Abstract
Purpose
Probability analysis with reporting of P values is often used to determine the statistical significance of study findings
in the orthopedic literature. The fragility index (FI) has been used to evaluate the
robustness of a significant result. The purpose of this study was to determine the
utility of applying a fragility analysis to randomized controlled trials (RCTs) evaluating
distal radius fractures (DRFs).
Methods
We identified all dichotomous outcome data for randomized controlled trials of distal
radius fractures (DRFs) published in 13 orthopedic journals from 2000 to 2020. The
fragility index (FI) was determined by the number of event reversals required to change
a P value from less than 0.05 to greater than 0.05, or vice-versa. The associated fragility
quotient (FQ) was determined by dividing the FI by the sample size. The interquartile
ranges (IQR) for the FI and FQ were calculated as the difference between the 25th
and 75th percentiles for the overall study.
Results
Of the 7352 studies screened, 221 met the search criteria, with 34 randomized controlled
trials evaluating distal radius fractures and 151 total outcome events included for
analysis. The overall FI was 9 (IQR 6.5–11) with an associated fragility quotient
of 0.097 (IQR 0.060–0.140). However, a majority of outcomes (78.8%) were not significant.
Fragility analysis of statistically significant outcomes had an FI of 4 (IQR 1–10).
All of the studies reported lost to follow-up (LTF) data where 20.6% reported lost
to follow-up of greater or equal to 9.
Conclusion
The RCTs in distal radius fracture outcomes have comparable statistical robustness
to literature in other orthopedic surgical specialties, are not as statistically stable
as previously thought and should be interpreted with caution. We recommend that orthopedic
literature report the FI and FQ along with the P values to help the reader draw reliable conclusions based on the fragility of outcome
measures.
Level of Evidence
Level I
Keywords
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Article info
Publication history
Published online: July 13, 2022
Accepted:
July 7,
2022
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
