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The HEALTHY study was a randomized, controlled, multicenter, middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Participants were a racially, ethnically and geographically diverse cohort from across the United States. Here, we describe the conceptual underpinnings and design of the social marketing-based communications component of the HEALTHY study intervention that combined changes in the school nutrition and physical education (PE) environment with behavior change initiatives. The communications intervention component coordinated multiple elements to deliver campaigns that served to integrate and support all aspects of the HEALTHY intervention. The campaigns unfolded across five semesters of middle school, each targeting a specific theme related to the HEALTHY objectives. Communications campaigns comprised (1) core elements such as branding, posters, banners and visual and verbal messaging, (2) student events supporting the nutrition, PE and behavior intervention components through the application of social marketing and communications strategies, including the incorporation of student-generated media and (3) distribution of premiums and theme enhancers to extend the visibility of the study beyond the intervention environment. Formative research conducted with students, parents and school administrators was used to refine the communications strategy. Student peer communicators selected from the student body were involved to influence the normative student environment. Marketing and creative design experts developed a brand, logo, activities and materials. In the latter half of the study, student-generated messages and media were used to reflect local interests and culture and enhance peer influence. The HEALTHY intervention delivery and impact were strengthened by the communications strategies. The HEALTHY experience provides practical considerations for systematically incorporating a social marketing-based communications approach within future school-based health behavior interventions.

AIMS: Despite many reports about complementary and alternative medicine (CAM) use in the general population, little information exists about specific CAM therapies used for particular health conditions. This study examines the use of CAM therapies among patients with temporomandibular disorders (TMD). METHODS: We surveyed 192 patients with documented TMD as part of a larger project on the effectiveness of various CAM modalities for TMD patients. The survey asked about use of and attitudes toward specific CAM therapies for treating TMD and other patient-identified health conditions. The survey also measured physical health, health behavior, and psychosocial functioning. RESULTS: Nearly two thirds of the respondents (62.5%; n = 120) reported using CAM therapies for TMD or a related condition. Of all the therapies reported, massage was rated as the most frequent and among the most satisfactory and helpful. In general, respondents who used CAM for their TMD reported being most satisfied with the 'hands on' CAM therapies (massage, acupuncture, and chiropractic care). The vast majority of respondents reported using CAM approaches for TMD simultaneously with conventional care (95.6%; 66 of 69). Those using CAM for TMD tended to be older, had a history of multiple medical problems, and reported more positive psychologic functioning. Respondents who most often reported CAM treatment as 'very helpful' for their TMD were likely to be healthier (i.e., reporting higher levels of exercise and fewer sleep disturbances). CONCLUSION: Given the frequent use of CAM treatments by our respondents, allopathic providers should inquire about the adjunctive use of CAM among their TMD patients. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to replicate and extend results of a previous blended efficacy and effectiveness trial of a low-intensity, manual-based guided self-help form of cognitive-behavioral therapy (CBT-GSH) for the treatment of binge eating disorders in a large health maintenance organization (HMO) and to compare them with usual care.Methods: To extend previous findings, the investigators modified earlier recruitment and assessment approaches and conducted a randomized clinical trial to better reflect procedures that may be reasonably carried out in real-world practices. The intervention was delivered by master's-level interventionists to 160 female members of a health maintenance organization who met diagnostic criteria for recurrent binge eating. Data collected at baseline, immediately posttreatment, and at six- and 12-month follow-ups were used in intent-to-treat analyses.Results: At the 12-month follow-up, CBT-GSH resulted in greater remission from binge eating (35%, N=26) than usual care (14%, N=10) (number needed to treat=5). The CBT-GSH group also demonstrated greater improvements in dietary restraint (d=.71) and eating, shape, and weight concerns (d=1.10, 1.24, and .98, respectively) but not weight change.Conclusions: Replication of the pattern of previous findings suggests that CBT-GSH is a robust treatment for patients with recurrent binge eating. The magnitude of changes was significantly smaller than in the original study, however, suggesting that patients recruited and assessed with less intensive procedures may respond differently from their counterparts enrolled in trials requiring more comprehensive procedures. [ABSTRACT FROM AUTHOR]

Context: Adolescent offspring of depressed parents are at markedly increased risk of developing depressive disorders. Although some smaller targeted prevention trials have found that depression risk can be reduced, these results have yet to be replicated and extended to large-scale, at-risk populations in different settings.Objective: To determine the effects of a group cognitive behavioral (CB) prevention program compared with usual care in preventing the onset of depression.Design, Setting, and Participants: A multicenter randomized controlled trial conducted in 4 US cities in which 316 adolescent (aged 13-17 years) offspring of parents with current or prior depressive disorders were recruited from August 2003 through February 2006. Adolescents had a past history of depression, current elevated but subdiagnostic depressive symptoms, or both. Assessments were conducted at baseline, after the 8-week intervention, and after the 6-month continuation phase.Intervention: Adolescents were randomly assigned to the CB prevention program consisting of 8 weekly, 90-minute group sessions followed by 6 monthly continuation sessions or assigned to receive usual care alone.Main Outcome Measure: Rate and hazard ratio (HR) of a probable or definite depressive episode (ie, depressive symptom rating score of > or = 4) for at least 2 weeks as diagnosed by clinical interviewers.Results: Through the postcontinuation session follow-up, the rate and HR of incident depressive episodes were lower for those in the CB prevention program than for those in usual care (21.4% vs 32.7%; HR, 0.63; 95% confidence interval [CI], 0.40-0.98). Adolescents in the CB prevention program also showed significantly greater improvement in self-reported depressive symptoms than those in usual care (coefficient, -1.1; z = -2.2; P = .03). Current parental depression at baseline moderated intervention effects (HR, 5.98; 95% CI, 2.29-15.58; P = .001). Among adolescents whose parents were not depressed at baseline, the CB prevention program was more effective in preventing onset of depression than usual care (11.7% vs 40.5%; HR, 0.24; 95% CI, 0.11-0.50), whereas for adolescents with a currently depressed parent, the CB prevention program was not more effective than usual care in preventing incident depression (31.2% vs 24.3%; HR, 1.43; 95% CI, 0.76-2.67).Conclusion: The CB prevention program had a significant prevention effect through the 9-month follow-up period based on both clinical diagnoses and self-reported depressive symptoms, but this effect was not evident for adolescents with a currently depressed parent.Trial Registration: clinicaltrials.gov Identifier: NCT00073671. [ABSTRACT FROM AUTHOR]

Objective: The authors sought to identify predictors of self-harm adverse events in treatment-resistant, depressed adolescents during the first 12 weeks of treatment.Method: Depressed adolescents (N=334) who had not responded to a previous trial with an SSRI antidepressant were randomized to a switch to either another SSRI or venlafaxine, with or without cognitive behavior therapy. Self-harm events, i.e., suicidal and non-suicidal self-injury adverse events were assessed by spontaneous report for the first 181 participants, and by systematic weekly assessment for the last 153 participants.Results: Higher rates of suicidal (20.8% vs. 8.8%) and nonsuicidal self-injury (17.6% vs. 2.2%), but not serious adverse events (8.4% vs. 7.3%) were detected with systematic monitoring. Median time to a suicidal event was 3 weeks, predicted by high baseline suicidal ideation, family conflict, and drug and alcohol use. Median time to nonsuicidal self-injury was 2 weeks, predicted by previous history of nonsuicidal self-injury. While there were no main effects of treatment, venlafaxine treatment was associated with a higher rate of self-harm adverse events in those with higher suicidal ideation. Adjunctive use of benzodiazepines, while in a small number of participants (N=10) was associated with higher rate of both suicidal and nonsuicidal self-injury adverse events.Conclusions: Since predictors of suicidal adverse events also predict poor response to treatment, and many of these events occurred early in treatment, improving the speed of response to depression, by targeting of family conflict, suicidal ideation, and drug use may help to reduce their incidence. The relationship of venlafaxine and of benzodiazepines to self-harm events requires further study and clinical caution. [ABSTRACT FROM AUTHOR]

