Current State of Evidence on Kidney Transplantation: How Fragile Are the Results?

BACKGROUND The study aims is to use the fragility index (FI) to examine the strength of evidence of randomized controlled trials (RCTs) published in the last decade on kidney transplantation. METHODS We searched MEDLINE for studies on kidney transplantation. We included the RCTs that compared 2 groups with 1:1 randomization and reported significant P-values ( 0.05). RESULTS 57 RCTs met our inclusion criteria. The median sample size was 100 participants in each arm, the median number of events was 16(IQR 8-30) in the intervention group. Among the included trials, 79% were industry-funded, 93% involved medications, and the majority were open-label. The median FI was 3 (IQR 1-11). In 43% of the trials, the number of patients reported lost to follow-up was higher than or equal to the FI. Only 4% of the RCTs imputed a value for the missing dichotomous outcome. Furthermore, the median number of subjects who discontinued the trial due to adverse effects was 21, which was greater than the FI in 60% of the RCTs. CONCLUSION The arbitrary classification of results into "significant" and "nonsignificant" based on p-value <0.05 should perhaps be interpreted with the help of other statistical parameters and FI is one of them.