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 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. Table of Contents Front Matter Preamble Extending Access to Health Care Containing Health Care Costs Assuring the Quality of Care Financing Reform Improving the Infrastructure for Effective Change Conclusion References

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. Table of Contents Front Matter Summary 1 Introduction 2 Principles for Identifying and Assessing Conflicts of Interest 3 Policies on Conflict of Interest: Overview and Evidence 4 Conflicts of Interest in Biomedical Research 5 Conflicts of Interest in Medical Education 6 Conflicts of Interest and Medical Practice 7 Conflicts of Interest and Development of Clinical Practice Guidelines 8 Institutional Conflicts of Interest 9 Role of Supporting Organizations References Appendix A: Study Activities Appendix B: U.S. Public Health Service Regulations: Objectivity in Research (42 CFR 50) Appendix C: Conflict of Interest in Four Professions: A Comparative Analysis Appendix D: How Psychological Research Can Inform Policies for Dealing with Conflicts of Interest in Medicine Appendix E: The Pathway from Idea to Regulatory Approval: Examples for Drug Development Appendix F: Model for Broader Disclosure Appendix G: Committee Biographies Index

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. Table of Contents FRONT MATTER SUMMARY 1 BACKGROUND AND INTRODUCTION 2 ORIGINS AND EVOLUTION OF EMPLOYMENT-BASED HEALTH BENEFITS 3 EMPLOYMENT-BASED HEALTH BENEFITS TODAY 4 WHATD DOES EMPLOYER MANAGEMENT OF HEALTH BENEFITS INVOLVE? OVERVIEW AND CASE STUDY 5 RISK SELECTION, RISK SHARING, AND POLICY 6 HEALTH CARE COSTS: MORE QUESTIONS THAN ANSWERS 7 FINDINGS AND RECOMMENDATIONS REFERENCES APPENDIXES A OPINION SURVEYS ON EMPLOYMENT-BASED HEALTH BENEFITS AND RELATED ISSUES B REGULATION OF EMPLOYMENT-BASED HEALTH BENEFITS: THE INTERSECTION OF STATE AND FEDERAL LAW C PARTICIPANTS IN MEETINGS HELD IN CONJUNCTION WITH PROJECT D BIOGRAPHIES OF COMMITTEE MEMBERS GLOSSARY AND ACRONYMS INDEX

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.

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. Table of Contents Front Matter Summary 1 Introduction 2 Definition and Monitoring of Disability 3 Disability Trends 4 Health Care Transitions for Young People 5 Secondary Conditions and Aging with Disability 6 The Environmental Context of Disability: The Case of Health Care Facilities 7 Assistive and Mainstream Technologies for People with Disabilities 8 Access to Health Insurance and the Role of Risk-Adjusted Payments to Health Plans 9 Coverage of Assistive Technologies and Personal Assistive Services 10 Organization and Support of Disability Research References Appendix A Study Activities Appendix B Table of Contents for Workshop on Disability in America: A New Look (2006) Appendix C Risk Adjustment of Insurance Premiums in the United States and Implications for People with Disabilities Appendix D The Americans with Disabilities Act in a Health Care Context Appendix E The Employment Discrimination Provisions of the Americans with Disabilities Act: Implementation and Impact Appendix F Access to Telecommunications Technology by Americans with Disabilities: Key Laws and Policies Appendix G Transportation Patterns and Problems of People with Disabilities Appendix H Committee on Disability in America Biographical Sketches Index

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. Table of Contents Front Matter Introduction Summary of Workshop Presentations and Discussions Appendix A Workshop Agenda and Participants Appendix B Conceptual Models of Disability: Past, Present, and Future--Gale Whiteneck Appendix C Defining and Classifying Disability in Children--Rune J. Simeonsson Appendix D How Does the Environment Influence Disability? Examining the Evidence--Julie J. Keysor Appendix E Late-Life Disability Trends: An Overview of Current Evidence--Vicki A. Freedman Appendix F Chronic Disease and Trends in Severe Disability in Working-Age Populations--Jay Bhattacharya, Kavita Choudhry, and Darius Lakdawalla Appendix G Trends in Disability in Early Life--Ruth E. K. Stein Appendix H Aspects of Disability Across the Life Span: Risk Factors for Disability in Late Life--Jack M. Guralnik Appendix I Health Care Transition of Adolescents and Young Adults with Disabilities and Special Health Care Needs: New Perspectives--John Reiss and Robert Gibson Appendix J Secondary Conditions and Disability--Margaret A. Turk Appendix K A User's Perspective on Midlife (Ages 18 to 65) Aging with Disability--June Isaacson Kailes Appendix L Impact of Exercise on Targeted Secondary Conditions--James H. Rimmer and Swati S. Shenoy Appendix M Secondary Conditions with Spinal Cord Injury--William A. Bauman Appendix N Depression as a Secondary Condition in People with Disabilities-Bryan Kemp Appendix O Promoting Health and Preventing Secondary Conditions Among Adults with Developmental Disabilities--Tom Seekins, Meg Traci, Donna Bainbridge, Kathy Humphries, Nancy Cunningham, Rod Brod, and James Sherman Appendix P Biographical Sketches of Workshop Committee and Workshop Presenters

