GEM/cochrane-simplification huggingface dataset:
Abstract: We included 12 trials enrolling 3474 patients. The overall risk of bias was unclear for the majority of articles due to a lack of reported data; however, the authors determined that this would be unlikely to impact negatively as most data outcomes were objective (e.g. death vs. no death). There was no evidence of the effectiveness in improving patient outcomes of PTCRA in non-complex lesions. In complex lesions, there were no statistically significant differences in re-stenosis rates at six months (RR 1.05; 95% confidence interval (CI) 0.83 to 1.33) and at one year (RR 1.21; 95% CI 0.95 to 1.55) in those receiving PTCRA with adjunctive balloon angioplasty (PTCA) (PTCRA/PTCA) compared to those receiving PTCA alone. Morphological characteristics distinguishing complex lesions have not been examined in parallel-arm randomised controlled trials. The evidence for the effectiveness of PTCRA in in-stent re-stenosis is unclear Compared to angioplasty alone, PTCRA/PTCA did not result in a statistically significant increase in the risk of major adverse cardiac events (myocardial infarction (MI), emergency cardiac surgery or death) during the in-hospital period (RR 1.27; 95% CI 0.86 to 1.90). Compared to angioplasty, PTCRA was associated with nine times the risk of an angiographically detectable vascular spasm (RR 9.23; 95% CI 4.61 to 18.47), four times the risk of perforation (RR 4.28; 95% CI 0.92 to 19.83) and about twice the risk of transient vessel occlusions (RR 2.49; 95% CI 1.25 to 4.99) while angiographic dissections (RR 0.48; 95% CI 0.34 to 0.68) and stents used as a bailout procedure (RR 0.29; 95% CI 0.09 to 0.87) were less common. When conventional PTCA is feasible, PTCRA appears to confer no additional benefits. There is limited published evidence and no long-term data to support the routine use of PTCRA in in-stent re-stenosis. Compared to angioplasty alone, PTCRA/PTCA did not result in a higher incidence of major adverse cardiac events, but patients were more likely to experience vascular spasm, perforation and transient vessel occlusion. In certain circumstances (e.g. patients ineligible for cardiac surgery, those with architecturally complex lesions, or those with lesions that fail PTCA), PTCRA may achieve satisfactory re-vascularisation in subsequent procedures.

Plain-language summary: This review sought to determine whether PTCRA leads to improved patient outcomes compared to balloon angioplasty. It was important to do this review as it is not known whether or not PTCRA provides greater benefits to patients compared to balloon angioplasty. The review analysed data from 12 studies, which showed that there is limited evidence to support the routine use of PTCRA for in-stent re-stenosis; however, only for those people who were not suitable for surgery. For those with complex lesions, PTCRA may provide some benefit in comparison to balloon angioplasty. The review also showed that patients receiving PTCRA were more likely to have perforations during the procedure compared to patients receiving balloon angioplasty. This review was limited by the small number of studies and deficiency of data reported in some of the studies.
Abstract: Three RCTs (333 participants) were identified, two of which were multicentre trials comprising only participants positive for respiratory syncytial virus (RSV). The other trial enrolled participants clinically diagnosed with bronchiolitis from a hospital in Italy. All studies used 2.5 mL (1 mg/mL) of nebulised rhDNase compared with placebo either as a daily or a twice daily dose. Adjunctive therapy included nebulised salbutamol, steroids, supplemental oxygen, intravenous fluids or tube feeding, nasal washing, nasal decongestants and antibiotics. Overall, nebulised rhDNase showed no benefit in clinically meaningful outcomes. Meta-analysis favoured the control group with a shorter duration of hospital stay (MD 0.50; 95% CI 0.10 to 0.90, P = 0.01) and better clinical score improvement (SMD -0.24; 95% CI -0.50 to 0.01, P = 0.06). The largest trial showed no difference in supplemental oxygen use or intensive care unit (ICU) admission. In one RCT, four out of 11 patients in the treatment group had atelectasis. Two of these patients showed distinctive clinical improvement after nebulised rhDNase. There was no significant difference in adverse events. These included temporary desaturation, temporary coughing, increased coughing, facial rash, hoarseness, dyspnoea and bad taste, reported in a total of 11 patients from both treatment groups. The results based on the three included studies in this review did not support the use of nebulised rhDNase in children under 24 months of age hospitalised with acute bronchiolitis. In these patients, treatment did not shorten the length of hospitalisation or improve clinical outcomes. It might have a role in severe bronchiolitis complicated by atelectasis, but further clinical studies would need to be performed.

