GEM/cochrane-simplification huggingface dataset:
Abstract: We included two trials enrolling 624 women in the review. It is uncertain whether breast surgery improves overall survival as the quality of the evidence has been assessed as very low (HR 0.83, 95% CI 0.53 to 1.31; 2 studies; 624 women). The two studies did not report quality of life. Breast surgery may improve local progression-free survival (HR 0.22, 95% CI 0.08 to 0.57; 2 studies; 607 women; low-quality evidence), while it probably worsened distant progression-free survival (HR 1.42, 95% CI 1.08 to 1.86; 1 study; 350 women; moderate-quality evidence). The two included studies did not measure breast cancer-specific survival. Toxicity from local therapy was reported by 30-day mortality and did not appear to differ between the two groups (RR 0.99, 95% CI 0.14 to 6.90; 1 study; 274 women; low-quality evidence). Based on existing evidence from two randomised clinical trials, it is not possible to make definitive conclusions on the benefits and risks of breast surgery associated with systemic treatment for women diagnosed with metastatic breast cancer. Until the ongoing clinical trials are finalised, the decision to perform breast surgery in these women should be individualised and shared between the physician and the patient considering the potential risks, benefits, and costs of each intervention.

Plain-language summary: The evidence is current to February 2016. We included only randomised clinical trials, as they are considered to be the best type of scientific study to answer questions about treatment, that compared the survival of women undergoing breast surgery combined with medical treatment versus medical treatment alone. We identified and included two randomised controlled trials involving a total of 624 women: 311 women underwent breast surgery plus medical treatment, and 313 women only received medical treatment. The review authors are uncertain whether breast surgery improves overall survival as the quality of the evidence has been assessed as very low. The included studies did not report any information relating to quality of life. Breast surgery may improve the control of local disease but it probably worsened control at distant sites. The two included studies did not measure breast cancer-specific survival. Toxicity from local therapy appeared to be the same in the group undergoing breast surgery combined with medical treatment and in the group receiving only medical treatment. It is not possible to make definitive conclusions about the benefits of breast surgery associated with medical treatment for women with metastatic breast cancer. The decision to perform surgery in such cases should be individualised and shared between the physician and the patient, considering the potential risks and benefits involved in this choice. The inclusion of results of ongoing trials involving women with these characteristics in the next update of this review will help to decrease existing uncertainties.
Abstract: Ten studies (786 patients) were included. Mupirocin ointment reduced the risk of catheter-related bacteraemia (RR 0.17, 95%CI 0.07 to 0.43) and had a significant effect on catheter-related infections caused by S. aureus. The risk of catheter-related bacteraemia was reduced by polysporin (RR 0.40, 95%CI 0.19 to 0.86) and povidone-iodine ointment (RR 0.10, 95%CI 0.01 to 0.72). Subgroup analysis suggested mupirocin (RR 0.12, 95%CI 0.01 to 2.13) and povidone-iodine ointment (RR 0.84, 95%CI 0.24 to 2.98) had no effect on all-cause mortality while polysporin ointment showed a significant reduction (RR 0.22, 95%CI 0.07 to 0.74). Mortality related to infection was not reduced by mupirocin, polysporin or povidone-iodine ointment. Topical honey did not reduce the risk of exit site infection (RR 0.45, 95%CI 0.10 to 2.11) or catheter-related bacteraemia (RR 0.80, 95%CI 0.37 to 1.73). Transparent polyurethane dressing compared to dry gauze dressing did not reduce the risk of CVC or exit site infection, or catheter-related bacteraemia. Mupirocin ointment appears effective in reducing the risk of catheter-related bacteraemia. Insufficient reporting on mupirocin resistance was noted and needs to be considered in future studies. A lack of high quality data on the routine use of povidone-iodine ointment, polysporin ointment and topical honey warrant larger RCTs. Insufficient data were available to determine which dressing type (transparent polyurethane or dry gauze dressing) has the lowest risk of catheter-related infections.

Plain-language summary: The review of 10 studies (786 patients) found that mupirocin ointment reduced the risk of patients developing catheter-related bacteraemia (bacteria in the blood). However, monitoring of mupirocin resistance needs to be considered in future studies. There was not enough evidence to determine which ointment (povidone-iodine and polysporin) or dressing was the best in preventing infection. There was also insufficient evidence to support the use of medicinal honey for the prevention of infection.
Abstract: We identified one RCT which met our inclusion criteria and was included in this review. Sixty-three participants with primary involutional lower eyelid entropion were randomised to everting sutures alone or everting sutures with a lateral tarsal strip. Eight participants were lost to follow-up. The trial indicates that the combined procedure for horizontal and vertical eyelid tightening in the form of everting sutures and lateral tarsal strip is highly curative for involutional entropion compared to vertical tightening in the form of everting sutures alone. The superiority of the combined approach is also supported by many good quality uncontrolled studies on specific surgical procedures but these were not included in the analysis as they were not part of the inclusion criteria. A single RCT showed that the combination of horizontal and vertical eyelid tightening with everting sutures and lateral tarsal strip is highly efficient for entropion compared to vertical tightening with everting sutures alone. Retrospective case series studies also support the combined surgical repair but details from these studies on specific surgical techniques cannot be included in the analysis. Evidence from a single RCT is unlikely to change clinical practice and thus it is still our view that there is a clear need for more randomised studies comparing two or more surgical techniques for entropion surgery addressing the recurrence and complications rate.

