A consensus conference on the use of placebo in mood disorder studies consisted of expert presentations on bioethics, biostatistics, unipolar depression, and bipolar disorder. Work groups considered evidence and presented statements to the group. Although it was not possible to write a document for which there was complete agreement on all issues, the final document incorporated input from all authors. There was consensus that placebo has a definite role in mood disorder studies. Findings of equivalence between a new drug and standard treatment in active control studies is not evidence of efficacy unless the new drug is also significantly more effective than placebo. Add-on studies in which patients are randomized to standard therapy plus the investigational drug or standard therapy plus placebo are especially indicated for high-risk patients. Mood disorders in elderly and pediatric patients are understudied, and properly designed trials are urgently needed. Research is needed on the ethical conduct of studies to limit risks of medication-free intervals and facilitate poststudy treatment. Patients must fully understand the risks and lack of individualized treatment involved in research.
Led by the Affordable Care Act, the U.S. health care system is undergoing a transformative shift toward greater accountability for quality and efficiency. Academic health centers (AHCs), whose triple mission of clinical care, research, and education serves a critical role in the country's health care system, must adapt to this evolving environment. Doing so successfully, however, requires a broader understanding of the wide-ranging roles of the AHC. This article proposes a conceptual framework through which the triple mission is expanded along four new dimensions: health, innovation, community, and policy. Examples within the conceptual framework categories, such as the AHCs' safety net function, their contributions to local economies, and their role in right-sizing the health care workforce, illustrate how each of these dimensions provides a more robust picture of the modern AHC and demonstrates the value added by AHCs. This conceptual framework also offers a basis for developing new performance metrics by which AHCs, both individually and as a group, can be held accountable, and that can inform policy decisions affecting them. This closer examination of the myriad activities of modern AHCs clarifies their essential role in our health care system and will enable these institutions to evolve, improve, be held accountable for, and more fully serve the health of the nation.
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