Comparing Patient-reported Functional Outcomes After Radical Prostatectomy in Historical and Contemporary Practice.

PURPOSE: Modifications to surgical technique, particularly the widespread adoption of robotic surgery, have been proposed to improve functional recovery after prostate cancer surgery. However, rigorous comparison of men in historical vs contemporary practice to evaluate the cumulative effect of these changes on urinary and sexual function after radical prostatectomy is lacking. MATERIALS AND METHODS: We compared prospectively collected patient-reported urinary and sexual function from historical (PROSTQA [Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment study], n=235) and contemporary (MUSIC-PRO [Michigan Urological Surgery Improvement Collaborative Patient Reported Outcome] registry, n=1,215) cohorts at the University of Michigan to understand whether modern techniques have resulted in functional improvements for men undergoing prostate cancer surgery. RESULTS: We found significant differences in baseline function, with better urinary (median [IQR]; 100 [93.8-100] vs 93.8 [85.5-100], P < .001) and sexual scores (median [IQR]; 83.3 [66.7-100] vs 74.4 [44.2-87.5], P < .001) prior to treatment in PROSTQA compared to MUSIC-PRO patients, respectively. There was no statistically significant difference in the pattern of urinary incontinence recovery after surgery from 6-24 months between groups (P = .14). However, men in the contemporary MUSIC-PRO group did have significantly better recovery of sexual function compared to men in the historical PROSTQA group (P < .0001). Further, we found that contemporary practice consists of men with more unfavorable demographic and clinical characteristics compared to historical practice. CONCLUSIONS: Our results demonstrate that the widespread alterations in prostate cancer surgery over the past 2 decades have yielded improvements in sexual, but not urinary, function recovery.

The added influence of genomics and post-MRI confirmatory biopsy results to MRI results alone on medical decision making for men with favorable risk prostate cancer being considered for active surveillance.

BACKGROUND: We examined how the results of genomic classifier (GC) or post-magnetic resonance imaging confirmatory biopsy (pMRI-CBx) influenced management strategy for men with an MRI considering active surveillance (AS). METHODS: We reviewed the Michigan Urological Surgery Improvement Collaborative registry for men with favorable-risk prostate cancer. Among men with an MRI after the diagnostic biopsy (n = 1162) a subset also had GC (n = 126) or pMRI-CBx (n = 309). Results of MRI, GC, and pMRI-CBx were deemed reassuring (RA) or non-reassuring (Non-RA). We assess the association of the combination of test results obtained with the selection of AS. Proportions were compared with the Fisher's exact test. Multivariable logistic regression models were fit for an association of test results with the selection of AS. RESULTS: The results of pMRI-CBx tended to influence management decisions greater than that of GC, especially in situation where testing results were discordant with the MRI result. Fewer men with a RA MRI and non-RA pMRI-CBx where managed with AS compared with RA MRI alone (31% vs. 86%, p < 0.001). non-RA genomics did not seem to have the same influence on management as non-RA pMRI-CBx as a similar proportion of men with RA MRI and non-RA genomics were managed with AS compared with RA MRI alone (85% vs. 86%, p = 0.753). More men with non-RA MRI and RA pMRI-CBx were managed with AS compared with non-RA MRI alone (89% vs. 40%, p < 0.001). Alternatively, a similar proportion of men with non-RA MRI and RA genomics were managed with AS compared with non-RA MRI alone (42% vs. 40%, p > 0.999). In the multivariable models, pMRI-CBx results influenced the decision for AS versus treatment. CONCLUSIONS: In men with newly diagnosed prostate cancer and an MRI, the additional information provided by pMRI-CBx influenced the decision of AS versus treatment, while the addition of GC results were less influential.

Delayed radical prostatectomy after a period of active surveillance is not associated with the use of secondary treatments compared with immediate prostatectomy.

