Principles of the SIRIS implant registry
User-friendly data entry
Collection of a minimum agreed data set by means of a flexible and user-friendly online platform. All non-applicable question and answer elements are hidden, i.e. excluded from the data documentation process. Surgeons, their assistants or – based on the operation report – administrative offices should be able to complete registration. The documentation system guides data entry via mandatory fields and predefined value lists.
High data quality The data is verified for plausibility as best as possible at the time it is entered to obtain “valid values” for each data record. The implant data is registered directly from the catalogue with the specifications maintained by the industry to ensure accurate implant identification.
User-friendly data access and meaningful reporting Resources and tools are provided to allow authorised users easy access to data and reports. Standardised reporting incorporates clinic and implant reports. The clinics receive free quarterly reports detailing their performance data, including benchmark comparisons, and a comprehensive annual report is prepared and published each year. The industry has access to fee-based, standardised implant reports.
High-level data protection
The security of registered data and conformity with the Swiss Data Protection Act (FADP) and the European Union’s General Data Protection Regulation (GDPR), which safeguards the rights of European citizens, are of fundamental importance.
The registry stores all data centrally, including any data that could potentially identify patients. Medically identifiable and patient identifiable data components are logically separated, and only the attending physician and the certified staff responsible for providing the necessary maintenance, operation and support services have access to patient identifiable data. The only people who can access data from patients at each clinic are authorised staff from the respective hospitals. Those authorised by and assigned “admin function” rights by each clinic can access all of the hospital’s data. Data protection, data sovereignty, access rights and further use of the data by third parties etc. are defined in a user regulation > LINK. The SIRIS Foundation owns the pseudonymous SIRIS database, while each registering hospital or clinic owns their own database together with personal identifying information.
Minimal data collection effort
Clinic and patient data In addition to patient name, type of procedure, time, surgeon and hospital, also recorded are patient characteristics (sex, age, height, weight, ASA score, Charnley score, diagnosis and technical details of operations. Clinics are required to obtain patient consent for collection of data. Patients are free to refuse registration.
Data on surgical procedures The catalogue of questions varies depending on surgical procedure (hip, knee, spine, etc.) and is categorised according to procedure type: primary, revision, re-operation or follow-up. The catalogue of questions was drawn up by expert groups from the respective medical expert associations and is constantly reviewed to ensure they are up to date. Particular attention is paid to ensuring that statistical analysis of the responses to the catalogue of questions results in inter-nationally comparable data.
Implant data Correct identification of the applied implants associated with specific procedures necessitates documentation of a number of features. All implanted components are recorded and can be assigned to the corresponding patient/procedure in the SIRIS database. SIRIS Hip & Knee maintains its own implant database, while SIRIS Spine utilises a common database with EUROSPINE Spine Tango.
Goal achievement The goal is to improve quality in implant medicine by means of a continuous learning process based on systematically collected data. This is accomplished by providing the industry, hospitals and surgeons with comparative feedback on performance data and by professional analysis of the data to identify possible reasons for inferior quality.
