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

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Most patients do not adequately read or understand informed consent forms for gastrointestinal endoscopy, despite receiving them. New strategies are needed to improve patient comprehension and involvement in the informed consent process.

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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.