Abstract: Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Abstract: Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Background: Back pain prevalence and burden increase with age; approximately one-third of U.S. adults 65 years of age and older experience lower back pain (LBP). For chronic low back pain (cLBP), typically defined as lasting three months or longer, many treatments for younger adults may be inappropriate for older adults given their greater prevalence of comorbidities with attendant polypharmacy. While acupuncture has been demonstrated to be safe and effective for cLBP in adults overall, few studies of acupuncture have either included or focused on adults ≥65 years old., Methods: The BackInAction study is a pragmatic, multi-site, three-arm, parallel-groups randomized controlled trial designed to test the effectiveness of acupuncture needling for improving back pain-related disability among 807 older adults ≥65 years old with cLBP. Participants are randomized to standard acupuncture (SA; up to 15 treatment sessions across 12 weeks), enhanced acupuncture (EA; SA during first 12 weeks and up to 6 additional sessions across the following 12 weeks), and usual medical care (UMC) alone. Participants are followed for 12 months with study outcomes assessed monthly with the primary outcome timepoint at 6 months., Discussion: The BackInAction study offers an opportunity to further understand the effectiveness, dose-dependence, and safety of acupuncture in a Medicare population. Additionally, study results may encourage broader adoption of more effective, safer, and more satisfactory options to the continuing over-reliance on opioid- and invasive medical treatments for cLBP among older adults., Trial Registration: ClinicalTrials.gov Identifier: NCT04982315. Clinical trial registration date: July 29, 2021., Competing Interests: Declaration of Competing Interest The authors have no competing interests to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Objective: Cognitive behavioral therapy for chronic pain (CBT-CP) is an evidence-based treatment for improving functioning and pain intensity for people with chronic pain with extensive evidence of effectiveness. However, there has been relatively little investigation of the factors associated with successful implementation and uptake of CBT-CP, particularly clinician and system level factors. This formative evaluation examined barriers and facilitators to the successful implementation and uptake of CBT-CP from the perspective of CBT-CP clinicians and referring primary care clinicians., Methods: Qualitative interviews guided by the Consolidated Framework for Implementation Research were conducted at nine geographically diverse Veterans Affairs sites as part of a pragmatic clinical trial comparing synchronous, clinician-delivered CBT-CP and remotely delivered, technology-assisted CBT-CP. Analysis was informed by a grounded theory approach., Results: Twenty-six clinicians (CBT-CP clinicians = 17, primary care clinicians = 9) from nine VA medical centers participated in individual qualitative interviews conducted by telephone from April 2019 to August 2020. Four themes emerged in the qualitative interviews: (1) the complexity and variability of referral pathways across sites, (2) referring clinician's lack of knowledge about CBT-CP, (3) referring clinician's difficulty identifying suitable candidates for CBT-CP, and (4) preference for interventions that can be completed from home., Conclusions: This formative evaluation identified clinician and system barriers to widespread implementation of CBT-CP and allowed for refinement of the subsequent implementation of two forms of CBT-CP in an ongoing pragmatic trial. Identification of relative difference in barriers and facilitators in the two forms of CBT-CP may emerge more clearly in a pragmatic trial that evaluates how treatments perform in real-world settings and may provide important information to guide future system-wide implementation efforts., (© 2022 World Institute of Pain. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

Background: Opioid use disorder (OUD) contributes to rising morbidity and mortality. Life-saving OUD treatments can be provided in primary care but most patients with OUD don't receive treatment. Comorbid depression and other conditions complicate OUD management, especially in primary care. The MI-CARE trial is a pragmatic randomized encouragement (Zelen) trial testing whether offering collaborative care (CC) to patients with OUD and clinically-significant depressive symptoms increases OUD medication treatment with buprenorphine and improves depression outcomes compared to usual care., Methods: Adult primary care patients with OUD and depressive symptoms (n ≥ 800) from two statewide health systems: Kaiser Permanente Washington and Indiana University Health are identified with computer algorithms from electronic Health record (EHR) data and automatically enrolled. A random sub-sample (50%) of eligible patients is offered the MI-CARE intervention: a 12-month nurse-driven CC intervention that includes motivational interviewing and behavioral activation. The remaining 50% of the study cohort comprise the usual care comparison group and is never contacted. The primary outcome is days of buprenorphine treatment provided during the intervention period. The powered secondary outcome is change in Patient Health Questionnaire (PHQ)-9 depression scores. Both outcomes are obtained from secondary electronic healthcare sources and compared in "intent-to-treat" analyses., Conclusion: MI-CARE addresses the need for rigorous encouragement trials to evaluate benefits of offering CC to generalizable samples of patients with OUD and mental health conditions identified from EHRs, as they would be in practice, and comparing outcomes to usual primary care. We describe the design and implementation of the trial, currently underway., Trial Registration: ClinicalTrials.gov Identifier: NCT05122676. Clinical trial registration date: November 17, 2021., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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).)

Background: Conducting an embedded pragmatic clinical trial in the workflow of a healthcare system is a complex endeavor. The complexity of the intervention delivery can have implications for study planning, ability to maintain fidelity to the intervention during the trial, and/or ability to detect meaningful differences in outcomes., Methods: We conducted a literature review, developed a tool, and conducted two rounds of phone calls with NIH Pragmatic Trials Collaboratory Demonstration Project principal investigators to develop the Intervention Delivery Complexity Tool. After refining the tool, we piloted it with Collaboratory demonstration projects and developed an online version of the tool using the R Shiny application (https://duke-som.shinyapps.io/ICT-ePCT/)., Results: The 6-item tool consists of internal and external factors. Internal factors pertain to the intervention itself and include workflow, training, and the number of intervention components. External factors are related to intervention delivery at the system level including differences in healthcare systems, the dependency on setting for implementation, and the number of steps between the intervention and the outcome., Conclusion: The Intervention Delivery Complexity Tool was developed as a standard way to overcome communication challenges of intervention delivery within an embedded pragmatic trial. This version of the tool is most likely to be useful to the trial team and its health system partners during trial planning and conduct. We expect further evolution of the tool as more pragmatic trials are conducted and feedback is received on its performance outside of the NIH Pragmatic Trials Collaboratory., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Opioid tapering has been identified as an effective strategy to prevent the dangers associated with long-term opioid therapy for patients with chronic pain. However, many patients are resistant to tapering, and conversations about tapering can be challenging for health care providers. Pharmacists can play a role in supporting both providers and patients with the process of opioid tapering., Objective: Qualitatively describe patient experiences with a unique phone-based and pharmacy-led opioid tapering program implemented within an integrated health care system., Methods: In-depth telephone interviews with patients who completed the program were recorded, transcribed, and analyzed. Themes were identified through a constant comparative approach., Results: We completed 25 interviews; 80% of patients were women (20), with a mean age of 58 years, and 72% (18) had been using opioids for pain management for 10 or more years. Most (60%) described a positive and satisfying experience with the tapering program. Strengths of the program reported by patients included a patient-centered and compassionate taper approach, flexible taper pace, easy access to knowledgeable pharmacist advocates, and resultant improvements in quality of life (e.g., increased energy). Challenges reported included: unhelpful or difficult-to-access nonpharmacological pain management options, negative quality of life impacts (e.g., inability to exercise), and lack of choice in the taper process. At the end of tapering, most patients (72%) described their pain as reduced or manageable rather than worse and expressed willingness to use the program in the future if a need should arise., Conclusions: Patients in a pharmacist-led opioid tapering program appreciated the program's individualized approach to care and access to pharmacist' expertise. Most interviewed patients successfully reduced their opioid use and recommended that the program should continue as an offered service. To improve the program, patients suggested increased personalization of the taper process and additional support for withdrawal symptoms and nonpharmacological pain management., (Copyright © 2022 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