Plain-language summary: We identified three randomised controlled trials involving 333 children up to 24 months of age hospitalised with bronchiolitis. All three studies compared nebulised rhDNase with placebo. Any additional treatments were given to both groups. Overall, the studies did not show that nebulised rhDNase shortened the duration of hospital admission, or improved the severity of symptoms. No serious side effects were reported by any of the studies. One study showed that in patients suffering from atelectasis, a severe complication of bronchiolitis wherein the lung does not expand completely, nebulised rhDNase treatment resulted in a distinct improvement within two days. To confirm this beneficial effect, further clinical studies in patients with severe bronchiolitis are needed. Currently, the use of this treatment in young children hospitalised with bronchiolitis is not recommended.
Abstract: Two trials met the inclusion criteria. The sponge was significantly less effective in both trials in preventing overall pregnancy than was the diaphragm. In the larger USA trial, the 12-month cumulative life-table termination rates per 100 women for overall pregnancy were 17.4 for the sponge and 12.8 for the diaphragm. The rates were 24.5 for the sponge and 10.9 for the diaphragm in the UK trial. Similarly, discontinuation rates at 12 months were higher with the sponge than with the diaphragm (Odds ratio 1.31; 95% CI 1.07 to 1.59). Allergic-type reactions were more common with the sponge, although discontinuation for discomfort differed in the two trials. No new trials have been identified since the initial review. The sponge was less effective than the diaphragm in preventing pregnancy. Discontinuation rates were higher at 12 months as well. Other randomized controlled trials will be needed to resolve the potential role of spermicides in preventing sexually transmitted infections or in causing adverse effects.

Plain-language summary: In April 2013, we did computer searches for randomized trials that compared the sponge with the diaphragm. For the original review, we looked at reference lists and book chapters to find trials. We also wrote to researchers to look for more trials. We found two trials. In a large USA trial, the sponge did not work as well as the diaphragm in preventing pregnancy. For every 100 women who used the sponge for a year, about 17 got pregnant. Of those who used the diaphragm, 13 became pregnant. A U.K. trial found similar results. For each 100 women who used the sponge for a year, about 25 got pregnant. Of the diaphragm users, 11 became pregnant. We have not found any new trials since the initial review. About 30% more women stopped using the sponge than the diaphragm. Allergy to the sponge was a problem for some women. However, discomfort caused about the same numbers of women to stop using their birth control method.
Abstract: There were fourteen studies (16 comparisons) with extractable data included in the review, of which ten studies examined TCAs, two examined SSRIs and two included both classes, all compared with placebo. The number of participants in the intervention groups was 1364 and in the placebo groups 919. Nearly all studies were of short duration, typically 6-8 weeks. Pooled estimates of efficacy data showed an RR of 1.24, 95% CI 1.11-1.38 in favour of TCAs against placebo. For SSRIs this was 1.28, 95% CI 1.15 to 1.43.. The numbers needed to treat (NNT) for TCAs ranged from 7 to 16 {median NNT 9} patient expected event rate ranged from 63% to 26% respectively) and for SSRIs from 7 to 8 {median NNT 7} (patient expected event rate ranged from 48% to 42% respectively) . The numbers needed to harm (NNH for withdrawal due to side effects) ranged from 4 to 30 for TCAs (excluding three studies with no harmful events leading to withdrawal) and 20 to 90 for SSRIs. Both TCAs and SSRIs are effective for depression treated in primary care.

Plain-language summary: However, most systematic reviews of antidepressant treatment have included trials conducted in secondary care settings. There has been doubt about the effectiveness of antidepressants in primary care, and hence the impetus to do this review. Through extensive searches of the literature we found 14 studies conducted in adults (not the elderly) in primary care setting, in which tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs) were compared against a placebo control group in the treatment of depression. The results showed that both TCAs and SSRIs were effective for depression. Most of the studies were supported by funds from pharmaceutical companies and were of short duration. There appeared to be more adverse effects with TCAs than with SSRIs, however rates of withdrawal from study medication due to adverse effects were very similar between the two antidepressant classes. Adverse effects not leading to medication cessation seemed to be more common with TCAs than SSRIs.
Abstract: One randomised trial in 136 patients studied maintaining lamivudine in second-line regimens or not. There was no difference in virological outcomes in the group who maintained lamivudine and those who did not in their subsequent regimens. Two other small observational studies reported in abstract form also did not report a difference in the proportion of those with viral suppression after six months and time to HIV-1 RNA suppression among those on a lamivudine (3TC) or emtricitabine (FTC) regimen compared to those on a 3TC/FTC-sparing second-line regimen. There were no trials identified comparing boosted protease inhibitors (PIs) or nucleoside backbone combinations after first-line failure on non-thymidine analog combinations. Observational studies of populations starting ART in resource-limited settings suggest that short-term response on boosted PI-based regimens is encouraging. There is limited evidence to evaluate second-line therapies in patients with HIV who fail first-line treatment with a WHO-recommended regimen. One randomised trial in 136 patients and two observational studies (both of low quality) suggest no difference in virological suppression whether or not lamivudine is maintained in a second-line regimen. While outcomes of second-line regimens with boosted PIs are favourable in general, there are no studies comparing boosted PIs directly in populations starting second-line regimens. Current recommendations are based on available resources and patient- and public-health-level considerations.

