Ann Rheum Dis doi:10.1136/annrheumdis-2013-203403
  • Clinical and epidemiological research
  • Extended report

The outcome and cost-effectiveness of nurse-led care in people with rheumatoid arthritis: a multicentre randomised controlled trial

Open Access
  1. Jackie Hill1
  1. 1Academic and Clinical Unit for Musculoskeletal Nursing, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
  2. 2Arthritis Research UK Primary Care Centre, Keele University, Staffordshire, UK
  3. 3School of Healthcare, University of Leeds, Leeds, UK
  4. 4Haywood Hospital, Stoke-on-Trent, UK
  5. 5Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
  6. 6NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  1. 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; m.e.ndosi{at}
  • 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

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