When the end of life makes its inevitable appearance, people should be able to expect reliable, humane, and effective caregiving. Yet too many dying people suffer unnecessarily. While an "overtreated" dying is feared, untreated pain or emotional abandonment are equally frightening. Approaching Death reflects a wide-ranging effort to understand what we know about care at the end of life, what we have yet to learn, and what we know but do not adequately apply. It seeks to build understanding of what constitutes good care for the dying and offers recommendations to decisionmakers that address specific barriers to achieving good care. This volume offers a profile of when, where, and how Americans die. It examines the dimensions of caring at the end of life: Determining diagnosis and prognosis and communicating these to patient and family. Establishing clinical and personal goals. Matching physical, psychological, spiritual, and practical care strategies to the patient's values and circumstances. Approaching Death considers the dying experience in hospitals, nursing homes, and other settings and the role of interdisciplinary teams and managed care. It offers perspectives on quality measurement and improvement, the role of practice guidelines, cost concerns, and legal issues such as assisted suicide. The book proposes how health professionals can become better prepared to care well for those who are dying and to understand that these are not patients for whom "nothing can be done." Table of Contents Front Matter Summary 1 Introduction 2 A Profile of Death and Dying in America 3 Caring at the End of Life 4 The Health Care System and The Dying Patient 5 Accountability and Quality in End-Of-Life-Care 6 Financial and Economic Issues in End-Of-Life Care 7 Legal Issues 8 Educating Clinicians and Other Professionals 9 Directions for Research to Improve Care at the End of Life 10 Conclusions and Recommendations References Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G Appendix H Appendix I Appendix J Index

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. Table of Contents Front Matter Summary 1 Introduction 2 Medical Devices for Infants, Children, and Adolescents 3 Regulatory Framework for Postmarket Surveillance of Medical Devices 4 Identifying and Understanding Adverse Medical Device Events 5 Monitoring of Postmarket Study Commitments Involving Medical Devices 6 Adequacy of Pediatric Postmarket Surveillance Studies 7 Children and Medical Device Safety: A Shared Responsibility References Appendix A Study Origins and Activities Appendix B Medical Devices for Pediatric Care Appendix C The Dynamics of Pediatric Device Innovation: Putting Evidence in Context Appendix D Questions and Methods in Surveillance Programs Appendix E The Regulatory History of Cerebrospinal Fluid Shunts for Hydrocephalus Appendix F Cochlear Implants in Children A Review of Reported Complications, Patterns of Device Failure, and Assessment of Current Approaches to Surveillance Appendix G Glossary and Acronyms Appendix H Committee Biographical Statements Index

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. Table of Contents Front Matter Summary 1. Introduction 2. Patterns of Childhood Death in America 3. Pathways to a Child 4. Communication, Goal Setting, and Care Planning 5. Care and Caring From Diagnosis Through Death and Bereavement 6. Providing, Organizing, and Improving Care 7. Financing of Palliative and End-of-Life Care for Children and Their Families 8. Ethical and Legal Issues 9. Educating Health Care Professionals 10. Directions for Research References Appendix A: Study Origins and Activities Appendix B: Prognostication Scores Appendix C: Assessing Health-Related Quality in End-of-Life Care for Children and Adolescents Appendix D: Cultural Dimensions of Care At Life Appendix E: Bereavement Experiences After the Death of a Child Appendix F: End-of-Life Care in Emergency Medical Services for Children Appendix G: Education in Pediatric Palliative Care Appendix H: Progress in Pediatric Palliative Care in New York State--A Demonstration Project Appendix I: Committee Biographical Statements Index

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. Table of Contents FRONT MATTER SUMMARY 1 INTRODUCTION AND BACKGROUND 2 EVOLUTION AND CURRENT APPLICATIONS OF TELEMEDICINE 3 THE TECHNICAL AND HUMAN CONTEXT OF TELEMEDICINE 4 THE POLICY CONTEXT OF TELEMEDICINE 5 PAST AND CURRENT EVALUATIONS OF TELEMEDICINE 6 A FRAMEWORK FOR PLANNING AND IMPROVING EVALUATIONS OF TELEMEDICINE 7 EVALUATING THE EFFECTS OF TELEMEDICINE ON QUALITY, ACCESS AND COST 8 FINDINGS AND RECOMMENDATIONS REFERENCES APPENDIXES A EXAMPLES OF FEDERAL TELEMEDICINE GRANTS B GLOSSARY AND ABBREVIATIONS C COMMITTEE BIOGRAPHIES INDEX

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. Table of Contents Front Matter Summary 1 Introduction 2 The Necessity and Challenges of Clinical Research Involving Children 3 Regulatory Framework for Protecting Child Participants in Research 4 Defining, Interpreting, and Applying Concepts of Risk and Benefit in Clinical Research Involving Children 5 Understanding and Agreeing to Children's Participation in Clinical Research 6 Payments Related to Children's Participation in Clinical Research 7 Regulatory Compliance, Accreditation, and Quality Improvement 8 Responsible Research Involving Children References Appendix A: Study Origins and Activities Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis Appendix C: Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research Appendix D: Glossary, Acronyms, and Laws and Regulations Appendix E: Committee Biographical Statements Index