Patients’ perceptions of informed consent in acute myocardial infarction research: a Danish study

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Abstract

Seeking informed consent from patients in the acute phase of acute myocardial infarction (AMI) poses an ethical challenge due to the fact that these patients are under stress and require urgent medical attention. The very procedure of informed consent, which is supposed to protect eligible patients, may in fact cause harm due to a potential delay in the provision of therapy. Whether or not informed consent can and should be obtained under these particular circumstances is far from evident. Patients participating in various large-scale AMI trials have been enrolled with, as well as without, informed consent in recent years. Little is known, however, about how patients experience the informed consent process in the emergency situation of an AMI.

This paper reports the results from qualitative interviews with 32 patients, who had to decide whether or not to participate in a large multi-centre clinical trial in Denmark. We analyse to what extent patients found the informed consent process acceptable as well as how various factors influenced their experience of the consent process. We argue that it is morally sound to involve those patients in a brief and concise informed consent process and that consent should be sought in such trials. Finally, we discuss how future AMI trials may nonetheless be improved by accommodating some of the concerns of the patients.

Introduction

Although a large number of patients with acute myocardial infarction (AMI) have participated in clinical trials, little is known about how they experience the informed consent process in the emergency situation of an AMI. The conditions for acquiring informed consent from AMI patients are obviously far from ideal as many patients are in pain, anxious or sedated at the time consent is required. Furthermore, only a limited amount of time is available for the informed consent process since AMI patients need immediate medical treatment. A special dilemma exists in obtaining informed consent in AMI trials due to the fact that this very procedure may be a cause of harm in itself due to the delay in the provision of treatment that may be experienced. Not surprisingly, the various enrolment procedures used in AMI research in recent years reflect a growing controversy over whether informed consent can and should be obtained under these particular circumstances (Collins, Doll, & Peto, 1992; Gammelgaard, in press; Hilden & Gammelgaard, 2002; Kennedy, 2002; Rasmussen et al., 2001; Verdu-Pascual & Castello-Ponce, 2001; Ågard, Hermeren, & Herlitz, 2001).

In A History and Theory of Informed Consent, Ruth Faden and Tom Beauchamp provide a comprehensive conceptual analysis of the basic requirements of informed consent (Faden & Beauchamp, 1986). First of all, patients must understand what the particular trial is all about; they must understand not only what they are authorising but, more basically, that they are authorising it. More specifically, patients must adequately understand what the trial entails and that they, rather than permitting the doctor to do whatever he finds relevant, permit him to enroll them in a trial. Secondly, patients must be competent to decide whether or not to participate in the trial; something that requires the ability to understand the information, reflect upon the information, make a decision, and express this decision. Finally, patients must not be coerced or manipulated by others to give consent. According to Faden and Beauchamp, coercion occurs only if a person intends to influence another person by presenting a severe, credible and irresistible threat, whereas manipulation is more subtle and includes any modification of the options or the information presented to the patients to modify their behaviour or beliefs.

In the context of the AMI trial, it is debatable whether the emergency situation in itself is ‘coercive’; not least since there is evidence that patients in the emergency ward adapt to a particular passive and dependent role (Boisaubin & Dresser, 1987; Lidz, Meisel, & Munetz, 1985). According to Faden and Beauchamp, the problem with people in dependent roles is that they believe that they are supposed to behave compliantly, almost without regard for personal preferences. They maintain, however, that even serious illness does not rule out the possibility of obtaining a valid consent; in the face of even extraordinarily difficult pressures patients may nevertheless be able to give informed consent. This is supported by Appelbaum and Grisso (1997), who studied the effects of severe illness and hospitalisation per se on decision-making and found that patients hospitalised for evaluation or treatment of a severe and potentially life-threatening medical disorder performed as well as a matched sample of community residents on a set of measures related to decision-making capacities. However, the emergency situation of AMI trials may make patients more inclined to participate in research. According to some studies of informed consent in AMI trials, several of the patients consented to the trial to rid themselves of pain and to receive treatment as quickly as possible (Ockene et al., 1991; Smith, 1974; Ågard et al., 2001) and consent in emergency situations is more often forthcoming than in circumstances where patients have time to absorb what has been said to them and reflect on how they feel (Edwards, Lilford, Thornton, & Hewison, 1998).

A few studies analyse AMI patients’ ability to recall and understand the information (Kucia & Horowitz, 2000; Ockene et al., 1991; Smith, 1974; Williams, French, & White, 1997; Yuval et al., 2000; Ågard et al., 2001). These studies indicate that patient comprehension of the information was limited and few had read the written consent form. Compared to studies of the informed consent process in non-emergency cardiovascular trials, the informed consent process in AMI trials seems indeed to be less informed. In the non-emergency cardiovascular trials, 90% of patients said that they had enough information to make a good decision (Sugarman et al., 1998), 80% were aware of the purpose of the trial, and 86% were aware of side effects (Howard & DeMets, 1981). In the AMI trials, the corresponding percentages are 52% (Smith, 1974), 68–70% (Ockene et al., 1991; Williams et al., 1997), and 46% (Ockene et al., 1991), respectively. From an ethical perspective, however, it is relevant to consider not only (1) whether the informed consents obtained from AMI patients are valid, but also (2) whether it is acceptable to involve AMI patients in an informed consent process in the first place. In the study by Ockene et al. (1991), 71% state that the consent process did not upset them, while only 7% state that they were upset. Ågard et al. (2001) however maintain that most of the patients in their study ’were willing to allow, or even wanted, their physicians to decide for them—at least if they were to be too ill to be asked about participation in research’. None of the other studies analyse whether patients find the consent procedure acceptable, and it remains an open question whether or not AMI patients in fact do feel too ill to be asked about participation in research.

On the basis of qualitative interviews with 32 patients, who had to decide whether or not they wished to participate in a recent AMI trial, this paper will address the ethical implications of patients’ experience with the informed consent process. It is our aim to analyse to what extent the patients did feel able to make the decision; to what extent they found the informed consent process acceptable; and how various factors influenced their experience of the consent process. On this basis, we will discuss how future AMI trials may be improved.

Section snippets

The DANAMI-2 trial

The patients in this study were candidates for the randomised clinical multi-centre trial, DANAMI-2 (second DANish Acute Myocardial Infarction study), comparing an interventional approach (primary angioplasty) with a medical strategy (fibrinolysis) in the management of AMI (Andersen et al., 2003). Recruitment to the trial took place from December 1997 to October 2001 in 29 Danish hospitals. The primary angioplasty was only performed in five (the angioplasty centres) of the 29 participating

Methods

This qualitative interview study involved 23 patients who consented to participate in the trial and nine eligible patients who did not give consent. Patients were strategically sampled from nine hospitals to achieve variation in the following parameters: age, sex, allocated treatment, hospital (angioplasty centre or referral hospital), travel distance from the referral hospital to the angioplasty centre, and the hospitals’ experience with the enrolment procedure (numbers of patients enrolled).

Understanding—What did patients know about the trial?

One of the non-participants did not remember the informed consent process or whether any trial or study had been mentioned in relation to his disease. The interview with this patient was omitted from further analysis. The 30 remaining interviews were analysed to determine in how far the patients understood that they were asked to participate in a trial; the purpose and basic procedures of the trial; its benefits and risks; the random allocation of treatments; and the alternative to

Problems of informed consent

This study confirms the finding of other studies of informed consent in AMI trials, that individuals who consent under these circumstances are not likely to be well informed (Kucia et al., 2000; Ockene et al., 1991; Smith, 1974; Williams et al., 1997; Yuval et al., 2000; Ågard et al., 2001). In this study, some patients did not understand that they had consented to a randomised trial but believed that they had consented to a specific treatment. This misconception gave rise to considerable

Acknowledgements

We would like to thank the patients and relatives who participated in this study. We would also like to thank the DANAMI-2 steering committee, in particular, Henning Rud Andersen, Peer Grande and Torsten Toftegaard Nielsen for making this study possible and facilitating our collaboration with the hospitals concerned. Furthermore, we would like to thank Niels Gadsbøll, Anne Rahbek Thomassen, Hans Ibsen, clinicians and study nurses for providing helpful information on DANAMI-2. We are grateful to

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