DYSLIM: Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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:
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Outcome Measures
Primary Outcome Measures
- Psychometric validity of the questionnaire [Until end of treatment (making a total of 6 months)]
Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire
Secondary Outcome Measures
- Analysis of responses distribution [Until end of treatment (making a total of 6 months)]
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
- Structural analysis (in principal components) [Until end of treatment (making a total of 6 months)]
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
- External and convergent validity [Until end of treatment (making a total of 6 months)]
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
- Internal coherence [Until end of treatment (making a total of 6 months)]
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
- Reproducibility [Until end of treatment (making a total of 6 months)]
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
- Reproducibility [7 days]
for a sub sample of 50 patients, Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
- Discriminating properties [Until end of treatment (making a total of 6 months)]
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
- Derivation of a scoring algorithm [Until end of treatment (making a total of 6 months)]
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
- Sensitivity to change [Until end of treatment (making a total of 6 months)]
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.
- Minimal difference clinically relevant [Until end of treatment (making a total of 6 months)]
Cross-sectional data necessary to assess the psychometric validity of a self-administered dyspnea questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Sample1: COPD GOLD / ATS > 2 without major co-morbidity
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Sample 1A: n = 50: group of patients with no change in usual care and no acute event (evaluation of reproducibility)
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Sample1B: n = 60: patients assessed before and after a qualifying period of pulmonary rehabilitation
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- 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.
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- Sample 3 (n = 30) primary or secondary arterial pulmonary hypertension (post embolic .....).
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- Sample4 (n = 30): Adult with Cystic fibrosis.
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- patient with stable Status (no exacerbation for at least one month)
Exclusion Criteria:
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- Patient under 18 years
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- Inability to fill in questionnaires
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- Other respiratory disease
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- left symptomatic heart failure
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- Obesity with a BMI> 35 kg/m2
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- Inability to perform PFT (Pulmonary Function Testing)
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- Pregnant or breastfeeding woman
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- Patient unable to consent
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- Lack of social insurance coverage
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- Patient in exclusion period because of another protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre | Paris | France | 75006 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- 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- Hopital Cochin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2009-A00181-56