To determine the effectiveness of nurse-led consultations in patients with stable rheumatoid arthritis (RA) in Hong Kong.
This is a single-centre, randomized, open-label, non-inferiority trial. RA patients with low disease activity (LDA) were randomized in a 1:1 ratio to nurse-led consultation or rheumatologist follow-up for 2 years. The primary endpoint was the proportion of patients who remained at LDA. Secondary endpoints included the proportion of patients in disease remission and the scores of Leeds satisfaction questionnaire (LSQ) at 2 years, changes from baseline in DAS28-CRP, modified Total Sharp Score (mTSS), Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form 36-item (SF-36) physical component score and Compliance Questionnaire of Rheumatology 19-item (CQR-19) score.
Among 280 patients who were randomized equally to either nurse-led consultation or rheumatologist follow-up, 267 patients completed the study. 92.1% and 91.4% patients remained at LDA at 2 years in nurse-led consultation and rheumatologist follow-up group, respectively. The 95% confidence intervals (CI) of the adjusted treatment difference were within the pre-defined non-inferiority 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 over 2 years were significantly different between the 2 treatment groups (p<0.001), there were no significant changes from baseline in mTSS, 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.
Nurse-led consultation is not inferior to rheumatologist follow-up in patients with stable RA.