Targeted antibiogram study
Research information note
ABC-MG
Research on methods of providing antibiograms to doctors (population trial)
Dear,
Your LabOuest laboratory engages in research with the aim of improving scientific and medical knowledge.
Your laboratory with which you work will soon deploy a new program for providing antibiograms to doctors, the evaluation of which is the subject of this research project.
The Hospital and University Center (CHU) of Nantes, the University of Nantes, the Caisse Primaire d’Assurance Maladie (CPAM) of Loire-Atlantique and LabOuest will thus carry out research whose objective will be to measure the impact of a new method for rendering antibiograms on antibiotic prescriptions.
The Nantes University Hospital and the Caisse Primaire d’Assurance Maladie (CPAM) of Loire-Atlantique are the two co-leaders of the study.
A CPAM reference person will be in charge of carrying out the “targeting” of doctors (in relation to the inclusion and exclusion criteria of the study) on the local health insurance databases (SIAM ERASME database ).
Your LabOuest laboratory will then be responsible for extracting, from its own database, the survey data of patients who have had a positive ECBU for E.coli prescribed by a doctor and sending these data as well as the results of the antibiogram and an identifier to connect to the data controllers CPAM 44 and the Nantes University Hospital via a secure server.
At the same time, a circuit proposed by the CNIL and involving a third party for reconstruction of the social security number (NIR), and the person responsible for the National Health Data System (SNDS*) database, will make it possible to secure your data:
- LabOuest will transmit to this reconstruction third party the identity traits of the patients (surname, first name and date of birth of the patient) with the attachment identifier,
- The third party will reconstruct the NIR from the identity features and transmit it to the head of the SNDS database,
- The manager of the SNDS database will identify the relevant data within the SNDS and transmit it to the data controllers with the attachment identifier. Managers will then be able to match the survey data and the data from the SNDS using the linking identifier.
*The SNDS lists all care resources reimbursed by Health Insurance and hospital data (as well as other information: www.snds.gouv.fr). The care resources that you are likely to use during the study (consultations, medications, hospitalizations, biology and imaging procedures, nursing procedures, etc.) will be collected using the SNDS.
Finally, a database compiling all the data: microbiological data, antibiotic reimbursement data, patient characteristics, general practitioner characteristics (age class, sex, mode of exercise (alone or in a group), type of municipality of exercise (based on INSEE urban area zoning), will be made available in a project space on the secure SNDS platform.
These data used for the analysis of the evaluation criteria of the study come from the SNDS and are in fact considered as coded.
All exchanges will be carried out on secure servers.
The analysis of the data will be carried out by authorized people who will at no time have access to the identity, the NIR of the patients, or any other data allowing the patient to be directly or indirectly re-identified.
The results of this research will promote the development of knowledge.
DATA PROCESSING
The legal basis for processing your personal data is the public interest in this research (article 6.1.e of Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of these data (GDPR). This is one of the exceptions provided for in Article 9 of the same text, allowing the processing of health data.
The processing is the subject of a procedure with the CNIL.
” your contacts “.
This research is consistent with :
- to the law “Informatique et Libertés” of January 6, 1978 as amended and Law No. 2018-493 of June 20, 2018 relating to the protection of personal data
- Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (GDPR)
The research received the favorable opinion of the Expert Committee for Research, Studies and Evaluations in the field of Health (CESREES) and authorization from the National Commission for Informatics and Liberties (CNIL)
Your participation in this research is free. You may refuse to participate in this research, and you may withdraw from this research at any time, without prejudice; you simply need to inform the investigator.
YOUR CONTACTS :
To exercise your rights regarding your data (access, rectification, etc.), your preferred contact is:
Le Délégué à la Protection des Données (DPD) / Data Protection Officer (DPO) of the CPAM of Loire-Atlantique:
dpo.cpam-loireatlantique@assurance-maladie.fr
For any questions regarding the study, your preferred contact is :
The research coordinating investigator : Dr Jean-Pascal FOURNIER
contact.abcmg@univ-nantes.fr
For any general questions about the processing of your data :
The research promoter, responsible for the processing :
Nantes University Hospital, research and innovation department, 5 allée de l’Ile Gloriette, 44093 NANTES Cedex 1
Le Délégué à la Protection des Données (DPD) / Data Protection Officer (DPO) :
vosdonneespersonnelles@chu-nantes.fr