Search

Interventions to reduce harms related to prescription opioids are needed in primary care settings.To determine whether a multicomponent intervention, Improving the safety of opioid therapy (ISOT), is efficacious in reducing prescription opioid harms.Clinician-level, cluster randomized clinical trial. ( ClinicalTrials.gov : NCT02791399) SETTING: Eight primary care clinics at 1 Veterans Affairs health care system.Thirty-five primary care clinicians and 286 patients who were prescribed long-term opioid therapy (LTOT).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.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.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.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.

The purpose of this study was to evaluate changes in pain intensity among Veterans transitioning from long-term opioid therapy (LTOT) to either intermittent therapy or discontinuation compared to continued LTOT. Pain intensity was assessed using the Numeric Rating Scale in 90-day increments starting in the 90-day period prior to potential opioid transitions and the two ensuing 90-day periods after transition. Primary analyses used a 1:1 greedy propensity matched sample. A total of 29,293 Veterans switching to intermittent opioids and 5,972 discontinuing opioids were matched to Veterans continuing LTOT. Covariates were well balanced after matching except minor differences in baseline mean pain scores. Pain scores were lower in the follow up periods for those switching to intermittent opioids and discontinuing opioids compared to those continuing LTOT (0-90 days: Intermittent: 3.79, 95%CI: 3.76, 3.82; LTOT: 4.09, 95%CI: 4.06, 4.12, P < .0001; Discontinuation: 3.06, 95%CI: 2.99, 3.13; LTOT: 3.86, 95%CI: 3.79, 3.94, P =

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. Identify the prevalence of UDT results that may identify substance misuse, including diversion, among patients prescribed opioids for chronic pain. Retrospective cohort study. 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. Experts adjudicated the clinical concern that UDT results suggest substance misuse or diversion as not concerning, uncertain, or concerning. 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. 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.

The Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study is a 12-month pragmatic randomized comparative effectiveness trial conducted at ten United States Veterans Affairs (VA) health care sites. The overall goal was to test interventions to improve pain while reducing opioid use among VA patients with moderate-severe chronic pain despite treatment with long-term opioid therapy (LTOT). Aims were 1) to compare lower-intensity telecare collaborative pain management (TCM) versus higher-intensity integrated pain team management (IPT), and 2) to test the option of switching to buprenorphine (versus no option) in a high-dose subgroup. Recruitment challenges included secular trends in opioid prescribing and the COVID-19 pandemic. Participants were recruited over 3.5 years. Of 6966 potentially eligible patients, 4731 (67.9%) were contacted for telephone eligibility interview; of those contacted, 3398 (71.8%) declined participation, 359 (7.6%) were ineligible, 821 (24.2%) enrolled, and 820 (24.1%) were randomized. The most common reason for declining was satisfaction with pain care (n = 731). The most common reason for ineligibility was not having moderate-severe chronic pain (n = 110). Compared with the potentially eligible population, randomized participants were slightly younger, more often female, had similar prescribed opioids, and had similar or higher rates of pain and mental health diagnoses. The enrolled patient number was lower than the original target, but sufficient to power planned analyses. In conclusion, the VOICE trial enrolled a diverse sample similar to the population of VA patients receiving LTOT. Results will add substantially to limited existing evidence for interventions to improve pain while reducing opioid use. ClinicalTrials.gov identifier: NCT03026790.

BACKGROUND: Sexual assault affects one in three U.S. women and may have lifelong consequences for women's health, including potential barriers to completing cervical cancer screening and more than twofold higher cervical cancer risk. The objective of this study was to determine whether a history of sexual assault is associated with reduced cervical cancer screening completion among women Veterans. MATERIALS AND METHODS: We analyzed data from a 2015 survey of women Veterans who use primary care or women's health services at 12 Veterans Health Administration facilities (VA's) in nine states. We linked survey responses with VA electronic health record data and used logistic regression to examine the association of lifetime sexual assault with cervical cancer screening completion within a guideline-concordant interval. RESULTS: The sample included 1049 women, of whom 616 (58.7%) reported lifetime sexual assault. Women with a history of sexual assault were more likely to report a high level of distress related to pelvic examinations, and to report ever delaying a gynecologic examination due to distress. However, in the final adjusted model, lifetime sexual assault was not significantly associated with reduced odds of cervical cancer screening completion (OR 1.35, 95% CI 0.93–1.97). CONCLUSIONS: Contrary to our expectations, sexual assault was not significantly associated with gaps in cervical cancer screening completion. Three- to five-year screening intervals may provide sufficient time to complete screening, despite barriers. Trauma-sensitive care practices promoted in the VA may allow women to overcome the distress and discomfort of pelvic examinations to complete needed screening. ClinicalTrials.gov (#NCT02039856).

