Recent scientific and technological advances have accelerated our understanding of the causes of disease development and progression, and resulted in innovative treatments and therapies. Ongoing work to elucidate the effects of individual genetic variation on patient outcomes suggests the rapid pace of discovery in the biomedical sciences will only accelerate. However, these advances belie an important and increasing shortfall between the expansion in therapy and treatment options and knowledge about how these interventions might be applied appropriately to individual patients. The impressive gains made in Americans' health over the past decades provide only a preview of what might be possible when data on treatment effects and patient outcomes are systematically captured and used to evaluate their effectiveness. Needed for progress are advances as dramatic as those experienced in biomedicine in our approach to assessing clinical effectiveness. In the emerging era of tailored treatments and rapidly evolving practice, ensuring the translation of scientific discovery into improved health outcomes requires a new approach to clinical evaluation. A paradigm that supports a continual learning process about what works best for individual patients will not only take advantage of the rigor of trials, but also incorporate other methods that might bring insights relevant to clinical care and endeavor to match the right method to the question at hand. The Institute of Medicine Roundtable on Value & Science-Driven Health Care's vision for a learning healthcare system, in which evidence is applied and generated as a natural course of care, is premised on the development of a research capacity that is structured to provide timely and accurate evidence relevant to the clinical decisions faced by patients and providers. As part of the Roundtable's Learning Healthcare System series of workshops, clinical researchers, academics, and policy makers gathered for the workshop "Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches." Participants explored cutting-edge research designs and methods and discussed strategies for development of a research paradigm to better accommodate the diverse array of emerging data resources, study designs, tools, and techniques. Presentations and discussions are summarized in this volume.

Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. As part of its Learning Health System Series, the Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss expanding the access to and use of clinical data as a foundation for care improvement. Table of Contents Front Matter Summary 1 Clinical Data as the Basic Staple of the Learning Health System 2 U.S. Healthcare Data Today: Current State of Play 3 Changing the Terms: Data System Transformation in Progress 4 Healthcare Data: Public Good or Private Property? 5 Healthcare Data as a Public Good: Privacy and Security 6 Creating a Next-Generation Data Utility: Building Blocks and the Action Agenda 7 Engaging the Public 8 Clinical Data as the Basic Staple of Health Learning: Ideas for Action Appendixes Appendix A: Workshop Agenda Appendix B: Biographical Sketches of Workshop Participants Appendix C: Workshop Attendee List Appendix D: The IOM Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule Other Publications in the Learning Healthcare System Series

The United States has the highest per capita spending on health care of any industrialized nation. Yet despite the unprecedented levels of spending, harmful medical errors abound, uncoordinated care continues to frustrate patients and providers, and U.S. healthcare costs continue to increase. The growing ranks of the uninsured, an aging population with a higher prevalence of chronic diseases, and many patients with multiple conditions together constitute more complicating factors in the trend to higher costs of care. A variety of strategies are beginning to be employed throughout the health system to address the central issue of value, with the goal of improving the net ratio of benefits obtained per dollar spent on health care. However, despite the obvious need, no single agreed-upon measure of value or comprehensive, coordinated systemwide approach to assess and improve the value of health care exists. Without this definition and approach, the path to achieving greater value will be characterized by encumbrance rather than progress. To address the issues central to defining, measuring, and improving value in health care, the Institute of Medicine convened a workshop to assemble prominent authorities on healthcare value and leaders of the patient, payer, provider, employer, manufacturer, government, health policy, economics, technology assessment, informatics, health services research, and health professions communities. The workshop, summarized in this volume, facilitated a discussion of stakeholder perspectives on measuring and improving value in health care, identifying the key barriers and outlining the opportunities for next steps.

Creating an environment in which children in the United States grow up healthy should be a high priority for the nation. Yet the prevailing pattern of food and beverage marketing to children in America represents, at best, a missed opportunity, and at worst, a direct threat to the health prospects of the next generation. Children's dietary and related health patterns are shaped by the interplay of many factors?their biologic affinities, their culture and values, their economic status, their physical and social environments, and their commercial media environments?all of which, apart from their genetic predispositions, have undergone significant transformations during the past three decades. Among these environments, none have more rapidly assumed central socializing roles among children and youth than the media. With the growth in the variety and the penetration of the media have come a parallel growth with their use for marketing, including the marketing of food and beverage products. What impact has food and beverage marketing had on the dietary patterns and health status of American children? The answer to this question has the potential to shape a generation and is the focus of Food Marketing to Children and Youth. This book will be of interest to parents, federal and state government agencies, educators and schools, health care professionals, industry companies, industry trade groups, media, and those involved in community and consumer advocacy. Table of Contents Front Matter Executive Summary 1 Setting the Stage 2 Health, Diet, and Eating Patterns of Children and Youth 3 Factors Shaping Food and Beverage Consumption of Children and Youth 4 Food and Beverage Marketing to Children and Youth 5 Influence of Marketing on the Diets and Diet- Related Health of Children and Youth 6 Public Policy Issues in Food and Beverage Marketing to Children and Youth 7 Findings, Recommendations, Next Steps A Acronyms B Glossary C Literature Review Appendix D Chapter 2 Appendix Appendix E Chapter 4 Appendix Appendix F Chapter 5 Appendix Appendix G Chapter 6 Appendix Appendix H Workshop Program Appendix I Biographical Sketches of Committee Members and Staff Index

This volume reports on discussions among multiple stakeholders about ways they might help transform health care in the United States. The U.S. healthcare system consists of a complex network of decentralized and loosely associated organizations, services, relationships, and participants. Each of the healthcare system's component sectors--patients, healthcare professionals, healthcare delivery organizations, healthcare product developers, clinical investigators and evaluators, regulators, insurers, employers and employees, and individuals involved in information technology--conducts activities that support a common goal: to improve patient health and wellbeing. Implicit in this goal is the commitment of each stakeholder group to contribute to the evidence base for health care, that is, to assist with the development and application of information about the efficacy, safety, effectiveness, value, and appropriateness of the health care delivered.

Risk assessment is a highly important activity of numerous governmental health and regulatory bodies. It is on the accuracy of quantitative and qualitative measurement that the decisions of government policymakers depend. Those decisions, of course, are intended to manage risks. That management frequently involves regulations over a wide range of individual and environmental exposures. Bailar and his colleagues examine the methodological challenges faced by federal agencies involved in risk assessment and the sometimes controversial implications and consequences of methodological considerations. The authors query how, given a choice of methods, one is chosen; the role that method-related issues and problems may have in the acceptance of risk assessment findings; and what impact the controversies regarding methods have on the role of risk assessment in overall risk management.

Ten hazards, as assessed by a range of federal agencies with a variety of assessment methods, give topicality and specificity to the analysis. Among the risks addressed are ethylene dibromide, formaldehyde, passive smoking, and the use of mammography for breast cancer screening. The authors conclude with a setting of priorities for risk assessment because risks to human health clearly outstrip resources available for accurate assessment.