Scientific Concept of the National Cohort (status ... - Nationale Kohorte

Executive Summary
essary to address the above described research objectives and to implement an epidemiologic
research tool with adequate statistical power.
4. The National Cohort in the context of existing German and European
studies
Added value in comparison to existing German cohorts
Several medium-sized epidemiologic cohort studies are currently ongoing in Germany,
covering a total of 100,000 – 120,000 individuals. Many of these studies, however, were
planned independently of each other and have different study elements. Thus, only for
some of the existing German cohorts could pooled data analyses be conducted, and then
only for part of the data collected, addressing a variety, but still limited number of research
questions. The National Cohort will have a homogeneous study protocol for a large sample
size, which will permit analyses of many research questions for which the existing German
cohorts are statistically under-powered.
A further major argument for setting up a new prospective cohort study is that most existing
cohorts in Germany already have a median age above 50 years (in some of the larger
cohorts [e.g., EPIC] even above 60 years) and cannot be used to study the development of
disease at younger ages. In addition, existing cohorts were initiated up to 25 years ago, and
lag-times between exposure assessments and including blood sample collection till disease
diagnosis are becoming very long. Moreover, for several of the larger German cohorts, such
as the two German EPIC cohorts, biobank resources will be largely used up in the coming
10-12 years. The National Cohort aims to ensure the continuing availability of up-to-date
prospective biobank resources after 2020.
Finally, the National Cohort will provide a population-based, highly standardized and comprehensive
database that covers much of the heterogeneity both with respect to risk factors
and major diseases in the general population across Germany.
Added value of the National Cohort in comparison to other European cohorts
Several large epidemiologic cohort studies exist or are being planned in other European
countries (e.g., the UK, Netherlands, France, and Sweden). The National Cohort will have
several advantages as compared with other large European cohorts, including
(i) High quality of bio-samples by highly standardized pre-analytical processing and automated
storage;
(ii) Collection and storage of a diverse range of specialized bio-samples, such as living
lymphocytes, saliva, nasal swabs, and faeces;
(iii) Prospective re-examination after 5 years for all 200,000 participants
(iv) Detailed functional characterisation and examination of intermediate phenotypes and
subclinical disease (body composition, cardiovascular examinations, pre-clinical diabetes,
neurocognitive functions, specific lung function measurements, musculoskeletal
examinations, oral health)
(v) Implementation of MRI techniques (e.g., MRI of brain, heart, whole body).
In addition, compatibility of questionnaires and medical examinations with those used in
other European studies is planned to the greatest extent possible. For example, elements
from the questionnaires used in the UK Biobank, CONSTANCES and LifeGene cohorts will
also be used in the National Cohort, and examinations such as step test, eye and ear test
modules and imaging protocols for MRI from UK Biobank will be adapted. This high compatibility
of questionnaires and examinations will enhance future data pooling for studies
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