GEM/cochrane-simplification huggingface dataset:
Abstract: We included 23 trials involving 1806 women, of whom 717 received cones. All of the trials were small, and in many the quality was hard to judge. Outcome measures differed between trials, making the results difficult to combine. Some trials reported high drop-out rates with both cone and comparison treatments. Seven trials were published only as abstracts. Cones were better than no active treatment (rate ratio (RR) for failure to cure incontinence 0.84, 95% confidence interval (CI) 0.76 to 0.94). There was little evidence of difference for a subjective cure between cones and PFMT (RR 1.01, 95% CI 0.91 to 1.13), or between cones and electrostimulation (RR 1.26, 95% CI 0.85 to 1.87), but the confidence intervals were wide. There was not enough evidence to show that cones plus PFMT was different to either cones alone or PFMT alone. Only seven trials used a quality of life measures and no study looked at economic outcomes. Seven of the trials recruited women with symptoms of incontinence, while the others required women with urodynamic stress incontinence, apart from one where the inclusion criteria were uncertain. This review provides some evidence that weighted vaginal cones are better than no active treatment in women with SUI and may be of similar effectiveness to PFMT and electrostimulation. This conclusion must remain tentative until larger, high-quality trials, that use comparable and relevant outcomes, are completed. Cones could be offered as one treatment option, if women find them acceptable.

Plain-language summary: Twenty-three small trials, involving 1806 women, were found. The results of these trials consistently showed that the use of vaginal weights is better than having no treatment. When vaginal weights were compared to other treatments, such as pelvic floor muscle training without the weights, and electrical stimulation of the pelvic floor, no clear differences between the treatments were evident. This may have been because the numbers of participants in the trials were small, and larger numbers may be required for any differences in the effectiveness of treatments to become clear. Some women find vaginal weights unpleasant or difficult to use, so this treatment may not be useful for all women. Many women with stress urinary incontinence will not be cured by these treatments, and so it is important for trials to assess quality of life during and after treatment, but few of these trials did. Most of the trials were of fairly short duration, so it is difficult to say what happens to women with stress urinary incontinence in the longer term.
Abstract: Eleven trials with a total of 2246 AF patients (ranging from 14 to 712 by study) were included within the review. Studies included education, decision aids, and self-monitoring plus education interventions. The effect of self-monitoring plus education on TTR was uncertain compared with usual care (MD 6.31, 95% CI -5.63 to 18.25, I2 = 0%, 2 trials, 69 participants, very low-quality evidence). We found small but positive effects of education on anxiety (MD -0.62, 95% CI -1.21 to -0.04, I2 = 0%, 2 trials, 587 participants, low-quality evidence) and depression (MD -0.74, 95% CI -1.34 to -0.14, I2 = 0%, 2 trials, 587 participants, low-quality evidence) compared with usual care. The effect of decision aids on decision conflict favoured usual care (MD -0.1, 95% CI -0.17 to -0.02, I2 = 0%, 2 trials, 721 participants, low-quality evidence). This review demonstrates that there is insufficient evidence to draw definitive conclusions regarding the impact of educational or behavioural interventions on TTR in AF patients receiving OAT. Thus, more trials are needed to examine the impact of interventions on anticoagulation control in AF patients and the mechanisms by which they are successful. It is also important to explore the psychological implications for patients suffering from this long-term chronic condition.

Plain-language summary: This is an update of the original review first published in 2013. We searched scientific databases in February 2016 and found 11 randomised clinical trials including 2246 adults with atrial fibrillation who were taking oral anticoagulant medication. The trials we found compared education, decision aids, and self-monitoring plus education to usual care, over any length of time. Few studies had comparable groups and data. There was uncertainty about the effect of self-monitoring plus education on the percentage of time the INR was within the therapeutic range because the proportion or time in the therapeutic range was similar between individuals who received self-monitoring plus education and those who did not. There were small and positive effects on anxiety and depression in individuals who received education compared to those who received usual care. There were small and negative effects on decision conflict in individuals who received decision aids compared to those who received usual care. The evidence should be interpreted with caution as the quality of the evidence ranged from very low to low across different outcomes because of the limitations of individual studies. It is likely that further high-quality trials may affect these reported results.
Abstract: Seventy randomised controlled trials (RCTs) (11,487 women) are included. In this update seven new RCTs (778 women) have been added. Two of these new trials compare PGE2 with no treatment, four compare different PGE2 formulations (gels versus tablets, or sustained release pessaries) and one trial compares PGF2a with placebo. The majority of trials were at unclear risk of bias for most domains. Overall, vaginal prostaglandin E2 compared with placebo or no treatment probably reduces the likelihood of vaginal delivery not being achieved within 24 hours. The risk of uterine hyperstimulation with fetal heart rate changes is increased (4.8% versus 1.0%, risk ratio (RR) 3.16, 95% confidence interval (CI) 1.67 to 5.98, 15 trials, 1359 women). The caesarean section rate is probably reduced by about 10% (13.5% versus 14.8%, RR 0.91, 95% CI 0.81 to 1.02, 36 trials, 6599 women). The overall effect on improving maternal and fetal outcomes (across a variety of measures) is uncertain. PGE2 tablets, gels and pessaries (including sustained release preparations) appear to be as effective as each other, small differences are detected between some outcomes, but these maybe due to chance. Prostaglandins PGE2 probably increase the chance of vaginal delivery in 24 hours, they increase uterine hyperstimulation with fetal heart changes but do not effect or may reduce caesarean section rates. They increase the likelihood of cervical change, with no increase in operative delivery rates. PGE2 tablets, gels and pessaries appear to be as effective as each other, any differences between formulations are marginal but may be important.

Plain-language summary: This review set out to determine the effectiveness and safety of vaginal prostaglandins for third trimester cervical ripening and induction of labour (the cervix softens, shortens and opens, the uterus starts to contract regularly). Eight different comparisons were made, different vaginal prostaglandins were compared with placebos or no treatment, or other vaginal prostaglandins (PGE2, PGF2a, except misoprostol) and different preparations and dosages were compared. We identified 70 studies involving a total of 11,487 women. Vaginal prostaglandins increase the likelihood of vaginal birth within 24 hours, but they can also stimulate the uterus to contract too much and this may cause the baby's heart to slow, however they did not increase the caesarean section rate and may reduce it. Overall, the trials do not show any effect (improvement or worsening) of many important outcomes. Prostaglandin E2 tablets, gels, or pessaries including sustained release preparations appear to be as good as each other or the differences between them are small and have not yet been detected in the trials. Lower-dose regimens, as defined in the review, appeared to be as good as higher-dose regimens (eight trials, 1615 women). Very limited data were available in the included trials on time in labour and patient satisfaction. Few studies have addressed issues relating to the safety of using vaginal prostaglandins for induction of labour as outpatients.
Abstract: We included six studies involving 355 infants - two using face mask CPAP, two CNP, one nasal CPAP and one both CNP (for less ill babies) and endotracheal CPAP (for sicker babies). For this update, we included no new trials. Continuous distending pressure (CDP) is associated with lower risk of treatment failure (death or use of assisted ventilation) (typical risk ratio (RR) 0.65, 95% confidence interval (CI) 0.52 to 0.81; typical risk difference (RD) -0.20, 95% CI -0.29 to -0.10; number needed to treat for an additional beneficial outcome (NNTB) 5, 95% CI 4 to 10; six studies; 355 infants), lower overall mortality (typical RR 0.52, 95% CI 0.32 to 0.87; typical RD -0.15, 95% CI -0.26 to -0.04; NNTB 7, 95% CI 4 to 25; six studies; 355 infants) and lower mortality in infants with birth weight above 1500 g (typical RR 0.24, 95% CI 0.07 to 0.84; typical RD -0.28, 95% CI -0.48 to -0.08; NNTB 4, 95% CI 2.00 to 13.00; two studies; 60 infants). Use of CDP is associated with increased risk of pneumothorax (typical RR 2.64, 95% CI 1.39 to 5.04; typical RD 0.10, 95% CI 0.04 to 0.17; number needed to treat for an additional harmful outcome (NNTH) 17, 95% CI 17.00 to 25.00; six studies; 355 infants). We found no difference in bronchopulmonary dysplasia (BPD), defined as oxygen dependency at 28 days (three studies, 260 infants), as well as no difference in outcome at nine to 14 years (one study, 37 infants). In preterm infants with respiratory distress, the application of CDP as CPAP or CNP is associated with reduced respiratory failure and mortality and an increased rate of pneumothorax. Four out of six of these trials were done in the 1970s. Therefore, the applicability of these results to current practice is difficult to assess. Further research is required to determine the best mode of administration.

