Objectives The study aimed to understand through qualitative research what patients considered material in their decision to consent to an acute surgical intervention.
Participants, setting and intervention The patients selected aged between 18 and 90, having been admitted to a major trauma centre to undergo an acute surgical intervention within 14 days of injury, where English was their first language. Data saturation point was reached after 21 patients had been recruited. Data collection and analysis were conducted simultaneously, through interviews undertaken immediately prior to surgery. The data were coded using NVIVO V.12 software.
Results The key theme that originated from the data analysis was patients were unable to identify any individual risk that would modify their decision-making process around giving consent. The patient’s previous experience and the experience of others around them were a further theme. Patients sensed that there were no non-operative options for their injuries.
Conclusion This is the first study investigating what patient considered a material risk in the consent process. Patients in this study did attribute significance to past experiences of friends and family as material, prompting us to suggest that the surgeon asks about these experiences as part of the consent process. Concern about functional recovery was important to patients but insufficient to stop them from consenting to surgery, thus could not be classified as material risk.
- medical law
- orthopaedic & trauma surgery
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AH and JW are joint first authors.
Contributors Conceptualisation: AH, PVG. Methodology: JW, NQ, AH. Formal analysis: JW, NQ, AH. Investigation: NQ, AH. Writing, original draft preparation: JW, AH. Writing, review and editing: JW, NQ, AH, PVG. Supervision: AH, PVG. All authors have read and agreed to the published version of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Obtained.
Ethics approval The protocol of the study conformed to the Declaration of Helsinki. The HRA and Health and Care Research Wales granted ethical approval (REC reference: 19/LO/0197).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. The data has been de-identified and stored on a University drive.