2023 ISAKOS Biennial Congress ePoster
The Statistical Fragility of Management Options for Clavicular Fractures: A Systematic Review of Randomized Controlled Trials with Fragility Analysis
Michael N Megafu, MPH, Jersey City, NJ UNITED STATES
Emmanuel Megafu, BA, Jamaica, NY UNITED STATES
Sulabh Singhal, BS, Philadelphia, PA UNITED STATES
Robert L Parisien, MD, New York, NY UNITED STATES
Alexander Lee, BS, Philadelphia UNITED STATES
Richawna Cassie, MS, New York, NY UNITED STATES
A.T. Still University Kirksville College of Osteopathic Medicine, Kirksville, MO, UNITED STATES
FDA Status Not Applicable
Summary
Randomized controlled trials evaluating clavicular fracture management options are prone to statistical fragility and interpretation of these findings must be done with caution.
ePosters will be available shortly before Congress
Abstract
Background
The P value has often been used as a tool to determine the statistical significance and evaluate the statistical robustness of study findings in the orthopedic literature. The purpose of this study was to apply both the fragility index (FI) and fragility quotient (FQ) to evaluate the degree of statistical fragility in the clavicular fracture literature. We hypothesized that the dichotomous outcomes within the clavicular fracture literature are statistically fragile.
Methods
We identified all dichotomous data for randomized controlled trials (RCTs) in clavicular fracture research and performed a PubMed search for DFF from 2000 to 2022. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ.
Results
Of the 2967 articles screened, 81 met the search criteria, with thirty RCTs evaluating clavicular included for analysis. Two hundred and fifty outcome events with 62 significant (p < 0.05) outcomes and 188 nonsignificant (p > 0.05) outcomes were identified. The overall FI and FQ for all 250 outcomes was 4 (IQR 3-5) and 0.045 (IQR 0.024-0.080). A majority of outcomes (75.2%) were nonsignificant findings and reported complications (77.2%). Fragility analysis of statistically significant outcomes and nonsignificant outcomes had an FI of 3.5 (IQR 2-7) and 4 (IQR 3-5), respectively. All of the studies reported a loss to follow-up (LTF) data where 63.3% (19) reported LTF greater or equal to 4.
Conclusions
The RCTs in the clavicular fracture peer-reviewed are not as statistically stable as previously thought. The sole reliance on the P value analysis for evaluating statistical significance is misleading. We recommend standardizing the reporting of the P value, FI and FQ in this area to aid readers in reliably drawing conclusions based on the fragility outcome measures that impact clinical decision making.