GEM/cochrane-simplification huggingface dataset:
Abstract: The search for the original version of the review identified 635 unique references. We found 31 references (which reported on 30 studies) in full text after inspection of titles and abstracts, but we excluded them all as they did not meet the inclusion criteria. However, we have included a comprehensive narrative account of studies where we identified an analysis of more than 10 women, as this forms the only evidence base in this rare disease. Surgery continues to be the mainstay of treatment in the current literature, with other treatments limited to case reports or treatment of inoperable or recurrent disease. This update between September 2013 and May 2018 identified 35 new studies. None of these met the inclusion criteria. There was only one prospective study of 5% imiquimod in recurrent Paget's disease of the vulva, which although of good quality only included eight women. Since the last version of the review was published there are many more cases in the literature reporting a clinical response to 5% imiquimod cream. There is one prospective study of eight women treated with 5% imiquimod for recurrent Paget's disease of the vulva, and one prospective trial of 20 women was due to be reported. This increasing evidence for the safety and efficacy of 5% imiquimod will be helpful for women and clinicians alike. Ideally, a multicentre RCT of reasonable size is needed, but ongoing publications of high-quality non-randomised prospective studies will enhance the current available literature.

Plain-language summary: We searched for randomised controlled trials (trials where treatment is allocated to women in a random manner) and well-designed non-randomised studies that compared different treatments in women aged 18 years or older with biopsy-confirmed Paget's disease of the vulva. We searched scientific databases and contacted experts and identified and checked the titles and abstracts of 635 possibly relevant articles and retrieved 31 of these references in full text. However, we found no studies that met our inclusion criteria. We identified several non-randomised studies and drafted a detailed narrative of their results, but these studies were of poor quality and were at high risk of bias. Therefore, there is currently no evidence to determine whether any form of treatment is better or worse in terms of prolonging survival, delaying progression or recurrence, improving QoL or minimising toxicity. The review highlights the need for good-quality studies comparing different interventions for the management of Paget's disease of the vulva. Women and clinicians would value more evidence for guiding surgical and non-surgical management of this disease. In particular, non-invasive medical management would spare women from the side effects and consequences of surgery.
Abstract: Four studies randomising 163 people could be included in the review. It is not clear if brief family intervention reduces the utilisation of health services by patients, as most results are equivocal at long term and only one study reported data for the primary outcomes of interest of hospital admission (n = 30, 1 RCT, RR 0.50, 95% CI 0.22 to 1.11, very low quality evidence). Data for relapse are also equivocal by medium term (n = 40, 1 RCT, RR 0.50, 95% CI 0.10 to 2.43, low quality evidence). However, data for the family outcome of understanding of family member significantly favoured brief family intervention (n = 70, 1 RCT, MD 14.90, 95% CI 7.20 to 22.60, very low quality evidence). No study reported data for other outcomes of interest including days in hospital; adverse events; medication compliance; quality of life or satisfaction with care; or any economic outcomes. The findings of this review are not outstanding due to the size and quality of studies providing data; the analysed outcomes were also minimal, with no meta-analysis possible. All outcomes in the 'Summary of findings' table were rated low or very low quality evidence. However, the importance of brief family intervention should not be dismissed outright, with the present state of demand and resources available. The designs of such brief interventions could be modified to be more effective with larger studies, which may then have enough power to inform clinical practice.

Plain-language summary: This review investigates the effects of brief family intervention for people with schizophrenia, compared to standard or usual care. A search of the Cochrane Schizophrenia Group's trial register was carried out in July 2012. Four randomised studies, with a total of 163 participants were included. Results were limited, so it is not clear if brief family intervention reduces admission to hospital, decreases people using health services and reduces relapse for people with schizophrenia. The review found some evidence that brief family intervention might increase the understanding of family members about mental illness. However, all main findings are not strong and based on low or very low quality evidence. Despite this, the authors of the review suggest that brief family intervention should not be completely dismissed, as it is in a current state of demand and there are usually resources or local services available for people with mental health problems and their families to participate in as a part of recovery. The authors also suggest that brief family intervention could be improved to be more effective but this would depend on larger and better studies of brief family intervention being carried out, which would help guide good practice and lead to better outcomes for people with schizophrenia. This plain language summary has been written by a consumer, Ben Gray, from RETHINK.
Abstract: We included two RCTs (with a total of 789 participants) comparing LMWH with 5-FU infusion and placebo. However, we did not perform a meta-analysis because of significant heterogeneity between these studies. One study found a significant beneficial effect of LMWH with 5-FU in reducing postoperative PVR compared to placebo (RR: 0.48, 95% confidence interval: 0.25 to 0.92), in 174 patients who were viewed at high-risk of developing postoperative PVR. The other study included 615 unselected cases of rhegmatogenous retinal detachment and could not show a difference between LMWH with 5-FU infusion and placebo in reducing PVR rates (RR:1.45, 95% confidence interval: 0.76 to 2.76). Results from this review indicate that there is inconsistent evidence from two studies on patients at different risk of PVR on the effect of LMWH and 5-FU used during vitrectomy to prevent PVR. Future research should be conducted on high risk patients only, until a benefit is confirmed at least in this patient subgroup.

