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Medical management
Original research
Development and testing of an opioid tapering self-management intervention for chronic pain: I-WOTCH
  1. Harbinder Kaur Sandhu1,
  2. Jane Shaw2,
  3. Dawn Carnes3,
  4. Andrea D Furlan4,5,
  5. Colin Tysall6,7,
  6. Henry Adjei1,
  7. Chockalingam Muthiah1,
  8. Jennifer Noyes2,
  9. Nicole K Y Tang8,
  10. Stephanie JC Taylor3,
  11. Martin Underwood1,9,
  12. Adrian Willis1,
  13. Sam Eldabe2
  14. On behalf of the I-WOTCH Team
    1. 1Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
    2. 2Department of Pain Medicine, James Cook University Hospital, Middlesbrough, UK
    3. 3Wolfson Institute of Population Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
    4. 4Toronto Rehabilitation Institute, University Health Network, Department of Medicine, University of Toronto, Toronto, Ontario, Canada
    5. 5Department of Medicine, Institute for Work & Health, Toronto, Ontario, Canada
    6. 6UNTRAP, University of Warwick, Coventry, West Midlands, UK
    7. 7SUCE, Coventry University, Coventry, West Midlands, UK
    8. 8Department of Psychology, University of Warwick, Coventry, West Midlands, UK
    9. 9University Hospitals Coventry and Warwickshire, Coventry, UK
    1. Correspondence to Professor Harbinder Kaur Sandhu; harbinder.k.sandhu{at}warwick.ac.uk

    Abstract

    Objectives To describe the design, development and pilot of a multicomponent intervention aimed at supporting withdrawal of opioids for people with chronic non-malignant pain for future evaluation in the Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial.

    Design The I-WOTCH intervention draws on previous literature and collaboration with stakeholders (patient and public involvement). Intervention mapping and development activities of Behaviour Change Taxonomy are described.

    Setting The intervention development was conducted by a multidisciplinary team with clinical, academic and service user perspectives. The team had expertise in the development and testing of complex health behaviour interventions, opioid tapering and pain management in primary and secondary care, I.T programming, and software development—to develop an opioid tapering App.

    Participants The I-WOTCH trial participants are adults (18 years and over) with chronic non-malignant pain using strong opioids for at least 3 months and on most days in the preceding month.

    Outcomes A multicomponent self-management support package to help people using opioids for chronic non-malignant pain reduce opioid use.

    Interventions and results Receiving information on the impact of long-term opioid use, and potential adverse effects were highlighted as important facilitators in making the decision to reduce opioids. Case studies of those who have successfully stopped taking opioids were also favoured as a facilitator to reduce opioid use. Barriers included the need for a ‘trade-off to fill the deficit of the effect of the drug’. The final I-WOTCH intervention consists of an 8–10 week programme incorporating: education; problem-solving; motivation; group and one to one tailored planning; reflection and monitoring. A detailed facilitator manual was developed to promote consistent delivery of the intervention across the UK.

    Conclusions We describe the development of an opioid reduction intervention package suitable for testing in the I-WOTCH randomised controlled trial.

    Trial registration number ISRCTN49470934.

    • pain management
    • rehabilitation medicine
    • medical education & training
    • pain management
    • primary care
    • clinical trials

    Data availability statement

    No data are available. No additional data available.

    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/.

    http://dx.doi.org/10.1136/bmjopen-2021-053725

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      Strengths and limitations of this study

      • The Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) Intervention draws on psychological and behaviour change frameworks.

      • The I-WOTCH intervention was developed with key stakeholders including patient and public involvement (those with chronic-non-malignant pain and experience of opioid use and/or tapering).

      • The pilot phases and feasibility testing gave valuable feedback and changes were made to the intervention accordingly.

      • At the time of designing the intervention, there was limited previous work and information to inform content of the intervention.

