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 language | English |
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Pages (from-to) | 1934-1937 |
Number of pages | 4 |
Journal | Injury |
Volume | 50 |
Issue number | 11 |
DOIs | |
State | Accepted/In press - 1 Jan 2019 |
Keywords
- Analysis
- Clinical trials
- Evidence
- Orthopaedic
- Orthopaedic trials
- P-value
- Randomized controlled trials
- Statistical significance
- Statistics
- Trauma
- Traumatology