Background/Purpose: To identify risk factors for premature study termination and patients’ motives for adherence to a long term follow-up clinical trial in rheumatoid arthritis (RA).

Methods: In 508 patients with early RA enrolled in the BeSt study, risk factors for premature study discontinuation were identified through univariable and then multivariable logistic regression analysis. In this analysis, for every patient ten endpoints were generated (still under follow-up at the end of a year, yes/no), and baseline characteristics and clinical characteristics as present in the preceding year of follow-up were entered as determinants. Patients who completed 10-year follow-up were asked to fill in a questionnaire on study experiences and possible motives for study adherence. 

Results: In total, 313/508 patients (62%) attended the final visit, and 288 (92%) filled in the questionnaire. Mean age of completers was 61 years and 67% were female. Based on 508 included patients, risk factors for early termination were a higher age (odds ratio, OR 1.04, 95% confidence interval, CI 1.03 – 1.06), worse functional ability during the preceding year (measured with the health assessment questionnaire, OR 1.63, 95% CI 1.27 – 2.08), having achieved drug-free remission during the preceding year (OR 1.85, 95% CI 1.38 – 2.47) and suffering a severe adverse event during the preceding year (OR 1.71, 95% CI 1.18 – 2.49). In the first part of the questionnaire, the majority of patients mentioned contributing to scientific research (97% of patients agreed), helping other patients (91%), ‘I have nothing to lose’ (80%), gaining understanding of new treatment strategies (84%) and of their disease (85%) as reasons to continue participation. Next, patients were asked to mark one or more possible reasons to continue participation. In total, 278 patients marked 912 reasons: tight disease control (202/278 patients), good treatment strategy (128/278), good medication prescribed by the protocol (117/278) and good half-time results (102/278) were most often mentioned. Over 95% of patients experienced participation ‘as expected’ or ‘better than expected’. In particular care by the study nurses was appreciated: 55 – 75% answered ‘better than expected’ to 4 questions regarding this issue. Additional examinations during the yearly visits (additional questionnaires, imaging techniques) were mentioned ‘worse than expected’ (10% of patients) as was filling in the 3-monthly questionnaires (7%). Most patients (74%) would participate in another trial and 94% would recommend participation to friends and family. 

Conclusion: Continued participation during 10 year follow-up in the BeSt study was relatively high (62%), although impaired functional ability, higher age, experiencing severe adverse events and achieving drug-free remission in the previous year were predictors for early termination. Motivators to continue participation were a wish to contribute to scientific research, to learn more about their disease and its treatment, personal benefit of available therapies, and a good rapport with the study nurse. By cultivating these motivators, early termination in future long-term follow-up studies might be reduced.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/continued-participation-in-a-10-year-tight-control-treat-to-target-study-in-rheumatoid-arthritis-why-keep-patients-doing-their-best/