A Practical Approach To Quantitative Validation Of Patient Reported Outcomes
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A Practical Approach To Quantitative Validation Of Patient Reported Outcomes
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Author : Andrew G. Bushmakin
language : en
Publisher: John Wiley & Sons
Release Date : 2022-12-20
A Practical Approach To Quantitative Validation Of Patient Reported Outcomes written by Andrew G. Bushmakin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-20 with Medical categories.
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.
Patient Reported Outcomes
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Author : Joseph C. Cappelleri
language : en
Publisher: CRC Press
Release Date : 2013-12-20
Patient Reported Outcomes written by Joseph C. Cappelleri and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-12-20 with Mathematics categories.
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 In Performance Measurement
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Author : David Cella
language : en
Publisher: RTI Press
Release Date : 2015-09-17
Patient Reported Outcomes In Performance Measurement written by David Cella and has been published by RTI Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-17 with Medical categories.
Patient-reported outcomes (PROs) are measures of how patients feel or what they are able to do in the context of their health status; PROs are reports, usually on questionnaires, about a patient's health conditions, health behaviors, or experiences with health care that individuals report directly, without modification of responses by clinicians or others; thus, they directly reflect the voice of the patient. PROs cover domains such as physical health, mental and emotional health, functioning, symptoms and symptom burden, and health behaviors. They are relevant for many activities: helping patients and their clinicians make informed decisions about health care, monitoring the progress of care, setting policies for coverage and reimbursement of health services, improving the quality of health care services, and tracking or reporting on the performance of health care delivery organizations. We address the major methodological issues related to choosing, administering, and using PROs for these purposes, particularly in clinical practice settings. We include a framework for best practices in selecting PROs, focusing on choosing appropriate methods and modes for administering PRO measures to accommodate patients with diverse linguistic, cultural, educational, and functional skills, understanding measures developed through both classic and modern test theory, and addressing complex issues relating to scoring and analyzing PRO data.
Patient Reported Outcomes
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Author : Annabel Nixon
language : en
Publisher: SEEd
Release Date : 2015-07-01
Patient Reported Outcomes written by Annabel Nixon and has been published by SEEd this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-01 with Medical categories.
Patient reported outcomes (PROs) are a measurement based on a report that comes directly from the patient about the status of their health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. Valid and reliable PRO instruments are able to provide a standardized, quantifiable measure of treatment benefit, upon which the outcomes of interventions and treatment effect from the patient’s perspective can be judged. In some instances, PROs provide the best evidence of a treatment’s effectiveness, for example when evaluating treatments for pain, gastrointestinal and urological symptoms, or psychological well-being. This book aims to provide an overview of PRO applications, methodology and validation in order to help reader approach this measurement that are playing an increasingly central role in drug development decision making.
Quality Of Life
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Author : Peter M. Fayers
language : en
Publisher: John Wiley & Sons
Release Date : 2015-11-23
Quality Of Life written by Peter M. Fayers and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11-23 with Medical categories.
The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies. The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis. This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.
Using Patient Reported Outcomes To Improve Health Care
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Author : John Appleby
language : en
Publisher: John Wiley & Sons
Release Date : 2016-01-19
Using Patient Reported Outcomes To Improve Health Care written by John Appleby and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-01-19 with Medical categories.
A practical, introductory guide to the best use of Patient Reported Outcomes (PROs) to improve the quality of health care and patient health. Only title to exclusively introduce, explain and show how PROs can be best used to improve healthcare and patient outcomes Includes real life examples and case studies of PROs in practice Assesses the growing evidence base for PROs in practice Editor team from Office of Health Economics (OHE), The King's Fund and King’s College London with contributions from practising clinicians, GPs and other healthcare professionals
Quality Of Life Outcomes In Clinical Trials And Health Care Evaluation
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Author : Stephen J. Walters
language : en
Publisher: John Wiley & Sons
Release Date : 2009-10-26
Quality Of Life Outcomes In Clinical Trials And Health Care Evaluation written by Stephen J. Walters and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-10-26 with Medical categories.
