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Economic evaluation within a factorial-design randomised controlled trial of exercise, manual therapy, or both interventions for osteoarthritis of the hip or knee: study protocol
  1. Daniel Pinto1,2,
  2. M Clare Robertson3,
  3. Paul Hansen4,
  4. J Haxby Abbott5 on behalf of the MOA Trial Team
  1. 1Centre for Physiotherapy Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand
  2. 2Department of Physical Therapy and Human Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
  3. 3Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
  4. 4Department of Economics, University of Otago, Dunedin, New Zealand
  5. 5Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
  1. Correspondence to Dr Daniel Pinto; daniel-pinto{at}northwestern.edu

Abstract

Introduction Clinical guidelines for the treatment of hip and knee osteoarthritis recommend non-pharmacological and non-surgical treatments. Exercise treatments are recommended as primary strategies, but specific exercise programme components have not been specified. Early evidence indicates that manual physiotherapy is effective for hip and knee osteoarthritis. The Management of Osteoarthritis (MOA) Trial was designed to evaluate the effectiveness and cost-effectiveness of physiotherapist-led, individualised exercise, manual physiotherapy and a combination of these two interventions in the treatment of adults with hip or knee osteoarthrits. This paper describes the methods that will be used to conduct the economic evaluation of these interventions within the MOA Trial.

Methods and analysis This comprehensive economic evaluation will assess the incremental cost-effectiveness of physiotherapy plus usual care versus usual care alone from a societal perspective. The authors will conduct a cost-consequences analysis using end-points such as Outcomes Measures in Rheumatology Clinical Trials—Osteoarthritis Research Society International responder criteria and quality-adjusted life years. The evaluation will have a time horizon of 1 year (and so discounting will not be necessary). All costs will be reported in 2009 New Zealand dollars. The authors will address uncertainty via bootstrapping to calculate CIs for the mean incremental cost-effectiveness ratios and by performing sensitivity analyses.

Ethics and dissemination Ethical approval was granted by the Lower South Regional Ethics Committee of the New Zealand Ministry of Health (ethics reference: LRS/07/11/044). All participants of the MOA Trial provided written informed consent for the capture of their healthcare costs. We will submit the results of the study for publication irrespective of outcome.

Clinical trials registration number ACTRN12608000130369.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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Footnotes

  • To cite: Pinto D, Robertson MC, Hansen P, et al. Economic evaluation within a factorial-design randomised controlled trial of exercise, manual therapy, or both interventions for osteoarthritis of the hip or knee: study protocol. BMJ Open 2011;1:e000136. doi:10.1136/bmjopen-2011-000136

  • Funding The MOA Trial was supported (in part) by contracts from the Health Research Council of New Zealand (HRC ref. 07/199 and 07/200) and a grant-in-aid from the New Zealand Lottery Grants Board (MR212664).

  • Competing interests None.

  • Patient consent Obtained.

  • Ethics approval Ethical approval was granted by the Lower South Regional Ethics Committee of the New Zealand Ministry of Health (ethics reference: LRS/07/11/044).

  • Contributors JHA conceived the study. DP led the design and coordination of the economic evaluation and wrote the manuscript. All authors participated in the study design, commented on drafts of this paper, and read and approved the final manuscript.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

  • Data sharing statement We welcome data sharing; policies and procedures are in place governing the access and use of these data; these will be administered by Dr Abbott, the principal investigator of the MOA Trial. The technical appendix, statistical code and dataset are available to researchers from haxby.abbott{at}otago.ac.nz. Informed consent for data sharing was not obtained from participants a priori, but the presented data are anonymised; risk of identification is low, and the potential benefits of sharing these data outweigh the potential harms.

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