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| Name | Class |
|---|---|
| Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire. | Other | Evaluation will be performed on a group of 200 patients deriving from 4 samples.
|
| 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) |
| 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) |
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Inclusion Criteria:
1) Sample1: COPD GOLD / ATS > 2 without major co-morbidity
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:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Perez, MD | CHRU de Lille / Hôpital Calmette - France | Study Chair |
| Nicolas ROCHE, MD, PhD | APHP- Hopital Cochin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre | Paris | 75006 | France |
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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) |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009362 | Neoplasm Metastasis |
| D004417 | Dyspnea |
| D000081029 | Pulmonary Arterial Hypertension |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D006976 | Hypertension, Pulmonary |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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