Patient Reported Outcomes E-Book

Willie Muehlhausen

• Herausgeber: SEEd Edizioni Scientifiche
• Kategorie: Fachliteratur
• Sprache: Englisch

Veröffentlichungsjahr: 2015

Beschreibung

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.

Leseprobe

Patient Reported Outcome

An overview

Annabel Nixon, Diane Wild, Willie Muehlhausen

© SEEd srl

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First edition June 2015

ISBN 978-88-9741-960-0

Although the information about medication given in this book has been carefully checked, the author and publisher accept no liability for the accuracy of this information. In every individual case the user must check such information by consulting the relevant literature.

This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilm or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the Italian Copyright Law in its current version, and permission for use must always be obtained from SEEd Medical Publishers Srl. Violations are liable to prosecution under the Italian Copyright Law.

Table of Contents

Colophon

Introduction to Patient Reported Outcomes

Definitions

Application

Taxonomy

Generic vs. disease specific

Examples of instruments

Format

Applications of PRO data

Clinical trials

Regulatory approvals

Real world evidence studies