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. 2007 Sep-Oct;14(5):662-73.
doi: 10.1197/jamia.M2157. Epub 2007 Jun 28.

Implementing Single Source: the STARBRITE proof-of-concept study

Rebecca Kush  1 , Liora Alschuler, Roberto Ruggeri, Sally Cassells, Nitin Gupta, Landen Bain, Karen Claise, Monica Shah, Meredith Nahm
Affiliations

Implementing Single Source: the STARBRITE proof-of-concept study

Rebecca Kush et al. J Am Med Inform Assoc. 2007 Sep-Oct.

Abstract

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.

Design: 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.

Conclusion: 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.

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Figures

Figure 1
Figure 1
Without Single Source
Figure 2
Figure 2
With Single Source
Figure 3
Figure 3
CDA and ODM sample fragment
Figure 4
Figure 4
Microsoft Office InfoPath Clinical Research Form
Figure 5
Figure 5
Business process integrating the document management system with the CTMS and the clinic notes repository
Figure 6
Figure 6
Data representation in Case Report Form and Clinic Note
Figure 6
Figure 6
Data representation in Case Report Form and Clinic Note
See this image and copyright information in PMC

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