GEM/cochrane-simplification huggingface dataset:
Abstract: This review included one RCT in which 38 women (41 pregnancies) were randomised, with only 26 women (28 pregnancies) being analysed. This RCT comparing the effect of betamethasone (1.5 mg/day) with no medication found no statistically significant difference in neonatal thrombocytopenia (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.62 to 2.05) and neonatal bleeding (RR 1.00, 95% CI 0.24 to 4.13). Review authors conducted an intention-to-treat analysis which showed similar findings: RR 1.18, 95% CI 0.57 to 2.45 and RR 1.05, 95% CI 0.24 to 4.61, respectively. Maternal death, perinatal mortality, postpartum haemorrhage and neonatal intracranial haemorrhage were not studied by this RCT. Current evidence indicates that compared to no medication, betamethasone did not reduce the risk of neonatal thrombocytopenia and neonatal bleeding in ITP during pregnancy. There is insufficient evidence to support the use of betamethasone for treating ITP. This Cohrane review does not provide evidence about other medical treatments for ITP during pregnancy. This systematic review also identifies the need for well-designed, adequately powered randomised clinical trials for this medical condition during pregnancy. Unless randomised clinical trials provide evidence of a treatment effect and the trade off between potential benefits and harms are established, policy-makers, clinicians, and academics should not use betamethasone for ITP in pregnant women. Any future trials on medical treatments for treating ITP during pregnancy should test a variety of important maternal, neonatal or both outcome measures, including maternal death, perinatal mortality, postpartum haemorrhage and neonatal intracranial haemorrhage.

Plain-language summary: Current evidence from one randomised controlled trial indicates that betamethasone does not reduce the risk of neonatal thrombocytopenia and neonatal bleeding in ITP during pregnancy when compared to no medication. We could not identify evidence on other medical treatments for ITP during pregnancy. This review included one controlled trial in which 38 women (41 pregnancies) were randomised, with only 26 women (28 pregnancies) being analysed. There was also a severe imbalance between comparison groups. Giving the mother betamethasone (1.5 mg/day) did not result in a difference in the neonatal platelet count at birth and at the first week of life. The study reported that the maternal platelet count of peripheral blood did not change significantly during the study period for both the betamethasone and no treatment groups. Maternal postpartum haemorrhage and neonatal intracranial haemorrhage were not studied. Nor were maternal clinical and pregnancy outcomes reported. The researchers used no treatment in the control group, which may have increased the risk of performance bias in the trial.
Abstract: Five studies were included in this review with a total of 1,726 patients. The top-up search resulted in an additional ongoing trial, the results of which have not been incorporated in this review. Among five included studies, no reduction in all-cause mortality was observed in the combination arm, with a summary hazard ratio (HR) of 0.91 (95% CI: 0.81-1.02). Longer progression-free survival was observed in those treated with the combination chemotherapy (HR: 0.68, 95% CI: 0.53-0.87), however, this result may have been driven by findings from the single first-line treatment setting study. The quality of evidence for overall survival was low and for progression-free survival was moderate, mainly due to study limitation from the lack of information on randomisation methods and allocation concealment. There were higher risks of toxicity outcomes grade 3 or 4 diarrhoea and grade 1 or 2 alopecia, and a lower risk of grade 3 or 4 neutropenia in controls compared to the invervention group. Evidence for toxicity has been assessed to be low to moderate quality. There was no overall survival benefit of the irinotecan and fluoropyrimidine treatment over irinotecan alone, thus both regimens remain reasonable options in treating patients with advanced or metastatic CRC. Given the low and moderate quality of the evidence, future studies with sufficient numbers of patients in each treatment arms are needed to clarify the benefit observed in progression-free survival with combination irinotecan and fluoropyrimidines.

