Clinical outcomes of nurse-led care for people with RA: a multicentre RCT

Background Despite the development of the innovative rheumatology nurse-led clinics (NLC) in the UK, the evidence of their effectiveness is limited.Objectives To compare the outcomes of NLC to those obtained by rheumatologist-led clinics (RLC) for people with RA. The null hypothesis tested is that NLC is inferior to RLC.Methods This was a multi-centred, non-inferiority RCT. The non-inferiority margin was DAS28 change of 0.6 from baseline (primary outcome) and standardised effect size for secondary outcomes (pain, fatigue, stiffness, RAQoL, HAQ, HAD, ASES and EQ5D-VAS). Patients were assessed at baseline and at weeks 13, 26, 39 & 52. Mean differences between the two groups at follow-up were estimated using linear mixed models controlling for age, gender, centre, baseline DAS28 and corresponding baseline values for secondary outcomes. This was done following per-protocol (PP) and Intention-to-treat (ITT) strategies. Level of patient satisfaction was also compared between groups.Results Patients under NLC (n=91) were comparable to those under RLC (n=90) in their demographic and baseline characteristics. Their mean (SD) age was 58.5 (11.6); disease duration 9.9 (10.7) years and 74% were female