Zheng Rui, Tao Liyuan, Sun Yang, Shang Hongcai, Levine Mitchell
Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
J Evid Based Med. 2025 Mar;18(1):e70006. doi: 10.1111/jebm.70006.
To assess the quality of harm reporting in randomized controlled trials (RCTs) published in high-impact general medical journals.
Publications of RCTs involving drugs compared with placebo controls, that were published in five general medical journals with high Impact Factors were identified from January 2022 to December 2023. Data relating to the presentation and discussion of harm were extracted and analyzed based on the Consort Harm framework.
We identified 175 eligible RCTs (AIM: n = 5; BMJ: n = 8; JAMA: n = 26, Lancet: n = 64, and NEJM: n = 72). None of the studies referenced the CONSORT Harms 2004 statement. Seventy-one percent of studies (n = 125) did not mention how harm data about patients' symptoms were collected and 86.3% of the analyses (n = 151) were limited to descriptive statistics. Only 45.1% of studies (n = 79) discussed the balance of benefits and harms. Common limitations included unclear methodological details, selective reporting, and inadequate analysis of results.
RCTs published in five highly cited general medical journals contain deficiencies in harm reporting. The recently updated Consort Harm 2022 provides an implementable evaluation and guidance tool and should be actively promoted among researchers, reviewers, and journal editors. More attention to adequate and reasonable reporting requirements for harms in RCTs is necessary to provide a better opportunity for evidence-based decision making.
评估发表在高影响力综合医学期刊上的随机对照试验（RCT）中危害报告的质量。
从2022年1月至2023年12月，在五本具有高影响因子的综合医学期刊上发表的、涉及药物与安慰剂对照的RCT出版物被识别出来。基于Consort危害框架提取并分析了与危害呈现和讨论相关的数据。
我们识别出175项符合条件的RCT（《美国医学会杂志》：n = 5；《英国医学杂志》：n = 8；《美国医学会杂志》：n = 26；《柳叶刀》：n = 64；《新英格兰医学杂志》：n = 72）。没有一项研究引用2004年的Consort危害声明。71%的研究（n = 125）未提及如何收集关于患者症状的危害数据，86.3%的分析（n = 151）仅限于描述性统计。只有45.1%的研究（n = 79）讨论了利弊平衡。常见的局限性包括方法细节不明确、选择性报告以及对结果的分析不足。
在五本高引用率的综合医学期刊上发表的RCT在危害报告方面存在缺陷。最近更新的2022年Consort危害声明提供了一个可实施的评估和指导工具，应在研究人员、审稿人和期刊编辑中积极推广。有必要更加关注RCT中危害的充分和合理报告要求，以便为循证决策提供更好的机会。
