Randomized controlled trial of a nurse-led rheumatology clinic for monitoring biological therapy

AIM: To compare and evaluate the treatment outcomes of a nurse-led rheumatology clinic and a rheumatologist-led clinic in patients with low disease activity or in remission who are undergoing biological therapy. BACKGROUND: Patients with chronic inflammatory arthritis treated with biological therapy are usually monitored by rheumatologists. Nurse-led rheumatology clinics have been proposed in patients with low disease activity or in remission. DESIGN: Randomized controlled trial. METHODS: A 12-month follow-up trial was conducted between October 2009 and August 2011, where 107 patients were randomized into two groups with a 6-month follow-up to a nurse-led rheumatology clinic based on person-centred care (intervention group; n = 53) or to a rheumatologist-led clinic (control group; n = 54). The hypothesis was that the nurse-led clinic outcomes would not be inferior to those obtained from a rheumatologist-led clinic at the 12-month follow-up. The primary outcome was disease activity measured by Disease Activity Score 28. RESULTS: A total of 47 patients in the intervention group and 50 in the control group completed the 12-month trial. The trial revealed no statistically significant differences between groups in mean change of Disease Activity Score 28, Visual Analogue Scales for pain, the Health Assessment Questionnaire, satisfaction with or confidence in obtaining rheumatology care. CONCLUSION: Patients with stable chronic inflammatory arthritis undergoing biological therapy could be monitored by a nurse-led rheumatology clinic without difference in outcome as measured by the Disease Activity Score 28.