Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design.ĭickert, Neal W Hendershot, Kristopher A Speight, Candace D Fehr, Alexandra E The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI. 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. Structured interviews were conducted with 30 patients with AMI.
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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. 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.
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