Interpreting Evaluating Respiratory Symptoms
Evaluating Respiratory Symptoms (E-RS) in Chronic Obstructive Pulmonary Disease (COPD)
PROs and clinical trials
interpretation recommendations for PRO measures
patient-reported outcome (PRO) measure
symptomatic relief
Journal
Chronic obstructive pulmonary diseases (Miami, Fla.)
ISSN: 2372-952X
Titre abrégé: Chronic Obstr Pulm Dis
Pays: United States
ID NLM: 101635411
Informations de publication
Date de publication:
26 Oct 2022
26 Oct 2022
Historique:
pubmed:
22
9
2022
medline:
22
9
2022
entrez:
21
9
2022
Statut:
ppublish
Résumé
Accurately interpreting scores on patient-reported outcome (PRO) measures is essential to understanding and communicating treatment benefit. Over the years, terminology and methods for developing recommendations for PRO score interpretation in clinical trials have evolved, leading to some confusion in the field. The phrase "minimal clinically important difference (MCID)" has been simplified to "minimal important difference (MID)" and use of responder thresholds to interpret statistically significant treatment effects has increased. Anchor-based derivation methods continue to be the standard, with specific variations preferred by regulatory authorities for drug development programs. In the midst of these changes, the Evaluating Respiratory Symptoms™ in COPD (E-RS:COPD) was developed and qualified for use as an endpoint in chronic obstructive pulmonary disease (COPD) drug development programs. This paper summarizes the evolution of terminology and method preferences for the development of recommendations for interpreting scores from PRO measures used in clinical trials, and how these changes are reflected in the E-RS:COPD recommendations. The intent is to add clarity to discussions around PRO endpoints and facilitate use of the E-RS:COPD as a key efficacy endpoint in clinical trials of COPD.
Identifiants
pubmed: 36130315
doi: 10.15326/jcopdf.2022.0307
pmc: PMC9718578
doi:
Types de publication
Journal Article
Langues
eng
Pagination
576-590Subventions
Organisme : Novartis
Pays : Switzerland
Informations de copyright
JCOPDF © 2022.
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