This report demonstrates the feasibility of implementing two Group Sequential (GS) approaches for monitoring adverse events in an automated fashion in the Mini-Sentinel Distributed Database (MSDD). The project explores the GS Generalized Estimating Equation regression approach (GS GEE) and the GS Inverse Probability Treatment Weighting regression (GS IPTW) approach, and produces automated code for extracting data and for statistical analyses. It also compares the performance of these methods in the Mini-Sentinel setting by evaluating the frequency of febrile seizure events in 11-23 month old children who received the Measles, Mumps, Rubella and Varicella (MMRV) combined vaccination (exposed group) and the frequency in those who received the Measles, Mumps and Rubella (MMR) vaccination and Varicella vaccination separately (comparator group).
Andrea Cook, PhD; Group Health Research Institute, Seattle, WA
Robert D. Wellman, MS; Denise Boudreau, PhD; Tracey L Marsh, MS; Jennifer C. Nelson, PhD; Group Health Research Institute, Seattle, WA
Azadeh Shoaibi, MS, MHS; Ram C. Tiwari, PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Sunali Goonesekera, SM; Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA