GEM/cochrane-simplification huggingface dataset:
Abstract: Three trials involving 126 patients were included, with complete data available for 93 patients. The participants were heterogeneous, none of the three studies examined exactly the same interventions or measured the same outcomes. Only two trials reported mortality data and the summary relative risk for mortality of the intervention was 5.4 (95% CI 0.27 to 107.09). One trial reported increased coagulation times in the transfused group, and reported these patients to have increased rates of rebleeding. None of the studies reported adverse events directly related to RBC transfusion. Methodological deficiencies, including allocation concealment, generation of random sequences and blinding, simply compound the uncertainty surrounding analysis. None of the studies were appropriately powered and in the largest study fewer than half the participants were included in the final analysis. One RCT of restrictive versus liberal RBC transfusion aims to recruit 860 patients but has yet to be completed. There were more deaths and more rebleeding in the transfusion arms of the combined studies, but the small numbers of participants and large volume of missing data limit the significance of the findings. The studies in this review do not provide useful data regarding outcomes following red blood cell transfusion for acute upper gastrointestinal haemorrhage. They appear to exclude large survival benefit. Large, well-concealed RCTs of sufficient power are urgently needed.

Plain-language summary: This update found no new eligible trials. The original review found three trials investigating the effects of red blood cell transfusion in patients with upper gastrointestinal tract bleeding. There were more deaths recorded in the transfusion arm of the combined studies compared to the control arm. It is by no means clear that transfusion is a surrogate marker for more severe haemorrhage. The deaths were too few and the trials too disparate to draw any firm conclusions regarding the effects of transfusion on mortality. We can only recommend that further, larger studies are done.
Abstract: One study with 85 participants met the selection criteria. This trial studied all the absorbent product designs included in this review. Data were presented on all included outcomes. For preventing leakage, for preference and for overall acceptability disposable insert pads are better than disposable menstrual pads which are better than washable pants with integral pad which are better than washable insert pads. There is no strong evidence that either disposables or washables are better for skin health. The disposable insert is the most expensive design and there is no dominant design for cost-effectiveness. There is evidence that some women will prefer alternative designs which are all cheaper than disposable inserts. Although data were available from only one eligible trial the data were sufficiently robust to make recommendations for practice. Disposable insert pads are typically more effective than the other designs considered. However, because they are the most expensive, providing choice of designs (or combinations of designs for different circumstances) is likely to be cost-effective.

Plain-language summary: This review found only one eligible clinical trial which compared different designs of these products and had been carried out in the last ten years. This trial included all the designs. There is evidence that for leakage prevention, overall acceptability and preference, disposable inserts are better than menstrual pads, which are better than washable pants with integral pad, which are better than washable inserts. There is no clear benefit for skin health using either washable or disposable designs. Most women preferred the disposable insert pad but some preferred the other cheaper designs or would find them acceptable in some situations. Allowing women to choose their preferred design of absorbent product (or combination of different designs for different circumstances) would be more cost-effective and provide better patient satisfaction than provision of disposable insert pads alone.
Abstract: We included 11 RCTs with 6750 participants, but only six of these included people with COPD (2469 participants). The others were conducted on elderly and high-risk individuals, some of whom had chronic lung disease. Interventions compared with placebo were inactivated virus injections and live attenuated intranasal virus vaccines. Some studies compared intra-muscular inactivated vaccine and intranasal live attenuated vaccine with intra-muscular inactivated vaccine and intranasal placebo. Studies were conducted in the UK, USA and Thailand. Inactivated vaccine reduced the total number of exacerbations per vaccinated participant compared with those who received placebo (mean difference (MD) –0.37, 95% confidence interval (CI) –0.64 to –0.11; P = 0.006; two RCTs, 180 participants; low quality evidence). This was due to the reduction in 'late' exacerbations, occurring after three or four weeks (MD –0.39, 95% CI –0.61 to –0.18; P = 0.0004; two RCTs, 180 participants; low quality evidence). Both in people with COPD, and in older people (only a minority of whom had COPD), there were significantly more local adverse reactions in people who had received the vaccine, but the effects were generally mild and transient. There was no evidence of an effect of intranasal live attenuated virus when this was added to inactivated intramuscular vaccination. Two studies evaluating mortality for influenza vaccine versus placebo were too small to have detected any effect on mortality. However, a large study (N=2215) noted that there was no difference in mortality when adding live attenuated virus to inactivated virus vaccination, It appeared, from the limited number of RCTs we were able to include, all of which were more than a decade old, that inactivated vaccine reduced exacerbations in people with COPD. The size of effect was similar to that seen in large observational studies, and was due to a reduction in exacerbations occurring three or more weeks after vaccination, and due to influenza. There was a mild increase in transient local adverse effects with vaccination, but no evidence of an increase in early exacerbations. Addition of live attenuated virus to the inactivated vaccine was not shown to confer additional benefit.

