GEM/cochrane-simplification huggingface dataset:
Abstract: Three RCTs (68 participants) were identified. All treatment comparisons contained only one study. No significant difference was found between prednisone compared with placebo for complete (RR 1.44, CI 0.95 to 2.19) and partial remission (RR 1.00, CI 0.07 to 14.45) of the nephrotic syndrome due to minimal change disease. There was no difference between intravenous methylprednisolone plus oral prednisone compared with oral prednisone alone for complete remission (RR 0.74, CI 0.50 to 1.08). Prednisone, compared with short-course intravenous methylprednisolone, increased the number of subjects who achieved complete remission (RR 4.95, CI 1.15 to 21.26). The lack of statistical evidence of efficacy associated with prednisone therapy was based on data derived from a single study that compared 'alternate-day prednisone' to no immunosuppression' with only a small number of participants in each group. No RCTs were identified comparing regimens in adults with a steroid-dependent or relapsing disease course or comparing treatments comprising alkylating agents, cyclosporine, tacrolimus, levamisole, or mycophenolate mofetil. Further comparative studies are required to examine the efficacy of immunosuppressive agents for achievement of sustained remission of nephrotic syndrome caused by minimal change disease. Studies are also needed to evaluate treatments for adults with steroid-dependent or relapsing disease.

Plain-language summary: This review identified three small studies (68 participants) comparing: 1) intravenous plus oral steroid treatment versus oral sterids; 2) oral versus short-course intravenous steroid treatment; and 3) oral steroid treatment versus placebo. Only oral steroid treatment (compared to short-course intravenous steroid treatment) showed an increase in the number of patients who achieved complete remission. However, the lack of available studies leaves important treatment questions unanswered; what is the optimal dose and duration of steroid treatment in new-onset adult minimal change disease; how are relapses following steroid-induced remission prevented and treated; and what are the appropriate treatments for steroid-dependent or treatment-resistant minimal change disease?
Abstract: We included six trials involving 1270 participants in the review: three trials involving 686 participants compared routine shunting with no shunting, one trial involving 200 participants compared routine shunting with selective shunting, one trial involving 253 participants compared selective shunting with and without near-infrared refractory spectroscopy monitoring, and the other trial involving 131 participants compared shunting with a combination of electroencephalographic and carotid pressure measurement with shunting by carotid pressure measurement alone. In general, reporting of methodology in the included studies was poor. For most studies, the blinding of outcome assessors and the report of prespecified outcomes were unclear. For routine versus no shunting, there was no significant difference in the rate of all stroke, ipsilateral stroke or death up to 30 days after surgery, although data were limited. No significant difference was found between the groups in terms of postoperative neurological deficit between selective shunting with and without near-infrared refractory spectroscopy monitoring, However, this analysis was inadequately powered to reliably detect the effect. There was no significant difference between the risk of ipsilateral stroke in participants selected for shunting with the combination of electroencephalographic and carotid pressure assessment compared with pressure assessment alone, although again the data were limited. This review concluded that the data available were too limited to either support or refute the use of routine or selective shunting in carotid endarterectomy. Large scale randomised trials of routine shunting versus selective shunting are required. No method of monitoring in selective shunting has been shown to produce better outcomes.

Plain-language summary: We identified six studies up to August 2013, for inclusion in the review. These studies included a total of 1270 participants. Three of the trials compared routine shunting with no shunting, one trial compared routine shunting versus selective shunting, and another two trials compared different methods of monitoring in selective shunting. We have not yet identified any trials that compared selective shunting with no shunting. All the included trials assessed the use of shunting in people undergoing endarterectomy under general anaesthetic. The age of the participants ranged from 40 to 89 years, and overall, there were more male than female participants. Where reported, participants were followed up for no longer than 30 days. There is still no evidence for the use of a carotid shunt during carotid endarterectomy. This review suggests a benefit from the use of a shunt, but the overall results were not statistically significant. More trials are needed. There were significant problems with the quality of the randomised trials and, overall, the reporting of study methodology was poor.
Abstract: Four studies involving 1642 participants made three eligible comparisons: (i) personal assistance versus usual care, (ii) personal assistance versus nursing homes, and (iii) personal assistance versus 'cluster care'. One was an RCT, three were non-randomised. Personal assistance was generally preferred over other services; however, some people prefer other models of care. This review indicates that personal assistance probably has some benefits for some recipients and caregivers. Paid assistance probably substitutes for informal care and may cost government more than alternatives; however, the total costs to recipients and society are currently unknown. Research in this field is limited. Personal assistance is expensive and difficult to organise, especially in places that do not already have services in place. When implementing new programmes, recipients could be randomly assigned to different forms of assistance. While advocates may support personal assistance for myriad reasons, this review demonstrates that further studies are required to determine which models of personal assistance are most effective and efficient.

