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Article ; Online: EDITORIAL COMMENT.

Shahinian, Vahakn B

2022 Volume 167, Page(s) 126–127

Language	English
Publishing date	2022-09-22
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	192062-5
ISSN	1527-9995 ; 0090-4295
ISSN (online)	1527-9995
ISSN	0090-4295
DOI	10.1016/j.urology.2022.03.046
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Article ; Online: Variations in Payment for Dialysis-Implications for Policy and Practice.

Hirth, Richard A / Shahinian, Vahakn B

JAMA network open

2022 Volume 5, Issue 10, Page(s) e2239139

MeSH term(s)	Humans ; Renal Dialysis ; Prospective Payment System ; Kidney Failure, Chronic/therapy ; Policy
Language	English
Publishing date	2022-10-03
Publishing country	United States
Document type	Journal Article ; Comment
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2022.39139
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Article ; Online: AUTHOR REPLY.

Lai, Lillian Y / Caram, Megan E V / Shahinian, Vahakn B / Hollenbeck, Brent K

Urology

2022 Volume 161, Page(s) 58

Language	English
Publishing date	2022-03-14
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	192062-5
ISSN	1527-9995 ; 0090-4295
ISSN (online)	1527-9995
ISSN	0090-4295
DOI	10.1016/j.urology.2021.10.045
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Zs.A 1142: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: The 340B Program and oral specialty drugs for advanced prostate cancer.

Faraj, Kassem S / Kaufman, Samuel R / Oerline, Mary / Herrel, Lindsey A / Maganty, Avinash / Caram, Megan E V / Shahinian, Vahakn B / Hollenbeck, Brent K

Cancer

2024

Abstract: Introduction: Expensive oral specialty drugs for advanced prostate cancer can be associated with treatment disparities. The 340B program allows hospitals to purchase medications at discounts, generating savings that can improve care of the ... ...

Abstract	Introduction: Expensive oral specialty drugs for advanced prostate cancer can be associated with treatment disparities. The 340B program allows hospitals to purchase medications at discounts, generating savings that can improve care of the socioeconomically disadvantaged. This study assessed the effect of hospital 340B participation on advanced prostate cancer. Methods: The authors performed a retrospective cohort study of Medicare beneficiaries with advanced prostate cancer from 2012 to 2019. The primary outcome was use of an oral specialty drug. Secondary outcomes included monthly out-of-pocket costs and treatment adherence. We evaluated the effects of 1) hospital 340B participation, 2) a regional measure vulnerability, the social vulnerability index (SVI), and 3) the interaction between hospital 340B participation and SVI on outcomes. Results: There were 2237 and 1100 men who received care at 340B and non-340B hospitals. There was no difference in specialty drug use between 340B and non-340B hospitals, whereas specialty drug use decreased with increased SVI (odds ratio, 0.95, p = .038). However, the interaction between hospital 340B participation and SVI on specialty drug use was not significant. Neither 340B participation, SVI, or their interaction were associated with out-of-pocket costs. Although hospital 340B participation and SVI were not associated with treatment adherence, their interaction was significant (p = .020). This demonstrated that 340B was associated with better adherence among socially vulnerable men. Conclusions: The 340B program was not associated with specialty drug use in men with advanced prostate cancer. However, among those who were started on therapy, 340B was associated with increased treatment adherence in more socially vulnerable men.
Language	English
Publishing date	2024-02-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	1429-1
ISSN	1097-0142 ; 0008-543X ; 1934-662X
ISSN (online)	1097-0142
ISSN	0008-543X ; 1934-662X
DOI	10.1002/cncr.35262
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Article ; Online: Real-World Effectiveness of Preventive Pharmacological Therapy in Patients With Urolithiasis: A Retrospective Cohort Study.

Hollingsworth, John M / Oerline, Mary K / Hsi, Ryan S / Crivelli, Joseph J / Krampe, Noah / Asplin, John R / Shahinian, Vahakn B

American journal of kidney diseases : the official journal of the National Kidney Foundation

2024

Abstract: Rationale & objective: Data supporting the efficacy of preventive pharmacological therapy (PPT) to reduce urolithiasis recurrence are based on clinical trials with composite outcomes that incorporate imaging findings and which have uncertain clinical ... ...

