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1.
JAMA Surg ; 2024 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-38809546

RESUMO

Importance: A new liver allocation policy was implemented by United Network for Organ Sharing (UNOS) in February 2020 with the stated intent of improving access to liver transplant (LT). There are growing concerns nationally regarding the implications this new system may have on LT costs, as well as access to a chance for LT, which have not been captured at a multicenter level. Objective: To characterize LT volume and cost changes across the US and within specific center groups and demographics after the policy implementation. Design, Setting, and Participants: This cross-sectional study collected and reviewed LT volume from multiple centers across the US and cost data with attention to 8 specific center demographics. Two separate 12-month eras were compared, before and after the new UNOS allocation policy: March 4, 2019, to March 4, 2020, and March 5, 2020, to March 5, 2021. Data analysis was performed from May to December 2022. Main Outcomes and Measures: Center volume, changes in cost. Results: A total of 22 of 68 centers responded comparing 1948 LTs before the policy change and 1837 LTs postpolicy, resulting in a 6% volume decrease. Transplants using local donations after brain death decreased 54% (P < .001) while imported donations after brain death increased 133% (P = .003). Imported fly-outs and dry runs increased 163% (median, 19; range, 1-75, vs 50, range, 2-91; P = .009) and 33% (median, 3; range, 0-16, vs 7, range, 0-24; P = .02). Overall hospital costs increased 10.9% to a total of $46 360 176 (P = .94) for participating centers. There was a 77% fly-out cost increase postpolicy ($10 600 234; P = .03). On subanalysis, centers with decreased LT volume postpolicy observed higher overall hospital costs ($41 720 365; P = .048), and specifically, a 122% cost increase for liver imports ($6 508 480; P = .002). Transplant centers from low-income states showed a significant increase in hospital (12%) and import (94%) costs. Centers serving populations with larger proportions of racial and ethnic minority candidates and specifically Black candidates significantly increased costs by more than 90% for imported livers, fly-outs, and dry runs despite lower LT volume. Similarly, costs increased significantly (>100%) for fly-outs and dry runs in centers from worse-performing health systems. Conclusions and Relevance: Based on this large multicenter effort and contrary to current assumptions, the new liver distribution system appears to place a disproportionate burden on populations of the current LT community who already experience disparities in health care. The continuous allocation policies being promoted by UNOS could make the situation even worse.

2.
Pharmacogenet Genomics ; 33(3): 59-65, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-36877088

RESUMO

OBJECTIVES: LCP tac has a recommended starting dose of 0.14 mg/kg/day in kidney transplant. The goal of this study was to assess the influence of CYP3A5 on perioperative LCP tac dosing and monitoring. METHODS: This was a prospective observational cohort study of adult kidney recipients receiving de-novo LCP tac. CYP3A5 genotype was measured and 90-day pharmacokinetic and clinical were assessed. Patients were classified as CYP3A5 expressors (*1 homozygous or heterozygous) or nonexpressors (LOF *3/*6/*7 allele). RESULTS: In this study, 120 were screened, 90 were contacted and 52 provided consent; 50 had genotype results, and 22 patients expressed CYP3A5*1. African Americans (AA) comprised 37.5% of nonexpressors versus 81.8% of expressors (P = 0.001). Initial LCP tac dose was similar between CYP3A5 groups (0.145 vs. 0.137 mg/kg/day; P = 0.161), whereas steady state dose was higher in expressors (0.150 vs. 0.117 mg/kg/day; P = 0.026). CYP3A5*1 expressors had significantly more tac trough concentrations of less than 6 ng/ml and significantly fewer tac trough concentrations of more than 14 ng/ml. Providers were significantly more likely to under-adjust LCP tac by 10 and 20% in CYP3A5 expressors versus nonexpressors (P < 0.03). In sequential modeling, CYP3A5 genotype status explained the LCP tac dosing requirements significantly more than AA race. CONCLUSION: CYP3A5*1 expressors require higher doses of LCP tac to achieve therapeutic concentrations and are at higher risk of subtherapeutic trough concentrations, persisting for 30-day posttransplant. LCP tac dose changes in CYP3A5 expressors are more likely to be under-adjusted by providers.