Conflicts of interest: No potential conflicts exist for any author listed.Abstract 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.

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.

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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07255-w.

BACKGROUND: Increasing pressures exist to reduce or discontinue opioid use among patients currently on long-term opioid therapy (LTOT). It is essential to understand the potential effects of opioid reduction. METHODS: This retrospective cohort study was conducted among veterans with chronic pain and on LTOT. Using 1:1 propensity score-matched samples of veterans switching to intermittent opioid therapy and those continuing LTOT, we examined the development of subsequent substance use disorders (SUD composite; individual SUD types: opioid, non-opioid drug, and alcohol use disorders) and opioid-related adverse outcomes (ORAO composite; individual ORAO types: accidents resulting in wounds/injuries, opioid-related and alcohol/non-opioid medication-related accidents and overdoses, self-inflicted and violence-related injuries). Sensitivity analyses were conducted using logistic regression with stabilized inverse probability of treatment weighting (SIPTW) and instrumental variable (IV) models. RESULTS: A total of 29,293 veterans switching to intermittent therapy were matched to veterans continuing LTOT. With matched samples, no differences were found in composite SUDs and OR AOs between the groups. With SIPTW, veterans switching to intermittent opioid therapy had higher odds of composite SUDs and ORAOs (SUDs aOR=1.12, 95%CI: 1.07,1.17; ORAOs aOR=1.05, 95%CI:1.00,1.09). IV models found lower risks for composite SUDs and ORAOs among veterans switching to intermittent opioid therapy (SUDs: β = −0.38, 95%CI:−0.63,−0.13; ORAOs: β = −0.27, 95%CI:−0.50,−0.04). CONCLUSIONS: There were no consistent associations between transitioning patients from LTOT to intermittent opioid therapy and the risk of SUDs and ORAOs.

BACKGROUND AND AIM: Prescribers are commonly confronted with discontinuing opioid therapy among patients prescribed chronic opioid therapy (COT). This study aimed to measure the association between discontinuing COT and diagnoses of substance use disorders (SUDs) and opioid-related adverse outcomes (AOs). DESIGN: Retrospective cohort study SETTING: U.S. Veterans Healthcare Administration PARTICIPANTS: Veterans with chronic pain on COT who discontinued opioid therapy were compared with those continuing COT using data from fiscal years 2009–2015. MEASUREMENTS: Newly diagnosed substance use disorders (SUD composite; individual types: opioid, non-opioid drug, and alcohol use disorders) and opioid-related adverse outcomes (AO composite; individual types: accidents resulting in wounds/injuries, opioid-related accidents/overdoses, alcohol and non-opioid medication-related accidents/overdoses, self-inflicted injuries, and violence-related injuries) were evaluated. Primary analyses were conducted using 1:1 matching of discontinuers with those continuing COT based on propensity score and index date (±180-day window). Sensitivity analyses were conducted using logistic regressions with stabilized inverse probability of treatment weighting (SIPTW) and instrumental variable (IV) models. FINDINGS: A total of 15,695 (75.4%) and 17,337 (76.6%) discontinuers were matched with those continuing COT among the cohorts testing SUD and AO development respectively. In the primary propensity score matched analyses, the composite SUD outcome was not different between discontinuers and those continuing COT (odds ratio (OR)=0.932, 95% confidence interval (CI): 0.850, 1.022). The composite AO outcome was lower among discontinuers (OR=0.660, 95%CI: 0.623, 0.699) compared with those continuing COT. SIPTW analyses found lower SUD (OR=0.789, 95%CI: 0.743, 0.837), and AO (OR=0.660, 95%CI: 0.623, 0.699) rates among discontinuers. IV models found mixed and sometimes contradictory results. CONCLUSIONS: Discontinuing patients from chronic opioid therapy appears to be associated with decreased diagnoses for opioid-related adverse outcomes. The association with substance use disorders appears to be inconclusive.

