GEM/cochrane-simplification huggingface dataset:
Abstract: We identified 30 new non-randomized cohort studies (45 comparisons): no new RCTs were found. This update now includes five RCTs (yielding 6 comparisons) and 80 non-randomized cohort studies (130 comparisons), with 86,640 patients treated in RCTs and 57,205 patients treated outside RCTs. In the randomised studies, patients were invited to participate in an RCT or not; these comparisons provided limited information because of small sample sizes (a total of 412 patients) and the nature of the questions they addressed. When the results of RCTs and non-randomized cohorts that reported dichotomous outcomes were combined, there were 98 comparisons; there was also heterogeneity (P < 0.00001, I2 = 42.2%) between studies. No statistical significant differences were found for 85 of the 98 comparisons. Eight comparisons reported statistically significant better outcomes for patients treated within RCTs, and five comparisons reported statistically significant worse outcomes for patients treated within RCTs. There was significant heterogeneity (P < 0.00001, I2 = 58.2%) among the 38 continuous outcome comparisons. No statistically significant differences were found for 30 of the 38 comparisons. Three comparisons reported statistically significant better outcomes for patients treated within RCTs, and five comparisons reported statistically significant worse outcomes for patients treated within RCTs. This review indicates that participation in RCTs is associated with similar outcomes to receiving the same treatment outside RCTs. These results challenge the assertion that the results of RCTs are not applicable to usual practice.

Plain-language summary: This updated review assessed whether there were harmful or beneficial effects from participating in randomized controlled trials (RCTs). The outcomes of patients who participated in RCTs were compared with outcomes of patients who were eligible for the trial and received similar clinical interventions, but did not participate. Comparisons were included both of 'experimental' treatment inside and outside of RCT and of 'control' treatment comparisons. On average, the outcomes of patients participating and not participating in RCTs were similar, suggesting that participation in RCTs, independent of the effects of the clinical interventions being compared, is likely to be comparable.
Abstract: Fifteen trials were included in the review (2064 participants). Three types of photocoagulation were used in the trials: direct photocoagulation of the entire CNV (11 trials), perifoveal photocoagulation (one trial) and grid photocoagulation (three trials). In 12 trials the control group was observation only. One trial compared photocoagulation to submacular surgery and two trials compared different lasers. Data on the progression of visual loss could be extracted from five of the eight trials of direct photocoagulation of the CNV versus observation. The treatment effect was in the direction of harm in all studies at three months follow up (RR 1.41, 95% confidence intervals (CI) 1.08 to 1.82). After two years the treatment effect was in the direction of benefit (RR 0.67, 95% CI 0.53 to 0.83). These studies were clinically heterogenous with participants having CNV lesions in different locations and different baseline visual acuities. There was little evidence of statistical heterogeneity at three months but substantial statistical heterogeneity at two years. However, all treatment effects in the individual trials were in the direction of benefit. One study comparing perifoveal photocoagulation or observation of subfoveal CNV found benefits that were statistically significant only at two years (RR 0.36, 95% CI 0.18 to 0.72). Other comparisons did not demonstrate differences. In the medium to long term laser photocoagulation of CNV slows the progression of visual loss in people with neovascular AMD. However, it is associated with an increased risk of visual loss immediately after treatment and this period may be longer in people with subfoveal AMD. With the advent of modern pharmacological therapies, and concern for the impact of iatrogenic scotoma in subfoveal CNV, laser photocoagulation of subfoveal CNV is not recommended. No studies have compared photocoagulation with modern pharmacological agents for AMD for non-subfoveal CNV.

Plain-language summary: Fifteen trials involving a total of 2064 participants were included. Three types of photocoagulation were used in the trials: direct photocoagulation of the entire CNV, perifoveal photocoagulation and grid photocoagulation. Control groups in the trials included observation only, submacular surgery and different lasers. This review found that the use of photocoagulation is effective for people with lesions that are outside the centre of the macula. However, these types of lesions are less common in AMD. Severe loss of vision can be prevented in about one in six people.
Abstract: Twenty-two trials with 12,455 participants randomised (9595 used in analyses) were included. For the 13 that contributed data for the permanent tooth surfaces meta-analysis, the pooled D(M)FS prevented fraction estimate comparing fluoride varnish with placebo or no treatment was 43% (95% confidence interval (CI) 30% to 57%; P < 0.0001). There was substantial heterogeneity, confirmed statistically (P < 0.0001; I2 = 75%), however this body of evidence was assessed as of moderate quality. The pooled d(e/m)fs prevented fraction estimate was 37% (95% CI 24% to 51%; P < 0.0001) for the 10 trials that contributed data for the primary tooth surfaces meta-analysis, also with some heterogeneity (P = 0.009; I2 = 59%). Once again this body of evidence was assessed as of moderate quality. No significant association between estimates of D(M)FS or d(e/m)fs prevented fractions and the pre-specified factors of baseline caries severity, background exposure to fluorides, application features such as prior prophylaxis, concentration of fluoride, frequency of application were found. There was also no significant association between estimates of D(M)FS or d(e/m)fs prevented fractions and the post hoc factors: whether a placebo or no treatment control was used, length of follow-up, or whether individual or cluster randomisation was used, in the meta-regression models. A funnel plot of the trials in the main meta-analyses indicated no clear relationship between prevented fraction and study precision. In both methods, power is limited when few trials are included. There was little information concerning possible adverse effects or acceptability of treatment. The conclusions of this updated review remain the same as those when it was first published. The review suggests a substantial caries-inhibiting effect of fluoride varnish in both permanent and primary teeth, however the quality of the evidence was assessed as moderate, as it included mainly high risk of bias studies, with considerable heterogeneity.

Plain-language summary: This review of existing studies was carried out by the Cochrane Oral Health Group and the evidence is current up to 13 May 2013. In this updated review there are now 22 trials published between 1975 and 2012 in which a total of 12,455 children were randomised to treatment with either fluoride varnish or placebo/no treatment. Study duration ranged from one to five years among included trials (12 of these lasted two years). The evidence produced has been found to be of moderate quality due to issues with trial designs. However in the 13 trials that looked at children and adolescents with permanent teeth the review found that the young people treated with fluoride varnish experienced on average a 43% reduction in decayed, missing and filled tooth surfaces. In the 10 trials looking at the effect of fluoride varnish on first or baby teeth the evidence suggests a 37% reduction in decayed, missing and filled tooth surfaces. There was little information concerning possible adverse effects or acceptability of treatment. The evidence presented is of moderate quality due to issues with trial designs.
Abstract: Thirty-three small studies ( 2267 patients) compared different fusion techniques. The major treatments were discectomy alone, addition of an interbody fusion procedure (autograft, allograft, cement, or cage), and addition of anterior plates. Eight studies had a low risk of bias. Few studies reported on pain, therefore, at best, there was very low quality evidence of little or no difference in pain relief between the different techniques. We found moderate quality evidence for these secondary outcomes: no statistically significant difference in Odom's criteria between iliac crest autograft and a metal cage (6 studies, RR 1.11 (95% CI 0.99 to1.24)); bone graft produced more effective fusion than discectomy alone (5 studies, RR 0.22 (95% CI 0.17 to 0.48)); no statistically significant difference in complication rates between discectomy alone and iliac crest autograft (7 studies, RR 1.56 (95% CI 0.71 to 3.43)); and low quality evidence that iliac crest autograft results in better fusion than a cage (5 studies, RR 1.87 (95% CI 1.10 to 3.17)); but more complications (7 studies, RR 0.33 (95% CI 0.12 to 0.92)). When the working mechanism for pain relief and functional improvement is fusion of the motion segment, there is low quality evidence that iliac crest autograft appears to be the better technique. When ignoring fusion rates and looking at complication rates, a cage has a weak evidence base over iliac crest autograft, but not over discectomy alone. Future research should compare additional instrumentation such as screws, plates, and cages against discectomy with or without autograft.

Plain-language summary: This review of 33 small studies (2267 participants) evaluated fusion techniques used to treat degenerative disc disease. The major treatments were discectomy (removal of the damaged disc) alone, addition of a fusion procedure (bone transplanted from another part of the body, cement, or cage), and addition of a plate. None of the evidence from this systematic review indicates that one technique is better than another for clinically significant pain relief for patients with chronic cervical degenerative disc disease or disc herniation. The choice for a specific technique cannot be made on the most important aspect, pain relief, which was the primary outcome parameter in our review. There is moderate quality evidence that there was little or no difference in Odom’s criteria (a tool that measures the success of the surgery at relieving the symptoms that were troublesome prior to the surgery) between those who received a bone transplant from the hip and a metal cage to help with fusion. There is moderate quality evidence that the use of a bone graft (bone transplanted from another part of the body) is more effective than discectomy alone in achieving fusion. There is low quality evidence that transplanting bone from the iliac crest is more effective in achieving fusion than using a cage, while cages are more effective in preventing complications. Further research is very likely to have an important impact on the results and our confidence in them.
Abstract: Four studies met the inclusion criteria (715 pregnant women), and reported on at least one of the outcomes of interest. We performed no meta-analyses as the interventions and outcomes measured in the studies were not sufficiently similar. For most outcomes there were no significant differences between groups; and results relating to abstaining or reducing alcohol consumption were mixed. Results from individual studies suggest that interventions may encourage women to abstain from alcohol in pregnancy. There was very little information provided on the effects of interventions on the health of mothers and babies. The evidence from the limited number of studies suggests that psychological and educational interventions may result in increased abstinence from alcohol, and a reduction in alcohol consumption among pregnant women. However, results were not consistent, and the paucity of studies, the number of total participants, the high risk of bias of some of the studies, and the complexity of interventions limits our ability to determine the type of intervention which would be most effective in increasing abstinence from, or reducing the consumption of, alcohol among pregnant women.

Plain-language summary: Four randomized controlled studies were included in the review; individual studies suggest that educational and counselling interventions may encourage women to abstain from alcohol or reduce the amount of alcohol they drink in pregnancy. The studies involved women who were less than 28 weeks pregnant who were consuming some alcohol. All were carried out in the USA. The interventions ranged from a 10-minute education session and provision of a self-help manual through to an hour-long motivational interview with reinforcement at each prenatal visit. Women in the control groups generally received routine care, which may have included advice on reducing alcohol intake. Outcomes were measured in different ways, and so results have been presented separately for each study. The studies provided very limited information on the effects of interventions on the health of women and their babies. There was very little information provided in these studies on the effects of interventions on the health of mothers and babies. There is an urgent need for more information in this area.
Abstract: We did not identify any new trials from the updated search so the results remain unchanged as follows. We have included 10 studies describing two dosages of paracetamol. Of these, five studies (526 women) assessed 500 mg to 650 mg and six studies (841 women) assessed 1000 mg of paracetamol. We chose to use random-effects meta-analyses because of the heterogeneity in dosage used. Studies were from the 1970s to the early 1990s, and there was insufficient information to assess the risk of bias adequately, hence the findings need to be interpreted within this context. More women experienced pain relief with paracetamol compared with placebo (average risk ratio (RR) 2.14, 95% confidence interval (CI) 1.59 to 2.89, 10 studies, 1279 women). In addition, there were significantly fewer women having additional pain relief with paracetamol compared with placebo (RR 0.34, 95% CI 0.21 to 0.55, eight studies, 1132 women). Both the 500 mg to 650 mg and 1000 mg doses were effective in providing more pain relief than placebo. Maternal and neonatal potential adverse drug effects were not assessed in any of the included studies. Indeed few secondary outcomes were assessed. More women experienced pain relief, and fewer had additional pain relief, with paracetamol compared with placebo, although potential adverse effects were not assessed and generally the quality of studies was unclear.

Plain-language summary: However, this review is part of a series of reviews looking at drugs to help relieve perineal pain once it is there in the early days after the birth. This review identified 10 studies, involving 1367 women, looking at how effective paracetamol might be in helping with this pain. The studies were quite old and thus not of high quality. However, they showed that paracetamol (either in a single 500 mg to 600 mg or a single 1000 mg dose) was effective at reducing the perineal pain, mostly caused by episiotomies. The studies did not look carefully at potential adverse effects but generally paracetamol at these doses causes few problems. There are also generally no identified problems for breastfed babies when mothers take paracetamol, but these outcomes were not specifically assessed in any of the included studies. The comparison of how effective paracetamol is compared with other drugs is being assessed in the other reviews in the series.
Abstract: The review currently includes ten short to medium term trials with 1549 participants on three comparisons: amisulpride versus olanzapine, risperidone and ziprasidone. The overall attrition rate was considerable (34.7%) with no significant difference between groups. Amisulpride was similarly effective as olanzapine and risperidone and more effective than ziprasidone (leaving the study early due to inefficacy: n=123, 1 RCT, RR 0.21 CI 0.05 to 0.94, NNT 8 CI 5 to 50). Amisulpride induced less weight gain than risperidone (n=585, 3 RCTs, MD -0.99 CI -1.61 to -0.37) or olanzapine (n=671, 3 RCTs, MD -2.11 CI -2.94 to -1.29). Olanzapine was also associated with a higher increase of glucose (n=406, 2 RCTs, MD -7.30 CI -7.62 to -6.99). There was no difference in terms of cardiac effects and extra pyramidal symptoms (EPS) compared with olanzapine (akathisia: n= 587, 2 RCTs, RR 0.66 CI 0.36 to 1.21), compared with risperidone (akathisia: n=586, 3 RCTs, RR 0.80 CI 0.58 to 1.11) and compared with ziprasidone (akathisia: n=123, 1 RCT, RR 0.63, CI 0.11 to 3.67). There is little randomised evidence comparing amisulpride with other second generation antipsychotic drugs. We could only find trials comparing amisulpride with olanzapine, risperidone and ziprasidone. We found amisulpride may be somewhat more effective than ziprasidone, and more tolerable in terms of weight gain and other associated problems than olanzapine and risperidone. These data, however, are based on only ten short to medium term studies and therefore too limited to allow for firm conclusions. Note: the 47 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.

