Background The NORwegian Disease Modifying Anti-Rheumatic Drugs (NOR-DMARD) registry has since 2000 been registering DMARD use and response in five different Norwegian rheumatology departments (ref). Almost 5,000 biologic treatment courses in 3,500 patients have been included so far, together contributing with 19,000 study visits. Clinical information was previously recorded on paper, but from May 2012 an electronic data capture (EDC) system has been implemented.
Objectives To enable transfer of clinical data from a structured electronic health record to an electronic case report form.
Methods A commercial EDC system, Viedoc™, has been set up in order to capture study data using electronic case report forms (e-CRFs). All centers have implemented a structured electronic health record (EHR), GoTreatIt™, which facilitates the export of un-identified source data. The workflow of a new patient is as follows:
1. The patient is included into the EDC system with patient information such as patient initial, date of birth and biologic treatment, and a visit is initiated with some information not collected in the EHR.
2. The EDC system generates a unique patient number, which is then registered in the EHR. This key enables the transfer from one system to the other.
3. Study data are then registered in the EHR, both by the treating physician/nurse (e.g. DAS28, ASDAS) and the patient (e.g. MHAQ, RAID).
Once a month each center extracts data in an XML-format from the site's EHR system. The contents of the extracted data are pre-specified and in accordance with the study protocol and e-CRF. The trial data manager uses a SAS program to parse the XML-files to a flat file format readable in the EDC system. The SAS program also runs a validation check against patient numbers, dates of birth and visit dates. We then import the flat files into the EDC system using the system's import routine, merging by patient number. The system facilitates an audit trail, so any changes are registered. A patient's e-CRF with all collected data is then accessible for both site and trial data management.
Results From May 2012 to June 2013, 1697 patients on biologic treatment have been successfully included into the EDC system. A Contract Research Organization (CRO) NOK handled the previous paper-CRF system at a price of 115 NOK (20 USD) per visit/CRF. The money saved from this contract has already made the shift into EDC profitable, taken the set-up and licensing costs of the EDC system into consideration. In addition to this, the paper CRF system required considerable manual resources at each participating center, including entering, copying and mailing of completed CRFs and administration of inclusion IDs.
Conclusions We have developed a novel methodology where we gather electronic health records from five different centers into a central trial database. We avoid time-consuming handling of paper-CRFs and eliminate data entry errors since we import source data directly into the study database. Compared to a standard e-CRF solution we gain efficacy effects because we avoid redundant registration, i.e. both in the patient journal and in the e-CRF system.
Disclosure of Interest : None declared