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2.
JMIR Form Res ; 6(5): e27277, 2022 May 05.
Artigo em Inglês | MEDLINE | ID: mdl-35511225

RESUMO

BACKGROUND: Inadequate adherence to prescribed immunosuppressive medication regimens among kidney transplant recipients is common, yet interventions are needed to support patients in sustaining adequate adherence to prescribed regimens and achieving optimal transplant outcomes. OBJECTIVE: We examined the preliminary fidelity of a transplant center-based, multifaceted adherence monitoring strategy known as TAKE IT. METHODS: The TAKE IT strategy includes: (1) routine, online, monthly patient self-report adherence assessments; (2) care alerts directed to nurses; (3) quarterly reports monitoring tacrolimus values and adherence trends; (4) support tools tailored to specific adherence concerns. A 2-arm, patient-randomized trial is underway at two large transplant centers (N=449). To evaluate the initial fidelity of TAKE IT, we investigated patient uptake of monthly adherence assessments during the course of a 3-month period, whether any disparities emerged, and the nature of any reported adherence concerns. RESULTS: Among 202 patients randomized and exposed to TAKE IT for 3-months or more, 81% (164/202) completed an adherence assessment, 73% (148/202) completed at least two, and 57% (116/202) completed all monthly assessments. Overall, 50% (82/164) of kidney transplant recipients reported at least one adherence concern over the 3-month assessment period. The most common barriers were classified as regimen-related (eg, regimen complexity), cognitive (eg, forgetfulness), and medical (eg, side effects). Higher-income participants were more likely to complete all surveys compared to lower-income participants (P=.01). CONCLUSIONS: TAKE IT demonstrated 81% (164/202) completion of an adherence assessment, 73% (148/202) completion of at least two, and 57% (116/202) completion of all monthly assessments during this brief, initial observation period. Among those that did respond to the online assessments, the majority demonstrated sustained engagement. Additional monitoring modalities could also be offered to meet patient preferences to ensure all patients' medication use can be properly monitored. TRIAL REGISTRATION: ClinicalTrials.gov NCT03104868; https://clinicaltrials.gov/ct2/show/NCT03104868.

3.
Ann Hepatol ; 27(5): 100718, 2022 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-35460882

RESUMO

BACKGROUND: Loneliness, "a subjective feeling of being isolated", is a strong predictor of adverse health. We characterized loneliness in patients with end-stage liver disease (ESLD) awaiting liver transplantation (LT). METHODS: We surveyed loneliness in ambulatory ESLD adults awaiting LT at 7 U.S. sites using the validated UCLA Three-Item Loneliness Scale, May2020-Jan2021; "lonely"=total ≥5. Liver Frailty Index (LFI) assessed frailty; "frail"=LFI≥4.4. Logistic regression associated loneliness and co-variables. RESULTS: Of 454 participants, median MELDNa was 14 (IQR 10-19) and 26% met criteria for "lonely". Compared to those not lonely, those lonely were younger (57 v. 61y), more likely to be female (48% v. 31%) or frail (21 v. 11%), and less likely to be working (15% v. 26%) or in a committed partnership (52% v. 71%). After multivariable adjustment, frailty (OR=2.24, 95%CI=1.23-4.08), younger age (OR=1.19, 95%CI=1.07-1.34), female sex (OR=1.83, 95%CI=1.14-2.92), not working (OR=2.16, 95%CI=1.16-4.03), and not in a committed partnership (OR=2.07, 95%CI=1.29-3.32) remained significantly associated with higher odds of loneliness. CONCLUSION: Loneliness is prevalent in adults awaiting LT, and independently associated with younger age, female sex and physical frailty. These data lay the foundation to investigate the extent to which loneliness impacts health outcomes in LT, as in the general population.

