Implementation, intervention, and downstream costs for implementation of a multidisciplinary complex pain clinic in the Veterans Health Administration.

OBJECTIVE: To determine the budget impact of implementing multidisciplinary complex pain clinics (MCPCs) for Veterans Health Administration (VA) patients living with complex chronic pain and substance use disorder comorbidities who are on risky opioid regimens. DATA SOURCES AND STUDY SETTING: We measured implementation costs for three MCPCs over 2 years using micro-costing methods. Intervention and downstream costs were obtained from the VA Managerial Cost Accounting System from 2 years prior to 2 years after opening of MCPCs. STUDY DESIGN: Staff at the three VA sites implementing MCPCs were supported by Implementation Facilitation. The intervention cohort was patients at MCPC sites who received treatment based on their history of chronic pain and risky opioid use. Intervention costs and downstream costs were estimated with a quasi-experimental study design using a propensity score-weighted difference-in-difference approach. The healthcare utilization costs of treated patients were compared with a control group having clinically similar characteristics and undergoing the standard route of care at neighboring VA medical centers. Cancer and hospice patients were excluded. DATA COLLECTION/EXTRACTION METHODS: Activity-based costing data acquired from MCPC sites were used to estimate implementation costs. Intervention and downstream costs were extracted from VA administrative data. PRINCIPAL FINDINGS: Average Implementation Facilitation costs ranged from $380 to $640 per month for each site. Upon opening of three MCPCs, average intervention costs per patient were significantly higher than the control group at two intervention sites. Downstream costs were significantly higher at only one of three intervention sites. Site-level differences were due to variation in inpatient costs, with some confounding likely due to the COVID-19 pandemic. This evidence suggests that necessary start-up investments are required to initiate MCPCs, with allocations of funds needed for implementation, intervention, and downstream costs. CONCLUSIONS: Incorporating implementation, intervention, and downstream costs in this evaluation provides a thorough budget impact analysis, which decision-makers may use when considering whether to expand effective programming.

Pain Care at Home to Amplify Function: Protocol Article.

Guidelines recommend strategies to optimize opioid medication safety, including frequent reassessment of the benefits and harms of long-term opioid therapy. Prescribers, who are predominantly primary care providers (PCPs), may lack the training or resources to implement these guideline-concordant practices. Two interventions have been designed to assist PCPs and tested within the Veterans Health Administration (VHA). Telemedicine Collaborative Management (TCM) provides primarily medication management support via care manager-prescriber teams. Cooperative Pain Education and Self-Management (COPES) promotes self-management strategies for chronic pain via cognitive behavior therapy techniques. Each intervention has been shown to improve prescribing and/or patient outcomes. The added value of combining these interventions is untested. With funding and central coordination by the Integrative Management of Chronic Pain and Opioid Use Disorder for Whole Recovery (IMPOWR) Network of the National Institutes of Health Helping to End Addiction Long-term (HEAL) Initiative, we will conduct a multisite patient-level randomized hybrid II effectiveness-implementation trial within VHA to compare TCM to TCM + COPES on the primary composite outcome of pain interference and opioid safety, secondary outcomes of alcohol use, anxiety, depression, and sleep, and other consensus IMPOWR Network measures. Implementation facilitation strategies informed by interviews with healthcare providers will target site-specific needs. The impact of these strategies on TCM implementation will be assessed via established formative and summative evaluation techniques. Economic analyses will evaluate intervention cost-effectiveness.

Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment.

BACKGROUND: Chronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap. OBJECTIVE: This study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD. METHODS: Adult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes. RESULTS: The study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025. CONCLUSIONS: Establishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54342.

Increasing buprenorphine access for patients with chronic pain: a quality improvement initiative.

OBJECTIVE: Buprenorphine is effective for chronic pain and safer than full-agonist opioids; however, limited education about and support for buprenorphine can result in under-prescribing in primary care and reduced access in specialty pain clinics. The purpose of this quality improvement initiative was to optimize and evaluate procedures for transferring patients stable on buprenorphine for chronic pain from a specialty pain clinic back to primary care. SETTING: Eight primary care clinics within a Veterans Health Administration health care system. METHODS: A standard operating procedure for facilitated transfer of prescribing was developed after a needs assessment and was introduced during an educational session with primary care providers, and providers completed a survey assessing attitudes about buprenorphine prescribing. Success of the initiative was measured through the number of patients transferred back to primary care over the course of 18 months. RESULTS: Survey results indicated that primary care providers with previous experience prescribing buprenorphine were more likely to view buprenorphine prescribing for pain as within the scope of their practice and to endorse feeling comfortable managing a buprenorphine regimen. Providers identified systemic and educational barriers to prescribing, and they identified ongoing support from specialty pain care and primary care as a facilitator of prescribing. Metrics suggested that the standard operating procedure was generally successful in transferring and retaining eligible patients in primary care. CONCLUSION: This quality improvement initiative suggests that a facilitated transfer procedure can be useful in increasing buprenorphine prescribing for pain in primary care. Future efforts to increase primary care provider comfort and address systemic barriers to buprenorphine prescribing are needed.

Qualitative Analysis of Patient Perspectives of Buprenorphine After Transitioning From Long-Term, Full-Agonist Opioid Therapy Among Veterans With Chronic Pain.

Guidelines recommend consideration of modification, tapering, or discontinuation of long-term, full-agonist opioid therapy when harms outweigh benefits; one alternative to tapering or discontinuing full-agonist opioids for the management of chronic pain is switching to the partial agonist buprenorphine. As the use of buprenorphine for pain expands, understanding the patient experience during and after the transition to buprenorphine is critical. We conducted 45- to 60-minute semistructured qualitative interviews with 19 patients to understand the experiences of patients with chronic pain actively maintained on buprenorphine after previously receiving full-agonist, long-term opioid therapy. Patients were recruited from 2 medical centers via provider referral. Through thematic analysis, 5 overall themes were identified, including satisfaction with buprenorphine, the importance of preconceptions about buprenorphine, experiences with transitions, patient-provider communication, and potential contributions to racial disparities in pain care. While we heard a range of experiences, most patients were satisfied with buprenorphine, reporting either equivalent pain control to their previous regimens or reporting less analgesia but improved functioning due to a reduction in side effects (eg, mental clarity). Patients also emphasized the importance of a nonjudgmental, patient-centered approach, including education about the risks and benefits of buprenorphine. The few Black patients interviewed all reported limited access to pain care, which is consistent with the well-documented existence of racial disparities in access to pain treatment. As buprenorphine is used more frequently for pain management, provider education focused on pain treatment disparities, patient-centered approaches informed by motivational interviewing, and increasing acceptance of buprenorphine as an option for pain are needed. PERSPECTIVE: Qualitative analyses of patient experiences transitioning from full-agonist opioids to buprenorphine for chronic pain revealed general satisfaction. Patients reflected on functioning, tradeoffs between analgesia and side effects, patient-centered care, and access to treatment, highlighting how future research should focus on outcomes valued by patients.

Video-telecare collaborative pain management during COVID-19: a single-arm feasibility study.

BACKGROUND: Chronic pain is among the most common conditions presenting to primary care and guideline-based care faces several challenges. A novel pain management program, Video-Telecare Collaborative Pain Management (VCPM), was established to support primary care providers and meet new challenges to care presented by the COVID-19 pandemic. METHODS: The present single-arm feasibility study aimed to evaluate the feasibility and acceptability of VCPM and its components among U.S. veterans on long-term opioid therapy for chronic pain at ≥ 50 mg morphine equivalent daily dose (MEDD). VCPM consists of evidence-based interventions, including opioid reassessment and tapering, rotation to buprenorphine and monitoring, and encouraging behavioral pain and opioid-use disorder self-management. RESULTS: Of the 133 patients outreached for VPCM, 44 completed an initial intake (33%) and 19 attended multiple VCPM appointments (14%). Patients were generally satisfied with VCPM, virtual modalities, and provider interactions. Nearly all patients who attended multiple appointments maintained a buprenorphine switch or tapered opioids (16/19; 84%), and buprenorphine switches were generally reported as acceptable by patients. Patients completing an initial intake with VCPM had reduced morphine equivalent daily dose after three months (means = 109 mg MEDD vs 78 mg), with greater reductions among those who attended multiple appointments compared to intake only (ΔMEDD = -58.1 vs. -8.40). Finally, 29 referrals were placed for evidence-based non-pharmacologic interventions. CONCLUSION: Pre-defined feasibility and acceptability targets for VCPM and its components were broadly met, and preliminary data are encouraging. Novel strategies to improve enrollment and engagement and future directions are discussed.

Delphi study to explore a new diagnosis for "ineffective" long-term opioid therapy for chronic pain.

ABSTRACT: A challenge in clinical, research, and policy spheres is determining whether and how to apply the Diagnostic and Statistical Manual-5 Opioid Use Disorder criteria to patients receiving long-term opioid therapy (LTOT) for the management of chronic pain. This study explored perspectives on the merits of creating a new diagnostic entity to characterize the problems that arise for certain patients prescribed LTOT and develop consensus on its definition and diagnostic criteria. We conducted 3 rounds of online surveys and held one discussion-based workshop to explore a new diagnostic entity and generate consensus with subject matter experts (n = 51) in pain and opioid use disorder, including a wide range of professional disciplines. The first survey included open-ended questions and rapid qualitative analysis to identify potential diagnostic criteria. Rounds 2 and 3 involved rating potential diagnostic criteria on a Likert-type scale to achieve consensus. The workshop was a facilitated conversation aimed at further refining criteria. Three-quarters of Delphi panelists were in favor of a new diagnostic entity; consensus was reached for 19 potential diagnostic criteria including benefits of LTOT no longer outweighing harms and a criterion related to difficulty tapering. A subgroup of expert panelists further refined the new diagnostic entity definition and criteria. Consensus on potential criteria for the new diagnostic entity was reached and further refined by a subgroup of experts. This Delphi study represents the opinions of a small group of subject matter experts; perspectives from other experts and additional stakeholder groups (including patients) are warranted.

Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) has a strong evidence base, but little is known about when treatment benefits are achieved. The present study is a secondary analysis of individuals with chronic back pain recruited for a noninferiority trial comparing interactive voice response (IVR) CBT-CP with in-person CBT-CP. METHODS: On the basis of data from daily IVR surveys, a clinically meaningful change was defined as a 30% reduction in pain intensity (n = 108) or a 45% increase in daily steps (n = 104) compared with the baseline week. We identified individuals who achieved a meaningful change at any point during treatment, and then we compared those who maintained a meaningful change in their final treatment week (i.e., responders) with those who did not or who achieved a meaningful change but lapsed (i.e., nonresponders). RESULTS: During treatment, 46% of participants achieved a clinically meaningful decrease in pain intensity, and 66% achieved a clinically significant increase in number of steps per day. A total of 54% of patients were classified as responders in terms of decreases in pain intensity, and 70% were responders in terms of increases in step count. Survival analyses found that 50% of responders first achieved a clinically meaningful change by week 4 for pain intensity and week 2 for daily steps. Dropout and demographic variables were unrelated to responder status, and there was low agreement between the two measures of treatment response. CONCLUSIONS: Collectively, results suggest that most responders improve within 4 weeks. Evaluating treatment response is highly specific to the outcome measure, with little correlation across outcomes.

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial.

Importance: Cognitive behavioral therapy for chronic pain (CBT-CP) is a safe and effective alternative to opioid analgesics. Because CBT-CP requires multiple sessions and therapists are scarce, many patients have limited access or fail to complete treatment. Objectives: To determine if a CBT-CP program that personalizes patient treatment using reinforcement learning, a field of artificial intelligence (AI), and interactive voice response (IVR) calls is noninferior to standard telephone CBT-CP and saves therapist time. Design, Setting, and Participants: This was a randomized noninferiority, comparative effectiveness trial including 278 patients with chronic back pain from the Department of Veterans Affairs health system (recruitment and data collection from July 11, 2017-April 9, 2020). More patients were randomized to the AI-CBT-CP group than to the control (1.4:1) to maximize the system's ability to learn from patient interactions. Interventions: All patients received 10 weeks of CBT-CP. For the AI-CBT-CP group, patient feedback via daily IVR calls was used by the AI engine to make weekly recommendations for either a 45-minute or 15-minute therapist-delivered telephone session or an individualized IVR-delivered therapist message. Patients in the comparison group were offered 10 therapist-delivered telephone CBT-CP sessions (45 minutes/session). Main Outcomes and Measures: The primary outcome was the Roland Morris Disability Questionnaire (RMDQ; range 0-24), measured at 3 months (primary end point) and 6 months. Secondary outcomes included pain intensity and pain interference. Consensus guidelines were used to identify clinically meaningful improvements for responder analyses (eg, a 30% improvement in RMDQ scores and pain intensity). Data analyses were performed from April 2021 to May 2022. Results: The study population included 278 patients (mean [SD] age, 63.9 [12.2] years; 248 [89.2%] men; 225 [81.8%] White individuals). The 3-month mean RMDQ score difference between AI-CBT-CP and standard CBT-CP was -0.72 points (95% CI, -2.06 to 0.62) and the 6-month difference was -1.24 (95% CI, -2.48 to 0); noninferiority criterion were met at both the 3- and 6-month end points (P < .001 for both). A greater proportion of patients receiving AI-CBT-CP had clinically meaningful improvements at 6 months as indicated by RMDQ (37% vs 19%; P = .01) and pain intensity scores (29% vs 17%; P = .03). There were no significant differences in secondary outcomes. Pain therapy using AI-CBT-CP required less than half of the therapist time as standard CBT-CP. Conclusions and Relevance: The findings of this randomized comparative effectiveness trial indicated that AI-CBT-CP was noninferior to therapist-delivered telephone CBT-CP and required substantially less therapist time. Interventions like AI-CBT-CP could allow many more patients to be served effectively by CBT-CP programs using the same number of therapists. Trial Registration: ClinicalTrials.gov Identifier: NCT02464449.

Opioid tapering support using a web-based app: Development and protocol for a pilot randomized controlled trial.

BACKGROUND: Given limited efficacy and potential harms of long-term opioid therapy, it is patient-centered and guideline-concordant to offer patients the opportunity to engage in a supportive, patient-centered tapering program. The goal of this study was to develop and pilot an interactive web-based program designed to support patients willing to consider an opioid taper; this manuscript describes the development and the protocol for a pilot randomized trial of Summit. METHODS: We used intervention mapping to develop the Summit program; during the development period we engaged multiple stakeholder groups and conducted usability testing to refine the interactive, theory-informed, multi-component mobile website program which includes education, video testimonials, self-management skills, and access to a peer specialist. We will evaluate the Summit program in a two-arm, 9 month randomized-controlled trial where 64 individuals will be assigned either to the Summit program or to a control group (pain tracking app). As a pilot trial, the primary outcomes are feasibility and acceptability; we will also measure patient-reported outcomes related to pain, quality of life, and opioid use. IMPLICATIONS: We developed an interactive program; results of the pilot trial are pending. If shown to be effective, Summit would be useful both in augmenting care for patients who are engaged in a taper with primary care.

Arguments for and Against a New Diagnostic Entity for Patients With Chronic Pain on Long-Term Opioid Therapy for Whom Harms Outweigh Benefits.

The goal of this study was to understand perspectives on whether a new diagnostic entity, distinct from Diagnostic and Statistical Manual - 5 (DSM-5) opioid use disorder (OUD), is needed for patients with chronic pain on long-term opioid therapy (LTOT) for whom the harms of continued opioid therapy outweigh the benefits. Data were collected as part of a larger Delphi study. We used rapid and thematic qualitative methods to analyze data from 51 panelists with expertise in internal medicine, psychiatry, psychology, and related fields. Three-quarters of panelists supported a new diagnostic entity; common themes included recognizing distinct experiences of patients prescribed LTOT, addressing problems with DSM-5 OUD criteria, facilitating research and improved treatment, and reducing stigma. Thirteen panelists opposed the creation of a new diagnostic entity; common themes included similarities in biological underpinnings of patients prescribed LTOT and diagnosed with OUD, belief that the continuum of OUD captured patients' experiences, finding better ways to address problems with DSM-5 OUD criteria, and concerns about stigma. While this expert panel disagreed about the need for a new diagnostic entity, there was an overall acknowledgement that the current implementation of DSM-5's OUD diagnosis is not meeting the needs of LTOT providers or patients. PERSPECTIVE: The DSM-5's OUD diagnosis may not adequately meet the needs of patients on LTOT for whom the harms of continued opioid therapy outweigh the benefits. Experts do not agree on how to address this problem; more work is needed to determine if a new diagnostic entity would be beneficial.

