Purpose
This study applied the fragility index (FI) and fragility quotient (FQ) to evaluate the degree of statistical fragility in the clavicle fracture literature.
Methods
This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A PubMed systematic search strategy was used to find all dichotomous data for randomized controlled trials (RCTs) in clavicle fracture research from 2000 to 2022. The FI of each outcome was calculated by reversing a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the 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 30 RCTs evaluating clavicle fractures included for analysis. There were 250 total outcomes, where 62 significant and 188 nonsignificant outcomes were identified. The overall FI and FQ were 4 (IQR 3–5) and 0.045 (IQR 0.024–0.080). Statistically significant and nonsignificant outcomes had an FI of 3.5 (IQR 2–7) and 4 (IQR 3–5), respectively. Regarding loss to follow-up (LTF), 63.3% (19) reported LTF greater or equal to the overall FI of 4.
Conclusions
Relying solely on P values to assess clavicle fracture RCTs may be deceptive and challenge the studies' validity. When scrutinizing management algorithms relying on statistical analysis, we recommend including the FI and FQ alongside the P value.