The public health crisis of chronic pain has only increased in recognition since the Institute of Medicine's (IOM) Relieving Pain in America (2011) called for a cultural transformation in the way pain is viewed, treated, and put forward specific recommendations for action. The National Pain Strategy (NPS) provides a roadmap for putting these recommendations into practice. We implemented a program that placed nurses and behavioral specialists at the head of an interdisciplinary team utilizing best practices. In this program, nurses enacted the NPS recommendations to advance care for patients with persistent pain on long-term opioid treatment. This program promoted professional growth in nurses along with fostering success for patients. Compared with patients receiving usual care, patients in the program achieved greater reductions in pain severity, pain-related disability, and pain-related functional interference and reported greater satisfaction with pain-related care and primary care services. This article will detail the NPS-aligned practice approaches these nurses and their teams used, describe the training for the nurses, and speak to opportunities to enhance the nurse's capacity for this role in hopes of providing a model for the future implementation of an NPS-based approach by nurses., Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interest., (Copyright © 2022 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.)

Introduction: Beginning around 2011, innumerable policies have aimed to improve pain treatment while minimizing harms from excessive use of opioids. It is not known whether changing insurance coverage for specific conditions is an effective strategy. We describe and assess the effect of an innovative Oregon Medicaid back/neck pain coverage policy on opioid prescribing patterns., Methods: This retrospective cohort study uses electronic health record data from a network of community health centers (CHCs) in Oregon to analyze prescription opioid dose changes among patients on long-term opioid treatment (LOT) affected by the policy., Results: Of the 1,789 patients on LOT at baseline, 41.6% had an average daily dose of <20 morphine milligram equivalents (MME), 32.3% had ≥20 to <50 MME, 14.5% had ≥50 to <90 MME, and 11.6% ≥90 MME. Around half of each group discontinued opioids within the 18-month policy period. Those who discontinued did so gradually (average of 11 months) regardless of starting dosage. Predictors of discontinuation included: diagnosis of opioid use disorder, older, non-Hispanic white, and less medical complexity., Conclusions: Regardless of starting opioid dose, nearly half of patients affected by the 2016 Oregon Medicaid back/neck pain treatment policy no longer received opioid prescriptions by the end of the 18-month study period; another 30% decreased their dose. Gradual dose reduction was typical. These outcomes suggest that the policy impacted opioid prescribing. Understanding patient experiences resulting from such policies could help clinicians and policy makers navigate the complex balance between potential harms and benefits of LOT., Competing Interests: Conflicting and competing interests: Dr. Livingston previously served as the Associate Medical Director of the Health Evidence Review Commission. She is currently employed as the Medical Director of Health Share of Oregon. This potential conflict of interest has been reviewed and managed by Oregon Health & Science University., (© Copyright 2022 by the American Board of Family Medicine.)

Background: In 1979, Marvin Zelen proposed a new design for randomized clinical trials intended to facilitate clinicians' and patients' participation. The defining innovation of Zelen's proposal was random assignment of treatment prior to patient or participant consent. Following randomization, a participant would receive information and asked to consent to the assigned treatment., Methods: This narrative review examined recent examples of Zelen design trials evaluating clinical and public health interventions., Results: Zelen designs have often been applied to questions regarding real-world treatment or intervention effects under conditions of incomplete adherence. Examples include evaluating outreach or engagement interventions (especially for stigmatized conditions), evaluating treatments for which benefit may vary according to participant motivation, and situations when assignment to a control or usual care condition might prompt a disappointment effect. Specific practical considerations determine whether a Zelen design is scientifically appropriate or practicable. Zelen design trials usually depend on identifying participants automatically from existing records rather than by advertising, referral, or active recruitment. Assessments of baseline or prognostic characteristics usually depend on available records data rather than research-specific assessments. Because investigators must consider how exposure to treatments or interventions might bias ascertainment of outcomes, assessment of outcomes from routinely created records is often necessary. A Zelen design requires a waiver of the usual requirement for informed consent prior to random assignment of treatment. The Revised Common Rule includes specific criteria for such a waiver, and those criteria are most often met for evaluation of a low-risk and potentially beneficial intervention added to usual care. Investigators and Institutional Review Boards must also consider whether the scientific or public health benefit of a Zelen design trial outweighs the autonomy interests of potential participants. Analysis of Zelen trials compares outcomes according to original assignment, regardless of any refusal to accept or participate in the assigned treatment., Conclusions: A Zelen design trial assesses the real-world consequences of a specific strategy to prompt or promote uptake of a specific treatment. While such trials are poorly suited to address explanatory or efficacy questions, they are often preferred for addressing pragmatic or policy questions., (© 2021. The Author(s).)

Objective: To identify factors that influence or interfere with referrals by primary care providers (PCPs) to a pharmacist-led telephone-based program to assist patients undergoing opioid tapering. The Support Team Onsite Resource for Management of Pain (STORM) program provides individualized patient care and supports PCPs in managing opioid tapers., Design: Qualitative interviews were conducted with referring PCPs and STORM staff. Interview guides addressed concepts from the RE-AIM framework, focusing on issues affecting referral to the STORM program., Setting: An integrated healthcare system (HCS) in the Northwest United States., Subjects: Thirty-five interviews were conducted with 20 PCPs and 15 STORM staff., Methods: Constant comparative analysis was used to identify key themes from interviews. A codebook was developed based on interview data and a qualitative software program was used for coding, iterative review, and content analysis. Representative quotes illustrate identified themes., Results: Use of the STORM opioid tapering program was influenced by PCP, patient, and HCS considerations. Factors motivating use of STORM included lack of PCP time to support chronic pain patients requiring opioid tapering and the perception that STORM is a valued partner in patient care. Impediments to referral included PCP confidence in managing opioid tapering, patient resistance to tapering, forgetting about program availability, and PCP resistance to evolving guidelines regarding opioid tapering goals., Conclusions: PCPs recognized that STORM supported patient safety and reduced clinician burden. Utilization of the program could be improved through ongoing PCP education about the service and consistent co-location of STORM pharmacists within primary care clinics., (© The Author(s) 2021. 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.)

