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, Stuart J Pocock, John Chalmers, Graeme J Hankey, J David Spence, Peter Sandercock, Hans-Christoph Diener, Shinichiro Uchiyama, Nikola Sprigg, Philip M Bath

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4 Citations (Scopus)


BACKGROUND: Vascular 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.

METHODS: Chief 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.

RESULTS: Data 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.

CONCLUSIONS: Ordinal 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.

Original languageEnglish
Article number218
JournalBMC Medical Research Methodology
Issue number1
Publication statusPublished - Dec 2021


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