An observational study in Adult, Risk Factors and Primary Care, sponsored by Gustavo Zabert, MD. Status unknown at 5 sites in Argentina. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-12-27.
Sponsored by Gustavo Zabert, MD · Observational
COPD is underdiagnosed and spirometry is not widely available in primary care settings. This study explore the value of PUMA´s questionnaire in a case finding strategy to detect patients to perform spirometry in a real world scenario of primary care health venues.
PUMA (Prevalence StUdy and Regular Practice, Diagnosis and TreatMent, Among General Practitioners in Populations at Risk of COPD in Latin America) study, a multicenter, multinational, cross-sectional, non-interventionist study, explored COPD prevalence among high risk patients assisted in primary care centers in 4 Latin American countries High risk condition was defined if the patient was older than 40 years and current or former smokers (≥10 pack-years, ≥50 pipes/year, or ≥50 cigars/year), and/or reported exposure to biomass smoke, such as wood or coal, for cooking or heating (exposure ≥100h/year). Patients were enrolled during routine, spontaneous or scheduled visits to their medical appointment neither related with the study nor respiratory services or specialists as well. COPD was defined as post-bronchodilator (post-BD) forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.70 and the lower limit of normal (LLN) of FEV1/FVC.
Based on PUMA study data, a simple and a weighted score was constructed with seven variables: sex, age, pack-years smoking, dyspnea, sputum, cough and previous spirometry selected from the PLATINO questionnaire. The score had a mean accuracy for detecting COPD (post-BD FEV1/FVC \<0.70) for high risk population of 76% and 79% for the simple and weighted scores, respectively.
This study is a prospective case finding study based on PUMA score as screening tool in unselected high risk patients attending to a primary care health care venue in real world scenario (e.g. community hospital, university institutions or other primary care settings). Patients older than 40 years of age and ever smoker of at least 10 pack year will be asked to complete the PUMA questionnaire through an specially designed application and electronic database (RedCap). All patients who with PUMA score ≥ 5, will be referred to perform spirometry at the institution.
Recruitment will be done by primary care physicians during regular consultations for any reason and spirometry will be performed by qualified technicians using the EasyOne® (nnd) spirometer. The quality of the spirometry will be evaluated by the central team that may request a second measurement to satisfy quality.
COPD will be diagnosed with fixed FEV1/FVC ratio (forced expiratory volume in the first second or FEV1 divided by forced vital capacity or FVC) less than 0.7.
Results will be reported to the primary care doctor and the patient
This is the only study on the registry with Gustavo Zabert, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The target population for this active case finding study will be patients older than 40 years old, smokers or ever-smokers of more than 10 pack-years, who attend to the first level of care in the real world scenario of primary care facilities (for example: community hospital, university institutions or other environments) without respiratory specialists.
Exclusion Criteria:
Every patient who meet the criteria for active search (older than 40 years, smokers or ex-smokers of more than 10 pack-years who attend the usual care in the first level of care) will be scored with the PUMA´s questionnaire in an application and electronic database (RedCap) specially designed for the active search of cases. Patients with PUMA´s score ≥ 5, and without exclusion criteria for spirometry will be referred to perform spirometry at the institution
Also known as: Spirometry
COPD prevalence
FEV1 / FVC post-BD \<0.70
Time frame: 2 days
PUMA ≥ 5 prevalence
cases with PUMA´s score ≥ 5
Time frame: 1 day
Plan to share: Yes — Questionnaire and spirometric data will be available for review and analysis
Supporting information: Study protocol, Icf, Csr
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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