Czech multicenter research database of severe COPD

Abstract

PurposeChronic obstructive pulmonary disease (COPD) has been recognized as a heterogeneous, multiple organ system-affecting disorder. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) places emphasis on symptom and exacerbation management. The aim of this study is examine the course of COPD and its impact on morbidity and all-cause mortality of patients, with respect to individual phenotypes and GOLD categories. This study will also evaluate COPD real-life patient care in the Czech Republic.Patients and methodsThe Czech Multicentre Research Database of COPD is projected to last for 5 years, with the aim of enrolling 1,000 patients. This is a multicenter, observational, and prospective study of patients with severe COPD (post-bronchodilator forced expiratory volume in 1 second ≤60%). Every consecutive patient, who fulfils the inclusion criteria, is asked to participate in the study. Patient recruitment is done on the basis of signed informed consent. The study was approved by the Multicentre Ethical Committee in Brno, Czech Republic.ResultsThe objective of this paper was to outline the methodology of this study.ConclusionThe establishment of the database is a useful step in improving care for COPD subjects. Additionally, it will serve as a source of data elucidating the natural course of COPD, comorbidities, and overall impact on the patients. Moreover, it will provide information on the diverse course of the COPD syndrome in the Czech Republic.

Respiratory parameters predict poor outcome in COPD patients, category GOLD 2017 B

“…This project (registered by the State Institute for Drug Control under the identifier 1301100001 and at ClinicalTrials.gov as NCT01923051) was initiated in August 2013. 13 The prospective CMRD study is being conducted in full accordance with Czech and European Union laws. The CMRD study and its protocol were approved by The Multicentre Ethical Committee of Masaryk University, Brno, Czech Republic (approval date: JAN-16-2013, protocol code: CHOPN) as well as ethics and regional review boards of all individual participating centers.…”

“…The CMRD study and its protocol were approved by The Multicentre Ethical Committee of Masaryk University, Brno, Czech Republic (approval date: JAN-16-2013, protocol code: CHOPN) as well as ethics and regional review boards of all individual participating centers. 13 All COPD participants signed a written consent form before study enrolment.…”

“…Longitudinal and prospective follow-up (in regular 6-month periods) of patients is planned for 5 consecutive years and will be finished in 2021. 13 At each control, the patients completed pulmonary function tests, an elementary physical examination, measurement of respiratory and nonrespiratory symptoms and systematic assessment of the patient’s history. Completing a 6-minute walking test (6-MWT) and/or an arterial blood gas (ABG) analysis was optional (not mandatory).…”

“…Completing a 6-minute walking test (6-MWT) and/or an arterial blood gas (ABG) analysis was optional (not mandatory). 13 If done, ABG analysis and/or a 6-MWT were performed without oxygen supplementation in all cases. Any changes in medication, onset of new comorbidities or number of exacerbations were recorded.…”

Hand grip endurance test relates to clinical state and prognosis in COPD patients better than 6-minute walk test distance

“…COPD patients were recruited from the Department of Pneumology, University Hospital Hradec Kralove, Czech Republic (most of them from the Czech multicentric research database of COPD – Registry of the Czech Pneumological and Phthisiological Society). The details concerning inclusion and exclusion criteria and records of a patient history including comorbidities and medications used were described by Novotná et al 8 All COPD subjects underwent a comprehensive examination to determine COPD severity and prognostic scales (eg, GOLD stage, combined COPD assessment, BODE, updated BODE and ADO indexes), and exercise tolerance by means of 6MWT.…”