Assuntos
Citocromo P-450 CYP3A , Transplante de Rim , Tacrolimo , Adulto , Humanos , Citocromo P-450 CYP3A/genética , Genótipo , Estudos Prospectivos , Tacrolimo/administração & dosagem
3.
J Am Coll Surg ; 236(4): 721-727, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-36728400

RESUMO

BACKGROUND: African Americans (AAs) have reduced access to kidney transplant (KTX). Our center undertook a multilevel quality improvement endeavor to address KTX access barriers, focused on vulnerable populations. This program included dialysis center patient/staff education, embedding telehealth services across South Carolina, partnering with community providers to facilitate testing/procedures, and increased use of high-risk donors. STUDY DESIGN: This was a time series analysis from 2017 to 2021 using autoregression to assess trends in equitable access to KTX for AAs. Equity was measured using a modified version of the Kidney Transplant Equity Index (KTEI), defined as the proportion of AAs in South Carolina with end-stage kidney disease (ESKD) vs the proportion of AAs initiating evaluation, completing evaluation, waitlisting, and undergoing KTX. A KTEI of 1.00 is considered complete equity; a KTEI of <1.00 is indicative of disparity. RESULTS: From January 2017 to September 2021, 11,487 ESKD patients (64.7% AA) were referred, 6,748 initiated an evaluation (62.8% AA), 4,109 completed evaluation (59.7% AA), 2,762 were waitlisted (60.0% AA), and 1,229 underwent KTX (55.3% AA). The KTEI for KTX demonstrated significant improvements in equity. The KTEI for initiated evaluations was 0.89 in 2017, improving to 1.00 in 2021 (p = 0.0045). Completed evaluation KTEI improved from 0.85 to 0.95 (p = 0.0230), while waitlist addition KTEI improved from 0.83 to 0.96 (p = 0.0072). The KTEI for KTX also improved from 0.76 to 0.91, which did not reach statistical significance (p = 0.0657). CONCLUSIONS: A multilevel intervention focused on improving access to vulnerable populations was significantly associated with reduced disparities for AAs.


Assuntos
Disparidades em Assistência à Saúde , Falência Renal Crônica , Transplante de Rim , Humanos , Negro ou Afro-Americano , Disparidades em Assistência à Saúde/etnologia , Falência Renal Crônica/cirurgia , Diálise Renal
4.
Am J Cardiol ; 172: 121-129, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35341576

RESUMO

New-onset heart failure is a frequent complication after orthotopic liver transplantation (OLT). Left atrial enlargement (LAE) may be a sign of occult left heart disease. Our primary objective was to determine invasive hemodynamic and clinical predictors of LAE and then investigate its effect on post-transplant outcomes. Of 609 subjects who received OLT between January 1, 2010, and October 1, 2018, 145 who underwent preoperative right-sided cardiac catheterization and transthoracic echocardiography were included. Seventy-eight subjects (54%) had pretransplant LAE. Those with LAE had significantly lower systemic vascular resistance with higher cardiac and stroke volume index (61.0 vs 51.7 ml/m2; p <0.001), but there was no difference in pulmonary artery wedge pressure. There was a linear relation between left atrial volume index and stroke volume index (R2 = 0.490, p<0.001), but not pulmonary artery wedge pressure. The presence of severe LAE was associated with a reduced likelihood (hazard ratio = 0.26, p = 0.033) of reaching the composite end point of new-onset systolic heart failure, heart failure hospitalization, or heart failure death within 12 months post-transplant. There was also a significant reduction in LAE after transplantation (p = 0.013). In conclusion, LAE was common in OLT recipients and was more closely associated with stroke volume than left heart filling pressures. The presence of LAE was associated with a reduced likelihood of reaching composite outcomes and tended to regress after transplant.


Assuntos
Insuficiência Cardíaca , Transplante de Fígado , Ecocardiografia , Átrios do Coração/diagnóstico por imagem , Hemodinâmica , Humanos , Pressão Propulsora Pulmonar
5.
Am J Kidney Dis ; 80(6): 707-717, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35301050

RESUMO

RATIONALE & OBJECTIVE: The national kidney allocation system (KAS) implemented in December 2014 in the United States redefined the start of waiting time from the time of waitlisting to the time of kidney failure. Waitlisting has declined post-KAS, but it is unknown if this is due to transplant center practices or changes in dialysis facility referral and evaluation. The purpose of this study was to assess the impact of the 2014 KAS policy change on referral and evaluation for transplantation among a population of incident and prevalent patients with kidney failure. STUDY DESIGN: Cohort study. SETTING & PARTICIPANTS: 37,676 incident (2012-2016) patients in Georgia, North Carolina, and South Carolina identified within the US Renal Data System at 9 transplant centers and followed through December 2017. A prevalent population of 6,079 patients from the same centers receiving maintenance dialysis in 2012 but not referred for transplantation in 2012. EXPOSURE: KAS era (pre-KAS vs post-KAS). OUTCOME: Referral for transplantation, start of transplant evaluation, and waitlisting. ANALYTICAL APPROACH: Multivariable time-dependent Cox models for the incident and prevalent population. RESULTS: Among incident patients, KAS was associated with increased referrals (adjusted HR, 1.16 [95% CI, 1.12-1.20]) and evaluation starts among those referred (adjusted HR, 1.16 [95% CI, 1.10-1.21]), decreased overall waitlisting (adjusted HR, 0.70 [95% CI, 0.65-0.76]), and lower rates of active waitlisting among those evaluated compared to the pre-KAS era (adjusted HR, 0.81 [95% CI, 0.74-0.90]). Among the prevalent population, KAS was associated with increases in overall waitlisting (adjusted HR, 1.74 [95% CI, 1.15-2.63]) and active waitlisting among those evaluated (adjusted HR, 2.01 [95% CI, 1.16-3.49]), but had no significant impact on referral or evaluation starts among those referred. LIMITATIONS: Limited to 3 states, residual confounding. CONCLUSIONS: In the southeastern United States, the impact of KAS on steps to transplantation was different among incident and prevalent patients with kidney failure. Dialysis facilities referred more incident patients and transplant centers evaluated more incident patients after implementation of KAS, but fewer evaluated patients were placed onto the waitlist. Changes in dialysis facility and transplant center behaviors after KAS implementation may have influenced the observed changes in access to transplantation.


