Comparative Effectiveness Research of Chronic Hepatitis B and C Cohort Study (CHeCS): Improving Data Collection and Cohort Identification
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Background and Aims
The Chronic Hepatitis Cohort Study (CHeCS) is a longitudinal observational study of risks and benefits of treatments and care in patients with chronic hepatitis B (HBV) and C (HCV) infection from four US health systems. We hypothesized that comparative effectiveness methods—including a centralized data management system and an adaptive approach for cohort selection—would improve cohort selection while controlling data quality and reducing the cost.
Cohort selection and data collection were performed primarily via the electronic health record (EHR); cases were confirmed via chart abstraction. Two parallel sources fed data to a centralized data management system: direct EHR data collection with common data elements, and chart abstraction via electronic data capture. An adaptive Classification and Regression Tree (CART) identified a set of electronic variables to improve case ascertainment accuracy.
Over 16 million patient records were collected on 23 case report forms in 2006–2008. The vast majority of data (99.2 %) were collected electronically from EHR; only 0.8 % was collected via chart abstraction. Initial electronic criteria identified 12,144 chronic hepatitis patients; 10,098 were confirmed via chart abstraction with positive predictive values (PPV) 79 and 83 % for HBV and HCV, respectively. CART-optimized models significantly increased PPV to 88 for HBV and 95 % for HCV.
CHeCS is a comparative effectiveness research project that leverages electronic centralized data collection and adaptive cohort identification approaches to enhance study efficiency. The adaptive CART model significantly improved the positive predictive value of cohort identification methods.
KeywordsChronic hepatitis B Chronic hepatitis C Comparative effectiveness research Classification and Regression Trees Cohort identification
Chronic Hepatitis Cohort Study
Hepatitis B virus
Hepatitis C virus
Electronic health record
Virtual Database Warehouse
Data coordinating center
Positive predictive value
Classification and Regression Trees
Receiver operating characteristic
Area under the ROC curve
CHeCS is funded by the CDC Foundation, which currently receives grants from AbbVie, Janssen Pharmaceuticals, Inc., and Vertex Pharmaceuticals. Past funders include Genentech, A Member of the Roche Group. Current and past partial funders include Gilead Sciences and Bristol-Myers Squibb. Granting corporations do not have access to CHeCS data and do not contribute to data analysis or writing of manuscripts.
Conflict of interest
Stuart C. Gordon receives grant/research support from AbbVie Pharmaceuticals, Bristol-Myers Squibb, Gilead Pharmaceuticals, GlaxoSmithKline, Intercept Pharmaceuticals, Merck, and Vertex Pharmaceuticals. He is also a consultant/advisor for Amgen, Bristol-Myers Squibb, CVS Caremark, Gilead Pharmaceuticals, Merck, Novartis, and Vertex Pharmaceuticals and is on the Data Monitoring Board for Tibotec/Janssen Pharmaceuticals. The other authors have no potential conflicts of interest.
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