Simulation study of instrumental variable approaches with an application to a study of the antidiabetic effect of bezafibrate

Pharmacoepidemiology and Drug Safety
Bing CaiDylan S Small

Abstract

We studied the application of the generalized structural mean model (GSMM) of instrumental variable (IV) methods in estimating treatment odds ratios (ORs) for binary outcomes in pharmacoepidemiologic studies and evaluated the bias of GSMM compared to other IV methods. Because of the bias of standard IV methods, including two-stage predictor substitution (2SPS) and two-stage residual inclusion (2SRI) with binary outcomes, we implemented another IV approach based on the GSMM of Vansteelandt and Goetghebeur. We performed simulations under the principal stratification setting and evaluated whether GSMM provides approximately unbiased estimates of the causal OR and compared its bias and mean squared error to that of 2SPS and 2SRI. We then applied different IV methods to a study comparing bezafibrate versus other fibrates on the risk of diabetes. Our simulations showed that unlike the standard logistic, 2SPS, and 2SRI procedures, our implementation of GSMM provides an approximately unbiased estimate of the causal OR even under unmeasured confounding. However, for the effect of bezafibrate versus other fibrates on the risk of diabetes, the GSMM and two-stage approaches yielded similarly attenuated and statistically non-significant OR ...Continue Reading

References

May 6, 2005·European Heart Journal·Alexander TenenbaumSolomon Behar
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Oct 22, 2010·Statistics in Medicine·Lang'o Odondi, Roseanne McNamee
Apr 16, 2011·Statistics in Medicine·Bing CaiThomas R Ten Have

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Citations

May 11, 2012·Pharmacoepidemiology and Drug Safety·Sebastian SchneeweissScott R Smith
Nov 14, 2015·Clinical Pharmacology and Therapeutics·C E LeonardS Hennessy

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