Czech multicenter research database of severe COPD

Abstract

Purpose

Chronic 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 methods

The 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.

Results

The objective of this paper was to outline the methodology of this study.

Conclusion

The 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.

Video abstract

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Keywords:

• phenotypes
• comorbidities
• exacerbations
• all-cause mortality
• prospective study

Acknowledgments

The authors would like to thank the Czech Pneumological and Phthiseological Society for their ongoing support, namely, Professor V Kolek (The President of the Czech Pneumological and Phthiseological Society), Professor M Marel (The Scientific Secretary of the Czech Pneumological and Phthiseological Society), and Associate Professor L Dusek (The Director of Institute of Biostatistics and Analyses, Masaryk University) for their indispensable assistance with initialization of this project. Furthermore, the authors are grateful to all of the experts responsible for the creation of the design of various subsections of this database: T Pavlik and J Svancara (statistical analysis), E Kocova (radiology), K Neumannova (activity of daily living), M Hronek and M Kovarik (anthropometry), L Pavlikova (densitometry), M Vytrisalova (compliance assessment), and R Praus, M Kopecky, M Orban, and T Konecny (cardiology). The authors would also like to thank the following physicians for their role in the implementation of this project at their study sites and their support with design finalization: A Vlachova, L Heribanova, S Jaresova, N Pauk, P Popelkova, B Snelerova, P Musilova, M Majerciakova, and T Vencalek.

The Czech Multicentre Research Database of COPD has been given funding via unrestricted grants from the following companies: AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Medicom International s.r.o., Novartis, Pfizer, and Takeda.

The Czech Multicentre Research Database of COPD is supported by a grant from the Czech Ministry of Health (grant number 15/14/NAP, The incidence of A1AT deficiency in patients with a severe form of COPD). Additionally, this project is supported by MH CZ – DRO (UHHK, 00179906) and by MH CZ NT13531-3/2013.

Author contributions

All authors contributed toward data analysis, drafting and revising the paper and agree to be accountable for all aspects of the work. The study design was created by V Koblizek, K Hejduk, J Jarkovsky, and Z Zbozinkova. V Koblizek, J Zatloukal, M Plutinsky, O Sobotik, T Dvorak, and P Safranek are the professional guarantors of the project. The case report form was edited to its final form by B Novotna. The manuscript was written by B Novotna, V Koblizek, and K Hejduk. The manuscript was edited by Z Zbozinkova.

Disclosure

The authors report no conflicts of interest in this work.