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Objective: The Graded Chronic Pain Scale (GCPS) is frequently used in pain research and treatment to classify mild, bothersome, and high impact chronic pain. This study's objective was to validate the revised version of the GCPS (GCPS-R) in a US Veterans Affairs (VA) healthcare sample to support its use in this high-risk population., Methods: Data were collected from Veterans (n = 794) via self-report (GCPS-R and relevant health questionnaires) and electronic health record extraction (demographics and opioid prescriptions). Logistic regression, adjusting for age and gender, was used to test for differences in health indicators by pain grade. Adjusted odds ratio (AOR) with 95% confidence intervals (CIs) were reported with CIs not including an AOR of 1 indicating that the difference exceeded chance., Results: In this population, the prevalence of chronic pain (pain present most or every day, prior 3 months) was 49.3%: 7.1% with mild chronic pain (mild pain intensity and lower interference with activities); 23.3% bothersome chronic pain (moderate to severe pain intensity with lower interference); and 21.1% high impact chronic pain (higher interference). Results of this study mirrored findings in the non-VA validation study; differences between bothersome and high impact were consistent for activity limitations and present but not fully consistent for psychological variables. Those with bothersome chronic pain or high impact chronic pain were more likely to receive long-term opioid therapy compared to those with no/mild chronic pain., Conclusions: Findings highlight categorical differences captured with the GCPS-R, and convergent validity supports use of the GCPS-R in US Veterans., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use., Methods: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment., Discussion: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services., Trial Registration: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020., (© 2023. The Author(s).)

Abstract: In response to the overuse of prescription opioid analgesics, clinical practice guidelines encourage opioid deprescribing (ie, dose reduction or cessation) in patients with chronic noncancer pain. Therefore, this study evaluated and compared international clinical guideline recommendations on opioid deprescribing in patients with chronic noncancer pain. We searched PubMed, EMBASE, PEDro, National Institute for Health and Care Excellence (United Kingdom), and MAGICapp databases from inception to June 4, 2021, with no language or publication restrictions. In addition, we searched the National Guideline Clearinghouse and International Guideline Network databases from inception to December 2018. Two independent reviewers conducted the initial title and abstract screening. After discrepancies were resolved through discussion, 2 independent reviewers conducted the full-text screening of each potentially eligible reference. Four independent reviewers completed the prepiloted, standardized data extraction forms of each included guideline. Extracted information included bibliographical details; strength of recommendations; and the outcomes, such as when and how to deprescribe, managing withdrawal symptoms, additional support, outcome monitoring, and deprescribing with coprescription of sedatives. A narrative synthesis was used to present the results. This study found that clinical practice guidelines agree on when and how to deprescribe opioid analgesics but lack advice on managing a patient's withdrawal symptoms, outcome monitoring, and deprescribing with coprescription of sedatives. Quality assessment of the guidelines suggests that greater discussion on implementation and dissemination is needed., (Copyright © 2022 International Association for the Study of Pain.)

Objective: The diagnostic criteria for opioid use disorder, originally developed for heroin, did not anticipate the surge in prescription opioid use and the resulting complexities in diagnosing prescription opioid use disorder (POUD), including differentiation of pain relief (therapeutic intent) from more common drug use motives, such as to get high or to cope with negative affect. The authors examined the validity of the Psychiatric Research Interview for Substance and Mental Disorders, DSM-5 opioid version, an instrument designed to make this differentiation., Methods: Patients (N=606) from pain clinics and inpatient substance treatment who ever received a ≥30-day opioid prescription for chronic pain were evaluated for DSM-5 POUD (i.e., withdrawal and tolerance were not considered positive if patients used opioids only as prescribed, per DSM-5 guidelines) and pain-adjusted POUD (behavioral/subjective criteria were not considered positive if pain relief [therapeutic intent] was the sole motive). Bivariate correlated-outcome regression models indicated associations of 10 validators with DSM-5 and pain-adjusted POUD measures, using mean ratios for dimensional measures and odds ratios for binary measures., Results: The prevalences of DSM-5 and pain-adjusted POUD, respectively, were 44.4% and 30.4% at the ≥2-criteria threshold and 29.5% and 25.3% at the ≥4-criteria threshold. Pain adjustment had little effect on prevalence among substance treatment patients but resulted in substantially lower prevalence among pain treatment patients. All validators had significantly stronger associations with pain-adjusted than with DSM-5 dimensional POUD measures (ratios of mean ratios, 1.22-2.31). For most validators, pain-adjusted binary POUD had larger odds ratios than DSM-5 measures., Conclusions: Adapting POUD measures for pain relief (therapeutic intent) improved validity. Studies should investigate the clinical utility of differentiating between therapeutic and nontherapeutic intent in evaluating POUD diagnostic criteria.

Pain has been established as a major public health problem in the United States (U.S.) with 50 million adults experiencing chronic pain and 20 million afflicted with high-impact chronic pain (ie, chronic pain that interferes with life or work activities). High financial and social costs are associated with chronic pain. Over the past 2 decades, pain management has been complicated by the marked increase in opioids prescribed to treat chronic noncancer pain and by the concurrent opioid crisis. Monitoring the prevalence of chronic pain and pain management is especially important because pain management is changing in uncertain ways. We review potential U.S. chronic pain surveillance systems, present potential difficulties of chronic pain surveillance, and explore how to address chronic pain surveillance in the current opioid era. We consider case definitions, severity, anatomic site, and varieties of chronic pain management strategies in reviewing and evaluating national surveys for chronic pain surveillance. Based on the criteria evaluated, the National Health Interview Survey offers the best single source for pain surveillance as the pain-related questions administered are brief, valid, and cover a broad scope of pain-related phenomena. PERSPECTIVE: This review article describes data sources that can be leveraged to conduct national chronic pain surveillance in the United States, explores case defining or pain-related questions administered, and evaluates them against 8 surveillance attributes., (Published by Elsevier Inc.)

