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1.
Lancet Oncol ; 25(6): 802-810, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38821085

RESUMO

BACKGROUND: Health care is a major source of greenhouse gas emissions, leading to climate change and public health harms. Changes are needed to improve the environmental sustainability of health-care practices, but such changes should not sacrifice patient outcomes or financial sustainability. Alternative dosing strategies that reduce the frequency with which specialty drugs are administered, without sacrificing patient outcomes, are an attractive possibility for improving environmental sustainability. We sought to inform environmentally sustainable cancer care by estimating and comparing the environmental and financial effects of alternative, clinically equivalent strategies for pembrolizumab administration. METHODS: We conducted a retrospective analysis using a cohort of patients from the Veterans Health Administration (VHA) in the USA who received one or more pembrolizumab doses between May 1, 2020, and Sept 30, 2022. Using baseline, real-world administration of pembrolizumab, we generated simulated pembrolizumab use data under three near-equivalent counterfactual pembrolizumab administration strategies defined by combinations of weight-based dosing, pharmacy-level vial sharing and dose rounding, and extended-interval dosing (ie, every 6 weeks). For each counterfactual dosing strategy, we estimated greenhouse gas emissions related to pembrolizumab use across the VHA cohort using a deterministic environmental impact model that estimated greenhouse gas emissions due to patient travel, drug manufacture, and medical waste as the primary outcome measure. FINDINGS: We identified 7813 veterans who received at least one dose of pembrolizumab-containing therapy in the VHA during the study period. 59 140 pembrolizumab administrations occurred in the study period, of which 46 255 (78·2%) were dosed at 200 mg every 3 weeks, 12 885 (21·8%) at 400 mg every 6 weeks, and 14 955 (25·3%) were coadministered with infusional chemotherapies. Adoption of weight-based, extended-interval pembrolizumab dosing (4 mg/kg every 6 weeks) and pharmacy-level stewardship strategies (ie, dose rounding and vial sharing) for all pembrolizumab infusions would have resulted in 24·7% fewer administration events than baseline dosing (44 533 events vs 59 140 events) and an estimated 200 metric tons less CO2 emitted per year as a result of pembrolizumab use within the VHA (650 tons vs 850 tons of CO2, a relative reduction of 24%), largely due to reductions in distance travelled by patients to receive treatment. Similar results were observed when weight-based and extended-interval dosing were applied only to pembrolizumab monotherapy and pembrolizumab in combination with oral therapies. INTERPRETATION: Alternative pembrolizumab administration strategies might have environmental advantages over the current dosing and compounding paradigms. Specialty medication dosing can be optimised for health-care spending and environmental sustainability without sacrificing clinical outcomes. FUNDING: None.


Assuntos
Anticorpos Monoclonais Humanizados , Humanos , Anticorpos Monoclonais Humanizados/administração & dosagem , Estudos Retrospectivos , Estados Unidos , Masculino , Feminino , Antineoplásicos Imunológicos/administração & dosagem , Antineoplásicos Imunológicos/efeitos adversos , Saúde Pública , Pessoa de Meia-Idade , Idoso , Neoplasias/tratamento farmacológico , Esquema de Medicação
2.
Ann Surg ; 277(1): e16-e23, 2023 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-33914460

RESUMO

OBJECTIVE: The aim of this study was to evaluate associations between hospital participation in Bundled Payments for Care Improvement (BPCI) and 30-day total episode and post-acute care spending for lower extremity joint replacement (LEJR), coronary artery bypass graft (CABG), and colec-tomy. SUMMARY BACKGROUND DATA: BPCI has been shown to reduce spending for LEJR episodes largely from reductions in post-acute care. However, BPCI efficacy in other common elective procedures, including CABG and colec-tomy, remains unclear. It is also unknown whether post-acute care spending reductions drive total spending reductions outside of LEJR. METHODS: Retrospective cohort study using 100% Medicare claims data to identify BPCI (312 total) and non-BPCI (1,977 total) acute care hospitals from January 1, 2010 to November 30, 2016 with Medicare-enrolled patient discharges for at least one of the following BPCI episodes: LEJR (454,369 episodes), CABG (107,307 episodes), or colectomy (73,717 episodes). Along with difference-in-differences (DiD) analysis, we constructed generalized synthetic controls in the presence of nonparallel trends to estimate associations between BPCI participation and 30-day total and post-acute care spending. RESULTS: DiD estimates indicated reduced spending for LEJR (-$541.6 [95% confidence interval (CI): -718.0 to -365.3]) and colectomy (-$582.1 [95% CI: -927.3 to -236.8]) but not CABG (-$268.9 [95% CI: -831.5 to 293.7]). Generalized synthetic control estimates indicated reduced spending for LEJR (-$795.3 [95% CI: -10,22.1 to -582.2]) but not colectomy (-$251.3 [95% CI: -997.9 to 335.2]) or CABG (-$257.8 [95% CI: -10,24.6 to 414.8]).Post-acute care comprised 42.6% of LEJR spending reductions and 53.0% of colectomy spending reductions. CONCLUSIONS: BPCI participation was associated with significant spending reductions for LEJR and colectomy but not CABG. We conclude that BPCI has episode-dependent efficacy, largely determined by post-acute care.


Assuntos
Cuidado Periódico , Medicare , Idoso , Humanos , Estados Unidos , Estudos Retrospectivos , Hospitais , Ponte de Artéria Coronária
3.
J Urol ; 208(6): 1295-1302, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36282060

RESUMO

PURPOSE: There is an age-related decline in male testosterone production. It is therefore surprising that young men are evaluated for testosterone deficiency with the same cutoff of 300 ng/dL that was developed from samples of older men. Our aim is to describe normative total testosterone levels and age-specific cutoffs for low testosterone levels in men 20 to 44 years old. MATERIALS AND METHODS: We analyzed the 2011-2016 National Health and Nutrition Examination Surveys, which survey nationally representative samples of United States residents. Men 20 to 44 years old with testosterone levels were included. Men on hormonal medications, with a history of testicular cancer or orchiectomy, and with afternoon/evening laboratory values were excluded. We separated men into 5-year intervals and evaluated the testosterone levels of each age group, and for all men 20 to 44 years old. We used the American Urological Association definition of a "normal testosterone level" (the "middle tertile") to calculate age-specific cutoffs for low testosterone levels. RESULTS: Our final analytic cohort contained 1,486 men. Age-specific middle tertile levels were 409-558 ng/dL (20-24 years old), 413-575 ng/dL (25-29 years old), 359-498 ng/dL (30-34 years old), 352-478 ng/dL (35-39 years old), and 350-473 ng/dL (40-44 years old). Age-specific cutoffs for low testosterone levels were 409, 413, 359, 352, and 350 ng/dL, respectively. CONCLUSIONS: Diagnosis of testosterone deficiency has traditionally been performed in an age-indiscriminate manner. However, young men have different testosterone reference ranges than older men. Accordingly, age-specific normative values and cutoffs should be integrated into the evaluation of young men presenting with testosterone deficiency.


Assuntos
Hipogonadismo , Neoplasias Testiculares , Humanos , Masculino , Estados Unidos/epidemiologia , Idoso , Adulto Jovem , Adulto , Hipogonadismo/tratamento farmacológico , Neoplasias Testiculares/tratamento farmacológico , Testosterona/uso terapêutico , Inquéritos Nutricionais , Valores de Referência
4.
J Urol ; 205(3): 732-739, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33080150

RESUMO

PURPOSE: The MyProstateScore test was validated for improved detection of clinically significant (grade group ≥2) prostate cancer relative to prostate specific antigen based risk calculators. We sought to validate an optimal MyProstateScore threshold for clinical use in ruling out grade group ≥2 cancer in men referred for biopsy. MATERIALS AND METHODS: Biopsy naïve men provided post-digital rectal examination urine prior to biopsy. MyProstateScore was calculated using the validated, locked multivariable model including only serum prostate specific antigen, urinary prostate cancer antigen 3 and urinary TMPRSS2:ERG. The MyProstateScore threshold approximating 95% sensitivity for grade group ≥2 cancer was identified in a training cohort, and performance was measured in 2 external validation cohorts. We assessed the 1) overall biopsy referral population and 2) population meeting guideline based testing criteria (ie, prostate specific antigen 3-10, or <3 with suspicious digital rectal examination). RESULTS: Validation cohorts were prospectively enrolled from academic (977 patients, median prostate specific antigen 4.5, IQR 3.1-6.0) and community (548, median prostate specific antigen 4.9, IQR 3.7-6.8) settings. In the overall validation population (1,525 patients), 338 men (22%) had grade group ≥2 cancer on biopsy. The MyProstateScore threshold of 10 provided 97% sensitivity and 98% negative predictive value for grade group ≥2 cancer. MyProstateScore testing would have prevented 387 unnecessary biopsies (33%), while missing only 10 grade group ≥2 cancers (3.0%). In 1,242 patients meeting guideline based criteria, MyProstateScore ≤10 provided 96% sensitivity and 97% negative predictive value, and would have prevented 32% of unnecessary biopsies, missing 3.7% of grade group ≥2 cancers. CONCLUSIONS: In a large, clinically pertinent biopsy referral population, MyProstateScore ≤10 provided exceptional sensitivity and negative predictive value for ruling out grade group ≥2 cancer. This straightforward secondary testing approach would reduce the use of more costly and invasive procedures after screening with prostate specific antigen.


Assuntos
Antígenos de Neoplasias/urina , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Neoplasias da Próstata/urina , Serina Endopeptidases/urina , Idoso , Biomarcadores Tumorais/sangue , Biomarcadores Tumorais/urina , Biópsia , Exame Retal Digital , Humanos , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Valor Preditivo dos Testes , Estudos Prospectivos , Neoplasias da Próstata/patologia , Encaminhamento e Consulta/estatística & dados numéricos , Medição de Risco/métodos , Sensibilidade e Especificidade
5.
J Natl Compr Canc Netw ; 19(8): 915-921, 2021 04 20.
Artigo em Inglês | MEDLINE | ID: mdl-33878726

RESUMO

BACKGROUND: Bone metastases and skeletal-related events (SREs) are a frequent cause of morbidity in patients with metastatic non-small cell lung cancer (mNSCLC). Data are limited on bone metastases and SREs in patients with mNSCLC treated using immune checkpoint inhibitors (ICIs), and on the efficacy of bone-modifying agents (BMAs) in this setting. Here we report the incidence, impact on survival, risk factors for bone metastases and SREs, and impact of BMAs in patients with mNSCLC treated with ICIs in a multi-institutional cohort. PATIENTS AND METHODS: We conducted a retrospective study of patients with mNSCLC treated with ICIs at 2 tertiary care centers from 2014 through 2017. Overall survival (OS) was compared between patients with and without baseline bone metastases using a log-rank test. A Cox regression model was used to evaluate the association between OS and the presence of bone metastases at ICI initiation, controlling for other confounding factors. RESULTS: We identified a cohort of 330 patients who had received ICIs for metastatic disease. Median patient age was 63 years, most patients were treated in the second line or beyond (n=259; 78%), and nivolumab was the most common ICI (n=211; 64%). Median OS was 10 months (95% CI, 8.4-12.0). In our cohort, 124 patients (38%) had baseline bone metastases, and 43 (13%) developed SREs during or after ICI treatment. Patients with bone metastases had a higher hazard of death after controlling for performance status, histology, line of therapy, and disease burden (hazard ratio, 1.57; 95% CI, 1.19-2.08; P=.001). Use of BMAs was not associated with OS or a decreased risk of SREs. CONCLUSIONS: Presence of bone metastases at baseline was associated with a worse prognosis for patients with mNSCLC treated with ICI after controlling for multiple clinical characteristics. Use of BMAs was not associated with reduced SREs or a difference in survival.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Inibidores de Checkpoint Imunológico/farmacologia , Inibidores de Checkpoint Imunológico/uso terapêutico , Neoplasias Pulmonares/patologia , Pessoa de Meia-Idade , Nivolumabe/uso terapêutico , Estudos Retrospectivos
6.
JAMA ; 329(14): 1221-1223, 2023 04 11.
Artigo em Inglês | MEDLINE | ID: mdl-37039798

RESUMO

This study examines the magnitude of reconciliation payments and clinical spending reductions necessary for the Centers for Medicare & Medicaid Services to break even in the first 4 performance periods of the BPCI-A (Bundled Payments for Care Improvement Advanced) program.


