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Article History

Received: 22 June 2023

Accepted: 29 August 2023

First Online: 22 September 2023

Declarations

:

: The project was reviewed and approved by the Ethics Committee of the University Medicine Greifswald, Germany (approval no. 88051/21). Any changes to the study protocol must be approved by the Ethics Committee. A data protection vote for the entire project was received from the data protection office at the University Medicine Greifswald, Germany. Written informed consent, including publication of results in peer-reviewed journals, will be obtained from all participating patients. No additional risks to patients are expected relative to standard care, as NeTKoH aims to improve the quality of care for patients by providing further access to medical care. All technical installations and data transfer protocols have been monitored by the local data protection officers of the participating institutions and are in compliance with the EU General Data Protection Regulation (GDPR), including the data for the evaluation, which will be anonymized. The analysis of NeTKoH is partially based on claims data. The release of the claims data for this purpose will have to be approved by the supervisory authority of the health insurance. The study will be conducted in accordance with the Declaration of Helsinki in its current version, the guidelines of the International Conference on Harmonization of Good Clinical Practice, and applicable national regulations. Important modifications to the protocol will be communicated to the funder, all relevant parties of the project, the trial registry and journals. The results of the evaluation will be reported to project stakeholders and the funding agency via a formal report. Furthermore, study findings will be published in peer-reviewed scientific journals and other publications. For manuscripts, press releases, and other formats of publication, authors, and collaborators will be involved. Dissemination of the results will also take place at conferences and on the project’s website.

: This study was registered at the German Clinical Trials Register (DRKS00024492) on the 28th of September, 2021. Patient recruitment started in October 2021 and will end in October 2024. Results are expected in July 2025.

: Not applicable.

: All authors report funding by the German Innovations Fund of the Federal Joint Committee (G-BA) for the duration of the project.