Evidence map›Paper›PMID 39592935›Full record

ArticleBMC medical research methodology2024

Non-collapsibility and built-in selection bias of period-specific and conventional hazard ratio in randomized controlled trials.

Helen Bian, Menglan Pang, Guanbo Wang, Zihang Lu

Abstract read
In one paragraph

Article in BMC medical research methodology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. 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

4 authors.

Helen BianDepartment of Epidemiology, Biostatistics and Occupational Health, McGill University, 2001, McGill College , Suite 1200, Montreal, QC, H3A 1G1, Canada. he.bian@mail.mcgill.ca.
Menglan Pang, Biogen, Cambridge, USA.
Guanbo WangCAUSALab, Harvard T.H. Chan School of Public Health, Cambridge, USA.
Zihang LuDepartment of Public Health Sciences & Department of Mathematics and Statistics, Queen's University, Kingston, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe hazard ratio of the Cox proportional hazards model is widely used in randomized controlled trials to assess treatment effects. However, two properties of the hazard ratio including the non-collapsibility and built-in selection bias need to be further investigated.

methodsWe conduct simulations to differentiate the non-collapsibility effect and built-in selection bias from the difference between the marginal and the conditional hazard ratio. Meanwhile, we explore the performance of the Cox model with inverse probability of treatment weighting for covariate adjustment when estimating the marginal hazard ratio. The built-in selection bias is further assessed in the period-specific hazard ratio.

resultsThe conditional hazard ratio is a biased estimate of the marginal effect due to the non-collapsibility property. In contrast, the hazard ratio estimated from the inverse probability of treatment weighting Cox model provides an unbiased estimate of the true marginal hazard ratio. The built-in selection bias only manifests in the period-specific hazard ratios even when the proportional hazards assumption is satisfied. The Cox model with inverse probability of treatment weighting can be used to account for confounding bias and provide an unbiased effect under the randomized controlled trials setting when the parameter of interest is the marginal effect.

conclusionsWe propose that the period-specific hazard ratios should always be avoided due to the profound effects of built-in selection bias.

Indexed as

Proportional Hazards ModelsRandomized Controlled Trials as TopicComputer SimulationHumansSelection BiasBuilt-in selection biasCox proportional hazards modelInverse probability of treatment weightingNon-collapsibilityRandomized controlled trials

Identifiers

PMID39592935
PMCPMC11590464

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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.