Background: Multisite chronic pain (MSCP) is associated with increased chronic pain impact, but methods for identifying MSCP for epidemiological research have not been evaluated., Objective: We assessed the validity of identifying MSCP using electronic health care data compared with survey questionnaires., Methods: Stratified random samples of adults served by Kaiser Permanente Northwest and Washington (N = 2,059) were drawn for a survey, oversampling persons with frequent use of health care for pain. MSCP and single-site chronic pain were identified by two methods, with electronic health care data and with self-report of common chronic pain conditions by survey questionnaire. Analyses were weighted to adjust for stratified sampling., Results: MSCP was somewhat less common when ascertained by electronic health records (14.7% weighted prevalence) than by survey questionnaire (25.9% weighted prevalence). Agreement of the two MSCP classifications was low (kappa agreement statistic of 0.21). Ascertainment of MSCP with electronic health records was 30.9% sensitive, 91.0% specific, and had a positive predictive value of 54.5% relative to MSCP identified by self-report as the standard. After adjusting for age and gender, patients with MSCP identified by either electronic health records or self-report showed higher levels of pain-related disability, pain severity, depressive symptoms, and long-term opioid use than persons with single-site chronic pain identified by the same method., Conclusions: Identification of MSCP with electronic health care data was insufficiently accurate to be used as a surrogate or screener for MSCP identified by self-report, but both methods identified persons with heightened chronic pain impact., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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.

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., (2019 American Academy of Pain Medicine.)

Purpose: Six key elements of opioid medication management redesign in primary care have been previously identified. Here, we examine the effect of implementing these Six Building Blocks on opioid-prescribing practices., Methods: Six rural-serving organizations with 20 clinic locations received support for 15 months during the period October 2015 to May 2017 to implement the Six Building Blocks. Patients undergoing long-term opioid therapy (LtOT) at these study sites were compared with patients undergoing LtOT enrolled in a regional health plan who did not receive care at the study sites but who resided in the same primary care service areas (control group). Outcomes were monthly trend in the proportion of patients undergoing LtOT prescribed a ≥100 morphine equivalent dose (MED) of opioids daily and the total number of patients receiving an opioid prescription. An interrupted time series using difference-indifference analysis was used for tests of significance., Results: The proportion of patients prescribed a ≥100 MED of opioids daily decreased 2.2% (11.8% to 9.6%) among patients at the intervention clinics and 1.3% (14.0% to 12.7%) among patients in the control group. The rate of decrease was significantly greater among study patients than among patients in the control group ( P = .018). The rate of decrease in the number of patients on LtOT at intervention clinics increased during the intervention period compared with the preintervention period ( P <.001)., Conclusions: Efforts to redesign opioid medication management in primary care resulted in a significant decrease in opioid prescribing. Future research is needed to determine if these results are generalizable to other settings and to assess implications for patient-reported outcomes., (© 2019 Annals of Family Medicine, Inc.)

The multidimensional nature of chronic pain is not reflected by definitions based solely on pain duration, resulting in high prevalence estimates limiting effective policy development. The newly proposed concept of high-impact chronic pain (HICP) incorporates both disability and pain duration to identify a more severely impacted portion of the chronic pain population yet remains uncharacterized at the population level. As such, we used the 2011 National Health Interview Survey (N = 15,670) to 1) assess the likelihood of disability in the overall chronic pain population, 2) estimate the prevalence of HICP, and 3) characterize the disability, health status, and health care use profile of this population in the United States. Overall, chronic pain, defined as pain experienced on most days or every day in the previous 3 months, was strongly associated with an increased risk of disability after controlling for other chronic health conditions (odds ratio = 4.43; 95% confidence interval = 3.73-5.26), where disability was more likely in those with chronic pain than in those with stroke or kidney failure, among others. HICP affected 4.8% of the U.S. adult population, or approximately 10.6 million individuals, in 2011. The HICP population reported more severe pain and more mental health and cognitive impairments than persons with chronic pain without disability, and was also more likely to report worsening health, more difficulty with self-care, and greater health care use. HICP clearly represents a more severely impacted portion of the chronic pain population. Understanding this heterogeneity will contribute to developing more effective legislation promoting safe and cost-effective approaches to the prevention and treatment of chronic pain. PERSPECTIVE: HICP is a powerful new classification that differentiates those with debilitating chronic pain from those with less impactful chronic pain. By addressing the multidimensionality of chronic pain, this classification will improve clinical practice, research, and the development of effective health policy., (Published by Elsevier Inc.)

