Clinical Investigations: Acute Ischemic Heart DiseaseIs informed consent to clinical trials an “upside selective” process in acute coronary syndromes?☆
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.Age (mean ± SD) 66.7 (±10.5) M:F (%) 60:40 Education Primary 20% Secondary 70% Tertiary 10% English first language 65% Presence of pain at index clinical trial entry 65% Presence of anxiety at index clinical trial entry 45% Presence of dyspnoea at index clinical trial entry 40%
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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Cited by (43)
Attitudes and considerations of patients with ST-elevation myocardial infarction toward participation in randomized clinical trials
2019, American Heart JournalCitation Excerpt :Taken together, this further speaks to enhancing patient recruitment in STEMI RCTs as underparticipation remains a long-standing systemic challenge worldwide.3 Significant determinants of understanding the information provided on participation in RCTs among STEMI patients have been found to be the absence of pain at inclusion, high educational level, and male sex.13 Especially, pain and other symptoms experienced during STEMI have been found to explain why some patients consent to RCTs to rid themselves of pain and to receive treatment immediately.4,8,10,11,16,17
Re-Visiting Consent for Clinical Research on Acute Myocardial Infarction and Other Emergent Conditions
2012, Progress in Cardiovascular DiseasesCitation Excerpt :It is unknown how AMI patients want to be involved in enrollment decisions. Not surprisingly, they do not like (or read) consent forms,15,22-24,27 which are often long and technical.27,29 Patients prefer verbal conversations,23,27 but what role they want to play in decisions remains uncertain.
Observed Behaviors of Subjects During Informed Consent for an Emergency Department Study
2010, Annals of Emergency MedicineCitation Excerpt :The 5 extended discussion studies included interventions ranging from 30-minute telephone conversations with a nurse to multiple counseling sessions lasting up to 2 hours. The extended discussion interventions resulted in statistically significant increases in understanding in 3 of the 5 studies, and the remaining 2 showed trends toward improvement in understanding.11,28-31 For the 5 test/feedback interventions examined, researchers quizzed patients about the information disclosed to them and were given a review of questions they answered incorrectly.
ST-elevation myocardial infarction patients can be enrolled in randomized trials before emergent coronary intervention without sacrificing door-to-balloon time
2009, American Heart JournalCitation Excerpt :Informed consent requires that the investigator explain to a competent patient “(1) the research project; the procedures involved, and the patient's expected role in the project; (2) expected benefits and risks; (3) alternative treatments, if available; (4) confidentiality and compensation; and (5) that participation is voluntary and that the patient may withdraw at any time”.36 Research trials involving STEMI patients generally require the same informed consent procedures for patients undergoing STEMI PCI as for patients undergoing elective cardiac procedures.37-45 However, most acute myocardial infarction (AMI) patients are not competent to render fully informed consent for participation in a medical trial due to their acute experience of pain, anxiety, sedation, hypoxemia, and the emotional shock of emergency treatment.40-42
Ethical, legal and social issues of genetic studies with African immigrants as research subjects
2008, Journal of the National Medical AssociationPatients acceptance and comprehension to written and verbal consent (PAC–VC)
2023, BMC Medical Ethics
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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.