GEM/cochrane-simplification huggingface dataset:
Abstract: We included 28 trials, involving 5855 participants, comparing stroke unit care with an alternative service. More-organised care was consistently associated with improved outcomes. Twenty-one trials (3994 participants) compared stroke unit care with care provided in general wards. Stroke unit care showed reductions in the odds of death recorded at final (median one year) follow-up (odds ratio (OR) 0.81, 95% Confidence Interval (CI) 0.69 to 0.94; P = 0.005), the odds of death or institutionalised care (OR 0.78, 95% CI 0.68 to 0.89; P = 0.0003) and the odds of death or dependency (OR 0.79, 95% CI 0.68 to 0.90; P = 0.0007). Sensitivity analyses indicated that the observed benefits remained when the analysis was restricted to securely randomised trials that used unequivocally blinded outcome assessment with a fixed period of follow-up. Outcomes were independent of patient age, sex, initial stroke severity or stroke type, and appeared to be better in stroke units based in a discrete ward. There was no indication that organised stroke unit care resulted in a longer hospital stay. Stroke patients who receive organised inpatient care in a stroke unit are more likely to be alive, independent, and living at home one year after the stroke. The benefits were most apparent in units based in a discrete ward. We observed no systematic increase in the length of inpatient stay.

Plain-language summary: This review of 28 trials, involving 5855 participants, showed that patients who receive this care are more likely to survive their stroke, return home and become independent in looking after themselves. A variety of different types of stroke unit have been developed. The best results appear to come from those which are based in a dedicated ward.
Abstract: Six trials with a total of 556 people were included. These trials were all placebo-controlled and double-blind, but of variable quality. They used different homeopathic treatments which precluded quantitative pooling of results for the primary outcome. Standardised treatments in these trials are unlikely to represent common homeopathic practice, where treatment tends to be individualised. No trial reported a significant difference on validated symptom scales. There were conflicting results in terms of lung function between the studies. There has been only a limited attempt to measure a 'package of care' effect (i.e., the effect of the medication as well as the consultation, which is considered a vital part of individualised homeopathic practice). An update search in August 2005 did not identify any new studies. There is not enough evidence to reliably assess the possible role of homeopathy in asthma. As well as randomised trials, there is a need for observational data to document the different methods of homeopathic prescribing and how patients respond. This will help to establish to what extent people respond to a 'package of care' rather than the homeopathic intervention alone.

Plain-language summary: The review of trials found that the type of homeopathy varied between the studies, that the study designs used in the trials were varied and that no strong evidence existed that usual forms of homeopathy for asthma are effective. There has been only a limited attempt to measure a 'package of care' effect (i.e., the effect of the medication as well as the consultation, which is considered a vital part of individualised homeopathic practice). Until stronger evidence exists for the use of homeopathy in the treatment of asthma, we are unable to make recommendations about homeopathic treatment.
Abstract: Four studies involving 127,891 men and 9342 women were included in this review. Only one study included women. Results for men and women were analysed separately. Three to five years after screening there was no significant difference in all-cause mortality between screened and unscreened groups for men or women (men, odds ratio (OR) 0.95; 95% Confidence interval (CI) 0.85 to 1.07; for women OR 1.06; 95% CI 0.93 to 1.21). There was a significant decrease in mortality from AAA in men (OR 0.60; 95% CI 0.47 to 0.78), but not for women (OR 1.99; 95% CI 0.36 to 10.88). In this analysis mortality includes death from rupture and from emergency or elective surgery for aneurysm repair. There was also a decreased incidence of ruptured aneurysm in men (OR 0.45; 95% CI 0.21 to 0.99) but not in women (OR 1.49; 95% CI 0.25 to 8.94). There was a significant increase in surgery for AAA in men (OR 2.03; 95% CI 1.59 to 2.59). This was not reported in women. There were no data on life expectancy, complications of surgery or subjective quality of life. There is evidence of a significant reduction in mortality from AAA in men aged 65 to 79 years who undergo ultrasound screening. There is insufficient evidence to demonstrate benefit in women. The cost effectiveness may be acceptable, but needs further expert analysis. These findings need careful consideration in judging whether a co-ordinated population-based screening programme should be introduced.