Purpose: The purpose of the study is to determine whether initiatives to improve the safety of opioid prescribing decreased injuries in people using chronic opioid therapy (COT)., Methods: We conducted an interrupted time series analysis using data from Group Health (GH), an integrated health care delivery system in the United States. In 2007, GH implemented initiatives which substantially reduced daily opioid dose and increased patient monitoring. Among GH members age 18 or older receiving COT between 2006 and 2014, we compared injury rates for patients in GH's integrated group practice (IGP; exposed to the initiatives) vs patients cared for by contracted providers (not exposed). Injuries were identified using a validated algorithm. We calculated injury incidence during the baseline (preintervention) period from 2006 to 2007; the dose reduction period, 2008 to 2010; and the risk stratification and monitoring period, 2010 to 2014. Using modified Poisson regression, we estimated adjusted relative risks (RRs) representing the relative change per year in injury rates., Results: Among 21 853 people receiving COT in the IGP and 8260 in contracted care, there were 2679 injuries during follow-up. The baseline injury rate was 1.0% per calendar quarter in the IGP and 0.9% in contracted care. Risk reduction initiatives did not decrease injury rates: Within the IGP, the RR in the dose reduction period was 1.01 (95% CI, 0.95-1.07) and in the risk stratification and monitoring period, 0.99 (95% CI, 0.95-1.04). Injury trends did not differ between the two care settings., Conclusions: Risk reduction initiatives did not decrease injuries in people using COT., (© 2018 John Wiley & Sons, Ltd.)

We assessed the effects of opioid dose and risk reduction initiatives on opioid overdose rates among patients on chronic opioid therapy (COT). Using an interrupted time series design, we compared trends in overdose rates. We compared patients on COT in settings that implemented a COT dose reduction initiative and then a COT risk stratification/monitoring initiative to similar patients on COT from control settings. From 2006 to 2014, 31,142 patients on COT (22,673 intervention, 8,469 control) experienced 311 fatal or nonfatal opioid overdoses. In primary analyses, changes in opioid overdose rates among patients on COT did not differ significantly between intervention and control settings with the implementation of either dose reduction or risk stratification/monitoring. In planned secondary analyses, overdose rates decreased significantly (17% per year) during the dose reduction initiative among patients on COT in intervention settings (relative annual change, 0.83; 95% confidence interval, 0.70-0.99), but not in control settings (0.98. 95% confidence interval, 0.70-1.39). We conclude that overdose rates among patients on COT were not decreased by risk stratification and monitoring initiatives. Results were inconsistent for COT dose reduction, with no significant difference between intervention and control settings (primary hypothesis test), but a significant decrease in overdose rates within the intervention setting during dose reduction (secondary hypothesis test). PERSPECTIVE: Risk stratification/monitoring interventions among patients on COT did not decrease opioid overdose rates. The effects of COT dose reduction on opioid overdose rates were inconsistent. Greater decreases in COT dose, a larger control group, or both may have been needed to identify conclusive reductions in opioid overdose rates., (Copyright © 2018. Published by Elsevier Inc.)

Background: Determinants of prescribing psychoactive medications for symptom management in older adults remain underexamined despite known risks and cautions concerning these medications., Objective: To examine independent and combined effects of pain, concurrent insomnia and depression symptoms on psychoactive medications supplied to older adults with osteoarthritis (OA)., Research Design: Survey data on pain, insomnia, and depression obtained from OA patients screened for a randomized controlled trial were used to identify predictors of psychoactive medication supply [opioids, sedatives, tricyclic antidepressants (TCAs), and non-TCAs] over a 4-year period., Subjects: Group Health Cooperative patients with a diagnosis of OA (N=2976)., Measures: Survey data on pain (Graded Chronic Pain Scale), insomnia (Insomnia Severity Index), and depression (Patient Health Questionnaire-8); and medications supply assessed from electronic medical records., Results: In negative binomial models, pain [incidence rate ratio (IRR), 2.8-3.5; P<0.001], insomnia (IRR, 2.0; P<0.001), and depression (IRR, 1.5; P<0.05) each independently predicted opioid supply. Insomnia (IRR, 3.2; P<0.001) and depression (IRR, 3.0; P<0.001) each independently predicted sedative supply. Pain (IRR, 2.1; P<0.05) and insomnia (IRR, 2.0; P<0.05) independently predicted TCA supply, whereas only depression (IRR, 2.2; P<0.001) independently predicted non-TCA supply. Combined effects of pain and insomnia/depression on these medications were additive and increased the rate of medication supply 1.5-7.5 times. Combined effects increased with insomnia or depression severity., Conclusions: Concurrent insomnia and depressive symptoms predicted increased supply of opioids, sedatives, and antidepressants after accounting for pain, indicating the importance of sleep and mood disorders as factors increasing supply of these medications.

Objective: We aimed to determine if opioid risk reduction initiatives including dose reduction and risk mitigation strategies for chronic noncancer pain patients receiving chronic opioid therapy (COT) had a differential impact on average daily opioid doses of COT patients at higher risk for opioid-related adverse outcomes compared with lower-risk patients., Design: Interrupted time series., Setting: Group Health Cooperative (GH), a health care delivery system and insurance within Washington State, between 2006 and 2014., Population: GH enrollees on COT defined as receiving a supply of 70 or more days of opioids within 90 days using electronic pharmacy data for filled prescriptions., Methods: We compared the average daily morphine equivalent doses (MED) of COT patients with and without each of the following higher-risk characteristics: mental disorders, substance use disorders, sedative use, and male gender., Results: In all four pairwise comparisons, the higher-risk subgroup had a higher average daily MED than the lower-risk subgroup across the study period. Adjusted for covariates, modest differences in the annual rate of reduction in average daily MED were noted between higher- and lower-risk subgroups in three pairwise comparisons: those with mental disorders vs without (-8.2 mg/y vs -5.2 mg/y, P = 0.005), with sedative use vs without (-9.2 mg/y vs -5.8 mg/y, P = 0.004); mg), in men vs women (-8.8 mg/y vs -5.9 mg/y, P = 0.01)., Conclusion: Using clinical policy initiatives in a health care system, dose reductions were achieved among COT patients at higher risk for opioid-related adverse outcomes that were at least as large as those among lower-risk patients.

Chronic pain, one of the most common reasons adults seek medical care (1), has been linked to restrictions in mobility and daily activities (2,3), dependence on opioids (4), anxiety and depression (2), and poor perceived health or reduced quality of life (2,3). Population-based estimates of chronic pain among U.S. adults range from 11% to 40% (5), with considerable population subgroup variation. As a result, the 2016 National Pain Strategy called for more precise prevalence estimates of chronic pain and high-impact chronic pain (i.e., chronic pain that frequently limits life or work activities) to reliably establish the prevalence of chronic pain and aid in the development and implementation of population-wide pain interventions (5). National estimates of high-impact chronic pain can help differentiate persons with limitations in major life domains, including work, social, recreational, and self-care activities from those who maintain normal life activities despite chronic pain, providing a better understanding of the population in need of pain services. To estimate the prevalence of chronic pain and high-impact chronic pain in the United States, CDC analyzed 2016 National Health Interview Survey (NHIS) data. An estimated 20.4% (50.0 million) of U.S. adults had chronic pain and 8.0% of U.S. adults (19.6 million) had high-impact chronic pain, with higher prevalences of both chronic pain and high-impact chronic pain reported among women, older adults, previously but not currently employed adults, adults living in poverty, adults with public health insurance, and rural residents. These findings could be used to target pain management interventions., Competing Interests: All authors have completed and submitted the ICMJE form for disclosure of potential conflicts of interest. Robert Kerns reports receiving honoraria for serving as a member of a research grant review board for the American Pain Society and as senior editor for the journal Pain Medicine. Michael Von Korff reports receipt of grants from Pfizer Inc. as an investigator of use and misuse of opioids at Kaiser Permanente Washington Health Research Institute and from inVentive as co-investigator for Food and Drug Administration–mandated postmarketing surveillance studies of extended release opioids. No other conflicts of interest were reported.

Objective: This analysis examined patients' perceptions about trust within the doctor-patient relationship related to managing opioid pain medications. We compared perceptions among chronic opioid therapy (COT) patients who were and were not exposed to opioid risk reduction initiatives., Methods: Between 2014 and 2016, we surveyed 1588 adults with chronic pain receiving COT about their trust in their prescribing doctor, their perceptions of their doctor's trust in them, their concerns about opioid prescribing, and their knowledge of opioid safety concerns. The population included adults receiving care in intervention settings that implemented opioid risk reduction initiatives and control settings with similar COT patients that did not., Results: Overall, 82.2% of COT patients said they trusted their doctor's judgment, with more agreement among patients in the control clinics (86.3%; n = 653) than in the intervention clinics (77.9%; n = 935; P = .002). Similarly, slightly more patients in the control clinics believed their physician trusted how they managed their opioid pain medicines (91.1%) compared with the intervention clinics (86.2%; P = .002). The percent who worried that their doctor would stop prescribing opioid pain medicine was 29.3% in intervention clinics and 21.8% in control clinics ( P = .007)., Conclusions: Although COT patients typically reported favorable perceptions of doctor-patient trust in managing opioid pain medicines, implementation of opioid risk reduction initiatives may have reduced levels of trust for a minority of COT patients. This suggests that it may be possible to implement opioid risk-reduction initiatives while sustaining high levels of doctor-patient trust for most COT patients., Competing Interests: Conflict of interest: Ms. Saunders owns stock in Merck. The remaining authors report no conflicts., (© Copyright 2018 by the American Board of Family Medicine.)

Objectives: To test whether change in fear-avoidance beliefs was a mediator of the effect of treatment on disability outcome, and to test an analytical approach, latent growth modeling, not often applied to mediation analysis., Methods: Secondary analysis was carried out on a randomized controlled trial designed to compare an intervention addressing fear-avoidance beliefs (n=119) with treatment as usual (n=121) for patients with low back pain, which found the intervention to be effective. Latent growth modelling was used to perform a mediation analysis on the trial data to assess the role of change in fear-avoidance beliefs on disability outcome. The product of coefficients with bias-corrected bootstrapped confidence intervals was used to calculate the mediating effect., Results: A statistically significant mediating effect of fear-avoidance beliefs on the effect of treatment on disability outcome was found (standardized indirect effect -0.35; bias-corrected 95% CI, -0.47 to -0.24). Poor fit of the model to the data suggested that other factors not accounted for in this model are likely to be part of the same mediating pathway., Discussion: Fear-avoidance beliefs were found to mediate the effect of treatment on disability outcome. Measurement of all potential mediator variables in future studies would help to more strongly identify which factors explain observed treatment effects. Latent growth modelling was found to be a useful technique to apply to studies of treatment mediation, suggesting that future studies could use this approach.

