GEM/cochrane-simplification huggingface dataset:
Abstract: We included eight RCTs with a total of 512 participants. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. Postoperative mortality (OR 0.64, 95% confidence interval (CI) 0.26 to 1.54; P = 0.32), overall survival (HR 0.84, 95% CI 0.61 to 1.16; P = 0.29), and morbidity showed no significant differences, except of delayed gastric emptying, which significantly favoured CW (OR 3.03, 95% CI 1.05 to 8.70; P = 0.04). Furthermore, we noted that operating time (MD -45.22 minutes, 95% CI -74.67 to -15.78; P = 0.003), intraoperative blood loss (MD -0.32 L, 95% CI -0.62 to -0.03; P = 0.03), and red blood cell transfusion (MD -0.47 units, 95% CI -0.86 to -0.07; P = 0.02) were significantly reduced in the PPW group. All significant results were associated with low-quality evidence based on GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria. Current evidence suggests no relevant differences in mortality, morbidity, and survival between the two operations. However, some perioperative outcome measures significantly favour the PPW procedure. Given obvious clinical and methodological heterogeneity, future high-quality RCTs of complex surgical interventions based on well-defined outcome parameters are required.

Plain-language summary: We included eight randomised controlled trials with a total of 512 participants in this review. The included trials revealed vast differences in sample size as well as clinical and methodological quality. We could identify no relevant differences in terms of main complications, long-term survival, or death due to complications after the operation, but operating time, intraoperative blood loss, and need for blood transfusion seem to be less frequent in the group treated with the pylorus-preserving Whipple operation. Our conclusion is that, at present, no relevant difference is evident between the two surgical procedures for the treatment of pancreatic or periampullary cancer. The quality of the body of evidence is still low since all trials revealed some shortcomings in terms of methodological quality or reporting.
Abstract: Six RCTs involving 1862 participants were included. The effect of calcium channel blockers on the risk of death was reported in five of the RCTs. The pooled odds ratio (OR) for the five studies was 0.91 (95% confidence interval [95% CI] 0.70 to 1.16). For the five RCTs that reported death and severe disability (unfavourable outcome), the pooled OR 0.97 (95%CI 0.81 to 1.18). In the two RCTs which reported the risk of death in a subgroup of traumatic subarachnoid haemorrhage patients, the pooled OR 0.59 (95% CI 0.37 to 0.94). Three RCTs reported death and severe disability as an outcome in this subgroup, and the pooled OR 0.67 (95% CI 0.46 to 0.98). This systematic review of randomised controlled trials of calcium channel blockers in acute traumatic head injury patients shows that considerable uncertainty remains over their effects. The effect of nimodipine in a subgroup of brain injury patients with subarachnoid haemorrhage shows a beneficial effect, though the increase in adverse reactions suffered by the intervention group may mean that the drug is harmful for some patients.

Plain-language summary: This review looked at all high quality trials comparing the use of calcium channel blockers with a control, in head-injured patients of any age. The authors also looked at trials involving patients suffering from subarachnoid haemorrhage (that is, bleeding into the space between the brain and the skull) caused by an injury, as a subgroup. The authors found six eligible trials involving 1862 patients. The results indicate that there is insufficient evidence to support the use of calcium channel blockers. The authors conclude that there is some evidence that a calcium channel blocker called nimodipine may be beneficial for some patients with subarachnoid haemorrhage. However, there is also an indication of certain adverse reactions amongst patients treated with nimodipine which may mean that the drug is harmful for some individuals. The authors recommend that the promising results in patients with subarachnoid haemorrhage are replicated in a larger well designed trial, before any firm conclusions about the effectiveness of the drug can be drawn. In future trials, data on outcomes other than death and severe disability, such as quality of life of the survivors and the economic utility of the drug, should be measured; such outcomes have not been considered in existing research.
Abstract: We included four RCTs with a total of 3090 enrolled participants (one study used a cluster-randomized design). Three trials were considered to have a relatively low risk of bias, and one trial was considered to have a relatively high risk. When survival to hospital discharge was compared, 38 of 320 (11.88%) participants survived to discharge in the initial CPR plus delayed defibrillation group compared with 39 of 338 participants (11.54%) in the immediate defibrillation group (RR 1.09, 95% CI 0.54 to 2.20, Chi2 = 10.78, degrees of freedom (df) = 5, P value 0.06, I2 = 54%, low-quality evidence). When we compared the neurological outcome at hospital discharge (RR 1.12, 95% CI 0.65 to 1.93, low-quality evidence), the rate of return of spontaneous circulation (ROSC) (RR 0.94, 95% CI 0.77 to 1.15,low-quality evidence) and survival at one year (RR 0.77, 95% CI 0.24 to 2.49, low-quality evidence), we could not rule out the superiority of either treatment. Adverse effects were not associated with either treatment. Owing to the low quality of available evidence, we have been unable to determine conclusively whether immediate defibrillation and one and one-half to three minutes of CPR as initial therapy before defibrillation have similar effects on rates of return of spontaneous circulation, survival to discharge or neurological insult. We have also been unable to conclude whether either treatment approach provides a degree of superiority in OHCA. We propose that this is an area that needs further rigorous research through additional high-quality RCTs, including larger sample sizes and proper subgroup analysis.

