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Sample size calculation for cluster randomized cross-over trials.

B Giraudeau1, P Ravaud, A Donner

  • 1INSERM, CIC 202, France. giraudeau@med.univ-tours.fr

Statistics in Medicine
|July 23, 2008
PubMed
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This study presents a new sample size formula for cluster randomized cross-over trials with continuous outcomes. The formula accounts for clustering and cross-over effects, improving internal validity in trial design.

Area of Science:

  • Biostatistics
  • Clinical Trials
  • Epidemiology

Background:

  • Cluster randomized trials (CRTs) can suffer from internal validity issues due to potential imbalances.
  • Cluster randomized cross-over (CRXO) designs offer an alternative to mitigate these imbalances.

Purpose of the Study:

  • To derive a sample size formula specifically for CRXO designs with continuous outcomes.
  • To address the statistical challenges posed by both clustering and the cross-over nature of the design.

Main Methods:

  • Development of a novel sample size formula for CRXO trials.
  • Inclusion of the intraclass correlation coefficient (ICC) to quantify clustering effects.
  • Inclusion of the interperiod correlation coefficient (IPCC) to account for the cross-over design.

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Main Results:

  • A derived sample size formula for continuous outcomes in CRXO trials.
  • The formula explicitly incorporates ICC and IPCC, crucial parameters for CRXO designs.
  • This provides a more accurate estimation of required sample size compared to standard methods.

Conclusions:

  • The proposed sample size formula enhances the internal validity of CRXO trials.
  • Accurate sample size calculation is vital for the successful execution and interpretation of CRXO studies.
  • This methodology offers a robust approach for planning future CRXO trials.