Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia.
Sentinel is a program sponsored by the US Food and Drug Administration to monitor the safety of medical products. We conducted a cohort assessment to evaluate the ability of the Sentinel Propensity Score Matching Tool to reproduce in an expedited fashion the known association between glyburide (vs....
| Published in: | Epidemiology Vol. 28; no. 6; pp. 838 - 847 |
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| Main Authors: | , , , , , , , , , , , , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Lippincott Williams & Wilkins
Nov2017
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=125535692&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 125535692 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10443983 N07 jtl: Epidemiology issn: 10443983 maglogo: N pubinfo: dt: Nov2017 vid: 28 iid: 6 pid: 433 pub: Lippincott Williams & Wilkins place: Baltimore, Maryland artinfo: ui: 125535692 125535692 NLM28682851 125535692 10.1097/EDE.0000000000000709 NLM28682851 125535692 ppf: 838 ppct: 9 formats: tig: atl: Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia. aug: au: Meijia Zhou Wang, Shirley V. Leonard, Charles E. Gagne, Joshua J. Fuller, Candace Hampp, Christian Archdeacon, Patrick Toh, Sengwee Iyer, Aarthi Woodworth, Tiffany Siu Cavagnaro, Elizabeth Panozzo, Catherine A. Axtman, Sophia Carnahan, Ryan M. Chrischilles, Elizabeth A. Hennessy, Sean Zhou, Meijia affil: Center for Pharmacoepidemiology Research and Training, Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA sug: subj: Glipizide Adverse Effects Hypoglycemic Agents Adverse Effects Glyburide Adverse Effects Sentinel Event Diabetes Mellitus, Type 2 Drug Therapy Hypoglycemia Chemically Induced Hypoglycemia Epidemiology Emergency Service Utilization Incidence Male Prospective Studies Adult Female Middle Age Cox Proportional Hazards Model Probability United States Hospitalization Statistics and Numerical Data Severity of Illness Indices Aged Funding Source Human Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Male Female ab: Sentinel is a program sponsored by the US Food and Drug Administration to monitor the safety of medical products. We conducted a cohort assessment to evaluate the ability of the Sentinel Propensity Score Matching Tool to reproduce in an expedited fashion the known association between glyburide (vs. glipizide) and serious hypoglycemia. Thirteen data partners who contribute to the Sentinel Distributed Database participated in this analysis. A pretested and customizable analytic program was run at each individual site. De-identified summary results from each data partner were returned and aggregated at the Sentinel Operations Center. We identified a total of 198,550 and 379,507 new users of glyburide and glipizide, respectively. The incidence of emergency department visits and hospital admissions for serious hypoglycemia was 19 per 1000 person-years (95% confidence interval = 17.9, 19.7) for glyburide users and 22 (21.6, 22.7) for glipizide users. In cohorts matched by propensity score based on predefined variables, the hazard ratio (HR) for glyburide was 1.36 (1.24, 1.49) versus glipizide. In cohorts matched on a high-dimensional propensity score based on empirically selected variables, for which the program ran to completion in five data partners, the HR was 1.49 (1.31, 1.70). In cohorts matched on propensity scores based on both predefined and empirically selected variables via the high-dimensional propensity score algorithm (the same five data partners), the HR was 1.51 (1.32, 1.71). These findings are consistent with the literature, and demonstrate the ability of the Sentinel Propensity Score Matching Tool to reproduce this known association in an expedited fashion.See video abstract at, http://links.lww.com/EDE/B275. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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