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The Effect of the Diffusion of the Surgical Robot on the Hospital-level Utilization of Partial Nephrectomy

Sivarajan, Ganesh; Taksler, Glen B; Walter, Dawn; Gross, Cary P; Sosa, Raul E; Makarov, Danil V
INTRODUCTION: The rapid diffusion of the surgical robot has been controversial because of the technology's high costs and its disputed marginal benefit. Some, however, have suggested that adoption of the robot may have improved care for patients with renal malignancy by facilitating partial nephrectomy, an underutilized, technically challenging procedure believed to be less morbid than radical nephrectomy. We sought to determine whether institutional acquisition of the robot was associated with increased utilization of partial nephrectomy. METHODS:: We used all payer data from 7 states to identify 21,569 nephrectomies. These patient-level records were aggregated to the hospital-level then merged with the American Hospital Association Annual Survey and publicly available data on timing of robot acquisition. We used a multivariable difference-in-difference model to assess at the hospital-level whether robot acquisition was associated with an increase in the proportion of partial nephrectomy, adjusting for hospital nephrectomy volume, year of surgery, and several additional hospital-level factors. RESULTS:: In the multivariable-adjusted differences-in-differences model, hospitals acquiring a robot between 2001 and 2004 performed a greater proportion of partial nephrectomy in both 2005 (29.9% increase) and 2008 (34.9% increase). Hospitals acquiring a robot between 2005 and 2008 also demonstrated a greater proportion of partial nephrectomy in 2008 (15.5% increase). In addition, hospital nephrectomy volume and urban location were also significantly associated with increased proportion of partial nephrectomy. CONCLUSIONS:: Hospital acquisition of the surgical robot is associated with greater proportion of partial nephrectomy, an underutilized, guideline-encouraged procedure. This is one of the few studies to suggest robot acquisition is associated with improvement in quality of patient care.
PMID: 25494234
ISSN: 0025-7079
CID: 1393772

Are hospitals "keeping up with the Joneses"?: Assessing the spatial and temporal diffusion of the surgical robot

Li, Huilin; Gail, Mitchell H; Braithwaite, R Scott; Gold, Heather T; Walter, Dawn; Liu, Mengling; Gross, Cary P; Makarov, Danil V
BACKGROUND: The surgical robot has been widely adopted in the United States in spite of its high cost and controversy surrounding its benefit. Some have suggested that a "medical arms race" influences technology adoption. We wanted to determine whether a hospital would acquire a surgical robot if its nearest neighboring hospital already owned one. METHODS: We identified 554 hospitals performing radical prostatectomy from the Healthcare Cost and Utilization Project Statewide Inpatient Databases for seven states. We used publicly available data from the website of the surgical robot's sole manufacturer (Intuitive Surgical, Sunnyvale, CA) combined with data collected from the hospitals to ascertain the timing of robot acquisition during year 2001 to 2008. One hundred thirty four hospitals (24%) had acquired a surgical robot by the end of 2008. We geocoded the address of each hospital and determined a hospital's likelihood to acquire a surgical robot based on whether its nearest neighbor owned a surgical robot. We developed a Markov chain method to model the acquisition process spatially and temporally and quantified the "neighborhood effect" on the acquisition of the surgical robot while adjusting simultaneously for known confounders. RESULTS: After adjusting for hospital teaching status, surgical volume, urban status and number of hospital beds, the Markov chain analysis demonstrated that a hospital whose nearest neighbor had acquired a surgical robot had a higher likelihood itself acquiring a surgical robot. (OR=1.71, 95% CI: 1.07-2.72, p=0.02). CONCLUSION: There is a significant spatial and temporal association for hospitals acquiring surgical robots during the study period. Hospitals were more likely to acquire a surgical robot during the robot's early adoption phase if their nearest neighbor had already done so.
PMID: 25821720
ISSN: 2213-0764
CID: 1540432

Patient reported outcomes in genital gender-affirming surgery: the time is now [Letter]