      Introduction

      Pain, and pain related disorders, continue to be the leading cause of disability and disease burden globally,1 with low back pain making the largest contribution to years lived with disability. In England, at least 8 million people (15% of the population) have moderate-to-severe persistent (chronic) pain2 defined as pain that lasts or recurs for more than 3 months.3 Over the past few decades, there has been a global epidemic of opioid prescribing for chronic non-malignant pain. A 2020 systematic review found that 30% of people with chronic non-malignant pain are prescribed opioid medication and, globally, this has steadily increased until recently with time.4 In the UK, prescribing rates have decreased slightly over recent years; however, the number of prescriptions remains high.5 Long-term use of opioids leads to tolerance and loss of effective pain relief. Adverse consequences include opioid-induced hyperalgesia, endocrine hypogonadism, drowsiness, a high risk of dependency, opioid use disorder, sleep apnoea, immune suppression, falls leading to increased fractures (particularly a risk in the elderly population) and increased risk for overdose and death.6 There are limited strategies to help with risk mitigation and evidence based interventions to help people with chronic non-malignant pain withdraw from opioids.7 A 2020 systematic review found ten randomised controlled trials (n=835) of patient-focused opioid de-prescribing interventions targeting people with chronic non-malignant pain. These included: dose reduction protocols (weekly reduction of 10%); opioid replacement including (buprenorphine, morphine sulphate or oxycodone hydrochloride or varenicline; non-pharmacological therapies including mindfulness (vs active control or support group); therapeutic interactive voice response programme (vs usual care); meditation; cognitive–behavioural therapy (vs usual care); and electroacupuncture (vs sham). The primary outcome was mean reduction of daily dose in morphine milligram equivalents (MME). Only one study reported a statistically significant difference in the daily dose between groups in favour of the intervention (a study using a dose tapering protocol) (mean difference −27.9 MME/day, 95% CI −41.1 to −14.7).8 None of these interventions reported increases in opioid cessation in the intervention groups. Overall, the authors were unable to recommend any particular deprescribing strategy due to the small number of studies and heterogeneity of the data.4

      Current recommendations on opioid tapering are based on the best practice and guidelines which need to be supported by further evidence.9 Here, we describe the development of a multicomponent opioid tapering programme (incorporating group and one to one sessions) as part of the I-WOTCH study (Improving the Wellbeing of people with Opioid Treated CHronic pain), funded by the National Institute of Health Research (14/224/04). The I-WOTCH study protocol has been published previously.10

      Methods

      The I-WOTCH intervention was developed in collaboration with the target population (those with chronic non-malignant pain and experience of opioid use). It employed theory and evidence-based implementation (with a view to implementation in the real world should it be effective) and included digital technologies to generate opioid tapering plans.11 The Medical Research Council Framework12 for designing complex interventions, evidence-based interventions13 and core theoretical principles were used to inform the design of content, structure and delivery of the intervention.

      Key stages of the intervention development are shown in figure 1. Adjustment and adaptation to the intervention were implemented inline with feedback received from stakeholders (service users, clinicians and facilitators delivering the I-WOTCH intervention).

      Figure 1
      Figure 1

      Stages of Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) intervention development. NIHR, National Institute for Health Research; RCT, randomised controlled trial.

      Aims and objectives of the I-WOTCH intervention

      In line with the overall study, the aims of the I-WOTCH intervention were:

      1. To reduce opioid and healthcare use for people with chronic, non-malignant pain.

      2. To increase study participants’ self-efficacy (confidence) to reduce opioid medication and implement self-management strategies of pain.

      3. To improve quality of life and help people live better with pain.

      Objectives:

      1. To provide education using a range of teaching methods; group discussion, problem-solving, experiential learning and case studies.

      2. To provide an environment which enhances motivation to reduce opioid use through group cohesion and one to one support.

      3. To provide an overall cost-effective intervention to be implemented in healthcare services.

      Defining the aims and objectives enabled us to consider what we wanted to achieve, how and for what purpose. In addition, we were aware of potential facilitators and barriers that could influence engagement with the intervention and the procedures of the trial. Figure 2 shows the direction of travel we were aiming for and what we needed to consider when designing the detail of the intervention and mechanism of behaviour change.

      Figure 2
      Figure 2

      Reducing opioids for people with chronic non-malignant pain.

      Patient and public involvement

      During the development stages of I-WOTCH, we held two PPI meetings with the Clinical Research Network (North East and Cumbria) at The James Cook University Hospital (South Tees Hospitals NHS Foundation Trust). A total of 19 volunteer participants (people with chronic pain and experience of opioid therapy and/or opioid tapering) attended. Discussions were facilitated by members of the study team (HS, DC, JS and SE) and included, intervention structure and design, content (topics to cover which would potentially increase motivation and confidence to taper opioids), length of programme, where the intervention should be delivered, support during opioid tapering (including frequency of contact with healthcare professionals) and delivery of the intervention (who should deliver the intervention) (table 1). In addition to this, two lay advisors who were part of the I-WOTCH study recruited via Universities/User Teaching14 gave considerable input into the design of, and training to deliver, the intervention.

