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[德国国家队列研究(NAKO健康研究)的基线评估:参与检查模块、质量保证及二次数据的使用]

[The baseline assessment of the German National Cohort (NAKO Gesundheitsstudie): participation in the examination modules, quality assurance, and the use of secondary data].

作者信息

Schipf Sabine, Schöne Gina, Schmidt Börge, Günther Kathrin, Stübs Gunthard, Greiser Karin H, Bamberg Fabian, Meinke-Franze Claudia, Becher Heiko, Berger Klaus, Brenner Hermann, Castell Stefanie, Damms-Machado Antje, Fischer Beate, Franzke Claus-Werner, Fricke Julia, Gastell Sylvia, Günther Matthias, Hoffmann Wolfgang, Holleczek Bernd, Jaeschke Lina, Jagodzinski Annika, Jöckel Karl-Heinz, Kaaks Rudolf, Kauczor Hans-Ulrich, Kemmling Yvonne, Kluttig Alexander, Krist Lilian, Kurth Bärbel, Kuß Oliver, Legath Nicole, Leitzmann Michael, Lieb Wolfgang, Linseisen Jakob, Löffler Markus, Michels Karin B, Mikolajczyk Rafael, Pigeot Iris, Mueller Ulrich, Peters Annette, Rach Stefan, Schikowski Tamara, Schulze Matthias B, Stallmann Christoph, Stang Andreas, Swart Enno, Waniek Sabine, Wirkner Kerstin, Völzke Henry, Pischon Tobias, Ahrens Wolfgang

机构信息

Institut für Community Medicine, Abteilung SHIP-KEF, Universitätsmedizin Greifswald, Walther-Rathenau-Str. 48, 17489, Greifswald, Deutschland.

Abteilung 2 - Epidemiologie und Gesundheitsmonitoring, Robert Koch-Institut, Berlin, Deutschland.

出版信息

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020 Mar;63(3):254-266. doi: 10.1007/s00103-020-03093-z.

Abstract

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.

摘要

背景

德国国民队列研究(NAKO)是一项跨学科健康研究,旨在阐明常见慢性病的病因并检测其临床前期阶段。本文基于招募的中期基线数据集(MBD),概述了研究设计、方法、检查参与情况及其质量保证。

方法

2014年至2019年期间,在18个研究中心招募了来自德国普通人群随机样本的20多万名年龄在20至69岁之间的男女。数据收集包括体格检查、标准化访谈和问卷调查,以及为所有参与者采集生物医学样本(一级)。至少20%的所有参与者接受了额外的深入检查(二级),30000人接受了全身磁共振成像(MRI)检查。还将通过医疗登记处、健康保险和养老基金等二级数据源收集更多信息。本概述基于MBD,其中包括101839名参与者,其中11371人接受了MRI检查。

结果

平均应答率为18%。检查参与率很高,大多数模块的参与率超过95%。在接受MRI检查的参与者中,96%完成了所有12个MRI序列。超过90%的参与者同意使用补充性二级数据和登记数据。

讨论

尽管项目耗时,但被选入NAKO的个体愿意参与所有检查。NAKO为基于人群的流行病学研究提供了一个核心资源,并将有助于制定慢性病预防、筛查和预测的创新策略。

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