2019
DOI: 10.1002/pds.4710
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Multistate methodology improves risk assessment under time‐varying drug intake—a new view on pregnancy outcomes following coumarin exposure

Abstract: Purpose Observational cohort studies are essential to evaluate the risk of adverse pregnancy outcomes associated with drug intake. Besides left truncation and competing events, it is crucial to account for the time‐dynamic pattern of drug exposure. In fact, potentially harmful medications are often discontinued, which might affect the outcome. Ignoring these challenges may lead to biased estimation of drug‐related risks highlighting the need for adequate statistical techniques. Methods We reanalyze updated dat… Show more

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Cited by 9 publications
(7 citation statements)
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References 41 publications
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“…The lacosamide study cohort comprised 54 prospectively ascertained pregnancies, resulting in three SABs (5.56%), eight IAs (14.81%), and 43 livebirths (79.63%). These crude event proportions are no valid probability estimates, as they neglect the left truncation 2 . Compared with Hoeltzenbein et al, 1 we excluded one stillbirth for technical purposes.…”
Section: Resultsmentioning
confidence: 99%
See 3 more Smart Citations
“…The lacosamide study cohort comprised 54 prospectively ascertained pregnancies, resulting in three SABs (5.56%), eight IAs (14.81%), and 43 livebirths (79.63%). These crude event proportions are no valid probability estimates, as they neglect the left truncation 2 . Compared with Hoeltzenbein et al, 1 we excluded one stillbirth for technical purposes.…”
Section: Resultsmentioning
confidence: 99%
“…These crude event proportions are no valid probability estimates, as they neglect the left truncation. 2 Compared with Hoeltzenbein et al, 1 we excluded one stillbirth for technical purposes. Furthermore, we considered a twin pregnancy resulting in two livebirths as one event.…”
Section: Resultsmentioning
confidence: 99%
See 2 more Smart Citations
“…We have described some of the more common approaches to addressing longitudinal exposure in medications-in-pregnancy studies, but other methods have been used as well. For instance, Bluhmki et al ( 79 ) incorporated time-varying medication exposure during pregnancy and miscarriage as separate states in a multistate model to deal with the problem of left truncation and competing risks from other pregnancy outcomes. As this field continues to develop, it is critical that researchers evaluate methodologic novelty in terms of the potential gains but also the risks of bias.…”
Section: Implications and Clinical Translationmentioning
confidence: 99%