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Authors
Goodman, Elizabeth https://orcid.org/0000-0002-9640-9884
Reuschenbach, Miriam https://orcid.org/0000-0003-4268-6250
Viering, Tammo https://orcid.org/0000-0003-4034-3297
Luzak, Agnes
Greiner, Wolfgang https://orcid.org/0000-0001-9552-6969
Hampl, Monika https://orcid.org/0000-0002-5949-5891
Jacob, Christian https://orcid.org/0000-0001-6960-728X
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Article History
Received: 17 April 2024
Accepted: 6 August 2024
First Online: 4 September 2024
Declarations
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: EG is employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. MR and AL are full-time employees of MSD Sharp & Dohme GmbH. TV and CJ are full-time employees of Xcenda GmbH, acting as contractors of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA for the execution of this study and the writing of the manuscript. WG received personal fees from Xcenda GmbH during the conduct of the study. MH received honoraria as speaker and member of medical advisory boards from MSD Sharp & Dohme GmbH.
: This study did not require ethics committee review. It used anonymized German claims data from the “Institut für angewandte Gesundheitsforschung Berlin” (InGef) research database. The InGef research database addresses all data protection regulations in Germany. Claims data from the participating SHI are joined in a specialized trust center, anonymized, and transferred to InGef before the data are made available for research. In accordance with the “GPS – Good Practice in Secondary Data Analysis” (Guideline 1: Ethics), the analysis of claims data from the statutory health insurance is permitted and does not require the approval of an ethics committee. Therefore, no patient informed consent or review by an independent ethics committee or institutional review board are required.
: Not applicable.
