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.
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.
Understanding the Role of Urology Practice Organization and Racial Composition in Prostate Cancer Treatment Disparities
Agochukwu-Mmonu, Nnenaya; Qin, Yongmei; Kaufman, Samuel; Oerline, Mary; Vince, Randy; Makarov, Danil; Caram, Megan V; Chapman, Christina; Ravenell, Joseph; Hollenbeck, Brent K; Skolarus, Ted A
PURPOSE/UNASSIGNED:Black men have a higher risk of prostate cancer diagnosis and mortality but are less likely to receive definitive treatment. The impact of structural aspects on treatment is unknown but may lead to actionable insights to mitigate disparities. We sought to examine the associations between urology practice organization and racial composition and treatment patterns for Medicare beneficiaries with incident prostate cancer. METHODS/UNASSIGNED:Using a 20% sample of national Medicare data, we identified beneficiaries diagnosed with prostate cancer between January 2010 and December 2015 and followed them through 2016. We linked urologists to their practices with tax identification numbers. We then linked patients to practices on the basis of their primary urologist. We grouped practices into quartiles on the basis of their proportion of Black patients. We used multilevel mixed-effects models to identify treatment associations. RESULTS/UNASSIGNED:< .05). CONCLUSION/UNASSIGNED:Despite Medicare coverage, we found less definitive treatment among Black beneficiaries consistent with ongoing prostate cancer treatment disparities. Our findings are reflective of the adverse effects of practice segregation and structural racism, highlighting the need for multilevel interventions.
An Evaluation of a Web-Based Decision Aid for Treatment Planning of Small Kidney Tumors: Pilot Randomized Controlled Trial
Fogarty, Justin; Siriruchatanon, Mutita; Makarov, Danil; Langford, Aisha; Kang, Stella
BACKGROUND:Surgery is the most common treatment for localized small kidney masses (SKMs) up to 4 cm, despite a lack of evidence for improved overall survival. Nonsurgical management options are gaining recognition, as evidence supports the indolence of most SKMs. Decision aids (DAs) have been shown to improve patient comprehension of the trade-offs of treatment options and overall decision quality, and may improve consideration of all major options according to individual health priorities and preferences. OBJECTIVE:This pilot randomized controlled trial (RCT) primarily aims to evaluate the impact of a new web-based DA on treatment decisions for patients with SKM; that is, selection of surgical versus nonsurgical treatment options. Secondary objectives include an assessment of decision-making outcomes: decisional conflict, decision satisfaction, and an understanding of individual preferences for treatment that incorporate the trade-offs associated with surgical versus nonsurgical interventions. METHODS:Three phases comprise the construction and evaluation of a new web-based DA on SKM treatment. In phase 1, this DA was developed in print format through a multidisciplinary design committee incorporating patient focus groups. Phase 2 was an observational study on patient knowledge and decision-making measures after randomization to receive the printed DA or institutional educational materials, which identified further educational needs applied to a web-based DA. Phase 3 will preliminarily evaluate the web-based DA: in a pilot RCT, 50 adults diagnosed with SKMs will receive the web-based DA or an existing web-based institutional website at urology clinics at a large academic medical center. The web-based DA applies risk communication and information about diagnosis and treatment options, elicits preferences regarding treatment options, and provides a set of options to consider with their doctor based on a decision-analytic model of benefits/harm analysis that accounts for comorbidity, age group, and tumor features. Questionnaires and treatment decision data will be gathered before and after viewing the educational material. RESULTS:This phase will consist of a pilot RCT from August 2022 to January 2023 to establish feasibility and preliminarily evaluate decision outcomes. Previous study phases from 2018 to 2020 supported the feasibility of providing the printed DA in urology clinics before clinical consultation and demonstrated increased patient knowledge about the diagnosis and treatment options and greater likelihood of favoring nonsurgical treatment just before consultation. This study was funded by the National Cancer Institute. Recruitment will begin in August 2022. CONCLUSIONS:A web-based DA has been designed to address educational needs for patients making treatment decisions for SKM, accounting for comorbidities and treatment-related benefits and risks. Outcomes from the pilot trial will evaluate the potential of a web-based DA in personalizing treatment decisions and in helping patients weigh attributes of surgical versus nonsurgical treatment options for their SKMs. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05387863; https://clinicaltrials.gov/ct2/show/NCT05387863. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:PRR1-10.2196/41451.
Development and Pilot Evaluation of a Decision Aid for Small Kidney Masses
Thomas, Shailin A; Siriruchatanon, Mutita; Albert, Stephanie L; Bjurlin, Marc; Hoffmann, Jason C; Langford, Aisha; Braithwaite, R Scott; Makarov, Danil V; Fagerlin, Angela; Kang, Stella K
OBJECTIVE:To develop and pilot test a patient decision aid (DA) describing small kidney masses and risks and benefits of treatment for the masses. METHODS:An expert committee iteratively designed a small kidney mass DA, incorporating evidence-based risk communication and informational needs for treatment options and shared decision making. After literature review and drafting content with the feedback of urologists, radiologists, and an internist, a rapid qualitative assessment was conducted using two patient focus groups to inform user-centered design. In a pilot study, 30 patients were randomized at the initial urologic consultation to receive the DA or existing institutional patient educational material (PEM). Preconsultation questionnaires captured patient knowledge and shared decision-making preferences. After review of the DA and subsequent clinician consultation, patients completed questionnaires on discussion content and satisfaction. Proportions between arms were compared using Fisher exact tests, and decision measures were compared using Mann-Whitney tests. RESULTS:Patient informational needs included risk of tumor growth during active surveillance and ablation, significance of comorbidities, and posttreatment recovery. For the DA, 84% of patients viewed all content, and mean viewing time was 20 min. Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, PÂ <Â .001). DA use also increased the proportion of patients discussing ablation (66.7% DA versus 18.2% PEM, PÂ = .02). Decision satisfaction measures were similar in both arms. DISCUSSION/CONCLUSIONS:Patients receiving a small kidney mass DA are likely to gain knowledge and preparedness to discuss all treatment options over standard educational materials.
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.
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%]; Pâ€‰=â€‰.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/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04397718.
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.
A Population-Level Analysis of the Protective Effects of Androgen Deprivation Therapy Against COVID-19 Disease Incidence and Severity
Lee, Kyung Min; Heberer, Kent; Gao, Anthony; Becker, Daniel J; Loeb, Stacy; Makarov, Danil V; Gulanski, Barbara; DuVall, Scott L; Aslan, Mihaela; Lee, Jennifer; Shih, Mei-Chiung; Lynch, Julie A; Hauger, Richard L; Rettig, Matthew
Background/UNASSIGNED:The incidence and severity of coronavirus disease 19 (COVID-19) is substantially higher in men. Sex hormones may be a potential mechanism for differences in COVID-19 outcome in men and women. We hypothesized that men treated with androgen deprivation therapy (ADT) have lower incidence and severity of COVID-19. Methods/UNASSIGNED:We conducted an observational study of male Veterans treated in the Veterans Health Administration from February 15th to July 15th, 2020. We developed a propensity score model to predict the likelihood to undergo Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing. We performed multivariable logistic regression modeling adjusted with inverse probability weighting to examine the relationship between ADT and COVID-19 incidence. We conducted logistic regression analysis among COVID-19 patients to test the association between ADT and COVID-19 severity. Results/UNASSIGNED:= 0.03). Conclusion/UNASSIGNED:ADT is associated with reduced incidence and severity of COVID-19 amongst male Veterans. Testosterone and androgen receptor signaling may confer increased risk for SARS-CoV-2 infection and contribute to severe COVID-19 pathophysiology in men.
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.