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The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

The future of disability in America will depend on how well the U.S. prepares for and manages the demographic, fiscal, and technological developments that will unfold during the next two to three decades. Building upon two prior studies from the Institute of Medicine (the 1991 Institute of Medicine's report Disability in America and the 1997 report Enabling America), The Future of Disability in America examines both progress and concerns about continuing barriers that limit the independence, productivity, and participation in community life of people with disabilities. This book offers a comprehensive look at a wide range of issues, including the prevalence of disability across the lifespan; disability trends the role of assistive technology; barriers posed by health care and other facilities with inaccessible buildings, equipment, and information formats; the needs of young people moving from pediatric to adult health care and of adults experiencing premature aging and secondary health problems; selected issues in health care financing (e.g., risk adjusting payments to health plans, coverage of assistive technology); and the organizing and financing of disability-related research. The Future of Disability in America is an assessment of both principles and scientific evidence for disability policies and services. This book's recommendations propose steps to eliminate barriers and strengthen the evidence base for future public and private actions to reduce the impact of disability on individuals, families, and society.

Beginning in late 2004, the IOM began a project to take a new look at disability in America. It will review developments and progress since the publication of the 1991 and 1997 Institute reports. For technical contracting reasons, the new project was split into two phases. During the limited first phase, a committee appointed by IOM planned and convened a 1-day workshop to examine a subset of topics as background for the second phase of project. As was agreed upon with the sponsor of the workshop, the Centers for Disease Control and Prevention (CDC), the topics were: methodological and policy issues related to the conceptualization, definition, measurement, and monitoring of disability and health over time; trends in the amount, types, and causes of disability; disability across the age spectrum and in the context of normal aging; and secondary health conditions. The phase-one workshop was held in Washington, D.C. on August 1, 2005. Its participants included researchers, clinicians, social service professionals, policy experts, and consumer representatives and advocates. The meeting agenda and list of participants are included in Appendix A. Workshop on Disability in America: A New Look- Summary and Background Papers summarizes the workshop presentations and discussions. The background papers prepared for the workshop are included in Appendixes B through O. Some papers were submitted and circulated in advance of the meeting, whereas others were first presented at the meeting. The analyses, definitions, and views presented in the papers are those of the paper authors and are not necessarily those of the IOM committee. Likewise, the discussion summary is limited to the views of the workshop participants.

Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers'fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

This document is a brief summary of the Institute of Medicine report entitled When Children Die: Improving Palliative and End-of-Life Care for Children. Better care is possible now, but current methods of organizing and financing palliative, end-of-life, and bereavement care complicate the provision and coordination of services to help children and families and sometimes require families to choose between curative or life-prolonging care and palliative services, in particular, hospice care. Inadequate data and scientific knowledge impede efforts to deliver effective care, educate professionals to provide such care, and design supportive public policies. Integrating effective palliative care from the time a child's life-threatening medical problem is diagnosed will improve care for children who survive as well as children who die-and will help the families of all these children. The report recognizes that while much can be done now to support children and families, much more needs to be learned. The analysis and recommendations reflect current knowledge and judgments, but new research and insights will undoubtedly suggest modifications and shifts in emphasis in future years.

The death of a child is a special sorrow. No matter the circumstances, a child's death is a life-altering experience. Except for the child who dies suddenly and without forewarning, physicians, nurses, and other medical personnel usually play a central role in the lives of children who die and their families. At best, these professionals will exemplify'medicine with a heart.'At worst, families'encounters with the health care system will leave them with enduring painful memories, anger, and regrets. When Children Die examines what we know about the needs of these children and their families, the extent to which such needs are—and are not—being met, and what can be done to provide more competent, compassionate, and consistent care. The book offers recommendations for involving child patients in treatment decisions, communicating with parents, strengthening the organization and delivery of services, developing support programs for bereaved families, improving public and private insurance, training health professionals, and more. It argues that taking these steps will improve the care of children who survive as well as those who do not—and will likewise help all families who suffer with their seriously ill or injured child. Featuring illustrative case histories, the book discusses patterns of childhood death and explores the basic elements of physical, emotional, spiritual, and practical care for children and families experiencing a child's life-threatening illness or injury.

Before effective treatments were introduced in the 1950s, tuberculosis was a leading cause of death and disability in the United States. Health care workers were at particular risk. Although the occupational risk of tuberculosis has been declining in recent years, this new book from the Institute of Medicine concludes that vigilance in tuberculosis control is still needed in workplaces and communities. Tuberculosis in the Workplacereviews evidence about the effectiveness of control measuresýsuch as those recommended by the Centers for Disease Control and Preventionýintended to prevent transmission of tuberculosis in health care and other workplaces. It discusses whether proposed regulations from the Occupational Safety and Health Administration would likely increase or sustain compliance with effective control measures and would allow adequate flexibility to adapt measures to the degree of risk facing workers.

This report, which was developed by an expert committee of the Institute of Medicine, reviews the first three services listed above. It is intended to assist policymakers by providing syntheses of the best evidence available about the effectiveness of these services and by estimating the cost to Medicare of covering them. For each service or condition examined, the committee commissioned a review of the scientific literature that was presented and discussed at a public workshop. As requested by Congress, this report includes explicit estimates only of costs to Medicare, not costs to beneficiaries, their families, or others. It also does not include cost-effectiveness analyses. That is, the extent of the benefits relative to the costs to Medicare—or to society generally—is not evaluated for the services examined. The method for estimating Medicare costs follows the generic estimation practices of the Congressional Budget Office (CBO). The objective was to provide Congress with estimates that were based on familiar procedures and could be compared readily with earlier and later CBO estimates. For each condition or service, the estimates are intended to suggest the order of magnitude of the costs to Medicare of extending coverage, but the estimates could be considerably higher or lower than what Medicare might actually spend were coverage policies changed. The estimates cover the five-year period 2000-2004. In addition to the conclusions about specific coverage issues, the report examines some broader concerns about the processes for making coverage decisions and about the research and organizational infrastructure for these decisions. It also briefly examines the limits of coverage as a means of improving health services and outcomes and the limits of evidence as a means of resolving policy and ethical questions.

