Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

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.

Reduction of Long-Term Opioid Prescribing for Back Pain in Community Health Centers After a Medicaid Policy Change.

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.

Economic Evaluation: A Randomized Pragmatic Trial of a Primary Care-based Cognitive Behavioral Intervention for Adults Receiving Long-term Opioids for Chronic Pain.

BACKGROUND: Chronic pain is prevalent and costly; cost-effective nonpharmacological approaches that reduce pain and improve patient functioning are needed. OBJECTIVE: Report the incremental cost-effectiveness ratio (ICER), compared with usual care, of cognitive behavioral therapy aimed at improving functioning and pain among patients with chronic pain on long-term opioid treatment. DESIGN: Economic evaluation conducted alongside a pragmatic cluster randomized trial. SUBJECTS: Adults with chronic pain on long-term opioid treatment (N=814). INTERVENTION: A cognitive behavioral therapy intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorists, nurses) with additional support from physical therapists, and pharmacists. OUTCOME MEASURES: Cost per quality adjusted life year (QALY) gained, and cost per additional responder (≥30% improvement on standard scale assessment of Pain, Enjoyment, General Activity, and Sleep). Costs were estimated as-delivered, and replication. RESULTS: Per patient intervention replication costs were $2145 ($2574 as-delivered). Those costs were completely offset by lower medical care costs; inclusive of the intervention, total medical care over follow-up was $1841 lower for intervention patients. Intervention group patients also had greater QALY and responder gains than did controls. Supplemental analyses using pain-related medical care costs revealed ICERs of $35,000, and $53,000 per QALY (for replication, and as-delivered intervention costs, respectively); the ICER when excluding patients with outlier follow-up costs was $106,000. LIMITATIONS: Limited to 1-year follow-up; identification of pain-related utilization potentially incomplete. CONCLUSION: The intervention was the optimal choice at commonly accepted levels of willingness-to-pay for QALY gains; this finding was robust to sensitivity analyses.

Addressing guideline and policy changes during pragmatic clinical trials.

While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-being of the participants, clinical equipoise, and the strength and quality of the evidence associated with the change; involving those charged with data and safety monitoring; and where possible, planning for potential external changes as the trial is being designed. Any solution must balance the primary obligation to protect the well-being of participants with the secondary obligation to protect the integrity of the trial in order to gain meaningful answers to important public health questions.

Development and Assessment of a Crosswalk Between ICD-9-CM and ICD-10-CM to Identify Patients with Common Pain Conditions.

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.

Cost-Effectiveness of Preventing Depression Among At-Risk Youths: Postintervention and 2-Year Follow-Up.

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.

Comparative Effectiveness of Usual Care With or Without Chiropractic Care in Patients with Recurrent Musculoskeletal Back and Neck Pain.

BACKGROUND: Chiropractic care is a popular alternative for back and neck pain, with efficacy comparable to usual care in randomized trials. However, the effectiveness of chiropractic care as delivered through conventional care settings remains largely unexplored. OBJECTIVE: To evaluate the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. STUDY DESIGN: Prospective cohort study using propensity score-matched controls. PARTICIPANTS: Using retrospective electronic health record data, we developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. MAIN MEASURES: Main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care. KEY RESULTS: Both groups' (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. (severity - 0.10 (95% CI - 0.30, 0.10), interference - 0.07 (- 0.31, 0.16), bothersomeness - 0.1 (- 0.39, 0.19)). After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group ($1996 [SD = 3874] vs $1086 [SD = 1212], p = .034). Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072). CONCLUSIONS: We found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.

Clinical Policy Recommendations from the VHA State-of-the-Art Conference on Non-Pharmacological Approaches to Chronic Musculoskeletal Pain.

As a large national healthcare system, Veterans Health Administration (VHA) is ideally suited to build on its work to date and develop a safe, evidence-based, and comprehensive approach to the care of chronic musculoskeletal pain conditions that de-emphasizes opioid use and emphasizes non-pharmacological strategies. The VHA Office of Health Services Research and Development (HSR&D) held a state-of-the-art (SOTA) conference titled "Non-pharmacological Approaches to Chronic Musculoskeletal Pain Management" in November 2016. Goals of the conference were (1) to establish consensus on the current state of evidence regarding non-pharmacological approaches to chronic musculoskeletal pain to inform VHA policy in this area and (2) to begin to identify priorities for the future VHA research agenda. Workgroups were established and asked to reach consensus recommendations on clinical and research priorities for the following treatment strategies: psychological/behavioral therapies, exercise/movement therapies, manual therapies, and models for delivering multimodal pain care. Participants in the SOTA identified nine non-pharmacological therapies with sufficient evidence to be implemented across the VHA system as part of pain care. Participants further recommended that effective integration of these non-pharmacological approaches across the VHA and especially into VHA primary care, pain care, and mental health settings should be a priority, and that these treatments should be offered early in the course of pain treatment and delivered in a team-based, multimodal treatment setting concurrently with active self-care and self-management approaches. In addition, we recommend that VHA leadership and policy makers systematically address the barriers to implementation of these approaches by expanding opportunities for clinician and veteran education on the effectiveness of these strategies; supporting and funding further research to determine optimal dosage, duration, sequencing, combination, and frequency of treatment; emphasizing multimodal care with rigorous evaluation grounded in team-based approaches to test integrated models of delivery and stepped-care approaches; and working to address socioeconomic and cultural barriers to veterans' access to non-pharmacological approaches.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.

BACKGROUND: Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. METHODS/DESIGN: This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. DISCUSSION: This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592.

Cost-effectiveness of Cognitive Behavioral Therapy for Depressed Youth Declining Antidepressants.

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.

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

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.

Health Care Systems Support to Enhance Patient-Centered Care: Lessons from a Primary Care-Based Chronic Pain Management Initiative.

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.

The feasibility of matching on a propensity score for acupuncture in a prospective cohort study of patients with chronic pain.

BACKGROUND: Propensity scores are typically applied in retrospective cohort studies. We describe the feasibility of matching on a propensity score derived from a retrospective cohort and subsequently applied in a prospective cohort study of patients with chronic musculoskeletal pain before the start of acupuncture or usual care treatment and enrollment in a comparative effectiveness study that required patient reported pain outcomes. METHODS: We assembled a retrospective cohort study using data from 2010 to develop a propensity score for acupuncture versus usual care based on electronic healthcare record and administrative data (e.g., pharmacy) from an integrated health plan, Kaiser Permanente Northwest. The propensity score's probabilities allowed us to match acupuncture-referred and non-referred patients prospectively in 2013-14 after a routine outpatient visit for pain. Among the matched patients, we collected patient-reported pain before treatment and during follow-up to assess the comparative effectiveness of acupuncture. We assessed balance in patient characteristics with the post-matching c-statistic and standardized differences. RESULTS: Based on the propensity score and other characteristics (e.g., patient-reported pain), we were able to match all 173 acupuncture-referred patients to 350 non-referred (usual care) patients. We observed a residual imbalance (based on the standardized differences) for some characteristics that contributed to the score; for example, age, -0.283, and the Charlson comorbidity score, -0.264, had the largest standardized differences. The overall balance of the propensity score appeared more favorable according to the post-matching c-statistic, 0.503. CONCLUSION: The propensity score matching was feasible statistically and logistically and allowed approximate balance on patient characteristics, some of which will require adjustment in the comparative effectiveness regression model. By transporting propensity scores to new patients, healthcare systems with electronic health records can conduct comparative effectiveness cohort studies that require prospective data collection, such as patient-reported outcomes, while approximately balancing numerous patient characteristics that might confound the benefit of an intervention. The approach offers a new study design option.

Acupuncture and chiropractic care: utilization and electronic medical record capture.

OBJECTIVES: To describe acupuncture and chiropractic use among patients with chronic musculoskeletal pain (CMP) at a health maintenance organization, and explore issues of benefit design and electronic medical record (EMR) capture. STUDY DESIGN: Cross-sectional survey. METHODS: Kaiser Permanente members meeting EMR diagnostic criteria for CMP were invited to participate. The survey included questions about self-identified presence of CMP, use of acupuncture and chiropractic care, use of ancillary self-care modalities, and communication with conventional medicine practitioners. Analysis of survey data was supplemented with a retrospective review of EMR utilization data. RESULTS: Of 6068 survey respondents, 32% reported acupuncture use, 47% reported chiropractic use, 21% used both, and 42% used neither. For 25% of patients using acupuncture and 43% of those using chiropractic care, utilization was undetected by the EMR. Thirty-five percent of acupuncture users and 42% of chiropractic users did not discuss this care with their health maintenance organization (HMO) clinicians. Among chiropractic users, those accessing care out of plan were older (P < .01), were more likely to use long-term opioids (P = .03), and had more pain diagnoses (P = .01) than those accessing care via clinician referral or self-referral. For acupuncture, those using the clinician referral mechanism exhibited these same characteristics. CONCLUSIONS: A majority of participants had used acupuncture, chiropractic care, or both. While benefit structure may materially influence utilization patterns, many patients with CMP use acupuncture and chiropractic care without regard to their insurance coverage. A substantial percentage of acupuncture and chiropractic use thus occurs beyond detection of EMR systems, and many patients do not report such care to their HMO clinicians.

A primary care-based, multicomponent lifestyle intervention for overweight adolescent females.

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.

Health-service use in women with binge eating disorders.

OBJECTIVE: To compare health-care utilization between participants who met DSM-IV criteria for binge eating disorder (BED) and those engaged in recurrent binge eating (RBE) and to evaluate whether objective binge eating (OBE) days, a key measurement for diagnosing BED, predicted health-care costs. METHOD: We obtained utilization and cost data from electronic medical records to augment patient reported data for 100 adult female members of a large health maintenance organization who were enrolled in a randomized clinical trial to treat binge eating. RESULTS: Total costs did not differ between the BED and RBE groups (ß = -0.117, z = -0.48, p = .629), nor did the number of OBE days predict total costs (ß = -0.017, z = -1.01, p = .313). DISCUSSION: Findings suggest that the medical impairment, as assessed through health care costs, caused by BED may not be greater than impairment caused by RBE. The current threshold number of two OBE days/week as a criterion for BED may need to be reconsidered.

Incremental cost-effectiveness of combined therapy vs medication only for youth with selective serotonin reuptake inhibitor-resistant depression: treatment of SSRI-resistant depression in adolescents trial findings.

CONTEXT: Many youth with depression do not respond to initial treatment with selective serotonin reuptake inhibitors (SSRIs), and this is associated with higher costs. More effective treatment for these youth may be cost-effective. OBJECTIVE: To evaluate the incremental cost-effectiveness over 24 weeks of combined cognitive behavior therapy plus switch to a different antidepressant medication vs medication switch only in adolescents who continued to have depression despite adequate initial treatment with an SSRI. DESIGN: Randomized controlled trial. SETTING: Six US academic and community clinics. PATIENTS: Three hundred thirty-four patients aged 12 to 18 years with SSRI-resistant depression. INTERVENTION: Participants were randomly assigned to (1) switch to a different medication only or (2) switch to a different medication plus cognitive behavior therapy. MAIN OUTCOME MEASURES: Clinical outcomes were depression-free days (DFDs), depression-improvement days (DIDs), and quality-adjusted life-years based on DFDs (DFD-QALYs). Costs of intervention, nonprotocol services, and families were included. RESULTS: Combined treatment achieved 8.3 additional DFDs (P = .03), 0.020 more DFD-QALYs (P = .03), and 11.0 more DIDs (P = .04). Combined therapy cost $1633 more (P = .01). Cost per DFD was $188 (incremental cost-effectiveness ratio [ICER] = $188; 95% confidence interval [CI], -$22 to $1613), $142 per DID (ICER = $142; 95% CI, -$14 to $2529), and $78,948 per DFD-QALY (ICER = $78,948; 95% CI, -$9261 to $677,448). Cost-effectiveness acceptability curve analyses suggest a 61% probability that combined treatment is more cost-effective at a willingness to pay $100,000 per QALY. Combined treatment had a higher net benefit for subgroups of youth without a history of abuse, with lower levels of hopelessness, and with comorbid conditions. CONCLUSIONS: For youth with SSRI-resistant depression, combined treatment decreases the number of days with depression and is more costly. Depending on a decision maker's willingness to pay, combined therapy may be cost-effective, particularly for some subgroups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00018902.

Cognitive behavioral guided self-help for the treatment of recurrent binge eating.

OBJECTIVE: Despite proven efficacy of cognitive behavioral therapy (CBT) for treating eating disorders with binge eating as the core symptom, few patients receive CBT in clinical practice. Our blended efficacy-effectiveness study sought to evaluate whether a manual-based guided self-help form of CBT (CBT-GSH), delivered in 8 sessions in a health maintenance organization setting over a 12-week period by master's-level interventionists, is more effective than treatment as usual (TAU). METHOD: In all, 123 individuals (mean age = 37.2; 91.9% female, 96.7% non-Hispanic White) were randomized, including 10.6% with bulimia nervosa (BN), 48% with binge eating disorder (BED), and 41.4% with recurrent binge eating in the absence of BN or BED. Baseline, posttreatment, and 6- and 12-month follow-up data were used in intent-to-treat analyses. RESULTS: At 12-month follow-up, CBT-GSH resulted in greater abstinence from binge eating (64.2%) than TAU (44.6%; number needed to treat = 5), as measured by the Eating Disorder Examination (EDE). Secondary outcomes reflected greater improvements in the CBT-GSH group in dietary restraint (d = 0.30); eating, shape, and weight concern (ds = 0.54, 1.01, 0.49, respectively; measured by the EDE Questionnaire); depression (d = 0.56; Beck Depression Inventory); and social adjustment (d = 0.58; Work and Social Adjustment Scale), but not weight change. CONCLUSIONS: CBT-GSH is a viable first-line treatment option for the majority of patients with recurrent binge eating who do not meet diagnostic criteria for BN or anorexia nervosa.

Cost-effectiveness of guided self-help treatment for recurrent binge eating.

OBJECTIVE: Adoption of effective treatments for recurrent binge-eating disorders depends on the balance of costs and benefits. Using data from a recent randomized controlled trial, we conducted an incremental cost-effectiveness analysis (CEA) of a cognitive-behavioral therapy guided self-help intervention (CBT-GSH) to treat recurrent binge eating compared to treatment as usual (TAU). METHOD: Participants were 123 adult members of an HMO (mean age = 37.2 years, 91.9% female, 96.7% non-Hispanic White) who met criteria for eating disorders involving binge eating as measured by the Eating Disorder Examination (C. G. Fairburn & Z. Cooper, 1993). Participants were randomized either to treatment as usual (TAU) or to TAU plus CBT-GSH. The clinical outcomes were binge-free days and quality-adjusted life years (QALYs); total societal cost was estimated using costs to patients and the health plan and related costs. RESULTS: Compared to those receiving TAU only, those who received TAU plus CBT-GSH experienced 25.2 more binge-free days and had lower total societal costs of $427 over 12 months following the intervention (incremental CEA ratio of -$20.23 per binge-free day or -$26,847 per QALY). Lower costs in the TAU plus CBT-GSH group were due to reduced use of TAU services in that group, resulting in lower net costs for the TAU plus CBT group despite the additional cost of CBT-GSH. CONCLUSIONS: Findings support CBT-GSH dissemination for recurrent binge-eating treatment.

Screening for binge eating disorders using the Patient Health Questionnaire in a community sample.

OBJECTIVE: To examine the operating characteristics of the Patient Health Questionnaire eating disorder module (PHQ-ED) for identifying bulimia nervosa/binge eating disorder (BN/BED) or recurrent binge eating (RBE) in a community sample and to compare true positive (TP) versus false positive (FP) cases on clinical validators. METHOD: Two hundred and fifty-nine screen-positive individuals and a random sample of 89 screen negative cases completed a diagnostic interview. Sensitivity, specificity, and positive predictive value (PPV) were calculated. TP and FP cases were compared using t-tests and Chi-square tests. RESULTS: The PHQ-ED had high sensitivity (100%) and specificity (92%) for detecting BN/BED or RBE, but PPV was low (10 or 19%). TP and FP cases did not differ significantly on frequency of subjective bulimic episodes, objective overeating, restraint, on BMI, and on self-rated health. DISCUSSION: The PHQ-ED is recommended for use in large populations only in conjunction with follow-up questions to rule out cases without objective bulimic episodes.