Schøler, Peter Næsborg http://orcid.org/0000-0002-1959-3251
Volke, Kristina Hasselbalch http://orcid.org/0009-0001-9100-6306
Andréasson, Sven http://orcid.org/0000-0003-0258-5762
Rasmussen, Sanne http://orcid.org/0000-0002-6965-3347
Søndergaard, Jens http://orcid.org/0000-0002-1629-1864
Nielsen, Anette Søgaard http://orcid.org/0000-0002-8569-4165
Funding for this research was provided by:
University of Southern Denmark
Article History
Received: 8 March 2024
Accepted: 13 May 2024
First Online: 13 June 2024
Declarations
:
: The iTAPP study is approved by the Research Ethics Committee at The University of Southern Denmark (REC 21/66119) and the Danish College of General Practitioners (MPU 18-2021). Data storage and handling is approved by Odense Patient data Explorative Network (OPEN) (license agreement OP1523, case number 21/61172) and by the Research and Innovation Organization at The University of Southern Denmark (ref. number 11.521). This study was not eligible for application to the Danish National Research Ethics Committee according to national regulations Sect. 14;1 of the Danish Act on Research Ethics Review of Health Research Projects (case no. 20212000144). The study adheres to the Declaration of Helsinki for ethical principles for medical research. Adverse events, unintended effects of the intervention or trials misconduct will be discussed in the research group and with the specific practice owner(s). Any issues not related to patients will be resolved between the research group and the practice owners. In the case of patient-related adverse events or unintended effects, the research group and practice owner(s) will plan relevant follow-up as needed. In the need of legal assistance, The Research and Innovation Organization at The University of Southern Denmark will be contacted. The owners of the participating practices must sign a written informed consent form including a contract between the practice owner(s) and The University of Southern Denmark prior to study commencement. The written consent form and contract include details on timeline for the study, economic compensation, details on training and implementation strategies, data management and security, data and intellectual property rights, and information on the questionnaire procedure to the patients affiliated with the practice. Patients (? 18 years) affiliated with the participating practices receive written information on the questionnaire and the informed consent procedure. The participants must consent via an embedded link to be forwarded to the electronic questionnaire.
: Consent for publication is obtained from practice owners through the consent form and contract with The University of Southern Denmark as described above. Consent for publication from participating patients is obtained through the electronic consent form.
: Important modifications and amendments to the protocol will be reported to trial participants, trial registries, and journals.
: Results will be presented at national and international scientific events and published along with the study protocol in scientific peer reviewed journals. Authorship will follow the International Committee of Medical Journal Editors guidelines.
: The authors declare no competing interests.