The fragility of significant results from randomized controlled trials in esophageal surgeries
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abstract
While randomized controlled trials (RCTs) are regarded as one of the highest forms of clinical research, the robustness of their P values can be difficult to ascertain. Defined as the minimum number of patients in a study arm that would need to be changed from a non-event to event for the findings to lose significance, the Fragility Index is a method for evaluating results from these trials. This study aims to calculate the Fragility Index for trials evaluating perioperative esophagectomy-related interventions to determine the strength of RCTs in this field. MEDLINE and EMBASE were searched for RCTs related to esophagectomy that reported a significant dichotomous outcome. Two reviewers independently screened articles and performed the data extractions with risk of bias assessment. The Fragility Index was calculated using a two-tailed Fisher's exact test. Bivariate correlation was conducted to evaluate associations between the Fragility Index and study characteristics. 41 RCTs were included, and the median sample size was 80 patients [Interquartile range (IQR) 60-161]. Of the included outcomes, 29 (71%) were primary, and 12 (29%) were secondary. The median Fragility Index was 1 (IQR 1-3), meaning that by changing one patient from a non-event to event, the results would become non-significant. Fragility Index was correlated with P value, number of events, and journal impact factor. The RCTs related to esophagectomy did not prove to be robust, as the significance of their results could be changed by altering the outcome status of a handful of patients in one study arm.
