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1.
Eur Urol ; 79(2): 177-179, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33461737

RESUMO

Cabazitaxel is used to treat patients with metastatic castration-resistant prostate cancer progressing after docetaxel. It is prepackaged in 60 mg single-dose vials, a quantity much higher than the average prescribed dose, which leads to, substantial drug wastage (DW) and associated costs. To minimize DW we implemented a cost-saving, cohorting strategy where multiple patients scheduled to receive cabazitaxel (at a dose of 20mg/m2 every 3 wks) were cohorted and treated on a single weekday whenever possible. Excess drug from each vial was then saved and used for subsequent patients treated on the same day. The drug cost with cohorting was calculated from the actual number of vials used, and the drug cost without cohorting was estimated by assumingthat one vial was used per treatment. The cost of DW was determined based on the amount of drug that was discarded. All cost calculations also accounted for the discount incentives offered by Sanofi-Aventis. Over a 3-yr period, 74 patients received 402 treatments of cabazitaxel. Multiple patients were treated on 67.4% of the treatment days, and grouping of three patients on one day saved one vial. The estimated total drug cost saved was $394 536 CAD (21.1%). Pending further studies on safety and efficacy, this strategy could potentially be adopted to mitigate DW for cabazitaxel and similarly for other oncology drugs. This would significantly decrease the overall financial burden on patients, institutions, and stakeholders. PATIENT SUMMARY: Cabazitaxel chemotherapy is associated with substantial drug wastage and associated costs. By cohorting patients scheduled to receive cabazitaxel on a single weekday, the total drug cost was decreased by $394 536 CAD (21.1%) over a 3-yr period. Similar strategies could be considered to overcome the prohibitory costs associated with drug wastage for cabazitaxel and other cancer drugs.

2.
Support Care Cancer ; 28(10): 5031-5036, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32601854

RESUMO

PURPOSE: People with cancer face an elevated risk of infection and severe sequelae from COVID-19. Dexamethasone is commonly used for antiemetic prophylaxis with systemic therapy for cancer. However, dexamethasone is associated with increased risk of viral and respiratory infections, and causes lymphopenia, which is associated with worse outcomes during COVID-19 infections. Our purpose was to minimize dexamethasone exposure during antiemetic prophylaxis for systemic therapy for solid tumors during the COVID-19 pandemic, while maintaining control of nausea and emesis. METHODS: We convened an expert panel to systematically review the literature and formulate consensus recommendations. RESULTS: No studies considered the impact of dexamethasone-based antiemetic regimens on the risk and severity of COVID-19 infection. Expert consensus recommended modifications to the 2019 Cancer Care Ontario Antiemetic Recommendations. CONCLUSION: Clinicians should prescribe the minimally effective dose of dexamethasone for antiemetic prophylaxis. Single-day dexamethasone dosing is recommended over multi-day dosing for regimens with high emetogenic risk excluding high-dose cisplatin, preferably in combination with palonosetron, netupitant, and olanzapine. For regimens with low emetogenic risk, 5-HT3 antagonists are recommended over dexamethasone.


Assuntos
Antieméticos/uso terapêutico , Antineoplásicos/efeitos adversos , Betacoronavirus , Infecções por Coronavirus , Dexametasona/uso terapêutico , Náusea/prevenção & controle , Neoplasias/tratamento farmacológico , Pandemias , Pneumonia Viral , Vômito/prevenção & controle , Antineoplásicos/uso terapêutico , Infecções por Coronavirus/epidemiologia , Humanos , Náusea/induzido quimicamente , Ontário , Pneumonia Viral/epidemiologia , Guias de Prática Clínica como Assunto , Vômito/induzido quimicamente
4.
Ann Transplant ; 25: e922723, 2020 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-32527989

RESUMO

BACKGROUND Hepatitis C virus (HCV)-seropositive donor hearts are underutilized for orthotopic heart transplantation (OHT). The advancement of direct-acting antiviral agent (DAA) treatment for HCV makes utilizing HCV-seropositive and viremic donor organs in HCV-seronegative recipients a possibility. MATERIAL AND METHODS From 1997 to 2019, adult patients who underwent OHT at our institution were retrospectively reviewed. Ten HCV-seronegative patients received HCV-seropositive donor hearts, 3 of which tested nucleic acid-positive. Kaplan-Meier curves were performed for survival analyses. This study was approved by the Institutional Review Board. RESULTS Recipient median age was 57.5 years old, and 2 (20%) were female. Donor median age was 42 years old, and 3 (30%) were female. One donor was cured from HCV with DAA prior to OHT. Four recipients developed hepatitis C viremia immediately after OHT. DAA treatment was completed in 3 recipients who demonstrated cure. Thirty-day and 1-year survival rates were both 80%. CONCLUSIONS We describe 10 HCV-seronegative patients who received HCV-seropositive donor hearts at our institution, with excellent short-term outcomes, even in those who received nucleic acid testing positive organs. DAA can be effective in treating hepatitis C viremia before and after OHT, with excellent recipient survival. Large clinical studies are needed to further evaluate the long-term outcomes of DAA therapy in patients after heart transplantation.

6.
Prev Med Rep ; 17: 101057, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32025476

RESUMO

Our objective was to determine which messaging approaches from a marketing campaign were most effective in recruiting African American individuals to a glaucoma screening and research study. We conducted a multimedia marketing campaign in Philadelphia from 01/31/2018 to 06/30/2018. Messaging approaches included radio advertisements and interviews (conducted in partnership with a local radio station with a large African American listener base), print materials, event tables, and online postings. Participants received free glaucoma screenings and the opportunity to enroll in our glaucoma genetics study. These screenings allowed individuals with glaucoma to receive a full examination and treatment plan with a glaucoma specialist, as well as to contribute to future efforts to identify genetic variants underlying this disease. We compared inquiry, enrollment, and cost yield for each messaging approach. Our campaign resulted in 154 unique inquiries, with 98 patients receiving glaucoma screenings (64%) and 60 patients enrolling in our study (39%). Commercials on WURD radio yielded the highest number of inquiries (62%) and enrollments (62%), but at relatively high cost ($814/enrolled patient). The most inexpensive approach that yielded more than five enrollments was postcards ($429/enrolled patient). Our campaign suggests that high-frequency commercials and postcards distributed at targeted healthcare locations are particularly effective and affordable options for connecting with the African American community. Our findings can help to inform recruitment efforts for other understudied diseases in minority populations.

7.
J Cardiol ; 76(1): 9-13, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32107069

RESUMO

BACKGROUND: Early medication administration in cardiac arrest improves outcomes. The primary objective was to evaluate the association between epinephrine administration in in-hospital cardiac arrest (IHCA) patients with non-shockable rhythm and the patient outcomes. The secondary objective was to assess the compliance of epinephrine and amiodarone administration in accordance with the advanced cardiovascular life support (ACLS) guideline. METHODS: IHCA patients aged 18 years or above were identified from the resuscitation registry of 2016 of two public hospitals and categorized according to their initial rhythms. For patients with non-shockable rhythms, the associations between IHCA outcomes, return of spontaneous circulation (ROSC), and survival to discharge, and the time of epinephrine administration were analyzed by logistic regression. The compliance rate of epinephrine and amiodarone administration during resuscitation to ACLS guideline were reported. RESULTS: Among 349 patients with non-shockable rhythm, the median time to epinephrine administration was 3 min (interquartile range, 1-6 min). Early epinephrine administration (<5 min), compared with late epinephrine administration (>5 min), was significantly associated with the rate of ROSC (49.2% vs 34.9%; adjusted odds ratio, 1.630; 95% confidence interval 1.008-2.635, p = 0.046). The time to epinephrine administration (as continuous interval) was significantly associated with the rate of ROSC (p = 0.002) and survival to discharge (p = 0.029). In addition, the compliance rate of epinephrine and amiodarone administration during resuscitation were 83.6% and 33.3%, respectively. CONCLUSION: Our study found that time of epinephrine administration was significantly associated with better results in ROSC and survival to discharge in IHCA patients with non-shockable rhythm. When we divided the IHCA patients with non-shockable rhythms into early and late administration group, early epinephrine administration was associated with significantly improved ROSC, but not survival to discharge after adjusting with potential confounding factors.

8.
Clin Transplant ; 33(10): e13692, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31403741

RESUMO

BACKGROUND: Despite significant advances in durable mechanical support survival, infectious complications remain the most common adverse event after ventricular assist device (VAD) implantation and the leading cause of early death after transplantation. In this study, we aim to describe our local infectious epidemiology and review short-term survival and infectious incidence rates in the post-transplantation period and assess risk factors for infectious episodes after transplantation. METHODS: Retrospective single-center study of all consecutive adult heart transplant patients from 2008 to 2017. Survival data were estimated and summarized using the Kaplan-Meier method. We quantified and evaluated the difference in the incidence rate between patients with and without infection using a Fine-Gray model. The outcome of interest is the time to first infection diagnosis with post-transplant death as the competing event. RESULTS: Among 278 heart transplant patients, 74 (26.5%) underwent LVAD implantation. Twenty-one patients (28.3%) developed an infection while supported by an LVAD. When compared to patients supported by an LVAD without a preceding infection, BMI was significantly greater (31.2 vs 27.8 kg/m2 , P = .03). Median follow-up post-transplantation was 3.01 years. Significant risk factors for the competing risk regression for infection after heart transplantation include LVAD infection (HR 1.94, [95% CI] 1.11-3.39, P = .020) and recipient COPD (HR 2.14, [95% CI] 1.39-3.32, P = .001) when adjusted for recipient age, gender, hypertension, diabetes mellitus, and body mass index. CONCLUSIONS: Patients with LVAD-related infection had a significantly increased risk of infectious complications after heart transplantation. Further research on the avoidance of induction agents and reduced maintenance immunosuppression in this patient population is warranted.


Assuntos
Insuficiência Cardíaca/mortalidade , Transplante de Coração/mortalidade , Coração Auxiliar/efeitos adversos , Infecções/mortalidade , Adulto , Feminino , Seguimentos , Insuficiência Cardíaca/cirurgia , Transplante de Coração/efeitos adversos , Humanos , Infecções/etiologia , Infecções/patologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida
9.
Am J Gastroenterol ; 114(10): 1574-1586, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31464740

RESUMO

OBJECTIVES: To systematically summarize the risk relationship between different levels of alcohol consumption and incidence of liver cirrhosis. METHODS: MEDLINE and Embase were searched up to March 6, 2019, to identify case-control and cohort studies with sex-specific results and more than 2 categories of drinking in relation to the incidence of liver cirrhosis. Study characteristics were extracted and random-effects meta-analyses and meta-regressions were conducted. RESULTS: A total of 7 cohort studies and 2 case-control studies met the inclusion criteria, providing data from 2,629,272 participants with 5,505 cases of liver cirrhosis. There was no increased risk for occasional drinkers. Consumption of one drink per day in comparison to long-term abstainers showed an increased risk for liver cirrhosis in women, but not in men. The risk for women was consistently higher compared to men. Drinking ≥5 drinks per day was associated with a substantially increased risk in both women (relative risk [RR] = 12.44, 95% confidence interval [CI]: 6.65-23.27 for 5-6 drinks, and RR = 24.58, 95% CI: 14.77-40.90 for ≥7 drinks) and men (RR = 3.80, 95% CI: 0.85-17.02, and RR = 6.93, 95% CI: 1.07-44.99, respectively). Heterogeneity across studies indicated an additional impact of other risk factors. DISCUSSION: Alcohol is a major risk factor for liver cirrhosis with risk increasing exponentially. Women may be at higher risk compared to men even with little alcohol consumption. More high-quality research is necessary to elucidate the role of other risk factors, such as genetic vulnerability, body weight, metabolic risk factors, and drinking patterns over the life course. High alcohol consumption should be avoided, and people drinking at high levels should receive interventions to reduce their intake.


Assuntos
Consumo de Bebidas Alcoólicas/efeitos adversos , Cirrose Hepática/epidemiologia , Consumo de Bebidas Alcoólicas/epidemiologia , Humanos , Incidência , Cirrose Hepática/etiologia , Fatores de Risco , Fatores Sexuais
10.
Artigo em Inglês | MEDLINE | ID: mdl-31192031

RESUMO

Objective: The purpose of this study is to evaluate the role mitochondrial inheritance plays in primary open-angle glaucoma (POAG) characteristics in African Americans. Methods: POAG cases from the L1c2 and L1b mitochondrial haplogroups were compared in a retrospective case-case study. Twenty-six pairs of self-identified African American POAG cases from L1c2 and L1b mitochondrial haplogroups matched on age (mean [SD] = 71.2 [9.6] and 71.3 [9.6] years, respectively; p = 0.97), sex (21 female and 5 male pairs), and family history of glaucoma (positive in 15/26 [58%] pairs) were included. Results: L1c2 subjects displayed higher vertical cup-to-disc ratio (0.75 [0.12] and 0.67 [0.16], respectively; p = 0.01, Bonferroni-corrected p = 0.08), worse pattern standard deviation on visual field (VF) testing (5.5 [3.5] and 3.5 [2.7]; p = 0.005, Bonferroni-corrected p = 0.02), and more severe glaucoma based on American Glaucoma Society staging criteria (p = 0.04, Bonferroni-corrected p = 0.32) compared to L1b subjects. L1c2 also trended towards worse mean deviation on VF compared to L1b (-8.2 [7.6] and -5.8 [6.8], respectively, p = 0.17). Best corrected visual acuity, central corneal thickness, maximum intraocular pressure (IOP), and cataract severity were comparable between L1c2 and L1b haplogroups (p ≥ 0.49), as was retinal nerve fiber layer thickness on optical coherence tomography (75.1 [14.1] and 75.1 [13.0]; p = 0.99). Conclusion: Results demonstrated worse glaucomatous cupping and more severe VF loss in the L1c2 compared to the L1b haplogroup despite comparable IOP. Findings implicate mitochondrial inheritance as a factor affecting POAG severity and may ultimately contribute to stratifying POAG patients into phenotypically and genotypically distinct subgroups.

11.
Clin Transplant ; 33(4): e13498, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30776137

RESUMO

We report a case of a 64-year-old woman who developed transfusion-dependent anemia after cardiac transplantation, the etiology of which was unknown after initial comprehensive evaluation. At the suggestion of the Transplant Infectious Diseases consultant, microbial agents with red blood cell tropism pertinent to this patient such as Parvovirus B 19 (B19V) were investigated. The B19V viral load by PCR in peripheral blood was >100 000 000 copies/ml and after treatment with intravenous immunoglobulin (IVIG), her anemia resolved. Here, we summarize the clinical and virologic characteristics, treatment, and outcome of fifteen cases of B19V-induced anemia in heart transplant recipients. Spontaneous recovery from anemia secondary to B19V has also been reported in some heart transplant recipients, possibly due to an absence of their B19V P-antigen receptor and/or reduction in their immunosuppression. Therefore, in heart transplant patients, B19V should be suspected early as a cause of severe anemia of unknown etiology. The extent that B19V-induced anemia is underdiagnosed in heart transplant recipients is unknown.


Assuntos
Anemia/etiologia , Transplante de Coração/efeitos adversos , Infecções por Parvoviridae/complicações , Parvovirus B19 Humano/isolamento & purificação , Anemia/patologia , Feminino , Humanos , Pessoa de Meia-Idade , Infecções por Parvoviridae/virologia , Prognóstico , Carga Viral
12.
Can J Cardiol ; 35(1): 104.e1-104.e3, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30595172

