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

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A.3 Study design
The respective rooms should comply with mandatory standards for drawing and processing
of blood and other specimens. Thus, they must be floored with suitable material permitting
adequate disinfection and cleaning, and adequate washing facilities must be provided.
For some of the examinations, room temperature must be maintained at a certain prespecified
level (e.g., at least 22° C for the rooms where blood pressure measurements and ECGs
are recorded). Thus, provision of air conditioning in some of the rooms is mandatory (including
the storage space for –80°C freezers).
Personnel and equipment needed for each study center
All study centers need to be fully equipped with all devices and instruments required to perform
the data collection, including medical examinations, interviews, laboratory processing,
and storage of biosamples. Provision of the necessary IT environment, data storage capacities,
and web access as outlined in Sect. A.4 (Integrated data management) is mandatory
for all study centers, and archiving cabinets for study documentation of the participants
must be in place. In addition, four of the study centers will provide dedicated MRI facilities
in order to perform the specialized imaging protocol (see Sect. A.3.4, Assessments through
medical imaging).
The personnel requirement for each center will depend on its capacity, the intended sample
size, the expected number of assessments to be carried out, and its opening hours. Personnel
skill-mix will include study nurses, health care technicians, data manager, receptionists,
and physicians.
Logistic organization of participants’ visit, interview, and physical examinations
The staff at the study centers will conduct the interviews and examinations of the study
participant. The responsibility for organizing a smooth examination process of 10 or more
subjects per center per day lies with the head and the personnel of the individual study
centers. The appointment scheduling will be organized by each coordinating/study center
following the standardized procedure as described above.
After welcoming and registering the participant at the study center, it will be ensured that the
participant has understood the study information and all examination procedures; completion
of the informed consent form will be checked.
The core program including examinations, interview, and collection of biosamples (Level 1)
will last about 2.5 h on average, while the intensified program (Level 2) will require about
4 h. Since participants in the intensified program will need to be fasting for the OGTT, their
appointments will start between 7 a.m. and 10.30 a.m. Subjects participating in the core
program only may not be fasting and can start their appointments later in the day.
Workflow will be standardized according to a detailed protocol that must be adhered to at
each study center. This will increase adherence to the envisaged examination times, help
standardize data collection across centers, and neutralize the effect that certain aspects
related to the examination order may have on study participants. The optimal workflow
will be tested during the pilot study and will subsequently be implemented in the main
study. Lengthy waiting times between the examination procedures and frequent changing
of rooms will be avoided. Therefore, as many examinations as possible will be conducted in
the same room. For example, the measurement of height, weight, waist, and hip circumferences,
blood pressure, and the recording of the resting ECG can be conducted in one room
so that participants do not need to take off their shoes and clothes several times.
A.3