Utility of Electronic Medical Record for Recruitment in Clinical Research: from Rare to Common Disease

BackgroundRecruitment for clinical trials is a major challenge. Movement disorders, which do not have associated diagnostic laboratory tests, might be especially prone to inaccuracy in coding. Our objective was to evaluate the accuracy of diagnostic codes such as cervical dystonia (CD) and Parkinson's disease (PD) in an electronic medical record (EMR). MethodsRetrospective chart review was performed to confirm the International Classification of Diseases, Ninth Revision (ICD-9) diagnoses of PD, CD, and diabetes mellitus type 2 (DM-2), using published clinical diagnostic criteria (PD, CD) and hemoglobin A1c 6.5 (DM-2). ResultsA total of 421 charts (n = 129, n = 142, n = 150 for PD, CD, and DM-2, respectively) were reviewed. The accuracy rate was different among all diseases examined, with an overall P < 0.001. In post hoc pairwise comparisons, the accuracy of DM-2 diagnosis by ICD-9 (96.6%) was greater than CD (88.0%) and both were greater than PD (55.0%) (P 0.003). ConclusionsThe use of an electronic medical-record-based screening of clinically diagnosed diseases such as CD might be more accurate than previously thought, and it may identify potential clinical trial participants even without the availability of confirmatory laboratory tests.