Opioid-related Mortality in United States Death Certificate Data: A Quantitative Bias Analysis With Expert Elicitation of Bias Parameters.

BACKGROUND: Opioid-related mortality is an important public health problem in the United States. Incidence estimates rely on death certificate data generated by health care providers and medical examiners. Opioid overdoses may be underreported when other causes of death appear plausible. We applied physician-elicited death certificate bias parameters to quantitative bias analyses assessing potential age-related differential misclassification in US opioid-related mortality estimates. METHODS: We obtained cause-of-death data (US, 2017) from the National Center for Health Statistics and calculated crude opioid-related outpatient death counts by age category (25-54, 55-64, 65+). We elicited beliefs from 10 primary care physicians on sensitivity of opioid-related death classification from death certificates. We summarized elicited sensitivity estimates, calculated plausible specificity values, and applied resulting parameters in a probabilistic bias analysis. RESULTS: Physicians estimated wide sensitivity ranges for classification of opioid-related mortality by death certificates, with lower estimated sensitivities among older age groups. Probabilistic bias analyses adjusting for physician-estimated misclassification indicated 3.1 times more (95% uncertainty interval: 1.2-23.5) opioid-related deaths than the observed death count in the 65+ age group. All age groups had substantial increases in bias-adjusted death counts. CONCLUSIONS: We developed and implemented a feasible method of eliciting physician expert opinion on bias parameters for sensitivity of a medical record-based death indicator and applied findings in quantitative bias analyses adjusting for differential misclassification. Our findings are consistent with the hypothesis that opioid-related mortality rates may be substantially underestimated, particularly among older adults, due to misclassification in cause-of-death data from death certificates.

A national population-based study of cannabis use and correlates among U.S. veterans prescribed opioids in primary care.

BACKGROUND: Cannabis is marketed as a treatment for pain. There is limited data on the prevalence of cannabis use and its correlates among Veterans prescribed opioids. OBJECTIVE: To examine the prevalence and correlates of cannabis use among Veterans prescribed opioids. DESIGN: Cross-sectional study. PARTICIPANTS: Veterans with a urine drug test (UDT) from Primary Care 2014-2018, in 50 states, Washington, D.C., and Puerto Rico. A total of 1,182,779 patients were identified with an opioid prescription within 90 days prior to UDT. MAIN MEASURES: Annual prevalence of cannabis positive UDT by state. We used multivariable logistic regression to assess associations of demographic factors, mental health conditions, substance use disorders, and pain diagnoses with cannabis positive UDT. RESULTS: Annual prevalence of cannabis positive UDT ranged from 8.5% to 9.7% during the study period, and in 2018 was 18.15% in Washington, D.C. and 10 states with legalized medical and recreational cannabis, 6.1% in Puerto Rico and 25 states with legalized medical cannabis, and 4.5% in non-legal states. Younger age, male sex, being unmarried, and marginal housing were associated with use (p < 0.001). Post-traumatic stress disorder (adjusted odds ratio [AOR] 1.17; 95% confidence interval [CI] 1.13-1.22, p < 0.001), opioid use disorder (AOR 1.14; CI 1.07-1.22, p < 0.001), alcohol use disorder or positive AUDIT-C (AOR 1.34; 95% CI 1.28-1.39, p < 0.001), smoking (AOR 2.58; 95% CI 2.49-2.66, p < 0.001), and other drug use disorders (AOR 1.15; 95% CI 1.03-1.29, p = 0.02) were associated with cannabis use. Positive UDT for amphetamines AOR 1.41; 95% CI 1.26-1.58, p < 0.001), benzodiazepines (AOR 1.41; 95% CI 1.31-1.51, p < 0.001) and cocaine (AOR 2.04; 95% CI 1.75-2.36, p < 0.001) were associated with cannabis positive UDT. CONCLUSIONS: Cannabis use among Veterans prescribed opioids varied by state and by legalization status. Veterans with PTSD and substance use disorders were more likely to have cannabis positive UDT. Opioid-prescribed Veterans using cannabis may benefit from screening for these conditions, referral to treatment, and attention to opioid safety.

A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT).