BACKGROUND: We evaluated the use of secondary treatments in men with grade group (GG) 1 PC following a period of active surveillance (AS) compared with men undergoing immediate radical prostatectomy (RP) to evaluate what is potentially lost in terms of cancer control, if a patient trials AS and transitions to treatment. METHODS: We reviewed the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry for men with GG1 PC undergoing RP from April 2012 to July 2018. Men were classified into groups based on time from diagnosis to RP: immediate (surgery within 1 year of diagnosis) and delayed RP (surgery >1 year after initiation of AS). Time to secondary treatment was estimated using Kaplan-Meier curves and compared using the log-rank test. A multivariable Cox proportional hazards model was fit to assess the association between timing of RP and use of secondary treatments. A chi-squared test was used to assess the association between delayed RP and adverse pathology. RESULTS: We identified 1878 men that underwent an RP during the study period, of which 1489 (79%) underwent immediate RP and 389 (21%) underwent delayed RP. The incidence of adverse pathology was higher in men with delayed versus immediate RP (49% vs. 36%, p < 0.0001, respectively). However, we noted only a small absolute difference in the estimated 24-month secondary treatment-free probability between men with delayed versus immediate RP (93% and 96%, respectively). On multivariable analysis, delayed RP was associated with increased use of secondary treatments (hazard ratio = 1.94, 95% confidence interval = 1.23-3.06, p = 0.004). CONCLUSIONS: The use of secondary treatment after RP in men with GG1 PC undergoing immediate or delayed prostatectomy was rare. These data suggest that the burden of treatment is near equivalent in patients who progress to treatment on AS compared with those who underwent immediate RP.

Urologic oncology patient perspectives during COVID-19 treatment delays.

PURPOSE: We sought to describe patient experiences during COVID-19 related delays in urologic cancer treatment. METHODS: We conducted a mixed methods study with an explanatory-sequential design. Survey findings are presented here. Patients from a Midwestern Cancer Center and the Bladder Cancer Advocacy Network (BCAN) self-reported via survey their experience of treatment delay, patient-provider communication, and coping strategies. We quantified patient distress with an ordinal scale (0-10), based on the National Comprehensive Cancer Network Distress Thermometer (NCCN-DT). RESULTS: Forty-four patients with bladder, prostate, and kidney cancers consented to the survey. Most individuals were male (n = 29; 66%) and older than 61 years of age (n = 34; 77%). Median time since diagnosis was 6 months. Dominant reactions to treatment delay included fear that cancer would progress (n = 22; 50%) and relief at avoiding COVID-19 exposure (n = 19; 43%). Most patients reported feeling that their providers acknowledged their emotions (n = 31; 70%), yet 23 patients (52%) did not receive follow-up phone calls and only 24 (55%) felt continually supported by their providers. Patients' median distress level was 5/10 with 68% (n = 30) of patients reaching a clinically significant level of distress (≥ 4). Thematically grouped suggestions for providers included better communication, more personalized support, and better patient education. CONCLUSION: During the COVID-19 pandemic, a high proportion of urologic cancer patients reached a clinically significant level of distress. While they felt concern from providers, they desired more engagement and personalized care.

Delayed urologic cancer care in the COVID-19 pandemic: Patients' experiences.

OBJECTIVE: To understand experiences of patients with genitourinary cancer who experienced delayed cancer care due to the COVID-19 pandemic. METHODS: We conducted a mixed methods study with an explanatory sequential design. Qualitative findings are reported here. Patients with muscle invasive bladder, advanced prostate or kidney cancer were eligible. Participants were selected for interviews if they self-reported low (0-3/10) or high (6-10/10) levels of distress on a previous survey. Participants were interviewed about their experiences. Interviews were transcribed, coded and categorised using thematic data analysis methodology. RESULTS: Eighteen patients were interviewed. Seven had prostate cancer, six bladder cancer and five kidney cancer. Six themes were derived from the interviews: (1) arriving at cancer diagnosis was hard enough, (2) response to treatment delay, (3) labelling cancer surgery as elective, (4) fear of COVID-19 infection, (5) quality of patient-provider relationship and communication and (6) what could have been done differently. CONCLUSION: These findings offer insight into the concerns of patients with genitourinary cancers who experienced treatment delays due to COVID-19. This information can be applied to support patients with cancers more broadly, should treatment delays occur in the future.

Limitations of abdominopelvic CT and multiparametric MR imaging for detection of lymph node metastases prior to radical prostatectomy.

