Article Text

Protocol
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
    1. 1Department of Health Sciences, University of York, York, UK
    2. 2Centre for Health Economics, University of York, York, UK
    3. 3Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, West Midlands, UK
    4. 4University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
    5. 5Pain Department, James Cook University Hospital, Middlesbrough, UK
    6. 6Danish Center for Healthcare Improvements, Aalborg University, Aalborg, Denmark
    1. Correspondence to Dr Cynthia P Iglesias Urrutia; cynthia.iglesias{at}york.ac.uk

    Abstract

    Introduction 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.

    Methods and analysis 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.

    Ethics and dissemination 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.

    Trial registration number International Standard Randomised Controlled Trial Number (49 470 934); Pre-result.

    • health economics
    • pain management
    • protocols & guidelines
    https://creativecommons.org/licenses/by/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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    Footnotes

    • Twitter @sheejamk, @VijayGC, @DrHSandhu, @Seldabe, @amancayork, @CynthiaIglesia7

    • Collaborators I-WOTCH team: (chief investigator)—Harbinder Kaur Sandhu, Warwick Clinical Trials Unit, University of Warwick. (co-chief investigators)—Sam Eldabe, The James Cook University Hospital, Cheriton House, Marton Road Middlesbrough; Charles Abraham, School of Psychological Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria 3010, Australia; Sharisse Alleyne, Warwick Clinical Trials Unit, University of Warwick; Shyam Balasubramanian, Department of Anaesthesia and Pain Medicine University Hospitals Coventry and Warwickshire NHS Trust; Lauren Betteley, Warwick Clinical Trials Unit, Warwick Medical School; Katie Booth, Warwick Clinical Trials Unit, University of Warwick; Dawn Carnes, Barts & The London Queen Mary's School of Medicine and Dentistry; Andrea Dompieri Furlan, Toronto Rehabilitation Institute, University Health Network, Canada; Kirstie Haywood, Division of Health Sciences, University of Warwick; Maddy Hill, Warwick Clinical Trials Unit, University of Warwick; Ranjit Lall, Warwick Clinical Trials Unit University of Warwick; Andrea Manca, Centre for Health Economics, University of York; Dipesh Mistry, Warwick Clinical Trials Unit, University of Warwick; Vivien Nichols, Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick; Jennifer Noyes, The James Cook University Hospital, Cheriton House, Marton Road Middlesbrough; Anisur Rahman, Centre for Rheumatology Research, University College London, London; Kate Seers, Warwick Research in Nursing, Warwick Medical School, University of Warwick; Jane Shaw, The James Cook University Hospital, Cheriton House, Marton Road Middlesbrough; Nicole Tang, Department of Psychology University of Warwick; Stephanie Taylor, Barts & The London Queen Mary's School of Medicine and Dentistry; Colin Tysall, University/User Teaching and Research Action Partnership, University of Warwick; Martin Underwood, Warwick Clinical Trials Unit, University of Warwick, Coventry; Emma Withers, Warwick Clinical Trials Unit, University of Warwick; Cynthia Urrutia, Centre for Health Economics, University of York.

    • Contributors SMK drafted the first version of this manuscript, CPIU is responsible for overseeing the design and implementation of the I-WOTCH economic analysis and for drafting subsequent versions of the manuscript, VSG contributed to the review of the literature of economic evaluation studies. AM provided expert advice and contributed to the draft of the manuscript. HKS and SE are co-chief Investigators and oversee the running of the trial. MU has provided input into all aspects of the trial study design and support in running of the study. SMK, VSG, CI, HKS, MU, SE and AM reviewed and approved the final version of the paper.

    • Funding This project is funded by the National Institute of Health Research (NIHR), Health Technology Assessment (HTA) (project number 14/224/04).

    • Disclaimer The views and opinions expressed therein are those of authors and do not necessarily reflect those of HTA, NIHR or NHS.

    • Competing interests MU was the chair of the NICE accreditation advisory committee until March 2017 for which he received a fee. He is the chief investigator or co-investigator on multiple previous and current research grants from the UK National Institute for Health Research, Arthritis Research UK, and is a co-investigator on grants funded by the Australian NHMRC. MU is an NIHR senior investigator and has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo that provides electronic data collection for health services research. MU is part of an academic partnership with Serco related to return to work initiatives. He is a co-investigator on a study receiving support in kind from Stryker. MU has accepted honoraria for teaching/lecturing from the consortium for advanced research training in Africa. He is an editor of the NIHR journal series, and a member of the NIHR Journal Editors Group, for which he receives a fee. SE is an investigator on number of NIHR and industry-sponsored studies. SE received travel expenses for speaking at conferences from the professional organisations organising these conferences. SE attended advisory boards and provided consultancy services for Medtronic, Abbott, Boston Scientific, and Mainstay Medical, none in relation to opioids. SE’s department has received research funding from Medtronic. HS is the director of Health Psychology Services, providing psychological services for a range of health-related conditions. AM has received consultancy fees for participating in Pharmaceutical and Medical Device Industry Advisory Boards in the area of musculoskeletal pain. AM is a member of the NICE Technology Appraisal Committee. CPIU is a member of the NICE Medical Technologies Advisory Committee.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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