Scientific Concept of the National Cohort (status ... - Nationale Kohorte
Scientific Concept of the National Cohort (status ... - Nationale Kohorte
Scientific Concept of the National Cohort (status ... - Nationale Kohorte
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
A.3<br />
A.3 Study design<br />
In addition, as many subjects are not able to give details about newly diagnosed diseases<br />
(e.g., invasive breast cancer versus in situ breast cancer; angina pectoris versus MI; stenting<br />
without prior MI versus stenting because <strong>of</strong> acute MI, etc.), <strong>the</strong> questionnaires will query<br />
diagnosis and treatment circumstances that can indicate incident outcomes <strong>of</strong> interest as<br />
closely as possible. For example, data from subjects who were admitted to hospitals for a<br />
cardiologic diagnostic check-up or treatment or for a cancer check-up will be validated by<br />
hospital chart review, etc.<br />
In a second step, selected self-reported incident diseases (and dates <strong>of</strong> diagnosis) will be<br />
systematically verified by contacting <strong>the</strong> participant’s pertinent physician(s) who made<br />
<strong>the</strong> diagnosis (i.e., general practitioners, specialists, or hospitals/clinics, respectively). Only<br />
verified cases will finally be considered for analyses, so as to ensure high specificity.<br />
For certain diseases, we will also obtain more specific medical information from <strong>the</strong> physician<br />
or use organized access to patients’ clinical records and/or pathology records for direct<br />
information retrieval, e.g., for fur<strong>the</strong>r classification into specific subtypes <strong>of</strong> disease. For example,<br />
information from patients’ clinical records will be used to classify cases <strong>of</strong> stroke into<br />
specific subtypes (ischemic versus hemorrhagic). Likewise, information from clinical records<br />
and pathology records will be used for <strong>the</strong> specific coding <strong>of</strong> histologic subtypes <strong>of</strong> cancer.<br />
In addition to active follow-up, we will make use <strong>of</strong> linkage with external data sources for<br />
detecting and verifying incident diseases. This is particularly relevant in <strong>the</strong> field <strong>of</strong> cancer,<br />
where epidemiologic cancer registries (with varying degrees <strong>of</strong> completeness <strong>of</strong> coverage)<br />
have now been established in every state in Germany. These registries will also be<br />
used to ascertain incident disease. Supporting epidemiologic research in <strong>the</strong> field <strong>of</strong> cancer<br />
etiology is among <strong>the</strong> primary aims <strong>of</strong> cancer registries in Germany. For many cases <strong>of</strong><br />
cancer and for many cancer types, <strong>the</strong> use <strong>of</strong> cancer registry data will reduce <strong>the</strong> workload<br />
for fur<strong>the</strong>r active verification <strong>of</strong> clinical and/or retrieval <strong>of</strong> pathology records, and thus will<br />
both facilitate <strong>the</strong> follow-up process and allow for major cost savings.Several successful<br />
examples exist in Germany to support <strong>the</strong> aforementioned strategy to ascertain incident disease.<br />
Similar strategies have been used in <strong>the</strong> Heinz Nixdorf Recall Study, CARLA, SHIP,<br />
EPIC, and KORA studies 746, 747 .<br />
Information on vital <strong>status</strong> will be collected from population registries at regular intervals for<br />
<strong>the</strong> participants who have not taken part in <strong>the</strong> follow-up or reassessment procedures. For<br />
subjects who have died, <strong>the</strong> death certificate that provides information on <strong>the</strong> cause <strong>of</strong><br />
death will be obtained from <strong>the</strong> public health <strong>of</strong>fices. A <strong>National</strong> Mortality Registry is presently<br />
being planned in Germany. As this national registry is expected to become progressively<br />
operational and increase its coverage – which will probably be not <strong>the</strong> case before year 3<br />
<strong>of</strong> <strong>the</strong> study – <strong>the</strong> procedure described above will be gradually substituted by data retrieval<br />
from this registry following a validation phase with parallel ascertainment <strong>of</strong> approximately<br />
ano<strong>the</strong>r 2 years.<br />
The use <strong>of</strong> secondary data from <strong>the</strong> health system as described in Sect. A.3.8 will be tested<br />
for its usability to support <strong>the</strong> follow-up process. Individual linkage to secondary data has a<br />
significant potential as an additional source <strong>of</strong> follow-up information 748 .<br />
For assessment <strong>of</strong> prevalent diseases at baseline we plan to use similar strategies, in conjunction<br />
with <strong>the</strong> results from physical and medical examinations conducted as part <strong>of</strong> <strong>the</strong><br />
baseline recruitment protocol.<br />
For ascertainment <strong>of</strong> dementia, depression, headache, and RLS, scores based on questionnaires<br />
will be established that can be used to supplement <strong>the</strong> self-reported data on<br />
physician-diagnosed diseases. These scores are described in more detail in Sect. A.2.2<br />
and A.2.3.<br />
130