Telemedicine management of obstructive sleep apnea disorder in China: a randomized, controlled, non-inferiority trial.

PURPOSE: Previous studies assessed different components of telemedicine management pathway for OSA instead of the whole pathway. This randomized, controlled, and non-inferiority trial aimed to assess whether telemedicine management is clinically inferior to in-person care in China. METHODS: Adults suspected of OSA were randomized to telemedicine (web-based questionnaires, self-administered home sleep apnea test [HSAT], automatically adjusting positive airway pressure [APAP], and video-conference visits) or in-person management (paper questionnaires, in-person HSAT set-up, APAP, and face-to-face visits). Participants with an apnea-hypopnea index (AHI) ≥ 15 events/hour received APAP for 3 months. The non-inferiority analysis was based on the change in Functional Outcomes of Sleep Questionnaire (FOSQ) score and APAP adherence. Cost-effectiveness analysis was performed. RESULTS: In the modified intent-to-treat analysis set (n = 111 telemedicine, 111 in-person), FOSQ scores improved 1.73 (95% confidence interval [CI], 1.31-2.14) points with telemedicine and 2.05 (1.64-2.46) points with in-person care. The lower bound of the one-sided 95% non-inferiority CI for the difference in change between groups of - 0.812 was larger than the non-inferiority threshold of - 1. APAP adherence at 3 months was 243.3 (223.1-263.5) minutes/night for telemedicine and 241.6 (221.3-261.8) minutes/night for in-person care. The lower bound of the one-sided 95% non-inferiority CI of - 22.2 min/night was higher than the non-inferiority delta of - 45 min/night. Telemedicine had lower total costs than in-person management (CNY 1482.7 ± 377.2 vs. 1912.6 ± 681.3; p < 0.0001), driven by patient costs, but no significant difference in QALYs. CONCLUSIONS: Functional outcomes and adherence were not clinically inferior in patients managed by a comprehensive telemedicine approach compared to those receiving in-person care in China. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn , Registration number ChiCTR2000030546. Retrospectively registered on March 06, 2020.

One-Year Quality of Life Post-Pneumonia Diagnosis in Japanese Adults.

BACKGROUND: Pneumonia is a common, serious illness in the elderly, with a poorly characterized long-term impact on health-related quality of life (HRQoL). The Japanese Goto Epidemiology Study is a prospective, active, population-based surveillance study of adults with X-ray/CT scan-confirmed community-onset pneumonia, assessing the HRQoL outcome quality-adjusted life-years (QALYs). We report QALY scores and losses among a subset of participants in this study. METHODS: QALYs were derived from responses to the Japanese version of the EuroQol-5D-5L health-state classification instrument at days 0, 7, 15, 30, 90, 180, and 365 after pneumonia diagnosis from participants enrolled from June 2017 to May 2018. We used patients as their own controls, calculating comparison QALYs by extrapolating EuroQol-5D-5L scores for day -30, accounting for mortality and changes in scores with age. RESULTS: Of 405 participants, 85% were aged ≥65 years, 58% were male, and 69% were hospitalized for clinically and radiologically confirmed pneumonia. Compliance with interviews by patients or proxies was 100%. Adjusted EuroQol-5D-5L scores were 0.759, 0.561, 0.702, and 0.689 at days -30, 0 (diagnosis), 180, and 365, respectively. Average scores at all time points remained below the average day -30 scores (P ≤ .001). Pneumonia resulted in a 1-year adjusted loss of 0.13 QALYs (~47.5 quality-adjusted days) (P < .001). CONCLUSIONS: Substantial QALY losses were observed among Japanese adults following pneumonia diagnosis, and scores had not returned to prediagnosis levels at 1 year postdiagnosis. QALY scores and cumulative losses were comparable to those in US adults with chronic heart failure, stroke, or renal failure.

Implementation fidelity, student outcomes, and cost-effectiveness of train-the-trainer strategies for Masters-level therapists in urban schools: results from a cluster randomized trial.

BACKGROUND: Little is known about the effectiveness and cost-effectiveness of train-the-trainer implementation strategies in supporting mental health evidence-based practices in schools, and about the optimal level of support needed for TT strategies. METHODS: The current study is part of a larger type 2 hybrid cluster randomized controlled trial. It compares two train-the-trainer strategies, Train-the-Trainer (TT) and Train-the-Trainer plus ongoing consultation for trainers (TT +) on the delivery of a group cognitive behavioral treatment protocol for anxiety disorders. Participants were 33 therapists, 29 supervisors, and 125 students who were at risk for anxiety disorders from 22 urban schools. Implementation outcomes were implementation fidelity and treatment dosage. Student outcomes were child- and parent-reported symptoms of anxiety, child-reported symptoms of depression, and teacher-reported academic engagement. We estimated the cost of implementing the intervention in each condition and examined the probability that a support strategy for supervisors (TT vs TT +) is a good value for varying values of willingness to pay. RESULTS: Therapists in the TT and TT + conditions obtained similarly high implementation fidelity and students in the conditions received similar treatment dosages. A mixed effects modeling approach for student outcomes revealed time effects for symptoms of anxiety and depression reported by students, and emotional disaffection reported by teachers. There were no condition or condition × times effects. For both conditions, the time effects indicated an improvement from pre-treatment to post-treatment in symptoms of anxiety and depression and academic emotional engagement. The average cost of therapist, supervisor, and consultant time required to implement the intervention in each condition was $1002 for TT and $1431 for TT + (p = 0.01). There was a greater than 80% chance that TT was a good value compared to TT + for all values of willingness to pay per one-point improvement in anxiety scores. CONCLUSIONS: A TT implementation approach consisting of a thorough initial training workshop for therapists and supervisors as well as ongoing supervision for therapists resulted in adequate levels of fidelity and student outcomes but at a lower cost, compared to the TT + condition that also included ongoing external expert consultation for supervisors. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02651402.

A comparison of two group cognitive behavioral therapy protocols for anxiety in urban schools: appropriateness, child outcomes, and cost-effectiveness.

Background: Cognitive behavioral therapy (CBT) for pediatric anxiety is efficacious for reducing anxiety symptoms and improving functioning, but many children are unable to access CBT for anxiety in community settings. Schools are an important setting in which children access mental health care, including therapy for anxiety. In this setting, therapy is usually delivered by Masters-level therapists. Objectives: Friends for Life (FRIENDS), a 12-session, manualized, group CBT program for anxiety has demonstrated effectiveness when implemented in schools. However, prior research has also found challenges regarding feasibility and cultural fit when delivering FRIENDS in the urban school context. To address these challenges, we adapted FRIENDS for implementation in the school setting so that it might be more feasible and culturally appropriate for low-income, urban schools in the United States, while maintaining the core components of treatment. The current study uses a mixed-method approach to compare the effectiveness, cost-effectiveness, and perceived appropriateness of FRIENDS and CATS when delivered by Masters-level therapists with train-the-trainer support. Materials and methods: First, we compared change scores for student outcomes (i.e., child-report MASC-2 total score, parent-report MASC-2 total score, teacher-report Engagement and Disaffection subscale scores) from pre- to post- treatment between students receiving FRIENDS and students receiving CATS to assess whether the two conditions resulted in equivalent outcomes. Second, we compared the cost and cost-effectiveness between the groups. Finally, we used an applied thematic analysis to compare appropriateness of the interventions as perceived by therapists and supervisors. Results: The mean change score for the child-reported MASC-2 was 1.9 (SE = 1.72) points in the FRIENDS condition and 2.9 (SE = 1.73) points in the CATS condition; results indicated that the conditions were similar in their treatment effects, and symptom reductions were small in both groups. The modified protocol, CATS, was shown to cost significantly less to implement compared to FRIENDS and showed greater cost-effectiveness. Finally, compared to therapists and supervisors in the CATS condition, therapists and supervisors in the FRIENDS condition more strongly described aspects of the intervention that were not appropriate for their context and in need of more extensive adaptations. Conclusion: Relatively brief, group CBT for anxiety, with adaptations to improve cultural fit, is a promising approach to treat youth anxiety symptom when delivered by school-based therapists with train-the-trainer implementation support.

Cost-effectiveness of a 3-year tele-messaging intervention for positive airway pressure use.

OBJECTIVES: To evaluate the cost-effectiveness of a 3-year tele-messaging intervention for positive airway pressure (PAP) use in obstructive sleep apnea (OSA). STUDY DESIGN: A post hoc cost-effectiveness analysis (from US payers' perspective) of data from a 3-month tele-OSA trial, augmented with 33 months of epidemiologic follow-up. METHODS: Cost-effectiveness was compared among 3 groups of participants with an apnea-hypopnea index of at least 15 events/hour: (1) no messaging (n = 172), (2) messaging for 3 months (n = 124), and (3) messaging for 3 years (n = 46). We report the incremental cost (2020 US$) per incremental hour of PAP use and the fraction probability of acceptability based on a willingness-to-pay threshold of $1825 per year ($5/day). RESULTS: The use of 3 years of messaging had similar mean annual costs ($5825) compared with no messaging ($5889; P = .89) but lower mean cost compared with 3 months of messaging ($7376; P = .02). Those who received messaging for 3 years had the highest mean PAP use (4.11 hours/night), followed by no messaging (3.03 hours/night) and 3 months of messaging (2.84 hours/night) (all P < .05). The incremental cost-effectiveness ratios indicated that 3 years of messaging showed lower costs and greater hours of PAP use compared with both no messaging and 3 months of messaging. Based on a willingness-to-pay threshold of $1825, there is a greater than 97.5% chance (ie, 95% confidence) that 3 years of messaging is acceptable compared with the other 2 interventions. CONCLUSIONS: Long-term tele-messaging is highly likely to be cost-effective compared with both no and short-term messaging, with an acceptable willingness-to-pay threshold. Future long-term cost-effectiveness studies in a randomized controlled trial setting are warranted.

Association Between Positive Airway Pressure Adherence and Health Care Costs Among Individuals With OSA.

BACKGROUND: The impact of positive airway pressure (PAP) therapy for OSA on health care costs is uncertain. RESEARCH QUESTION: Are 3-year health care costs associated with PAP adherence in participants from the Tele-OSA clinical trial? STUDY DESIGN AND METHODS: Participants with OSA and prescribed PAP in the Tele-OSA study were stratified into three PAP adherence groups based on usage patterns over 3 years: (1) high (consistently ≥ 4 h/night), (2) moderate (2-3.9 h/night or inconsistently ≥ 4 h/night), and (3) low (< 2 h/night). Using data from 3 months of the Tele-OSA trial and 33 months of posttrial follow up, average health care costs (2020 US dollars) in 6-month intervals were derived from electronic health records and analyzed using multivariable generalized linear models. RESULTS: Of 543 participants, 25% were categorized as having high adherence, 22% were categorized as having moderate adherence, and 52% were categorized as having low adherence to PAP therapy. Average PAP use mean ± SD was 6.5 ± 1.0 h, 3.7 ± 1.2 h, and 0.5 ± 0.5 h for the high, moderate, and low adherence groups, respectively. The high adherence group had the lowest average covariate-adjusted 6-month health care costs ± SE ($3,207 ± $251) compared with the moderate ($3,638 ± $363) and low ($4,040 ± $304) adherence groups. Significant cost differences were observed between the high and low adherence groups ($832; 95% CI, $127 to $1,538); differences between moderate and low adherence were nonsignificant ($401; 95% CI, -$441 to $1,243). INTERPRETATION: In participants with OSA, better PAP adherence was associated with significantly lower health care costs over 3 years. Findings support the importance of strategies to enhance long-term PAP adherence.

A randomized, controlled trial of financial incentives for smoking cessation.

BACKGROUND: Smoking is the leading preventable cause of premature death in the United States. Previous studies of financial incentives for smoking cessation in work settings have not shown that such incentives have significant effects on cessation rates, but these studies have had limited power, and the incentives used may have been insufficient. METHODS: We randomly assigned 878 employees of a multinational company based in the United States to receive information about smoking-cessation programs (442 employees) or to receive information about programs plus financial incentives (436 employees). The financial incentives were $100 for completion of a smoking-cessation program, $250 for cessation of smoking within 6 months after study enrollment, as confirmed by a biochemical test, and $400 for abstinence for an additional 6 months after the initial cessation, as confirmed by a biochemical test. Individual participants were stratified according to work site, heavy or nonheavy smoking, and income. The primary end point was smoking cessation 9 or 12 months after enrollment, depending on whether initial cessation was reported at 3 or 6 months. Secondary end points were smoking cessation within the first 6 months after enrollment and rates of participation in and completion of smoking-cessation programs. RESULTS: The incentive group had significantly higher rates of smoking cessation than did the information-only group 9 or 12 months after enrollment (14.7% vs. 5.0%, P<0.001) and 15 or 18 months after enrollment (9.4% vs. 3.6%, P<0.001). Incentive-group participants also had significantly higher rates of enrollment in a smoking-cessation program (15.4% vs. 5.4%, P<0.001), completion of a smoking-cessation program (10.8% vs. 2.5%, P<0.001), and smoking cessation within the first 6 months after enrollment (20.9% vs. 11.8%, P<0.001). CONCLUSIONS: In this study of employees of one large company, financial incentives for smoking cessation significantly increased the rates of smoking cessation. (ClinicalTrials.gov number, NCT00128375.)

Study protocol: cluster randomized trial of consultation strategies for the sustainment of mental health interventions in under-resourced urban schools: rationale, design, and methods.

BACKGROUND: The school is a key setting for the provision of mental health services to children, particularly those underserved through traditional service delivery systems. School-wide Positive Behavioral Interventions and Supports (PBIS) is a tiered approach to service delivery based on the public health model that schools use to implement universal (Tier 1) supports to improve school climate and safety. As our prior research has demonstrated, PBIS is a useful vehicle for implementing mental and behavioral health evidence-based practices (EBPs) at Tier 2 for children with, or at risk for, mental health disorders. Very little research has been conducted regarding the use of mental health EBPs at Tier 2 or how to sustain implementation in schools. METHODS/DESIGN: The main aim of the study is to compare fidelity, penetration, cost-effectiveness, and student outcomes of Tier 2 mental health interventions across 2 sustainment approaches for school implementers in 12 K-8 schools. The study uses a 2-arm, cluster randomized controlled trial design. The two arms are: (a) Preparing for Sustainment (PS)-a consultation strategy implemented by school district coaches who receive support from external consultants, and (b) Sustainment as Usual (SAU)-a consultation strategy implemented by school district coaches alone. Participants will be 60 implementers and 360 students at risk for externalizing and anxiety disorders. The interventions implemented by school personnel are: Coping Power Program (CPP) for externalizing disorders, CBT for Anxiety Treatment in Schools (CATS) for anxiety disorders, and Check-in/Check-out (CICO) for externalizing and internalizing disorders. The Interactive Systems Framework (ISF) for Dissemination and Implementation guides the training and support procedures for implementers. DISCUSSION: We expect that this study will result in a feasible, effective, and cost-effective strategy for sustaining mental health EBPs that is embedded within a multi-tiered system of support. Results from this study conducted in a large urban school district would likely generalize to other large, urban districts and have an impact on population-level child mental health. Trial registration ClinicalTrials.gov identifier number NCT04869657. Registered May 3, 2021.

Evaluation of COVID-19 Testing Strategies for Repopulating College and University Campuses: A Decision Tree Analysis.

PURPOSE: The optimal approach to identify SARS-CoV-2 infection among college students returning to campus is unknown. Recommendations vary from no testing to two tests per student. This research determined the strategy that optimizes the number of true positives and negatives detected and reverse transcription polymerase chain reaction (RT-PCR) tests needed. METHODS: A decision tree analysis evaluated five strategies: (1) classifying students with symptoms as having COVID-19, (2) RT-PCR testing for symptomatic students, (3) RT-PCR testing for all students, (4) RT-PCR testing for all students and retesting symptomatic students with a negative first test, and (5) RT-PCR testing for all students and retesting all students with a negative first test. The number of true positives, true negatives, RT-PCR tests, and RT-PCR tests per true positive (TTP) was calculated. RESULTS: Strategy 5 detected the most true positives but also required the most tests. The percentage of correctly identified infections was 40.6%, 29.0%, 53.7%, 72.5%, and 86.9% for Strategies 1-5, respectively. All RT-PCR strategies detected more true negatives than the symptom-only strategy. Analysis of TTP demonstrated that the repeat RT-PCR strategies weakly dominated the single RT-PCR strategy and that the thresholds for more intensive RT-PCR testing decreased as the prevalence of infection increased. CONCLUSION: Based on TTP, the single RT-PCR strategy is never preferred. If the cost of RT-PCR testing is of concern, a staged approach involving initial testing of all returning students followed by a repeat testing decision based on the measured prevalence of infection might be considered.

What do international pharmacoeconomic guidelines say about economic data transferability?

OBJECTIVES: The objectives of this article were to assess the positions of the various national pharmacoeconomic guidelines on the transferability (or lack of transferability) of clinical and economic data and to review the methods suggested in the guidelines for addressing issues of transferability. METHODS: A review of existing national pharmacoeconomic guidelines was conducted to assess recommendations on the transferability of clinical and economic data, whether there are important differences between countries, and whether common methodologies have been suggested to address key transferability issues. Pharmacoeconomic guidelines were initially identified through the ISPOR Web site. In addition, those national guidelines not included in the ISPOR Web site, but known to us, were also considered. RESULTS: Across 27 sets of guidelines, baseline risk and unit costs were uniformly considered to be of low transferability, while treatment effect was classified as highly transferable. Results were more variable for resource use and utilities, which were considered to have low transferability in 63% and 45% of cases, respectively. There were some differences between older and more recent guidelines in the treatment of transferability issues. CONCLUSIONS: A growing number of jurisdictions are using guidelines for the economic evaluation of pharmaceuticals. The recommendations in existing guidelines regarding the transferability of clinical and economic data are quite diverse. There is a case for standardization in dealing with transferability issues. One important step would be to update guidelines more frequently.

Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report.

ABSTRACT A growing number of jurisdictions now request economic data in support of their decision-making procedures for the pricing and/or reimbursement of health technologies. Because more jurisdictions request economic data, the burden on study sponsors and researchers increases. There are many reasons why the cost-effectiveness of health technologies might vary from place to place. Therefore, this report of an ISPOR Good Practices Task Force reviews what national guidelines for economic evaluation say about transferability, discusses which elements of data could potentially vary from place to place, and recommends good research practices for dealing with aspects of transferability, including strategies based on the analysis of individual patient data and based on decision-analytic modeling.

A critical comparison of clinical decision instruments for computed tomographic scanning in mild closed traumatic brain injury in adolescents and adults.

STUDY OBJECTIVE: A number of clinical decision aids have been introduced to limit unnecessary computed tomographic scans in patients with mild traumatic brain injury. These aids differ in the risk factors they use to recommend a scan. We compare the instruments according to their sensitivity and specificity and recommend ones based on incremental benefit of correctly classifying patients as having surgical, nonsurgical, or no intracranial lesions. METHODS: We performed a secondary analysis of prospectively collected database from 7,955 patients aged 10 years or older with mild traumatic brain injury to compare sensitivity and specificity of 6 common clinical decision strategies: the Canadian CT Head Rule, the Neurotraumatology Committee of the World Federation of Neurosurgical Societies, the New Orleans, the National Emergency X-Radiography Utilization Study II (NEXUS-II), the National Institute of Clinical Excellence guideline, and the Scandinavian Neurotrauma Committee guideline. Excluded from the database were patients for whom the history of trauma was unclear, the initial Glasgow Coma Scale score was less than 14, the injury was penetrating, vital signs were unstable, or who refused diagnostic tests. Patients revisiting the emergency department within 7 days were counted only once. RESULTS: The percentage of scans that would have been required by applying each of the 6 aids were Canadian CT head rule (high risk only) 53%, Canadian (medium & high risk) 56%, the Neurotraumatology Committee of the World Federation of Neurosurgical Societies 56%, New Orleans 69%, NEXUS-II 56%, National Institute of Clinical Excellence 71%, and the Scandinavian 50%. The 6 decision aids' sensitivities for surgical hematomas could not be distinguished statistically (P>.05). Sensitivity was 100% (95% confidence interval [CI] 96% to 100%) for NEXUS-II, 98.1% (95% CI 93% to 100%) for National Institute of Clinical Excellence, and 99.1% (95% CI 94% to 100%) for the other 4 clinical decision instruments. Sensitivity for any intracranial lesion ranged from 95.7% (95% CI 93% to 97%) (Scandinavian) to 100% (95% CI 98% to 100%) (National Institute of Clinical Excellence). In contrast, specificities varied between 30.9% (95% CI 30% to 32%) (National Institute of Clinical Excellence) and 52.9% (95% CI 52% to 54) (Scandinavian). CONCLUSION: NEXUS-II and the Scandinavian clinical decision aids displayed the best combination of sensitivity and specificity in this patient population. However, we cannot demonstrate that the higher sensitivity of NEXUS-II for surgical hematomas is statistically significant. Therefore, choosing which of the 2 clinical decision instruments to use must be based on decisionmakers' attitudes toward risk.

Preference-based quality of life in patients with Alzheimer's disease.

BACKGROUND: This study was developed to evaluate the feasibility, reliability, and validity of use of patients' ratings of health preference measures as outcomes for cost-effectiveness analyses in persons with very mild to moderate Alzheimer's disease (AD). METHODS: Patients and caregivers completed ratings of the EuroQol-5D system (EQ-5D) and the Health Utilities Index Mark 2 (HUI2) and instruments that assess cognition, mood, insight, AD-specific and generic health-related quality of life (QOL) and activities of daily living. RESULTS: Patients' HUI2 scores were reliable. EQ-5D scores were somewhat less so. Patients rated their utility high, with overall EQ-5D and HUI2 scores greater than 0.8. Neither the EQ-5D nor the HUI2 scores had a relationship with severity of cognitive impairment. Both the EQ-5D and the HUI2 had expected relationships with patient-rated measures of QOL, function, mood, and specific subscales we hypothesized should be associated with patient preferences. Patient insight into functional and cognitive impairments had little association with their health preference scores. CONCLUSIONS: AD patients' scores on the EQ-5D and the HUI2 have many of the characteristics of valid preference measures. However, the proportions of persons who do not perceive any disability, the lack of association with the caregivers' ratings of activities of daily living, limited associations with insight, and no association with their Mini-Mental State Exam scores suggest that patients' reports of disability might reflect legitimate self-perceptions of mood and function that are associated with comorbidities rather than with AD.

Caregivers' assessments of preference-based quality of life in Alzheimer's disease.

BACKGROUND: This study was designed to evaluate the feasibility, reliability, and validity of use of caregivers' ratings of two health preference measures as outcomes for cost-effectiveness analyses in persons with very mild to moderate Alzheimer's disease (AD). METHODS: Caregivers completed ratings of preference for AD patients' health by use of the EuroQol-5D system (EQ-5D) and the Health Utilities Index Mark 2 (HUI2). They also rated patients' cognition, mood, burden, AD-specific and generic health-related quality of life (QOL), and activities of daily living. RESULTS: Caregivers' HUI2 scores were reliable. Neither the caregiver ratings of the patients' health by use of the EQ-5D nor the HUI2 had a relationship with severity of cognitive impairment. Both the EQ-5D and the HUI2 had expected relationships with caregivers' assessments of patients' function, AD-specific QOL, and physical and mental health and selected subscales of the measures of AD-specific QOL and overall health. In addition, caregiver scores showed relationships with patient self-rated function, mood, and physical health but not AD-specific QOL. Caregiver burden was associated with caregivers' scores. CONCLUSIONS: Caregiver-completed ratings of preference for patients' health made by use of the EQ-5D and the HUI2 have many of the characteristics of valid preference measures. However, the lack of association with patient Mini-Mental Status Exam scores and patient self-rated AD-specific QOL and the associations with caregiver subjective burden might present limitations to their use as proxy measures for cost-effectiveness analyses.

Medicare coverage of tumor necrosis factor alpha inhibitors as an influence on physicians' prescribing behavior.

BACKGROUND: Rheumatoid arthritis is a chronic debilitating disease that affects 1% of the population. Tumor necrosis factor alpha inhibitors, such as etanercept and infliximab, have revolutionized the treatment of rheumatoid arthritis by averting disability but at great financial expense, generally borne by third-party payors. Prior to implementation of the Medicare Modernization Act, Medicare reimbursed for the infusion drug infliximab but not for the self-injectable drug etanercept. To determine the impact of this differential Medicare drug coverage on physicians' prescribing behavior in clinical practice, we analyzed patterns of prescribing etanercept and infliximab for patients with rheumatoid arthritis who had public insurance compared with those who had private insurance. METHODS: We conducted an observational cohort study of 1663 patients with rheumatoid arthritis newly prescribed etanercept or infliximab after enrollment in the National Databank for Rheumatic Diseases. Univariate and multivariable analyses of patient demographic and disease characteristics were conducted to characterize predictors of the biologic drug prescribed. RESULTS: Treatment groups who received etanercept and infliximab differed in 6 of 8 demographic variables and in 8 of 10 disease variables. However, stratification by type of insurance reduced many of these differences. In multivariable analyses, type of insurance plan and demographic factors were strong predictors of differential prescribing of etanercept compared with prescribing of infliximab, whereas disease characteristics generally were not. Patients with public insurance were 30% more likely to receive infliximab than those who were privately insured (P<.001). CONCLUSIONS: Public insurance predicted prescription of infliximab, reflecting preferential Medicare reimbursement for infusion drugs. Financial considerations are influential in physicians' prescription decisions. Differential drug coverage has an impact on patient care and health care costs because it influences physicians' prescribing behavior.

Clinical trial-based cost-effectiveness analyses of antipsychotic use.

OBJECTIVE: Second-generation antipsychotics make up one of the fastest growing segments of the rapidly growing pharmaceutical sector. Given limited health care resources, assessment of the value for the cost of second-generation antipsychotics relative to first-generation antipsychotics is critical for resource-allocation decisions. METHOD: With a MEDLINE search, the authors identified eight studies (based on six randomized clinical trials) that analyzed the cost-effectiveness of second-generation antipsychotics relative to first-generation antipsychotics in individuals with schizophrenia disorders. The authors reviewed appropriate methods of measurement, analysis, and design of cost-effectiveness studies in randomized clinical trials and evaluated the validity of economic results derived from the studies in light of appropriate methods. RESULTS: The eight randomized clinical trial-based cost-effectiveness studies of antipsychotic medications faced a variety of threats to validity related to 1) measurement of costs, 2) measurement of effectiveness, 3) analysis of costs, 4) measurement of sampling uncertainty, 5) analysis of incomplete cost data, 6) minimizing loss to follow-up, and 7) threats to external validity. CONCLUSIONS: Economic claims made by the authors of a number of trial-based economic evaluations have generally been favorable to second-generation antipsychotics. However, the methodological issues the authors of the current study identified suggest that there is no clear evidence that atypical antipsychotics generate cost savings or are cost-effective in general use among all schizophrenia patients. Psychiatrists, researchers, and administrators should consider the methodological issues highlighted in interpreting study results. These issues should be addressed in future trial designs.

A hybrid effectiveness-implementation cluster randomized trial of group CBT for anxiety in urban schools: rationale, design, and methods.

