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

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C.1 C.1 Annex: Description of the study centers surveys which challenged the concept of fibromyalgia as a distinct rheumatological disease entity, a large cohort study of initially 10,000 subjects to develop an algorithm to assess rehabilitation needs of insurants of a regional statutory pension fund for blue collar workers with severe, disabling BP (Luebeck Algorithm). A previous population-based survey in Hanover addressed more than 11,000 adult residents of the city studying the prevalence and health care for rheumatoid arthritis and various rheumatic complaints, including back pain. Since 1997, the Institute for Cancer Epidemiology (IKE) is running the populationbased cancer registry of Schleswig-Holstein (in cooperation with the medical association Schleswig-Holstein). Each year, approximately 20,000 incident cases occur in the area. The registry processes some 50,000 notifications (mandatory notification) and 30,000 death certificates per year. Currently more than 600,000 notifications representing more than 250,000 cancer patients are stored in the registry. These data are used for multiple purposes, including public health reporting, small area analyses, or epidemiologic research. Furthermore, several large cohort studies were or are being conducted at the institute, as the worldwide largest controlled cohort study of children conceived after employing artificial reproductive techniques (ICSI follow-up study = intra cytoplasmatic sperm injection, n=3,300) or the OVIS study (health care research in cancer survivors, n=5,000). Since 2001, a cohort of women after diagnostic mammography is being built up and analyzed. Up to now more than 300,000 women have been documented, and a record linkage to the cancer registry was established. In 2011 the University of Luebeck launched the recently established Institute for Clinical Epidemiology (IfKE) (W3 professorship in epidemiology). The new institute will work in close collaboration with the Institute for Cancer Epidemiology and support the academic center of population medicine and health care research. Research activities at Medical Department II of the UzL are focused upon epidemiologic aspects of cardiac geometry and function and on the molecular genetics of MI. The investigators have more than 15 years of experience in conducting epidemiologic research in the context of the MONICA studies. In particular, ECG studies were introduced and repeatedly carried out in the Augsburg KORA study, producing multiple novel observations. With respect to MI genetics the group coordinates the German (NGFN, Atherogenomics), European (EU frame-work 6, Cardiogenics), and global initiatives (CARDIoGRAM) on genomewide association studies for this pertinent disease. Description of the study center Kiel For the National cohort, the Biobank popgen will be responsible for the field work of recruiting 10,000 study participants in Schleswig-Holstein and therefore a study center will be established at the University Hospital Schleswig-Holstein, campus Kiel. Popgen will be responsible for all tasks related to recruitment and follow-up, with assistance by the partner institutes at the CAU and UzL. For example the ICMB will assist in collecting biomaterials whereas IMIS and SP-PM will supervise ethical and data safety issues. IfSM and IfKE will be responsible for exposure assessments related to health care research, IKE will be responsible for record linkages to the cancer registry Schleswig-Holstein during follow-up and the Medical Department II will be responsible for cardiovascular phenotyping following the general protocol of the National Cohort. Comprehensive non responder analyses will be done at IfKE. In Kiel 10,000 individuals will be recruited including inhabitants of the city of Kiel and adjacent municipalities. The catchment area for the SH cluster will include the city of Kiel (population 170,000) and adjacent municipalities (population 175,000). This results in a total source population of about 345,000. Registration offices for drawing random populationbased samples have been successfully accessed in the past. 266
267 C.1 Annex: Description of the study centers The study center will be located at the University Hospital Schleswig-Holstein Campus Kiel. The campus of the University Hospital Schleswig-Holstein in Kiel is centrally located in Kiel and easily accessible by public transport. The study center will comprise rooms for investigations, and interviews and terminals for self-administered questionnaires. The laboratory of the Biobank popgen is located on the same campus and will be used for preanalytical preparation of biosamples. The biorepository of the Biobank popgen is located at the university campus Center for Molecular Biosciences (ZMB) in Kiel. Close cooperation with the cancer registry of Schleswig-Holstein, which is a partner in this project, ensures efficient tracing of incident cases. By using the biobanking network popgen 2.0 tumor samples can be collected and individuals traced for incident diseases. Close cooperation with clinicians is ensured by established connections to institutes of the Medical Faculties of CAU, Kiel and UzL, Luebeck. C.1.8 Cluster mecklenburg-western Pomerania The Cluster Mecklenburg-Western Pomerania comprises one study center in the area of North-East Germany, located in the city of Neubrandenburg. Recruitment cluster figure 8: Geographical overview of recruitment areas and study center the the cluster Mecklenburg-Western Pomerania Mecklenburg-Western Pomerania University Greifswald SC Neubrandenburg Study center (SC) Coordinating institution Participating institution Recruitment areas: Neubrandenburg city County of Demmin County of Uecker-Randow County of Mecklenburg-Strelitz County of Mueritz Greifswald Neubrandenburg C.1
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The National Cohort A prospective e
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Applicants Applicants Applicants Cl
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Applicants IV
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Executive Summary 2. The National C
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Executive Summary 3. Scientific aim
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Executive Summary essary to address
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Executive Summary 7. Examples for s
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Contents A.2.4 major areas of expos
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Contents A.3.8.2 Social security da
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Contents A.6.4.2 Minimally detectab
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Abbreviations C.2 mEThOdS fOr STATI
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Abbreviations DXA Dual-energy x-ray
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Abbreviations CHS Cardiovascular He
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A.1 A.1 Introduction and overview a
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A.1 A.1 Introduction and overview s
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A.1 A.1 Introduction and overview A
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A.2 A.2. Scientific background and
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A.3 A.3 Study design ment instrumen
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A.3 A.3 Study design Table 3.2: Des
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A.3 A.3 Study design Table 3.3: Dis
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A.3 A.3 Study design the participan
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A.3 A.3 Study design with a prepare
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A.3 A.3 Study design rural areas, t
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A.3 A.3 Study design A.3.2 Baseline
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A.3 A.3 Study design Modules 70 Int
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A.3 A.3 Study design ovarian carcin
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A.3 A.3 Study design Table 3.5: Spe
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A.3 A.3 Study design depression and
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A.3 A.3 Study design to the extent
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A.3 A.3 Study design ers to vaccina
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A.3 A.3 Study design certain foods)
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A.3 A.3 Study design A short instru
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A.3 A.3 Study design ticipants and
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A.3 A.3 Study design a resting time
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A.3 A.3 Study design index, convent
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A.3 A.3 Study design Although the i
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A.3 A.3 Study design air and then t
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A.3 A.3 Study design hemorrhages (0
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A.3 A.3 Study design genetics of BM
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A.3 A.3 Study design hand grip stre
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A.3 A.3 Study design Project title
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A.3 A.3 Study design diseases in va
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A.3 A.3 Study design associations,
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A.3 A.3 Study design Informed Conse
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A.3 A.3 Study design 6. Since being
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A.3 A.3 Study design the possible d
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A.3 A.3 Study design A.3.5 Collecti
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A.3 A.3 Study design Blood In addit
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A.3 A.3 Study design the anterior n
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A.3 A.3 Study design study. For exa
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A.3 A.3 Study design large-size sto
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A.3 A.3 Study design routinely prep
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A.3 A.3 Study design Subjects who m
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A.3 A.3 Study design A.3.6.3 reliab
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A.3 A.3 Study design In addition, a
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A.3 A.3 Study design Disease Questi
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A.3 A.3 Study design Data routinely
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A.3 A.3 Study design tial misclassi
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A.3 A.3 Study design � The KORA c
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A.4 A.4 Integrated Data Management
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A.5 A.5 Methods for quality assuran
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A.6 A.6 Planned statistical analyse
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A.6 A.6 Table Planned 6.4: Expected
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A.7 A.7 Ethical aspects logical/gen
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A.7 A.7 Ethical aspects The more ex
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C.3 References 757. BSI-Standard 10
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