Agochukwu-Mmonu, Nnenaya; Radix, Asa; Zhao, Lee; Makarov, Danil; Bluebond-Langner, Rachel; Fendrick, A Mark; Castle, Elijah; Berry, Carolyn
Transgender and non-binary (TGNB) individuals often experience gender dysphoria. TGNB individuals with gender dysphoria may undergo genital gender-affirming surgery including vaginoplasty, phalloplasty, or metoidioplasty so that their genitourinary anatomy is congruent with their experienced gender. Given decreasing social stigma and increasing coverage from private and public payers, there has been a rapid increase in genital gender-affirming surgery in the past few years. As the incidence of genital gender-affirming surgery increases, a concurrent increase in the development and utilization of patient reported outcome measurement tools is critical. To date, there is no systematic way to assess and measure patients' perspectives on their surgeries nor is there a validated measure to capture patient reported outcomes for TGNB individuals undergoing genital gender-affirming surgery. Without a systematic way to assess and measure patients' perspectives on their care, there may be fragmentation of care. This fragmentation may result in challenges to ensure patients' goals are at the forefront of shared- decision making. As we aim to increase access to surgical care for TGNB individuals, it is important to ensure this care is patient-centered and high-quality. The development of patient-reported outcomes for patients undergoing genital gender-affirming surgery is the first step in ensuring high quality patient-centered care. Herein, we discuss the critical need for development of validated patient reported outcome measures for transgender and non-binary patients undergoing genital reconstruction. We also propose a model of patient-engaged patient reported outcome measure development.
PMID: 35467181
ISSN: 2509-8020
CID: 5217282

Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical Trial

Nickols, Nicholas G; Mi, Zhibao; DeMatt, Ellen; Biswas, Kousick; Clise, Christina E; Huggins, John T; Maraka, Spyridoula; Ambrogini, Elena; Mirsaeidi, Mehdi S; Levin, Ellis R; Becker, Daniel J; Makarov, Danil V; Adorno Febles, Victor; Belligund, Pooja M; Al-Ajam, Mohammad; Muthiah, Muthiah P; Montgomery, Robert B; Robinson, Kyle W; Wong, Yu-Ning; Bedimo, Roger J; Villareal, Reina C; Aguayo, Samuel M; Schoen, Martin W; Goetz, Matthew B; Graber, Christopher J; Bhattacharya, Debika; Soo Hoo, Guy; Orshansky, Greg; Norman, Leslie E; Tran, Samantha; Ghayouri, Leila; Tsai, Sonny; Geelhoed, Michelle; Rettig, Mathew B
Importance/UNASSIGNED:SARS-CoV-2 entry requires the TMPRSS2 cell surface protease. Antiandrogen therapies reduce expression of TMPRSS2. Objective/UNASSIGNED:To determine if temporary androgen suppression induced by degarelix improves clinical outcomes of inpatients hospitalized with COVID-19. Design, Setting, and Participants/UNASSIGNED:The Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH) phase 2, placebo-controlled, double-blind, randomized clinical trial compared efficacy of degarelix plus standard care vs placebo plus standard care on clinical outcomes in men hospitalized with COVID-19 but not requiring invasive mechanical ventilation. Inpatients were enrolled at 14 Department of Veterans Affairs hospitals from July 22, 2020, to April 8, 2021. Data were analyzed from August 9 to October 15, 2021. Interventions/UNASSIGNED:Patients stratified by age, history of hypertension, and disease severity were centrally randomized 2:1 to degarelix, (1-time subcutaneous dose of 240 mg) or a saline placebo. Standard care included but was not limited to supplemental oxygen, antibiotics, vasopressor support, peritoneal dialysis or hemodialysis, intravenous fluids, remdesivir, convalescent plasma, and dexamethasone. Main Outcomes and Measures/UNASSIGNED:The composite primary end point was mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at day 15 after randomization. Secondary end points were time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a temperature within reference range, maximum severity of COVID-19, and the composite end point at 30 days. Results/UNASSIGNED:The trial was stopped for futility after the planned interim analysis, at which time there were 96 evaluable patients, including 62 patients randomized to the degarelix group and 34 patients in the placebo group, out of 198 initially planned. The median (range) age was 70.5 (48-85) years. Common comorbidities included chronic obstructive pulmonary disorder (15 patients [15.6%]), hypertension (75 patients [78.1%]), cardiovascular disease (27 patients [28.1%]), asthma (12 patients [12.5%]), diabetes (49 patients [51.0%]), and chronic respiratory failure requiring supplemental oxygen at baseline prior to COVID-19 (9 patients [9.4%]). For the primary end point, there was no significant difference between the degarelix and placebo groups (19 patients [30.6%] vs 9 patients [26.5%]; P = .67). Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]). There were no differences between degarelix and placebo groups in the overall rates of adverse events (13 patients [21.0%] vs 8 patients [23.5%) and serious adverse events (19 patients [30.6%] vs 13 patients [32.4%]), nor unexpected safety concerns. Conclusions and Relevance/UNASSIGNED:In this randomized clinical trial of androgen suppression vs placebo and usual care for men hospitalized with COVID-19, degarelix did not result in amelioration of COVID-19 severity. Trial Registration/ Identifier: NCT04397718.
PMID: 35438754
ISSN: 2574-3805
CID: 5205312

