Survey of informed consent in a gastrointestinal endoscopy unit

Gastrointestinal endoscopy, like all diagnostic and therapeutic techniques, must be preceded by written informed consent. The aim of this study was to evaluate the patients' acceptance and understanding of the aim of informed consent as well as to determine their perception of the investigation. For 2 months, informed consent forms were given together with a questionnaire to 221 consecutive patients who underwent diagnostic gastrointestinal endoscopy. Distribution of the patients according to level of education was: university graduated (6.5%), high-school graduate (21.1%) those who had completed primary school (48.6%) and those with no schooling (23.9%). The document was read by 144 patients (65.1%) and the attending physician had previously explained it to 69.6%. Informed consent was understood by 90.7% of the patients who read the document. Understanding was related to education (university and high-school graduates (83.3%) vs. those who had completed primary school or who had no schooling (60%); p < 0.005) and was not related to the information given by the attending physician. Patients' opinion on the aim of informed consent was: absolve the doctor of responsibility (42%), provide information in the patients' interests (51.1%) and senseless document (42%). Signing the document provoked fear in 20% of those surveyed. This fear was greater in patients who had not been informed by the attending physician (31.2% vs. 14.5%; p > 0.01). Informed consent is understood by most patients who read the form but a significant proportion perceive it as designed to defend the physician. When the technique is explained by the attending physician and the doctor performing the procedure, acceptance is increased and fear is reduced.