This book serves as a roadmap for the development and application of patient-reported outcome (PRO) measures, supporting beginners through to experts, as a practical guide. To elucidate on key concepts in the book, examples from clinical research in hyperhidrosis and health-related quality of life and medicines clinical development context, are used. Health-related quality of life represents one of the most commonly measured PROs in both routine clinical practice and research. The book demonstrates the importance of PROs to patients with chronic disease and how such outcomes can assist clinicians in managing patients and monitoring their response to treatment in terms of both symptoms and impacts.
This book will benefit readers as a single-source practical guide on the development of modern PRO measures and may also serve as a blueprint for the conceptualization and planning of evidence generation related to PROs in various settings. Ideas and suggestions on how to navigate recent developments shaping the field of PRO measurement are also offered.
Table of Content
1. Overview.- 2. Approaches to the Development and Use of PROs: A Unified Framework.- 3. An Illustration of the New PRO Measure Development Roadmap Using an Example from Skin Disease.- 4. Determination of Fitness for Purpose: Content Verification by Patients and Experts.- 5. Conventional Methods Meeting Modern Techniques: Factor Analysis Versus Rasch Analysis.- 6. Assessing the Performance of PROs Against Expectation: Psychometric Calibration.- 7. Integrating Patient Reported Outcomes in Clinical Trials, Routine Clinical Practice and Medicines Development Programmes.About the author
Dr Paul Kamudoni (Ph D MSc.) is a Scientific Associate Director in the Global Evidence and Value Development – R&D department at Merck Kga A in Darmstadt (Germany) where he leads the Centre of Excellence for Patient Reported Outcomes. Dr Kamudoni trained as a Pharmacoeconomist and a Clinical Outcome Measurement Scientist at Cardiff University. In his day to day work, he is involved in the development and validation of PRO measures, and the design and integration of PRO endpoints in clinical trials and other types of studies. He maintains an active research interest in methodological issues in the integration of electronic health records with prospective PRO assessments, and the application of item response theory in PRO measurement among others.Dr Nutjaree Pratheepawanit Johns (Ph D Pharm D) is an Associate Professor at the Faculty of Pharmaceutical Sciences, and melatonin research group, Khon Kaen University, Thailand. She has held a number of academic positions both in Thailand and abroad, including a fellowship at the Western Institutional Review Board (WIRB) (Olympia, WA, USA). Dr Johns has an expertise in cancer care and quality of life (Qo L) research and collaborates with several cancer centres in Northeastern Thailand. She has developed and tested a number of PRO measures including cross-cultural adaptation into the Thai language. Dr Johns is also a principal investigator in many clinical trials investigating the effects of disease or interventions on Qo L of cancer patients. She has been a recipient of several prestigious awards including Scholarship for Developing Country, International Society for Quality of Life Research and the Doyle Prize: Postgraduate section, Palliative Medicine Journal.
Professor Sam Salek (Ph D RPh FFPM FRPS MCMS FESCP) is Professor of Pharmacoepidemiology at the University of Hertfordshire, Hatfield, visiting Professor at the Estate of Hessen, Germany, and Director of the Institute for Medicines Development, Cardiff, UK. Professor Salek’s research focuses mainly on four areas: development and application of PRO measures; drug safety evaluation and pharmacovigilance; pharmacoeconomics and economic evaluation of healthcare; and pharmaceutical regulation & medicines development in the mature and emerging markets. He has published 22 books and 600+ journal articles and abstracts. Professor Salek is a member of five Editorial Boards and an active member of several societies.
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