Assessing the generalizability of randomized evidence by comparing results from a clinical trial and established quality improvement collaborative: results from g-minor and music

You have accessJournal of UrologyCME1 Apr 2023PD21-02 ASSESSING THE GENERALIZABILITY OF RANDOMIZED EVIDENCE BY COMPARING RESULTS FROM A CLINICAL TRIAL AND ESTABLISHED QUALITY IMPROVEMENT COLLABORATIVE: RESULTS FROM G-MINOR AND MUSIC Udit Singhal, Ralph Jiang, Daniel E. Spratt, Matthew Schipper, Simpa S. Salami, Stephanie Daignault-Newton, Rodney Dunn, Thomas J. Maatman, Brian R. Lane, Frank N. Burks, Paul Rodriguez, Eduardo Kleer, Richard Sarle, Felix Y. Feng, Michael L. Cher, Robert T. Dess, and Todd M. Morgan Udit SinghalUdit Singhal More articles by this author , Ralph JiangRalph Jiang More articles by this author , Daniel E. SprattDaniel E. Spratt More articles by this author , Matthew SchipperMatthew Schipper More articles by this author , Simpa S. SalamiSimpa S. Salami More articles by this author , Stephanie Daignault-NewtonStephanie Daignault-Newton More articles by this author , Rodney DunnRodney Dunn More articles by this author , Thomas J. MaatmanThomas J. Maatman More articles by this author , Brian R. LaneBrian R. Lane More articles by this author , Frank N. BurksFrank N. Burks More articles by this author , Paul RodriguezPaul Rodriguez More articles by this author , Eduardo KleerEduardo Kleer More articles by this author , Richard SarleRichard Sarle More articles by this author , Felix Y. FengFelix Y. Feng More articles by this author , Michael L. CherMichael L. Cher More articles by this author , Robert T. DessRobert T. Dess More articles by this author , and Todd M. MorganTodd M. Morgan More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003287.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Although randomized controlled trials (RCTs) represent the gold standard for clinical research, results from RCTs are often substantially less dramatic when implemented in practice. Previous studies have evaluated the congruence of observational studies with RCTs and shown conflicting results. However, minimal to no data exist comparing RCT populations with their non-RCT contemporaries. We aimed to assess the generalizability of RCT evidence by comparing results from an RCT with those from a prospectively collected, geographically equivalent, quality improvement collaborative. METHODS: The G-MINOR RCT randomized 356 men with localized prostate cancer at high-risk of recurrence after prostatectomy to clinical risk stratification with or without Decipher testing to assess its utility in clinical decision-making. Enrollment of patients occurred across 12 practices within the Michigan Urological Surgery Improvement Collaborative (MUSIC). Matching between MUSIC and G-MINOR was performed using 3:1 nearest neighbor matching on propensity scores. Differences between the matched populations were assessed via Kaplan-Meier estimates and multivariable Cox regression, with a primary endpoint of failure-free survival (FFS), which was defined as any biochemical recurrence or receipt of salvage treatment. Secondary endpoints were adjuvant treatment-free survival and cumulative incidence of salvage treatment. RESULTS: After matching, a total of 1352 men were included in the analysis (338 G-MINOR, 1014 MUSIC), with no differences in age, race, comorbidity, PSA, grade group, clinical T-stage, margin status, presence of extra-prostatic extension, or Decipher risk between the groups. Despite matching, FFS was greater at 48 months follow-up in the G-MINOR group compared to MUSIC (20.1% vs 19.9%, p=0.041). Men in MUSIC received significantly more adjuvant therapy (20.1% vs 9.2%, p<0.0001), but salvage treatment rates were similar between the groups (G-MINOR 11.2% vs MUSIC 8.6%, p=0.62). CONCLUSIONS: Despite similar geographic, practice-level, and disease-related characteristics, men enrolled in a RCT were less likely to have failure after initial treatment compared to matched patients in the same communities not enrolled in the RCT. These results suggest possible unmeasured differences between these populations or unmeasured benefits of trial participation that may result in improved outcomes for RCT participants. Source of Funding: U.S. is supported by an AUA/UCF Research Scholar Award © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e590 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Udit Singhal More articles by this author Ralph Jiang More articles by this author Daniel E. Spratt More articles by this author Matthew Schipper More articles by this author Simpa S. Salami More articles by this author Stephanie Daignault-Newton More articles by this author Rodney Dunn More articles by this author Thomas J. Maatman More articles by this author Brian R. Lane More articles by this author Frank N. Burks More articles by this author Paul Rodriguez More articles by this author Eduardo Kleer More articles by this author Richard Sarle More articles by this author Felix Y. Feng More articles by this author Michael L. Cher More articles by this author Robert T. Dess More articles by this author Todd M. Morgan More articles by this author Expand All Advertisement PDF downloadLoading ...