Assuntos
Falência Renal Crônica , Transplante de Rim , Humanos , Estados Unidos/epidemiologia , Falência Renal Crônica/diagnóstico , Falência Renal Crônica/epidemiologia , Falência Renal Crônica/cirurgia , Estudos de Coortes , Listas de Espera , Encaminhamento e Consulta , Rim
6.
Prog Transplant ; 32(1): 27-34, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34874194

RESUMO

Introduction: The optimal treatment for end-stage kidney disease is renal transplant. However, only 1 in 5 (21.5%) patients nationwide receiving dialysis are on a transplant waitlist. Factors associated with patients not initiating a transplant evaluation are complex and include patient specific factors such as transplant knowledge and self-efficacy. Research Question: Can a dialysis center-based educational video intervention increase dialysis patients' transplant knowledge, self-efficacy, and transplant evaluations initiated? Design: Dialysis patients who had not yet completed a transplant evaluation were provided a transplant educational video while receiving hemodialysis. Patients' transplant knowledge, self-efficacy to initiate an evaluation, and dialysis center rates of transplant referral and evaluation were assessed before and after this intervention. Results: Of 340 patients approached at 14 centers, 252 (74%) completed the intervention. The intervention increased transplant knowledge (Likert scale 1 to 5: 2.53 [0.10] vs 4.62 [0.05], P < .001) and transplant self-efficacy (2.55 [0.10] to 4.33 [0.07], P < .001. The incidence rate per 100 patient years of transplant evaluations increased 85% (IRR 1.85 [95% CI: 1.02, 3.35], P = .0422) following the intervention. The incidence rates of referrals also increased 56% (IRR 1.56 [95% CI: 1.03, 2.37], P = .0352), while there was a nonsignificant 47% increase in incidence rates of waitlist entries (IRR 1.47 [95% CI: 0.45, 4.74], P = .5210). Conclusion: This dialysis center-based video intervention provides promising preliminary evidence to conduct a large-scale randomized controlled trial to test its effectiveness in increasing self-efficacy of dialysis patients to initiate a transplant evaluation.


Assuntos
Falência Renal Crônica , Transplante de Rim , Feminino , Humanos , Falência Renal Crônica/epidemiologia , Falência Renal Crônica/cirurgia , Masculino , Diálise Renal , Autoeficácia , Listas de Espera
7.
JAMA Surg ; 156(7): 639-645, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-34037705

RESUMO

Importance: The Organ Procurement and Transplantation Network (OPTN) approved changes to the US kidney allocation system in 2019. The potential effects of this policy change using transplant rates normalized to end-stage kidney disease (ESKD) incidence have not been investigated. Objective: To estimate how the OPTN kidney allocation policy will affect areas of the US currently demonstrating low rates of kidney transplant, when accounting for the regional burden of ESKD. Design, Setting, and Participants: This cross-sectional population-based economic evaluation analyzed access of patients with ESKD to kidney transplant in the US. Participants included patients with incident ESKD, those on the kidney transplant wait list, and those who received a kidney transplant. Data were collected from January 1 to December 31, 2017, and were analyzed in 2019. Main Outcomes and Measures: The probability of a patient with ESKD being placed on the transplant wait list or receiving a deceased donor kidney transplant. States and donor service areas (DSAs) were compared for gains and losses in rates of transplanted kidneys under the new allocation system. Transplant rates were normalized for ESKD burden. Results: A total of 122 659 patients had incident ESKD in the US in 2017 (58.2% men; mean [SD] age, 62.8 [15.1] years). The probability of a patient with ESKD receiving a deceased donor kidney transplant varied 3-fold across the US (from 6.36% in West Virginia to 18.68% in the District of Columbia). Modeling of the OPTN demonstrates that DSAs from New York (124%), Georgia (65%), and Illinois (56%) are estimated to experience the largest increases in deceased donor kidney allocation. Other than Georgia, these states have kidney transplant rates per incident ESKD cases above the mean (of 50 states plus the District of Columbia, New York is 16th and Illinois is 24th). In contrast, DSAs from Nevada (-74%), Ohio (-67%), and North Carolina (-61%)-each of which has a transplant rate per incident ESKD cases significantly below the mean-are estimated to experience the largest decreases in deceased donor allocation (of 50 states plus the District of Columbia, North Carolina is 34th, Ohio is 38th, and Nevada is 47th). Conclusions and Relevance: The new OPTN-approved kidney allocation policy may result in worsening geographic disparities in access to transplants when measured against the burden of ESKD within a particular region of the US.


Assuntos
Política de Saúde , Falência Renal Crônica/epidemiologia , Falência Renal Crônica/cirurgia , Transplante de Rim/estatística & dados numéricos , Seleção de Pacientes , Obtenção de Tecidos e Órgãos/organização & administração , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Efeitos Psicossociais da Doença , Estudos Transversais , Feminino , Humanos , Incidência , Falência Renal Crônica/diagnóstico , Masculino , Pessoa de Meia-Idade , Estados Unidos , Listas de Espera , Adulto Jovem
8.
Am J Transplant ; 20(8): 1969-1983, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32406604

RESUMO

Tacrolimus (Tac) is widely used to prevent rejection and graft loss in solid organ transplantation. A limiting characteristic of Tac is the high intra and interpatient variability associated with its use. Routine therapeutic drug monitoring (TDM) is necessary to facilitate Tac management and to avoid undesirable clinical outcomes. However, whole blood trough concentrations commonly utilized in TDM are not strong predictors of the detrimental clinical outcomes of interest. Recently, researchers have focused on Tac intrapatient variability (Tac IPV) as a novel marker to better assess patient risk. Higher Tac IPV has been associated with a number of mechanisms leading to shortened graft survival. Medication nonadherence (MNA) is considered to be the primary determinant of high Tac IPV and perhaps the most modifiable risk factor. An understanding of the methodology behind Tac IPV is imperative to its recognition as an important prognostic measure and integration into clinical practice. Therapeutic interventions targeting MNA and reducing Tac IPV are crucial to improving long-term graft survival.


Assuntos
Transplante de Rim , Tacrolimo , Rejeição de Enxerto/tratamento farmacológico , Rejeição de Enxerto/etiologia , Rejeição de Enxerto/prevenção & controle , Sobrevivência de Enxerto , Humanos , Imunossupressores/uso terapêutico
9.
Am J Transplant ; 20(8): 2113-2125, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-31981441

RESUMO

Variability in transplant access exists, but barriers to referral and evaluation are underexplored due to lack of national surveillance data. We examined referral for kidney transplantation evaluation and start of the evaluation among 34 857 incident, adult (18-79 years) end-stage kidney disease patients from 690 dialysis facilities in the United States Renal Data System from January 1, 2012 through August 31, 2016, followed through February 2018 and linked data to referral and evaluation data from nine transplant centers in Georgia, North Carolina, and South Carolina. Multivariable-adjusted competing risk analysis examined each outcome. The median within-facility cumulative percentage of patients referred for kidney transplantation within 1 year of dialysis at the 690 dialysis facilities in Network 6 was 33.7% (interquartile range [IQR]: 25.3%-43.1%). Only 48.3% of referred patients started the transplant evaluation within 6 months of referral. In multivariable analyses, factors associated with referral vs evaluation start among those referred at any time differed. For example, black, non-Hispanic patients had a higher rate of referral (hazard ratio [HR]: 1.22; 95% confidence interval [CI]: 1.18-1.27), but lower evaluation start among those referred (HR: 0.93; 95% CI: 0.88-0.98), vs white non-Hispanic patients. Barriers to transplant varied by step, and national surveillance data should be collected on early transplant steps to improve transplant access.