      View this table:
      Table 1

      Feedback from PPI informing intervention development

      Opioid tapering and behaviour change

      The target behaviour change was defined as the participants engaging in the I-WOTCH intervention: reducing participant opioid use, and implementing non-pharmacological strategies of pain management. The biopsychosocial framework,15 Michie’s taxonomy of behaviour change and the COM-B framework for behaviour change (Capability, Opportunity, Motivation) were consulted.16 Capability includes psychological capability (eg, can patients engage in the necessary thought processes needed to commit and adhere to the tapering processes?) and physical capability (eg, do participants have the capacity to engage in the tapering?). Psychological capability is broken down to cognitive functioning and executive functioning. To promote cognitive functioning (which includes a range of mental abilities such as learning, problem-solving and attention), we produced handouts of material covered on each day of the programme. This allowed opportunity for participants to recap over the core messages and information in their own time. We also included time for group reflection at the start of each session and summarising discussions at the end of each of the group days (with opportunities for questions). In addition to this, we developed an educational DVD, a mindfulness CD and relaxation CD for each participant (at the time we developed the intervention DVDs and CDs were still in common use). By providing material to take home, we were giving participants an opportunity to revisit and take in the information at their own pace.17 Executive functioning includes the capacity to plan and think, explore challenges that may occur (eg, fear of withdrawal symptoms), stay focused on the goal (opioid reduction) and resist temptation.18 In the I-WOTCH intervention, we gave participants opportunity to set goals (through an educational session and support in generating goals related to opioid tapering and their general life). We also encouraged self-reflection to identify perceived barriers and facilitators to tapering and gave further guidance to overcome the perceived barriers in the tailored one to one support sessions with the clinical facilitator. Physical capability refers to whether the participants exposed to the I-WOTCH intervention felt they had the right skills to engage in the tapering of their opioids, this may include management of withdrawal, confidence and having structure and support in place. The I-WOTCH intervention was designed to help participants adapt and put into place lifestyle changes.

      Opportunity is the second component of the COM-B model. For this, we explored factors external to the individual that would promote opioid tapering. For example, physical opportunity includes costs of opioids and travel, access and availability, developing a tapering plan (clear and informative) and enhancing communication between the clinical facilitator and participant through motivational interviewing (MI) during the tapering processes. In relation to social opportunity, we referred to what other factors may impact the decision to taper such as stigma and cultural beliefs.

      Motivation, this refers to both the cognitive motivation and emotional processes to energise and direct the behaviour change of opioid tapering. Reflective processes included exploring perceptions and meaning of chronic pain during the group sessions as well as beliefs about tapering, possible outcomes concerns and self-efficacy. There was opportunity to evaluate and be reflective during the group sessions as well as one to one support. Automatic processes refer to the emotional responses which may occur during the I-WOTCH intervention and these include anxiety, fear, stress and low mood. All topics were covered in the group sessions including recognition of thoughts and emotions and management strategies.

      Each component of the I-WOTCH intervention was informed and mapped on to behaviour change taxonomies. The intervention also drew on psychological theories of self-efficacy,19 theory of planned behaviour and reasoned action,20 21 social learning22 and group-based interventions,23 cognitive–behavioural change,24 MI25 and evidence-based interventions for self-managing chronic pain (COPERS)26 described in table 2.

      View this table:
      Table 2

      Behaviour change taxonomy and opioid tapering

      Feasibility testing

      Funding from the Hambelton and Richmond Clinical Commissioning Group for a community pain management service allowed us to test the feasibility of the I-WOTCH intervention. Seven people were trained by the study team to deliver the intervention (three community team clinicians, two nurses and two volunteer patients). Two courses were observed by a member of the study team to evaluate how the course content was delivered and received by both the group facilitators and the group participants (five participants in total). Discussions included, what worked well, what did not work well, and whether participants felt that the aims and objectives of the programme were met and suggestions for changes.

      The second stage of feasibility was part of the pilot phase of the randomised controlled trial and involved facilitator training for the trial. Two groups were delivered in Coventry. From both stages of feasibility testing, feedback was taken on board and adaptions implemented for the training (table 3) and course content and structure (table 4).

      View this table:
      Table 3

      Feedback and changes pilot phases I and II: training

      View this table:
      Table 4

      Feedback and changes pilot phases I and II: course content and structure

      Overall, the feedback regarding the content of programme was positive. Participants felt that the distraction techniques worked well and helped break up the sessions. They also valued understanding the link between mood and pain and found the case studies useful in helping to motivate them to start reducing their opioids. Facilitators and participants in both pilot phases reported that it was an informative interactive course. Observations showed good delivery and interaction between facilitators and participants, good use of questions and answer sessions and role play. Both facilitators and patients agreed it may have been more interactive had the group been larger.

