artcat: Sample-size calculation for an ordered categorical outcome
Ian White,
Ella Marley-Zagar (),
Tim P. Morris (),
Mahesh K. B. Parmar (),
Patrick Royston () and
Abdel G. Babiker ()
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Ella Marley-Zagar: University College London
Tim P. Morris: University College London
Mahesh K. B. Parmar: University College London
Patrick Royston: University College London
Abdel G. Babiker: University College London
Stata Journal, 2023, vol. 23, issue 1, 3-23
Abstract:
We describe a new command, artcat, that calculates sample size or power for a randomized controlled trial or similar experiment with an ordered categorical outcome, where analysis is by the proportional-odds model. artcat implements the method of Whitehead (1993, Statistics in Medicine 12: 2257–2271). We also propose and implement a new method that 1) allows the user to specify a treatment effect that does not obey the proportional-odds assumption, 2) offers greater accuracy for large treatment effects, and 3) allows for noninferiority trials. We illustrate the command and explore the value of an ordered categorical outcome over a binary outcome in various settings. We show by simulation that the methods perform well and that the new method is more accurate than Whitehead’s method.
Keywords: artcat; sample size; power; clinical trial; randomized controlled trial; noninferiority trial; substantial-superiority trial; categorical variable; proportional-odds model; evaluation (search for similar items in EconPapers)
Date: 2023
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Persistent link: https://EconPapers.repec.org/RePEc:tsj:stataj:v:23:y:2023:i:1:p:3-23
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DOI: 10.1177/1536867X231161934
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