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

A.3
A.3 Study design
rural areas, this may require the inclusion of selected communities within the greater rural
area. The study centers will either be newly created in academic or clinical research facilities
or will be based in pre-existing study centers. Each study center will be identically equipped
for examinations that will be performed on Level 1 or Level 2 subjects, i.e., in the full cohort or
in the cohort of 40,000 subjects included in the intensified examination program. Additionally,
all centers need to be identically equipped with the necessary information technology (IT)
facilities, including touch screens to capture self-administered questionnaire data and PCs
for conducting computer-assisted interviews. Network connections to servers on which the
data will be stored and internet access will be required.
Room and space requirements
Each study center will provide dedicated space for carrying out medical examinations (e. g.,
anthropometric measurements, ultrasound of carotid arteries, ophthalmological examinations,
exercise tests, and drawing of venous blood samples) as well as space for conducting
interviews, and space equipped with touch screens and furnished with tables for completing
self-administered questionnaires. Laboratory facilities for preanalytical processing and interim
storage of blood, urine, and other biological samples will also be needed. This includes
the provision of deep-freeze storage facilities. Moreover, all centers need to be equipped
with appropriate toilettes for urine sampling, including rest rooms for handicapped persons.
Easy accessibility to the study center (e.g., availability of an elevator) must be ensured.
In order to enable the examination of at least 10 subjects per day with an examination and
interview program of 2.5 or 4 hours as described in Sects. A.3.2 and A.3.3 (Baseline assessments
at Levels 1 and 2), a number of rooms equipped for the following examination
modules, interview, and other purposes must be provided:
� Reception/front desk area, including a waiting area for study subjects
� Two rooms for personal interviews
� One larger area with cubicles for touch screen-based self-administered questionnaires
and tests (incl. selected tests of cognitive function, speech-in-noise test)
� One kitchen and breakfast area for subjects who participate in the OGTT
� One laboratory, including centrifuges, refrigerators, and deep freezer storage space
� Rooms for general examinations (including anthropometric measures, blood pressure
measurements, resting ECG, pulse-wave analysis, hand grip, spirometry, AGE
reader, venipuncture)
� Rooms for specialized measurements, such as
– Ultrasound (e.g., carotid ultrasound, 3D-Echocardiography)
– Cardiorespiratory function testing (step test)
– Sensory measurements (ophthalmological measurements, sniffing sticks)
– Neuropsychiatric function testing (face-to-face), posturometry / balance tests, examination
of the musculoskeletal system
– Dental examinations
– DXA scan
� Several rooms for study personnel, e. g.,
– One separate room for the study physician who performs the final discussion of
examination results with the study participants
– One room for medical documentalists, including archive space
– One room for technical assistants who prepare and complete study documentation
� Toilets (suited for male, female, and handicapped persons)
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