ArticleBMJ open2013
Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension.
Article in BMJ open, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 16 of them syntheses that pooled it.
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
40 citing papers in PubMed, 16 syntheses or guidelines pooled it.
- Systematic review with cross sectional comparative analysis identifies adverse event reporting discrepancies between ClinicalTrials.gov and published glaucoma randomized controlled trials.Scientific reports · 2025Pooled it
- Adverse Events Following Short-Course Systemic Corticosteroids Among Children and Adolescents: A Systematic Review and Meta-Analysis.JAMA network open · 2025Pooled it
- Risk of Adverse Events Associated with Domperidone and Metoclopramide in Gastroparesis: Systematic Review and Meta-analysis.Drugs in R&D · 2023Pooled it
- Biases in reporting of adverse effects in clinical trials, and potential impact on safety assessments in systematic reviews and therapy guidelines.Basic & clinical pharmacology & toxicology · 2022Pooled it
- Pooled it
- Identification, collection, and reporting of harms among non-industry-sponsored randomized clinical trials of pharmacologic interventions in the critically ill population: a systematic review.Critical care (London, England) · 2020Pooled it
- Systematic review of reporting benefits and harms of surgical interventions in randomized clinical trials.BJS open · 2020Pooled it
- Pooled it
- Adverse events in people taking macrolide antibiotics versus placebo for any indication.The Cochrane database of systematic reviews · 2019Pooled it
- Serious adverse events reported in placebo randomised controlled trials of oral naltrexone: a systematic review and meta-analysis.BMC medicine · 2019Pooled it
- Pooled it
- Blood pressure lowering efficacy of renin inhibitors for primary hypertension.The Cochrane database of systematic reviews · 2017Pooled it
- Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review.PLoS medicine · 2016Pooled it
- Pooled it
- Common harms from amoxicillin: a systematic review and meta-analysis of randomized placebo-controlled trials for any indication.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2015Pooled it
- Relation of completeness of reporting of health research to journals' endorsement of reporting guidelines: systematic review.BMJ (Clinical research ed.) · 2014Pooled it
- Assessing the Completeness of Adverse Event Reporting in Clinical Trials of Psoriasis Treatments: A Registry-Publication Comparison Study.Clinical drug investigation · 2026Article
- Article
- Adverse Events in Older Adults at Risk for Dementia During Remote Physical Exercise and Cognitive Training.Canadian geriatrics journal : CGJ · 2026Article
- Measurement of Adverse Events in Studies of Digital Health Interventions for Psychosis: Guidance and Recommendations Based on a Literature Search and Framework Analysis of Standard Operating Procedures.Schizophrenia bulletin · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
objectiveTo 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.
designSystematic review. DATA SOURCES: The Cochrane library, Ovid MEDLINE, Scopus and ISI Web of Knowledge were searched for relevant literature. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included publications of studies that used the CONSORT harms extension to assess the reporting of harms in RCTs.
resultsWe 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.
conclusionsReaders 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.
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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.