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.

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).

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.

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).

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.

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.

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.

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.

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.

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).

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.

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.

Low Health Literacy Predicts Misperceptions of Diabetes Control in Patients With Persistently Elevated A1C.

Purpose: The purpose of this study is to identify factors associated with perceived control of diabetes in a group of poorly controlled patients. Identifying factors associated with perceived control in these patients is an important step in improving actual control as measured by A1C. As health literacy is essential for understanding complex medical information, we hypothesized that low health literacy would be associated with inaccurate perceptions of diabetes control.

Impact of an intensive lifestyle intervention on use and cost of medical services among overweight and obese adults with type 2 diabetes: the action for health in diabetes.

Objective: To assess the relative impact of an intensive lifestyle intervention (ILI) on use and costs of health care within the Look AHEAD trial.

Research Design And Methods: A total of 5,121 overweight or obese adults with type 2 diabetes were randomly assigned to an ILI that promoted weight loss or to a comparison condition of diabetes support and education (DSE). Use and costs of health-care services were recorded across an average of 10 years.

Roux-en-Y gastric bypass compared with aggressive diet and exercise therapy for morbidly obese patients awaiting renal transplant: a decision analysis.

Background: The optimal management of morbidly obese patients awaiting renal transplant is controversial and unknown. The objective of this study was to compare the impact of Roux-en-Y gastric bypass (RYGB) versus diet and exercise on the survival of morbidly obese patients with end-stage renal disease awaiting renal transplant.

Methods: A decision analytic Markov state transition model was designed to simulate the life of morbidly obese patients with end-stage renal disease awaiting transplant.

Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study.

Objective: Hyperbaric oxygen (HBO) is a device that is used to treat foot ulcers. The study goal was to compare the effectiveness of HBO with other conventional therapies administered in a wound care network for the treatment of a diabetic foot ulcer and prevention of lower-extremity amputation.

Research Design And Methods: This was a longitudinal observational cohort study.

Comparative effectiveness of nonbiologic versus biologic disease-modifying antirheumatic drugs for rheumatoid arthritis.

Objective: To evaluate the comparative effectiveness of nonbiologic disease-modifying antirheumatic drugs (DMARD) versus biologic DMARD (bDMARD) for treatment of rheumatoid arthritis (RA), using 2 common analytic approaches.

Methods: We analyzed change in Clinical Disease Activity Index (CDAI) scores in patients with RA enrolled in a US-based observational registry from 2001 to 2008 using multivariable (MV) regression and propensity score (PS) matching. Among patients who initiated treatment with a nonbiologic DMARD (n = 1729), we compared patients who switched to, or added, another nonbiologic (n = 182) or a bDMARD (n = 342) at 5, 9, and 24 months after treatment change.

Clinical effectiveness, access to, and satisfaction with care using a telehomecare substitution intervention: a randomized controlled trial.

Background. Hospitalization accounts for 70% of heart failure (HF) costs; readmission rates at 30 days are 24% and rise to 50% by 90 days. Agencies anticipate that telehomecare will provide the close monitoring necessary to prevent HF readmissions.

Sample size and power for cost-effectiveness analysis (Part 2): the effect of maximum willingness to pay.

Sample size and power for cost-effectiveness analysis depend on assumptions about the difference in cost and effect, the standard deviations of cost and effect, the correlation of the difference in cost and effect, the α and β errors and maximum willingness to pay (W). The first seven of these parameters share much in common in their effect on sample size and power for cost-effectiveness analysis, including that each is associated with a single pattern of power. W, on the other hand, is unique in that, when plotted for positive values, we can potentially observe any of six patterns of power associated with positive values of W.

Sample size and power for cost-effectiveness analysis (part 1).

Basic sample size and power formulae for cost-effectiveness analysis have been established in the literature. These formulae are reviewed and the similarities and differences between sample size and power for cost-effectiveness analysis and for the analysis of other continuous variables such as changes in blood pressure or weight are described. The types of sample size and power tables that are commonly calculated for cost-effectiveness analysis are also described and the impact of varying the assumed parameter values on the resulting sample size and power estimates is discussed.

Estimation and validation of a multiattribute model of Alzheimer disease progression.

Objectives: To estimate and validate a multiattribute model of the clinical course of Alzheimer disease (AD) from mild AD to death in a high-quality prospective cohort study, and to estimate the impact of hypothetical modifications to AD progression rates on costs associated with Medicare and Medicaid services.

Data And Methods: The authors estimated sex-specific longitudinal Grade of Membership (GoM) models for AD patients (103 men, 149 women) in the initial cohort of the Predictors Study (1989-2001) based on 80 individual measures obtained every 6 mo for 10 y. These models were replicated for AD patients (106 men, 148 women) in the 2nd Predictors Study cohort (1997-2007).

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.

Cost-effectiveness of extended buprenorphine-naloxone treatment for opioid-dependent youth: data from a randomized trial.

Aims: The objective is to estimate cost, net social cost and cost-effectiveness in a clinical trial of extended buprenorphine-naloxone (BUP) treatment versus brief detoxification treatment in opioid-dependent youth.

Design: Economic evaluation of a clinical trial conducted at six community out-patient treatment programs from July 2003 to December 2006, who were randomized to 12 weeks of BUP or a 14-day taper (DETOX). BUP patients were prescribed up to 24 mg per day for 9 weeks and then tapered to zero at the end of week 12.