[The baseline assessment of the German National Cohort (NAKO Gesundheitsstudie): participation in the examination modules, quality assurance, and the use of secondary data]. / Die Basiserhebung der NAKO Gesundheitsstudie: Teilnahme an den Untersuchungsmodulen, Qualitätssicherung und Nutzung von Sekundärdaten.

BACKGROUND: The German National Cohort (NAKO) is an interdisciplinary health study aimed at elucidating causes for common chronic diseases and detecting their preclinical stages. This article provides an overview of design, methods, participation in the examinations, and their quality assurance based on the midterm baseline dataset (MBD) of the recruitment. METHODS: More than 200,000 women and men aged 20-69 years derived from random samples of the German general population were recruited in 18 study centers (2014-2019). The data collection comprised physical examinations, standardized interviews and questionnaires, and the collection of biomedical samples for all participants (level 1). At least 20% of all participants received additional in-depth examinations (level 2), and 30,000 received whole-body magnet resonance imaging (MRI). Additional information will be collected through secondary data sources such as medical registries, health insurances, and pension funds. This overview is based on the MBD, which included 101,839 participants, of whom 11,371 received an MRI. RESULTS: The mean response proportion was 18%. The participation in the examinations was high with most of the modules performed by over 95%. Among MRI participants, 96% completed all 12 MRI sequences. More than 90% of the participants agreed to the use of complementary secondary and registry data. DISCUSSION: Individuals selected for the NAKO were willing to participate in all examinations despite the time-consuming program. The NAKO provides a central resource for population-based epidemiologic research and will contribute to developing innovative strategies for prevention, screening and prediction of chronic diseases.

[Quality standards for epidemiologic cohort studies : An evaluated catalogue of requirements for the conduct and preparation of cohort studies]. / Qualitätsstandards für epidemiologische Kohortenstudien : Ein bewerteter Anforderungskatalog zur Studienvorbereitung und Studiendurchführung.

BACKGROUND: Cohort studies are a longitudinal observational study type. They are firmly established within epidemiology to assess the course of diseases and risk factors. Yet, standards to describe and evaluate quality characteristics of cohort studies need further development. OBJECTIVE: Within the TMF ("Technologie- und Methodenplattform für die vernetzte medizinische Forschung e. V.") project "Quality management standards in cohort studies", a catalogue of requirements was compiled and evaluated, focusing on the preparation and conduct of epidemiologic cohort studies. MATERIALS AND METHODS: The catalogue of requirements was established based on a consensus process between representatives of seven German epidemiologic cohort studies. For this purpose, a set of expert meetings (telephone, face-to-face, web-based) was conducted and the importance of each element of the catalogue was assessed as well as its implementation. RESULTS: A catalogue of requirements with 138 requirements was consented. It is structured into ten sections: 1. Study documentation; 2. Selection of instruments; 3. Study implementation, 4. Organizational structure; 5. Qualification and certification; 6. Participant recruitment; 7. Preparation, conduct and follow-up processing of examinations; 8. Study logistics and maintenance, 9. Data capture and data management; 10. Reporting and monitoring. In total, 41 elements were categorized as being essential, 91 as important, and 6 as less important. CONCLUSION: The catalogue of requirements provides a guideline to improve the preparation and operation of cohort studies. The evaluation of the importance and degree of implementation of requirements depended on the study design. With adaptations, the catalogue might be transferable to other study types.

New data for action. Data collection for KiGGS Wave 2 has been completed.

The fieldwork of the second follow-up to the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) was completed in August 2017. KiGGS is part of the Robert Koch Institute's Federal Health Monitoring. The study consists of the KiGGS cross-sectional component (a nationally representative, periodic cross-sectional survey of children and adolescents aged between 0 and 17) and the KiGGS cohort (the follow-up into adulthood of participants who took part in the KiGGS baseline study). KiGGS collects data on health status, health-related behaviour, psychosocial risk and protective factors, health care and the living conditions of children and adolescents in Germany. The first interview and examination survey (the KiGGS baseline study; undertaken between 2003 and 2006; n=17,641; age range: 0-17) was carried out in a total of 167 sample points in Germany. Physical examinations, laboratory analyses of blood and urine samples and various physical tests were conducted with the participants and, in addition, all parents and participants aged 11 or above were interviewed. The first follow-up was conducted via telephone-based interviews (KiGGS Wave 1 2009-2012; n=11,992; age range: 6-24) and an additional sample was included (n=4,455; age range: 0-6). KiGGS Wave 2 (2014-2017) was conducted as an interview and examination survey and consisted of a new, nationwide, representative cross-sectional sample of 0- to 17-year-old children and adolescents in Germany, and the second KiGGS cohort follow-up. The completion of the cross-sectional component of KiGGS Wave 2 means that the health of children and adolescents in Germany can now be assessed using representative data gained from three study waves. Trends can therefore be analysed over a period stretching to over ten years now. As the data collected from participants of the KiGGS cohort can be individually linked across the various surveys, in-depth analyses can be conducted for a period ranging from childhood to young adulthood and developmental processes associated with physical and mental health and the associated risk and protective factors can be explored. As such, KiGGS Wave 2 expands the resources available to health reporting, as well as policy planning and research, with regard to assessing the health of children and adolescents in Germany.