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

figure 3.2: Interaction between study center and imaging site.
Availability
Technical scanner specifications
Study Center
� Subject selection according to criteria
� Inforamtion on imaging process
� Informed consent by physician
� Appointment scheduling
Imaging Site
� 10 slots available / day
� Image acquisition
� Quality check
� Data transfer
� Initiate feedback mechanism on important
incidental findings
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A.3 Study design
Identification /
Scheduling
Given the aforementioned objectives of the National Cohort, the current proposal takes into
account the following requirements:
1. Highest flexibility of the MRI system as regards physiognomy of the volunteers and
especially to body size and weight; otherwise, a potential bias by exclusion of certain
cohorts in the imaging part may be introduced. For example, improper selection of a
system with limited capability to scan obese volunteers will potentially bias the evaluation
of cardiometabolic disorders.
2. The system should support technologies for assuring a high predictability of examination
durations and also support new imaging techniques that would reduce the total
rooming time required for scanning a volunteer. The number of volunteers scanned
will have a direct correlation to the achieved evidence level of the National Cohort and
consequently also to recruitment for the subgroups.
3. To reduce the influence of potential variation in technologists’ skill levels, intelligent
guidance and (semi-automation) of the scanning process is mandatory. This is expected
to improve the robustness of the examination (and therefore predictability of
scan time) and assure a standard of image quality throughout the cohort and imaging
centers. In addition, an intelligent reduction in variables that can be influenced by the
technologist during the MRI examination is mandatory to avoid excluding scans due
to violation of sequence parameters of the individual MRI examination / sequences.
4. For multicenter studies, the distribution of sequence protocols and the assurance of
their integrity during scanning is associated with a high level of quality checks and
is often an error-prone process. Scanner technologies should therefore assist in the
distribution of protocols and their application at the individual MRI site.
5. MRI screening generates large data volumes with the highest level of complexity of
all imaging modalities used in clinical routine. In combination with the high volume of
MRI studies, data storage, data handling, data interpretation, and an efficient reading
process are crucial. In addition, reproducibility of image findings and standardization
of reporting has to be considered.
A.3