Article Text
Abstract
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.
- adult cardiology
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Footnotes
Contributor JP collected the data, led data analysis, drafted the paper, finalised this version and is accountable for all aspects of the work.
JG and JH contributed to the design of the work and data analysis, provided critical comments on drafts of the paper, approved the final version and is accountable for all aspects of the work.
DC contributed to the design of the work, provided critical comments on drafts of the paper, approved the final version and are accountable for all aspects of the work.
FA conceived the idea and led the design and funding application, contributed to data analysis and to writing the paper, approved the final version and is accountable for all aspects of the work.
Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0712-28089).
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. This report contains anonymised excerpts from interviews and discussions conducted during the research.
Competing interests We have read and understood BMJ policy on declaration of interests and declare that we have no competing interests.
Ethics approval This study was approved by Yorkshire & the Humber Research Ethics Committee (Ref: 13/YH/0418).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Patients did not give consent for data to be shared beyond the research team.
Correction notice This paper has been amended since it was published Online First. Owing to a scripting error, some of the publisher names in the references were replaced with 'BMJ Publishing Group'. This only affected the full text version, not the PDF. We have since corrected theseerrors and the correct publishers have been inserted into the references.