Plain-language summary: Six studies of moderate quality were identified for inclusion. The source of distending pressure was a negative pressure chamber in two studies, face mask continuous positive airway pressure (CPAP) in two studies, nasal CPAP in one study and negative pressure for less severe illness and endotracheal CPAP when more severe in another study. The studies were small, and four of the six were conducted before surfactant therapy was available. The review of trials found that outcomes for babies were improved. Fewer required IPPV and fewer died, and with these two outcomes combined, fewer babies died or required IPPV. It was also found that CDP can increase the rate of pneumothorax (air outside the lung within the chest cavity). Some meaningful benefits were found when continuous distending pressure (CDP) was used for respiratory distress syndrome in preterm babies.
Abstract: We included six studies (157 participants) in this review. Meta analysis of two studies indicated that foam dressings do not promote the healing of diabetic foot ulcers compared with basic wound contact dressings (RR 2.03, 95%CI 0.91 to 4.55). Pooled data from two studies comparing foam and alginate dressing found no statistically significant difference in ulcer healing (RR 1.50, 95% CI 0.92 to 2.44). There was no statistically significant difference in the number of diabetic foot ulcers healed when foam dressings were compared with hydrocolloid (matrix) dressings. All included studies were small and/or had limited follow-up times. Currently there is no research evidence to suggest that foam wound dressings are more effective in healing foot ulcers in people with diabetes than other types of dressing however all trials in this field are very small. Decision makers may wish to consider aspects such as dressing cost and the wound management properties offered by each dressing type e.g. exudate management.

Plain-language summary: Existing reviews have not found evidence that one dressing type is more effective than other types in healing foot ulcers in people with diabetes. This review (157 participants) confirms that currently there is no research evidence to suggest that foam wound dressings are more effective in healing diabetic foot ulcers than other types of dressing. Current decisions on choice of wound dressing if any, should be based where possible, on dressing costs and selecting the most useful management properties offered by each dressing type, for example, the management of wound discharge.
Abstract: Only one trial was identified for inclusion in this review. This trial was at a high risk of bias. This trial included 857 patients undergoing minor skin excision surgery in the primary care setting. The wounds were sutured after the excision. Patients were randomised to early post-operative bathing (dressing to be removed after 12 hours and normal bathing resumed) (n = 415) or delayed post-operative bathing (dressing to be retained for at least 48 hours before removal and resumption of normal bathing) (n = 442). The only outcome of interest reported in this trial was surgical site infection (SSI). There was no statistically significant difference in the proportion of patients who developed SSIs between the two groups (857 patients; RR 0.96; 95% CI 0.62 to 1.48). The proportions of patients who developed SSIs were 8.5% in the early bathing group and 8.8% in the delayed bathing group. There is currently no conclusive evidence available from randomised trials regarding the benefits or harms of early versus delayed post-operative showering or bathing for the prevention of wound complications, as the confidence intervals around the point estimate are wide, and, therefore, a clinically significant increase or decrease in SSI by early post-operative bathing cannot be ruled out. We recommend running further randomised controlled trials to compare early versus delayed post-operative showering or bathing.

Plain-language summary: We identified only one randomised controlled trial. This trial was at high risk of bias, i.e. there were flaws in the way it was conducted that could have given incorrect results.This trial included 857 people undergoing minor skin operations performed at a General Practitioner (GP) surgery. No steri-strips were used in this trial, as the wounds were stitched. The people running the trial used a method similar to the toss of a coin to decide which group participants went into. One group of 415 people was advised to remove the dressing 12 hours after surgery and then to bathe normally, while the other group of 442 people was advised to keep the dressing on for at least 48 hours and then to bathe normally. The only outcome of interest reported in this trial was wound infection. The authors reported no statistically significant difference in the proportion of people who developed wound infection in the two groups (8.5% in the early bathing group and 8.8% in the delayed bathing group). There is currently no conclusive evidence available from randomised trials about the benefits, or harms, with regard to wound complications of early or delayed post-operative showering or bathing. We recommend further randomised controlled trials to compare early versus delayed post-operative showering or bathing.
Abstract: We included nine RCTs randomising a total of 1414 participants (age range 24 to 70; mean age 45 to 59, where reported) to whole grain versus lower whole grain or refined grain control groups. We found no studies that reported the effect of whole grain diets on total cardiovascular mortality or cardiovascular events (total myocardial infarction, unstable angina, coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, total stroke). All included studies reported the effect of whole grain diets on risk factors for cardiovascular disease including blood lipids and blood pressure. All studies were in primary prevention populations and had an unclear or high risk of bias, and no studies had an intervention duration greater than 16 weeks. Overall, we found no difference between whole grain and control groups for total cholesterol (mean difference 0.07, 95% confidence interval -0.07 to 0.21; 6 studies (7 comparisons); 722 participants; low-quality evidence). Using GRADE, we assessed the overall quality of the available evidence on cholesterol as low. Four studies were funded by independent national and government funding bodies, while the remaining studies reported funding or partial funding by organisations with commercial interests in cereals. There is insufficient evidence from RCTs of an effect of whole grain diets on cardiovascular outcomes or on major CVD risk factors such as blood lipids and blood pressure. Trials were at unclear or high risk of bias with small sample sizes and relatively short-term interventions, and the overall quality of the evidence was low. There is a need for well-designed, adequately powered RCTs with longer durations assessing cardiovascular events as well as cardiovascular risk factors.

