GEM/cochrane-simplification huggingface dataset:
Abstract: Among 409 retrieved references, we identified 16 RCTs; six of them, published between 1987 and 2007, met the selection criteria and were included in this review. Five hundred and forty RR patients and 1049 PMS contributed to the analysis. In RR MS, a decrease in the mean EDSS score (-0.33 and -0.45), was found respectively at 2 years and 35 months without any significant effect on sustained disease progression. The reduction of mean number of relapse was evident at 1 year (-0.35 ) 2 years (-0.51 ) and 35 months (-0.64), but significant studies ' heterogeneity was found. The number of hospitalisations and steroid courses were significantly reduced. No benefit was shown in P MS patients. No major toxicity was found. The most common systemic adverse event was a transient and self-limiting patterned reaction of flushing, chest tightness, sweating, palpitations, anxiety. Local injection-site reactions were observed in up to a half of patients treated with glatiramer acetate, thus making a blind assessment of outcomes questionable. Glatiramer acetate did show a partial efficacy in RR MS in term of relapse -related clinical outcomes, without any significant effect on clinical progression of disease measured as sustained disability. The drug is not effective in progressive MS patients.

Plain-language summary: Previous studies indicate that glatiramer acetate, a synthetic drug, is effective in animal models of MS, and shows some benefits in MS patients. The objective of this review was to assess the efficacy of glatiramer acetate in RRMS and PMS patients. Among the pertinent medical literature six studies met the criteria of the methodological quality necessary for their inclusion in this review. 540 RRMS patients and 1049 PMS patients contributed to this analysis. The data showed no beneficial effects on disease progression in both MS forms, a slight beneficial effect  in the reduction of risk of relapses in RRMS patients and no benefits in PMS patients. Adverse events such as flushing, chest tightness, sweating, palpitations, anxiety and  local injection-site reactions occurred quite frequently, but no major adverse effects were observed.
Abstract: The 2005 update includes a new trial (Kuriyama 2002) to bring the total of included studies to three (total n=33). One study, which used a cross-over design (Tolbert 1993) provided insufficient data to conduct an analysis. Another crossover study (Findling 1997) yielded no significant differences between treatment and placebo group performances following the B6 intervention on measures of social interaction, communication, compulsivity, impulsivity, or hyperactivity. The latest study (Kuriyama 2002) was motivated by evidence from epilepsy research and was focussed on a subgroup of children with pervasive developmental disorders (PDDs) who exhibited clinical features similar to those with pyroxidine-dependent epilepsy. This small study (n=8) only measured IQ and 'Social Quotient' and found a statistically significant benefit for IQ (5.2, 95% CI = [0.2 to 10.3]) when in the treated group, by using change scores. Due to the small number of studies, the methodological quality of studies, and small sample sizes, no recommendation can be advanced regarding the use of B6-Mg as a treatment for autism.

Plain-language summary: Studies investigating the effect of vitamin B6 in improving the behaviour of children with autism spectrum disorder have been reported for over three decades. The purpose of this review was to summarize those studies and analyse the effectiveness of vitamin B6 as an intervention. Only three studies met the inclusion criteria of this review and of these only one study reported adequate data for analysis. Results were inconclusive and sample sizes were small. Therefore the use of vitamin B6 for improving the behaviour of individuals with autism cannot currently be supported. Further research using larger, well-designed trials is needed.
Abstract: This review detected 36 eligible randomized controlled trials involving four major groups of developmental care interventions, 19 sub-groups and multiple clinical outcomes. In addition, the long-term outcomes of a previously included trial were added to the review. The results of the review indicate that developmental care interventions demonstrate limited benefit to preterm infants with respect to: decreased moderate-severe chronic lung disease, decreased incidence of necrotizing enterocolitis and improved family outcome. Conversely, an increase in mild lung disease and an increase in the length of stay were demonstrated in infants receiving developmental care compared to controls. There is also very limited evidence of the long-term positive effect of NIDCAP on behavior and movement at 5 years corrected age but no effect on cognition. Other individualized developmental care interventions have also demonstrated some effect in enhancing neurodevelopmental outcome. Although a limited number of other benefits were demonstrated, those results were from single studies with small sample sizes. The lack of blinding of the assessors was a significant methodological flaw in half of the studies. The cost of the interventions and personnel was not considered in any of the studies. Because of the inclusion of multiple interventions in most studies, the determination of the effect of any single intervention is difficult. Although there is evidence of limited benefit of developmental care interventions overall, and no major harmful effects reported, there were a large number of outcomes for which no or conflicting effects were demonstrated. The single trials that did show a significant effect of an intervention on a major clinical outcome were based on small sample sizes, and the findings were often not supported in other small trials. Before a clear direction for practice can be supported, evidence demonstrating more consistent effects of developmental care interventions on important short- and long-term clinical outcomes is needed. The economic impact of the implementation and maintenance of developmental care practices should be considered by individual institutions.

Plain-language summary: The review of trials suggests that these interventions may have some benefit to the outcomes of preterm infants; however, there continues to be conflicting evidence among the multiple studies. Before a clear direction for practice can be supported, evidence demonstrating more consistent effects of developmental care interventions on important short- and long-term clinical outcomes is needed. The economic impact of the implementation and maintenance of developmental care practices should be considered by individual institutions.
Abstract: Eight studies with 343 participants were included. The review found evidence for lower post-treatment OCD severity and reduced risk of continuing with OCD for the BT/CBT group compared to pill placebo or wait-list comparisons. There was no evidence found that the efficacy of BT/CBT alone and medication alone differ in terms of post treatment symptom severity or in the risk of having OCD. There was some evidence of a benefit for combined BT/CBT and medication compared to medication alone but not relative to BT/CBT alone. The low rates of drop out suggested BT/CBT is an acceptable treatment to child and adolescent patients and their families. Although only based on a small number of studies which vary in quality, behavioural or cognitive-behaviour therapy alone appears to be an effective treatment for OCD in children and adolescents. It is as effective as medication alone and may lead to better outcomes when combined with medication compared to medication alone. Additional higher quality trials are needed to confirm these findings.

Plain-language summary: This review identified eight randomised controlled trials involving 343 participants, evaluating the benefits of behavioural and cognitive-behavioural therapy. The results show that, compared to a wait-list or pill placebo, BT/CBT is an effective treatment for reducing OCD symptoms and lowering the risk of having OCD after treatment. Based on three studies that directly compared BT/CBT with medication, there was no current evidence to suggest that either BT/CBT or medication was superior to the other. When combined with medication, BT/CBT produces better outcomes than medication alone. Although based on a small number of studies, these findings provide support for the value of BT/CBT in the treatment of children and adolescents with OCD.
Abstract: We identified only one randomised controlled trial, which compared open surgery and radiotherapy in 234 patients with early glottic laryngeal cancer. The overall risk of bias in this study was high. For T1 tumours, the five-year survival was 91.7% following radiotherapy and 100% following surgery and for T2 tumours, 88.8% following radiotherapy and 97.4% following surgery. There were no significant differences in survival between the two groups. For T1 tumours, the five-year disease-free survival rate was 71.1% following radiotherapy and 100.0% following surgery, and for the T2 tumours, 60.1% following radiotherapy and 78.7% following surgery. Only the latter comparison was statistically significant (P value = 0.036), but statistical significance would not have been achieved with a two-sided test. Data were not available on side effects, quality of life, voice outcomes or cost. We identified no randomised controlled trials that included endolaryngeal surgery. A number of trials comparing endolaryngeal resection and radiotherapy have terminated early because of difficulty recruiting participants. One randomised controlled trial is still ongoing. There is only one randomised controlled trial comparing open surgery and radiotherapy but its interpretation is limited because of concerns about the adequacy of treatment regimens and deficiencies in the reporting of the study design and analysis.

Plain-language summary: This review of trials identified just one trial including 234 patients with early glottic cancer, which compared radiotherapy to open surgery. This was a multicentre randomised controlled trial undertaken in the former Soviet Union, Hungary and Czechoslovakia. Patients were followed up for five years and recurrence-free and survival rates were measured. The results of this trial showed that there was no significant difference in survival between patients treated with radiotherapy or open surgery. Further data from trials comparing radiotherapy and endolaryngeal surgery are needed to determine the best way of treating early laryngeal cancer, however a number of studies have been abandoned because of difficulties in recruiting participants. One trial is still ongoing. We found that there is not enough evidence to show which form of treatment might be better for people with early-stage larynx cancer. The included study is of low quality. The evidence in this review is up to date to September 2014.
Abstract: Ten studies were found including 366 patients in total. We included eight studies in the as-published data analysis, comprising 337 patients . The methodological quality of the studies was overall satisfactory, however there was potential for introduction of significant bias in several specific areas relating to performance of the index test and to the timing of index versus reference tests. Results demonstrated a sensitivity estimate of 0.84 (95% confidence interval (CI) 0.69 to 0.93). The 95% approximate prediction interval was very wide (0.34 to 0.98). Data in three studies were available as a four-vessel interpretation model and the data could be re-analysed to a four-vessel interpretation model in a further five studies, comprising 314 patient events. Results demonstrated a similar sensitivity estimate of 0.85 (95% CI 0.77 to 0.91) but with an improved 95% approximate prediction interval (0.56 to 0.96). The available evidence cannot support the use of CT angiography as a mandatory test, or as a complete replacement for neurological testing, in the management pathway of patients who are suspected to be clinically brain dead. CT angiography may be useful as a confirmatory or add-on test following a clinical diagnosis of death, assuming that clinicians are aware of the relatively low overall sensitivity. Consensus on a standard radiological interpretation protocol for future published studies would facilitate further meta-analysis.

Plain-language summary: Ten studies were found, including 366 patients in total. Most of the studies were performed in intensive care departments but involved only small numbers of patients. In most studies it would be possible for the doctors performing the CTA test to already know the results of the clinical test. This might affect the study results, however this situation would also be the case in normal medical practice. Methods used to report the CTA study also varied from study to study and so the published results were re-analysed to take this into account. When compared to clinical testing for brain death, the CTA test had a sensitivity of 0.85. This means that in 100 cases of patients satisfying the clinical tests for death, the CTA test will correctly identify 85 of the cases. The data also showed that this might be as few as 77 cases per 100 and as many as 91 cases per 100. Our review was unable to tell us how many patients the CTA might falsely give a diagnosis of death for, when the patient was not dead. Based on these results, it appears that CTA is not good enough to be a compulsory test.
Abstract: The search identified 2178 citations, 28 of which were considered potentially relevant. After independent review of the full text of these studies, no eligible studies were identified for inclusion in this review due to the absence of studies with a randomised controlled study design. There was no evidence available to support conclusions about the effectiveness of nursing handover styles for ensuring continuity of information in hospitalised patients because we found no studies that fulfilled the methodological criteria for this review. As a consequence, uncertainty about the most effective practice remains. Research efforts should focus on strengthening the evidence abut the effectiveness of nursing handover styles using well designed, rigorous studies. According to current knowledge, the following guiding principles can be applied when redesigning the nursing handover process: face-to-face communication, structured documentation, patient involvement and use of IT technology to support the process.

Plain-language summary: This review tried to find out which nursing handover style works best. In March 2013 the review authors conducted a wide search for suitable relevant studies (randomised controlled studies) that compared different styles of nursing handover. However, they were not able to identify any randomised controlled studies that investigated the question, and so could draw no conclusions. Further research in this area is urgently needed.
Abstract: We included 5 randomised trials with 662 participants out of 93 publications identified through the literature searches. The number of deaths was 47 in the wait-and-see group (334 patients) compared to 26 in the prophylactic cholecystectomy group (328 patients) for a 78% increased risk of mortality (RR 1.78, 95% CI 1.15 to 2.75, P = 0.010). The survival benefit of prophylactic cholecystectomy was independent of trial design, inclusion of high risk patients or inclusion of any one of the five trials. Patients in the wait-and-see group had higher rates of recurrent biliary pain (RR 14.56, 95% CI 4.95 to 42.78, P < 00001), jaundice or cholangitis (RR 2.53, 95% CI 1.09 to 5.87, P = 0.03), and of repeat ERCP or other forms of cholangiography (RR 2.36, 95% CI 1.29 to 4.32, P = 0.005). Cholecystectomy was eventually performed in 35% (115 patients) of the wait-and-see group. Prophylactic cholecystectomy should be offered to patients whose gallbladders remain in-situ after endoscopic sphincterotomy and common bile duct clearance.

Plain-language summary: We included 5 randomised trials with 662 participants out of 93 publications identified through the literature searches. The number of deaths was 47 in the wait-and-see group (334 patients) compared with 26 in the prophylactic cholecystectomy group (328 patients). This review of randomised clinical trials suggests that early removal of the gallbladder decreases the risk of death or of complications from gallstones. The number of patients (662) reviewed in this report prevents some of the subgroup analyses from being conclusive. Further clinical trials, particularly of high-risk patients, would solve this problem.
Abstract: Two studies (involving 286 women) from amniocentesis (but none from CVS) compared the impact of communicating results of rapid testing with waiting for definitive karyotype. Unfortunately, it was not possible to perform pooled analysis because one study reported only median (interquartile range) data, presumably because the data were not normally distributed. One study reported a statistically significant reduction in the average anxiety during the waiting period for women who had had a rapid test compared with those who had not (mean difference (MD) -2.30, 95% confidence intervals (CI) -3.08 to - 1.52). The other study compared median (interquartile range) for the trait- and state-anxiety scores and found no difference between the two groups. We found no conclusive evidence that, while waiting for the full karyotype following amniocentesis, issuing results from a rapid analysis reduces maternal anxiety. The limited evidence from the two trials included in this review does not help resolve the dilemma about whether full karyotyping should be abandoned in favour of limited rapid testing for women undergoing Down's syndrome screening. This choice will rest on clinical arguments and cost-effectiveness rather than impact on anxiety. There is also no evidence to support the view that issuing amniocentesis results as soon as they are available is more user friendly than using a pre-defined fixed date. Studies evaluating the effect of different strategies for disclosing results on women anxiety for CVS are needed.

