GEM/cochrane-simplification huggingface dataset:
Abstract: We included six RCTs that fulfilled the above criteria, with a total of 119 participants. The beta blockers studied were atenolol, propranolol, pindolol and metoprolol. All trials were of poor quality with the drugs administered over a short time (10 days to two months). None of the primary outcomes were reported by more than one study. Similarly, secondary outcome measures, with the exception of vascular resistance (as reported by three studies), were reported, each by only one study. Pooling of such results was deemed inappropriate. None of the trials showed a statistically significant worsening effect of beta blockers on time to claudication, claudication distance and maximal walking distance as measured on a treadmill, nor on calf blood flow, calf vascular resistance and skin temperature, when compared with placebo. No reports described adverse events associated with the beta blockers studied. Currently, no evidence suggests that beta blockers adversely affect walking distance, calf blood flow, calf vascular resistance and skin temperature in people with intermittent claudication. However, because of the lack of large published trials, beta blockers should be used with caution, if clinically indicated.

Plain-language summary: Currently, no evidence from randomised controlled trials suggests that beta blockers adversely affect walking distance in people with intermittent claudication, and beta blockers should be used with caution, if clinically indicated. The review authors identified six randomised controlled trials that involved a total of only 119 people with mild to moderate peripheral arterial disease. The beta blockers studied were propranolol, pindolol, atenolol and metoprolol. None of the trials showed clear worsening effects of beta blockers on time to claudication, claudication distance and maximal walking distance as measured on a treadmill, nor on calf blood flow, calf vascular resistance and skin temperature, when compared with placebo. Trial investigators reported no adverse events or issues regarding taking the beta blockers studied. Most of the trials were over 20 years old and reported findings between 1980 and 1991. All were small and of poor quality. The drugs were administered over a short time (10 days to two months), and most of the outcome measures were reported in single studies. Additional drugs－calcium channel blockers and combined alpha and beta blockers－were given during some of the trials.
Abstract: Altogether 223 patients with DTC participated in four trials. Overall, studies had a high risk of bias. We found no statistically significant differences between rhTSH and THW treatment in terms of successful ablation rate but significant benefits in radiation exposure to blood and bone marrow. One trial reported on benefits in some domains of health-related quality of life. There were no deaths and no serious adverse effects in DTC patients treated with either rhTSH or THW. Maximum follow up was 12 months. None of the included trials investigated complete or partial remission of metastatic tumour, secondary malignancies or economic outcomes. We did not find sufficient data comparing rhTSH with THW-aided radioiodine treatment for metastatic DTC. Results from four randomised controlled clinical trials suggest that rhTSH is as effective as THW on iodine-131 thyroid remnant ablation, with limited data on significant benefits in decreased whole body radiation exposure and health-related quality of life. It is still uncertain whether lower iodine-131 doses (1110 MBq or 1850 MBq versus 3700 MBq) are equally effective for remnant ablation under rhTSH stimulation. Randomised controlled clinical trials are needed to guide treatment selection for metastatic differentiated thyroid cancer.

Plain-language summary: Overall 223 patients with differentiated thyroid cancer participated in four studies. The duration of the intervention (injections of recombinant human thyrotropin) was two days in all trials. Studies were of rather low quality. We found no statistically significant differences between recombinant human thyrotropin and thyroid hormone withdrawal treatment in terms of successful reduction of thyroid remnants or cancer cells but significant benefits in radiation exposure to blood and bone marrow. One trial reported on benefits in some domains of health-related quality of life. There were no deaths and no serious adverse effects observed, however maximum follow up was only 12 months. None of the included trials investigated complete or partial remission of metastatic tumour, secondary malignancies or economic outcomes. We did not find sufficient data comparing recombinant human thyrotropin with thyroid hormone withdrawal-aided radioiodine treatment for metastatic differentiated cancer.
Abstract: We included six randomised controlled trials with moderate or high risk of bias, involving 2123 participants. There is moderate quality evidence that involving consumers in the development of patient information material results in material that is more relevant, readable and understandable to patients, without affecting their anxiety. This 'consumer-informed' material can also improve patients' knowledge. There is low quality evidence that using consumer interviewers instead of staff interviewers in satisfaction surveys can have a small influence on the survey results. There is low quality evidence that an informed consent document developed with consumer input (potential trial participants) may have little if any impact on understanding compared to a consent document developed by trial investigators only. There is very low quality evidence that telephone discussions and face-to-face group meetings engage consumers better than mailed surveys in order to set priorities for community health goals. They also result in different priorities being set for these goals. There is little evidence from randomised controlled trials of the effects of consumer involvement in healthcare decisions at the population level. The trials included in this review demonstrate that randomised controlled trials are feasible for providing evidence about the effects of involving consumers in these decisions.

Plain-language summary: This review shows that little research has been done to find the best ways of involving consumers in healthcare decisions at the population level. Most of the included trials compared consultations with consumers with no consultations with consumers. There is moderate quality evidence from two trials that involving consumers in the development of patient information material results in material that is more relevant, readable and understandable, without affecting anxiety. This 'consumer-informed' material can also improve knowledge. Two trials, which compared using consumer interviewers with staff interviewers as data collectors for patient satisfaction surveys, found small differences in satisfaction survey results, with less favourable results obtained when consumers were the interviewers. One trial comparing two informed consent documents, one developed with consumer input and the other developed by the trial investigators, showed that consumer input may have little if any impact on understanding of the trial described in the consent document. One trial, comparing two different methods for involving the public (telephone discussion and a face-to-face group meeting), showed that a face-to-face meeting is most likely to engage consumers and may result in different community health priorities.
Abstract: We did not identify any completed RCTs that met our inclusion criteria. However, three eligible studies are in progress: ADEPT is a phase III trial comparing postoperative radiotherapy with or without cisplatin in HPV-positive T1-4a OPSCC patients. Included patients must have received minimally invasive surgery and demonstrated extra-capsular spread from disease in the neck. ECOG-E3311 is a phase II trial of treatment for HPV-positive locally advanced OPSCC (stages III-IVa + IVb without distant metastasis). Patients are stratified after minimally invasive surgery. Medium-risk patients are randomised to either standard or reduced-dose radiotherapy. PATHOS is a phase III trial of treatment for HPV-positive OPSCC (T1-3, N0-2b). Patients are stratified after minimally invasive surgery. Medium-risk patients are randomised to either standard or reduced-dose radiotherapy. High-risk patients are randomised to radiotherapy with or without concurrent cisplatin. This review highlights the current lack of high-quality randomised controlled trials studying treatment de-escalation after minimally invasive surgery in patients with HPV-positive OPSCC. However, trials that will meet the inclusion criteria for this review are in progress with results expected between 2021 and 2023.

Plain-language summary: In April 2018, we searched for randomised controlled trials (RCTs) that had compared reduced-dose radiotherapy/chemotherapy treatment with standard-dose treatment. We were interested in the outcomes of overall survival and disease-free survival, as well as the effects on swallowing ability and voice. Our searches did not identify any completed RCTs, however three relevant studies are ongoing and the first results are expected between 2021 and 2023. Currently there is no high-quality evidence comparing these two treatments, however such trials are in progress.
Abstract: We included 19 trials with 19 different randomised dose comparisons. No studies reported data on relapse rates or quality of life and only one compared low dose (> 1.5 to 3 mg/day) haloperidol to higher dose ranges. Using standard lower dose (> 3 to 7.5 mg/day) did not result in loss of efficacy (no clinically important improvement in global state, versus standard higher dose (> 7.5 to 15 mg/day, n = 48, 1 RCT, RR 1.09, 95% CI 0.7 to 1.8, very-low-quality evidence); versus high dose (> 15 to 35 mg/day, n = 81, 2 RCTs, RR 0.95, 95% CI 0.8 to 1.2, very-low-quality evidence). Doses of haloperidol in the range of > 3 to 7.5 mg/day had a lower rate of development of clinically significant extrapyramidal adverse effects than higher doses (clinically significant extrapyramidal adverse effects, versus standard higher dose, n = 64, 2 RCTs, RR 0.12, 95% CI 0.01 to 2.1, very-low-quality evidence); versus high dose, n = 144, 3 RCTs, RR 0.59, 95% CI 0.5 to 0.8, very-low-quality evidence; versus very high dose (> 35 mg/day, n = 86, 2 RCTs, RR 0.70, 95% CI 0.5 to 1.1, very-low-quality evidence). None of the other comparisons between dose ranges yielded statistically significant differences, but several, particularly with lower dose ranges, were underpowered to detect clinically meaningful differences. Noresults were conclusive and all were based on small, short studies of limited quality. However, it would be understandable if clinicians were cautious in prescribing doses in excess of 7.5 mg/day of haloperidol to a person with uncomplicated acute schizophrenia, and if people with schizophrenia were equally reticent to take greater doses. Further research is needed regarding the efficacy and tolerability of the lower dose ranges, especially > 1.5 to 3 mg/day.

