Holthuis, Emily http://orcid.org/0000-0002-2556-4553
Smits, Elisabeth http://orcid.org/0000-0003-1882-4748
Spentzouris, George
Beier, Dominik
Enders, Dirk
Gini, Rosa
Bartolini, Claudia http://orcid.org/0000-0001-8630-4598
Mazzaglia, Giampiero http://orcid.org/0000-0003-4933-2148
Penning-van Beest, Fernie http://orcid.org/0000-0002-1906-9724
Herings, Ron http://orcid.org/0000-0002-2561-8734
Funding for this research was provided by:
Daiichi-Sankyo
Article History
Accepted: 29 May 2022
First Online: 5 July 2022
Declarations
:
: This study was funded by Daiichi Sankyo Europe GmbH.
: George Spentzouris was employed at Daiichi Sankyo Europe GmbH. The study was financed by Daiichi Sankyo Europe GmbH. The authors had complete autonomy in the process of establishing the protocol, carrying out the analyses, and interpreting the results and the authors retained the full right to publish the results without limitation. Emily Holthuis, Elisabeth Smits, Fernie Penning-van Beest and Ron Herings are employees of the PHARMO Institute for Drug Outcomes Research. This independent research institute performs financially supported studies for government and related healthcare authorities and pharmaceutical companies. ARS, Giampiero Mazzaglia and InGef were subcontracted by PHARMO. Rosa Gini and Claudia Bartolini are employed by ARS, a public health agency that conducts or participates in pharmacoepidemiology studies compliant with the ENCePP Code of Conduct. The budget of ARS is partially sustained by such studies. Dominik Beier and Dirk Enders are employed by InGef (Institute for Applied Health Research Berlin GmbH), which acted as a subcontractor and received funding from PHARMO for the execution of the study.
: This observational study analysed de-identified data from the PHARMO Database Network; therefore, the study was exempt from ethical review and informed consent was not required. Regarding the ARS database, this study was approved by the ‘Agenzia Regionale di Sanità della Toscana’ Internal Governance Board. All patient-level and provider-level data in the InGef research database are anonymized and are no longer social data in the sense of §67 para. 2 SGB X (Social Security Code X) in combination with Art. 4 Nr. 1 GDPR. Hence, use of the study database for healthcare services research is therefore fully compliant with German federal law and, accordingly, institutional review board or ethical approval for this study was not needed. As this study is based on anonymized claims data, no informed consent of patients was required.
: Not applicable.
: Not applicable.
: Not applicable.
: Not applicable.
: All authors contributed to the study conception and design. Material preparation and analysis were performed by EH, ES, DE and CB. The first draft of the manuscript was written by EH, ES, DB and GM and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.