Recovery of Social Continence and Sexual Function in Men With High-risk Prostate Cancer After Radical Prostatectomy: Results From a Statewide Collaborative.

OBJECTIVES: To examine post-operative urinary and sexual functional outcomes for men with high-risk prostate cancer (HRPCa) who underwent radical prostatectomy (RP) within the Michigan Urological Surgery Improvement Collaborative (MUSIC). METHODS: We identified patients who underwent RP for HRPCa in MUSIC between 2014 and 2023. HRPCa was defined according to American Urological Association criteria. Patients completed Expanded Prostate Cancer Index Composite (EPIC-26) pre-RP and 3-, 6-, 12-, and 24-months postoperatively. Primary outcomes included social continence, defined as 0-1 pads used daily; and recovery of sexual function, defined as the ability to achieve erections firm enough for intercourse. Multivariable and bivariate analyses were performed to identify factors associated with recovery of social continence and sexual function. RESULTS: Around 1323 patients were included in the post-RP urinary continence analysis and 422 men in the sexual function analysis. Fifty-eight percent and 86% of patients achieved social continence at 3- and 12-months post-RP, respectively. Continence recovery was associated with higher baseline EPIC-26 urinary continence scores (OR 1.10, per 5 points, 95% CI 1.06-1.15, P <.001), and negatively associated with increasing age (OR 0.78 per 5-year increase, 95% CI 0.71-0.85 P <.001). Fifteen percent of patients had recovery of sexual function at 12-month post-RP. On bivariate analysis, recovery of sexual function was associated with nerve-sparing at time of RP, lower pre-operative PSA, and not receiving post-RP ADT/RT. CONCLUSION: RP for HRPCa has acceptable rates of postoperative social continence. However, post-RP recovery of sexual function remains a challenge. This information has important implications for pre-operative counseling and post-operative follow-up for patients with HRPCa.

Uptake of Same-Day Discharge for Patients Undergoing Robot-Assisted Radical Prostatectomy in the Michigan Urological Surgery Improvement Collaborative.

INTRODUCTION: Postoperative length of stay (LOS) after robot-assisted radical prostatectomy (RARP) is a potentially modifiable aspect of prostate cancer care. Our objective was to evaluate the use of same-day discharge (SDD) RARP and compare pre- and perioperative characteristics of these men with those who underwent hospitalization postoperatively. METHODS: Perioperative outcomes for patients undergoing RARP were evaluated from the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry. Men were classified by hospital LOS: SDD, 1 day, and 2 days. Practice and surgeon-level variation of SDD and the change in SDD use over time were assessed. The primary outcome was 30-day readmission after RARP. RESULTS: We identified 10,249 men undergoing RARP in MUSIC from 2018 to 2022. Most patients had 1-day LOS (79.6%), with 2.8% undergoing SDD. The proportion of patients undergoing RARPs with SDD rose from 0.6% in 2018 to 1.2% in 2019 and 4.4% for 2020 to 2022. At least one SDD was performed in 12 of 28 MUSIC practices (42.9%) and by 52 of 138 urologists (37.7%). In multivariable analysis, odds of 30-day readmission were not significantly different between patients .undergoing SDD and LOS 1 day (OR: 1.72, 95% CI: 0.92-3.22, P = .090). Limitations include retrospective, registry-based observational study with nonuniform utilization of SDD. CONCLUSIONS: Although more patients have undergone SDD after RARP beginning in 2018, rates across Michigan have remained < 5% annually. Importantly, patients undergoing SDD RARP did not experience significantly more readmissions compared to hospitalized patients. SDD appears safe and feasible for select patients who are motivated by this approach.

Design and analysis heterogeneity in observational studies of COVID-19 booster effectiveness: A review and case study.

We investigated the design and analysis of observational booster vaccine effectiveness (VE) studies by performing a scoping review of booster VE literature with a focus on study design and analytic choices. We then applied 20 different approaches, including those found in the literature, to a single dataset from Michigan Medicine. We identified 80 studies in our review, including over 150 million observations in total. We found that while protection against infection is variable and dependent on several factors including the study population and time period, both monovalent boosters and particularly the bivalent booster offer strong protection against severe COVID-19. In addition, VE analyses with a severe disease outcome (hospitalization, intensive care unit admission, or death) appear to be more robust to design and analytic choices than an infection endpoint. In terms of design choices, we found that test-negative designs and their variants may offer advantages in statistical efficiency compared to cohort designs.

Design and Analysis Heterogeneity in Observational Studies of COVID-19 Booster Effectiveness: A Review and Case Study.

Background: Observational vaccine effectiveness (VE) studies based on real-world data are a crucial supplement to initial randomized clinical trials of Coronavirus Disease 2019 (COVID-19) vaccines. However, there exists substantial heterogeneity in study designs and statistical methods for estimating VE. The impact of such heterogeneity on VE estimates is not clear. Methods: We conducted a two-step literature review of booster VE: a literature search for first or second monovalent boosters on January 1, 2023, and a rapid search for bivalent boosters on March 28, 2023. For each study identified, study design, methods, and VE estimates for infection, hospitalization, and/or death were extracted and summarized via forest plots. We then applied methods identified in the literature to a single dataset from Michigan Medicine (MM), providing a comparison of the impact of different statistical methodologies on the same dataset. Results: We identified 53 studies estimating VE of the first booster, 16 for the second booster. Of these studies, 2 were case-control, 17 were test-negative, and 50 were cohort studies. Together, they included nearly 130 million people worldwide. VE for all outcomes was very high (around 90%) in earlier studies (i.e., in 2021), but became attenuated and more heterogeneous over time (around 40%-50% for infection, 60%-90% for hospitalization, and 50%-90% for death). VE compared to the previous dose was lower for the second booster (10-30% for infection, 30-60% against hospitalization, and 50-90% against death). We also identified 11 bivalent booster studies including over 20 million people. Early studies of the bivalent booster showed increased effectiveness compared to the monovalent booster (VE around 50-80% for hospitalization and death).Our primary analysis with MM data using a cohort design included 186,495 individuals overall (including 153,811 boosted and 32,684 with only a primary series vaccination), and a secondary test-negative design included 65,992 individuals tested for SARS-CoV-2. When different statistical designs and methods were applied to MM data, VE estimates for hospitalization and death were robust to analytic choices, with test-negative designs leading to narrower confidence intervals. Adjusting either for the propensity of getting boosted or directly adjusting for covariates reduced the heterogeneity across VE estimates for the infection outcome. Conclusion: While the advantage of the second monovalent booster is not obvious from the literature review, the first monovalent booster and the bivalent booster appear to offer strong protection against severe COVID-19. Based on both the literature view and data analysis, VE analyses with a severe disease outcome (hospitalization, ICU admission, or death) appear to be more robust to design and analytic choices than an infection endpoint. Test-negative designs can extend to severe disease outcomes and may offer advantages in statistical efficiency when used properly.