Involving patients in enrolment decisions for acute myocardial infarction trials

• Type of Material: Article
• Authors: Neal Dickert Jr, Emory University; Franklin G Miller, National Institutes of Health
• Language: English
• Date: 2015-07-29
• Publisher: BMJ Publishing Group: BMJ
• Publication Version: Final Published Version
• Copyright Statement: © BMJ Publishing Group Ltd 2015
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1136/bmj.h3791
• Title of Journal or Parent Work: BMJ
• ISSN: 0959-8138
• Volume: 351
• Start Page: h3791
• End Page: h3791
• Keywords: Humans; Randomized Controlled Trials as Topic; Patient Selection; Mental Competency; Patient Participation; Informed Consent; Myocardial Infarction
• Research Categories: Health Sciences, General; Health Sciences, Medicine and Surgery

Abstract

Controversy over informed consent for clinical trials in acute ST elevation myocardial infarction (STEMI) has existed for over 30 years.1 2 3 How can a patient with dyspnoea and angina in need of emergency percutaneous coronary intervention possibly make an informed, considered decision about whether to enrol in a clinical trial? Some authors have argued that seeking consent for research in this context is not only impracticable but unethical.4 Nevertheless, it has remained standard practice to ask STEMI patients or surrogates to consent to enrolment in trials. The recent Unfractionated Heparin versus Bivalirudin in Primary Percutaneous Coronary Intervention (HEAT-PPCI) trial, in which patients were randomised without prospective consent, has forced a re-examination of this long simmering question.5 6 7 This discussion is particularly timely given the growing emphasis on pragmatic comparative effectiveness trials that integrate clinical care and research. We contend that the principle of respect for persons supports involving patients in enrolment decisions for trials, even when trials pose few risks and patients cannot give valid consent.