The European Cystic Fibrosis Society Patient Registry (ECFSPR) uses a universal, data-collection platform “ECFSTracker” to collect data from the participating countries for epidemiological and research purposes. ECFSTracker is an open source, multipurpose and multinational software program, custom-designed for the collection of Cystic Fibrosis patient data.
ECFSTracker is accessed from the internet and has a simple, user-friendly interface. It is structured in such a way that additional modules can be added in the future e.g. to collect project specific clinical data or to refine data analysis and extraction for specific scientific or health services research.
Advanced security technology is employed to ensure data is safely managed. There are strict rules for de-identification of data and user management, and the system complies with European data protection laws.
Authorised users connect to the secure website and either input data by completing a web-based form, or upload a data file in Excel format. Only anonymised patient data – i.e. no patient or centre names – are sent to the ECFSPR database. Pre-agreed variable definitions, parameters and coding are used, to allow reliable statistical analysis and reporting at centre, country and European level.
Participating centres can choose to input patient information once a year, or to collect lineair data from individual patient visits throughout the year, in real-time. From the completed encounter forms, once a year, an Annual Summary with anonymised data is extracted from the system and exported to the ECFSPR.
The quality of the data is guaranteed on several levels:
- At input level, in-built, automatic, controls and validation rules are applied by ECFSTracker. The software will block input or flag something that may be wrong, e.g. out of range values.
- Before data is transmitted to the ECFSPR, another series of controls is automatically applied by the software, and users have the possibility to modify data.
- The final data checks are carried out by the ECFSPR Statistician.
National registries need to perform checks on their own data, as defined in a consensus document, before uploading their national data set to ECFSTracker. During upload and before transmission the software will apply inbuilt checks and offer the opportunity to make corrections.
Reports, based on the data in the system for the centre, can be generated in real time. Graphs and tables can be downloaded and printed or visualised online.