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Designing a theory-based intervention to improve the guideline-concordant use of imaging to stage incident prostate cancer
Ciprut, Shannon; Sedlander, Erica; Watts, Kara L; Matulewicz, Richard S; Stange, Kurt C; Sherman, Scott E; Makarov, Danil V
Among US men, most new prostate cancer cases are clinically localized and do not require imaging as part of staging workup according to guidelines. Two leading specialty societies promote stewardship of health resources by encouraging guideline-concordant care, thereby limiting inappropriate and obsolete imaging. However, imaging to stage low-risk prostate cancer remains high, as almost half of men with localized prostate cancer undergo wasteful imaging following diagnosis. We employed a theory-based approach, based on current evidence and data on existing practice patterns revealing that providers are the drivers to imaging decisions, to design an intervention to improve guideline -concordant prostate cancer staging imaging across populations. We conceptualized preliminary results using the theoretical domains framework and the behavior change wheel, frameworks used concurrently to investigate physicians' behaviors and intervention design in various clinical settings. Through these 2 frameworks, we designed a theory-based, physician-focused intervention to efficiently encourage guideline-concordant prostate cancer imaging, prostate cancer imaging stewardship (PCIS). Prostate cancer imaging stewardship consists of interventions (clinical order check, academic detailing, and audit and feedback) implemented at the individual, facility, and system level to enact provider behavior change by enabling facilitators and appealing to physician motivation.
PMID: 29398250
ISSN: 1873-2496
CID: 3101102
Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. Part II: Recommended Approaches and Details of Specific Care Options
Sanda, Martin G; Cadeddu, Jeffrey A; Kirkby, Erin; Chen, Ronald C; Crispino, Tony; Fontanarosa, Joann; Freedland, Stephen J; Greene, Kirsten; Klotz, Laurence H; Makarov, Danil V; Nelson, Joel B; Rodrigues, George; Sandler, Howard M; Taplin, Mary Ellen; Treadwell, Jonathan R
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.
PMID: 29331546
ISSN: 1527-3792
CID: 3703702
The implications of baseline bone health assessment at initiation of androgen deprivation therapy for prostate cancer
Kirk, Peter S; Borza, Tudor; Shahinian, Vahakn B; Caram, Megan E V; Makarov, Danil V; Shelton, Jeremy B; Leppert, John T; Blake, Ryan M; Davis, Jennifer A; Hollenbeck, Brent K; Sales, Anne; Skolarus, Ted A
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.
PMCID:5878705
PMID: 29124881
ISSN: 1464-410x
CID: 2772902
Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. Part I: Risk Stratification, Shared Decision Making, and Care Options
Sanda, Martin G; Cadeddu, Jeffrey A; Kirkby, Erin; Chen, Ronald C; Crispino, Tony; Fontanarosa, Joann; Freedland, Stephen J; Greene, Kirsten; Klotz, Laurence H; Makarov, Danil V; Nelson, Joel B; Rodrigues, George; Sandler, Howard M; Taplin, Mary Ellen; Treadwell, Jonathan R
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.
PMID: 29203269
ISSN: 1527-3792
CID: 3703692
Management of Penile Cancer
Bjurlin, Marc A; Makarov, Danil V
PMCID:6003306
PMID: 29942204
ISSN: 1523-6161
CID: 3703712
Evaluation of Unplanned Hospital Readmissions after Major Urologic Inpatient Surgery in the Era of Accountable Care
Stone, Benjamin V; Cohn, Matthew R; Donin, Nicholas M; Schulster, Michael; Wysock, James S; Makarov, Danil V; Bjurlin, Marc A
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.
PMID: 28801217
ISSN: 1527-9995
CID: 2664282
Tweet this: how advocacy for breast and prostate cancers stacks up on social media [Letter]
Loeb, Stacy; Stork, Brian; Gold, Heather T; Stout, Natasha K; Makarov, Danil V; Weight, Christopher J; Borgmann, Hendrik
PMID: 28471484
ISSN: 1464-410x
CID: 2594232
Exploration of the ASCO and ESMO Value Frameworks for Antineoplastic Drugs
Becker, Daniel J; Lin, Daniel; Lee, Steve; Levy, Benjamin P; Makarov, Danil V; Gold, Heather T; Sherman, Scott
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.
PMID: 28493760
ISSN: 1935-469x
CID: 2549142
Teaching Hospitals and the Disconnect Between Technology Adoption and Comparative Effectiveness Research: The Case of the Surgical Robot
Makarov, Danil V; Li, Huilin; Lepor, Herbert; Gross, Cary P; Blustein, Jan
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.
PMID: 27034439
ISSN: 1552-6801
CID: 2179612
Accuracy of Prostate-Specific Antigen Values in Prostate Cancer Registries [Letter]
Mittakanti, Harsha R; Thomas, I-Chun; Chung, Benjamin I; Sonn, Geoffrey A; Brooks, James D; Leppert, John T; Shelton, Jeremy B; Cooperberg, Mathew R; Makarov, Danil V; Skolarus, Ted A
PMID: 27458297
ISSN: 1527-7755
CID: 2191492