The ECFS Patient Registry has developed a new, universal, data-collection platform ECFSTracker; 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 is easy to use. It has a simple, user-friendly interface and 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. The software program doesn’t need to be installed and updates of the software will be done remotely.
ECFSTracker employs advanced security technology 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 a compatible format e.g. Excel or XML. 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, as in the past, or can take advantage of a new tool offered in ECFSTracker: the Patient Encounter module. The Encounter software gives users the option to collect interesting lineal data from individual patient visits throughout the year, in real-time. This is very useful for long-term CF monitoring, with many aspects of CF patient progress viewed in the format of graphs and tables with one click of the mouse. From the completed encounter forms, once a year, an Annual Summary with anonymised data is extracted from the system and exported to the ECFSPR. Potentially, this module can be further refined at centre or country level, to allow the collection of additional data according to a centre’s or county’s particular needs or requirements.
The quality of the data is guaranteed on several levels:
- Level 1: 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.
- Level 2: 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.
- Level 3: 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 at patient and centre level. This function is a useful tool for centre clinical staff and a source of information for patients.