Abstract

PURPOSE: To assess the readability and comprehensibility the written informed consent form in our hospital, and to evaluate the pateint anxiety and satisfaction aroused by the informed consent process. MATERIALS AND METHODS: Hundred and twenty two patients, who were referred to the Radiology Department for a contrast enhanced Computed Tomography, were enrolled in the study. To evaluate the changes in the anxiety level, a 5-point Visual Analog scale was used before and after presenting the consent form to the patients. Then, a short questionnaire form was given to assess the comprehensibility of the text and patients’ satisfaction aroused by the informed consent process. Readability was assessed independently by using SMOG (Simple Measure of Gobbledygook) index. The differential anxiety level and the results of the questionnaire were analyzed statisticaly with regard to age, sex and education level. FINDINGS: The anxiety level of the patinets increased significantly after reading the informed consent form, regardless of the age, sex and education level. In the short questionnnaire, approximately 20 percent of the patients reported difficulty in understanding the content of the descriptive text, whereas the difficulty in comprehending the “shared decision” concept reached up to 48 percent. The percentage of the correct answers was significantly related to the level of education. CONCLUSION: Patients are generally satisfied with being informed. To decrease the anxiety aroused by the consent form, as well as to increase the readability and comprehensibility of the descriptive text, it is necessary to get technical support from public relation practitioners, psychologists and educationists. As a future projection, we suggest that the shared decision making concept should be presented to the public attention by Turkish Ministry of Health.