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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Universidad Peruana Cayetano Heredia | OTHER |
| Asociacion Benefica Prisma | OTHER |
| Makerere University |
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This study will test how well short questionnaires, with and without a simple breathing test called 'peak flow', can identify people with COPD compared to the gold-standard diagnostic test called spirometry. We will test this in 10,500 people from three low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of implementing our case-finding intervention at scale.
The investigators will determine whether case-finding for COPD can be facilitated using 5-item questionnaires with and without a measurement of Peak-Flow. The investigators hypothesise that 5-item questionnaires will be a valid case-finding tool for COPD in LMIC and will be acceptable and feasible for use in these settings.
The design of the intervention will be informed by formative work prior to commencement of the main study.
Study fieldworkers will enroll and screen a randomly-selected age- and sex-stratified population sample of adults aged ≥40 years; a total of 10,500 between the following three countries in the catchment areas of existing community census areas in Bhaktapur (Nepal), Lima (Peru), and Nakaseke (Uganda).
The investigators will report the sensitivity, specificity and positive predictive value of the case-finding questionnaire, with and without PEF, in relation to a gold standard COPD diagnosis made at spirometry (post-bronchodilator FEV1/VC ratio \
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools | Sensitivity, Specificity and Positive Predictive Value of the case-finding questionnaires with and without peak-expiratory flow (PEF), compared to spirometry. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Process Evaluation - Actual number of participants recruited against target. | Total number of participants successfully recruited into the study against the target figure determined by the power calculations. | 12 months |
| Fidelity - Spirometry Quality Control Failures |
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Inclusion Criteria:
Exclusion Criteria:
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A randomly-selected age- and sex-stratified population sample of adults aged ≥40 years; a total of 10,500 will be recruited from the following three countries in the catchment areas of existing community census areas, in Bhaktapur (Nepal), Lima (Peru), and Nakaseke (Uganda).
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| Name | Affiliation | Role |
|---|---|---|
| John Hurst, PhD FRCP | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medicine | Kathmandu | Nepal | ||||
| Universidad Peruana Cayetano Heredia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33476252 | Derived | Robertson NM, Siddharthan T, Pollard SL, Alupo P, Flores-Flores O, Rykiel NA, Romani ED, Ascencio-Dias I, Kirenga B, Checkley W, Hurst JR, Quaderi S; GECo Investigators. Development and Validity Assessment of a Chronic Obstructive Pulmonary Disease Knowledge Questionnaire in Low- and Middle-Income Countries. Ann Am Thorac Soc. 2021 Aug;18(8):1298-1305. doi: 10.1513/AnnalsATS.202007-884OC. | |
| 30340648 |
| Label | URL |
|---|---|
| The Johns Hopkins Center for Global NCD Research and Training | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| OTHER |
| University of York | OTHER |
| Tribhuvan University Teaching Hospital, Institute Of Medicine. | OTHER |
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Extent to which delivery adheres to the protocol developed. Spirometry delivery - Only tests which meet both acceptability and repeatability criteria as per ERS/ATS (European Respiratory Society / American Thoracic Society) guidelines will be accepted. Spirometry interpretation - All Spirometry preformed will be over-read locally, and a proportion (see below) will be over-read centrally. Two separate researchers, at each site, adequately trained in both spirometry delivery and interpretation will separately perform interpretation of all spriometry carried out in the field, to ensure correct interpretation in relation to a gold standard COPD diagnosis made at spirometry (post-bronchodilator FEV1/VC ratio \ |
| 12 months |
| Fidelity - Proportion of Questionnaires with Missing Data Fields | Extent to which delivery adheres to the protocol developed. The investigators will report the proportion of incomplete questionnaires (any questionnaires with one or more missing data fields) in total and at each individual site. | 12 months |
| Health Economics | Health-related productivity costs measured as hours of lost work from COPD and related symptoms. Inequalities in productivity costs according to illness severity and wealth status. | 12 months |
| Lima |
| Peru |
| Makerere University Lung Institute | Makerere | Uganda |
| Derived |
| Siddharthan T, Pollard SL, Quaderi SA, Mirelman AJ, Cardenas MK, Kirenga B, Rykiel NA, Miranda JJ, Shrestha L, Chandyo RK, Cattamanchi A, Michie S, Barber J, Checkley W, Hurst JR; GECo Study Investigators. Effectiveness-implementation of COPD case finding and self-management action plans in low- and middle-income countries: global excellence in COPD outcomes (GECo) study protocol. Trials. 2018 Oct 19;19(1):571. doi: 10.1186/s13063-018-2909-8. |
| Trial Twitter account - @COPDGECo | View source |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |