Christopher T Rentsch1, Emily J Cartwright2, Neel R Gandhi3, Sheldon T Brown4, Maria C Rodriguez-Barradas5, Matthew Bidwell Goetz6, Vincent C Marconi7, Cynthia L Gibert8, Vincent Lo Re9, David A Fiellin10, Amy C Justice11, Janet P Tate12. 1. Veterans Aging Cohort Study Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA; Internal Medicine, Yale University School of Medicine, New Haven, CT, USA; Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: Christopher.Rentsch@va.gov. 2. Division of Infectious Diseases, Atlanta VA Medical Center, Decatur, GA, USA; School of Medicine, Emory University, Atlanta, GA, USA. 3. School of Medicine, Emory University, Atlanta, GA, USA; Rollins School of Public Health, Emory University, Atlanta, GA, USA. 4. Medicine, James J. Peters VA Medical Center, New York, NY, USA; Icahn School of Medicine, Mount Sinai, New York, NY, USA. 5. Medicine, Michael E. DeBakey VA Medical Center, Houston, TX, USA; Medicine-Infectious Diseases, Baylor College of Medicine, Houston, TX, USA. 6. Medicine, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA; David Geffen School of Medicine, UCLA, CA, USA. 7. Division of Infectious Diseases, Atlanta VA Medical Center, Decatur, GA, USA; School of Medicine, Emory University, Atlanta, GA, USA; Rollins School of Public Health, Emory University, Atlanta, GA, USA. 8. Medicine, Washington DC VA Medical Center, Washington, DC, USA. 9. Medicine (Division of Infectious Diseases) and Department of Epidemiology, Biostatistics, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. 10. Internal Medicine, Yale University School of Medicine, New Haven, CT, USA; School of Public Health, Yale University, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale University, New Haven, CT, USA. 11. Veterans Aging Cohort Study Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA; Internal Medicine, Yale University School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale University, New Haven, CT, USA. 12. Veterans Aging Cohort Study Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA; Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.
Abstract
PURPOSE: Pharmacoepidemiologic studies using electronic health record data could serve an important role in assessing safety and effectiveness of direct-acting antiviral therapy for chronic hepatitis C virus (HCV) infection, but the validity of these data needs to be determined. We evaluated the accuracy of pharmacy fill records in the national Veterans Health Administration (VA) Corporate Data Warehouse (CDW) as compared to facility-level electronic health record. METHODS: Patients prescribed a direct-acting antiviral regimen at five VA sites between 2014 and 2016 were randomly selected and reviewed. A random sample of patients with chronic HCV infection without evidence of HCV treatment during the study period also underwent chart review. We calculated positive predictive value and negative predictive value overall and by site. RESULTS: Of the 501 patients who received a total of 2416 prescriptions, 494 were validated using data extracted from CDW 6 months after the study period, yielding a positive predictive value of 98.6% (95% confidence interval, 97.6%-99.6%). Of the 100 patients with chronic HCV infection without prescriptions for HCV treatment, 99 were confirmed not to have received antiviral treatment (negative predictive value, 99.0%; 95% confidence interval, 97.1%-100%). CONCLUSIONS: These findings provide assurance to researchers who use national VA CDW data for retrospective cohort studies that the CDW contains accurate information on HCV therapies in the modern treatment era.
PURPOSE: Pharmacoepidemiologic studies using electronic health record data could serve an important role in assessing safety and effectiveness of direct-acting antiviral therapy for chronic hepatitis C virus (HCV) infection, but the validity of these data needs to be determined. We evaluated the accuracy of pharmacy fill records in the national Veterans Health Administration (VA) Corporate Data Warehouse (CDW) as compared to facility-level electronic health record. METHODS:Patients prescribed a direct-acting antiviral regimen at five VA sites between 2014 and 2016 were randomly selected and reviewed. A random sample of patients with chronic HCV infection without evidence of HCV treatment during the study period also underwent chart review. We calculated positive predictive value and negative predictive value overall and by site. RESULTS: Of the 501 patients who received a total of 2416 prescriptions, 494 were validated using data extracted from CDW 6 months after the study period, yielding a positive predictive value of 98.6% (95% confidence interval, 97.6%-99.6%). Of the 100 patients with chronic HCV infection without prescriptions for HCV treatment, 99 were confirmed not to have received antiviral treatment (negative predictive value, 99.0%; 95% confidence interval, 97.1%-100%). CONCLUSIONS: These findings provide assurance to researchers who use national VA CDW data for retrospective cohort studies that the CDW contains accurate information on HCV therapies in the modern treatment era.
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