Objective Seeking prospective informed consent is difficult in clinical trials for emergent conditions such as acute myocardial infarction (AMI). Prior data suggest that enrolment decisions of patients are often poorly informed in AMI trials but that patients prefer to be asked permission before enrolment. It is unknown whether this is true across trial designs or in comparative effectiveness research (CER) with approved treatments.
Methods Structured interviews were conducted with 30 patients with AMI. Participants considered three scenarios: (1) a CER trial of approved antiplatelet drugs; (2) a placebo-controlled trial of a novel drug to reduce myocardial injury and (3) a CER trial of an intra-aortic balloon pump versus medication. Participants were asked their desired involvement in enrolment decisions and willingness to participate. Descriptive analysis was performed of Likert scale data, and qualitative descriptive analysis was performed of textual data.
Results Across scenarios, most participants (73%–80%) preferred to be asked permission prior to trial enrolment. Reasons for involvement included wanting to be the decision maker and a desire for transparency. Willingness to enrol was affected by trial type. Fewer participants stated they would likely enrol in a CER procedural trial than in a CER trial of approved medications (p=0.012).
Conclusions These findings suggest that patients prefer prospective involvement in enrolment decisions to enrolment without consent across trial types. However, their desire to participate was affected by trial type. There is a need to develop and evaluate context-sensitive approaches to consent in AMI trials that account for both the acuity of the situation and trial characteristics.
- Informed Consent
- Research Ethics
- Clinical trials
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Contributors NWD drafted and revised the manuscript, conceptualised and designed the study and analysed and interpreted the data. KAH participated in participant recruitment and data collection, analysed and interpreted the data and contributed to drafting and revising the manuscript. CDS participated in participant recruitment and data collection, analysed and interpreted the data and contributed to drafting and revising the manuscript. AEF contributed to conceptualising and designing the study, participated in participant recruitment and data collection, analysed and interpreted the data and contributed to drafting and revising the manuscript.
Funding This study was supported by the Greenwall Foundation Faculty Scholars Program.
Competing interests NWD receives research funding from the Greenwall Foundation, National Institutes of Health and the Patient-Centered Outcomes Research Institute.
Ethics approval Emory University IRB.
Provenance and peer review Not commissioned; externally peer reviewed.
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