Plain-language summary: The review authors searched the medical literature and found a single trial that met the inclusion criteria of the review. Sixty-three participants with lower eyelid entropion were enrolled and randomised to either everting sutures alone or everting sutures and a lateral tarsal strip. Eight participants were lost to follow-up. The trial showed that the combination of horizontal and vertical eyelid tightening with everting sutures and lateral tarsal strip is highly efficient for entropion compared to vertical tightening with everting sutures alone. Further research is needed to provide more credible evidence for the comparison of surgical treatments to correct an inward turning eyelid.
Abstract: No randomised controlled trials or controlled trials were found that examined the efficacy of non-pharmacological swallowing therapy for the treatment of dysphagia in Parkinson's disease. However there is one large RCT currently recruiting patients that will compare 'chin down' posture with thickened liquids in the treatment of dysphagia. The main outcomes will be the rates of aspiration and pneumonia. There is currently no evidence to support or refute the efficacy of non-pharmacological swallowing therapy for dysphagia in Parkinson's disease. Large well designed placebo-controlled RCTs are required to assess the effectiveness of swallowing therapy for dysphagia in Parkinson's disease and reported according to CONSORT guidelines. Suitable outcome measures should be chosen so that the efficacy and effectiveness of non-pharmacological swallowing therapy can be assessed and an economic analysis performed. Outcomes which have meaning to patients and carers should be used wherever possible since they need to know the value of this therapy in practical terms. The patients should be followed for at least 6 months to determine the duration of any improvement.

Plain-language summary: Only randomised controlled trials (RCT) were eligible for this review. In RCTs the patients are assigned to each of the groups in a random fashion so as to reduce the potential for bias. Either one group of patients had swallowing therapy, the other had a sham treatment or no treatment, or two forms of swallowing therapy were compared to each other. There were no controlled trials, randomised or otherwise, in this field. Therefore there is no trial evidence to prove or disprove the benefit of swallowing therapy for the treatment of swallowing disorders in people with Parkinson's disease. It should be emphasised that this lack of evidence does not mean lack of effect. There is one large RCT currently recruiting patients that will compare 'chin down' posture with thickened liquids in the treatment of dysphagia. The main outcomes in this study will be the rates of aspiration and pneumonia. Large well designed placebo-controlled RCTs are needed to assess the effectiveness of swallowing therapy for swallowing disorders in Parkinson's disease. The design of the trials should minimise bias and be reported fully using CONSORT guidelines. Outcome measures with particular relevance to patients should be chosen and the patients followed for at least 6 months to determine the duration of any improvement.
Abstract: The four trials examining tracheostomy-free survival included a total of 974 riluzole-treated patients and 503 placebo-treated patients. No new randomized controlled trials were found when we updated the searches for this update in 2011. The methodological quality was acceptable and three trials were easily comparable, although one trial (169 participants) included older patients in more advanced stages of amyotrophic lateral sclerosis and one (195 participants) had multiple primary endpoints. Riluzole 100 mg per day provided a benefit for the homogeneous group of patients in the first two trials (hazard ratio (HR) 0.80, 95% confidence internal (CI) 0.64 to 0.99, P= 0.042) and there was no evidence of heterogeneity (P = 0.33). When the third trial (which included older and more seriously affected patients) was added, there was evidence of heterogeneity (P < 0.0001) and the overall treatment effect was reduced but still significant (HR 0.84, 95% CI 0.698 to 0.997, P= 0.046). This represented a 9% gain in the probability of surviving one year (49% in the placebo and 58% in the riluzole group), and increased median survival from 11.8 to 14.8 months. There was a small beneficial effect on both bulbar and limb function, but not on muscle strength. A three-fold increase in serum alanine transferase was more frequent in riluzole-treated patients than controls (mean difference 2.62, 95% CI 1.59 to 4.31). Riluzole 100 mg daily is reasonably safe and probably prolongs median survival by about two to three months in patients with amyotrophic lateral sclerosis.