4.
Transplant Direct ; 8(4): e1299, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35310603

RESUMO

Procurement biopsies suffer from challenges with quality and reproducibility and are linked to kidney discard. Nonetheless, procurement biopsies are obtained for the majority of kidneys in the United States, and biopsy findings are commonly relied upon in kidney acceptance decisions. Methods: We conducted in-depth, semistructured interviews with 30 surgeons, nephrologists, nurse coordinators, and organ procurement organization (OPO) staff and directors to assess perceptions of factors contributing to kidney discard and strategies to reduce kidney discard, with a focus on the role of procurement biopsies. Thematic analysis was used to analyze qualitative data. Results: Three main themes emerged: (1) participants emphasized the importance of biopsy findings in making acceptance decisions but expressed concerns about a lack of standardization and quality control; (2) participants reported large variations in the level of importance placed on biopsy findings, the level of reliance on glomerulosclerosis in particular, and the cutoffs used; and (3) participants disagreed about how often procurement biopsies should be taken, with some supporting stricter limits on which kidneys are biopsied and others preferring a biopsy for most kidney offers. Conclusions: These findings support the development of standard practices for which kidneys require biopsy, how the biopsy material is prepared, and how the biopsy is interpreted. Variability in kidney acceptance practices across centers and the use of biopsy findings in guiding recipient selection also lend support to policies to allocate kidneys with suboptimal histological findings to the centers that are willing to use such kidneys and the patients who could most benefit from such offers.

6.
Hepatol Commun ; 6(1): 237-246, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34558844

RESUMO

Physical frailty and impaired cognition are common in patients with cirrhosis. Physical frailty can be assessed using performance-based tests, but the extent to which impaired cognition may impact performance is not well characterized. We assessed the relationship between impaired cognition and physical frailty in patients with cirrhosis. We enrolled 1,623 ambulatory adult patients with cirrhosis waiting for liver transplantation at 10 sites. Frailty was assessed with the liver frailty index (LFI; "frail," LFI ≥ 4.4). Cognition was assessed at the same visit with the number connection test (NCT); continuous "impaired cognition" was examined in primary analysis, with longer NCT (more seconds) indicating worse impaired cognition. For descriptive statistics, "impaired cognition" was NCT ≥ 45 seconds. Linear regression associated frailty and impaired cognition; competing risk regression estimated subhazard ratios (sHRs) of wait-list mortality (i.e., death/delisting for sickness). Median NCT was 41 seconds, and 42% had impaired cognition. Median LFI (4.2 vs. 3.8) and rates of frailty (38% vs. 20%) differed between those with and without impaired cognition. In adjusted analysis, every 10-second NCT increase associated with a 0.08-LFI increase (95% confidence interval [CI], 0.07-0.10). In univariable analysis, both frailty (sHR, 1.63; 95% CI, 1.43-1.87) and impaired cognition (sHR, 1.07; 95% CI, 1.04-1.10) associated with wait-list mortality. After adjustment, frailty but not impaired cognition remained significantly associated with wait-list mortality (sHR, 1.55; 95% CI, 1.33-1.79). Impaired cognition mediated 7.4% (95% CI, 2.0%-16.4%) of the total effect of frailty on 1-year wait-list mortality. Conclusion: Patients with cirrhosis with higher impaired cognition displayed higher rates of physical frailty, yet frailty independently associated with wait-list mortality while impaired cognition did not. Our data provide evidence for using the LFI to understand mortality risk in patients with cirrhosis, even when concurrent impaired cognition varies.


Assuntos
Disfunção Cognitiva/etiologia , Fragilidade/etiologia , Cirrose Hepática/complicações , Idoso , Feminino , Humanos , Cirrose Hepática/psicologia , Transplante de Fígado , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Listas de Espera/mortalidade
7.
Am J Transplant ; 22(2): 474-488, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34559944