Background: No studies have assessed the comparative effectiveness of guideline-recommended interventions to reduce risk of prescription opioid use disorder among chronic opioid therapy (COT) patients. We compared the prevalence of prescription opioid use disorder among COT patients from intervention clinics that had implemented opioid dose and risk reduction initiatives for more than 4 years relative to control clinics that had not., Methods: After a healthcare system in Washington State implemented interventions to reduce opioid dose and risks, we surveyed 1588 adult primary care COT patients to compare the prevalence of prescription opioid use disorder among COT patients from the intervention and control clinics. Intervention clinics managed COT patients at lower COT doses and with more consistent use of risk reduction practices. Control clinics cared for similar COT patients but prescribed higher opioid doses and used COT risk reduction practices inconsistently. Prescription opioid use disorder was assessed with the Psychiatric Research Interview for Substance and Mental Disorders., Results: The prevalence of prescription opioid use disorder was 21.5% (95% CI=18.9% to 24.4%) among COT patients in the intervention clinics and 23.9% (95% CI=20.5% to 27.6%) among COT patients in the control clinics. The adjusted relative risk of prescription opioid use disorder was 1.08 (95% CI=0.89, 1.32) among the control clinic patients relative to the intervention clinic patients., Conclusions: Long-term implementation of opioid dose and risk reduction initiatives was not associated with lower rates of prescription opioid use disorder among prevalent COT patients. Extreme caution should be exercised by clinicians considering COT for patients with chronic non-cancer pain until benefits of this treatment and attendant risks are clarified., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Chronic pain patients at increased risk of unfavorable pain and opioid misuse outcomes may be those most likely to use opioids long-term, but this has not been evaluated prospectively., Objectives: To ascertain whether pain prognostic risk, problem opioid use risk, and depression predict opioid use 1 year later among patients recently initiating opioid therapy with a moderate likelihood of long-term opioid use., Materials and Methods: Self-report and electronic health record data were collected from patients aged 45+ years who recently initiated opioid therapy (N=762), in an integrated health care system. Logistic regression models tested whether baseline patient chronic pain prognostic risk, problem opioid use risk, depression, and expectations concerning continued opioid use independently predicted continuing use at 1 year (≥30 d supply in the prior 4 mo)., Results: At 1 year, 46% of participants continued to use opioids. Baseline problem opioid use risk score (adjusted odds ratio, 1.15; 95% confidence interval, 1.04-1.26) and expectations about continuing opioid use, but not pain prognostic risk score or depression, were significant predictors of 1-year opioid use. Compared with patients who thought continued opioid use unlikely, those who thought it was extremely or very likely had 4 times the odds of opioid use at 1 year (adjusted odds ratio, 4.05; 95% confidence interval, 2.59-6.31)., Discussion: The strongest predictors of long-term opioid use were not patient-related or medication-related factors, but expectations about using opioids in the future. Asking about such expectations may be the easiest way to identify patients likely to continue opioid use long-term.

Background: The challenge of responding to prescription opioid overuse within the United States has fallen disproportionately on the primary care clinic setting. Here we describe a framework comprised of 6 Building Blocks to guide efforts within this setting to address the use of opioids for chronic pain., Methods: Investigators conducted site visits to thirty primary care clinics across the United States selected for their use of team-based workforce innovations. Site visits included interviews with leadership, clinic tours, observations of clinic processes and team meetings, and interviews with staff and clinicians. Data were reviewed to identify common attributes of clinic system changes around chronic opioid therapy (COT) management. These concepts were reviewed to develop narrative descriptions of key components of changes made to improve COT use., Results: Twenty of the thirty sites had addressed improvements in COT prescribing. Across these sites a common set of 6 Building Blocks were identified: 1) providing leadership support; 2) revising and aligning clinic policies, patient agreements (contracts) and workflows; 3) implementing a registry tracking system; 4) conducting planned, patient-centered visits; 5) identifying resources for complex patients; and 6) measuring progress toward achieving clinic objectives. Common components of clinic policies, patient agreements and data tracked in registries to assess progress are described., Conclusions: In response to prescription opioid overuse and the resulting epidemic of overdose and addiction, primary care clinics are making improvements driven by a common set of best practices that address complex challenges of managing COT patients in primary care settings., Competing Interests: Conflicts of Interest: None declared., (© Copyright 2017 by the American Board of Family Medicine.)

Purpose: Although prescription opioids have been associated with higher motor vehicle crash (MVC) risk, it is unknown whether health system initiatives to better manage chronic opioid therapy (COT) can reduce MVC risk at the population level., Methods: We conducted an interrupted time series population-level cohort study at Group Health (GH), between January 2006 and September 2014, comparing MVC risk among COT patients who were GH members receiving care in either group practice or contracted care settings. Group practice COT risk reduction initiatives were implemented in two phases: (1) altered prescribing expectations and (2) multifaceted initiatives. These initiatives did not exist in the contracted care network. We compared the adjusted quarterly rate of MVC between group practice and contracted care patients over time using a modified Poisson regression model for a binary outcome., Results: A total of 32 691 COT patients (27.4% from contracted care) met eligibility criteria and experienced a total of 1956 MVCs during study follow-up (mean, 8.1 quarters per person), of which 810 were serious injury crashes. Crash rates were not significantly different between the patient groups within any of the time periods. Analyses stratified by concurrent prescription of a sedative hypnotic or benzodiazepine found no significant difference between the group practice and contracted care patients. There was a modest elevation of MVC risk for high-dose patients relative to former COT patients who stopped receiving opioids., Conclusions: The risk of MVC was not mitigated in a large cohort of COT patients exposed to a health plan policy initiative that substantially lowered mean opioid dose. Copyright © 2016 John Wiley & Sons, Ltd., (Copyright © 2016 John Wiley & Sons, Ltd.)

