期刊
BMJ OPEN
卷 3, 期 9, 页码 -出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2013-003436
关键词
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资金
- Medical Research Council (MRC) [G1000397 - 1/1]
- North West Hub for Trials Methodology Research, UK [G0800792]
- Medical Research Council [1247324] Funding Source: researchfish
Objective: To determine the standard of reporting of harms-related data, in randomised controlled trials (RCTs) according to the Consolidated Standards of Reporting Trials (CONSORT) statement extension for harms. Design: Systematic review. Data sources: The Cochrane library, Ovid MEDLINE, Scopus and ISI Web of Knowledge were searched for relevant literature. Eligibility criteria for selecting studies: We included publications of studies that used the CONSORT harms extension to assess the reporting of harms in RCTs. Results: We identified 7 studies which included between 10 and 205 RCTs. The clinical areas of the 7 studies were: hypertension (1), urology (1), epilepsy (1), complimentary medicine (2) and two not restricted to a clinical topic. Quality of the 7 studies was assessed by a risk of bias tool and was found to be variable. Adherence to the CONSORT harms criteria reported in the 7 studies was inadequate and variable across the items in the checklist. Adverse events are poorly defined, with 6 studies failing to exceed 50% adherence to the items in the checklist. Conclusions: Readers of RCT publications need to be able to balance the trade-offs between benefits and harms of interventions. This systematic review suggests that this is compromised due to poor reporting of harms which is evident across a range of clinical areas. Improvements in quality could be achieved by wider adoption of the CONSORT harms criteria by journals reporting RCTs.
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