Download or read book Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation written by Wolfgang Ecker and published by BoD – Books on Demand. This book was released on 2020-06-04 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services.

Download or read book Clinical Evaluation of Medical Devices written by Karen M. Becker and published by Springer Science & Business Media. This book was released on 2007-11-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.

Download or read book Economic Evaluation in Clinical Trials written by Henry A. Glick and published by OUP Oxford. This book was released on 2014-10-02 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is becoming increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, drugs, devices or diagnostics. It can aid companies seeking to make claims about the cost-effectiveness of their product, as well as allowing early consideration of the economic value of therapies which may be important to improving initial adoption decisions. It is also vital for addressing the requirements of regulatory bodies. Economic Evaluation in Clinical Trials provides practical advice on how to conduct cost-effectiveness analyses in controlled trials of medical therapies. This new edition has been extensively rewritten and revised; topics discussed range from design issues such as the types of services that should be measured and price weights, to assessment of quality-adjusted life years. Illustrative materials, case histories and worked examples are included to encourage the reader to apply the methods discussed. These exercises are supported with datasets, programmes and solutions made available online.

Download or read book Sports Related Concussions in Youth written by National Research Council and published by National Academies Press. This book was released on 2014-02-04 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past decade, few subjects at the intersection of medicine and sports have generated as much public interest as sports-related concussions - especially among youth. Despite growing awareness of sports-related concussions and campaigns to educate athletes, coaches, physicians, and parents of young athletes about concussion recognition and management, confusion and controversy persist in many areas. Currently, diagnosis is based primarily on the symptoms reported by the individual rather than on objective diagnostic markers, and there is little empirical evidence for the optimal degree and duration of physical rest needed to promote recovery or the best timing and approach for returning to full physical activity. Sports-Related Concussions in Youth: Improving the Science, Changing the Culture reviews the science of sports-related concussions in youth from elementary school through young adulthood, as well as in military personnel and their dependents. This report recommends actions that can be taken by a range of audiences - including research funding agencies, legislatures, state and school superintendents and athletic directors, military organizations, and equipment manufacturers, as well as youth who participate in sports and their parents - to improve what is known about concussions and to reduce their occurrence. Sports-Related Concussions in Youth finds that while some studies provide useful information, much remains unknown about the extent of concussions in youth; how to diagnose, manage, and prevent concussions; and the short- and long-term consequences of concussions as well as repetitive head impacts that do not result in concussion symptoms. The culture of sports negatively influences athletes' self-reporting of concussion symptoms and their adherence to return-to-play guidance. Athletes, their teammates, and, in some cases, coaches and parents may not fully appreciate the health threats posed by concussions. Similarly, military recruits are immersed in a culture that includes devotion to duty and service before self, and the critical nature of concussions may often go unheeded. According to Sports-Related Concussions in Youth, if the youth sports community can adopt the belief that concussions are serious injuries and emphasize care for players with concussions until they are fully recovered, then the culture in which these athletes perform and compete will become much safer. Improving understanding of the extent, causes, effects, and prevention of sports-related concussions is vitally important for the health and well-being of youth athletes. The findings and recommendations in this report set a direction for research to reach this goal.

Download or read book Bayesian Approaches to Clinical Trials and Health Care Evaluation written by David J. Spiegelhalter and published by John Wiley & Sons. This book was released on 2004-01-16 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: READ ALL ABOUT IT! David Spiegelhalter has recently joined the ranks of Isaac Newton, Charles Darwin and Stephen Hawking by becoming a fellow of the Royal Society. Originating from the Medical Research Council’s biostatistics unit, David has played a leading role in the Bristol heart surgery and Harold Shipman inquiries. Order a copy of this author’s comprehensive text TODAY! The Bayesian approach involves synthesising data and judgement in order to reach conclusions about unknown quantities and make predictions. Bayesian methods have become increasingly popular in recent years, notably in medical research, and although there are a number of books on Bayesian analysis, few cover clinical trials and biostatistical applications in any detail. Bayesian Approaches to Clinical Trials and Health-Care Evaluation provides a valuable overview of this rapidly evolving field, including basic Bayesian ideas, prior distributions, clinical trials, observational studies, evidence synthesis and cost-effectiveness analysis. Covers a broad array of essential topics, building from the basics to more advanced techniques. Illustrated throughout by detailed case studies and worked examples Includes exercises in all chapters Accessible to anyone with a basic knowledge of statistics Authors are at the forefront of research into Bayesian methods in medical research Accompanied by a Web site featuring data sets and worked examples using Excel and WinBUGS - the most widely used Bayesian modelling package Bayesian Approaches to Clinical Trials and Health-Care Evaluation is suitable for students and researchers in medical statistics, statisticians in the pharmaceutical industry, and anyone involved in conducting clinical trials and assessment of health-care technology.

Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Download or read book Lupus Erythematosus written by Peter H. Schur and published by Springer Science & Business Media. This book was released on 2012-07-06 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Often considered the prototypic autoimmune disease, Lupus is characterized by protean manifestations and affects a wide range of organ systems. Despite widespread availability of anti nuclear antibody testing and other technological diagnostic advances, the diagnosis of lupus can be elusive, difficult, and inexact. Treatment of the disease can also be challenging. Advances in immunology and biotechnology have led to a burgeoning world of new therapies in development that offer patients the real possibility of new therapies and physicians and scientists novel insights into the pathogenesis of this complicated immunological disease. Lupus Erythematosus: Clinical Evaluation and Treatment summarizes the clinical aspects of lupus facing the general clinician in the 21st century. In this invaluable, practical book, the reader will find introductory chapters regarding general diagnostic and treatment principles, followed by chapters addressing the lupus-specific organ manifestations. Special topics regarding pregnancy and comorbidities are also presented. Written by highly experienced physicians with special expertise in lupus, Lupus Erythematosus: Clinical Evaluation and Treatment is an indispensable reference for the common and not so common problems affecting patients with lupus.

Download or read book Clinical Mentation Evaluation written by Michael Hoffmann and published by Springer Nature. This book was released on 2020-05-31 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first-of-its-kind book offers clinicians a unique and comprehensive system of cognitive and behavioral testing that is tiered and context-appropriate for the diagnosis of mental status. Because the challenge nowadays with neurologic syndrome presentations is no longer merely lesion localization, but the degree, extent and nature of a cognitive and/or behavioral impairment, this work proposes a more targeted system of mentation evaluation -- one that incorporates behavioral, neurological, neuropsychiatric, and neuropsychological components. Developed by synthesizing outcomes data from a range of stroke registries, this novel work offers a stepwise, hierarchical approach to mentation evaluation largely determined by level of consciousness and degree of cooperation. Organized across 14 chapters, the book begins with an introduction to the challenges of cognitive and behavioral assessment, as well as a discussion of various clinical presentations ranging from mild behavioral impairment to cognitive reserve and its implications. Subsequent chapters then address various approaches to mental status evaluation and explore how these tests affect brain physiology. The work closes with a unique discussion of the various lay populations that may benefit from cognitive and behavioral evaluation. Authored by a renowned expert in the field, Clinical Mentation Evaluation: A Connectomal Approach to Rapid and Comprehensive Assessment is an invaluable reference that seeks to revitalize neurological and psychiatric disease measurement within the clinical setting. The work will be of interest to all clinicians in training and clinical practice who regularly, or even periodically, conduct mental status examination.

Download or read book Fluid Electrolyte and Acid Base Disorders written by Alluru S. Reddi and published by Springer Science & Business Media. This book was released on 2013-10-23 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fluid, Electrolyte and Acid-Base Disorders: Clinical Evaluation & Management is a clear and concise presentation of the fundamentals of fluid, electrolyte and acid-base disorders frequently encountered in clinical practice. Each chapter begins with pertinent basic physiology followed by its clinical disorder. Cases for each fluid, electrolyte and acid-base disorder are discussed with answers. In addition, board-type questions with explanations are provided for each clinical disorder to increase the knowledge for the clinician. Practical and clinically oriented, this book is a handy reference for practicing physicians, students, residents and fellows.

Download or read book Acid Base Disorders written by Alluru S. Reddi and published by Springer Nature. This book was released on 2019-10-31 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a concise yet comprehensive overview of acid-base disorders. Each chapter reviews an acid-base disorder, covering pathophysiology, evaluation, and management of the disorder. The chapters also include clinical cases and a Q&A section, based on scenarios and questions that clinicians regularly encounter when treating patients with these disorders. The book concludes with two chapters on acid-based disorders in special patient populations, including critically ill patients, pregnant patients, and surgical patients. Written by an expert in the field, Acid-Base Disorders: Clinical Evaluation and Management is a state-of-the-art resource that should assist clinicians and practitioners in managing patients with acid-base disorders.

Download or read book Practical Guide to the Evaluation of Clinical Competence written by Eric S. Holmboe and published by . This book was released on 2017-05-01 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed to help medical educators implement better assessment methods, tools, and models directly into training programs, Practical Guide to the Evaluation of Clinical Competence, 2nd Edition, by Drs. Eric S. Holmboe, Steven J. Durning, and Richard E. Hawkins, is a hands-on, authoritative guide to outcomes-based assessment in clinical education. National and international experts present an organized, multifaceted approach and a diverse combination of methods to help you perform effective assessments. This thoroughly revised edition is a valuable resource for developing, implementing, and sustaining effective systems for evaluating clinical competence in medical school, residency, and fellowship programs.

