Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide PDF Download

Author: Agency for Health Care Research and Quality (U.S.)
Publisher: Government Printing Office
ISBN: 1587634236
Category : Medical
Languages : en
Pages : 236

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Book Description
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)

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309164257
Category : Medical
Languages : en
Pages : 267

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Book Description
Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309138361
Category : Medical
Languages : en
Pages : 252

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Book Description
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.

Author: U. S. Department of Health and Human Services
Publisher: Createspace Independent Pub
ISBN: 9781484997062
Category : Medical
Languages : en
Pages : 226

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Book Description
The Agency for Healthcare Research and Quality (AHRQ) commissioned the RTI International–University of North Carolina at Chapel Hill (RTI-UNC) Evidence-based Practice Center (EPC) to explore how systematic review groups have dealt with clinical heterogeneity and to seek out best practices for addressing clinical heterogeneity in systematic reviews (SRs) and comparative effectiveness reviews (CERs). Such best practices, to the extent they exist, may enable AHRQ's EPCs to address critiques from patients, clinicians, policymakers, and other proponents of health care about the extent to which “average” estimates of the benefits and harms of health care interventions apply to individual patients or to small groups of patients sharing similar characteristics. Such users of reviews often assert that EPC reviews typically focus on broad populations and, as a result, often lack information relevant to patient subgroups that are of particular concern to them. More important, even when EPCs evaluate literature on homogeneous groups, there may be varying individual treatment for no apparent reason, indicating that average treatment effect does not point to the best treatment for any given individual. Thus, the health care community is looking for better ways to develop information that may foster better medical care at a “personal” or “individual” level. To address our charge for this methods project, the EPC set out to answer six key questions (KQ). Key questions for methods report on clinical heterogeneity include: 1. What is clinical heterogeneity? a. How has it been defined by various groups? b. How is it distinct from statistical heterogeneity? c. How does it fit with other issues that have been addressed by the AHRQ Methods Manual for CERs? 2. How have systematic reviews dealt with clinical heterogeneity in the key questions? a. What questions have been asked? b. How have they pre-identified population subgroups with common clinical characteristics that modify their intervention-outcome association? c. What are best practices in key questions and how these subgroups have been identified? 3. How have systematic reviews dealt with clinical heterogeneity in the review process? a. What do guidance documents of various systematic review groups recommend? b. How have EPCs handled clinical heterogeneity in their reviews? c. What are best practices in searching for and interpreting results for particular subgroups with common clinical characteristics that may modify their intervention-outcome association? 4. What are critiques in how systematic reviews handle clinical heterogeneity? a. What are critiques from specific reviews (peer and public) on how EPCs handled clinical heterogeneity? b. What general critiques (in the literature) have been made against how systematic reviews handle clinical heterogeneity? 5. What evidence is there to support how to best address clinical heterogeneity in a systematic review? 6. What questions should an EPC work group on clinical heterogeneity address? Heterogeneity (of any type) in EPC reviews is important because its appearance suggests that included studies differed on one or more dimensions such as patient demographics, study designs, coexisting conditions, or other factors. EPCs then need to clarify for clinical and other audiences, collectively referred to as stakeholders, what are the potential causes of the heterogeneity in their results. This will allow the stakeholders to understand whether and to what degree they can apply this information to their own patients or constituents. Of greatest importance for this project was clinical heterogeneity, which we define as the variation in study population characteristics, coexisting conditions, cointerventions, and outcomes evaluated across studies included in an SR or CER that may influence or modify the magnitude of the intervention measure of effect (e.g., odds ratio, risk ratio, risk difference).

Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 1119413419
Category : Medical
Languages : en
Pages : 1220

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Book Description
Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.

Author: Constantine Gatsonis
Publisher: CRC Press
ISBN: 1351659456
Category : Mathematics
Languages : en
Pages : 634

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Book Description
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.

Author: Marthe R. Gold
Publisher: Oxford University Press
ISBN: 0199880425
Category : Medical
Languages : en
Pages : 450

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Book Description
A unique, in-depth discussion of the uses and conduct of cost-effectiveness analyses (CEAs) as decision-making aids in the health and medical fields, this volume is the product of over two years of comprehensive research and deliberation by a multi-disciplinary panel of economists, ethicists, psychometricians, and clinicians. Exploring cost-effectiveness in the context of societal decision-making for resource allocation purposes, this volume proposes that analysts include a "reference-case" analysis in all CEAs designed to inform resource allocation and puts forth the most explicit set of guidelines (together with their rationale) ever defined on the conduct of CEAs. Important theoretical and practical issues encountered in measuring costs and effectiveness, evaluating outcomes, discounting, and dealing with uncertainty are examined in separate chapters. Additional chapters on framing and reporting of CEAs elucidate the purpose of the analysis and the effective communication of its findings. Cost-Effectiveness in Health and Medicine differs from the available literature in several key aspects. Most importantly, it represents a consensus on standard methods--a feature integral to a CEA, whose principal goal is to permit comparisons of the costs and health outcomes of alternative ways of improving health. The detailed level at which the discussion is offered is another major distinction of this book, since guidelines in journal literature and in CEA-related books tend to be rather general--to the extent that the analyst is left with little guidance on specific matters. The focused overview of the theoretical background underlying areas of controversy and of methodological alternatives, and, finally, the accessible writing style make this volume a top choice on the reading lists of analysts in medicine and public health who wish to improve practice and comparability of CEAs. The book will also appeal to decision-makers in government, managed care, and industry who wish to consider the uses and limitations of CEAs.

Author: Andrew R. Willan
Publisher: John Wiley & Sons
ISBN: 0470856270
Category : Mathematics
Languages : en
Pages : 210

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Book Description
The statistical analysis of cost-effectiveness data is becoming increasingly important within health and medical research. Statistical Analysis of Cost-Effectiveness Data provides a practical book that synthesises the huge amount of research that has taken place in the area over the last two decades. Comprising an up-to-date overview of the statistical analysis of cost-effectiveness data, the book is supported by numerous worked examples from the author’s own experience. It has been written in a style suitable for medical statisticians and health care professionals alike. Key features include: an overview of statistical methods used in the analysis of cost-effectiveness data. coverage of Bayesian methodology. illustrated throughout by worked examples using real data. suitability for health care professionals with limited statistical knowledge. discussion of software used for data analysis. An essential reference for biostatisticians and health economists engaged in cost-effectiveness analysis of health-care interventions, both in academia and industry. Also of interest to graduate students of biostatistics, public health and economics.

Author: Irene Dankwa-Mullan
Publisher: John Wiley & Sons
ISBN: 1119374812
Category : Science
Languages : en
Pages : 548

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Book Description
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.

Author: Alastair Gray
Publisher: Oxford University Press, USA
ISBN: 0199227284
Category : Business & Economics
Languages : en
Pages : 326

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Book Description
This book provides the reader with a comprehensive set of instructions and examples of how to perform an economic evaluation of a health intervention, focusing solely on cost-effectiveness analysis in healthcare.