NAKO health study

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The NAKO Health Study - formerly the National Cohort (NAKO) - is Germany's largest cohort study , in which 200,000 people between the ages of 20 and 69 are questioned about their living conditions and their medical history and are medically examined. The study began in October 2014 and is designed to run for 20 to 30 years. The aim of the study is the detailed research of common diseases , for example cardiovascular diseases , cancer , diabetes mellitus , neurological and psychiatric diseases, infectious diseases , respiratory diseases, diseases of the musculoskeletal system .

The study examines the development of diseases including the risk factors that promote this development. In addition, the role of genes and environmental influences to which humans are exposed as well as their lifestyle and social factors should be determined . Based on the results of the study, measures and strategies for improved prevention, early detection and treatment of diseases are to be developed.

Naming

The original name “National Cohort” has a scientific background. In epidemiology - this science researches the spread, causes and consequences of health-related conditions and events in the population - a cohort is a group of people who are observed over a longer period of time ( cohort study ). The term “national” signals the nationwide approach of the project, because the study is being carried out at 18 locations in Germany. It is also to be understood as a German contribution to international health research. Despite this scientific background, the name of the study was often not understood or perceived negatively by the public. For example, the study was assumed to have a military or even radical right-wing background. That is why the scientists responsible for the project agreed in spring 2016 to rename the study. The new name is: NAKO Health Study or NAKO for short. It should better convey what the study is about, namely an improved health situation throughout Germany.

Sponsorship and funding

The preparatory work for the NAKO has been going on since 2009. Your scientific concept was submitted to the Federal Ministry of Education and Research (BMBF) for assessment in February 2011 . The appraisal by an international committee took place in April 2011. All key points of the study were rated positively by the appraisers. The Joint Science Conference (GWK) decided in its meeting on June 29, 2012 to set up the NAKO.

The study is a joint interdisciplinary project by scientists from the Helmholtz Association , the universities and the Leibniz Association in Germany. A total of 25 research institutions nationwide are involved. The funding volume for the first ten years is 210 million euros and is financed by public funds from the BMBF, the federal states and the Helmholtz Association. The member institutions contribute to the financing with their own contributions. In September 2013, the Nationale Kohorte e. V. was founded to conduct the study. The office of the association is based in Heidelberg .

Course of studies

The study is being carried out in 18 study centers nationwide. In each study region, 10,000 citizens will be randomly selected by the regional registration offices over the next four years ( 20,000 residents in Neubrandenburg and Augsburg each) and invited by the study centers. After extensive clarification in the study center, also for the intended query of health and social data from doctors, health insurers, authorities and other data owners , and the written consent of the study participants, an examination date will be arranged.

There are two levels of investigation. Level 1 lasts three to four hours and is carried out with each study participant. The somewhat more extensive Level 2 program takes about five hours and is completed by 20% of the study participants, i.e. a total of 40,000 people. Together with the team in the study center, the participants decide which program they want to take part in.

Examination program level 1

  • Surveys on lifestyle, previous illnesses and other health factors as well as on taking medication
  • Attention, concentration and memory tests
  • Measurement of height and weight, waist circumference and body composition
  • Measurement of hand gripping force
  • Measurement of blood pressure and heart rate as well as functional parameters for cardiovascular diseases
  • Measurement of lung function ( spirometry )
  • Recording of the tooth status

Examination program level 2

  • Surveys on lifestyle, previous illnesses and other health factors as well as on taking medication
  • Attention, concentration and memory tests
  • Measurement of height and weight, waist circumference , body composition and ultrasound examination of belly fat
  • Measurement of hand grip strength and physical activity
  • Measurement of the sugar metabolism (blood sugar stress test) and the saccharified (glycosylated) end products in the skin
  • Measurement of blood pressure and heart rate as well as functional parameters relating to cardiovascular diseases, 3-D echocardiography , resting ECG , long-term ECG and determination of sleep characteristics
  • Analysis of exhaled air and measurement of lung function
  • Recording of tooth status and dental examination
  • Examination of the musculoskeletal system (hands, knees, hips for mobility)
  • Eye health examinations, hearing test , smell test

Magnetic resonance imaging

In five study centers (Augsburg, Essen , Berlin-Nord / MDC, Greifswald and Mannheim ) an additional magnetic resonance tomography is carried out for 6,000 participants .

Regular queries

Every two to three years, the participants receive a questionnaire to provide an update on their health and life situation. The diseases that occurred in some participants over the course of 20 to 30 years of follow-up can be linked to the previously collected data, so that risk and protective factors can be identified.

Follow-up examination

After four to five years, all study participants are invited again and examined a second time according to the same scheme.

participation

Participation in the NAKO is based on voluntary, informed consent in accordance with the requirements of Section 4a of the Federal Data Protection Act (BDSG) and No. 25 and 26 of the Declaration of Helsinki . People invited to participate in the study will receive written participant information in advance, in which they will be informed about the study, the planned examinations, advantages and disadvantages of participating in the study and questions about data protection. In the study center, a detailed explanation is given by an employee. A study participant or his / her legal representative can revoke the granted consent at any time and without giving reasons in writing to the study center responsible for him. He can revoke each consent individually or all together (complete revocation).

