Evidence map›Paper›PMID 36416302›Full record

ArticleBiometrics2023

Assessing exposure-time treatment effect heterogeneity in stepped-wedge cluster randomized trials.

Lara Maleyeff, Fan Li, Sebastien Haneuse, Rui Wang

Abstract read
In one paragraph

Article in Biometrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing 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

25 citing papers in PubMed.

  1. Trial
  2. Article
  3. Using the NIH Research Methods Resources Website.Prevention science : the official journal of the Society for Prevention Research · 2026
    Article
  4. Article
  5. Article
  6. Model-robust standardization in stepped wedge cluster randomized trials.Journal of the Royal Statistical Society. Series A, (Statistics in Society) · 2026
    Article
  7. Article
  8. Article
  9. Article
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  11. Article
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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.

Lara MaleyeffDepartment of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.ORCID 0000-0002-4237-142X
Fan LiDepartment of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USA.ORCID 0000-0001-6183-1893
Sebastien HaneuseDepartment of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.ORCID 0000-0003-4963-0655
Rui WangDepartment of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.ORCID 0000-0001-5007-193X

Funding

BIOSTATISTICS/EPIDEMIOLOGY TRAINING GRANTS IN AIDST32AI007358 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI Michael David Hughes · 1989 to 2026
$12.4M
Network modeling and robust estimation of the intraclass correlation coefficient to inform the design and analysis of cluster randomized trials for infectious diseasesR01AI136947 · NIAID · HARVARD PILGRIM HEALTH CARE, INC. · PI WANG, RUI · 2018 to 2020
$759k
NIAID NIH HHS R01 AI136947NIAID NIH HHS T32 AI007358
6 · The paper itself

Abstract

A stepped-wedge cluster randomized trial (CRT) is a unidirectional crossover study in which timings of treatment initiation for clusters are randomized. Because the timing of treatment initiation is different for each cluster, an emerging question is whether the treatment effect depends on the exposure time, namely, the time duration since the initiation of treatment. Existing approaches for assessing exposure-time treatment effect heterogeneity either assume a parametric functional form of exposure time or model the exposure time as a categorical variable, in which case the number of parameters increases with the number of exposure-time periods, leading to a potential loss in efficiency. In this article, we propose a new model formulation for assessing treatment effect heterogeneity over exposure time. Rather than a categorical term for each level of exposure time, the proposed model includes a random effect to represent varying treatment effects by exposure time. This allows for pooling information across exposure-time periods and may result in more precise average and exposure-time-specific treatment effect estimates. In addition, we develop an accompanying permutation test for the variance component of the heterogeneous treatment effect parameters. We conduct simulation studies to compare the proposed model and permutation test to alternative methods to elucidate their finite-sample operating characteristics, and to generate practical guidance on model choices for assessing exposure-time treatment effect heterogeneity in stepped-wedge CRTs.

Indexed as

Research DesignCluster AnalysisCross-Over StudiesRandomized Controlled Trials as TopicSample Sizecluster randomized trialsexposure timegeneralized linear mixed modelsheterogeneous treatment effectsstepped-wedge designs

Identifiers

PMID36416302
PMCPMC10203056

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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.