Effects of a Weight and Pain Management Program in Patients With Rheumatoid Arthritis With Obesity: A Randomized Controlled Pilot Investigation.

BACKGROUND: Obesity is associated with poor outcomes for patients with rheumatoid arthritis (RA). Effective weight management is imperative. Although traditional lifestyle behavioral weight loss programs have demonstrated efficacy for reducing weight, these interventions do not meet the pain-related weight loss challenges of RA patients with obesity. OBJECTIVE: A 12-session group program (90 minutes per session) was developed integrating pain coping skills training into a lifestyle behavioral weight loss intervention. In addition to the weekly group sessions, participants engaged in supervised exercise sessions 3 times per week. METHODS: Through a small, pilot randomized trial, 50 participants were randomized to receive the intervention (n = 29) or standard care of RA (n = 21). Feasibility data (i.e., accrual, attrition, adherence) was examined using descriptive statistics (e.g., percent). We examined patterns of change in study outcomes from baseline to follow-up separately for the intervention and standard care arms using descriptive statistics and paired t tests. Effect sizes are also presented. RESULTS: Of those randomized to the intervention group,79.3% initiated treatment, with participants attending 74.3% of group skills sessions and 64.2% of exercise sessions. Intervention participants evidenced reductions in weight (mean, -2.28 kg) and waist circumference (mean, -4.76 cm) and improvements in physical functioning, eating behaviors, pain, and self-efficacy for weight control. CONCLUSIONS: Findings suggest that incorporating a combined pain coping skills training and behavioral weight loss intervention into medical management of RA may improve outcomes. Study accrual and attrition, as well as intervention adherence, will inform future, larger randomized efficacy trials of the intervention.Retrospectively registered: January 29, 2020, NCT04246827.

As A Mother With COVID-19, I Faced Stigma And Shame.

A positive COVID-19 test shortly before birth upends a mother's birth experience and brings suspicion from her providers.

ICD-10 Coding of Musculoskeletal Conditions in the Veterans Health Administration.

OBJECTIVE: We describe the most frequently used musculoskeletal diagnoses in Veterans Health Administration care. We report the number of visits and patients associated with common musculoskeletal International Classification of Diseases (ICD)-10 codes and compare trends across primary and specialty care settings. DESIGN: Secondary analysis of a longitudinal cohort study. SUBJECTS: Veterans included in the Musculoskeletal Diagnosis Cohort with a musculoskeletal diagnosis from October 1, 2015, through September 30, 2017. METHODS: We obtained counts and proportions of all musculoskeletal diagnosis codes used and the number of unique patients with each musculoskeletal diagnosis. Diagnosis use was compared between primary and specialty care settings. RESULTS: Of more than 6,400 possible ICD-10 M-codes describing "Diseases of the Musculoskeletal System and Connective Tissue," 5,723 codes were used at least once. The most frequently used ICD-10 M-code was "Low Back Pain" (18.3%), followed by "Cervicalgia" (3.6%). Collectively, the 100 most frequently used codes accounted for 80% of M-coded visit diagnoses, and 95% of patients had at least one of these diagnoses. The most common diagnoses (spinal pain, joint pain, osteoarthritis) were used similarly in primary and specialty care settings. CONCLUSION: A diverse sample of all available musculoskeletal diagnosis codes were used; however, less than 2% of all possible codes accounted for 80% of the diagnoses used. This trend was consistent across primary and specialty care settings. The most frequently used diagnosis codes describe the types of musculoskeletal conditions, among a large pool of potential diagnoses, that prompt veterans to present to the Veterans Health Administration for musculoskeletal care.

Validity of Incident Opioid Use Disorder (OUD) Diagnoses in Administrative Data: a Chart Verification Study.