Assuntos
Centers for Medicare and Medicaid Services, U.S. , Pacotes de Assistência ao Paciente , Melhoria de Qualidade , Humanos , Centers for Medicare and Medicaid Services, U.S./economia , Readmissão do Paciente/economia , Melhoria de Qualidade/normas , Estados Unidos , Pacotes de Assistência ao Paciente/economia , Pacotes de Assistência ao Paciente/normas
7.
J Urol ; 208(6): 1302, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36282057
10.
Health Aff (Millwood) ; 43(5): 623-631, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38709974

RESUMO

The Bundled Payments for Care Improvement Advanced Model (BPCI-A), a voluntary Alternative Payment Model for Medicare, incentivizes hospitals and physician group practices to reduce spending for patient care episodes below preset target prices. The experience of physician groups in BPCI-A is not well understood. We found that physician groups earned $421 million in incentive payments during BPCI-A's first four performance periods (2018-20). Target prices were positively associated with bonuses, with a mean reconciliation payment of $139 per episode in the lowest decile of target prices and $2,775 in the highest decile. In the first year of the COVID-19 pandemic, mean bonuses increased from $815 per episode to $2,736 per episode. These findings suggest that further policy changes, such as improving target price accuracy and refining participation rules, will be important as the Centers for Medicare and Medicaid Services continues to expand BPCI-A and develop other bundled payment models.


Assuntos
COVID-19 , Prática de Grupo , Medicare , Pacotes de Assistência ao Paciente , Estados Unidos , Humanos , Medicare/economia , Pacotes de Assistência ao Paciente/economia , Prática de Grupo/economia , COVID-19/economia , Reembolso de Incentivo/economia , Mecanismo de Reembolso , SARS-CoV-2 , Gastos em Saúde/estatística & dados numéricos
11.
AEM Educ Train ; 8(2): e10965, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38525368

RESUMO

Objectives: Our study aims to better understand and describe the current state of diversity, equity, and inclusion (DEI) leadership in emergency medicine (EM) by identifying the prevalence of department DEI leadership positions, their demographics, and their job duty characteristics. Methods: We disseminated an electronic survey from April to July 2022 to Society for Academic Emergency Medicine (SAEM) Association of Academic Chairs of Emergency Medicine, Academy for Diversity and Inclusion in Emergency Medicine, and the Equity and Inclusion Committee to identify department DEI leads. From July to August 2022, a 45-question survey was sent to all identified DEI leaders on individual characteristics, DEI experience, and DEI lead job description. Results: We received a response from 79 out of 120 academic EM departments identified (65.8%). Of the responding institutions, 59 (74.7%) reported a DEI leader. A total of 74.6% of these DEI leaders responded at least partially to our survey and 57.6% responded in full. The most common titles were vice/associate chair of DEI (34.4%), director of DEI (28.1%), and DEI committee chair (18.8%). Most respondents (84.4%) were the inaugural DEI lead in their department and 84.4% of respondents did not have a formal DEI role in their department previously. On average, respondents have had their DEI title for 2 years (range 0-7 years) with an average of 7 years (range 0-30 years) of experience performing DEI work. Many (63.4%) do not receive any funded effort for their DEI roles. Most DEI leads were not tenure track (72.2%) and most commonly at the rank of assistant professor (47.2%) followed by associate professor (33.3%), full professor (16.7%), and instructor (2.8%). Conclusions: This is the first known study to assess the characteristics of DEI department leaders in EM. EM DEI leadership positions are new, common, and led by diverse personal identities and are often not funded. Future directions could gain qualitative insight into this workforce to guide best practices in EM DEI leadership.