BACKGROUND: Schools present a context with great potential for the implementation of psychosocial evidence-based practices. Cognitive behavioral therapy (CBT) is an evidence-based practice that has been found to be very effective in treating anxiety in various community settings, including schools. Friends for Life (FRIENDS) is an efficacious group CBT protocol for anxiety. Unfortunately, evidence-based practices for anxiety are seldom employed in under-resourced urban schools, because many treatment protocols are not a good fit for the urban school context or the population, existing behavioral health staff do not receive adequate training or support to allow them to implement the treatment with fidelity, or school districts do not have the resources to contract with external consultants. In our prior work, we adapted FRIENDS to create a more culturally sensitive, focused, and feasible CBT protocol for anxiety disorders (CBT for Anxiety Treatment in Schools (CATS)). METHODS/DESIGN: The aim of this 5-year study is to evaluate both the effectiveness of CATS for urban public schools compared to the original FRIENDS as well as compare the implementation strategies (train-the-trainer vs. train-the-trainer + ongoing consultation) by conducting a three-arm, parallel group, type 2 hybrid effectiveness-implementation trial in 18 K-8 urban public schools. We will also assess the cost-effectiveness and the mediators and moderators of fidelity. Ninety therapists, 18 agency supervisors, and 360 children will participate. The interactive systems framework for dissemination and implementation guides the training and support procedures for therapists and supervisors. DISCUSSION: This study has the potential to demonstrate that agency therapists and supervisors who have had little to no prior exposure to evidence-based practices (EBPs) can implement an anxiety disorder EBP with fidelity. Comparisons of the implementation strategies would provide large urban mental health systems with data to make decisions about the adoption of EBPs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02651402.

Impact of intensive lifestyle intervention on preference-based quality of life in type 2 diabetes: Results from the Look AHEAD trial.

OBJECTIVE: To assess the effect of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) on preference-based health-related quality of life (HRQOL) in persons with overweight or obesity and type 2 diabetes. METHODS: Look AHEAD was a multisite, randomized trial of 5,145 participants assigned to ILI or DSE. Four instruments were administered during the trial: Feeling Thermometer (FT), Health Utilities Index Mark 2 (HUI2), Health Utilities Index Mark 3 (HUI3), and Short Form 6D (SF-6D). Linear mixed effect models were used to estimate the mean difference in preference scores by treatment group for 9 years. RESULTS: The ILI had higher mean FT (0.019, 95% CI, 0.015-0.024, P < 0.001) and SF-6D (0.011, 95% CI, 0.006-0.014, P < 0.001) scores than the DSE. No significant group differences were observed for the HUI2 (0.004, 95% CI, -0.003 to 0.010, P = 0.23) and HUI3 (0.004, -0.004 to 0.012, P = 0.36). In year 1, the ILI had higher mean preference scores for all instruments. Thereafter, the increases remained significant only for FT and SF-6D, and the effects also become smaller. CONCLUSIONS: ILI aimed at reducing body weight among persons with overweight or obesity and type 2 diabetes improves preference-based HRQOL in the short term, but its long-term effect is unclear.

The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy.

The National Institutes of Health National Heart, Lung, and Blood Institute convened a working group in March 2008 to discuss how therapies for heart failure (HF) might be best advanced using clinical trials involving left ventricular assist devices (LVAD). This group opined that the field was ready for a trial to assess the use of long-term ventricular assist device therapy in patients who are less ill than patients currently eligible for destination therapy, which resulted in the Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) pilot study. The specific objective of REVIVE-IT was to compare LVAD therapy with optimal medical management in patients with less advanced HF than current LVAD indications to determine if wider application of permanent LVAD use to less ill patients would be associated with improved survival, quality of life, or functional capacity. REVIVE-IT represented an extraordinary effort to provide data from a randomized clinical trial to inform clinicians, scientists, industry, and regulatory agencies about the efficacy and safety of LVAD therapy in a population with less advanced HF. Despite significant support from the medical community, industry, and governmental agencies, REVIVE-IT failed to accomplish its goal. The reasons for its failure are instructive, and the lessons learned from the REVIVE-IT experience are likely to be relevant to any future study of LVAD therapy in a population with less advanced HF.