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

A.3
A.3 Study design
A.3.2 Baseline interview and questionnaires
Basic information about sociodemographic variables, medical history, medication use, and
lifestyle will be assessed by computer-assisted, face-to-face interviews. Furthermore, selfadministered
questionnaires will be applied via touch screen during the visit to the study
center, as a web-based questionnaire, or as a traditional paper-and-pencil method. As for
the physical examinations, the baseline interview and questionnaires will focus on further
information on major pre-existing diseases, subclinical intermediates, and functions pertaining
to CVD, diabetes, cancer, neurologic and psychiatric diseases, respiratory diseases,
and infections, as well as on the assessment of potential risk factors for these diseases.
Through the combination of extensive information on physical examinations, biomaterials,
and risk factors, a wide range of innovative research questions can be addressed.
This section is subdivided into core modules (A.3.2.1) covering more general topics which
will be applied to all 200,000 study participants and specific modules (A.3.2.2) covering
topics that were identified and proposed by the thematic expert working groups. These
working groups provided information on possible short and valid instruments covering different
organs and systems, disease groups, and exposures. They also reviewed specific
questionnaire modules. For some of the topics, specific modules will only be administered
to the intensively phenotyped subgroup (Level 2, n=40,000).
The envisaged face-to-face total interview time of the modules presented below will be
about 1 h for all 200,000 participants, supplemented by self-administered questionnaires
by touch screen or on paper (partly to be filled in at home), for which the estimated time
of completing the questionnaires will be less than 1 h. Personnel time only needs to be
calculated for the interview. Self-administered questionnaires do not require continuous
presence of study personnel, although support may be offered by trained receptionists as
needed.
The web-based questionnaires which can be filled out at the participant’s convenience from
any location with internet access (e.g., at home) may take up to 1 h for completion. Some of
the instruments will be completed around the time of the examination visit, but some of the
web-based instruments are planned for later completion by the participant. Web access for
completion of the respective instruments will also be offered to the participants at the study
centers.
A.3.2.1 Core interview and questionnaires
An overview of the modules of the baseline core interview and questionnaires is given in
Table 3.4, and some additional information on the modules is provided in the following text.
Sociodemographic and socioeconomic factors
As further outlined in Sect. A.2.4.5, there is an inverse association of SES with morbidity
and mortality for a wide range of chronic diseases and with their associated risk factors 319,
325, 327, 332, 339, 424, 425 . It has also been shown that SES at different stages of the course of life
has an independent and cumulative effect on health outcomes and mortality 344, 345, 349, 426-429 .
Moreover, general sociodemographic factors are potential confounders and need to be collected
routinely for epidemiologic studies.
Instruments:
General sociodemographic information (e.g., age, gender, place of birth, ethnicity/migration
background, marital status, partnership, and offspring) and information on SES will be obtained
using standardized instruments that have been used successfully in existing German
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