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

Objective: we wanted to know if patients read and understand the informed consent (IC) document used for endoscopic procedures, and to evaluate the readability of IC. Method: during two months we gave patients studied in our endoscopy unit an anonymous questionnaire with different items concerning reading degree, knowledge of the technique, complications, sedation used, and information received. We evaluated IC readability using the Flesch index. Results: 309 patients were included (mean age: 53 years, 55% males, 86% outpatients, 50% with basic education); 85% of patients read the IC, 96% considered they understood the exploration technique, 22% were not aware of severe complications, and 82% knew which kind of sedation would be used; 88% of patients received additional information from their doctors. Outpatients read the IC in a greater percentage versus inpatients (p < 0.05); patients with only basic education tended to ignore the possibility of complications (p < 0.05). Doctors gave more information to rural patients (p = 0.08), offered better information about complications to urban patients (p = 0.09), and offered more information on other diagnostic procedures to patients older than 50 years (p < 0.05). With the Flesch index we found that gastroscopy and colonoscopy ICs had a "standard" level of readability, while ERCP ICs were more complex. Conclusions: the majority of our patients read and understands the IC. Doctors adapt information to patient characteristics. Our IC documents have an acceptable level of readability, but given that 50% of our patients have only a basic educational status, we should attempt to provide an easier IC document.