In a health care environment undergoing major restructuring, health services researchers have an important contribution to make in evaluating the impact of change and in guiding policymakers, clinicians, corporate purchasers, and patients. This book examines the health services research work force and its education. Conclusions focus on the quantity and quality of the work force, prospects for the future, and directions for government policy.

The United States is unique among economically advanced nations in its reliance on employers to provide health benefits voluntarily for workers and their families. Although it is well known that this system fails to reach millions of these individuals as well as others who have no connection to the work place, the system has other weaknesses. It also has many advantages. Because most proposals for health care reform assume some continued role for employers, this book makes an important contribution by describing the strength and limitations of the current system of employment-based health benefits. It provides the data and analysis needed to understand the historical, social, and economic dynamics that have shaped present-day arrangements and outlines what might be done to overcome some of the access, value, and equity problems associated with current employer, insurer, and government policies and practices. Health insurance terminology is often perplexing, and this volume defines essential concepts clearly and carefully. Using an array of primary sources, it provides a store of information on who is covered for what services at what costs, on how programs vary by employer size and industry, and on what governments do—and do not do—to oversee employment-based health programs. A case study adapted from real organizations'experiences illustrates some of the practical challenges in designing, managing, and revising benefit programs. The sometimes unintended and unwanted consequences of employer practices for workers and health care providers are explored. Understanding the concepts of risk, biased risk selection, and risk segmentation is fundamental to sound health care reform. This volume thoroughly examines these key concepts and how they complicate efforts to achieve efficiency and equity in health coverage and health care. With health care reform at the forefront of public attention, this volume will be important to policymakers and regulators, employee benefit managers and other executives, trade associations, and decisionmakers in the health insurance industry, as well as analysts, researchers, and students of health policy.

Guidelines for the clinical practice of medicine have been proposed as the solution to the whole range of current health care problems. This new book presents the first balanced and highly practical view of guidelines—their strengths, their limitations, and how they can be used most effectively to benefit health care. The volume offers: Recommendations and a proposed framework for strengthening development and use of guidelines. Numerous examples of guidelines. A ready-to-use instrument for assessing the soundness of guidelines. Six case studies exploring issues involved when practitioners use guidelines on a daily basis. With a real-world outlook, the volume reviews efforts by agencies and organizations to disseminate guidelines and examines how well guidelines are functioning—exploring issues such as patient information, liability, costs, computerization, and the adaptation of national guidelines to local needs.

This book examines methods for selecting topics and setting priorities for clinical practice guideline development and implementation. Clinical practice guidelines are'systematically defined statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.'In its assessment of processes for setting priorities, the committee considers the principles of consistency with the organization's mission, implementation feasibility, efficiency, utility of the results to the organization, and openness and defensibility—a principle that is especially important to public agencies. The volume also examines the implications of health care restructuring for priority setting and topic selection, including the link between national and local approaches to guidelines development.

Six dental schools have closed in the last decade and others are in jeopardy. Facing this uncertainty about the status of dental education and the continued tension between educators and practitioners, leaders in the profession have recognized the need for purpose and direction. This comprehensive volume—the first to cover the education, research, and patient care missions of dental schools—offers specific recommendations on oral health assessment, access to dental care, dental school curricula, financing for education, research priorities, examinations and licensing, workforce planning, and other key areas. Well organized and accessible, the book: Recaps the evolution of dental practice and education. Reviews key indicators of oral health status, outlines oral health goals, and discusses implications for education. Addresses major curriculum concerns. Examines health services that dental schools provide to patients and communities. Looks at faculty and student involvement in research. Explores the relationship of dental education to the university, the dental profession, and society at large. Accreditation, the dental workforce, and other critical policy issues are highlighted as well. Of greatest interest to deans, faculty, administrators, and students at dental schools, as well as to academic health centers and universities, this book also will be informative for health policymakers, dental professionals, and dental researchers.

The Alberta clinical practice guidelines program is supporting appropriate, effective and quality medical care in Alberta through promotion, development and implementation of evidence-based clinical practice guidelines.

Telemedicine—the use of information and telecommunications technologies to provide and support health care when distance separates the participants—is receiving increasing attention not only in remote areas where health care access is troublesome but also in urban and suburban locations. Yet the benefits and costs of this blend of medicine and digital technologies must be better demonstrated before today's cautious decision-makers invest significant funds in its development. Telemedicine presents a framework for evaluating patient care applications of telemedicine. The book identifies managerial, technical, policy, legal, and human factors that must be taken into account in evaluating a telemedicine program. The committee reviews previous efforts to establish evaluation frameworks and reports on results from several completed studies of image transmission, consulting from remote locations, and other telemedicine programs. The committee also examines basic elements of an evaluation and considers relevant issues of quality, accessibility, and cost of health care. Telemedicine will be of immediate interest to anyone with interest in the clinical application of telemedicine.

This book establishes a framework for assessing health care reform proposals and their implementation. It helps clarify objectives, identifies issues to be addressed in proposals, distinguishes between short- and long-term expectations and achievements, and directs attention to important but sometimes neglected questions about the organization and provision of health care services. In addition, the volume presents a discussion and analysis of issues essential to achieving fundamental goals of health care reform: to maintain and improve health and well-being, to make basic health coverage universal, and to encourage the efficient use of limited resources. The book is a useful resource for anyone developing or assessing options for reform.