Document is current

Article History

Received: 30 January 2021

Accepted: 1 March 2021

First Online: 1 April 2021

Declarations

:

: The latest “GPS – Good Practice in Secondary Data Analysis” recommendations (Version 2, 2008) of the respective German Working Group for the Survey and Utilization of Secondary Data (AGENS; with representatives from the German Society for Social Medicine and Prevention [DGSMP] and the German Society for Epidemiology [DGEpi]) and the Working Group for Epidemiological Methods (with representatives from the German Society for Epidemiology [DGEpi], the German Society for Medical Informatics, Biometry and Epidemiology [GMDS] and the German Society for Social Medicine and Prevention [DGSMP]) explicate as “Guideline 1” that the “...recommendation to consult with an ethics committee need not apply to secondary data analyses, if all the data protection provisions on pseudo-anonymization of all personal data are fulfilled ... and no link to primary data is intended.” Datasets used for this analysis were completely anonymized data provided by the German federal statistical office (DRG-statistic, ExternalRef removed) in compliance with the German data protection regulations and this also applied to the evaluation of the quality reports. Since there was no access to any individualized patient data whatsoever, no informed patient consent or ethical approval was needed for this study.

: Not applicable.

: DR receives FoRUM grant (K136–20) of the Ruhr-University of Bochum. RW has received speaker honoraria from Medtronic/Covidien and Bristol-Myers Squibb and from serving on a scientific advisory board of Medtronic. JE has received travel grants from Daiichi-Sankyo, UCB Pharma, and Bayer Vital; grants for the realization of scientific meetings by Bayer Health Care, Boehringer Ingelheim, Sanofi Aventis, and Pfizer; remuneration for advisory boards by Boehringer Ingelheim; no ownership interest and does not own stocks of any pharmaceutical company. AG has received public funding by the “Innovationsfonds des Gemeinsamen Bundesausschusses”. WH has received speaker and consultancy honoraria from Boehringer Ingelheim, Medtronic, and Cerenovus and a research grant from Boehringer Ingelheim. BM has no competing interests. WH has received consultancy fees from Cerenovus, Phenox and Angels. He has received an unrestricted grant from Boehringer Ingelheim to perform ECASS4-Extend, an investigator-initiated trial. CK has received speaker honoraria or travel grants for scientific meetings from Bayer Vital, and Daichii Sankyo.