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Digestive Diseases and Sciences

, Volume 59, Issue 12, pp 3053–3061 | Cite as

Comparative Effectiveness Research of Chronic Hepatitis B and C Cohort Study (CHeCS): Improving Data Collection and Cohort Identification

  • Mei Lu
  • Loralee B. Rupp
  • Anne C. Moorman
  • Jia Li
  • Talan Zhang
  • Lois E. Lamerato
  • Scott D. Holmberg
  • Philip R. Spradling
  • Eyasu H. Teshale
  • Vinutha Vijayadeva
  • Joseph A. Boscarino
  • Mark A. Schmidt
  • David R. Nerenz
  • Stuart C. Gordon
Original Article

Abstract

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.

Methods

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.

Results

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.

Conclusions

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.

Keywords

Chronic hepatitis B Chronic hepatitis C Comparative effectiveness research Classification and Regression Trees Cohort identification 

Abbreviations

CHeCS

Chronic Hepatitis Cohort Study

HBV

Hepatitis B virus

HCV

Hepatitis C virus

EHR

Electronic health record

VDW

Virtual Database Warehouse

DCC

Data coordinating center

PPV

Positive predictive value

CART

Classification and Regression Trees

ROC

Receiver operating characteristic

AUROC

Area under the ROC curve

TN

Terminal node

Notes

Acknowledgments

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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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Mei Lu
    • 1
  • Loralee B. Rupp
    • 1
  • Anne C. Moorman
    • 2
  • Jia Li
    • 1
  • Talan Zhang
    • 1
  • Lois E. Lamerato
    • 1
  • Scott D. Holmberg
    • 2
  • Philip R. Spradling
    • 2
  • Eyasu H. Teshale
    • 2
  • Vinutha Vijayadeva
    • 3
  • Joseph A. Boscarino
    • 4
  • Mark A. Schmidt
    • 5
  • David R. Nerenz
    • 1
  • Stuart C. Gordon
    • 1
  1. 1.Departments of Public Health Sciences, Center for Health Services Research, and GastroenterologyHenry Ford Health SystemDetroitUSA
  2. 2.Division of Viral Hepatitis National Center for HIV, Hepatitis, STD, and TB PreventionCenters for Disease Control and PreventionAtlantaUSA
  3. 3.The Center for Health ResearchKaiser Permanente HawaiiHonoluluUSA
  4. 4.Center for Health ResearchGeisinger ClinicDanvilleUSA
  5. 5.The Center for Health ResearchKaiser Permanente NorthwestPortlandUSA

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