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Challenges in reaching patients with severe mental illness for trials in general practice—a convergent mixed methods study based on the SOFIA pilot trial

Crossref DOI link: https://doi.org/10.1186/s40814-023-01395-y

Published Online: 2023-10-31

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Tranberg, Katrine https://orcid.org/0000-0001-8659-592X
Due, Tina Drud

Rozing, Maarten

Jønsson, Alexandra Brandt Ryborg

Kousgaard, Marius Brostrøm

Møller, Anne
Funding

Funding for this research was provided by:

Novo Nordisk Fonden (NNF16OC0022038)

Royal Library, Copenhagen University Library
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Text and Data Mining valid from 2023-10-31

Version of Record valid from 2023-10-31
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Article History

Received: 11 May 2023

Accepted: 11 September 2023

First Online: 31 October 2023

Declarations

:

: The SOFIA study was conducted following the protocol, the Helsinki Declaration in its latest form, good clinical practice guidelines, and followed the rules for informed consent. GPs or staff contacted potentially eligible patients and obtained written informed consent. GPs and staff who participated in the interviews signed an informed consent form before the interviews. Danish law required no ethical approval for this study because it constituted a quality improvement project according to the National Committee on Health Research Ethics in Denmark. The waiver of ethical approval was approved by the Center of Regional Development, the Capital Region of Denmark (cf. journal no. 20038096). All participants were anonymized, identifiers altered, and data derived from patients’ medical journals were encrypted. Data were stored and processed per the requirements of the European General Data Protection Regulation (EU GDPR).

: Not applicable.

: The authors declare that they have no competing interests.

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