An Evaluation of Randomized Controlled Trials Utilizing Mesh in Abdominal Wall Reconstruction

Background The fragility index (FI) was developed in order to assess the robustness of clinical trials. FI calculates the number of individual outcomes that would need to change in order to make a significant result insignificant. The aim of this study is to evaluate the fragility of mesh RCTs in AWR. Methods Google Scholar® and PubMed were used to query for mesh RCTs in AWR from 2000–2023. FI and Reverse Fragility Index (RFI) I were calculated. Fragility quotient (FQ) and reverse fragility quotient (RFQ) were determined by dividing FI and RFI by sample size. The impact factor (IF) of each journal and conflicts of interest (COI) were reported. Results There were 37 RCTs identified. The median FI for positive RCTs was 2 (range: 0–37), and the median RFI nor negative RCTs was 3.5 (range:1–8). For all studies, 11 of 17 (64.7%) had an FI or RFI ≤3. Four studies had an FI/RFI of one, and one study that had an FI of zero, which indicated that if a different statistical test was used for the same data (e.g., Fisher’s exact), then the study outcomes would not be significant. Mean FQ was 0.04 ± 0.06 and mean RFQ was 0.04 ± 0.04. IF of journal did not correlate with FI/RFI (p = 0.67). There was COI reported in 5/17 (29.4%) of studies; 4/5 of these studies had an FI/RFI ≤3. Conclusions The majority of mesh RCTs in AWR were fragile and lacked robustness. For fragile studies, a change in very few patient outcomes would have altered their conclusions.