Informed consent document in gastrointestinal endoscopy: understanding and acceptance by patients

Area of Science:

• Gastroenterology
• Medical Education
• Patient Communication

Background:

• Informed consent (IC) is crucial for patient autonomy in medical procedures.
• Understanding of IC documents varies among patient populations.
• Readability of medical information impacts patient comprehension and decision-making.

Purpose of the Study:

• To assess patient comprehension of informed consent (IC) documents for endoscopic procedures.
• To evaluate the readability of IC documents used in an endoscopy unit.
• To identify factors influencing patient understanding of procedural information.

Main Methods:

• Anonymous questionnaires administered to 309 patients undergoing endoscopic procedures.
• Assessed patient reading habits, knowledge of technique, complications, and sedation.
• Utilized the Flesch index to determine the readability level of IC documents.

Main Results:

• 85% of patients reported reading the IC, and 96% felt they understood the procedure.
• Awareness of severe complications was low (22%), while sedation knowledge was higher (82%).
• Outpatients and younger patients (≤50 years) demonstrated better understanding; IC readability was standard for gastroscopy/colonoscopy but complex for ERCP.

Conclusions:

• The majority of patients read and comprehend informed consent documents.
• Physicians tailor information delivery based on patient demographics and characteristics.
• While generally acceptable, IC documents require simplification to better accommodate patients with basic educational backgrounds.