Jørgensen, Susanne Fogh https://orcid.org/0000-0003-4534-0351
Sagstad, Silje
Louro, Javier https://orcid.org/0000-0002-2985-3301
Román, Marta https://orcid.org/0000-0001-9076-8918
Castells, Xavier https://orcid.org/0000-0002-2528-0382
Hofvind, Solveig https://orcid.org/0000-0003-0178-8939
Njor, Sisse https://orcid.org/0000-0003-0429-4176
Funding for this research was provided by:
University of Southern Denmark
Article History
Received: 25 July 2023
Accepted: 10 December 2023
First Online: 29 January 2024
Declarations
:
: Financial and non-financial interests: Dr Xavier Castells, and Dr Marta Román participated in iCAD, Inc. PROFOUND AI RISK Trial and their institution received money from iCAD outside the submitted work. All other authors declare no financial or non-financial interests.
: Danish data: According to the Consolidation Act on Research Ethics Review of Health Research Projects, Consolidation Act number 1083 of 15 September 2017 section 14 (2) notification of questionnaire surveys or medical database research projects to the research ethics committee system is only required if the project involves human biological material. Therefore, this study may be conducted without an approval from the committees. Spanish data: In Spain, no ethics committee approval was required, since completely anonymized and aggregated data were provided for the study. The requirement to obtain informed consent was waived. Norwegian data: This study has legal basis in accordance with Articles 6 (1) (e) and 9 (2) (j) of the GDPR. The data were disclosed with legal basis in the Cancer Registry Regulations section 3–1 () and the Personal Health Data Filing System Act section 19 a to 19 h ().