The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology.

Clinical utility describes the benefits of each laboratory test for that patient. Many stakeholders have adopted narrow definitions for the clinical utility of molecular testing as applied to targeted pharmacotherapy in oncology, regardless of the population tested or the purpose of the testing. This definition does not address all of the important applications of molecular diagnostic testing. Definitions consistent with a patient-centered approach emphasize and recognize that a clinical test result's utility depends on the context in which it is used and are particularly relevant to molecular diagnostic testing because of the nature of the information they provide. Debates surrounding levels and types of evidence needed to properly evaluate the clinical value of molecular diagnostics are increasingly important because the growing body of knowledge, stemming from the increase of genomic medicine, provides many new opportunities for molecular testing to improve health care. We address the challenges in defining the clinical utility of molecular diagnostics for inherited diseases or cancer and provide assessment recommendations. Starting with a modified analytic validity, clinical validity, clinical utility, and ethical, legal, and social implications model for addressing clinical utility of molecular diagnostics with a variety of testing purposes, we recommend promotion of patient-centered definitions of clinical utility that appropriately recognize the valuable contribution of molecular diagnostic testing to improve patient care.

Impact of systems of care and blood pressure management on stroke outcomes.

Stroke is the third leading cause of death in the United States and the leading cause of disability. Stroke patients' outcomes are strongly determined by how long they remain untreated ("time is brain"). The Joint Commission's adoption of stroke performance improvement measures combined with the Centers for Medicare and Medicaid's more recent adoption in October 2009 make a systems approach to improving stroke outcomes a higher priority. As hospitals establish local and regional stroke care systems to meet these performance measures, treatment of emergent high blood pressure (BP) is a major consideration to improve rapid triage and management of acute stroke patients. Intravenous thrombolysis with tissue plasminogen activator (tPA) is a critical quality of care component for acute ischemic stroke (AIS) treatment, but its administration is contingent on BP management. For patients with AIS who are potentially eligible for tPA and patients with intracerebral hemorrhage, timely, controlled BP may improve patient outcomes. Appropriate BP management, however, is still controversial given the heterogeneity of stroke subtypes, the varying attributes of candidate antihypertensive agents, and both local and central hemodynamics. Additionally, organizational delivery system factors may be suboptimal at some hospitals. Under current hospital stroke performance measures, payment mechanisms, and emergency department throughput measures, the impact of BP management may become transparent to patients and payers, and have important consequences for hospital-derived stroke outcomes.