Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial

Anneli Olsson, Camilla Ring, Johan Josefsson, Annika Eriksson, Rebecca Rylance, Ole Fröbert, Stefan James, David Sparv, David Erlinge, Anneli Olsson, Camilla Ring, Johan Josefsson, Annika Eriksson, Rebecca Rylance, Ole Fröbert, Stefan James, David Sparv, David Erlinge

Abstract

Objective: We aimed to assess the patient experience of informed consent (IC) during acute myocardial infarction (AMI) in a sub-study of the VALIDATE-SWEDEHEART trial. The original trial compared two anticoagulant agents in patients undergoing coronary intervention. A witnessed oral IC was required prior to randomization in patients with ST-segment elevation myocardial infarction, which was subsequently complemented with a written IC after percutaneous coronary intervention. Written consent was obtained before angiography in patients with non-ST-segment elevation myocardial infarction.

Background: The IC process in patients with AMI is under debate. Earlier trials in this population have required prospective consent before randomization. A trial published some years ago used deferred consent, but the patient experience of this process is poorly studied.

Methods: A total of 414 patients who participated in the main trial were enrolled and asked the following questions: (1) Do you remember being asked to participate in a study? (2) How was your experience of being asked to participate; do you remember it being positive or negative? (3) Would you have liked more information about the study? (4) Do you think it would have been better if you were included in the study without being informed until a later time?

Results: Of these patients, 94% remembered being included; 85% of them experienced this positively, 12% were neutral and 3% negative. Regarding more information, 88% did not want further information, and 68% expressed that they wanted to be consulted before inclusion. Of the patients, 5% thought it would have been better to have study inclusion without consent, and 27% considered it of no importance.

Conclusion: It is reasonable to ask patients for verbal IC in the acute phase of AMI. Most patients felt positively about being asked to participate and had knowledge of being enrolled in a scientific study. In addition they objected to providing IC after randomization and treatment.

Trial registration: VALIDATE-SWEDEHEART European Union Clinical Trials Register: 2012-005260-10. ClinicalTrials.gov: NCT02311231. Registered on 8 Dec 2014.

Keywords: Informed consent; Myocardial infarction.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Remembrance of the informed consent process in the main trial population (a) and in the sub-groups of gender (b), clinical presentation (c) and age (d). There were no significant differences in any of the sub-groups
Fig. 2
Fig. 2
Patients’ experience of being asked in the main trial population (a) and in the sub-groups of gender (b), clinical presentation (c) and age (d). The STEMI group were significantly less positive than the NSTEMI group, p = 0.005
Fig. 3
Fig. 3
a–d as in Fig. 1. Patients’ preference to have more information. There were no significant differences in any of the sub-groups
Fig. 4
Fig. 4
a–d as in Fig. 1. Patients’ view of delayed consent. b Females tended to be more negative to delayed consent than men, p = 0.06. c There were no significant differences between STEMI and NSTEMI or in the age sub-group

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