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Finding a Path to Safety in Food Allergy - Health And Medicine Division - Bog - National Academies Press - Plusbog.dk

Finding a Path to Safety in Food Allergy - Health And Medicine Division - Bog - National Academies Press - Plusbog.dk

Over the past 20 years, public concerns have grown in response to the apparent rising prevalence of food allergy and related atopic conditions, such as eczema. Although evidence on the true prevalence of food allergy is complicated by insufficient or inconsistent data and studies with variable methodologies, many health care experts who care for patients agree that a real increase in food allergy has occurred and that it is unlikely to be due simply to an increase in awareness and better tools for diagnosis. Many stakeholders are concerned about these increases, including the general public, policy makers, regulatory agencies, the food industry, scientists, clinicians, and especially families of children and young people suffering from food allergy. At the present time, however, despite a mounting body of data on the prevalence, health consequences, and associated costs of food allergy, this chronic disease has not garnered the level of societal attention that it warrants. Moreover, for patients and families at risk, recommendations and guidelines have not been clear about preventing exposure or the onset of reactions or for managing this disease. Finding a Path to Safety in Food Allergy examines critical issues related to food allergy, including the prevalence and severity of food allergy and its impact on affected individuals, families, and communities; and current understanding of food allergy as a disease, and in diagnostics, treatments, prevention, and public policy. This report seeks to: clarify the nature of the disease, its causes, and its current management; highlight gaps in knowledge; encourage the implementation of management tools at many levels and among many stakeholders; and delineate a roadmap to safety for those who have, or are at risk of developing, food allergy, as well as for others in society who are responsible for public health. Table of ContentsFront MatterSummary1 Introduction2 Definitions3 Prevalence4 Assessments, Diagnostic Testing, Disease Monitoring, and Prognosis5 Potential Genetic and Environmental Determinants of Food Allergy Risk and Possible Prevention Strategies6 Management in the Health Care Setting7 Management of Packaged Foods8 Managing Food Allergies in Retail, Food Service, Schools, Higher Education, and Travel Settings9 Research Needs10 Final Comments: A Roadmap to SafetyAppendix A: Open Session AgendasAppendix B: Food Allergy Prevalence Literature Search StrategyAppendix C: Risk Determinants Literature Search StrategyAppendix D: Acronyms and AbbreviationsAppendix E: DefinitionsAppendix F: Committee Members Biographical Sketches

DKK 474.00
1

Biomarker Tests for Molecularly Targeted Therapies - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

Biomarker Tests for Molecularly Targeted Therapies - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

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. Table of ContentsFront MatterSummary1 Introduction2 Envisioning a Rapid Learning System for Biomarker Tests for Molecularly Targeted Therapies3 Supportive Policy Environment for Biomarker Tests for Molecularly Targeted Therapies4 Supporting Data Infrastructure for Biomarker Tests for Molecularly Targeted Therapies5 Processes to Improve Patient CareAppendix A: Committee Member and Staff BiographiesAppendix B: Coding: Payment Infrastructure for Biomarker Tests for Molecularly Targeted TherapiesAppendix C: Information-Gathering Sessions and SpeakersGlossary

DKK 383.00
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Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests - Institute Of Medicine - Bog - National

Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests - Institute Of Medicine - Bog - National

Many drug developers have examined new strategies for creating efficiencies in their development processes, including the adoption of genomics-based approaches. Genomic data can identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specific treatment, and has the potential to significantly reduce the cost of clinical trials by reducing the number of patients that must be enrolled in order to demonstrate safety and efficacy. A key component of the approval of targeted therapeutics is the ability to identify the population of patients who will benefit from treatment, and this has largely hinged on the co-development and co-submission to the FDA of a companion diagnostic test.The co-development process, or the development of the test and drug for the simultaneous submission to FDA, has led to a major alteration in the way that drugs are being developed, with traditionally separate entities—pharmaceutical and diagnostic companies—now working in close collaboration. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests is the summary of a workshop held by the Roundtable on Translating Genomic-Based Research for Health on February 27, 2013 to examine and discuss challenges and potential solutions for the codevelopment of targeted therapeutics and companion molecular tests for the prediction of drug response. Prior to the workshop, key stakeholders, including laboratory and medical professional societies, were individually asked to provide possible solutions to resolve the concerns raised about co-development of companion diagnostic tests and therapies. Workshop speakers were charged with addressing these solutions in their presentations by providing insight on (1) whether the proposed solutions address the problems described, (2) whether there are other solutions to propose, and (3) what steps could be taken to effectively implement the proposed solutions.Table of ContentsFront Matter1 Introduction2 Regulatory Perspectives3 Perspectives from Patients, Providers, and Laboratory Representatives4 Perspectives of Diagnostic Test and Pharmaceutical Developers5 Perspectives of Payers and Regulators6 Concluding ObservationsReferencesAppendix A: Workshop AgendaAppendix B: Speaker Biographical SketchesAppendix C: Statement of TaskAppendix D: Registered Attendees

