Electronic screening improves efficiency in clinical trial recruitment

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>or=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.

Figure 1

The E-screening workflow. The shaded boxes indicate computer-generated recommendations (i.e., “ineligible”, “pending”, or “potentially eligible”). E-screening reduced the cases that need investigator review from 193 to 23. All cases were over read by an investigator to determine the accuracy of E-screening to identify ineligible patients (NPA was 100%). Dashed lines depict investigator over read of patients who were categorized as ineligible by E-screening. Patients with incomplete data were classified as pending if E-screening was done < 24 hours after admission.