GEM/cochrane-simplification huggingface dataset:
Abstract: We included three trials involving 1671 participants; oxytocin was the only uterotonic drug that was used. The dose and route of administration of oxytocin varied among the included studies. Administration of oxytocin before and after the expulsion of placenta does not significantly influence the incidence of postpartum haemorrhage (blood loss greater than 500 ml) (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.62 to 1.04; n = 1667, three trials); retained placenta (RR 1.54, 95% CI 0.76 to 3.11; n = 1667, three trials); length of third stage of labour (minutes) (mean difference (MD) -0.30, 95% CI -0.95 to 0.36; n = 1667, three trials); postpartum blood loss (ml) (MD 22.32, 95% CI -58.21 to 102.86; n = 181, two trials); changes in haemoglobin (g/dL) (MD 0.06, 95% CI -0.60 to 0.72; n = 51, one trial); blood transfusion (RR 0.79, 95% CI 0.23 to 2.73; n = 1667, three trials); the use of additional uterotonics (RR 1.10, 95% CI 0.80 to 1.52; n = 1667, three trials); the incidence of maternal hypotension (RR 2.48, 95% CI 0.23 to 26.70; n = 130, one trial) and the incidence of severe postpartum haemorrhage (blood loss 1000 ml or more) (RR 0.98, 95% CI 0.48 to 1.98; n = 130, one trial). No data on other maternal or neonatal outcome measures were available. Administration of oxytocin before and after the expulsion of placenta did not have any significant influence on many clinically important outcomes such as the incidence of postpartum haemorrhage, rate of placental retention and the length of the third stage of labour. However, the number of available studies were limited. The only uterotonic drug used was oxytocin, mainly through intravenous infusion, therefore its extrapolation to other routes of administration should be interpreted cautiously. More studies are required to examine other maternal and neonatal outcomes using consistent approaches.

Plain-language summary: This review of three trials (1671 participants) found that routine administration of oxytocin with the anterior shoulder compared with use of oxytocin after delivery of the placenta did not have any influence on the amount of bleeding postpartum or retained placenta. The route of administration of oxytocin in two of the three included studies was through intravenous infusion. Cord management at delivery was consistent with double clamping and immediate cutting after delivery of the baby. Application of controlled cord traction was slightly different among the included studies. In two of the studies, the placenta was delivered with controlled cord traction when signs of placental separation were present. Fundal pressure on the uterus was used in one study from the beginning to ensure continued uterine contraction. Oxytocin was the only uterotonic assessed. There were no assessments of any impact on neonatal health. More well designed studies using consistent approaches in this area of the management of the third stage of labour are required.
Abstract: The meta-analysis included 894 men. No studies reported live birth. The combined fixed-effect odds ratio (OR) of the 10 studies for the outcome of pregnancy was 1.47 (95% confidence interval (CI) 1.05 to 2.05, very low quality evidence), favouring the intervention. The number needed to treat for an additional beneficial outcome was 17, suggesting benefit of varicocele treatment over expectant management for pregnancy rate in subfertile couples in whom varicocele in the man was the only abnormal finding. Omission of the studies including men with normal semen analysis and subclinical varicocele, some of which had semen analysis improvement as the primary outcome rather than live birth or pregnancy rate, was the subject of a planned subgroup analysis. The outcome of the subgroup analysis (five studies) also favoured treatment, with a combined OR 2.39 (95% CI 1.56 to 3.66). The number needed to treat for an additional beneficial outcome was 7. The evidence was suggestive rather than conclusive, as the main analysis was subject to fairly high statistical heterogeneity (I2 = 67%) and findings were no longer significant when a random-effects model was used or when analysis was restricted to higher quality studies. There is evidence suggesting that treatment of a varicocele in men from couples with otherwise unexplained subfertility may improve a couple's chance of pregnancy. However, findings are inconclusive as the quality of the available evidence is very low and more research is needed with live birth or pregnancy rate as the primary outcome.

