Janssens, Arne
Hashmi, Sumbul
Budts, Anne-Laure
Van der Linden, Lorenz
Kestens, Wies
Marcinko, Spencer
Hex, Chiel
Neyens, Thomas
D’Hondt, Ellie
Van Cauwelaert, Caroline
Vaes, Bert
Funding for this research was provided by:
Novartis Pharma Belgium
Article History
Received: 19 December 2025
Accepted: 7 April 2026
First Online: 23 April 2026
Declarations
:
: This study was conducted in accordance with the Declaration of Helsinki and approved by the UZ/KU Leuven Ethics Committee Research (approval number S70610). The use of pseudonymized health data for the Intego project was approved by the KU Leuven Ethics Committee (approval number S68557) and the Belgian Privacy Committee, specifically the Social Security and Health Chamber (in Dutch: “Informatieveiligheidscomité (IVC), Kamer sociale zekerheid en gezondheid”), in their decision number 13.026, dated March 19th, 2013, with the most recent update in decision number 23.424, dated December 5th, 2023, also waiving the requirement of informed consent. Intego uses an opt-out procedure for patients who do not wish their data to be included. All patients are informed about Intego procedures via a poster in the waiting room of the participating general practice centres and can inform via their general practitioner if they do not want their data to be exported to the Intego registry. All this was approved by the aforementioned Belgian Privacy Commission and the KU Leuven Ethics Committee. Participant data were pseudonymized before use. All protocols are carried out in accordance with relevant guidelines and regulations.
: Not Applicable.
: The authors declare no competing interests.