New drugs, new devices, improved surgical techniques, and innovative diagnostic procedures and equipment emerge rapidly. But development of these technologies has outpaced evaluation of their safety, efficacy, cost-effectiveness, and ethical and social consequences. This volume, which is "strongly recommended" by The New England Journal of Medicine "to all those interested in the future of the practice of medicine," examines how new discoveries can be translated into better care, and how the current system's inefficiencies prevent effective health care delivery. In addition, the book offers detailed profiles of 20 organizations currently involved in medical technology assessment, and proposes ways to organize U.S. efforts and create a coordinated national system for evaluating new medical treatments and technology.
New drugs, new devices, improved surgical techniques, and innovative diagnostic procedures and equipment emerge rapidly. But development of these technologies has outpaced evaluation of their safety, efficacy, cost-effectiveness, and ethical and social consequences. This volume, which is "strongly recommended" by The New England Journal of Medicine "to all those interested in the future of the practice of medicine," examines how new discoveries can be translated into better care, and how the current system's inefficiencies prevent effective health care delivery. In addition, the book offers detailed profiles of 20 organizations currently involved in medical technology assessment, and proposes ways to organize U.S. efforts and create a coordinated national system for evaluating new medical treatments and technology.
The problem of deciding which health care technologies to evaluate is urgent. With new technologies proliferating alongside steadily increasing health care costs, it is critical to discriminate among technologies to direct tests and treatments at those who can benefit the most. Given the vast number of clinical problems and technologies to be evaluated, the many months of work required to study just one problem, and the relatively few clinicians with highly developed analytic skills, institutions must set priorities for assessment. This book sets forth criteria and a method that can be used by public agencies such as the Office of Health Technology Assessment (in the U.S. Public Health Service) and by any private organization conducting such work to decide which technologies to assess or reassess.
The outlook for women with breast cancer has improved in recent years. Due to the combination of improved treatments and the benefits of mammography screening, breast cancer mortality has decreased steadily since 1989. Yet breast cancer remains a major problem, second only to lung cancer as a leading cause of death from cancer for women. To date, no means to prevent breast cancer has been discovered and experience has shown that treatments are most effective when a cancer is detected early, before it has spread to other tissues. These two facts suggest that the most effective way to continue reducing the death toll from breast cancer is improved early detection and diagnosis. Building on the 2001 report Mammography and Beyond, this new book not only examines ways to improve implementation and use of new and current breast cancer detection technologies but also evaluates the need to develop tools that identify women who would benefit most from early detection screening. Saving Women's Lives: Strategies for Improving Breast Cancer Detection and Diagnosis encourages more research that integrates the development, validation, and analysis of the types of technologies in clinical practice that promote improved risk identification techniques. In this way, methods and technologies that improve detection and diagnosis can be more effectively developed and implemented.
Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.
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.
The nation's health care system has changed dramatically and the country is debating further significant changes. Comprehensive information is needed to guide policymakers in understanding and evaluating the current problems and in formulating federal health care policy. This book contains an evaluation of the plan developed by the National Center for Health Statistics for restructuring its existing provider surveys. It identifies current and future data needed by researchers and policymakers to assess the effect of changes in financing, organization, and delivery of health care on access, quality, costs, and outcomes of care and determines the extent to which the design and content of the proposed survey can meet these data needs. The book goes beyond a simple review and recommends a design framework to develop a coordinated and integrated data system to gather information about people and their illness over time and to link this information to costs and health care outcomes.
What information and decision-making processes determine how and whether an experimental medical technology becomes accepted and used? Adopting New Medical Technology reviews the strengths and weaknesses of present coverage and adoption practices, highlights opportunities for improving both the decision-making processes and the underlying information base, and considers approaches to instituting a much-needed increase in financial support for evaluative research. Essays explore the nature of technological change; the use of technology assessment in decisions by health care providers and federal, for-profit, and not-for-profit payers; the role of the courts in determining benefits coverage; strengthening the connections between evaluative research and coverage decision-making; manufacturers' responses to the increased demand for outcomes research; and the implications of health care reform for technology policy.
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Approximately 4 million U.S. service members took part in the wars in Afghanistan and Iraq. Shortly after troops started returning from their deployments, some active-duty service members and veterans began experiencing mental health problems. Given the stressors associated with war, it is not surprising that some service members developed such mental health conditions as posttraumatic stress disorder, depression, and substance use disorder. Subsequent epidemiologic studies conducted on military and veteran populations that served in the operations in Afghanistan and Iraq provided scientific evidence that those who fought were in fact being diagnosed with mental illnesses and experiencing mental healthâ€"related outcomesâ€"in particular, suicideâ€"at a higher rate than the general population. This report provides a comprehensive assessment of the quality, capacity, and access to mental health care services for veterans who served in the Armed Forces in Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn. It includes an analysis of not only the quality and capacity of mental health care services within the Department of Veterans Affairs, but also barriers faced by patients in utilizing those services.
The Patient Protection and Affordable Care Act (herein known as the Affordable Care Act [ACA]) was signed into law on March 23, 2010. Several provisions of the law went into effect in 2010 (including requirements to cover children up to age 26 and to prohibit insurance companies from denying coverage based on preexisting conditions for children). Other provisions will go into effect during 2014, including the requirement for all individuals to purchase health insurance. In 2014, insurance purchasers will be allowed, but not obliged, to buy their coverage through newly established health insurance exchanges (HIEs)-marketplaces designed to make it easier for customers to comparison shop among plans and for low and moderate income individuals to obtain public subsidies to purchase private health insurance. The exchanges will offer a choice of private health plans, and all plans must include a standard core set of covered benefits, called essential health benefits (EHBs). The Department of Health and Human Services requested that the Institute of Medicine (IOM) recommend criteria and methods for determining and updating the EHBs. In response, the IOM convened two workshops in 2011 where experts from federal and state government, as well as employers, insurers, providers, consumers, and health care researchers were asked to identify current methods for determining medical necessity, and share decision-making approaches to determining which benefits would be covered and other benefit design practices. Essential Health Benefits summarizes the presentations in this workshop. The committee's recommendations will be released in a subsequent report.
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
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.
Each year more than 180,000 new cases of breast cancer are diagnosed in women in the U.S. If cancer is detected when small and local, treatment options are less dangerous, intrusive, and costly-and more likely to lead to a cure. Yet those simple facts belie the complexity of developing and disseminating acceptable techniques for breast cancer diagnosis. Even the most exciting new technologies remain clouded with uncertainty. Mammography and Beyond provides a comprehensive and up-to-date perspective on the state of breast cancer screening and diagnosis and recommends steps for developing the most reliable breast cancer detection methods possible. This book reviews the dramatic expansion of breast cancer awareness and screening, examining the capabilities and limitations of current and emerging technologies for breast cancer detection and their effectiveness at actually reducing deaths. The committee discusses issues including national policy toward breast cancer detection, roles of public and private agencies, problems in determining the success of a technique, availability of detection methods to specific populations of women, women's experience during the detection process, cost-benefit analyses, and more. Examining current practices and specifying research and other needs, Mammography and Beyond will be an indispensable resource to policy makers, public health officials, medical practitioners, researchers, women's health advocates, and concerned women and their families.
This is the first part of an in-depth study focusing on medical liability and its effect on access to and delivery of obstetrical care. The book addresses such questions as: Do liability concerns impede the use of new technologies? Have liability issues affected the physician-patient relationship? Are community health and maternity centers being harmed? What specific remedies are being considered and what are their prospects for success?
Advances in genetics and genomics are transforming medical practice, resulting in a dramatic growth of genetic testing in the health care system. The rapid development of new technologies, however, has also brought challenges, including the need for rigorous evaluation of the validity and utility of genetic tests, questions regarding the best ways to incorporate them into medical practice, and how to weigh their cost against potential short- and long-term benefits. As the availability of genetic tests increases so do concerns about the achievement of meaningful improvements in clinical outcomes, costs of testing, and the potential for accentuating medical care inequality. Given the rapid pace in the development of genetic tests and new testing technologies, An Evidence Framework for Genetic Testing seeks to advance the development of an adequate evidence base for genetic tests to improve patient care and treatment. Additionally, this report recommends a framework for decision-making regarding the use of genetic tests in clinical care.
In 2010, an estimated 50 million people were uninsured in the United States. A portion of the uninsured reflects unemployment rates; however, this rate is primarily a reflection of the fact that when most health plans meet an individual's needs, most times, those health plans are not affordable. Research shows that people without health insurance are more likely to experience financial burdens associated with the utilization of health care services. But even among the insured, underinsurance has emerged as a barrier to care. The Patient Protection and Affordable Care Act (ACA) has made the most comprehensive changes to the provision of health insurance since the development of Medicare and Medicaid by requiring all Americans to have health insurance by 2016. An estimated 30 million individuals who would otherwise be uninsured are expected to obtain insurance through the private health insurance market or state expansion of Medicaid programs. The success of the ACA depends on the design of the essential health benefits (EHB) package and its affordability. Essential Health Benefits recommends a process for defining, monitoring, and updating the EHB package. The book is of value to Assistant Secretary for Planning and Evaluation (ASPE) and other U.S. Department of Health and Human Services agencies, state insurance agencies, Congress, state governors, health care providers, and consumer advocates.
The new Agency for Health Care Policy and Research in the U.S. Public Health Service is funding a set of multidisciplinary groups called Patient Outcomes Research Teams (PORTs). Their purpose is to assess alternative treatments for medical conditions using a variety of outcome measures. In guiding insurance coverage, these PORTs are expected to wield considerable influence on medical practice and health policy. This book addresses possible threats to their credibility that might be based on real or apparent conflicts of interest, including both financial and other conflicts. It raises points to consider for the new agency, for PORTs and their institutions, for industry, for the health services research community, and for the U.S. Congress in avoiding and managing conflicts of interest.
In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.
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