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

Autor: Kevin P. Weinfurt, Dominick J. Angiolillo, Victoria M. Scicluna, James C. Blankenship, Manesh R. Patel, Sara F. Goldkind, Rebecca D. Pentz, Michael Frankel, Gautam Kumar, Opeolu Adeoye, Raul G. Nogueria, Michele Riedford, Andrea R. Mitchell, Ilana Spokoyny, Neal W. Dickert, Chandan Devireddy, Candace D. Speight, Ruth M. Parker, Yi-An Ko, Robert Silbergleit
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Male
medicine.medical_specialty
Decision Making
Myocardial Infarction
acute myocardial infarction
0603 philosophy
ethics and religion
Interviews as Topic
03 medical and health sciences
0302 clinical medicine
Informed consent
Clinical Studies
medicine
Coronary Heart Disease
Humans
030212 general & internal medicine
Myocardial infarction
cardiovascular diseases
Stroke
Acute stroke
Original Research
Randomized Controlled Trials as Topic
Retrospective Studies
Informed Consent
business.industry
clinical trial
06 humanities and the arts
Middle Aged
medicine.disease
ethics
stroke
Clinical trial
Cross-Sectional Studies
Emergency medicine
Ethics and Policy
Cerebrovascular Disease/Stroke
Female
060301 applied ethics
Emergencies
Cardiology and Cardiovascular Medicine
business
Emergency Service
Hospital
Acute Coronary Syndromes
Zdroj: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
ISSN: 2047-9980
Popis: 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 1.9 years (stroke) and 2.8 years (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.
Databáze: OpenAIRE
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