BACKGROUND: Interventions to reduce harms related to prescription opioids are needed in primary care settings. OBJECTIVE: To determine whether a multicomponent intervention, Improving the safety of opioid therapy (ISOT), is efficacious in reducing prescription opioid harms. DESIGN: Clinician-level, cluster randomized clinical trial. ( ClinicalTrials.gov : NCT02791399) SETTING: Eight primary care clinics at 1 Veterans Affairs health care system. PARTICIPANTS: Thirty-five primary care clinicians and 286 patients who were prescribed long-term opioid therapy (LTOT). INTERVENTION: All clinicians participated in a 2-hour educational session on patient-centered care surrounding opioid adherence monitoring and were randomly assigned to education only or ISOT. ISOT is a multicomponent intervention that included a one-time consultation by an external clinician to the patient with monitoring and feedback to clinicians over 12 months. MAIN MEASURES: The primary outcomes were changes in risk for prescription opioid misuse (Current Opioid Misuse Measure) and urine drug test results. Secondary outcomes were quality of the clinician-patient relationship, other prescription opioid safety outcomes, changes in clinicians' opioid prescribing characteristics, and a non-inferiority analysis of changes in pain intensity and functioning. KEY RESULTS: ISOT did not decrease risk for prescription opioid misuse (difference between groups = -1.12, p = 0.097), likelihood of an aberrant urine drug test result (difference between groups = -0.04, p=0.401), or measures of the clinician-patient relationship. Participants allocated to ISOT were more likely to discontinue prescription opioids (20.0% versus 8.1%, p = 0.007). ISOT did not worsen participant-reported scores of pain intensity or function. CONCLUSIONS: ISOT did not impact risk for prescription opioid misuse but did lead to increased likelihood of prescription opioid discontinuation. More intensive interventions may be needed to impact treatment outcomes.

Do Urine Drug Tests Reveal Substance Misuse Among Patients Prescribed Opioids for Chronic Pain?

BACKGROUND: Urine drug testing (UDT) is a recommended risk mitigation strategy for patients prescribed opioids for chronic pain, but evidence that UDT supports identification of substance misuse is limited. OBJECTIVE: Identify the prevalence of UDT results that may identify substance misuse, including diversion, among patients prescribed opioids for chronic pain. DESIGN: Retrospective cohort study. SUBJECTS: Patients (n=638) receiving opioids for chronic pain who had one or more UDTs, examining up to eight substances per sample, during a one 1-year period. MAIN MEASURES: Experts adjudicated the clinical concern that UDT results suggest substance misuse or diversion as not concerning, uncertain, or concerning. KEY RESULTS: Of 638 patients, 48% were female and 49% were over age 55 years. Patients had a median of three UDTs during the intervention year. We identified 37% of patients (235/638) with ≥1 concerning UDT and a further 35% (222/638) having ≥1 uncertain UDT. We found concerning UDTs due to non-detection of a prescribed substance in 24% (156/638) of patients and detection of a non-prescribed substance in 23% (147/638). Compared to patients over 65 years, those aged 18-34 years were more likely to have concerning UDT results with an adjusted odds ratio (AOR) of 4.8 (95% confidence interval [CI] 1.9-12.5). Patients with mental health diagnoses (AOR 1.6 [95% CI 1.1-2.3]) and substance use diagnoses (AOR 2.3 [95% CI 1.5-3.7]) were more likely to have a concerning UDT result. CONCLUSIONS: Expert adjudication of UDT results identified clinical concern for substance misuse in 37% of patients receiving opioids for chronic pain. Further research is needed to determine if UDTs impact clinical practice or patient-related outcomes.

Teaming in Interdisciplinary Chronic Pain Management Interventions in Primary Care: a Systematic Review of Randomized Controlled Trials.

BACKGROUND: Current pain management recommendations emphasize leveraging interdisciplinary teams. We aimed to identify key features of interdisciplinary team structures and processes associated with improved pain outcomes for patients experiencing chronic pain in primary care settings. METHODS: We searched PubMed, EMBASE, and CINAHL for randomized studies published after 2009. Included studies had to report patient-reported pain outcomes (e.g., BPI total pain, GCPS pain intensity, RMDQ pain-related disability), include primary care as an intervention setting, and demonstrate some evidence of teamwork or teaming; specifically, they needed to involve at least two clinicians interacting with each other and with patients in an ongoing process over at least two timepoints. We assessed study quality with the Cochrane Risk of Bias tool. We narratively synthesized intervention team structures and processes, comparing among interventions that reported a clinically meaningful improvement in patient-reported pain outcomes defined by the minimal clinically important difference (MCID). RESULTS: We included 13 total interventions in our review, of which eight reported a clinically meaningful improvement in at least one patient-reported pain outcome. No included studies had an overall high risk of bias. We identified the role of a care manager as a common structural feature of the interventions with some clinical effect on patient-reported pain. The team processes involving clinicians varied across interventions reporting clinically improved pain outcomes. However, when analyzing team processes involving patients, six of the interventions with some clinical effect on pain relied on pre-scheduled phone calls for continuous patient follow-up. DISCUSSION: Our review suggests that interdisciplinary interventions incorporating teamwork and teaming can improve patient-reported pain outcomes in comparison to usual care. Given the current evidence, future interventions might prioritize care managers and mechanisms for patient follow-up to help bridge the gap between clinical guidelines and the implementation of interdisciplinary, team-based chronic pain care.

Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials.

BACKGROUND: The PROMIS depression scales are reliable and valid measures that have extensive normative data in general population samples. However, less is known about how responsive they are to detect change in clinical settings and how their responsiveness compares to legacy measures. The purpose of this study was to assess and compare the responsiveness of the PROMIS and Patient Health Questionnaire (PHQ) depression scales in three separate samples. METHODS: We used data from three clinical trials (two in patients with chronic pain and one in stroke survivors) totaling 651 participants. At both baseline and follow-up, participants completed four PROMIS depression fixed-length scales as well as legacy measures: Patient Health Questionnaire 9-item and 2-item scales (PHQ-9 and PHQ-2) and the SF-36 Mental Health scale. We measured global ratings of depression change, both prospectively and retrospectively, as anchors to classify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area-under-curve analysis. RESULTS: The PROMIS depression and legacy scales had generally comparable responsiveness. Moreover, the four PROMIS depression scales of varying lengths were similarly responsive. In general, measures performed better in detecting depression improvement than depression worsening. For all measures, responsiveness varied based on the study sample and on whether depression improved or worsened. CONCLUSIONS: Both PROMIS and PHQ depression scales are brief public domain measures that are responsive (i.e., sensitive to change) and thus appropriate as outcome measures in research as well as for monitoring treatment in clinical practice. Trial registration ClinicalTrials.gov ID: NCT01236521, NCT01583985, NCT01507688.

Opioid Use as a Predictor of Pain Outcomes in Iraq and Afghanistan Veterans with Chronic Pain: Analysis of a Randomized Controlled Trial.

OBJECTIVE: Our objectives were to: 1) assess the relationship between self-reported opioid use and baseline demographics, clinical characteristics and pain outcomes; and 2) examine whether baseline opioid use moderated the intervention effect on outcomes at 9 months. DESIGN: We conducted a secondary analysis of data from the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial, which found stepped-care to be effective for chronic pain in military veterans. SETTING: A post-deployment clinic and five general medicine clinics at a Veteran Affairs Medical Center. SUBJECTS: In total 241 veterans with chronic musculoskeletal pain; 220 with complete data at 9 months. METHODS: Examination of baseline relationships and multivariable linear regression to examine baseline opioid use as a moderator of pain-related outcomes including Roland Morris Disability Questionnaire (RMDQ), Brief Pain Inventory (BPI) Interference scale, and Graded Chronic Pain Scale (GCPS) at 9 months. RESULTS: Veterans reporting baseline opioid use (n = 80) had significantly worse RMDQ (16.0 ± 4.9 vs. 13.4 ± 4.2, P < .0001), GCPS (68.7 ± 12.0 vs. 65.0 ± 14.4, P = .049), BPI Interference (6.2 ± 2.2 vs. 5.0 ± 2.1, P < .0001), and depression (PHQ-9 12.5 ± 6.2 vs. 10.6 ± 5.7, P = .016) compared to veterans not reporting baseline opioid use. Using multivariable modeling we found that baseline opioid use moderated the intervention effect on pain-related disability (RMDQ) at 9 months (interaction Beta = -3.88, P = .0064) but not pain intensity or interference. CONCLUSIONS: In a stepped-care trial for pain, patients reporting baseline opioid use had greater improvement in pain disability at 9 months compared to patients not reporting opioid use.

Multifocal Pain as a Predictor of Pain Outcomes in Military Veterans with Chronic Musculoskeletal Pain: A Secondary Data Analysis of a Randomized Controlled Trial.

