title: The accuracy and efficiency of electronic screening for recruitment into a clinical trial on COPD.
abstract: 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.
authors.affiliation: Multidisciplinary Epidemiology and Translational Research in Intensive Care, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. cschmickl83@gmail.com
authors.forename: Christopher N
authors.initials: CN
authors.lastname: Schmickl
authors.forename: Man
authors.initials: M
authors.lastname: Li
authors.forename: Guangxi
authors.initials: G
authors.lastname: Li
authors.forename: Marnie M
authors.initials: MM
authors.lastname: Wetzstein
authors.forename: Vitaly
authors.initials: V
authors.lastname: Herasevich
authors.forename: Ognjen
authors.initials: O
authors.lastname: Gajic
authors.forename: Roberto P
authors.initials: RP
authors.lastname: Benzo
mesh_terms: D057225:Data Mining; D004608:Eligibility Determination / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D008297:Male; D010358:Patient Participation / Q000706:statistics & numerical data; D018579:Patient Selection; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive; D016032:Randomized Controlled Trials as Topic; D012680:Sensitivity and Specificity; D057188:Workflow