Sacco, Guillaume
Ben-Sadoun, Grégory
Gautier, Jennifer
Simon, Romain
Goupil, Maude
Laureau, Pauline
Terrien, Jade
Annweiler, Cédric
Article History
Received: 19 April 2022
Accepted: 8 February 2023
First Online: 7 March 2023
Declarations
:
: The study was conducted in accordance with the ethical standards in the Helsinki Declaration adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975, the 35th World Medical Assembly, Venice, Italy, October 1983, and the 41st World Medical Assembly, Hong Kong, September 1989.In accordance with French law, this retrospective study collecting data from usual care was carried out as part of “research not involving human beings”, and not of “research involving human beings”. Therefore, the informed consent is not required. Nevertheless, in accordance with French law, a “non-opposition” of the patient and/or their legal guardian(s) is required to the use of his data (from usual care) for future researches (retrospective). General information concerning cares, data management, the use of data from usual care in the context of scientific researches, and the procedure to address the opposition to the use of data for future researches, are given using several communication media to every patient during the hospitalization (i.e., public display in the care units <i>plus</i> information booklet given individually). Consequently, the patient and/or their legal guardian(s) can manifest their opposition to the use of his data for future researches at any time from the time of their hospitalization. All data from this study were collected from patients who did not oppose the use of their data for future researches.The relevant legislation is the article 79 law n° 78 − 17 january 6, 1978 related du informatics, files and liberties of the French Law; in application of the european regulation (UE) 2016/679 of april 27th, 2016 and in the conditions of the point 5b, article 14 of this european regulation.The study was approved by “the Ethics committee of the university hospital of Angers” (in French: “Comité d’Ethique du Centre Hospitalier Universitaire d’Angers”). Study declaration number: 2020/110. Date of acceptance: 07/09/2020.The study protocol was declared to the “National Commission for Information Technology and Civil Liberties” (in French: “Commission Nationale de l’Informatique et des Libertés”, [CNIL]). Study declaration number: ar20-0104v0. Registration date: 17/10/2020.The study was registered in <i>ClinicalTrials.gov</i>. NCT number: NCT04557592. First registration date: 21/09/2020.
: Not applicable.
: The authors declare that they have no competing interests.