Implementing Single Source: the STARBRITE proof-of-concept study.
OBJECTIVE
Inefficiencies in clinical trial data collection cause delays, increase costs, and may reduce clinician participation in medical research. In this proof-of-concept study, we examine the feasibility of using point-of-care data capture for both the medical record and clinical research in the setting of a working clinical trial. We hypothesized that by doing so, we could increase reuse of patient data, eliminate redundant data entry, and minimize disruption to clinic workflow.


METHODS
We developed and used a point-of-care electronic data capture system to record data during patient visits. The standards-based system was used for clinical research and to generate the clinic note for the medical record. The system worked in parallel with data collection procedures already in place for an ongoing multicenter clinical trial. Our system was iteratively designed after analyzing case report forms and clinic notes, and observing clinic workflow patterns and business procedures. Existing data standards from CDISC and HL7 were used for database insertion and clinical document exchange.


RESULTS
Our system was successfully integrated into the clinic environment and used in two live test cases without disrupting existing workflow. Analyses performed during system design yielded detailed information on practical issues affecting implementation of systems that automatically extract, store, and reuse healthcare data.


CONCLUSIONS
Although subject to the limitations of a small feasibility study, our study demonstrates that electronic patient data can be reused for prospective multicenter clinical research and patient care, and demonstrates a need for further development of therapeutic area standards that can facilitate researcher use of healthcare data.
Kush
Rebecca
R
The Clinical Data Interchange Standards Consortium, Austin, TX, USA.
Alschuler
Liora
L
Ruggeri
Roberto
R
Cassells
Sally
S
Gupta
Nitin
N
Bain
Landen
L
Claise
Karen
K
Shah
Monica
M
Nahm
Meredith
M
D002986:Clinical Trials as Topic; D003199:Computer Systems; D003625:Data Collection / Q000379:methods*; D005240:Feasibility Studies; D005568:Forms and Records Control; D006751:Hospital Information Systems; D006801:Humans; D016347:Medical Records Systems, Computerized; D019095:Point-of-Care Systems; D012984:Software; D014584:User-Computer Interface