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An R-Based Landscape Validation of a Competing Risk Model
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Landmarking for Left-Truncated Competing Risk Data.

Theresa Unseld1, Tobias Bluhmki2, Jan Beyersmann2

  • 1Institute of Medical Biometry and Epidemiology, Ulm University, Helmholtzstraße 22, Ulm, Germany.

Biometrical Journal. Biometrische Zeitschrift
|October 29, 2024
PubMed
Summary
This summary is machine-generated.

Landmarking offers dynamic predictions for drug safety in pregnancy, comparing risks of adverse outcomes like spontaneous abortions (SABs) with fluoroquinolone exposure. While landmarking showed some effect attenuation, results align with previous findings.

Keywords:
competing riskslandmarkingleft truncationpregnancy datatime‐dependent covariates

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Area of Science:

  • Epidemiology
  • Biostatistics
  • Pharmacovigilance

Background:

  • Assessing drug safety during pregnancy requires accurate dynamic predictions for adverse outcomes.
  • Complex multistate models can be challenging for real-time risk assessment.

Purpose of the Study:

  • To develop and evaluate the landmarking method for analyzing left-truncated data with competing risks in pregnancy drug safety.
  • To compare landmarking predictions with traditional methods using simulations and real-world data.

Main Methods:

  • Application of the landmarking technique to a cohort study from the German Embryotox Pharmacovigilance Institute.
  • Simulation studies comparing landmarking, nonparametric multistate models, and Cox regression.
  • Analysis of cumulative incidence for spontaneous abortions (SABs) and elective termination of pregnancy.

Main Results:

  • Landmarking estimates showed some attenuation but remained close to multistate model estimates.
  • Fluoroquinolone exposure in early pregnancy may increase cumulative incidence of elective pregnancy termination.
  • No significant increase in spontaneous abortion (SAB) risk or cumulative incidence was observed in fluoroquinolone-exposed women.

Conclusions:

  • Landmarking is a viable alternative for dynamic predictions in complex scenarios like pregnancy drug safety.
  • Findings support previous analyses, indicating no increased SAB risk with first-trimester fluoroquinolone exposure.
  • A potential link between fluoroquinolone exposure and elective pregnancy termination warrants further investigation.