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There is a growing appreciation that our current approach to clinical research leaves important gaps in evidence from the perspective of patients, clinicians, and payers wishing to make evidence-based clinical and health policy decisions. This has been a major driver in the rapid increase in interest in comparative effectiveness research (CER), which aims(More)
While advances in medical science have led to continued improvements in medical care and health outcomes, evidence of the comparative effectiveness of alternative management options remains inadequate for informed medical care and health policy decision making. The result is frequently suboptimal and inefficient care as well as unsustainable costs. To(More)
Comparative effectiveness research (CER), or research design to meet the needs of post-regulatory decision makers, has been brought into the spotlight with the introduction of the American Recovery and Reinvestment Act, which provided $US1.1 billion over 2 years to support CER. In the short run, the majority of this money will be invested in observational(More)
BACKGROUND Electronic clinical data (ECD) will increasingly serve as an important source of information for comparative effectiveness research (CER). Although many retrospective studies have relied on ECD, new study designs propose using ECD for prospective CER. These designs have great potential but they also raise important ethics questions. AIMS(More)
C urrently, there is widespread recognition that much of health care is insufficiently grounded in evidence as to what works for whom under what circumstances. An important reason for this is that research efforts often do not compare alternative options of health care nor are they sufficiently focused on outcomes that matter to patients. 1,2 In addition,(More)
BACKGROUND In the debate on improving the quality and efficiency of the United States healthcare system, comparative effectiveness research is increasingly seen as a tool for reducing costs without compromising outcomes. Furthermore, the recent American Recovery and Reinvestment Act explicitly describes a prioritization function for establishing a(More)
The National Oncologic PET Registry (NOPR) was one of the first attempts of the Centers for Medicare & Medicaid Services (CMS) at coverage with evidence development. Under this coverage policy, the agency will provide payment for a technology only if patients and providers agree to enroll in a prospective study or registry. The NOPR was designed to(More)
CONTEXT Comparative effectiveness research is increasingly being recognized as a method to link research with the information needs of decision makers. As the United States begins to invest in comparative effectiveness, it would be wise to look at other functioning research networks to understand the infrastructure and funding required to support them. (More)
Recently, there have been increasing numbers of activities labeled as either quality improvement (QI) or comparative effectiveness research (CER), both of which are designed to learn what works and what does not in routine clinical care settings. These activities can create confusion for researchers, Institutional Review Board members, and other(More)