Abstract
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.
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The authors have no proprietary interest in any material used in this study.
The authors have full control of all primary data, and agree to allow Graefe's Archive for Clinical and Experimental Ophthalmology to review their data upon request.
Kui Dong Kang, Aman Shah B. Abdul Majid and Jee Hyun Kwag contributed equally to this work.
Appendices
Appendix 1
Questionnaire of Good Practice in Consent
Health Professional Form
Appendix 2
Consent Form
Patient Agreement to investigate or treatment
Appendix 3
Questionnaire of Good Practice in Consent
Patient Form
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Kang, K.D., Abdul Majid, A.S.B., Kwag, J.H. et al. A prospective audit on the validity of written informed consent prior to glaucoma surgery: an Asian perspective. Graefes Arch Clin Exp Ophthalmol 248, 687–701 (2010). https://doi.org/10.1007/s00417-009-1209-0
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DOI: https://doi.org/10.1007/s00417-009-1209-0