Objective: Opioid tapering is recommended when risks of chronic opioid use outweigh benefits. Little is known about patient characteristics or factors related to tapering success. We sought to identify characteristics that predict a 50% reduction in opioid use and qualitatively characterize factors that impact tapering success., Methods: We used multilevel hierarchical modeling to identify predictors of a 50% reduction in opioid use among Kaiser Permanente Northwest patients who underwent pharmacist-led tapering between 2012 and 2017. We conducted qualitative interviews among patients and pharmacists to identify factors influencing tapering success., Results: We identified 1384 patients who, on average, were dispensed 207 milligram morphine equivalents per day at baseline. After 12 months, 56% of patients reduced their opioid use by 50%. Increased odds of 50% reduction were associated with younger age 21-49 years (Odds ratio [OR] 1.32, P = 0.004); previous surgery (OR 2.24, P < 0.001); increased number of Addiction Medicine encounters (OR 1.25, P = 0.011); substance use disorder (OR 1.62, P = 0.001); anxiety (OR 1.32, P = 0.003); non-narcotic analgesic (OR 1.22, P = 0.025) or antipsychotic medication use (OR 1.53, P = 0.006); and opioid days supplied in the previous year (OR 1.08, P < 0.001). Patients and pharmacists noted that success was influenced by patients' willingness or resistance to change opioid use, the level of patient engagement achieved through communication with their provider, aspects of the tapering process such as pace, and external factors including health issues or caregiving responsibilities., Conclusions: Over one-half of patients who underwent tapering reduced their opioid use by 50%. Patient demographic and clinical characteristics were predictive of tapering success; however, patients and pharmacists noted that patient willingness, motivation, and personal circumstances also influence tapering outcome. Opioid tapering requires an individualized approach. Both clinical factors and personal circumstances should be considered when opioid tapering is being discussed as a possible solution for a patient., (Copyright © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

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.

Background: Intervention adherence and trial retention are challenging for clinical trials testing intensive behavioral interventions. Operational constraints or trial designs may preclude using effective retention strategies such as financial incentives. We examined whether implementing pre-enrollment orientation sessions was associated with higher intervention adherence and retention in a pragmatic clinical trial., Methods: The trial tested an intensive behavioral intervention for patients with chronic pain on long-term opioids. Orientation sessions were implemented two years into trial recruitment at one site. Held before informed consent and randomization, these mandatory, group-based orientation sessions provided trial specifics, explained research methods principles, and leveraged motivational interviewing techniques. Using a pre-post design and multivariate models, we assessed adherence (number of intervention meetings attended) and retention (completed quarterly pain assessments over 12 months) before (04/2014-12/2015; n = 209) and after (01/2016-02/2017; n = 258) implementation. Also, we evaluated whether session implementation affected the proportion and characteristics of enrolled patients., Results: After implementing orientation sessions, patients had higher intervention adherence than before (M = 7.6, SD = 3.8 vs. M = 5.6, SD = 4.5, respectively; mean difference = 2.0, 95% CI [0.9, 3.2], p = .001), and 2.8 times greater odds of completing quarterly assessments (95% CI [1.3, 5.8], p = .007). Fewer patients enrolled after implementing sessions than before (38.1% vs. 70.8%, 95% CI [26.4, 39.1], p < .001), with no differences in patient characteristics., Conclusions: Implementing orientation sessions during recruitment may be useful for promoting trial adherence and retention. To ensure enrollment goals are met, target population size and barriers affecting patients' ability to attend orientation sessions should be considered, especially for patients with complex medical conditions., Clinical Trials Registration Number: NCT02113592., Competing Interests: The authors declare that they have no competing interests., (© 2020 The Authors.)

Background: Chronic pain is a prevalent health concern in the United States (US) and a frequent reason for patients to seek primary care. The challenges associated with developing effective pain management strategies can be perceived as a burden on the patient-provider relationship., Objective: This study explored the relationship between patients' overall satisfaction with their primary care providers (PCPs) and their satisfaction with their chronic pain treatment, as well as the provider behaviors that contributed to chronic pain patients' satisfaction with their PCPs., Design: Concurrent nested mixed-methods design PARTICIPANTS: 97 patients with chronic pain who were assigned to the usual care arm of the Pain Program for Active Coping and Training (PPACT) study., Approach: We analyzed phone interview and survey data (n = 97). Interviews assessed provider behaviors that led to patient satisfaction. Interview transcripts were analyzed based on a content analysis approach. Survey responses assessed patient satisfaction with primary care and pain services. We calculated a Pearson's correlation coefficient using five response categories., Key Results: Interviews revealed that high satisfaction with primary care was driven by five concrete PCP behaviors: (1) listening, (2) maintaining communication with patients, (3) acting as an access point to comprehensive pain care, (4) providing an honest assessment of the possibilities of pain care, and (5) taking time during consultations with patients. In surveys, participants reported higher satisfaction with their primary care services than with the pain services they received; these variables were only moderately correlated (r = 0.586)., Conclusions: Results suggest that patients with chronic pain can view the relationship with their PCPs as positive, even in the face of low satisfaction with their pain treatment. The expectations that these patients held of PCPs could be met regardless of providers' ability to successfully relieve chronic pain.

Introduction: Primary care practitioners (PCPs) are concerned about adverse effects and poor outcomes of opioid use but may find opioid tapering difficult because of a lack of pain management training or time constraints limiting patient counseling. In 2010, Kaiser Permanente Northwest implemented a pharmacist-led opioid tapering program-Support Team Onsite Resource for Management of Pain (STORM)-to address high rates of opioid use, alleviate PCPs' workload demands, and improve patient outcomes., Objective: To describe the rationale, structure, and delivery of this unique pharmacist-led program, which partners with PCPs and provides individualized care to help patients reduce opioid use, and the Facilitating Lower Opioid Amounts through Tapering study, which examines the program's effectiveness, cost-effectiveness, and implementation., Results: The STORM program includes a pain medicine physician, a social worker or nurse, and pharmacists who have received specialized clinical and communications training. The program has a 2-fold role: 1) to provide PCP education about pain management and opioid use and 2) to offer clinician and patient support with opioid tapering and pain management. After program training, PCPs are equipped to discuss the need for tapering with a patient and to refer to the program. Program pharmacists provide a range of services, including opioid taper plans, nonopioid pain management recommendations, and taper-support outreach to patients., Discussion: The STORM program provides individualized care to assist patients with opioid tapering while reducing the burden on PCPs., Conclusion: The STORM program may be a valuable addition to health care systems and settings seeking options to address their patients' opioid tapering needs.

Effective management of patients with pain requires accurate information about the prevalence, outcomes, and co-occurrence of common pain conditions. However, the transition from ICD-9-CM to ICD-10-CM diagnostic coding in 2015 left researchers without methods for comparing the prevalence of pain conditions before and after the transition. In this study, we developed and assessed a diagnostic framework to serve as a crosswalk between ICD-9-CM and ICD-10-CM diagnosis codes for common pain-related health conditions. We refined existing ICD-9-CM definitions for diagnostic clusters of common pain conditions consistent with the US National Pain Strategy and developed corresponding ICD-10-CM definitions. We then assessed the stability of prevalence estimates and associated patient socio-demographic features of each diagnostic cluster during 1-year periods before and after the transition to ICD-10-CM in 3 US health care systems using electronic health records data for in-person encounters. Prevalence estimates and socio-demographic characteristics were similar before and after the transition. The Pain Condition ICD-9-CM to ICD-10-CM Crosswalk includes a full spectrum of common pain conditions to enable prevalence estimates of multiple and chronic overlapping pain conditions. This allows the tool to serve as a foundation for a broad array of pain-related health services research utilizing electronic databases. PERSPECTIVE: This article details the development and assessment of the Pain Condition ICD-9-CM to ICD-10-CM Crosswalk, a diagnostic framework for assessing pain condition prevalence across the ICD-9-CM to ICD-10-CM transition. This framework can serve as a standardized tool for research on pain conditions, including health services and epidemiologic research., (Copyright © 2019 the American Pain Society. All rights reserved.)

