GEM/cochrane-simplification huggingface dataset:
Abstract: We included three trials in this review, involving 134 patients who were 60 years of age or younger. The time window for the intervention was 30 hours from stroke onset in two studies and 96 hours in one study. All trials were stopped early. Surgical decompression reduced the risk of death at the end of follow-up (OR 0.19, 95% CI 0.09 to 0.37) and the risk of death or disability defined as mRS > 4 at 12 months (OR 0.26, 95% CI 0.13 to 0.51). Death or disability defined as mRS > 3 at the end of follow-up was no different between the treatment arms (OR 0.56, 95% CI 0.27 to 1.15). Surgical decompression lowers the risk of death and death or severe disability defined as mRS > 4 in selected patients 60 years of age or younger with a massive hemispheric infarction and oedema. Optimum criteria for patient selection and for timing of decompressive surgery are yet to be defined. Since survival may be at the expense of substantial disability, surgery should be the treatment of choice only when it can be assumed, based on their preferences, that it is in the best interest of patients. Since all the trials were stopped early, an overestimation of the effect size cannot be excluded.

Plain-language summary: Results from recent clinical trials showed that surgery reduced the risk of death. However, survivors were left with moderate to severe disability requiring help in their daily life activities. These results only apply to people 60 years of age or younger.
Abstract: We identified three trials with high risk of bias which compared veno-venous bypass (n = 65) versus no veno-venous bypass (n = 66). None of the trials reported patient or graft survival. There were no significant differences regarding renal failure or blood transfusion requirements between the two groups. None of the trials reported on the morbidity related to veno-venous bypass or the requirement of veno-venous bypass in the control group. We identified one trial with high risk of bias which compared percutaneous (n = 20) versus open technique (n =19) of veno-venous bypass. The patient or graft survival was not reported. There was no difference in veno-venous bypass related morbidity between the two groups. The operating time was significantly shorter in the percutaneous technique group (MD -59 minutes; 95% CI -102 to -16). There is no evidence to support or refute the use of veno-venous bypass in liver transplantation. There is no evidence to prefer any particular technique of veno-venous bypass in liver transplantation.

Plain-language summary: We systematically searched various medical databases to determine whether veno-venous bypass is required routinely during liver transplantation. We identified a total of three randomised clinical trials with high risk of systematic error and high risk of random errors which compared veno-venous bypass (n = 65) with no veno-venous bypass (n = 66). None of the trials reported patient or graft survival. There were no differences regarding kidney failure or blood transfusion requirements between the two groups. None of the trials reported on the complications related to veno-venous bypass or the requirement of veno-venous bypass in the control group. We also identified one trial with high risk of systematic error and high risk of random errors which compared needle technique (percutaneous approach) (n = 20) with open technique (n =19) of veno-venous bypass. The patient or graft survival was not reported in this trial. There was no difference in veno-venous bypass related complications between the two groups. The operating time was shorter in the percutaneous technique group. There is currently no evidence to support the routine use of veno-venous bypass in liver transplantation.
Abstract: We included 13 articles reporting on nine studies with nine interventions. Four studies with 407 participants evaluated post-treatment programmes and five studies with 1113 participants evaluated exercise as a treatment modality. Four studies had a low risk of bias, one study a high risk and the remainder an unclear risk of bias. We found moderate quality evidence that post-treatment exercises were more effective than no intervention for reducing the rate of recurrences at one year (Rate Ratio 0.50; 95% Confidence Interval 0.34 to 0.73). There was moderate quality evidence that the number of recurrences was significantly reduced in two studies (Mean Difference -0.35; 95% CI -0.60 to -0.10) at one-half to two years follow-up. There was very low quality evidence that the days on sick leave were reduced by post-treatment exercises (Mean Difference -4.37; 95% CI -7.74 to -0.99) at one-half to two years follow-up. We found conflicting evidence for the effectiveness of exercise treatment in reducing the number of recurrences or the recurrence rate. There is moderate quality evidence that post-treatment exercise programmes can prevent recurrences of back pain but conflicting evidence was found for treatment exercise. Studies into the validity of measurement of recurrences and the effectiveness of post-treatment exercise are needed.