PURPOSE: To investigate the performance of pre-surgery CT and multiparametric MRI (mpMRI) to identify lymph node (LN) metastases in the Michigan Urological Surgery Improvement Collaborative (MUSIC). Abdominopelvic CT and mpMRI are commonly used for intermediate- and high-risk prostate cancer (PCa) staging. METHODS: Retrospective analysis of the MUSIC registry identified patients undergoing robot-assisted radical prostatectomy (RP) between 3/2012 and 7/2018. Patients were classified according to pre-surgery imaging modality. Primary outcomes were operating characteristics of CT and mpMRI for detection of pathologic LN involvement (pN1). RESULTS: A total of 10,250 patients underwent RP and 3924 patients (38.3%) underwent CT and/or mpMRI prior to surgery. Suspicion for LN involvement was identified on 2.3% CT and 1.9% mpMRI. Overall, 391 patients were pN1(3.8%), including 0.1% low-, 2.1% intermediate-, and 10.9% high-risk PCa patients. Of 235 pN1 patients that underwent CT prior, far more had negative (91.1%) than positive (8.9%) findings, yielding sensitivity: 8.9%, specificity: 98.3%, negative predictive value (NPV): 92.1%, and positive predictive value (PPV): 32.3% for CT with regard to LN metastases. Similarly, more patients with pN1 disease had negative mpMRI (81.0%) then suspicious or indeterminate MRI (19.0%), yielding sensitivity: 19.0%, specificity: 97.3%, NPV: 95.9%, and PPV: 26.7%. CONCLUSIONS: Abdominopelvic CT and mpMRI have clear limitations in identifying LN metastases. Additional clinicopathologic features should be considered when making management decisions, as 2.1% and 10.9% with intermediate-and high-risk cancer had metastatic LNs. The majority of pN1 patients had a negative CT or a negative/indeterminate mpMRI prior to RP. Pelvic LN dissection should be performed in RP patients with intermediate- or high-risk PCa, independent of preoperative imaging results.

Grade Groups Provide Improved Predictions of Pathological and Early Oncologic Outcomes Compared with Gleason Score Risk Groups.

PURPOSE: The GG (Grade Group) system was introduced in 2013. Data from academic centers suggest that GG better distinguishes between prostate cancer risk groups than the Gleason score (GS) risk groups. We compared the performance of the 2 systems to predict pathological/recurrence outcomes using data from the MUSIC (Michigan Urological Surgery Improvement Collaborative). MATERIALS AND METHODS: Patients who underwent biopsy and radical prostatectomy in the MUSIC from March 2012 to June 2017 were classified according to GG and GS. Outcomes included the presence or absence of extraprostatic extension, seminal vesical invasion, positive lymph nodes, positive surgical margins and time to cancer recurrence (defined as postoperative prostate specific antigen 0.2 ng/ml or greater). Logistic and Cox regression models were used to compare the difference in outcomes. RESULTS: A total of 8,052 patients were identified. When controlling for patient characteristics, significantly higher risks of extraprostatic extension, seminal vesical invasion and positive lymph nodes were observed for biopsy GG 3 vs 2 and for GG 5 vs 4 (p <0.001). Biopsy GGs 3, 4 and 5 also showed shorter time to biochemical recurrence than GGs 2, 3 and 4, respectively (p <0.001). GGs 3, 4 and 5 at radical prostatectomy were each associated with a greater probability of recurrence compared to the next lower GG (p <0.001). GG (vs GS) had better predictive power for extraprostatic extension, seminal vesical invasion, positive lymph nodes and biochemical recurrence. CONCLUSIONS: GG at biopsy and radical prostatectomy allows for better discrimination of recurrence-free survival between individual risk groups than GS risk groups with GGs 2, 3, 4 and 5 each incrementally associated with increased risk.

Pathological upgrading at radical prostatectomy for patients with Grade Group 1 prostate cancer: implications of confirmatory testing for patients considering active surveillance.

OBJECTIVE: To examine the association between National Comprehensive Cancer Network (NCCN) risk, number of positive biopsy cores, age, and early confirmatory test results on pathological upgrading at radical prostatectomy (RP), in order to better understand whether early confirmatory testing and better risk stratification are necessary for all men with Grade Group (GG) 1 cancers who are considering active surveillance (AS). PATIENTS AND METHODS: We identified men in Michigan initially diagnosed with GG1 prostate cancer, from January 2012 to November 2017, who had a RP within 1 year of diagnosis. Our endpoints were: (i) ≥GG2 cancer at RP and (ii) adverse pathology (≥GG3 and/or ≥pT3a). We compared upgrading according to NCCN risk, number of positive biopsy cores, and age. Last, we examined if confirmatory test results were associated with upgrading or adverse pathology at RP. RESULTS: Amongst 1966 patients with GG1 cancer at diagnosis, the rates of upgrading to ≥GG2 and adverse pathology were 40% and 59% (P < 0.001), and 10% and 17% (P = 0.003) for patients with very-low- and low-risk cancers, respectively. Upgrading by volume ranged from 49% to 67% for ≥GG2, and 16% to 23% for adverse pathology. Generally, more patients aged ≥70 vs <70 years had adverse pathology. Unreassuring confirmatory test results had a higher likelihood of adverse pathology than reassuring tests (35% vs 18%, P = 0.017). CONCLUSIONS: Upgrading and adverse pathology are common amongst patients initially diagnosed with GG1 prostate cancer. Early use of confirmatory testing may facilitate the identification of patients with more aggressive disease ensuring improved risk classification and safer selection of patients for AS.

Optimizing active surveillance strategies to balance the competing goals of early detection of grade progression and minimizing harm from biopsies.

BACKGROUND: Active surveillance (AS) for prostate cancer includes follow-up with serial prostate biopsies. The optimal biopsy frequency during follow-up has not been determined. The goal of this investigation was to use longitudinal AS biopsy data to assess whether the frequency of biopsy could be reduced without substantially prolonging the time to the detection of disease with a Gleason score ≥ 7. METHODS: With data from 1375 men with low-risk prostate cancer enrolled in AS at Johns Hopkins, a hidden Markov model was developed to estimate the probability of undersampling at diagnosis, the annual probability of grade progression, and the 10-year cumulative probability of reclassification or progression to Gleason score ≥ 7. It simulated 1024 potential AS biopsy strategies for the 10 years after diagnosis. For each of these strategies, the model predicted the mean delay in the detection of disease with a Gleason score ≥ 7. RESULTS: The model estimated the 10-year cumulative probability of reclassification from a Gleason score of 6 to a Gleason score ≥ 7 to be 40.0%. The probability of undersampling at diagnosis was 9.8%, and the annual progression probability for men with a Gleason score of 6 was 4.0%. On the basis of these estimates, a simulation of an annual biopsy strategy estimated the mean time to the detection of disease with a Gleason score ≥ 7 to be 14.1 months; however, several strategies eliminated biopsies with only small delays (<12 months) in detecting grade progression. CONCLUSIONS: Although annual biopsy for low-risk men on AS is associated with the shortest time to the detection of disease with a Gleason score ≥ 7, several alternative strategies may allow less frequent biopsying without sizable delays in detecting grade progression. Cancer 2018;124:698-705. © 2017 American Cancer Society.

Cost-effectiveness of magnetic resonance imaging and targeted fusion biopsy for early detection of prostate cancer.

OBJECTIVE: To determine how best to use magnetic resonance imaging (MRI) and targeted MRI/ultrasonography fusion biopsy for early detection of prostate cancer (PCa) in men with elevated prostate-specific antigen (PSA) concentrations and whether it can be cost-effective. METHODS: A Markov model of PCa onset and progression was developed to estimate the health and economic consequences of PCa screening with MRI. Patients underwent PSA screening from ages 55 to 69 years. Patients with elevated PSA concentrations (>4 ng/mL) underwent MRI, followed by targeted fusion or combined (standard + targeted fusion) biopsy on positive MRI, and standard or no biopsy on negative MRI. Prostate Imaging Reporting and Data System (PI-RADS) score on MRI was used to determine biopsy decisions. Deaths averted, quality-adjusted life-years (QALYs), cost and incremental cost-effectiveness ratio (ICER) were estimated for each strategy. RESULTS: With a negative MRI, standard biopsy was more expensive and had lower QALYs than performing no biopsy. The optimum screening strategy (ICER $23 483/QALY) recommended combined biopsy for patients with PI-RADS score ≥3 and no biopsy for patients with PI-RADS score <3, and reduced the number of screening biopsies by 15%. Threshold analysis suggests MRI continues to be cost-effective when the sensitivity and specificity of MRI and combined biopsy are simultaneously reduced by 19 percentage points. CONCLUSIONS: Our analysis suggests MRI followed by targeted MRI/ultrasonography fusion biopsy can be a cost-effective approach to the early detection of PCa.

Evaluation of a needle disinfectant technique to reduce infection-related hospitalisation after transrectal prostate biopsy.

OBJECTIVES: To determine whether a needle disinfectant step during transrectal ultrasonography (TRUS)-guided prostate biopsy is associated with lower rates of infection-related hospitalisation. PATIENTS AND METHODS: We conducted a retrospective analysis of all TRUS-guided prostate biopsies taken across the Michigan Urological Surgery Improvement Collaborative (MUSIC) from January 2012 to March 2015. Natural variation in technique allowed us to evaluate for differences in infection-related hospitalisations based on whether or not a needle disinfectant technique was used. The disinfectant technique was an intra-procedural step to cleanse the biopsy needle with antibacterial solution after each core was sampled (i.e., 10% formalin or 70% isopropyl alcohol). After grouping biopsies according to whether or not the procedure included a needle disinfectant step, we compared the rate of infection-related hospitalisations within 30 days of biopsy. Generalised estimating equation models were fit to adjust for potential confounders. RESULTS: During the evaluated period, 17 954 TRUS-guided prostate biopsies were taken with 5 321 (29.6%) including a disinfectant step. The observed rate of infection-related hospitalisation was lower when a disinfectant technique was used during biopsy (0.60% vs 0.90%; P = 0.04). After accounting for differences between groups the adjusted hospitalisation rate in the disinfectant group was 0.85% vs 1.12% in the no disinfectant group (adjusted odds ratio 0.76, 95% confidence interval 0.50-1.15; P = 0.19). CONCLUSIONS: In this observational analysis, hospitalisations for infectious complications were less common when the TRUS-guided prostate biopsy included a needle disinfection step. However, after adjusting for potential confounders the effect of needle disinfection was not statistically significant. Prospective evaluation is warranted to determine if this step provides a scalable and effective method to minimise infectious complications.

Repeat Prostate Biopsy Practice Patterns in a Statewide Quality Improvement Collaborative.

PURPOSE: We examined rebiopsies in MUSIC (Michigan Urological Surgery Improvement Collaborative) to understand adherence to guidelines recommending repeat prostate biopsy in patients with multifocal high grade prostatic intraepithelial neoplasia or atypical small acinar proliferation. MATERIALS AND METHODS: We analyzed data on men undergoing repeat biopsy, practice patterns and cancer detection rates. Multivariate regression modeling was used to calculate the proportion of patients undergoing rebiopsy. We used claims data to validate the treatment classification in MUSIC. To understand reasons for not performing rebiopsy we reviewed records of a sample of patients with atypical small acinar proliferation. RESULTS: We identified 5,375 men with a negative biopsy, of whom 411 (7.6%) underwent repeat biopsy. In 718 men with high grade prostatic intraepithelial neoplasia, 350 with atypical small acinar proliferation and 587 with high grade prostatic intraepithelial neoplasia and atypical small acinar proliferation or atypical small acinar proliferation alone at initial biopsy the rebiopsy rate was 20.7%, 42.5% and 55.6%, respectively. The adjusted proportion of patients with rebiopsy in each practice ranged from 0% to 17.2% (p <0.001). The overall cancer detection rate at rebiopsy was 39.3%. It was highest after atypical small acinar proliferation (adjusted probability 0.39, 95% CI 0.30-0.48), and after high grade prostatic intraepithelial neoplasia and atypical small acinar proliferation (adjusted probability 0.50, 95% CI 0.35-0.65). The greatest Gleason 7 or greatest detection rate of 41.1% was found in patients with high grade prostatic intraepithelial neoplasia and atypical small acinar proliferation. Chart review revealed that 45.5% of patients with atypical small acinar proliferation underwent prostate specific antigen testing instead of rebiopsy while 36% failed to undergo rebiopsy despite a recommendation. CONCLUSIONS: Rebiopsy rates vary in Michigan practices with relatively low use in men with high grade prostatic intraepithelial neoplasia and atypical small acinar proliferation or atypical small acinar proliferation alone. Quality improvement strategies should target patients with atypical small acinar proliferation and high grade prostatic intraepithelial neoplasia as they have the highest likelihood of cancer detection.

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.

Appropriateness Criteria for Active Surveillance of Prostate Cancer.