Plain-language summary: This review identified four controlled trials involving 127,891 men and 9342 women who were randomly assigned to aortic aneurysm screening using ultrasound or no screening. Only one trial included women. Two of the trials were conducted in the UK, one in Denmark and one in Australia. The results provide evidence of a benefit from screening in men with a strongly significant reduction in deaths from abdominal aortic aneurysm. The odds ratio (OR) for death was 0.60 (range 0.47 to 0.78, three trials) in men aged 65 to 83 years but was not reduced for women. From one trial there was also a decreased incidence of ruptured aneurysm in men but not women. All-cause mortality was not significantly different between screened and unscreened groups some three to five years after screening, which is to be expected given the relative infrequency of abdominal aortic aneurysm as a cause of death. Men who had been screened underwent more surgery for abdominal aortic aneurysm (OR 2.03; range 1.59 to 2.59, four trials) but resource analysis appears to demonstrate overall cost effectiveness of screening. There were no data on life expectancy, complications of surgery or quality of life.
Abstract: We included 10 RCTs involving a total of 844 participants. The primary outcome was overall incidence of parastomal herniation. Secondary outcomes were rate of reoperation at 12 months, operative time, postoperative length of hospital stay, stoma-related infections, mesh-related infections, quality of life, and rehospitalisation rate. We judged the risk of bias across all domains to be low in six trials. We judged four trials to have an overall high risk of bias. The overall incidence of parastomal hernia was less in participants receiving a prophylactic mesh compared to those who had a standard ostomy formation (RR 0.53, 95% CI 0.43 to 0.66; 10 studies, 771 participants; I2 = 69%; low-quality evidence). In absolute numbers, the incidence of parastomal hernia was 22 per 100 participants (18 to 27) receiving prophylactic mesh compared to 41 per 100 participants having a standard ostomy formation. There were no differences in the need for reoperation (RR 0.90, 95% CI 0.50 to 1.64; 9 studies, 757 participants; I2 = 0%; low-quality evidence); operative time (MD -6.50 (min), 95% CI -18.24 to 5.24; 6 studies, 671 participants; low-quality evidence); postoperative length of hospital stay (MD -0.95 (days), 95% CI -2.03 to 0.70; 4 studies, 500 participants; moderate-quality evidence); or stoma-related infections (RR 0.89, 95% CI 0.32 to 2.50; 6 studies, 472 participants; I2 = 0%; low-quality evidence) between the two groups. We were unable to analyse mesh-related infections, quality of life, and rehospitalisation rate due to sparse data or because the outcome was not reported in the included studies. This Cochrane Review included 10 RCTs with a total of 844 participants. The review demonstrated a reduction in the incidence of parastomal hernia in people who had a prophylactic synthetic mesh placed at the time of the index operation compared to a standard ostomy formation. However, our confidence in this estimate is low due to the presence of a large degree of clinical heterogeneity, as well as high variability in follow-up duration and technique of parastomal herniation detection. We found the rate of stoma-related infection to be similar in both the intervention and control groups.

Plain-language summary: Following our data search in January 2018, we included 10 trials with a total of 844 participants, which we assessed using the standard Cochrane Review protocol. The trials compared the incidence of hernia development around a stoma between a group having a mesh placement at the time of stoma formation and a control group having a conventional stoma formation without mesh placement. We found that mesh placement around the stoma at the time of stoma formation reduces the incidence of future hernia formation. The participants having a mesh fitted had a similar level of complications as those not having a mesh. We found low-quality evidence favouring the insertion of a mesh into people having a stoma.
Abstract: Fourteen randomised controlled trials comparing exercise against no exercise in type 2 diabetes were identified involving 377 participants. Trials ranged from eight weeks to twelve months duration. Compared with the control, the exercise intervention significantly improved glycaemic control as indicated by a decrease in glycated haemoglobin levels of 0.6% (-0.6 % HbA1c, 95% confidence interval (CI) -0.9 to -0.3; P < 0.05). This result is both statistically and clinically significant. There was no significant difference between groups in whole body mass, probably due to an increase in fat free mass (muscle) with exercise, as reported in one trial (6.3 kg, 95% CI 0.0 to 12.6). There was a reduction in visceral adipose tissue with exercise (-45.5 cm2, 95% CI -63.8 to -27.3), and subcutaneous adipose tissue also decreased. No study reported adverse effects in the exercise group or diabetic complications. The exercise intervention significantly increased insulin response (131 AUC, 95% CI 20 to 242) (one trial), and decreased plasma triglycerides (-0.25 mmol/L, 95% CI -0.48 to -0.02). No significant difference was found between groups in quality of life (one trial), plasma cholesterol or blood pressure. The meta-analysis shows that exercise significantly improves glycaemic control and reduces visceral adipose tissue and plasma triglycerides, but not plasma cholesterol, in people with type 2 diabetes, even without weight loss.

