What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics
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 b...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07221-3 |
| _version_ | 1797863617670938624 |
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| author | Brian Dewar Stephanie Chevrier Julie De Meulemeester Mark Fedyk Rosendo Rodriguez Simon Kitto Raphael Saginur Michel Shamy |
| author_facet | Brian Dewar Stephanie Chevrier Julie De Meulemeester Mark Fedyk Rosendo Rodriguez Simon Kitto Raphael Saginur Michel Shamy |
| author_sort | Brian Dewar |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T22:39:30Z |
| format | Article |
| id | doaj.art-919522d9f43a41539889c865e7a587e8 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:39:30Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-919522d9f43a41539889c865e7a587e82023-03-22T12:17:44ZengBMCTrials1745-62152023-03-0124111210.1186/s13063-023-07221-3What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethicsBrian Dewar0Stephanie Chevrier1Julie De Meulemeester2Mark Fedyk3Rosendo Rodriguez4Simon Kitto5Raphael Saginur6Michel Shamy7Ottawa Hospital Research InstituteOttawa Hospital Research InstituteOttawa Hospital Research InstituteUniversity of CaliforniaDepartment of Medicine, University of OttawaDepartment of Innovation in Medical Education, University of OttawaOttawa Hospital Research InstituteOttawa Hospital Research InstituteAbstract 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.https://doi.org/10.1186/s13063-023-07221-3EthicsClinical trialsResearchEquipoise |
| spellingShingle | Brian Dewar Stephanie Chevrier Julie De Meulemeester Mark Fedyk Rosendo Rodriguez Simon Kitto Raphael Saginur Michel Shamy What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics Trials Ethics Clinical trials Research Equipoise |
| title | What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics |
| title_full | What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics |
| title_fullStr | What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics |
| title_full_unstemmed | What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics |
| title_short | What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics |
| title_sort | what do we talk about when we talk about equipoise stakeholder interviews assessing the use of equipoise in clinical research ethics |
| topic | Ethics Clinical trials Research Equipoise |
| url | https://doi.org/10.1186/s13063-023-07221-3 |
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