Implementing And Evaluating Genomic Screening Programs In Health Care Systems
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National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health Publisher : National Academies Press Page : 151 pages File Size : 49,8 Mb Release : 2018-06-16 Category : Medical ISBN : 9780309473415
Implementing and Evaluating Genomic Screening Programs in Health Care Systems by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health Pdf
Genomic applications are being integrated into a broad range of clinical and research activities at health care systems across the United States. This trend can be attributed to a variety of factors, including the declining cost of genome sequencing and the potential for improving health outcomes and cutting the costs of care. The goals of these genomics-based programs may be to identify individuals with clinically actionable variants as a way of preventing disease, providing diagnoses for patients with rare diseases, and advancing research on genetic contributions to health and disease. Of particular interest are genomics- based screening programs, which will, in this publication, be clinical screening programs that examine genes or variants in unselected populations in order to identify individuals who are at an increased risk for a particular health concern (e.g., diseases, adverse drug outcomes) and who might benefit from clinical interventions. On November 1, 2017, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop to explore the challenges and opportunities associated with integrating genomics-based screening programs into health care systems. This workshop was developed as a way to explore the challenges and opportunities associated with integrating genomics-based programs in health care systems in the areas of evidence collection, sustainability, data sharing, infrastructure, and equity of access. This publication summarizes the presentations and discussions from the workshop.
Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health
Author : Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health Publisher : National Academies Press Page : 116 pages File Size : 45,6 Mb Release : 2015-07-08 Category : Medical ISBN : 9780309371155
Genomics-Enabled Learning Health Care Systems by Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health Pdf
The inclusion of genomic data in a knowledge-generating health care system infrastructure is one promising way to harness the full potential of that information to provide better patient care. In such a system, clinical practice and research influence each other with the goal of improving the efficiency and effectiveness of disease prevention, diagnosis, and treatment. To examine pragmatic approaches to incorporating genomics in learning health care systems, the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health hosted a workshop which convened a variety of stakeholder groups, including commercial developers, health information technology professionals, clinical providers, academic researchers, patient groups, and government and health system representatives, to present their perspectives and participate in discussions on maximizing the value that can be obtained from genomic information. The workshop examined how a variety of systems are capturing and making use of genomic data to generate knowledge for advancing health care in the 21st century. It also sought to evaluate the challenges, opportunities, and best practices for capturing or using genomic information in knowledge-generating health care systems. Genomics-Enabled Learning Health Care Systems summarizes the presentations and discussion of the workshop.
National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on the Health of Select Populations,Committee on the Evidence Base for Genetic Testing
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on the Health of Select Populations,Committee on the Evidence Base for Genetic Testing Publisher : National Academies Press Page : 149 pages File Size : 50,7 Mb Release : 2017-04-21 Category : Medical ISBN : 9780309453295
An Evidence Framework for Genetic Testing by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on the Health of Select Populations,Committee on the Evidence Base for Genetic Testing Pdf
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.
Oxford Textbook of Global Public Health by Roger Detels,Martin Gulliford,Quarraisha Abdool Karim,Chorh Chuan Tan Pdf
Sixth edition of the hugely successful, internationally recognised textbook on global public health and epidemiology, with 3 volumes comprehensively covering the scope, methods, and practice of the discipline
Assessing Genetic Risks by Institute of Medicine,Committee on Assessing Genetic Risks Pdf
Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.
Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health
Author : Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health Publisher : National Academies Press Page : 103 pages File Size : 51,8 Mb Release : 2009-11-10 Category : Medical ISBN : 9780309147415
Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health by Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health Pdf
With the advent of genome-wide association studies, numerous associations between specific gene loci and complex diseases have been identified-for breast cancer, coronary artery disease, and asthma, for example. This rapidly advancing field of genomics has stirred great interest in "personalized" health care from both the public and private sectors. The hope is that using genomic information in clinical care will lead to reduced health care costs and improved health outcomes as therapies are tailored to the genetic susceptibilities of patients. A variety of genetically based health care innovations have already reached the marketplace, but information about the clinical use of these treatments and diagnostics is limited. Currently data do not provide information about how a genomic test impacts clinical care and patient health outcomes-other approaches are needed to garner such information. This volume summarizes a workshop to address central questions related to the development of systems to evaluate clinical use of health care innovations that stem from genome-based research: What are the practical realities of creating such systems? What different models could be used? What are the strengths and weaknesses of each model? How effectively can such systems address questions about health outcomes?