Aim To understand the potential harmful effects of dose escalation among patients with chronic, non-cancer pain (CNCP) on chronic opioid therapy. Design Retrospective cohort study. Setting United States Veterans Healthcare Administration. Participants Veterans with CNCP and on chronic opioid therapy were identified using data from fiscal years 2008-15. The Veteran sample was approximately 90% male and 70% white. Measurements Dose escalators [increase of > 20% average morphine milligram equivalent (MME) daily dose] were compared with dose maintainers (change of ±20% average MME daily dose). A composite measure of subsequent substance use disorders (SUDs: opioid, non-opioid and alcohol use disorders) and opioid-related adverse outcomes (AOs: accidents resulting in wounds/injuries, opioid-related and alcohol and non-opioid medication-related accidents and overdoses, self-inflicted injuries) as well as the individual SUDs and AOs was examined. The primary analyses were conducted among a 1 : 1 matched sample of escalators and maintainers matched on propensity score and index date. Propensity scores were generated using demographic characteristics, medical comorbidities, medication and health-care utilization characteristics. Subgroup analyses were conducted by quartile of the propensity score. Sensitivity analyses were conducted using adjusted logistic regression, logistic regression using stabilized inverse probability of treatment weighting (SIPTW) and instrumental variable (IV) models using geographic variation in opioid dose escalation as the IV. Findings There were 32 420 maintainers and 20 767 escalators resulting in 19 358 (93.2%) matched pairs. Composite AOs [odds ratio (OR) = 1.31, 95% confidence interval (CI) = 1.23, 1.40], composite SUDs (OR = 1.31, 95% CI = 1.22, 1.41) and individual SUD and AO subtypes were higher among dose escalators, except for opioid-related accidents and overdoses and violence-related injuries. Subgroup analyses within the propensity score quartiles found similar results. Sensitivity analyses with the adjusted and SIPTW logistic regressions found similar results to the primary analyses for all outcomes except for opioid-related accidents and overdoses, which were found to be significantly higher among escalators. Sensitivity analyses with IV models provided mixed results with SUDs and the individual types of AOs. Conclusion Escalating the opioid dose for those with chronic, non-cancer pain is associated with increased risks of substance use disorder and opioid-related adverse outcomes.

OBJECTIVEOpioids are commonly prescribed after surgery for painful spinal conditions, yet little is known about postoperative opioid use. The relationship between chronic opioid use and patient-reported outcomes and satisfaction with surgery is also unclear. The purpose of this study was to evaluate factors associated with opioid use 1 year after elective cervical spine surgery for degenerative conditions causing radiculopathy and myelopathy. The authors hypothesized that patients with preoperative opioid use would be more likely to report postoperative opioid use at 1 year, and that postoperative opioid use would be associated with patient-reported outcomes and dissatisfaction with surgery.METHODSThe authors performed a retrospective study of a prospective cohort of adult patients who underwent elective cervical spine surgery for degenerative changes causing radiculopathy or myelopathy. Patients were prospectively and consecutively enrolled from a single academic center after the decision for surgery had been made. Postoperative in-hospital pain management was conducted using a standardized protocol. The primary outcome was any opioid use 1 year after surgery. Secondary outcomes were the Neck Disability Index (NDI); 36-Item Short-Form Health Survey (SF-36) physical function (PF), bodily pain (BP), and mental component summary (MCS) scores; the modified Japanese Orthopaedic Association (mJOA) score among myelopathy patients; and patient expectations surveys. Patients with and without preoperative opioid use were compared using the chi-square and Student t-tests, and multiple logistic regression was used to study the associations between patient and surgical characteristics and postoperative opioid use 1 year after surgery.RESULTSTwo hundred eleven patients were prospectively and consecutively enrolled, of whom 39 were lost to follow-up for the primary outcome; 43.6% reported preoperative opioid use. Preoperative NDI and SF-36 PF and BP scores were significantly worse in the preoperative opioid cohort. More than 94% of both cohorts rated expectations of pain relief as extremely or somewhat important. At 1 year after surgery, 50.7% of the preoperative-opioid-use cohort reported ongoing opioid use, and 17.5% of patients in the no-preoperative-opioid-use cohort reported ongoing opioid use. Despite this, both cohorts reported similar improvements in NDI as well as SF-36 PF, BP, and MCS scores. More than 70% of both cohorts also reported being extremely or somewhat satisfied with pain relief after surgery. Predictors of 1-year opioid use included preoperative opioid use, duration of symptoms for more than 9 months before surgery, tobacco use, and higher comorbidity index.CONCLUSIONSOne year after elective cervical spine surgery, patients with preoperative opioid use were significantly more likely to report ongoing opioid use. However, patients in both groups reported similar improvements in patient-reported outcomes and satisfaction with pain relief. Interventions targeted at decreasing opioid use may need to focus on patient factors such as preoperative opioid use or duration of symptoms before surgery.

ObjectiveSleep 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.DesignParticipants with chronic back pain or hip or knee osteoarthritis pain were randomized to either opioid therapy (N = 120) or nonopioid medication therapy (N = 120).MethodsWe 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.ResultsThe 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 (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164).ConclusionsBaseline 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.

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 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.

