Validation and Meaningful Change Thresholds for an Objective Cough Frequency Measurement in Chronic Cough

Purpose Objective cough frequency is used to assess efficacy of chronic cough (CC) treatments. The objective of this study was to explore the relationship between objective cough frequency and cough-specific patient-reported outcomes (PROs) and estimate a clinically meaningful change threshold (MCT)...

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Bibliographic Details
Published in:Lung 2022-12, Vol.200 (6), p.717-724
Main Authors: Schelfhout, Jonathan, Nguyen, Allison Martin, Birring, Surinder S., Bacci, Elizabeth D., Vernon, Margaret, Muccino, David R., La Rosa, Carmen, Smith, Jaclyn A.
Format: Article
Language:English
Subjects:
Analysis
Clinical trials
Cough
Cough - diagnosis
Frequency measurement
Humans
Measurement
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Pain Measurement
Patient Reported Outcome Measures
Patients
Pharmaceutical industry
Pneumology/Respiratory System
Reduction
ROC Curve
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Summary:Purpose Objective cough frequency is used to assess efficacy of chronic cough (CC) treatments. The objective of this study was to explore the relationship between objective cough frequency and cough-specific patient-reported outcomes (PROs) and estimate a clinically meaningful change threshold (MCT) for objective cough frequency. Methods Data collected in a phase 2b study in participants with refractory or unexplained CC were used to investigate the relationship between 24-h cough frequency (measured using an ambulatory cough monitor) and cough-specific PROs (i.e., cough severity visual analog scale, cough severity diary, Leicester Cough Questionnaire). Convergent validity was assessed using Spearman ρ . An MCT for 24-h cough frequency was estimated using the patient global impression of change (PGIC) scale as an anchor. Results Correlations between 24-h cough frequency and cough-specific PROs at baseline, Week 4, and Week 12 were significant ( P  
ISSN:0341-2040
1432-1750
DOI:10.1007/s00408-022-00587-2