Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP): a guideline developed by the German Society for Epidemiology

ObjectiveTo revise the German guidelines and recommendations for ensuring Good Epidemiological Practice (GEP) that were developed in 1999 by the German Society for Epidemiology (DGEpi), evaluated and revised in 2004, supplemented in 2008, and updated in 2014.MethodsThe executive board of the DGEpi tasked the third revision of the GEP. The revision was arrived as a result of a consensus-building process by a working group of the DGEpi in collaboration with other working groups of the DGEpi and with the German Association for Medical Informatics, Biometry and Epidemiology, the German Society of Social Medicine and Prevention (DGSMP), the German Region of the International Biometric Society (IBS-DR), the German Technology, Methods and Infrastructure for Networked Medical Research (TMF), and the German Network for Health Services Research (DNVF). The GEP also refers to related German Good Practice documents (e.g. Health Reporting, Cartographical Practice in the Healthcare System, Secondary Data Analysis).ResultsThe working group modified the 11 guidelines (after revision: 1 ethics, 2 research question, 3 study protocol and manual of operations, 4 data protection, 5 sample banks, 6 quality assurance, 7 data storage and documentation, 8 analysis of epidemiological data, 9 contractual framework, 10 interpretation and scientific publication, 11 communication and public health) and modified and supplemented the related recommendations. All participating scientific professional associations adopted the revised GEP.ConclusionsThe revised GEP are addressed to everyone involved in the planning, preparation, execution, analysis, and evaluation of epidemiological research, as well as research institutes and funding bodies.

[1]  Douglas G Altman,et al.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. , 2014, International journal of surgery.

[2]  Allianz der deutschen Wissenschaftsorganisationen.  Grundsätze zum Umgang mit Forschungsdaten , 2010 .

[3]  L. Bouter,et al.  Responsible Epidemiologic Research Practice: a guideline developed by a working group of the Netherlands Epidemiological Society. , 2018, Journal of clinical epidemiology.

[4]  D. Moher,et al.  Guidelines for Reporting Health Research: A User's Manual: Simera/Guidelines for Reporting Health Research: A User's Manual , 2014 .

[5]  E. Swart,et al.  A Consensus German Reporting Standard for Secondary Data Analyses, Version 2 (STROSA-STandardisierte BerichtsROutine für SekundärdatenAnalysen). , 2016, Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)).

[6]  S. Pocock,et al.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies , 2007, The Lancet.

[7]  J. Ioannidis,et al.  STrengthening the reporting of OBservational studies in Epidemiology—Molecular Epidemiology (STROBE-ME): an extension of the STROBE statement , 2011, European Journal of Epidemiology.

[8]  M M Hansen,et al.  Big Data in Science and Healthcare: A Review of Recent Literature and Perspectives , 2014, Yearbook of Medical Informatics.

[9]  H. Thornton-Jones,et al.  Cancer Registry data. , 1990, British Journal of Cancer.

[10]  U. Latza,et al.  [Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP) -- revised version after evaluation]. , 2005, Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)).

[11]  David Moher,et al.  The REporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) Statement: Methods for Arriving at Consensus and Developing Reporting Guidelines , 2015, PloS one.

[12]  W. Sauerbrei,et al.  STRengthening Analytical Thinking for Observational Studies: the STRATOS initiative , 2014, Statistics in medicine.

[13]  M. Blettner,et al.  Study design in medical research: part 2 of a series on the evaluation of scientific publications. , 2009, Deutsches Arzteblatt international.

[14]  Philip M. Jones,et al.  Guidelines for Reporting Health Research: A User’s Manual , 2014, Canadian Journal of Anesthesia/Journal canadien d'anesthésie.

[15]  W. Vach,et al.  A systematic approach to initial data analysis is good research practice. , 2016, The Journal of thoracic and cardiovascular surgery.

[16]  Paolo Vineis,et al.  STrengthening the Reporting of OBservational studies in Epidemiology--Molecular Epidemiology (STROBE-ME): an extension of the STROBE statement. , 2011, Mutagenesis.

[17]  J. Butler,et al.  Gute Praxis Gesundheitsberichterstattung – Leitlinien und Empfehlungen , 2017 .

[18]  D. Moher,et al.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement , 2009, BMJ : British Medical Journal.

[19]  John P A Ioannidis,et al.  Ethics and Epistemology in Big Data Research , 2017, Journal of Bioethical Inquiry.

[20]  J. Stausberg,et al.  Datenqualität in der medizinischen Forschung: Leitlinie zum adaptiven Management von Datenqualität in Kohortenstudien und Registern , 2014 .

[21]  Sarah Callaghan,et al.  Joint declaration of data citation principles , 2014 .

[22]  Maria Blettner,et al.  Types of study in medical research: part 3 of a series on evaluation of scientific publications. , 2009, Deutsches Arzteblatt international.

[23]  B. Bellach,et al.  Leitlinien und Empfehlungen zur Sicherung von Guter Epidemiologischer Praxis (GEP) Eine Mitteilung der Arbeitsgruppe Epidemiologische Methoden der Deutschen Arbeitsgemeinschaft Epidemiologie (DAE) , 2000, Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz.

[24]  Harald Binder,et al.  Big data in medical science--a biostatistical view. , 2015, Deutsches Arzteblatt international.

[25]  Aart Hendriks,et al.  Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. , 2000, The Journal of medicine and philosophy.

[26]  Robert Uerpmann-Wittzack.  Convention on Human Rights and Biomedicine , 2017 .

[27]  D. Moher,et al.  Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement , 2009, BMJ : British Medical Journal.

[28]  Trish Groves,et al.  Enhancing the quality and transparency of health research , 2008, BMJ : British Medical Journal.

[29]  C. Lengeler,et al.  Essentials of good epidemiological practice. , 2005, Sozial- und Praventivmedizin.

[30]  Uwe K. Schneider.  Sekundärnutzung klinischer Daten – Rechtliche Rahmenbedingungen , 2015 .

[31]  David A Chambers,et al.  Big Data and Large Sample Size: A Cautionary Note on the Potential for Bias , 2014, Clinical and Translational Science.

[32]  Felix D. Schönbrodt,et al.  Der Umgang mit Forschungsdaten im Fach Psychologie: Konkretisierung der DFG-Leitlinien , 2017 .

[33]  Thomas Ganslandt,et al.  Leitfaden zum Datenschutz in medizinischen Forschungsprojekten: Generische Lösungen der TMF 2.0 , 2014 .

[34]  D. Moher,et al.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. , 2009, Journal of clinical epidemiology.