Elsevier

The Lancet

Volume 361, Issue 9361, 15 March 2003, Pages 918-922
The Lancet

Articles
Informed consent during the clinical emergency of acute myocardial infarction (HER0-2 consent substudy): a prospective observational study*

https://doi.org/10.1016/S0140-6736(03)12773-0Get rights and content

Summary

Background

Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial.

Methods

We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent.

Findings

The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0·009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent.

Interpretation

Although the consent process for HER0-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

Introduction

Fibrinolytic and adjunctive treatments for acute myocardial infarction with ST elevation have been assessed in clinical trials that have enrolled more than 200 000 patients.1, 2, 3, 4, 5, 6 Although in some early trials patients were not required to give written informed consent,1, 2, 3, 4 it is now mandatory.7, 8

There have been several studies of informed consent in non-emergency conditions,9, 10, 11, 12, 13, 14 but few have focused on the process of obtaining informed consent in emergency situations, such as during acute myocardial infarction.15, 16, 17 In 1983, the ethics committees that considered the Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto miocardico (GISSI-1) trial concluded that the patients' condition was too acute for a consent procedure to be acceptable.1 The updated Declaration of Helsinki 2000 and the European Union clinical trials directive do not specifically address the issue of informed consent in trials in patients presenting with a clinical emergency,7, 8 such as acute myocardial infarction.

Because delay in reperfusion treatment increases the risk of death,6 informed consent for participation in trials of this treatment is needed urgently from patients with acute myocardial infarction with ST elevation. However, little is known about factors that affect patients' decisions to give or decline consent.15, 16, 17 To give written informed consent, a patient has to understand verbal and written information about the trial, but in emergency situations this ability might be impaired by factors such as anxiety, fear, pain, the effects of morphine, and a patient's level of education. We studied the process of obtaining consent in patients with acute myocardial infarction who were invited to participate in the Hirulog and Reperfusion or Occlusion (HERO)-2 trial of two antithrombin regimens (bivalirudin vs heparin) administered adjunctively with streptokinase, details of which are described elsewhere.18

Section snippets

Patients

Between Dec 9, 1998, and May 1, 2001, we recruited patients with ST-elevation acute myocardial infarction from 16 hospitals in New Zealand and Australia who met enrolment criteria for the HER0-2 trial.18 Study coordinators at every site screened all patients who were potentially eligible for HER0-2, and included them in the consent substudy. We did not exclude patients who were unable to read the consent from (because they were illiterate or did not have reading glasses), who needed a

Results

91% of patients (367/402) who were randomised into the HER0-2 trial and 32 patients who declined participation at the 16 participating sites over the period of the substudy were interviewed during admission (median 5 days, IQR 4–7). Table 1 shows that baseline characteristics of patients who gave consent were the same as those of patients who declined participation in HER0-2. Median age of participants was 64·5 years (IQR 53–72), and women were older than men (69 [58–76] vs 61 [51–71] years,

Discussion

Our assessment of the informed consent process during acute myocardial infarction showed that few patients gave consent that was truly autonomous and informed. We noted that fewer than a fifth of patients read the patient information sheet before giving or declining consent, although nearly 60% of those who gave consent did read it later. Comprehension of the patient information sheet, which had been approved by local ethics committees, needed a higher educational level than most patients had

References (28)

  • The GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction

    N Engl J Med

    (1993)
  • World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects....
  • The European Parliament and the Council of the European Union

    Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

    Off J Eur Communities

    (2001)
  • SA DeLuca et al.

    Are we promoting ture informed consent in cardiovascular clinical trials?

    J Cardiovasc Nurs

    (1995)
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