Evidence map›Paper›PMID 40011934›Full record

ArticleTrials2025

Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials.

Karla Hemming, Jacqueline Y Thompson, Richard L Hooper, Obioha C Ukoumunne, Fan Li, Agnes Caille, Brennan C Kahan, Clemence Leyrat, Michael J Grayling, Nuredin I Mohammed and 9 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. 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

19 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.
Richard L HooperWolfson Institute of Population Health, Mary University of London, London, Queen, UK.
Obioha C UkoumunneNIHR Applied Research Collaboration South West Peninsula, University of Exeter, Exeter, UK.
Fan LiDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
Agnes CailleUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France.
Brennan C KahanMRC Clinical Trials Unit at UCL, London, UK.
Clemence LeyratDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Michael J GraylingJanssen R and D, High Wycombe, London, UK.
Nuredin I MohammedMRC Unit The Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Jennifer A ThompsonDepartment of Infectious Diseases and International Health, London, School of Hygiene and Tropical Medicine , London, UK.
Bruno GiraudeauUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France.
Elizabeth L TurnerDepartment of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham, NC, 27705, USA.
Samuel I WatsonInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Beatriz GoulãoHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Jessica KaszaSchool of Public Health and Preventive Medicine, Monash University, Victoria, Melbourne, Australia.
Andrew B ForbesSchool of Public Health and Preventive Medicine, Monash University, Victoria, Melbourne, Australia.
Andrew J CopasMRC Clinical Trials Unit, University College London, London, UK.
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON, Canada.

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
National Institute for Health Research Applied Research Collaboration West NIHR200165NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundGuidance exists to inform the content of statistical analysis plans in clinical trials. Though not explicitly stated, this guidance is generally focused on clinical trials in which the randomization units are individual patients and not groups of patients. There are critical considerations for the analysis of cluster randomized trials, such as accounting for clustering, the risk of imbalances between the arms due to post-randomization recruitment, and the need to use small sample corrections when the number of clusters is small.

methodsThis paper outlines the protocol for the development of a set of reporting guidelines for the content of statistical analysis plans for cluster randomized trials (including variations such as the stepped wedge cluster randomized trial and other cluster cross-over designs) by extending the minimum reporting analysis requirements as previously defined for individually randomized trials to cluster randomized trials. The guideline will be developed using a consensus-based approach, modifying existing reporting items from the guideline for individually randomized trials and extending to include new items. DISCUSSION: The guideline will be developed so it can be used independently of the guideline for individually randomized designs. The consensus guidelines will be published in an open-access journal, including key guidance as well as exploration and elaboration.

Indexed as

Randomized Controlled Trials as TopicResearch DesignCluster AnalysisConsensusData Interpretation, StatisticalGuidelines as TopicHumansAnalysis plansCluster randomized trialsGroup randomizationGuidelinesStatistical analysis plans

Identifiers

PMID40011934
PMCPMC11866560

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.