From: The European Register of Cystic Echinococcosis, ERCE: state-of-the-art five years after its launch
Item | Feature |
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Patients enrolled in ERCE | With confirmed or probable CE (according to WHO-IWGE 2010 Expert Consensus definition) In- and out-patients All ages and both sexes Diagnosed at the time of the recorded visit or previously; follow-up visits |
Data recorded for each patient | Personal data: year of first diagnosis of CE Clinical data: cyst(s) localization, size and stage History of treatments and treatment/management approach currently being received Biological samples collected (if any) |
ERCE structure | Multicentre database located within the secured IT network of the Italian National Institute of Health (Istituto Superiore di Sanità, ISS) in Rome Currently available in English, Italian, Romanian, Bulgarian and Turkish Organized in sheets where patient data are recorded Each registered patient is automatically given a unique ERCE ID code Data are uncoupled and pseudonymized Only the physician who entered the patient’s data and the ERCE manager can access the record |
ERCE users | Physicians working in health centres where patients with CE are managed Join the ERCE network voluntarily Are provided with personal credentials to login into the register Different roles are envisaged: - the “person in charge” in each centre enters patients’ data - the “supervisor” in each centre can read only data of his/her centre - the Register “coordinator” has access to and can download data from all national centres Possibility to have a National Centre coordinating data collection from centres of the Countrya |
Requirements to join ERCE | To be a physician working in centres where CE patients (in- and out-patients) are visited To obtain the approval from the ethics committee of each centre/country involved (although the implementation of the Register is only observational and does not involve clinical experimentation) |
Ownership of data | Data from individual centres belong to the individual centres themselves The coordinator can only use cumulative data for periodic presentations on the progress of the ERCE Publication of data requires the consent of the individual centres |
Confidentiality and security | ERCE was approved by the ISS ethics committee (Prot. PRE-C-915/14 of November 25th, 2014), extending the agreement to the Italian Register of CE (Ns Prot. CE/12/347 of May 7th, 2012) ERCE complies with EU Regulation on the protection and use of personal data (Reg. EU 2016/679) Two informed consent forms must be signed by patients at initial registration to allow: - their data to be recorded in the Register - their biological samples to be shipped to the Echino-Biobank The ISS datacentre, through the Azure Backup Server System, makes a complete backup every night and an online backup copy on cloud daily, weekly, monthly and yearly, stored for up to 20 years |