Plain-language summary: This review attempted to assess the best ART regimen for HIV-infected people in low- and middle-income countries following treatment failure; however, the review found limited studies addressing this topic. One randomised trial and one abstract of an observational study evaluated whether or not to maintain lamivudine in second-line regimens; both suggested no difference in outcomes. There were no studies comparing boosted PI-containing second-line regimens in patients failing an NNRTI-based first-line regimen, nor any evaluating NRTI combinations after first-line with non-thymidine analog combinations. While such trials are difficult to conduct for a variety of reasons, randomised controlled trails comparing second-line therapies are needed, especially in resource-limited settings.
Abstract: Sixty-three studies met the inclusion criteria with a total of 8014 participants. Of these, 56 trials recruited infants and young children. The trials varied in the definition used for acute diarrhoea and the end of the diarrhoeal illness, as well as in the risk of bias. The trials were undertaken in a wide range of different settings and also varied greatly in organisms tested, dosage, and participants' characteristics. No adverse events were attributed to the probiotic intervention. Probiotics reduced the duration of diarrhoea, although the size of the effect varied considerably between studies. The average of the effect was significant for mean duration of diarrhoea (mean difference 24.76 hours; 95% confidence interval 15.9 to 33.6 hours; n=4555, trials=35) diarrhoea lasting ≥4 days (risk ratio 0.41; 0.32 to 0.53; n=2853, trials=29) and stool frequency on day 2 (mean difference 0.80; 0.45 to 1.14; n=2751, trials=20). The differences in effect size between studies was not explained by study quality, probiotic strain, the number of different strains, the viability of the organisms, dosage of organisms, the causes of diarrhoea, or the severity of the diarrhoea, or whether the studies were done in developed or developing countries. Used alongside rehydration therapy, probiotics appear to be safe and have clear beneficial effects in shortening the duration and reducing stool frequency in acute infectious diarrhoea. However, more research is needed to guide the use of particular probiotic regimens in specific patient groups.

Plain-language summary: A number of randomized controlled trials have been done to see whether probiotics are beneficial in acute infectious diarrhoea. We have searched for as many of these trials as possible and collected together the data in a systematic way to try to discover whether or not probiotics are beneficial in acute diarrhoea. We identified 63 trials, which included a total of 8014 people - mainly infants and children. Probiotics were not associated with any adverse effects. Nearly all studies reported a shortened duration of diarrhoea and reduced stool frequency in people who received probiotics compared to the controls. Overall, probiotics reduced the duration of diarrhoea by around 25 hours, the risk of diarrhoea lasting four or more days by 59% and resulted in about one fewer diarrhoeal stool on day 2 after the intervention. However, there was very marked variability in the study findings and so these estimates are approximate. We concluded that these results were very encouraging but more research is needed to identify exactly which probiotics should be used for which groups of people, and also to assess the cost effectiveness of this treatment.
Abstract: We included one trial (involving 135 women with mild pre-eclampsia at term). An additional six studies are awaiting further assessment. The included trial compared magnesium sulphate with a placebo and was at a low risk of bias. The trial did not report any of this review's prespecified primary outcomes. There was no significant difference between magnesium sulphate and placebo in Apgar score less than seven at five minutes (risk ratio (RR) 0.51; 95% confidence interval (CI) 0.05 to 5.46; 135 infants), nor gestational age at birth (mean difference (MD) -0.20 weeks; 95% CI -0.62 to 0.22; 135 infants). There were significantly more maternal side effects (feeling warm and flushed) in the magnesium sulphate group than in the placebo group (RR 3.81; 95% CI 2.22 to 6.53; 135 women). However, no significant difference in adverse effects severe enough to cease treatment was observed (RR 3.04; 95% CI 0.13 to 73.42; 135 women). There were no significant differences seen between groups in the rates of postpartum haemorrhage (RR 4.06; 95% CI 0.47 to 35.38; 135 women) and caesarean section (RR 0.80; 95% CI 0.39 to 1.63; 135 women). There is currently insufficient evidence to assess the efficacy and safety of magnesium sulphate when administered to women for neuroprotection of the term fetus. As there has been recent evidence for the use of magnesium sulphate for neuroprotection of the preterm fetus, high-quality randomised controlled trials are needed to determine the safety profile and neurological outcomes for the term fetus. Strategies to reduce maternal side effects during treatment also require evaluation.

Plain-language summary: This review included one randomised controlled study involving 135 women with mild pre-eclampsia (high blood pressure and/or protein in the urine). There was not enough evidence from this study to determine the effects of magnesium sulphate on babies born at term. Women receiving magnesium sulphate were more likely to feel warm and flushed in this study than women who received a placebo, but they were not more likely to stop treatment due to side effects. The rates of haemorrhage after birth and rates of caesarean birth were similar for women who received magnesium sulphate and those who received a placebo. More studies are needed to establish whether magnesium sulphate given to the mother at term is protective for the baby's brain. The babies in these trials should be followed up over a long period so that we can monitor the effects of magnesium on child development. We are awaiting further information from another six studies so that they can be assessed.
Abstract: Four studies met all of the eligibility criteria for inclusion within the review. Two used combination therapies consisting of a pharmacotherapy combined with cognitive and behavioural therapies, whilst the remaining two used cognitive and behavioural therapy through counselling, one via text message support and the other delivered via clinic doctors trained in smoking cessation techniques. Smoking cessation data were pooled across all studies producing a statistically and clinically significant effect in favour of the intervention (risk ratio 1.43, 95%CI 1.03 to 1.98, p=0.032), however following sensitivity analysis a statistically non-significant but clinically significant effect was observed in favour of the intervention (risk ratio 1.33, 95%CI 0.95 to 1.85, p=NS) . A significant health disparity exists, whereby Indigenous populations, a minority, are over-represented in the burden of smoking-related morbidity and mortality. This review highlights the paucity of evidence available to evaluate the effectiveness of smoking cessation interventions, despite the known success of these interventions in non-Indigenous populations. Due to this lack of published investigations, the external validity of this review is limited, as is the ability to draw reliable conclusions from the results. The limited but available evidence reported does indicate that smoking cessation interventions specifically targeted at Indigenous populations can produce smoking abstinence. However this evidence base is not strong with a small number of methodologically sound trials investigating these interventions. More rigorous trials are now required to assist in bridging the gap between tobacco related health disparities in Indigenous and non-Indigenous populations.

Plain-language summary: This review of four studies found that published studies evaluating smoking cessation interventions specifically aiming to reduce and/or stop the use of tobacco in Indigenous people are significantly lacking. The limited evidence reported in this review does indicate some benefit in these interventions to help Indigenous people stop smoking. However, the change in attitudes after one study was negative with fewer people 'ready to quit' after the smoking cessation intervention was completed. Consideration needs to be given to cultural differences and traditions when tailoring interventions for Indigenous people. Modified or innovative interventions and careful outcomes research are needed to improve the usefulness of smoking cessation interventions aimed at Indigenous populations.
Abstract: Six studies (n = 478) of variable quality were included. A composite outcome of Infant Pain Scale (NIPS), Neonatal Facial Action Coding System (NFCS) and/or Premature Infant Pain Profile (PIPP) score was reported in 288 infants, who did not receive a sweet tasting solution. Meta-analysis showed a significant reduction in the venepuncture versus the heel lance group (SMD -0.76, 95% CI -1.00 to -0.52; I2 = 0%). When a sweet tasting solution was provided the SMD remained significant favouring the venepuncture group (SMD - 0.38, 95% CI -0.69 to -0.07). The typical RD for requiring more than one skin puncture for venepuncture versus heel lance (reported in 4 studies; n = 254) was -0.34 (95% CI -0.43 to -0.25; I2 = 97%). The NNT to avoid one repeat skin puncture was 3 (95% CI 2 to 4). Cry characteristics favoured the venepuncture group but the differences were reduced by the provision of sweet tasting solutions prior to either procedure. Venepuncture, when performed by a skilled phlebotomist, appears to be the method of choice for blood sampling in term neonates. The use of a sweet tasting solution further reduces the pain. Further well designed randomised controlled trials should be conducted in settings where several individuals perform the procedures.

Plain-language summary: This review of trials found evidence that venepuncture, when done by a trained practitioner, caused less pain than heel lance. The use of a sweet tasting solution given to the baby prior to the event reduced pain further. The evidence included outcome measures using pain scales, how long the baby cried and how the mother rated their baby's pain.