Hølmkjær, Pernille
Leick, Christian https://orcid.org/0009-0005-1304-1818
Drivsholm, Thomas
Siersma, Volkert
Bro, Flemming
Kousgaard, Marius Brostrøm
Funding for this research was provided by:
KiAP (EMN-2022-01571)
Copenhagen University
Article History
Received: 27 January 2025
Accepted: 13 June 2026
First Online: 29 June 2026
Declarations
Ethics approval and consent to participate {24}: The trial will be conducted according to the Helsinki Declaration and following the protocol. National regulations on informed consent and good clinical practice will be followed. The study has been submitted to The Committees of Health Research Ethics for The Capital Region of Denmark. As defined by the Danish Act on Research Ethics of research projects section 2, the current study does not require approval from The Committees of Health Research Ethics for The Capital Region of Denmark (Journal no.: F-24067136). Due to the design of the study where patient-level data will be acquired from the Danish Clinical Laboratory Information Register through application, no informed consent from individual patients will be required. Informed consents are procured and obtained from the quality clusters.
Consent for publication {32}: Not applicable.
Competing interests {28}: MK and VS have no competing interest.CL has previously been employed at KiAP (the funder) and constructed cluster packages and is currently on leave from KiAP until the end of this project.PH has worked as an external consultant for an unrelated project in KiAP in 2024.TD and FB are currently employed at KiAP as medical consultants. They supply knowledge on development on cluster packages in general. They will not be directly involved in the analysis of data for the primary outcome, nor do they decide how to disseminate the results.