J Am Board Fam Med
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Pragmatic clinical trials (PCTs) are increasingly recommended to evaluate interventions in real-world conditions. Although PCTs share a common approach of evaluating variables from actual clinical practice, multiple characteristics can differ. These differences affect interpretation of the trial. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) model was developed in 2009 by the CONSORT Work Group on Pragmatic Trials, published by Thorpe et al, to aid in trial design. PRECIS provides clarity about the generalizability and applicability of a trial by depicting multiple study characteristics. We recently completed a National Institutes of Health-sponsored pilot study examining health-related outcomes for 2 complementary therapies for chronic low back pain in patients referred by primary care providers in the Kentucky Ambulatory Network. In preparation for a larger study, we sought to characterize the pragmatic features of the study to aid in our design decisions. The purpose of this article is to introduce clinical researchers to the PRECIS model while demonstrating its application to refine a practice based research network study. ⋯ The study was not as pragmatic as expected. The exercise results seem to be useful in identifying necessary refinements to the study methodology that may benefit future study design and increase generalizability. Readers can identify how the PRECIS model may be used to provide clarity and transparency for proposed or existing studies and may wish to replicate our exercise in planning their own studies.
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As the Affordable Care Act (ACA) is implemented and many uninsured become insured, rates of underinsurance may persist or increase. This study was designed to estimate the rate of underinsurance in primary care safety net clinics serving low income, multiethnic populations in New Mexico. ⋯ A high level of underinsurance was found in these safety net clinics. Because millions of Americans gain health care insurance benefits, monitoring whether the current reform provides adequate health care coverage or whether those with new and existing health care insurance are underinsured is critical.