Fragility of randomized controlled trials on treatment of proximal humeral fracture

Carroll, Austin H.; Rigor, Paolo; Wright, Melissa A.; Murthi, Anand M.

doi:10.1016/j.jse.2022.01.141

Cited by 7 publications

(3 citation statements)

References 24 publications

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“…Nine reviews investigated the relationship between FI values and journal impact factor. Eight reviews reported no significant correlation between journal impact factor and FI [3, 12, 15, 21, 29, 32, 51, 52], while Shen et al [51] stated that higher journal impact factors were correlated with higher FI values ( p = 0.029).…”

Section: Resultsmentioning

confidence: 99%

“…Fisher's exact test is preferentially used in RCTs with lower sample size, as opposed to the commonly used Chi‐square test [61]. Similarly, it is also expected that the total event number has an impact on FI values as studies with few events typically have lower statistical powers, increasing the chance of false negatives [12]. Defining a set number of events that are required to be truly confident in effect size is difficult as this number would be variable for different interventions [4].…”

Section: Discussionmentioning

confidence: 99%

“…There are a few limitations associated with this study. The outcome variables associated with RCTs are not always dichotomous; therefore, the usage of FI is prohibited in some outcomes, such as most patient‐reported outcome measures [12]. A limitation of the FI metric is that it is only calculated for statistically significant results ( p < 0.05).…”

Section: Discussionmentioning

confidence: 99%

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Predictors of Increased Fragility Index Scores in Surgical Randomized Controlled Trials: An Umbrella Review

Vivekanantha

Shah²,

Hoit³

et al. 2023

World j. surg.

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Background The fragility index (FI) is defined as the minimum number of patients or subjects needed to switch experimental groups for statistical significance to be lost in a randomized control trial (RCT). This index is used to determine the robustness of a study's findings and recently as a measure of evaluating RCT quality. The objective of this review was to identify and describe published systematic reviews utilizing FI to evaluate surgical RCTs and to determine if there were common factors associated with higher FI values. Methods Three databases (PubMed, MEDLINE [Ovid], Embase) were searched, followed by a subsequent abstract/ title and full-text screening to yield 50 reviews of surgical RCTs. Authors, year of publication, name of journal, study design, number of RCTs, subspecialty, sample size, median FI, patients lost to follow-up, and associations between variables and FI scores were collected. Results Among 1007 of 2214 RCTs in 50 reviews reporting FI (median sample size 100), the pooled median FI was 3 (IQR: 1-7). Most reviews investigated orthopaedic surgery RCTs (n = 32). There was a moderate correlation between FI and p value (r = 0.-413), a mild correlation between FI and sample size (r = 0.188), and a mild correlation between FI and event number (r = 0.129). Conclusion Based on a limited sample of systematic reviews, surgical RCT FI values are still low (2-5). Future RCTs in surgery require improvement to study design in order to increase the robustness of statistically significant findings.

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