Scott, Jan
Langsrud, Knut
Vethe, Daniel
Kjørstad, Kaia
Vestergaard, Cecilie L.
Faaland, Patrick
Lydersen, Stian
Vaaler, Arne
Morken, Gunnar
Torgersen, Terje
Kallestad, Håvard http://orcid.org/0000-0002-9173-942X
Funding for this research was provided by:
St. Olavs Hospital Universitetssykehuset i Trondheim (17/10533-134, 18/10647-110)
Norges Teknisk-Naturvitenskapelige Universitet (81850077, 81850104)
Article History
Received: 8 February 2019
Accepted: 16 July 2019
First Online: 1 August 2019
Ethics approval and consent to participate
: The study protocol was approved by the Regional Ethics Committee of Central Norway on 6 June 2018 (REK 2018/946). The Ethics Committee support the rationale for and use of a deferred consent and agreed that this procedure allowed randomization at the time of acute admission at the discretion of the investigators (and according to recognized guidelines and criteria that were made explicit during the ethical review of the protocol). It was emphasized that informed consent must be sought at the earliest possible time once each individual patient was deemed to have mental capacity by the clinician in charge of the patient [CitationRef removed–CitationRef removed,CitationRef removed,CitationRef removed] and that this should be prior to discharge. The consent form specifies that study participants can discontinue participation in the study without stating any reason, and that all study participants are covered by Norwegian System of Patient Injury Compensation system in case of any harm. The consent form is in Norwegian and available upon request. Following the ethics approval, the review by the Ethics Committee and a trial description was made public on the Ethics Committee’s webpages, the trial was listed on The Current Research Information System In Norway, Cristin-ID 602154, and patient information about the trial and participation was listed on the website for clinical trials in Norway.
: Not applicable.
: The authors declare that they have no competing interests.