OBJECTIVE: We aimed to examine 1) the relationship between multifocal pain and clinical characteristics, including demographics, pain outcomes, somatic symptoms, health-related quality of life, depression, and anxiety, and 2) whether multifocal pain was independently associated with treatment response. METHODS: We conducted a secondary data analysis on veterans with chronic pain enrolled in the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial with complete data at 9 months (n = 222). We examined baseline relationships and used multivariable linear regression to examine whether multifocal pain was independently associated with outcomes that included Brief Pain Inventory (BPI) Interference scale and Graded Chronic Pain Scale (GCPS) scores between baseline and 9 months. RESULTS: The sample had a mean BPI Interference score of 5.3 ± 2.2 and a mean GCPS score of 65.6 ± 13.7, 55% had significant depression (Patient Health Questionnaire 9-item depression scale [PHQ-9] score of ≥10), and 42% had significant anxiety (Generalized Anxiety Disorder Scale [GAD-7] score of ≥10). Veterans reporting three or more pain sites (the "more diffuse pain" group) had significantly less improvement on GCPS (b = 4.6, standard error [SE] = 2.3, P = 0.045), BPI Interference (b = 1.0, SE = 0.2, P = 0.0011), and health-related quality of life (Short-Form 36-item scale, Physical Component Summary) (b = 4.1, SE = 1.0, P < 0.0001) than did veterans reporting fewer than three pain sites (the "less diffuse pain" group). More diffuse pain was not associated with changes in PHQ-9 or GAD-7 scores. CONCLUSIONS: Multifocal pain predicted worse pain outcomes between baseline and 9 months in veterans enrolled in a trial for treating chronic musculoskeletal pain.

Fibromyalgia.

Fibromyalgia is characterized by chronic, widespread musculoskeletal pain and associated fatigue, sleep disturbances, and other cognitive and somatic symptoms. For many patients, these symptoms persist for years and lead to frequent health care use; for some, fibromyalgia and its symptoms can be debilitating. Although many treatments are available, management remains challenging. This article highlights the clinical features of fibromyalgia, discusses diagnostic criteria and their evolution, and reviews treatment options.

Complementary, Integrative, and Nondrug Therapy Use for Pain Among US Military Veterans on Long-term Opioids.

BACKGROUND: Long-term opioid therapy for chronic pain arose amid limited availability and awareness of other pain therapies. Although many complementary and integrative health (CIH) and nondrug therapies are effective for chronic pain, little is known about CIH/nondrug therapy use patterns among people prescribed opioid analgesics. OBJECTIVE: The objective of this study was to estimate patterns and predictors of self-reported CIH/nondrug therapy use for chronic pain within a representative national sample of US military veterans prescribed long-term opioids for chronic pain. RESEARCH DESIGN: National two-stage stratified random sample survey combined with electronic medical record data. Data were analyzed using logistic regressions and latent class analysis. SUBJECTS: US military veterans in Veterans Affairs (VA) primary care who received ≥6 months of opioid analgesics. MEASURES: Self-reported use of each of 10 CIH/nondrug therapies to treat or cope with chronic pain in the past year: meditation/mindfulness, relaxation, psychotherapy, yoga, t'ai chi, aerobic exercise, stretching/strengthening, acupuncture, chiropractic, massage; Brief Pain Inventory-Interference (BPI-I) scale as a measure of pain-related function. RESULTS: In total, 8891 (65%) of 13,660 invitees completed the questionnaire. Eighty percent of veterans reported past-year use of at least 1 nondrug therapy for pain. Younger age and female sex were associated with the use of most nondrug therapies. Higher pain interference was associated with lower use of exercise/movement therapies. Nondrug therapy use patterns reflected functional categories (psychological/behavioral, exercise/movement, manual). CONCLUSIONS: Use of CIH/nondrug therapies for pain was common among patients receiving long-term opioids. Future analyses will examine nondrug therapy use in relation to pain and quality of life outcomes over time.

Yoga Practice Among Veterans With and Without Chronic Pain: A Mixed Methods Study.

OBJECTIVES: The primary aim of this study was to examine differences in yoga practice between persons with and without chronic pain. Secondarily, we describe use of the Essential Properties of Yoga Questionnaire, Short Form (EPYQ-SF) for self-report. DESIGN: Participants were members of an existing cohort of veterans who completed a 2015-2016 survey focused on pain and nonpharmacological health practices. Cohort members who reported yoga in the past year [n=174 (9.4%) of 1850] were eligible for the present study, which used multiple-contact mixed-mode survey methodology to collect data on yoga practices. The EPYQ-SF was used to assess properties and context of yoga practice. Practice patterns were compared for participants with and without chronic pain. To explore potential reasons for reported yoga practice patterns, focused semistructured interviews were conducted with a subset of participants. RESULTS: Of 174 participants contacted, 141 (82%) returned the yoga questionnaire and 110 (78% of respondents) were still practicing yoga. Among yoga practitioners, 41 (37%) had chronic pain. Practitioners with chronic pain reported gentler (2.8 vs. 3.1, 5-point scale) and less active (2.9 vs. 3.3) yoga practice than those without. Those with chronic pain attended yoga studios less frequently and reported shorter yoga practices than those without. Most yoga practice was self-directed and at home. CONCLUSIONS: Differences in yoga practice of persons with and without chronic pain have implications for implementation of yoga interventions for chronic pain. Future interventions should focus on alternative individual delivery formats or addressing barriers to group practice among people with chronic pain.

Association Between Opioid Dose Reduction Against Patients' Wishes and Change in Pain Severity.

BACKGROUND: There is inadequate evidence of long-term benefit from opioid medications for chronic pain and substantial evidence of potential harms. For patients, dose reduction may be beneficial when implemented voluntarily and supported by a multidisciplinary team but experts have advised against involuntary opioid reduction. OBJECTIVES: To assess the prevalence of self-reported involuntary opioid reduction and to examine whether involuntary opioid reduction is associated with changes in pain severity. DESIGN: Prospective observational cohort study. PARTICIPANTS: Primary care patients treated with long-term opioid therapy in the Veterans Health Administration (N = 290). MAIN MEASURES: The primary exposure was self-reported past year involuntary opioid reduction. The primary outcome was the three-item PEG scale, which measures past-week average pain intensity and interference with enjoyment of life and general activity. KEY RESULTS: Past year opioid reduction or discontinuation was reported by 63% (184/290). Similar numbers reported involuntary (88/290) and voluntary (96/290) opioid reduction. At baseline, there were no significant differences in pain severity between the groups (mean PEG, 7.08 vs. 6.73 vs. 7.07 for past year involuntary opioid reduction, past year voluntary opioid reduction, and no past year opioid reduction, respectively; P = 0.32). For the primary outcome of change in pain severity from baseline to 18 months, there were no significant differences between groups (mean PEG change, - 0.05 vs. - 0.44 vs. - 0.23 for past year involuntary opioid reduction, past year voluntary opioid reduction, and no past year opioid reduction, respectively; P = 0.28). CONCLUSIONS: Self-reported past year involuntary opioid reduction was common among a national sample of veterans treated with long-term opioid therapy. Opioid dose reduction, whether involuntary or voluntary, was not associated with change in pain severity. Future studies should examine involuntary opioid reduction in different populations and trends over time and explore further patient- and provider-level factors that may impact patient experience and outcomes during opioid reduction.

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.

Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial.

OBJECTIVE: Sleep disturbance may limit improvement in pain outcomes if not directly addressed in treatment. Moreover, sleep problems may be exacerbated by opioid therapy. This study examined the effects of baseline sleep disturbance on improvement in pain outcomes using data from the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial, a pragmatic 12-month randomized trial of opioid vs nonopioid medication therapy. DESIGN: Participants with chronic back pain or hip or knee osteoarthritis pain were randomized to either opioid therapy (N = 120) or nonopioid medication therapy (N = 120). METHODS: We used mixed models for repeated measures to 1) test whether baseline sleep disturbance scores modified the effect of opioid vs nonopioid treatment on pain outcomes and 2) test baseline sleep disturbance scores as a predictor of less improvement in pain outcomes across both treatment groups. RESULTS: The tests for interaction of sleep disturbance by treatment group were not significant. Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (ß = 0.058, P = 0.0002) and BPI severity (ß = 0.026, P = 0.0164). CONCLUSIONS: Baseline sleep disturbance adversely affects pain response to treatment regardless of analgesic regimen. Recognition and treatment of sleep impairments that frequently co-occur with pain may optimize outcomes.

Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain.