Plain-language summary: There were nine studies with 1520 participants. There was moderate quality evidence that post-treatment exercises can reduce both the rate and the number of recurrences of back pain. However, the results of exercise treatment studies were conflicting. Adverse (side) effects of exercising were not mentioned in any of the studies. Limitations of this review include the difference in exercises across studies, thus making it difficult to specify the content of such a programme to prevent back pain recurrences.
Abstract: Five RCTs involving a total of 687 participants with a range of clinical indications were included. No new studies were included in this update. In one three-pronged study, vessel patency was greater with intra-arterial recombinant tissue plasminogen activator (rt-PA) than with intra-arterial streptokinase (P < 0.04) or intravenous rt-PA (P < 0.01). In participants with peripheral arterial occlusion there was no statistically significant difference in limb salvage at 30 days with either urokinase or rt-PA, though this may reflect the small numbers in the studies. Incidences of haemorrhagic complications varied with fibrinolytic regime but there was no statistically significant difference between intra-arterial urokinase and intra-arterial rt-PA. In the three-pronged study intravenous rt-PA and intra-arterial streptokinase were associated with a significantly higher risk of haemorrhagic complications than with intra-arterial rt-PA (P < 0.05). There is some evidence to suggest that intra-arterial rt-PA is more effective than intra-arterial streptokinase or intravenous rt-PA in improving vessel patency in people with peripheral arterial occlusion. There was no evidence that rt-PA was more effective than urokinase for patients with peripheral arterial occlusion and some evidence that initial lysis may be more rapid with rt-PA, depending on the regime. Incidences of haemorrhagic complications were not statistically significantly greater with rt-PA than with other regimes. However, all of the findings come from small studies and a general paucity of results means that it is not possible to draw clear conclusions.

Plain-language summary: This review found some evidence from five randomized controlled trials, involving a total of 687 patients that suggested local infusion of a drug into the affected artery is more effective than infusion into a vein, and is also associated with a lower risk of unwanted bleeding. No particular drug was more effective in preventing limb loss or death than another. The drugs investigated were streptokinase, urokinase, recombinant tissue plasminogen activator and pro-urokinase. More research is needed to confirm these findings. All of the findings of this review came from small studies that involved people with peripheral arterial ischaemia of differing severity.
Abstract: There were 15 trials with 11 included in the meta-analysis. Five trials showed relaxation reduced self-reported depression compared to wait-list, no treatment, or minimal treatment post intervention (SMD -0.59 (95% CI -0.94 to -0.24)). For clinician-rated depression, two trials showed a non-significant difference in the same direction (SMD -1.35 (95% CI -3.06 to 0.37)). Nine trials showed relaxation produced less effect than psychological (mainly cognitive-behavioural) treatment on self-reported depression (SMD = 0.38 (95% CI 0.14 to 0.62)). Three trials showed no significant difference between relaxation and psychological treatment on clinician-rated depression at post intervention (SMD 0.29 (95% CI -0.18 to 0.75)). Inconsistent effects were found when comparing relaxation training to medication and there were few data available comparing relaxation with complementary and lifestyle treatments. Relaxation techniques were more effective at reducing self-rated depressive symptoms than no or minimal treatment. However, they were not as effective as psychological treatment. Data on clinician-rated depressive symptoms were less conclusive. Further research is required to investigate the possibility of relaxation being used as a first-line treatment in a stepped care approach to managing depression, especially in younger populations and populations with subthreshold or first episodes of depression.

Plain-language summary: The review of 15 trials found that it was better than no treatment or minimal treatment, but not as effective as psychological therapies like cognitive-behaviour therapy. Relaxation techniques have potential as a simple first-line psychological treatment for depression. Those who do not respond within a set time could be offered more complex psychological treatment such as cognitive-behaviour therapy.
Abstract: We included 16 studies with a total of 1146 participants in the meta-analysis. Only one study including 52 participants had a low risk of bias and low applicability concern in the patient selection domain. The median pre-test probability of unresectable disease after CT scanning across studies was 41.4% (that is 41 out of 100 participants who had resectable cancer after CT scan were found to have unresectable disease on laparotomy). The summary sensitivity of diagnostic laparoscopy was 64.4% (95% confidence interval (CI) 50.1% to 76.6%). Assuming a pre-test probability of 41.4%, the post-test probability of unresectable disease for participants with a negative test result was 0.20 (95% CI 0.15 to 0.27). This indicates that if a person is said to have resectable disease after diagnostic laparoscopy and CT scan, there is a 20% probability that their cancer will be unresectable compared to a 41% probability for those receiving CT alone. A subgroup analysis of people with pancreatic cancer gave a summary sensitivity of 67.9% (95% CI 41.1% to 86.5%). The post-test probability of unresectable disease after being considered resectable on both CT and diagnostic laparoscopy was 18% compared to 40.0% for those receiving CT alone. Diagnostic laparoscopy may decrease the rate of unnecessary laparotomy in people with pancreatic and periampullary cancer found to have resectable disease on CT scan. On average, using diagnostic laparoscopy with biopsy and histopathological confirmation of suspicious lesions prior to laparotomy would avoid 21 unnecessary laparotomies in 100 people in whom resection of cancer with curative intent is planned.

