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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.
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.
Technology assessment can lead to the rapid application of essential diagnostic technologies and prevent the wide diffusion of marginally useful methods. In both of these ways, it can increase quality of care and decrease the cost of health care. This comprehensive monograph carefully explores methods of and barriers to diagnostic technology assessment and describes both the rationale and the guidelines for meaningful evaluation. While proposing a multi-institutional approach, it emphasizes some of the problems involved and defines a mechanism for improving the evaluation and use of medical technology and essential resources needed to enhance patient care.
Many published books that comment on the medical model have been written by doctors, who assume that readers have the same knowledge of medicine, or by those who have attempted to discredit and attack the medical practice. Both types of book have tended to present diagnostic categories in medicine as universally scientifically valid examples of clear-cut diseases easily distinguished from each other and from health; with a fixed prognosis; and with a well-understood aetiology leading to disease-reversing treatments. These are contrasted with psychiatric diagnoses and treatments, which are described as unclear and inadequate in comparison. The Medical Model in Mental Health: An Explanation and Evaluation explores the overlap between the usefulness of diagnostic constructs (which enable prognosis and treatment decisions) and the therapeutic effectiveness of psychiatry compared with general medicine. The book explains the medical model and how it applies in mental health, assuming little knowledge or experience of medicine, and defends psychiatry as a medical practice.
In this book, Kraemer presents a systematic, objective methodology by which to determine the effectiveness of medical tests. She shows clearly and concisely how to define statistical terms and approaches consistently from study to study, how to stipulate statistical assumptions underlying various approaches, how to check for empirical validity and how to judge the robustness of statistical outcomes, resulting in models that integrate many different approaches and extend the strengths of each.
Mood disorders are a global health issue. National guidance for their detection and management have been published in the US and in Europe. Despite this, the rate at which depression is recognized and managed in primary and secondary care settings remains low and suggests that many clinicians are still unsure how to screen people for mood disorders. Against the backdrop of this problem, the editors of this volume have designed a book with a dynamic two-fold purpose: to provide an evidence-based overview of screening methods for mood disorders, and to synthesize the evidence into a practical guide for clinicians in a variety of settings—from cardiologists and oncologists, to primary care physicians and neurologists, among others. The volume considers all important aspects of depression screening, from the overview of specific scales, to considerations of technological approaches to screening, and to the examination of screening with neurological disorders, prenatal care, cardiovascular conditions, and diabetes and cancer care, among others. This book is sure to capture the attention of any clinician with a stake in depression screening.
WJ IV Clinical Use and Interpretation: Scientist-Practitioner Perspectives provides clinical use and interpretive information for clinical practitioners using the Woodcock-Johnson, Fourth Edition (WJ IV). The book discusses how the cognitive, achievement, and oral language batteries are organized, a description of their specific content, a brief review of their psychometric properties, and best practices in interpreting scores on the WJ IV. Coverage includes the predictive validity of its lower order factors and the clinical information that can be derived from its 60 individual subtests. Part II of this book describes the clinical and diagnostic utility of the WJ IV with young children for diagnosing learning disabilities in both school age and adult populations, and for identifying gifted and talented individuals. Additionally, the book discusses the use of the WJ IV with individuals whose culture and language backgrounds differ from those who are native English speakers and who were born and raised in mainstream US culture. - Discusses the organization and content of all three batteries in the WJ-IV - Reviews best practices for score interpretation - Covers psychometric properties and predictive validity - Explores clinical information that can be extracted from 60 individual subtests - Includes diagnostic utility for learning disabilities, giftedness, and non-English speaking populations
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
This new edition of Norbert Tietz's classic handbook presents information on common tests as well as rare and highly specialized tests and procedures - including a summary of the utility and merit of each test. Biological variables that may affect test results are discussed, and a focus is placed on reference ranges, diagnostic information, clinical interpretation of laboratory data, interferences, and specimen types. New and updated content has been added in all areas, with over 100 new tests added. - Tests are divided into 8 main sections and arranged alphabetically. - Each test includes necessary information such as test name (or disorder) and method, specimens and special requirements, reference ranges, chemical interferences and in vivo effects, kinetic values, diagnostic information, factors influencing drug disposition, and clinical comments and remarks. - The most current and relevant tests are included; outdated tests have been eliminated. - Test index (with extensive cross references) and disease index provide the reader with an easy way to find necessary information - Four new sections in key areas (Preanalytical, Flow Cytometry, Pharmacogenomics, and Allergy) make this edition current and useful. - New editor Alan Wu, who specializes in Clinical Chemistry and Toxicology, brings a wealth of experience and expertise to this edition. - The Molecular Diagnostics section has been greatly expanded due to the increased prevalence of new molecular techniques being used in laboratories. - References are now found after each test, rather than at the end of each section, for easier access.
Published in August of 2008, WAIS–IV is the most widely used intelligence test for adults in the world. Substantive changes were made to the WAIS-IV from the WAIS-III leaving clinicians with questions as to how to use and interpret the measure effectively. Written by the creators of the new test, this book serves as the ultimate insider's guide to the new test, providing users with the kind of access to norms and data that would be unavailable to any subsequent book on clinical use of this measure. The book discusses the changes made between 3rd and 4th editions along with an FAQ and answers about use and interpretation. The reader is instructed how to interpret composite scores, and everything needed to use and interpret two entirely new composite scores: the General Ability Index (GAI), and the Cognitive Proficiency Index (CPI). This information does NOT appear in the manual accompanying the test. The second section of the book focuses on WAIS–IV use and interpretation with special clinical applications and populations, including with multicultural clients, in neuropsychological settings, with individuals experiencing psychological disorders, and with older adults. The editors and chapter authors have exclusive access to proprietary WAIS–IV data to run advanced analyses and provide information beyond what is offered in the WAIS-IV manual. - Provides practical advice on scoring and administration - Facilitates understanding WAIS-IV use with special populations - Describes use of the WAIS-IV with WMS-II