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The Fragility Index in Hand Surgery Randomized Controlled Trials.

Joseph J Ruzbarsky1, Sariah Khormaee1, Aaron Daluiski1

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The fragility index reveals how robust randomized controlled trials (RCTs) are. Many hand surgery RCTs have low fragility, meaning their conclusions could be easily reversed.

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Area of Science:

  • Orthopedic Surgery
  • Clinical Trials
  • Biostatistics

Background:

  • Randomized controlled trials (RCTs) are essential for comparing clinical interventions.
  • P values indicate statistical significance but not study robustness.
  • The fragility index measures how many participants would need to change outcomes to alter statistical significance.

Purpose of the Study:

  • To assess the fragility of randomized controlled trials (RCTs) with dichotomous outcomes in hand surgery.
  • To evaluate the robustness of conclusions drawn from hand surgery RCTs.

Main Methods:

  • Systematic search of MEDLINE for hand surgery RCTs published in high-impact journals (2007-2017).
  • Included studies had 2 parallel arms, 1:1 allocation, and reported dichotomous outcomes.
  • Calculated the fragility index using Fisher's exact test.

Main Results:

  • Five hand surgery RCTs were identified, with fragility indices ranging from 0 to 26.
  • 40% of trials had a fragility index of 2 or less.
  • In 40% of trials, the number of patients lost to follow-up exceeded the fragility index, potentially reversing study conclusions.

Conclusions:

  • The fragility of hand surgery RCTs is comparable to findings in broader orthopedic surgery literature.
  • The fragility index is a valuable tool for assessing the robustness of RCT findings, complementing P values and effect sizes.
  • There is a need to enhance the robustness of conclusions in future hand surgery RCTs.