Abstract	Rationale & objective: Data supporting the efficacy of preventive pharmacological therapy (PPT) to reduce urolithiasis recurrence are based on clinical trials with composite outcomes that incorporate imaging findings and which have uncertain clinical significance. This study sought to evaluate if the use of PPT leads to fewer symptomatic stone events. Study design: Retrospective cohort study. Setting: & Participants: Medicare enrollees with urolithiasis who completed 24-hour urine collections that revealed hypercalciuria, hypocitraturia, low urine pH, or hyperuricosuria. Exposure: PPT (thiazide diuretics for hypercalciuria, alkali for hypocitraturia or low urine pH, or uric acid lowering drugs for hyperuricosuria) categorized as, 1) adherent to guideline-concordant PPT, 2) nonadherent to guideline-concordant PPT, or 3) untreated. Outcome: Symptomatic stone event occurrence (emergency department [ED] visit or hospitalization for urolithiasis or stone-directed surgery). Analytical approach: Cox proportional hazards regression. Results: Among 13,942 patients, 31.0% were prescribed PPT. Compared to no treatment, concordant/adherent PPT use was associated with a significantly lower hazard of symptomatic stone events for patients with hypercalciuria (hazard ratio [HR], 0.736 [95% confidence interval (CI), 0.593 to 0.915]) and low urine pH (HR, 0.804 [CI, 0.650 to 0.996]) but not for patients with hypocitraturia or hyperuricosuria. These associations were largely driven by significantly lower rates of ED visits after initiating PPT among the concordant/adherent group versus untreated patients. Patients with hypercalciuria had adjusted two-year predicted probabilities of a visit of 3.8% [95% CI, 2.5% to 5.2%%] and 6.9% [95% CI, 6.0% to 7.7%] for the concordant/adherent PPT and no-treatment groups, respectively. Among patients with low urine pH, these probabilities were 4.3% [95% CI, 2.9% to 5.7%] and 7.3% [95% CI, 6.5% to 8.0%] for the concordant/adherent PPT and no-treatment groups, respectively. Limitations: Potential bias from the possibility that patients prescribed PPT had more severe disease than untreated patients. Conclusion: Patients with urolithiasis and hypercalciuria who were adherent to treatment with thiazide diuretics as well as those with low urine pH adherent to prescribed alkali therapy had fewer symptomatic stone events than untreated patients.
Language	English
Publishing date	2024-02-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	604539-x
ISSN	1523-6838 ; 0272-6386
ISSN (online)	1523-6838
ISSN	0272-6386
DOI	10.1053/j.ajkd.2023.12.015
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Zs.A 1669: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 468: Show issues

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Article ; Online: Preventive Pharmacological Therapy and Risk of Recurrent Urinary Stone Disease.

Arivoli, Kumaran / Valicevic, Autumn N / Oerline, Mary K / Hsi, Ryan S / Patel, Sanjeevkumar R / Hollingsworth, John M / Shahinian, Vahakn B

Clinical journal of the American Society of Nephrology : CJASN

2024

Abstract: Background: Urinary stone disease is a prevalent condition associated with a high recurrence risk. Preventive pharmacological therapy has been proposed to reduce recurrent stone episodes. However, limited evidence exists regarding its effectiveness, ... ...

Abstract	Background: Urinary stone disease is a prevalent condition associated with a high recurrence risk. Preventive pharmacological therapy has been proposed to reduce recurrent stone episodes. However, limited evidence exists regarding its effectiveness, contributing to its underutilization by physicians. This study aimed to evaluate the association between preventive pharmacological therapy (thiazide diuretics, alkali therapy, and uric acid-lowering medications) and clinically significant urinary stone disease recurrence. Methods: Using data from the Veterans Health Administration, adults with an index episode of urinary stone disease from 2012 through 2019 and at least one urinary abnormality (hypercalciuria, hypocitraturia, or hyperuricosuria) on 24-hour urine collection were included. The primary outcome was a composite variable representing recurrent stone events that resulted in emergency department visits, hospitalizations, or surgery for urinary stone disease. Cox proportional hazards regression was performed to estimate the association between preventive pharmacological therapy use and recurrent urinary stone disease while adjusting for relevant baseline patient characteristics. Results: Among the cohort of patients with urinary abnormalities ( n =5637), treatment with preventive pharmacological therapy was associated with a significant 19% lower risk of recurrent urinary stone disease during the 12-36-month period after the initial urine collection (hazard ratio, 0.81; 95% confidence interval, 0.65 to 1.00; P = 0.0496). However, the effectiveness of preventive pharmacological therapy diminished over longer follow-up periods (12-48 and 12-60 months after the urine collection) and did not reach statistical significance. When examining specific urinary abnormalities, only alkali therapy for hypocitraturia was associated with a significant 26% lower recurrence risk within the 12-36-month timeframe (hazard ratio, 0.74; 95% confidence interval, 0.56 to 0.97; P = 0.03). Conclusions: When considering all urinary abnormalities together, this study demonstrates that the use of preventive pharmacological therapy is associated with a lower risk of clinically significant recurrent episodes of urinary stone disease in the 12-36 month timeframe after urine collection, although only the association with the use of alkali therapy for hypocitraturia was significant when individual abnormalities were examined.
Language	English
Publishing date	2024-02-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	2226665-3
ISSN	1555-905X ; 1555-9041
ISSN (online)	1555-905X
ISSN	1555-9041
DOI	10.2215/CJN.0000000000000428
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Zs.A 6584: Show issues

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Article ; Online: Effects of In-office Dispensing by Single-specialty Urology Practices on Management of Advanced Prostate Cancer.