Plain-language summary: After reviewing the studies and their available data, we could not be certain that one approach had superiority over another, and we could not establish whether the two treatments had similar effects on outcomes. We found no adverse effects associated with either treatment. Currently, no definitive evidence allows us to conclude that chest compressions should be the initial therapy for patients with OHCA over immediate electric shock treatment. However, we believe that the amount and quality of research in this area currently are not sufficient to allow strong conclusions. To further our understanding of the efficacy of these two different strategies, further rigorous randomized controlled trials are required.
Abstract: The new search identified fifteen trials. Three trials were eligible for inclusion. Ten trials involving eight different comparison groups have been included. Only one trial reported live birth rates. The number of oocytes retrieved were significantly less in the conventional GnRHa long protocol compared to stop protocol and GnRH antagonist protocol. Total dose of gonadotrophins used was significantly higher in the GnRHa long protocol group compared to the Stop protocol and GnRH antagonist groups. Cancellation rates were significantly higher in the GnRHa flare up group compared to the GnRHa long protocol group. None of the studies reported a difference in the miscarriage and ectopic pregnancy rates. There is insufficient evidence to support the routine use of any particular intervention either for pituitary down regulation, ovarian stimulation or adjuvant therapy in the management of poor responders to controlled ovarian stimulation in IVF. More robust data from good quality RCTs with relevant outcomes are needed.

Plain-language summary: This review of ten randomised controlled trials suggests there is insufficient evidence to support the routine use of any one particular intervention in the management of women who are poor responders. More research is needed with good quality trials looking at relevant outcomes such as live birth rates rather than treatment-associated outcomes such as positive pregnancy rates or number of eggs. Research is also recommended in adverse outcomes and costs of these treatments.
Abstract: This 2009-10 update adds 21 additional studies, with a total of 53 randomised controlled trials included. Family intervention may decrease the frequency of relapse (n = 2981, 32 RCTs, RR 0.55 CI 0.5 to 0.6, NNT 7 CI 6 to 8), although some small but negative studies might not have been identified by the search. Family intervention may also reduce hospital admission (n = 481, 8 RCTs, RR 0.78 CI 0.6 to 1.0, NNT 8 CI 6 to 13) and encourage compliance with medication (n = 695, 10 RCTs, RR 0.60 CI 0.5 to 0.7, NNT 6 CI 5 to 9) but it does not obviously affect the tendency of individuals/families to leave care (n = 733, 10 RCTs, RR 0.74 CI 0.5 to 1.0). Family intervention also seems to improve general social impairment and the levels of expressed emotion within the family. We did not find data to suggest that family intervention either prevents or promotes suicide. Family intervention may reduce the number of relapse events and hospitalisations and would therefore be of interest to people with schizophrenia, clinicians and policy makers. However, the treatment effects of these trials may be overestimated due to the poor methodological quality. Further data from trials that describe the methods of randomisation, test the blindness of the study evaluators, and implement the CONSORT guidelines would enable greater confidence in these findings.