Plain-language summary: This review investigated the effectiveness of personal assistance versus any other form of care for older adults (65+). An exhaustive literature search identified 4 studies that met the inclusion criteria, which included 1642 participants. They suggested that personal assistance may be preferred over other services; however, some people prefer other models of care. This review indicates that personal assistance probably has some benefits for some recipients and their informal caregivers. Paid assistance might substitute for informal care and cost government more than alternative arrangements; however, the relative total costs to recipients and society are unknown.
Abstract: Of a total of 216 citations identified by the systematic literature search, we included six randomised controlled trials (reported in nine publications), with a total of 576 participants. We identified a moderate heterogeneity of methodological quality and risk of bias of the included trials. None of the pooled results for our main outcomes of interest showed significant differences: delayed gastric emptying (OR 0.60; 95% CI 0.31 to 1.18; P = 0.14), mortality (RD -0.01; 95% CI -0.03 to 0.02; P = 0.72), postoperative pancreatic fistula (OR 0.98; 95% CI 0.65 to 1.47; P = 0.92), postoperative haemorrhage (OR 0.79; 95% CI 0.38 to 1.65; P = 0.53), intra-abdominal abscess (OR 0.93; 95% CI 0.52 to 1.67; P = 0.82), bile leakage (OR 0.89; 95% CI 0.36 to 2.15; P = 0.79), reoperation rate (OR 0.59; 95% CI 0.27 to 1.31; P = 0.20), and length of hospital stay (MD -0.67; 95%CI -2.85 to 1.51; P = 0.55). Furthermore, the perioperative outcomes duration of operation, intraoperative blood loss and time to NGT removal showed no relevant differences. Only one trial reported quality of life, on a subgroup of participants, also without a significant difference between the two groups at any time point. The overall quality of the evidence was only low to moderate, due to heterogeneity, some inconsistency and risk of bias in the included trials. There was low to moderate quality evidence suggesting no significant differences in morbidity, mortality, length of hospital stay, or quality of life between antecolic and retrocolic reconstruction routes for gastro- or duodenojejunostomy. Due to heterogeneity in definitions of the endpoints between trials, and differences in postoperative management, future research should be based on clearly defined endpoints and standardised perioperative management, to potentially elucidate differences between these two procedures. Novel strategies should be evaluated for prophylaxis and treatment of common complications, such as delayed gastric emptying.

Plain-language summary: We included six randomised controlled trials (reported in nine publications), reporting data on a total of 576 adult participants, who underwent pancreaticoduodenectomy for any pancreatic disease. The evidence is current to September 2015. We did not identify significant differences in delayed gastric emptying; postoperative mortality; postoperative pancreatic fistula, or other complications; reoperations; or length of hospital stay. Quality of life, only reported for a subset of participants in one trial, did not differ between the two groups. Our results do not suggest any relevant differences between antecolic and retrocolic reconstruction of the gastro- or duodenojejunostomy after partial pancreaticoduodenectomy. The quality of the evidence was only low to moderate, due to clinical and statistical differences between individual trials, and risk of bias, due to shortcomings in the way the trials were conducted. Therefore, the results should be viewed with caution.
Abstract: Thirty-one trials involving 17,771 women are included in this review. This review found that folic acid supplementation has no impact on pregnancy outcomes such as preterm birth (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.73 to 1.38; three studies, 2959 participants), and stillbirths/neonatal deaths (RR 1.33, 95% CI 0.96 to 1.85; three studies, 3110 participants). However, improvements were seen in the mean birthweight (mean difference (MD) 135.75, 95% CI 47.85 to 223.68). On the other hand, the review found no impact on improving pre-delivery anaemia (average RR 0.62, 95% CI 0.35 to 1.10; eight studies, 4149 participants; random-effects), mean pre-delivery haemoglobin level (MD -0.03, 95% CI -0.25 to 0.19; 12 studies, 1806 participants), mean pre-delivery serum folate levels (standardised mean difference (SMD) 2.03, 95% CI 0.80 to 3.27; eight studies, 1250 participants; random-effects), and mean pre-delivery red cell folate levels (SMD 1.59, 95% CI -0.07 to 3.26; four studies, 427 participants; random-effects). However, a significant reduction was seen in the incidence of megaloblastic anaemia (RR 0.21, 95% CI 0.11 to 0.38, four studies, 3839 participants). We found no conclusive evidence of benefit of folic acid supplementation during pregnancy on pregnancy outcomes.