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 Conclusions Multifocal pain predicted worse pain outcomes between baseline and 9 months in veterans enrolled in a trial for treating chronic musculoskeletal pain.

Objective To determine the diagnostic operating characteristics of The Patient Reported Outcomes Measurement Information Systems (PROMIS) depression scales in screening for major depression. Methods Interview data from patients enrolled in clinical trials involving patients with chronic pain (2 trials) or post-stroke (1 trial) were analyzed. This included baseline and follow-up interviews in 648 and 586 study patients, respectively. Patients completed PROMIS depression scales of varying lengths (4-item, 6-item, and two 8-item scale versions) as well as the Patient Health Questionnaire 9-item (PHQ-9) depression scale. A Structured Clinical Interview for DSM Disorders (SCID) was administered to establish diagnoses of major depression and any depression. Sensitivity and specificity at various score cutpoints as well as area under the curve (AUC) were calculated. Results PROMIS scales of varying lengths had similar diagnostic operating characteristics. The optimal screening cutpoint for PROMIS raw scores on the 4-, 6-, and 8-item scales was 8, 12, and 16, respectively, which corresponds to a PROMIS T-score of 55. The average sensitivity and specificity of the two PROMIS 8-item scales for major depression across the 3 trials using a T-score cutpoint ≥55 was 0.81 and 0.84, respectively. This was almost identical to 0.81 and 0.82 for the PHQ-9 at its standard cutpoint score ≥ 10. The average AUC for major depression was identical (0.91) for the two PROMIS 8-item scales and PHQ-9, and also similar for any depression (0.87 to 0.89). Conclusion PROMIS scales ranging from 4 to 8 items have strong operating characteristics comparable to the PHQ-9 in screening for depression. Trial registration: ClinicalTrials.gov ID: NCT01236521 , NCT01583985 , NCT01507688

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

Purpose The rise in opioid prescribing, often for chronic pain management, resulted in an increased prevalence of opioid use disorder (OUD) throughout the United States, including within the Veterans Affairs (VA) healthcare system. The veteran population has been especially vulnerable to opioid-related harms, but rates of prescribing medications for OUD have been low. Use of care manager models for OUD have increased access to treatment. In this article we provide an overview of a clinical pharmacist care manager (CPCM) model for medications for OUD treatment implemented within the Minneapolis Veterans Affairs Health Care System. Summary A CPCM model for medications for OUD was identified as a care model that would address patient and facility barriers to effective OUD treatment. Pharmacists were integral in program development and implementation and served as the main care providers. An interim evaluation of the program established that the proportion of patients with OUD receiving medications for opioid use disorder (MOUD) had increased, with use of the program resulting in treatment of 109 unique patients during 625 visits. Key program implementation facilitators included the facility leadership establishing increased use of MOUD as a priority area, identification of a physician champion, and a history of successful expansion of clinical pharmacy specialist practice within the VA system. Implementation barriers included factors related to provider engagement, patient identification, and program support. The CPCM model of provision of MOUD expanded the pharmacist role in buprenorphine management. Conclusion The need to increase the number of patients receiving MOUD led to the implementation of a CPCM model. The program was effectively implemented into practice and expanded the availability of MOUD, which allowed patients to access treatment in multiple care settings.

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.

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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-020-06294-z) contains supplementary material, which is available to authorized users.

OBJECTIVE: 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 semi-structured 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 versus 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.

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.

Chronic musculoskeletal pain is a major public health problem. Although opioid prescribing for chronic pain has increased dramatically since the 1990s, this practice has come under scrutiny because of increases in opioid-related harms and lack of evidence for long-term effectiveness. The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial was a pragmatic 12-month randomized trial comparing the benefits and harms of opioid versus nonopioid medications for chronic musculoskeletal pain. The current qualitative study was designed to better understand trial results by exploring patients’ experiences, including perceptions of medications, experiences with the intervention, and whether expectations were met. Thirty-four participants who were purposefully sampled based on treatment group and intervention response participated in semistructured interviews. The constant comparison method guided analysis. Results revealed that participants often held strong beliefs about opioid medications, which sometimes changed during the trial as they gained experience with medications; participants described a wide variety of experiences with treatment effectiveness, regardless of study group or their response to the intervention; and participants highly valued the personalized pain care model used in SPACE. Perspective SPACE trial results indicated no advantage for opioid over nonopioid medications. Qualitative findings suggest that, for both treatment groups, preexisting expectations and anticipated improvement in pain shaped experiences with and responses to medications. The personalized pain care model was described as contributing to positive outcomes in both groups.

