Validation of prognostic indices ADO, BODEx and DOSE in a primary care international cohort (cohort PROEPOC/PROCOPD)

Not Applicable

Completed

• Conditions: Chronic obstructive pulmonary disease (COPD); Respiratory

• Registration Number: ISRCTN52402811
• Lead Sponsor: Instituto de Salud Carlos III (Spain)

Brief Summary

2016 Results article in https://pubmed.ncbi.nlm.nih.gov/27835945/ (added 26/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-05
• Study Completion: 2020-12-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 477

Inclusion Criteria

Current inclusion criteria as of 20/01/2016:
Setting: Primary Care Centres in Teis, Matamá, Pazos de Borbén and Sárdoma in the Vigo Health Authority (Pontevedra, Galicia), and Son Pisà, Escola Graduada and Coll dén Rebassa in the Balearic Islands Health Authority (Balearic Islands). Through these centres, doctors/nurses potentially willing to participate were identified (using the ‘snowball’ method) both in Spain (Aragón, Catalonia, Canary Islands) and other European countries (Bulgaria, Croatia, Germany, Macedonia, Romania and Slovenia, in Europe).

Subjects: Patients diagnosed with COPD.

1. Patients with an obstruction, defined by a FEV1 lower than 80% of the expected post-bronchodilator FEV in the presence of a FEV1 quotient/forced vital capacity (FVC) lower than 70%.
2. Patients in a stable phase of COPD, clinically defined as at least 6 weeks since the last exacerbation
3. Acceptance to participate in the study by providing written informed consent

Previous inclusion criteria:
Setting: Primary Care Centres in Teis, Matamá, Pazos de Borbén and Sárdoma in the Vigo Health Authority (Pontevedra, Galicia), and Son Pisà, Escola Graduada and Coll dén Rebassa in the Balearic Islands Health Authority (Balearic Islands). Through these centres, doctors/nurses potentially willing to participate will be identified (using the ‘snowball’ method) both in Spain and other European countries to be confirmed.
Subsequently, they will be invited and informed by e-mail about the description of the background and objectives of the study, as well as the implications of their participation.

Subjects: Patients diagnosed with COPD.

1. Patients with an obstruction, defined by a FEV1 lower than 80% of the expected post-bronchodilator FEV in the presence of a FEV1 quotient/forced vital capacity (FVC) lower than 70%.
2. Patients in a stable phase of COPD, clinically defined as at least 6 weeks since the last exacerbation
3. Acceptance to participate in the study by providing written informed consent

Exclusion Criteria

COPD patients.

1. Patients diagnosed with cystic fibrosis, or bronchiectasis of a different origin to COPD (tuberculosis, childhood infections, immunodeficiencies, and severe cognitive or mobility impairment).
2. Patients diagnosed with a severe chronic disease, besides COPD (active malignancy, AIDS, heart failure, severe kidney or liver failure, etc.)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival without exacerbations will be assessed after 3, 4 and 5 years.

Secondary Outcome Measures

Name	Time	Method
Mortality from all causes and those specifically due to respiratory causes (secondary)