Many consider chronic opioid therapy (COT) to be ineffective for fibromyalgia, but empirical evidence is limited. Among patients identified as initiating COT, we examined whether fibromyalgia was associated with different relationships of opioid use to pain and activity interference outcomes 12 months later. We obtained electronic data on diagnoses and opioid prescriptions. We obtained patient self-report data, including pain and activity interference measures, at baseline, 4 months, and 12 months. Among 1218 patients, 429 (35%) met our definition of fibromyalgia. Patients with and without fibromyalgia who had intermittent/lower-dose or regular/higher-dose opioid use at 12 months had similar 12-month pain intensity scores. However, among patients with minimal/no opioid use at 12 months, 12-month pain intensity was greater for those with fibromyalgia (adjusted mean = 5.15 [95% confidence interval, 4.80-5.51]; 0-10 scale) than for those without (4.44 [4.15-4.72]). Similar patterns were observed for 12-month activity interference. Among patients who discontinued opioids by 12 months, those with fibromyalgia were more likely to report bothersome side effects and less likely to report pain improvement as important reasons for discontinuation (P < 0.05). In sum, at 12 months, among patients who had discontinued opioids or used them minimally, those with fibromyalgia had worse outcomes and were less likely to have discontinued because of pain improvement. Among patients continuing COT, pain and activity interference outcomes were worse than those of patients with minimal/no opioid use and did not differ for those with fibromyalgia vs those with diverse other chronic pain conditions.

Unlabelled: National Pain Strategy population research objectives include: estimating chronic pain prevalence, studying pain treatment with electronic health care data, and developing metrics to assess progress in reducing chronic pain impact. In this article, the National Pain Strategy Population Research Workgroup reviews concepts relevant to achieving these aims. High-impact chronic pain was defined as persistent pain with substantial restriction of life activities lasting 6 months or more. In pilot work, we tested a brief assessment of high-impact chronic pain, and used electronic health records data to describe pain-related health care. A mail survey of adult health plan enrollees (N = 770) reported that 14% had high-impact chronic pain. Relative to persons with lower-impact chronic pain, those with high-impact chronic pain were more often frequent users of health care for pain, reported lower quality of life, greater pain-related interference with activities, and more often reported pain at multiple anatomic locations. Analyses of health care data (N = 289,464) reported that pain patients had higher health care costs compared with others and that pain services were typically delivered in primary care. These results support the feasibility of developing data on chronic pain through national health interview surveys and large electronic health care databases., Perspective: Pilot analyses supported the feasibility of brief chronic pain assessments suitable for national health surveys and use of electronic health care databases to develop data regarding trends in the delivery of pain treatments, costs, and effectiveness. These methods are relevant to achieving the aims of the US National Pain Strategy., (Copyright © 2016 American Pain Society. All rights reserved.)

Little is known about long-term pain and function outcomes among patients with chronic noncancer pain initiating chronic opioid therapy (COT). In the Middle-Aged/Seniors Chronic Opioid Therapy study of patients identified through electronic pharmacy records as initiating COT for chronic noncancer pain, we examined the relationships between level of opioid use (over the 120 days before outcome assessment) and pain and activity interference outcomes at 4- and 12-month follow-ups. Patients aged 45+ years (N = 1477) completed a baseline interview; 1311 and 1157 of these comprised the 4- and 12-month analysis samples, respectively. Opioid use was classified based on self-report and electronic pharmacy records for the 120 days before the 4- and 12-month outcome assessments. Controlling for patient characteristics that predict sustained COT and pain outcomes, patients who had used opioids minimally or not at all, compared with those with intermittent/lower-dose and regular/higher-dose opioid use, had better pain intensity and activity interference outcomes. Adjusted mean (95% confidence interval) pain intensity (0-10 scale) at 12 months was 4.91 (4.68-5.13) for the minimal/no use group and 5.71 (5.50-5.92) and 5.72 (5.51-5.93) for the intermittent/lower-dose and regular/higher-dose groups, respectively. A similar pattern was observed for pain intensity at 4 months and for activity interference at both time points. Better outcomes in the minimal/no use group could reflect pain improvement leading to opioid discontinuation. The similarity in outcomes of regular/higher-dose and intermittent/lower-dose opioid users suggests that intermittent and/or lower-dose use vs higher-dose use may confer risk reduction without reducing benefits.

