Evidence map›Paper›PMID 38679930›Full record

ArticleClinical trials (London, England)2024

Causal interpretation of the hazard ratio in randomized clinical trials.

Michael P Fay, Fan Li

Abstract read
In one paragraph

Article in Clinical trials (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Estimating clinical trial hazard functions.Clinical trials (London, England) · 2026
    Article
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  5. Principal stratification with U-statistics under principal ignorability.Journal of the Royal Statistical Society. Series B, Statistical methodology · 2026
    Article
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  11. Correcting for bias due to mismeasured exposure in mediation analysis with a survival outcome.Journal of the Royal Statistical Society. Series C, Applied statistics · 2025
    Article
  12. Article
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  15. Article
  16. Article
  17. Reply to Heitjan's commentary.Clinical trials (London, England) · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Michael P FayBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.ORCID 0000-0002-8643-9625
Fan LiDepartment of Biostatistics and Center for Methods in Implementation and Prevention Science, Yale School of Public Health, New Haven, CT, USA.ORCID 0000-0001-6183-1893

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Advancing the design, analysis, and interpretation of acute respiratory distress syndrome trials using modern statistical toolsR01HL168202 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI Michael Oscar Harhay, Fan Li · 2023 to 2026
$2.9M
NCATS NIH HHS UL1 TR001863NHLBI NIH HHS R01 HL168202
6 · The paper itself

Abstract

backgroundAlthough the hazard ratio has no straightforward causal interpretation, clinical trialists commonly use it as a measure of treatment effect.

methodsWe review the definition and examples of causal estimands. We discuss the causal interpretation of the hazard ratio from a two-arm randomized clinical trial, and the implications of proportional hazards assumptions in the context of potential outcomes. We illustrate the application of these concepts in a synthetic model and in a model of the time-varying effects of COVID-19 vaccination.

resultsWe define causal estimands as having either an

conclusionWe conclude that the population-level hazard ratio remains a useful estimand, but one must interpret it with appropriate attention to the underlying causal model. This is especially important for interpreting hazard ratios over time.

Indexed as

COVID-19Proportional Hazards ModelsRandomized Controlled Trials as TopicCausalityCOVID-19 VaccinesData Interpretation, StatisticalHumansModels, StatisticalResearch DesignSARS-CoV-2COVID-19 VaccinesCausal inferenceclinical trialestimandhazard ratioproportional hazards modelsurvival analysis

Identifiers

PMID38679930
PMCPMC11502288

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.