artcat: Sample-size calculation for an ordered categorical outcome

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...

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Veröffentlicht in:The Stata journal 2023-03, Vol.23 (1), p.3-23
Hauptverfasser: White, Ian R., Marley-Zagar, Ella, Morris, Tim P., Parmar, Mahesh K. B., Royston, Patrick, Babiker, Abdel G.
Format: Artikel
Sprache:eng
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Zusammenfassung: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.
ISSN:1536-867X
1536-8734
DOI:10.1177/1536867X231161934