RESUMO

Hispanic patients receive disproportionately fewer living donor kidney transplants (LDKTs) than non-Hispanic Whites (NHWs). The Northwestern Medicine Hispanic Kidney Transplant Program (HKTP), designed to increase Hispanic LDKTs, was evaluated as a nonrandomized, implementation-effectiveness hybrid trial of patients initiating transplant evaluation at two intervention and two similar control sites. Using a mixed method, observational design, we evaluated the fidelity of the HKTP implementation at the two intervention sites. We tested the impact of the HKTP intervention by evaluating the likelihood of receiving LDKT comparing pre-intervention (January 2011-December 2016) and postintervention (January 2017-March 2020), across ethnicity and centers. The HKTP study included 2063 recipients. Intervention Site A exhibited greater implementation fidelity than intervention Site B. For Hispanic recipients at Site A, the likelihood of receiving LDKTs was significantly higher at postintervention compared with pre-intervention (odds ratio [OR] = 3.17 95% confidence interval [1.04, 9.63]), but not at the paired control Site C (OR = 1.02 [0.61, 1.71]). For Hispanic recipients at Site B, the likelihood of receiving an LDKT did not differ between pre- and postintervention (OR = 0.88 [0.40, 1.94]). The LDKT rate was significantly lower for Hispanics at paired control Site D (OR = 0.45 [0.28, 0.90]). The intervention significantly improved LDKT rates for Hispanic patients at the intervention site that implemented the intervention with greater fidelity. Registration: ClinicalTrials.gov registered (retrospectively) on September 7, 2017 (NCT03276390).


Assuntos
Transplante de Rim , Doadores Vivos , Assistência à Saúde Culturalmente Competente , Humanos , Rim , Estudos Retrospectivos
8.
Hepatol Commun ; 6(4): 910-919, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34676697

RESUMO

Acute kidney injury (AKI) and frailty are major drivers of outcomes among patients with cirrhosis. What is unknown is the impact of physical frailty on the development of AKI. We included adults with cirrhosis without hepatocellular carcinoma listed for liver transplantation at nine US centers (n = 1,033). Frailty was assessed using the Liver Frailty Index (LFI); "frail" was defined by LFI ≥ 4.2. Chronic kidney disease as a baseline estimated glomerular filtration rate <60 mL/min/1.73 m2 . Our primary outcome, AKI, was defined as an increase in serum creatinine ≥0.3 mg/dL or a serum creatinine ≥1.5-fold increase. Wait-list mortality was defined as either a death on the wait list or removal for being too sick. We performed Cox regression analyses to estimate the hazard ratios (HRs) for AKI and wait-list mortality. Of 1,033 participants, 41% were frail and 23% had CKD. Twenty-one percent had an episode of AKI during follow-up. Frail versus nonfrail patients were more likely to develop AKI (25% vs. 19%) and wait-list mortality (21% vs. 13%) (P < 0.01 for each). In multivariable Cox regression, each of the following groups was associated with a higher risk of AKI as compared with not frail/no CKD: frail/no CKD (adjusted HR [aHR] = 1.87, 95% confidence interval [CI] = 1.29-2.72); not frail/CKD (aHR = 4.30, CI = 2.88-6.42); and frail/CKD (aHR = 4.85, CI = 3.33-7.07). We use a readily available metric, LFI, to identify those patients with cirrhosis most at risk for AKI. We highlight that serum creatinine and creatinine-based estimations of glomerular filtration rate may not fully capture a patient's vulnerability to AKI among the frail phenotype. Conclusion: Our work lays the foundation for implementing physical frailty in clinical practice to identify AKI earlier, implement reno-protective strategies, and expedite liver transplantation.


Assuntos
Injúria Renal Aguda , Fragilidade , Injúria Renal Aguda/diagnóstico , Fragilidade/complicações , Humanos , Cirrose Hepática/complicações , Estudos Prospectivos , Listas de Espera
9.
Transplant Direct ; 8(1): e1254, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34934806