Background: Opioid treatment for chronic pain has garnered heightened public attention and political pressure to control a devastating public health crisis in the United States (U.S.). Resulting policy changes, together with ongoing public and political attention, have pushed health care systems and providers to lower doses or deprescribe and taper patients off opioids. However, little attention has been paid to the impact of such practice changes on patients who had relied on opioid treatment to manage their chronic pain. The aim of this article is to explore experiences with opioid-related care under aggressive tapering efforts and concomitant heightened monitoring and institutional oversight among patients with chronic pain in an integrated delivery system through in-depth interviews., Methods: We interviewed 97 patients with chronic pain who were assigned to the usual care arm of the Pain Program for Active Coping and Training (PPACT) study. These patients had been prescribed opioids as part of their treatment regimens and taken opioids closely monitored by their health care providers. We followed the framework method for coding and analysing transcripts using NVivo 12., Results: The experiences of these patients during this period of change can be understood through three interconnected themes: (1) many patients taking opioids experience debilitating physical side effects; (2) navigating opioid treatment contributes to significant emotional distress among many patients with chronic pain and; (3) the quality of patients' relationship with their primary care provider can be negatively affected by negotiations regarding long-term opioid treatment for chronic pain., Conclusion: We highlight the importance of utilizing communication approaches that are patient-centered and include shared decision making during the tapering and/or deprescribing processes of opioids and ensuring alternative pain treatments are available to patients with chronic pain., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Importance: Few studies have examined the relationship between nonmalignant chronic pain (NMCP) and suicide death, and even fewer have specifically explored what role sleep disturbance might play in the association between NMCP and suicide death., Objective: To assess whether sleep disturbance mediates the relationship between NMCP and suicide death., Design: This case-control study included 2,674 individuals who died by suicide between 2000 and 2013 (cases) and 267,400 matched individuals (controls)., Setting: Eight Mental Health Research Network (MHRN)-affiliated healthcare systems., Participants: All cases and matched controls were health plan members for at least 10 months during the year prior to the index date., Main Outcomes and Measures: Sociodemographic data and diagnosis codes for NMCP and sleep disorders were extracted from the MHRN's Virtual Data Warehouse. Suicide mortality was identified using International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes from official government mortality records matched to health system records., Results: After accounting for covariates, there was a significant relationship between NMCP and sleep disturbance; those who were diagnosed with NMCP were more likely to develop subsequent sleep disturbance. Similarly, sleep disturbance was significantly associated with suicide death. Finally, a significant indirect effect of NMCP on suicide death, through sleep disturbance, and a nonsignificant direct effect of NMCP on suicide death provide support for a fully mediated model., Conclusions and Relevance: There is a need for clinicians to screen for both sleep disturbance and suicidal ideation in NMCP patients and for health systems to implement more widespread behavioral treatments that address comorbid sleep problems and NMCP., (© 2018 World Institute of Pain.)

Objective: Youth depression can be prevented, yet few programs are offered. Decision makers lack cost information. This study evaluated the cost-effectiveness of a cognitive-behavioral prevention program (CBP) versus usual care., Methods: A cost-effectiveness analysis was conducted with data from a randomized controlled trial of 316 youths, ages 13-17, randomly assigned to CBP or usual care. Youths were at risk of depression because of a prior depressive disorder or subthreshold depressive symptoms, or both, and had parents with a prior or current depressive disorder. Outcomes included depression-free days (DFDs), quality-adjusted life years (QALYs), and costs., Results: Nine months after baseline assessment, youths in CBP experienced 12 more DFDs (p=.020) and .018 more QALYs (p=.007), compared with youths in usual care, with an incremental cost-effectiveness ratio (ICER) of $24,558 per QALY. For youths whose parents were not depressed at baseline, CBP youths had 26 more DFDs (p=.001), compared with those in usual care (ICER=$10,498 per QALY). At 33 months postbaseline, youths in CBP had 40 more DFDs (p=.05) (ICER=$12,787 per QALY). At 33 months, CBP youths whose parents were not depressed at baseline had 91 more DFDs (p=.001) (ICER=$13,620 per QALY). For youths with a currently depressed parent at baseline, CBP was not significantly more effective than usual care at either 9 or 33 months, and costs were higher., Conclusions: CBP produced significantly better outcomes than usual care and was particularly cost-effective for youths whose parents were not depressed at baseline. Depression prevention programs could improve youths' health at a reasonable cost; services to treat depressed parents may also be warranted.

Objectives: The authors employ a Whole Systems framework to explore implementation of new guidelines for back and neck pain in Oregon's Medicaid system. Whole Systems research is useful for understanding the relationship between complementary and integrative health care (CIH) and conventional health care systems in real-world clinical and practice settings., Design: Preliminary results are from an observational study designed to evaluate state-wide implementation of CIH and other non-pharmacological treatments for neck and back pain among Oregon Medicaid patients. This natural experiment, even in early stages, provides insight into the challenges of integrating Whole Systems oriented therapies into Medicaid billing and treatment., Methods: Qualitative data are drawn from: (1) semi-structured interviews with representatives of each of the 16 coordinated care organizations (CCOs) responsible for administering the Oregon's Medicaid insurance through the Oregon Health Plan (OHP); and (2) open-ended survey responses from acupuncturists in all 16 CCO areas., Results: Implementation of the new policy guidelines poses logistical and epistemological challenges. Differences in worldview, inadequate reimbursement, and simple lack of awareness of CIH among medical providers are some of the factors that pose barriers to merging CIH therapies into conventional frameworks., Conclusions: In this article, we explore the potential for a Whole Systems perspective to better explain the complexity of integrating CIH and other non-pharmacological services into a state financed health care system. Oregon's expansion of services for back and neck pain presents an opportunity to explore challenges and successes in melding multiple approaches to health and pain management into a managed system such as the OHP.

Objectives: To determine whether a pharmacist-led, patient-directed intervention can reduce opioid use following total hip arthroplasty (THA) or total knee arthroplasty (TKA)., Study Design: Randomized trial., Methods: Patients scheduled to undergo THA or TKA (during 2015 and 2016) were randomized to usual care or intervention. We ranked patients according to predicted risk of persistent opioid use and selected the top 60% for inclusion (n = 561); all contributed to the analysis. Intervention patients were mailed materials 2 weeks before and after surgery, plus they received telephone intervention from specially trained pharmacists if they filled opioid prescriptions in the 28 to 90 days following surgery. Our primary outcome was the dispensed morphine equivalents (DME) in the 90 days following surgery, modeled using a natural log transformation., Results: A total of 561 patients were randomized (286 usual care, 118 THA and 168 TKA; 275 intervention, 107 THA and 168 TKA); the mean age was 66 years, and 60% were female. Overall, we found no meaningful reduction in DME for intervention versus usual care (geometric mean ratio, 0.92 [95% CI, 0.69-1.21]). However, there was effect modification by whether the patient had TKA or THA (interaction P <.01). Those undergoing THA in the intervention group used significantly less DME than did those undergoing THA in the usual care group (geometric mean ratio, 0.52 [95% CI, 0.33-0.82])., Conclusions: Our pharmacist-led, patient-directed intervention to reduce opioid use demonstrated a reduction in opioid dispensings in the 90 days following THA but not TKA.

Chronic pain is widely prevalent among Veterans and can have serious negative consequences for functional status and quality of life among other domains. 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 non-pharmacological management of chronic musculoskeletal pain. In this perspective article, we present the methods and consensus recommendations for research priorities emanating from the SOTA. In the months leading up to the SOTA, a core group of researchers defined four areas of focus: psychological/behavioral therapies; exercise/movement therapies; manual therapies; and models for delivering multi-modal pain care and divided into workgroups. Each workgroup, in their respective areas of focus, identified seminal studies capturing the state of the evidence. Herein, we present consensus recommendations ranging from efficacy to effectiveness to implementation/dissemination research depending on the state of the evidence as assessed by participants, including commentary on common elements across workgroups and future areas of innovation in study design, measurement, and outcome ascertainment.

Background and Objectives: Adolescents with depression identified in primary care settings often have limited treatment options beyond antidepressant (AD) therapy. We assessed the cost-effectiveness of a brief cognitive behavioral therapy (CBT) program among depressed adolescents who declined or quickly stopped using ADs., Methods: A total of 212 youth with depression were randomly assigned to treatment as usual (TAU) or TAU plus brief individual CBT. Clinical outcomes included depression-free days (DFDs) and estimated quality-adjusted life-years (QALYs). Costs were adjusted to 2008 US dollars. Incremental cost-effectiveness ratios (ICERs) comparing CBT to TAU were calculated over 12- and 24-month follow-up periods., Results: Youth randomly assigned to CBT had 26.8 more DFDs ( P = .044) and 0.067 more QALYs ( P = .044) on average compared with TAU over 12 months. Total costs were $4976 less ( P = .025) by the end of the 24-month follow-up among youth randomly assigned to CBT. Total costs per DFD were -$51 (ICER = -$51; 95% confidence interval [CI]: -$394 to $9) at 12 months and -$115 (ICER = -$115; 95% CI: -$1090 to -$6) at 24 months. Total costs per QALY were -$20 282 (ICER = -$20 282; 95% CI: -$156 741 to $3617) at 12 months and -$45 792 (ICER = -$45 792; 95% CI: -$440 991 to -$2731) at 24 months., Conclusions: Brief primary care CBT among youth declining AD therapy is cost-effective by widely accepted standards in depression treatment. CBT becomes dominant over TAU over time, as revealed by a statistically significant cost offset at the end of the 2-year follow-up., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2018 by the American Academy of Pediatrics.)

Background: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped., Methods: To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design., Results: In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs., Conclusion: A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

Introduction: Self-reporting by patients though the use of electronic patient-reported outcome (PRO) measures has been shown to use increase patient satisfaction with care, and improve patient-provider communication, symptom management, and health quality. Additionally, PROs are increasingly used in research to expand understanding regarding the relative risks, benefits, and burdens of interventions. While experience embedding patient-reported outcomes (PROs) into registries and clinical workflow is growing, there is little in the literature to guide those interested in incorporating PROs into routine clinical care and for use in research., Case Descriptions: The NIH Health Care Systems Research Collaboratory PRO Core interviewed investigators from seven programs to get their first-hand experiences on the incorporation of PROs for both care and research, and the investigators have contributed to this manuscript as authors., Findings: We use these case studies to present practical approaches to initiating and implementing PROS, including instrument selection, tips for integrating PRO collection systems into clinical workflow, considerations for user experience and data collection, and the methods to assess and monitor quality., Conclusion: Because the decision to initiate and implement PRO collection impacts many different stakeholders, the solution requires collaboration among the involved parties, careful planning, and integration into clinical workflow.

Background: Current literature describes the limits and pitfalls of using opioid pharmacotherapy for chronic pain and the importance of identifying alternatives. The objective of this study was to identify the practical issues patients and providers face when accessing alternatives to opioids, and how multiple parties view these issues., Methods: Qualitative data were gathered to evaluate the outcomes of acupuncture and chiropractic (A/C) services for chronic musculoskeletal pain (CMP) using structured interview guides among patients with CMP (n = 90) and primary care providers (PCPs) (n = 25) purposively sampled from a managed care health care system as well as from contracted community A/C providers (n = 14). Focus groups and interviews were conducted patients with CMP with varying histories of A/C use. Plan PCPs and contracted A/C providers took part in individual interviews. All participants were asked about their experiences managing chronic pain and experience with and/or attitudes about A/C treatment. Audio recordings were transcribed and thematically coded. A summarized version of the focus group/interview guides is included in the Additional file 1., Results: We identified four themes around opioid use: (1) attitudes toward use of opioids to manage chronic pain; (2) the limited alternative options for chronic pain management; (3) the potential of A/C care as a tool to help manage pain; and (4) the complex system around chronic pain management. Despite widespread dissatisfaction with opioid medications for pain management, many practical barriers challenged access to other options. Most of the participants' perceived A/C care as helpful for short term pain relief. We identified that problems with timing, expectations, and plan coverage limited A/C care potential for pain relief treatment., Conclusions: These results suggest that education about realistic expectations for chronic pain management and therapy options, as well as making A/C care more easily accessible, might lead to more satisfaction for patients and providers, and provide important input to policy makers., Trial Registration: ClinicalTrials.gov NCT01345409 , date of registration 28/4/2011.

Background: Supporting day-to-day self-care activities has emerged as a best practice when caring for patients with chronic pain, yet providing this support may introduce challenges for both patients and primary care physicians. It is essential to develop tools that help patients identify the issues and outcomes that are most important to them and to communicate this information to primary care physicians at the point of care., Objective: We describe our process to engage patients, primary care physicians, and other stakeholders in the context of a pilot randomized controlled trial of a patient-centered assessment process implemented in an everyday practice setting. We identify lessons on how to engage stakeholders and improve patient-centered care for those with chronic conditions within the primary care setting., Methods: A qualitative analysis of project minutes, interviews, and focus groups was conducted to evaluate stakeholder experiences. Stakeholders included patients, caregivers, clinicians, medical office support staff, health plan administrators, an information technology consultant, and a patient advocate., Results: Our stakeholders included many patients with no prior experience with research. This approach enriched the applicability of feedback but necessitated extra time for stakeholder training and meeting preparation. Types of stakeholders varied over the course of the project, and more involvement of medical assistants and Information Technology staff was required than originally anticipated., Conclusion: Meaningful engagement of patient and physician stakeholders must be solicited in a well-coordinated manner with broad health care system supports in place to ensure full execution of patient-centered processes.

Background and Objective: Health care providers have few alternatives for youth depression other than antidepressants. We examined whether brief cognitive behavioral therapy (CBT) is a viable alternative in primary care., Methods: A total of 212 adolescents aged 12 to 18 with major depression who had recently declined or quickly discontinued new antidepressant treatment were randomized to self-selected treatment as usual (TAU) control condition or TAU plus brief individual CBT. Blinded evaluators followed youth for 2 years. The primary outcome was time to major depression diagnostic recovery., Results: CBT was superior to the control condition on the primary outcome of time to diagnostic recovery from major depression, with number needed to treat from 4 to 10 across follow-up. A similar CBT advantage was found for time to depression diagnosis response, with number needed to treat of 5 to 50 across time points. We observed a significant advantage for CBT on many secondary outcomes over the first year of follow-up but not the second year. Cohen's d effect sizes for significant continuous measures ranged from 0.28 to 0.44, in the small to medium effect range. Most TAU health care services did not differ across conditions, except for psychiatric hospitalizations, which occurred at a significantly higher rate in the control condition through the first year of follow-up., Conclusions: Observed results were consistent with recent meta-analyses of CBT for youth depression. The initial year of CBT superiority imparted an important clinical benefit and may reduce the risk of future recurrent depression episodes., (Copyright © 2016 by the American Academy of Pediatrics.)