Assuntos
Falência Renal Crônica , Transplante de Rim , Adulto , Humanos , Falência Renal Crônica/cirurgia , North Carolina/epidemiologia , Encaminhamento e Consulta , Diálise Renal , Estados Unidos
10.
Transpl Int ; 33(4): 414-422, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31930584

RESUMO

The number of adults with heart failure (HF) will increase by ~50% between 2012 and 2030. Among kidney transplant recipients, HF accounts for 16% of all post-transplant admissions. We describe the burden of HF and predictors of healthcare utilization following kidney transplantation. We retrospectively identified adults who underwent kidney transplantation at our institution (01/2007-12/2017). Data were acquired from electronic health records, with healthcare utilization obtained from a statewide database. The HF incidence rate and prevalence were estimated for each year, total charges for HF and non-HF patients were compared, and logistic regression was employed for a 3-year predictive model of healthcare utilization associated with HF. Among 1731 kidney transplant recipients, the post-transplant HF incidence rate ranged from 1.91 (year 3) to 6.80 (year 10) per 100 person-years, while the prevalence increased from 31.7% (year 1) to 48.1% (year 10). Median charges were $75 837 (HF) compared to $42 940 (non-HF) per person-year (P < 0.001). Pretransplant HF [odds ratio (OR) = 3.12] and an eGFR < 45 (OR = 4.73) were the strongest predictors of HF encounters (P < 0.05 for both). We observed a high and increasing prevalence of HF, which was associated with twice the costs. Kidney transplant recipients would benefit from interventions aimed at mitigating HF risk factors.


Assuntos
Insuficiência Cardíaca , Transplante de Rim , Adulto , Custos e Análise de Custo , Taxa de Filtração Glomerular , Insuficiência Cardíaca/epidemiologia , Hospitalização , Humanos , Transplante de Rim/efeitos adversos , Estudos Retrospectivos
11.
Clin Transplant ; 33(5): e13522, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30861180

RESUMO

Reducing acute care utilization is a means of improving long-term patient outcomes. We sought to assess high inpatient (IP) admission and standalone emergency department (ED) utilization within a 9-month period post-kidney transplantation and to identify mutable factors to reduce utilization. In this ten-year retrospective study, 1599 adult kidney transplant recipients were identified. A previous transplant, graft loss, or death within 3 months post-transplantation excluded 319 patients. Comprehensive resource utilization data were obtained from a statewide database. Those with ≥2 IP admissions or standalone ED visits 4-12 months post-transplantation were classified as high utilizers. Multivariable logistic regression models were used for examining associations of predictors with high IP or ED utilization. Of 1280 kidney recipients, 209 and 183 were categorized as IP and ED high utilizers, respectively. Factors significantly associated with high IP utilization included valvular disease, body mass index ≥35, and IP or ED use <3 months post-transplantation; while factors associated with high ED utilization included IP or ED use <3 months post-transplantation, younger age, female, smoker, congestive heart failure, depression, and IP or ED use 1 year pre-transplantation. Inpatient and standalone ED utilization within a 9-month period after kidney transplantation is high and associated with sociodemographic factors, mutable comorbidities, and healthcare utilization.


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Falência Renal Crônica/cirurgia , Transplante de Rim/métodos , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Adulto , Feminino , Seguimentos , Taxa de Filtração Glomerular , Sobrevivência de Enxerto , Humanos , Testes de Função Renal , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Fatores de Risco
12.
Prog Transplant ; 29(2): 164-172, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30845889

RESUMO

INTRODUCTION: Studies demonstrate that family notification is much less frequent in African Americans than in Caucasians. Familial notification of one's decision to become a registered organ donor (ROD) is important to ensure adherence to the decedent's donation decision and to disseminate prodonation attitudes. The purpose of this study was to explore the experiences of familial notification among recent African American RODs and to identify intervention strategies to overcome potential barriers to the notification process. METHODS/APPROACH: The study used a qualitative focus group approach. An inductive thematic analysis identified common categories and themes in the recorded and transcribed discussions. FINDINGS: The focus groups consisted of 50 African American participants who had recently visited Alabama Department of Motorized Vehicles and made the voluntary decision (yes or no) about becoming an organ donor. Three major themes describing the African American experiences with notifying their family members about their decision to become a ROD emerged. These themes were as follows: motivation for the notification, notification conversation, and promoting familial notification. Specific discussions centered upon the importance of and barriers to familial notification, information, and strategies needed for successful notification. Strategies identified were use of media and social networks to provide enhanced knowledge on the notification process and the importance of health-care, community-provided knowledge about the donation process. DISCUSSION: Findings from this study provide a framework for future interventions designed to assist African American RODs in notifying family members of their status.