      Final I-WOTCH intervention

      The final I-WOTCH intervention (figure 3) consists of group day 1 (delivered week 1), group day 2 (delivered week 2), a one-to-one consultation with an I-WOTCH trained nurse (also in week 2 and after group day 2), group day 3 (week 3) and then two telephone consultations and a final face-to-face consultation to offer continual support for tapering. Each component of the intervention builds on previous knowledge and experience, and where the one-to-one consultation allows consolidation and tailoring of advice and support for tapering. At the beginning of the intervention, the learning is centred on pain and opioid education, with day 2 of the programme then introducing changes in beliefs and adapting different strategies as reduction of opioids occur. It is at this point tailoring support and MI to action a change in beliefs is promoted through the one-to-one support sessions with an opportunity for further regulation and group cohesion/support on the wider impact of opioid reduction and long term behaviour change (group day 3). The additonal one to one support, self-regulation, reflection and monitoring.

      Figure 3
      Figure 3

      Final model of Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) intervention.

      One-to-one consultations

      The one-to-one sessions with a trained I-WOTCH nurse were based on a MI model.27 The aims of MI are to enhance behaviour change through a patient-centred framework, where the patient is able to explore personal goals, ambivalence to change and reach self-actualisation in a supportive environment. We trained the I-WOTCH nurses on the five principles of MI: (1) expressing empathy through reflective learning, (2) expressing empathy through reflective listening, (3) developing discrepancy between participant goals or values (related to opioid tapering and pain management) and their current behaviour, avoiding argument and direct confrontation, (4) adjusting to participant resistance to reducing opioid reduction rather than opposing it directly and (5) supporting self-efficacy and optimism. The one-to-one consultations included a review of medication, reflection on the opioid education and group session where case studies and information were presented and exploring any challenges to opioid tapering such as concerns about withdrawal. Nurses were also trained to calculate total opioid daily dose and how to use that to produce a tapering regime according to the I-WOTCH study protocol. Although MI has been widely applied in substance misuse, there are limited data available for its use in opioid cessation for people with chronic non-malignant pain. A 2020 pilot study testing MI to support opioid tapering in post joint arthroplasty surgery found a 62% increase in the rate of participants returning to baseline opioid use after surgery (HR 1.62; 95% CI 1.06 to 2.46; p=0.03).28 Opioid tapering conversations maybe challenging and each participant will bring their own experiences and motivation to change; however by using MI as a tool, we encouraged I-WOTCH facilitators to support participants in their tapering.29

      One-to-one tapering: App

      We adopted an opioid tapering regimen based on the Mayo Clinic experience as it provided some evidence to support the notion that slow tapering is unlikely to be associated with severe withdrawal symptoms and therefore likely to facilitate adherence.30 This consisted of a 10% reduction of the original total daily dose every 7 days until a 30% of the original daily dose is reached. This is followed by a weekly decrease by 10% of the remaining dose. The 10% was rounded up to suit prescribing. For the calculation of equianalgesic doses, we used the tables from the Faculty of Pain Medicine.31 In order to ensure standardisation of tapering methodology across sites and various opioid preparations, the team developed a tapering App for use by the I-WOTCH trained nurses across sites. The I-WOTCH tapering App was developed by JN and SE working with the University of Warwick's Clinical Trials Unit (CTU) programming team (HA, CM and AW) and provided to the nurses on a handheld tablet. The I-WOTCH tapering App was based on a mathematical algorithm applying the Mayo Clinic tapering regime while accounting for UK commercial preparations. Nurses used the App to generate a participant specific tapering plan, which was synchronised to the I-WOTCH Trial database. The study team at Warwick CTU then logged into the centralised trial management website, printed and posted the tapering plan to the participant for their information and general practitioner for prescribing.

      The I-WOTCH trained nurse entered the total daily dose of the participant-specific opioid preparation into the home screen of the App (eg, 60 mg oxycodone/day). The App algorithm then calculated 10% of the total daily dose and rounded this up or down to suit prescribing. All tablet, capsule or patch denominations of all opioid preparations were tabulated and added to the App to ensure the algorithm not only produced a 10% per week tapering regime but also recommended various prescribing methods (eg, oxycodone 35 mg could be prescribed as 30 and 5 mg or 20, 10 and 5 mg tablets or 10, 10, 10 and 5 mg tablets).

