ArticleBMJ (Clinical research ed.)2022
Visualising harms in publications of randomised controlled trials: consensus and recommendations.
Article in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis 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
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Antidepressants for low back pain and spine-related leg pain.The Cochrane database of systematic reviews · 2025Pooled it
- Effectiveness of Escitalopram and Nortriptyline on Depressive Symptoms in Parkinson's disease: the ADepT-PD RCT pilot.Health technology assessment (Winchester, England) · 2025Trial
- Communication of information on benefits and harms of multiple competing medical interventions: three-group, open-label, randomised controlled trial.The British journal of psychiatry : the journal of mental science · 2026Article
- Reporting of the harms from randomized controlled trials for psoriasis: a cross-sectional meta-epidemiological study.Frontiers in medicine · 2026Article
- Analysis of recurrent events in cluster randomised trials: The PLEASANT trial case study.Statistical methods in medical research · 2025Article
- Article
- Treating severe paediatric asthma with mepolizumab or omalizumab: a protocol for the TREAT randomised non-inferiority trial.BMJ open · 2024Article
- A proposal for using benefit-risk methods to improve the prominence of adverse event results when reporting trials.Trials · 2024Article
- Involving patients and the public In sTatistIcal Analysis pLans (INITIAL): A delphi survey.PloS one · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
Abstract
objectiveTo improve communication of harm in publications of randomised controlled trials via the development of recommendations for visually presenting harm outcomes.
designConsensus study.
setting15 clinical trials units registered with the UK Clinical Research Collaboration, an academic population health department, Roche Products, and
participantsExperts in clinical trials: 20 academic statisticians, one industry statistician, one academic health economist, one data graphics designer, and two clinicians. MAIN OUTCOME:
results28 visualisations were considered, of which 10 are recommended for researchers to consider in publications of main research findings. The choice of visualisations to present will depend on outcome type (eg, binary, count, time-to-event, or continuous), and the scenario (eg, summarising multiple emerging events or one event of interest). A decision tree is presented to assist trialists in deciding which visualisations to use. Examples are provided of each endorsed visualisation, along with an example interpretation, potential limitations, and signposting to code for implementation across a range of standard statistical software. Clinician feedback was incorporated into the explanatory information provided in the recommendations to aid understanding and interpretation.
conclusionsVisualisations provide a powerful tool to communicate harms in clinical trials, offering an alternative perspective to the traditional frequency tables. Increasing the use of visualisations for harm outcomes in clinical trial manuscripts and reports will provide clearer presentation of information and enable more informative interpretations. The limitations of each visualisation are discussed and examples of where their use would be inappropriate are given. Although the decision tree aids the choice of visualisation, the statistician and clinical trial team must ultimately decide the most appropriate visualisations for their data and objectives. Trialists should continue to examine crude numbers alongside visualisations to fully understand harm profiles.
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.