Faculty Bibliography

OBJECTIVES: To assess bone density testing (BDT) use among prostate cancer survivors receiving ADT, and downstream implications for osteoporosis and fracture diagnoses as well as pharmacologic osteoporosis treatment in a national integrated delivery system. METHODS: We identified 17,017 men with prostate cancer who received any ADT between 2005 and 2014 using Veterans Health Administration cancer registry and administrative data. We identified claims for BDT within a 3-year period of ADT initiation. We then used multivariable regression to examine the association between BDT use and incident osteoporosis, fracture, and use of pharmacologic treatment. RESULTS: We found a minority of patients received BDT (n=2,502, 15%), however the rate of testing increased to over 20% by the end of the study period. Men receiving BDT were older at diagnosis and had higher-risk prostate cancer (both p<0.001). Osteoporosis and fracture diagnoses, use of vitamin D +/- calcium, and bisphosphonates were all more common in men who received BDT. After adjustment, BDT, and to a lesser degree, 2 or more years of ADT, were both independently associated with incident osteoporosis, fracture, and osteoporosis treatment. CONCLUSIONS: Bone density testing is rare among prostate cancer patients treated with ADT in this integrated delivery system. However, BDT was associated with substantially increased treatment of osteoporosis indicating an underappreciated burden of osteoporosis among prostate cancer survivors initiating ADT. Optimizing BDT use and osteoporosis management in this at-risk population appears warranted.

PURPOSE/OBJECTIVE:This guideline is structured to provide a clinical framework stratified by cancer severity to facilitate care decisions and guide the specifics of implementing the selected management options. The summary presented herein represents Part II of the two-part series dedicated to Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline discussing risk stratification and care options by cancer severity. Please refer to Part I for discussion of specific care options and outcome expectations and management. MATERIALS AND METHODS/METHODS:The systematic review utilized in the creation of this guideline was completed by the Agency for Healthcare Research and Quality and through additional supplementation by ECRI Institute. This review included articles published between January 2007 and March 2014 with an update search conducted through August 2016. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. Additional information is provided as Clinical Principles and Expert Opinions (table 2 in supplementary unabridged guideline, http://jurology.com/). RESULTS:The AUA (American Urological Association), ASTRO, and SUO (Society of Urologic Oncology) formulated an evidence-based guideline based on a risk stratified clinical framework for the management of localized prostate cancer. CONCLUSIONS:This guideline attempts to improve a clinician's ability to treat patients diagnosed with localized prostate cancer, but higher quality evidence in future trials will be essential to improve the level of care for these patients. In all cases, patient preferences should be considered when choosing a management strategy.

PURPOSE/OBJECTIVE:This guideline is structured to provide a clinical framework stratified by cancer severity to facilitate care decisions and guide the specifics of implementing the selected management options. The summary presented represents Part I of the two-part series dedicated to Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline discussing risk stratification and care options by cancer severity. MATERIALS AND METHODS/METHODS:The systematic review utilized in the creation of this guideline was completed by the Agency for Healthcare Research and Quality and through additional supplementation by ECRI Institute. This review included articles published between January 2007 and March 2014 with an update search conducted through August 2016. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. Additional information is provided as Clinical Principles and Expert Opinions (table 2 in supplementary unabridged guideline, http://jurology.com/). RESULTS:The AUA (American Urological Association), ASTRO, and SUO (Society of Urologic Oncology) formulated an evidence-based guideline based on a risk stratified clinical framework for the management of localized prostate cancer. CONCLUSIONS:This guideline attempts to improve a clinician's ability to treat patients diagnosed with localized prostate cancer, but higher quality evidence in future trials will be essential to improve the level of care for these patients. In all cases, patient preferences should be considered when choosing a management strategy.

OBJECTIVE: To provide a multi-institutional analysis of clinical factors predicting unplanned hospital readmission after major inpatient urologic surgery. MATERIALS AND METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) is a risk-adjusted data collection mechanism for analyzing clinical outcomes data including 30-day perioperative readmissions and complications. We identified 23,108 patients who underwent major inpatient urologic surgery from 2011 to 2012. Readmission rates were determined and stratified by procedure type. Multiple logistic regression was used to determine independent risk factors for 30-day unplanned hospital readmissions. RESULTS: Of 23,108 total patients undergoing urologic surgery, 1329 patients (5.8%) had unplanned readmissions. Upper tract reconstruction and urinary diversion without cystectomy (21/102) and cystectomy (291/1,662) had the highest rates of readmission of all procedures analyzed. Readmitted patients had a 64.2% (853/1329) and 64.4% (855/1329 patients) rate of major and minor complications, respectively, compared to 6.7% (1459/21779) and 15.9% (3462/21779) for patients not readmitted (p<0.02). Organ space infection (OR 15.23), pulmonary embolism (OR 12.14), deep venous thrombosis (OR 10.96), and return to the operating room (OR 8.46) were the most substantial predictors of readmission. Laparoscopic/robotic procedures had significantly lower readmission rates compared to open procedures for prostatectomy, partial nephrectomy, and nephrectomy (p<0.01). CONCLUSIONS: Readmission after inpatient urological surgery occurs at a rate of 5.8%, with cystectomy and urinary diversion demonstrating the highest rates. Major and minor postoperative complications were the most substantial predictors of readmission. These results may guide risk reduction initiatives to prevent readmissions after major urologic surgery.