An essential, up-to-date guide to the design of studies and selection of the correct QoL instruments for observational studies and clinical trials. Quality of Life (QoL) outcomes or Person/Patient Reported Outcome Measures (PROMs) are now frequently being used in randomised controlled trials (RCTs) and observational studies. This book provides a practical guide to the design, analysis and interpretation of studies that use such outcomes. QoL outcomes tend to generate data with discrete, bounded and skewed distributions. Many investigators are concerned about the appropriateness of using standard statistical methods to analyse QoL data and want guidance on what methods to use. QoL outcomes are frequently used in cross-sectional surveys and non-randomised health-care evaluations. Provides a user-friendly guide to the design and analysis of clinical trials and observational studies in relation to QoL outcomes. Discusses the problems caused by QoL outcomes and presents intervention options to help tackle them. Guides the reader step-by-step through the selection of appropriate QoLs. Features exercises and solutions and a supporting website providing downloadable data files. Illustrated throughout with examples and case studies drawn from the author’s experience, this book offers statisticians and clinicians guidance on choosing between the numerous available QoL instruments.
Conducting Patient Interviews Within A Clinical Trial Setting
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Author : Dana B DiBenedetti
language : en
Publisher: RTI Press
Release Date : 2018-08-14
Conducting Patient Interviews Within A Clinical Trial Setting written by Dana B DiBenedetti and has been published by RTI Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-14 with Medical categories.
Qualitative data centered on patients’ experiences and perspectives typically go uncollected in clinical trial settings. Yet patients’ treatment experiences offer complementary insights and context on topics such as disease management, treatment gaps, and previous treatments outside of those gathered in traditional patient-reported outcome questionnaires. Qualitative interviews can capture patients’ perceptions of treatment needs, more fully explore meaningful changes experienced as a result of treatment, and reveal outcomes that are most important to patients. Asking patients detailed questions can provide insight into the “why” of a patient’s expressed thought or feeling. The inclusion of patient interviews within clinical trials is a relatively new and evolving field of research. This article delineates the types of data that may be collected during interviews with clinical trial participants and outlines two approaches to conducting qualitative research in the clinical trial setting, with a focus on maximizing the value of the resulting data.
Electronic Patient Reported Outcome Measures
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Author : Bill Byrom
language : en
Publisher:
Release Date : 2018-09-19
Electronic Patient Reported Outcome Measures written by Bill Byrom and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-19 with categories.
The book concisely covers the entire landscape of ePROs and helps to dispel some of the myths and doubts on the topic. After making the case for ePRO assessment, the authors take the readers on a tour of issues related to design, validation, and implementation of ePRO solutions. The authors have provided recommendations ("Should skipping of items allowed?"), mitigation strategies ("How can we minimize issues that may arise during user acceptance testing?") and common pitfalls, such as issues that may arise when administering these assessments to patients from a variety of cultures. The bibliography of industry standards and best practices and the key references related to ePRO assessment make this book a valuable resource for anyone who wants to take a deep dive into the topic. Although the title of the book refers to patient-reported outcomes, the volume is a must-have for those who want to collect accurate and high-quality data relating to clinical outcomes in clinical trials. The authors are donating all royalties from the sale of this book. All royalties from book sales prior to October 2019 will be shared between the following registered charities. 50% of the royalties from the sale of this book will be donated to StoneBridge City Farm, Nottingham, UK. Stonebridge City Farm is a city farm in St. Ann's, Nottingham, looking after a range of animals, large and small and growing seasonal vegetables and herbs. They are a registered charity supporting people from Nottingham with learning disabilities. http: //www.stonebridgecityfarm.com/. Registered Charity Number: 1125245. 50% of the royalties will go to Make-A-Wish Ireland. Make-A-Wish Ireland has one simple aim - to grant the wishes of children with life-threatening medical conditions, to bring hope, strength and happiness. Since 1992, Make-A-Wish has granted wishes for more than 2,300 brave children across Ireland. A wish granted is true magic for the child, providing respite from their normal routines of hospitals, doctors and treatment. Make-A-Wish does not receive any government funding, and relies overwhelmingly on the kindness of the Irish public to continue granting wishes. https: //www.makeawish.ie/ Charity Registration Number: CRA20052256 / CHY15267
Patient Reported Outcomes
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Author : Joseph C. Cappelleri
language : en
Publisher: CRC Press
Release Date : 2013-12-20
Patient Reported Outcomes written by Joseph C. Cappelleri and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-12-20 with Mathematics categories.
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 healt