12.
JAMA Oncol ; 10(6): 726-736, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38635241

RESUMO

Importance: Benefits of prostate cancer (PCa) screening with prostate-specific antigen (PSA) alone are largely offset by excess negative biopsies and overdetection of indolent cancers resulting from the poor specificity of PSA for high-grade PCa (ie, grade group [GG] 2 or greater). Objective: To develop a multiplex urinary panel for high-grade PCa and validate its external performance relative to current guideline-endorsed biomarkers. Design, Setting, and Participants: RNA sequencing analysis of 58 724 genes identified 54 markers of PCa, including 17 markers uniquely overexpressed by high-grade cancers. Gene expression and clinical factors were modeled in a new urinary test for high-grade PCa (MyProstateScore 2.0 [MPS2]). Optimal models were developed in parallel without prostate volume (MPS2) and with prostate volume (MPS2+). The locked models underwent blinded external validation in a prospective National Cancer Institute trial cohort. Data were collected from January 2008 to December 2020, and data were analyzed from November 2022 to November 2023. Exposure: Protocolized blood and urine collection and transrectal ultrasound-guided systematic prostate biopsy. Main Outcomes and Measures: Multiple biomarker tests were assessed in the validation cohort, including serum PSA alone, the Prostate Cancer Prevention Trial risk calculator, and the Prostate Health Index (PHI) as well as derived multiplex 2-gene and 3-gene models, the original 2-gene MPS test, and the 18-gene MPS2 models. Under a testing approach with 95% sensitivity for PCa of GG 2 or greater, measures of diagnostic accuracy and clinical consequences of testing were calculated. Cancers of GG 3 or greater were assessed secondarily. Results: Of 761 men included in the development cohort, the median (IQR) age was 63 (58-68) years, and the median (IQR) PSA level was 5.6 (4.6-7.2) ng/mL; of 743 men included in the validation cohort, the median (IQR) age was 62 (57-68) years, and the median (IQR) PSA level was 5.6 (4.1-8.0) ng/mL. In the validation cohort, 151 (20.3%) had high-grade PCa on biopsy. Area under the receiver operating characteristic curve values were 0.60 using PSA alone, 0.66 using the risk calculator, 0.77 using PHI, 0.76 using the derived multiplex 2-gene model, 0.72 using the derived multiplex 3-gene model, and 0.74 using the original MPS model compared with 0.81 using the MPS2 model and 0.82 using the MPS2+ model. At 95% sensitivity, the MPS2 model would have reduced unnecessary biopsies performed in the initial biopsy population (range for other tests, 15% to 30%; range for MPS2, 35% to 42%) and repeat biopsy population (range for other tests, 9% to 21%; range for MPS2, 46% to 51%). Across pertinent subgroups, the MPS2 models had negative predictive values of 95% to 99% for cancers of GG 2 or greater and of 99% for cancers of GG 3 or greater. Conclusions and Relevance: In this study, a new 18-gene PCa test had higher diagnostic accuracy for high-grade PCa relative to existing biomarker tests. Clinically, use of this test would have meaningfully reduced unnecessary biopsies performed while maintaining highly sensitive detection of high-grade cancers. These data support use of this new PCa biomarker test in patients with elevated PSA levels to reduce the potential harms of PCa screening while preserving its long-term benefits.


Assuntos
Biomarcadores Tumorais , Gradação de Tumores , Neoplasias da Próstata , Masculino , Humanos , Neoplasias da Próstata/genética , Neoplasias da Próstata/urina , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia , Idoso , Biomarcadores Tumorais/urina , Biomarcadores Tumorais/genética , Pessoa de Meia-Idade , Antígeno Prostático Específico/sangue , Detecção Precoce de Câncer/métodos
13.
Infect Control Hosp Epidemiol ; 44(8): 1314-1320, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-36330692

