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.

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

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.

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

This book provides a guide to the assessment of quality of life and patient reported outcomes measures in general surgery. The rapidly emerging field helps contextualise patients and helps the decision-making process within health economics, bedside medicine, public health, and health policy. All subspecialties of general surgery are covered, as well as the core principles of quality of life. The book aims to demonstrate how clinicians and policymakers can easily get access to a single source of patient reported outcomes measures and quality of life evidence to help them make the best-informed decisions in the field of general surgery. This book is relevant to healthcare managers, doctors, allied health professionals, healthcare scientists, consultants, healthcare economists, and medical statisticians working in healthcare.

This issue is devoted to patient reported outcomes and their impact in the study of rheumatic diseases and the authors will also discuss PROs and vulnerable populations with rheumatic disease; technology, electronic health records and PROs: past, present and future; the promise of PROMIS – a uniform approach to PROs across rheumatic diseases, quality measures and PROs and how they relate and the importance of PROs in delivering quality care in the rheumatic diseases, and many more exciting articles.

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

This book provides a guide to the assessment of patient reported outcomes measures and quality of life in cardiovascular interventions, which have become a fundamental component of decision making in bedside medicine, health policy, health economics, and public health. Cardiac surgery, cardiovascular interventions, vascular interventions, and the core principles of quality of life are all covered. This book is the first book to demonstrate how clinicians and policy makers can easily get access to a single source of quality of life and patient reported outcomes measures evidence to help them make the best informed decisions in the field of cardiovascular interventions. This is a rapidly emerging field and the book would be relevant to doctors, healthcare scientists, allied-health professionals, healthcare managers, medical statisticians, healthcare economists, and consultants working in healthcare.

In this issue of Endocrinology and Metabolism Clinics, guest editor Eliza B. Geer brings her considerable expertise to the topic of Patient-Reported Outcomes in Endocrine Diseases. - Provides in-depth reviews on the latest updates in Patient-Reported Outcomes in Endocrine Diseases, providing actionable insights for clinical practice. - Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field; Authors synthesize and distill the latest research and practice guidelines to create these timely topic-based reviews.

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.