PURPOSE: The adoption of active surveillance varies widely across urological communities, which suggests a need for more consistency in the counseling of patients. To address this need we used the RAND/UCLA Appropriateness Method to develop appropriateness criteria and counseling statements for active surveillance. MATERIALS AND METHODS: Panelists were recruited from MUSIC urology practices. Combinations of parameters thought to influence decision making were used to create and score 160 theoretical clinical scenarios for appropriateness of active surveillance. Recent rates of active surveillance among real patients across the state were assessed using the MUSIC registry. RESULTS: Low volume Gleason 6 was deemed highly appropriate for active surveillance whereas high volume Gleason 6 and low volume Gleason 3+4 were deemed appropriate to uncertain. No scenario was deemed inappropriate or highly inappropriate. Prostate specific antigen density, race and life expectancy impacted scores for intermediate and high volume Gleason 6 and low volume Gleason 3+4. The greatest degree of score dispersion (disagreement) occurred in scenarios with long life expectancy, high volume Gleason 6 and low volume Gleason 3+4. Recent rates of active surveillance use among real patients ranged from 0% to 100% at the provider level for low or intermediate biopsy volume Gleason 6, demonstrating a clear opportunity for quality improvement. CONCLUSIONS: By virtue of this work urologists have the opportunity to present specific recommendations from the panel to their individual patients. Community-wide efforts aimed at increasing rates of active surveillance and reducing practice and physician level variation in the choice of active surveillance vs treatment are warranted.

Bladder cancer in 2010: how far have we come?

Bladder cancer is the fourth most common cancer and ranks eighth as a cause of death from cancer among men in the United States. Although guidelines assist in treatment, the art of managing bladder cancer, such as the decision to use neoadjuvant chemotherapy and the timing of cystectomy, is still variable. Bladder cancer has a propensity to recur, and with recurrence, a significant number of cases progress, which makes the early detection of high-risk patients imperative. Advances in detection, surveillance, and treatment of bladder cancer are reviewed in this article.

Notable Outcomes and Trackable Events after Surgery: Evaluating an Uncomplicated Recovery after Radical Prostatectomy.

PURPOSE: A priority of MUSIC (Michigan Urological Surgery Improvement Collaborative) is to improve patient outcomes after radical prostatectomy. As part of these efforts we developed a novel system that uses unambiguous events to define an uncomplicated 30-day postoperative recovery and compares these outcomes across diverse urology practices. MATERIALS AND METHODS: MUSIC used a consensus approach to develop an uncomplicated recovery pathway comprising a set of precise perioperative events that are reliably measured and collectively reflect resource utilization, technical complications and coordination of care. Events that occurred outside the uncomplicated recovery pathway were considered deviations, including rectal injury, high blood loss, extended length of stay, prolonged drain or catheter placement, catheter replacement, hospital readmission or mortality. For men undergoing radical prostatectomy trained abstractors prospectively recorded clinical and perioperative data in an electronic registry. When a deviation from the NOTES (Notable Outcomes and Trackable Events after Surgery) pathway occurred, precipitating events were described by abstractors and we analyzed the events. RESULTS: From April 2014 through July 2015 a total of 2,245 radical prostatectomies were performed by 100 surgeons in a total of 37 diverse participating MUSIC practices. In the 29 practices in which 10 or more radical prostatectomies were performed during the interval analyzed the risk adjusted deviation rate ranged from 0.0% to 46.1% (p <0.0001). Anastomotic and gastrointestinal events were contributing factors in 50.2% of deviated cases. CONCLUSIONS: The novel NOTES system provides comparative data on unambiguous and actionable short-term outcomes after radical prostatectomy. The observed variation in outcomes across practices suggests opportunities for quality improvement initiatives. Decreasing anastomotic and gastrointestinal events represents a high impact opportunity for initial quality improvement efforts.

Evaluation of point-of-care PRO assessment in clinic settings: integration, parallel-forms reliability, and patient acceptability of electronic QOL measures during clinic visits.

