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Title: Outcomes of nurse-led care for people with rheumatoid arthritis : a nation-wide multicentre randomised controlled study
Author: Ndosi, Mwidimi Emmanuel
ISNI:       0000 0004 2742 118X
Awarding Body: University of Leeds
Current Institution: University of Leeds
Date of Award: 2011
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Objective To establish whether nurse-led care (NLC) was clinically effective in managing rheumatoid arthritis (RA). Methods This was a multicentre RCT with a non-inferiority design. The hypothesis was that the outcomes from NLC would not be inferior to those obtained from the rheumatologist-led care (RLC). Patients with RA were recruited from 10 rheumatology centres across the UK and were allocated randomly to either NLC or RLC. The primary outcome (disease activity - measured by DAS28) and secondary outcomes (ESR, CRP, pain, fatigue, stiffness, quality of life, self-efficacy, disability, psychological well-being and satisfaction) were compared between the two groups at each follow-up time point and using data pooled over time (52 weeks). The primary analysis followed a "per-protocol" approach and one-sided 95%CI was used to test the null hypothesis using a priori-defined threshold of 0.6 DAS28 score change. Results Patients under NLC (n=91) were comparable to those under RLC (n=90) in their demographic and baseline characteristics. NLC made fewer medication changes, ordered fewer X-Rays but made more conferrals, gave more patient education and psychosocial support than RLC. DAS28 change scores demonstrated that NLC was not inferior to RLC at any follow-up time point. The pooled average difference in DAS28 score was 0.17 (95%CI = -0.12, 0.46); therefore, the null hypothesis was rejected. NLC did not have higher risk than RLC for failing to achieve a low disease activity state or for having non-responders. The intention-to-treat analysis provided similar results. At week 26, patients under NLC had more general satisfaction than those under RLC. There were no significant differences in any other secondary outcomes during the follow-up period (weeks 26 to week 52). Conclusions The main results demonstrated that NLC is not inferior to RLC in managing RA. This will contribute to the evidence for NLC in rheumatology and may influence future policy. Further research is needed to determine the pathway that leads to NLC impact.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available