Transplantation. 2021 May 6. doi: 10.1097/TP.0000000000003805. Online ahead of print.
ABSTRACT
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) for a dichotomous outcome and were published in the top 10 transplant journals. We calculated the FI; a calculation used to determine the minimum number of subjects needed to change from a nonevent to an event to make the study results nonsignificant (P-value >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.
PMID:33966022 | DOI:10.1097/TP.0000000000003805