Plain-language summary: Studies were conducted in Europe, Asia and North America with packages of family intervention varying among studies, although there were no clear differences in study design. Results indicated that family intervention may reduce the risk of relapse and improve compliance with medication. However data were often inadequately reported and therefore unusable. As this package of care is widely employed, there should be further research to properly clarify several of the short-term and long-term outcomes.
Abstract: We included twelve studies containing data on 2196 participants; four of these studies were newly included in this 2011 update of our 2006 Cochrane review. Six intervention groups in four trials provided data on the percentage of pills taken. Reminder packaging increased the percentage of pills taken (mean difference (MD) 11% (95% confidence interval (CI) 6% to 17%)). Notable heterogeneity occurred among these trials (I2 = 96.3%). Two trials provided data for the proportion of self-reported adherent patients, reporting a reduction in the intervention group which was not statistically significant (odds ratio = 0.89 (95% CI 0.56 to 1.40)). We conducted meta-analysis on data from two trials assessing the effect of reminder packaging on blood pressure measurements. We found that reminder packaging significantly decreased diastolic blood pressure (MD = -5.89 mmHg (95% CI -6.70 to -5.09; P < 0.00001; I2 = 0%). No effect was seen on systolic blood pressure (mean change -1.01, 95% CI -2.22 to 0.20; P = 0.1, I2 = 0%). We also conducted meta-analysis on extracted data from two trials that looked at change in glycated haemoglobin. We found that reminder packaging significantly reduced glycated haemoglobin levels (MD -0.72; 95% CI -0.83 to -0.60; P < 0.00001; I2 = 92%), although there was considerable heterogeneity. No appropriate data were available for meta-analysis of remaining clinical outcomes, which included serum vitamin C and E levels, and self-reported psychological symptoms (one trial each). We reported remaining data narratively. In one study the presence of a reminder packaging aid was found to be preferred by patients with low literacy levels. Reminder packing may represent a simple method for improving adherence for patients with selected conditions. Further research is warranted to improve the design and targeting of these devices.

Plain-language summary: We assessed twelve studies involving 2196 participants who were taking self-administered medications for at least one month. The studies involved different types of packaging, and different medications for various health problems. We found that reminder packaging increased the proportion of people taking their medications when measured by pill count; however, this effect was not large. We also found some evidence that reminder packaging may be beneficial in improving clinical outcomes such as blood pressure. Reminder packing for certain individuals may represent a simple method for improving the adherence to medications; further research is needed to improve the design and targeting of these devices.
Abstract: Two trials (182 participants) and two phytomedicines Niprisan® (also known as Nicosan®) and Ciklavit® were included. The Phase IIB (pivotal) trial suggests that Niprisan® was effective in reducing episodes of severe painful sickle cell disease crisis over a six-month period (low-quality evidence). It did not affect the risk of severe complications or the level of anaemia (low-quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit®) reported a possible benefit to individuals with painful crises (low-quality evidence), and a possible adverse effect (non-significant) on the level of anaemia (low-quality evidence). While Niprisan® appeared to be safe and effective in reducing severe painful crises over a six-month follow-up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit®. Based on the published results for Niprisan® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease.

Plain-language summary: Two trials (182 participants) and two phytomedicines Niprisan® (also known as Nicosan®) and Ciklavit® were included. This review found that Niprisan® may help to reduce episodes of sickle cell disease crises associated with severe pain. Ciklavit®, which has been reported to reduce painful crises in people with sickle cell disease, deserves further study before recommendations can be made regarding its use. The trial of Ciklavit® also reported a possible adverse effect on the level of anaemia. Both formulations reported no serious adverse symptoms or derangement of liver or kidney function in the participants. More detailed and larger trials of these medicines will need to be carried out before we can make any recommendations about their use. Further research should also assess long-term outcome measures. We judged the quality of the evidence from this review to be of low to very low quality, depending on the outcome measured.
Abstract: Nine high-methodological-quality RCTs(260 participants) met the inclusion criteria. Six trials focussed on comparison of exercise therapy versus no exercise therapy, whereas three trials compared two interventions that both met our definition of exercise therapy. Best evidence synthesis showed strong evidence in favour of exercise therapy compared to no exercise therapy in terms of muscle power function, exercise tolerance functions and mobility-related activities. Moderate evidence was found for improving mood. No evidence was observed for exercise therapy on fatigue and perception of handicap when compared to no exercise therapy. Finally, no evidence was found that specific exercise therapy programmes were more successful in improving activities and participation than other exercise treatments. No evidence of deleterious effects of exercise therapy was described in included studies. The results of the present review suggest that exercise therapy can be beneficial for patients with MS not experiencing an exacerbation. There is an urgent need for consensus on a core set of outcome measures to be used in exercise trials. In addition, these studies should experimentally control for 'dose' of treatment, type of MS and should include sufficient contrast between experimental and control groups.

