Evidence map›Paper›PMID 42558039›Full record

ArticleStatistics in medicine2026

Fixed or Random Effects: Analysis of Clustered Data.

Kevin He, Xiangeng Fang, Yubo Shao, Nicholas Hartman, John D Kalbfleisch

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. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Kevin HeDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0002-8354-426X
Xiangeng FangDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0009-0005-8521-7958
Yubo ShaoDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0009-0009-2646-9193
Nicholas HartmanDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0002-8475-1973
John D KalbfleischDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0001-9198-9667

Funding

Improve Statistical Methods for Profiling of Healthcare ProvidersR01DK129539 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Zhi Kevin He · 2022 to 2026
$1.6M
HRSA HHS HHSH250-2019-00001CNIDDK NIH HHS DK129539NIDDK NIH HHS R01 DK129539
6 · The paper itself

Abstract

In analyzing clustered data, random effects (RE) and fixed effects (FE) models are two primary approaches. The RE model assumes that the cluster-specific effects are random and uncorrelated with individual characteristics. If this assumption is violated, the RE approach can lead to biased estimates of the coefficients of individual covariates and cluster effects. In contrast, the FE approach, which models cluster effects as fixed effects, yields unbiased estimates even if the cluster effects are correlated with individual covariates. Numerous studies have compared the FE and RE approaches. However, the practical importance of the biases observed in RE-based methods remains unclear. Some studies have demonstrated significant biases in RE models when the assumption of no correlation is violated, whereas others have found these biases to be negligible. These differences may be due to variations in study design, with some evaluations focusing on settings that may not reflect realistic data scenarios. In this paper, we compare FE and RE models through theoretical evaluation, simulation studies, and real-data applications. Specifically, we derive an approximate formula to quantify the asymptotic bias in the RE model and verify its accuracy through simulations. These results help to explain the different conclusions reached in the existing literature. Our goal is not to propose a new estimator or a fundamentally new inferential framework, but to provide an analytical clarification and practical quantification of the bias incurred by the standard RE estimator under a specific, interpretable dependence model, and to clarify how this bias relates to fixed-effects and correlated random-effects/between-within specifications.

Indexed as

Models, StatisticalBiasCluster AnalysisComputer SimulationData Interpretation, StatisticalHumansbetween and within modelsbiased estimationprovider profilingsimulation

Identifiers

PMID42558039
PMCPMC13445157

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.