PRO Task Force: Good Research Practices for the Assessment of Patient-Reported Outcomes in Children and Adolescents

Chair: Louis Matza PhD, Research Scientist, Center for Health Outcomes Research, United BioSource Corporation

Leadership Team:
John J. Alexander MD, Lead Medical Officer, FDA, Washington, DC, USA
Monika Bullinger MD, PhD, Professor & Vice Chief, Institute and Polyclinic for Medical Psychology, University Clinics-Eppendorf, University of Hamburg, Hamburg, Germany
Donald L. Patrick PhD, MSPH, Professor, Department of Health Services, University of Washington and Director, Seattle QoL Group, Seattle, WA, USA
Andreas M. Pleil PhD, Senior Director / Lead, Ophthalmology and Endocrinology Outcomes Research, Clinical Development & Medical Affairs, Specialty Care Business Unit, Pfizer Global Pharmaceuticals, Pfizer, Inc,
San Diego, CA, USA
Luis Rajmil MD, PhD, MPH, Senior Researcher, Catalan Agency for Health Technology Assessment (CAHTA), Research & Health Services Research Unit & Collaborator, Municipal Institute of Medical Research (IMIM)-Hospital del Mar, Barcelona, Spain
Anne W. Riley PhD, MS, Professor, Dept of Population, Family & Reproductive Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA 

Background and Project Description:
A patient-reported outcomes (PRO) measure is any report coming directly from patients about how they feel or function in relation to their health and treatment.  In recent years, clinical trials evaluating medical product effectiveness have increasingly incorporated PROs because of the unique information these measures can provide.  Many aspects of medical conditions are known only by the patients themselves, and direct assessment of the patient perspective is necessary to thoroughly understand patients’ experiences of disease and treatment.

Background and Project Description continued…

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