Carsten Oliver Schmidt1, Christine E M Krabbe2, Janka Schössow2, Klaus Berger3, Cornelia Enzenbach4, Panagiotis Kamtsiuris5, Gina Schöne5, Robin Houben5, Christa Meisinger6, Fabian Bamberg7, Thomas Hendel8, Sonja Selder8, Michael Nonnemacher9, Susanne Moebus9, Jürgen Stausberg9. 1. Institut für Community Medicine - Abteilung SHIP-KEF, SHIP, Universitätsmedizin Greifswald, Walther-Rathenau-Str. 48, 17475, Greifswald, Deutschland. carsten.schmidt@uni-greifswald.de. 2. Institut für Community Medicine - Abteilung SHIP-KEF, SHIP, Universitätsmedizin Greifswald, Walther-Rathenau-Str. 48, 17475, Greifswald, Deutschland. 3. Institut für Epidemiologie und Sozialmedizin, BiDirect, Universität Münster, Münster, Deutschland. 4. Institut für Medizinische Informatik, Statistik und Epidemiologie, LIFE-ADULT, Universität Leipzig, Leipzig, Deutschland. 5. KiGGS und DEGS, Robert Koch-Institut, Berlin, Deutschland. 6. Institut für Epidemiologie II, KORA, Helmholtz Zentrum München, München, Deutschland. 7. Universitätsklinikum Tübingen, NAKO - MRT, Klinikum der Universität München, München, Deutschland. 8. Klinik und Poliklinik für Radiologie - NAKO MRT, Universität München , München, Deutschland. 9. Institut für Medizinische Informatik, Biometrie und Epidemiologie (IMIBE), Heinz-Nixdorf Recall Studie, Universitätsklinikum Essen, Essen, Deutschland.
Abstract
BACKGROUND: Cohort studies are a longitudinal observational study type. They are firmly established within epidemiology to assess the course of diseases and risk factors. Yet, standards to describe and evaluate quality characteristics of cohort studies need further development. OBJECTIVE: Within the TMF ("Technologie- und Methodenplattform für die vernetzte medizinische Forschung e. V.") project "Quality management standards in cohort studies", a catalogue of requirements was compiled and evaluated, focusing on the preparation and conduct of epidemiologic cohort studies. MATERIALS AND METHODS: The catalogue of requirements was established based on a consensus process between representatives of seven German epidemiologic cohort studies. For this purpose, a set of expert meetings (telephone, face-to-face, web-based) was conducted and the importance of each element of the catalogue was assessed as well as its implementation. RESULTS: A catalogue of requirements with 138 requirements was consented. It is structured into ten sections: 1. Study documentation; 2. Selection of instruments; 3. Study implementation, 4. Organizational structure; 5. Qualification and certification; 6. Participant recruitment; 7. Preparation, conduct and follow-up processing of examinations; 8. Study logistics and maintenance, 9. Data capture and data management; 10. Reporting and monitoring. In total, 41 elements were categorized as being essential, 91 as important, and 6 as less important. CONCLUSION: The catalogue of requirements provides a guideline to improve the preparation and operation of cohort studies. The evaluation of the importance and degree of implementation of requirements depended on the study design. With adaptations, the catalogue might be transferable to other study types.
BACKGROUND: Cohort studies are a longitudinal observational study type. They are firmly established within epidemiology to assess the course of diseases and risk factors. Yet, standards to describe and evaluate quality characteristics of cohort studies need further development. OBJECTIVE: Within the TMF ("Technologie- und Methodenplattform für die vernetzte medizinische Forschung e. V.") project "Quality management standards in cohort studies", a catalogue of requirements was compiled and evaluated, focusing on the preparation and conduct of epidemiologic cohort studies. MATERIALS AND METHODS: The catalogue of requirements was established based on a consensus process between representatives of seven German epidemiologic cohort studies. For this purpose, a set of expert meetings (telephone, face-to-face, web-based) was conducted and the importance of each element of the catalogue was assessed as well as its implementation. RESULTS: A catalogue of requirements with 138 requirements was consented. It is structured into ten sections: 1. Study documentation; 2. Selection of instruments; 3. Study implementation, 4. Organizational structure; 5. Qualification and certification; 6. Participant recruitment; 7. Preparation, conduct and follow-up processing of examinations; 8. Study logistics and maintenance, 9. Data capture and data management; 10. Reporting and monitoring. In total, 41 elements were categorized as being essential, 91 as important, and 6 as less important. CONCLUSION: The catalogue of requirements provides a guideline to improve the preparation and operation of cohort studies. The evaluation of the importance and degree of implementation of requirements depended on the study design. With adaptations, the catalogue might be transferable to other study types.
Authors: André Karch; Daniela Schindler; Andrea Kühn-Steven; Rainer Blaser; Klaus A Kuhn; Lisa Sandmann; Claudia Sommerer; Markus Guba; Uwe Heemann; Jens Strohäker; Stephan Glöckner; Rafael Mikolajczyk; Dirk H Busch; Thomas F Schulz Journal: Eur J Epidemiol Date: 2021-01-25 Impact factor: 8.082
Authors: Carsten Oliver Schmidt; Stephan Struckmann; Cornelia Enzenbach; Achim Reineke; Jürgen Stausberg; Stefan Damerow; Marianne Huebner; Börge Schmidt; Willi Sauerbrei; Adrian Richter Journal: BMC Med Res Methodol Date: 2021-04-02 Impact factor: 4.615
Authors: Elke Peters; Aiham Alabid; Susanne Elsner; Christine Klein; Max Borsche; Jan Rupp; Alexander Katalinic Journal: Z Evid Fortbild Qual Gesundhwes Date: 2022-08-25