title: Patients' views of consent for research enrollment during acute myocardial infarction.
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.
authors.affiliation: Department of Medicine, Division of Cardiology, Emory University School of Medicine , Atlanta, GA , USA.
authors.forename: Neal W
authors.initials: NW
authors.lastname: Dickert
authors.forename: Alexandra E
authors.initials: AE
authors.lastname: Fehr
authors.forename: Alex
authors.initials: A
authors.lastname: Llanos
authors.forename: Victoria M
authors.initials: VM
authors.lastname: Scicluna
authors.forename: Habib
authors.initials: H
authors.lastname: Samady
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001290:Attitude; D032882:Comprehension; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D011939:Mental Recall; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy; D010865:Pilot Projects; D035842:Research Subjects / Q000523:psychology*
keywords: Myocardial infarction; coronary artery disease; ethics; informed consent