Evidence map›Paper›PMID 34657596›Full record

SynthesisBMC medical research methodology2021

Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials.

Lisa J Woodhouse, Alan A Montgomery, Jonathan Mant, Barry R Davis, Ale Algra, Jean-Louis Mas, Jan A Staessen, Lutgarde Thijs, Andrew Tonkin, Adrienne Kirby and 9 more

Abstract readSystematic Review
In one paragraph

Synthesis in BMC medical research methodology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. 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

19 authors.

Lisa J WoodhouseStroke, Mental Health & Clinical Neurosciences, University of Nottingham, Nottingham, UK.
Alan A MontgomeryNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Jonathan MantDepartment of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
Barry R DavisThe University of Texas Health Science Center at Houston, Houston, USA.
Ale AlgraUniversity Medical Center Utrecht, Utrecht, Netherlands.
Jean-Louis MasHopital Sainte-Anne, Université Paris-Descartes, Paris, France.
Jan A StaessenDepartment of Cardiovascular Sciences, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
Lutgarde ThijsDepartment of Cardiovascular Sciences, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
Andrew TonkinChronic Disease & Aging Unit, Monash University, Clayton, Australia.
Adrienne KirbyNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Stuart J PocockLondon School of Hygiene & Tropical Medicine, London, UK.
John ChalmersGeorge Institute for Global Health, Sydney, Australia.
Graeme J HankeyDepartment of Neurology, University of Western Australia, Crawley, Australia.
J David SpenceRobarts Research Institute, London, Canada.
Peter SandercockCentre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
Hans-Christoph DienerDepartment of Neurology, University of Duisburg-Essen, Duisburg, Germany.
Shinichiro UchiyamaInternational University of Health and Welfare, Otawara, Tochigi, Japan.
Nikola SpriggStroke, Mental Health & Clinical Neurosciences, University of Nottingham, Nottingham, UK.
Philip M BathStroke, Mental Health & Clinical Neurosciences, University of Nottingham, Nottingham, UK. philip.bath@nottingham.ac.uk.

Funding

Medical Research Council G0501797Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

backgroundVascular prevention trials typically use dichotomous event outcomes although this may be inefficient statistically and gives no indication of event severity. We assessed whether ordinal outcomes would be more efficient and how to best analyse them.

methodsChief investigators of vascular prevention randomised controlled trials that showed evidence of either benefit or harm, or were included in a systematic review that overall showed benefit or harm, shared individual participant data from their trials. Ordered categorical versions of vascular event outcomes (such as stroke and myocardial infarction) were analysed using 15 statistical techniques and their results then ranked, with the result with the smallest p-value given the smallest rank. Friedman and Duncan's multiple range tests were performed to assess differences between tests by comparing the average ranks for each statistical test.

resultsData from 35 trials (254,223 participants) were shared with the collaboration. 13 trials had more than two treatment arms, resulting in 59 comparisons. Analysis approaches (Mann Whitney U, ordinal logistic regression, multiple regression, bootstrapping) that used ordinal outcome data had a smaller average rank and therefore appeared to be more efficient statistically than those that analysed the original binary outcomes.

conclusionsOrdinal vascular outcome measures appear to be more efficient statistically than binary outcomes and provide information on the severity of event. We suggest a potential role for using ordinal outcomes in vascular prevention trials.

Indexed as

Myocardial InfarctionStrokeHumansResearch DesignSecondary PreventionAnalysisOrdinalPreventionVascular event

Identifiers

PMID34657596
PMCPMC8520648

What OpenQuestion holds

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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.