Download or read book Statistical Procedures for the Medical Device Industry written by Wayne A. Taylor and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Statistical Methods in Healthcare written by Frederick W. Faltin and published by John Wiley & Sons. This book was released on 2012-07-24 with total page 533 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Methods in Healthcare In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed. With a focus on finding solutions to these challenges, this book: Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development. Offers a broad coverage of standards and established methods through leading edge techniques. Uses an integrated case study based approach, with focus on applications. Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance. Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes. Addresses the use of modern statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision. Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.

Download or read book Medical Product Safety Evaluation written by Jie Chen and published by CRC Press. This book was released on 2018-09-03 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.

Download or read book Statistical Methods and Analyses for Medical Devices written by Scott A. Pardo and published by Springer Nature. This book was released on 2023-04-24 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a reference for people working in the design, development, and manufacturing of medical devices. ​While there are no statistical methods specifically intended for medical devices, there are methods that are commonly applied to various problems in the design, manufacturing, and quality control of medical devices. The aim of this book is not to turn everyone working in the medical device industries into mathematical statisticians; rather, the goal is to provide some help in thinking statistically, and knowing where to go to answer some fundamental questions, such as justifying a method used to qualify/validate equipment, or what information is necessary to support the choice of sample sizes. While, there are no statistical methods specifically designed for analysis of medical device data, there are some methods that seem to appear regularly in relation to medical devices. For example, the assessment of receiver operating characteristic curves is fundamental to development of diagnostic tests, and accelerated life testing is often critical for assessing the shelf life of medical device products. Another example is sensitivity/specificity computations are necessary for in-vitro diagnostics, and Taguchi methods can be very useful for designing devices. Even notions of equivalence and noninferiority have different interpretations in the medical device field compared to pharmacokinetics. It contains topics such as dynamic modeling, machine learning methods, equivalence testing, and experimental design, for example. This book is for those with no statistical experience, as well as those with statistical knowledgeable—with the hope to provide some insight into what methods are likely to help provide rationale for choices relating to data gathering and analysis activities for medical devices.

Download or read book Computational and Statistical Methods for Analysing Big Data with Applications written by Shen Liu and published by Academic Press. This book was released on 2015-11-20 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to the scale and complexity of data sets currently being collected in areas such as health, transportation, environmental science, engineering, information technology, business and finance, modern quantitative analysts are seeking improved and appropriate computational and statistical methods to explore, model and draw inferences from big data. This book aims to introduce suitable approaches for such endeavours, providing applications and case studies for the purpose of demonstration. Computational and Statistical Methods for Analysing Big Data with Applications starts with an overview of the era of big data. It then goes onto explain the computational and statistical methods which have been commonly applied in the big data revolution. For each of these methods, an example is provided as a guide to its application. Five case studies are presented next, focusing on computer vision with massive training data, spatial data analysis, advanced experimental design methods for big data, big data in clinical medicine, and analysing data collected from mobile devices, respectively. The book concludes with some final thoughts and suggested areas for future research in big data. - Advanced computational and statistical methodologies for analysing big data are developed - Experimental design methodologies are described and implemented to make the analysis of big data more computationally tractable - Case studies are discussed to demonstrate the implementation of the developed methods - Five high-impact areas of application are studied: computer vision, geosciences, commerce, healthcare and transportation - Computing code/programs are provided where appropriate

