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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)
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.
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.
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 classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
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 actualising 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.
Integrates the various disciplines of the science of health disparities in one comprehensive volume The Science of Health Disparities Research is an indispensable source of up-to-date information on clinical and translational health disparities science. Building upon the advances in health disparities research over the past decade, this authoritative volume informs policies and practices addressing the diseases, disorders, and gaps in health outcomes that are more prevalent in minority populations and socially disadvantaged communities. Contributions by recognized scholars and leaders in the field—featuring contemporary research, conceptual models, and a broad range of scientific perspectives—provide an interdisciplinary approach to reducing inequalities in population health, encouraging community engagement in the research process, and promoting social justice. In-depth chapters help readers better understand the specifics of minority health and health disparities while demonstrating the importance of advancing theory, refining measurement, improving investigative methods, and diversifying scientific research. In 26 chapters, the book examines topics including the etiology of health disparities research, the determinants of population health, research ethics, and research in African American, Asians, Latino, American Indian, and other vulnerable populations. Providing a unified framework on the principles and applications of the science of health disparities research, this important volume: Defines the field of health disparities science and suggests new directions in scholarship and research Explains basic definitions, principles, and concepts for identifying, understanding and addressing health disparities Provides guidance on both conducting health disparities research and translating the results Examines how social, historical and contemporary injustices may influence the health of racial and ethnic minorities Illustrates the increasing national and global importance of addressing health disparities Discusses population health training, capacity-building, and the transdisciplinary tools needed to advance health equity A significant contribution to the field, The Science of Health Disparities Research is an essential resource for students and basic and clinical researchers in genetics, population genetics, and public health, health care policymakers, and epidemiologists, medical students, and clinicians, particularly those working with minority, vulnerable, or underserved populations.
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.
In the past decade there has been a worldwide evolution in evidence-based medicine that focuses on real-world Comparative Effectiveness Research (CER) to compare the effects of one medical treatment versus another in real world settings. While most of this burgeoning literature has focused on research findings, data and methods, Howard Birnbaum and Paul Greenberg (both of Analysis Group) have edited a book that provides a practical guide to decision making using the results of analysis and interpretation of CER. Decision Making in a World of Comparative Effectiveness contains chapters by senior industry executives, key opinion leaders, accomplished researchers, and leading attorneys involved in resolving disputes in the life sciences industry. The book is aimed at 'users' and 'decision makers' involved in the life sciences industry rather than those doing the actual research. This book appeals to those who commission CER within the life sciences industry (pharmaceutical, biologic, and device manufacturers), government (both public and private payers), as well as decision makers of all levels, both in the US and globally.
Comparative Effectiveness Research (CER) is, by definition, intended to provide evidence that informs real world decision making by physicians and patients in choosing between treatment options. The underlying premise of CER as defined in the health reform law is that such evidence is too often lacking. CER attempts to rectify that by conducting studies that differ in critical ways from many traditional clinical studies. What those differences are, how they will be carried out, and the role of the new Patient Centered Outcomes Research (PCOR) Institute in defining and implementing these approaches will be addressed by some of the nation's leading authorities and decision makers in CER.