Quality of Informed Consent Process and Factors Affecting it among Patients Undergoing Surgery, an Empirical Study in Hospitals of Kashan, Iran

We studied the factors that affect quality of informed consent process among patients undergoing surgery in the teaching hospitals in Kashan province, Iran. In a cross sectional study, we surveyed 300 randomly selected patients in teaching hospitals of Kashan, Iran in 2008 and interviewed them before surgery, using a questionnaire. Patients were asked about disclosure of information, voluntary decisions, consent form understandability, and physician-patient relationship. We used descriptive and analytical approaches to analyze our data. Consent-givers evaluated the information disclosure, comprehensibility, voluntariness and interaction as “average”, “poor”, “poor” and “excellent”, respectively. Information disclosure was worse in the general hospital and general operations (p<0.001). Those who had received information brochures reported higher levels of comprehensibility for the forms. 266 patients (88.7%) stated that the physician or surgeon must explain the severe complications including risk of mortality (P < 0.0001) however, 56.7% had not been informed about the complications. In addition, learning the information was associated with lower level of anxiety (P<0.05). The present i nformed consent process seems not to be of high-quality. Patients like to receive more information even about severe complications or risk of mortality. Therefore, appropriate approaches to enhance patients’ awareness, especially in general hospitals, seems to be necessary. Providing alternative information, including brochures, have positive impacts on giving voluntary informed consent, comprehensibility of the consent form and the physician-patient relationship. Finally, conveying appropriate information will not lead to anxiety among patients.