A Practical Approach to Quantitative Validation of Patient-Reported Outcomes: A Simulation-Based Guide Using SAS (Hardcover)
暫譯: 患者報告結果的定量驗證實務方法：基於模擬的SAS指南（精裝版）

Bushmakin, Andrew G., Cappelleri, Joseph C.

A Practical Approach to Quantitative Validation of Patient-Reported Outcomes: A Simulation-Based Guide Using SAS (Hardcover)
  • 出版商: Wiley
  • 出版日期: 2022-12-01
  • 售價: $1,850
  • 貴賓價: 9.8 折 $1,813
  • 語言: 英文
  • 頁數: 368
  • 裝訂: Hardcover - also called cloth, retail trade, or trade
  • ISBN: 1119376378
  • ISBN-13: 9781119376378
  • 相關分類: 大數據 Big-data

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商品描述

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:

  • A thorough introduction to patient-reported outcomes, including their definition, development, and psychometric validation
  • 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
  • In-depth discussions of key concepts related to a validation of a measurement scale
  • 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

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:

  • HUMAN AND BIOLOGICAL SCIENCES
  • EARTH AND ENVIRONMENTAL SCIENCES
  • INDUSTRY, COMMERCE AND FINANCE

商品描述(中文翻譯)

基於模擬的SAS指南

在患者報告結果的定量驗證實用方法一書中，兩位傑出的研究者擁有50年的共同研究經驗和數百篇有關以患者為中心的研究的出版物，詳細而全面地闡述了進行患者報告結果（PROs）定量驗證所需的關鍵步驟。該書對PROs的心理測量驗證方法的主要方面提供了深刻且具指導性的解釋和討論，特別適用於由製藥行業贊助的醫療應用，其中SAS是主要軟體，並在監管及其他醫療環境中進行評估。

主要主題包括測試-重測信度、探索性和確認性因素分析、構念和標準效度、反應性和敏感性、PRO分數和結果的解釋，以及患者內部的有意義變化和臨床重要差異。作者提供逐步指導，帶領讀者了解如何在PRO分析之前結構化數據，並展示如何使用基於現實情境的模擬範例來實施分析。

讀者還將發現：


  • 對患者報告結果的全面介紹，包括其定義、發展和心理測量驗證

  • 對驗證工作流程的全面探索，包括將臨床試驗作為驗證數據來源的討論，以及單項和多項量表的驗證工作流程

  • 對與測量量表驗證相關的關鍵概念的深入討論

  • 特別關注美國食品藥品監督管理局（FDA）對PROs的開發和驗證指導，這為執行的分析方法奠定了基礎和靈感

患者報告結果的定量驗證實用方法是一本必備的參考書，將惠及心理測量學家、統計學家、生物統計學家、流行病學家、健康服務和公共衛生研究人員、結果研究科學家、監管機構和支付者。

實務中的統計學

一系列實用書籍，概述了統計技術在廣泛應用領域中的使用：


  • 人類與生物科學

  • 地球與環境科學

  • 工業、商業與金融

作者簡介

ANDREW G. BUSHMAKIN earned his M.S. in applied mathematics and physics from the National Research Nuclear University (former Moscow Engineering Physics Institute, Moscow, Russia). He has more than 20 years of experience in mathematical modeling and data analysis. He is a director of biostatistics in the Statistical Research and Data Science Center at Pfizer Inc. He has co-authored numerous articles and presentations on topics ranging from mathematical modeling of neutron physics processes to patient-reported outcomes, as well as several monographs.

JOSEPH C. CAPPELLERI earned his M.S. in statistics from the City University of New York, Ph.D. in psychometrics from Cornell University, and M.P.H. in epidemiology from Harvard University. He is an Executive Director of biostatistics in the Statistical Research and Data Science Center at Pfizer Inc. As an adjunct professor, he has served on the faculties of Brown University, University of Connecticut, and Tufts Medical Center. He has delivered numerous conference presentations and has published extensively on clinical and methodological topics. He is a fellow of the American Statistical Association and recipient of the ISPOR Avedis Donabedian Outcomes Research Lifetime Achievement Award.

作者簡介(中文翻譯)

安德魯·G·布什馬金獲得了國立研究核能大學（前莫斯科工程物理學院，俄羅斯莫斯科）的應用數學和物理碩士學位。他在數學建模和數據分析方面擁有超過20年的經驗。他是輝瑞公司統計研究與數據科學中心的生物統計學主任。他共同撰寫了多篇文章和報告，主題涵蓋從中子物理過程的數學建模到病人報告結果，以及幾本專著。

約瑟夫·C·卡佩萊里獲得了紐約市立大學的統計碩士學位、康奈爾大學的心理測量學博士學位，以及哈佛大學的流行病學公共衛生碩士學位。他是輝瑞公司統計研究與數據科學中心的生物統計學執行董事。作為兼任教授，他曾在布朗大學、康乃爾大學和塔夫茨醫學中心任教。他在多個會議上發表了演講，並在臨床和方法論主題上發表了大量文章。他是美國統計協會的會員，並獲得ISPOR Avedis Donabedian成果研究終身成就獎。

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