The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline - 22/04/16

Doi : 10.1016/j.rmed.2016.03.008

Annika Karch ^a,^{^{1
Karch A and Vogelmeier C contributed equally.}}, Claus Vogelmeier ^b,^{^{1
Karch A and Vogelmeier C contributed equally.}}, Tobias Welte ^c, Robert Bals ^d, Hans-Ulrich Kauczor ^e, Jürgen Biederer ^e, Joachim Heinrich ^f, Holger Schulz ^f, Sven Gläser ^g, Rolf Holle ^h, Henrik Watz ⁱ, Stephanie Korn ^j, Nina Adaskina ^a, Frank Biertz ^a, Charlotte Vogel ^a, Jørgen Vestbo ^k, Emiel F.M. Wouters ^l, Klaus Friedrich Rabe ⁱ, Sandra Söhler ^m, Armin Koch ^a,^⁎ , Rudolf A. Jörres ^n,^⁎
for
the COSYCONET Study Group
^a Institute for Biostatistics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
^b Department of Respiratory Medicine, University of Marburg, University Giessen and Marburg Lung Center (UGMLC), Member of the German Center for Lung Research, Baldingerstraße, 35043 Marburg, Germany
^c Clinic for Pneumology, Hannover Medical School, Member of the German Center for Lung Research, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
^d Department of Internal Medicine V – Pulmonology, Allergology, Respiratory Intensive Care Medicine, Saarland University Hospital, Kirrberger Straße 1, 66424 Homburg, Germany
^e Department of Diagnostic and Interventional Radiology, University of Heidelberg, Translational Lung Research Center (TLRC), Member of the German Center for Lung Research, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany
^f Institute of Epidemiology I, Helmholtz Zentrum München, German Research Center for Environmental Health, Member of the German Center for Lung Research, Comprehensive Pneumology Center Munich (CPC-M), Ingolstaedter Landstr. 1, 85764 Neuherberg, Germany
^g Department of Internal Medicine B – Cardiology, Intensive Care, Pulmonary Medicine and Infectious Diseases, University Medicine Greifswald, Scientific Division of Pneumology and Pneumological Epidemiology, Ferdinand-Sauerbruch-Strasse, 17475 Greifswald, Germany
^h Institute of Health Economics and Health Care Management, Helmholtz Zentrum München (GmbH), German Research Center for Environmental Health, Member of the German Center for Lung Research, Comprehensive Pneumology Center Munich (CPC-M), Ingolstaedter Landstr. 1, 85764 Neuherberg, Germany
ⁱ LungenClinic Grosshansdorf, Pulmonary Research Institute, Airway Research Center North, Member of the German Center for Lung Research, Woehrendamm 80, 22927 Grosshansdorf, Germany
^j Pulmonary Department, Mainz University Hospital, Langenbeckstrasse 1, 55131 Mainz, Germany
^k Centre for Respiratory Medicine and Allergy, Institute for Inflammation and Repair, University of Manchester, Southmoor Rd, Manchester M23 9LT, UK
^l Department of Respiratory Medicine, Maastricht University Medical Center, P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands
^m ASCONET Study Coordination Office, University of Marburg, Baldingerstraße, 35043 Marburg, Germany
ⁿ Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ludwig-Maximilians-Universität München, Ziemssenstr. 1, 80336 Munich, Germany

^∗Corresponding author. Institute for Biostatistics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.Institute for Biostatistics, Hannover Medical SchoolCarl-Neuberg-Str. 1Hannover30625Germany^∗∗Corresponding author. Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ludwig-Maximilians-Universität München, Ziemssenstr. 1, 80336 München, Germany.Institute and Outpatient Clinic for Occupational, Social and Environmental MedicineLudwig-Maximilians-Universität MünchenZiemssenstr. 1München80336Germany

Abstract

Background

The German COPD cohort study COSYCONET (“COPD and SYstemic consequences-COmorbidities NETwork”) investigates the interaction of lung disease, comorbidities and systemic inflammation. Recruitment took place from 2010 to 2013 in 31 study centers. In addition to the baseline visit, follow-up visits are scheduled at 6, 18, 36 and 54 months after baseline. The study also comprises a biobank, image bank, and includes health economic data. Here we describe the study design of COSYCONET and present baseline data of our COPD cohort.

Methods

Inclusion criteria were broad in order to cover a wide range of patterns of the disease. In each visit, patients undergo a large panel of assessments including e.g. clinical history, spirometry, body plethysmography, diffusing capacity, blood samples, 6-min walk-distance, electrocardiogram and echocardiography. Chest CTs are collected if available and CTs and MRIs are performed in a subcohort. Data are entered into eCRFs and subjected to several stages of quality control.

Results

Overall, 2741 subjects with a clinical diagnosis of COPD were included (59% male; mean age 65 ± 8.6 years (range 40–90)). Of these, 8/35/32/9% presented with GOLD stages I–IV; 16% were uncategorized, including the former GOLD-0 category. 24% were active smokers, 68% ex-smokers and 8% never-smokers. Data completeness was 96% for the baseline items.

Conclusion

The German COPD cohort comprises patients with advanced and less advanced COPD. This is particularly useful for studying the time course of COPD in relation to comorbidities. Baseline data indicate that COSYCONET offers the opportunity to investigate our research questions in a large-scale, high-quality dataset.

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Highlights

•	The German COPD cohort COSYCONET has completed recruitment with 2741 patients.
•	The focus is on analyzing the association between COPD and comorbidities.
•	Patients of all severity stages incl. “GOLD 0” were enrolled, 59% male, mean age 65.
•	Baseline data quality is very good with >95% completeness.
•	Regular follow-up visits of up to 4.5 years are still ongoing.

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Keywords : COPD, Comorbidity, Systemic inflammation, Cohort, Study design

Plan

Introduction

Network structure

Materials and methods

Quality control and assurance

Baseline characteristics

Data quality

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Vol 114

P. 27-37 - mai 2016 Retour au numéro

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The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline - 22/04/16

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