BACKGROUND: An important strategy to address the opioid overdose epidemic involves identifying people at elevated risk of overdose, particularly those with opioid use disorder (OUD). However, it is unclear to what degree OUD diagnoses in administrative data are inaccurate. OBJECTIVE: To estimate the prevalence of inaccurate diagnoses of OUD among patients with incident OUD diagnoses. SUBJECTS: A random sample of 90 patients with incident OUD diagnoses associated with an index in-person encounter between October 1, 2016, and June 1, 2018, in three Veterans Health Administration medical centers. DESIGN: Direct chart review of all encounter notes, referrals, prescriptions, and laboratory values within a 120-day window before and after the index encounter. Using all available chart data, we determined whether the diagnosis of OUD was likely accurate, likely inaccurate, or of indeterminate accuracy. We then performed a bivariate analysis to assess demographic or clinical characteristics associated with likely inaccurate diagnoses. KEY RESULTS: We identified 1337 veterans with incident OUD diagnoses. In the chart verification subsample, we assessed 26 (29%) OUD diagnoses as likely inaccurate; 20 due to systems error and 6 due to clinical error; additionally, 8 had insufficient information to determine accuracy. Veterans with likely inaccurate diagnoses were more likely to be younger and prescribed opioids for pain. Clinical settings associated with likely inaccurate diagnoses were non-mental health clinical settings, group visits, and non-patient care settings. CONCLUSIONS: Our study identified significant levels of likely inaccurate OUD diagnoses among veterans with incident OUD diagnoses. The majority of these cases reflected readily addressable systems errors. The smaller proportion due to clinical errors and those with insufficient documentation may be addressed by increased training for clinicians. If these inaccuracies are prevalent throughout the VHA, they could complicate health services research and health systems responses.

A Research Agenda for Advancing Strategies to Improve Opioid Safety: Findings from a VHA State of the Art Conference.

US military Veterans have been disproportionately impacted by the US opioid overdose crisis. In the fall of 2019, the Veterans Health Administration (VHA) convened a state-of-the-art (SOTA) conference to develop research priorities for advancing the science and clinical practice of opioid safety, including both use of opioid analgesics and managing opioid use disorder. We present the methods and consensus recommendations from the SOTA. A core group of researchers and VA clinical stakeholders defined three areas of focus for the SOTA: managing opioid use disorder, long-term opioid therapy for pain including consideration for opioid tapering, and treatment of co-occurring pain and substance use disorders. The SOTA participants divided into three workgroups and identified key questions and seminal studies related to those three areas of focus. The strongest recommendations included testing implementation strategies in the VHA for expanding access to medication treatment for opioid use disorder, testing collaborative tapering programs for patients prescribed long-term opioids, and larger trials of behavioral and exercise/movement interventions for pain among patients with substance use disorders.

Considerations of trial design and conduct in behavioral interventions for the management of chronic pain in adults.

INTRODUCTION: A growing number and type of nonpharmacological approaches for the management of chronic pain have demonstrated at least modest evidence of efficacy, and for some, there is emerging evidence of their effectiveness in relatively large scale trials. Behavioral approaches are those that generally seek to promote adaptive behavioral change in the service of reducing pain and improving physical and emotional functioning and quality of life. Despite a substantial empirical literature supporting the clinical utility of these approaches, a large number of unanswered questions remain and clinical trials to answer some of these questions are needed. Although considerations for development and enactment of data-analytic plans are generally similar to those in pharmacological trials (eg, intent-to-treat, prespecifying outcomes and time points, and handling of missing data), there may be some important differences to consider when planning and conducting clinical trials examining these behavioral approaches. OBJECTIVES: The primary objective of this article is to describe some aspects of clinical trials for behavioral approaches for the management of chronic pain that requires special consideration. METHODS: Important topics discussed include: (1) intervention development, (2) research design considerations (adequate and appropriate control and comparison conditions), (3) appropriate outcomes, (4) recruitment and sampling biases and blinding, (5) intervention fidelity and adherence, and (6) demographic and cultural considerations. RESULTS AND CONCLUSIONS: A number of methodological recommendations are made in the service of encouraging the conduct of high-quality research comparable with that performed for pharmacological and other medical interventions.