National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health Publisher : National Academies Press Page : 137 pages File Size : 52,5 Mb Release : 2016-07-06 Category : Medical ISBN : 9780309437790
Applying an Implementation Science Approach to Genomic Medicine by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health Pdf
Although it is becoming increasingly more common for clinicians to use genomic data in their practices for disease prevention, diagnosis, and treatment, the process of integrating genomic data into the practice of medicine has been a slow and challenging one. Some of the major barriers impeding the incorporation of new genomic technology into clinical practice are: the difficulty of changing routine medical practices to account for the use of genetic testing, the limited knowledge of patients and providers about genomic medicine, assessing sufficient evidence to support the use of genetic tests, privacy and data security issues, and uncertainty about reimbursement. The field of implementation science may be able to provide insights concerning efficient ways to incorporate genomic applications into routine clinical practice. The focus of implementation science studies is to identify integration bottlenecks and optimal approaches for a given setting and ultimately to promote the up-take of research findings. To explore the potential of implementation science to improve the integration of genomics into medicine, the National Academies of Sciences, Engineering, and Medicine held a workshop in Washington, DC, in November 2015. Participants explored the challenges and opportunities of integrating genomic advances into the clinic through the lens of implementation science. This report summarizes the presentations and discussions from the workshop.
Health Economics of Genomic Medicine by Sarah Wordsworth,Dean Regier Pdf
Although genomic medicine is still a fairly new clinical area, the history of health economics involvement in genomics has a longer history than might be anticipated. Some of the earliest health economics input into genomics was in areas such as neonatal and newborn screening, where health economists contributed to decisions about adding new conditions into newborn screening programmes worldwide. More recently, the first human genome was only sequenced in 2003, costing between US$500 million and US$1 billion. However, by 2008 costs had fallen to a level where so called 'next-generation sequencing (NGS)' approaches started to enter clinical research. NGS approaches allow either the whole genome using methods such as whole-genome sequencing (WGS) or parts of it using whole-exome sequencing (WES) or targeted panels to be sequenced in hours with increased sensitivity compared to older less advanced genetic testing approaches. These sequencing approaches provide information that can inform diagnosis, prognosis and clinical management for a variety of disorders, such as rare diseases and some cancers. However, the current costs are still too expensive for some health care providers and the benefit of the tests is largely unknown. Indeed, a lack of evidence on the cost-effectiveness of novel genomic technologies such as WGS is considered a key translational challenge. This is partly because economic evaluations of genomic technologies often fall outside the remit of health technology assessment (HTA) agencies, such as NICE and PBAC. Where they are undertaken (in a HTA context), the methods used for the assessment sometimes differ from those recommended by HTA agencies for cost-effectiveness analysis. This is against a background of uncertainty as to whether the terms precision medicine, personalised medicine or genomic medicine best capture this space in health care. Methodological challenges Some applications of genomic sequencing generate information that may not improve quality of life (as measured using preference-based health-related quality of life [HRQoL] instruments such as the EuroQol-five dimensions questionnaire) or extend life expectancy. One example is the use of WGS and WES to guide diagnosis in autism spectrum disorder. However, genomic sequencing results may influence patient wellbeing via non-clinical routes, generating 'personal utility'. This is a particular issue for individuals with rare diseases, who often have lengthy diagnostic journeys but few (if any) treatment options available once they receive a diagnosis. This could also be an issue if individuals without known health problems (healthy cohorts) undergo genomic sequencing and find out that they have an elevated risk of a disease, but no preventive action can be taken to manage this risk. With respect to costs, the costs of undertaking genomic tests are only one component of the cost of the overall genomic testing process. The costs that are incurred beyond those associated with the production of genomic information (so probably beyond the scope of any national tariffs that might be generated) include the costs of bioinformatics analysis, interpretation of results in multidisciplinary team (MDT) meetings and genetic counselling services. Such issues have raised questions about whether or not genomics is exceptional for health economists - possibly not, but the combined issues perhaps lead to it often requiring additional attention. There is also a consideration of the importance of accounting for the 'personal' when evaluating personalized medicine and considers the extent to which extra-welfarist and welfarist approaches to economic evaluation achieve this objective. Extra-welfarist approaches are currently used by many health technology assessment agencies but may not capture all of the outcomes that are important to patients in this context. Extensions to the extra-welfarist approach that might better capture the 'personal' are outlined, including multi-criteria decision analysis and the capability approach. Evidence A recent literature review identified only 36 economic evaluations of either WGS or WES, six of which were cost-effectiveness analyses using diagnostic yield as the outcome measure. Only two publications presented cost-utility analyses using quality-adjusted life-years (QALYs) as the measure of health outcomes. HTA agencies generally require data on survival and quality of life when evaluating new healthcare interventions, which, when combined, allow clinical utility to be quantified using QALYs. However, existing studies have primarily quantified the clinical utility of genomic tests in terms of changes in diagnostic yield. Methodological uncertainty among health economists is one potential explanation for the lack of evidence on the health outcomes associated with genomic sequencing. Over the past decade, health economists have repeatedly questioned whether metrics such as the QALY in genomic medicine, which focuses on clinical utility, can fully quantify the outcomes that are important to patients when they undergo genomic testing. Policy picture There are high-level discussions in several countries, including the UK, about extending the use of genomic sequencing into newborning screening, so effectively screening everyone at birth for a large range of conditions, far more than those currently being screened for and which there might not be treatments for yet. This is in addition to long term epidemiological and health economic discussions on using newborn screening for conditions such as hereditary hemochromatosis. A further area of uncertainty is the use of genomic sequencing in 'healthy populations', including direct to consumer testing (private genetic tests). In a public health care system setting, the UK Department of health is exploring the value of establishing a healthy cohort of volunteer. Furthermore, research studies are assessing the costs and effects of polygenetic risk scores in the context of primary care as an opportunistic 'health check' approach, which could incorporate risks for cardiovascular disease, diabetes, different cancers and conditions such as chrohn's disease etc. Clearly, there are health economic questions to be asked about the downstream costs and consequences of genomic tests in these newborn and 'healthy' populations. In cancer, there are discussions about how to handle the new invention of agnostic cancer drugs (which essentially target the mutation rather than the cancer, so the same drug can treat several cancers). This is an area where assessments are going through HTA agencies who are unsure about the best approaches to adopt to these assessments where drug companies are putting forward a drug for assessment that can potentially treat different cancers with very different disease profiles. These developments require careful consideration from many perspectives, including health economics. Besides highlighting some of the challenges in assessing the economic impact of genomic medicine and the use of advanced (and less advanced) technologies, the book will propose potential solutions to these key challenges. For example, in terms of data availability, one obstacle to translating genomic sequencing into routine health care has been a lack of large randomised controlled clinical trials data for health economists and others to use to populate cost-effectiveness analyses (CEAs). Arguably, in response, reimbursement decisions have moved towards lower evidentiary standards, with the development of managed access programs that hope to balance the intense pressure for patient access with the need to consider the sustainability objectives of health care systems. Single arm trials are common for assessing clinical utility of precision medicine. By excluding a counterfactual, these trials introduce outcomes uncertainty through their inability to establish causal treatment effects. In this section of the book, we illustrate the application of quasi-experimental methods for evaluating precision medicine in case studies linking real-world big data and single arm trials. A further potential option here might be provided by 'big data' can be used to partially support CEAs in genomics. Advanced genomic sequencing is considered to be a prominent example of big data because of the quantity and complexity of data it produces and because it presents an opportunity to use powerful information sources that could reduce clinical and health economic uncertainty at a patient level. The creation of large national sequencing initiatives with sequencing data linked to clinical data (including health outcomes) and resource use data such as hospital episode statistics data and claims data. Large-scale sequencing projects such as the 100,000 Genome Project in the UK and the All of Us Program in the US are collecting an unprecedented amount of genomic, clinical and healthcare resource use data on individuals with cancer or rare diseases, as well as healthy individuals. Some of these large-scale projects are now approaching completion, and national health services are deciding whether WGS and WES should be translated into clinical practice for specific disorders.
Implementing Biomedical Innovations into Health, Education, and Practice by James O. Woolliscroft Pdf
Our increased understanding of health and disease coupled with major technologic advances has resulted in rapid and significant changes in the practice of medicine. How we prepare physicians for clinical practice 20, 30, or 40 years from now is of paramount importance to medical educators, to the future professionals, and to society at large. Implementing Biomedical Innovations into Health, Education, and Practice delves into this important question, discussing the effects of precision medicine, bioinformatics, biologic and environmental forces, and societal shifts on the physician’s approach to diagnosis and therapy. The author interviewed world-renowned physicians, medical educators, healthcare leaders, and research professionals—their insights and quotes are woven throughout the narrative. Professionally illustrated, this relevant resource is a must-have for all medical professionals who incorporate technology and biomedical innovations in their research and clinical practice. It encourages thoughtful analysis on adapting and developing the foundational knowledge, skills, and aptitudes of future physicians and other healthcare professionals, and it belongs in your library. “Having completed deanship at one of America’s leading medical schools, Jim Woolliscroft produces an insightful, contemplative projection of the likely skill and behavioral needs of the physician workforce for the mid-21st century...The result is a playbook for physician training that responds effectively to the daunting challenges faced in the coming transformation of the role of physicians in protecting the health of our nation. James L. Madara, MD, CEO, American Medical Association “Dr. Woolliscroft’s provocative new book will become must reading for all who are serious about educating the next generation of physicians and health care leaders. Leveraging his own experience as a consummate educator and interviews with numerous thought leaders, he identifies the uncertainties, challenges and disruptions to the practice of medicine in the decades ahead. The implications and imperatives for the coming generations of physicians are compelling and of critical importance for care givers, policy makers, and most pointedly educators in the U.S. and around the world. Gary S. Kaplan MD, Chairman and CEO, Virginia Mason Health System “This ambitious masterpiece, by one of the leading medical educators of our time, fully captures the ongoing changes and disruptions in medicine today, and how they will influence the care of patients and the training of young physicians in the future. Eric Topol, MD, Executive Vice President, Scripps Research, Author of Deep Medicine Discusses likely technologic disruptors: sensors, AI, machine learning, and robotics Highlights microbiota, genetics, molecular biology, gene therapy, and regenerative and precision medicine as likely disruptors Presents an intriguing set of scenarios depicting the life of future physicians
Author : Laura V. Milko,Muin J. Khoury Publisher : Frontiers Media SA Page : 324 pages File Size : 55,6 Mb Release : 2022-11-28 Category : Science ISBN : 9782832507346
Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health
Author : Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health Publisher : National Academies Press Page : 126 pages File Size : 42,6 Mb Release : 2014-08-19 Category : Medical ISBN : 9780309304979
Assessing Genomic Sequencing Information for Health Care Decision Making by Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health Pdf
Rapid advances in technology have lowered the cost of sequencing an individual's genome from the several billion dollars that it cost a decade ago to just a few thousand dollars today and have correspondingly greatly expanded the use of genomic information in medicine. Because of the lack of evidence available for assessing variants, evaluation bodies have made only a few recommendations for the use of genetic tests in health care. For example, organizations, such as the Evaluation of Genomic Applications in Practice and Prevention working group, have sought to set standards for the kinds of evaluations needed to make population-level health decisions. However, due to insufficient evidence, it has been challenging to recommend the use of a genetic test. An additional challenge to using large-scale sequencing in the clinic is that it may uncover "secondary," or "incidental," findings - genetic variants that have been associated with a disease but that are not necessarily related to the conditions that led to the decision to use genomic testing. Furthermore, as more genetic variants are associated with diseases, new information becomes available about genomic tests performed previously, which raises issues about how and whether to return this information to physicians and patients and also about who is responsible for the information. To help develop a better understanding of how genomic information is used for healthcare decision making, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine held a workshop in Washington,DC in February 2014. Stakeholders, including clinicians, researchers, patients, and government officials, discussed the issues related to the use of genomic information in medical practice. Assessing Genomic Sequencing Information for Health Care Decision Making is the summary of that workshop. This report compares and contrasts evidence evaluation processes for different clinical indications and discusses key challenges in the evidence evaluation process.
