Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases (DYSLIM)

Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases

The purpose of this study is the psychometric validation of a self-administered dyspnea questionnaire, usable in clinical practice in order to assess dyspnea and its impact on patients with chronic respiratory diseases.

Study Overview

• Status: Completed
• Conditions: COPD (With - Without Rehabilitation); Diffuse Interstitial Lung Diseases; Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....); Cystic Fibrosis of the Adult
• Intervention / Treatment: Other: Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.

Detailed Description

Dyspnea is a cardinal Respiratory symptom.

According to the ATS dyspnea is the term used to characterize a subjective experience of breathing discomfort, covering qualitatively distinct sensations of varying intensity.

The subjective nature of dyspnea and the high complexity of its determinants explain the often moderate correlations obtained with physiological data. Dyspnea must therefore be measured specifically.

The aim of this study is the cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire (assessing the impact of dyspnea on activities restriction), usable in clinical practice in order to assess dyspnea and its alterations in adult patients with chronic respiratory diseases.

(COPD, diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis)

Like any psychometric instrument, an efficient evaluation of dyspnea scale should ideally satisfy all the following required features: evaluative, discriminant, good reproducibility, and high sensitivity to change.

The desired features apart from content validity are reproducibility and especially a high sensitivity to change, particularly following pulmonary rehabilitation.

Thus, this questionnaire should precisely enable to assess the benefit of rehabilitation and it's sustainment in maintenance phase.

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• France
  • Paris, France, 75006
    • Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study Population are adults patients with chronic respiratory diseases (Sample1: COPD; Sample 2: Diffuse interstitial lung diseases; Sample 3: Pulmonary Arterial Hypertension primary or secondary (post embolic .....); Sample 4: Adult with Cystic fibrosis)

Description

Inclusion Criteria:

• 1) Sample1: COPD GOLD / ATS > 2 without major co-morbidity

  • Sample 1A: n = 50: group of patients with no change in usual care and no acute event (evaluation of reproducibility)
  • Sample1B: n = 60: patients assessed before and after a qualifying period of pulmonary rehabilitation
• 2) Sample 2 (n = 30): diffuse interstitial lung diseases Criteria: Pulmonary Fibrosis: Idiopathic or nonspecific interstitial lung diseases (NILD) according to international criteria (ATS), sarcoidosis with parenchymal lesions (old classification stage II and III), and exceptionally alveolar proteinosis.
• 3) Sample 3 (n = 30) primary or secondary arterial pulmonary hypertension (post embolic .....).
• 4) Sample4 (n = 30): Adult with Cystic fibrosis.
• 5) patient with stable Status (no exacerbation for at least one month)

Exclusion Criteria:

• 1) Patient under 18 years
• 2) Inability to fill in questionnaires
• 3) Other respiratory disease
• 4) left symptomatic heart failure
• 5) Obesity with a BMI> 35 kg/m2
• 6) Inability to perform PFT (Pulmonary Function Testing)
• 7) Pregnant or breastfeeding woman
• 8) Patient unable to consent
• 9) Lack of social insurance coverage
• 10) Patient in exclusion period because of another protocol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adults patients with chronic respiratory diseases; - 200 adult patients with chronic respiratory diseases will be studied longitudinally and transversely (follow-up: 6 months) in 12 centres.; Sample 1 (n=110 patients) with COPD; Sample 2 (n=30 patients) with Diffuse interstitial lung diseases; Sample 3 (n=30 patients) with Pulmonary Arterial Hypertension primary or secondary (post embolic .....).; Sample 4 (n=30 patients) Adult with Cystic fibrosis

Other: Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.; Evaluation will be performed on a group of 200 patients deriving from 4 samples.; From these 200 patients, a sub-sample will be evaluated at 7 days (DYSLIM questionnaire only) for reproducibility (n = 50 patients: 10 patients with diffuse interstitial lung disease, 10 patients with cystic fibrosis, 10 patients with arterial pulmonary hypertension, 20 patients with COPD).; From these 200 patients, a sub-sample (COPD, n = 60) will be recruited among patients undergoing pulmonary rehabilitation at the beginning of the 6 months separating follow up visit and the initial assessment.; Other Names: Self-administered dyspnea questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychometric validity of the questionnaire	Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire	Until end of treatment (making a total of 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of responses distribution	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire	Until end of treatment (making a total of 6 months)
Structural analysis (in principal components)	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire	Until end of treatment (making a total of 6 months)
External and convergent validity	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire	Until end of treatment (making a total of 6 months)
Internal coherence	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire	Until end of treatment (making a total of 6 months)
Reproducibility	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire	Until end of treatment (making a total of 6 months)
Reproducibility	for a sub sample of 50 patients, Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire	7 days
Discriminating properties	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire	Until end of treatment (making a total of 6 months)
Derivation of a scoring algorithm	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire	Until end of treatment (making a total of 6 months)
Sensitivity to change	Sensitivity to change will be analyzed in relation to: The TDI score, at the Likert scale on changes in dyspnea The scores of quality of life with their respective significant thresholds A the overall medical evaluation A changing EFR parameters with their respective significant thresholds (FEV, DLCO, walk test .....). All this are the transversal data necessaries to assess the validation of a psychometric self-administered dyspnea questionnaire.	Until end of treatment (making a total of 6 months)
Minimal difference clinically relevant	Cross-sectional data necessary to assess the psychometric validity of a self-administered dyspnea questionnaire	Until end of treatment (making a total of 6 months)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin; Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris
• Investigators: Study Chair: Thierry Perez, MD, CHRU de Lille / Hôpital Calmette - France; Principal Investigator: Nicolas ROCHE, MD, PhD, APHP- Hôpital Cochin

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2010
• Primary Completion (Actual): March 27, 2014
• Study Completion (Actual): December 30, 2015

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: August 29, 2014
• First Posted (Estimated): September 3, 2014

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Cystic fibrosis; Pulmonary arterial hypertension; Dyspnea; Chronic respiratory disease; Self-administered questionnaire; Diffuse interstitial lung diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Respiration Disorders; Infant, Newborn, Diseases; Lung Diseases, Obstructive; Pancreatic Diseases; Neoplastic Processes; Signs and Symptoms, Respiratory; Hypertension, Pulmonary; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pulmonary Arterial Hypertension; Pulmonary Disease, Chronic Obstructive; Neoplasm Metastasis; Cystic Fibrosis; Dyspnea
• Other Study ID Numbers: 2009-A00181-56