Health affairs
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Under Food and Drug Administration (FDA) policy, communications by prescription drug manufacturers must be backed by "substantial evidence" from "adequate and well-controlled investigations." But numerous exceptions permit manufacturer promotion based on data other than randomized trials. The observational research presented in the Hemikrane hypothetical case in this month's Health Affairs is methodologically flawed and also does not meet any of these exceptions. ⋯ Further work is required to define the characteristics of high-quality observational research. However, as this field matures, higher-quality observational studies could meet the legal standard of an "adequate and well-controlled investigation." At that point, the FDA will need to issue formal guidance to minimize confusion on what kinds of observational research can meet its evidentiary standards.
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The Affordable Care Act created the Patient-Centered Outcomes Research Institute (PCORI) to help patients, clinicians, and policy makers make well-informed decisions about health care. Because its funding expires in 2019, the institute has little time in which to produce timely, practice-changing results that will build public support for comparative effectiveness research. ⋯ In January 2012 PCORI's first research agenda described broad research priorities rather than specific clinical questions. The institute must drive the burgeoning discipline of comparative effectiveness research forward, starting with a research project agenda that conveys a sense of urgency and strategic direction.
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Decision aids are evidence-based sources of health information that can help patients make informed treatment decisions. However, little is known about how decision aids affect health care use when they are implemented outside of randomized controlled clinical trials. ⋯ Consistent with prior randomized trials, our introduction of decision aids was associated with 26 percent fewer hip replacement surgeries, 38 percent fewer knee replacements, and 12-21 percent lower costs over six months. These findings support the concept that patient decision aids for some health conditions, for which treatment decisions are highly sensitive to both patients' and physicians' preferences, may reduce rates of elective surgery and lower costs.