Willingness and Motivation of Egyptian Patients with diabetic retinopathy to Participate in Clinical Trials

Abstract

Purpose is to identify the motivational factors and barriers to clinical trial recruitment of the Egyptian DR patients. Patients and methods: Patients with DM either type I or II came to our outpatient clinic were subjected to fundus examination. Patients with any degree of diabetic retinopathy were included. A questionnaire was distributed to them. It included the sociodemographic, clinical characteristics and questions to identify the motivational factors or barriers to participate in a trial. We divided them according to their tendency for recruitment, the first group that accepts the participation; we asked them about the most motivational factors. The second group that refused the participation, we asked them about their potential barriers. Results Among the 206 recruited patients (145/206) (70.4%), accepted to participate while the remaining (61/206) (29.6%) refused to. Fear from blindness was the commonest motivational factor (93.1%) and the risk of side effects was the commonest barrier (100%). Acceptance to participate was higher among those with positive family history (P = 0.01). Refusal to participate was higher in mild NPDR (P < 0.001). Patients with PDR and macular edema accepted to participate (P < 0.001). High education was significantly associated with acceptance compared to those who refuse (81.1% versus 18.9% respectively) (P = 0.004). Ocular history of previous intervention significantly associated with accepting to paricipate (P = 0.001). Conclusion Acceptance was unpredictably high. The results of this questionnaire should encourage researchers to conduct more clinical trials.