The following is a summary of “What’s in a P-Value? A Fragility Analysis of RCTs in the AUA Guidelines for Benign Prostatic Hyperplasia,” published in the JUNE 2023 issue of Urology by Anderson, et al.

For a study, researchers sought to assess the strength of statistically significant findings for randomized controlled trials (RCTs) cited in the American Urological Association (AUA) guidelines for benign prostatic hyperplasia using the fragility index (FI) and fragility quotient (FQ).

Two independent investigators screened the AUA guidelines for managing benign prostatic hyperplasia to identify RCTs cited as evidence for recommendations. Data on event rate per group and loss to follow-up were extracted for analysis against the FI. The FI and FQ were calculated using Stata 17.0 and summarized according to primary or secondary endpoints.

Among the 373 citations in the AUA guidelines, 24 RCTs were eligible for inclusion, comprising 29 distinct outcomes. The median fragility index was 12 (Interquartile Range [IQR] = 4-38), indicating that twelve alternative events in either study arm would nullify statistical significance. Six studies had a FI of ≤2, signifying that only 1-2 outcomes would need to be altered to render the results nonsignificant. Notably, in 10 out of 24 RCTs, the number of patients lost to follow-up exceeded the FI.

The AUA Clinical Practice Guidelines for managing benign prostatic hyperplasia reference RCTs with more robust findings compared to previous studies assessing fragility in the field of Urology. Despite several included studies exhibiting high fragility, the median FI in the analysis was approximately 4-5 times higher than comparable studies of urologic RCTs. However, areas remained where improvement was necessary to support the highest quality of evidence-based medicine.

Source: goldjournal.net/article/S0090-4295(23)00192-9/fulltext