Plain-language summary: The review authors found 31 trials (involving 17,771 women) that looked at the impact of providing folic acid supplementation during pregnancy. The data showed that taking folate during pregnancy was not associated with reducing the chance of preterm births, stillbirths, neonatal deaths, low birthweight babies, pre-delivery anaemia in the mother or low pre-delivery red cell folate, although pre-delivery serum levels were improved. The review also did not show any impact of folate supplementation on improving mean birthweight and the mother’s mean haemoglobin levels during pregnancy compared with taking a placebo. However, the review showed some benefit in indicators of folate status in the mother. The evidence provided so far from these trials did not find conclusive results for any overall benefit of folic acid supplementation during pregnancy. Most of the studies were conducted over 30 to 45 years ago.
Abstract: We included 16 studies out of the 243 identified. Most of the included studies showed methodological weaknesses that hamper the strength and reliability of their findings. When fees were introduced or increased, we found the use of health services decreased significantly in most studies. Two studies found increases in health service use when quality improvements were introduced at the same time as user fees. However, these studies have a high risk of bias. We found no evidence of effects on health outcomes or health expenditure. The review suggests that reducing or removing user fees increases the utilisation of certain healthcare services. However, emerging evidence suggests that such a change may have unintended consequences on utilisation of preventive services and service quality. The review also found that introducing or increasing fees can have a negative impact on health services utilisation, although some evidence suggests that when implemented with quality improvements these interventions could be beneficial. Most of the included studies suffered from important methodological weaknesses. More rigorous research is needed to inform debates on the desirability and effects of user fees.

Plain-language summary: The studies in this review took place in 12 different countries. They evaluated either the effects of introducing user fees; removing fees; or increasing or decreasing fees. The studies varied according to the type of health services and the level and nature of payment. While some of the studies looked at the impact of large-scale national reforms, other studies looked at small-scale pilot projects. All of the evidence was of very low quality and the studies showed mixed results: When user fees were introduced or increased: - People’s use of preventive healthcare services decreased. - People’s use of curative services generally decreased. However, when quality improvements were made to the health services at the same time as fees were introduced, people’s use of curative services increased. In addition, poor parts of the population began to use health care services more. When user fees were removed: - There was usually no immediate impact on people’s use of preventive healthcare services. But in several cases, people’s use of these services did increase after some time. - There was some increase in the number of outpatient visits, but no increase in the number of inpatient visits. When user fees were decreased: - There was an increase in the use of preventive and curative healthcare services, ranging from a very small to a large increase. To summarise, results were mixed and the quality of the evidence was very low. We are therefore uncertain about the effects of user fees on health service use.
Abstract: We included seven trials including 521 patients for this review. The sample size in the trials varied from 12 to 180 patients. All the trials were of high risks of systematic errors and of random errors. Four trials included patients who underwent liver resection only. In the remaining three trials, patients underwent combined liver resection with extrahepatic biliary resection resulting in a biliary enteric anastomosis. Four trials included only major liver resection. The remaining three trials included a mixture of major and minor liver resections. It appears that the proportion of cirrhotic patients in the trials was very low. The comparisons performed included whether antibiotics are necessary routinely during the peri-operative period of liver resection, the duration of antibiotics, the use of prebiotics and probiotics in the perioperative period, use of recombinant bactericidal-permeability increasing protein 21 (rBPI21), and the use of topical povidone iodine gel at the time of wound closure. Only one or two trials were included under each comparison. There was no significant differences in mortality or severe morbidity in any of the comparisons. Quality of life was not reported in any of the trials. There is currently no evidence to support or refute the use of any treatment to reduce infectious complications after liver resections. Further well designed trials with low risk of systematic error and low risk of random errors are necessary.

