Cardiologists’ and patients’ views about the informed consent process and their understanding of the anticipated treatment benefits of coronary angioplasty
Survey Study
Felicity Astin, John Stephenson, Joy Probyn, Janet Holt, Keith Marshall, Dwayne Conway
European Journal of Cardiovascular Nursing, 9 September 2019
Abstract
Background: Percutaneous Coronary Intervention (PCI) is a common revascularisation technique. Serious complications are uncommon, but death is one of them. Seeking informed consent in advance of PCI is mandatory. Research shows that PCI patients have inaccurate perceptions of risks, benefits, and alternative treatments. Aim: To assess cardiologists’ and patients’ views about the informed consent process and anticipated treatment benefits. Methods: Two cross-sectional, anonymous surveys were distributed in England. An electronic version to a sample of cardiologists, and a paper based version to patients recruited from 10 centres. Results: A sample of 118 cardiologists and 326 patients completed the surveys. Cardiologists and patients shared similar views on the purpose of informed consent; however, over 40% of patients and over a third of cardiologists agreed with statements that patients do not understand, or remember, the information given to them. Patients placed less value than cardiologists upon the consent process and over 60% agreed that patients depended on their doctor to make the decision for them. Patients’ and cardiologists views on the benefits of PCI were significantly different; notably, 60% of patients mistakenly believed PCI was curative. Conclusions: The PCI informed consent process requires improvement to ensure that patients are more involved and accurately understand treatment benefits to make an informed decision. Redesign of the patient pathway is recommended to allow protected time for health professionals to engage in discussions using evidence based approaches such as ‘teach back’ and decision support which improve patient comprehension.
Month: December 2019
Meaningful Consent From a Willfully Noninformed Patient
Meaningful Consent From a Willfully Noninformed Patient
Michael E. Bowdish, Peter F. Crookes
The Annals of Thoracic Surgery, December 2019; 108(6) pp 1613-1614
Abstract
The cornerstone of contemporary medical practice is the belief that the patient has a right to self-determination.1 A doctor who performs a procedure in the absence, or in defiance, of the patient’s expressed wishes is guilty of battery. This is rare nowadays. It is more common for it to be alleged that the potential downside of treatment was not explained clearly enough, and that if it had been, the patient would not have consented to the procedure. Or that, because no alternatives were offered, there was de facto coercion to undergo a particular procedure.
Waived Consent in Perinatal/Neonatal Research—When Is It Appropriate?
Waived Consent in Perinatal/Neonatal Research—When Is It Appropriate?
Review Article
Wade D. Rich, Anup C. Katheria
Fronteirs in Pediatrics, 26 November 2019
Open Access
Abstract
Informed consent is a process ensuring that subjects enrolled in research are appropriately informed of the risks and benefits. While this process is well-defined when it is possible and practical to obtain consent prior to the research intervention, it can be less clear in cases of deferred or waived consent. Defining minimal risk, such as when research is attempting to determine which of two currently practiced interventions is safest and/or most effective, is critical to moving forward in establishing appropriate care in newborns. For perinatal/neonatal research the challenge lies between the ethical justification for approaching women in labor or under medication vs. the scientific integrity of excluding a number of subjects that may potentially benefit the most from an intervention. Researchers must work with their IRBs as well as families who have participated in trials to determine the most appropriate method for obtaining informed consent from expectant parents. Clinical researchers and IRBs ultimately need to find a middle ground for the appropriate use of deferred or waived consent.
Vulnerability and the Consenting Subject: Reimagining Informed Consent in Embryo Donation
Vulnerability and the Consenting Subject: Reimagining Informed Consent in Embryo Donation
Rebecca Hewer
Feminist Legal Studies, 14 November 2019; 27(3) pp 287-310
Open Access
Abstract
Informed consent is medico-legal orthodoxy and the principal means by which research encounters with the body are regulated in the UK. However, biomedical advancements increasingly frustrate the degree to which informed consent can be practiced, whilst introducing ambiguity into its legal significance. What is more, feminist theory fundamentally disrupts the ideologically liberal foundations of informed consent, exposing it as a potentially inadequate mode of bioethical regulation. This paper explores these critiques by reference to a case study—embryo donation to health research, following fertility treatment, as regulated by the HFEA 1990—and contends that informed consent cannot adequately respond to the material realities of this research encounter. Thereafter, by drawing on feminist theories of vulnerability, this paper proffers an alternative bioethical approach, which calls for structural reform in recognition of the fundamentally bilateral constitution of self and society and a renewed appreciation for the affective/dispositional tenor of lived experience.
Center for Informed Consent Integrity 