RESUMO

BACKGROUND: Although the impact of the kidney donor profile index (KDPI) on kidney discard is well researched, less is known about how patients make decisions about whether to give consent for KDPI > 85 kidney offers. METHODS: We conducted in-depth, semistructured interviews with 16 transplant recipients, 15 transplant candidates, and 23 clinicians (transplant surgeons, nephrologists, and nurse coordinators) to assess and compare perceptions of transplant education, informed consent for KDPI > 85 kidneys' and the decision-making process for accepting kidney offers. Thematic analysis was used to analyze qualitative data. RESULTS: Four themes emerged: (1) patients reported uncertainty about the meaning of KDPI or could not recall information about KDPI; (2) patients reported uncertainty about their KDPI > 85 consent status and a limited role in KDPI > 85 consent decision making; (3) patients' reported willingness to consider KDPI > 85 kidneys depended on their age, health status, and experiences with dialysis, and thus it changed over time; (4) patients' underestimated the survival benefit of transplantation compared with dialysis, which could affect their KDPI > 85 consent decision making. CONCLUSIONS: To better support patients' informed decision making about accepting KDPI > 85 kidneys, centers must ensure that all patients receive education about the trade-offs between accepting a KDPI > 85 kidney and remaining on dialysis. Additionally, education about KDPI and discussions about informed consent for KDPI > 85 kidneys must be repeated at multiple time points while patients are on the waiting list.

10.
Hepatology ; 2021 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-34862808

RESUMO

BACKGROUND AND AIMS: Frailty is a well-established risk factor for poor outcomes in patients with cirrhosis awaiting liver transplantation (LT), but whether it predicts outcomes among those who have undergone LT is unknown. APPROACH AND RESULTS: Adult LT recipients from 8 US centers (2012-2019) were included. Pre-LT frailty was assessed in the ambulatory setting using the Liver Frailty Index (LFI). "Frail" was defined by an optimal cut point of LFI ≥ 4.5. We used the 75th percentile to define "prolonged" post-LT length of stay (LOS; ≥12 days), intensive care unit (ICU) days (≥4 days), and inpatient days within 90 post-LT days (≥17 days). Of 1166 LT recipients, 21% were frail pre-LT. Cumulative incidence of death at 1 and 5 years was 6% and 16% for frail and 4% and 10% for nonfrail patients (overall log-rank p = 0.02). Pre-LT frailty was associated with an unadjusted 62% increased risk of post-LT mortality (95% CI, 1.08-2.44); after adjustment for body mass index, HCC, donor age, and donation after cardiac death status, the HR was 2.13 (95% CI, 1.39-3.26). Patients who were frail versus nonfrail experienced a higher adjusted odds of prolonged LT LOS (OR, 2.00; 95% CI, 1.47-2.73), ICU stay (OR, 1.56; 95% CI, 1.12-2.14), inpatient days within 90 post-LT days (OR, 1.72; 95% CI, 1.25-2.37), and nonhome discharge (OR, 2.50; 95% CI, 1.58-3.97). CONCLUSIONS: Compared with nonfrail patients, frail LT recipients had a higher risk of post-LT death and greater post-LT health care utilization, although overall post-LT survival was acceptable. These data lay the foundation to investigate whether targeting pre-LT frailty will improve post-LT outcomes and reduce resource utilization.

11.
PLoS One ; 16(8): e0256428, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34464403

RESUMO

OBJECTIVE: Liver cirrhosis is a leading cause of death and effects millions of people in the United States. Early mortality prediction among patients with cirrhosis might give healthcare providers more opportunity to effectively treat the condition. We hypothesized that laboratory test results and other related diagnoses would be associated with mortality in this population. Our another assumption was that a deep learning model could outperform the current Model for End Stage Liver disease (MELD) score in predicting mortality. MATERIALS AND METHODS: We utilized electronic health record data from 34,575 patients with a diagnosis of cirrhosis from a large medical center to study associations with mortality. Three time-windows of mortality (365 days, 180 days and 90 days) and two cases with different number of variables (all 41 available variables and 4 variables in MELD-NA) were studied. Missing values were imputed using multiple imputation for continuous variables and mode for categorical variables. Deep learning and machine learning algorithms, i.e., deep neural networks (DNN), random forest (RF) and logistic regression (LR) were employed to study the associations between baseline features such as laboratory measurements and diagnoses for each time window by 5-fold cross validation method. Metrics such as area under the receiver operating curve (AUC), overall accuracy, sensitivity, and specificity were used to evaluate models. RESULTS: Performance of models comprising all variables outperformed those with 4 MELD-NA variables for all prediction cases and the DNN model outperformed the LR and RF models. For example, the DNN model achieved an AUC of 0.88, 0.86, and 0.85 for 90, 180, and 365-day mortality respectively as compared to the MELD score, which resulted in corresponding AUCs of 0.81, 0.79, and 0.76 for the same instances. The DNN and LR models had a significantly better f1 score compared to MELD at all time points examined. CONCLUSION: Other variables such as alkaline phosphatase, alanine aminotransferase, and hemoglobin were also top informative features besides the 4 MELD-Na variables. Machine learning and deep learning models outperformed the current standard of risk prediction among patients with cirrhosis. Advanced informatics techniques showed promise for risk prediction in patients with cirrhosis.


Assuntos
Registros Eletrônicos de Saúde , Cirrose Hepática/mortalidade , Aprendizado de Máquina , Algoritmos , Estudos de Coortes , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Modelos Teóricos , Redes Neurais de Computação
12.
Liver Int ; 41(10): 2467-2473, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34219362

RESUMO

BACKGROUND & AIMS: Cirrhosis leads to malnutrition and muscle wasting that manifests as frailty, which may be influenced by cirrhosis aetiology. We aimed to characterize the relationship between frailty and cirrhosis aetiology. METHODS: Included were adults with cirrhosis listed for liver transplantation (LT) at 10 US centrer who underwent ambulatory testing with the Liver Frailty Index (LFI; 'frail' = LFI ≥ 4.4). We used logistic regression to associate aetiologies and frailty, and competing risk regression (LT as the competing risk) to determine associations with waitlist mortality (death/delisting for sickness). RESULTS: Of 1,623 patients, rates of frailty differed by aetiology: 22% in chronic hepatitis C, 31% in alcohol-associated liver disease (ALD), 32% in non-alcoholic fatty liver disease (NAFLD), 21% in autoimmune/cholestatic and 31% in 'other' (P < .001). In univariable logistic regression, ALD (OR 1.53, 95% CI 1.12-2.09), NAFLD (OR 1.64, 95% CI 1.18-2.29) and 'other' (OR 1.58, 95% CI 1.06-2.36) were associated with frailty. In multivariable logistic regression, only ALD (OR 1.40; 95% 1.01-1.94) and 'other' (OR 1.59; 95% 1.05-2.40) remained associated with frailty. A total of 281 (17%) patients died/were delisted for sickness. In multivariable competing risk regression, LFI was associated with waitlist mortality (sHR 1.05, 95% CI 1.03-1.06), but aetiology was not (P > .05 for each). No interaction between frailty and aetiology on the association with waitlist mortality was found (P > .05 for each interaction term). CONCLUSIONS: Frailty is more common in patients with ALD, NAFLD and 'other' aetiologies. However, frailty was associated with waitlist mortality independent of cirrhosis aetiology, supporting the applicability of frailty across all cirrhosis aetiologies.


Assuntos
Doença Hepática Terminal , Fragilidade , Transplante de Fígado , Adulto , Fragilidade/diagnóstico , Humanos , Cirrose Hepática , Listas de Espera
13.
Hepatology ; 74(2): 926-936, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34128254