DKK 240.00
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Indoor Allergens - Committee On The Health Effects Of Indoor Allergens - Bog - National Academies Press - Plusbog.dk

Indoor Allergens - Committee On The Health Effects Of Indoor Allergens - Bog - National Academies Press - Plusbog.dk

More than 50 million Americans, one out of five, suffer from hay fever, asthma, and other allergic diseases. Many of these conditions are caused by exposure to allergens in indoor environments such as the house, work, and school—where we spend as much as 98 percent of our time. Developed by medical, public health, and engineering professionals working together, this unique volume summarizes what is known about indoor allergens, how they affect human health, the magnitude of their effect on various populations, and how they can be controlled. The book addresses controversies, recommends research directions, and suggests how to assist and educate allergy patients, as well as professionals. Indoor Allergens presents a wealth of information about common indoor allergens and their varying effects, from significant hay fever to life-threatening asthma. The volume discusses sources of allergens, from fungi and dust mites to allergenic chemicals, plants, and animals, and examines practical measures for their control. Indoor Allergens discusses how the human airway and immune system respond to inhaled allergens and assesses patient testing methods, covering the importance of the patient's medical history and outlining procedures and approaches to interpretation for skin tests, in vitro diagnostic tests, and tests of patients' pulmonary function. This comprehensive and practical volume will be important to allergists and other health care providers; public health professionals; specialists in building design, construction, and maintenance; faculty and students in public health; and interested allergy patients. Table of ContentsFront MatterExecutive Summary1 Introduction2 Magnitude and Dimensions of Sensitization and Disease Caused by Indoor Allergens3 Agents, Sources, Source Controls, and Diseases4 Mechanisms of Immune Function5 Medical Testing Methods6 Assessing Exposure and Risk7 Engineering Control Strategies8 The Role of EducationReferencesAcronymsGlossaryCommittee and Staff BiographiesIndex

DKK 552.00
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Genome-Based Diagnostics - Board On Health Sciences Policy - Bog - National Academies Press - Plusbog.dk

Genome-Based Diagnostics - Board On Health Sciences Policy - Bog - National Academies Press - Plusbog.dk

The sequencing of the human genome and the identification of associations between specific genetic variants and diseases have led to an explosion of genomic-based diagnostic tests. These tests have the potential to direct therapeutic interventions, predict risk or onset of disease, or detect residual disease. As research progresses and an increasing number of associations are found, further tests will be developed that can aid in providing personalized treatment options for patients. However, the adoption of genomic diagnostic tests by health care providers has been limited due to a lack of evidence regarding the clinical utility of many tests. Health funders and practitioners lack the data necessary to distinguish which tests can improve practice or the clinical settings in which tests will provide the greatest value. The Roundtable on Translating Genomic-Based Research for Health held a workshop in November 2010 to determine what evidence is needed and how it is viewed by different stakeholders in order to develop genomic diagnostic tests of clinical value. Genome-Based Diagnostics summarizes the presentations and discussions that took place throughout the workshop. Two presentations, in particular, sparked extensive discussion. One presentation proposed that all genomic diagnostic tests be reviewed and approved by the Food and Drug Administration. The other observed that venture capitalists are no longer investing substantially in the development of genomic diagnostic tests because of a lack of clarity surrounding regulatory and reimbursement pathways. Both presentations suggested the need for major changes in the systems used to develop, regulate, and reimburse genomic diagnostic tests. The report also presents the perspectives of different stakeholders in the development of genomic diagnostic tests. Each stakeholder group has a different set of needs and issues of importance, yet commonalities among them are apparent, such as the need to put patients and health outcomes at the center of discussion and action. Table of ContentsFront Matter1 Introduction2 Calls for Change3 Test Developers4 Patients5 Payers6 Regulation, Reimbursement, and Public Health7 Discussion of Major ProposalsReferencesAppendix A: Workshop AgendaAppendix B: Speaker Biographical SketchesAppendix C: Statement of TaskAppendix D: Registered Attendees