RESUMO

OBJECTIVE: To describe the natural course of procalcitonin (PCT) in patients with coronavirus disease 2019 (COVID-19) and the correlation between PCT and antimicrobial prescribing to provide insight into best practices for PCT data utilization in antimicrobial stewardship in this population. DESIGN: Single-center, retrospective, observational study. SETTING: Michigan Medicine. PATIENTS: Inpatients aged ≥18 years hospitalized March 1, 2020, through October 31, 2021, who were positive for severe acute respiratory coronavirus virus 2 (SARS-CoV-2), with ≥1 PCT measurement. Exclusion criteria included antibiotics for nonpulmonary bacterial infection on admission, treatment with azithromycin only for chronic obstructive pulmonary disease (COPD) exacerbation, and pre-existing diagnosis of cystic fibrosis with positive respiratory cultures. METHODS: A structured query was used to extract data. For patients started on antibiotics, bacterial pneumonia (bPNA) was determined through chart review. Multivariable models were used to assess associations of PCT level and bPNA with antimicrobial use. RESULTS: Of 793 patients, 224 (28.2%) were initiated on antibiotics: 33 (14.7%) had proven or probable bPNA, 125 (55.8%) had possible bPNA, and 66 (29.5%) had no bPNA. Patients had a mean of 4.1 (SD, ±5.2) PCT measurements if receiving antibiotics versus a mean of 2.0 (SD, ±2.6) if not. Initial PCT level was highest for those with proven/probable bPNA and was associated with antibiotic initiation (odds ratio 95% confidence interval [CI], 1.17-1.30). Initial PCT (rate ratio [RR] 95% CI, 1.01-1.08), change in PCT over time (RR 95% CI, 1.01-1.05), and bPNA group (RR 95% CI, 1.23-1.84) were associated with antibiotic duration. CONCLUSIONS: PCT trends are associated with the decision to initiate antibiotics and duration of treatment, independent of bPNA status and comorbidities. Prospective studies are needed to determine whether PCT level can be used to safely make decisions regarding antibiotic treatment for COVID-19.


Assuntos
COVID-19 , Pneumonia Bacteriana , Humanos , Adolescente , Adulto , Pró-Calcitonina , Estudos Retrospectivos , SARS-CoV-2 , Antibacterianos/uso terapêutico , Pneumonia Bacteriana/tratamento farmacológico , Biomarcadores
14.
Cancer J ; 29(5): 279-284, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37796646

RESUMO

ABSTRACT: The liver is a common site of metastasis for many primary malignancies, but the quantitative impact on survival is unknown. We performed a systematic review and meta-analysis of 83 studies (604,853 patients) assessing the overall hazard associated with liver metastases by primary tumor type and treatment regimen. The pooled overall survival hazard ratio (HR) for all included studies was 1.77 (95% confidence interval [CI], 1.62-1.93). Patients with breast cancer primaries fared the worst (HR, 2.37; 95% CI, 1.64-3.44), as did patients treated with immunotherapies (HR, 1.86; 95% CI, 1.42-2.42). Liver metastases negatively impact survival, necessitating new approaches to disease management.


Assuntos
Neoplasias da Mama , Neoplasias Hepáticas , Humanos , Feminino , Prognóstico , Neoplasias da Mama/terapia , Modelos de Riscos Proporcionais , Neoplasias Hepáticas/secundário
15.
Health Aff (Millwood) ; 42(9): 1190-1197, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37669498

RESUMO

Increases in Medicare Advantage (MA) enrollment, coupled with concerns about overpayment to plans, have prompted calls for change. Benchmark setting in MA, which determines plan payment, has received relatively little attention as an avenue for reform. In this study we used national data from the period 2010-20 to examine the relationships among unobserved favorable selection, benchmark setting, and payments to plans in MA. We found that unobserved favorable selection in MA led to underpayment to counties with lower MA penetration and overpayment to counties with higher MA penetration. Because the distribution of MA beneficiaries has shifted over time toward counties that were overpaid, we estimate that plans were overpaid by an average of $9.3 billion per year between 2017 and 2020. Changes to risk adjustment in benchmark setting could likely mitigate the impact of favorable selection in MA.