BACKGROUND: Low back pain is a leading cause of disability in veterans. Chiropractic care is a well-integrated, nonpharmacological therapy in Veterans Affairs health care facilities, where doctors of chiropractic provide therapeutic interventions focused on the management of low back pain and other musculoskeletal conditions. However, important knowledge gaps remain regarding the effectiveness of chiropractic care in terms of the number and frequency of treatment visits needed for optimal outcomes in veterans with low back pain. DESIGN: This pragmatic, parallel-group randomized trial at four Veterans Affairs sites will include 766 veterans with chronic low back pain who are randomly allocated to a course of low-dose (one to five visits) or higher-dose (eight to 12 visits) chiropractic care for 10 weeks (Phase 1). After Phase 1, participants within each treatment arm will again be randomly allocated to receive either monthly chiropractic chronic pain management for 10 months or no scheduled chiropractic visits (Phase 2). Assessments will be collected electronically. The Roland Morris Disability Questionnaire will be the primary outcome for Phase 1 at week 10 and Phase 2 at week 52. SUMMARY: This trial will provide evidence to guide the chiropractic dose in an initial course of care and an extended-care approach for veterans with chronic low back pain. Accurate information on the effectiveness of different dosing regimens of chiropractic care can greatly assist health care facilities, including Veterans Affairs, in modeling the number of doctors of chiropractic that will best meet the needs of patients with chronic low back pain.

Whole Health Options and Pain Education (wHOPE): A Pragmatic Trial Comparing Whole Health Team vs Primary Care Group Education to Promote Nonpharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans-Rationale, Methods, and Implementation.

BACKGROUND: The Whole Health model of the U.S. Department of Veterans Affairs (VA) emphasizes holistic self-care and multimodal approaches to improve pain, functioning, and quality of life. wHOPE (Whole Health Options and Pain Education) seeks to be the first multisite pragmatic trial to establish evidence for the VA Whole Health model for chronic pain care. DESIGN: wHOPE is a pragmatic randomized controlled trial comparing a Whole Health Team (WHT) approach to Primary Care Group Education (PC-GE); both will be compared to Usual VA Primary Care (UPC). The WHT consists of a medical provider, a complementary and integrative health (CIH) provider, and a Whole Health coach, who collaborate with VA patients to create a Personalized Health Plan emphasizing CIH approaches to chronic pain management. The active comparator, PC-GE, is adapted group cognitive behavioral therapy for chronic pain. The first aim is to test whether the WHT approach is superior to PC-GE and whether both are superior to UPC in decreasing pain interference in functioning in 750 veterans with moderate to severe chronic pain (primary outcome). Secondary outcomes include changes in pain severity, quality of life, mental health symptoms, and use of nonpharmacological and pharmacological therapies for pain. Outcomes will be collected from the VA electronic health record and patient-reported data over 12 months of follow-up. Aim 2 consists of an implementation-focused process evaluation and budget impact analysis. SUMMARY: This trial is part of the Pain Management Collaboratory, which seeks to create national-level infrastructure to support evidence-based nonpharmacological pain management approaches for veterans and military service personnel.

Setting Expectations, Following Orders, Safety, and Standardization: Clinicians' Strategies to Guide Difficult Conversations About Opioid Prescribing.

BACKGROUND: Evidence has continued to accumulate regarding the potential risks of treating chronic pain with long-term opioid therapy (LTOT). Clinical practice guidelines now encourage clinicians to implement practices designed to reduce opioid-related risks. Yet how clinicians implement these guidelines within the context of the patient encounter has received little attention. OBJECTIVE: This secondary analysis aimed to identify and describe clinicians' strategies for managing prescription opioid misuse and aberrant behaviors among patients prescribed LTOT for chronic pain. DESIGN: Individual interviews guided by a semi-structured interview protocol probed: (1) methods clinicians utilize to reduce prescription opioid misuse and address aberrant opioid-related behaviors; (2) how clinicians respond to misuse; and (3) resources and constraints faced in managing and treating misuse among their patients. PARTICIPANTS: Interviews were conducted with 24 physicians and nurse practitioners, representing 22 Veterans Health Administration (VA) facilities across the USA, who had one or more patients in their clinical panels who were prescribed LTOT for the treatment of chronic non-cancer pain. APPROACH: Qualitative content analysis was the analytic approach utilized. A codebook was developed iteratively following group coding and discussion. All transcripts were coded with the finalized codebook. Quotes pertaining to key themes were retrieved and, following careful review, sorted into themes, which were then further categorized into sub-themes. Quotes that exemplified key sub-themes were selected for inclusion. KEY RESULTS: We detail the challenges clinicians describe in navigating conversations with patients around prescription opioid misuse, which include patient objection as well as clinician ambivalence. We identify verbal heuristics as one strategy clinicians utilize to structure these difficult conversations, and describe four heuristics: setting expectations, following orders, safety, and standardization. CONCLUSION: Clinicians frequently use verbal heuristics to routinize and increase the efficiency of care management discussions related to opioid prescribing, redirect responsibility, and defuse the potential emotional charge of the encounter.

