Cardiologists' and patients' views about the informed consent process and their understanding of the anticipated treatment benefits of coronary angioplasty: A survey study.

BACKGROUND: Percutaneous coronary intervention is a common revascularisation technique. Serious complications are uncommon, but death is one of them. Seeking informed consent in advance of percutaneous coronary intervention is mandatory. Research shows that percutaneous coronary intervention 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 on 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 percutaneous coronary intervention were significantly different; notably, 60% of patients mistakenly believed that percutaneous coronary intervention was curative. CONCLUSIONS: The percutaneous coronary intervention 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.

Percutaneous coronary intervention patients' and cardiologists' experiences of the informed consent process in Northern England: a qualitative study.

OBJECTIVE: Informed consent is central to ethical medical practice, but little is known about how the process takes place in clinical practice. Percutaneous coronary intervention (PCI) is a common revascularisation procedure. Studies report that patients overestimate benefits, forget the risks and are unaware of alternative treatments. The aim of this study was to describe PCI patients' and cardiologists' experiences of the informed consent process in acute care settings. DESIGN/SETTING/PARTICIPANTS: A qualitative study with a maximum variation sample of elective and acute PCI patients and cardiologists taking their consent, recruited from a district general hospital and tertiary centre. In-depth interviews were conducted, and consent discussions were audio recorded. Data collection, coding and theorising occurred simultaneously. FINDINGS: Forty-one (26 male) patients scheduled for elective (20) or urgent (21) PCI and 19 cardiologists (5 female) participated. Despite diversity in patients' experiences of informed consent, elective and acute patients experienced a common four-stage process of consent. Most patients made the decision to have treatment at PCI referral and took a passive role in the discussions we recorded. They recognised cardiologists as experts, trusted the medical system to 'fix' their health problem and were unaware of their role in the informed consent process. Informed consent discussions functioned as a formal 'event',enabling cardiologists to check patients' understanding and enabling patients to access treatment. CONCLUSIONS: The configuration of services and patients' perceptions of their role in informed consent underpin a mismatch between legal and ethical principles of informed consent and current practice. The variation in patients' experiences of the current place of informed consent in service delivery represents a missed opportunity for cardiologists to work in decision-making partnerships with patients. In light of recent changes in the law, a new approach to informed consent is required.