Assuntos
Benchmarking , Medicare Part C , Idoso , Estados Unidos , Humanos
16.
Health Aff (Millwood) ; 42(7): 946-955, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37406228

RESUMO

Immune checkpoint inhibitors, a class of drugs used in approximately forty unique cancer indications, are a sizable component of the economic burden of cancer care in the US. Instead of personalized weight-based dosing, immune checkpoint inhibitors are most commonly administered at "one-size-fits-all" flat doses that are higher than necessary for the vast majority of patients. We hypothesized that personalized weight-based dosing along with common stewardship efforts at the pharmacy level, such as dose rounding and vial sharing, would lead to reductions in immune checkpoint inhibitor use and lower spending. Using data from the Veterans Health Administration (VHA) and Medicare drug prices, we estimated reductions in immune checkpoint inhibitor use and spending that would be associated with pharmacy-level stewardship strategies, in a case-control simulation study of individual patient-level immune checkpoint inhibitor administration events. We identified baseline annual VHA spending for these drugs of approximately $537 million. Combining weight-based dosing, dose rounding, and pharmacy-level vial sharing would generate expected annual VHA health system savings of $74 million (13.7 percent). We conclude that adoption of pharmacologically justified immune checkpoint inhibitor stewardship measures would generate sizable reductions in spending for these drugs. Combining these operational innovations with value-based drug price negotiation enabled by recent policy changes may improve the long-term financial viability of cancer care in the US.


Assuntos
Neoplasias , Farmácias , Farmácia , Idoso , Humanos , Estados Unidos , Inibidores de Checkpoint Imunológico , Medicare , Estudos de Casos e Controles , Custos de Medicamentos , Neoplasias/tratamento farmacológico
17.
Prostate Cancer Prostatic Dis ; 26(3): 563-567, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-36585434

RESUMO

BACKGROUND: Men with persistent risk of Grade Group (GG) ≥ 2 cancer after a negative biopsy present a unique clinical challenge. The validated MyProstateScore test is clinically-available for pre-biopsy risk stratification. In biopsy-naïve patients, we recently validated a straightforward testing approach to rule-out GG ≥ 2 cancer with 98% negative predictive value (NPV) and 97% sensitivity. In the current study, we established a practical MPS-based testing approach in men with a previous negative biopsy being considered for repeat biopsy. METHODS: Patients provided post-digital rectal examination urine prior to repeat biopsy. MyProstateScore was calculated using the validated, locked model including urinary PCA3 and TMPRSS2:ERG scores with serum PSA. In a clinically-appropriate primary (i.e., training) cohort, we identified a lower (rule-out) threshold approximating 90% sensitivity and an upper (rule-in) threshold approximating 80% specificity for GG ≥ 2 cancer. These thresholds were applied to an external validation cohort, and performance measures and clinical outcomes associated with their use were calculated. RESULTS: MyProstateScore thresholds of 15 and 40 met pre-defined performance criteria in the primary cohort (422 patients; median PSA 6.4, IQR 4.3-9.1). In the 268-patient validation cohort, 25 men (9.3%) had GG ≥ 2 cancer on repeat biopsy. The rule-out threshold of 15 provided 100% NPV and sensitivity for GG ≥ 2 cancer and would have prevented 23% of unnecessary biopsies. Use of MyProstateScore >40 to rule-in biopsy would have prevented 67% of biopsies while maintaining 95% NPV. In the validation cohort, the prevalence of GG ≥ 2 cancer was 0% for MyProstateScore 0-15, 6.5% for MyProstateScore 15-40, and 19% for MyProstateScore >40. CONCLUSIONS: In patients who previously underwent a negative prostate biopsy, the MyProstateScore values of 15 and 40 yielded clinically-actionable rule-in and rule-out risk groups. Using this straightforward testing approach, MyProstateScore can meaningfully inform patients and physicians weighing the need for repeat biopsy.


Assuntos
Antígeno Prostático Específico , Neoplasias da Próstata , Masculino , Humanos , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia , Antígenos de Neoplasias , Biópsia , Próstata/patologia
18.
Cureus ; 14(4): e24180, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35592186

RESUMO

Intrathecal drug delivery (IDD) has multiple indications, including chronic pain, spasticity, and spinal cord injury. Patients with an IDD device implanted who are undergoing decompressive spinal surgery may be at risk for intrathecal (IT) drug overdose in the perioperative setting. The present report describes a patient with an IDD device who underwent elective spinal surgery that was complicated by prolonged, severe alteration in mental status over several days, requiring discontinuation of his IT medications. The patient eventually returned to his neurological baseline by postoperative day 14. In the setting of severe spinal stenosis cranially in relation to an IDD device, consideration for weaning IT medications prior to elective surgery is recommended to avoid potential IT overdose. Patients undergoing weaning should be monitored for signs and symptoms of medication withdrawal.

