The statistical fragility of outcomes in calcaneus fractures: A systematic review of randomized controlled trials

Michael Megafu; Emmanuel Megafu; Hassan Mian; Sulabh Singhal; Katrina Nietsch; Avanish Yendluri; Paul Tornetta 3rd; Robert L Parisien

doi:10.1016/j.foot.2023.102047

The statistical fragility of outcomes in calcaneus fractures: A systematic review of randomized controlled trials

Foot (Edinb). 2023 Dec:57:102047. doi: 10.1016/j.foot.2023.102047. Epub 2023 Aug 24.

Authors

Michael Megafu¹, Emmanuel Megafu², Hassan Mian³, Sulabh Singhal⁴, Katrina Nietsch⁵, Avanish Yendluri⁵, Paul Tornetta 3rd⁶, Robert L Parisien⁷

Affiliations

¹ A.T. Still University Kirksville College of Osteopathic Medicine, Kirksville, MO, USA. Electronic address: Michael.Megafu@atsu.edu.
² Geisinger Commonwealth School of Medicine, Scranton, PA, USA.
³ University of Minnesota Medical School, Twin Cities Campus, Minneapolis, MN, USA.
⁴ Drexel University College of Medicine, Philadelphia, PA, USA.
⁵ Ichan School of Medicine at Mount Sinai, New York, NY, USA.
⁶ Boston University School of Medicine, Department of Orthopedic Surgery, Boston, MA, USA.
⁷ Ichan School of Medicine at Mount Sinai, New York, NY, USA; Mount Sinai Hospital, Department of Orthopedic Surgery, New York, NY, USA.

PMID: 37672893
DOI: 10.1016/j.foot.2023.102047

Abstract

Introduction: The purpose of this study was to utilize the fragility index to assess the robustness of randomized controlled trials (RCTs) evaluating the management of calcaneus fractures. We hypothesize that the dichotomous outcomes in calcaneus fracture literature will be statistically fragile and comparable to other orthopedic specialties.

Methods: We performed a PubMed search for calcaneus fracture RCTs from 2000 to 2022 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The fragility index (FI) of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient (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 3003 studies screened, 97 met the search criteria, with 19 RCTs evaluating calcaneus fractures included in the analysis. Seventy-nine dichotomous outcomes with 30 significant (P < 0.05) outcomes and 49 with nonsignificant (P> 0.05) outcomes were identified. The overall FI and FQ of all outcomes were 6 (IQR 3-8) and 0.067 (IQR 0.032-0.100), respectively.

Conclusions: The literature surrounding calcaneus fractures may not be as statistically stable as previously thought. The sole reliance on the P value may depict misleading results. We, therefore, recommend reporting the P value in conjunction with the FI and FQ to give a robust contextualization of clinical findings in the calcaneus fracture literature.

Keywords: Calcaneus fractures; Fragility index; Randomized controlled trials; Statistical significance.

Publication types

Systematic Review
Review

MeSH terms

Calcaneus*
Fractures, Bone* / therapy
Humans
Randomized Controlled Trials as Topic
Sample Size