Plain-language summary: We evaluated nine randomised studies assessing the effects of whole grain diets compared to diets with refined grains or a usual diet on levels of cholesterol in the blood or blood pressure (major risk factors for cardiovascular disease including heart attacks or stroke). The evidence is current to August 2016. The diets were followed for at least 12 weeks, but most studies had some methodological limitations, numbers of participants were small, and the overall quality of the evidence was low. We found no studies reporting on the effect of whole grains on deaths from cardiovascular disease or cardiovascular events. All nine included studies reported the effects of whole grain diets on levels of cholesterol in the blood or blood pressure. We found no effects on blood cholesterol or blood pressure in favour of whole grain diets. Four studies were funded by independent national and government funding bodies, while the remaining studies reported funding or partial funding by organisations with commercial interests in cereals. There is insufficient evidence from randomised controlled trials to date to recommend consumption of whole grain diets to reduce the risk of cardiovascular disease, or lower blood cholesterol, or blood pressure.
Abstract: Four studies met the inclusion criteria. No single intervention was evaluated by more than one trial. Two studies were conducted in low-income countries. Two studies were randomised controlled trials (RCT), and two were non-randomised trials. An RCT of a home-based nursing programme showed a positive effect of the intervention on knowledge and medication refills (p=.002), but no effect on CD4 count and viral load. A second RCT of caregiver medication diaries showed that the intervention group had fewer participants reporting no missed doses compared to the control group (85% vs. 92%, respectively), although this difference was not statistically significant (p=.08). The intervention had no effect on CD4 percentage or viral load. A non-randomised trial of peer support group therapy for adolescents demonstrated no change in self-reported adherence, yet the percentage of participants with suppressed viral load increased from 30% to 80% (p=.06). The second non-randomised trial found that the percentage of children achieving >80% adherence was no different between children on a lopinavir-ritonavir (LPV/r) regimen compared to children on a non-nucleoside reverse transcriptase regimen (p=.781). However, the proportion of children achieving virological suppression was significantly greater for children on the LPV/r regimen than for children on the NNRTI-containing regimen (p=.002). A home-based nursing intervention has the potential to improve ART adherence, but more evidence is needed. Medication diaries do not appear to have an effect on adherence or disease outcomes. Two interventions, an LPV/r-containing regimen and peer support therapy for adolescents, did not demonstrate improvements in adherence, yet demonstrated greater viral load suppression compared to control groups, suggesting a different mechanism for improved health outcomes. Well-designed evaluations of interventions to improve paediatric adherence to ART are needed.

Plain-language summary: We identified four studies that evaluated interventions designed to improve adherence to ART among children and adolescents age 18 years and younger. These studies showed that home-based nursing, peer support for adolescents and LPV/r-containing regimens have the potential to improve ART adherence, but more evidence is needed. Medication diaries do not appear to have an effect on adherence. There is a need for well-designed evaluations of interventions to improve paediatric adherence to ART.
Abstract: Five studies (696 participants) met the inclusion criteria; 24 participants were treated with fenoprofen 12.5 mg, 23 with fenoprofen 25 mg, 79 with fenoprofen 50 mg, 78 with fenoprofen 100 mg, 146 with fenoprofen 200 mg, 55 with fenoprofen 300 mg, 43 with zomepirac 100 mg, 30 with morphine 8 mg, 77 with codeine 60 mg, and 141 with placebo. Participants had pain following third molar extraction, laparoscopy, minor day surgery and episiotomy. The NNT for at least 50% pain relief over 4 to 6 hours with a single dose of fenoprofen 200 mg compared to placebo was 2.3 (1.9 to 3.0). There were insufficient data to analyse other doses or active comparators, time to use of rescue medication, or numbers of participants needing rescue medication. There was no difference in numbers of participants experiencing any adverse events between fenoprofen 200 mg and placebo. No serious adverse events or adverse event withdrawals were reported in these studies. Oral fenoprofen 200 mg is effective at treating moderate to severe acute postoperative pain, based on limited data for at least 50% pain relief over 4 to 6 hours. Efficacy of other doses, other efficacy outcomes, and safety and tolerability could not be assessed.

Plain-language summary: Five studies looking at a total of 696 participants were included. Because fewer than 200 participants were treated with any one dose of fenoprofen within each study, results must be treated with caution. A good level of pain relief was experienced by better than one in two (over half; 57%) of those with moderate or severe postoperative pain after a single dose of fenoprofen 200 mg, compared to about 1 in 7 (14%) with placebo. This level of pain relief is comparable to that experienced with ibuprofen 400 mg. The frequency of adverse events did not differ between fenoprofen 200 mg and placebo in these studies.