Hradetzky, E.
Ohlmeier, C.
Brinkmann, C.
Schild, M.
Galetzka, W.
Schmedt, N.
John, T.
Kaleth, D.
Gothe, H. http://orcid.org/0000-0003-0425-3788
Funding for this research was provided by:
Technische Universität Dresden
Article History
Received: 13 November 2021
Accepted: 9 February 2022
First Online: 18 March 2022
Declarations
:
: In accordance with the Good Practice in Secondary Data Analysis (GPS), “Guideline 1: Ethics” (English version available at ExternalRef removed) “secondary data analyses must be conducted in accordance with ethical principles and respect human dignity as well as human rights.” According to this guideline, it is not mandatory to consult with an ethics committee “if all the data protection provisions on de-identification of all personal data are fulfilled … and no link to primary data is intended” (Swart et al. CitationRef removed). All patient-level data in the InGef research database are de-identified to comply with German data protection regulations. Use of the study database for health services research is therefore fully compliant with German federal law and, accordingly, institutional review board/ethical approval and informed consent of the patient have not been requested.
: This study was funded by Pfizer Pharma GmbH. The authors had complete autonomy for the process of establishing the protocol, carrying out the analyses and interpreting the results. This also includes the full right to publish the results without limitation.EH is a paid employee of Pfizer. MS was a paid employee of Pfizer at the time the study was conducted.HG is a senior research affiliate of both the Medical Faculty of TU Dresden and UMIT – Private University for Health Sciences, Medical Informatics and Technology. He is also a paid employee of the vendor IGES GmbH. CO and CB were paid employees of IGES GmbH at the time the study was conducted. IGES GmbH is a paid consultant to Pfizer and Eli Lilly for data analysis and development of the manuscript.WG and NS were paid employees of the vendor InGef, at the time the study was conducted. InGef was contracted by the IGES GmbH. The costs for data analysis carried out by InGef were included in the costs paid to vendor IGES GmbH by Pfizer.DK and TJ received honoraria from Pfizer related to their advisory services during the study protocol development and data analysis. DK and TJ did not receive honoraria from Pfizer related to the development of this manuscript.