PURPOSE: Assessment of patient-reported outcomes (PROs), such as health-related quality of life, has become an important component of healthcare that measures the impact of disease and medical treatment on patient health. Collecting PROs during point-of-care assessments and integrating them into the clinical setting, however, remains challenging. The objective of this pilot study was to evaluate the reliability, usability, and acceptability of point-of-care electronic PRO assessments implemented in a prostate cancer clinic. METHODS: Fifty subjects completed paper-pencil and computerized formats of the Expanded Prostate Cancer Index Composite (EPIC), a validated, condition-specific QOL instrument, at separate times before treatment. Parallel-forms reliability was evaluated by comparing mean scores, variations in response distribution, and correlations between administration formats. Correlation coefficients of at least 0.70 were used for reliability testing. Differences between administration forms, indicating potential bias, were compared using the signed-rank test. A 6-item acceptability scale was also used to evaluate patient acceptability and satisfaction with the electronic format. RESULTS: Mean scores and standard deviations were similar between the paper-pencil and electronic forms across all EPIC instrument domains, and no assessment bias was found. Each EPIC domain demonstrated a high reliability between administration formats (correlation coefficients: 0.70-0.98). The majority (>90 %) of respondents found that the computerized QOL format was user friendly and simple to use. CONCLUSIONS: Point-of-care computerized QOL assessments were reliable and acceptable to patients in this study, supporting the feasibility of PRO integration at the point-of-care in clinical settings.

Sexual Health Concerns Among Cancer Survivors: Testing a Novel Information-Need Measure Among Breast and Prostate Cancer Patients.

While it is recognized that cancer treatment can contribute to problems in sexual function, much less is currently known about the specific sexual health concerns and information needs of cancer survivors. This study tested a new instrument to measure cancer survivors' sexual health concerns and needs for sexual information after cancer treatment. The Information on Sexual Health: Your Needs after Cancer (InSYNC), developed by a multidisciplinary team of experts, is a novel 12-item questionnaire to measure sexual health concerns and information needs of cancer survivors. We tested the measure with a sample of breast and prostate cancer survivors. A convenience sample of 114 cancer survivors (58 breast, 56 prostate) was enrolled. Results of the InSYNC questionnaire showed high levels of sexual concern among cancer survivors. Areas of concern differed by cancer type. Prostate cancer survivors were most concerned about being able to satisfy their partners (57 %) while breast cancer survivors were most concerned with changes in how their bodies worked sexually (46 %). Approximately 35 % of all cancer survivors wanted more information about sexual health. Sexual health concerns and unmet information needs are common among breast and prostate cancer survivors, varying in some aspects by type of cancer. Routine screening for sexual health concerns should be included in comprehensive cancer survivorship care to appropriately address health care needs. The InSYNC questionnaire is one tool that may help clinicians identify concerns facing their patients.

Assessment of long-term outcomes associated with urinary prostate cancer antigen 3 and TMPRSS2:ERG gene fusion at repeat biopsy.

BACKGROUND: In men with clinically localized prostate cancer who have undergone at least 1 previous negative biopsy and have elevated serum prostate-specific antigen (PSA) levels, long-term health outcomes associated with the assessment of urinary prostate cancer antigen 3 (PCA3) and the transmembrane protease, serine 2 (TMPRSS2):v-ets erythroblastosis virus E26 oncogene homolog (avian) (ERG) gene fusion (T2:ERG) have not been investigated previously in relation to the decision to recommend a repeat biopsy. METHODS: The authors performed a decision analysis using a decision tree for men with elevated PSA levels. The probability of cancer was estimated using the Prostate Cancer Prevention Trial Risk Calculator (version 2.0). The use of PSA alone was compared with the use of PCA3 and T2:ERG scores, with each evaluated independently, in combination with PSA to trigger a repeat biopsy. When PCA3 and T2:ERG score evaluations were used, predefined thresholds were established to determine whether the patient should undergo a repeat biopsy. Biopsy outcomes were defined as either positive (with a Gleason score of <7, 7, or >7) or negative. Probabilities and estimates of 10-year overall survival and 15-year cancer-specific survival were derived from previous studies and a literature review. Outcomes were defined as age-dependent and Gleason score-dependent 10-year overall and 15-year cancer-specific survival rates and the percentage of biopsies avoided. RESULTS: Incorporating the PCA3 score (biopsy threshold, 25; generated based on the urine PCA3 level normalized to the amount of PSA messenger RNA) or the T2:ERG score (biopsy threshold, 10; based on the urine T2:ERG level normalized to the amount of PSA messenger RNA) into the decision to recommend repeat biopsy would have avoided 55.4% or 64.7% of repeat biopsies for the base-case patient, respectively, and changes in the 10-year survival rate were only 0.93% or 1.41%, respectively. Multi-way sensitivity analyses suggested that these results were robust with respect to the model parameters. CONCLUSIONS: The use of PCA3 or T2:ERG testing for repeat biopsy decisions can substantially reduce the number of biopsies without significantly affecting 10-year survival.