Informed consent in endoscopy: Read, understood, or just signed?

Background and Aims

Although informed consent is a requirement for all interventional procedures such as those in GI endoscopy, its standardization is a challenge. Very thorough documents have been proposed, but it is unknown whether patients actually read them. We evaluated if patients read and understand informed consent forms and information leaflets for GI endoscopy.

Methods

This single-center, prospective, observational study was performed between April 2021 and April 2022 and included adult patients proposed for outpatient elective EGD and colonoscopy. Informed consent forms and information leaflets were mailed to patients, with a small text instruction added to the informed consent form. Before endoscopy, we assessed whether patients adequately read the informed consent form, based on patient signature, table questionnaire completion, and performance of the text instruction.

Results

The study included 232 patients (50.6% men; mean age, 63.8 ± 12.76 years). Most had only a basic education (78.0%) and had previously undergone GI endoscopy (90.6%). Of the patients, 86.6% stated they had read the form and 13.4% did not. Although most signed the form (83.6%), only 24.6% adequately read and understood it. No statistically significant association between an adequate reading of the informed consent form and any of the assessed variables was found.

Conclusions

Despite the timely provision of information, most patients do not read or adequately understand the provided documents. It is necessary to develop new strategies to enhance patients’ involvement in decision-making, thus improving the doctor–patient relationship in obtaining informed consent. (Clinical trial registration number: NCT05414435.)