PURPOSE: In 2015, both ASCO and the European Society for Medical Oncology (ESMO) proposed frameworks to quantify the benefit of antineoplastic drugs in the face of rising costs. We applied these frameworks to drugs approved by the US Food and Drug Administration over the past 12 years and examined relationships between costs and benefits. METHODS: We searched FDA.gov for drugs that received initial approval for solid tumors from 2004 to 2015 and calculated the ASCO Net Health Benefit version 2016 (NHB16) and 2015 (NHB15) and the ESMO Magnitude of Clinical Benefit Scale scores for each drug. We calculated descriptive statistics and explored correlations and associations among benefit scores, cost, and independent variables. RESULTS: We identified 55 drug approvals supported by phase II (18.2%) and III (81.8%) trials, with primary outcomes of overall survival (36.4%), progression-free survival (43.6%), or response rate (20.0%). No significant association was found between NHB16 and year of approval ( P = .81), organ system ( P = .20), or trial comparator arm ( P = .17), but trials with progression-free survival outcomes were associated with higher scores ( P = .007). Both NHB15 and Magnitude of Clinical Benefit Scale scores were approximately normally distributed, but only a moderate correlation existed between them ( r = 0.40, P = .006). No correlation between benefit score and cost (NHB16, r = 0.19; ESMO, r = -0.07) was found. Before 2010, two (15.3%) of 13 approved drugs exceeded $500/NHB point x month compared with 10 (25.0%) of 40 drugs subsequently approved. CONCLUSION: Our analysis of the ASCO and ESMO value frameworks illuminates the heterogeneous benefit of new medications and highlights challenges in constructing a unified concept of drug value. Drug benefit does not correlate with cost, and the number of high cost/benefit outliers has increased.

The surgical robot, a costly technology for treatment of prostate cancer with equivocal marginal benefit, rapidly diffused into clinical practice. We sought to evaluate the role of teaching in the early adoption phase of the surgical robot. Teaching hospitals were the primary early adopters: data from the Healthcare Cost and Utilization Project showed that surgical robots were acquired by 45.5% of major teaching, 18.0% of minor teaching and 8.0% of non-teaching hospitals during the early adoption phase. However, teaching hospital faculty produced little comparative effectiveness research: By 2008, only 24 published studies compared robotic prostatectomy outcomes to those of conventional techniques. Just ten of these studies (41.7%) were more than minimally powered, and only six (25%) involved cross-institutional collaborations. In adopting the surgical robot, teaching hospitals fulfilled their mission to innovate, but failed to generate corresponding scientific evidence.

BACKGROUND: Approximately half of veterans with low-risk prostate cancer receive guideline-discordant imaging. Our objective was to identify and describe (1) physician knowledge, attitudes, and practices related to the use of imaging to stage prostate cancer, (2) patient attitudes and behaviors related to use of imaging, and (3) to compare responses across three VA medical centers (VAMCs). METHODS: A qualitative approach was used to explore patient and provider knowledge and behaviors relating to the use of imaging. We conducted 39 semi-structured interviews total-including 22 interviews with patients with newly diagnosed with prostate cancer and 17 interviews with physicians caring for them-between September 2014 and July 2015 at three VAMCs representing a spectrum of inappropriate imaging rates. After core theoretical concepts were identified, the Theoretical Domains Framework (TDF) was selected to explore linkages between themes within the dataset and existing domains within the framework. Interviews were audio-recorded, transcribed verbatim, and then coded and analyzed using Nvivo software. RESULTS: Themes from patient interviews were categorized within four TDF domains. Patients reported little interest in staging as compared to disease treatment (goals), and many could not remember if they had imaging at all (knowledge). Patients tended to trust their doctor to make decisions about appropriate tests (beliefs about capabilities). Some patients expressed a minor concern for radiation exposure, but anxiety about cancer outcomes outweighed these fears (emotion). Themes from physician interviews were categorized within five TDF domains. Most physicians self-reported that they know and trust imaging guidelines (knowledge) yet some were still likely to follow their own intuition, whether due to clinical suspicion or years of experience (beliefs about capabilities). Additionally, physicians reported that medico-legal concerns, fear of missing associated diagnoses (beliefs about consequences), influence from colleagues who image frequently (social influences), and the facility where they practice influences rates of imaging (environmental context). CONCLUSIONS: Interviews with patients and physicians suggest that physicians are the primary (and in some cases only) decision-makers regarding staging imaging for prostate cancer. This finding suggests a physician-targeted intervention may be the most effective strategy to improve guideline-concordant prostate cancer imaging.