Evidence map›Paper›PMID 42487285›Full record

ArticleStatistics in medicine2026

A Cautionary Note for Plasmode Simulation Studies in the Setting of Causal Inference.

Pamela A Shaw, Susan Gruber, Brian D Williamson, Rishi Desai, Susan M Shortreed, Chloe Krakauer, Jennifer C Nelson, Mark J van der Laan

Abstract read
In one paragraph

Article in Statistics in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

8 authors.

Pamela A ShawBiostatistics Division, Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.ORCID https://orcid.org/0000-0003-1883-8410
Susan GruberTL Revolution, LLC, Cambridge, Massachusetts, USA.
Brian D WilliamsonBiostatistics Division, Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-7024-548X
Rishi DesaiDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Susan M ShortreedBiostatistics Division, Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.ORCID https://orcid.org/0000-0001-7918-601X
Chloe KrakauerBiostatistics Division, Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
Jennifer C NelsonBiostatistics Division, Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
Mark J van der LaanDepartment of Biostatistics, School of Public Health, University of California at Berkeley, Berkeley, California, USA.

Funding

Statistical methods and designs for correlated outcome and covariate errors in studies of HIV/AIDSR37AI131771 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Pamela A Shaw, Bryan Earl Shepherd · 2023 to 2026
$3.4M
Statistical methods for correlated outcome and covariate errors in studies of HIV/AIDSR01AI131771 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI SHAW, PAMELA A, SHEPHERD, BRYAN EARL · 2018 to 2022
$3.0M
National Institute of Allergy and Infectious Diseases R37-AI131771NIAID NIH HHS R01 AI131771NIAID NIH HHS R37 AI131771U.S. Food and Drug Administration 75F40119D10037
6 · The paper itself

Abstract

Plasmode simulation has become an important tool for evaluating operating characteristics of different statistical methods in complex settings, such as pharmacoepidemiological studies of treatment effectiveness using electronic health records (EHR) data. These studies provide insight into how estimator performance is impacted by challenges including rare events, small sample size and so forth that can indicate which among a set of methods performs best in a real-world dataset. Plasmode simulation combines data resampled from a real-world dataset with data from a probabilistic model to generate a known truth for an estimand in realistic data. There are different potential plasmode strategies currently in use. We compare two popular plasmode simulation frameworks for the evaluation of methods estimating a point treatment estimand. We provide numerical evidence and a theoretical result that shows one of these frameworks can cause certain estimators to incorrectly appear overly biased. Detailed simulation studies using both model-generated and real-world EHR data demonstrate these pitfalls remain at large sample sizes and when analyzing data from a randomized controlled trial. We conclude with guidance for the choice of a plasmode framework that maintains good theoretical properties to allow a fair evaluation of statistical methods while also maintaining the desired similarity to real data.

Indexed as

CausalityModels, StatisticalPharmacoepidemiologyBiasComputer SimulationData Interpretation, StatisticalElectronic Health RecordsHumansRandomized Controlled Trials as TopicSample Sizedata‐generating processoutcome‐generating modelparametric simulationsresamplingsimulation studiesstatistical plasmodes

Identifiers

PMID42487285
PMCPMC13392349

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.