Observational Studies in a Learning Health System

Observational Studies in a Learning Health System

Author: A Learning Health System Activity

Publisher: National Academies Press

Published: 2013-12-16

Total Pages: 0

ISBN-13: 9780309290814

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Clinical research strains to keep up with the rapid and iterative evolution of medical interventions, clinical practice innovation, and the increasing demand for information on the clinical effectiveness of these advancements. In response to the growing availability of archived and real-time digital health data and the opportunities this data provides for research, as well as the increasing number of studies using prospectively collected clinical data, the Institute of Medicine\'s Roundtable on Value & Science-Driven Health Care convened a workshop on Observational Studies in a Learning Health System. Participants, including experts from a wide range of disciplines - clinical researchers, statisticians, biostatisticians, epidemiologists, health care informaticians, health care analytics, research funders, health products industry, clinicians, payers, and regulators - explored leading edge approaches to observational studies, charted a course for the use of the growing health data utility, and identified opportunities to advance progress. Workshop speakers and individual participants strove to identify stakeholder needs and barriers to the broader application of observational studies. Observational Studies in a Learning Health Systemis the summary of the workshop. This report explores the role of observational studies in the generation of evidence to guide clinical and health policy decisions. The report discusses concepts of rigorous observational study design and analysis, emerging statistical methods, and opportunities and challenges of observational studies to complement evidence from experimental methods, treatment heterogeneity, and effectiveness estimates tailored toward individual patients.


Observational Studies in a Learning Health System

Observational Studies in a Learning Health System

Author: Observational Studies in a Learning Health System (Workshop)

Publisher:

Published: 2013

Total Pages: 134

ISBN-13:

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"Clinical research strains to keep up with the rapid and iterative evolution of medical interventions, clinical practice innovation, and the increasing demand for information on the clinical effectiveness of these advancements. In response to the growing availability of archived and real-time digital health data and the opportunities this data provides for research, as well as the increasing number of studies using prospectively collected clinical data, the Institute of Medicine's Roundtable on Value & Science-Driven Health Care convened a workshop on Observational Studies in a Learning Health System. Participants, including experts from a wide range of disciplines - clinical researchers, statisticians, biostatisticians, epidemiologists, health care informaticians, health care analytics, research funders, health products industry, clinicians, payers, and regulators - explored leading edge approaches to observational studies, charted a course for the use of the growing health data utility, and identified opportunities to advance progress. Workshop speakers and individual participants strove to identify stakeholder needs and barriers to the broader application of observational studies. Observational Studies in a Learning Health System is the summary of the workshop. This report explores the role of observational studies in the generation of evidence to guide clinical and health policy decisions. The report discusses concepts of rigorous observational study design and analysis, emerging statistical methods, and opportunities and challenges of observational studies to complement evidence from experimental methods, treatment heterogeneity, and effectiveness estimates tailored toward individual patients"--Publisher's description.


The Learning Healthcare System

The Learning Healthcare System

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2007-06-01

Total Pages: 374

ISBN-13: 0309133939

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As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.


Finding What Works in Health Care

Finding What Works in Health Care

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-07-20

Total Pages: 267

ISBN-13: 0309164257

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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.


Clinical Research Informatics

Clinical Research Informatics

Author: Rachel Richesson

Publisher: Springer Science & Business Media

Published: 2012-02-15

Total Pages: 415

ISBN-13: 1848824475

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The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.


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

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

Author: Agency for Health Care Research and Quality (U.S.)

Publisher: Government Printing Office

Published: 2013-02-21

Total Pages: 236

ISBN-13: 1587634236

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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)


Observational Studies

Observational Studies

Author: Paul R. Rosenbaum

Publisher: Springer Science & Business Media

Published: 2013-06-29

Total Pages: 244

ISBN-13: 1475724438

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An observational study is an empirical investigation of the effects of treatments, policies, or exposures. It differes from an experiment in that the investigator cannot control the assignments of treatments to subjects. Scientists across a wide range of disciplines undertake such studies, and the aim of this book is to provide a sound statistical account of the principles and methods for the design and analysis of observational studies. Readers are assumed to have a working knowledge of basic probability and statistics, but otherwise the account is reasonably self-contained. Throughout there are extended discussions of actual observational studies to illustrate the ideas discussed. These are drawn from topics as diverse as smoking and lung cancer, lead in children, nuclear weapons testing, and placement programs for students. As a result, many researchers involved in observational studes will find this an invaluable companion to their work.


Knowing What Works in Health Care

Knowing What Works in Health Care

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2008-05-29

Total Pages: 279

ISBN-13: 0309113563

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There is currently heightened interest in optimizing health care through the generation of new knowledge on the effectiveness of health care services. The United States must substantially strengthen its capacity for assessing evidence on what is known and not known about "what works" in health care. Even the most sophisticated clinicians and consumers struggle to learn which care is appropriate and under what circumstances. Knowing What Works in Health Care looks at the three fundamental health care issues in the United States-setting priorities for evidence assessment, assessing evidence (systematic review), and developing evidence-based clinical practice guidelines-and how each of these contributes to the end goal of effective, practical health care systems. This book provides an overall vision and roadmap for improving how the nation uses scientific evidence to identify the most effective clinical services. Knowing What Works in Health Care gives private and public sector firms, consumers, health care professionals, benefit administrators, and others the authoritative, independent information required for making essential informed health care decisions.


Best Care at Lower Cost

Best Care at Lower Cost

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2013-05-10

Total Pages: 437

ISBN-13: 0309282810

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America's health care system has become too complex and costly to continue business as usual. Best Care at Lower Cost explains that inefficiencies, an overwhelming amount of data, and other economic and quality barriers hinder progress in improving health and threaten the nation's economic stability and global competitiveness. According to this report, the knowledge and tools exist to put the health system on the right course to achieve continuous improvement and better quality care at a lower cost. The costs of the system's current inefficiency underscore the urgent need for a systemwide transformation. About 30 percent of health spending in 2009-roughly $750 billion-was wasted on unnecessary services, excessive administrative costs, fraud, and other problems. Moreover, inefficiencies cause needless suffering. By one estimate, roughly 75,000 deaths might have been averted in 2005 if every state had delivered care at the quality level of the best performing state. This report states that the way health care providers currently train, practice, and learn new information cannot keep pace with the flood of research discoveries and technological advances. About 75 million Americans have more than one chronic condition, requiring coordination among multiple specialists and therapies, which can increase the potential for miscommunication, misdiagnosis, potentially conflicting interventions, and dangerous drug interactions. Best Care at Lower Cost emphasizes that a better use of data is a critical element of a continuously improving health system, such as mobile technologies and electronic health records that offer significant potential to capture and share health data better. In order for this to occur, the National Coordinator for Health Information Technology, IT developers, and standard-setting organizations should ensure that these systems are robust and interoperable. Clinicians and care organizations should fully adopt these technologies, and patients should be encouraged to use tools, such as personal health information portals, to actively engage in their care. This book is a call to action that will guide health care providers; administrators; caregivers; policy makers; health professionals; federal, state, and local government agencies; private and public health organizations; and educational institutions.


Real-World Evidence Generation and Evaluation of Therapeutics

Real-World Evidence Generation and Evaluation of Therapeutics

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-07-05

Total Pages: 103

ISBN-13: 0309455650

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The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.