Scientific peculiarities

There are numerous other population studies in Germany and also in Europe. The NAKO is currently unique because of its size and specific characteristics.

  • With 200,000 citizens, the NAKO has a very large number of participants.
  • The examinations are carried out in a standardized manner, i. H. In all 18 study centers, all examinations and surveys are carried out according to identical schedules (SOPs, glossary). This ensures that the data collected can be compared with one another.
  • Younger age groups from the age of 20 are also involved in the study.
  • After four years, a second examination of all 200,000 study participants takes place.
  • Magnetic resonance imaging (MRI) imaging is carried out on 30,000 study participants in five study centers.
  • The selection of the studies is based on the structure of other European studies in order to make the data basically comparable.
  • In the course of the study, a total of around 28 million biosamples will be collected and stored and made available for scientific research.

Data protection and ethics

The NAKO is carried out on the basis of German data protection laws, recommendations of the German Ethics Council on human biobanks and other ethically relevant guidelines as well as other regulations. The data protection concept of the study was developed in close coordination with the Federal Commissioner for Data Protection and Freedom of Information (BfDI) and on the basis of the recommendations of the German Ethics Council on biomaterials. The study will be accompanied by an external ethics committee throughout the entire duration. The Federal Data Protection Officer will also continuously support the major project.

All documents on data protection and ethics can be viewed on the association's homepage. The public criticized the fact that the NAKO was started without a corresponding data protection concept having been completed. In this context, the NAKO refers to a positive vote by the BfDI for the data protection concept, which has been in place since March 2014. On this basis, it was possible to start inviting the study participants in 2014.

Due to the dimensions of the research project, the establishment of the data protection concept represents a challenge for all involved. Due to the study design, new processes have to be defined, checked and implemented under data protection aspects. This requires discussions and weighing up of all interests as well as careful implementation and implementation. The BfDI has assured the NAKO that the project will be continuously monitored so that legal changes, adapted guidelines and innovations can be reacted to immediately.

Relevance of social and psychosocial influences on the health of the population

In June 2012, the Bündnis 90 / Die Grünen parliamentary group asked for a small question about the NAKO . The health policy spokeswoman for the Greens parliamentary group in the German Bundestag, Birgitt Bender , criticized the study for showing a "one-sided biomedical and scientific study orientation" and that a large part of the funding was "already reserved for the purchase and use of large medical equipment" ; that would not do justice to the state of social medical research. In its answer, the Federal Ministry of Education and Research assumes that "a reliable clinical database on the health situation in the population" will be obtained. The NAKO emphasized the great importance of the investigation of social determinants in population-based epidemiological studies under medical-sociological and health-scientific aspects, and had therefore set itself the goal of focusing not only on biomedical factors but also on the recording of social determinants of health. The study questionnaires reflected this focus. The respective living conditions (family, work, living conditions, environmental pollution) as well as psychosocial factors (social support, stress, etc.) and central demographic and socio-economic variables, e.g. B. Education and parental home would be queried. Due to the size of the study, this offers the opportunity to describe the health of many social groups in detail. The coupling of social and health research represents an important aid in identifying groups of people who are particularly health-threatened and in promoting the targeted improvement of preventive measures and care priorities in the sense of modern public health research and practice.

Web links

Individual evidence

  1. ^ German National Cohort (GNC) Consortium: German National Cohort: aims, study design and organization . In: European Journal of Epidemiology . tape 29 , no. 5 , 2014, p. 371-382 , doi : 10.1007 / s10654-014-9890-7 .
  2. ↑ National cohort: NAKO anniversary: ​​50,000 nationwide are already participating. (PDF, 8 MB) April 19, 2016, accessed May 18, 2016 .
  3. ^ National Cohort: The National Cohort: A prospective epidemiologic study resource for health and disease research in Germany. (PDF, 8 MB) August 2, 2011, accessed June 24, 2015 (English).
  4. ↑ a b National Cohort: INFORMATION ON STUDY PARTICIPATION. Retrieved June 24, 2015 .
  5. ↑ National cohort: data protection concept. Retrieved June 24, 2015 .
  6. ↑ NAKO ethics advisory board . Retrieved June 24, 2015.
  7. ↑ Health data in stock? Search on gen-ethisches-netzwerk.de with multiple hits.
  8. ↑ Printed matter 17/10410, Minor question from the MPs Birgitt Bender, Dr. Harald Terpe, Maria Klein-Schmeink, Elisabeth Scharfenberg, Krista Sager, Sven-Christian Kindler, Kai Gehring, Tabea Rößner and the BÜNDNIS 90 / DIE GRÜNEN parliamentary group. July 27, 2012 and printed matter 17/10507, answer from the Federal Government . 20th August 2012.
  9. ↑ Florian Staeck: Greens complain about the list in the research project “National Cohort” . Doctors newspaper, August 26, 2012.
  10. ^ A b German Society for Medical Sociology : The Social Determinants of Health in the National Cohort. (PDF, 92 kB) dgms.de, September 26, 2012, accessed on June 21, 2019 .