Evidence map›Paper›PMID 36647031›Full record

Trial reportBMC medical research methodology2023

Comparing g-computation, propensity score-based weighting, and targeted maximum likelihood estimation for analyzing externally controlled trials with both measured and unmeasured confounders: a simulation study.

Jinma Ren, Paul Cislo, Joseph C Cappelleri, Patrick Hlavacek, Marco DiBonaventura

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medical research methodology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

  1. Article
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  8. Outcomes after intranasal human milk therapy in preterm infants with intraventricular hemorrhage.Journal of perinatology : official journal of the California Perinatal Association · 2025
    Article
  9. Article
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  11. Evaluating Effects of Multilevel Interventions on Disparity in Health and Healthcare Decisions.Prevention science : the official journal of the Society for Prevention Research · 2024
    Article
  12. Article
  13. Implementing TMLE in the presence of a continuous outcome.Research methods in medicine & health sciences · 2024
    Article
  14. 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

5 authors.

Jinma RenStatistical Research & Data Science Center, Pfizer Inc, 500 Arcola Rd, Collegeville, PA, 19426, USA. jinma.ren@pfizer.com.
Paul CisloStatistical Research & Data Science Center, Pfizer Inc, New York, NY, USA.
Joseph C CappelleriStatistical Research & Data Science Center, Pfizer Inc, Groton, CT, USA.
Patrick HlavacekValue & Evidence, Pfizer Inc, New York, NY, USA.
Marco DiBonaventuraValue & Evidence, Pfizer Inc, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo have confidence in one's interpretation of treatment effects assessed by comparing trial results to external controls, minimizing bias is a critical step. We sought to investigate different methods for causal inference in simulated data sets with measured and unmeasured confounders.

methodsThe simulated data included three types of outcomes (continuous, binary, and time-to-event), treatment assignment, two measured baseline confounders, and one unmeasured confounding factor. Three scenarios were set to create different intensities of confounding effect (e.g., small and blocked confounding paths, medium and blocked confounding paths, and one large unblocked confounding path for scenario 1 to 3, respectively) caused by the unmeasured confounder. The methods of g-computation (GC), inverse probability of treatment weighting (IPTW), overlap weighting (OW), standardized mortality/morbidity ratio (SMR), and targeted maximum likelihood estimation (TMLE) were used to estimate average treatment effects and reduce potential biases.

resultsThe results with the greatest extent of biases were from the raw model that ignored all the potential confounders. In scenario 2, the unmeasured factor indirectly influenced the treatment assignment through a measured controlling factor and led to medium confounding. The methods of GC, IPTW, OW, SMR, and TMLE removed most of bias observed in average treatment effects for all three types of outcomes from the raw model. Similar results were found in scenario 1, but the results tended to be biased in scenario 3. GC had the best performance followed by OW.

conclusionsThe aforesaid methods can be used for causal inference in externally controlled studies when there is no large, unblockable confounding path for an unmeasured confounder. GC and OW are the preferable approaches.

Indexed as

Research DesignBiasComputer SimulationHumansLikelihood FunctionsPropensity ScoreExternal controlG-computationPropensity ScoreSimulationTargeted maximum likelihood estimationUnmeasured confounder

Identifiers

PMID36647031
PMCPMC9843888

What Socratic holds

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LicenceCC BY
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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 Socratic graph.