Plain-language summary: We performed a thorough literature search to identify studies published up to 15 May 2016. We identified 16 studies reporting information on 1146 people with pancreatic or periampullary cancers which were considered to be eligible for potentially curative surgery based on CT scan staging. These studies evaluated diagnostic laparoscopy and compared results of the procedure with the eventual diagnosis by the surgeon that the cancer was not resectable during major abdominal operation or examination under microscope. All of the studies were of unclear or low methodological quality in one or more aspects, which may undermine the validity of our findings. Of those people with what CT suggests seems to be a potentially surgically curable cancer, the percentage in whom more extensive cancer was found on further staging with diagnostic laparoscopy or laparotomy ranged between 17% and 82% across studies. The median percentage of people in whom cancer spread was not detected by CT scan was 41%. Adding staging laparoscopy to CT scan might decrease the number of people with unremovable disease undergoing unnecessary major operations to 20% compared to those who undergo unnecessary major operation after CT scan alone (41%). This means that using diagnostic laparoscopy could halve the rate of unnecessary major open operations in people undergoing major surgery for potentially surgically curable pancreatic cancer.
Abstract: There are now 30 studies involving 6334 participants (6339 fractures) included in this review, which was published in 2011. There was considerable variation in the quality of trial methodology and generally inadequate reporting of methods and trial findings. Allocation concealment was confirmed in one trial only. The main outcome measures reported were fracture healing complications, re-operations and mortality. The reporting of functional outcomes was particularly poor. Few trials tested the same comparison. Most of the results for the 25 separate comparisons, frequently tested within one trial only, showed no statistically significant differences between the two implants under test. It was noted that the more rare findings of favourable results were often for implants developed within the same institutions as the trial. There was a consistent finding of less avascular necrosis with the sliding hip screw in comparison with five different types of cancellous screws but there was no significant difference found for re-operations. Additionally, the sliding hip screw was found to take longer to insert and to have an increased operative blood loss compared with multiple screws or pins. No clear conclusions can be made on the choice of implant for internal fixation of intracapsular fractures from the available evidence within randomised trials.

Plain-language summary: This review of randomised controlled trials included 30 studies involving more than 6000 participants. Most of the trials were poorly reported and had flaws in their methods that could have affected their results. Few trials tested the same comparison. Most of the results for the 25 separate comparisons, frequently tested within one trial only, failed to show that one implant was better than the other under comparison. There was a consistent finding of one serious complication (avascular necrosis) with the sliding hip screw in comparison with five different types of cancellous screws. However, this was not reflected in a decrease in re-operations for this group. Additionally, the sliding hip screw was found to take longer to insert and to have an increased operative blood loss compared with multiple screws or pins. This review found no evidence from trials undertaken so far that there were any major differences between different implants in patient survival or complications related to the operation.
Abstract: One study fulfilled inclusion criteria involving 113 children randomised to an asthma education programme involving an IHW, compared to a similar education programme without an IHW. Eighty eight of these children completed the trial. Parents' asthma knowledge score (mean difference (MD) (7.49; 95% CI 5.52 to 9.46), parents' asthma skill score (MD 0.98; 95% CI 0.52 to 1.44) and days absent from school (100% school-aged children in the intervention group missed <7 days, 21% of controls missed 7-14 days, difference = 21%, 95% CI 5-36%) were significantly better in the intervention group compared to controls. There was no significant difference in mean number of exacerbations (per year) between groups. There was no difference in quality of life or children's asthma skill score; both were limited to one study only and the direction favoured IHW group. There were no studies in adults. The involvement of IHW in asthma programs targeted for their own ethnic group in one small trial was beneficial in improving most, but not all asthma outcomes in children with asthma. It is very likely that involvement of an IHW is beneficial. However as exacerbation frequency was not significantly different between groups, we cannot be confident of the results in all settings. Nevertheless, given the complexity of health outcomes and culture as well as the importance of self-determination for indigenous peoples, the practice of including IHW in asthma education programs for indigenous children and adults with asthma is justified, but should be subject to further randomised controlled trials.