Background Women comprise a growing proportion of Veterans seeking care at Veterans Affairs (VA) healthcare facilities. VA initiatives have accelerated changes in services for female Veterans, yet the corresponding literature has not been systematically reviewed since 2008. In 2015, VA Women’s Health Services and the VA Women’s Health Research Network requested an updated literature review to facilitate policy and research planning. Methods The Minneapolis VA Evidence-based Synthesis Program performed a systematic search of research related to female Veterans’ health published from 2008 through 2015. We extracted study characteristics including healthcare topic, design, sample size and proportion female, research setting, and funding source. We created an evidence map by organizing and presenting results within and across healthcare topics, and describing patterns, strengths, and gaps. Results We identified 2276 abstracts and assessed each for relevance. We excluded 1092 abstracts and reviewed 1184 full-text articles; 750 were excluded. Of 440 included articles, 208 (47%) were related to mental health, particularly post-traumatic stress disorder (71 articles), military sexual trauma (37 articles), and substance abuse (20 articles). The number of articles addressing VA priority topic areas increased over time, including reproductive health, healthcare organization and delivery, access and utilization, and post-deployment health. Three or fewer articles addressed each of the common chronic diseases: diabetes, hypertension, depression, or anxiety. Nearly 400 articles (90%) used an observational design. Eight articles (2%) described randomized trials. Conclusions Our evidence map summarizes patterns, progress, and growth in the female Veterans’ health and healthcare literature. Observational studies in mental health make up the majority of research. A focus on primary care delivery over clinical topics in primary care and a lack of sex-specific results for studies that include men and women have contributed to research gaps in addressing common chronic diseases. Interventional research using randomized trials is needed.

Physicians are, by definition, contributing partners in "difficult" patient-physician encounters. Although research on relevant physician qualities is limited, common themes mirror the more extensive literature on physician burnout. Focusing on primary care, we discuss physician-level factors in difficult encounters related to psychosocial attitudes and self-awareness, communication skills, and practice environments. Potential approaches to mitigating these factors include changes to medical training, such as structured peer case discussion groups and communication skills development, and changes to workplace environments, such as integrated mental health. Modifying physician-level factors in difficult encounters could ease perceived difficulties and improve outcomes for both physicians and patients.

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.

Background Patient Reported Outcomes Measurement Information Systems (PROMIS) scales are increasingly being used to measure symptoms in research and practice. The purpose of this study was to determine the minimally important difference (MID) and severity thresholds (cut-points) for the four fixed-length PROMIS depression scales. Methods The study sample was adult participants in three randomized clinical trials (N=651). MID was estimated using multiple distribution- and anchor-based approaches including assessing correspondence between Patient Health Questionnaire (PHQ-9) and PROMIS depression scores. Results The best MID estimate was a PROMIS depression T-score of 3.5 points with most methods producing an MID in the 3 to 4 point range across all three samples. MID estimates were similar for all four PROMIS scales. A PHQ-9 1-point change equated to a PROMIS 1.25-point T-score change. PROMIS T-scores of 55, 60, 65, and 70 appeared to be reasonable thresholds for mild, moderate, moderately severe, and severe depression, respectively. Limitations The study sample was predominantly male veterans with either chronic pain (2 trials) or previous stroke (1 trial). The severity of depression was mild to moderate. Conclusion A T-score of 3 to 4 points is a reasonable MID for PROMIS depression scales and can be used to assess treatment effects in both practice and research as well to calculate sample sizes for clinical trials. Severity cut-points can help interpret the meaning of scores and action thresholds for treatment decisions.

BACKGROUND: Prescribing limits are one policy strategy to reduce short-term opioid prescribing, but there is limited evidence of their impact. OBJECTIVE: Evaluate implementation of a state prescribing limit law and health system electronic medical record (EMR) alert on characteristics of new opioid prescriptions, refill rates, and clinical encounters. DESIGN: Difference-in-differences study comparing new opioid prescriptions from ambulatory practices in New Jersey (NJ) to controls in Pennsylvania (PA) from 1 year prior to the implementation of a NJ state prescribing limit (May 2016–May 2017) to 10 months after (May 2017–March 2018). PARTICIPANTS: Adults with new opioid prescriptions in an academic health system with practices in PA and NJ. INTERVENTIONS: State 5-day opioid prescribing limit plus health system and health system EMR alert. MAIN MEASURES: Changes in morphine milligram equivalents (MME) and tablet quantity per prescription, refills, and encounters, adjusted for patient and prescriber characteristics. KEY RESULTS: There were a total of 678 new prescriptions in NJ and 4638 in PA. Prior to the intervention, median MME/prescription was 225 mg in NJ and 150 mg in PA, and median quantity was 30 tablets in both. After implementation, median MME/prescription was 150 mg in both states, and median quantity was 20 in NJ and 30 in PA. In the adjusted model, there was a greater decrease in mean MME and tablet quantity in NJ relative to PA after implementation of the policy plus alert (− 82.99 MME/prescription, 95% CI − 148.15 to − 17.84 and − 10.41 tabs/prescription, 95% CI − 19.70 to − 1.13). There were no significant differences in rates of refills or encounters at 30 days based on exposure to the interventions. CONCLUSIONS: Implementation of a prescribing limit and EMR alert was associated with an approximately 22% greater decrease in opioid dose per new prescription in NJ compared with controls in PA. The combination of prescribing limits and alerts may be an effective strategy to influence prescriber behavior. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-019-05302-1) contains supplementary material, which is available to authorized users.

In the United States (US), long-term opioid therapy has been commonly prescribed for chronic pain. Since recognition of the opioid overdose epidemic, clinical practice guidelines have recommended tapering long-term opioids to reduced doses or discontinuation. The Effects of Prescription Opioid Changes for veterans (EPOCH) study is a national population-based prospective observational study of US Veterans Health Administration primary care patients designed to assess effects of evolving opioid prescribing practice on patients treated with long-term opioids for chronic pain. A stratified random sampling design was used to identify a survey sample from the target population of patients treated with opioid analgesics for ≥ 6 months. Demographic, diagnostic, visit, and pharmacy dispensing data were extracted from existing datasets. A 2016 mixed-mode mail and telephone survey collected patient-reported data, including the main patient-reported outcomes of pain-related function (Brief Pain Inventory interference; BPI-I scores 0-10, higher scores = worse) and health-related quality of life. Data on survey participants and non-participants were analyzed to assess potential nonresponse bias. Weights were used to account for design. Linear regression models were used to assess cross-sectional associations of opioid treatment with patient-reported measures. Of 14,160 patients contacted, 9253 (65.4%) completed the survey. Participants were older than non-participants (63.9 ± 10.6 vs. 59.6 ± 13.0 years). The mean number of bothersome pain locations was 6.8 (SE 0.04). Effectiveness of pain treatment and quality of pain care were rated fair or poor by 56.1% and 45.3%, respectively. The opioid daily dosage range was 1.6 to 1038.2 mg, with mean = 50.6 mg (SE 1.1) and median = 30.9 mg (IQR 40.7). Among the 73.2% of patients who did not receive long-acting opioids, the mean daily dosage was 30.4 mg (SE 0.6) and mean BPI-I was 6.4 (SE 00.4). Among patients who received long-acting opioids, the mean daily dosage was 106.2 mg (SE 2.8) and mean BPI-I was 6.8 (SE 0.07). Higher daily dosage was associated with worse pain-related function and quality of life among patients without long-acting opioids, but not among patients with long-acting opioids. Future analyses will use follow-up data to examine effects of opioid dose reduction and discontinuation on patient outcomes.

Drawing on advances in chronic pain metrics, a simplified Graded Chronic Pain Scale-Revised was developed to differentiate mild, bothersome, and high-impact chronic pain. Graded Chronic Pain Scale-Revised was validated among adult enrollees of 2 health plans (N = 2021). In this population, the prevalence of chronic pain (pain present most or every day, prior 3 months) was 40.5%: 15.4% with mild chronic pain (lower pain intensity and interference); 10.1% bothersome chronic pain (moderate to severe pain intensity with lower interference with life activities); and 15.0% high-impact chronic pain (sustained pain-related activity limitations). Persons with mild chronic pain vs those without chronic pain showed small differences on 10 health status indicators (unfavorable health perceptions, activity limitations, and receiving long-term opioid therapy), with nonsignificant differences for 7 of 10 indicators. Persons with bothersome vs mild chronic pain differed significantly on 6 of 10 indicators (eg, negative pain coping beliefs, psychological distress, unfavorable health perceptions, and pain-related interference with overall activities). Persons with high-impact chronic pain differed significantly from those with mild chronic pain on all 10 indicators. Persons with high-impact chronic pain, relative to those with bothersome chronic pain, were more likely to have substantial activity limitations (significant differences for 4 of 5 disability indicators) and more often received long-term opioid therapy. Graded Chronic Pain Scale-Revised strongly predicted 5 activity-limitation indicators with area under receiver operating characteristic curve coefficients of 0.76 to 0.89. We conclude that the 5-item Graded Chronic Pain Scale-Revised and its scoring rules provide a brief, simple, and valid method for assessing chronic pain.

