Protocol for an economic analysis of the randomised controlled trial of Improving the Well-being of people with Opioid Treated CHronic pain: I-WOTCH Study.

Journal: BMJ open

Volume: 10

Issue: 11

Year of Publication: 2021

Affiliated Institutions:  Department of Health Sciences, University of York, York, UK. Centre for Health Economics, University of York, York, UK. Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, West Midlands, UK. Pain Department, James Cook University Hospital, Middlesbrough, UK. Department of Health Sciences, University of York, York, UK cynthia.iglesias@york.ac.uk.

Abstract summary 

Over the last two decades, the use of opioids for the treatment of chronic pain in England has steadily increased despite lack of evidence of both long-term effectiveness in pain relief and significant, well-documented physical and mental adverse events. Guidelines recommend tapering when harms outweigh benefits, but the addictive nature of opioids hinders simple dose-reduction strategies. Improving the Well-being of people with Opioid Treated CHronic pain (I-WOTCH) trial tests a multicomponent self-management intervention aimed to help patients with chronic non-malignant pain taper opioid doses. This paper outlines the methods to be used for the economic analysis of the I-WOTCH intervention compared with the best usual care.Economic evaluation alongside the I-WOTCH study, prospectively designed to identify, measure and value key healthcare resource use and outcomes arising from the treatment strategies being compared. A within-trial cost-consequences analysis and a model-based long-term cost-effectiveness analysis will be conducted from the National Health Service and Personal Social Service perspective in England. The former will quantify key parameters to populate a Markov model designed to estimate the long-term cost and quality-adjusted life years of the I-WOTCH intervention against best usual care. Regression equations will be used to estimate parameters such as transition probabilities, utilities, and costs associated with the model's states and events. Probabilistic sensitivity analysis will be used to assess the impact of parameter uncertainty onto the predicted costs and health outcomes, and the resulting value for money assessment of the I-WOTCH intervention.Full ethics approval was granted by Yorkshire & The Humber-South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). Current protocol: V.1.7, date 31 July 2019. Findings will be disseminated in peer-reviewed journals, scientific conferences, newsletters and websites.International Standard Randomised Controlled Trial Number (49 470 934); Pre-result.

Authors & Co-authors:  Manchira Krishnan Sheeja S Gc Vijay Singh VS Sandhu Harbinder Kaur HK Underwood Martin M Eldabe Sam S Manca Andrea A Iglesias Urrutia Cynthia P CP

Study Outcome 

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Statistics
Citations :  Fayaz A, Croft P, Langford RM, et al. . Prevalence of chronic pain in the UK: a systematic review and meta-analysis of population studies. BMJ Open 2016;6:e010364 10.1136/bmjopen-2015-010364
Authors :  8
Identifiers
Doi : e037243
SSN : 2044-6055
Study Population
Male,Female
Mesh Terms
Activities of Daily Living
Other Terms
health economics;pain management;protocols & guidelines
Study Design
Cross Sectional Study
Study Approach
Country of Study
Mali
Publication Country
England