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Significant Management Variability of Urethral stricture Disease in United States: Data from the AUA Quality (AQUA) Registry
Cohen, Andrew J; Agochukwu-Mmonu, Nnenaya; Makarov, Danil V; Meeks, William; Murphy, John; Fang, Raymond; Cooperberg, Matthew R; Breyer, Benjamin N
OBJECTIVE:To determine the degree of contemporary practice variation for the treatment of urethral stricture disease (USD) given repeated endoscopic management yields poor long-term success. MATERIALS AND METHODS/METHODS:The AUA Quality (AQUA) Registry collects data from participating urologists across practice settings by direct interface with local electronic health record systems. We identified procedures used for USD using Current Procedural Terminology (CPT) and International Statistical Classification of Diseases (ICD-9/-10) codes. We assessed the association between patient and provider factors and repeated endoscopic treatment using generalized linear models. Provider details were derived from AUA Census. RESULTS:We identified 20,640 male patients with USD treated surgically in AQUA from 2014-2018. The patients were cared for by 1343 providers at 171 practices, 95% of these community-based. Among patients with USD who had treatment, 20,101(97.9%) underwent endoscopic management. 6218(31%) underwent repeated endoscopic treatment during the study period. Urethroplasty was performed in 539(2.6%) patients.  Median patient age at first procedure for endoscopic surgery vs. urethroplasty was 73 vs. 39 years old, respectively (p<0.001). At the practice level, significant variation in rates of repeated endoscopic management was noted. Patients of older age (OR=1.08, 95%CI: 1.06-1.11 for ages ≥80) and patients with a bladder cancer diagnosis (OR=1.17, 95%CI: 1.15-1.20) had higher odds of receiving repeated endoscopic management. Increasing practitioner age was also associated with increased odds of repeated endoscopic management. (OR=1.13, 95%CI: 1.11- 1.16, for practitioners ≥64). CONCLUSIONS:Repeated endoscopic management for USD is overused. The utilization of endoscopic management is variable across practices and frequently guideline-discordant, presenting an opportunity for quality improvement.
PMID: 32777368
ISSN: 1527-9995
CID: 4554832
A Clinical Reminder Order Check (CROC) Intervention to Improve Guideline-Concordant Imaging Practices for men with Prostate Cancer: A Pilot Study
Ciprut, Shannon E; Kelly, Matthew D; Walter, Dawn; Hoffman, Renee; Becker, Daniel J; Loeb, Stacy; Sedlander, Erica; Tenner, Craig T; Sherman, Scott E; Zeliadt, Steven B; Makarov, Danil V
OBJECTIVE:To understand how to potentially improve inappropriate prostate cancer imaging rates we used National Comprehensive Cancer Network's (NCCN) guidelines to design and implement a Clinical Reminder Order Check (CROC) that alerts ordering providers of potentially inappropriate imaging orders in real-time based on patient features of men diagnosed with low-risk prostate cancer. METHODS:We implemented the CROC at VA New York Harbor Healthcare System (VANYHHS) from April 2, 2015 to November 15, 2017. We then used VA administrative claims from the VA's Corporate Data Warehouse to analyze imaging rates among men with low-risk prostate cancer at VHANYHHS before and after CROC implementation. We also collected and cataloged provider responses in response to overriding the CROC in qualitative analysis. RESULTS:57% (117/205) of Veterans before CROC installation and 73% (61/83) of Veterans post-intervention with low-risk prostate cancer received guideline-concordant care. CONCLUSION/CONCLUSIONS:While the decrease in inappropriate imaging during our study window was almost certainly due to many factors, a CPRS-based CROC intervention is likely associated with at least moderate improvement in guideline-concordant imaging practices for Veterans with low-risk prostate cancer.
