Background/Purpose: There is a drive to offer all patients the opportunity to participate in clinical research. We aimed to investigate the eligibility, screening and participation of rheumatology patients in clinical research studies in a single academic rheumatology department to identify targets for improving patient engagement with research

Methods: Methods: This study was conducted in two phases. Phase 1 was a retrospective analysis of study screening logs over 12 months. In phase 2; the outpatient population was surveyed using a questionnaire to identify the motivators and barriers to research participation. Comparisons were made using chi-squared tests and logistic regression models where appropriate.

Results: In phase 1 of the study we identified 1025 patients who were eligible for screening (median [IQR] age 47 [18-85] years; 87% female); 566 (55%) had been screened for any study. Of these, 217/566 (38%) were subsequently enrolled. Enrollment varied by ethnicity. Reasons for screen failure included study ineligibility (54%) and patient factors (29%). There was significant variation in these reasons by ethnicity (P=0.047), however this was not clearly due to patient factor (P = 0.091). Females were more likely to be ineligible (OR [95% CI] 1.78 [1.08, 2.95]) and increased age was associated with declining research participation (OR 0.98 [0.95, 0.998]). In phase 2, 152 participants including 117 (77%) women, responded to our survey (overall response rate 25% [Caucasians 45%, Non-Caucasians 7%]). Their median [IQR] age was 50 [17-84] yrs and our sample included 111 (73%) Caucasians and 41(27%) non-Caucasian ethnicity. Overall, 50 (33%) had ever been invited to research, of whom 71% participated. The key motivational factors were to contribute to scientific knowledge (94%), to help other patients (89%) and personal health benefits (47%). The major factors for non-participation were study ineligibility (47%), stopping/changing current medication (33%), inadequate information about the study (27%) and inconvenience (27%). Overall, 87/152 (57%) were happy to participate in future studies .The main influencing factors were potential help to others (98%),contributing to scientific knowledge(96%),quality of information given about the study (79%) and understanding of what study involved (76%). Non-Caucasians were less likely to participate (p=0.052); however, main spoken language (p=0.102) and employment status (P=0.395) had no influence on deciding whether to take part in research. We also found that Caucasians were significantly more likely to be approached to research (P=0.004) and previous research experience had a positive impact to participate in future research (P=0.001).

Conclusion: Our study identified a number of barriers to research participation. Almost half of patients were never even considered or screened for research eligibility, and many failed screening. This may reflect study case mix/design; however there was also variability in participation according to ethnicity. Strategies to facilitate a universal research offer and support study involvement will need to account for ethnic variation in patient characteristics and beliefs about research.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/factors-influencing-patients-participation-in-rheumatology-research-studies-experience-from-a-single-academic-centre/