Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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On May 13, 2014, a 1-hour panel discussion session titled "Gender-specific Regulatory Challenges to Product Approval" was held during the Academic Emergency Medicine consensus conference, "Gender-specific Research in Emergency Medicine: Investigate, Understand, and Translate How Gender Affects Patient Outcomes." The session sought to bring together leaders in emergency medicine (EM) research, authors, and reviewers in EM research publications, as well as faculty, fellows, residents, and students engaged in research and clinical practice. A panel was convened involving a representative from the Office of Women's Health of the U. S. ⋯ The moderated discussion also involved audience members who contributed significantly to the dialogue. Historical background leading up to the session along with the main themes of the discussion are reproduced in this article. These revolve around sex- and gender-specific research, statistical analysis of sex and gender, clinical practice, financial costs associated with pharmaceutical development, adaptive design, and specific recommendations on the regulatory process as it affects the specialty of EM.
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Coronary artery disease (CAD) is the most common cause of death for both men and women. However, over the years, emergency physicians, cardiologists, and other health care practitioners have observed varying outcomes in men and women with symptomatic CAD. Women in general are 10 to 15 years older than men when they develop CAD, but suffer worse postinfarction outcomes compared to age-matched men. ⋯ Through three rounds of nomination and refinement, followed by an in-person meeting on May 13, 2014, we achieved consensus on five priority themes and 30 research questions. The overarching themes were as follows: 1) the full spectrum of sex-specific risk as well as presentation of cardiac ischemia may not be captured by our standard definition of CAD and needs to incorporate other forms of ischemic heart disease (IHD); 2) diagnosis is further challenged by sex/gender differences in presentation and variable sensitivity of cardiac biomarkers, imaging, and risk scores; 3) sex-specific pathophysiology of cardiac ischemia extends beyond conventional obstructive CAD to include other causes such as microvascular dysfunction, takotsubo, and coronary artery dissection, better recognized as IHD; 4) treatment and prognosis are influenced by sex-specific variations in biology, as well as patient-provider communication; and 5) the changing definitions of pathophysiology call for looking beyond conventionally defined cardiovascular outcomes to patient-centered outcomes. These emergency care priorities should guide future clinical and basic science research and extramural funding in an area that greatly influences patient outcomes.
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The emergency department (ED) is the point of first contact for patients with acute heart failure and arrhythmias, with 1 million annual ED visits in the United States. Although the total numbers of men and women living with heart failure are similar, female patients are underrepresented in clinical studies, with current knowledge predominantly based on data from male patients. This has led to an underappreciation of the sex-specific differences in clinical characteristics and pathophysiology-based management of heart failure. ⋯ Additionally, peripartum and postpartum cardiomyopathy represent a diagnostic and treatment dilemma. This article is the result of a breakout session in the cardiovascular and resuscitation work group of the 2014 Academic Emergency Medicine consensus conference "Gender-Specific Research in Emergency Medicine: Investigate, Understand, and Translate How Gender Affects Patient Outcomes." A nominal group technique was used to identify and prioritize themes and research questions using electronic mail, monthly conference calls, in-person meetings, and Web-based surveys between June 2013 and May 2014. Consensus was achieved through three rounds of nomination followed by the meeting on May 13, 2014, and resulted in seven priority themes that are essential to the common complex clinical syndrome of heart failure for both men and women and include the areas of pathophysiology; presentation and symptomatology; and diagnostic strategies using biomarkers, treatment, and mortality, with special consideration to arrhythmia management and pregnancy.
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Cerebrovascular neurologic emergencies including ischemic and hemorrhagic stroke, subarachnoid hemorrhage (SAH), and migraine are leading causes of death and disability that are frequently diagnosed and treated in the emergency department (ED). Although sex and gender differences in neurologic emergencies are beginning to become clearer, there are many unanswered questions about how emergency physicians should incorporate sex and gender into their research initiatives, patient evaluations, and overall management plans for these conditions. ⋯ Recommendations for future research on the role of sex and gender in the diagnosis, treatment, and outcomes pertinent to ED providers are described for each of three diagnoses: stroke, SAH, and migraine. Recommended future research also includes investigation of the biologic and pathophysiologic differences between men and women with neurologic emergencies as they pertain to ED diagnoses and treatments.
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The Centers for Disease Control and Prevention report that among older adults (≥65 years), falls are the leading cause of injury-related death. Fall-related fractures among older women are more than twice as frequent as those for men. ⋯ As part of the 2014 Academic Emergency Medicine (AEM) consensus conference on "Gender-Specific Research in Emergency Care: Investigate, Understand, and Translate How Gender Affects Patient Outcomes," a breakout group convened to generate a research agenda on priority questions to be answered on this topic. The consensus-based priority research agenda is presented in this article.