A prospective audit on the validity of written informed consent prior to glaucoma surgery: an Asian perspective

• Published in: Graefe's archive for clinical and experimental ophthalmology 2010-05, Vol.248 (5), p.687-701
• Main Authors: Kang, Kui Dong, Abdul Majid, Aman Shah B., Kwag, Jee Hyun, Kim, Yeon Deok, Yim, Hye Bin
• Format: Article
• Language: English
• Subjects: Adult; Aged; Cataract Extraction; Female; Glaucoma; Glaucoma - epidemiology; Glaucoma - surgery; Glaucoma Drainage Implants; Health Knowledge, Attitudes, Practice; Humans; Informed Consent; Korea - epidemiology; Male; Medical Audit; Medicine; Medicine & Public Health; Mental Recall; Middle Aged; Ophthalmology; Patient Education as Topic; Patient Participation; Prospective Studies; Surveys and Questionnaires; Trabeculectomy; Young Adult
• ISSN: 0721-832X; 1435-702X
• DOI: 10.1007/s00417-009-1209-0

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.