The informed consent process when it comes to percutaneous coronary intervention (PCI), a common intervention in high- and middle-income countries, lacks an effective informed consent process as over 40% of patients acknowledge that they didn’t understand, or even remember being told the true purposes of the common intervention. In a recent study conducted by the UK’s University of Huddersfield, it was revealed many patients thought that opening up blocked arteries will cure them of heart disease.
Formerly known as angioplasty with stent, PCI is a non-surgical procedure where the physicians use a catheter (a thin flexible tube) to place a small structure called a stent to open up blood vessels in the heart that have been narrowed by plaque buildup, a condition known as atherosclerosis.
Of course, for a clinical trial, proper informed consent represents a foundational principal of adherence to ethical principles associated with medical research, which dates back to the Declaration of Helsinki. Physicians and investigators must convey through the consent process the details concerning a procedure or a study clearly and concisely communicating risks and benefits—this is a legal and ethical requirement. Patients should understand their options without any coercion while health professionals must confirm that the patient has the capacity to decide at that time.
In a study led by University of Hudderfield and published in the European Journal of Cardiovascular Nursing (a journal of the European Society of Cardiology or ESC), it appears that patients are not getting the point of informed consent knowledge transfers.
Patients in this study were treated with either elective or urgent PCI precluding emergency PCI where speed is critical. When queried about the consent process, 60% of the patients with coronary heart disease undergoing elective PCI to unblock an artery was under the impression that it would cure their coronary heart disease. Just about all of the patients (95%) believed it would reduce the risk of future heart attack and a great majority (91%) thought it would increase their life span. Almost half (47%) would have liked to have a family member with them when the informed consent process occurred; and almost a third (33%) needed some time to understand health-related written information.
It is likely that the current informed consent process is severely limited. Patients (and family members) and health professionals should work together to advance new approaches for information sharing and decision-making. For example, the lead author of the study, professor Felicity Astin, University of Huddersfield, suggests transferring smaller chunks of information with reviews to ensure the patient is understanding the material. In this way, the health professionals serve the patient as a teacher rather than a spot test giver. Present pathways preclude such a luxury—health systems, even if non-profit, are concerned with efficiency and productivity. But without a solid informed consent, the ultimate downstream cost to “efficient” existing pathways is clear. Hence, more time for the informed consent process should be built into the pathways suggested the study author. Moreover, a use of technology in today’s day and age is vital—think interactive video where serious game approaches.
University of Huddersfield
Based in Huddersfield, West Yorkshire, England, this university has been active since 1992, but has origins that go way back to the Huddersfield Philosophical Society in the early 19th Century. The University has placed an emphasis on high-quality teaching and won the inaugural Higher Education Academy Global Teaching Excellence Award and achieved a Teaching Excellence Framework (TEF) Gold Award all in 2017.
University of Huddersfield maintains a robust Research section emphasizing advanced research, innovation and collaboration across academic departments, and more than 70 institutes and centers.
Professor Felicity Astin, University of Huddersfield