A National Assessment of the Association Between Patient Race and Physician Visit Time During New Outpatient Urology Consultations

Appiah, Jude; Barlow, LaMont; Mmonu, Nnenaya A; Makarov, Danil V; Sugarman, Allison; Matulewicz, Richard S
OBJECTIVE:To determine if there is an association between patient race and physician time spent with the patient during outpatient urology consultations. METHODS:We identified all adult urology new outpatient visits in the National Ambulatory Medical Care Survey dataset for 2012-2016. Patient race was dichotomized as White or non-White. Our primary outcome was time spent during the visit between the patient and urologist. Using population-level weighting, we compared differences in mean time spent during visits with White and non-White patients. Mixed-effects linear regression was used to adjust for confounding factors and to account for clustering among individual physicians. Secondary outcomes included number of services provided and if ancillary providers were seen. RESULTS:Over the 5 year period, 1668 raw visits met criteria and were used to estimate 21million new outpatient urology visits nationwide. 80% of all visits were with White patients. Mean physician time spent among visits with white patients was 23.9 minutes and 24.4 minutes for non-White patients. There was no difference in number of services provided but visits with non-white patients were less likely to include an ancillary provider. After adjustment, there was no significant difference in mean time spent with the urologist among visits with White and non-White patients (difference 0.9 minutes, 95% CI: -0.6-2.4). There were also no differences in adjusted mean time spent among return visits or new visits for hematuria, urologic cancers, or BPH. CONCLUSION/CONCLUSIONS:We found no statistically significant difference in time spent with a urologist during outpatient office consultations between White and non-White patients.
PMID: 34380056
ISSN: 1527-9995
CID: 5085382

National assessment of recommendations from healthcare providers for smoking cessation among adults with cancer

Matulewicz, Richard S; Feuer, Zachary; Birken, Sarah A; Makarov, Danil V; Sherman, Scott E; Bjurlin, Marc A; El Shahawy, Omar
Cancer survivors benefit from evidence-based smoking cessation treatment. A crucial first step in this process is a clinician recommending that the patient quit smoking. However, contemporary delivery of advice to quit among patients with cancer is not well known. In a cross-sectional analysis of all adult smokers included in a prospective population-representative study of US adults, we analyzed the frequency that patients reported receiving advice to quit smoking from a healthcare professional according to reported cancer history (no cancer, tobacco-related cancer, non-tobacco related cancer history). Among an estimated 28.3 million smokers, 9.3% reported a history of cancer, 48.8% of which were tobacco-related cancers. In general, advice to quit was reported by more (67.8%) cancer survivors than those adults without any cancer (56.0%). After adjustment for sociodemographic factors, smokers with a non tobacco-related cancer (0.51, 95% CI 0.32-0.83) and those without any cancer history (0.43, 95% CI 0.30-0.63) were both less likely to report being advised to quit smoking than patients with a tobacco-related cancer history.
PMID: 34930697
ISSN: 1877-783x
CID: 5085422

Socioeconomic Determinants of the Use of Molecular Testing in Stage IV Colorectal Cancer

