trials specifically investigated the preoperative fasting regimen for patient populations considered to be at increased risk during anaesthesia of regurgitation/aspiration and related morbidity. There was no evidence to suggest a shortened fluid fast results in an increased risk of aspiration, regurgitation or related morbidity compared with the standard 'nil by mouth from midnight' fasting policy. Permitting patients to drink water preoperatively resulted in significantly lower gastric volumes. Clinicians should be encouraged to appraise this evidence for themselves and when necessary adjust any remaining standard fasting policies (nil-by-mouth from midnight) for patients that are not considered 'at-risk' during anaesthesia.

Plain-language summary: However, the review of trials found that drinking clear fluids up to a few hours before surgery did not increase the risk of regurgitation during or after surgery. Some people are considered more likely to regurgitate under anaesthetic, including those who are pregnant, elderly, obese or have stomach disorders. More research is needed to determine whether these people can also safely drink up to a few hours before surgery.