Recruitment rate comparison between a virtual tele-research cohort and a traditional centre-based cohort in idiopathic inflammatory myopathy

Abstract

Objectives Idiopathic inflammatory myopathy (IIM, myositis) faces recruitment and retention challenges in clinical studies due to disease rarity, geographical barriers and logistic difficulties. This study aimed to compare recruitment, enrolment, retention and data completion between a decentralized telemedicine-based research cohort (TRC) and a traditional centre-based cohort (CBC) in IIM. Methods The Myositis Patient Centered Research (MyPacer) study, a large prospective observational study, collected data on core set measures, patient-reported outcomes and functional tests. TRC patients were recruited online across the USA using a mobile app/website, while CBC participants were recruited from two myositis centres. Both cohorts followed the same protocol and were observed for 6 months. Recruitment was defined as participants who completed the pre-eligibility questionnaire, while enrolment referred to those who passed screening and participated for 6 months. Recruitment, enrolment and retention rates were compared between the two cohorts. Results In 6 months, TRC recruited 781 patients, 13 times faster than CBC (n = 60), and enrolled twice as many (P < 0.001). Screening success was similar, 78% for TRC and 87% in the CBC (P = 0.17). Among 120 enrolled, DM was the most common diagnosis (52%), with most participants being female (75%) and White (81%), with a mean age of 55 ± 13.4 years, similar across both cohorts. Dropout rates were similar (TRC, 7.6%: CBC, 5.5%; P = 0.67). TRC had higher compliance with study forms (93%) than CBC (69%) (P < 0.01). Conclusion The decentralized TRC demonstrated higher recruitment and enrolment, with similar compliance and retention rates compared with CBC. Decentralized approaches offer promise for rare diseases with recruitment challenges.