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The Use of Claims Data Algorithms to Recruit Eligible Participants Into Clinical Trials
Leonardo Tamariz, MD, MPH; Ana Palacio, MD, MPH; Jennifer Denizard, RN; Yvonne Schulman, MD; and Gabriel Contreras, MD, MPH
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The Use of Claims Data Algorithms to Recruit Eligible Participants Into Clinical Trials

Leonardo Tamariz, MD, MPH; Ana Palacio, MD, MPH; Jennifer Denizard, RN; Yvonne Schulman, MD; and Gabriel Contreras, MD, MPH
Using an ICD-9-CM code algorithm, the authors effectively identified potentially difficult-to-reach populations for a hypertension clinical trial.
The validity of single specific codes has been well described5,6,12; however, most reports do not describe the combination of ICD-9-CM codes with other codes. This validation of single codes is a critical component of outcomes, pharmacovigilance signaling, and comparative effectiveness research. However, there is a lack of data reporting on the validity of combinations of ICD- 9-CM codes or the combination of ICD-9-CM codes with other claims-based information to identify specific clinical presentations or populations of interest. These strategies have been used to report events in cohorts of specific populations, such as intestinal perforation among rheumatoid arthritis patients,13 or progression of liver disease.14 However, there has been no translation of this knowledge to identify the ideal potential clinical trial participant. As we showed in this report, it is possible to identify the subgroup of subjects who are likely to be eligible by creating algorithms of well-validated individual codes that represent the inclusion/exclusion criteria of the clinical trial.

CONCLUSIONS

Identifying a set of validated codes and creating algorithms that include the inclusion/exclusion criteria of a randomized study can potentially aid in the recruitment of the study using mailings. It will be necessary to evaluate the impact of this strategy after ICD-10-CM is implemented, as well as in the recruitment of minorities.

Author Affiliations: Department of Medicine, Miller School of Medicine, University of Miami (LT, AP, YS, GC), Miami, FL; Veterans Affairs Medical Center (LT, AP, JD, YS, GC), Miami, FL.

Source of Funding: None.

Author Disclosures: The authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (LT,AP); acquisition of data (LT, JD, GC); analysis and interpretation of data (LT, GC, YS); drafting of the manuscript (LT, GC, AP, YS); critical revision of the manuscript for important intellectual content (LT, AP, GC, YS); statistical analysis (LT, GC); provision of study materials or patients (LT, GC, JD); obtaining funding (LT, GC); administrative, technical, or logistic support (JD); supervision (GC, AP).

Address correspondence to: Leonardo Tamariz, MD, MPH, Miller School of Medicine, University of Miami, 1120 NW 14th St, Ste 971 (H- 201), Miami, FL 33136. E-mail: ltamariz@med.miami.edu.
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