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© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

Equipoise, generally defined as uncertainty about the relative effects of the treatments being compared in a trial, is frequently referenced as an ethical standard for the conduct of randomized clinical trials. However, it seems to be defined in several different ways and may be used differently by different individuals. We explored how clinical researchers, chairs of research ethics boards, and philosophers of science define and reason with this term.

Methods

We completed semi-structured interviews about clinical trial ethics with 15 clinical researchers, 15 research ethics board chairs, and 15 philosophers of science/bioethicists. Each participant was asked a standardized set of 10 questions, 4 of which were specifically about equipoise. All interviews were conducted telephonically and transcribed. Responses were grouped and analysed via a modified grounded theory method.

Results

Forty-three respondents defined equipoise in 7 logically distinct ways, and 2 respondents could not explicitly define it. The most common definition, offered by 14 respondents (31%), defined “equipoise” as a disagreement at the level of a community of physicians. There was significant variability in definitions offered between and within groups. When asked how they would “operationalize” equipoise — i.e. check or test for its presence — respondents provided 7 alternatives, the most common being in relation to a literature review (15/45, 33%). The vast majority of respondents (35/45, 78%) felt the concept was helpful, though many acknowledged that the lack of a clear definition or operationalization was problematic.

Conclusion

There is significant variation in definitions of equipoise offered by respondents, suggesting that parties within groups and between groups may be referring to different concepts when they reference “equipoise”. This non-uniformity may impact fairness and transparency and opens the door to potential ethical problems in the evaluation of clinical trials — for instance, a patient may understand equipoise very differently than the researchers enrolling her in a trial, which could cause her agreement to participate to be based upon false premises.

Details

Title
What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics
Author
Dewar, Brian 1   VIAFID ORCID Logo  ; Chevrier, Stephanie 1 ; De Meulemeester, Julie 1 ; Fedyk, Mark 2 ; Rodriguez, Rosendo 3 ; Kitto, Simon 4 ; Saginur, Raphael 1 ; Shamy, Michel 5 

 Ottawa Hospital Research Institute, Ottawa, Canada (GRID:grid.412687.e) (ISNI:0000 0000 9606 5108) 
 University of California, Davis, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684) 
 University of Ottawa, Department of Medicine, Ottawa, Canada (GRID:grid.28046.38) (ISNI:0000 0001 2182 2255) 
 University of Ottawa, Department of Innovation in Medical Education, Ottawa, Canada (GRID:grid.28046.38) (ISNI:0000 0001 2182 2255) 
 Ottawa Hospital Research Institute, Ottawa, Canada (GRID:grid.412687.e) (ISNI:0000 0000 9606 5108); University of Ottawa, Department of Medicine, Ottawa, Canada (GRID:grid.28046.38) (ISNI:0000 0001 2182 2255) 
Pages
203
Publication year
2023
Publication date
Dec 2023
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2787984885
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.