title: The outcome and cost-effectiveness of nurse-led care in people with rheumatoid arthritis: a multicentre randomised controlled trial.
abstract: 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.
  
  
  BACKGROUND
  ISRCTN29803766.
authors: Academic and Clinical Unit for Musculoskeletal Nursing, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors: Mwidimi
authors: M
authors: Ndosi
authors: Arthritis Research UK Primary Care Centre, Keele University, Staffordshire, UK.
authors: Martyn
authors: M
authors: Lewis
authors: Academic and Clinical Unit for Musculoskeletal Nursing, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK School of Healthcare, University of Leeds, Leeds, UK.
authors: Claire
authors: C
authors: Hale
authors: School of Healthcare, University of Leeds, Leeds, UK.
authors: Helen
authors: H
authors: Quinn
authors: Haywood Hospital, Stoke-on-Trent, UK.
authors: Sarah
authors: S
authors: Ryan
authors: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors: Paul
authors: P
authors: Emery
authors: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors: Howard
authors: H
authors: Bird
authors: Academic and Clinical Unit for Musculoskeletal Nursing, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors: Jackie
authors: J
authors: Hill
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000191:economics* / Q000451:nursing*; D015400:Clinical Nursing Research / Q000379:methods; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care / Q000191:economics / Q000458:organization & administration*; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D009720:Nurse Clinicians / Q000191:economics / Q000458:organization & administration*; D017060:Patient Satisfaction; D019057:Quality-Adjusted Life Years; D012720:Severity of Illness Index; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D018501:Antirheumatic Agents
keywords: Economic Evaluations; Health services research; Multidisciplinary team-care; Nursing; Rheumatoid Arthritis
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