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Futility analysis showed that the probability to validate out hypothesis was near from 15%
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The objective of this multicentre prospective study is to validate CAPTURE as a French case finding tool for undiagnosed patients suffering from obstructive pulmonary disease.
A large number of healthcare professional across the country will screen participants.
Participants willing to participate will have a short interview, and then will have to answer the 5-item CAPTURE questionnaire. They will be assisted to perform a peak expiratory flow measurement with a portable device. The comparison will be made between the CAPTURE decision and a portable spirometry assessing the presence or not of an obstructive disorder.
Patient screened either by the tool or the spirometry will be addressed to a doctor. Follow-up at 6 months will be set up in order to assess the entry or not of those patients to an approved health care pathway.
At the end of each center's participation, a questionnaire will be sent to all healthcare professionals working on the study, to assess the ease of use of spirometry and the CAPTURE tool and its possible implementation in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants aged 40 or more, without diagnosis of COPD or asthma | Men and women attending aged 40 or more, without previous diagnosis of chronic obstructive pulmonary disease or asthma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAPTURE tool | Other | CAPTURE 5-item questionnaire and a selected use of peak expiratory flow measurement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity and area under the ROC curve of the CAPTURE tool | Sensitivity, specificity and area under the ROC curve of the CAPTURE tool; i.e. its ability to identify undiagnosed patients with an obstructive ventilatory disorder assessed with a portable spirometry. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor | Number of patients screened by the CAPTURE tool who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor, i.e. the impact of the screening process at 6 months on patient diagnosis, management and follow-up. | 6 months after |
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Inclusion Criteria:
Exclusion Criteria:
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Adult men and women over 40 years old will be recruited from a broad range of healthcare professional in primary care across the country. Any patient attending an appointment will be screened for inclusion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier du Havre | Le Havre | Normandy | 76600 | France |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D008173 | Lung Diseases, Obstructive |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| Spirometry | Other | Spirometry performed with a portable device, used for comparison with the CAPTURE tool. |
|
| Primary care investigators' opinion of the CAPTURE tool used in this study | Responses on a Likert scale from all investigators to a questionnaire on the easiness of use of spirometry and CAPTURE tool and its implementation in clinical practice once each center's inclusions had been completed. | Baseline to 2 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |