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1.
Am J Pharm Educ ; 87(11): 100134, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37914462

RESUMO

OBJECTIVE: Pharmacy students with substantial educational debt are at risk for excessive workloads, burnout, and clinical errors. During the COVID-19 pandemic, policies addressing economic hardships for all student debt borrowers included temporary suspension of monthly payments and 0% interest during the pause. This study aimed to understand student-level factors regarding student debt from the lived experiences of current pharmacy students and aimed to understand how current pharmacy students view temporary loan relief. METHODS: We used semi-structured interviews of pharmacy students across 4 years of progression in their pharmacy program to better understand student experiences with debt, different factors that may influence the impact of student debt on short-term and long-term outcomes for students, and student perspectives on debt relief policies and potential solutions. Our thematic analysis was grounded in existing evidence and a conceptual framework, while also allowing codes to emerge directly from the data. RESULTS: A total of 20 pharmacy students were interviewed with a median student debt of $77,000, with debt amounts ranging from $0 to $209,000. Students described what mediating factors influenced their experiences, the influence of student debt on clinician burnout, and other outcomes impacted by student debt. Six overarching themes emerged relevant to current students: student debt influences education and career decisions, debt is risky given the saturated pharmacy market, debt is an accepted burden, debt will inhibit starting a life, the COVID-19 loan relief is revealing, and early financial education is needed. CONCLUSION: Pharmacy students burdened with debt described a variety of different experiences and attitudes toward that debt and provided their perspectives on how student debt influences short-term education and career decisions. While students accept the trade-off of debt for their education as an inevitable burden, reported coping mechanisms and strategies shared suggest some solutions may be available to ameliorate this burden.


Assuntos
Educação em Farmácia , Estudantes de Farmácia , Humanos , Pandemias , Apoio ao Desenvolvimento de Recursos Humanos , Escolha da Profissão , Esgotamento Psicológico
2.
J Clin Pharmacol ; 63(12): 1417-1429, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37507728

RESUMO

Pharmacokinetic (PK) comparisons between therapeutic biologics have largely been based on the total area under the concentration-time curve (AUC) and the maximum concentration (Cmax ). For biologics with a long half-life, a PK comparability study may be long in duration and costly to conduct. The goal of this study was to evaluate whether a truncated AUC (tAUC) can be used to assess PK comparability when bridging prefilled syringe (PFS) and autoinjector (AI) treatment options for biologics with a long half-life. Fifteen biologics license applications (BLAs) were included to determine the concordance and geometric percent coefficient of variation (%CV) between tAUCs evaluated on days 7, 14, 21, and 28 and AUC evaluated to infinity (AUC0-inf ). Concordance is established if the tAUCs are comparable with AUC0-inf . Trial simulation was performed to examine the effect of the absorption rate constant (ka ) and sample size on the concordance of tAUCs. The tAUCs evaluated on day 14, 21, and 28 had 100% concordance with AUC0-inf for all 15 BLAs. The concordance of tAUC evaluated at day 7 was 87.5%. Based on the trial simulation, tAUC evaluated to day 28 post-dose can achieve high concordance (≥85%) for biologics exhibiting linear or nonlinear elimination with a ka of ≥0.1/day and with a sample size of 70 subjects per arm. tAUC appears to be a promising alternative PK measure, relative to AUC0-inf , for PK comparability assessments.


Assuntos
Medicamentos Biossimilares , Seringas , Humanos , Equivalência Terapêutica , Área Sob a Curva , Medicamentos Biossimilares/farmacocinética , Injeções Subcutâneas
3.
J Cardiovasc Magn Reson ; 22(1): 37, 2020 05 18.
Artigo em Inglês | MEDLINE | ID: mdl-32423456

RESUMO

BACKGROUND: There is a renewed interest in lower field magnetic resonance imaging (MRI) systems for cardiovascular magnetic resonance (CMR), due to their favorable physical properties, reduced costs, and increased accessibility to patients with implants. We sought to assess the diagnostic capabilities of high-performance low-field (0.55 T) CMR imaging for quantification of right and left ventricular volumes and systolic function in both healthy subjects and patients referred for clinical CMR. METHODS: Sixty-five subjects underwent paired exams at 1.5 T using a clinical CMR scanner and using an identical CMR system modified to operate at 0.55 T. Volumetric coverage of the right ventricle (RV) and left ventricles (LV) was obtained using either a breath-held cine balanced steady-state free-precession acquisition or a motion-corrected free-breathing re-binned cine acquisition. Bland-Altman analysis was used to compare LV and RV end-systolic volume (ESV), end-diastolic volume (EDV), ejection fraction (EF), and LV mass. Diagnostic confidence was scored on a Likert-type ordinal scale by blinded readers. RESULTS: There were no significant differences in LV and RV EDV between the two scanners (e.g., LVEDV: p = 0.77, bias = 0.40 mL, correlation coefficient = 0.99; RVEDV: p = 0.17, bias = - 1.6 mL, correlation coefficient = 0.98), and regional wall motion abnormality scoring was similar (kappa 0.99). Blood-myocardium contrast-to-noise ratio (CNR) at 0.55 T was 48 ± 7% of the 1.5 T CNR, and contrast was sufficient for endocardial segmentation in all cases. Diagnostic confidence of images was scored as "good" to "excellent" for the two field strengths in the majority of studies. CONCLUSION: A high-performance 0.55 T system offers good bSSFP CMR image quality, and quantification of biventricular volumes and systolic function that is comparable to 1.5 T in patients. TRIAL REGISTRATION: Clinicaltrials.gov NCT03331380, NCT03581318.


Assuntos
Cardiomiopatias/diagnóstico por imagem , Ventrículos do Coração/diagnóstico por imagem , Imagem Cinética por Ressonância Magnética/métodos , Função Ventricular Esquerda , Função Ventricular Direita , Adulto , Cardiomiopatias/fisiopatologia , Estudos de Casos e Controles , Feminino , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Volume Sistólico , Sístole
4.
Radiology ; 293(2): 384-393, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31573398

RESUMO

Background Commercial low-field-strength MRI systems are generally not equipped with state-of-the-art MRI hardware, and are not suitable for demanding imaging techniques. An MRI system was developed that combines low field strength (0.55 T) with high-performance imaging technology. Purpose To evaluate applications of a high-performance low-field-strength MRI system, specifically MRI-guided cardiovascular catheterizations with metallic devices, diagnostic imaging in high-susceptibility regions, and efficient image acquisition strategies. Materials and Methods A commercial 1.5-T MRI system was modified to operate at 0.55 T while maintaining high-performance hardware, shielded gradients (45 mT/m; 200 T/m/sec), and advanced imaging methods. MRI was performed between January 2018 and April 2019. T1, T2, and T2* were measured at 0.55 T; relaxivity of exogenous contrast agents was measured; and clinical applications advantageous at low field were evaluated. Results There were 83 0.55-T MRI examinations performed in study participants (45 women; mean age, 34 years ± 13). On average, T1 was 32% shorter, T2 was 26% longer, and T2* was 40% longer at 0.55 T compared with 1.5 T. Nine metallic interventional devices were found to be intrinsically safe at 0.55 T (<1°C heating) and MRI-guided right heart catheterization was performed in seven study participants with commercial metallic guidewires. Compared with 1.5 T, reduced image distortion was shown in lungs, upper airway, cranial sinuses, and intestines because of improved field homogeneity. Oxygen inhalation generated lung signal enhancement of 19% ± 11 (standard deviation) at 0.55 T compared with 7.6% ± 6.3 at 1.5 T (P = .02; five participants) because of the increased T1 relaxivity of oxygen (4.7e-4 mmHg-1sec-1). Efficient spiral image acquisitions were amenable to low field strength and generated increased signal-to-noise ratio compared with Cartesian acquisitions (P < .02). Representative imaging of the brain, spine, abdomen, and heart generated good image quality with this system. Conclusion This initial study suggests that high-performance low-field-strength MRI offers advantages for MRI-guided catheterizations with metal devices, MRI in high-susceptibility regions, and efficient imaging. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Grist in this issue.


Assuntos
Cateterismo , Aumento da Imagem/instrumentação , Imageamento por Ressonância Magnética/instrumentação , Adulto , Artefatos , Cateterismo Cardíaco/instrumentação , Meios de Contraste , Desenho de Equipamento , Feminino , Humanos , Imagem por Ressonância Magnética Intervencionista/instrumentação , Metais , Razão Sinal-Ruído
5.
J Cardiovasc Magn Reson ; 20(1): 62, 2018 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-30201013

RESUMO

BACKGROUND: The hallmark of heart failure is increased blood volume. Quantitative blood volume measures are not conveniently available and are not tested in heart failure management. We assess ferumoxytol, a marketed parenteral iron supplement having a long intravascular half-life, to measure the blood volume with cardiovascular magnetic resonance (CMR). METHODS: Swine were administered 0.7 mg/kg ferumoxytol and blood pool T1 was measured repeatedly for an hour to characterize contrast agent extraction and subsequent effect on Vblood estimates. We compared CMR blood volume with a standard carbon monoxide rebreathing method. We then evaluated three abbreviated acquisition protocols for bias and precision. RESULTS: Mean plasma volume estimated by ferumoxytol was 61.9 ± 4.3 ml/kg. After adjustment for hematocrit the resultant mean blood volume was 88.1 ± 9.4 ml/kg, which agreed with carbon monoxide measures (91.1 ± 18.9 ml/kg). Repeated measurements yielded a coefficient of variation of 6.9%, and Bland-Altman repeatability coefficient of 14%. The blood volume estimates with abbreviated protocols yielded small biases (mean differences between 0.01-0.06 L) and strong correlations (r2 between 0.97-0.99) to the reference values indicating clinical feasibility. CONCLUSIONS: In this swine model, ferumoxytol CMR accurately measures plasma volume, and with correction for hematocrit, blood volume. Abbreviated protocols can be added to diagnostic CMR examination for heart failure within 8 min.


Assuntos
Determinação do Volume Sanguíneo/métodos , Volume Sanguíneo , Meios de Contraste/administração & dosagem , Óxido Ferroso-Férrico/administração & dosagem , Imageamento por Ressonância Magnética , Animais , Monóxido de Carbono/administração & dosagem , Modelos Animais , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Sus scrofa
6.
J Cardiovasc Magn Reson ; 20(1): 41, 2018 06 21.
Artigo em Inglês | MEDLINE | ID: mdl-29925397

RESUMO

BACKGROUND: Cardiovascular magnetic resonance (CMR) fluoroscopy allows for simultaneous measurement of cardiac function, flow and chamber pressure during diagnostic heart catheterization. To date, commercial metallic guidewires were considered contraindicated during CMR fluoroscopy due to concerns over radiofrequency (RF)-induced heating. The inability to use metallic guidewires hampers catheter navigation in patients with challenging anatomy. Here we use low specific absorption rate (SAR) imaging from gradient echo spiral acquisitions and a commercial nitinol guidewire for CMR fluoroscopy right heart catheterization in patients. METHODS: The low-SAR imaging protocol used a reduced flip angle gradient echo acquisition (10° vs 45°) and a longer repetition time (TR) spiral readout (10 ms vs 2.98 ms). Temperature was measured in vitro in the ASTM 2182 gel phantom and post-mortem animal experiments to ensure freedom from heating with the selected guidewire (150 cm × 0.035″ angled-tip nitinol Terumo Glidewire). Seven patients underwent CMR fluoroscopy catheterization. Time to enter each chamber (superior vena cava, main pulmonary artery, and each branch pulmonary artery) was recorded and device visibility and confidence in catheter and guidewire position were scored on a Likert-type scale. RESULTS: Negligible heating (< 0.07°C) was observed under all in vitro conditions using this guidewire and imaging approach. In patients, chamber entry was successful in 100% of attempts with a guidewire compared to 94% without a guidewire, with failures to reach the branch pulmonary arteries. Time-to-enter each chamber was similar (p=NS) for  the two approaches. The guidewire imparted useful catheter shaft conspicuity and enabled interactive modification of catheter shaft stiffness, however, the guidewire tip visibility was poor. CONCLUSIONS: Under specific conditions, trained operators can apply low-SAR imaging and using a specific fully-insulated metallic nitinol guidewire (150 cm × 0.035" Terumo Glidewire) to augment clinical CMR fluoroscopy right heart catheterization. TRIAL REGISTRATION: Clinicaltrials.gov NCT03152773 , registered May 15, 2017.


Assuntos
Cateterismo Cardíaco/instrumentação , Cateteres Cardíacos , Imagem por Ressonância Magnética Intervencionista/instrumentação , Ligas , Animais , Cateterismo Cardíaco/efeitos adversos , Desenho de Equipamento , Temperatura Alta , Humanos , Imagem por Ressonância Magnética Intervencionista/efeitos adversos , Teste de Materiais , Modelos Animais , Imagens de Fantasmas , Valor Preditivo dos Testes , Sus scrofa , Fatores de Tempo , Fluxo de Trabalho
7.
Radiol Technol ; 88(1): 18-26, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27601689

RESUMO

PURPOSE: To assess alternatives to sedation and general anesthesia to prepare children for magnetic resonance (MR) imaging examinations. METHODS: Online databases were searched for articles discussing methods of preparing children for MR imaging procedures. Because of the large number of articles returned, criteria were limited to only studies that prepared patients without the use of sedation or general anesthesia. RESULTS: Twenty-four studies were deemed appropriate for inclusion in the review. The following methods emerged as alternatives to pediatric sedation: mock scanners, MR-compatible audiovisual systems, feed-sleep manipulation, play therapy, infant incubators/immobilizers, photo diaries, sucrose solutions, and guided imagery. The approaches with the most extensive research were mock MR scanners and feed-sleep manipulation. DISCUSSION: Evidence supports the use of these alternative techniques as valid substitutes for pediatric sedation and general anesthesia. CONCLUSION: To reduce the risks associated with sedation of pediatric patients, institutions could implement the alternatives discussed in this review. Cost analyses should be conducted first because some methods are more expensive than others. Finally, further research is needed to better assess the effectiveness of lesser-practiced methods, including photo diaries, sucrose solutions, and guided imagery.


Assuntos
Ansiedade/prevenção & controle , Imobilização/métodos , Imageamento por Ressonância Magnética/psicologia , Educação de Pacientes como Assunto/métodos , Ludoterapia/métodos , Anestesia Geral/métodos , Ansiedade/etiologia , Ansiedade/psicologia , Criança , Pré-Escolar , Sedação Consciente/métodos , Feminino , Humanos , Imobilização/psicologia , Lactente , Recém-Nascido , Imageamento por Ressonância Magnética/efeitos adversos , Masculino , Pediatria , Resultado do Tratamento
8.
Radiol Technol ; 87(6): 622-6, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27390230

RESUMO

BACKGROUND: A patient with a history of cancer in remission and congestive heart failure with no acute symptoms presented for a follow-up echocardiogram. The scan revealed a new echodense mass filling his right ventricular apex. An endomyocardial biopsy guided by x-ray fused with magnetic resonance (MR) imaging (XFM) was performed. This case report outlines the steps of XFM image preparation involving MR image acquisition, processing, and coregistration with x-ray fluoroscopy. DISCUSSION: In cases of focal pathology or cardiac masses, endomyocardial biopsy can be challenging because x-ray fluoroscopy guidance offers limited visualization of soft-tissue structures. XFM overcomes this issue by overlaying high-resolution MR images onto x-ray fluoroscopy images. CONCLUSION: This case report illustrates the clinical use of XFM for endomyocardial biopsy of an apical right ventricular mass and provides a practical, step-by-step description of MR image acquisition, processing, and coregistration with fluoroscopy, as performed by the MR technologist.


Assuntos
Fluoroscopia , Neoplasias Cardíacas/diagnóstico por imagem , Neoplasias Cardíacas/secundário , Ventrículos do Coração/diagnóstico por imagem , Biópsia Guiada por Imagem , Melanoma/diagnóstico por imagem , Melanoma/secundário , Imagem Multimodal , Meios de Contraste , Diagnóstico Diferencial , Ecocardiografia , Marcadores Fiduciais , Humanos , Iopamidol , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada
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