Background: A variety of people, with multiple perspectives, make up the system comprising chronic musculoskeletal pain (CMP) treatment. While there are frequently problems in communication and coordination of care within conventional health systems, more opportunities for communicative disruptions seem possible when providers use different explanatory models and are not within the same health management system. We sought to describe the communication system surrounding the management of chronic pain from the perspectives of allopathic providers, acupuncture and chiropractor (A/C) providers, and CMP patients., Methods: We collected qualitative data from CMP patients (n = 90) and primary care physicians (PCPs) (n = 25) in a managed care system, and community acupuncture and chiropractic care providers (n = 14) who received high levels of referrals from the system, in the context of a longitudinal study of CMP patients' experience., Results: Multiple points of divergence and communicative barriers were identified among the main stakeholders in the system. Those that were most frequently mentioned included issues surrounding the referral process (requesting, approving) and lack of consistent information flow back to providers that impairs overall management of patient care. We found that because of these problems, CMP patients were frequently tasked and sometimes overwhelmed with integrating and coordinating their own care, with little help from the system., Conclusions: Patients, PCPs, and A/C providers desire more communication; thus systems need to be created to facilitate more open communication which could positively benefit patient outcomes.

There is a need for treatment interventions to address the high prevalence of disordered eating throughout adolescence and early adulthood. We developed an adolescent-specific manualized CBT protocol to treat female adolescents with recurrent binge eating and tested its efficacy in a small, pilot randomized controlled trial. We present lessons learned in recruiting adolescents, a description of our treatment approach, acceptability of the treatment for teens and parents, as well as results from the pilot trial. Participants in the CBT group had significantly fewer posttreatment eating binges than those in a treatment as usual/delayed treatment (TAU-DT) control group; 100% of CBT participants were abstinent at follow-up. Our results provide preliminary support for the efficacy of this adolescent adaptation of evidence-based CBT for recurrent binge eating. The large, robust effect size estimate observed for the main outcome (NNT=2) places this among the larger effects observed for any mental health intervention.

Background: The LIFE study was a randomized controlled trial assessing the impact of a self-acupressure intervention, Tapas Acupressure Technique® (TAT®), on weight-loss maintenance. The primary analysis showed no significant difference between TAT and social support (SS) for weight-loss maintenance, while exploratory post hoc tests suggested that, among participants with highest initial weight-loss, those in the TAT condition regained less weight than those in the SS condition., Objective: The aim of the current study was to assess adherence to, and satisfaction with, the experimental self-acupressure intervention in the LIFE weight loss maintenance trial., Design: This was a secondary analysis of adherence and satisfaction patterns in a large randomized controlled trial., Setting: The study was conducted at a prominent health maintenance organization in the Pacific Northwest., Subjects: This study involved 142 obese participants who had lost >10 pounds in a conventional weight-loss program and who were randomized to the experimental acupressure intervention., Interventions: The experimental intervention ( n =142) arm consisted of instruction and application of a self-acupressure intervention, the Tapas Acupressure Technique ® (TAT ® )., Outcome Measures: The outcome sought was self-reported satisfaction and frequency of TAT practice., Results: Sixty-six percent of TAT participants attended at least 6 of 8 intervention sessions. More than 80% of participants reported practicing TAT at home, on average, at least 2 days per week. Sixty two percent reported practicing <10 minutes per session, while 27% reported practicing 10-20 minutes per session. Higher satisfaction scores were significantly correlated with less weight regain ( p =0.001). Frequency of TAT practice was not significantly associated with changes in weight, stress, insomnia, depression, or quality of life., Conclusions: These data suggest moderate acceptance of, and adherence to, the TAT intervention. Further research is required to identify and achieve optimal home-practice levels of self-acupressure techniques.

Chronic pain affects at least 116 million adults in the USA and exacts a tremendous cost in suffering and lost productivity. While health systems offer specialized pain services, the primary care setting is where most patients seek and receive care for pain. Primary care-based treatment of chronic pain by interdisciplinary teams (including behavioral specialists, nurse case managers, physical therapists, and pharmacists) is one of the most effective approaches for improving outcomes and managing costs. To ensure robust integration of such services into sustainable health-care programs, evaluations must be conducted by researchers well versed in the methodologies of clinical trials, mixed methods and implementation research, bioinformatics, health services, and cost-effectiveness. Recent national health policy changes, in addition to the increasing recognition of the high prevalence and cost of chronic pain conditions, present a unique opportunity to shift the care paradigm for patients with chronic pain.

Primary care clinics are an ideal setting for early identification and possibly treatment of adolescent obesity. However, despite practice recommendations promoting preventive screening and monitoring of obesity, implementation has been modest. In this study, we interviewed providers to determine barriers to managing pediatric obesity, perceived skill in obesity interventions, and interest in additional training. The sensitivity of weight-related discussions and time were the 2 most significant barriers reported. We designed a brief training program, implemented it within a larger randomized controlled trial, and surveyed providers regarding its utility. The training was satisfactory to attendees and led to reported changes in practice patterns. Providers who received more complete training reported greater ease working with overweight teens and greater confidence that they could motivate teen patients to make healthy lifestyle changes compared with those who received less training. A fairly modest training intervention could improve patient care in the primary care setting.

Background: Traditional recruitment methods for clinical trials, such as telephone, mail, and print media, are often inefficient, costly, and use large amounts of staff time and resources., Purpose: This analysis was conducted to determine whether retention, demographics, and outcomes differed between enrolled participants who responded to recruitment outreach using an Internet-based information and registration system and enrollees whose first contact was with study staff via telephone., Methods: We identified potentially eligible participants from Kaiser Permanente Northwest (KPNW) databases and mailed brochures inviting them to participate in the Life weight loss maintenance study. We also used employee newsletters, a member-directed website, and messages to employee email distribution lists to publicize the study. All outreach methods contained both a website address and a telephone number through which respondents could register for an information session. The website contained the same information as was provided by staff over the telephone., Results: Out of 2122 potential participants who expressed interest in the study, 70% did so through the website. There was no difference in retention rates between enrollees who initiated contact through the website (WEB = 308) and enrollees who contacted the study by telephone (staff = 161). The WEB group was younger (p = 0.01), had higher income (p = 0.01) and education (p < 0.01) levels, and lower body mass index (BMI; p < 0.01). There was a trend toward greater weight loss in the WEB group (p = 0.06)., Limitations: We did not conduct a formal cost analysis of the two methods. Also, the population for this analysis was mostly Caucasian and middle income; thus, we cannot draw conclusions about the generalizability of our findings to more racially and economically diverse populations., Conclusion: Enrolled participants who used a website to register for an initial study information session had similar study retention and outcome performance as enrollees who used a more traditional telephone method. For larger clinical trials, a website may help researchers more efficiently and cost-effectively achieve recruitment, eligibility, and randomization goals. More research is needed to determine whether similar recruitment and retention patterns are observed among racially and economically diverse populations when these and similar methods are compared.