Plain-language summary: The two studies included in this review looked at using LMWH with 5-FU during retinal detachment repair to see if there was an effect of reducing PVR levels after surgery. One study focused on patients who are considered at high-risk of developing PVR after surgery because of pre-existing ocular features, and found beneficial effects of this treatment in this group. The other study looked at a wider group of patients and did not find a benefit in using this combination treatment, and in certain patients the treatment was associated with poorer vision. Due to the inconsistency of the evidence, until further data are available, future research on the use of LMWH with 5-FU should be conducted only in retinal detachment patients who are likely to develop considerable retinal scarring after surgery.
Abstract: We included eleven randomised clinical trials with 1664 participants who were mostly at low anaesthetic risk, low frequency of co-morbidities, low risk of conversion to open surgery, and low risk of infectious complications. None of the trials had low risk of bias. We found no statistically significant differences between antibiotic prophylaxis and no prophylaxis in the proportion of surgical site infections (odds ratio (OR) 0.87, 95% CI 0.49 to 1.54) or extra-abdominal infections (OR 0.77, 95% CI 0.41 to 1.46). Heterogeneity was not statistically significant. This systematic review shows that there is not sufficient evidence to support or refute the use of antibiotic prophylaxis to reduce surgical site infection and global infections in patients with low risk of anaesthetic complications, co-morbidities, conversion to open surgery, and infectious complications, and undergoing elective laparoscopic cholecystectomy. Larger randomised clinical trials with intention-to-treat analysis and patients also at high risk of conversion to open surgery are needed.

Plain-language summary: This meta-analysis of eleven randomised clinical trials could not find sufficient evidence to support or refute the use of antibiotic prophylaxis to reduce surgical site infection or global infections in patients with low anaesthetic risk, low co-morbidities, and low-risk of conversion to open surgery, and undergoing elective laparoscopic cholecystectomy. This is why large and well-designed randomised trials including patients with high-risk of conversion to open surgery should be conducted in order to define the beneficial or harmful effects of the antibiotics when given as a prophylaxis.
Abstract: Two completed and one ongoing clinical trial met the inclusion criteria. One trial (34 patients randomised) examined the effects of H pylori eradication on levodopa absorption and motor symptoms and found significant improvements in both. The ongoing trial has similar objectives and aims to recruit 100 patients. The other completed trial (20 patients analysed) sought to find a causal link between infection with H pylori and Parkinsonism and was non-contributory. A worsening of symptoms was noted with eradication failure. The prevalence of H pylori in Parkinson's disease was reported in four studies and ranged from 37% to 59% which is similar to that of the general population. There is currently a lack of evidence on the effects of screening and treating H pylori in patients with Parkinson's disease. There is limited evidence to suggest that H Pylori eradication improves the absorption of levodopa and improves motor symptoms. Results from an ongoing trial will inform the evidence base and will be incorporated in an update of this review. There is a need for well-conducted randomised controlled trials with standard outcome measures for motor symptoms and incorporating the costs of screening and treatment.

Plain-language summary: We used clinical trials to see if treatment of H pylori-positive Parkinson's disease patients with antibiotics improved the absorption of levodopa and improved their motor symptoms. Only two completed trials were found from our searching. We did not pool these as they had different objectives and used different outcome measures. One of the trials reported a significant increase in levodopa absorption and improvement in motor symptoms when antibiotics were used to eradicate H pylori. The other completed trial did not have any usable results. A further trial of H pylori eradication in Parkinson's disease is still underway and the results, which are due in 2010, will help inform further studies. Very little information was found about H pylori eradication in Parkinson's disease. More clinical trials are needed using standard measures of motor symptoms. It will be important also to look at the cost of both screening for H pylori and treatment of H pylori in Parkinson's disease patients to see if this is worthwhile.
Abstract: We included 13 trials in this review. Eight studies reported data on the Bayley Scales of Infant Development (BSID) in 2134 participants. We combined the data in a meta-analysis to assess the effect on development as measured by the Mental Development Index (MDI) and Psychomotor Development Index (PDI). There was no significant effect of zinc supplementation: the mean difference between the zinc supplementation and placebo groups on the MDI was -0.50 (95% confidence interval (CI) -2.06 to 1.06; P = 0.53; I2 = 70%) and the mean difference between the groups for the PDI was 1.54 (95% CI -2.26 to 5.34; P = 0.43; I2 = 93%). Most studies had low or unclear risk of bias but there was significant heterogeneity, which was not adequately explained by our subgroup analyses. The overall quality of evidence was considered 'moderate'. Two trials provided data on motor milestone attainment. There was no significant difference in the time to attainment of milestones between the placebo group and the zinc supplementation group in either of the studies. No study provided data on cognition score or intelligence quotient (IQ) or on adverse effects of zinc supplementation. There is no convincing evidence that zinc supplementation to infants or children results in improved motor or mental development.

