Optimizing Opioid Pain Medication Use After Vasectomy-A Prospective Study.

OBJECTIVE: To act as good stewards, urologists need to balance patient's pain requirements against the risk of narcotic abuse. MATERIALS AND METHODS: We prospectively consented subjects who underwent vasectomies. Procedural technique was not standardized. All subjects received hydrooxycodone/acetaminophen 5-325 mg tablets and Ibuprofen 800 mg tablets. The subjects were then contacted by phone 1-3 weeks after their procedure with a follow-up questionnaire. Data collected included age, weight, number of pills used and pills remaining, number of days pain medication used, need for additional medication, pain treatment satisfaction, disposal knowledge, and complications. RESULTS: A total of 76 subjects completed the study. Overall, 88.3% rated excellent pain treatment satisfaction with score ⩾4 (scale 1-5). No opioid medication was used by 18.2% of subjects, 33.8% used 1-5 tablets, and 24.7% used all 15 tablets. At the end, 9 subjects (11.7%) reporting needing more pain medication. Using Pearson correlation, younger age was significantly related to number of pills used. (P <.001) In total, 648 additional narcotic tablets were prescribed. In terms of disposal, 20 (25.9%) subjects disposed of extra medication, 14 (24.7%) used all medication, and 50.6% did not dispose of medication. Proper disposal technique was known by 50 (64.9%) subjects. CONCLUSION: Opioid medication use after vasectomy is variable though correlated with age. Clinicians should weigh the need versus potential abuse to determine the amount of tablets they are comfortable prescribing. Counseling and documentation on proper use and disposal of opioid medication is strongly encouraged.

A Statewide Intervention Improves Appropriate Imaging in Localized Prostate Cancer.

PURPOSE: We implemented a statewide intervention to improve imaging utilization for the staging of patients with newly diagnosed prostate cancer. MATERIALS AND METHODS: MUSIC (Michigan Urological Surgery Improvement Collaborative) is a quality improvement collaborative comprising 42 diverse practices representing approximately 85% of the urologists in Michigan. MUSIC has developed imaging appropriateness criteria (prostate specific antigen greater than 20 ng/ml, Gleason score 7 or higher and clinical stage T3 or higher) which minimize unnecessary imaging with bone scan and computerized tomography. After baseline rates of radiographic staging were established in 2012 and 2013, we used multidimensional interventions to deploy these criteria in 2014. Imaging utilization was then remeasured in 2015 to evaluate for changes in practice patterns. RESULTS: A total of 10,554 newly diagnosed patients with prostate cancer were entered into the MUSIC registry from January 1, 2012 through December 31, 2013 and January 1, 2015 through December 31, 2015. Of these patients 7,442 (79%) and 7,312 (78%) met our criteria to avoid bone scan and computerized tomography imaging, respectively. The use of bone scan imaging when not indicated decreased from 11.0% at baseline to 6.5% after interventions (p <0.0001). The use of computerized tomography when not indicated decreased from 14.7% at baseline to 7.7% after interventions (p <0.0001). Variability among practices decreased substantially after the interventions as well. The use of recommended imaging remained stable during these periods. CONCLUSIONS: An intervention aimed at appropriate use of imaging was associated with decreased use of bone scans and computerized tomography among men at low risk for metastases.

Factors Influencing Selection of Active Surveillance for Localized Prostate Cancer.

OBJECTIVE: To determine how well demographic and clinical factors predict the initiation of Active Surveillance (AS). METHODS: AS has been suggested as a way to reduce overtreatment of men who have prostate cancer; however, factors associated with the decision to choose AS are poorly quantified. Using the Michigan Urological Surgery Improvement Collaborative registry, we identified 2977 men with prostate cancer who made treatment decisions from January 1, 2012, through December 31, 2013. We used chi-square and Wilcoxon tests to examine the association between factors and initiation of AS. Logistic regression models were fit for D'Amico risk categories. Measures of model discrimination and calibration were estimated, including area under the curve (AUC) and Brier score (BS). RESULTS: Patient age, Gleason score, clinical T-stage, urology practice, and tumor volume (greatest percent of a core involved with cancer and proportion of positive cores) were associated with the decision to choose AS in the intermediate-risk cohort (AUC = 0.875, BS = 0.07) and the complete cohort (AUC = 0.89, BS = 0.10). Patient age, urology practice, and tumor volume were significant in the low-risk cohort (AUC = 0.71, BS = 0.22). The addition of urology practice increased AUC in the low-risk cohort from 0.71 to 0.76 and reduced BS from 0.22 to 0.21. CONCLUSION: The urology practice at which a patient is seen is an important predictor for whether patients will initiate AS. Predictions were least accurate for low-risk patients, suggesting that factors such as patient preference play a role in treatment decisions.

Understanding the Performance of Active Surveillance Selection Criteria in Diverse Urology Practices.

PURPOSE: We used data from MUSIC (Michigan Urological Surgery Improvement Collaborative) to evaluate the performance of published selection criteria for active surveillance in diverse urology practice settings. MATERIALS AND METHODS: For several active surveillance guidelines we calculated the proportion of men meeting each set of selection criteria who actually entered active surveillance, defined as the sensitivity of the guideline. After identifying the most sensitive guideline for the entire cohort we compared demographic and tumor characteristics between patients who met this guideline and entered active surveillance, and those who received initial definitive therapy. RESULTS: Of 4,882 men with newly diagnosed prostate cancer 18% underwent active surveillance. When applied to the entire cohort, the sensitivity of published guidelines ranged from 49% in Toronto to 62% at Johns Hopkins. At a practice level the sensitivity of Johns Hopkins criteria varied widely from 27% to 84% (p <0.001). Compared with men undergoing active surveillance, those meeting Johns Hopkins criteria who received definitive therapy were younger (p <0.001) and more likely to have a positive family history (p = 0.003), lower prostate specific antigen (p <0.001), a greater number of positive cores (2 vs 1) on biopsy (p <0.001) and a higher cancer volume in positive core(s) (p = 0.002). CONCLUSIONS: The sensitivity of published active surveillance selection criteria varies widely across diverse urology practices. Among patients meeting the most stringent criteria those who received initial definitive therapy had characteristics suggesting greater cancer risk, underscoring the nuanced clinical factors that influence treatment decisions.

A Statewide Intervention to Reduce Hospitalizations after Prostate Biopsy.

PURPOSE: Recent data suggest that increasing rates of hospitalization after prostate biopsy are mainly due to infections from fluoroquinolone-resistant bacteria. We report the initial results of a statewide quality improvement intervention aimed at reducing infection related hospitalizations after transrectal prostate biopsy. MATERIALS AND METHODS: From March 2012 through May 2014 data on patient demographics, comorbidities, prophylactic antibiotics and post-biopsy complications were prospectively entered into an electronic registry by trained abstractors in 30 practices participating in the MUSIC. During this period each practice implemented one or both of the interventions aimed at addressing fluoroquinolone resistance, namely 1) use of rectal swab culture directed antibiotics or 2) augmented antibiotic prophylaxis with a second agent in addition to standard fluoroquinolone therapy. We identified all patients with an infection related hospitalization within 30 days after biopsy and validated these events with claims data for a subset of patients. We then compared the frequency of infection related hospitalizations before (5,028 biopsies) and after (4,087 biopsies) implementation of the quality improvement intervention. RESULTS: Overall the proportion of patients with infection related hospitalizations after prostate biopsy decreased by 53% from before to after implementation of the quality improvement intervention (1.19% before vs 0.56% after, p=0.002). Among post-implementation biopsies the rates of hospitalization were similar for patients receiving culture directed (0.47%) vs augmented (0.57%) prophylaxis. At a practice level the relative change in hospitalization rates varied from a 7.4% decrease to a 3.0% increase. Fourteen practices had no post-implementation hospitalizations. CONCLUSIONS: A statewide intervention aimed at addressing fluoroquinolone resistance reduced post-prostate biopsy infection related hospitalizations in Michigan by 53%.

Contemporary use of initial active surveillance among men in Michigan with low-risk prostate cancer.

BACKGROUND: Active surveillance (AS) has been proposed as an effective strategy to reduce overtreatment among men with lower risk prostate cancers. However, historical rates of initial surveillance are low (4-20%), and little is known about its application among community-based urology practices. OBJECTIVE: To describe contemporary utilization of AS among a population-based sample of men with low-risk prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: We performed a prospective cohort study of men with low-risk prostate cancer managed by urologists participating in the Michigan Urological Surgery Improvement Collaborative (MUSIC). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The principal outcome was receipt of AS as initial management for low-risk prostate cancer including the frequency of follow-up prostate-specific antigen (PSA) testing, prostate biopsy, and local therapy. We examined variation in the use of surveillance according to patient characteristics and across MUSIC practices. Finally, we used claims data to validate treatment classification in the MUSIC registry. RESULTS AND LIMITATIONS: We identified 682 low-risk patients from 17 MUSIC practices. Overall, 49% of men underwent initial AS. Use of initial surveillance varied widely across practices (27-80%; p=0.005), even after accounting for differences in patient characteristics. Among men undergoing initial surveillance with at least 12 mo of follow-up, PSA testing was common (85%), whereas repeat biopsy was performed in only one-third of patients. There was excellent agreement between treatment assignments in the MUSIC registry and claims data (κ=0.93). Limitations include unknown treatment for 8% of men with low-risk cancer. CONCLUSIONS: Half of men in Michigan with low-risk prostate cancer receive initial AS. Because this proportion is much higher than reported previously, our findings suggest growing acceptance of this strategy for reducing overtreatment. PATIENT SUMMARY: We examined the use of initial active surveillance for the management of men with low-risk prostate cancer across the state of Michigan. We found that initial surveillance is used much more commonly than previously reported, but the likelihood of a patient being placed on surveillance depends strongly on where he is treated.

