GEM/cochrane-simplification huggingface dataset:
Abstract: Eight studies, including a total of 1007 participants, met our inclusion criteria. We did not pool the results of all the studies because of substantial methodological, statistical and clinical heterogeneity. For caregivers' stress or strain we found no significant results within categories of intervention, with the exception of one single-centre study examining the effects of a 'vocational training' type intervention which found a mean difference between the intervention and comparator group at the end of scheduled follow-up of -8.67 (95% confidence interval -11.30 to -6.04, P < 0.001) in favour of the 'teaching procedural knowledge' type intervention group. It was not possible to carry out a meta-analysis of the evidence from RCTs because of methodological, clinical and statistical heterogeneity. One limitation across all studies was the lack of a description of important characteristics that define the informal caregiver population. However, 'vocational educational' type interventions delivered to caregivers prior to the stroke survivor's discharge from hospital appear to be the most promising intervention. However, this is based on the results from one, small, single-centre study.

Plain-language summary: Based on the results of this review, which included eight studies involving 1007 participants, there is currently not enough information available to help us work out what services might be best for informal caregivers of stroke survivors. However, another 11 studies are currently underway, which may help us find out what works best.
Abstract: Eighteen studies were included involving more than 467 health care professionals. The reporting of study methods was inadequate for all studies. In all but one study, nurses were the targeted professional group; one study was aimed solely at dieticians. The various behaviours targeted included the management of hypertension, low back pain and hyperlipidaemia. Nine studies were identified for comparison 1. Three out of five studies observed improvements in at least some processes of care and six out of eight studies observed improvements in outcomes of care. Only one study included a formal economic evaluation, with equivocal findings. Three studies were identified for comparison 2 but it was difficult to draw firm conclusions because of poor methods. Six studies were identified for comparison 3 (post hoc). These studies generally supported the hypothesis that there was no difference between care given by nurses using clinical guidelines and standard physician care. There is some evidence that guideline-driven care is effective in changing the process and outcome of care provided by professions allied to medicine. However, caution is needed in generalising findings to other professions and settings.

Plain-language summary: This review found that, despite limited research, there is some evidence that guidelines can improve care and that professional roles can be substituted effectively, for instance a nurse can perform the function of a physician in certain circumstances. Such interventions offer the possibility of reduced costs but further research is needed in all areas of this topic.
Abstract: We identified three randomised clinical trials, involving a total of 120 participants, comparing packed red blood cells with ≥ 21 days storage ('prolonged' or 'older') versus packed red blood cells with < 21 days storage ('fresh'). We pooled data to assess the effect of prolonged storage on death from any cause. The confidence in the results from these trials was very low, due to the bias in their design and their limited sample sizes. The estimated effect of packed red blood cells with ≥ 21 days storage versus packed red blood cells with < 21 days storage for the outcome death from any cause was imprecise (5/45 [11.11%] versus 2/46 [4.34%]; RR 2.36; 95% CI 0.65 to 8.52; I2: 0%, P = 0.26, very low quality of evidence). Trial sequential analysis, with only two trials, shows that we do not yet have convincing evidence that older packed red blood cells induce a 20% relative risk reduction of death from any cause compared with fresher packed red blood cells. No trial included other outcomes of interest specified in this review, namely transfusion-related acute lung injury, postoperative infections, and adverse events. The safety profile is unknown. Recognising the limitations of the review, relating to the size and nature of the included trials, this Cochrane Review provides no evidence to support or reject the use of packed red blood cells for blood transfusion which have been stored for ≥ 21 days ('prolonged' or 'older') compared with those stored for < 21 days ('fresh'). These results are based on three small single centre trials with high risks of bias. There is insufficient evidence to determine the effects of fresh or older packed red blood cells for blood transfusion. Therefore, we urge readers to interpret the trial results with caution. The results from four large ongoing trials will help to inform future updates of this review.

Plain-language summary: We identified three studies, involving a total of 120 participants, comparing packed red blood cells stored for ≥ 21 days versus < 21 days. The results of the studies for the outcome death from any cause were uncertain due to the small number of participants who contributed information. We could not exclude an effect on death with either longer or shorter storage. None of the trials considered the other outcomes of interest in this review, namely transfusion-related acute lung injury, postoperative infections, and adverse events. The safety profiles of the two approaches are unknown. The level of confidence in the results of this review is very low. The studies have limitations in the way they were designed and executed. Moreover, the limited number of people included in the studies led to imprecise results. We are aware of four large ongoing trials in this area which will help us to better understand the effects of storage on red blood cells in relation to outcomes for patients.
Abstract: Three included therapeutic studies had 182 randomised participants with 162 completing the trials although in one study, children with recurrent wheeze were also included. The four included safety evaluation studies randomised 3166 participants with 2862 completing the trials. Clinical heterogeneity was evident and limited data prevented combining data for meta-analysis. The two larger therapeutic studies described significant improvement in both the intervention and the placebo/placebo-like arms with no significant difference between the two groups. In the study with the smallest sample size, cetirizine (a second generation anti-histamine) was significantly more efficacious than placebo in reducing chronic cough in children associated with seasonal allergic rhinitis, and the effect was seen within two weeks of therapy. In contrast three of the larger evaluation studies that enrolled children with allergic rhinitis described a non-significant increase in cough as an adverse event. Combined data from the four safety evaluation studies revealed a non-significant difference between groups (OR 1.47 , 95% CI 0.86, 2.49) for cough as an adverse event but the trend favoured the placebo arm. This review has significant limitations. However, our finding of uncertain efficacy of anti-histamines for chronic cough are similar to that for acute cough in children. In contrast to recommendations in adults with chronic cough, anti-histamines cannot be recommended as empirical therapy for children with chronic cough. If anti-histamines were to be trialled in these children, current data suggest a clinical response (time to response) occurs within two weeks of therapy. However the use of anti-histamines in children with non-specific cough has to be balanced against the well known risk of adverse events especially in very young children.

Plain-language summary: The objective of this review was to evaluate the effectiveness of anti-histamines in children with prolonged cough that is not related to an underlying respiratory disease, that is, non-specific chronic cough. We included three therapeutic studies with 182 randomised participants. Two studies found that chronic cough significantly improved in both treatment and placebo groups with no difference between the two groups. One small study however described that children who had chronic cough associated with seasonal allergic rhinitis treated with cetirizine improved significantly more than children on placebo and this difference was evident by two weeks. Four studies that evaluated safety profiles included 3166 randomised participants and described a non significant increase in cough in participants who received the active medication. Despite the limitations of this review, our findings are similar to the review on anti-histamines for acute cough which showed no good evidence for or against the use of anti-histamines. In contrast to recommendations in adults with chronic cough, anti-histamines cannot be recommended as empirical therapy for children with chronic cough. Further research examining the effects of this treatment using child appropriate cough outcome measures is needed.
Abstract: We identified 17 trials that randomised a total of 9627 people. Phacoemulsification gave a better visual outcome than extracapsular surgery but similar average cost per procedure in Europe but not in poorer countries. Extracapsular surgery with posterior chamber lens implant and ICCE with or without an anterior chamber intraocular lens (IOL) implant gave acceptable visual outcomes but extracapsular surgery had less complications. Manual small incision surgery provides better visual outcome than ECCE but slightly inferior unaided visual acuity compared to phacoemulsification. This review provides evidence from seven RCTs that phacoemulsification gives a better outcome than ECCE with sutures. We also found evidence that ECCE with a posterior chamber lens implant provides better visual outcome than ICCE with aphakic glasses. The long term effect of posterior capsular opacification (PCO) needs to be assessed in larger populations. The data also suggests that ICCE with an anterior chamber lens implant is an effective alternative to ICCE with aphakic glasses, with similar safety. Phacoemulsification provides the best visual outcomes but will only be accessible to the poorer countries if the cost of phacoemulsification and foldable IOLs decrease. Manual small incision cataract surgery provides early visual rehabilitation and comparable visual outcome to PHACO. It has better visual outcomes than ECCE and can be used in any clinic that is currently carrying out ECCE with IOL. Further research from developing regions are needed to compare the cost and longer term outcomes of these procedures e.g. PCO and corneal endothelial cell damage.

