Gather detailed data on prescription of Antibiotics of second or third line and collect information on patient adherence to antibiotic prescriptions, including the handling of leftover medication and the role of laboratory reports in prescribing antibiotics.
Citizens may dynamically interact with researchers, ensuring efficient, accurate, and secure data gathering while maintaining privacy through anonymisation. This approach promises to enhance public health research by offering valuable insights into antibiotic use and fostering deeper patient-researcher interactions, ultimately informing better public health recommendations and practices.
The European EHRxF laboratory report is used to analyse if prescription of certain antibiotics has been done after a lab check has been performed. The use of EEHRxF will allow comparison between EU countries. Furthermore patients matching possible inclusion criteria based on the patient’s health records, such as recent antibiotic dispensation and lab reportsare asked to answer a specific survey, which includes data not usually available in the European EHRxF, such as the handling of leftover pills and quantity of antibiotics stored at home.
Document Version: V1.0
Responsible Party: xShare WP4
Source:
As-Is Situation
Antimicrobial consumption is currently usually monitored following national and international protocols through longitudinal or cross-sectional studies. Longitudinal studies rely on existing administrative data with few details that are continuously collected, whereas cross-sectional studies collect details on the applied preventive or curative regimen at a given point in time (point prevalence study). The data currently used are those collected for reimbursement purpose and data collected locally through a network of volunteer hospital and long term facilities network. The report on antibiotics consumption and AMR is thus often the result of a consolidation of different reports and is often delayed by a few years.
Currently available products/services and its vendors
PHR systems are only emerging with countries having focused first on patient portals. Current AMR data collection process are either indirect or ad hoc.
Which health-related standard does your organisation uses and its alignment to the EEHRxF?
Antimicrobial agents are classified using the Anatomical Therapeutic Chemical (ATC) classification of the World Health Organization (WHO) Collaborating Centre for Drugs Statistics and Methodology.
Most of PHR systems have readily been relying on HL7 FHIR.
The workflow proposed rely on e-prescription, e-dispensation and laboratory reports on one side and ad hoc patient generated data on the other side.
Actors/Users and their Roles
| Patients | Receive notification of their eligibility for the study and provide specific information to the Public Health Agency if matching selection criteria |
| Healthcare providers | Provide prescription report |
| Public Health National agencies | Monitors if second and third generation antibiotics are prescribed after laboratory check Design study protocol and define selection criteria Analyse Patient generated data |
| Laboratory providers | Provide laboratory report |
| Pharmacies | Provide dispensation report |
User Perspective
Pending the availability of the three mentioned reports, no specific action other than producing the reports is expected from Healthcare providers. Eligible Patients receives a notification to ask consent to participate in the study and fill the questionnaire. The Research unit is allowed to interact with
System Perspective
The system used by the Research unit is integrated to the national data sharing infrastructure. Patients can be easily and securely notified.
Health Information Domain(s) – HIDs:
- Electronic prescription
- Electronic dispensiation
- Laboratory Report
- Patient reported outcome report
Scenarios for the xShare Yellow Button
| HIDs | xShare Yellow Button basic functionality | Maturity | |||
| Download | One-time share | Linked options | Start TRL | End TRL | |
| Other (PROs) | x | x | 0 | 0 | |
xShare Yellow Button
The yellow Button is used to transfer information generated by the patient to the Research Unit in the agreed format.
National/regional strategy
The scenario requires a mature and integrated regional/data sharing infrastructure.
Strategy towards EHDS
Use the same EEHRxF allows comparison between EU countries with the possibility of EU near real time monitoring of essential indicators. Patient generated data will possibly lead to the creation of new HID for Patient Reported outcomes.
Business Goals/Benefits and KPIs
The availability of real time information on prescription behaviours should allow quicker adaptations in term of prescription authorisation processes and directly impact progression of resistance. Patient generated data will also allow to adapt communication messages and collect new evidence.
KPIs
- % of prescriptions emitted without prior lab check
- Number of Patients matching selection criteria
- Number of Patients accepting to participate in the study
Application
DATA need to be analysed in a secured processed environment using core privacy and security validated services.
Data Preconditions
Data available from EHR and other systems have been mapped and are interoperable (See also use case 1). Ideally Unqiue Reference validated data source for Medicines are being used by all sytems and EEHRxF specifications compliant.
System Preconditions
EHR, pharmacy and Laboratory systems are EEHRxF compatible.
The system used by the Research Unit has been integrated in the National Data Sharing Infrastructure and is also EEHRxF compliant. The system can make use of a Secure Process Environment which relies on core trusted privacy and security services.
User Preconditions
Patients provide specific consent to be included in the study.
Trigger
No specific action is needed by the clinical users as the monitoring relies entirely on data available in the EEHRxF.
Challenges/Limitations
- Internal Processes at Hospital/Long term facilities level level might not be monitored and require additional specifications.
- PHR needs to be widely used and an efficient notification system needs to be operational.
- Specific data analysis tools connected to the Secure Processing Environment are available.
Involved stakeholders in the BUC definition
Charité, EHTEL, Sciensano
Application of pseudonymisation filters
Yes for all sequences
Basic Workflow
- The research unit is registered in the official national directory as a trusted third party which has access to the (primary use) data sharing infrastructure. The unit has identified the molecules which need to be monitored specifically.
- Through the validated secure processing environment, the unit requests access to all prescriptions including the selected molecules. It checks then if for the selected patients first line antibiotics had been prescribed previously. If yes, and for the patients concerned, it checks if a laboratory exam (antibiogram) has been performed before the prescription.
- The results are returned and integrated in a dashboard which shows the evolution of the number of second- and third-line antibiotics prescribed and the % of prescriptions which was made based on results of lab reports.
- The patients who had met the selection criteria receive a notification through their PHR or secured messaging system connected to a patient web portal asking their consent to be approached in the context of a study related to the fight against AMR. Their positive response triggers the sending of a structured form by the research unit to collect specific PROMs. The patient fills the form which is fully encrypted using trusted core encryption services by the PHR (or the secured webportal) which feeds the study registry.
