Factors Associated with Quality of Informed Consent in Patients Admitted for Surgery: An Iranian Study

Informed consent is regarded as a pillar of medical ethics. The purpose of this study was to evaluate perceptions of the informed consent process prior to surgery. Three hundred elective surgery patients were randomly selected from three teaching hospitals in Kashan, Iran, and asked to complete a questionnaire about four key aspects of the informed consent process: information disclosure, voluntariness, comprehension, and their relationship with physicians. Data were scored and analyzed using univariate and multivariate methods. Based on the responses, the perceived quality of information disclosure (7.96 ± 4.9 out of 18 points), comprehension of the consent form (0.55 ± 1.1 out of 4 points), and voluntariness (1.73 ± 2.1 out of 8 points) were considered to be unacceptable and the perceived quality of the physician–patient relationships (10.6 ± 4.1 out of 14 points) acceptable. Most of the participants (88.7%) reported that they had requested to be informed about the complications of the surgical procedures, including severe complications such as death, but most of them did not receive this information. The most important factors associated with the perceived quality of informed consent were the patient's level of education and type of surgery. In conclusion, practices consistent with the principles of informed consent have not been adequately implemented in the surgical departments of these hospitals in Kashan. To improve current practices, patients should receive more information about the risks and benefits of surgery as well as any available alternatives. Information about the expected length of hospital stay, post-discharge follow-up, and the cost of surgery should also be provided to patients. To improve the perceived quality of the informed consent process, more emphasis should be placed on ensuring that patients receive the requested information in a manner they can comprehend. Redesigning consent forms may be an important step in improving the patients’ experience of the informed consent process.