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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

Ndosi, M, Lewis, M, Hale, C, Quinn, H, Ryan, S, Emery, P, Bird, H and Hill, J (2011) 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. International Journal of Nursing Studies, 48 (8). 995 - 1001 . ISSN 0020-7489

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Abstract

Background The rise in the number of patients with arthritis coupled with under-staffing 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. Design and 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. Power calculations 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. Trial registration The International Standard Randomised Controlled Trial Number ISRCTN29803766. Keywords: Nurse-led care; Clinical nurse specialists; Rheumatoid arthritis; Randomised controlled trial; Economic evaluation; Protocol

Item Type: Article
Institution: The University of Leeds
Academic Units: The University of Leeds > Faculty of Medicine and Health (Leeds) > Institute of Molecular Medicine (LIMM) (Leeds)
The University of Leeds > Faculty of Medicine and Health (Leeds) > Institute of Molecular Medicine (LIMM) (Leeds) > Section of Musculoskeletal Disease (Leeds)
The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Healthcare (Leeds) > Leeds Inst for Innov in Prof Practice
The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Healthcare (Leeds) > Leeds Inst for Innov in Prof Practice > AU Advanced Practice (Leeds)
Depositing User: Symplectic Publications
Date Deposited: 23 Jan 2012 14:49
Last Modified: 15 Sep 2014 03:43
Published Version: http://dx.doi.org/10.1016/j.ijnurstu.2011.01.010
Status: Published
Publisher: Elsevier
Identification Number: 10.1016/j.ijnurstu.2011.01.010
Related URLs:
URI: http://eprints.whiterose.ac.uk/id/eprint/43677

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