Plain-language summary: In this review, we examine the evidence from four randomized clinical trials involving 1477 people with ALS. The methodological quality of the trials was acceptable and three of the trials were easily comparable (although one of them included older patients with more advanced ALS). The searches for this review were last updated in 2011, when we found no new randomized controlled trials. The results indicate that riluzole 100 mg probably prolongs median survival in people with ALS by two to three months and the safety of the drug is not a major concern. The evidence from randomized controlled trials indicates that participants taking riluzole probably survive longer than participants taking placebo. The beneficial effects are very modest and the drug is expensive. There was a small beneficial effect on both bulbar and limb function, but not on muscle strength. Adverse effects from riluzole are relatively minor and for the most part reversible after stopping the drug.
Abstract: We included four studies with 166 participants. No studies compared the effects of home-based upper limb therapy programmes with placebo or no intervention. Three studies compared the effects of home-based upper limb therapy programmes with usual care. Primary outcomes: we found no statistically significant result for performance of ADL (mean difference (MD) 2.85; 95% confidence interval (CI) -1.43 to 7.14) or functional movement of the upper limb (MD 2.25; 95% CI -0.24 to 4.73)). Secondary outcomes: no statistically significant results for extended ADL (MD 0.83; 95% CI -0.51 to 2.17)) or upper limb motor impairment (MD 1.46; 95% CI -0.58 to 3.51). One study compared the effects of a home-based upper limb programme with the same upper limb programme based in hospital, measuring upper limb motor impairment only; we found no statistically significant difference between groups (MD 0.60; 95% CI -8.94 to 10.14). There is insufficient good quality evidence to make recommendations about the relative effect of home-based therapy programmes compared with placebo, no intervention or usual care.

Plain-language summary: This review of four studies with 166 relevant participants, looked at whether participating in home-based therapy programmes, targeted at the upper limb, could improve performance in activities of daily living (ADL), functional movement of the upper limb, performance in extended ADL and arm motor impairment. In comparison with usual care, home-based upper limb programmes had no difference in effect on any of the outcomes. In comparison with an upper limb programme based in hospital, we found home-based upper limb programmes to be no more or no less effective for arm motor impairment outcomes. The evidence in this area is limited. Further research is needed to determine the effects of home-based therapy programmes.
Abstract: Thirteen trials involving 269 people were included. All trials compared EMG-BFB plus standard physiotherapy to standard physiotherapy either alone or with sham EMG-BFB. Only one study used a motor strength assessment scale for evaluation of patients, which indicated benefit from EMG-BFB (WMD 1.09, 95% CI 0.48 to 1.70). EMG-BFB did not have a significant benefit in improving range of motion (ROM) through the ankle (SMD 0.05, 95% CI -0.36 to 0.46), knee or wrist joints. However, one trial suggested a benefit in ROM at the shoulder (SMD 0.88, 95% CI 0.07 to 1.70). Change in stride length or gait speed was not improved by EMG-BFB. Two studies used different assessment scores to quantify gait quality. One of these suggested a beneficial effect of EMG-BFB (SMD 0.90, 95% CI 0.01 to 1.78). Most of the studies examining functional outcomes used different assessment scales, which made meta-analysis impossible. Two studies that used the same scale did show a beneficial effect (SMD 0.69, 95% CI 0.15 to 1.23). Despite evidence from a small number of individual studies to suggest that EMG-BFB plus standard physiotherapy produces improvements in motor power, functional recovery and gait quality when compared to standard physiotherapy alone, combination of all the identified studies did not find a treatment benefit. Overall the results are limited because the trials were small, generally poorly designed and utilised varying outcome measures.

Plain-language summary: Amongst the 13 studies identified, there was a small amount of evidence to suggest that EMG-BFB had a beneficial effect when used with standard physiotherapy techniques. However EMG-BFB cannot currently be recommended as an effective routine treatment because other studies found no effect, and the positive trials were small.
Abstract: We identified 11 trials for inclusion in the review. All trials were small (total participants 665) and had various methodological limitations including uncertainty about methods to ensure allocation concealment and blinding. Most participants were clinically stable preterm infants of less than about 34 weeks' gestational age or with birth weight less than about 1750 g. Fewer participants were extremely preterm, extremely low birth weight, or growth restricted. Most trials found no effects on feed intolerance, assessed variously as mean pre-feed gastric residual volume, incidence of abdominal distension or other gastrointestinal signs of concern, or time taken to achieve full enteral feeds (meta-analysis was limited because studies used different measures). Meta-analysis showed no effect on the risk of necrotising enterocolitis (typical risk ratio 1.10, 95% CI 0.36 to 3.34; risk difference 0.00, 95% CI -0.03 to 0.04; 5 trials, 385 infants) (low-certainty evidence; downgraded for imprecision and design weaknesses). The identified trials provide only low-certainty evidence about the effects of feeding preterm infants protein hydrolysate versus standard formula. Existing data do not support conclusions that feeding protein hydrolysate affects the risk of feed intolerance or necrotising enterocolitis. Additional large, pragmatic trials are needed to provide more reliable and precise estimates of effectiveness and cost-effectiveness.

