Statistical Methods in Healthcare
Statistical Methods in Healthcare

Author: Frederick W. Faltin

Publisher: John Wiley & Sons

Published: 2012-07-24

Total Pages: 533

ISBN-13: 1119942047

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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.

Statistical Methods and Analyses for Medical Devices
Statistical Methods and Analyses for Medical Devices

Author: Scott A. Pardo

Publisher: Springer Nature

Published: 2023-04-24

Total Pages: 384

ISBN-13: 3031261399

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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.

Medical Product Safety Evaluation
Medical Product Safety Evaluation

Author: Jie Chen

Publisher: CRC Press

Published: 2018-09-03

Total Pages: 372

ISBN-13: 1351021974

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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.

Computational and Statistical Methods for Analysing Big Data with Applications
Computational and Statistical Methods for Analysing Big Data with Applications

Author: Shen Liu

Publisher: Academic Press

Published: 2015-11-20

Total Pages: 208

ISBN-13: 0081006519

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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

Munro's Statistical Methods for Health Care Research
Munro's Statistical Methods for Health Care Research

Author: Stacey Beth Plichta

Publisher: Lippincott Williams & Wilkins

Published: 2012

Total Pages: 567

ISBN-13: 9781451115611

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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.

Registries for Evaluating Patient Outcomes
Registries for Evaluating Patient Outcomes

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 385

ISBN-13: 1587634333

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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.

Statistical Analysis of Empirical Data
Statistical Analysis of Empirical Data

Author: Scott Pardo

Publisher: Springer Nature

Published: 2020-05-04

Total Pages: 278

ISBN-13: 3030433285

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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.

Statistical Methods for Healthcare Performance Monitoring
Statistical Methods for Healthcare Performance Monitoring

Author: Alex Bottle

Publisher: CRC Press

Published: 2016-08-05

Total Pages: 292

ISBN-13: 1482246104

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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.