      For patch preparations, we advised participants to taper using their original opioid if 10% was not achievable (eg, 12 μg of fentanyl being the smallest step down), the app algorithm was adjusted to recommend a 20% taper at 2-week intervals. Lowest dosage patch preparations were finally converted to slow release morphine equianalgesic doses and tapered accordingly.

      My opioid manager

      The My Opioid Manager Book and App is the output of a project of Toronto Rehabilitation Institute, University Health Network. In 2010, Dr. Andrea Furlan, a Physician and Scientist at Toronto Rehabilitation Institute, developed a tool for physicians prescribing opioids for patients with chronic non-malignant pain. In 2012, the Opioid Manager was converted to an App for smartphones and tablets. The My Opioid Manager Book (and App) is intended to complement the Opioid Manager by providing the same information in a format that can be used by people with chronic pain who are on opioids, or by people who are not on opioids but who might be considering this option to help manage their chronic pain. The goal of My Opioid Manager is preparing the patient for upcoming consultations with their healthcare provider. Some of the topics discussed include: understanding the causes of various types of pains, uses of opioids and the side effects and risks, managing pain by tracking opioid usefilness, and tips on using opioids. For this study, we Anglicised the content in terms of language used as well as the name of medication brands and pictures to be more representative of the UK population.

      Venue for delivering the intervention

      Where possible, the I-WOTCH intervention is delivered in the community. Factors to consider when booking a venue included, access to a building, parking and public transport links, a room to accommodate participants and facilitators with chairs and equipment, stairs, lifts, kitchen facilities and room for equipment such as a flipchart, laptop screen, speakers and internet access.

      I-WOTCH facilitator training

      The delivery–receipt–enactment chain of the I-WOTCH intervention provided a framework for training of facilitators and defining dosage received for participants to promote behaviour change (opioid tapering).32 The I-WOTCH training included two full days for all facilitators (clinical and lay facilitators) and an additional day for clinical facilitators only, to learn the clinical aspects of tapering, opioid specific education, generating tapering plans and MI for the one-to-one consultations. The design of the training package and implementation was adapted to Kolb’s experiential learning cycle (training, experience and reflective observation).33 The training days gave all facilitators exposure to the different components of the intervention through education and use of case studies. Trainers were given copies of the I-WOTCH manual and all participant intervention materials. Throughout the training days, facilitators had the opportunity to ask questions and get clarity on any of the topics being covered. At the end of the training, a short assessment was completed by each trainee. If any of the trainees scored below 70%, they were then contacted by phone to go over any areas needing further explanation and offered further training if needed.

      Discussion

      We have used a theory driven approach to developing an intervention for opioid reduction for people with chronic non-malignant pain. Based on the COPERS intervention for the management of pain, the best available empirical evidence at the time, and consultation with lay people, we have developed a manualised intervention and training package. It has been piloted, revised and adapted considering all feedback received. The I-WOTCH intervention has the potential to help people reduce their opioid use and improve their overall quality of life. We are not aware of any other programme of analogous interventions targeting similar populations. Previous non-pharmacological interventions have included mindfulness, cognitive–behavioural therapy and meditation and the use of electroacupuncture which showed no reduction in the number of participants who ceased their opioid use.4 The I-WOTCH intervention differs in that it combines group and one to one support, with the mechanisms of change and opioid reduction targeted through peer support, education, case studies, reflection and MI. It is a time and resource intensive intervention, however, having a multicomponent intervention will increase the potential to address the complex psychological, social and physical aspects of opioid tapering. We have developed an opioid tapering App which can be used to calculate individual opioid tapering plans.

      The roll out and scalability of the I-WOTCH training have been considered, a step-by-step manual with materials to set up and deliver the programme was created. The I-WOTCH facilitator training can be delivered to groups of clinicians and ongoing support given throughout the delivery of the intervention. The I-WOTCH trial will allow us to assess: the delivery of the intervention on a large scale, the training of multiple facilitators and managing the group element of the programme.

      Conclusion

      We have designed an opioid reduction intervention package suitable for testing in a randomised controlled trial.

      Data availability statement

      No data are available. No additional data available.

      Ethics statements

      Patient consent for publication

      Ethics approval

      Ethics approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September 2016 16/YH/0325. Participants gave informed consent to participate in the study before taking part.