Assuntos
Tomada de Decisões , Família , Conhecimentos, Atitudes e Prática em Saúde , Veículos Automotores/legislação & jurisprudência , Doadores de Tecidos/psicologia , Negro ou Afro-Americano , Idoso , Idoso de 80 Anos ou mais , Alabama , Feminino , Grupos Focais , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Obtenção de Tecidos e Órgãos , Adulto Jovem
13.
Clin Pharmacol Drug Dev ; 8(8): 995-1008, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-30667591

RESUMO

The pharmacokinetics of once-daily extended-release tacrolimus tablets (LCPT) in de novo liver transplantation have not been previously reported. In this phase II, randomized, open-label study, de novo liver transplant recipients were randomized to LCPT 0.07-0.13 mg/kg/day (taken once daily; n = 29) or twice-daily immediate-release tacrolimus capsules (IR-Tac) at 0.10-0.15 mg/kg/day (divided twice daily; n = 29). Subsequent doses of both drugs were adjusted to maintain tacrolimus trough concentrations of 5 to 20 ng/mL through day 90, and 5-15 ng/mL thereafter. Twenty-four-hour pharmacokinetic profiles were obtained on days 1, 7, and 14, with trough concentration and efficacy/safety monitoring through year 1. Similar proportions of patients in both groups achieved therapeutic trough concentrations on days 7 and 14 (day 7: LCPT = 78%, IR-Tac = 75%; day 14: LCPT = 86%, IR-Tac = 91%) as well as similar systemic and peak exposure. There was a robust correlation between drug concentration at time 0 and area under the concentration-time curve for both LCPT and IR-Tac (respectively, day 7: r = 0.86 and 0.79; day 14: r = 0.93 and 0.86; P < .0001 for all). Dose adjustments during days 1 to 14 were frequent. Thirty-five patients completed the extended-use period. No significant differences in adverse events were seen between groups. Incidence of biopsy-proven acute rejection (LCPT = 6 and IR-Tac = 4) was similar on day 360. Between formulations, overall exposure was similar at 1 week after transplant with the characteristic delayed-release pharmacokinetic profile of LCPT demonstrated in this novel population. These data support further investigation of the safety and efficacy of LCPT in de novo liver transplantation.


Assuntos
Rejeição de Enxerto/prevenção & controle , Imunossupressores/administração & dosagem , Imunossupressores/sangue , Transplante de Fígado , Tacrolimo/administração & dosagem , Tacrolimo/sangue , Área Sob a Curva , Disponibilidade Biológica , Cápsulas , Preparações de Ação Retardada , Esquema de Medicação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Rejeição de Enxerto/imunologia , Humanos , Imunossupressores/efeitos adversos , Masculino , Taxa de Depuração Metabólica , Pessoa de Meia-Idade , Comprimidos , Tacrolimo/efeitos adversos
14.
Nephrology (Carlton) ; 24(8): 855-862, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30198104

RESUMO

AIM: Identifying kidney transplant patients at highest risk for graft loss prior to loss may allow for effective interventions to improve 5 years survival. METHODS: We performed a 10 years retrospective cohort study of adult kidney transplant recipients (n = 1747). We acquired data from electronic health records, United Network of Organ Sharing, social determinants of health, natural language processing data extraction, and real-time capture of dynamically evolving clinical data obtained within 1 year of transplant; from which we developed a 5 years graft survival model. RESULTS: Total of 1439 met eligibility; 265 (18.4%) of them experienced graft loss by 5 years. Graft loss patients were characterized by: older age, being African-American, diabetic, unemployed, smokers, having marginal donor kidneys and cardiovascular comorbidities. Predictive dynamic variables included: low mean blood pressure, higher pulse pressures, higher heart rate, anaemia, lower estimated glomerular filtration rate peak, increased tacrolimus variability, rejection and readmissions. This Big Data analysis generated a 5 years graft loss model with an 82% predictive capacity, versus 66% using baseline United Network of Organ Sharing data alone. CONCLUSION: Our analysis yielded a 5 years graft loss model demonstrating superior predictive capacity compared with United Network of Organ Sharing data alone, allowing post-transplant individualized risk-assessed care prior to transitioning back to community care.


Assuntos
Sobrevivência de Enxerto , Transplante de Rim , Modelos Estatísticos , Adulto , Estudos de Coortes , Feminino , Previsões , Rejeição de Enxerto/epidemiologia , Rejeição de Enxerto/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco , Fatores de Tempo , Transplante Homólogo
15.
Clin Transplant ; 32(10): e13402, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30179271

RESUMO

African American (AA) organ donation registration rates fall short of national objectives. The goal of the present study was to utilize data acquired from a quantitative telephone survey to provide information for a future Department of Motorized Vehicles (DMV) intervention to increase AA organ donor registration at the DMV. AAs (n = 20 177) that had visited an Alabama DMV office within a 3-month period were recruited via direct mailing to participate in a quantitative phone survey. Data from 155 respondents that participated in the survey were analyzed. Of those respondents deciding to become a registered organ donor (ROD; n = 122), one-third made that decision at the time of visiting the DMV. Of those who chose not to become a ROD (n = 33), one-third made the decision during the DMV visit. Almost 85% of all participants wanted to learn more about organ donation while waiting at the DMV, preferably via TV messaging (digital signage), with the messaging delivered from organ donors, transplant recipients, and healthcare experts. Altruism, accurate organ donation information, and encouragement from family and friends were the most important educational topics to support AAs becoming a ROD. These data provide a platform to inform future interventions designed to increase AAs becoming a ROD at the DMV.


