A Practical Approach to Quantitative Validation of Patient-Reported Outcomes

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1119376378
Total Pages : 372 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis A Practical Approach to Quantitative Validation of Patient-Reported Outcomes by : Andrew G. Bushmakin

Download or read book A Practical Approach to Quantitative Validation of Patient-Reported Outcomes written by Andrew G. Bushmakin and published by John Wiley & Sons. This book was released on 2022-12-20 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher : CRC Press
ISBN 13 : 1439873674
Total Pages : 354 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Patient-Reported Outcomes by : Joseph C. Cappelleri

Download or read book Patient-Reported Outcomes written by Joseph C. Cappelleri and published by CRC Press. This book was released on 2013-12-20 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher : RTI Press
ISBN 13 : 193483114X
Total Pages : 97 pages
Book Rating : 4.9/5 (348 download)

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Book Synopsis Patient-Reported Outcomes in Performance Measurement by : David Cella

Download or read book Patient-Reported Outcomes in Performance Measurement written by David Cella and published by RTI Press. This book was released on 2015-09-17 with total page 97 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher : SEEd
ISBN 13 : 8897419607
Total Pages : 42 pages
Book Rating : 4.8/5 (974 download)

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Book Synopsis Patient Reported Outcomes by : Annabel Nixon

Download or read book Patient Reported Outcomes written by Annabel Nixon and published by SEEd. This book was released on 2015-07-01 with total page 42 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Registries for Evaluating Patient Outcomes

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Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Quality of Life

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 111875901X
Total Pages : 648 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Quality of Life by : Peter M. Fayers

Download or read book Quality of Life written by Peter M. Fayers and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 648 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Patient-Reported Outcomes

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Author :
Publisher : Chapman & Hall/CRC
ISBN 13 : 9781138199590
Total Pages : 0 pages
Book Rating : 4.1/5 (995 download)

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Book Synopsis Patient-Reported Outcomes by : Joseph C. Cappelleri

Download or read book Patient-Reported Outcomes written by Joseph C. Cappelleri and published by Chapman & Hall/CRC. This book was released on 2016-11-16 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advancing the development, validation, and use of PRO measures, this book 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 authors include many real-life applications and implement a wealth of simulated datasets to illustrate concepts. Most chapters contain SAS code and output that demonstrate the methodology.

Health Measurement Scales

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Publisher : Oxford University Press, USA
ISBN 13 : 0199685215
Total Pages : 415 pages
Book Rating : 4.1/5 (996 download)

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Book Synopsis Health Measurement Scales by : David L. Streiner

Download or read book Health Measurement Scales written by David L. Streiner and published by Oxford University Press, USA. This book was released on 2015 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: A new edition of this practical guide for clinicians who are developing tools to measure subjective states, attitudes, or non-tangible outcomes in their patients, suitable for those who have no knowledge of statistics.

Conducting patient interviews within a clinical trial setting

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Author :
Publisher : RTI Press
ISBN 13 :
Total Pages : 11 pages
Book Rating : 4./5 ( download)

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Book Synopsis Conducting patient interviews within a clinical trial setting by : Dana B DiBenedetti

Download or read book Conducting patient interviews within a clinical trial setting written by Dana B DiBenedetti and published by RTI Press. This book was released on 2018-08-14 with total page 11 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Using Patient Reported Outcomes to Improve Health Care

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1118948602
Total Pages : 120 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Using Patient Reported Outcomes to Improve Health Care by : John Appleby

Download or read book Using Patient Reported Outcomes to Improve Health Care written by John Appleby and published by John Wiley & Sons. This book was released on 2016-01-19 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Getting the Most Out of PROMs

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Publisher :
ISBN 13 : 9781857175912
Total Pages : 83 pages
Book Rating : 4.1/5 (759 download)

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Book Synopsis Getting the Most Out of PROMs by : N. J. Devlin

Download or read book Getting the Most Out of PROMs written by N. J. Devlin and published by . This book was released on 2010 with total page 83 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patient-reported outcome measures (PROMs) use a series of structured questions that ask patients about their health from their point of view, with the aim of improving decision-making at all levels of the NHS. This report looks at the ways in which PROMs data can be used.

Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation

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Publisher : John Wiley & Sons
ISBN 13 : 047075382X
Total Pages : 389 pages
Book Rating : 4.4/5 (77 download)

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Book Synopsis Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation by : Stephen J. Walters

Download or read book Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation written by Stephen J. Walters and published by John Wiley & Sons. This book was released on 2009-10-26 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

ePro

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Publisher : CRC Press
ISBN 13 : 1317141911
Total Pages : 296 pages
Book Rating : 4.3/5 (171 download)

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Book Synopsis ePro by : Brian Tiplady

Download or read book ePro written by Brian Tiplady and published by CRC Press. This book was released on 2016-05-13 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patient self-reported data has become increasingly important in today's clinical trials. Trials in some disease indications rely upon patient recorded diary data as the primary endpoint to demonstrate drug efficacy - including, for example, indications such as insomnia, migraine and pain. In addition, improvements in quality of life measured using patient questionnaires can now be included as claims on drug labelling. Traditionally these data have been collected using paper questionnaires and diaries issued to subjects. Regulators and the industry have become increasingly aware of the limitations of recording patient reported outcomes data on paper including data quality and integrity issues. As a result there is a growing interest in collection of patient reported outcomes data using electronic means (ePRO). Solutions include handheld PDAs, Interactive Voice Response (IVR) systems, and other site-based hardware such as touchscreen PCs. Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. These include: ¢ How should instruments developed on paper be adapted for electronic use, and what degree of validation should be done between paper and electronic forms? ¢ How can researchers ensure they are complying with regulatory requirements including the PRO guidance published by FDA in 2009 when using ePRO solutions? ¢ Can fewer patients be exposed in a clinical trial as a result of improved data quality obtained using electronic diaries? ¢ What type of solution should be used for certain patient populations and protocols, and how can ePRO solutions be designed optimally to increase patient acceptability and compliance? Bill Byrom and Brian Tiplady's ePro addresses all these issues, reviews the new FDA guidance, and provides a very contemporary view on this important subject.

Electronic Patient-Reported Outcome Measures

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Author :
Publisher :
ISBN 13 : 9781720281108
Total Pages : 96 pages
Book Rating : 4.2/5 (811 download)

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Book Synopsis Electronic Patient-Reported Outcome Measures by : Bill Byrom

Download or read book Electronic Patient-Reported Outcome Measures written by Bill Byrom and published by . This book was released on 2018-09-19 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

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Author :
Publisher : Government Printing Office
ISBN 13 : 1587634236
Total Pages : 204 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)

Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

High Quality Care for All

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Author :
Publisher : The Stationery Office
ISBN 13 : 9780101743228
Total Pages : 92 pages
Book Rating : 4.7/5 (432 download)

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Book Synopsis High Quality Care for All by : Secretary of State for Health

Download or read book High Quality Care for All written by Secretary of State for Health and published by The Stationery Office. This book was released on 2008 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: This review incorporates the views and visions of 2,000 clinicians and other health and social care professionals from every NHS region in England, and has been developed in discussion with patients, carers and the general public. The changes proposed are locally-led, patient-centred and clinically driven. Chapter 2 identifies the challenges facing the NHS in the 21st century: ever higher expectations; demand driven by demographics as people live longer; health in an age of information and connectivity; the changing nature of disease; advances in treatment; a changing health workplace. Chapter 3 outlines the proposals to deliver high quality care for patients and the public, with an emphasis on helping people to stay healthy, empowering patients, providing the most effective treatments, and keeping patients as safe as possible in healthcare environments. The importance of quality in all aspects of the NHS is reinforced in chapter 4, and must be understood from the perspective of the patient's safety, experience in care received and the effectiveness of that care. Best practice will be widely promoted, with a central role for the National Institute for Health and Clinical Excellence (NICE) in expanding national standards. This will bring clarity to the high standards expected and quality performance will be measured and published. The review outlines the need to put frontline staff in control of this drive for quality (chapter 5), with greater freedom to use their expertise and skill and decision-making to find innovative ways to improve care for patients. Clinical and managerial leadership skills at the local level need further development, and all levels of staff will receive support through education and training (chapter 6). The review recommends the introduction of an NHS Constitution (chapter 7). The final chapter sets out the means of implementation.

Equity and excellence:

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Author :
Publisher : The Stationery Office
ISBN 13 : 9780101788120
Total Pages : 64 pages
Book Rating : 4.7/5 (881 download)

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Book Synopsis Equity and excellence: by : Great Britain: Department of Health

Download or read book Equity and excellence: written by Great Britain: Department of Health and published by The Stationery Office. This book was released on 2010-07-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equity and Excellence : Liberating the NHS: Presented to Parliament by the Secretary of State for Health by Command of Her Majesty