PMID: 32721517
ISSN: 1527-9995
CID: 4540602
Life expectancy estimates for patients diagnosed with prostate cancer in the Veterans Health Administration
Sohlberg, Ericka M; Thomas, I-Chun; Yang, Jaden; Kapphahn, Kristopher; Daskivich, Timothy J; Skolarus, Ted A; Shelton, Jeremy B; Makarov, Danil V; Bergman, Jonathan; Bang, Christine Ko; Goldstein, Mary K; Wagner, Todd H; Brooks, James D; Desai, Manisha; Leppert, John T
PURPOSE/OBJECTIVE:Accurate life expectancy estimates are required to inform prostate cancer treatment decisions. However, few models are specific to the population served or easily implemented in a clinical setting. We sought to create life expectancy estimates specific to Veterans diagnosed with prostate cancer. MATERIALS AND METHODS/METHODS:Using national Veterans Health Administration electronic health records, we identified Veterans diagnosed with prostate cancer between 2000 and 2015. We abstracted demographics, comorbidities, oncologic staging, and treatment information. We fit Cox Proportional Hazards models to determine the impact of age, comorbidity, cancer risk, and race on survival. We stratified life expectancy estimates by age, comorbidity and cancer stage. RESULTS:Our analytic cohort included 145,678 patients. Survival modeling demonstrated the importance of age and comorbidity across all cancer risk categories. Life expectancy estimates generated from age and comorbidity data were predictive of overall survival (C-index 0.676, 95% CI 0.674-0.679) and visualized using Kaplan-Meier plots and heatmaps stratified by age and comorbidity. Separate life expectancy estimates were generated for patients with localized or advanced disease. These life expectancy estimates calibrate well across prostate cancer risk categories. CONCLUSIONS:Life expectancy estimates are essential to providing patient-centered prostate cancer care. We developed accessible life expectancy estimation tools for Veterans diagnosed with prostate cancer that can be used in routine clinical practice to inform medical-decision making.
PMID: 32674954
ISSN: 1873-2496
CID: 4539142
Exploring Variation in the Use of Conservative Management for Low-risk Prostate Cancer in the Veterans Affairs Healthcare System
Loeb, Stacy; Byrne, Nataliya K; Wang, Binhuan; Makarov, Danil V; Becker, Daniel; Wise, David R; Lepor, Herbert; Walter, Dawn
Current guidelines recommend conservative management as the preferred option for most low-risk prostate cancer cases, with certain possible exceptions (age <55yr, African Americans, and high-volume grade group 1). Although previous studies have documented substantial heterogeneity in the uptake of conservative management, less is known about the underlying reason for this variation and whether it is due to guideline-concordant factors (age, race, and biopsy cancer volume). We explored variation in the use of conservative management for low-risk prostate cancer among 20 597 men diagnosed in the US Veterans Affairs health care system from 2010 to 2016. Conservative management increased substantially over this time from 51% to 76% (p< 0.001). However, there was substantial variation by facility (35-100%). Multivariable analysis revealed that patient factors included in the guidelines (e.g., age and biopsy cores), other patient factors (eg, marital status and PSA) and non-patient factors (eg, geographic region, case volume, year) were associated with conservative management use. In conclusion, even within an integrated health care system, there remains significant heterogeneity in the uptake of conservative management for low-risk prostate cancer. Both guideline-concordant factors and other factors not discussed in the guidelines were associated with conservative management use. PATIENT SUMMARY: In the US Veterans Affairs health care system the vast majority of men with low-risk prostate cancer were managed conservatively by 2016, although there was significant variation by facility. Patient factors specifically mentioned in guidelines had the greatest impact on prediction of conservative management.
PMID: 32098730
ISSN: 1873-7560
CID: 4323382
Geographic-Level Association of Contemporary Changes in Localized and Metastatic Prostate Cancer Incidence in the Era of Decreasing PSA Screening
Yang, Daniel X; Makarov, Danil V; Gross, Cary P; Yu, James B
Decreased prostate-specific antigen screening since 2008 has generated much concern, including report of recent increase in metastatic prostate cancer incidence among older men. Although increased metastatic disease was temporally proceeded by decreased screening and decreased localized prostate cancer at diagnosis, it is unclear whether the 2 trends are geographically connected. We therefore used the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database to assess geographic-specific associations between changes in localized (2008-2011) and later changes in metastatic prostate cancer incidence (2012-2015). We examined trends from 200 health-care service areas (HSAs) within SEER 18 registries. While on average for each HSA, localized incidence decreased by 27.4 and metastatic incidence increased by 2.3 per 100 000 men per year, individual HSA-level changes in localized incidence did not correlate with later changes in metastatic disease. Decreased detection of localized disease may not fully explain the recent increase in metastatic disease at diagnosis.
