Informed consent research at a tertiary hospital: How impactful is competency in simpler versus standard consent forms for intravitreal injection therapy?

Abstract

Aim: To compare the impact of competency in intravitreal injection therapy (IVIT)-related simpler versus standard consent forms (CFs). Material and methods: Four hundred patients scheduled for IVIT in a tertiary hospital were enrolled between April 1, 2022 and June 30, 2022. These patients were eligible for the study if they had their first IVIT in one eye; those scheduled for IVIT in the other eye were not. Data, including age, gender, educational level, whether the patient was admitted alone or with a companion, and prior IVIT status were collected. A trained clinic secretary first gave the patients the commonly used standard CFs, followed by simpler CFs. Results: The mean age was 66.10±9.90 years. 93.80% had previously received IVIT. 53.80% of the patients consented on their own. While 98.00% consented without reading standard CFs, 56.00% consented after reading simpler CFs (p<0.001). The need for IVIT-related extra information and the desire against having IVIT were significantly higher in simpler than standard CFs (p<0.001). 5.00% of those who approved IVIT without reading both forms were illiterate, and 29.20% had vision issues. The probability of simpler CF reading increased by 4.653 and 7.510 times in high school and university graduates, respectively, relative to primary school graduates. Conclusion: Simpler CFs had a much higher reading rate, which was linked to a higher rate of patients opting against IVIT. In medical fields like ophthalmology, where many procedures and research are performed, ethically approved informed consent requires consideration of patients' education and prior treatment experience.

Keywords

• Consent forms
• educational level
• ethics
• intravitreal injection therapy
• readability