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 Statistical Methods in Diagnostic Medicine written by Xiao-Hua Zhou and published by John Wiley & Sons. This book was released on 2014-08-21 with total page 597 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition " . . . the book is a valuable addition to the literature in the field, serving as a much-needed guide for both clinicians and advanced students."—Zentralblatt MATH A new edition of the cutting-edge guide to diagnostic tests in medical research In recent years, a considerable amount of research has focused on evolving methods for designing and analyzing diagnostic accuracy studies. Statistical Methods in Diagnostic Medicine, Second Edition continues to provide a comprehensive approach to the topic, guiding readers through the necessary practices for understanding these studies and generalizing the results to patient populations. Following a basic introduction to measuring test accuracy and study design, the authors successfully define various measures of diagnostic accuracy, describe strategies for designing diagnostic accuracy studies, and present key statistical methods for estimating and comparing test accuracy. Topics new to the Second Edition include: Methods for tests designed to detect and locate lesions Recommendations for covariate-adjustment Methods for estimating and comparing predictive values and sample size calculations Correcting techniques for verification and imperfect standard biases Sample size calculation for multiple reader studies when pilot data are available Updated meta-analysis methods, now incorporating random effects Three case studies thoroughly showcase some of the questions and statistical issues that arise in diagnostic medicine, with all associated data provided in detailed appendices. A related web site features Fortran, SAS®, and R software packages so that readers can conduct their own analyses. Statistical Methods in Diagnostic Medicine, Second Edition is an excellent supplement for biostatistics courses at the graduate level. It also serves as a valuable reference for clinicians and researchers working in the fields of medicine, epidemiology, and biostatistics.

Download or read book Munro s Statistical Methods for Health Care Research written by Stacey Beth Plichta and published by Lippincott Williams & Wilkins. This book was released on 2012 with total page 567 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work provides a foundation in the statistics portion of nursing. Topics expanded in this edition include reliability analysis, path analysis, measurement error, missing data, and survival analysis.

Download or read book Statistical Analysis of Empirical Data written by Scott Pardo and published by Springer Nature. This book was released on 2020-05-04 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Researchers and students who use empirical investigation in their work must go through the process of selecting statistical methods for analyses, and they are often challenged to justify these selections. This book is designed for readers with limited background in statistical methodology who seek guidance in defending their statistical decision-making in the worlds of research and practice. It is devoted to helping students and scholars find the information they need to select data analytic methods, and to speak knowledgeably about their statistical research processes. Each chapter opens with a conundrum relating to the selection of an analysis, or to explaining the nature of an analysis. Throughout the chapter, the analysis is described, along with some guidance in justifying the choices of that particular method. Designed to offer statistical knowledge to the non-specialist, this volume can be used in courses on research methods, or for courses on statistical applications to biological, medical, life, social, or physical sciences. It will also be useful to academic and industrial researchers in engineering and in the physical sciences who will benefit from a stronger understanding of how to analyze empirical data. The book is written for those with foundational education in calculus. However, a brief review of fundamental concepts of probability and statistics, together with a primer on some concepts in elementary calculus and matrix algebra, is included. R code and sample datasets are provided.

Download or read book Statistical Methods for Healthcare Performance Monitoring written by Alex Bottle and published by CRC Press. This book was released on 2016-08-05 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare is important to everyone, yet large variations in its quality have been well documented both between and within many countries. With demand and expenditure rising, it’s more crucial than ever to know how well the healthcare system and all its components – from staff member to regional network – are performing. This requires data, which inevitably differ in form and quality. It also requires statistical methods, the output of which needs to be presented so that it can be understood by whoever needs it to make decisions. Statistical Methods for Healthcare Performance Monitoring covers measuring quality, types of data, risk adjustment, defining good and bad performance, statistical monitoring, presenting the results to different audiences and evaluating the monitoring system itself. Using examples from around the world, it brings all the issues and perspectives together in a largely non-technical way for clinicians, managers and methodologists. Statistical Methods for Healthcare Performance Monitoring is aimed at statisticians and researchers who need to know how to measure and compare performance, health service regulators, health service managers with responsibilities for monitoring performance, and quality improvement scientists, including those involved in clinical audits.

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

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 Essential Statistical Methods for Medical Statistics written by J. Philip Miller and published by Elsevier. This book was released on 2010-11-08 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essential Statistical Methods for Medical Statistics presents only key contributions which have been selected from the volume in the Handbook of Statistics: Medical Statistics, Volume 27 (2009). While the use of statistics in these fields has a long and rich history, the explosive growth of science in general, and of clinical and epidemiological sciences in particular, has led to the development of new methods and innovative adaptations of standard methods. This volume is appropriately focused for individuals working in these fields. Contributors are internationally renowned experts in their respective areas. - Contributors are internationally renowned experts in their respective areas - Addresses emerging statistical challenges in epidemiological, biomedical, and pharmaceutical research - Methods for assessing Biomarkers, analysis of competing risks - Clinical trials including sequential and group sequential, crossover designs, cluster randomized, and adaptive designs - Structural equations modelling and longitudinal data analysis

Download or read book Statistical Modeling for Biomedical Researchers written by William D. Dupont and published by Cambridge University Press. This book was released on 2009-02-12 with total page 543 pages. Available in PDF, EPUB and Kindle. Book excerpt: A second edition of the easy-to-use standard text guiding biomedical researchers in the use of advanced statistical methods.

Download or read book Statistical Models and Methods for Lifetime Data written by Jerald F. Lawless and published by John Wiley & Sons. This book was released on 2011-01-25 with total page 662 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition "An indispensable addition to any serious collection on lifetime data analysis and . . . a valuable contribution to the statistical literature. Highly recommended . . ." -Choice "This is an important book, which will appeal to statisticians working on survival analysis problems." -Biometrics "A thorough, unified treatment of statistical models and methods used in the analysis of lifetime data . . . this is a highly competent and agreeable statistical textbook." -Statistics in Medicine The statistical analysis of lifetime or response time data is a key tool in engineering, medicine, and many other scientific and technological areas. This book provides a unified treatment of the models and statistical methods used to analyze lifetime data. Equally useful as a reference for individuals interested in the analysis of lifetime data and as a text for advanced students, Statistical Models and Methods for Lifetime Data, Second Edition provides broad coverage of the area without concentrating on any single field of application. Extensive illustrations and examples drawn from engineering and the biomedical sciences provide readers with a clear understanding of key concepts. New and expanded coverage in this edition includes: * Observation schemes for lifetime data * Multiple failure modes * Counting process-martingale tools * Both special lifetime data and general optimization software * Mixture models * Treatment of interval-censored and truncated data * Multivariate lifetimes and event history models * Resampling and simulation methodology

Download or read book Statistical Methods for Health Care Research written by Barbara Hazard Munro and published by Lippincott Williams & Wilkins. This book was released on 2005 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on the statistical methods most frequently used in the health care literature and featuring numerous charts, graphs, and up-to-date examples from the literature, this text provides a thorough foundation for the statistics portion of nursing and all health care research courses. All Fifth Edition chapters include new examples and new computer printouts using the latest software, SPSS for Windows, Version 12. New material on regression diagnostics has been added.

Download or read book Statistical Methods for Six Sigma written by Anand M. Joglekar and published by John Wiley & Sons. This book was released on 2003-09-19 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to achieving business successes through statistical methods Statistical methods are a key ingredient in providing data-based guidance to research and development as well as to manufacturing. Understanding the concepts and specific steps involved in each statistical method is critical for achieving consistent and on-target performance. Written by a recognized educator in the field, Statistical Methods for Six Sigma: In R&D and Manufacturing is specifically geared to engineers, scientists, technical managers, and other technical professionals in industry. Emphasizing practical learning, applications, and performance improvement, Dr. Joglekar?s text shows today?s industry professionals how to: Summarize and interpret data to make decisions Determine the amount of data to collect Compare product and process designs Build equations relating inputs and outputs Establish specifications and validate processes Reduce risk and cost-of-process control Quantify and reduce economic loss due to variability Estimate process capability and plan process improvements Identify key causes and their contributions to variability Analyze and improve measurement systems This long-awaited guide for students and professionals in research, development, quality, and manufacturing does not presume any prior knowledge of statistics. It covers a large number of useful statistical methods compactly, in a language and depth necessary to make successful applications. Statistical methods in this book include: variance components analysis, variance transmission analysis, risk-based control charts, capability and performance indices, quality planning, regression analysis, comparative experiments, descriptive statistics, sample size determination, confidence intervals, tolerance intervals, and measurement systems analysis. The book also contains a wealth of case studies and examples, and features a unique test to evaluate the reader?s understanding of the subject.