Plain-language summary: One study reported a statistically significant reduction in the average anxiety during the waiting period for women who had had a rapid test, but the other found no difference between the two groups. There was also no evidence to support the view that issuing amniocentesis results as soon as they are available is more user friendly than informing women on a pre-defined fixed date. The results remain inconclusive and, therefore, for the time being the choice of communication strategies should be influenced by clinical arguments and cost-effectiveness rather than impact on anxiety. Studies evaluating the effect of different strategies for disclosing results on women anxiety for chorionic villous sampling are needed.
Abstract: We include 10 RCTs (n = 1850); almost all participants had moderate or severe ARDS. For the primary analysis, the risk of bias was low in three studies and unclear in five studies; the overall quality of evidence was very low due to imprecision, inconsistency, indirectness and methodologic limitations. In participants randomized to HFO, there was no significant difference in hospital or 30-day mortality (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.72 to 1.16; P = 0.46, I² = 66%; 8 trials, 1779 participants, 807 deaths) compared with conventional ventilation. One large multicentre RCT was terminated early because of increased mortality in participants randomized to HFO compared to mechanical ventilation with low tidal volume and high positive end expiratory pressure, with HFO reserved only as a rescue therapy. We found substantial between-trial statistical heterogeneity (I² = 0% to 66%) for clinical outcomes, including mortality. The findings of this systematic review suggest that HFO does not reduce hospital and 30-day mortality due to ARDS; the quality of evidence was very low. Our findings do not support the use of HFO as a first-line strategy in people undergoing mechanical ventilation for ARDS.

Plain-language summary: We included 10 randomized controlled trials (RCTs) enrolling 1850 participants in this updated review. One large trial was stopped early because of increased deaths among participants who were randomized to HFO. Four trials reported at least some funding from manufacturers of HFO ventilators. HFO did not reduce the risk of death in hospital in eight trials enrolling 1779 participants. The ability of the lungs to oxygenate blood, measured at 24 to 72 hours of ventilation after randomization, was 18% to 26% better in participants receiving HFO. HFO had no effect on the length of time an artificial breathing machine was required. The risk of unwanted side effects, including low blood pressure or further injury to the lung due to high airway pressure, was not increased. We found substantial inconsistency among clinical trials which reported the effect of HFO on the risk of death in participants with ARDS. The quality of evidence is very low for outcomes that would be most important to patients. This is because of a lack of precision and consistency, and because in many cases the methods used by investigators during clinical trials were not of the highest standard. This indicates that there is considerable uncertainty regarding the effect of HFO on death. Additional randomized trials could change these findings.
Abstract: One double blind randomised crossover trial met the inclusion criteria and compared 5% albumin to normal saline in patients with a previous history of IDH. Results from 45 assessable participants did not lead to rejection of the null hypothesis of no difference between 5% albumin and normal saline in the primary outcome measure of percentage target ultrafiltration achieved, nor in 11/12 secondary outcomes. Additional (unblinded) saline was given less often when 5% albumin was used compared with saline (16% versus 36%, P = 0.04). However, the volume of additional fluid administered was similar in both groups. There were no significant differences in the nursing time required to treat IDH and the time to restore BP. No randomised or controlled trial was identified comparing albumin to crystalloids (other than normal saline) or non-protein colloids, or a combination of both, in the treatment of symptomatic hypotension during dialysis. One double blind crossover RCT in 45 assessable patients showed that 5% albumin is not superior to normal saline for the treatment of symptomatic hypotension in maintenance haemodialysis patients with a previous history of IDH. Given the cost and relative rarity of albumin use compared to saline, saline should be first line of therapy for treatment of IDH in stable dialysis patients.

Plain-language summary: We found one trial comparing albumin to normal saline; no trials were found comparing albumin to other fluids used to treat hypotension. This trial showed no difference between albumin and normal saline in all outcomes except for the amount of additional saline given, which was less in the group treated with albumin. We concluded that normal saline should be the first choice for treating IDH.