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Abstract
Objective: The goal of this study was to improve understanding of patients’ perspectives of informed consent for clinical trial enrollment during ST-elevation myocardial infarction (STEMI).
Background: STEMI research poses challenges regarding informed consent due to time constraints, symptom severity, and potential cognitive impairment.
Methods: An interview study was embedded within a clinical trial of an ischemic post-conditioning procedure for STEMI. An interactive, structured interview guide was used.
Results: Twenty interviews were conducted (median 1.5 days after initial procedure). Only 11/20 (55%) initially remembered being asked to participate in a trial. Comprehension of study details and the research process was limited; for example, many patients believed their decision was primarily clinical or that the study intervention was clearly superior. Patients described limitations regarding their ability to make a decision, including pain, discomfort, lack of time, and stress. However, patients generally felt they were able to make a decision at presentation and wanted to be the primary decision maker; few supported surrogate decision-making by family or physicians.
Conclusions: This study demonstrates that patients recognize barriers to understanding but value elements of consent. Further research is needed to develop approaches that meet patients’ goals while recognizing the limitations inherent to this context.
Funding sources
This study was supported by the Public Responsibility in Medicine and Research Pillars of PRIM&R Award. Dr. Dickert received salary support during the study period from the National Heart Lung and Blood Institute (1F32HL095358-01A1). The parent trial received support from the Atlanta Clinical and Translational Science Institute.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.