ReviewJournal of evidence-based medicine2025
Inadequate Reporting of Harm From Randomized Clinical Trials in Top Medical Publications.
Review in Journal of evidence-based medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Therapeutic Misconception as a Problem of Nonmaleficence by Way of False Hope.Health care analysis : HCA : journal of health philosophy and policy · 2026Article
- A literature review and reflection on clinical trials: current challenges, future directions, and potential strategies to overcome practical barriers.AME clinical trials review · 2026Article
- Variability among large language models in assessing CONSORT compliance of published randomized clinical trials.PloS one · 2026Article
- Do we value the safety of our treatments? An empirical assessment of reporting of Harms in Randomized Controlled Trials in Orthodontics.European journal of orthodontics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
objectiveTo assess the quality of harm reporting in randomized controlled trials (RCTs) published in high-impact general medical journals. STUDY DESIGN AND
settingPublications 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.
resultsWe identified 175 eligible RCTs (
aimn = 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.
conclusionsRCTs 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.