Visualising harms in publications of randomised controlled trials: consensus and recommendations.

Autor:	Phillips R; Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK r.phillips@imperial.ac.uk.; Pragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK., Cro S; Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK., Wheeler G; Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK., Bond S; Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Morris TP; MRC Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology, London, UK., Creanor S; Exeter Clinical Trials Unit, University of Exeter, Exeter, UK., Hewitt C; York Trials Unit, University of York, York, UK., Love S; MRC Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology, London, UK., Lopes A; CRUK Cancer Trials Centre, University College London, London, UK., Schlackow I; Nuffield Department of Population Health, University of Oxford, Oxford, UK., Gamble C; Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK., MacLennan G; Centre for Health Care Randomised Trials, University of Aberdeen, Aberdeen, UK., Habron C; Roche Products, Welwyn Garden City, UK., Gordon AC; Division of Anaesthetics, Pain Medicine, and Intensive Care, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare NHS Trust, London, UK., Vergis N; Imperial College London and Imperial NHS Trust, London, UK., Li T; Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA., Qureshi R; Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA., Everett CC; Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK., Holmes J; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Kirkham A; Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK., Peckitt C; Royal Marsden Clinical Trials Unit, Royal Marsden NHS Foundation Trust, London, UK., Pirrie S; Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK., Ahmed N; Comprehensive Clinical Trials Unit, University College London, London, UK., Collett L; Bristol Trials Centre, University of Bristol, Bristol, UK., Cornelius V; Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.
Jazyk:	angličtina
Zdroj:	BMJ (Clinical research ed.) [BMJ] 2022 May 16; Vol. 377, pp. e068983. Date of Electronic Publication: 2022 May 16.
DOI:	10.1136/bmj-2021-068983
Abstrakt:	Objective: To improve communication of harm in publications of randomised controlled trials via the development of recommendations for visually presenting harm outcomes. Design: Consensus study. Setting: 15 clinical trials units registered with the UK Clinical Research Collaboration, an academic population health department, Roche Products, and The BMJ . Participants: Experts in clinical trials: 20 academic statisticians, one industry statistician, one academic health economist, one data graphics designer, and two clinicians. Main Outcome: measures A methodological review of statistical methods identified visualisations along with those recommended by consensus group members. Consensus on visual recommendations was achieved (at least 60% of the available votes) over a series of three meetings with participants. The participants reviewed and critically appraised candidate visualisations against an agreed framework and voted on whether to endorse each visualisation. Scores marginally below this threshold (50-60%) were revisited for further discussions and votes retaken until consensus was reached. Results: 28 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. Conclusions: Visualisations 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. Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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