The LEAD (Lung, Heart, Social, Body) Study: Objectives, Methodology, and External Validity of the Population-Based Cohort Study

Robab Breyer-Kohansal, Sylvia Hartl, Otto Chris Burghuber, Matthias Urban, Andrea Schrott, Alvar Agusti, Torben Sigsgaard, Claus Vogelmeier, Emiel Wouters, Michael Studnicka, Marie-Kathrin Breyer, Robab Breyer-Kohansal, Sylvia Hartl, Otto Chris Burghuber, Matthias Urban, Andrea Schrott, Alvar Agusti, Torben Sigsgaard, Claus Vogelmeier, Emiel Wouters, Michael Studnicka, Marie-Kathrin Breyer

Abstract

Background: The Lung, hEart, sociAl, boDy (LEAD) Study (ClinicalTrials.gov; NCT01727518; http://clinicaltrials.gov) is a longitudinal, observational, population-based Austrian cohort that aims to investigate the relationship between genetic, environmental, social, developmental and ageing factors influencing respiratory health and comorbidities through life. The general working hypothesis of LEAD is the interaction of these genetic, environmental and socioeconomic factors influences lung development and ageing, the risk of occurrence of several non-communicable diseases (respiratory, cardiovascular, metabolic and neurologic), as well as their phenotypic (ie, clinical) presentation.

Methods: LEAD invited from 2011-2016 a random sample (stratified by age, gender, residential area) of Vienna inhabitants (urban cohort) and all the inhabitants of six villages from Lower Austria (rural cohort). Participants will be followed-up every four years. A number of investigations and measurements were obtained in each of the four domains of the study (Lung, hEart, sociAl, boDy) including data to screen for lung, cardiovascular and metabolic diseases, osteoporosis, and cognitive function. Blood and urine samples are stored in a biobank for future investigations.

Results: A total of 11.423 males (47.6%) and females (52.4%), aged 6-80 years have been included in the cohort. Compared to governmental statistics, the external validity of LEAD with respect to age, gender, citizenship, and smoking status was high.

Conclusions: In conclusion, the LEAD cohort has been established following high quality standards; it is representative of the Austrian population and offers a platform to understand lung development and ageing as a key mechanism of human health both in early and late adulthood.

Keywords: epidemiology; population based cohort; respiratory diseases.

Figures

Figure 1.. Flow chart of study population…
Figure 1.. Flow chart of study population including invitation, inclusion, and main measurements.
Figure 2.. Flow chart for additional measurements.…
Figure 2.. Flow chart for additional measurements. FeNO Fractional exhaled Nitric Oxide; FEV1 forced expiratory volume in the first second; VC Vital capacity; LLN lower limit of normal. References: Six-minute walking test (6 MWT) expressed as a percentage of the predicted distance and perceived dyspnoea using the modified BORG dyspnoea scale. CAT test; http://www.catestonline.org; 36-item short form (SF-36). ACT; https://www.asthmacontroltest.com/.
Figure 3.. Monitoring units in Vienna, Austria…
Figure 3.. Monitoring units in Vienna, Austria and average PM 10 and NOX in the year 2015 [Reference from the following source: City of Vienna, Municipal Department MA 22 - Environmental Protection].
Figure 4.. Smoking status LEAD study cohort…
Figure 4.. Smoking status LEAD study cohort compared to microcensus.

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