Background: Benefits and harms identified in phase Ⅱ and Ⅲ randomized controlled trials (RCTs) can provide valuable information for clinical practice. Adverse event reporting in an RCT has a greater opportunity for validation when compared to results obtained from observational studies. The CONSORT framework provides guidance on reporting of harms in RCT publications. The degree to which authors follow this guidance is uncertain.
Objectives: To assess the quality of harm reporting in randomized controlled trials (RCTs) published in general medical journals.
Methods: Publications of RCTs involving drug therapies compared to placebo controls that were published in five general medical journals with high Impact Factors were identified from January to December 2022. Data relating to the presentation and discussion of harm in those publications were extracted and analyzed using the Consort Harm framework.
Results: 406 trials were initially screened, and 38 eligible publications were identified (Ann Intern Med n=1; BMJ n=5; JAMA n=8, Lancet n=20 and NEJM n=2). The 38 trials had randomized 98,324 participants. The Consort Harm 2004 statement was not mentioned in any study. Nine studies claimed to be following the general CONSORT statement of 2010. Seventy-four percent (n=28) of studies did not provide a plan to compare harms between treatment groups and 68% (n=26) limited the analysis to descriptive statistics. Only 39% (n=15) of studies assessed the balance of benefits and harms in the discussion.
Conclusions: RCTs published in five highly cited general medical journals contain deficiencies in harm reporting. The new Consort Harm 2022 provides an implementable evaluation and guidance tool and should be encouraged for use by researchers, reviewers, and journals. More attention to adequate and reasonable reporting requirements for harms in RCTs is necessary to provide optimal support for evidence-based decision making by clinicians.