Economic Evaluation in Genomic Medicine by Vasilios Fragoulakis,Christina Mitropoulou,Marc Williams,George P. Patrinos Pdf
Economic Evaluation in Genomic Medicine introduces health economics and economic evaluation to genomic clinicians and researchers, while also introducing the topic to health economists. Each chapter includes an executive summary, questions, and case studies, along with supplementary online materials, including process guides, maps, flow charts, diagrams, and economic evaluation spreadsheets to enhance the learning process. The text can easily be used as course material for related graduate and undergraduate courses, providing a succinct overview of the existing, state-of-the-art application of economic evaluation to genomic healthcare and precision medicine. Interrelates economic evaluation and genomic medicine Instructs healthcare professionals and bioscientists about economic evaluation in genomic medicine Teaches health economists about application of economic evaluation in genomic medicine Introduces health economics and economic evaluation to clinicians and researchers involved in genomics Includes process guides, maps, flow charts and diagrams
Adam C. Berger,Samuel G. Johnson,Institute of Medicine,Board on Health Sciences Policy,Sarah H. Beachy,Steve Olson
Author : Adam C. Berger,Samuel G. Johnson,Institute of Medicine,Board on Health Sciences Policy,Sarah H. Beachy,Steve Olson Publisher : Unknown Page : 0 pages File Size : 42,6 Mb Release : 2015 Category : Education ISBN : 0309316057
Improving Genetics Education in Graduate and Continuing Health Professional Education by Adam C. Berger,Samuel G. Johnson,Institute of Medicine,Board on Health Sciences Policy,Sarah H. Beachy,Steve Olson Pdf
"Workshop, August 18, 2014 ... Washington, DC"--Page 73.
National Research Council,Institute of Medicine,Board on Health Care Services,National Cancer Policy Forum,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health,Forum on Drug Discovery, Development, and Translation,Division on Earth and Life Studies,Board on Life Sciences,Policy and Global Affairs,Committee on Science, Technology, and Law
Author : National Research Council,Institute of Medicine,Board on Health Care Services,National Cancer Policy Forum,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health,Forum on Drug Discovery, Development, and Translation,Division on Earth and Life Studies,Board on Life Sciences,Policy and Global Affairs,Committee on Science, Technology, and Law Publisher : National Academies Press Page : 106 pages File Size : 41,9 Mb Release : 2011-01-16 Category : Medical ISBN : 9780309162166
Direct-to-Consumer Genetic Testing by National Research Council,Institute of Medicine,Board on Health Care Services,National Cancer Policy Forum,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health,Forum on Drug Discovery, Development, and Translation,Division on Earth and Life Studies,Board on Life Sciences,Policy and Global Affairs,Committee on Science, Technology, and Law Pdf
Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they offer demonstrate a public appetite for this information and where the future of genetics may be headed; they also demonstrate the need for serious discussion about the regulatory environment, patient privacy, and other policy implications of direct-to-consumer (DTC) genetic testing. Rapid advances in genetic research already have begun to transform clinical practice and our understanding of disease progression. Existing research has revealed a genetic basis or component for numerous diseases, including Parkinson's disease, Alzheimer's disease, diabetes, heart disease, and several forms of cancer. The availability of the human genome sequence and the HapMap, plummeting costs of high-throughput screening, and increasingly sophisticated computational analyses have led to an explosion of discoveries of linkages between patterns of genetic variation and disease susceptibility. While this research is by no means a straight path toward better public health, improved knowledge of the genetic linkages has the potential to change fundamentally the way health professionals and public health practitioners approach the prevention and treatment of disease. Realizing this potential will require greater sophistication in the interpretation of genetic tests, new training for physicians and other diagnosticians, and new approaches to communicating findings to the public. As this rapidly growing field matures, all of these questions require attention from a variety of perspectives. To discuss some of the foregoing issues, several units of the National Academies held a workshop on August 31 and September 1, 2009, to bring together a still-developing community of professionals from a variety of relevant disciplines, to educate the public and policy-makers about this emerging field, and to identify issues for future study. The meeting featured several invited presentations and discussions on the many technical, legal, policy, and ethical questions that such DTC testing raises, including: (1) overview of the current state of knowledge and the future research trajectory; (2) shared genes and emerging issues in privacy; (3) the regulatory framework; and (4) education of the public and the medical community.
Author : Muin J. Khoury,Wylie Burke,Elizabeth Jean Thomson Publisher : Oxford University Press, USA Page : 661 pages File Size : 46,9 Mb Release : 2000 Category : Language Arts & Disciplines ISBN : 9780195128307