Plain-language summary: This review compared the effects of amisulpride with those of other so called second generation (atypical) antipsychotic drugs. For half of the possible comparisons not a single relevant study could be identified. Based on very limited data there was no difference in efficacy comparing amisulpride with olanzapine and risperidone, but a certain advantage compared with ziprasidone. Amisulpride was associated with less weight gain than risperidone and olanzapine.
Abstract: Three trials were identified in this review as satisfying inclusion criteria. Results of all three trials were evaluated, however, one of these trials had compromised methodological quality and, therefore the focus was placed on the other two trials. Data were not pooled due to the heterogeneity between trials. The first trial (n = 24) showed a benefit of cognitive behavioural therapy (CBT) in people with mild TBI and acute stress disorder. Fewer people receiving CBT had diagnosis of post-traumatic stress disorder (PTSD) at post-treatment compared to the control supportive counselling group, with maintenance of treatment gains found at six-month follow up. The second trial (n = 20) showed that post-treatment anxiety symptomatology of people with mild to moderate TBI was lower in the combined CBT and neurorehabilitation group compared to the no intervention control group. This review provides some evidence for the effectiveness of CBT for treatment of acute stress disorder following mild TBI and CBT combined with neurorehabilitation for targeting general anxiety symptomatology in people with mild to moderate TBI. These findings need to be viewed in light of the small number, small sample size and heterogeneous characteristics of current trials published in this area. More trials focusing on comparable psychological interventions, severity of injury of participants and diagnosis of anxiety disorder(s) are needed.

Plain-language summary: This review identified three randomised controlled trials in the area of psychological treatments for anxiety after TBI. Some evidence was found for the effectiveness of the following interventions: cognitive behavioural therapy (CBT) for treatment of acute stress disorder following mild TBI, and combining CBT and neurorehabilitation for treatment of general anxiety symptoms in people with mild to moderate TBI. The ability to make strong conclusions on the effectiveness of these approaches is limited by the small number of trials available for pooling of data, especially trials with similar conditions and participants.
Abstract: There were no data comparing best supportive care with chemotherapy. Cisplatin-based regimens are the most widely used and therefore we have concentrated on these trials. In terms of response rates some non-platinum regimens are equivalent but toxicity is higher. The most common cisplatin regimen was 50 mg/m2 day 1 q21days. Higher doses had similar survivals. There was no direct comparison between single-agent cisplatin and carboplatin. Overall survival (OS) and progression-free survival (PFS) were not adequately reported and quality of life (QoL) outcomes were incompletely documented. Combination regimens were more toxic than single agents, but in the limited reported data this did not appear to adversely affect QoL. No significant difference in response rate by site of recurrence was found, although there was a trend towards improved response when the main site of disease was beyond the previously irradiated pelvis. Combination cisplatin-based chemotherapy could be a viable option for patients of good performance status with recurrent/metastatic cervical cancer, but further trials that report adequate survival and QoL data are sought. Response rates and improvements in survival are low. Cisplatin-based combinations have significant toxicity. Outcomes are poor and novel cytotoxic/biological agents and optimal scheduling need further investigation. Future trials need to stratify for and perform planned subgroup analysis with respect to previous treatment and site of recurrence.

Plain-language summary: A literature search was conducted identifying 30 potential trials; four trials were excluded. The 26 clinical trials included in this review encompass a large range of different drugs, doses and combinations in a mixed group of patients over a long time period (1976 to 2011), making it difficult to compare treatment options. Although there are no trials directly comparing chemotherapy with symptomatic management alone, chemotherapy is widely used in this setting and assumed to be of benefit. Cisplatin and carboplatin chemotherapy were shown to shrink the cancer in 10% to 30% of patients and are widely used in current practice. Cisplatin chemotherapy when combined with other drugs has been shown to prolong survival by a few months compared with cisplatin alone, but with the cost of increased side effects. Other chemotherapy has been used, but has been found to be less effective or more toxic. Quality of life for patients on chemotherapy appears to be similar for cisplatin and cisplatin-based combinations. Nearly all patients in these studies were relatively fit and well prior to starting treatment, despite their cancer; these results may not be the same in patients who are not fit and well.