Plain-language summary: In this review, we examined if involvement of an indigenous healthcare worker (IHW) (when compared to absence of an IHW) in asthma education programs improves asthma related outcomes in Indigenous children and adults with asthma. There was only one study involving 113 people eligible for inclusion in this review. The participants showed improvement in the patient's asthma knowledge score, the parent's asthma skill score and a reduction in the number of days missed from school in children who were cared for by an indigenous healthcare worker. However as exacerbation frequency was not reduced and there was only a single, small study, we cannot be confident of the results although we think it is likely that the involvement of IHW is beneficial. Nevertheless, given the complexity of health outcomes and culture as well as the importance of self-determination for indigenous peoples, the practice of including IHW in asthma education programs for indigenous children and adults with asthma is justified, but should be subject to further randomised controlled trials
Abstract: We included one trial reporting outcome at follow-up times ranging between two and 47 months for 81 participants with Mason type 1 and 2 radial head fractures. This poorly-reported trial was at particular high risk of detection and reporting biases. The trial found no significant differences between early and delayed mobilisation in the numbers of participants with pain or limitations in their range of elbow motion. All participants were reported as being able to use their arms for full activities of daily living and none had changed their occupation or lifestyle. There was no mention of fracture complications. There is a lack of robust evidence to inform on the timing of mobilisation, and specifically on the use of early mobilisation, after non-surgical or surgical treatment for adults with elbow fractures. There is a need for high quality, well-reported, adequately powered, randomised controlled trials that compare early versus delayed mobilisation in people with commonly-occurring elbow fractures, treated with or without surgery. Trials should use validated upper limb function scales, and assessment should be both short-term (to monitor recovery and early complications) and long-term (at least one year).

Plain-language summary: We searched for randomised controlled trials that compared early movement with delayed movement of the elbow after elbow fracture. We included one trial reporting results at times ranging from two to 47 months for 81 people who had had an elbow fracture that involved the head of the radius. The evidence from this trial is of very low quality. The trial found no important differences between early and delayed mobilisation in the numbers of participants with pain or limitations in their range of elbow motion. All participants were reported as being able to use their arms for full activities of daily living and none had changed their occupation or lifestyle. There was no mention of fracture complications. We concluded that there was a lack of reliable evidence to answer the question of whether early mobilisation improved function without increasing complications in adults with elbow fractures.
Abstract: We only found studies (47 studies, 3581 participants) for 18 of the 29 eligible TCHMs as defined by our inclusion criteria. All were superiority trials conducted in China between 1997 and 2013, with most employing a two-arm parallel design with sample sizes ranging from 26 to 240 and a median treatment duration of 12 weeks (range: 2 to 24 weeks). We found that reporting and trial methodology were generally poor; in particular, there was a lack of information on randomisation, an absence of blinding of participants and outcome assessors and incomplete reporting of adverse events (AEs). None of the 30 trials published from 2007 onwards adopted the CONSORT recommendations for reporting RCTs of herbal interventions. We found seven TCHMs which each had potentially large benefits in studies estimating the TCHM versus 'no treatment' effect and in studies estimating the TCHM versus the WM effect. Two TCHMs (NaoXinTong and TongXinLuo) were common to both groups. Three of these TCHMs – Nao XinTong, NaoMaiTai and TongXinLuo – had the strongest evidence to justify further research. Two TCHMs (NaoMaiTai and TongXinLuo) had a 5% or more increased risk of AEs compared to the 'no Treatment' control, but the quality of this evidence was poor. We found moderate- to very low-quality evidence of benefit and harm of TCHMs for VaD. Methodological inadequacies need to be addressed by better conducted and reported trials. We identified NaoMaiTai, NaoXinTong and TongXinLuo as warranting special research priority.

Plain-language summary: We included 47 trials with 3581 participants of 18 TCHMs in this review. All were conducted in mainland China between 1997 and 2013 with participant numbers ranging from 26 to 240 and an average study duration of 12 weeks. There were significant problems with the methods in many of the trials, particularly with how participants were allocated to treatments, how outcomes were measured and how thoroughly harmful effects were monitored. For these and other reasons, we rated the overall quality of the evidence as variable, ranging from moderate to very low. This means that we are uncertain, and often very uncertain, about the accuracy of the results. Despite these reservations, we found seven TCHMs which each had potentially large benefits in studies comparing TCHMs to no treatment or Western Medicine. Three of these – Nao XinTong, NaoMaiTai and TongXinLuo – had the strongest evidence to justify further research. We found that the risk of harmful effects was at least 5% higher than the risk for participants in the control group for NaoMaiTai and TongXinLuo, but the quality of this evidence was poor. We think further research of some TCHMs for vascular dementia is justified, but it is important that the quality of trial conduct and reporting be improved by adhering to published best-practice standards.