Outcome metrics utilized in evaluations of programs and interventions for combat and operational stress: A review of psychometric properties.

The Department of Defense has mandated combat and operational stress control (COSC) efforts for the Services since 1999. Although several COSC-related programs have been implemented, few have undergone evaluation, and no standardized metrics have been established to assess their effectiveness and utility. The purpose of this review was to characterize the content and psychometrics of measures that have been utilized as outcome metrics in evaluations of COSC-related programs and interventions. Systematic literature searches were conducted for publications that: a) evaluated at least one measure from U.S. service members who participated in a program or intervention to prevent or reduce the adverse effects of combat and operational stress; and b) reported U.S. data on the internal consistency, test-retest reliability, convergent validity, and sensitivity/specificity of the identified measures. This process identified 15 measures for which psychometric properties were reviewed for acceptability based on recommended criteria. Identified measures varied from well-validated measures to newer instruments for which more data is needed on one or more of the target psychometric properties. Aside from internal consistency, psychometric data from U.S. military samples were sparse. Results further suggested that some measures might have reduced sensitivity in service members under certain conditions, such as large-scale screening. Additional studies are needed to validate COSC-relevant measures in service members. Future evaluations of programs and interventions for combat and operational stress should select measures that will increase the consistency of the literature, allow comparisons across studies, and ensure alignment with the objectives of identified programs.

Biosimilar Cost Savings in the United States: Initial Experience and Future Potential.

The Biologics Price Competition and Innovation Act (BPCIA), enacted as part of the 2010 Patient Protection and Affordable Care Act (ACA), authorized the U.S. Food and Drug Administration (FDA) to create a new regulatory approval pathway for biosimilars, which are biologic drugs that are very similar to already approved "reference" biologics in terms of potency, safety, and efficacy, but are manufactured by different companies. In the seven years since the ACA, many drug manufacturers worked to push new biosimilars through development and FDA review. As of July 2017, there were three marketed biosimilars and two more that were approved by the FDA but not yet marketed. BPCIA's shorter, lower-cost biosimilar approval pathway was designed to introduce competition among biologic manufacturers. This article estimates potential future savings from biosimilars in the United States, summarizes the experience to date with the first marketed biosimilar in the United States, and discusses key policy issues surrounding biosimilars. We estimate that biosimilars will reduce direct spending on biologic drugs by $54 billion from 2017 to 2026, or about 3 percent of total estimated biologic spending over the same period, with a range of $24 to $150 billion. While our estimate uses recent data and transparent assumptions, we caution that actual savings will hinge on industry and regulatory decisions as well as potential policy changes to strengthen the biosimilar market.