Factors influencing clinical research participation in ophthalmology: a mixed-methods study in keratoconus

Résumé fourni par la source

Keratoconus (KC) disproportionately affects young and underserved populations, yet clinical research participation remains unevenly distributed. To inform equitable recruitment strategies, we investigated demographic, behavioral, and perceptual factors influencing engagement in a non-interventional KC study. We compared demographic and socioeconomic profiles of patients solicited for participation in a non-interventional clinical study involving the laboratory analysis of excess tissue produced during a corneal cross-linking procedure. We conducted structured telephone surveys of participants and non-participants to assess barriers, facilitators, and attitudes toward clinical research. Here we show that, compared to participants, non-participants of the non-interventional KC study were older (33.2 ± 10.3 vs. 27.6 ± 7.3, p = 0.001) and predominantly male (90.2% vs. 64.8%, p = 0.003), while socioeconomic indices did not differ significantly. Prior clinical research participation strongly predicted future willingness to participate (p = 0.01). Key barriers included concerns about side effects, insurance copays, and job flexibility. Facilitators included transportation assistance, provider-led information sessions, and work absence documentation. Despite participants and non-participants sharing similar preferred language profiles, non-participants were significantly more likely to report availability of translated materials as important interventions (p = 0.04). Demographic variables alone did not predict participation. Behavioral and contextual factors, rather than fixed demographics, shaped clinical research engagement. Strategies such as personalized provider outreach, logistical support, and culturally tailored materials may improve recruitment and retention in KC clinical research; supporting participant-centered frameworks that address practical needs and readiness to engage, particularly in underserved populations.

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