Assuntos
Negro ou Afro-Americano/psicologia , Tomada de Decisões , Conhecimentos, Atitudes e Prática em Saúde/etnologia , Licenciamento/estatística & dados numéricos , Transplante de Órgãos , Doadores de Tecidos/psicologia , Adulto , Feminino , Humanos , Masculino , Motivação
16.
Am J Nephrol ; 47(3): 191-199, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29539601

RESUMO

BACKGROUND: Several studies have been performed to evaluate surrogate markers of long-term allograft function in renal transplant recipients. These include serum creatinine, estimated glomerular filtration rate (eGFR), slope of eGFR, and more recently eGFR variability. The aim of this study was to measure eGFR slope while assessing the variability of this slope and if high variability occurring at any time post-transplant was predictive of poorer long-term outcomes in a large cohort of kidney transplant recipients. METHODS: Adult solitary kidney transplant recipients transplanted between July 1, 2005 and July 31, 2015 were included. The primary outcome was time to graft loss, defined as return to chronic dialysis, retransplant, or death. Secondary outcomes were death-censored graft loss and acute allograft rejection. Cox regression was utilized for primary and secondary outcomes. Multivariate logistic regression was used to determine baseline factors predictive of high eGFR variability. RESULTS: A total of 1,543 patients were included in the analysis. The percentage of patients who experienced an eGFR coefficient of variation of <30% was 79.6% (1,229/1,543), while 20.4% (314/1,543) patients had high eGFR variability (≥30%). Patients with high eGFR variability tended to be younger, African-American and female. Those with higher eGFR variability, accounting for confounding and other eGFR measures (peak and slope), had significantly lower overall patient and graft survival. CONCLUSION: This study provides a novel analysis of the utility of eGFR variability in a large cohort. The clinical use of the slope of eGFR and eGFR variability may aid in predicting long-term graft outcomes and facilitate early patient discussions to change the trajectory of allograft function.


Assuntos
Taxa de Filtração Glomerular , Rejeição de Enxerto/epidemiologia , Transplante de Rim/mortalidade , Adulto , Idoso , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos/epidemiologia
17.
BMC Med Ethics ; 19(1): 7, 2018 02 12.
Artigo em Inglês | MEDLINE | ID: mdl-29433496

RESUMO

BACKGROUND: The allocation of any scarce health care resource, especially a lifesaving resource, can create profound ethical and legal challenges. Liver transplant allocation currently is based upon urgency, a sickest-first approach, and does not utilize capacity to benefit. While urgency can be described reasonably well with the MELD system, benefit encompasses multiple dimensions of patients' well-being. Currently, the balance between both principles is ill-defined. METHODS: This survey with 502 participants examines how urgency and benefit are weighted by different stakeholders (medical staff, patients on the liver transplant list or already transplanted, medical students and non-medical university staff and students). RESULTS: Liver transplant patients favored the sickest-first allocation, although all other groups tended to favor benefit. Criteria of a successful transplantation were a minimum survival of at least 1 year and recovery of functional status to being ambulatory and capable of all self-care (ECOG 2). An individual delisting decision was accepted when the 1-year survival probability would fall below 50%. Benefit was found to be a critical variable that may also trigger the willingness to donate organs. CONCLUSIONS: The strong interest of stakeholder for successful liver transplants is inadequately translated into current allocation rules.


Assuntos
Atitude , Transplante de Fígado/ética , Seleção de Pacientes , Ética Baseada em Princípios , Obtenção de Tecidos e Órgãos , Listas de Espera , Adulto , Idoso , Idoso de 80 Anos ou mais , Beneficência , Feminino , Humanos , Masculino , Corpo Clínico , Pessoa de Meia-Idade , Participação dos Interessados , Estudantes de Medicina , Inquéritos e Questionários , Universidades , Adulto Jovem
18.
J Surg Res ; 221: 88-94, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29229159

RESUMO

BACKGROUND: Despite numerous initiatives to increase solid organs for transplant, the gap between donors and recipients widens. There is little in the literature identifying socioeconomic predictors for donation. We evaluate the correlation between socioeconomic factors and familial authorization for donation. METHODS: A retrospective analysis of adult potential donor referrals between 2007 and 2012 to our organ procurement organization (OPO) was performed. Potential donor information was obtained from the OPO database, death certificates, and the US Census Report. Data on demographics, education, residence, income, registry status, cause and manner of death, as well as OPO assessments and approach for donation were collected. End point was familial authorization for donation. RESULTS: A total of 1059 potential donors were included, with an overall authorization rate of 47%. The majority was not on the donor registry (73%). Younger donors (18-39 y: odds ratio [OR] = 4.9, P < 0.001; 40-60 y: OR = 2.1, P < 0.001), higher levels of education (college: OR = 2.5, P = 0.005; graduate studies: OR = 3.9, P = 0.002), prior listing on the donor registry (OR = 10.3, P < 0.001), and residence in counties with lower poverty rates than the US rates (OR = 1.7, P = 0.02) were independently associated with higher authorization rates. Decoupling (OR = 3.1, P < 0.001) and donation first mentioned by the local health care provider (OR = 1.8, P = 0.01) were also independently associated with higher authorization rates. CONCLUSIONS: Donor registration correlated most strongly with the highest authorization rates. These results indicate that public educational efforts in populations with unfavorable socioeconomic considerations may be beneficial in improving donor registration. Collaborations with local providers as well as OPO in-hospital assessments and approach techniques can help with improving authorization rates.


Assuntos
Obtenção de Tecidos e Órgãos/estatística & dados numéricos , Adolescente , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores Socioeconômicos , Adulto Jovem
19.
J Natl Med Assoc ; 109(4): 287-293, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29173936

RESUMO

BACKGROUND: African Americans (AA) are a third as likely as Caucasians to become registered organ donors at the Department of Motorized Vehicles (DMV). The Department of Health and Human Services has set the goal that at least 50% of adults in each state are registered donors. AIMS: The purpose of this study was to explore the personal, behavioral and environmental factors associated with AA donor registration decision-making at the DMV. METHODS: Guided by the Social Cognitive Theory, 13 focus groups (n = 100 participants) were conducted with AAs within 3 months of visiting a DMV and making a decision regarding whether to become or to not become a registered donor. The data were analyzed using inductive thematic and qualitative content analyses. RESULTS: Study participants expressed a desire to learn more information while waiting in line at the DMV. Knowing a family member or friend in need of an organ transplant, and the desire to make one's own decision were two salient factors associated with the decision to become a registered organ donor. Several aspects of the DMV environment (e.g., noisy, overcrowded, lacking privacy) were cited as deterrents to becoming a registered donor. DISCUSSION: This study highlights the personal, behavioral and environmental factors associated with AA organ donor registration decision-making at the DMV. CONCLUSION: The DMV is a setting where many adults make a decision about organ donation. Policies that create an environment in the DMV to support informed decision-making (e.g., privacy, informed clerks, available educational materials, etc.) are indicated.


Assuntos
Negro ou Afro-Americano/psicologia , Tomada de Decisões , Conhecimentos, Atitudes e Prática em Saúde/etnologia , Motivação , Doadores de Tecidos/psicologia , Adulto , Idoso , Alabama , Feminino , Grupos Focais , Humanos , Masculino , Pessoa de Meia-Idade , Veículos Automotores , Teoria Psicológica , Pesquisa Qualitativa
20.
Hepatol Commun ; 1(4): 338-346, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-29404463

RESUMO

Transarterial chemoembolization (TACE) is the most common oncologic therapy used according to the American Association for the Study of Liver Diseases (AASLD) guidelines established in 2005, revised in 2011. The purpose of this study was to determine how AASLD criteria for the management of hepatocellular carcinoma (HCC) have impacted TACE practice in the community. Clinical, demographic, and cause of death information were collected for patients diagnosed with HCC in the 2012 linkage of the Surveillance, Epidemiology, and End Results Medicare database. Propensity score survival analysis was used to compare survival outcomes in patients whose HCC tumor characteristics were less than, met, or were beyond AASLD criteria. The proportion of patients with HCC receiving TACE who met the AASLD-recommended criteria increased after the 2005 guidelines were published. Up to 17% of patients treated with TACE had tumor characteristics less than the AASLD criteria and were not offered potentially curative therapies. Propensity score matching demonstrated the largest survival advantage in patients with HCC whose tumor characteristics met the AASLD criteria (hazard ratio, 0.42; 95% confidence interval, 0.38-0.47). A significant survival advantage was also observed in patients with HCC whose tumor characteristics exceeded the AASLD criteria. Conclusion: The AASLD criteria successfully identify a population of patients with HCC that maximally benefit from TACE therapy. However, patients with HCC with tumor characteristics beyond the AASLD criteria also appear to receive a significant survival advantage with TACE. Further studies are necessary to improve referral patterns and appropriate use of chemoembolization in the management of unresectable HCC. (Hepatology Communications 2017;1:338-346).

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