Punekar, Salman R; Griffin, Megan M; Masri, Lena; Roman, Stefanie D; Makarov, Danil V; Sherman, Scott E; Becker, Daniel J
OBJECTIVES/OBJECTIVE:Treatment with epidermal growth factor receptor monoclonal antibodies extends life for patients with advanced colorectal cancers (CRCs) whose tumors exhibit wild-type KRAS, but KRAS testing may be underused. We studied the role of socioeconomic factors in the application of KRAS testing. MATERIALS AND METHODS/METHODS:We identified subjects with stage IV colorectal adenocarcinoma diagnosed 2010-2015 in the Surveillance, Epidemiology, and End Results (SEER) database. We used multivariable logistic regression models to evaluate associations between clinical/demographic factors and the rate of KRAS testing. We used multivariable-adjusted Cox proportional hazards models to assess survival. RESULTS:We identified 37,676 patients with stage IV CRC, 31.1% of whom were tested for KRAS mutations, of those who had documented KRAS testing, 44% were KRAS mutant. Patients were more likely to be tested if they were younger (odds ratio [OR]=5.10 for age 20 to 29 vs. 80+, 95% confidence interval [CI]: 3.99-6.54, P<0.01), diagnosed more recently (OR=1.92 for 2015 vs. 2010, 95% CI: 1.77-2.08, P<0.01), or lived in an area of high median household income (OR=1.24 for median household income of >$69,311 vs. <$49,265, 95% CI: 1.14-1.35, P<0.01). Patients were less likely to be tested if they had Medicaid (OR=0.83, 95% CI: 0.77-0.88, P<0.01) or were unmarried (OR=0.78, 95% CI: 0.75-0.82, P<0.0001). The risk of death was decreased in patients who received KRAS testing (hazard ratio=0.77, 95% CI: 0.75-0.80, P<0.01). CONCLUSIONS:We found a low rate of KRAS testing in CRC patients with those living in low-income areas less likely to be tested, even after controlling for Medicaid insurance. Our study suggests that socioeconomic disparities persist despite Medicaid insurance.
PMID: 34753883
ISSN: 1537-453x
CID: 5050402

Impact of the COVID-19 Pandemic on Urological Care Delivery in the United States

Lee, Daniel J; Shelton, Jeremy B; Brendel, Paul; Doraiswami, Rahul; Makarov, Danil; Meeks, William; Fang, Raymond; Roe, Matthew T; Cooperberg, Matthew R
PURPOSE:We examined changes in urological care delivery due to COVID-19 in the U.S. based on patient, practice, and local/regional demographic and pandemic response features. MATERIALS AND METHODS:We analyzed real-world data from the American Urological Association Quality (AQUA) Registry collected from electronic health record systems. Data represented 157 outpatient urological practices and 3,165 providers across 48 U.S. states and territories, including 3,297,721 unique patients, 12,488,831 total outpatient visits and 2,194,456 procedures. The primary outcome measure was the number of outpatient visits and procedures performed (inpatient or outpatient) per practice per week, measured from January 2019 to February 2021. RESULTS:We found large (>50%) declines in outpatient visits from March 2020 to April 2020 across patient demographic groups and states, regardless of timing of state stay-at-home orders. Nonurgent outpatient visits decreased more across various nonurgent procedures (49%-59%) than for procedures performed for potentially urgent diagnoses (38%-52%); surgical procedures for nonurgent conditions also decreased more (43%-79%) than those for potentially urgent conditions (43%-53%). African American patients had similar decreases in outpatient visits compared with Asians and Caucasians, but also slower recoveries back to baseline. Medicare-insured patients had the steepest declines (55%), while those on Medicaid and government insurance had the lowest percentage of recovery to baseline (73% and 69%, respectively). CONCLUSIONS:This study provides real-world evidence on the decline in urological care across demographic groups and practice settings, and demonstrates a differential impact on the utilization of urological health services by demographics and procedure type.
PMID: 34470508
ISSN: 1527-3792
CID: 5063072

Interaction between race and prostate cancer treatment benefit in the Veterans Health Administration