Plain-language summary: We included six studies with 2469 participants with COPD, and a further five studies with 4281 older or high risk participants, a proportion of whom had chronic lung disease. We found some moderate-quality evidence that inactivated influenza vaccine did decrease 'flare ups' of COPD, especially those that are related to the influenza virus itself. The inactivated influenza virus vaccine was given as an injection in the muscle, and was associated with an increase in local side effects (such as pain) at the site of injection, which were short-lived. The inactivated virus vaccine did not cause influenza, or any significant worsening of COPD. Adding a live attenuated virus to the inactivated virus did not add any further protection for the participants. The evidence was of moderate quality. There have been no new trials since 2004. We conducted the last literature search in December 2017.
Abstract: We included two studies, involving 319 women. There was no statistically significant difference between the two groups in either of the primary outcomes of caesarean section (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.42 to 2.12) or instrumental delivery (RR 0.88, 95% CI 0.72 to 1.08). Similarly, there were no statistically significant differences between the two groups in any of the secondary outcomes for which data were available. This included Apgar score less than seven at five minutes (RR 3.06, 0.13 to 73.33), admission to neonatal intensive care unit (RR 1.07, 95% CI 0.29 to 3.93), uterine hyperstimulation (RR 1.32, 95% CI 0.97 to 1.80) and postpartum haemorrhage (RR 0.96, 95% CI 0.58, 1.59). There was no statistically significant difference identified between women in spontaneous labour with epidural analgesia who were augmented with oxytocin, compared with those who received placebo. However, due to the limited number of women included in the studies, further research in the form of randomised controlled trials are required.

Plain-language summary: Data were collected from two randomised studies (involving 319 women) which compared women with epidurals who were given either oxytocin, or a placebo. The rates of operative deliveries were not clearly different between the two groups There were also no significant differences between the other outcomes analysed, such as the Apgar scores of the newborn babies, admissions to the neonatal nursery, rates of post birth haemorrhage or rates of over stimulation of the uterus. Both studies appeared to have a low risk of bias. Overall, there was no significant difference between the rates of operative deliveries in women with epidurals who were given oxytocin compared with those who received the placebo. However, as there were limited data available, in order to fully determine whether augmentation of women with epidurals reduces the rate of operative deliveries and therefore reduces the complications associated, further studies are required.
Abstract: Nine trials were identified in the searches and five trials, with a total of 547 participants, met the inclusion criteria. Only one trial reported incidence of pneumococcal infection, and this demonstrated that the polysaccharide pneumococcal vaccine used (PPV14) failed to reduce significantly the risk of infection in children under three years of age, but was associated with only minor adverse events. Three trials of conjugate pneumococcal vaccines found that antibody responses were increased compared to control groups, including those in infants, although clinical outcomes were not measured in these trials. Previous trials have shown that conjugate pneumococcal vaccines are safe and effective in normal healthy individuals, including those under the age of two years. The controlled trials included in this review have demonstrated immunogenicity (the ability to induce the body's immune response, without which there is no protection) of these vaccines, and observational studies in people with sickle cell disease support these findings. We therefore recommend that conjugate pneumococcal vaccines are used in people with sickle cell disease. Randomised trials in people with sickle cell disease will be needed to determine the optimal vaccination regimen when further, potentially more effective vaccines become available. Such trials should measure clinical outcomes of effectiveness. The trials included in this review were published between 1983 and 2003. We have not identified any further relevant trials up to December 2011. We therefore do not plan to update this review until new trials are published.

