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

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A.1 A.1 Introduction and overview and early pathophysiological responses and chronic disease outcomes with such a study design, Finally, prospective studies are indispensable for investigating risk determinants for overall and cause-specific mortality and other conditions that are either associated with a high fatality risk, such as MI, or with memory losses and poor responses to questionnaires or personal interviews, such as cognitive impairment and dementia. A.1.3 The National Cohort: Overview of study design The National Cohort will include a total of 200,000 women and men in the age range of 20 to 69 years (40,000 individuals under age 40 and 160,000 individuals over age 40 years), who will be recruited through a network of 18 local study centers (figure 1.1) spread all over North, East, South, West, and central Germany (Level 1). In a representative subcohort of 40,000 women and men (i.e., a 20% subsample, distributed equally over all 18 study Figure centers), an 1.1intensified study protocol is foreseen, which will include a series of additional, more in-depth medical examinations. (Level 2). In a further subcohort of 40,000 women and men, comprehensive whole-body, heart and brain magnetic resonance imaging (MRI) will be applied (Figure 1.2). Lower Saxony/ Hamburg/Bremen North Rhine- Westphalia SC Bremen BIPS SC Brunswick/Hanover TiHo Hanover HZI Brunswick SC Muenster University Muenster SC Essen University Hospital Essen SC Duesseldorf German Diabetes Center IUF Baden-Wuerttemberg/ Saarland SC Freiburg University Freiburg Schleswig-Holstein SC Kiel University Kiel University Luebeck SC Hamburg figure 1.1: Recruitment clusters and study centers of the National Cohort UKE SC Saarbruecken SC Heidelberg/ Mannheim University Heidelberg Cancer Registry Saarland DKFZ Heidelberg 2 SC Neubrandenburg SC Halle University Halle–Wittenberg SC Leipzig University Leipzig SC Regensburg University Regensburg SC Augsburg HMGU Munich University Munich Mecklenburg- Western Pomerania University Greifswald RKI MDC Charité DIfE SC Berlin-North SC Berlin-Center SC Berlin-South/Brandenburg Saxony/Saxony-Anhalt Bavaria Berlin-Brandenburg Study center (SC) Coordinating institution Participating institution
3 A.1 Introduction and overview The local study centers are organized in eight geographic clusters throughout Germany, covering the population of almost all federal states. At each of the centers, study participants will be drawn from local municipal population registries within defined strata of age and gender, and covering metropolitan, urban, and rural regions. Eligible subjects will be invited by letter, with written reminders and, when needed, further contacts by telephone. An overall study participation proportion of at least 50% will be targeted. As described in detail in Sect. A.3.1, study participants will be invited to a local study center; data collection will include a computer-assisted personal interview, computer-aided questionnaires, several physical and medical examinations, and biosampling. Information will be collected at different levels of intensity: Level 3 The National Cohort Level 1 (200,000) Level 3 Level 2 (40,000) MRI (40,000) figure 1.2: The National Cohort will be organized on several levels Level 1: 200,000 participants in all study centers; Level 2: 40,000 participants in all study centers; MRI: 40,000 participants in 4 study centers; Level 3: possible other activities with separate funding Baseline Assessment � At the basic study level (“Level 1”), applying to all 200,000 study participants, baseline interviews, questionnaire and examinations will be performed by using a 2.5-h examination protocol. Physical and medical examinations will include measurements of anthropometric indices (height, weight, waist, and hip circumferences), a dual-energy x-ray absorptiometry (DXA) of body composition and bone density, blood pressure measurements, measurements of arterial stiffness, an electrocardiogram (ECG), three-dimensional echocardiography (3D-ECG), spirometry, measurements of physical activity through accelerometry (7 days), a basic test of physical fitness, and an assessment of cognitive function. � A further key element of the core study protocol (Level 1) is the collection of biomaterials from all study participants. A blood sampling protocol will be used that leaves open the greatest possible choice of future laboratory analyses, and includes the collection and storage of intact mononuclear leukocytes. For each study subject, aliquots of plasma, serum, dimethylsulfoxide (DMSO)-preserved viable white blood cells (in a A.1
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A.3 A.3 Study design a resting time
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A.3 A.3 Study design study. For exa
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A.3 A.3 Study design routinely prep
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A.4 A.4 Integrated Data Management
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C.3 References 17. Keil, U., et al.
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