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Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?

Stephen J WaltersRichard M JacquesInês Bonacho Dos Anjos Henriques-CadbyJane CandlishNikki TottonMica Teo Shu Xian
Published in: Trials (2019)
There is a general consistency in the correlations between the repeated PROMs, with the majority being in the range of 0.4 to -0.6. The implications are that we can reduce the sample size in an RCT by 25% if we use an ANCOVA model, with a correlation of 0.50, for the design and analysis. There is a decline in correlation amongst more distant pairs of time points.
Keyphrases
  • patient reported outcomes
  • lymph node
  • skeletal muscle