Plain-language summary: In searches of medical databases up to 28 January 2019, we found 11 relevant trials; most were small (involving 665 infants in total) and had methodological weaknesses. Currently available evidence suggests that feeding preterm infants hydrolysed formula (rather than standard formula) during their initial hospital admission has no important benefits or harms. However, this finding is not yet conclusive, and larger trials of better quality are needed to provide evidence to help clinicians and families make informed choices about this issue. Data from these trials provide no strong or consistent evidence that feeding preterm infants hydrolysed formula rather than standard formula improved or worsened digestion or changed the risk of severe bowel problems.
Abstract: No new trials were identified for inclusion in this update. We identified 12 trials for inclusion, 10 of which contributed outcomes data. There were a total of 6820 participants. In trials of healthy children living in low-income communities, two trials did not demonstrate a significant difference between the zinc-supplemented and placebo groups in the numbers of participants experiencing an episode of definite otitis media during follow-up (3191 participants); another trial showed a significantly lower incidence rate of otitis media in the zinc group (rate ratio 0.69, 95% confidence interval (CI) 0.61 to 0.79, n = 1621). A small trial of 39 infants undergoing treatment for severe malnutrition suggested a benefit of zinc for the mean number of episodes of otitis media (mean difference (MD) -1.12 episodes, 95% CI -2.21 to -0.03). Zinc supplements did not seem to cause any serious adverse events but a small minority of children were reported to have vomited shortly after ingestion of the supplements. The trial evidence included is generally of good quality, with a low risk of bias. Evidence on whether zinc supplementation can reduce the incidence of otitis media in healthy children under the age of five years living in low- and middle-income countries is mixed. There is some evidence of benefit in children being treated for marasmus (severe malnutrition), but this is based on one small trial and should therefore be treated with caution.

Plain-language summary: The review authors searched the medical literature for studies up to March 2014. We searched for trials which compared middle ear infections in people randomly selected to receive zinc supplements or who did not receive supplements. We found 10 eligible studies, all conducted amongst young children. The total number of participants was 6820. Nine trials were conducted in low- and middle-income countries. Seven trials were conducted on healthy children. Participants included both males and females. The results of the trials provided no convincing evidence that zinc supplements reduce the occurrence of middle ear infections in healthy children. However, in one small study of severely malnourished children, those receiving zinc supplements had fewer middle ear infections. The only adverse effect was vomiting. The trial evidence included is generally of good quality, with a low risk of bias. All the included trials included otitis media only as a secondary outcome. Therefore, there was a potential to miss trials which were less publicised or less well indexed within the electronic databases.
Abstract: All nine identified trials compared different types of contraceptive implant. Eight, involving 1578 women, compared Implanon with Norplant , and one, involving 1198 women, compared Jadelle with Norplant. There was no difference between Implanon and Norplant for contraceptive effectiveness rates or continuation over 4 years. Both were highly effective methods of contraception with no pregnancies occurring in any of the trials during 26,972 and 28,108 women months of follow up respectively. The most common side-effect with Implanon and Norplant was changes in bleeding pattern. The pattern with Implanon was initially more variable, bleeding with both implants became less frequent with duration of use. After two years use the amenorrhoea rate was significantly higher with Implanon. The trials reported no significant difference in hormonal side-effects or adverse events. Implanon was significantly quicker to insert and remove than Norplant.  There was no difference in contraceptive effectiveness and in continuation rates between Jadelle and Norplant. Jadelle was significantly quicker to remove than Norplant. Implanon, Norplant and Jadelle are highly effective contraceptive methods. No significant differences were found in contraceptive effectiveness or continuation. The most common side-effect with all implants was unpredictable vaginal bleeding. Time taken for removal of Implanon and Jadelle was less than that for Norplant.  Although this systematic review was unable to provide a definitive answer on relative effectiveness, tolerability and acceptability of contraceptive implants in comparison to other contraceptive methods, it has raised issues around the conduct of contraceptive research.

Plain-language summary: All the trials identified compared different types of contraceptive implant. No trials were found that compared implants to other contraceptive methods. All the implants were highly effective methods of contraception in the selected women. The majority of women using contraceptive implants chose to continue with the method long term, over 80% of women were still using their implant at two years. Women in developed country studies were less likely to continue with these methods when compared to women in developing country studies. The most common reported side -effect was of irregular vaginal bleeding. Bleeding with all implants became less frequent with time. Removal was quicker for Implanon and Jadelle than for Norplant. Insertion problems were rare with any of the implants. Problems at removal were uncommon but were significantly more likely to occur in Norplant users than Implanon users.