Clinical predictors and recommendations for staging computed tomography scan among men with prostate cancer.

OBJECTIVE: To identify clinical variables associated with a positive computed tomography (CT) scan and estimate the performance of imaging recommendations in patients from a diverse sample of urology practices. MATERIALS AND METHODS: This study comprised 2380 men with newly diagnosed prostate cancer seen at 28 practices in the Michigan Urological Surgery Improvement Collaborative from March 2012 through September 2013. Data included age, prostate-specific antigen (PSA) level, Gleason score (GS), clinical T stage, total number of positive biopsy cores, whether or not the patient received a staging abdominal and/or pelvic CT scan, and CT scan result. We fit a multivariate logistic regression model to identify clinical variables associated with metastases detected by CT scan. We estimated the sensitivity and specificity of existing imaging recommendations. RESULTS: Among 643 men (27.4%) who underwent a staging CT scan, 62 men (9.6%) had a positive study. In the multivariate analysis, PSA, GS, and clinical T stage were independently associated with the occurrence of a positive CT scan (all P values <.05). The American Urological Association's Best Practice Statements' recommendations for imaging when PSA level >20 ng/mL or GS ≥ 8 or locally advanced cancer had a sensitivity of 87.3% and specificity of 82.6%. Compared with current practice, implementing this recommendation in the Michigan Urological Surgery Improvement Collaborative population was estimated to result in approximately 0.5% of positive study results being missed, and 26.1% of fewer study results overall. CONCLUSION: Successful implementation of CT imaging criterion of PSA level >20, GS ≥ 8, or clinical stage ≥ T3 would ensure that CT scans are performed for almost all men who would have positive study results while reducing the number of negative study results.

Toward better use of bone scans among men with early-stage prostate cancer.

OBJECTIVE: To evaluate the performance of published guidelines compared with that of current practice for radiographic staging of men with newly diagnosed prostate cancer. MATERIALS AND METHODS: Using data from the Michigan Urological Surgery Improvement Collaborative clinical registry, we identified 1509 men diagnosed with prostate cancer from March 2012 through June 2013. Clinical data included age, prostate-specific antigen (PSA) level, Gleason score (GS), clinical trial stage, number of biopsy cores, and bone scan (BS) results. We then fit a multivariate logistic regression model to examine the association between clinical variables and the occurrence of bone metastases. Because some patients did not undergo BS, we used established methods to correct for verification bias and estimate the diagnostic accuracy of published guidelines. RESULTS: Among 416 men who received a BS, 48 (11.5%) had evidence of bone metastases. Patients with bone metastases were older, with higher PSA levels and GS (all P <.05). In multivariate analyses, PSA (P <.001) and GS (P = .004) were the only independent predictors of positive BS. Guidelines from the American Urological Association and the National Comprehensive Cancer Network demonstrated similar performance in detecting bone metastases in our population, with fewer negative study results than those of the European Association of Urology guideline. Applying the American Urological Association recommendations (ie, image when PSA level >20 ng/mL or GS ≥ 8) to current clinical practice, we estimate that <1% of positive study results would be missed, whereas the number of negative study results would be reduced by 38%. CONCLUSION: Based on current practice patterns, more uniform application of existing guidelines would ensure that BS is performed for almost all men with bone metastases, while avoiding many negative imaging studies.

Variation in prostate cancer detection rates in a statewide quality improvement collaborative.

PURPOSE: There remains significant controversy surrounding the optimal criteria for recommending prostate biopsy. To examine this issue further urologists in MUSIC assessed statewide prostate biopsy practice patterns and variation in prostate cancer detection. MATERIALS AND METHODS: MUSIC is a statewide, physician led collaborative designed to improve prostate cancer care. From March 2012 through June 2013 at 17 MUSIC practices standardized clinical and pathological data were collected on a total of 3,015 men undergoing first-time prostate biopsy. We examined pathological biopsy outcomes according to patient characteristics and across MUSIC practices. RESULTS: The average cancer detection rate was 52% with significant variability across MUSIC practices (range 43% to 70%, p<0.0001). Of all patients biopsied 27% were older than 69 years, ranging from 19% to 36% at individual practices. Men with prostate specific antigen less than 4 ng/ml comprised an average of 26% of the study population (range 10% to 37%). The detection rate in patients older than 69 years ranged from 42% to 86% at individual practices (p=0.0008). In the 793 patients with prostate specific antigen less than 4 ng/ml the cancer detection rate ranged from 22% to 58% across individual practices (p=0.0065). The predicted probability of cancer detection varied significantly across MUSIC practices even after adjusting for patient age, prostate specific antigen, prostate size, family history and digital rectal examination findings (p<0.0001). CONCLUSIONS: While overall detection rates are higher than previously reported, the cancer yield of prostate biopsy varies widely across urology practices in Michigan. These data serve as a foundation for our efforts to understand and improve patient selection for prostate biopsy.

Infection related hospitalizations after prostate biopsy in a statewide quality improvement collaborative.

PURPOSE: While transrectal prostate biopsy is the cornerstone of prostate cancer diagnosis, serious post-biopsy infectious complications are reported to be increasing. A better understanding of the true prevalence and microbiology of these events is needed to guide quality improvement in this area and ultimately better early detection practices. MATERIALS AND METHODS: Using data from the MUSIC registry we identified all men who underwent transrectal prostate biopsy at 21 practices in Michigan from March 2012 to June 2013. Trained data abstractors recorded pertinent data including prophylactic antibiotics and all biopsy related hospitalizations. Claims data and followup telephone calls were used for validation. All men admitted to the hospital for an infectious complication were identified and their culture data were obtained. We then compared the frequency of infection related hospitalization rates across practices and according to antibiotic prophylaxis in concordance with AUA best practice recommendations. RESULTS: The overall 30-day hospital admission rate after prostate biopsy was 0.97%, ranging from 0% to 4.2% across 21 MUSIC practices. Of these hospital admissions 95% were for infectious complications and the majority of cultures identified fluoroquinolone resistant organisms. AUA concordant antibiotics were administered in 96.3% of biopsies. Patients on noncompliant antibiotic regimens were significantly more likely to be hospitalized for infectious complications (3.8% vs 0.89%, p=0.0026). CONCLUSIONS: Infection related hospitalizations occur in approximately 1% of men undergoing prostate biopsy in Michigan. Our findings suggest that many of these events could be avoided by implementing new protocols (eg culture specific or augmented antibiotic prophylaxis) that adhere to AUA best practice recommendations and address fluoroquinolone resistance.

A phase II clinical trial of neoadjuvant ketoconazole and docetaxel chemotherapy before radical prostatectomy in high risk patients.

PURPOSE: Patients with high risk prostate cancer (prostate specific antigen greater than 20 ng/ml, Gleason score greater than 7, or clinical stage T2b or greater) have been shown to have a 30% to 40% biochemical recurrence rate after definitive local therapy. Looking for improvement on these outcomes, we conducted a phase II clinical trial examining the combination of ketoconazole and docetaxel in the neoadjuvant setting before radical prostatectomy. MATERIALS AND METHODS: A total of 22 patients with clinically localized, high risk prostate cancer were enrolled in the study. For 12 weeks they were treated with neoadjuvant docetaxel and ketoconazole, with dosing based on phase I data. Patients were monitored for tolerance of therapy and dosing adjustments were made for significant toxicities. Radical prostatectomy with extended lymph node dissection was subsequently performed and patients were followed postoperatively for biochemical recurrence. RESULTS: At a median followup of 18 months 8 patients remained biochemically free of recurrence after surgery alone. An additional 6 patients received salvage therapy and had an undetectable prostate specific antigen. Of the 22 patients 16 experienced National Cancer Institute grade 3 or 4 toxicity at some point during the therapy. However, 16 patients completed all 4 cycles of chemotherapy. CONCLUSIONS: Neoadjuvant ketoconazole combined with docetaxel has appreciable but acceptable toxicity with 73% of the patients completing all 4 courses of therapy. Of those who underwent radical prostatectomy 36% remained continuously biochemically free of recurrence at a median followup of 18 months.