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Briefly stated, comparative effectiveness research pertains to the direct, succinct and precise comparison of existing healthcare interventions to determine what works best for each individual patient, and which treatment course poses the greatest benefits, costs and harms. The core question of comparative effectiveness research goes beyond establishing what treatment works best, for whom, and under what circumstances: it is a hypothesis-driven endeavor designed to uncover and implement the consensus of the best evidence base for patient-centered, effectiveness-focused and evidence-based health care. Members at the Institute of Medicine and the Patient-Centered Outcomes Research concur that comparative effectiveness research involves the generation and synthesis of the best available evidence for a treatment intervention by means of a process driven by the PICOTS question/hypothesis, and are directed at comparing and contrasting the benefits, costs and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical conditions with the specified intent of improving the delivery of health care. The purpose of comparative effectiveness research is to assist healthcare providers, patients, allied clinicians, caregivers and other stakeholders to engage together and make informed decisions that will improve healthcare at both the individual and population levels, and in so doing utilize the identified best evidence base in specific clinical settings, a process that the Agency for Healthcare Research and Quality defines as "Translational Effectiveness". In brief, comparative effectiveness research is the tool and the process necessary for translational effectiveness. In this light, it is critical and timely to facilitate comparative effectiveness research as one of the essential and primary components of patient-centered, effectiveness-focused and evidence-based clinical decision-making in healthcare, as the premier process that results in improved patient outcomes, enhanced research planning, better products, and novel evidence-based policy development. This book is a compilation of the writings of several experts in the field and their collaborators. Each chapter examines specific facets of the process of comparative effectiveness research-based clinical decision-making in the principal domains of healthcare, which are subsumed in this work as dentistry, Western and alternative medicine, nursing, and pharmacology. Taken together, the chapters in this book present a brief, yet comprehensive overview and discussion of the current state of comparative effectiveness in healthcare. They establish the central role of systematic reviews in the process of clinical decision-making in evidence-based health care, and examine in depth the statistical significance and the clinical relevance of actualizing and evaluating clinical decision-making. Additionally, policies in optimizing evidence-based, patient-centered and effectiveness-focused clinical outcomes, stakeholders engagement for raising health literacy in the U.S. and worldwide in this decade of the twenty-first century and beyond are discussed.
Clinical research presents health care providers with information on the natural history and clinical presentations of disease as well as diagnostic and treatment options. In today's healthcare system, patients, physicians, clinicians and family caregivers often lack the sufficient scientific data and evidence they need to determine the best course of treatment for the patients' medical conditions. Initial National Priorities for Comparative Effectiveness Research(CER) is designed to fill this knowledge gap by assisting patients and healthcare providers across diverse settings in making more informed decisions. In this 2009 report, the Institute of Medicine's Committee on Comparative Effectiveness Research Prioritization establishes a working definition of CER, develops a priority list of research topics, and identifies the necessary requirements to support a robust and sustainable CER enterprise. As part of the 2009 American Recovery and Reinvestment Act, Congress appropriated $1.1 billion in federal support of CER, reflecting legislators' belief that better decisions about the use of health care could improve the public's health and reduce the cost of care. The Committee on Comparative Effectiveness Research Prioritization was successful in preparing a list 100 top priority CER topics and 10 recommendations for best practices in the field.
This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Comparative Effectiveness Research: Evidence, Medicine, and Policy provides the first complete account of how — and why — the federal government decided to make comparative effectiveness research (CER) an important feature of health reform and the Affordable Care Act of 2010.
In 2010, the Patient-Centered Outcomes Research Institute (PCORI) was established as a federally funded, nonprofit corporation to improve the quality and relevance of comparative clinical effectiveness research (CER). PCORI, which began operation in 2010, is required to identify research priorities, establish a research project agenda, fund research consistent with its research agenda, and disseminate research results, among other things. PCORI is funded by the Patient-Centered Outcomes Research Trust Fund, through which the institute is expected to receive an estimated $3.5 billion from FY 2010 through 2019. This review examines (1) the extent to which PCORI established priorities and processes for funding and disseminating comparative clinical effectiveness research consistent with its legislative requirements; (2) the status of PCORI's efforts to fund comparative clinical effectiveness research; and (3) PCORI's plans, if any, to evaluate the effectiveness of its work. Tables and figures. This is a print on demand report.
Comparative Effectiveness: Initial Assessment of the Patient-Centered Outcomes Research Institute
Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions at both the individual and population levels. CER encompasses a very broad range of types of studies—experimental, observational, prospective, retrospective, and research synthesis. This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections—causal inference; clinical trials; research synthesis; and specialized topics. The audience includes CER methodologists, quantitative-trained researchers interested in CER, and graduate students in statistics, epidemiology, and health services and outcomes research. The book assumes a masters-level course in regression analysis and familiarity with clinical research.
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.