Download or read book ASHT Clinical Assessment Recommendations 3rd Edition written by Joy MacDermid and published by . This book was released on 2015-09-30 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Practical Guide to the Evaluation of Clinical Competence E Book written by Eric S. Holmboe and published by Elsevier Health Sciences. This book was released on 2023-11-24 with total page 467 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offering a multifaceted, practical approach to the complex topic of clinical assessment, Practical Guide to the Assessment of Clinical Competence, 3rd Edition, is designed to help medical educators employ better assessment methods, tools, and models directly into their training programs. World-renowned editors and expert contributing authors provide hands-on, authoritative guidance on outcomes-based assessment in clinical education, presenting a well-organized, diverse combination of methods you can implement right away. This thoroughly revised edition is a valuable resource for developing, implementing, and sustaining effective systems for assessing clinical competence in medical school, residency, and fellowship programs. - Helps medical educators and administrators answer complex, ongoing, and critical questions in today's changing medical education system: Is this undergraduate or postgraduate medical student prepared and able to move to the next level of training? To be a competent and trusted physician? - Provides practical suggestions and assessment approaches that can be implemented immediately in your training program, tools that can be used to assess and measure clinical performance, overviews of key educational theories, and strengths and weaknesses of every method. - Covers assessment techniques, frameworks, high-quality assessment of clinical reasoning and procedural competence, psychometrics, and practical approaches to feedback. - Includes expanded coverage of fast-moving areas where concepts now have solid research and data that support practical ways to connect judgments of ability to outcomes—including work-based assessments, clinical competency committees, milestones and entrustable professional assessments (EPAs), and direct observation. - Offers examples of assessment instruments along with suggestions on how you can apply these methods and instruments in your own setting, as well as guidelines that apply across the medical education spectrum. - Includes online access to videos of medical interviewing scenarios and more, downloadable assessment tools, and detailed faculty guidelines. - An eBook version is included with purchase. The eBook allows you to access all of the text, figures, and references, with the ability to search, make notes and highlights, and have content read aloud.

Download or read book Clinical Evaluation and Management of Spasticity written by David A. Gelber and published by Springer Science & Business Media. This book was released on 2001-11-02 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: David A. Gelber, MD, and Douglas R. Jeffery, MD, have assembled a much-needed collection of authoritative review articles discussing the pathophysiology of chronic neurologic spasticity and detailing its often complex medical and surgical management. Written by leading experts in neurology and rehabilitation, the book covers physical and occupational therapy, splinting and orthotics, electrical stimulation, orthopedic interventions, nerve blocks, the use of botulinum toxin, and novel treatments such as tizanidine, intrathecal medications, and neurosurgical techniques. The contributors also review coordinated approaches to the treatment of spasticity and specific neurological diseases such as spinal cord injury, multiple sclerosis, stroke, cerebral palsy, and traumatic brain injury.

Download or read book The Statistical Evaluation of Medical Tests for Classification and Prediction written by Margaret Sullivan Pepe and published by OUP Oxford. This book was released on 2003-03-13 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes statistical techniques for the design and evaluation of research studies on medical diagnostic tests, screening tests, biomarkers and new technologies for classification and prediction in medicine.

Download or read book Clinical Pharmacist s Guide to Biostatistics and Literature Evaluation written by Robert DiCenzo and published by . This book was released on 2011 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: Whether you are interpreting the medical literature to optimize patient care, improve health outcomes, or generate hypothesis for research, an understanding of biostatistics is essential for success. Despite exposure to biostatistics in undergraduate and professional education, pharmacists tend to be less confident in their knowledge of biostatistics and their ability to interpret the medical literature than in their clinical skills. This book was developed to bolster the pharmacist's knowledge and confidence for using biostatistical tools for interpreting the literature. With material drawn from ACCP's renowned Pharmacotherapy Self-Assessment Program (PSAP) and the live pharmacotherapy preparatory course Updates in Therapeutics, editor Robert DiCenzo, Pharm.D., FCCP, BCPS, has designed this review to support pharmacists' preparation for the Pharmacotherapy and Ambulatory Care Board of Pharmacy Specialties (BPS) examinations.

Download or read book Diagnostic and Statistical Manual of Mental Disorders DSM 5 written by American Psychiatric Association and published by American Psychiatric Publishing. This book was released on 2021-09-24 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: