INFORMED CONSENT IN ENDOSCOPY: READ, UNDERSTOOD OR MERELY SIGNED

Aims While informed consent is a requirement for all invasive procedures such as those in gastrointestinal endoscopy, its standardization is a challenge. Recently, our national digestive endoscopy society developed proposals for informed consent forms and information leaflets for esophagogastroduodenoscopy and colonoscopy.

The main objective was to evaluate if patients read and understood these documents.

Methods Adult patients proposed for elective esophagogastroduodenoscopy and colonoscopy and who were able to give their informed consent were included. Informed consent forms and information leaflets were sent to patients, with a small text instruction added to the body of the informed consent form.

Prior to endoscopy it was assessed whether patients adequately read the informed consent form, based on 3 criteria: patient signature, table questionnaire completion and performance of the text instruction.

Results In total, 184 patients were included: 80 women and 104 men with a mean age of 63.6±12.4 years. Most had only basic education (77.2%) and had previously undergone an endoscopy (91.8%). 157 patients stated they had read the form (85.3%), while 27 (14.7%) did not. While most signed the form (141, 76.6%), only 46 patients (25.0%) met all 3 criteria for adequate reading and comprehension.

No statistically significant association between informed consent form adequate reading and any of the assessed variables was found.

Conclusions Most patients do not adequately read informed consent forms. Infographic strategies can direct patients’ attention and may improve these results, but they are no substitute of an effective doctor-patient relationship in obtaining informed consent.

Publication History

Article published online:
14 April 2022