Patient reported outcomes : an overview / Annabel Nixon, Diane Wild, Willie Muehlhausen.

Format:

Book

Author/Creator:

Nixon, Annabel, author.

Wild, Diane, author.

Muehlhausen, Willie, author.

Language:

English

Subjects (All):

Outcome assessment (Medical care).

Physical Description:

1 online resource (43 pages) : illustrations

Edition:

First edition.

Place of Publication:

Torino, Italy : SEEd, 2015.

Summary:

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.

Contents:

Cover

Title Page

Colophon

Summary

Introduction to Patient Reported Outcomes

Definitions

Application

Taxonomy

Format

Applications of PRO data

Clinical trials

Regulatory approvals

Real world evidence studies

Clinical practice

Health technology assessment

Prescribers and patients

Collecting PRO data to support product evaluation

Develop a PRO strategy considering issues important to patients, the target product profile and stakeholder requirements

Select validated PRO instruments

Ensure the trial or study design is appropriate for PRO collection

Linguistic Validation

The Need for Linguistically Validated PROs

Methodology

Same Language Different Country

Measurement Equivalence

Regulators

ePRO Technology Overview

Introduction

Technologies

Patient &amp

Site Staff Acceptance

Regulatory Perspective

Migration &amp

Validation

Analysing and reporting PRO data

Statistical analysis plan

Reporting PRO results

References

Authors.

Notes:

Includes bibliographical references.

Description based on online resource; title from PDF title page (ebrary, viewed December 29, 2016).

ISBN:

9788897419600

8897419607

OCLC:

960759672