Plain-language summary: This review analysed 10 studies (894 participants) and found evidence (combined odds ratio was 1.47 (95% CI 1.05 to 2.05) to suggest an increase in pregnancy rates after varicocele treatment compared to no treatment in subfertile couples, in whom, apart from poor sperm quality, varicocele in the man was the only abnormal finding. This means that 17 men would need to be treated to achieve one additional pregnancy. However, findings were inconclusive as the quality of the available evidence was very low and more research is needed with live birth or pregnancy rate as the primary outcome.
Abstract: Six trials with 658 participants met the inclusion criteria. At the time of this review, five trials were published in full text, and one study was available in abstract form only. No significant differences were demonstrated between the two delivery methods in terms of the need for hospital admission (RR 1.00, 95% CI 0.63 to 1.59), change in oxygen saturation (SMD -0.03, 95% CI -0.39 to 0.33), PEFR (SMD 0.04, 95% CI -0.72 to 0.80), clinical score (WMD 0.00, 95% CI -0.37 to 0.37), in terms of need for additional treatment (RR 1.18, 95% CI 0.84 to 1.65), or regarding change in heart rate per minute (SMD 0.09, 95% CI -0.24 to 0.42). Overall, this review did not identify a statistically significant difference between these two methods for delivering bronchodilator therapy to children with acute asthma or lower airways obstruction attacks. Care should be taken in the interpretation and applicability of our results because of the small number of RCTs along with few events available meeting the criteria for inclusion in the review, absence of the primary outcome of interest and other clinically important outcomes in the majority of included studies. The possible need for a face-mask in younger children using home-made spacers should also be considered in practice.

Plain-language summary: The aim of this review was to compare the response to inhaled beta-2 agonists delivered through a metered-dose inhaler (MDI) attached to home-made spacers, compared with beta-2 agonists delivered through a MDI attached to commercially produced spacers in children with acute exacerbations of wheezing or asthma. Six randomized clinical trials (RCTs) with 658 participants met the inclusion criteria of the review. Overall, this review fails to identify a difference between these two delivery methods for delivering bronchodilator therapy to children with acute asthma or lower airways obstruction attacks. However, given the small total sample and wide confidence intervals, equivalence between the treatments cannot be claimed.
Abstract: Thirteen randomized controlled trials were included in the analysis. The studies demonstrated an initial improvement in respiratory status (improved oxygenation and decreased need for ventilator support). The meta-analysis supports a significant decrease in the risk of any air leak (typical relative risk 0.47, 95% CI 0.39, 0.58; typical risk difference -0.16, 95% CI -0.21, -0.12), pneumothorax (typical relative risk 0.42, 95% CI 0.34, 0.52; typical risk difference -0.17, 95% CI -0.21, -0.13), and a significant decrease in the risk of pulmonary interstitial emphysema (typical relative risk 0.45, 95% CI 0.37, 0.55; typical risk difference -0.20, 95% CI -0.25, -0.15). There is a significant decrease in the risk of neonatal mortality (typical relative risk 0.68, 95% CI 0.57, 0.82; typical risk difference -0.09, 95% CI -0.13, -0.05), a significant decrease in the risk of mortality prior to hospital discharge (typical relative risk 0.63, 95% CI 0.44, 0.90; typical risk difference -0.10, 95% CI -0.18, -0.03) and a significant decrease in the risk of bronchopulmonary dysplasia (BPD) or death at 28 days of age (typical relative risk 0.83, 95% CI 0.77, 0.90; typical risk difference -0.11, 95 CI -0.16, -0.06). No differences are reported in the risk of patent ductus arteriosus, necrotizing enterocolitis, intraventricular hemorrhage, BPD or retinopathy of prematurity. Infants with established respiratory distress syndrome who receive animal derived surfactant extract treatment have a decreased risk of pneumothorax, a decreased risk of pulmonary interstitial emphysema, a decreased risk of mortality, and a decreased risk of bronchopulmonary dysplasia or death.

