<p>Statistical fragility describes how stable or unstable the results of clinical studies are when faced with small changes in individual data points. Particularly in arthroscopy and joint surgery where many studies rely on small sample sizes and rare events, the change of only a&#xa0;few patient outcomes can already be enough to eliminate statistical significance. The Fragility Index and its extensions for continuous and nonsignificant endpoints provide an intuitive assessment of this robustness and complement traditional metrics such as the <i>p</i>-value and confidence intervals. This review article outlines the concepts of statistical fragility, the calculation of fragility for binary and continuous variables and its relevance for interpreting studies in joint surgery.</p>

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Statistische Fragilität in klinischen Studien

  • Adrian Deichsel,
  • Christoph Kittl,
  • Arasch Wafaisade,
  • Larissa Eckl,
  • Josina Maiti Münchgesang,
  • Jakob Ackermann,
  • Lukas N. Münch,
  • Dominic T. Mathis,
  • Andreas Martin Seitz,
  • Gergo Merkely,
  • Lena Eggeling,
  • Anton Schmidt,
  • Riccardo D’Ambrosi,
  • Karl F. Schüttler,
  • Daniel Günther

摘要

Statistical fragility describes how stable or unstable the results of clinical studies are when faced with small changes in individual data points. Particularly in arthroscopy and joint surgery where many studies rely on small sample sizes and rare events, the change of only a few patient outcomes can already be enough to eliminate statistical significance. The Fragility Index and its extensions for continuous and nonsignificant endpoints provide an intuitive assessment of this robustness and complement traditional metrics such as the p-value and confidence intervals. This review article outlines the concepts of statistical fragility, the calculation of fragility for binary and continuous variables and its relevance for interpreting studies in joint surgery.