Electronic Screening Improves Efficiency in Clinical Trial Recruitment
- Department of Medicine (SRT, JTB), Department of Biomedical Informatics (CW, DW), The Clinical Trials Office (JTB), The Irving Institute for Clinical and Translational Research (CW, JTB), Columbia University Medical Center, New York-Presbyterian Hospital, New York, NY; The Western Institutional Review Board, Olympia, WA (JFE); California Pacific Medical Center, San Francisco, CA
- Correspondence: Chunhua Weng, PhD, MS, Department of Biomedical Informatics, Columbia University, 630 West 168th Street, VC-5, room 564, New York, NY 10032; e-mail: <cw2384{at}columbia.edu>
- Received 29 December 2008
- Accepted 16 August 2009
Abstract
This study evaluated the performance of an electronic screening (E-screening) method and used it to recruit patients for the NIH sponsored ACCORD trial. Out of the 193 E-screened patients, 125 met the age criterion (“age ≥ 40”). For all of these 125 patients, the performance of E-screening was compared with investigator review. E-screening achieved a negative predictive accuracy of 100% (95% CI: 98–100%), a positive predictive accuracy of 13% (95% CI: 6–13%), a sensitivity of 100% (95% CI: 45–100%), and a specificity of 84% (95% CI: 82–84%). The method maximized the use of a patient database query (i.e., excluded ineligible patients with a 100% accuracy and automatically assembled patient information to facilitate manual review of only patients who were classified as “potentially eligible” by E-screening) and significantly reduced the screening burden associated with the ACCORD trial.
Footnotes
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This research was funded under NIH/NHLBI Contracts HHSN268200455208C and N01-HC-95184, NLM grant 1R01 LM009886, and CTSA award UL1 RR024156. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NIH.