Plain-language summary: We searched for trials which compared a polysaccharide or conjugate pneumococcal vaccine schedule with a different schedule or no vaccination in people with sickle cell disease. The review includes five trials with a total of 547 participants. One trial showed that the polysaccharide vaccine did not reduce the risk of infection very much in children younger than three years old, but it was linked with only minor adverse events. Three trials of conjugate vaccines showed increased antibody responses compared to control groups in people of all ages, although clinical outcomes were not measured in these trials. This review did not show if the vaccines prevent infection or decrease death rates. We recommend that conjugate pneumococcal vaccines are used in people with sickle cell disease. Randomised trials will be needed to determine the best vaccination schedule when further, potentially more effective vaccines become available. Such trials should measure clinical outcomes of effectiveness.
Abstract: We included one randomised cross-over study, enrolling 87 participants, which compared TPD with continuous equilibrating PD (CEPD) for patients with AKI. Sequence generation was adequate while allocation concealment was not reported. Our primary outcomes of mortality and recovery of renal function (complete or partial) were not reported (high risk of selective reporting bias). The results from this one study showed TPD resulted in higher creatinine clearance (CrCl) (MD 1.88 mL/min, 95% CI 0.91 to 2.85) and blood urea nitrogen (BUN) clearance (MD 14.71 mL/min, 95% CI 8.24 to 21.18) than CEPD; was superior to CEPD in the removal of potassium, phosphates and in generating ultrafiltrate; was better tolerated; consumed less time and was less expensive than CEPD. There was greater protein loss with TPD. No adverse events were reported. At present, there is insufficient RCT evidence to enable evaluation of the effect of TPD in patients with AKI. Well-designed and larger RCTs are required to better understand the risks and benefits of TPD for AKI.

Plain-language summary: We looked for evidence from randomised controlled trials that investigated TPD versus other forms of dialysis for people with AKI. Only one study of enrolling 87 participants was found that compared TPD with continuous equilibrating PD (CEPD). This study showed that TPD produced higher solute clearances in less time with greater protein loss than CEPD, but did not report how well patients recovered kidney function, nor if any people died. There was insufficient evidence to determine if TPD is better or worse than other types of PD for patients with AKI.
Abstract: Four studies were included in this review enrolling a total of 123 babies. In one study, persistent hypotension was more common in hydrocortisone treated infants as compared to those who received dopamine as primary treatment for hypotension (RR 8.2, 95% CI 0.47 to 142.6; RD 0.19, 95% CI 0.01 to 0.37). In two studies comparing steroid versus placebo, persistent hypotension (defined as a continuing need for inotrope infusion) was less common in steroid treated infants as compared to controls who received placebo for refractory hypotension (RR 0.35, 95% CI 0.19 to 0.65; RD -0.47, 95% CI - 0.68 to - 0.26; NNT = 2.1, 95% CI 1.47, 3.8). There were no statistically significant effects on any other short or long-term outcome. A further two studies that have only been published in abstract form to date, may be eligible for inclusion in a future update of this review. Hydrocortisone may be as effective as dopamine when used as a primary treatment for hypotension. But the long term safety data on the use of hydrocortisone in this manner is unknown.Steroids are effective in treatment of refractory hypotension in preterm infants without an increase in short term adverse consequences. However, long term safety or benefit data is lacking. With long term benefit or safety data lacking steroids cannot be recommended routinely for the treatment of hypotension in preterm infants.

Plain-language summary: This review found four small studies that evaluated the effect of steroids on low blood pressure in premature infants. At present, there is insufficient information on which to base recommendations about the value of giving steroids to babies born before term who have low blood pressure.
Abstract: For the 2013 update, we identified and excluded one new clinical trial. This updated review includes 14 trials, randomizing a total of 8033 women. The unstratified analysis found early intervention with amniotomy and oxytocin to be associated with a modest reduction in the risk of caesarean section; however, the confidence interval (CI) included the null effect (risk ratio (RR) 0.89; 95% CI 0.79 to 1.01; 14 trials; 8033 women). In prevention trials, early augmentation was associated with a modest reduction in the number of caesarean births (RR 0.87; 95% CI 0.77 to 0.99; 11 trials; 7753). A policy of early amniotomy and early oxytocin was associated with a shortened duration of labour (average mean difference (MD) - 1.28 hours; 95% CI -1.97 to -0.59; eight trials; 4816 women). Sensitivity analyses excluding four trials with a full package of active management did not substantially affect the point estimate for risk of caesarean section (RR 0.87; 95% CI 0.73 to 1.05; 10 trials; 5165 women). We found no other significant effects for the other indicators of maternal or neonatal morbidity. In prevention trials, early intervention with amniotomy and oxytocin appears to be associated with a modest reduction in the rate of caesarean section over standard care.

