Turner, Rosanne J.
Coenen, Femke
Roelofs, Femke
Hagoort, Karin
Härmä, Aki
Grünwald, Peter D.
Velders, Fleur P.
Scheepers, Floortje E.
Article History
Received: 12 January 2022
Accepted: 10 June 2022
First Online: 17 June 2022
Declarations
:
: We have not analyzed clinical trial data in our manuscript; our manuscript concerns analysis of retrospective data from anonymized, routinely collected electronic health records, interviews with clinical staff and two literature reviews. This study conforms to the declaration of Helsinki for ethical principles involving human participants. For the two literature reviews, no ethical approval needed to be obtained because of the theoretical nature of the researchFor the interviews and retrospective analysis, a study protocol (number 20–360/C) was assessed by the UMCU Medical Review Ethics Committee, which declared that this study does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO). The study protocol was approved by a UMCU quality officer specialized in research that does not fall under the Medical Research Involving Human Subjects Act.For the interviews with clinical staff, (electronically) written informed consent was obtained from all participants. With respect to the anonymized routinely collected retrospective data, it was deemed a disproportional effort to obtain informed consent of each individual patient because of the retrospective nature of the study and number of patients, of which many could not be contacted anymore because they continued their treatment elsewhere. However, the center where this study was carried out uses an opt-out policy for patients who do not want their data to be used for research. Only data from patients who did not object to the use of their routinely collected electronic health record data were analyzed. To assure patients’ privacy data were anonymized, for which the DEDUCE software was used (12).
: Not applicable.
: The authors declare that they have no competing interests.