DKK 240.00
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Evolution of Translational Omics - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

Evolution of Translational Omics - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. Table of ContentsFront MatterSummary1 Introduction2 Omics-Based Clinical Discovery: Science, Technology, and Applications3 Best Practices for Omics-Based Test Validation Prior to Use for Patient Management Decisions in a Clinical Trial Setting4 Evaluation of Omics-Based Tests for Clinical Utility and Use5 Responsible Parties6 Lessons from the Case StudiesAppendix A: Case StudiesAppendix B: Gene ExpressionBased Tests Developed at Duke University and Used in Clinical TrialsAppendix C: Introduction to BiomarkersAppendix D: Reporting GuidelinesAppendix E: Committee Member and Staff BiographiesAppendix F: Information Gathering Sessionsand SpeakersAcronyms and AbbreviationsGlossary

DKK 396.00
1

Exposure of the American Population to Radioactive Fallout from Nuclear Weapons Tests - Committee To Review The Cdc Nci Feasibility Study Of The

Psychological Testing in the Service of Disability Determination - Board On The Health Of Select Populations - Bog - National Academies Press -

Psychological Testing in the Service of Disability Determination - Board On The Health Of Select Populations - Bog - National Academies Press -

The United States Social Security Administration (SSA) administers two disability programs: Social Security Disability Insurance (SSDI), for disabled individuals, and their dependent family members, who have worked and contributed to the Social Security trust funds, and Supplemental Security Income (SSSI), which is a means-tested program based on income and financial assets for adults aged 65 years or older and disabled adults and children. Both programs require that claimants have a disability and meet specific medical criteria in order to qualify for benefits. SSA establishes the presence of a medically-determined impairment in individuals with mental disorders other than intellectual disability through the use of standard diagnostic criteria, which include symptoms and signs. These impairments are established largely on reports of signs and symptoms of impairment and functional limitation. Psychological Testing in the Service of Disability Determination considers the use of psychological tests in evaluating disability claims submitted to the SSA. This report critically reviews selected psychological tests, including symptom validity tests, that could contribute to SSA disability determinations. The report discusses the possible uses of such tests and their contribution to disability determinations. Psychological Testing in the Service of Disability Determination discusses testing norms, qualifications for administration of tests, administration of tests, and reporting results. The recommendations of this report will help SSA improve the consistency and accuracy of disability determination in certain cases. Table of ContentsFront MatterSummary1 Introduction2 Disability Evaluation and the Use of Psychological Tests3 Overview of Psychological Testing4 Self-Report Measures and Symptom Validity Tests5 Cognitive Tests and Performance Validity Tests6 Economic Considerations7 Conclusions and RecommendationsAppendix A: Public Workshop AgendasAppendix B: Biographical Sketches of Committee MembersAppendix C: Glossary

DKK 370.00
1

An Evidence Framework for Genetic Testing - Health And Medicine Division - Bog - National Academies Press - Plusbog.dk

DKK 312.00
1

Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) - Board On Military And Veterans Health - Bog - National

Generating Evidence for Genomic Diagnostic Test Development - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

Generating Evidence for Genomic Diagnostic Test Development - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

Ten years after the sequencing of the human genome, scientists have developed genetic tests that can predict a person's response to certain drugs, estimate the risk of developing Alzheimer's disease, and make other predictions based on known links between genes and diseases. However, genetic tests have yet to become a routine part of medical care, in part because there is not enough evidence to show they help improve patients' health. The Institute of Medicine (IOM) held a workshop to explore how researchers can gather better evidence more efficiently on the clinical utility of genetic tests. Generating Evidence for Genomic Diagnostic Test Development compares the evidence that is required for decisions regarding clearance, use, and reimbursement, to the evidence that is currently generated. The report also addresses innovative and efficient ways to generate high-quality evidence, as well as barriers to generating this evidence. Generating Evidence for Genomic Diagnostic Test Development contains information that will be of great value to regulators and policymakers, payers, health-care providers, researchers, funders, and evidence-based review groups. Table of ContentsFront Matter1 Introduction2 Stakeholder Perspectives on Evidence3 Approaches to Evidence Generation4 Overcoming Barriers for Evidence Generation5 Considerations Moving Forward6 Final RemarksReferencesAppendix A: Workshop AgendaAppendix B: Speaker Biographical SketchesAppendix C: Registered Attendees

