Mini-Sentinel: Analytic Methods for Using Laboratory Test Results in Active Database Surveillance

Project Title Mini-Sentinel: Analytic Methods for Using Laboratory Test Results in Active Database Surveillance
Date Posted
Wednesday, April 12, 2017

The objective of this project was to select and test statistical methods appropriate for use when analyzing cross-sectional and longitudinal observational healthcare administrative, claims, and clinical data, with specific attention to clinical laboratory results when missing data are expected. Recognizing that different uses of laboratory results data (e.g., confounding adjustment, detecting outcomes, cohort identification) in medical product safety surveillance could optimally employ different methods to handle the missing results data, we evaluated more than one method for use in the Mini-Sentinel Distributed Database environment.

To select and evaluate the performance of statistical methods with intent to potentially recommend techniques for including laboratory test results data in Mini-Sentinel safety surveillance, we had the following Specific Aims:

  • Specific Aim 1. Summarize the literature on the use of clinical laboratory test results databases in administrative claims and electronic health records (EHR) database studies of medical product safety.
  • Specific Aim 2. Utilize the Mini-Sentinel Distributed Database resources to evaluate analytic methods for incorporating laboratory test results data into medical product safety analyses.
  • Specific Aim 3. Develop recommendations and detailed specifications for incorporating laboratory results table data into Mini-Sentinel safety analyses.

Please contact the Sentinel Operations Center if you are interested in acquring a copy of this project's accompanying Access Database.

Workgroup Leader(s)

Marsha A. Raebel PharmD; Kaiser Permanente Colorado, Denver, CO

Workgroup Members

Susan Shetterly MS; Andrea R. Paolino MA; Kaiser Permanente Colorado, Denver, CO

Christine Y. Lu PhD, MSc; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Joshua J. Gagne PharmD, ScD; Elisabetta Patorno MD, DrPH; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

Kevin Haynes PharmD, MSCE; HealthCore, Wilmington, DE

James Flory MD, MS; Department of Medicine, Weill Cornell Medical College, New York, NY

David H. Smith PhD; Kaiser Permanente Northwest, Portland, OR

Mano Selvan PhD; Comprehensive Health Insights, Humana Inc., Louisville, KY

Lisa J. Herrinton PhD; Kaiser Permanente Northern California, Oakland, CA

Frank E. Harrell Jr. PhD; Department of Biostatistics, Vanderbilt University School of Medicine Nashville, TN

Azadeh Shoaibi PhD, MHS; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Jason Roy PhD; University of Pennsylvania Perelman School of Medicine, Philadelphia, PA

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