The outcome and cost-effectiveness of nurse-led care in people with rheumatoid arthritis: a multicentre randomised controlled trial
- Mwidimi Ndosi1,
- Martyn Lewis2,
- Claire Hale1,3,
- Helen Quinn3,
- Sarah Ryan4,
- Paul Emery5,6,
- Howard Bird5,
- Jackie Hill1
- 1Academic and Clinical Unit for Musculoskeletal Nursing, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
- 2Arthritis Research UK Primary Care Centre, Keele University, Staffordshire, UK
- 3School of Healthcare, University of Leeds, Leeds, UK
- 4Haywood Hospital, Stoke-on-Trent, UK
- 5Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
- 6NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
- Correspondence to Dr Mwidimi Ndosi, Academic and Clinical Unit for Musculoskeletal Nursing, Leeds Institute of Rheumatic and Musculoskeletal Medicine, 2nd Floor, Chapel Allerton Hospital, Leeds, UK;
- Received 5 February 2013
- Revised 1 June 2013
- Accepted 9 July 2013
- Published Online First 27 August 2013
Objective To determine the clinical effectiveness and cost-effectiveness of nurse-led care (NLC) for people with rheumatoid arthritis (RA).
Methods In a multicentre pragmatic randomised controlled trial, the assessment of clinical effects followed a non-inferiority design, while patient satisfaction and cost assessments followed a superiority design. Participants were 181 adults with RA randomly assigned to either NLC or rheumatologist-led care (RLC), both arms carrying out their normal practice. The primary outcome was the disease activity score (DAS28) assessed at baseline, weeks 13, 26, 39 and 52; the non-inferiority margin being DAS28 change of 0.6. Mean differences between the groups were estimated controlling for covariates following per-protocol (PP) and intention-to-treat (ITT) strategies. The economic evaluation (NHS and healthcare perspectives) estimated cost relative to change in DAS28 and quality-adjusted life-years (QALY) derived from EQ5D.
Results Demographics and baseline characteristics of patients under NLC (n=91) were comparable to those under RLC (n=90). Overall baseline-adjusted difference in DAS28 mean change (95% CI) for RLC minus NLC was −0.31 (−0.63 to 0.02) for PP and -0.15 (−0.45 to 0.14) for ITT analyses. Mean difference in healthcare cost (RLC minus NLC) was £710 (−£352, £1773) and −£128 (−£1263, £1006) for PP and ITT analyses, respectively. NLC was more cost-effective with respect to cost and DAS28, but not in relation to QALY utility scores. In all secondary outcomes, significance was met for non-inferiority of NLC. NLC had higher ‘general satisfaction’ scores than RLC in week 26.
Conclusions The results provide robust evidence to support non-inferiority of NLC in the management of RA.
Trial registration ISRCTN29803766
- Economic Evaluations
- Health services research
- Multidisciplinary team-care
- Rheumatoid Arthritis
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