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[The center effect in multicenter studies: fixed or random?]

B Falissard1, M Chavance

  • 1Unité INSERM U 169, Villejui.

Revue D'Epidemiologie Et De Sante Publique
|October 1, 1996
PubMed
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Multicentric studies often use a center effect in statistical analyses, typically via two-way ANOVA. This paper clarifies whether the center effect should be fixed or random, impacting study generalizability and statistical power.

Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Statistical Modeling

Background:

  • Multicentric clinical studies increasingly incorporate a center effect in statistical analyses.
  • This often involves a two-way Analysis of Variance (ANOVA) model, including a factor of interest and a center factor, frequently with an interaction term.

Purpose of the Study:

  • To clarify the distinction between fixed and random center effects in statistical analyses.
  • To explain the implications of each approach for study generalizability and statistical power.
  • To provide a conceptual, formal, and numerical comparison of fixed versus random effects.

Main Methods:

  • Discussion of Analysis of Variance (ANOVA) principles.
  • Detailed explanation of the conceptual, formal, and numerical differences between fixed and random effects.

Related Experiment Videos

  • Presentation of a numerical example illustrating the concepts.
  • Main Results:

    • Choosing between fixed and random effects impacts the generalizability of study conclusions.
    • A fixed effect limits conclusions to the specific centers studied.
    • A random effect allows generalization to a larger population of centers but may reduce statistical power, especially with significant interactions.

    Conclusions:

    • The choice between fixed and random center effects is critical in multicentric studies.
    • Understanding these differences is essential for appropriate statistical analysis and interpretation of results.
    • Proper model specification is necessary to balance generalizability and statistical power.