Is informed consent possible in acute myocardial infarction? | Heart

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Is informed consent possible in acute myocardial infarction?

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Informed consent in acute myocardial infarction is possible
Anne Gammelgaard
Published on: 23 November 2015

Published on: 23 November 2015
Informed consent in acute myocardial infarction is possible
- Anne Gammelgaard, MSc., PhD
- Other Contributors:
  Ole S. Mortensen, and Peter Rossel
Dear Editor,
In the editorial "Is informed consent possible in acute myocardial infarction?" published in the November issue of Heart, Dr. Foëx argues that clinicians must learn to empower their patients to make autonomous decisions when they can. According to Dr. Foëx, the empirical studies on informed consent in acute myocardial infarction (AMI) that he cites suggest that some patients are competent and consider...
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Dear Editor,
In the editorial "Is informed consent possible in acute myocardial infarction?" published in the November issue of Heart, Dr. Foëx argues that clinicians must learn to empower their patients to make autonomous decisions when they can. According to Dr. Foëx, the empirical studies on informed consent in acute myocardial infarction (AMI) that he cites suggest that some patients are competent and consider themselves competent to make a decision.
This is in contrast to the impression of the vast majority (86%) of cardiologists, surveyed in the study by Ågård and colleagues, who felt that patients in interventional trials in AMI were unable to understand all the information given to them [1]. In Ågård et al’s study of patients’ perception of the informed consent process in an AMI trial, most of the patients ”were willing to allow, or even wanted, their physician to decide for them – at least if they were to be too ill to be asked about participation in research” [2].
In our recent study, published in the October issue of Heart, we analyse to what extent patients in the DANAMI-2 trial felt able to make the decision, and to what extent they found the consent process acceptable [3]. We found that the majority (76% of the trial participants and 63% of the non-participants) agreed or almost agreed that they felt able to make the decision, and 50% of the trial participants and 34% of the non-participants found it acceptable that patients in their situation have to make such a decision. We conclude that informed consent should be sought in AMI trials, and we further argue that patients’ self-assessed ability to make a decision should be explicitly addressed during the informed consent process to avoid that patients who do not feel competent are pressurised into decision-making.
Arguably, few patients are able to reach a deliberate autonomous decision - in the strictly limited sense of reaching a well-informed decision after due deliberation - under acute circumstances. What, then, is the specific aim of an informed consent process in AMI trials? In her book, Autonomy and trust in bioethics, O’Neill argues that the requirement of informed consent should not be grounded in some conception of individual autonomy [4]. Instead, she argues that informed consent requirements are justified because they have the potential to prevent and limit deception and coercion of patients, and to preserve a basis of trust in the relationship between patients and physicians. This modest, but nevertheless important, role of informed consent makes sense particularly in the context of AMI trials. Likewise, Ågård et al. suggest that what really seems to matter is not that patients are fully informed, but that their right to say yes or no is respected.
References
(1). Ågård A, Herlitz J, Hermeren G. Obtaining informed consent from patients in the early phase of acute myocardial infarction: physicians' experiences and attitudes. Heart 2004;90:208-10.
(2). Ågård A, Hermeren G, Herlitz J. Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity? Heart 2001;86:632-7.
(3). Gammelgaard A, Mortensen OS, Rossel P. Patients' perceptions of informed consent in acute myocardial infarction research: a questionnaire based survey of the consent process in the DANAMI-2 trial. Heart 2004;90:1124-8.
(4). O'Neill O. Autonomy and trust in bioethics. Cambridge: Cambridge University Press, 2002.
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Conflict of Interest:
None declared.
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