Abstract 228: Patients’ Views of Consent for STEMI Trials: Are All Trials the Same?

Background: Informed consent for clinical trials in acute MI- especially STEMI- is controversial. Prior data suggest patients want to be asked for permission before enrollment. It is unknown whether trial features affect this desire. This is particularly important in the context of debate about the role of consent in standard of care comparative effectiveness trials. Methods: This interview study included patients admitted with acute MI. Structured, in-depth interviews were conducted in hospital or after discharge. Participants considered 3 scenarios modeled on existing STEMI trials: 1) comparative effectiveness trial of approved antiplatelet drugs; 2) placebo-controlled trial of a novel drug to reduce myocardial injury; and 3) comparative effectiveness trial of intraaortic balloon pump versus medical therapy. Participants were asked their desired involvement in enrollment decisions and willingness to participate in each trial. Results: Thirty patients were interviewed. Most (73-80%) wanted to be asked for permission to be enrolled in all scenarios (Table 1). Willingness to enroll, however, was affected by trial type. For example, 50% vs 20% were unlikely to enroll in scenario 3 vs. scenario 1 (p=0.018). Attitudes regarding enrollment focused on distinctive trial features. Many participants specifically stated they were comfortable with scenario 1 because it involved only approved drugs. Participants split regarding scenario 2 based on whether they viewed the novel agent as a potential benefit or risk, and some had concerns about placebo. The invasive nature of the balloon pump in scenario 3 was the most common basis for not wanting to enroll. For some, this was driven by a desire to receive the intervention; for others, it was driven by a desire to avoid it. Conclusion: In this exploratory study, most patients would prefer to be asked for permission prior to enrollment in 3 different STEMI trial scenarios, including 2 trials evaluating standard of care alternatives. While desire to be involved in enrollment decisions was relatively insensitive to trial features, these features impacted willingness to enroll. This study supports the notion that the form and content of consent processes for STEMI trials should be trial and context specific. Refining these processes requires further study. ![][1] [1]: /embed/graphic-1.gif