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Immortal time bias from selection: a principal stratification perspective.

Bronner P Gonçalves1, Etsuji Suzuki2

  • 1Faculty of Health and Medical Sciences, University of Surrey, Guildford GU2 7YH, United Kingdom.

American Journal of Epidemiology
|July 15, 2025
PubMed
Summary

Eligibility-related immortal time bias, often overlooked, can skew study results. This research uses principal stratification to explain selection bias and offers a potential outcomes framework for more accurate causal inference in research.

Keywords:
causal inferenceimmortal time biaspotential outcomesprincipal stratification

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Area of Science:

  • Epidemiology
  • Biostatistics
  • Causal Inference

Background:

  • Immortal time bias, particularly due to post-treatment eligibility criteria, is a significant methodological challenge in both experimental and observational studies.
  • While classical immortal time bias is well-documented, eligibility-related immortal time bias receives less attention in methodological literature.

Purpose of the Study:

  • To propose a novel explanation for eligibility-related immortal time bias using the principal stratification framework.
  • To demonstrate how this framework addresses the non-comparability of treatment arms introduced by selection criteria.
  • To offer a potential outcomes-based interpretation of this bias and suggest alternative causal estimands.

Main Methods:

  • Application of the principal stratification framework to model selection based on eligibility criteria defined after treatment initiation.
  • Interpretation of statistical estimands that condition on observed eligibility using partially overlapping principal strata.
  • Analysis of the relationship between the timing of eligibility assessment and unconditional expected potential outcomes.

Main Results:

  • The principal stratification framework elucidates the non-comparability between treatment groups arising from eligibility criteria.
  • Statistical models conditioning on post-treatment eligibility can be understood through the lens of principal strata.
  • As eligibility assessment time approaches the start of follow-up, outcomes for eligible individuals converge towards unconditional potential outcomes.

Conclusions:

  • This study provides a potential outcomes-based explanation for eligibility-related immortal time bias.
  • Principal effects are suggested as valuable causal estimands, complementing target trial emulation for certain research designs.
  • The findings advocate for careful consideration of eligibility criteria timing to mitigate bias in causal inference.