Plain-language summary: A wide variety of surfactant products have been formulated and studied in clinical trials. These include synthetic surfactants and animal derived surfactant extracts. Animal derived surfactant extracts are obtained from animal or human sources. Trials of surfactant replacement have either tried to prevent the development of respiratory distress in high-risk premature infants or treat established respiratory distress in premature infants. Infants with established respiratory distress syndrome who receive animal derived surfactant extract treatment have a decreased risk of lung rupture (pneumothorax), a decreased risk of lung injury (pulmonary interstitial emphysema), a decreased risk of dying, and a decreased risk of chronic lung injury (bronchopulmonary dysplasia) or death.
Abstract: Four studies enrolling a total of 179 participants with cystic fibrosis (143 (80%) were children aged 1 to 16 years) were included in this review. There was no study comparing a vaccine to a placebo or a whole virus vaccine to a subunit or split virus vaccine. Two studies compared an intranasal applied live vaccine to an intramuscular inactivated vaccine and the other two studies compared a split virus to a subunit vaccine and a virosome to a subunit vaccine (all intramuscular). The incidence of all reported adverse events was high depending on the type of influenza vaccine. The total adverse event rate ranged from 48 out of 201 participants (24%) for the intranasal live vaccine to 13 out of 30 participants (43%) for the split virus vaccine. With the limitation of a statistical low power there was no significant difference between the study vaccinations. None of the events were severe. All study influenza vaccinations generated a satisfactory serological antibody response. No study reported other clinically important benefits. There is currently no evidence from randomised studies that influenza vaccine given to people with cystic fibrosis is of benefit to them. There remains a need for a well-constructed clinical study, that assesses the effectiveness of influenza vaccination on important clinical outcome measures.

Plain-language summary: We searched for studies which compared different vaccines or compared vaccination to placebo. We were able to include four studies with 179 people in the review. Most (143) were under 16 years old. No study compared one vaccine to placebo. There were a high number of drop outs in two of the studies. Vaccination does result in an immune system response to the types of influenza used in the vaccine. However, this response may not result in protection against influenza infection or lung damage. There were a high number of adverse events, but none were serious or persistent. There is no evidence to show if regular influenza vaccine benefits people with cystic fibrosis.
Abstract: Three trials, all classified at high risk of bias, contributed to this review (Miller 1961; BPSM 1995; Zivadinov 2001) resulting in a total of 183 participants (91 treated). Corticosteroid therapy did not reduce the risk of being worse at the end of follow-up (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.26 to 1.02) but there was a substantial heterogeneity between studies (I2: 78.4%). I. v. periodic high dose methylprednisolone (MP) was associated with a significant reduction in the risk of disability progression at 5 years in relapsing-remitting (RR) MS (OR 0.26, 95% CI 0.10 to 0.66), while oral continuous low dose prednisolone was not associated with any risk reduction in disability progression at 18 months (OR 1.23, 95% CI 0.43 to 3.56). Risk of experiencing at least one exacerbation at end of follow-up was not significantly reduced with corticosteroid treatment (OR 0.36; 95% CI 0.10 to 1.25).  Only one study recorded adverse events: in one patient i. v. MP was discontinued after the fourth pulse when he developed acute glomerulonephritis; a second patient was removed from the study after the fifth i. v. MP pulse because of severe osteoporosis. There is no enough evidence that long-term corticosteroid treatment delays progression of long term disability in patients with MS. Since one study at high risk of bias showed that the administration of pulsed high dose i. v. MP is associated with a significant reduction in the risk of long term disability progression in patients with RR MS, an adequately powered, high quality RCT is needed to investigate this finding.

