Evidence map›Paper›PMID 38582924›Full record

ArticleTrials2024

Statistical analyses of ordinal outcomes in randomised controlled trials: a scoping review.

Chris J Selman, Katherine J Lee, Kristin N Ferguson, Clare L Whitehead, Brett J Manley, Robert K Mahar

Abstract readScoping Review
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 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Optimizing endpoints in early phase clinical trials of acute respiratory distress syndrome.American journal of respiratory and critical care medicine · 2026
    Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Making Sense of Hierarchical Composite End Points in Randomized Clinical Trials-A Primer for Infectious Diseases Clinicians and Researchers.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  12. Article
  13. Article
  14. Beyond Binary: The Potential of Ordinal Outcomes in Critical Care Trials.American journal of respiratory and critical care medicine · 2025
    Article
  15. Article
  16. Article
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

6 authors.

Chris J SelmanClinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, VIC, 3052, Australia. chris.selman@unimelb.edu.au.ORCID http://orcid.org/0000-0002-1277-5538
Katherine J LeeClinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, VIC, 3052, Australia.
Kristin N FergusonDepartment of Obstetrics and Gynaecology, University of Melbourne, Parkville, VIC, 3052, Australia.
Clare L WhiteheadDepartment of Obstetrics and Gynaecology, University of Melbourne, Parkville, VIC, 3052, Australia.
Brett J ManleyDepartment of Obstetrics and Gynaecology, University of Melbourne, Parkville, VIC, 3052, Australia.
Robert K MaharClinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, VIC, 3052, Australia.

Funding

National Health and Medical Research Council 1159225National Health and Medical Research Council ID 1035261National Health and Medical Research Council ID 1127984National Health and Medical Research Council ID 1171422
6 · The paper itself

Abstract

backgroundRandomised controlled trials (RCTs) aim to estimate the causal effect of one or more interventions relative to a control. One type of outcome that can be of interest in an RCT is an ordinal outcome, which is useful to answer clinical questions regarding complex and evolving patient states. The target parameter of interest for an ordinal outcome depends on the research question and the assumptions the analyst is willing to make. This review aimed to provide an overview of how ordinal outcomes have been used and analysed in RCTs.

methodsThe review included RCTs with an ordinal primary or secondary outcome published between 2017 and 2022 in four highly ranked medical journals (the British Medical Journal, New England Journal of Medicine, The Lancet, and the Journal of the American Medical Association) identified through PubMed. Details regarding the study setting, design, the target parameter, and statistical methods used to analyse the ordinal outcome were extracted.

resultsThe search identified 309 studies, of which 144 were eligible for inclusion. The most used target parameter was an odds ratio, reported in 78 (54%) studies. The ordinal outcome was dichotomised for analysis in 47 (

conclusionsThe results of this review indicate that in RCTs that use an ordinal outcome, there is variation in the target parameter and the analytical approaches used, with many dichotomising the ordinal outcome. Few studies provided assurance regarding the appropriateness of the assumptions and methods used to analyse the ordinal outcome. More guidance is needed to improve the transparent reporting of the analysis of ordinal outcomes in future trials.

Indexed as

Randomized Controlled Trials as TopicResearch DesignData Interpretation, StatisticalEndpoint DeterminationHumansModels, StatisticalTreatment OutcomeOrdinal outcomesProportional odds modelRandomised controlled trialsScoping review

Identifiers

PMID38582924
PMCPMC10998402

What OpenQuestion holds

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LicenceCC BY
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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.