Resumen de artcat: Sample-size calculation for an ordered categorical outcome

Ian R. White, Ella Marley Zagar, Tim P. Morris, Mahesh K. B. Parmar, Patrick Royston, Abdel G. Babiker

• 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.