Key result
Among 1,007 surgical RCTs across 50 systematic reviews, the pooled median Fragility Index was 3 (IQR: 1-7), with a moderate correlation between FI and p-value (r = -0.413).
Why the study?
The objective was to identify and describe published systematic reviews using the fragility index to evaluate surgical RCTs and determine factors associated with higher fragility index values.
Systematic Review (n=1,007)
Effect estimate: Median 3
Surgical RCTs demonstrate low fragility index values (median 3), indicating that statistical significance often hinges on a very small number of patient events, highlighting a need for more robust study designs.
Surgical RCT results warrant interpretive caution; confirms widespread fragility and extends calls for larger, more robust trials.
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.
No takes yet. Share an insight, caveat, or question.
Vivekanantha et al. (2023) conducted a systematic review in Surgical conditions (n=1,007). Study characteristics (p-value, sample size, event number) was evaluated on Fragility Index (FI) score (Median 3). Among 1,007 surgical RCTs across 50 systematic reviews, the pooled median Fragility Index was 3 (IQR: 1-7), with a moderate correlation between FI and p-value (r = -0.413).
Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context: