Fragility Analysis of Statistically Significant Outcomes of Randomized Control Trials in Spine Surgery: A Systematic Review

Study Design. Systematic review.
Objectives. The aim of this study was to assess the robustness
of statistically significant outcomes from randomized control
trials (RCTs) in spine surgery using Fragility Index (FI) which is a
novel metric measuring the number of events upon which
statistical significance of the outcome depends.
Summary of Background Data. Many trials in Spine surgery
were characterized by fewer outcome events along with small
sample size. FI helps us identify the robustness of the results from such studies with statistically significant dichotomous outcomes.Methods. We conducted independent and in duplicate, a systematic review of published RCTs in spine surgery from PubMed Central, Embase, and Cochrane Database. RCTs with 1:1 prospective study design and reporting statistically significant dichotomous primary or secondary outcomes were included. FI was calculated for each RCT and its correlation with various factors was analyzed.