Clinical Investigations: Acute Ischemic Heart Disease
Is informed consent to clinical trials an “upside selective” process in acute coronary syndromes?

https://doi.org/10.1067/mhj.2000.106625Get rights and content

Abstract

Methods Patient understanding of clinical trial details was assessed on 2 occasions (10 ± 4 and 24 ± 3 hours after randomization) in 20 patients enrolled for randomized investigation of pharmacotherapy for unstable angina pectoris or non-Q-wave myocardial infarction in the Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organized Network (PARAGON B) and Organization to Assess Strategies in Ischemic Syndromes (OASIS-2) trials. Results Initial total score for understanding of 52.0% (±15.7%) of maximal values improved to 67.7% (±18.3%) at repeat interview (P <.001). The mean initial score for knowledge of potential benefit was 85.0% (±33.3%) with no significant improvement at repeat interview. Scores for knowledge of risk improved from 35.0% (±36.6%) to 68.2% (±41.2%) at repeat interview (P <.005). Significant determinants of poor initial score were female sex, limited education, and presence of pain during the consent process; young age was the only determinant of improvement on repeat assessment. Conclusion: Thus initial understanding of the research protocols for patients with unstable angina pectoris or non-Q-wave acute myocardial infarction was imperfect, with far greater impairment of knowledge of risk than of benefit. (Am Heart J 2000;140:94-7.)

Section snippets

Methods

The study was performed in a group of patients admitted to coronary care units in 2 hospitals associated with the North Western Adelaide Health Service who were enrolled in double-blind clinical trials (the Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organized Network [PARAGON B] and Organization to Assess Strategies in Ischemic Syndromes [OASIS-2]) investigating the effects of pharmacotherapy with glycoprotein IIb/IIIa inhibitors for UAP/NQAMI.

Patient characteristics

Participants ranged in age from 40 to 78 years (median 71 years). Demographic variables are summarized in Table I.

. Demographics of study group (n = 20)

Age (mean ± SD)66.7 (±10.5)
M:F (%)60:40
Education
 Primary20%
 Secondary70%
 Tertiary10%
English first language65%
Presence of pain at index clinical trial entry65%
Presence of anxiety at index clinical trial entry45%
Presence of dyspnoea at index clinical trial entry40%
Only one patient had received narcotic or sedating medication before consent; in that

Discussion

A general requirement for ethically conducted research is that informed consent be obtained from all subjects after they have had an opportunity to consider potential risks, benefits and alternate treatments. However, it has been suggested that it is not possible to obtain truly informed consent from severely ill individuals, such as those with acute transmural myocardial infarction.3, 4 Little attention has been given to issues of understanding and consent in patients with UAP/NQAMI. In many

Acknowledgements

We thank R.D. Wuttke for statistical advice.

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Reprint requests: J.D. Horowitz, PhD, Department of Cardiology, The Queen Elizabeth Hospital Campus, North Western Adelaide Health Service, 28 Woodville Rd, Woodville, South Australia 5011, Australia.

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