Introduction: Opioids are routinely prescribed to manage acute postoperative pain, but changes in postoperative opioid prescribing associated with the marketing of long-acting opioids such as OxyContin have not been described in the surgical cohort. Methods: Using a large commercial claims data set, we studied postoperative opioid prescribing after selected common surgical procedures between 1994 and 2014. For each procedure and year, we calculated the mean postoperative morphine milligram equivalents (MME) filled on the index prescription and assessed the proportion of patients who filled a high-dose prescription (≥350 MME). We reported changes in postoperative opioid prescribing over time and identified predictors of filling a high-dose postoperative opioid prescription. Results: We identified 1,321,264 adult patients undergoing selected common surgical procedures between 1994 and 2014, of whom 80.3% filled a postoperative opioid prescription. One in five surgery patients filled a high-dose postoperative opioid prescription. Between 1994 and 2014, the mean MME filled increased by 145%, 84%, and 85% for lumbar laminectomy/laminotomy, total knee arthroplasty, and total hip arthroplasty, respectively. The procedures most likely to be associated with a high-dose opioid fill were all orthopaedic procedures (AOR 5.20 to 7.55, P < 0.001 for all). Patients whose postoperative opioid prescription included a long-acting formulation had the highest odds of filling a prescription that exceeded 350 MME (AOR 32.01, 95% CI, 30.23–33.90). Discussion: After the US introduction of long-acting opioids such as OxyContin, postoperative opioid prescribing in commercially insured patients increased in parallel with broader US opioid-prescribing trends, most notably among patients undergoing orthopaedic surgical procedures. The increase in the mean annual MME filled starting in the late 1990s was driven in part by the higher proportion of long-acting opioid formulations on the index postoperative opioid prescription filled by orthopaedic surgery patients.

Background While military service members are at risk for pain conditions, receipt of prescribed opioids is associated with a range of serious adverse outcomes. The goal of this study is to examine the association between pre-deployment personality traits and receipt of prescription opioids after return from deployment. Method Data were drawn from the Readiness and Resilience in National Guard Soldiers (RINGS) cohort study, an ongoing study of post-deployment health. Participants (N = 522) completed baseline assessments one month prior to deploying to Iraq (2006–2007). At baseline, we assessed personality traits using abbreviated versions of the Personality Psychopathology Five scales from the Minnesota Multiphasic Personality Inventory-2. Follow-up assessments were conducted three months, one year, and two years post-deployment. The primary outcome was total amount of prescribed opioids dispensed from Department of Veterans Affairs outpatient pharmacies in the two-year period following soldiers’ return from deployment. Unadjusted and adjusted negative binomial regression models examined the relationships of pre-deployment personality traits, demographics (age, gender, and rank), baseline trauma symptoms, deployment related risk factors (difficult living/working environment, deployment injury, combat exposure), and post-deployment trauma symptoms with post-deployment opioid prescribing. Results Disconstraint, negative emotionality, and introversion/low positive emotionality were associated with receipt of more prescribed opioids over the two years after return from deployment. Personality traits measured at baseline remained statistically significantly after adjusting for all eight baseline and deployment risk factors of interest. Conclusions Understanding how pre-deployment personality traits contribute to post-deployment prescription opioid use could inform efforts to improve veterans’ health.

There is growing evidence that opioid prescribing in the United States follows a pattern in which patients who are at the highest risk of adverse outcomes from opioids are more likely to receive long-term opioid therapy. These patients include, in particular, those with substance use disorders (SUDs) and other psychiatric conditions. This study examined health insurance claims among 10,311,961 patients who filled prescriptions for opioids. Specifically, we evaluated how opioid receipt differed among patients with and without a wide range of preexisting psychiatric and behavioral conditions (ie, opioid and nonopioid SUDs, suicide attempts or other self-injury, motor vehicle crashes, and depressive, anxiety, and sleep disorders) and psychoactive medications (ie, antidepressants, benzodiazepines, hypnotics, mood stabilizers, antipsychotics, and medications used for SUD, tobacco cessation, and attention-deficit/hyperactivity disorder). Relative to those without, patients with all assessed psychiatric conditions and medications had modestly greater odds of subsequently filling prescriptions for opioids and, in particular, substantially greater risk of long-term opioid receipt. Increases in risk for long-term opioid receipt in adjusted Cox regressions ranged from approximately 1.5-fold for prior attention-deficit/hyperactivity disorder medication prescriptions (hazard ratio [HR] = 1.53; 95% confidence interval [CI], 1.48-1.58) to approximately 3-fold for prior nonopioid SUD diagnoses (HR = 3.15; 95% CI, 3.06-3.24) and nearly 9-fold for prior opioid use disorder diagnoses (HR = 8.70; 95% CI, 8.20-9.24). In sum, we found evidence of greater opioid receipt among commercially insured patients with a breadth of psychiatric conditions. Future studies assessing behavioral outcomes associated with opioid prescribing should consider preexisting psychiatric conditions.

