A Simulation-Based Guide Using SAS In A Practical Approach to Quantitative Validation of Patient-Reported Outcomes, two distinguished researchers, with 50 years of collective research experience and hundreds of publications on patient-centered research, deliver a detailed and comprehensive exposition on the critical steps required for quantitative validation of patient-reported outcomes (PROs). The book provides an incisive and instructional explanation and discussion on major aspects of psychometric validation methodology on PROs, especially relevant for medical applications sponsored by the pharmaceutical industry, where SAS is the primary software, and evaluated in regulatory and other healthcare environments. Central topics include test-retest reliability, exploratory and confirmatory factor analyses, construct and criterion validity, responsiveness and sensitivity, interpretation of PRO scores and findings, and meaningful within-patient change and clinical important difference. The authors provide step-by-step guidance while walking readers through how to structure data prior to a PRO analysis and demonstrate how to implement analyses with simulated examples grounded in real-life scenarios. Readers will also find: <ul> <li>A thorough introduction to patient-reported outcomes, including their definition, development, and psychometric validation</li> <li>Comprehensive explorations of the validation workflow, including discussions of clinical trials as a data source for validation and the validation workflow for single and multi-item scales</li> <li>In-depth discussions of key concepts related to a validation of a measurement scale</li> <li>Special attention is given to the US Food and Drug Administration (FDA) guidance on development and validation of the PROs, which lay the foundation and inspiration for the analytic methods executed</li> </ul> A Practical Approach to Quantitative Validation of Patient-Reported Outcomes is a required reference that will benefit psychometricians, statisticians, biostatisticians, epidemiologists, health service and public health researchers, outcome research scientists, regulators, and payers. STATISTICS IN PRACTICE A series of practical books outlining the use of statistical techniques in a wide range of applications areas: <ul> <li>HUMAN AND BIOLOGICAL SCIENCES</li> <li>EARTH AND ENVIRONMENTAL SCIENCES</li> <li>INDUSTRY, COMMERCE AND FINANCE</li> </ul>

A Practical Approach to Quantitative Validation of Patient-Reported Outcomes: A Simulation-based Guide Using SAS (Statistics in Practice)

Science & Math

Cappelleri, Joseph C.

Bushmakin, Andrew G.

Biological Sciences

wiley

Patient-Reported Outcomes: Measurement, Implementation and Interpretation (Chapman & Hall/CRC Biostatistics Series)

Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up-to-date volume on conceptual and analytical issues of PRO measures. The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO measures. It covers both introductory and advanced psychometric and biostatistical methods for constructing and analyzing PRO measures. The authors include many relevant real-life applications based on their extensive first-hand experiences in the pharmaceutical industry. They implement a wealth of simulated datasets to illustrate concepts and heighten understanding based on practical scenarios. For readers interested in conducting statistical analyses of PRO measures and delving more deeply into the analytic details, most chapters contain SAS code and output that illustrate the methodology. Along with providing numerous references, the book highlights current regulatory guidelines.

Patient-Reported Outcomes (Chapman & Hall/CRC Biostatistics Series)

Routledge

Zou, Kelly H.

Alvir, Jose Ma. J.

Alemayehu, Demissie

Symonds, Tara

Chapman and Hall/CRC

This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.

Phase II Clinical Development of New Drugs (ICSA Book Series in Statistics)

Business & Money

Ting, Naitee

Chen, Ding-Geng

Ho, Shuyen

Management & Leadership

Springer

See the best price to sell, buy, or rent books by Cappelleri, Joseph C.. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Cappelleri, Joseph C.