title: A randomised, controlled study of outcome and cost effectiveness for RA patients attending nurse-led rheumatology clinics: study protocol of an ongoing nationwide multi-centre study.
abstract: BACKGROUND
  The rise in the number of patients with arthritis coupled with understaffing of medical services has seen the deployment of Clinical Nurse Specialists in running nurse-led clinics alongside the rheumatologist clinics. There are no systematic reviews of nurse-led care effectiveness in rheumatoid arthritis. Few published RCTs exist and they have shown positive results for nurse-led care but they have several limitations and there has been no economic assessment of rheumatology nurse-led care in the UK.
  
  
  OBJECTIVE
  This paper outlines the study protocol and methodology currently being used to evaluate the outcomes and cost effectiveness for patients attending rheumatology nurse-led clinics.
  
  
  METHODS
  A multi-centred, pragmatic randomised controlled trial with a non-inferiority design; the null hypothesis being that of 'inferiority' of nurse-led clinics compared to physician-led clinics. The primary outcome is rheumatoid arthritis disease activity (measured by DAS28 score) and secondary outcomes are quality of life, self-efficacy, disability, psychological well-being, satisfaction, pain, fatigue and stiffness. Cost effectiveness will be measured using the EQ-5D, DAS28 and cost profile for each centre.
  In this trial, a DAS28 change of 0.6 is considered to be the threshold for clinical distinction of 'inferiority'. A sample size of 180 participants (90 per treatment arm) is needed to reject the null hypothesis of 'inferiority', given 90% power. Primary analysis will focus on 2-sided 95% confidence interval evaluation of between-group differences in DAS28 change scores averaged over 4 equidistant follow up time points (13, 26, 39 and 52 weeks). Cost effectiveness will be evaluated assessing the joint parameterisation of costs and effects.
  
  
  RESULTS
  The study started in July 2007 and the results are expected after July 2011.
  
  
  BACKGROUND
  The International Standard Randomised Controlled Trial Number ISRCTN29803766.
authors.affiliation: Academic & Clinical Unit for Musculoskeletal Nursing, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK. M.E.Ndosi@Leeds.ac.uk
authors.forename: Mwidimi
authors.initials: M
authors.lastname: Ndosi
authors.forename: Martyn
authors.initials: M
authors.lastname: Lewis
authors.forename: Claire
authors.initials: C
authors.lastname: Hale
authors.forename: Helen
authors.initials: H
authors.lastname: Quinn
authors.forename: Sarah
authors.initials: S
authors.lastname: Ryan
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.forename: Howard
authors.initials: H
authors.lastname: Bird
authors.forename: Jackie
authors.initials: J
authors.lastname: Hill
mesh_terms: D000554:Ambulatory Care Facilities / Q000458:organization & administration*; D001172:Arthritis, Rheumatoid / Q000451:nursing / Q000628:therapy*; D003362:Cost-Benefit Analysis; D006801:Humans; D016896:Treatment Outcome; D006113:United Kingdom