Clinical Strategies for the Treatment and Management of Patients Prescribed Long-term Opioid Therapy.

OBJECTIVES: Across diverse health care systems, growing recognition of the harms associated with long-term opioid therapy (LTOT) for chronic pain has catalyzed substantial changes to policy and practice designed to promote safer prescribing and patient care. Although clear goals have been defined, how clinics and providers should most effectively implement these changes has been less well defined, and facilities and providers have had substantial flexibility to innovate. METHODS: Qualitative interviews were conducted with 24 Department of Veterans Affairs (VA) clinicians across the United States who prescribe LTOT for chronic pain. Interviews probed the practices and initiatives providers utilized to meet opioid safety requirements and address common challenges in caring for patients prescribed LTOT. RESULTS: Innovative strategies in the design and organization of clinical practice (urine drug testing, informed consent, limiting transfer requests, specialty patient panel) and resources utilized (engaged pharmacists, non-opioid pain treatments, intra-organizational collaborations) are described. CONCLUSIONS: We conclude with recommendations designed to improve opioid prescribing practices, both within the VA and in other settings.

Core Outcome Measures for Chronic Musculoskeletal Pain Research: Recommendations from a Veterans Health Administration Work Group.

OBJECTIVE: Chronic musculoskeletal pain (CMSP) disorders are among the most prevalent and disabling conditions worldwide. It would be advantageous to have common outcome measures when comparing results across different CMSP research studies. METHODS: The Veterans Health Administration appointed a work group to recommend core outcome measures for assessing pain intensity and interference as well as important secondary domains in clinical research. The work group used three streams of data to inform their recommendations: 1) literature synthesis augmented by three recently completed trials; 2) review and comparison of measures recommended by other expert groups; 3) two Delphi surveys of work group members. RESULTS: The single-item numerical rating scale and seven-item Brief Pain Inventory interference scale emerged as the recommended measures for assessing pain intensity and interference, respectively. The secondary domains ranked most important included physical functioning and depression, followed by sleep, anxiety, and patient-reported global impression of change (PGIC). For these domains, the work group recommended the Patient-Reported Outcome Information System four-item physical function and sleep scales, the Patient Health Questionnaire two-item depression scale, the Generalized Anxiety Disorder two-item anxiety scale, and the single-item PGIC. Finally, a single-item National Health Interview Survey item was favored for defining chronic pain. CONCLUSIONS: Two scales comprising eight items are recommended as core outcome measures for pain intensity and interference in all studies of chronic musculoskeletal pain, and brief scales comprising 13 additional items can be added when possible to assess important secondary domains.

Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline: A Consensus Panel Report.

BACKGROUND: A national crisis of opioid-related morbidity, mortality, and misuse has led to initiatives to address the appropriate role of opioids to treat pain. Deployment of a guideline from the Centers for Disease Control and Prevention to reduce the risks of opioid therapy has raised substantial clinical and public policy challenges. The agency anticipated implementation challenges and committed to reevaluating the guideline for intended and unintended effects on clinician and patient outcomes. OBSERVATIONS: A multidisciplinary expert panel met to review the influence of the core recommendations of the guideline on pain management practices, principally regarding the estimated 5 to 8 million Americans with chronic pain currently on opioids. The panel identified implementation challenges, including application of dosage ceilings and prescription duration guidance, failure to appreciate the importance of patient involvement in decisions to taper or discontinue opioids, barriers to diagnosis and treatment of opioid use disorder, and impeded access to recommended comprehensive, multimodal pain care. Furthermore, policy-making and regulatory bodies may misapply guideline recommendations without flexibility and, sometimes, without full awareness of what the guideline contains. CONCLUSIONS AND RELEVANCE: The panel largely supported the guideline, endorsing its focal points of safety and comprehensive assessment and monitoring. To mitigate clinical and policy challenges identified with implementing the guideline, the panel discussed areas where viewpoints diverged and arrived at consensus proposals. The target audience includes the leaders and institutions that create policy and influence guideline implementation to include regulatory agencies, legislators, public and private payers, and health care systems.