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.

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.

Hospitals monitoring is becoming more complex and is increasing both because staff want their data analysed and because of increasing mandated surveillance. This book provides a suite of functions in R, enabling scientists and data analysts working in infection management and quality improvement departments in hospitals, to analyse their often non-independent data which is frequently in the form of trended, over-dispersed and sometimes auto-correlated time series; this is often difficult to analyse using standard office software. This book provides much-needed guidance on data analysis using R for the growing number of scientists in hospital departments who are responsible for producing reports, and who may have limited statistical expertise. This book explores data analysis using R and is aimed at scientists in hospital departments who are responsible for producing reports, and who are involved in improving safety. Professionals working in the healthcare quality and safety community will also find this book of interest Statistical Methods for Hospital Monitoring with R: Provides functions to perform quality improvement and infection management data analysis. Explores the characteristics of complex systems, such as self-organisation and emergent behaviour, along with their implications for such activities as root-cause analysis and the Pareto principle that seek few key causes of adverse events. Provides a summary of key non-statistical aspects of hospital safety and easy to use functions. Provides R scripts in an accompanying web site enabling analyses to be performed by the reader http://www.wiley.com/go/hospital_monitoring Covers issues that will be of increasing importance in the future, such as, generalised additive models, and complex systems, networks and power laws.

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.

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.

Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

Praise for the Second Edition "As a comprehensive statistics reference book for quality improvement, it certainly is one of the best books available." —Technometrics This new edition continues to provide the most current, proven statistical methods for quality control and quality improvement The use of quantitative methods offers numerous benefits in the fields of industry and business, both through identifying existing trouble spots and alerting management and technical personnel to potential problems. Statistical Methods for Quality Improvement, Third Edition guides readers through a broad range of tools and techniques that make it possible to quickly identify and resolve both current and potential trouble spots within almost any manufacturing or nonmanufacturing process. The book provides detailed coverage of the application of control charts, while also exploring critical topics such as regression, design of experiments, and Taguchi methods. In this new edition, the author continues to explain how to combine the many statistical methods explored in the book in order to optimize quality control and improvement. The book has been thoroughly revised and updated to reflect the latest research and practices in statistical methods and quality control, and new features include: Updated coverage of control charts, with newly added tools The latest research on the monitoring of linear profiles and other types of profiles Sections on generalized likelihood ratio charts and the effects of parameter estimation on the properties of CUSUM and EWMA procedures New discussions on design of experiments that include conditional effects and fraction of design space plots New material on Lean Six Sigma and Six Sigma programs and training Incorporating the latest software applications, the author has added coverage on how to use Minitab software to obtain probability limits for attribute charts. new exercises have been added throughout the book, allowing readers to put the latest statistical methods into practice. Updated references are also provided, shedding light on the current literature and providing resources for further study of the topic. Statistical Methods for Quality Improvement, Third Edition is an excellent book for courses on quality control and design of experiments at the upper-undergraduate and graduate levels. the book also serves as a valuable reference for practicing statisticians, engineers, and physical scientists interested in statistical quality improvement.

With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to request for HEOR evidence, in addition to data from clinical trials, to inform decisions about patient access to new treatment options. While there is a great deal of literature on HEOR, there is a need for a volume that presents a coherent and unified review of the major issues that arise in application, especially from a statistical perspective. Statistical Topics in Health Economics and Outcomes Research fulfils that need by presenting an overview of the key analytical issues and best practice. Special attention is paid to key assumptions and other salient features of statistical methods customarily used in the area, and appropriate and relatively comprehensive references are made to emerging trends. The content of the book is purposefully designed to be accessible to readers with basic quantitative backgrounds, while providing an in-depth coverage of relatively complex statistical issues. The book will make a very useful reference for researchers in the pharmaceutical industry, academia, and research institutions involved with HEOR studies. The targeted readers may include statisticians, data scientists, epidemiologists, outcomes researchers, health economists, and healthcare policy and decision-makers.

Encyclopedic in breadth, yet practical and concise, Medical Biostatistics, Fourth Edition focuses on the statistical aspects ofmedicine with a medical perspective, showing the utility of biostatistics as a tool to manage many medical uncertainties. This edition includes more topics in order to fill gaps in the previous edition. Various topics have been enlarged and modified as per the new understanding of the subject.

An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.