Wainwright, Kerstin
Mayer, Imke
Oliveira Gonçalves, Ana S.
Schulz, Ricarda S.
Kiel, Simone
Chenot, Jean-François
Flöel, Agnes
von Podewils, Felix
Angermaier, Anselm
Kurth, Tobias
,
Funding for this research was provided by:
Charité - Universitätsmedizin Berlin
Article History
Received: 17 May 2023
Accepted: 21 June 2023
First Online: 14 July 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.
: Not applicable.
: All authors report funding by the German Innovations Fund of the Federal Joint Committee (G-BA) for the duration of the project. Outside of the submitted work, TK reports to have received research grants from the Bundesministerium für Gesundheit (BMG – Federal Ministry of Health, Germany). He further has received personal compensation from Eli Lilly and Company, Teva Pharmaceuticals, TotalEnergies S.E., The BMJ, and Frontiers. All the remaining authors have no competing interest.