Process evaluation protocol for the I-WOTCH study: an opioid tapering support programme for people with chronic non-malignant pain

58.<Nichols VP, Abraham C, Eldabe S, Sandhu HK, Underwood M, Seers K onbehalf of the I-WOTCH Team (Iglesias CP is member of the I-WOTCH team).. BMJ Open 2019; 9(10):e028998. Published online 2019 Oct 10. DOI: 10.1136/bmjopen-2019-028998PMID: 3160158

Protocol for an economic analysis of the randomised controlled trial of improving the wellbeing of people with opioid treated chronic pain : I-WOTCH study

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 Wellbeing 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 to 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 programme 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 programme. Ethics and dissemination: Full ethics approval was granted by Yorkshire & The Humber – South Yorkshire Research Ethics Committee on September 13th, 2016 (16/YH/0325). Current protocol: version 1.7, date 31 July 2019. Findings will be disseminated in peer reviewed journals, scientific conferences, newsletters, and websites. Registration details: International Standard Randomised Controlled Trial Number: 49470934 (6 Feb 2017)

Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial

IMPORTANCE: Opioid use for chronic nonmalignant pain can be harmful. OBJECTIVE: To test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care. DESIGN, SETTING, AND PARTICIPANTS: Multicentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020. INTERVENTION: Participants were randomized 1:1 to either usual care or 3-day-long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months. MAIN OUTCOMES AND MEASURES: The 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report. RESULTS: Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (-4.1 in the intervention and -3.17 in the usual care groups; between-group difference: mean difference, -0.52 [95% CI, -1.94 to 0.89]; P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001). Serious adverse events occurred in 8% (25/305) of the participants in the intervention group and 5% (16/303) of the participants in the usual care group. The most common serious adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care group). Four people (1%) in the intervention group received additional medical care for possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever and pain, small intestinal bleed, and an overdose suicide attempt). CONCLUSIONS AND RELEVANCE: In people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN49470934

Testing a support programme for opioid reduction for people with chronic non-malignant pain: The I-WOTCH randomised controlled trial protocol

Introduction: Chronic non-malignant pain has a major impact on the wellbeing, mood and productivity of those affected. Opioids are increasingly being prescribed to manage this type of pain, but the increasing risk of other disabling symptoms, and their effectiveness for this type of pain has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in patients with chronic pain. . Methods and analysis: A pragmatic, multi–centre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation CD). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The twoprimary outcomes are activities of daily living (measured by PROMIS Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events, and NHS health care resource use. Participants are followed up at four, eight, and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40-77). We will undertake an NHS perspective cost-effectiveness analysis using Quality Adjusted Life Years. Ethics: Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on September 13th, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6. date 19th December 2018. Dissemination: Publication of results in peer reviewed journals, including the development and theoretical framework of the intervention, will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website. Trial registration: This trial is registered with an International Standard Randomised Controlled Trial Number (ISRCTN) Register. ISRCTN number: 49470934 (06 Feb 2017

Reducing opioid use for chronic pain with a group-based intervention

Importance Opioid use for chronic nonmalignant pain can be harmful. Objective To test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care. Design, Setting, and Participants Multicentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020. Intervention Participants were randomized 1:1 to either usual care or 3-day–long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months. Main Outcomes and Measures The 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report. Results Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (−4.1 in the intervention and −3.17 in the usual care groups; between-group difference: mean difference, −0.52 [95% CI, −1.94 to 0.89]; P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001). Serious adverse events occurred in 8% (25/305) of the participants in the intervention group and 5% (16/303) of the participants in the usual care group. The most common serious adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care group). Four people (1%) in the intervention group received additional medical care for possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever and pain, small intestinal bleed, and an overdose suicide attempt). Conclusions and Relevance In people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities. Trial Registration isrctn.org Identifier: ISRCTN4947093

Variation in UK fracture liaison service consultation conduct and content before and during the COVID pandemic: results from the iFraP-D UK survey.

Acknowledgements: We would like to acknowledge the Keele Osteoporosis Research User Group, the NIHR Clinician Scientist Award Steering Committee, and the members of the study Community of Practice for support with design and interpretation, the Royal Osteoporosis Society for support with recruitment, and the healthcare participants themselves.Funder: Haywood FoundationUNLABELLED: We conducted a survey of FLSs' consultation conduct and content which identified marked variation in whether FLS HCPs discussed osteoporosis medicine with patients. A review of service pro formas showed more content related to 'investigating' and 'intervening' than to 'informing'. We propose an expanded FLS typology and model FLS pro forma. PURPOSE: To investigate the nature of direct patient contact in fracture liaison service (FLS) delivery, examine the use and content of pro formas to guide information eliciting and sharing in FLS consultations, and determine service changes which were implemented as a result of the COVID-19 pandemic. METHODS: An electronic survey of UK FLS healthcare practitioners (HCPs) was distributed through clinical networks, social media, and other professional networks. Participants were asked to upload service pro formas used to guide consultation content. Documentary analysis findings were mapped to UK FLS clinical standards. RESULTS: Forty-seven HCPs responded, providing data on 39 UK FLSs, over half of all 74 FLSs reporting to FLS-database. Results showed variation in which HCP made clinical decisions, whether medicines were discussed with patients or not, and in prescribing practice. Services were variably affected by COVID, with most reporting a move to more remote consulting. The documentary analysis of eight service pro formas showed that these contained more content related to 'investigating' and 'intervening', with fewer pro formas prompting the clinician to offer information and support (e.g., about coping with pain). Based on our findings we propose an expanded FLS typology and have developed a model FLS pro forma. CONCLUSION: There is marked variation in the delivery of services and content of consultations in UK FLSs including discussion about osteoporosis medications. Clinical standards for FLSs should clarify the roles of primary and secondary HCPs and the importance of holistic approaches to patient care

Variation in UK fracture liaison service consultation conduct and content before and during the COVID pandemic: results from the iFraP-D UK survey

Summary: We conducted a survey of FLSs’ consultation conduct and content which identified marked variation in whether FLS HCPs discussed osteoporosis medicine with patients. A review of service pro formas showed more content related to ‘investigating’ and ‘intervening’ than to ‘informing’. We propose an expanded FLS typology and model FLS pro forma. Purpose: To investigate the nature of direct patient contact in fracture liaison service (FLS) delivery, examine the use and content of pro formas to guide information eliciting and sharing in FLS consultations, and determine service changes which were implemented as a result of the COVID-19 pandemic. Methods: An electronic survey of UK FLS healthcare practitioners (HCPs) was distributed through clinical networks, social media, and other professional networks. Participants were asked to upload service pro formas used to guide consultation content. Documentary analysis findings were mapped to UK FLS clinical standards. Results: Forty-seven HCPs responded, providing data on 39 UK FLSs, over half of all 74 FLSs reporting to FLS-database. Results showed variation in which HCP made clinical decisions, whether medicines were discussed with patients or not, and in prescribing practice. Services were variably affected by COVID, with most reporting a move to more remote consulting. The documentary analysis of eight service pro formas showed that these contained more content related to ‘investigating’ and ‘intervening’, with fewer pro formas prompting the clinician to offer information and support (e.g., about coping with pain). Based on our findings we propose an expanded FLS typology and have developed a model FLS pro forma. Conclusion: There is marked variation in the delivery of services and content of consultations in UK FLSs including discussion about osteoporosis medications. Clinical standards for FLSs should clarify the roles of primary and secondary HCPs and the importance of holistic approaches to patient care

Synthesizing cross-design evidence and cross-format data using network meta-regression.

In network meta-analysis (NMA), we synthesize all relevant evidence about health outcomes with competing treatments. The evidence may come from randomized clinical trials (RCT) or non-randomized studies (NRS) as individual participant data (IPD) or as aggregate data (AD). We present a suite of Bayesian NMA and network meta-regression (NMR) models allowing for cross-design and cross-format synthesis. The models integrate a three-level hierarchical model for synthesizing IPD and AD into four approaches. The four approaches account for differences in the design and risk of bias (RoB) in the RCT and NRS evidence. These four approaches variously ignoring differences in RoB, using NRS to construct penalized treatment effect priors and bias-adjustment models that control the contribution of information from high RoB studies in two different ways. We illustrate the methods in a network of three pharmacological interventions and placebo for patients with relapsing-remitting multiple sclerosis. The estimated relative treatment effects do not change much when we accounted for differences in design and RoB. Conducting network meta-regression showed that intervention efficacy decreases with increasing participant age. We also re-analysed a network of 431 RCT comparing 21 antidepressants, and we did not observe material changes in intervention efficacy when adjusting for studies' high RoB. We re-analysed both case studies accounting for different study RoB. In summary, the described suite of NMA/NMR models enables inclusion of all relevant evidence while incorporating information on the within-study bias in both observational and experimental data and enabling estimation of individualized treatment effects through the inclusion of participant characteristics. This article is protected by copyright. All rights reserved

Exploring practice and perspectives on shared decision-making about osteoporosis medicines in Fracture Liaison Services: the iFraP development qualitative study.

Acknowledgements: We would like to acknowledge the Keele Osteoporosis Research User Group, the NIHR Clinician Scientist Award Steering Committee, and the members of the study Keele Osteoporosis Community of Practice for the support with design and interpretation, the Royal Osteoporosis Society for the support with recruitment, and the participants themselves.Funder: Haywood FoundationUNLABELLED: Interviews and focus groups with patients, FLS clinicians, and GPs identified challenges relating to clinical and shared decision-making about bone health and osteoporosis medicines. Findings will inform the development of the multicomponent iFraP intervention to address identified training needs and barriers to implementation to facilitate SDM about osteoporosis medicines. PURPOSE: The iFraP (improving uptake of Fracture Prevention treatments) study aimed to develop a multicomponent intervention, including an osteoporosis decision support tool (DST), to support shared decision-making (SDM) about osteoporosis medicines. To inform iFraP intervention development, this qualitative study explored current practice in relation to communication about bone health and osteoporosis medicines, anticipated barriers to, and facilitators of, an osteoporosis DST, and perceived training needs. METHODS: Patients attending an FLS consultation (n = 8), FLS clinicians (n = 9), and general practitioners (GPs; n = 7) were purposively sampled to participate in a focus group and/or telephone interview. Data were transcribed, inductively coded, and then mapped to the Theoretical Domains Framework (TDF) as a deductive framework to systematically identify possible barriers to, and facilitators of, implementing a DST. RESULTS: Inductive codes were deductively mapped to 12 TDF domains. FLS clinicians were perceived to have specialist expertise (knowledge). However, clinicians described aspects of clinical decision-making and risk communication as difficult (cognitive skills). Patients reflected on decisional uncertainty about medicines (decision processes). Discussions about current practice and the proposed DST indicated opportunities to facilitate SDM, if identified training needs are met. Potential individual and system-level barriers to implementation were identified, such as differences in FLS configuration and a move to remote consulting (environmental context and resources). CONCLUSIONS: Understanding of current practice revealed unmet training needs, indicating that using a DST in isolation would be unlikely to produce a sustained shift to SDM. Findings will shape iFraP intervention development to address unmet needs