About this item:

149 Views | 136 Downloads

Author Notes:

Neal W. Dickert, MD, PhD, Emory University School of Medicine, 1462 Clifton Road, #508, Atlanta, GA. E-mail: njr@emory.edu

The authors would like to thank the members of the P‐CARE Patient Advisory Panel for their contributions to the design and implementation of this study.

Complete list of disclosures available in full text.

Subjects:

Research Funding:

Research reported in this article was funded through a PCORI (Patient‐Centered Outcomes Research Institute) Award (ME‐1402‐10638).

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • acute myocardial infarction
  • clinical trial
  • ethics
  • informed consent
  • stroke
  • INFORMED-CONSENT
  • PATIENTS PERCEPTIONS
  • VALIDATION
  • SURVIVORS

Emergency Consent: Patients' and Surrogates' Perspectives on Consent for Clinical Trials in Acute Stroke and Myocardial Infarction

Show all authors Show less authors

Tools:

Journal Title:

Journal of the American Heart Association

Volume:

Volume 8, Number 2

Publisher:

, Pages e010905-e010905

Type of Work:

Article | Final Publisher PDF

Abstract:

Background: Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients’ and surrogates’ experiences. Methods and Results: We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9years (stroke) and 2.8years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions: Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context-sensitive approaches to consent is important.

Copyright information:

© 2019 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
Export to EndNote