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

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A.3 A.3 Study design Data routinely collected as part of the statutory health insurance system The following data that are routinely collected as part of the statutory health insurance system and are of primary interest with regard to the National Cohort: (1) Outpatient medical care; (2) inpatient medical care; and (3) prescribed medication. Outpatient contacts to general practitioners and medical specialists are regularly documented on a quarterly basis and include information on date of each contact, diagnoses, and services according to the EBM code (“Einheitlicher Bewertungsmaßstab”). More than 90 % of the population has at least one documented contact per year. On average more than ten different ICD codes (acute or chronic diseases) are documented per patient and per year. Another parameter of interest for the National Cohort may be the utilization of screening data (e.g., cancer screening). In-patient stays are documented with information on time, diagnoses (admission, discharge, and claims diagnoses) as well as information about the treatment, coded via the ”Operationen- und Prozeduren-Schlüssel (OPS)”, the German-language modification of the International Classification of Procedures in Medicine. With this tool events leading to hospitalization and many clinical interventions can be identified, e.g., hysterectomy, hip replacements, coronary bypass grafts, or PTCA. Medication qualifying for reimbursement is recorded by date dispensed, number of packages dispensed, and the specific ID for each dispensed product (‘Pharmazentralnummer’). Therefore, product-based information such as the Anatomical Therapeutic Chemical Classification System (ATC), the pharmacological strength, defined daily doses (DDD), contraindications, and interactions can be unequivocally assigned. The aforementioned data must be sent by providers in strictly standardized formats and are held by the various statutory health insurances together with the health insurance ID of the insured person. In addition to the aforementioned data, total health-related spending of the insurance and work inability data are documented at a person-level by health insurances and could possibly be used for the National Cohort. As we expect that the organization of the health care system will evolve in the course of the cohort, adaptations regarding changes in legal regulations and access to additional data will be considered. Data routinely collected as part of the German statutory pension insurance scheme and administrative data of the Federal Employment Agency / Institute for Employment Research Membership in the statutory pension insurance system is compulsory in Germany for more than 95 % of the German workforce. While the main focus of the pension insurance is on old-age retirement, the system also covers work disability pensions. These pensions apply in the event of early retirement due to permanent severe reduction of an employee’s ability to work. The German statutory pension insurance provides access to claims data at the individual level. A major portion of rehabilitation measures are also covered by pension insurance rather than health insurance. Thus, these data are relevant for assessing efforts to keep people (with chronic disease) in work, given the high importance of an active working status for a person's health and well-being. Most of the service claims in the German social insurance system are related to labor force participation and income of insurance members. Data are provided by employers at least annually and transferred by the health insurance to the pension and unemployment insurances. Data include sociodemographic information of each employee as well their occupational code and the economic sector of employment, both classified according 134
135 A.3 Study design to standard classifications of the Federal Office of Statistics. However, for reasons of data confidentiality, only certain institutions are given access to these data. The Institute for Employment Research (Institut für Arbeitsmarkt- und Berufsforschung) is part of the Federal Employment Agency and holds what is known as an "Integrated Employment Biography”. Here, individuals who either have been employed subject to social security, have received benefits according to the German Social Code Book II or III, participated in programs of active labor market policies, or have officially been registered as job-seekers at the German Federal Employment Agency are covered for the periods 1975 to 2008 and 2000 to 2008 in formerly West and East Germany, respectively. Therefore, the data provide a life-course follow-up of work and unemployment/job-seeking histories. A former version of that file has been used, for example, to create occupational biographies and estimate risks for early retirement 749 . All access to secondary data will be based on individual informed consent. Only pseudonymized data will be used in the analyses. A.3.8.3 Environmental data Several sources for secondary data on environmental hazards are already available. More and spatially more refined data will be generated in the future. We envision combining publicly available databases with research-based databases and developing integrated model predictions. For the National Cohort, the following data will be of specific interest: � Noise maps are mandatory in cities with inhabitants of more than 200,000 individuals under a European directive (http://europa.eu/legislation_summaries/environment/noise_pollution/l21180_ en.htm). Complete coverage and refinements of exposure from all sources of traffic are envisioned for the study areas included in the National Cohort. � Spatially resolved weather maps (http://www.wetterpool.de/wetterkarte_temperatur.php) will enable us to characterize increased chronic heat stress during summers or exposure to weather extremes throughout the seasons. � Spatially resolved maps on natural radiation (environmental radioactivity based on the integrated measurement and information system (IMIS) http://www.bfs.de/ ion/imis and, indoor and outdoor radon http://www.bfs.de/de/ion/radon/radon_boden/radonkarte.html) are currently available from the BfS. Other parameters (e.g., distance from high-voltage power lines) will be made available in the future. A.3.8.4 Strengths and possible limitations of secondary data use for the National Cohort How secondary data can enhance the scientific value of the National Cohort can be summarized as follows: 1. Reduce misclassification and complete data: Individual population-based data on health and utilization of health care, employment, and unemployment are collected continuously by statutory health insurances and statutory pension insurances according to legal standards and requirements. Similarly, data from environmental surveillance systems are collected continuously on a routine basis in Germany. As data acquisition is close in time and independent of individual constraints, this data source is largely independent of self-reports and thus may be less susceptible to errors in reporting. Use of secondary data may therefore help reduce differential or nondifferen- A.3
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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.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.7 A.7 Ethical aspects logical/gen
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A.7 A.7 Ethical aspects pants, trav
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A.7 A.7 Ethical aspects Data handli
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A.7 Table 7.2 Availability of ident
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A.7 A.7 Ethical aspects Should bios
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A.7 A.7 Ethical aspects ing finding
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C.1 C.1 Annex: Description of the s
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C.2 Table S6.5: Sample size needed
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C.3 References 17. Keil, U., et al.
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C.3 References 50. Benjamin, E.J.,
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C.3 References 85. Calle, E.E. and
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C.3 References 121. Walter, R., D.J
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C.3 References 189. Ghiotto, F., et
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C.3 References 225. Schmidt, C.O.,
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C.3 References 260. Eussen, S., et
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C.3 References 294. McCrae, R.R. an
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C.3 References 360. Mair, C., A.V.
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C.3 References 431. Statistisches B
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C.3 References 462. Bundeszentrale
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C.3 References 494. Rammstedt, B. a
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C.3 References 526. Mack, F., et al
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C.3 References 560. Palatini, P., A
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C.3 References 623. Olin, A.C., et
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C.3 References 727. Ryu, O.H., et a
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C.3 References 757. BSI-Standard 10
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