The accuracy and efficiency of electronic screening for recruitment into a clinical trial on COPD.
The accuracy and efficiency of electronic screening for recruitment into a clinical trial on COPD.
Respir Med. 2011 May 14;
Authors: Schmickl CN, Li M, Li G, Wetzstein MM, Herasevich V, Gajic O, Benzo RP
Participant recruitment is an important process in successful conduct of randomized controlled trials. To facilitate enrollment into a National Institutes of Health-sponsored clinical trial involving patients with chronic obstructive pulmonary disease (COPD), we developed and prospectively validated an automated electronic screening tool based on boolean free-text search of admission notes in electronic medical records. During a 2-week validation period, all patients admitted to prespecified general medical services were screened for eligibility by both the electronic screening tool and a COPD nurse. Group discussion was the gold standard for confirmation of true-positive results. Compared with the gold standard, electronic screening yielded 100% sensitivity, 92% specificity, 100% negative predictive value, and 72% positive predictive value. Compared with traditional manual screening, electronic screening demonstrated time-saving potential of 76%. Thus, the electronic screening tool accurately identifies potential study subjects and improves efficiency of patient accrual for a clinical trial on COPD. This method may be expanded into other institutional and clinical settings.
PMID: 21576012 [PubMed - as supplied by publisher]