19.
J Neurosurg Spine ; : 1-6, 2022 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-35426819

RESUMO

OBJECTIVE: Cervical nerve 5 palsy can occur following surgery for cervical spine pathology. The prognosis of C5 palsy is generally favorable, and most patients recover useful function. However, some patients do not recover useful strength. Nerve transfers are a potential effective treatment of postoperative severe C5 palsy. This study aimed to further delineate the natural history of recovery from postoperative C5 palsy, determine whether lack of recovery at specific time points predicts poor recovery prognosis, and thereby determine a reasonable time point for referral to a complex peripheral nerve specialist. METHODS: The authors conducted a retrospective review of 72 patients who underwent surgery for cervical spondylosis and stenosis complicated by C5 palsy. Medical Research Council (MRC) motor strength grades were recorded preoperatively; immediately postoperatively; at discharge; and at 2 weeks, 3 months, 6 months, and 12 months postoperatively. Univariate and multivariate logistic regression models were used to identify demographic and clinical risk factors associated with recovery of useful strength after severe C5 palsy. RESULTS: The mean patient age was 62.5 years, and 36.1% of patients were female. Thirty patients (41.7%) experienced severe C5 palsy with less than antigravity strength (MRC grade 2 or less) at discharge. Twenty-one (70%) of these patients recovered useful strength (MRC grade 3 or greater) at 12 months postoperatively, and 9 patients (30%) did not recover useful strength at 12 months. Of those patients with persistent severe C5 palsy at 3 months postoperatively, 50% recovered useful strength at 12 months. Of those patients with persistent severe C5 palsy at 6 months postoperatively, 25% recovered useful strength at 12 months. No patient with MRC grade 0 or 1 strength at 6 months postoperatively recovered useful strength. A history of diabetes was associated with the occurrence of severe C5 palsy. On multivariate analysis, female sex was associated with recovery of useful strength. CONCLUSIONS: Most patients with severe C5 palsy recover useful strength in their C5 myotome within 12 months of onset. However, at 3 months postoperatively, patients with persistent severe C5 palsy had only a 50% chance of recovering useful strength by 12 months. Lack of recovery of useful strength at 3 months postoperatively is a reasonable time point for referral to a complex peripheral nerve center to establish care and to determine candidacy for nerve transfer surgery if severe C5 palsy persists.

20.
Ann Surg Open ; 3(2): e162, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36936723

RESUMO

To estimate the nationwide prevalence of individualized out-of-pocket (OOP) price estimators at US hospitals, characterize patterns of inclusion of 14 specified "shoppable" surgical procedures, and determine hospital-level characteristics associated with estimators that include surgical procedures. Background: Price transparency for shoppable surgical services is a key requirement of several recent federal policies, yet the extent to which hospitals provide online OOP price estimators remains unknown. Methods: We reviewed a stratified random sample of 485 U.S. hospitals for the presence of a tool to allow patients to estimate individualized OOP expenses for healthcare services. We compared characteristics of hospitals that did and did not offer online price estimators and performed multivariable modeling to identify facility-level predictors of hospitals offering price estimator with and without surgical procedures. Results: Nearly two-thirds (66.0%) of hospitals in the final sample (95% confidence interval 61.6%-70.1%) offered an online tool for estimating OOP healthcare expenses. Approximately 58.5% of hospitals included at least one shoppable surgical procedure while around 6.6% of hospitals included all 14 surgical procedures. The most common price reported was laparoscopic cholecystectomy (55.1%), and the least common was recurrent cataract removal (20.0%). Inclusion of surgical procedures varied by total annual surgical volume and health system membership. Only 26.9% of estimators explicitly included professional fees. Conclusions: Our findings highlight an ongoing progress in price transparency, as well as key areas for improvement in future policies to help patients make more financially informed decisions about their surgical care.

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