Patient-Centered Outcomes Research Institute (PCORI) Research Agenda: Input from the American College of Emergency Physicians and Society for Academic Emergency Medicine ACEP and SAEM Missions The American College of Emergency Physicians (ACEP) is the largest professional organization in emergency medicine representing over 25,000 practicing emergency physicians, residents, and medical students. ACEP’s mission is to promote the highest quality of emergency care and is the leading advocate for emergency physicians, their patients, and the public. The Society for Academic Emergency Medicine (SAEM) is dedicated to the improvement of care of the acutely ill and injured patient by improving research and education. SAEM provides administrative support to the Association of Academic Chairs of Emergency Medicine (AACEM). The mission of the SAEM is to improve patient care by advancing research and education in emergency medicine. Patient-Centered Outcomes Research in Emergency Care Could Broadly Improve Health Rapid diagnosis and early treatment in patients with acute illness or injury, or in acutely decompensated chronic illness, improves patient outcomes, prevents long term disability, and decreases health care costs. Over 120 million patients who annually seek care in America’s emergency departments (EDs). Emergency care, including Emergency Medical Services (EMS) and EDs, represent a key intersection with healthcare systems, especially for patients requiring intensive resources. Approximately, 50% of all hospitalizations now come through the ED (up from 35% fifteen years ago). Emergency care comparative effectiveness research (CER) and patient oriented outcomes research (POCR) programs have the potential to study a broad spectrum of disease processes (both acute illness and exacerbations of chronic illnesses) in all patient populations, including vulnerable populations and the underserved. Such research is most likely to benefit these same broad populations. The ED setting is inherently multidisciplinary and always open. Thus, CER and POCR on device technologies, diagnostics, treatments, patient access strategies and healthcare systems interventions can be rapidly evaluated by leveraging the 24/7 access, broad patient population, and staffing by a small number of health care providers capable of managing a wide range of diseases and care issues. Emergency Care Research is Consistent with the Ten CER Research Agendas Acute care was noted as a top ten CER priority area in Table 2 of the draft PCORI report. Specifically, acute care was listed as a leading priority by the Federal Coordinating Council for Comparative Effectiveness Research, the Agency for Healthcare Research and Quality and the National Quality Forum. Emergency Care Research Intersects with All Five of the PCORI Proposed Research Priorities Assessment of Prevention, Diagnosis and Treatment Options A key characteristic of emergency medicine is the rapid assessment of potentially serious, morbid, or life threatening illness, and the institution of empiric treatment intended to minimize morbidity, disability, or loss of life, often before a definitive diagnosis is possible. The need to simultaneously identify and empirically treat potentially devastating medical and surgical conditions motivates the frequent use of imperfect but resource intensive diagnostic strategies and therapies in many patients who, ultimately, are found not to have the disease in question. A priority in emergency care CER and POCR is to assess modalities and strategies for the efficient and rapid identification of serious injury and illness, especially in a setting in which the clinical manifestations of the disease may be subtle or non-specific, the disease prevalence is quite low, but the potential impact of a missed diagnosis or delay in definitive therapy is quite large. Improving Healthcare Systems Matching patients across a region and population with the right health resource at the right time in the right place is key to emergency care. Thus, emergency care CER and POCR research could be critical to determining the optimal configuration of regional healthcare systems. Emergency healthcare settings are highly accessible, often costly, and important to the public, yet existing evidence regarding clinical effectiveness and optimal patient oriented outcomes for many emergency treatments is sparse. Addressing Disparities The 120 million patients who annually seek care in America’s emergency departments (EDs) represent every health status, race, and socioeconomic group, many of whom are underserved. There is no other health setting that provides such direct and broad access to all Americans or opportunity for CER and POCR. Many ED patients do not otherwise access the healthcare system and are at considerable risk for preventable illness and injury. Indeed, visiting an ED has been shown to be a marker for health disparities. Communication and Dissemination Research The identification of cost-effective, rapid, and accurate diagnostic strategies to be used in the setting of potentially serious but non-specific patient presentations (e.g., fever, shock, altered mental status, abdominal pain, chest pain, respiratory distress) could improve shared decision-making between patients and providers in distinct ways: o Patients with serious illness will be more quickly and unambiguously identified, leading to more rapid initiation of effective treatment; and o Patients without serious illness will be more rapidly identified, leading to reduced resource utilization from additional testing, reductions in unnecessary and potentially harmful empiric treatment, reduced lengths of stay in the emergency department (ED), and reduction in unnecessary hospitalization. These latter effects will reduce ED and hospital overcrowding, which currently impact the quality of and access to emergency care for many Americans. Concurrently, there is an imperative to identify effective therapeutic strategies for broad classes of patients (e.g., those with shock, altered mental status, and respiratory distress) prior to definitive diagnosis. Here again, the emergency care provider must make shared therapeutic decisions under tremendous diagnostic uncertainty--a process that occurs daily but has been rarely studied. Accelerating Patient-Centered Outcomes Research and Methodological Research In response to key recommendations from the Institute of Medicine’s 2006 report, “The Future Of Emergency Care In The United States Health System,” the Department of Health and Human Services has been studying the gaps and opportunities in emergency and trauma care research in order to develop a strategy for the optimal organization and funding of the emergency care research effort. Last year, an NIH-led review of emergency care research priorities and opportunities was concluded, including a summary of “roundtable” meetings examining neurological and behavioral emergencies, medical and surgical emergencies, and emergency trauma care. These reviews have led to a robust research agenda, including highlighting areas of importance in patient-oriented outcomes research and methodological research into acute and emergency care settings. These areas include: Development of protocols for emergency patients that are rigorously defined, conditionspecific and time-sequenced. Standardization and integration of data collection elements among clinical care and research systems. Linkage of patient data across multiple care domains (e.g., EMS, rural and urban hospitals, clinics, public health system) and institutions. Creation of population-based, de-identified datasets that include key measures of emergency care processes and outcomes. Linkage of patient data across multiple care domains (e.g., EMS, rural and urban hospitals, clinics, public health system) and institutions. Development of emergency care research networks and adaptive, innovative study designs to efficiently conduct CER and POCR. These healthcare settings are highly accessible, often costly, and important to the public, yet existing evidence regarding clinical effectiveness of many emergency treatments is sparse. The availability of an emergency CER and POCR research network would decrease the cost and time required to answer important questions regarding the clinical effectiveness of emergency diagnostic and treatment strategies. In addition, such a network would provide an ideal environment in which to train new CER and POCR investigators in work in the emergency care arena.