Assessment of patient-reported outcomes

Abstract

Patient-reported outcomes (PROs), from specific symptoms to health-related quality life, have been important outcome measures in pulmonary rehabilitation for a long time and paved the way for their use in clinical research in general. The Chronic Respiratory Questionnaire and the St. George's Respiratory Questionnaire are the most commonly used instruments in trials of pulmonary rehabilitation. While the development process of PROs received less attention than the validation of PROs, recent developments including guidance from regulatory agencies emphasize the need of a thorough development process including patient input as a basis for the validity, reliability and responsiveness of PROs. The selection of a PRO instrument is greatly facilitated if the systematic approach, presented here, with predefined criteria about the content, measurement properties and practical aspects is followed.