Urologic oncology randomized controlled trials are frequently fragile - A review of the urology literature.

Urologic Oncology
Leon ChertinMiki Haifler

Abstract

Randomized controlled trials (RCT) in urologic oncology are the basis of patient management. Considerable debate exists on the limitation of statistical reporting of randomized controlled trials. Fragility index (FI) is a measure of the number of events upon which the trials statistical results depend on. The FI is defined as the minimum number of patients whose status would have to change from a 'non-event' to 'event', in order to turn a statistically significant result to a non-significant result and vice versa. Our aim is to examine the FI of RCT's in urologic oncology published in the urology literature. We exhaustively searched MEDLINE and EMBASE from January 1, 2016 to December 31 2019 for RCT's in urology journals. Only studies reporting dichotomous outcomes were included and FI was calculated for each outcome. The distributions of FI across different journals and types of outcome (primary/ secondary, significant/ non-significant) were assessed. We examined the correlation of FI with sample size and P-value. We identified 216 RCT's, 79 were eligible for analysis. Median FI was 3.0 (2.5, 6.0). One hundred and forty-six (89.6%) outcomes from 72 (94.7%) RCT's had a FI lower than 10 and 6 (3.7%) outcomes from 6 (7.9%) RCT's ...Continue Reading

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