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Immortal Time Bias in the Study of Stillbirth Risk Factors: The Example of Gestational Diabetes

Hutcheon, Jennifer A.; Kuret, Verena; Joseph, K. S.; Sabr, Yasser; Lim, Kenneth

doi: 10.1097/EDE.0b013e3182a6d9aa
Perinatal

Background: Current understanding of the increased risk for stillbirth in gestational diabetes mellitus is often based on large cohort studies in which the risk of stillbirth in women with this disease is compared with the risk in women without. However, such studies could be susceptible to immortal time bias because, although many cohorts begin at 20 weeks’ gestation, pregnancies must “survive” until 24–28 weeks in order to be screened and diagnosed with gestational diabetes.

Methods: We describe the theoretical potential for immortal time bias in studies of stillbirth and gestational diabetes and then quantify the magnitude of the bias using 2006 United States vital statistics data.

Results: Although gestational diabetes was protective against stillbirth when including all births (relative risk = 0.88 [95% confidence interval = 0.79–0.99]), restricting analyses to births at >28 weeks’ gestation reversed the effect and diabetes became associated with an increased risk of stillbirth (1.25 [1.11–1.41]).

Conclusion: Immortal time before diagnosis of gestational diabetes may bias our understanding of the stillbirth risk associated with this condition.

From the aUniversity of British Columbia, Department of Obstetrics & Gynaecology, Vancouver, Canada; and bUniversity of British Columbia, School of Population and Public Health, Vancouver, Canada.

J.A.H. is supported by a New Investigator Award from the Canadian Institutes of Health Research and a Scholar Award from the Michael Smith Foundation for Health Research. K.S.J. is supported by a salary award from the Child & Family Research Institute, Vancouver, Canada.

Correspondence: Jennifer A. Hutcheon, SHY E421A, BC Children’s & Women’s Hospital, 4500 Oak Street, Vancouver, Canada, V6H 3N1. E-mail: jhutcheon@cfri.ca.

Received January 7, 2013

Accepted April 27, 2013

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