MP24-01 WHAT'S IN A P-VALUE? A FRAGILITY ANALYSIS OF RANDOMIZED CONTROLLED TRIALS CITED IN THE AMERICAN UROLOGIC ASSOCIATION GUIDELINES FOR BENIGN PROSTATIC HYPERPLASIA

Abstract

You have accessJournal of UrologyCME1 Apr 2023MP24-01 WHAT'S IN A P-VALUE? A FRAGILITY ANALYSIS OF RANDOMIZED CONTROLLED TRIALS CITED IN THE AMERICAN UROLOGIC ASSOCIATION GUIDELINES FOR BENIGN PROSTATIC HYPERPLASIA Reece Anderson, Andriana Pena, Bradley Johnson, Ross Nowlin, Tillman Hudson, and Matt Vassar Reece AndersonReece Anderson More articles by this author , Andriana PenaAndriana Pena More articles by this author , Bradley JohnsonBradley Johnson More articles by this author , Ross NowlinRoss Nowlin More articles by this author , Tillman HudsonTillman Hudson More articles by this author , and Matt VassarMatt Vassar More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003249.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To use the Fragility Index (FI) and Fragility Quotient (FQ) 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. METHODS: Two investigators independently screened the AUA guidelines for management of benign prostatic hyperplasia (BPH) for RCTs cited as evidence for recommendations. Investigators extracted data related to event rate per group and loss to follow-up which was compared against the FI. Stata 17.0 was used to calculate the FI and FQ which was then summarized and reported according to primary or secondary endpoints. RESULTS: Among the 373 citations in the AUA guidelines, twenty-four RCTs met inclusion criteria with 29 distinct outcomes analyzed. The median fragility index was 15 (IQR=4–38), indicating that twelve alternative events to either study arm would nullify statistical significance. Six studies had a FI of ≤2, indicating that only 1-2 outcomes would need to be changed in order to render non-significance of results. In 10/24 RCTs, the number of patients lost to follow-up was greater than the FI. CONCLUSIONS: The AUA clinical practice guidelines for management of BPH cite RCTs with more robust findings when compared to previous studies assessing fragility in the field of urology. While several included studies had high fragility, the median FI in our analysis was approximately 4-5 times higher than comparable studies of urological RCTs. However, there are areas where improvement is necessary to support the highest quality of evidence-based medicine. Source of Funding: None. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e316 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Reece Anderson More articles by this author Andriana Pena More articles by this author Bradley Johnson More articles by this author Ross Nowlin More articles by this author Tillman Hudson More articles by this author Matt Vassar More articles by this author Expand All Advertisement PDF downloadLoading ...