Plain-language summary: This review found that exercise improves blood sugar control and that this effect is evident even without weight loss. Furthermore, exercise decreases body fat content, thus the failure to lose weight with exercise programmes is probably explained by the conversion of fat to muscle. Exercise improved the body's reaction to insulin and decreased blood lipids. Quality of life was only assessed in one study, which found no difference between the two groups. No significant difference was found between groups in blood levels of cholesterol or blood pressure. A total of 14 randomised controlled trials were assessed. These included 377 participants and compared groups that differed only with respect to an exercise programme intervention. The duration of the interventions in the studies ranged from eight weeks to one year. Two studies reported follow-up information, one at six months after the end of the six month exercise intervention and one at twelve months post-intervention. Generally, the studies were well-conducted, but blinding of outcome assessors was not reported and although all studies reported that randomisation was performed, few gave details of the method.   No adverse effects with exercise were reported. The effect of exercise on diabetic complications was not assessed in any of the studies. The relatively short duration of trials prevented the reporting of any significant long term complications or mortality. Another limitation was the small number of participants included in the analyses for adiposity, blood pressure, cholesterol, body's muscle and quality of life.
Abstract: We included two randomised controlled trials that involved a total of 147 adult outpatients with acute sinusitis confirmed by radiology or nasal endoscopy who were assigned to Cyclamen europaeum nasal spray or placebo study arms for up to 15 days. The risk of selection and detection bias was unclear, as allocation concealment and blinding of outcome assessors were not reported in either study. Attrition was high (60%) in one study, although dropouts were balanced between study arms. Neither study reported our two primary outcomes: proportion of participants whose symptoms resolved or improved at 14 days and 30 days. No serious adverse events or complications related to treatment were reported; however, more mild adverse events such as nasal and throat irritation, mild epistaxis, and sneezing occurred in Cyclamen europaeum group participants (50%) compared to placebo group participants (24%) (risk ratio 2.11, 95% confidence interval 1.35 to 3.29); moderate-quality evidence. The effectiveness of Cyclamen europaeum for people with acute sinusitis is unknown. Although no serious side effects were observed, 50% of participants who received Cyclamen europaeum reported adverse events compared with 24% of those who received placebo.

Plain-language summary: We included two studies involving 147 adults with acute sinusitis. Participants were randomly allocated to receive Cyclamen europaeum delivered as an intranasal spray or a non-active substance for up to 15 days. Pharmaceutical companies funded both studies. We wanted to find out the proportion of participants whose symptoms resolved or improved up to 14 days and 30 days, but did not find any evidence. The included studies provided data for changes in symptom scores for acute sinusitis with treatment. One study reported improvement in facial pain up to seven days. Neither study reported complications or days off school or work. People who received Cyclamen europaeum rather than a non-active substance reported more side effects like nasal irritation, sneezing, and mild nasal bleeding. No major side effects occurred. We found no evidence as to whether Cyclamen europaeum is effective or not. We assessed the quality of both studies and judged the evidence to be moderately reliable for the only outcome that could be assessed, that is side effects. One study had a high dropout rate (60%), but dropouts were described and balanced between study arms. We found consistent results between studies for adverse events. Neither study reported whether the outcomes assessors knew which treatments the participants received. Due to the small number of participants and weaknesses in study design, we cannot be sure of the result.
Abstract: We included two RCTs involving 3375 women. Tamoxifen after surgery for DCIS reduced recurrence of both ipsilateral (same side) DCIS (HR 0.75; 95% CI 0.61 to 0.92) and contralateral (opposite side) DCIS (RR 0.50; 95% CI 0.28 to 0.87). There was a trend towards decreased ipsilateral invasive cancer (HR 0.79; 95% CI 0.62 to 1.01) and reduced contralateral invasive cancer (RR 0.57; 95% CI 0.39 to 0.83). The number needed to treat in order for tamoxifen to have a protective effect against all breast events is 15. There was no evidence of a difference detected in all cause mortality (RR 1.11; 95% CI 0.89 to 1.39). Only one study, involving 1799 participants followed-up for 163 months (median) reported on adverse events (i.e. toxicity, mood changes, deep vein thrombosis, pulmonary embolism, endometrial cancer) with no significant difference between tamoxifen and placebo groups, but there was a non-significant trend towards more endometrial cancer in the tamoxifen group. While tamoxifen after local excision for DCIS (with or without adjuvant radiotherapy) reduced the risk of recurrent DCIS (in the ipsi- and contralateral breast), it did not reduce the risk of overall mortality.

