Schultze, Michael
Garal-Pantaler, Elena
Pignot, Marc
Levy, Roger A
Carnarius, Heike http://orcid.org/0000-0001-7317-8270
Schneider, Matthias
Gairy, Kerry
Funding for this research was provided by:
GSK
Article History
Received: 20 July 2023
Accepted: 15 April 2024
First Online: 17 May 2024
Declarations
:
: We used anonymized claims data from a German BKK health insurance fund database– the “BKK German Sickness Fund Database”. No direct subject contact or primary collection of individual human subject data occurred. Study results were in tabular form and aggregate analyses that omits subject identification. Health insurance companies were informed about the project and required approvals were obtained. The use of such data is not subject to ethics committee approval in Germany according to German national regulations as all data in the “BKK German Sickness Fund Database” are anonymized to comply with the German national legislation of the Federal Data Protection Act (BDSG, Federal Data Protection Act of 30 June 2017 [Federal Law Gazette I p. 2097], as last amended by Article 10 of the Act of 23 June 2021 [Federal Law Gazette I, p. 1858; 2022 I p. 1045]). Use of this database for health services research is fully compliant with German federal law. Approval of this research by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) is not required for analyses based solely on secondary anonymized data in Germany (Swart et al. Gesundheitswesen. 2015;77 []:120-6. ) however approval from the respective health insurance companies was achieved. Finally, subjects informed consent procedures do not apply in Germany for the conduct of secondary data projects using health insurance fund data due to the anonymized nature of the data and the fact that ethics approval procedures are not required for such studies in Germany as described above. The study conformed with the Helsinki Declaration of 1964, as revised in 2013, concerning human and animal rights.
: Not applicable.
: MiS and MP were employees of Kantar Health at the time of the study, which was contracted by GSK to conduct this study, and they now work for ZEG– Berlin Center for Epidemiology and Health Research GmbH. EG-P is an employee of Team Gesundheit GmbH and has nothing to disclose. HC and RAL are employees of GSK and hold stocks and shares in the company. KG is a former employee of GSK and holds stocks and shares in the company. MaS received consulting and lecture fees from MSD, Abbott, AbbVie, Pfizer, GSK, UCB, Roche, AstraZeneca, Lilly, Janssen-Cilag, Sanofi-Aventis, Chugai, Celgene, Novartis, Boehringer Ingelheim and Bristol-Myers Squibb.