Plain-language summary: The main aim of this review was to determine the best range of doses of haloperidol for the treatment of schizophrenia. Nineteen trials were included that compared varying doses of haloperidol. Despite over 30 years of trials, data on the effects of differing doses of haloperidol are sparse and poorly reported. This is especially so for the lower dose ranges generally used for the treatment of schizophrenia today. However, lower doses of haloperidol may be just as effective as higher doses but result in fewer side effects. This review also suggests that an important bias against haloperidol may exist in modern trials comparing new drugs with haloperidol. Results are not conclusive and are based on small, short studies of limited quality. The authors of the review note that it would be understandable if psychiatrists were cautious about prescribing doses above 7.5 mg a day and if people with schizophrenia did not want to take higher dosages. Further research is needed to assess the tolerability and effectiveness of lower doses. Low doses of haloperidol may be just as good as higher doses, but with fewer side effects. This plain language summary was written by a consumer, Benjamin Gray, Service User and Service User Expert. Rethink Mental Illness. Email: [email protected].
Abstract: Eight trials met the inclusion criteria involving 504 patients in four cross-over and four parallel-group randomised controlled trials. Only two of the pre-stated six comparisons were addressed in these trials.   Four trials compared antibiotic prophylaxis with antibiotics when clinically indicated. For patients using intermittent catheterisation, there were inconsistent findings about the effect of antibiotic prophylaxis on symptomatic urinary tract infection (UTI). Only one study found a significant difference in the frequency of UTI favouring prophylaxis. For patients using indwelling urethral catheterisation, one small trial reported fewer episodes of symptomatic UTI in the prophylaxis group. Four trials compared antibiotic prophylaxis with giving antibiotics when microbiologically indicated. For patients using intermittent catheterisation, there was limited evidence that receiving antibiotics reduced the rate of bacteriuria (asymptomatic and symptomatic). There was weak evidence that prophylactic antibiotics were better in terms of fewer symptomatic bacteriuria. No eligible trials were identified that compared alternative routes of catheter insertion. The data from eight trials comparing different antibiotic policies were sparse, particularly when intermittent catheterisation was considered separately from indwelling catheterisation. Possible benefits of antibiotic prophylaxis must be balanced against possible adverse effects, such as development of antibiotic resistant bacteria. These cannot be reliably estimated from currently available trials.

Plain-language summary: No trials were found comparing these different methods with each other. Sometimes people using the catheters develop urinary tract infections. There was some weak evidence that using antibiotics all the time reduced the chance of having a urinary tract infection while using intermittent catheters, but there was not enough information about side effects.
Abstract: We did not identify any studies for inclusion in the previous version of this review. For this update, the literature search identified one low-quality controlled clinical trial involving 106 participants. The findings from this study suggest 'low-level' evidence to support high-intensity ambulatory (outpatient) multidisciplinary rehabilitation in reducing short- and long-term motor disability (continence, mobility and locomotion, cognition), when compared with standard outpatient care. We found improvement in some domains of disability (continence, communication) and psychosocial gains were maintained at six months follow-up. We found no evidence for improvement in overall participation (quality of life and societal relationship). No adverse events were reported as a result of multidisciplinary rehabilitation. We found no evidence for improvement in quality of life or cost-effectiveness of rehabilitation. It was also not possible to suggest best 'dose' of therapy. Since the last version of this review, one new study has been identified for inclusion. The best evidence to date comes from this CCT, which provides low quality evidence that higher intensity ambulatory (outpatient) multidisciplinary rehabilitation reduces short- and long-term disability in people with brain tumour compared with standard outpatient care. Our conclusions are tentative at best, given gaps in current research in this area. Although the strength of evidence has increased with the identification of a new controlled clinical trial in this updated review, further research is needed into appropriate and robust study designs; outcome measurement; caregiver needs; evaluation of optimal settings; type, intensity, duration of therapy; and cost-effectiveness of multidisciplinary rehabilitation in the brain tumour population.

Plain-language summary: We found one controlled clinical trial (poor quality) that compared multidisciplinary rehabilitation to standard outpatient care. The 106 people in this trial received treatment in the hospital outpatient clinic. Participants were in the multidisciplinary rehabilitation programme for up to eight weeks, and the results were measured at three and six months after completion of the programme. There was some evidence to support the benefit of multidisciplinary rehabilitation in reducing disability in people with primary brain tumour. People in the multidisciplinary rehabilitation group showed improvement in their functional abilities (e.g. continence, mobility) and cognitive function compared to the group with standard care only. Multidisciplinary rehabilitation was not harmful. Current research gaps highlight the need for high-quality research to explore the effectiveness of various aspects of multidisciplinary rehabilitation and caregiver needs in this patient population. The evidence in this review is up to date to January 2015.
Abstract: In total, 65 trials (total number of patients = 11,237) were included in this review. Twenty-eight trials (42%) were considered high quality. Statistically significant effects were found in favour of NSAIDs compared to placebo, but at the cost of statistically significant more side effects. There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low-back pain, but paracetamol had fewer side effects. There is moderate evidence that NSAIDs are not more effective than other drugs for acute low-back pain. There is strong evidence that various types of NSAIDs, including COX-2 NSAIDs, are equally effective for acute low-back pain. COX-2 NSAIDs had statistically significantly fewer side-effects than traditional NSAIDs. The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low-back pain without sciatica. However, effect sizes are small. Furthermore, there does not seem to be a specific type of NSAID which is clearly more effective than others. The selective COX-2 inhibitors showed fewer side effects compared to traditional NSAIDs in the RCTs included in this review. However, recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient populations.

