Sheikhtaheri A¹ * , (PhD candidate) Farzandipour M², (PhD)

  ¹ Department of Health Information Management, School of Management and

  Medical Information Sciences, Iran University of Medical Sciences. Tehran. Iran

  ² Department of Medical Record, School of Paramedical Sciences,

  Kashan University of Medical Sciences. Kashan. Iran

  Received: 15 Oct 2009, Accepted: 9 Jan 2010

  Abstract

Introduction: We studied the factors that affect quality of informed consent process among patients undergoing surgery in the teaching hospitals in Kashan province, Iran.

Methods: 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.

Results: 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).

Conclusion: 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.

Key words: Informed Consent, Inpatient, General Surgery.

  Hakim Research Journal 2010 12(4): 33- 41.

  * Corresponding Author: Department of Health Information Management, Faculty of Management and Medical Information Sciences, Iran University of Medical Sciences, Babak Bahrami St., across Niayesh Highway-Valey-e-Asr St. Tehran, Iran. Tel-fax: +98- 21- 22663330 , Email: taheri@iums.ac.ir