RESUMO

Dyslipidemia is common in patients undergoing heart transplantation and is associated with the progression of cardiac allograft vasculopathy. Two monoclonal antibodies directed against PCSK9i-evolocumab and alirocumab-are currently available. However, their use, safety and efficacy in the post-transplant setting have not been studied. We present our experience with 6 heart transplant recipients treated with a PCSK9i. A > 70% reduction in LDL-cholesterol was observed after evolocumab therapy. PCSK9 inhibitors are a potentially lipid-lowering therapeutic option for heart transplant patients with suboptimal LDL despite maximal tolerated statin doses.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Dislipidemias/tratamento farmacológico , Rejeição de Enxerto/prevenção & controle , Transplante de Coração/efeitos adversos , Lipídeos/sangue , Pró-Proteína Convertase 9/antagonistas & inibidores , Adulto , Idoso , Anticorpos Monoclonais Humanizados , Anticolesterolemiantes/uso terapêutico , Dislipidemias/complicações , Feminino , Rejeição de Enxerto/sangue , Rejeição de Enxerto/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Pró-Proteína Convertase 9/sangue , Resultado do Tratamento
13.
Eye (Lond) ; 33(5): 838-844, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30635643

RESUMO

OBJECTIVE: To introduce a new method of grading optic nerve stereo disc photographs and evaluate reproducibility of assessments by non-physician graders in a reading center. METHODS: Three non-physician graders, experienced in grading features of the retina but not the optic nerve head (ONH), were trained by glaucoma specialists to assess digital stereo color images of the ONH. These graders assessed a total of 2554 digital stereo disc images from glaucoma cases and controls participating in the Primary Open-Angle African American Glaucoma Genetics (POAAGG) study by outlining the optic cup and disc. Inter-grader reproducibility of area, height, and width measurements was analyzed. RESULTS: Among all images, the intraclass correlation (95% confidence interval) was 0.90 (0.89, 0.90) for the cup area using only color cues; 0.92 (0.91, 0.92) for the cup area using contour and vascular cues; and 0.99 (0.99, 0.99) for the optic disc area. The intraclass correlation for cup-to-disc ratio (CDR) was 0.61 (0.58, 0.63), as determined by the ratio of optic cup area to optic disc area (using contour and vascular cues). The CDR difference by graders for area was ≤ 0.1 in 65% of images using color/vascular cues and ≤0.1 in 71% of images using color cues. CONCLUSIONS: After adequate training, non-physician graders were able to measure the optic nerve CDR with high inter-grader reliability.


Assuntos
Pessoal Técnico de Saúde/estatística & dados numéricos , Glaucoma de Ângulo Aberto/diagnóstico , Processamento de Imagem Assistida por Computador/métodos , Disco Óptico/patologia , Doenças do Nervo Óptico/diagnóstico , Fotografação/métodos , Adulto , Afro-Americanos/genética , Feminino , Glaucoma de Ângulo Aberto/genética , Humanos , Masculino , Pessoa de Meia-Idade , Doenças do Nervo Óptico/genética , Reprodutibilidade dos Testes
15.
J Oncol Pharm Pract ; 25(4): 875-883, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29722605

RESUMO

BACKGROUND: Mannitol is an osmotic diuretic given routinely as part of cisplatin regimens to prevent nephrotoxicity, but there are limited data on the ideal dosage. At our center, three different doses of mannitol are used: 12, 20, and 40 g per cycle for cisplatin doses of ≥50 mg/m2. The primary objective was to determine if variations in mannitol dosing significantly influence the incidence of cisplatin-induced acute nephrotoxicity. METHODS: A case-control study was performed. Electronic records of 1462 consecutive outpatients who received cisplatin at ≥ 50 mg/m2 per cycle between January 2010 and December 2014 were reviewed. Patients experiencing nephrotoxicity of any grade within 30 days of last cisplatin dose, as defined by NCI CTCAE 4.0, were matched to a minimum of two and maximum of five controls based on the following criteria: age ± 5 years, baseline estimated glomerular filtration rate ± 10 ml/min/1.73 m2, cisplatin dose per cycle, and presence of diabetes. Conditional logistic regression was used to identify baseline predictors of cisplatin-induced acute nephrotoxicity. RESULTS: Of the 1245 included patients, 237 had nephrotoxicity and 1008 were matched controls. Median baseline estimated glomerular filtration rate for cases and controls were 83 and 80 ml/min/1.73 m2, respectively. A total of 3.8% of cases experienced ≥ grade 3 nephrotoxicity. Univariable analysis showed that diabetes, lymphoma, low baseline estimated glomerular filtration rate, and low baseline magnesium level were significantly associated with nephrotoxicity, whereas mannitol dosing did not show any association (odds ratio 1.08; p = 0.29). In multivariable analysis, diabetes and lymphoma retained statistical significance, but baseline estimated glomerular filtration rate and baseline magnesium level showed nonsignificant associations with nephrotoxicity. CONCLUSIONS: Cisplatin-induced acute nephrotoxicity remains common in patients with good baseline renal function despite preventive measures. Diabetes and lymphoma are predictors of nephrotoxicity, whereas mannitol dosing has no significant influence, suggesting that doses may be standardized across cisplatin regimens.