Plain-language summary: We searched the literature on January 13, 2016. We identified five randomised controlled trials with a total of 1,726 patients comparing the combination of IRI and fluoropyrimidine with IRI alone. The search in January 2016 resulted in an additional ongoing trial, the results of which have not been incorporated in this review. This review compared IRI and fluoropyrimidine with IRI alone in terms of overall survival, progression-free survival, toxicity, response rates and quality of life. There is no evidence to suggest any superiority of the combination of IRI and fluoropyrimidine over IRI alone, but our results on overall survival are limited by the number of studies available to date. Longer progression-free survival was seen from adding fluoropyrimidines to IRI. Based on current evidence, both the combination regimens and IRI alone seem equally effective for treating advanced or metastatic patients. Patients in the intervention arm were less likely to develop grade 3 or 4 diarrhea and grade 1 or 2 alopecia, and more likely to have grade 3 or 4 neutropenia, compared to patients receiving IRI alone. There was moderate quality evidence from these studies suggesting longer progression-free survival from adding fluoropyrimidines to IRI. However, findings need to be confirmed by larger, high-quality randomised clinical trials.
Abstract: Due to the differences in the method of assessment, the variability of data and the heterogeneity of the participant groups it was difficult to pool some of the outcome data. Despite these limitations and potentially significant biases related to methodological quality there was evidence to suggest that a transverse or oblique incision has less impact on pulmonary function particularly in the early post-operative period and is less prone to rupture (wound dehiscence/incisional hernia). The data on pain is less clear and should be interpreted with caution but some data suggests a transverse incision is less painful. There was no difference seen in other early or late post-operative complications and recovery times were similar although the transverse incision may be cosmetically more acceptable. The analgesia use and the pulmonary compromise may be reduced with a transverse/oblique incision but this does not seem to be significant clinically as pulmonary complication rates and recovery times were the same. The likelihood of wound dehiscence and rupture appears to be reduced with a transverse incision and a transverse incision may look better. The methodological and clinical diversity and the potential for bias also mean that the results in favour of a transverse/oblique incision (particularly with regard to analgesic use) should be treated with caution. The optimal incision for abdominal surgery still remains the preference of the surgeon.

Plain-language summary: The choice of abdominal surgical incision is determined largely by access. However, a transverse incision may be superior to a midline incision in terms of recovery and complications. All randomised controlled trials comparing these incisions were identified. Outcomes included analgesic use, pulmonary function, complication rates and hospital stay. Marked variability in methodology made comparison difficult and potential biases in all of the studies suggests results should be treated with caution. Nevertheless a trend was seen toward less analgesic requirement, less effect on pulmonary function and lower wound dehiscence and incisional hernia rates with a transverse incision. However, the lower pain and reduced effect on pulmonary function were not translated into other clinical advantages as recovery times and other complication rates (except cosmetic appearance) were similar.
Abstract: This review includes just one cluster-randomised study of 306 older people with dementia and an average age of 86 years, conducted across 16 nursing homes in France. The study did not measure any of our primary or secondary outcomes but did measure behavioural change using three measurement scales: the Cohen-Mansfield Agitation Inventory (CMAI; 29-item scale), the Neuropsychiatric Inventory (NPI; 12-item scale), and the Observation Scale (OS; 25-item scale). For the CMAI, the study reports a Global score (29 items rated on a seven-point scale (1 = never occurs to 7 = occurs several times an hour) and summed to give a total score ranging from 29 to 203) and mean scores (evaluable items (rated on the same 7-point scale) divided by the theoretical total number of items) for the following four domains: Physically Non-Aggressive Behaviour, such as pacing (13 items); Verbally Non-Aggressive Behaviour, such as repetition (four items); Physically Aggressive Behaviour, such as hitting (nine items); and Verbally Aggressive Behaviour, such as swearing (three items). Four of the five CMAI scales improved in the intervention group (Global: change mean difference (MD) −5.69 points, 95% confidence interval (CI) −9.59 to −1.79; Physically Non-Aggressive: change MD −0.32 points, 95% CI −0.49 to −0.15; Verbally Non-Aggressive: change MD −0.44 points, 95% CI −0.69 to −0.19; and Verbally Aggressive: change MD −0.16 points, 95% CI −0.31 to −0.01). There was no difference in change scores on the Physically Aggressive scale (MD −0.08 points, 95% CI −0.37 to 0.21). Using GRADE guidelines, we rated the quality of this evidence as very low due to high risk of bias and indirectness of the outcome measures. There were no differences in NPI or OS change scores between groups by the end of the study. We also identified one ongoing study. The limited evidence means that uncertainty remains around the effectiveness of de-escalation and the relative efficacy of different techniques. High-quality research on the effectiveness of this intervention is therefore urgently needed.

Plain-language summary: We looked for all available evidence on this topic, finding just two studies. One of these included 306 people with dementia and an average age of 86 years, living in 16 nursing homes in France. The second study is still in progress and did not provide results for the review. The study did not assess areas important to us, such as the number of injuries sustained by staff or residents. It did, however, measure the impact of staff training on residents' level of aggression three months after the end of the training. Some measures of physical and verbal aggression showed reductions, but not all. The reliability of evidence available in the one included trial is very low and did not address important questions such as injury. Therefore, we cannot say whether de-escalation techniques are effective. The evidence is current to September 2017.
Abstract: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions.

Plain-language summary: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands.
Abstract: We did not find any completed randomised trials. Comparing antiplatelets with anticoagulants across 36 observational studies (1285 patients), there were no significant differences in the odds of death (Peto odds ratio (Peto OR) 2.02, 95% CI 0.62 to 6.60), or the occurrence of ischaemic stroke (OR 0.63, 95% CI 0.21 to 1.86) (34 studies, 1262 patients). For the outcome of death or disability, there was a non-significant trend in favour of anticoagulants (OR 1.77, 95% CI 0.98 to 3.22; P = 0.06) (26 studies, 463 patients). Symptomatic intracranial haemorrhages (5/627; 0.8%) and major extracranial haemorrhages (7/425; 1.6%) occurred only in the anticoagulation group; however, for both these outcomes, the estimates were imprecise and indicated no significant difference between the two treatment modalities. There were no randomised trials comparing either anticoagulants or antiplatelet drugs with control, thus there is no evidence to support their routine use for the treatment of extracranial internal carotid artery dissection. There were also no randomised trials that directly compared anticoagulants with antiplatelet drugs and the reported non-randomised studies did not show any evidence of a significant difference between the two.

Plain-language summary: We did not find any completed randomised trials testing these drugs in people with carotid artery dissection. However, there is one ongoing trial. We found only poor quality non-randomised studies that compared anticoagulants with aspirin. There was no evidence that anticoagulants were better than aspirin. Aspirin is likely to be similarly effective and safe as anticoagulants in such patients. More research is needed.
Abstract: We identified 26 RCTs (2066 patients). Heterogeneity of treatments and outcomes precluded meta-analysis. We grouped results according to wound type, and silver preparation. Burns Thirteen trials compared topical silver (in a variety of formulations - including silver sulphadiazine (SSD) cream) with non-silver dressings. One trial showed fewer infections with silver nitrate when compared with a non-silver dressing, but three trials showed significantly more infection with SSD than with the non-silver dressing. Six trials compared SSD cream with silver-containing dressings. One showed significantly fewer infections with the silver-containing dressing (Hydron AgSD) compared with SSD, the remaining five found no evidence of a difference. One trial compared two silver-containing dressings, and showed a significantly lower infection rate with silver-coated gauze (Acticoat®) than with silver nitrate gauze. Other wounds Six trials compared SSD/silver-containing dressings with non-silver dressings (nine dressings in total). Most comparisons (seven) found no significant differences in infection rates; one trial in a variety of wounds exhibited significantly fewer infections with SSD/hydrocolloid, but another, in acute wounds, found significantly more infections with SSD. Only one comparison showed a significant reduction in healing time associated with a silver-containing hydrofibre dressing in diabetic foot ulcers. There is insufficient evidence to establish whether silver-containing dressings or topical agents promote wound healing or prevent wound infection; some poor quality evidence for SSD suggests the opposite.

Plain-language summary: This review identified 26 trials (involving 2066 participants) comparing silver-containing dressings or creams against dressings or creams that did not contain silver. Twenty of the trials were on burn wounds, while the other trials were on a mixture of wound types. Most studies were small and of poor quality. After examining them all, the authors concluded that there is not enough evidence to support the use of silver-containing dressings or creams, as generally these treatments did not promote wound healing or prevent wound infections. Some evidence from a number of small, poor-quality studies suggested that one silver-containing compound (silver sulphadiazine) has no effect on infection, and actually slows down healing in patients with partial-thickness burns.
Abstract: We included 29 ITS analyses (12 were controlled) investigating policies targeting 11 drug classes for restriction. Participants were most often senior citizens or low income adult populations, or both, in publically subsidized or administered pharmaceutical benefit plans. Impact of policies varied by drug class and whether restrictions were implemented or relaxed. When policies targeted gastric-acid suppressant and non-steroidal anti-inflammatory drug classes, decreased drug use and substantial savings on drugs occurred immediately and for up to two years afterwards, with no increase in the use of other health services (6 studies). Targeting second generation antipsychotic drugs increased treatment discontinuity and the use of other health services without reducing overall drug expenditures (2 studies). Relaxing restrictions for reimbursement of antihypertensives and statins increased appropriate use and decreased overall drug expenditures. Two studies which measured health outcomes directly were inconclusive. Implementing restrictions to coverage and reimbursement of selected medications can decrease third-party drug spending without increasing the use of other health services (6 studies). Relaxing reimbursement rules for drugs used for secondary prevention can also remove barriers to access. Policy design, however, needs to be based on research quantifying the harm and benefit profiles of target and alternative drugs to avoid unwanted health system and health effects. Health impact evaluation should be conducted where drugs are not interchangeable. Impacts on health equity, relating to the fair and just distribution of health benefits in society (sustainable access to publically financed drug benefits for seniors and low income populations, for example), also require explicit measurement.

Plain-language summary: This review found 29 studies that evaluated policies that restrict reimbursement of specific prescriptions drugs. Where drugs have cheaper, effective alternatives and they target symptoms, this review found that reimbursement restriction polices can ensure better use of the medications with reduced costs and without an increase in the use of other health services, as would be expected if there were negative health effects of the restriction policies. Evaluation is required if alternative drugs are not effective substitutes. Removing restrictions for drugs that prevent complications of disease can result in an intended increase in their use as well as cost savings. When restrictions to reimbursement policies are designed using the best available evidence on the health impact of the medications, they support equitable access to the drugs that best support health by supporting the sustainability of publically subsidized drug plans. A summary of this review for policy-makers is availablehere
Abstract: Three randomised, placebo-controlled trials with a total of 50 participants were included in the review. All three trials compared rTMS with sham TMS. All the trials were of poor methodological quality and were insufficiently homogeneous to allow the pooling of results. Moreover, the high rate of attrition further increased the risk of bias. None of the trials provided detailed data on the ALS Functional Rating Scale-Revised (ALSFRS-R) scores at six months follow-up which was pre-assigned as our primary outcome. One trial contained data in a suitable form for quantitative analysis of our secondary outcomes. No difference was seen between rTMS and sham rTMS using the ALSFRS-R scores and manual muscle testing (MMT) scores at 12 months follow-up in this trial. Additionally, none of the trials reported any adverse events associated with the use of rTMS. However, in view of the small sample size, the methodological limitations and incomplete outcome data, treatment with rTMS cannot be judged as completely safe. There is currently insufficient evidence to draw conclusions about the efficacy and safety of rTMS in the treatment of ALS. Further studies may be helpful if their potential benefit is weighed against the impact of participation in a randomised controlled trial on people with ALS.

Plain-language summary: For this review we searched widely for clinical trials of rTMS in people with ALS and found three studies, which involved 50 participants in total. All three compared rTMS with sham (inactive) rTMS. None of the three studies reported on disability or limitation in activity as assessed by a specific ALS scale (ALSFRS-R) at six months follow-up, which was what we chose as our primary measure of the effectiveness of rTMS. Other outcome measures were only available from 12 participants in one poor quality trial, in which there was no difference between rTMS and sham rTMS in ALSFRS-R or a test of muscle strength at 12 months’ follow-up. None of the studies reported any adverse effects with rTMS. The trials in this review had small numbers of participants and some problems of design, so larger, well-designed trials should be considered, to determine the efficacy and safety of rTMS in ALS. However, the potential benefit should be balanced against the impact of taking part in trials for people with ALS.