Inadequate Reporting of Harm From Randomized Clinical Trials in Top Medical Publications

Abstract

Objective: To assess the quality of harm reporting in randomized controlled trials (RCTs) published in high-impact general medical journals.

Study Design and Setting: 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.

Results: 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.

Conclusions: 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.

Keywords

CONSORT Harm 2022 / cross-sectional survey / harm / randomized clinical trials / reporting quality

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2025 The Author(s). Journal of Evidence-Based Medicine published by Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.