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

Area of Science:

• Gastroenterology
• Medical Ethics
• Patient Education

Background:

• Informed consent is mandatory for gastrointestinal (GI) endoscopy.
• Standardizing informed consent documents and ensuring patient comprehension remains a challenge.
• The extent to which patients read and understand provided information is often unknown.

Purpose of the Study:

• To evaluate patient reading and understanding of informed consent forms and information leaflets for GI endoscopy.
• To assess the effectiveness of mailed information and specific instructions.
• To identify factors influencing patient comprehension of informed consent.

Main Methods:

• A single-center, prospective, observational study conducted from April 2021 to April 2022.
• Included adult patients undergoing elective outpatient EGD (esophagogastroduodenoscopy) and colonoscopy.
• Assessed informed consent comprehension through patient signature, questionnaire completion, and a text instruction task after mailing documents.

Main Results:

• 232 patients participated (50.6% male, mean age 63.8 years).
• 86.6% reported reading the form, but only 24.6% demonstrated adequate reading and understanding.
• No significant association was found between adequate reading and demographic or educational variables.

Conclusions:

• Despite timely information delivery, most patients do not adequately read or understand GI endoscopy consent documents.
• Novel strategies are required to enhance patient engagement in decision-making.
• Improving informed consent processes can strengthen the doctor-patient relationship.