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

TL;DR

Most patients don't read or understand informed consent forms for GI endoscopy, suggesting a need for better strategies to improve patient engagement.

Contribution

The study introduces a method to assess whether patients actually read and understand informed consent documents for GI procedures.

Findings

86.6% of patients claimed to have read the consent form, but only 24.6% demonstrated adequate understanding.

No significant associations were found between adequate reading and patient characteristics like education or prior endoscopy experience.

Despite receiving information, most patients do not engage deeply with informed consent documents.

Abstract

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.

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.

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.

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.)

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