Willingness and Motivation of Saudi Patients with Keratoconus to Participate in Clinical Trials

Abstract

IntroductionKeratoconus is a bilateral non-inflammatory ectasia, characterized by well-described histopathological changes such as stromal thinning, epithelial iron deposition, and breaks in Bowman's layer. The success of clinical intervention among patients with keratoconus is widely determined by randomized clinical trials, and despite associated difficulties, such trials may improve vision and quality of life. AimThis study aimed to assess the willingness of patients with keratoconus in Saudi Arabia to undergo clinical trials. We further aimed to identify patients' beliefs and attitudes towards clinical trials and to establish possible barriers to trial recruitment, potentially improving the quality of future clinical trials and research. Materials and methodsThis was a quantitative analytical cross-sectional study conducted between October 2020 and March 2021 among patients with keratoconus in Saudi Arabia. A self-administered questionnaire was distributed among the targeted patients. The questionnaire identified the socio-demographic characteristics of the patients and included questions on willingness, motivation, potential barriers, and helpful resources. All statistical analyses were performed using SPSS version 21 (IBM Corp, Armonk, USA). ResultsA total of 462 patients were recruited. The most common age group was 16-25 years (39.8%). There were slightly more females (51.3%) than males (48.7%). The prevalence of patients with a previous history of keratoconus was 36.8%. Results revealed that 37.2% of the patients had great motivation to take part in clinical research, and 22.3% indicated a high score in potential barriers to participation, whereas nearly 48% showed a high score in helpful resources. Statistical tests revealed that being in an older age group, having children, and possessing a higher monthly income were factors associated with increased barriers to participation in clinical research. ConclusionPatients with keratoconus showed great motivation to participate in clinical research studies and provided helpful resources. The knowledge that participation could benefit others was a primary motivator, while encouragement from other patients who participated in clinical research was the main helpful resource. Possible side effects were shown to be the major concern of the patients.

Factors influencing willingness to participate in ophthalmic clinical trials and strategies for effective recruitment

“…Our investigation revealed a higher propensity for participation among individuals with lower annual income, aligning with a domestic study [18][19] . This observation contrasts with surveys from Western countries, where individuals with higher incomes exhibit greater willingness [9,12,20] . Diverse national contexts and socio-cultural backgrounds likely underlie this disparity.…”

“…Encouraging flexible communication between potential participants and trial staff can offset the relative rigidity of formal information resources [7,26] . Moreover, consistent with prior research reporting physicians and nurses as trusted sources of information [9,19,26] , our study emphasizes the influence of patients' trust in healthcare professionals as a key motivator in decision-making process. Therefore, when engaging with potential subjects, healthcare professionals should take a leadership role in communication, exhibit professionalism, and actively engage in recruitment activities.…”

“…Open and Positive Attitudes Towards Participation in Ophthalmic Clinical Trials Previous investigations have often focused on specific population groups or particular clinical trials, reporting a willingness to participate in ophthalmic clinical trials within a range of 21% to 50% [8][9][10] .…”

“…In a study involving 54 patients with retinitis pigmentosa, merely 21% expressed a willingness to participate in a trial related to retinal implant [8] . Similarly, among 462 patients with keratoconus, only 37.2% expressed motivation to take part [9] , while just 50% of the 40 cataract patients were open to engaging in a trial related to cataract surgery [10] . This lack of willingness not only obstructs recruitment efforts but also disrupts the progress of trials, potentially leading to invalid results.…”