Background: Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance., Methods: Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®), or a control intervention comprised of social-support group meetings (SS) led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation., Results: Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd) = 11), mean BMI at randomization was 34 (sd = 5), and mean initial weight loss was 9.8 kg (sd = 5). In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85) weight regain for TAT and 2.96 kg (se 0.96) weight regain for SS, p < 0.097) Tests of between- arm differences for secondary outcomes were also not significant. A secondary analysis showed a significant interaction between treatment and initial weight loss (p < .036), with exploratory post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT., Conclusions: The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research.

Background and Objective: Most clinic-based weight control treatments for youth have been designed for preadolescent children by using family-based care. However, as adolescents become more autonomous and less motivated by parental influence, this strategy may be less appropriate. This study evaluated a primary care-based, multicomponent lifestyle intervention specifically tailored for overweight adolescent females., Methods: Adolescent girls (N = 208) 12 to 17 years of age (mean ± SD: 14.1 ± 1.4 years), with a mean ± SD BMI percentile of 97.09 ± 2.27, were assigned randomly to the intervention or usual care control group. The gender and developmentally tailored intervention included a focus on adoptable healthy lifestyle behaviors and was reinforced by ongoing feedback from the teen's primary care physician. Of those randomized, 195 (94%) completed the 6-month posttreatment assessment, and 173 (83%) completed the 12-month follow-up. The primary outcome was reduction in BMI z score., Results: The decrease in BMI z score over time was significantly greater for intervention participants compared with usual care participants (-0.15 in BMI z score among intervention participants compared with -0.08 among usual care participants; P = .012). The 2 groups did not differ in secondary metabolic or psychosocial outcomes. Compared with usual care, intervention participants reported less reduction in frequency of family meals and less fast-food intake., Conclusions: A 5-month, medium-intensity, primary care-based, multicomponent behavioral intervention was associated with significant and sustained decreases in BMI z scores among obese adolescent girls compared with those receiving usual care.

Background: The LIFE study is a two-phase randomized clinical trial comparing two approaches to maintaining weight loss following guided weight loss. Phase I provided a nonrandomized intensive 6-month behavioral weight loss intervention to 472 obese (body mass index 30-50) adult participants. Phase II is the randomized weight loss maintenance portion of the study. This paper focuses on Phase I measures of sleep, screen time, depression and stress., Methods: The Phase I intervention consisted of 22 group sessions led over 26 weeks by behavioral counselors. Recommendations included reducing dietary intake by 500 calories per day, adopting the Dietary Approaches to Stop Hypertension (DASH) dietary pattern and increasing physical exercise to at least 180 min per week. Measures reported here are sleep time, insomnia, screen time, depression and stress at entry and post-weight loss intervention follow-up., Results: The mean weight loss for all participants over the intensive Phase I weight loss intervention was 6.3 kg (s.d. 7.1). Sixty percent (N=285) of participants lost at least 4.5 kg (10 lbs) and were randomized into Phase II. Participants (N=472) attended a mean of 73.1% (s.d. 26.7) of sessions, completed 5.1 (s.d. 1.9) daily food records/week, and reported 195.1 min (s.d. 123.1) of exercise per week. Using logistic regression, sleep time (quadratic trend, P=0.030) and lower stress (P=0.024) at entry predicted success in the weight loss program, and lower stress predicted greater weight loss during Phase I (P=0.021). In addition, weight loss was significantly correlated with declines in stress (P=0.048) and depression (P=0.035)., Conclusion: Results suggest that clinicians and investigators might consider targeting sleep, depression and stress as part of a behavioral weight loss intervention.

Background: Substantial recent research examines the efficacy of many types of complementary and alternative (CAM) therapies. However, outcomes associated with the "real-world" use of CAM has been largely overlooked, despite calls for CAM therapies to be studied in the manner in which they are practiced. Americans seek CAM treatments far more often for chronic musculoskeletal pain (CMP) than for any other condition. Among CAM treatments for CMP, acupuncture and chiropractic (A/C) care are among those with the highest acceptance by physician groups and the best evidence to support their use. Further, recent alarming increases in delivery of opioid treatment and surgical interventions for chronic pain--despite their high costs, potential adverse effects, and modest efficacy--suggests the need to evaluate real world outcomes associated with promising non-pharmacological/non-surgical CAM treatments for CMP, which are often well accepted by patients and increasingly used in the community., Methods/design: This multi-phase, mixed methods study will: (1) conduct a retrospective study using information from electronic medical records (EMRs) of a large HMO to identify unique clusters of patients with CMP (e.g., those with differing demographics, histories of pain condition, use of allopathic and CAM health services, and comorbidity profiles) that may be associated with different propensities for A/C utilization and/or differential outcomes associated with such care; (2) use qualitative interviews to explore allopathic providers' recommendations for A/C and patients' decisions to pursue and retain CAM care; and (3) prospectively evaluate health services/costs and broader clinical and functional outcomes associated with the receipt of A/C relative to carefully matched comparison participants receiving traditional CMP services. Sensitivity analyses will compare methods relying solely on EMR-derived data versus analyses supplementing EMR data with conventionally collected patient and clinician data., Discussion: Successful completion of these aggregate aims will provide an evaluation of outcomes associated with the real-world use of A/C services. The trio of retrospective, qualitative, and prospective study will also provide a clearer understanding of the decision-making processes behind the use of A/C for CMP and a transportable methodology that can be applied to other health care settings, CAM treatments, and clinical populations., Trial Registration: ClinicalTrials.gov: NCT01345409.

Background: As concern about youth obesity continues to mount, there is increasing consideration of widespread policy changes to support improved nutritional and enhanced physical activity offerings in schools. A critical element in the success of such programs may be to involve students as spokespeople for the program. Making such a public commitment to healthy lifestyle program targets (improved nutrition and enhanced physical activity) may potentiate healthy behavior changes among such students and provide a model for their peers. This paper examines whether student's "public commitment"--voluntary participation as a peer communicator or in student-generated media opportunities--in a school-based intervention to prevent diabetes and reduce obesity predicted improved study outcomes including reduced obesity and improved health behaviors., Methods: Secondary analysis of data from a 3-year randomized controlled trial conducted in 42 middle schools examining the impact of a multi-component school-based program on body mass index (BMI) and student health behaviors. A total of 4603 students were assessed at the beginning of sixth grade and the end of eighth grade. Process evaluation data were collected throughout the course of the intervention. All analyses were adjusted for students' baseline values. For this paper, the students in the schools randomized to receive the intervention were further divided into two groups: those who participated in public commitment activities and those who did not. Students from comparable schools randomized to the assessment condition constituted the control group., Results: We found a lower percentage of obesity (greater than or equal to the 95th percentile for BMI) at the end of the study among the group participating in public commitment activities compared to the control group (21.5% vs. 26.6%, p = 0.02). The difference in obesity rates at the end of the study was even greater among the subgroup of students who were overweight or obese at baseline; 44.6% for the "public commitment" group, versus 53.2% for the control group (p = 0.01). There was no difference in obesity rates between the group not participating in public commitment activities and the control group (26.4% vs. 26.6%)., Conclusions: Participating in public commitment activities during the HEALTHY study may have potentiated the changes promoted by the behavioral, nutrition, and physical activity intervention components., Trial Registration: ClinicalTrials.gov number, NCT00458029.