Evidence map›Paper›PMID 33751620›Full record

ArticleBiometrical journal. Biometrische Zeitschrift2021

Sample size and power considerations for cluster randomized trials with count outcomes subject to right truncation.

Fan Li, Guangyu Tong

Abstract read
In one paragraph

Article in Biometrical journal. Biometrische Zeitschrift, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

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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

2 authors.

Fan LiDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA.ORCID 0000-0001-6183-1893
Guangyu TongDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA.ORCID 0000-0002-7697-5029

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale University Clinical and Translational Science Award ProgramUL1TR000142 · NCATS · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2012 to 2015
$31.8M
NCATS NIH HHS UL1 TR000142NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

Cluster randomized trials (CRTs) are widely used in epidemiological and public health studies assessing population-level effect of group-based interventions. One important application of CRTs is the control of vector-borne disease, such as malaria. However, a particular challenge for designing these trials is that the primary outcome involves counts of episodes that are subject to right truncation. While sample size formulas have been developed for CRTs with clustered counts, they are not directly applicable when the counts are right truncated. To address this limitation, we discuss two marginal modeling approaches for the analysis of CRTs with truncated counts and develop two corresponding closed-form sample size formulas to facilitate the design of such trials. The proposed sample size formulas allow investigators to explore the power under a large number of scenarios without computationally intensive simulations. The proposed formulas are validated in extensive simulations. We further explore the implication of right truncation on power and apply the proposed formulas to illustrate the power calculation for a malaria control CRT where the primary outcome is subject to right truncation.

Indexed as

Research DesignCluster AnalysisRandomized Controlled Trials as TopicSample Sizearm-specific exchangeable correlationcoefficient of variationgeneralized estimating equationsgroup-randomized trialsPoisson distributionunequal cluster sizes

Identifiers

PMID33751620
PMCPMC9132617

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Registered trials

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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.