Funding for this research was provided by:
University of Cambridge
Text and Data Mining valid from 2019-03-15
Received: 28 November 2018
Accepted: 12 February 2019
First Online: 15 March 2019
Change Date: 15 April 2019
Change Type: Correction
Change Details: Incorrect family name of Nino Stocchetti.
Compliance with ethical standards
: Data used in these analyses were collected as part of the CENTER-TBI study which had individual national or local regulatory approval; the UK approval is provided as an exemplar: (IRAS No: 150943; REC 14/SC/1370). The CENTER-TBI study (EC grant 602150) has been conducted in accordance with all relevant laws of the EU if directly applicable or if direct effect and all relevant laws of the country where the Recruiting sites were located, including but not limited to, the relevant privacy and data protection laws and regulations (the “Privacy Law”), the relevant laws and regulations on the use of human materials, and all relevant guidance relating to clinical studies from time to time in force including, but not limited to, the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) (“ICH GCP”) and the World Medical Association Declaration of Helsinki entitled “Ethical Principles for Medical Research Involving Human Subjects”. Informed consent by the patients and/or the legal representative/next of kin was obtained, accordingly to the local legislations, for all patients recruited in the Core Dataset of CENTER-TBI and documented in the e-CRF.
: PS and MC receive part of licensing fees for the software ICM+ used for data collection and analysis in this study.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (name of institute/committee) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Data used in these analyses were collected as part of the CENTER-TBI study which had individual national or local regulatory approval; the UK approval is provided as an exemplar: (IRAS No: 150943; REC 14/SC/1370). Participation in the study followed informed consent from all patients, or in the event they did not possess capacity, following discussions with a consultee, or with relatives, according to local national regulations.