Patients' views of consent for research enrollment during acute myocardial infarction
Neal W Dickert1, Alexandra E Fehr, Alex Llanos
1Department of Medicine, Division of Cardiology, Emory University School of Medicine , Atlanta, GA , USA.
Insights
Patients with ST-elevation myocardial infarction (STEMI) often struggle with informed consent due to their condition. While recognizing barriers, they value participation and wish to make decisions themselves.
Area of Science:
- Cardiology
- Clinical Trials
- Informed Consent Research
Background:
- Informed consent in ST-elevation myocardial infarction (STEMI) research is challenging due to acute conditions.
- Time constraints, symptom severity, and cognitive impairment impact patient understanding.
Purpose of the Study:
- To understand patient perspectives on informed consent during clinical trial enrollment for STEMI.
- To identify challenges and preferences in the informed consent process for acute cardiac events.
Main Methods:
- An embedded interview study using a structured guide was conducted within a STEMI clinical trial.
- Twenty interviews were performed with patients post-procedure.
Main Results:
- 55% of patients did not recall being asked to participate in a trial.
- Patient comprehension of study details was limited; many perceived the intervention as clinically superior or mandatory.
- Patients cited pain, stress, and time constraints as barriers but desired to be the primary decision-makers.
Conclusions:
- Patients acknowledge understanding barriers in STEMI informed consent but value the consent process.
- Future research should focus on consent approaches that respect patient autonomy within the acute STEMI context.
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.
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