Plain-language summary: The review authors searched the medical literature for studies that evaluated mental and motor development in infants and children randomly assigned to receive either zinc supplements or a 'placebo' (fake) supplement. We found 13 relevant studies. Eight studies measured development using the Mental Development Index and the Psychomotor Development Index of the Bayley Scales of Infant Development. We found no difference between the results for those who had taken zinc supplements and those who had taken a placebo. Two studies measured children's attainment of motor milestones. Again, no difference as found whether zinc supplements were taken or not. No study measured possible side effects of zinc supplementation such as vomiting, diarrhea or anemia. Overall, the results of the studies provided no convincing evidence that zinc supplements had any beneficial effect on mental and motor development in infants and children.
Abstract: We included six RCTs with a total of 248 participants; none of the trials were determined to have overall low risk of bias. We found 12 ongoing trials, from which we were unable to retrieve any data. Only two trials provided data on mortality, and one was a zero event study; thus the meta-analysis showed no statistically significant effect on overall mortality (2.6% vs 9.5%, RR 0.28, 95% CI 0.03 to 2.33). Our analyses on blood transfusion data suggest a beneficial effect of fibrinogen concentrate in reducing the incidence of allogenic transfusions (RR 0.47, 95% CI 0.31 to 0.72) but show no effect on other predefined outcomes, including adverse events such as thrombotic episodes. In the six available RCTs of elective surgery, fibrinogen concentrate appears to reduce transfusion requirements, but the included trials are of low quality with high risk of bias and are underpowered to detect mortality, benefit or harm. Furthermore, data on mortality are lacking, heterogeneity is high and acute or severe bleeding in a non-elective surgical setting remains unexplored. Currently, weak evidence supports the use of fibrinogen concentrate in bleeding patients, as tested here in primarily elective cardiac surgery. More research is urgently needed.

Plain-language summary: In the present Cochrane systematic review, we set out to assess the benefits and harms of fibrinogen concentrate in patients with bleeding. We searched the databases to August 2013, we identified six randomized trials in cardiac and elective surgical settings that compared fibrinogen concentrate (248 participants) with placebo/other sources or no treatment. Additionally, we found 12 ongoing trials, but we were unable to retrieve any data from them. We could not identify beneficial effects of fibrinogen concentrate on patient survival. In our predefined outcomes, we identified a reduced proportion of patients requiring donor blood transfusion. We could not identify reduced blood loss or any harms or adverse events caused by treatment with fibrinogen concentrate. However, all trials were of low quality and were small, so evidence in support of fibrinogen concentrate in patients with bleeding remains weak.
Abstract: Four trials involving 91 infants were included. No difference was detected between intravenous doxapram or methylxanthine in the incidence of failed treatment within 48 hours [typical relative risk 0.91, 95% confidence interval (95% CI) 0.45, 1.85] . Only one trial reported results at 7 days and there was no difference in results. No infants were reported to have been given mechanical ventilation on either treatment. No adverse effects were reported. Intravenous doxapram and intravenous methylxanthine appear to be similar in their short term effects for treating apnea in preterm infants, although these trials are too small to exclude an important difference between the two treatments or to exclude the possibility of less common adverse effects. Long term outcome of infants treated in these trials has not been reported. Further studies would require a large number of infants to clarify whether there might be differences in responses or adverse effects with these two drugs at different ages.

