Patient comprehension necessary for informed consent for vascular procedures is poor and related to frailty

Abstract

Objective: Informed consent is an essential principle of high-quality health care. A core component of surgical informed consent is patient comprehension of basic information such as the diagnosis, risks, benefits, and alternatives of the proposed surgery. We sought to assess informed consent among vascular surgery patients and the association between frailty, education, decisional conflict, and patient comprehension.

Methods: We tested patient comprehension of basic information required for informed consent with a procedure-specific questionnaire in 102 consecutive patients undergoing selected vascular surgery procedures. Two patients who underwent open aortic aneurysm repair were excluded because of small sample size. All patients underwent assessment using the decisional conflict scale and the Frail/Nondisabled questionnaire. Analyses were performed to determine relationships between being informed and frailty, education level, and decisional conflict score. Patients included in this cohort had a median age of 71 years, and 25%, 14%, 28%, and 33% underwent carotid endarterectomy, endovascular aortic aneurysm repair, dialysis access creation, and percutaneous lower extremity procedures.

Results: Overall, 14% of patients were classified as "informed" and correctly answered all questions. Procedure type (P = .001), consent obtained by the attending surgeon vs a trainee (P = .04), and frailty score (P = .005) were all associated with whether a patient was informed or not. However, after multivariable adjustment, only frailty score was independently associated with being informed (odds ratio, 0.54; 95% confidence interval, 0.30-0.95; P = .03). The median decisional conflict scale score was 7.8, suggesting that patients feel well informed and supported in spite of poor understanding of procedural indications, risks, benefits, and alternatives.

Conclusions: As a group, patients have a poor comprehension of basic information related to surgical informed consent. These findings have potential ethical and clinical implications, and additional work is required to best determine causes of poor comprehension and strategies to mitigate the same.

Keywords: Consent; Frailty; Patient comprehension; Patient education; Risks.