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.

ObjectiveChronic 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.MethodsThe 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.ResultsThe 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.ConclusionsTwo 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.

Objective: Urine drug testing (UDT) is recommended for patients who are prescribed opioid medications, but little is known about the various strategies clinicians use to respond to aberrant UDT results. We sought to examine changes in opioid prescribing and implementation of other risk reduction activities following an aberrant UDT. Methods: In a national cohort of Veterans Affairs patients with new initiations of opioid therapy through 2013, we identified a random sample of 100 patients who had aberrant positive UDTs (results positive for nonprescribed/illicit substance), 100 who had aberrant negative UDTs (results negative for prescribed opioid), and 100 who had expected UDT results. We examined medical record data for opioid prescribing changes and risk reduction strategies in the 12 months following UDT. Results: Following an aberrant UDT, 17.5% of clinicians documented planning to discontinue or change the opioid dose and 52.5% initiated another strategy to reduce opioid-related risk. In multivariate analyses, variables associated with a planned change in opioid prescription status were having an aberrant positive UDT (odds ratio [OR], 30.77; 95% confidence interval [CI], 5.92-160.10) and higher prescription opioid dose (OR, 1.01; 95% CI, 1.01-1.02). The only variable associated with implementation of other risk reduction activities was having an aberrant positive UDT (OR, 0.29; 95% CI, 0.16-0.55). Discussion: The majority of clinicians enacted some type of opioid prescribing or other change to reduce risk following an aberrant UDT, and the action depended on whether the result was an aberrant positive or aberrant negative UDT. Experimental studies are needed to develop and test strategies for managing aberrant UDT results.

There are adverse effects associated with long-term opioid therapy (LTOT) for chronic pain and clinicians infrequently adhere to opioid treatment guideline recommendations for reducing risk and mitigating opioid-related harms. The primary goal of the Improving the Safety of Opioid Therapy (ISOT) intervention is to reduce harms related to prescription opioids. Secondary aims focus on enhancing the clinician-patient relationship and not having a negative impact on pain-related outcomes (to be examined through a non-inferiority analysis). The study is a cluster-randomized trial and the 44 primary care providers (PCPs) who enrolled were randomized to receive either (1) a two-hour educational workshop about a patient-centered approach to opioid therapy or (2) the educational workshop plus a collaborative care intervention delivered by a nurse care manager (NCM). Patients were assigned to the same condition as their treating PCP. ISOT was based on the chronic care model and includes patient and provider activation, outcomes monitoring, and feedback to the PCP over 12 months. The NCM conducted a baseline assessment with intervention patients, tracked opioid-related behaviors and outcomes, and provided decision support to the opioid-prescribing clinician about opioid safety. Between June 2016 and October 2018, 293 veterans who were prescribed LTOT for chronic pain were enrolled, completed a baseline assessment, and assigned to a treatment condition. Participants were enrolled for 12 months. Masked assessments were conducted with participants at baseline, 6-months, and 12-months. This manuscript describes study rationale, research methods, and baseline findings.

The Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) scales are reliable and publicly accessible; however, little is known about how responsive they are to detect change in clinical trials and how their responsiveness compares with legacy measures. The study purpose was to evaluate responsiveness for the PROMIS-PI scales and to compare their responsiveness with legacy pain measures. We used data from 3 clinical trials totaling 759 participants. The clinical trials included patients with chronic low back pain (n = 261), chronic back or osteoarthritis pain (n = 240), and a history of stroke (n = 258). At both baseline and follow-up, participants completed PROMIS-PI scales and legacy pain measures (Brief Pain Inventory Interference scale; Pain, Enjoyment, General Activity scale; 36-Item Short Form Survey (SF-36) Bodily Pain scale; and Roland-Morris Disability Questionnaire). We measured global ratings of pain change, both prospectively and retrospectively, as anchors to identify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area under the curve analysis. The PROMIS-PI scales had largely comparable responsiveness with the Brief Pain Inventory Interference and Pain, Enjoyment, General Activity scales. The 4 PROMIS-PI short forms had comparable responsiveness. For all pain questionnaires, responsiveness varied based on the study population and whether pain improved or worsened. Perspective This article presents 1) how responsive the PROMIS-PI scales were to detect change over time in the context of 3 clinical trials and 2) how their responsiveness compared with legacy pain measures. The findings can help researchers and clinicians choose between different patient-reported pain outcome measures.