Plain-language summary: Our findings are based on two large studies with 3375 participants and should be applicable to most women having treatment for DCIS. Overall tamoxifen did reduce the number of future cancers or DCIS in either breast. However, women taking tamoxifen did not live longer than those who did not take it. A total of 15 women would have to take tamoxifen after treatment of DCIS for one woman to experience a benefit (i.e. no future cancers or DCIS in either breast after taking tamoxifen for five years). There are side effects of tamoxifen treatment such as blood clotting problems (stroke, deep vein thrombosis, pulmonary embolism) and endometrial cancer. However, no risk/benefit conclusions are possible because there was limited information about the side effects in this review. The effects of tamoxifen may have been 'diluted' by the effects of radiotherapy. This review cannot recommend which women might have more benefit from using tamoxifen in terms of age, menopausal status or type of DCIS (oestrogen receptor (ER)-positive versus ER-negative or human epidermal growth factor receptor 2 (HER2)-positive or HER2-negative DCIS).
Abstract: A total of five studies including 868 participants met the inclusion criteria for this review. The five studies included in this review reported the value of drain fluid amylase at different thresholds and different postoperative days. The sensitivities and specificities were variable; the sensitivities ranged between 0.72 and 1.00 while the specificities ranged between 0.73 and 0.99 for different thresholds on different postoperative days. At the median prevalence (pre-test probability) of 15.9%, the post-test probabilities for pancreatic leak ranged between 35.9% and 95.4% for a positive drain fluid amylase test and ranged between 0% and 5.5% for a negative drain fluid amylase test. None of the studies used the reference standard of confirmation by surgery or by a combination of surgery and clinical follow-up, but used the International Study Group on Pancreatic Fistula (ISGPF) grade B and C as the reference standard. The overall methodological quality was unclear or high in all the studies. Because of the paucity of data and methodological deficiencies in the studies, we are uncertain whether drain fluid amylase should be used as a method for testing for pancreatic leak in an unselected population after pancreatic resection; and we judge that the optimal cut-off of drain fluid amylase for making the diagnosis of pancreatic leak is also not clear. Further well-designed diagnostic test accuracy studies with pre-specified index test threshold of drain fluid amylase (at three times more on postoperative day 5 or another suitable pre-specified threshold), appropriate follow-up (for at least six to eight weeks to ensure that there are no pancreatic leaks), and clearly defined reference standards (of surgical, clinical, and radiological confirmation of pancreatic leak) are important to reliably determine the diagnostic accuracy of drain fluid amylase in the diagnosis of pancreatic leak.

Plain-language summary: We performed a thorough literature search for studies reporting the accuracy of drain fluid amylase in identifying pancreatic leaks. We included studies reported up to 20 February 2017. We identified five studies reporting information on 868 people who underwent pancreatic resections for cancer and non-cancerous growths. Most studies included only people in whom the head of the pancreas (right side of the pancreas) was removed. Variations in when the studies measured the amylase content in the drain and what level was considered abnormal meant that we were not able to combine the data to provide the overall results. We are uncertain whether drain fluid amylase is useful in identifying pancreatic leaks because of the following reasons. 1. The way that study authors confirmed that a participant had or did not have pancreatic leak was itself subject to error (i.e. there was no true 'gold standard'). 2. The studies included few participants. As a result, there was significant uncertainty in the results. 3. The studies were of poor methodological quality. This introduced additional uncertainty in the results. All of the studies were of unclear or low methodological quality, which may result in arriving at false conclusions.
Abstract: Twelve trials met the inclusion criteria. Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E2C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E2V) 5 mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons. Acceptability results favored the CIC in one study and the progestin-only in another. Studies comparing two CICs found that NET-EN 50 mg plus E2V 5 mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E2C 5 mg. However, these differences were not detected in all trials. The NET-EN plus E2V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E2C group. The groups did not differ in their amenorrhea rates. While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward improving the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.

Plain-language summary: In January and February 2013, we did computer searches to find randomized trials of combination injectable contraceptives. We included studies that compared a CIC with another birth control method. The other method could be another injectable contraceptive, either combined or having only a progestin. The CIC could also be compared to another hormonal method (like the pill) or to condoms, the diaphragm, or a placebo (or 'dummy'). We found 12 trials that studied four types of CICs. The combined methods required monthly injections. Four trials compared a CIC to 'depo', which has only a progestin. 'Depo' injections should be taken every three months. Five trials compared a CIC with a different combined injectable. Three trials compared a combined injectable with a different dose of the same hormones, with a progestin-only injectable, or with an intrauterine device (IUD). More women using combined injectables had normal bleeding than women using progestin-only injectables like 'depo.' Also, fewer women using CICs stopped using them because of bleeding reasons than progestin-only users. However, users of combined injectables were more likely to stop using them overall and to stop for other medical reasons. Many factors can affect whether women keep using the method, including whether the women liked it.