Plain-language summary: The review of four small trials found that there was no large difference between the drugs in the short term. There is not enough evidence to exclude a small difference in benefit, long term effects or a difference in less common adverse effects. More research is needed into the long term and adverse effects of these drugs.
Abstract: Nineteen studies enrolling approximately 5000 preterm and/or LBW infants met inclusion criteria. No new trials were identified in May 2013. When all studies were combined, a significant reduction in sepsis was noted (typical risk ratio (RR) 0.85, 95% confidence interval (CI) 0.74 to 0.98; typical risk difference (RD) -0.03, 95% CI 0.00 to -0.05; number needed to treat for an additional beneficial outcome (NNTB) 33, 95% CI 20 to infinity), and moderate between-study heterogeneity was reported (I2 54% for RR, 55% for RD). A significant reduction of one or more episodes was found for any serious infection when all studies were combined (typical RR 0.82, 95% CI 0.74 to 0.92; typical RD -0.04, 95% CI -0.02 to -0.06; NNTB 25, 95% CI 17 to 50), and moderate between-study heterogeneity was observed (I2 50% for RR, 62% for RD). No statistically significant differences in mortality from all causes were noted (typical RR 0.89, 95% CI 0.75 to 1.05; typical RD -0.01, 95% CI -0.03 to 0.01), and no heterogeneity for RR (I2 = 21%) or low heterogeneity for RD was documented (I2 = 28%). No statistically significant difference was seen in mortality from infection; in incidence of necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) or intraventricular haemorrhage (IVH) or in length of hospital stay. No major adverse effects of IVIG were reported in any of these studies. IVIG administration results in a 3% reduction in sepsis and a 4% reduction in one or more episodes of any serious infection but is not associated with reductions in other clinically important outcomes, including mortality. Prophylactic use of IVIG is not associated with any short-term serious side effects. The decision to use prophylactic IVIG will depend on the costs and the values assigned to the clinical outcomes. There is no justification for conducting additional RCTs to test the efficacy of previously studied IVIG preparations in reducing nosocomial infections in preterm and/or LBW infants.

Plain-language summary: To date, approximately 5000 infants have been enrolled in studies conducted to evaluate the effects of prophylactic use of intravenous immunoglobulin on neonatal outcomes. Intravenous administration of immunoglobulin results in a 3% reduction in blood-borne infection and a 4% reduction in serious infection. Intravenous administration of immunoglobulin is not associated with reductions in other important neonatal outcomes or in length of hospital stay. Most important, intravenous immunoglobulin administration does not have any important effect on mortality. Prophylactic use of IVIG is not associated with any short-term serious side effects. From a clinical perspective, a 3% to 4% reduction in nosocomial infection without a reduction in mortality or other important clinical outcomes is of marginal importance.
Abstract: The review includes seven trials; five on aspects of lifestyle changes (eg, diet, physical exercise) and two on treatment with a weight reduction drug 'orlistat'. In total, 373 participants were enrolled, and the duration of the trials ranged from 1 month to 1 year. Only one trial on lifestyle programme was judged to be of low risk of bias. We could not perform meta-analyses for the main outcomes as they were either not reported or there were insufficient number of trials for each outcome to be meta-analysed. We could meta-analyse the available data for body weight and body mass index only. Adverse events were poorly reported. The sparse data and high risk of bias preclude us from drawing any definite conclusion on lifestyle programme or orlistat for treatment of NAFLD. Further randomised clinical trials with low risk of bias are needed to test the beneficial and harmful effects of weight reduction for NAFLD patients. The long-term prognosis of development of fibrosis, mortality, and quality of life should be studied.

Plain-language summary: We performed this systematic review to investigate the beneficial and harmful effects of weight reduction with different measures for NAFLD patients, but we could not find firm evidence. Five trials on lifestyle programme and two trials on orlistat were obtained, and all but one had high risk of bias. There seemed to be some beneficial effects of lifestyle programme involving restricted diet and physical exercise for NAFLD patients. However, the data were sparse, and meta-analyses could not be performed. Well-designed randomised clinical trials are needed to establish the true effect of the weight reduction measures identified for our review. The long-term prognosis of development of fibrosis, mortality, and quality of life modified by weight reduction should be studied. Special attention should be paid to the amount of weight loss.
Abstract: Eight trials involving 3417 people were included. AA may help patients to accept treatment and keep patients in treatment more than alternative treatments, though the evidence for this is from one small study that combined AA with other interventions and should not be regarded as conclusive. Other studies reported similar retention rates regardless of treatment group. Three studies compared AA combined with other interventions against other treatments and found few differences in the amount of drinks and percentage of drinking days. Severity of addiction and drinking consequence did not seem to be differentially influenced by TSF versus comparison treatment interventions, and no conclusive differences in treatment drop out rates were reported. Included studies did not allow a conclusive assessment of the effect of TSF in promoting complete abstinence. No experimental studies unequivocally demonstrated the effectiveness of AA or TSF approaches for reducing alcohol dependence or problems. One large study focused on the prognostic factors associated with interventions that were assumed to be successful rather than on the effectiveness of interventions themselves, so more efficacy studies are needed.

Plain-language summary: The available experimental studies did not demonstrate the effectiveness of AA or other 12-step approaches in reducing alcohol use and achieving abstinence compared with other treatments, but there were some limitations with these studies. Furthermore, many different interventions were often compared in the same study and too many hypotheses were tested at the same time to identify factors which determine treatment success.