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.
Telemedicineâ€"the use of information and telecommunications technologies to provide and support health care when distance separates the participantsâ€"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.
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.
The U.S. health care system is in a state of flux, and changes currently under way seem capable of exerting sizable effects on medical innovation. This volume explores how the rapid transition to managed care might affect the rate and direction of medical innovation. The experience with technological change in medicine in other nations whose health care systems have "single-payer" characteristics is thoroughly examined. Technology and Health Care in an Era of Limits examines how financing and care delivery strategies affect the decisions made by hospital administrators and physicians to adopt medical technologies. It also considers the patient's stake in the changing health care economy and the need for a stronger independent contribution of patients to the choice of technology used in their care. Finally, the volume explores the impact of changes in the demand for medical technology in pharmaceutical, medical device, and surgical procedure innovation.
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.
Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
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.
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.
Every patient is unique, and the evolving field of precision medicine aims to ensure the delivery of the right treatment to the right patient at the right time. In an era of rapid advances in biomedicine and enhanced understanding of the genetic basis of disease, health care providers increasingly have access to advanced technologies that may identify molecular variations specific to an individual patient, which subsequently can be targeted for treatment. Known as biomarker tests for molecularly targeted therapies, these complex tests have the potential to enable the selection of the most beneficial treatment (and also to identify treatments that may be harmful or ineffective) for the molecular underpinnings of an individual patient's disease. Such tests are key to unlocking the promise of precision medicine. Biomarker tests for molecularly targeted therapies represent a crucial area of focus for developing methods that could later be applicable to other areas of precision medicine. The appropriate regulatory oversight of these tests is required to ensure that they are accurate, reliable, properly validated, and appropriately implemented in clinical practice. Moreover, common evidentiary standards for assessing the beneficial impact of biomarker-guided therapy selection on patient outcomes, as well as the effective collection and sharing of information related to those outcomes, are urgently needed to better inform clinical decision making. Biomarker Tests of Molecularly Targeted Therapies examines opportunities for and challenges to the use of biomarker tests to select optimal therapy and offers recommendations to accelerate progress in this field. This report explores regulatory issues, reimbursement issues, and clinical practice issues related to the clinical development and use of biomarker tests for targeting therapies to patients. Properly validated, appropriately implemented biomarker tests hold the potential to enhance patient care and improve outcomes, and therefore addressing the challenges facing such tests is critical.
Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
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 guidelinesâ€"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 functioningâ€"exploring issues such as patient information, liability, costs, computerization, and the adaptation of national guidelines to local needs.
The U.S. Census Bureau has reported that 56.7 million Americans had some type of disability in 2010, which represents 18.7 percent of the civilian noninstitutionalized population included in the 2010 Survey of Income and Program Participation. The U.S. Social Security Administration (SSA) provides disability benefits through the Social Security Disability Insurance (SSDI) program and the Supplemental Security Income (SSI) program. As of December 2015, approximately 11 million individuals were SSDI beneficiaries, and about 8 million were SSI beneficiaries. SSA currently considers assistive devices in the nonmedical and medical areas of its program guidelines. During determinations of substantial gainful activity and income eligibility for SSI benefits, the reasonable cost of items, devices, or services applicants need to enable them to work with their impairment is subtracted from eligible earnings, even if those items or services are used for activities of daily living in addition to work. In addition, SSA considers assistive devices in its medical disability determination process and assessment of work capacity. The Promise of Assistive Technology to Enhance Activity and Work Participation provides an analysis of selected assistive products and technologies, including wheeled and seated mobility devices, upper-extremity prostheses, and products and technologies selected by the committee that pertain to hearing and to communication and speech in adults.
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.
A significant medical event is expected in 1992: the first human use of a fully implantable, long-term cardiac assist device. This timely volume reviews the artificial heart program-and in particular, the National Institutes of Health's major investment-raising important questions. The volume includes: Consideration of the artificial heart versus heart transplantation and other approaches to treating end-stage heart disease, keeping in mind the different outcomes and costs of these treatments. A look at human issues, including the number of people who may require the artificial heart, patient quality of life, and other ethical and societal questions. Examination of how this technology's use can be targeted most appropriately. Attention to achieving access to this technology for all those who can benefit from it. The committee also offers three mechanisms to aid in allocating research and development funds.
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.
Introduction -- The Veterans Health Administration -- The Veterans Health Administration's Mental Health Services -- Clinical management of mental health conditions at the Veterans Health Administration -- Methodology -- Department of Veteran's Affairs mental health services: need, usage, and access and barriers to care -- Dimensions of quality in mental health care -- Mental health workforce and facilities infrastructure -- Timely access to mental health care -- Patient-centered care and the veteran experience -- Effective mental health care -- Efficient mental health care -- Equitable mental health care -- Health technology for mental health care -- Quality management -- Findings, conclusions, and recommendations -- Appendices. Supporting the documentation for the survey -- Supporting documentation for the site visits: questionnaires and NVivo codes.
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.
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.
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.
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