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Instruments assessing risk of bias of randomized trials frequently included items that are not addressing risk of bias issues
Objectives: To establish whether items included in instruments published in the last decade assessing risk of bias of randomized controlled trials (RCTs) are indeed addressing risk of bias.Study Design and Setting: We searched Medline, Embase, Web of Science, and Scopus from 2010 to October 2021 for instruments assessing risk of bias of RCTs. By extracting items and summarizing their essential content, we generated an item list. Items that two re-viewers agreed clearly did not address risk of bias were excluded. We included the remaining items in a survey in which 13 experts judged the issue each item is addressing: risk of bias, applicability, random error, reporting quality, or none of the above.Results: Seventeen eligible instruments included 127 unique items. After excluding 61 items deemed as clearly not addressing risk of bias, the item classification survey included 66 items, of which the majority of respondents deemed 20 items (30.3%) as addressing risk of bias; the majority deemed 11 (16.7%) as not addressing risk of bias; and there proved substantial disagreement for 35 (53.0%) items. Conclusion: Existing risk of bias instruments frequently include items that do not address risk of bias. For many items, experts disagree on whether or not they are addressing risk of bias.(c) 2022 Elsevier Inc. All rights reserved.
期刊论文
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Drug treatments for covid-19: living systematic review and network meta-analysis
OBJECTIVE To compare the effects of treatments for coronavirus disease 2019 (covid-19). DESIGN Living systematic review and network meta-analysis. DATA SOURCES US Centers for Disease Control and Prevention COVID-19 Research Articles Downloadable Database, which includes 25 electronic databases and six additional Chinese databases to 20 July 2020. STUDY SELECTION Randomised clinical trials in which people with suspected, probable, or confirmed covid-19 were randomised to drug treatment or to standard care or placebo. Pairs of reviewers independently screened potentially eligible articles. METHODS After duplicate data abstraction, a bayesian random effects network meta-analysis was conducted. Risk of bias of the included studies was assessed using a modification of the Cochrane risk of bias 2.0 tool, and the certainty of the evidence using the grading of recommendations assessment, development and evaluation (GRADE) approach. For each outcome, interventions were classified in groups from the most to the least beneficial or harmful following GRADE guidance. RESULTS 23 randomised controlled trials were included in the analysis performed on 26 June 2020. The certainty of the evidence for most comparisons was very low because of risk of bias (lack of blinding) and serious imprecision. Glucocorticoids were the only intervention with evidence for a reduction in death compared with standard care (risk difference 37 fewer per 1000 patients, 95% credible interval 63 fewer to 11 fewer, moderate certainty) and mechanical ventilation (31 fewer per 1000 patients, 47 fewer to 9 fewer, moderate certainty). These estimates are based on direct evidence; network estimates for glucocorticoids compared with standard care were less precise because of network heterogeneity. Three drugs might reduce symptom duration compared with standard care: hydroxychloroquine (mean difference -4.5 days, low certainty), remdesivir (-2.6 days, moderate certainty), and lopinavir-ritonavir (-1.2 days, low certainty). Hydroxychloroquine might increase the risk of adverse events compared with the other interventions, and remdesivir probably does not substantially increase the risk of adverse effects leading to drug discontinuation. No other interventions included enough patients to meaningfully interpret adverse effects leading to drug discontinuation. CONCLUSION Glucocorticoids probably reduce mortality and mechanical ventilation in patients with covid-19 compared with standard care. The effectiveness of most interventions is uncertain because most of the randomised controlled trials so far have been small and have important study limitations.
期刊论文
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Multidisciplinary biopsychosocial rehabilitation for subacute low back pain among working age adults
BACKGROUND: Multidisciplinary biopsychosocial rehabilitation programs are widely applied for chronic low back pain patients. The biopsychosocial approach can also prevent chronicity, by providing rehabilitation for patients who still have pain past the initial acute phase. Nevertheless, multidisciplinary treatment programmes are often laborious and long processes and require good collaboration between the patient, the rehabilitation team and the work place. By using workplace visits and developing close relationships with occupational health care providers, one might expect patients' working ability to improve. OBJECTIVES: The objective of this systematic review was to determine the effectiveness of multidisciplinary rehabilitation for subacute low back pain among working age adults. SEARCH STRATEGY: The reviewed studies for this review were electronically identified from MEDLINE, EMBASE, PsycLIT, CENTRAL, Medic, the Science Citation Index, reference checking and consulting experts in the rehabilitation field. The original search was planned and performed for the broader area of musculoskeletal disorders. Trials on subacute low back pain were separated afterwards. The literature search was last updated in November 2002 in EMBASE and MEDLINE. SELECTION CRITERIA: From all references identified in our original search, we selected randomised controlled trials (RCTs) and non-randomised controlled clinical trials (CCTs). Trials had to assess the effectiveness of multidisciplinary rehabilitation for working age patients suffering from subacute low back pain (more than four weeks but less than three months). The rehabilitation program was required to be multidisciplinary, i.e., it had to consist of a physician's consultation plus either a psychological, social or vocational intervention, or a combination of these. DATA COLLECTION AND ANALYSIS: Four reviewers blinded to journal and author selected trials that met the specified inclusion criteria. Two experts in the field of rehabilitation evaluated the clinical relevance and applicability of the findings of the selected studies for actual clinical use. Two other reviewers blinded to journal and author extracted the data and assessed the main results and the methodological quality of the studies, using standardized forms. Finally, a qualitative analysis was performed to evaluate the level of scientific evidence for the effectiveness of multidisciplinary rehabilitation. MAIN RESULTS: After screening 1808 abstracts, and the references of 65 reviews, we found only two relevant studies that satisfied our criteria on subacute low back pain. No more studies were found during the updates. Both studies were considered to be methodologically low quality RCTs. The clinical relevance of included studies was sufficient. There was moderate scientific evidence showing that multidisciplinary rehabilitation, which includes a workplace visit or more comprehensive occupational health care intervention, helps patients to return to work faster, results in fewer sick leaves and alleviates subjective disability. REVIEWER'S CONCLUSIONS: We conclude that there is moderate evidence of positive effectiveness of multidisciplinary rehabilitation for subacute low back pain and that a workplace visit increases the effectiveness. But because this evidence is based on trials that had some methodological shortcomings, and several expensive multidisciplinary rehabilitation programmes are commonly used for uncomplicated/non-specific subacute low back problems, there is an obvious need for high quality trials in this field.
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