Manz, Karina C.
Murphy, Daniel
Stavenow, Flora
Astorquiza, Luis Guillermo Correa
Cengia, Anja
Višković, Vukašin
Höer, Ariane
Mocek, Anja
Article History
Received: 28 May 2024
Accepted: 1 September 2025
First Online: 24 September 2025
Declarations
:
: In Germany, the use of social data for scientific research is regulated by the SGB X (Social Security Code X). However, all patient- 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 (General Data Protection Regulation) and as such are no longer subject to these regulations. The use of the study database for this study was therefore fully compliant with legal and regulatory requirements. Since anonymized administrative claims data were used and presented only in aggregate form, informed consent of patients was not required. The pre-existing database did not allow direct identification of patients, and no contact was made with patients. This study was conducted in accordance with research practices described in the Good Epidemiological Practice (GEP) guidelines of the German Society for Epidemiology (DGEpi) [22] and in accordance with the guidelines and recommendations described in the Good Practice of Secondary Data Analysis (GPS) of the Working Group for the Survey and Utilisation of Secondary Data (AGENS) of the German Society for Social Medicine and Prevention (DGSMP) and the German Society for Epidemiology (DGEpi) [23]. Accordingly, a consultation with an ethics committee was not required because the analyses were based exclusively on secondary data. The study was conducted in accordance with the Declaration of Helsinki.
: Not applicable. The manuscript does not contain patient-identifiable data.
: DM is an employee of Norgine Ltd. FS is an employees of Norgine GmbH. LGCA is an employee of Norgine de España S. L. U. KCM and AH are employees of the IGES Institut GmbH, which is a paid consultant to Norgine Ltd. for conducting the study and preparing the manuscript. At the time of this study, AM was an employee of the IGES Institut GmbH. AC and VV are employees of InGef – Institute for Applied Health Research Berlin GmbH, which was contracted and reimbursed by IGES Institut GmbH for providing the data and carrying out the analyses. As such the authors are either direct employees of Norgine, the funder of this study, or have acted as consultants or sub-contractors on the project. Norgine is the rights holder of FERACCRU® (ferric maltol), which was partly a focal point of this investigation. The design of the study, which focuses partly on Norgine's product, has been influenced by funding from Norgine. While the authors assert that this funding did not impact the conduct of the study, the interpretation of the results, and the right to publish the results without limitation, the focus on ferric maltol reflects the interests of the funding source. The authors have not included comparative analyses of other iron deficiency treatments in this manuscript.