Assuntos
Antineoplásicos/efeitos adversos , Cisplatino/efeitos adversos , Rim/efeitos dos fármacos , Manitol/administração & dosagem , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Taxa de Filtração Glomerular/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
16.
Lung Cancer ; 125: 1-7, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30429004

RESUMO

INTRODUCTION: Osimertinib improves progression-free survival in previously untreated EGFR-positive advanced non-small cell lung cancer (NSCLC) patients, with marked intracranial response rates. However, its cost-effectiveness in a publically funded health care system has not been established. We assessed the cost-effectiveness of first-line osimertinib from the public payer perspective in the Canadian health care system. METHODS: A Markov model was developed to project the outcomes and direct medical costs of initial treatment with osimertinib or current standard-of-care (SoC) EGFR TKIs, gefinitib or afatinib, in patients with previously untreated EGFR-mutant advanced NSCLC. Clinical and cost input estimates were informed from the available literature. Model outcomes included costs (in 2018 Canadian dollars), life years (LYs), quality-adjusted life-years (QALYs), and the cost utility of osimertinib compared to SoC EGFR TKI, or incremental cost per QALY gained. RESULTS: Initial treatment with osimertinib was associated with a gain of 0.79 QALY [95% confidence interval (CI), 0.74 to 0.83] at an incremental cost of $176,394 CAD (95% CI, 176,383 to 176,405) vs. SoC EGFR TKI (incremental cost-effectiveness ratio [ICER]: $223,133/QALY gained; 95%CI, 198,144 to 252,805). Osimertinib had a 0% probability of being cost-effective at a willingness-to-pay threshold of $100,000 per QALY. Deterministic sensitivity analysis showed that the cost of osimertinib had the largest impact on ICER results. CONCLUSION: At the current marketed price, first-line osimertinib therapy in patients with advanced EGFR-mutant lung adenocarcinoma is not cost-effective in Canada. Reduction of osimertinib cost, for example by 25%, can significantly improve the cost-effectiveness profile.


Assuntos
Acrilamidas/economia , Acrilamidas/uso terapêutico , Compostos de Anilina/economia , Compostos de Anilina/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/economia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/etiologia , Afatinib/economia , Afatinib/uso terapêutico , Canadá , Análise Custo-Benefício/economia , Intervalo Livre de Doença , Receptores ErbB/genética , Gefitinibe/economia , Gefitinibe/uso terapêutico , Humanos , Mutação/genética , Inibidores de Proteínas Quinases/economia , Inibidores de Proteínas Quinases/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida
18.
Can J Hosp Pharm ; 70(4): 270-275, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28894310

