Department of Biostatistics, MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.
BMJ Open. 2013 Sep 27;3(9):e003436. doi: 10.1136/bmjopen-2013-003436.
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.
Systematic review.
The Cochrane library, Ovid MEDLINE, Scopus and ISI Web of Knowledge were searched for relevant literature.
We included publications of studies that used the CONSORT harms extension to assess the reporting of harms in RCTs.
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.
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.
根据 CONSORT 损害扩展声明，确定随机对照试验（RCT）中与损害相关数据报告的标准。
系统评价。
Cochrane 图书馆、Ovid MEDLINE、Scopus 和 ISI Web of Knowledge 检索相关文献。
我们纳入了使用 CONSORT 损害扩展来评估 RCT 中损害报告的研究出版物。
我们确定了 7 项研究，其中包括 10 至 205 项 RCT。这 7 项研究的临床领域为：高血压（1）、泌尿科（1）、癫痫（1）、补充医学（2）和两个不限于临床主题。这 7 项研究的质量通过偏倚风险工具进行评估，发现其质量参差不齐。对这 7 项研究中 CONSORT 损害标准的依从性不足，且在清单项目中存在差异。不良事件定义不明确，有 6 项研究在清单项目的遵守程度上低于 50%。
RCT 出版物的读者需要能够在干预措施的获益和损害之间进行权衡。这项系统评价表明，由于损害报告不佳，这一平衡受到影响，这种情况在多个临床领域都存在。通过更广泛地采用 CONSORT 损害标准，报告 RCT 的期刊可以提高质量。