Plain-language summary: The reviewers found three studies addressing this issue. A meta-analysis showed a trend towards a beneficial effect of long-term corticosteroids on accumulation of disability; however only two small studies contributed to this result. It was not possible to reliably comment on the effect of long-term corticosteroids on the frequency of relapses. Side effects were poorly documented. Therefore rigorous randomised controlled trials of this treatment are warranted.
Abstract: Two trials met criteria for an RCT of antenatal psychosocial assessment. One trial examined the impact of an antenatal tool (ALPHA) on clinician awareness of psychosocial risk, and the capacity of the antenatal ALPHA to predict women with elevated postnatal Edinburgh Depression Scale (EDS) scores, finding a trend towards increased clinician awareness of 'high level' psychosocial risk where the ALPHA intervention had been used (relative risk (RR) 4.61 95% confidence interval (CI) 0.99 to 21.39). No differences between groups were seen for numbers of women with antenatal EDS scores, a score of greater than 9 being identified by ALPHA as of concern for depression (RR 0.69 95% CI 0.35 to 1.38); 139 providers. The other trial reported no differences in EPS scores greater than 12 at 16 weeks postpartum between the intervention (communication about the EDS scores with the woman and her healthcare providers plus a patient information booklet) and the standard care groups (RR 0.86 95% CI 0.61 to 1.21; 371 women). While the use of an antenatal psychosocial assessment may increase the clinician's awareness of psychosocial risk, neither of these small studies provides sufficient evidence that routine antenatal psychosocial assessment by itself leads to improved perinatal mental health outcomes. Further studies with better sample size and statistical power are required to further explore this important public health issue. It will also be important to examine outcomes up to one year postpartum not only for mother, but also infant and family.

Plain-language summary: The one study that met the criteria for this review randomised healthcare providers to either psychosocial assessment or routine care and involved a total of 273 women. The providers who assessed psychosocial factors were more likely than those giving routine care to identify psychosocial concerns and to rate the level of concern as high. They were also more likely to detect concerns about family violence. The trial did not look at the development of anxiety or depression in these women. Not all healthcare providers chose to take part in the trial and some dropped out, leaving only 48 of the original 185 approached. This could mean that providers who were less interested in this area of clinical practice did not participate and bias the findings toward better than average detection of psychosocial risk. Two studies are currently in progress looking at the impact of early postnatal psychosocial assessment on the prevalence of antenatal and postnatal anxiety and depression.
Abstract: Only one eligible study, involving 21 participants, was included. The study compared platelet-rich therapy and allogenic bone graft with allogenic bone graft alone in patients undergoing corrective osteotomy for medial compartment osteoarthrosis of the knee. The risk of bias associated with this study was substantial. There was no significant difference in patient-reported or clinician-assessed functional outcome scores between groups at one year. There was a statistically significant benefit from platelet-rich therapy in the proportion of bones that were united at one year (8/9 versus 3/9; RR 2.67; 95% CI 1.03 to 6.91). This benefit, however, was not maintained when assuming poor outcomes for participants who were lost to follow-up (8/11 versus 3/10; RR 2.42; 95% CI 0.88 to 6.68). One adverse event was reported in a participant receiving platelet-rich therapy. One other eligible study involving hip fracture patients is currently underway. While a potential benefit of platelet-rich therapies to augment long bone healing in adults cannot be ruled out, the currently available evidence from a single trial is insufficient to support the routine use of this intervention in clinical practice. Future trials should focus on reporting patient-reported functional outcomes from all trial participants for a minimum follow-up of one year.