Plain-language summary: To date, there is no effective treatment for MS, however, a number of studies suggest that exercise interventions aimed to improve daily functioning of patients with MS are effective. Nine randomized controlled trials of exercise therapy for MS patients were included in this review six of which used no therapy as the comparator. There was strong evidence in favor of exercise therapy, compared to no therapy, regarding muscle function and mobility while no evidence was found of improved fatigue, in one study only. No one specifically targeted exercise program was more successful than others. No deleterious effects were described in the included studies.
Abstract: A total of 11 trials were included in this review. Most of the studies had an unclear risk of bias prompting us to downgrade the quality of evidence for our outcomes. Seven of these trials provided evidence for the main comparison and the primary outcome and these were pooled. Overall, long-term antibiotic prophylaxis probably reduces the risk of SSI (plausible effects range between a 76% to a 0.26% relative reduction in SSI with long-term antibiotic prophylaxis) (472 participants; RR 0.42, 95% CI 0.24 to 0.74; moderate-quality evidence). There is uncertainty surrounding the relative effects of short-term antibiotics compared with a single dose (220 participants; RR 0.34, 95% CI 0.09 to 1.22; low-quality evidence). No reports described adverse effects associated with the drugs in those trials that reported in this outcome. None of these trials assessed or reported data regarding other outcomes, and information was insufficient to show whether a specific antibiotic is better than another. For people undergoing orthognathic surgery, long term antibiotic prophylaxis decreases the risk of SSI compared with short-term antibiotic prophylaxis and the is uncertainty of whether short-term antibiotic prophylaxis decreases SSi risk relative to a single pre-operative dose of prophylactic antibiotics.

Plain-language summary: We conducted a comprehensive search for studies on this topic. We collected data from all studies addressing this question and summarised them to determine whether antibiotics could prevent infection after surgery, whether this treatment has any adverse effects, whether it reduces the number of days that patients need to be in the hospital and whether it improves overall health status. We found 11 studies. Overall, long-term antibiotics reduce the risk of SSI, and there is uncertainty regarding the effects of receiving one dose of antibiotics preoperatively versus short term antibiotics. There was no investigation of side effects of antibiotics in these studies, but in the studies where side effects were investigated, no side effects were found. None of the other effects of interest to clinicians or patients were measured in the studies, and information was insufficient to show whether any single antibiotic is better than any other.
Abstract: We included one study, involving 40 infants and 42 women. The trial was underpowered to detect clinically important outcome differences between the two policies. There were no significant benefits or adverse effects of elective preterm birth at 36 weeks' gestation for fetal gastroschisis. The primary outcomes were caesarean section and neonatal survival to discharge. Two babies died after birth but before discharge in the elective (intervention) group versus none in the spontaneous group (risk ratio (RR) 5.00; 95% confidence interval (CI) 0.26 to 98.00; one study, n = 40). Seven women (33%) in the elective group and nine women (43%) in the spontaneous group delivered by caesarean section (RR 0.78; 95% CI 0.36 to 1.70). Similarly, for the secondary outcomes, there were no statistical differences in birthweight, ventilation requirements, necrotising enterocolitis and requirement for repeat surgery between the two groups. None of our prespecified maternal secondary outcomes were reported in the included study. We also examined gestational age at birth as a non-prespecified outcome. There was a difference in gestational age at birth between the two arms of the trial (35.8 weeks (SD 0.7) in the elective group and 36.7 (SD 1.5) in the spontaneous group. Possible reasons for this small mean difference include a trend towards spontaneous preterm birth in pregnancies complicated by fetal gastroschisis. This review is unable to draw any firm conclusions regarding preterm birth for infants with gastroschisis. It is not possible to say whether the intervention is beneficial or harmful for these babies or their mothers. Only one small trial is included. Further research is needed in this area.

Plain-language summary: This review identified one small randomised controlled trials, involving 42 women. There were no significant differences in outcomes for mother or baby when pre-term birth at 36 weeks was planned, compared with later birth. However, it was such a small trial that it does not rule out important benefits or harms from early birth. There was also small overall difference in gestational age at birth between the two groups in the trial, possibly because of the high rate of spontaneous preterm birth with this condition. Further trials are needed.