PURPOSE: To assess the validity of written informed consent taken from patients prior to undergoing glaucoma surgery by testing their ability to understand the information offered to them during the consent-taking process. METHODS: Seventy-three patients were asked to complete a standardised confidential questionnaire after giving a written informed consent. Surgeons who were taking the consent were also requested to submit their self-evaluation form. Patients' understanding of the information they were given was evaluated using a standardised point scoring system. RESULTS: Fifty patients (68.5%) agreed that they were given enough time to make an informed decision, while 67 doctors (91.8%) claimed that they had allocated enough time to explain the procedures. Fifty-two patients (71.2%) reported that they were given adequate information on the details or diagnosis of their problems, 65 patients (89.0%) on the details of the procedure and 69 patients (94.5%) on the risks and complications. Thirty-four patients (46.6%) were not sure, or refused information on the risks and complications of the procedure. Only half of the patients (57.5%) had overall moderate understanding of their surgical problem, and only 13 patients (17.8%) were able to demonstrate a good overall understanding of their surgical problem. CONCLUSIONS: Although most patients acknowledged that they received sufficient information to give consent, few could objectively recall the information given to them. This study thus raises some doubts on the validity and quality of written informed consent, and highlights the importance of giving clear information to patients undergoing glaucoma surgery.
PURPOSE: To assess the validity of written informed consent taken from patients prior to undergoing glaucoma surgery by testing their ability to understand the information offered to them during the consent-taking process. METHODS: Seventy-three patients were asked to complete a standardised confidential questionnaire after giving a written informed consent. Surgeons who were taking the consent were also requested to submit their self-evaluation form. Patients' understanding of the information they were given was evaluated using a standardised point scoring system. RESULTS: Fifty patients (68.5%) agreed that they were given enough time to make an informed decision, while 67 doctors (91.8%) claimed that they had allocated enough time to explain the procedures. Fifty-two patients (71.2%) reported that they were given adequate information on the details or diagnosis of their problems, 65 patients (89.0%) on the details of the procedure and 69 patients (94.5%) on the risks and complications. Thirty-four patients (46.6%) were not sure, or refused information on the risks and complications of the procedure. Only half of the patients (57.5%) had overall moderate understanding of their surgical problem, and only 13 patients (17.8%) were able to demonstrate a good overall understanding of their surgical problem. CONCLUSIONS: Although most patients acknowledged that they received sufficient information to give consent, few could objectively recall the information given to them. This study thus raises some doubts on the validity and quality of written informed consent, and highlights the importance of giving clear information to patients undergoing glaucoma surgery.
Authors: S J Edwards; R J Lilford; D A Braunholtz; J C Jackson; J Hewison; J Thornton Journal: Health Technol Assess Date: 1998-12 Impact factor: 4.014