Development and Validation of the GLORI-COPD Score
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the diagnostic accuracy of the GLORI-COPD score in ambulatory care, to enable the screening of COPD patients at risk of complications, requiring early management
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Chronic obstructive pulmonary disease (COPD) is a chronic disease with a high prevalence in France, but which remains under-diagnosed due to the trivialization of symptoms and difficulty in accessing diagnostic investigations. It is associated with other co-morbidities, with an impact on the occurrence of complications and quality of life. Early management of the most severe patients would allow better control of these risks of complications. Our objective is to better identify patients with COPD at risk of complications in general practice, taking into account the totality of the patient, to improve their management.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| suspected COPD Patients aged >35yo and > 10Pack.Year |
Outcome Measures
Primary Outcome Measures
- diagnostic accuracy of the score [12 months]
The diagnostic accuracy of the score will be evaluated to determine the risk of pulmonary complication in patients with COPD. Sensitivity, specificity, positive predictive value and negative predictive value
Secondary Outcome Measures
- COPD diagnosis [Baseline]
FEV1/FVC < 0.7
- complications [6 and 12 months]
-Composite criterion: Occurrence of a low respiratory infection (bronchitis, COPD exacerbation, lung infection or pneumonitis) in an outpatient or inpatient setting or following a death (1st event)
- death [12 months]
- Modified Medical Research Council Dyspnea scale score (mMRC) [baseline, 6 and 12 months]
evaluating dyspnea from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing
- COPD Assessment test (CAT) [baseline, 6 and 12 months]
scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life
- ADO index (Age, Dyspnea, Obstruction) [baseline, 6 and 12 months]
evaluates mortality risk in copd patients from 0 to 14 (higher scores are linked woh higher mortality risk)
- GOLD stage [baseline]
COPD severity from A (less severe) to D (very severe)
Eligibility Criteria
Criteria
Inclusion Criteria:
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age > 35 yo
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smoker or former smoker > 10 Pack Years
Exclusion Criteria:
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Patients who have already been diagnosed with COPD by spirometry,
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have a contraindication to spirometry,
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have an estimated life expectancy of less than 5 years
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are under protective measures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Université Paris Cité | Paris | France |
Sponsors and Collaborators
- University of Paris 5 - Rene Descartes
- Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
- Assistance Publique - Hôpitaux de Paris
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 2018-A03259-46