RESUMO

BACKGROUND: The addition of the immunostimulant plerixafor to the current standard-of-care regimens of granulocyte colony-stimulating growth factor with or without chemotherapy has improved clinical results in terms of successful stem cell mobilization and the outcomes of stem cell transplant in various settings. With this medical innovation has come an added financial cost for institutions where stem cell transplants are routinely performed, and there may be a further financial burden when the contents of partial vials of the drug are wasted, given that plerixafor vials (Mozobil, Sanofi-Aventis Canada Inc) are currently deemed suitable only for single use. OBJECTIVE: To determine whether the portion of plerixafor remaining in an opened vial of the Mozobil product after administration of a single dose is chemically stable, by comparison with the original product. METHODS: Stability testing of partial drug contents of an opened vial, stored at room temperature or under refrigeration (4°C), was conducted using liquid chromatography-tandem mass spectrometry analysis. The mean concentration of plerixafor (µmol/L), standard deviation, coefficient of variation, and bias were determined on days 2, 3, 11, 17, 24, and 31. Method validation included determination of precision, sensitivity, recovery, dilution linearity, and carryover. RESULTS: Throughout the 4-week testing period, measured plerixafor concentration in aliquots stored at room temperature and under refrigeration, tested in series over time, appeared similar. The mean residual drug concentration after initial opening was slightly, but not significantly, higher for the sample designated for storage at room temperature than the one designated for refrigerated storage (40.4 versus 39.9 µmol/L; p = 0.37). CONCLUSIONS: Residual plerixafor after initial opening of a vial of the Mozobil product remained chemically stable for at least 2 weeks both at room temperature and under refrigeration. The results of this study provide in vitro evidence to support multiple uses, instead of single use, of vials of this drug in an aseptic, controlled environment.

19.
BMC Med Res Methodol ; 17(1): 101, 2017 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-28705151

RESUMO

BACKGROUND: African Americans have been historically under-represented in genetic studies. More research is needed on effective recruitment strategies for this population, especially on approaches that supplement traditional clinic enrollment. This study evaluates the cost and efficacy of four supplemental recruitment methods employed by the Primary Open-Angle African American Glaucoma Genetics (POAAGG) study. METHODS: After enrolling 2304 patients from University of Pennsylvania ophthalmology clinics, the POAAGG study implemented four new recruitment methods to supplement clinic enrollment. These methods included: 1) outreach in the local community, 2) in-house screening of community members ("in-reach"), 3) expansion to two external sites, and 4) sampling of the Penn Medicine Biobank. The cost per subject was calculated for each method and enrollment among cases, controls, and suspects was reported. RESULTS: The biobank offered the lowest cost ($5/subject) and highest enrollment yield (n = 2073) of the four methods, but provided very few glaucoma cases (n = 31). External sites provided 88% of cases recruited from the four methods (n = 388; $85/subject), but case enrollment at these sites declined over the next 9 months as the pool of eligible subjects was depleted. Outreach and in-reach screenings of community members were very high cost for low return on enrollment ($569/subject for 102 subjects and $606/subject for 45 subjects, respectively). CONCLUSIONS: The biobank offered the most cost-effective method for control enrollment, while expansion to external sites was necessary to recruit richly phenotyped cases. These recruitment methods helped the POAAGG study to exceed enrollment of the discovery cohort (n = 5500) 6 months in advance of the predicated deadline and could be adopted by other large genetic studies seeking to supplement clinic enrollment.


Assuntos
Afro-Americanos/genética , Testes Genéticos/métodos , Glaucoma de Ângulo Aberto/genética , Seleção de Pacientes , Adulto , Afro-Americanos/estatística & dados numéricos , Idoso , Análise Custo-Benefício , Testes Genéticos/economia , Glaucoma de Ângulo Aberto/diagnóstico , Humanos , Pessoa de Meia-Idade , Philadelphia , Reprodutibilidade dos Testes
20.
J Phys Ther Sci ; 29(5): 884-890, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28603365

RESUMO

[Purpose] To examine the efficacy of Ai Chi in relieving the pain and stiffness of knee osteoarthritis and improving, physical functioning, proprioception and quality of life. [Subjects and Methods] Twenty-five persons with knee osteoarthritis completed 5 weeks Ai Chi practice (60 minutes per session, twice per week, 10 sessions in total). Knee pain and stiffness were measured before and after the intervention program. [Results] Significant improvements in pain, self-perceived physical functioning and self-perceived stiffness were observed after the Ai-Chi intervention. On average, no significant change in knee range of motion, 6-minute walk test distances or proprioception was observed. [Conclusion] A five-week Ai Chi intervention can improve the pain and stiffness of knee osteoarthritis and self-perceived physical functions and quality of life improvement. Ai Chi may be another treatment choice for people with knee OA to practice in the community.

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