      Acknowledgments

      We would like to thank Ms Sally Brown for her valuable input in the development of the intervention. We would also like to thank all of our PPI volunteers and the Clinical Research Network (North East and Cumbria) for hosting the events which provided valuable insight to the structure and content of the intervention. We would like to thank our clinical and lay facilitators who attended training, delivered the intervention and provided valuable feedback. We would like to thank all participants involved in the pilot stages of the intervention. We would also like to thank Dr Alison Hipwell for her contribution to the intervention development and Dr Celia Bernstein and Dr Jodie Westhead for their contribution to the I-WOTCH study.

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      Footnotes

      • Twitter @DrHSandhu, @adfurlan

      • Collaborators I-WOTCH team: Sharisse Alleyne, University of Warwick, Charles Abraham, Deakin University, Shyam Balasubramanian, Department of Anaesthesia & Pain Medicine University Hospitals Coventry and Warwickshire NHS Trust, Lauren Betteley, University of Warwick, Katie Booth, University of Warwick, Kirstie Haywood, University of Warwick, Sheeja Manchira Krishnan, The University of York, Ranjit Lall, University of Warwick. Andrea Manca, The University of York. Dipesh Mistry, University of Warwick, Vivien P Nichols, University of Warwick, Emma Padfield, University of Warwick, Anisur Rahman, Kate Seers, University of Warwick, University College London, Cynthia Paola Iglesis Urrutia.

      • Contributors All authors read and approved the manuscript. HKS and SE are Co-Chief Investigators and oversee the running of the study. All named authors contributed to the design and/or delivery of the I-WOTCH intervention. HKS, SE, JS and DC were involved in the design of the I-WOTCH intervention and design and delivery of facilitator training. CT contributed to the design and delivery of the I-WOTCH intervention, providing feedback on all materials and a trained facilitator. ADF developed My Opioid Manager, the content was anglicised for this study and also contributed to the design of the overall I-WOTCH intervention. SE, JN, HA, CM and AW developed the I-WOTCH Opioid tapering App. MU, NKYT and ST contributed to the design of the intervention, training manuals and to this manuscript. HKS is responsible for the overall content as guarantor.

      • Funding This project has received funding from the National Institute for Health Research (NIHR), Health Technology Assessment (HTA) (project number 14/224/04). SJCT supported by the National Institute for Health Research ARC North Thames.

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

      • Competing interests SE is the Chair of the specialised pain CRG at NHS England, he is Chief investigator and principal investigator of a number of NIHR and Industry funded trials, he has received personal fees from Medtronic Ltd, Mainstay Medical, Boston Scientific Corp for consultancy work. His department has received research funding from the National Institute of Health Research, Medtronic Ltd and Boston Scientific Corp. HS is director of Health Psychology Services Ltd, providing psychological services for a range of health related conditions. NKYT is chief investigator or coinvestigator of other chronic pain related projects funded by the NIHR, MRC, Warwick-Wellcome Translational Partnership. MU is chief investigator or coinvestigator on multiple previous and current research grants from the UK National Institute for Health Research, Arthritis Research UK and is a coinvestigator on grants funded by the Australian NHMRC. He was an NIHR Senior Investigator until March 2021. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo Ltd that provides electronic data collection for health services research. He is part of an academic partnership with Serco Ltd, funded by the European Social Fund, related to return to work initiatives. He receives some salary support from University Hospitals Coventry and Warwickshire. He is a coinvestigator on three NIHR funded studies receiving additional support from Stryker Ltd. He has accepted honoraria for teaching/lecturing from consortium for advanced research training in Africa. Until March 2020, he was an editor of the NIHR journal series, and a member of the NIHR Journal Editors Group, for which he received a fee. ADF is author of the My Opioid Manager book and App distributed in iTunes and Google Play. Both book and app are free of charge. She is author of the Opioid Manager App, a paid app distributed only in iTunes for healthcare professionals. The app is owned by UHN, the hospital where ADF works. ADF does not get any financial benefit from the sales of the app. ADF has a monetized YouTube channel since January 2021 that contains some videos about opioids and opioid tapering. Since April 2021, ADF has an unrestricted educational grant to maintain an online self-assessment opioid course for healthcare professionals in Canada. The funding is provided by the Canadian Generics Pharmaceutical Association (CGPA). The funding organisation has no role in the preparation, approval, recruitment of participants, or data analysis of the course content. Responsibility for the course content is solely that of the authors. ST is chief investigator or coinvestigator on multiple previous and current research grants from the UK National Institute for Health Research.

      • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

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