Public perspective on potential treatment intervention harm in clinical trials-terminology and communication.

Autor: Phillips R; Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK. r.phillips@imperial.ac.uk., Bi D; Pragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Queen Mary University of London, London, UK., Goulão B; Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Miller M; Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK., El-Askary M; Public Partner, London, UK., Fagbemi O; Public Partner, London, UK., Freeborn C; Public Partner, London, UK., Giammetta M; Public Partner, London, UK., El Masri N; Public Partner, London, UK., Flockhart P; Public Partner, London, UK., Kumar M; Public Partner, London, UK., Melvin M; Public Partner, London, UK., Murray D; Public Partner, London, UK., Myhill A; Public Partner, London, UK., Saeid L; Public Partner, London, UK., Thomas S; Public Partner, London, UK., MacLennan G; Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Cornelius V; Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Aug 31; Vol. 25 (1), pp. 573. Date of Electronic Publication: 2024 Aug 31.
DOI: 10.1186/s13063-024-08418-w
Abstrakt: Background: Randomised controlled trials (RCTs) are typically designed to determine beneficial intervention effects. In addition, an important aspect of every trial is to collect data on any potential harmful effects, with the aim of ensuring that the benefit-risk balance is appropriate. The language used by trialists to describe these potential harmful effects is inconsistent. In pharmacological trials, researchers collect adverse events; when a causal relationship is suspected adverse events are further classified as adverse reactions. Academic researchers have moved to collectively refer to these as harm outcomes; the pharmaceutical industry refer to these events as safety outcomes. In trials of complex interventions, phrases such as unintended consequences or effects are used. With the inconsistent use of terminology by researchers and the potential benefits to be gained from harmonising communications, we sought public opinion on terminology used to describe harmful effects and how these outcomes are communicated in the scientific literature, as well as in public facing material on medications.
Methods: We held two in-person public involvement meetings with public partners, in London and Aberdeen in 2023. Both meetings followed a pre-specified format. We provided a background to the topic including the information researchers collect on potential harms in clinical trials and shared examples on how this information gets presented in practice. We then discussed public partners' perspectives on terminology used and communication of intervention harm in academic journals and in public facing materials. A summary of these discussions and the main topics raised by public partners are presented.
Results: Public partners endorsed the use of different terms for different situations, preferring the use of 'side-effect' across all contexts and reserving the use of 'harm' to indicate more severe events. Generally, public partners were happy with the type of information presented in public facing materials but discussions revealed that presentation of information on public NHS websites led to misconceptions about harm.
Conclusion: This work provides a starting point on preferred terminology by patients and the public to describe potential harmful intervention effects. Whilst researchers have tried to seek agreement, public partners endorsed use of different terms for different situations. We highlight some key areas for improvement in public facing materials that are necessary to avoid miscommunication and incorrect perception of harm.
(© 2024. The Author(s).)
Databáze: MEDLINE
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