title: A review of the most common patient-reported outcomes in COPD--revisiting current knowledge and estimating future challenges.
abstract: Patient-reported outcome (PRO) measures that quantify disease impact have become important measures of outcome in COPD research and treatment. The objective of this literature review was to comprehensively evaluate psychometric properties of available PRO instruments and the ability of each of them to characterize pharmaceutical treatment effects from published clinical trial evidence. Identified in this study were several PRO measures, both those that have been used extensively in COPD clinical trials (St George's Respiratory Questionnaire and Chronic Respiratory Questionnaire) and new instruments whose full value is still to be determined. This suggests a great need for more information about the patient experience of treatment benefit, but this also may pose challenges to researchers, clinicians, and other important stakeholders (eg, regulatory agencies, pharmaceutical companies) who develop new treatment entities and payers (including but not limited to health technology assessment agencies such as the National Institute for Health and Care Excellence and the Canadian Agency for Drugs and Technologies in Health). The purpose of this review is to enable researchers and clinicians to gain a broad overview of PRO measures in COPD by summarizing the value and purpose of these measures and by providing sufficient detail for interested audiences to determine which instrument may be the most suitable for evaluating a particular research purpose.
authors.affiliation: University of Rome 'Tor Vergata', Department of Medicine of Systems, Unit of Respiratory Clinical Pharmacology, Rome, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Cazzola
authors.affiliation: Section of Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Nicola Alexander
authors.initials: NA
authors.lastname: Hanania
authors.affiliation: University of Edinburgh/MRC Centre for Inflammation Research, The Queen's Medical Research Institute, Edinburgh, United Kingdom.
authors.forename: William
authors.initials: W
authors.lastname: MacNee
authors.affiliation: Patient Reported Outcome Center of Excellence, Global Market Access, Primary Care Business Unit, Pfizer, Tadworth, United Kingdom.
authors.forename: Katja
authors.initials: K
authors.lastname: Rüdell
authors.affiliation: Patient Reported Outcome Center of Excellence, Global Market Access, Primary Care Business Unit, Pfizer, Tadworth, United Kingdom.
authors.forename: Claire
authors.initials: C
authors.lastname: Hackford
authors.affiliation: Patient Reported Outcome Center of Excellence, Global Market Access, Primary Care Business Unit, Pfizer, Tadworth, United Kingdom.
authors.forename: Nihad
authors.initials: N
authors.lastname: Tamimi
mesh_terms: D006801:Humans; D008168:Lung / Q000187:drug effects / Q000503:physiopathology*; D011237:Predictive Value of Tests; D011594:Psychometrics; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: COPD; health related quality of life; patient reported outcome; psychometric properties; quality of life