Background: Informed consent is a fundamental requirement of any invasive procedure. Failure to obtain appropriate and informed consent may result in unwanted or unnecessary procedures, as well as financial penalty in case of litigation. The aim of this study was to identify key constructs of the consent process which might be used to determine the performance of clinicians taking informed consent in surgery.
Methods: A multimodal methodology was used. A systematic review was conducted in accordance with PRISMA guidelines to identify evidence-based components of the consent process. Results were supplemented by semistructured interviews with senior trainees and attending surgeons which were transcribed and subjected to emergent theme analysis with repeated sampling until thematic saturation was reached.
Results: A total of 710 search results were returned, with 26 articles included in the final qualitative synthesis of the systematic review. Significant variation existed between articles in the description of the consent procedure. Sixteen semistructured interviews were conducted before saturation was reached. Key components of the consent process were identified with broad consensus for the most common elements. Trainers felt that experiential learning and targeted skills training courses should be used to improve practice in this area.
Conclusions: Key components for obtaining informed consent in surgery have been identified. These should be used to influence curricular design, possible assessment methods, and focus points to improve clinical practice and patient experience in future.
Keywords: Consent; Simulation; Standardized patient; Validation.
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