Evidence map›Paper›PMID 39695707›Full record

ArticleTrials2024

Re-analysis of data from cluster randomised trials to explore the impact of model choice on estimates of odds ratios: study protocol.

Karla Hemming, Jacqueline Y Thompson, Monica Taljaard, Samuel I Watson, Jessica Kasza, Jennifer A Thompson, Brennan C Kahan, Andrew J Copas

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. 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

8 authors.

Karla HemmingInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Jacqueline Y ThompsonInstitute of Applied Health Research, University of Birmingham, Birmingham, UK. J.Y.Thompson@bham.ac.uk.
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Samuel I WatsonInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Jessica KaszaSchool of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Jennifer A ThompsonDepartment of Infectious Disease, London School of Hygiene & Tropical Medicine, London, UK.
Brennan C Kahan *MRC Clinical Trials Unit at UCL, University College London, London, UK.
Andrew J Copas *MRC Clinical Trials Unit at UCL, University College London, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are numerous approaches available to analyse data from cluster randomised trials. These include cluster-level summary methods and individual-level methods accounting for clustering, such as generalised estimating equations and generalised linear mixed models. There has been much methodological work showing that estimates of treatment effects can vary depending on the choice of approach, particularly when estimating odds ratios, essentially because the different approaches target different estimands.

methodsIn this manuscript, we describe the protocol for a planned re-analysis of data from a large number of cluster randomised trials. Our main objective is to examine empirically whether and how odds ratios estimated using different approaches (for both primary and secondary binary outcomes) vary in cluster randomised trials. We describe the methods that will be used to identify the datasets for inclusion and how they will be analysed and reported. DISCUSSION: There have been a number of small comparisons of empirical differences between the different approaches to analysis for CRTs. The systematic approach outlined in this protocol will allow a much deeper understanding of when there are important choices around the model approach and in which settings. This will be of importance given the heightened awareness of the importance of estimands and the specification of statistical analysis plans.

Indexed as

Randomized Controlled Trials as TopicCluster AnalysisData Interpretation, StatisticalHumansModels, StatisticalOdds RatioResearch Design

Identifiers

PMID39695707
PMCPMC11653799

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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.