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

Informed consent in endoscopy: read, understood, or just signed?
Ana Catarina Carvalho, Ricardo Cardoso, Hugo Marcelo Vieira, Américo Silva
iGIE, 2 April 2024
Abstract
Background And Study Aims
While informed consent is a requirement for all interventional procedures such as those in gastrointestinal endoscopy, its standardization is a challenge. While very thorough documents have been proposed, it is unknown whether patients actually read them. We intended to evaluate if patients read and understand informed consent forms and information leaflets for gastrointestinal endoscopy.
Patients And Methods
This single center prospective observational study was performed between April 2021 and April 2022 and included adult patients proposed for outpatient elective esophagogastroduodenoscopy and colonoscopy. Informed consent forms and information leaflets were mailed to patients, with a small text instruction added to the informed consent form. Prior to endoscopy it was 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% males, mean age 63.8±12.76 years). Most had only basic education (78.0%) and had previously undergone gastrointestinal endoscopy (90.6%). 86.6% of patients stated they had read the form while 13.4% did not. While most signed the form (83.6%), only 24.6% adequately read and understood it. No statistically significant association between informed consent form adequate reading 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, improving the doctor-patient relationship in obtaining informed consent.

Editor’s note: iGIE is published by Elsevier Inc. on behalf of American Society for Gastrointestinal Endoscopy.