Rude, Temitope; Walter, Dawn; Ciprut, Shannon; Kelly, Matthew D; Wang, Chan; Fagerlin, Angela; Langford, Aisha T; Lepor, Herbert; Becker, Daniel J; Li, Huilin; Loeb, Stacy; Ravenell, Joseph; Leppert, John T; Makarov, Danil V
BACKGROUND:Studies have demonstrated that Black men may undergo definitive prostate cancer (CaP) treatment less often than men of other races, but it is unclear whether they are avoiding overtreatment of low-risk disease or experiencing a reduction in appropriate care. The authors' aim was to assess the role of race as it relates to treatment benefit in access to CaP treatment in a single-payer population. METHODS:The authors used the Veterans Health Administration (VHA) Corporate Data Warehouse to perform a retrospective cohort study of veterans diagnosed with low- or intermediate-risk CaP between 2011 and 2017. RESULTS:The authors identified 35,427 men with incident low- or intermediate-risk CaP. When they controlled for covariates, Black men had 1.05 times the odds of receiving treatment in comparison with non-Black men (P < .001), and high-treatment-benefit men had 1.4 times the odds of receiving treatment in comparison with those in the low-treatment-benefit group (P < .001). The interaction of race and treatment benefit was significant, with Black men in the high-treatment-benefit category less likely to receive treatment than non-Black men in the same treatment category (odds ratio, 0.89; P < .001). CONCLUSIONS:Although race does appear to influence the receipt of definitive treatment in the VHA, this relationship varies in the context of the patient's treatment benefit, with Black men receiving less definitive treatment in high-benefit situations. The influence of patient race at high treatment benefit levels invites further investigation into the driving forces behind this persistent disparity in this consequential group.
PMID: 34184271
ISSN: 1097-0142
CID: 4926392

Learning from the "tail end" of de-implementation: the case of chemical castration for localized prostate cancer

Skolarus, Ted A; Forman, Jane; Sparks, Jordan B; Metreger, Tabitha; Hawley, Sarah T; Caram, Megan V; Dossett, Lesly; Paniagua-Cruz, Alan; Makarov, Danil V; Leppert, John T; Shelton, Jeremy B; Stensland, Kristian D; Hollenbeck, Brent K; Shahinian, Vahakn; Sales, Anne E; Wittmann, Daniela A
BACKGROUND:Men with prostate cancer are often treated with the suppression of testosterone through long-acting injectable drugs termed chemical castration or androgen deprivation therapy (ADT). In most cases, ADT is not an appropriate treatment for localized prostate cancer, indicating low-value care. Guided by the Theoretical Domains Framework (TDF) and the Behavior Change Wheel's Capability, Opportunity, Motivation Model (COM-B), we conducted a qualitative study to identify behavioral determinants of low-value ADT use to manage localized prostate cancer, and theory-based opportunities for de-implementation strategy development. METHODS:We used national cancer registry and administrative data from 2016 to 2017 to examine the variation in low-value ADT use across Veterans Health Administration facilities. Using purposive sampling, we selected high- and low-performing sites to conduct 20 urology provider interviews regarding low-value ADT. We coded transcripts into TDF domains and mapped content to the COM-B model to generate a conceptual framework for addressing low-value ADT practices. RESULTS:Our interview findings reflected provider perspectives on prescribing ADT as low-value localized prostate cancer treatment, including barriers and facilitators to de-implementing low-value ADT. We characterized providers as belonging in 1 of 3 categories with respect to low-value ADT use: 1) never prescribe 2); willing, under some circumstances, to prescribe: and 3) prescribe as an acceptable treatment option. Provider capability to prescribe low-value ADT depended on their knowledge of localized prostate cancer treatment options (knowledge) coupled with interpersonal skills to engage patients in educational discussion (skills). Provider opportunity to prescribe low-value ADT centered on the environmental resources to inform ADT decisions (e.g., multi-disciplinary review), perceived guideline availability, and social roles and influences regarding ADT practices, such as prior training. Provider motivation involved goals of ADT use, including patient preferences, beliefs in capabilities/professional confidence, and beliefs about the consequences of prescribing or not prescribing ADT. CONCLUSIONS:Use of the TDF domains and the COM-B model enabled us to conceptualize provider behavior with respect to low-value ADT use and clarify possible areas for intervention to effect de-implementation of low-value ADT prescribing in localized prostate cancer. TRIAL REGISTRATION/ , NCT03579680.
PMID: 34711274
ISSN: 2662-2211
CID: 5042702