Effects of a proposal to alter the statistical significance threshold on previously published orthopaedic trauma randomized controlled trials

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Abstract

Introduction: A recent proposal suggests changing the threshold for statistical significance from a P value of.05 to.005 to minimize bias and increase reproducibility of future studies. P values less than.05 but greater than.005 would be reclassified as “suggestive”, whereas P values less than.005 would be considered significant. The present study explores how lowering the P value threshold would affect the interpretation of previously published orthopaedic trauma randomized controlled trials (RCTs) and whether outcomes from these trials would maintain statistical significance under the proposed P value threshold. Methods: All RCTs published between January 01, 2016 and January 31, 2018 in the Journal of Orthopaedic Trauma, Injury, and Archives of Orthopaedic and Trauma Surgery were screened by at least 2 authors. Data from included trials were extracted in blinded and duplicate fashion. All P values for primary endpoints were included from each study. Results: We identified 124 primary endpoints from 48 trials: 39.5% (49/124) of endpoints had a P value less than.05 and 60.5% (75/124) had a P value greater than.05. Overall, 51.0% (25/49) of statistically significant primary endpoints were less than.005, while 49.0% (24/49) would be reclassified as suggestive. Conclusion: Based on our results, adopting a lower threshold of significance would heavily alter the significance of orthopaedic trauma RCTs and should be further evaluated and cautiously considered when viewing the effect such a proposal on orthopaedic practice.

Original languageEnglish
Pages (from-to)1934-1937
Number of pages4
JournalInjury
Volume50
Issue number11
DOIs
StateAccepted/In press - 1 Jan 2019

Keywords

  • Analysis
  • Clinical trials
  • Evidence
  • Orthopaedic
  • Orthopaedic trials
  • P-value
  • Randomized controlled trials
  • Statistical significance
  • Statistics
  • Trauma
  • Traumatology

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