Plain-language summary: We included seven trials involving 521 patients for this review. The number of patients included in the trials varied from 12 to 180. The comparisons performed included whether antibiotics are necessary routinely during the peri-operative period of liver resection, the duration of antibiotics, and the use of other agents to improve the general body resistance to infection. There was no difference in the risk of death or in the major complication rates between the compared groups in any of the comparisons. Quality of life was not reported in any of the trials. All the trials were of high risk of systematic errors (ie, there was a potential to arrive at wrong conclusions because of the way the trial was conducted) and random errors (there was a potential to arrive at wrong conclusions because of play of chance). We are unable to advocate or refute any method of decreasing infectious complications after liver resection. Further well designed trials with low risk of systematic error and low risk of random errors are necessary.
Abstract: Twenty three trials are included, allocation concealment was adequate in nine. Sixteen trials compared artemisinin drugs with quinine in 2653 patients. Artemisinin drugs were associated with better survival (mortality odds ratio 0.61, 95% confidence interval 0.46 to 0.82, random effects model). In trials where concealment of allocation was adequate (2261 patients), this was barely statistically significant (odds ratio 0.72, 95% CI 0.54 to 0.96, random effects model). In 1939 patients with cerebral malaria, mortality was also lower with artemisinin drugs overall (odds ratio 0.63, 95% CI 0.44 to 0.88, random effects model). The difference was not significant however when only trials reporting adequate concealment of allocation were analysed (odds ratio 0.78, 95% CI 0.55 to 1.10, random effects model) based on 1607 patients. No difference in neurological sequelae was shown. Compared with quinine, artemisinin drugs showed faster parasite clearance from the blood and similar adverse effects. The evidence suggests that artemisinin drugs are no worse than quinine in preventing death in severe or complicated malaria. No artemisinin derivative appears to be better than the others. This review summarizes trials up to 1999. For the reasons in the 'What's new' section, this review will no longer be updated.

Plain-language summary: The review shows that treatment with artemisinin drugs may be better than quinine at preventing death in adults and children with severe and complicated malaria. There is no evidence so far against early treatment with suppositories in rural areas whilst patients are transferred to hospital. Few side effects have been reported with these drugs.
Abstract: We included five trials (involving 960 women). In three trials of 471 women, we found no significant differences in the incidence of mastitis between use of antibiotics and no antibiotics (risk ratio (RR) 0.43; 95% confidence interval (CI) 0.11 to 1.61; or in one trial of 99 women comparing two doses (RR 0.38; 95% CI 0.02 to 9.18). We found no significant differences for mastitis in three trials of specialist breastfeeding education with usual care (one trial); anti-secretory factor cereal (one trial); and mupirocin, fusidic acid ointment or breastfeeding advice (one trial). Generally we found no differences in any of the trials for breastfeeding initiation or duration; or symptoms of mastitis. There was insufficient evidence to show effectiveness of any of the interventions, including breastfeeding education, pharmacological treatments and alternative therapies, regarding the occurrence of mastitis or breastfeeding exclusivity and duration. While studies reported the incidence of mastitis, they all used different interventions. Caution needs to be applied when considering the findings of this review as the conclusion is based on studies, often with small sample sizes. An urgent need for further adequately powered research is needed into this area to conclusively determine the effectiveness of these interventions.

Plain-language summary: This review found five randomised controlled trials that involved a total of 960 women. They looked at a variety of preventive interventions including breastfeeding education, taking antibiotic medication, topical ointments and anti-secretory factor cereal. None of the therapies made any difference in reducing breast infections or the length of breastfeeding exclusivity and duration with this limited evidence. Generally studies were of low quality, with limited findings highlighting the need for better quality research in this area.
Abstract: Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most common types of grey literature were abstracts (55%) and unpublished data (30%). There is limited evidence to show whether grey trials are of poorer methodological quality than published trials. This review shows that published trials tend to be larger and show an overall greater treatment effect than grey trials. This has important implications for reviewers who need to ensure they identify grey trials, in order to minimise the risk of introducing bias into their review.

Plain-language summary: This methodology review identified five studies which investigated the effect of including trials found in the grey literature in systematic reviews of health care interventions. They showed that trials found in the published literature tend to be larger and show larger effects of a health care intervention than those trials found in the grey literature. There was limited evidence to show whether grey trials are of poorer methodological quality than published trials. This means that those carrying out systematic reviews need to search for trials in both the published and grey literature in order to help minimise the effects of publication bias in their review.