Lai, Lillian Y / Kaufman, Samuel R / Oerline, Mary / Caram, Megan E V / Maganty, Avinash / Shahinian, Vahakn B / Hollenbeck, Brent K

Urology practice

2023 Volume 10, Issue 3, Page(s) 230–235

Abstract: Introduction: We examine changes in the volume of patients with advanced prostate cancer and prescriptions for abiraterone and enzalutamide among urology practices with and without in-office dispensing.: Methods: Using data from the National Council ... ...

Abstract	Introduction: We examine changes in the volume of patients with advanced prostate cancer and prescriptions for abiraterone and enzalutamide among urology practices with and without in-office dispensing. Methods: Using data from the National Council for Prescription Drug Programs, we identified in-office dispensing by single-specialty urology practices from 2011 to 2018. As the greatest growth in implementing dispensing occurred among large groups in 2015, outcomes were measured at the practice level in 2014 (before) and 2016 (after) for dispensing and non-dispensing practices. Outcomes included the volume of men with advanced prostate cancer managed by a practice and prescriptions for abiraterone and/or enzalutamide. Using national Medicare data, generalized linear mixed models were fit to compare the practice-level ratio of each outcome (2016 relative to 2014) adjusting for regional contextual factors. Results: In-office dispensing increased from 1% to 30% of single-specialty urology practices from 2011 to 2018, with 28 practices implementing dispensing in 2015. In 2016 compared to 2014, adjusted changes in the volume of patients with advanced prostate cancer managed by a practice were similar between non-dispensing (0.88, 95% CI 0.81-0.94) and dispensing (0.93, 95% CI 0.76-1.09) practices ( Conclusions: In-office dispensing is increasingly common in urology practices. This emerging model is not associated with changes in patient volume but is associated with increased prescriptions for abiraterone and enzalutamide.
MeSH term(s)	Male ; Humans ; Aged ; United States ; Abiraterone Acetate ; Prostatic Neoplasms, Castration-Resistant ; Urology ; Medicare
Chemical Substances	enzalutamide (93T0T9GKNU) ; Abiraterone Acetate (EM5OCB9YJ6)
Language	English
Publishing date	2023-01-30
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
ISSN	2352-0787
ISSN (online)	2352-0787
DOI	10.1097/UPJ.0000000000000390
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Article ; Online: In-office dispensing of oral targeted agents by urology practices in men with advanced prostate cancer.

Hill, Dawson / Kaufman, Samuel R / Oerline, Mary K / Faraj, Kassem / Caram, Megan E V / Shahinian, Vahakn B / Hollenbeck, Brent K / Maganty, Avinash

JNCI cancer spectrum

2023 Volume 7, Issue 5

Abstract: Background: Management of men with advanced prostate cancer has evolved to include urologists, made possible by oral targeted agents (eg, abiraterone or enzalutamide) that can be dispensed directly to patients in the office. We sought to investigate ... ...

Abstract	Background: Management of men with advanced prostate cancer has evolved to include urologists, made possible by oral targeted agents (eg, abiraterone or enzalutamide) that can be dispensed directly to patients in the office. We sought to investigate whether this increasingly common model improves access to these agents, especially for Black men who are historically undertreated. Methods: We used 20% national Medicare data to perform a retrospective cohort study of men with advanced prostate cancer from 2011 through 2019, managed by urology practices with and without in-office dispensing. Using a difference-in-difference framework, generalized estimating equations were used to measure the effect of in-office dispensing on prescriptions for abiraterone and/or enzalutamide, adjusting for differences between patients, including race. Results: New prescription fills for oral targeted agents increased after the adoption of in-office dispensing (+4.4%, 95% confidence interval [CI] = 3.4% to 5.4%) relative to that for men managed by practices without dispensing (+2.4%, 95% CI = 1.4% to 3.4%). The increase in the postintervention period (difference-in-difference estimate) was 2% higher (95% CI = 0.6% to 3.4%) for men managed by practices adopting dispensing relative to men managed by practices without dispensing. The effect was strongest for practices adopting dispensing in 2015 (difference-in-difference estimate: +4.2%, 95% CI = 2.3% to 6.2%). The effect of dispensing adoption did not differ by race. Conclusion: Adoption of in-office dispensing by urology practices increased prescription fills for oral targeted agents in men with advanced prostate cancer. This model of delivery may improve access to this important class of medications.
MeSH term(s)	Male ; Humans ; Aged ; United States ; Retrospective Studies ; Urology ; Medicare ; Antineoplastic Agents/therapeutic use ; Prostatic Neoplasms/drug therapy
Chemical Substances	enzalutamide (93T0T9GKNU) ; Antineoplastic Agents
Language	English
Publishing date	2023-08-27
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2515-5091
ISSN (online)	2515-5091
DOI	10.1093/jncics/pkad062
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Article ; Online: Acquisition of Urology Practices by Private Equity Firms and Performance in the Merit-based Incentive Payment System.

