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.

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.

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.

The spatial propagation and increasing dominance of Gilbertiodendron dewevrei (Fabaceae) in the eastern Congo basin.

Though substantial research has been conducted on possible historical, physiological, and symbiotic mechanisms that permit monodominance to occur within tropical lowland rainforests, less is known about the successional rates at which monodominance exerts itself on surrounding forest structures. Here we extend efforts to evaluate the longitudinal dynamics of Gilbertiodendron dewevrei-dominated forest in Central Africa by considering this species' spatial dynamics. Using three 10-ha censused field plots measured across three time periods, we present the first quantitative estimates of the spatial propagation of Gilbertiodendron into adjacent mixed species forest. Using three analytical strategies, we demonstrate that Gilbertiodendron is increasing in dominance and that monodominant forest patches are expanding into the surrounding forest at a statistically significant rate. The rates of successional advance vary by patch and direction, but average 0.31 m year-1, with speeds greatest in the direction of the prevailing winds. We show that the advancement of Gilbertiodendron is significantly slower than documented rates from other forest ecotones across Central Africa. When paired with stress tolerance traits and ectomycorrhizal associations, these findings help to clarify the means by which Gilbertiodendron dewevrei gains dominance in otherwise species-diverse regions.

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.

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.

Cost-Effectiveness of a Risk-Tailored Pancreatic Cancer Early Detection Strategy Among Patients With New-Onset Diabetes.

BACKGROUND & AIMS: Screening for pancreatic ductal adenocarcinoma (PDAC) in asymptomatic adults is not recommended, however, patients with new-onset diabetes (NoD) have an 8 times higher risk of PDAC than expected. A novel risk-tailored early detection strategy targeting high-risk NoD patients might improve PDAC prognosis. We sought to evaluate the cost effectiveness of this strategy. METHODS: We compared PDAC early detection strategies targeting NoD individuals age 50 years and older at various minimal predicted PDAC risk thresholds vs standard of care in a Markov state-transition decision model under the health care sector perspective using a lifetime horizon. RESULTS: At a willingness to pay (WTP) threshold of $150,000 per quality-adjusted life-year, the early detection strategy targeting patients with a minimum predicted 3-year PDAC risk of 1% was cost effective (incremental cost-effectiveness ratio, $116,911). At a WTP threshold of $100,000 per quality-adjusted life-year, the early detection strategy at the 2% risk threshold was cost effective (incremental cost-effectiveness ratio, $63,045). The proportion of PDACs detected at local stage, costs of treatment for metastatic PDAC, utilities of local and regional cancers, and sensitivity of screening were the most influential parameters. Probabilistic sensitivity analysis confirmed that at a WTP threshold of $150,000, early detection at the 1.0% risk threshold was favored (30.6%), followed by the 0.5% risk threshold (20.4%) vs standard of care (1.7%). At a WTP threshold of $100,000, early detection at the 1.0% risk threshold was favored (27.3%) followed by the 2.0% risk threshold (22.8%) vs standard of care (2.0%). CONCLUSIONS: A risk-tailored PDAC early detection strategy targeting NoD patients with a minimum predicted 3-year PDAC risk of 1.0% to 2.0% may be cost effective.

Attributable Cost of Healthcare-Associated Methicillin-Resistant Staphylococcus aureus Infection in a Long-term Care Center.

BACKGROUND: Studies have shown that healthcare-associated infections (HAIs) due to methicillin-resistant Staphylococcus aureus (MRSA) can lead to substantial healthcare costs in acute care settings. However, little is known regarding the consequences of these infections on patients in long-term care centers (LTCCs). The purpose of this study was to estimate the attributable cost of MRSA HAIs in LTCCs within the Department of Veterans Affairs (VA). METHODS: We performed a retrospective cohort study of patients admitted to VA LTCCs between 1 January 2009 and 30 September 2015. MRSA HAIs were defined as a positive clinical culture at least 48 hours after LTCC admission so as to exclude community-acquired infections. Positive cultures were further classified by site (sterile or nonsterile). We used multivariable generalized linear models and 2-part models to compare the LTCC and acute care costs between patients with and without an MRSA HAI. RESULTS: In our primary analysis, there was no difference in LTCC costs between patients with and without a MRSA HAI. There was, however, a significant increase in the odds of being transferred to an acute care facility (odds ratio, 4.40 [95% confidence interval {CI}, 3.40-5.67]) and in acute care costs ($9711 [95% CI, $6961-$12 462]). CONCLUSIONS: Our findings of high cost and increased risk of transfer from LTCC to acute care are important because they highlight the substantial clinical and economic impact of MRSA infections in this population.

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.

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.

Prospective CYP2C19 Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial.

BACKGROUND: CYP2C19 loss-of-function alleles impair clopidogrel effectiveness after percutaneous coronary intervention, but the clinical impact of implementing CYP2C19 genotyping in a real-world setting is unknown. The purpose of the study was to determine whether returning CYP2C19 genotype results along with genotype-guided pharmacotherapy recommendations using a rapid turnaround test would change antiplatelet prescribing following percutaneous coronary intervention.The primary outcome was the rate of prasugrel or ticagrelor prescribing in each arm. Secondary outcomes included agreement to the genotype-guided recommendations. METHODS: At the time of percutaneous coronary intervention, participants were randomly assigned to prospective rapid point-of-care genotyping of CYP2C19 major alleles (*2, *3, *17) via salivary swab (genotyped group) or no genotyping (usual care) to guide antiplatelet drug selection. Interventional cardiologists at 2 cardiac catheterization laboratories within the same health system were provided genotype information along with genotype-guided pharmacotherapy recommendations. RESULTS: A total of 504 participants were randomized, 249 to the genotyped and 255 to the usual care group. The participants were primarily men (73%); age, 63±10 years; and 50% had acute coronary syndromes. In the genotyped group, 28% were carriers of loss-of-function alleles (*2, *3). The use of prasugrel or ticagrelor was significantly higher in the genotyped group compared with the usual care group (30% versus 21%; odds ratio, 1.60 [95% CI, 1.07-2.42]; P=0.03). Within the genotyped group, 53% of loss-of-function allele carriers were started on prasugrel/ticagrelor, while 47% were started on clopidogrel. CONCLUSIONS: In a randomized controlled trial of clinical CYP2C19 genotyping implementation, pharmacogenetic test results significantly influenced antiplatelet drug prescribing; however, almost half of CYP2C19 loss-of-function carriers continued to receive clopidogrel. Interventional cardiologists consider both clinical and genetic factors when selecting antiplatelet therapy following percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT02508116.

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.

Positive biodiversity-productivity relationship predominant in global forests.

The biodiversity-productivity relationship (BPR) is foundational to our understanding of the global extinction crisis and its impacts on ecosystem functioning. Understanding BPR is critical for the accurate valuation and effective conservation of biodiversity. Using ground-sourced data from 777,126 permanent plots, spanning 44 countries and most terrestrial biomes, we reveal a globally consistent positive concave-down BPR, showing that continued biodiversity loss would result in an accelerating decline in forest productivity worldwide. The value of biodiversity in maintaining commercial forest productivity alone-US$166 billion to 490 billion per year according to our estimation-is more than twice what it would cost to implement effective global conservation. This highlights the need for a worldwide reassessment of biodiversity values, forest management strategies, and conservation priorities.

Spatially-explicit models of global tree density.

Remote sensing and geographic analysis of woody vegetation provide means of evaluating the distribution of natural resources, patterns of biodiversity and ecosystem structure, and socio-economic drivers of resource utilization. While these methods bring geographic datasets with global coverage into our day-to-day analytic spheres, many of the studies that rely on these strategies do not capitalize on the extensive collection of existing field data. We present the methods and maps associated with the first spatially-explicit models of global tree density, which relied on over 420,000 forest inventory field plots from around the world. This research is the result of a collaborative effort engaging over 20 scientists and institutions, and capitalizes on an array of analytical strategies. Our spatial data products offer precise estimates of the number of trees at global and biome scales, but should not be used for local-level estimation. At larger scales, these datasets can contribute valuable insight into resource management, ecological modelling efforts, and the quantification of ecosystem services.

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 relationship between Positive and Negative Syndrome Scale (PANSS) schizophrenia severity scores and risk for hospitalization: an analysis of the CATIE Schizophrenia Trial.

BACKGROUND: Little is known about the effect of treatment-related changes in Positive and Negative Syndrome Scale (PANSS) schizophrenia severity scores on the risk for subsequent hospitalization. METHODS: We used limited-access data from the Clinical Antipsychotic Trials of Intervention Effectiveness Project Schizophrenia Trial (CATIE Sz) to evaluate the relationship between baseline and changes in PANSS clinical symptom scores and risks for subsequent psychiatric hospitalization. RESULTS: Reductions in PANSS total scores during a three-month period were associated with a significantly lower risk for psychiatric hospitalization (OR, 0.78, 95% CI, 0.72 to 0.84, p<0.001 for 10 point reductions). Ten-point reductions in PANSS total score during three months reduced predicted number of psychiatric hospitalizations by 0.02 (95% CI, 0.012 to 0.027) and nights in the hospital by 0.24 (95% CI, 0.07 to 0.41). Maintenance of this reduction for a year is expected to reduce psychiatric hospitalizations by 0.10 (95% CI, 0.08 to 0.13) and nights hospitalized by 1.4 (95% CI, 0.9 to 1.9). A 10-point reduction in PANSS total score was associated with a savings in psychiatric hospitalization cost of $192 over three months and $1135 over a year. CONCLUSIONS: Reductions in PANSS total scores significantly reduced risks for psychiatric hospitalizations, total number of psychiatric hospitalizations, total nights for psychiatric admissions, and the costs of these hospitalizations. These data highlight the benefits of symptom control on the direct costs of care in schizophrenia.

Comparative effectiveness and cost-effectiveness analyses frequently agree on value.

The Patient-Centered Outcomes Research Institute, known as PCORI, was established by Congress as part of the Affordable Care Act (ACA) to promote evidence-based treatment. Provisions of the ACA prohibit the use of a cost-effectiveness analysis threshold and quality-adjusted life-years (QALYs) in PCORI comparative effectiveness studies, which has been understood as a prohibition on support for PCORI's conducting conventional cost-effectiveness analyses. This constraint complicates evidence-based choices where incremental improvements in outcomes are achieved at increased costs of care. How frequently this limitation inhibits efficient cost containment, also a goal of the ACA, depends on how often more effective treatment is not cost-effective relative to less effective treatment. We examined the largest database of studies of comparisons of effectiveness and cost-effectiveness to see how often there is disagreement between the more effective treatment and the cost-effective treatment, for various thresholds that may define good value. We found that under the benchmark assumption, disagreement between the two types of analyses occurs in 19 percent of cases. Disagreement is more likely to occur if a treatment intervention is musculoskeletal and less likely to occur if it is surgical or involves secondary prevention, or if the study was funded by a pharmaceutical company.