Hyland, Karin http://orcid.org/0000-0001-6261-0224
Hammarberg, Anders
Hedman-Lagerlöf, Erik
Johansson, Magnus
Andreasson, Sven
Funding for this research was provided by:
Forskningsrådet om Hälsa, Arbetsliv och Välfärd (STYA-2016/0007)
Stockholms Läns Landsting (20150189)
Article History
Received: 16 August 2019
Accepted: 12 November 2019
First Online: 30 December 2019
Ethics approval and consent to participate
: The trial has been approved by the Regional Ethics Review Board in Stockholm, Dnr 2016/1367–31/2 and retrospectively registered on 7 June 2018 with ISRCTN registry no.: ISRCTN69957414. The Regional Ethics Review Board in Stockholm serves as both our central and local Ethics Review Board, covering all the primary care centers included in our study.Informed consent will be obtained digitally from all participants prior to inclusion after being provided with information about the study. The consent form is available on request. All patients must agree to participate voluntarily and will be free to withdraw from the study at any time. The studies in this research program will be conducted in accordance with national rules and guidelines for research, secrecy legislation and regulations regarding ethics in research. All participant data will be kept in a secure room accessible only by research personnel following standard protocols recommended by the Karolinska Institutet. Previous research in this area have shown minimal risk to cause harm for participating patients. Guidelines will be developed for project staff to guide decisions regarding when to refer participants to other forms of treatment and terminate participation in the study. The benefits of the studies are believed to outweigh the risks. Protocol modifications will be implemented only if permitted by the Regional Ethics Review Board in Stockholm.Results will be disseminated through journal articles, conference presentations and reports to the funding agencies.
: No individual-level participant data will be presented in scientific papers.
: The authors declare that they have no competing interests.