Faraj, Kassem S / Kaufman, Samuel R / Herrel, Lindsey A / Maganty, Avinash / Oerline, Mary / Caram, Megan E V / Shahinian, Vahakn B / Hollenbeck, Brent K

Urology practice

2023 Volume 10, Issue 6, Page(s) 597–603

Abstract: Introduction: Private equity is increasingly engaged in the acquisition of urology practices. The implications of strategies to enhance practice value deployed by these firms for patients are unclear.: Methods: We conducted a retrospective study of ... ...

Abstract	Introduction: Private equity is increasingly engaged in the acquisition of urology practices. The implications of strategies to enhance practice value deployed by these firms for patients are unclear. Methods: We conducted a retrospective study of urologist performance in the MIPS (Merit-based Incentive Payment System) program for 2017 to 2020 using national Medicare data from the Quality Payment Program file. The primary outcome was the overall MIPS score. Secondary outcomes included MIPS component scores (ie, quality, interoperability, improvement activities, cost) and the percentage of urologists receiving a bonus payment. Generalized estimating equations were used to estimate the relationship between private equity acquisition and outcomes using a difference-in-differences framework. Results: Between 2017 and 2020, 181 urologists were in a urology practice acquired by private equity with MIPS data available the year before and after acquisition. Compared to urologists in practices not acquired by private equity, those in acquired practices had worse overall MIPS performance after acquisition (difference-in-differences estimate, -14 points, Conclusions: Private equity acquisition of urology practices was associated with significantly lower MIPS performance. As private equity acquisition of urology practices becomes more prevalent, key stakeholders should ensure that the quality of patient care is maintained and that the involvement of for-profit entities in health care is being made transparent to patients.
MeSH term(s)	Humans ; Aged ; United States ; Medicare ; Motivation ; Urology ; Retrospective Studies ; Reimbursement, Incentive
Language	English
Publishing date	2023-10-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2352-0787
ISSN (online)	2352-0787
DOI	10.1097/UPJ.0000000000000441
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Article ; Online: Potential for Urolithiasis-related Research Using the Novel Medicare-Litholink Database.

Krampe, Noah A / Oerline, Mary K / Asplin, John R / Hsi, Ryan S / Crivelli, Joseph J / Shahinian, Vahakn B / Hollingsworth, John M

Urology practice

2023 Volume 10, Issue 2, Page(s) 147–152

Abstract: Introduction: To overcome the data availability hurdle of observational studies on urolithiasis, we linked claims data with 24-hour urine results from a large cohort of adults with urolithiasis. This database contains the sample size, clinical ... ...

Abstract	Introduction: To overcome the data availability hurdle of observational studies on urolithiasis, we linked claims data with 24-hour urine results from a large cohort of adults with urolithiasis. This database contains the sample size, clinical granularity, and long-term follow-up needed to study urolithiasis on a broad level. Methods: We identified adults enrolled in Medicare with urolithiasis who had a 24-hour urine collection processed by Litholink (2011 to 2016). We created a linkage of their collections results and paid Medicare claims. We characterized them across a variety of sociodemographic and clinical factors. We measured frequencies of prescription fills for medications used to prevent stone recurrence, as well as frequencies of symptomatic stone events, among these patients. Results: In total, there were 11,460 patients who performed 18,922 urine collections in the Medicare-Litholink cohort. The majority were male (57%), White (93.2%), and lived in a metropolitan county (51.5%). Results from their initial urine collections revealed abnormal pH to be the most common abnormality (77.2%), followed by low volume (63.8%), hypocitraturia (45.6%), hyperoxaluria (31.1%), hypercalciuria (28.4%), and hyperuricosuria (11.8%). Seventeen percent had prescription fills for alkali monotherapy, and 7.6% had prescription fills for thiazide diuretic monotherapy. Symptomatic stone events occurred in 23.1% at 2 years of follow-up. Conclusions: We successfully linked Medicare claims with results from 24-hour urine collections performed by adults that were processed by Litholink. The resulting database is a unique resource for future studies on the clinical effectiveness of stone prevention strategies and urolithiasis more broadly.
MeSH term(s)	United States/epidemiology ; Adult ; Humans ; Male ; Aged ; Female ; Risk Factors ; Medicare ; Urolithiasis/drug therapy ; Hypercalciuria/urine ; Hyperoxaluria/urine
Language	English
Publishing date	2023-01-25
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ISSN	2352-0787
ISSN (online)	2352-0787
DOI	10.1097/UPJ.0000000000000378
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