Development and early Evaluation of a novel tool for assessment of individualised risk tolerance during surgical consent.

Purpose: The legal interpretation of consent has transitioned over the last decade. Surgeons must identify what patients value to individualise surgical consent. This presents a considerable challenge during busy ward rounds or outpatient clinics. We aimed to develop and evaluate a novel risk tolerance tool to aid surgical consent.

Methods: This prospective, longitudinal cohort study evaluated the views of adult, elective surgical patients from a single centre. Attitudes to the existing surgical consent process were assessed (n = 48) and responses underwent thematic analysis. From these responses and a stakeholder focus group, a novel risk tolerance tool was developed. The risk tool was evaluated using questionnaires in 25 pre-operative patients. Post-operatively, the same cohort were followed-up with a telephone clinic 6-8 weeks after discharge.

Results: Overall patients were satisfied with the current consent process, but negative themes emerged including that it is generalised, impersonal, and time pressured. The developed risk tool contained six domains: death, pain, loss of physical function, loss of cognitive function, need for repeat medical interventions, and social disability. Loss of physical function (mean = 34.0, SD = 12.8) and loss of cognitive function (mean = 34.0, SD = 6.1) had lowest risk tolerance, and need for repeat medical interventions (mean = 18.8, SD = 10.9) had the highest risk tolerance. Thirteen (93%) patients had a positive experience of the consent process vs 85% of patients in pre-consent tool cohort.

Conclusions: The tool demonstrated good patient acceptability and patient reported experience. The tool gathered data that may enhance understanding of patient risk tolerance and personalise the surgical consent process.