Background: Chronic opioid therapy (COT) guidelines recommend developing a COT care plan at the initiation of COT., Objective: Assess the timeliness of care planning upon initiation of COT., Design: Observational cohort study in a setting incentivizing and tracking documentation of COT care plans in electronic health records (EHRs)., Participants: Study participants (N = 896) were aged 45 years or older, had initiated an episode of opioid use within the prior 6 months, and reported regular use of prescription analgesics when screened for a baseline interview about 3 months after an index opioid prescription MEASURES: A timely care plan was defined by an EHR documented care plan prior to or within 4 months after the index opioid prescription., Results: Among COT initiators, 30% had a timely COT care plan documented in the EHR within 4 months following index prescription, while 51% had a documented COT care plan within 12 months following index prescription. Among those interviewed at 1 year follow-up (N = 735), 252 (34.2%) reported opioid use on 7 or more days in the prior 2 weeks. Less than half (45.6%) of the 252 individuals who sustained regular opioid use at 1 year had predicted at baseline that it was somewhat, very, or extremely likely they would be using opioids regularly in 1 year., Conclusions: Patients initiating COT were unlikely to have timely COT care plans. Many who sustained regular opioid use at 1 year had not anticipated using opioids long term., (© 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Unlabelled: Avoiding high opioid doses may reduce chronic opioid therapy (COT) risks, but the feasibility of reducing opioid doses in community practice is unknown. Washington State and a health plan's group practice implemented initiatives to reduce high-dose COT prescribing. The group practice physicians were exposed to both initiatives, whereas contracted physicians were exposed only to statewide changes. Using interrupted time series analyses, we assessed whether these initiatives reduced opioid doses among COT patients in group practice (n = 16,653) and contracted care settings (n = 5,552). From 2006 to June 2014, the percentage of COT patients receiving ≥120 mg morphine equivalent dose declined from 16.8% to 6.3% in the group practice versus 20.6 to 13.6% among COT patients of contracted physicians. The proportion receiving excess opioid days supplied declined from 24.0 to 10.4% among group practice COT patients and from 20.1 to 14.7% among COT patients of contracted physicians. Reductions in prescribing of high opioid dose and excess opioid days supplied followed state and health plan initiatives to change opioid prescribing. Reductions were substantially greater in the group practice setting that implemented additional initiatives to alter shared physician expectations regarding appropriate COT prescribing, compared with the contracted physicians' patients., Perspective: Washington State and a health plan's group practice implemented initiatives to reduce high-dose COT prescribing. Group practice physicians were exposed to both initiatives, whereas the health plan's contracted physicians were exposed to only the statewide changes. Reductions in prescribing of high opioid dose, average daily dose, and excess opioid days supplied followed state and health plan initiatives to change opioid prescribing. Reductions were substantially greater in the group practice setting that implemented additional initiatives to alter shared physician expectations regarding appropriate COT prescribing, compared with the contracted physicians' patients., (Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.)

Back pain affects most adults, causes disability for some, and is a common reason for seeking healthcare. In the United States, opioid prescription for low back pain has increased, and opioids are now the most commonly prescribed drug class. More than half of regular opioid users report back pain. Rates of opioid prescribing in the US and Canada are two to three times higher than in most European countries. The analgesic efficacy of opioids for acute back pain is inferred from evidence in other acute pain conditions. Opioids do not seem to expedite return to work in injured workers or improve functional outcomes of acute back pain in primary care. For chronic back pain, systematic reviews find scant evidence of efficacy. Randomized controlled trials have high dropout rates, brief duration (four months or less), and highly selected patients. Opioids seem to have short term analgesic efficacy for chronic back pain, but benefits for function are less clear. The magnitude of pain relief across chronic non-cancer pain conditions is about 30%. Given the brevity of randomized controlled trials, the long term effectiveness and safety of opioids are unknown. Loss of long term efficacy could result from drug tolerance and emergence of hyperalgesia. Complications of opioid use include addiction and overdose related mortality, which have risen in parallel with prescription rates. Common short term side effects are constipation, nausea, sedation, and increased risk of falls and fractures. Longer term side effects may include depression and sexual dysfunction. Screening for high risk patients, treatment agreements, and urine testing have not reduced overall rates of opioid prescribing, misuse, or overdose. Newer strategies for reducing risks include more selective prescription of opioids and lower doses; use of prescription monitoring programs; avoidance of co-prescription with sedative hypnotics; and reformulations that make drugs more difficult to snort, smoke, or inject., (© BMJ Publishing Group Ltd 2015.)

Unlabelled: Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed nonspecific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. Therefore, NIH Pain Consortium charged a research task force to draft standards for research on cLBP. The resulting multidisciplinary panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimum data set to describe research participants (drawing heavily on the Patient Reported Outcomes Measurement Information System methodology); reporting "responder analyses" in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved the recommendations, which investigators should incorporate into NIH grant proposals. The research task force believes that these recommendations will advance the field, help resolve controversies, and facilitate future research addressing the genomic, neurological, and other mechanistic substrates of cLBP. We expect that the research task force recommendations will become a dynamic document and undergo continual improvement., Perspective: A task force was convened by the NIH Pain Consortium with the goal of developing research standards for cLBP. The results included recommendations for definitions, a minimum data set, reporting outcomes, and future research. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes.

Unlabelled: If persons at risk of developing chronic pain could be identified early in a pain episode, treatment could be tailored on the basis of risk. Responses to psychophysical tests differ in persons with chronic pain vs pain-free controls and thus appear promising as indicators of susceptibility to chronic pain. In a cohort of 157 patients making their first primary care visit during a back pain episode, we explored the relationships of psychophysical test responses (pressure pain thresholds at low back and thenar sites, cold pressor pain ratings, conditioned pain modulation, and mechanical temporal summation) to baseline measures of pain and psychological distress and assessed whether test responses predicted clinically significant back pain 4 months later. Examiner-standardized pressure pain thresholds were significantly (P < .05) correlated with baseline back pain severity and diffuseness of bodily pain (Pearson correlations = -.21 to -.35). Lower baseline pressure pain thresholds significantly predicted back pain at 4 months (odds ratio [95% confidence interval]: low back, .66 [.44, .96]; thenar, .62 [.40, .92]); however, after controlling for participant age and sex, these associations were no longer significant. Cold pressor pain, conditioned pain modulation, and mechanical temporal summation were not significant predictors of 4-month back pain in either model., Perspective: Some psychophysical test responses have been found to differ in persons with chronic pain vs pain-free controls. In this prospective study, psychophysical test responses had limited utility for predicting which primary care back pain patients would have clinically significant chronic pain 4 months later., (Copyright © 2013 American Pain Society. Published by Elsevier Inc. All rights reserved.)

Background: Chronic opioid therapy has increased dramatically, as have complications related to prescription opioids. Little is known about the problems and concerns attributed to opioids by patients receiving different opioid doses., Methods: We surveyed 1883 patients who were receiving chronic opioid therapy for chronic noncancer pain. Opioid regimen characteristics were ascertained from electronic pharmacy records. Patient-reported opioid-related problems and concerns were measured using the Prescription Opioid Difficulties Scale. Depression was assessed with the Patient Health Questionnaire., Results: Patients prescribed higher opioid doses reported modestly higher pain intensity and pain impact. After adjustment, patients on higher doses attributed higher levels of psychosocial problems and control concerns to prescribed opioids (P<.0001). They also had higher levels of depression and were more likely to meet criteria for clinical depression. Over 60% of patients receiving 120+ mg daily (morphine equivalent) were clinically depressed, a 2.6-fold higher risk (95% confidence interval: 1.5-4.4) than patients on low-dose regimens (<20 mg daily)., Conclusions: Higher opioid doses were associated with somewhat higher pain severity and higher levels of patient-reported opioid-related psychosocial problems, control concerns and depression. These findings may result from patient selection for high-dose therapy or problems caused by higher-dose opioids., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objectives: Chronic opioid therapy (COT) for chronic noncancer pain (CNCP) is characterized by both high rates of patient-initiated discontinuation and by perceived helpfulness among those who sustain opioid use. This study examines predictors of the desire to cut down or stop opioid therapy among patients receiving COT who report that opioids are helpful for relieving pain., Methods: We conducted a cross-sectional survey of 1737 selected patients receiving COT for CNCP who perceived opioids to be helpful in relieving their pain. Ambivalence about opioid use was assessed by agreement/disagreement with a statement indicating that they would like to stop or cut down the use of prescribed opioid medications. Depression was measured with the 8-item Patient Health Questionnaire., Results: A high percentage (43.3%) of survey respondents who found opioids helpful also reported the desire to stop or cut down opioids. Half of these patients reporting the desire to stop or cut down were clinically depressed, compared with a third of those not wanting to stop or cut down, a highly significant difference after controlling for covariates (P<0.0001). The group wanting to stop or cut down opioid use also reported significantly higher levels of opioid-related psychosocial problems and opioid control concerns., Discussion: There are high rates of ambivalence about opioid use among COT recipients who consider opioids helpful for pain relief. Depressed patients are more likely to be ambivalent about use of prescribed opioids. Eliciting patient ambivalence may be helpful in patients who are not benefiting from long-term opioid use as an initial step toward consideration of discontinuation.

Unlabelled: Taking opioids with other central nervous system (CNS) depressants can increase risk of oversedation and respiratory depression. We used telephone survey and electronic health care data to assess the prevalence of, and risk factors for, concurrent use of alcohol and/or sedatives among 1,848 integrated care plan members who were prescribed chronic opioid therapy (COT) for chronic noncancer pain. Concurrent sedative use was defined by receiving sedatives for 45+ days of the 90 days preceding the interview; concurrent alcohol use was defined by consuming 2+ drinks within 2 hours of taking an opioid in the prior 2 weeks. Some analyses were stratified by substance use disorder (SUD) history (alcohol or drug). Among subjects with no SUD history, 29% concurrently used sedatives versus 39% of those with an SUD history. Rates of concurrent alcohol use were similar (12 to 13%) in the 2 substance use disorder strata. Predictors of concurrent sedative use included SUD history, female gender, depression, and taking opioids at higher doses and for more than 1 pain condition. Male gender was the only predictor of concurrent alcohol use. Concurrent use of CNS depressants was common among this sample of COT users regardless of substance use disorder status., Perspective: Risks associated with concurrent use of CNS depressants are not restricted to COT users who abuse those substances. And, the increased risk of concurrently using CNS depressants is not restricted to opioid users with a prior SUD history. COT requires close monitoring, regardless of substance use disorder history., (Copyright © 2012 American Pain Society. Published by Elsevier Inc. All rights reserved.)

Objective. Medication-use among headache patients 2 and 5 years after a primary care headache visit is assessed, and the pattern of medication-use compared before and after the introduction of subcutaneous sumatriptan among migraineurs. Setting and patients. The study was carried out among headache patients visiting a primary care physician at the Group Health Cooperative of Puget Sound in 1989–90. Methods. We report medication-use patterns 2 and 5 years later for the 530 subjects completing both a 2-year (1991–92) and a 5-year (1994–95) follow-up interview. Medication-use was determined by self-report for the month prior to the interview. Medication-use to control or prevent headache is shown for all headache patients and for those meeting International Headache Society criteria for migraine at the 2-year and the 5-year follow-up. Results. The overall pattern of medication-use was similar at the 2-year and the 5-year follow-up, before and after the introduction of subcutaneous sumatriptan (March, 1993). There was a modest but statistically significant decline in the use of opioid and sedative-hypnotic medications, and in the use of ergotamine. At 5 years, 11% of migraineurs reported use of sumatriptan in the prior month. The large majority of study patients used symptomatic medications, usually non-prescription analgesics, sedative-hypnotics, and opiates. Only one-fifth of the migraineurs reported use of a prophylactic medication for headache. Conclusions. Continuing use of symptomatic headache medications was characteristic of patients with migraine and other common forms of headache. The introduction of subcutaneous sumatriptan was not associated with notable change in this pattern, although a modest reduction in use of sedative-hypnotics and opiates was observed. Overall, the pattern of use of headache medications was similar before and after the introduction of subcutaneous sumatriptan. [ABSTRACT FROM AUTHOR]