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Author: Andrew G. Bushmakin Publisher: John Wiley & Sons ISBN: 1119376378 Category : Medical Languages : en Pages : 372
Book Description
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.
Author: Andrew G. Bushmakin Publisher: John Wiley & Sons ISBN: 1119376378 Category : Medical Languages : en Pages : 372
Book Description
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.
Author: Joseph C. Cappelleri Publisher: CRC Press ISBN: 1439873674 Category : Mathematics Languages : en Pages : 354
Book Description
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.
Author: Andrew G. Bushmakin Publisher: John Wiley & Sons ISBN: 1119376300 Category : Medical Languages : en Pages : 372
Book Description
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
Author: David Cella Publisher: RTI Press ISBN: 193483114X Category : Medical Languages : en Pages : 97
Book Description
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.
Author: Peter M. Fayers Publisher: John Wiley & Sons ISBN: 1118699459 Category : Medical Languages : en Pages : 460
Book Description
Quality of life studies form an essential part of the evaluation of any treatment. Written by two authors who are well respected within this field, Quality of Life: The Assessment, Analysis and Interpretation of Patient-reported Outcomes, Second Edition lays down guidelines on assessing, analysing and interpreting quality of life data. The new edition of this standard book has been completely revised, updated and expanded to reflect many methodological developments emerged since the publication of the first edition. Covers the design of instruments, the practical aspects of implementing assessment, the analyses of the data, and the interpretation of the results Presents all essential information on Quality of Life Research in one comprehensive volume Explains the use of qualitative and quantitative methods, including the application of basic statistical methods Includes copious practical examples Fills a need in a rapidly growing area of interest New edition accommodates significant methodological developments, and includes chapters on computer adaptive testing and item banking, choosing an instrument, systematic reviews and meta analysis This book is of interest for everyone involved in quality of life research, and it 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 practitioners in the fields of cancer and other chronic diseases. Reviews of the First Edition – Winner of the first prize in the Basis of Medicine Category of the BMA Medical Book Competition 2001: “This book is highly recommended to clinicians who are actively involved in the planning, analysis and publication of QoL research.” CLINICAL ONCOLOGY “This book is highly recommended reading.” QUALITY OF LIFE RESEARCH
Author: Agency for Healthcare Research and Quality/AHRQ Publisher: Government Printing Office ISBN: 1587634333 Category : Medical Languages : en Pages : 385
Book Description
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.
Author: David L. Streiner Publisher: Oxford University Press, USA ISBN: 0199685215 Category : Language Arts & Disciplines Languages : en Pages : 415
Book Description
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.
Author: Agency for Health Care Research and Quality (U.S.) Publisher: Government Printing Office ISBN: 1587634236 Category : Medical Languages : en Pages : 236
Book Description
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)
Author: Joseph C. Cappelleri Publisher: CRC Press ISBN: 1439873704 Category : Mathematics Languages : en Pages : 344
Book Description
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
Author: Shane P. Desselle Publisher: Academic Press ISBN: 0323914268 Category : Medical Languages : en Pages : 672
Book Description
Emerging methods, as well as best practices in well-used methods, in pharmacy are of great benefit to researchers, graduate students, graduate programs, residents and fellows also in other health science areas. Researchers require a text to assist in the design of experiments to address seemingly age-old problems. New interventions are needed to improve medication adherence, patients' lived experiences in health care, provider-patient relationships, and even various facets of pharmacogenomics. Advances in systems re-engineering can optimize health care practitioners' roles. Contemporary Research Methods in Pharmacy and Health Services includes multi-authored chapters by renowned experts in their field. Chapters cover examples in pharmacy, health services and others transcendent of medical care, following a standardized format, including key research points; valid and invalid assumptions; pitfalls to avoid; applications; and further inquiry. This is a valuable resource for researchers both in academia and corporate R&D, primarily in pharmacy but also in health services, and other health disciplines. Social science researchers and government scientists can also benefit from the reading. - Provides multi-authored chapters by renowned experts in their field - Includes examples for pharmacy and health services and others that are transcendent of medical care - Covers key research points, valid and invalid assumptions, pitfalls to avoid, applications, and further inquiry
Author: Andrew G. Bushmakin
Author: Andrew G. Bushmakin
Author: Joseph C. Cappelleri
Author: Andrew G. Bushmakin
Author: David Cella
Author: Peter M. Fayers
Author: Agency for Healthcare Research and Quality/AHRQ
Author: David L. Streiner
Author: Agency for Health Care Research and Quality (U.S.)
Author: Joseph C. Cappelleri
Author: Shane P. Desselle