Electronic screening improves efficiency in clinical trial recruitment.
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.
Thadani
Samir R
SR
Department of Medicine, Columbia University Medical Center, New York-Presbyterian Hospital, New York, NY 10032, USA.
Weng
Chunhua
C
Bigger
J Thomas
JT
Ennever
John F
JF
Wajngurt
David
D
D000328:Adult; D057225:Data Mining; D003924:Diabetes Mellitus, Type 2; D004608:Eligibility Determination; D006801:Humans; D016247:Information Storage and Retrieval; D016347:Medical Records Systems, Computerized; D009519:New York City; D018579:Patient Selection; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D057188:Workflow