Nurse-Led Consultation for Patients With Rheumatoid Arthritis at Low Disease Activity: A Randomized Noninferiority Trial.

Objective: To determine the effectiveness of nurse-led consultations in patients with stable rheumatoid arthritis (RA) in Hong Kong.

Methods: The present work was a single-center, randomized, open-label, noninferiority trial. Patients who had rheumatoid arthritis (RA) with low disease activity (LDA) were randomized at a 1:1 ratio to attend a nurse-led consultation or rheumatologist follow-up visit for 2 years. The primary end point was the proportion of patients whose RA remained at LDA. Secondary end points included the proportion of patients with RA in disease remission and the scores recorded on the Leeds Satisfaction Questionnaire at 2 years, changes from baseline on the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP), modified Sharp/van der Heijde score (SHS), Health Assessment Questionnaire disability index (HAQ DI), Short Form 36 (SF-36) physical component score, and 19-item Compliance Questionnaire for Rheumatology (CQR-19) score.

Results: Among 280 patients who were randomized equally to either attend nurse-led consultations or rheumatologist follow-up visits, 267 patients completed the study. In the nurse-led consultation and rheumatologist follow-up groups, 92.1% and 91.4% patients, respectively, remained at LDA at 2 years. The 95% confidence intervals (95% CIs) of the adjusted treatment difference were within the predefined noninferiority margin in both the intention-to-treat analysis (95% CI 5.75, 7.15) and the per-protocol analysis (95% CI 1.67, 7.47). Although the changes in DAS28-CRP score over 2 years were significantly different between the 2 treatment groups (P < 0.001), there were no significant changes from baseline in SHS, HAQ DI, SF-36 physical component scores, and CQR-19 scores. At the end of the study, more patients expressed satisfaction with nurse-led consultations.

Conclusion: Nurse-led consultations were not inferior to rheumatologist follow-up visits in patients with stable RA.