DKK 208.00
1

State Assessment Systems - Division Of Behavioral And Social Sciences And Education - Bog - National Academies Press - Plusbog.dk

State Assessment Systems - Division Of Behavioral And Social Sciences And Education - Bog - National Academies Press - Plusbog.dk

Educators and policy makers in the United States have relied on tests to measure educational progress for more than 150 years, and have used the results for many purposes. They have tried minimum competency testing; portfolios; multiple-choice items, brief and extended constructed-response items; and more. They have contended with concerns about student privacy, test content, and equity--and they have responded to calls for tests to answer many kinds of questions about public education and literacy, international comparisons, accountability, and even property values. State assessment data have been cited as evidence for claims about many achievements of public education, and the tests have also been blamed for significant failings. States are now considering whether to adopt the "common core" academic standards, and are also competing for federal dollars from the Department of Education's Race to the Top initiative. Both of these activities are intended to help make educational standards clearer and more concise and to set higher standards for students. As standards come under new scrutiny, so, too, do the assessments that measure their results. This book summarizes two workshops convened to collect information and perspectives on assessment in order to help state officials and others as they review current assessment practices and consider improvements.

DKK 305.00
1

Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense) - Institute Of Medicine - Bog - National Academies Press -

Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense) - Institute Of Medicine - Bog - National Academies Press -

Between 1963 and 1969, the U.S. military carried out a series of tests, termed Project SHAD (Shipboard Hazard and Defense), to evaluate the vulnerabilities of U.S. Navy ships to chemical and biological warfare agents. These tests involved use of active chemical and biological agents, stimulants, tracers, and decontaminants. Approximately 5,900 military personnel, primarily from the Navy and Marine Corps, are reported to have been included in Project SHAD testing. In the 1990s some veterans who participated in the SHAD tests expressed concerns to the Department of Veterans Affairs (VA) that they were experiencing health problems that might be the result of exposures in the testing. These concerns led to a 2002 request from VA to the Institute of Medicine (IOM) to carry out an epidemiological study of the health of SHAD veterans and a comparison population of veterans who had served on similar ships or in similar units during the same time period. In response to continuing concerns, Congress in 2010 requested an additional IOM study. This second study expands on the previous IOM work by making use of additional years of follow up and some analysis of diagnostic data from Medicare and the VA health care system. Table of ContentsFront MatterSummary1 Introduction2 BackgroundAnnex Brief Descriptions of SHAD Tests3 Data and Methods for the SHAD II Study4 The Mortality Experience of SHAD Veterans5 Morbidity Results6 DiscussionAppendix A: Committee and Consultant BiographiesAppendix B: Agendas for Information-Gathering MeetingsAppendix C: Review of Literature on Known Project SHAD Agents, Simulants, Tracers, and DecontaminantsAppendix D: Additional Information on Data and Methods Used for AnalysisAppendix E: Units Participating in Project SHAD Tests and Units Selected as Unexposed ComparisonsAppendix F: Diagnostic Codes Used to Define Health Outcomes

DKK 318.00
1

Improving Cancer Diagnosis and Care - Health And Medicine Division - Bog - National Academies Press - Plusbog.dk

Improving Cancer Diagnosis and Care - Health And Medicine Division - Bog - National Academies Press - Plusbog.dk

A hallmark of high-quality cancer care is the delivery of the right treatment to the right patient at the right time. Precision oncology therapies, which target specific genetic changes in a patient's cancer, are changing the nature of cancer treatment by allowing clinicians to select therapies that are most likely to benefit individual patients. In current clinical practice, oncologists are increasingly formulating cancer treatment plans using results from complex laboratory and imaging tests that characterize the molecular underpinnings of an individual patient's cancer. These molecular fingerprints can be quite complex and heterogeneous, even within a single patient. To enable these molecular tumor characterizations to effectively and safely inform cancer care, the cancer community is working to develop and validate multiparameter omics tests and imaging tests as well as software and computational methods for interpretation of the resulting datasets. To examine opportunities to improve cancer diagnosis and care in the new precision oncology era, the National Cancer Policy Forum developed a two-workshop series. The first workshop focused on patient access to expertise and technologies in oncologic imaging and pathology and was held in February 2018. The second workshop, conducted in collaboration with the Board on Mathematical Sciences and Analytics, was held in October 2018 to examine the use of multidimensional data derived from patients with cancer, and the computational methods that analyze these data to inform cancer treatment decisions. This publication summarizes the presentations and discussions from the second workshop. Table of ContentsFront MatterProceedings of a WorkshopAppendix A: Statement of TaskAppendix B: Workshop Agenda