Plain-language summary: Only one study, involving 21 participants, was included in this review. The study compared PRT and bone graft versus bone graft alone (control) in patients with osteoarthritis of the knee who had surgery where a wedge of bone was cut (osteotomy) from their tibia (shin bone) in order to change the pattern of weight bearing on the knee. As in a fracture, the time for the bone to heal is an important factor in determining recovery after an osteotomy. The study found no difference between the PRT and control groups in patient-reported or clinician-assessed functional outcomes at one year. However, based on radiographic (x-ray) measures of bone healing, the study found a higher proportion of bones had healed by one year in those participants who had completed the study. One adverse event was reported in a participant receiving platelet-rich therapy From the limited evidence that is currently available, the review found that PRT had no effect on functional outcomes. PRT may be beneficial in accelerating and improving the incidence of union in osteotomies. The only complication reported was not necessarily related to the PRT treatment. No data were available regarding PRT in the treatment of acute fractures, non-united fractures or large bony defects. One other study involving hip fracture patients is currently underway, and will provide further evidence concerning the use of PRT in the future.
Abstract: We included three RCTs in this review. The studies reported mean logMAR visual acuity achieved. Mean difference in visual acuity was calculated. When comparing conventional part-time occlusion (with any necessary glasses), PEDIG 2006 reported that this treatment was more beneficial than glasses alone for strabismic amblyopia; the mean difference between groups was -0.18 LogMAR (statistically significant 95% confidence interval (CI) -0.32 to -0.04). Supplementing occlusion therapy with near activities may produce a better visual outcome compared to non-near activities after four weeks of treatment (PEDIG 2005). The results of the pilot study showed mean difference between groups was -0.17 LogMAR (95% CI -0.53 to 0.19). Results from a larger RCT (PEDIG 2008) are now available, showing that supplementing occlusion therapy with near activities may produce a better visual outcome after eight weeks of treatment; the mean difference between groups was -0.02 LogMAR (95% CI -0.10 to 0.06). One further article ia awaiting assessment as in its current format there is insufficient information to include (Alotaibi 2012). Occlusion, whilst wearing necessary refractive correction, appears to be more effective than refractive correction alone in the treatment of strabismic amblyopia. The benefit of combining near activities with occlusion is unproven. No RCTs were found that assessed the role of either partial occlusion or optical penalisation to refractive correction for strabismic amblyopia.

Plain-language summary: Key results: The results of one of these trials indicate that patching therapy combined with any necessary glasses is more effective than glasses alone in the treatment of this condition. Two of the trials analysed the role of adding near activities to supplement patching therapy. These trials suggest there may be benefit to adding near activities to prescribed occlusion regime. No trial examining the role of optical penalisation (altering glasses strength) or using partial occlusion (frosted lens opposed to a patch) was found. The effectiveness of optical penalisation and partial occlusion for the treatment of strabismic amblyopia is unknown.  Quality of the evidence: The quality of the available evidence is high.
Abstract: Three trials, which included 140 infants, met the inclusion criteria. All three trials compared a nebulized dose of salbutamol with placebo; in one of the three trials newborns were assigned to two different doses of the intervention. We found differences in the duration of oxygen therapy (mean difference (MD) -43.10 hours, 95% confidence interval (CI) -81.60 to -4.60). There were no differences in the need for continuous positive airway pressure (risk ratio (RR) 0.73, 95% CI 0.38 to 1.39; risk difference (RD) -0.15, 95% CI -0.45 to 0.16; 1 study, 46 infants) or the need for mechanical ventilation (RR 1.50, 95% CI 0.06 to 34.79; RD 0.03, 95% CI -0.08 to 0.14; 1 study, 46 infants). Tests for heterogeneity were not applicable for any of the analyses as only one study was included. Among secondary outcomes, we found no differences in terms of duration of hospital stay and tachypnea. The quality of the evidence was very low due to the imprecision of the estimates. One trial is ongoing. At present there is insufficient evidence to determine the efficacy and safety of salbutamol in the management of transient tachypnea of the newborn. The quality of evidence was low due to paucity of included trials, small sample sizes and overall poor methodologic quality.

Plain-language summary: In medical literature searches complete to March 2016, we identified and included three clinical trials with 140 newborns comparing salbutamol with placebo. Two studies evaluated a single, nebulized (where the medicine is given in a fine mist) dose of salbutamol, and one study evaluated two different dosages. We found one additional trial that is still underway. Salbutamol reduced the duration of treatment with oxygen in newborns with transient tachypnea (reported in one study); whereas it did not affect the need for respiratory support or any other relevant outcomes. The results of this systematic review were consistent with either a benefit or a detrimental effect of salbutamol and did not provide a definitive answer to the review question.