Decision Making in a World of Comparative Effectiveness Research

Decision Making in a World of Comparative Effectiveness Research PDF Author: Howard G. Birnbaum
Publisher: Springer
ISBN: 9811032629
Category : Medical
Languages : en
Pages : 289

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Book Description
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.

Decision Making in a World of Comparative Effectiveness Research

Decision Making in a World of Comparative Effectiveness Research PDF Author: Howard G. Birnbaum
Publisher: Springer
ISBN: 9811032629
Category : Medical
Languages : en
Pages : 289

Get Book Here

Book Description
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.

Applying Comparative Effectiveness Data to Medical Decision Making

Applying Comparative Effectiveness Data to Medical Decision Making PDF Author: Carl Asche
Publisher: Springer
ISBN: 3319233297
Category : Medical
Languages : en
Pages : 116

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Book Description
This textbook introduces students to the basic concepts and methods used to measure and compare the expected benefits, risks and cost of preventive and therapeutic medical interventions. It provides an easily accessible overview of comparative effectiveness and its practical applications to daily medical decisions. The book includes learning objectives for each topic, definitions of key terms and topic summaries. Each chapter is written by a highly regarded academic and extensive reference is made throughout to other sources of literature where the interested reader can find further details. The book considers, among other topics, evidence based medicine and the role of comparative effectiveness research in the development of medical guidelines, bias and confounding, quality of life, randomized controlled trials, analyses of retrospective databases, screening and economic evaluation. The book is intended to serve as a “what is it?”, “why do we need it?” and “how does it or could it effect positive change in health care?” rather than just a “how to?” technical overview. As such, it provides an essential resource for both under- and post-graduate students in health sciences.

Initial National Priorities for Comparative Effectiveness Research

Initial National Priorities for Comparative Effectiveness Research PDF 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.

Finding What Works in Health Care

Finding What Works in Health Care PDF 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.

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

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

What is Comparative Effectiveness Research and what Will it Mean for Patients, Physicians, and Payors?

What is Comparative Effectiveness Research and what Will it Mean for Patients, Physicians, and Payors? PDF Author: Raj Sabharwal
Publisher:
ISBN:
Category :
Languages : en
Pages : 13

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Book Description
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.

Methods in Comparative Effectiveness Research

Methods in Comparative Effectiveness Research PDF Author: Constantine Gatsonis
Publisher: CRC Press
ISBN: 1466511974
Category : Mathematics
Languages : en
Pages : 575

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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.

Examining the Impact of Real-World Evidence on Medical Product Development

Examining the Impact of Real-World Evidence on Medical Product Development PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030948832X
Category : Medical
Languages : en
Pages : 231

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Book Description
Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

The Science of Health Disparities Research

The Science of Health Disparities Research PDF 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.

Understanding Health Outcomes and Pharmacoeconomics

Understanding Health Outcomes and Pharmacoeconomics PDF Author: George E. MacKinnon III
Publisher: Jones & Bartlett Publishers
ISBN: 1449673945
Category : Medical
Languages : en
Pages : 241

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Book Description
Understanding Health Outcomes and Pharmacoeconomics presents an overview of the tools used to assess patient-related health status including associated health outcomes and the analyses that are used to determine cost-effectiveness in evaluating pharmacotherapeutic interventions to improve health. Including data and examples from several different countries, this comprehensive text will help students understand the basis for decisions made at the local and governmental level that impact the use of pharmaceuticals and provide a strong foundation for understanding the principles used in cost-effective decision making. With commentaries, cases studies, and highlighting international differences, this text concludes with a discussion of the need for a universal system for documenting medication use. Understanding Health Outcomes and Pharmacoeconomics provides definitions of comparative effectiveness research (CER) and comparisons of pharmacoeconomic models (including cost-effectivess, cost-benefit, and cost utility analyses). This inclusive text provides describes how CER is linked to various pharmacoeconomic models by providing examples from clinical trials with comparative pharmacotherapy and cost parameters. From the Introduction: "The need for interprofessional education was made apparent in the 2003 Health Professions Education: A Bridge to Quality report. All healthcare professionals must be educated to deliver patient-centered care as members of an interprofessional team, emphasizing evidence-based practice, quality improvement approaches, and informatics. An enhanced understanding of pharmacoeconomic principles is a step in the right direction for healthcare practitioners as we do our best to ensure optimal medication therapy outcomes for patients and society at-large." -- George E. MacKinnon III, PhD, RPh, FASHP