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

A.3
A.3 Study design
Disease Question to
participant
(Physiciandiagnosed
disease, date of
diagnosis)
Respiratory diseases
COPD X
(COPD/Chronic
bronchitis)
Additional information
from participant
considered
to support self-report
(and increase sensitivity)
Questionnaire on specific
symptoms, medication
(bronchodilatators,
inhalative glucocorticoids)
Asthma X Questionnaire on specific
symptoms, medication
(bronchodilatators,
inhalative glucocorticoids)
Infectious diseases
Respiratory
infections
Gastrointestinal
infections
Vaccine
preventable
diseases,
Immune
senescence
(Questionnaire)
Active
surveillance**
132
Physicians’
diagnosis
(including
diagnosis, date of
diagnosis,
interventions)
subtypes
X,
small airway
disease,
emphysema,
medication
X,
allergic,
nonallergic
X
Immune status,
lab results,
differential
diagnoses
Passive
followup
Death
certificate
* Optional use of information from assessment modules where appropriate, e.g. ECG information for
the diagnosis of MI
** See also Sect. A.2.2.6
A.3.7.4 Prospective assessment of changes in exposures/risk factors
Table 3.15: Assessment of incident diseases in the National Cohort
The repeated contact to the study participants by mail to ascertain incident disease will also
be used to update information about exposures/risk factors. This includes information on
changes in lifestyle such as smoking behavior, physical activity, etc. In the National Cohort
we will evaluate whether some of these factors can be assessed by internet-based instruments
that cover the habits during the previous day (e.g., physical activity, diet) or events
during the past weeks or months (acute infectious diseases such as respiratory infections
and gastroenteritis).
A.3.7.5 Endpoint committees
Standard criteria to verify endpoints of interest will be used. Data from subjects with endpoint
information that appears inconsistent, implausible, or arbitrary will be reviewed by a
specialized endpoint criteria committee that includes clinical experts and various specialists
such as pathologists, radiologists, and others. As the National Cohort study includes several
medically diverse endpoints, several committees will be set up. These committees are:
X
(X)