PMID: 32003227
ISSN: 1526-2359
CID: 4294422
Novel Clinical Trial to Improve the Quality of PSA Screening Decisions for Black Men and Their Healthcare Providers: NYU Case of the Month, November 2019
Makarov, Danil V; Ravenell, Joseph E
PMCID:7020276
PMID: 32071568
ISSN: 1523-6161
CID: 4312252
Artificial Intelligence Outperforms Clinical Judgment in Triage for Postoperative ICU Care: Prospective Preliminary Results [Meeting Abstract]
Carrano, F M; Wang, B; Sherman, S E; Makarov, D V; Berman, R S; Newman, E; Pachter, H L; Melis, M
Introduction: The decision of admitting a stable patient to the ICU after major operation currently relies on clinical judgment and local hospital policies. We programmed an artificial intelligence (AI) to determine the appropriate level of care after major operation and compared its performance with clinician's judgement.
Method(s): ICU admission was deemed "appropriate" when at least 1 of 15 criteria (eg re-intubation, prolonged hypotension, new-onset arrhythmia) was observed. Using Institutional data (512 patients, 87 clinical variables), we programmed an AI to predict when ICU admission would have been appropriate. We prospectively evaluated whether surgeon, anesthesiologist, intensivist, or AI was the most accurate predictor in determining appropriateness of ICU admissions across 50 patients undergoing major surgery (general, vascular, urological). Accuracy of predictions was compared using receiver operating characteristic curve analysis.
Result(s): ICU care was appropriate (at least 1 of 15 objective criteria met) in 9 of 50 patients. Artificial intelligence correctly triaged to the appropriate level of care 82% of patients (surgeon 70%, anesthesiologist 58%, intensivist 64%). Receiver operating characteristic curve analysis revealed that AI's triage was the most accurate (area under the curve [AUC] 0.82), followed by anesthesiologist's (AUC 0.70), intensivist's (AUC 0.69), and surgeon's (AUC 0.60). Overall, clinicians leaned toward over-triaging patients to the ICU (Table).
Conclusion(s): Our study provides the first evidence that AI can have a role in supporting clinical decisions on postoperative triage. In the future, more sophisticated platforms can become integrated in daily clinical practice. [Figure presented]
Copyright
EMBASE:2002921787
ISSN: 1072-7515
CID: 4109102
Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: FDA Oncology Center of Excellence Public Workshop
Weinstock, Chana; Suzman, Daniel; Kluetz, Paul; Baxley, John; Viviano, Charles; Ibrahim, Amna; Jarow, Jonathan; Sridhara, Raejshwari; Liu, Ke; Carroll, Peter; Eggener, Scott; Freidlin, Boris; Hu, Jim C; Hussain, Maha; King, Martin; Klein, Eric; Kungel, Terry; Makarov, Danil; Pinto, Peter A; Rini, Brian; Roach, Mack; Sandler, Howard; Schlegel, Peter N; Song, Daniel; Goldberg, Kirsten; Pazdur, Richard; Beaver, Julia
PURPOSE/OBJECTIVE:The following is a summary of discussion at a U.S. Food and Drug Administration (FDA) public workshop reviewing potential trial designs and endpoints for development of therapies to treat localized prostate cancer. MATERIALS AND METHODS/METHODS:The workshop focused on the challenge that drug and device development for the treatment of localized prostate cancer has been limited by the large trial sizes and lengthy timelines required to demonstrate an improvement in overall survival or metastasis-free survival and by the lack of agreed-upon alternative endpoints. Additionally, evolving treatment paradigms in the management of localized prostate cancer include the widespread use of active surveillance for patients with low- and some intermediate-risk prostate cancer and the availability of advances in imaging and genomics. RESULTS:The workshop addressed issues related to trial design in this setting and discussed several potential novel endpoints such as delay of morbidity due to radiation or prostatectomy, and pathologic endpoints such as Gleason Grade Group upgrade. CONCLUSIONS:The workshop provided an open forum for multi-stakeholder engagement to advance the development of effective treatment options in localized prostate cancer. Full workshop proceedings are available online at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm608328.htm.
PMID: 31502940
ISSN: 1527-3792
CID: 4101262
Treatment of Metastatic Castration-resistant Prostate Cancer With Abiraterone and Enzalutamide Despite PSA Progression
Becker, Daniel J; Iyengar, Arjun D; Punekar, Salman R; Ng, Jason; Zaman, Anika; Loeb, Stacy; Becker, Kevin D; Makarov, Danil
BACKGROUND/AIM/OBJECTIVE:National guidelines offer little guidance on the use of PSA progression (PSA increase as defined below) as a clinical endpoint in metastatic castration-resistant prostate cancer (mCRPC). The aim of the study was to examine treatment patterns/outcomes with abiraterone (abi)/enzalutamide (enza) throughout PSA progression and near the end of life (EOL). PATIENTS AND METHODS/METHODS:Cases of mCRPC treated with abi or enza from the New York Veterans Affairs (VA) from 6/2011-8/2017 were reviewed. Regression analyses were conducted to identify factors associated with continuation of abi/enza treatment up to the EOL, and survival. RESULTS:Of 184 patients, 72 received abi alone, 28 received enza alone, and 84 received both. Treatment was changed for PSA progression alone in 39.1% (abi) and 25.7% (enza) of patients. A total of 37 patients (20%) received abi/enza within 1 month before death, 30% of whom were receiving hospice services. Older patients and black patients were less likely to receive abi/enza up to the EOL. CONCLUSION/CONCLUSIONS:Abi/enza are frequently discontinued for PSA progression alone and continued at EOL. The clinical benefit of these practices warrants additional study.
PMID: 31092441
ISSN: 1791-7530
CID: 3898002
An Evaluation of Guideline-Discordant Ordering Behavior for CT Pulmonary Angiography in the Emergency Department
Simon, Emma; Miake-Lye, Isomi M; Smith, Silas W; Swartz, Jordan L; Horwitz, Leora I; Makarov, Danil V; Gyftopoulos, Soterios
PURPOSE/OBJECTIVE:The aim of this study was to determine rates of and possible reasons for guideline-discordant ordering of CT pulmonary angiography for the evaluation of suspected pulmonary embolism (PE) in the emergency department. METHODS:A retrospective review was performed of 212 consecutive encounters (January 6, 2016, to February 25, 2016) with 208 unique patients in the emergency department that resulted in CT pulmonary angiography orders. For each encounter, the revised Geneva score and two versions of the Wells criteria were calculated. Each encounter was then classified using a two-tiered risk stratification method (PE unlikely versus PE likely). Finally, the rate of and possible explanations for guideline-discordant ordering were assessed via in-depth chart review. RESULTS:The frequency of guideline-discordant studies ranged from 53 (25%) to 79 (37%), depending on the scoring system used; 46Â (22%) of which were guideline discordant under all three scoring systems. Of these, 18 (39%) had at least one patient-specific factor associated with increased risk for PE but not included in the risk stratification scores (eg, travel, thrombophilia). CONCLUSIONS:Many of the guideline-discordant orders were placed for patients who presented with evidence-based risk factors for PE that are not included in the risk stratification scores. Therefore, guideline-discordant ordering may indicate that in the presence of these factors, the assessment of risk made by current scoring systems may not align with clinical suspicion.
PMID: 31047834
ISSN: 1558-349x
CID: 3834512