Development and Validation of the GLORI-COPD Score

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Screening of COPD Patients at Risk of Complications in General Practice:

Conditions
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Pulmonary Disease, Chronic Obstructive

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 35 yo smoker or former smoker ≥ 10 Pack Years Exclusion Criteria: Patients who have already been diagnosed with COPD by spirometry, have a contraindication to spirometry, have an estimated life expectancy of less than 5 years are under protective measures

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| suspected COPD<br>Patients aged ≥ 35yo and ≥10Pack.Year | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of the score | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD diagnosis | FEV1/FVC < 0.7 | Baseline | 
| complications | -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) | 6 and 12 months | 
| death |  | 12 months | 
| Modified Medical Research Council Dyspnea scale score (mMRC) | 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 | baseline, 6 and 12 months | 
| COPD Assessment test (CAT) | scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life | baseline, 6 and 12 months | 
| ADO index (Age, Dyspnea, Obstruction) | evaluates mortality risk in copd patients from 0 to 14 (higher scores are linked woh higher mortality risk) | baseline, 6 and 12 months | 
| GOLD stage | COPD severity from A (less severe) to D (very severe) | baseline |