Plain-language summary: This review includes 14 trials, randomizing a total of 8033 women, and showed that a policy of early routine augmentation for mild delays in labour progress resulted in a modest reduction of the caesarean section rate compared with expectant management. The reduction in caesarean sections was most evident in the 11 trials looking at prevention of abnormal progression, rather than therapy (three trials). In these women, the time from admission to giving birth was also reduced (mean difference 1.3 hours). The trials did not provide sufficient evidence on indicators of maternal or neonatal health, including women’s satisfaction and views on the experience. Documentation of other aspects of care, such as continuous professional support, mobility and positions during labour, was limited as was the degree of contrast between groups. Women in the control group also received oxytocin but often later than in the intervention group. The severity of delay which was sufficient to justify interventions remains to be defined.
Abstract: Three studies provided data on the comparison between vitrectomy and observation in eyes with macular hole and visual acuity less than 20/50. Two studies, conducted in the USA and published in 1996 and 1997, used a similar protocol and included participants with stage II macular hole (42 eyes randomised, 36 analysed, number of participants not reported) or participants with stage III/IV hole (129 eyes of 120 participants, 115 eyes in analyses). The third study, conducted in the UK and published in 2004, included 185 eyes of 174 participants with full-thickness macular hole (41 eyes with stage II holes and 74 eyes with stage III/IV holes in analyses). Studies were of good quality for randomisation and allocation concealment, whereas visual acuity measurement was unmasked. At 6 to 12 months, visual acuity was improved by about 1.5 Snellen lines (-0.16 logMAR, 95% confidence intervals -0.23 to -0.09 logMAR, 270 eyes, moderate-quality evidence). The chances of macular hole closure at 6 to 12 months were greatly increased using vitrectomy, yielding an odds ratio of 31.4 (95% confidence intervals 14.9 to 66.3, 265 eyes, high-quality evidence; raw sum data: 76% vitrectomy, 11% observation). Vitrectomy was beneficial both in smaller (stage II) and in larger (stage III/IV) macular holes. The largest study reported that cataract surgery was needed in about half of cases at two years after operation and that retinal detachment occurred in about 5% of operated eyes. Vitrectomy is effective in improving visual acuity, resulting in a moderate visual gain, and in achieving hole closure in people with macular hole. However, these results may not apply to modern surgery due to technological improvements in vitrectomy techniques.

Plain-language summary: We included three studies, published between 1996 and 2004 and conducted in the USA and the UK, including 270 eyes in analyses, comparing vitrectomy and observation after 6 or 12 months. The evidence is current as of March 2015. Vitrectomy improved visual acuity in participants with macular hole by about 1.5 lines of a standard distance acuity chart. Macular hole closure was much more likely with vitrectomy compared to observation, with mean closure rates of 76% versus 11%, respectively. Cataract surgery was common in operated eyes. In the largest study, retinal detachment occurred in the months following vitrectomy in about 5% of cases. The evidence was of moderate quality, as the visual acuity measurement was unmasked. Vitrectomy is effective in improving visual acuity, resulting in a moderate visual gain, and in achieving hole closure in people with macular hole. However, as vitrectomy technology has improved since the included trials were conducted, with use of a smaller incision and outpatient care, the results of this review may not apply to modern surgery.
Abstract: No new studies were included for this update. Seven studies with a combined total of 802 participants were included in this review. No significant difference was observed between heparin treatment and control groups for pain-free walking distance or maximum walking distance at the end of treatment. There were no data to indicate that LMWHs benefit walking distance. Revascularisation or amputation-free survival rates were reported in one study only with a five year follow-up. No study reported a significant effect on overall mortality or cardiovascular events and the pooled odds ratios were not significant for these outcomes either. Major and minor bleeding events were significantly more frequent in the group treated with oral anticoagulants compared to control, with a non-significant increase in fatal bleeding events. No major bleeding events were reported in the study evaluating heparin, while a non-significant increase in minor bleeding events was reported. The benefit of heparin, LMWHs and oral anticoagulants for treatment of intermittent claudication has not been established while an increased risk of major bleeding events has been observed, especially with oral anticoagulants. There is no clear evidence to support the use of anticoagulants for intermittent claudication at this stage.

Plain-language summary: No new studies were included for this update. Seven studies with 802 participants were included in this review. The review of trials found that the benefit of heparin, LMWHs and oral anticoagulants for treatment of intermittent claudication has not been established while an increased risk of major bleeding events has been observed, especially with oral anticoagulants. There is no clear evidence to support the use of anticoagulants for intermittent claudication at this stage. More research is needed.