Plain-language summary: The review authors searched the medical literature and identified 17 randomised controlled trials (9627 participants) investigating the different surgical interventions. Six of these trials suggested that PHACO gives a better outcome than ECCE. They suggest a better uncorrected visual acuity (UCVA) following PHACO than ECCE but the majority of the trials showed no difference in best corrected visual acuity (BCVA) between the two groups. The costs per procedure were not markedly different between the two techniques in a UK based study, however, a Malaysian study showed ECCE to be significantly cheaper. A study comparing MSICS and ECCE, advocated MSICS as the procedure of choice due to equal costs and better visual results. Two studies compared the results of PHACO and MSICS. Phacoemulsification having a significantly higher proportion of patients with UCVA > 6/18 (81.1% versus 71%) but there was no difference in BSCVA. Trials comparing costs of PHACO and MSICS are important for future research. Manual small incision surgery offers an alternative technique in developing countries as it provides acceptable visual outcomes when compared to PHACO yet is likely to be more economical as it avoids the initial outlay of costs of PHACO. It is important to remember that the studies in this review were based in a variety of countries and situations (hospital based or cataract camps); a knowledge of the setting is vital before drawing conclusions from the data.
Abstract: Three studies included in this systematic review used different kinds of aerobic activity: walking/jogging and rowing training for participants from 17 to 65 years old (from USA, Portugal and Israel). In the meta-analyses, only maximal treadmill grade was improved after aerobic exercise training programmes (4.26 grades (%) [95% CI 2.06, 6.45]). Other variables relative to work performance that could not be combined in a meta-analysis were also improved in the intervention group: maximal test time (P=0.0003), total turns of fan wheel (P=0.02), resistance of ergometer (p=0.003), power knee extension and flexion (p<0.00001), and timed up and go test (p=0.008). Thirty other outcomes including, oxidative stress and body composition, could not be combined in the meta-analysis. Apart from work performance, trials reported no statistically significant improvements. There is insufficient evidence to demonstrate that aerobic exercise in adults with Down syndrome improves physical or psychosocial outcomes . Although evidence exists to support improvements in physiological and psychological aspects from strategies using mixed physical activity programmes, well-conducted research examining long-term physical outcomes, adverse effects, psychosocial outcomes and costs is required before informed practice decisions can be made.

Plain-language summary: This review identified only three small randomized trials. The results showed that only aspects of work performance (for example, maximal test time, maximal distance at the end of the exercise test) were improved after aerobic exercise training programs. Further well-designed research on larger population samples is required to evaluate potential benefits for psychosocial aspects in adults with Down syndrome.
Abstract: Four studies, with a total of 204 participants were included and analysed. The trials compared metoclopramide with placebo (two trials) or with no intervention (two trials). Metoclopramide was investigated at doses of 10 mg (two trials) and 20 mg (two trials). There was no statistically significant difference between metoclopramide versus placebo or no intervention administered to promote tube placement (RR 0.82, 95% CI 0.61 to 1.10). Metoclopramide at doses of 10 mg (RR 0.82, 95% CI 0.60 to 1.11) and 20 mg (RR 0.62, 95% CI 0.15 to 2.62) were equally ineffective in facilitating post-pyloric intubation when compared with placebo or no intervention. In this review, we found only four studies that fitted our inclusion criteria. These were small, underpowered studies, in which metoclopramide was given at doses of 10 mg and 20 mg. Our analysis showed that metoclopramide did not assist post-pyloric placement of naso-enteral feeding tubes. Ideally randomised clinical trials should be performed that have a significant sample size, administering metoclopramide against control, however, given the lack of efficacy revealed by this review it is unlikely that further studies will be performed.

Plain-language summary: We originally searched for clinical trials in 2002; and again in 2008 and 2014. We identified four studies that investigated the use of metoclopramide in placement of post-pyloric naso-enteral feeding tubes. The trials included a total of 204 adult participants; 108 participants were treated with metoclopramide, and 96 were given a placebo or no treatment. All four studies were done in hospitals in the USA. The number of participants included in the trials varied from 105 to 10. The trials were all performed before 1995. They were all small, and examined two different doses of metoclopramide (10 mg and 20 mg), delivered in two different ways (intravenously, and injected into muscle). The way in which they were conducted and reported was poor. Analysis of the four trials revealed that metoclopramide did not have a clear beneficial on the placement of post-pyloric naso-enteral feeding tubes. No harms (adverse reactions) were reported, though it was not clear how thoroughly the people running the trials recorded them. No costs of treatment were reported. The quality of the evidence is very low. The four trials were too small to identify any effect clearly; they also used different doses of metoclopramide, (tested against placebo or no treatment). It is unlikely that further studies will be performed to establish whether metoclopramide is helpful in placement of post-pyloric naso-enteral feeding tubes.
Abstract: Two RCTs, including 262 participants, met the inclusion criteria. Both trials scored poorly for methodological quality. There was 'low level' evidence that multidisciplinary rehabilitation produced short-term gains at the levels of impairment (that is range of shoulder movement), psychosocial adjustment and quality of life after breast cancer treatment (up to 12 months). No evidence was available for the longer-term functional outcomes for caregivers or the cost effectiveness of these programmes. It was not possible to suggest the most appropriate frequency and duration of therapy or choice of one type of intervention over another. There was 'low level' evidence that multidisciplinary rehabilitation can improve the outcomes of people with breast cancer in terms of functional ability, psychosocial adjustment and participation in social activities. There was no evidence available on functional gain at the level of activity. This review highlights the limitations of RCTs in rehabilitation settings and the need for high-quality trial-based research in this area. Regular evaluation and assessment of breast cancer survivors for rehabilitation is recommended.

Plain-language summary: The review identified only two randomised controlled trials, involving 262 patients with breast cancer. The data from these studies provide low-grade evidence for multidisciplinary rehabilitation in producing short-term gains at the levels of impairment (range of shoulder movement), psychosocial adjustment and quality of life after breast cancer treatment. None of the studies reported the longer-term functional outcomes of such care, the impact on caregivers or cost effectiveness of these programmes. Overall, the results of this review suggest that multidisciplinary rehabilitation is not harmful and may improve functional ability and quality of life in the short term. This review highlights the lack of robust trials in the field and the need for further high-quality trial-based research.
Abstract: The search identified no RCTs; therefore we were unable to perform any meta-analyses. RCTs in GTN are scarce owing to the low prevalence of this disease and its highly chemosensitive nature. As chemotherapeutic agents may be associated with substantial side effects, the ideal treatment should achieve maximum efficacy with minimal side effects. For methotrexate-resistant or recurrent low-risk GTN, a common practice is to use sequential five-day dactinomycin, followed by MAC (methotrexate, dactinomycin, cyclophosphamide) or EMA/CO (etoposide, methotrexate, dactinomycin, cyclophosphamide, vinblastine) if further salvage therapy is required. However, five-day dactinomycin is associated with more side effects than pulsed dactinomycin, therefore an RCT comparing the relative efficacy and safety of these two regimens in the context of failed primary methotrexate treatment is desirable. For high-risk GTN, EMA/CO is the most commonly used first-line therapy, with platinum-etoposide combinations, particularly EMA/EP (etoposide, methotrexate, dactinomycin/etoposide, cisplatin), being favoured as salvage therapy. Alternatives, including TP/TE (paclitaxel, cisplatin/ paclitaxel, etoposide), BEP (bleomycin, etoposide, cisplatin), FAEV (floxuridine, dactinomycin, etoposide, vincristine) and FA (5-fluorouracil (5-FU), dactinomycin), may be as effective as EMA/EP and associated with fewer side effects; however, this is not clear from the available evidence and needs testing in well-designed RCTs. In the UK, an RCT comparing interventions for resistant/recurrent GTN will be very challenging owing to the small numbers of patients with this scenario. International multicentre collaboration is therefore needed to provide the high-quality evidence required to determine which salvage regimen/s have the best effectiveness-to-toxicity ratio in low- and high-risk disease. Future research should include economic evaluations and long-term surveillance for secondary neoplasms.

Plain-language summary: We undertook this review because it was unclear which of the various salvage combinations, if any, was the most effect and the least toxic. We searched the literature up to November 2015 to find all relevant studies. Unfortunately, we were unable to find any good quality studies that compared the different types of salvage treatments. This is partly because the disease has a high cure rate with several combination chemotherapy options, but is also owing to the rarity of the disease that makes recruiting for large studies difficult. Hence we were unable to draw conclusions about how these drug combinations compare with regard to their effectiveness and side effects, and we urge researchers in this field to collaborate to provide this important evidence.
Abstract: We included one randomised trial (involving 98 women) that evaluated the effectiveness of one type of COX inhibitor (rofecoxib) for preventing preterm birth. The included study did not report any data for one of our primary outcomes: preterm labour. Rofecoxib use was associated with an increased risk for preterm birth and preterm premature rupture of membranes (PPROM). Rofecoxib was associated with a higher risk of oligohydramnios and low fetal urine production but the effects were reversible after stopping treatment. There were no differences in the number of women who discontinued treatment before 32 weeks of gestation. There was no difference in neonatal morbidities and admission to neonatal intensive care unit. There were no maternal adverse effects or perinatal mortalities in either group. There was very little evidence about using COX inhibitors for preventing preterm labour. There are inadequate data to make any recommendation about using COX inhibitor in practice to prevent preterm labour. Future research should include follow-up of the babies to examine the short-term and long-term effects of COX inhibitors.

Plain-language summary: We included one small randomised trial (involving 98 women) that involved the drug rofecoxib, which is one type of COX inhibitor. The included study did not report any information about prevention of labour before full-term pregnancy. However, use of this COX inhibitor was associated with an increased risk of the baby being born before full term. We found insufficient data to make any recommendation about using COX inhibitors for preventing preterm labour. Future research should include the follow-up of babies to examine the short- and longer-term effects associated with using COX inhibitors during pregnancy.