Plain-language summary: Non-steroidal anti-inflammatory drugs (NSAIDs) are the most frequently prescribed medications worldwide and are commonly used for treating low-back pain. This review found 65 studies (including over 11,000 patients) of mixed methodological quality that compared various NSAIDs with placebo (an inactive substance that has no treatment value), other drugs, other therapies and with other NSAIDs. The review authors conclude that NSAIDs are slightly effective for short-term symptomatic relief in patients with acute and chronic low-back pain without sciatica (pain and tingling radiating down the leg). In patients with acute sciatica, no difference in effect between NSAIDs and placebo was found. The review authors also found that NSAIDs are not more effective than other drugs (paracetamol/acetaminophen, narcotic analgesics, and muscle relaxants). Placebo and paracetamol/acetaminophen had fewer side effects than NSAIDs, though the latter has fewer side effects than muscle relaxants and narcotic analgesics. The new COX-2 NSAIDs do not seem to be more effective than traditional NSAIDs, but are associated with fewer side effects, particularly stomach ulcers. However, other literature has shown that some COX-2 NSAIDs are associated with increased cardiovascular risk. The review noted a number of limitations in the studies. Only 42% of the studies were considered to be of high quality. Many of the studies had small numbers of patients, which limits the ability to detect differences between the NSAID and the control group. There are few data on long term results and long-term side effects.
Abstract: Twenty-nine RCTs were included: 28 were placebo-controlled, double-blind RCTs and one compared different doses of rFVIIa. In the 'Risk of bias' assessment, most studies were found to have some threats to validity although therapeutic RCTs were found to be less prone to bias than prophylactic RCTs. Sixteen trials involving 1361 participants examined the prophylactic use of rFVIIa; 729 received rFVIIa. There was no evidence of mortality benefit (risk ratio (RR) 1.04; 95% confidence interval (CI) 0.55 to 1.97). There was decreased blood loss (mean difference (MD) -297 mL; 95% CI -416 to -178) and decreased red cell transfusion requirements (MD -261 mL; 95% CI -367 to -154) with rFVIIa treatment; however, these values were likely overestimated due to the inability to incorporate data from trials (four RCTs in the outcome of blood loss and three RCTs in the outcome of transfusion requirements) showing no difference of rFVIIa treatment compared to placebo. There was a trend in favour of rFVIIa in the number of participants transfused (RR 0.85; 95% CI 0.72 to 1.01). However, there was a trend against rFVIIa with respect to thromboembolic adverse events (RR 1.35; 95% CI 0.82 to 2.25). Thirteen trials involving 2929 participants examined the therapeutic use of rFVIIa; 1878 received rFVIIa. There were no outcomes where any observed advantage or disadvantage of rFVIIa over placebo could not have been observed by chance alone. There was a trend in favour of rFVIIa for reducing mortality (RR 0.91; 95% CI 0.78 to 1.06). However, there was a trend against rFVIIa for increased thromboembolic adverse events (RR 1.14; 95% CI 0.89 to 1.47). When all trials were pooled together to examine the risk of thromboembolic events, a significant increase in total arterial events was observed (RR 1.45; 95% CI 1.02 to 2.05). The effectiveness of rFVIIa as a more general haemostatic drug, either prophylactically or therapeutically, remains unproven. The results indicate increased risk of arterial events in patients receiving rFVIIa. The use of rFVIIa outside its current licensed indications should be restricted to clinical trials.

Plain-language summary: This review included 29 randomised controlled trials with 4290 patients. The trials showed modest reductions in total blood loss or red cells transfused (equivalent to less than one unit of red cell transfusion) with the use of rFVIIa. However, the reductions were likely to be overestimated due to the limitations of the data. We also observed an increase in the risk of having a blood clot in the arteries (such as a heart attack or stroke) in those patients receiving rFVIIa. When taken together, the data supporting the off-license use of recombinant FVIIa are weak. The use of rFVIIa outside its current licensed indications should be restricted to clinical trials.