DKK 344.00
1

The Emerging Threat of Drug-Resistant Tuberculosis in Southern Africa - Board On Health Sciences Policy - Bog - National Academies Press - Plusbog.dk

Evaluation of Demonstration Test Results of Alternative Technologies for Demilitarization of Assembled Chemical Weapons - Committee On Review And

Evaluation of Demonstration Test Results of Alternative Technologies for Demilitarization of Assembled Chemical Weapons - Committee On Review And

In 1996, the U.S. Congress enacted two laws, Public Law 104-201 (authorization legislation) and Public Law 104-208 (appropriation legislation), mandating that the U.S. Department of Defense (DOD) conduct an assessment of alternative technologies to the baseline incineration process for the demilitarization of assembled chemical munitions. The PMACWA had previously requested that the National Research Council (NRC) perform and publish an independent evaluation of the seven technologies packages that had been selected during earlier phases of the Assembled Chemical Weapons Assessment (ACWA) program and deliver a report by September 1, 1999. However, to meet that deadline, the NRC Committee on Review and Evaluation of Alternative Technologies for Demilitarization of Assembled Chemical Weapons (ACW Committee) had to terminate its data-gathering activities on March 15, 1999, prior to the completion of demonstration tests. In September 1999, the PMACWA requested that the ACW Committee examine the reports of the demonstration tests and determine if the results changed the committee's original findings, recommendations, and comments. Evaluation of Demonstration Test Results of Alternative Technologies for Demilitarization of Assembled Chemical Weapons documents the committee's reassessment of the findings and recommendations in the original report, Review and Evaluation of Alternative Technologies for Demilitarization of Assembled Chemical Weapons.

DKK 305.00
1

The Five Series Study - Harriet Crawford - Bog - National Academies Press - Plusbog.dk

Setting Priorities for Health Technologies Assessment - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

Application of Systematic Review Methods in an Overall Strategy for Evaluating Low-Dose Toxicity from Endocrine Active Chemicals - Board On

Application of Systematic Review Methods in an Overall Strategy for Evaluating Low-Dose Toxicity from Endocrine Active Chemicals - Board On

To safeguard public health, the US Environmental Protection Agency (EPA) must keep abreast of new scientific information and emerging technologies so that it can apply them to regulatory decision-making. For decades the agency has dealt with questions about what animal-testing data to use to make predictions about human health hazards, how to perform dose-response extrapolations, how to identify and protect susceptible subpopulations, and how to address uncertainties. As alternatives to traditional toxicity testing have emerged, the agency has been faced with additional questions about how to incorporate data from such tests into its chemical assessments and whether such tests can replace some traditional testing methods. Endocrine active chemicals (EACs) have raised concerns that traditional toxicity-testing protocols might be inadequate to identify all potential hazards to human health because they have the ability to modulate normal hormone function, and small alterations in hormone concentrations, particularly during sensitive life stages, can have lasting and significant effects. To address concerns about potential human health effects from EACs at low doses, this report develops a strategy to evaluate the evidence for such low-dose effects. Table of ContentsFront MatterSummary1 Introduction2 Strategy for Evaluating Low-Dose Effects3 Phthalates and Male Reproductive-Tract Development4 Effect of Polybrominated Diphenyl Ethers on Neurodevelopment5 Lessons Learned and Reflections on the Statement of TaskAppendix A: Biosketches of the Committee on Endocrine-Related Low-Dose ToxicityAppendix B: Workshop on Potential Case Studies for Unraveling Endocrine-Related Low-Dose ToxicityAppendix C: Supporting Materials for the Phthalate (Animal) Systematic ReviewAppendix D: Supporting Materials for the Phthalate (Human) Systematic ReviewAppendix E: Supporting Materials for the PBDE (Animal) Systematic ReviewAppendix F: Supporting Materials for the PBDE (Human) Systematic Review

DKK 422.00
1

Hurricane Elena, Gulf Coast - Commission On Engineering And Technical Systems - Bog - National Academies Press - Plusbog.dk