The accuracy and efficiency of electronic screening for recruitment into a clinical trial on COPD

Respir Med. 2011 Oct;105(10):1501-6. doi: 10.1016/j.rmed.2011.04.012. Epub 2011 May 14.


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Validation Study

MeSH terms

  • Data Mining
  • Eligibility Determination / methods*
  • Eligibility Determination / standards
  • Female
  • Humans
  • Male
  • Patient Participation* / statistics & numerical data
  • Patient Selection*
  • Prospective Studies
  • Pulmonary Disease, Chronic Obstructive*
  • Randomized Controlled Trials as Topic*
  • Sensitivity and Specificity
  • Workflow