The statistical fragility of the distal fibula fracture literature: A systematic review of randomized controlled trials

Hassan Mian; Michael Megafu; Emmanuel Megafu; Sulabh Singhal; Nicholas G Richardson; Paul Tornetta 3rd; Robert L Parisien

doi:10.1016/j.injury.2023.03.022

The statistical fragility of the distal fibula fracture literature: A systematic review of randomized controlled trials

Injury. 2023 Mar 20:S0020-1383(23)00278-4. doi: 10.1016/j.injury.2023.03.022. Online ahead of print.

Authors

Hassan Mian¹, Michael Megafu², Emmanuel Megafu³, Sulabh Singhal⁴, Nicholas G Richardson⁵, Paul Tornetta 3rd⁶, Robert L Parisien⁵

Affiliations

¹ University of Minnesota Medical School, United States. Electronic address: Mian0004@umn.edu.
² AT Still University Kirksville College of Osteopathic Medicine, United States.
³ City University of New York, York College, United States.
⁴ Drexel University College of Medicine, United States.
⁵ Department of Orthopedic Surgery, Mount Sinai Health System, New York, NY, United States.
⁶ Department of Orthopedic Surgery, Boston University Medical Center, Boston, MA, United States.

PMID: 36964035
DOI: 10.1016/j.injury.2023.03.022

Abstract

Background: 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 distal fibular fracture (DFF) literature. We hypothesized that the dichotomous outcomes within the DFF literature are statistically fragile.

Methods: We performed a PubMed search for distal fibular fractures clinical trials from 2000 to 2022 reporting dichotomous outcomes. 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 1158 articles screened, 23 met the search criteria, with six RCTs included for analysis. Forty-five outcome events with 5 significant (p < 0.05) outcomes and 40 nonsignificant (p ≥ 0.05) outcomes were identified. The overall FI and FQ was 5 (IQR 4-6) and 0.089 (IQR 0.061-0.107), respectively.

Conclusions: The randomized controlled trials in the peer-reviewed distal fibular fracture literature may not be as robust as previously thought, as incorporating statistical analyses solely on a P value threshold is misleading. Standardized reporting of the P value, FI and FQ can help the clinician reliably draw conclusions based on the fragility of outcome measures.

Keywords: Distal fibular fracture; Fragility index; Fragility quotient; P value; Statistical fragility.