RESUMO

BACKGROUND AND AIMS: Estimates of racial disparity in cirrhosis have been limited by lack of large-scale, longitudinal data, which track patients from diagnosis to death and/or transplant. APPROACH AND RESULTS: We analyzed a large, metropolitan, population-based electronic health record data set from seven large health systems linked to the state death registry and the national transplant database. Multivariate competing risk analyses, adjusted for sex, age, insurance status, Elixhauser score, etiology of cirrhosis, HCC, portal hypertensive complication, and Model for End-Stage Liver Disease-Sodium (MELD-Na), examined the relationship between race, transplant, and cause of death as defined by blinded death certificate review. During the study period, 11,277 patients met inclusion criteria, of whom 2,498 (22.2%) identified as Black. Compared to White patients, Black patients had similar age, sex, MELD-Na, and proportion of alcohol-associated liver disease, but higher comorbidity burden, lower rates of private insurance, and lower rates of portal hypertensive complications. Compared to White patients, Black patients had the highest rate all-cause mortality and non-liver-related death and were less likely to be listed or transplanted (P < 0.001 for all). In multivariate competing risk analysis, Black patients had a 26% increased hazard of liver-related death (subdistribution HR, 1.26; 95% CI, [1.15-1.38]; P < 0.001). CONCLUSIONS: Black patients with cirrhosis have discordant outcomes. Further research is needed to determine how to address these real disparities in the field of hepatology.


Assuntos
/estatística & dados numéricos , Doença Hepática Terminal/mortalidade , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde/estatística & dados numéricos , Cirrose Hepática/mortalidade , Adulto , Idoso , Conjuntos de Dados como Assunto , Registros Eletrônicos de Saúde/estatística & dados numéricos , Doença Hepática Terminal/diagnóstico , Doença Hepática Terminal/patologia , Doença Hepática Terminal/cirurgia , Feminino , Seguimentos , Humanos , Cirrose Hepática/diagnóstico , Cirrose Hepática/patologia , Cirrose Hepática/cirurgia , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Análise de Sobrevida , Resultado do Tratamento
14.
Liver Transpl ; 27(9): 1262-1272, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33993632

RESUMO

Nearly half of living liver donors in North America are women of child-bearing age. Fetal and maternal outcomes after donation are unknown. We conducted a retrospective cohort study of female living liver donors (aged 18-50 years at donation) from 6 transplant centers. Participants were surveyed about their pregnancies and fertility. Outcomes were compared between predonation and postdonation pregnancies. Generalized estimating equations were clustered on donor and adjusted for age at pregnancy, parity, and pregnancy year. Among the 276 donors surveyed, 151 donors responded (54.7% response rate) and reported 313 pregnancies; 168/199 (68.8%) of the predonation pregnancies and 82/114 (71.9%) of the postdonation pregnancies resulted in live births, whereas 16.6% and 24.6% resulted in miscarriage, respectively. Women with postdonation pregnancies were older (32.0 versus 26.7 years; P < 0.001) and more frequently reported abnormal liver enzymes during pregnancy (3.5% versus 0.0%; P = 0.02) and delivery via cesarean delivery (35.4% versus 19.7%; P = 0.01). On adjusted analysis, there was no difference in cesarean delivery (odds ratio [OR], 2.44; 95% confidence interval [95% CI], 0.98-6.08), miscarriage (OR, 1.59; 95% CI, 0.78-3.24), combined endpoints of pregnancy-induced hypertension and preeclampsia (OR, 1.27; 95% CI, 0.36-4.49), or intrauterine growth restriction and preterm birth (OR, 0.91; 95% CI, 0.19-4.3). Of the 49 women who attempted pregnancy after donation, 11 (22.5%) self-reported infertility; however, 8/11 (72.7%) eventually had live births. Aside from increased reporting of abnormal liver enzymes and cesarean deliveries, there was no significant difference in pregnancy outcomes before and after living liver donation. One-fifth of women who attempt pregnancy after liver donation reported infertility, and although the majority went on to successful live births, further exploration is needed to understand the contributing factors. Future research should continue to monitor this patient-centered outcome across a large cohort of donors.


Assuntos
Transplante de Fígado , Nascimento Prematuro , Feminino , Humanos , Recém-Nascido , Fígado , Transplante de Fígado/efeitos adversos , Gravidez , Resultado da Gravidez/epidemiologia , Estudos Retrospectivos
15.
Contemp Clin Trials ; 103: 106294, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33515781

RESUMO

BACKGROUND: Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy ('TAKE IT') that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence. METHODS: The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined. CONCLUSION: The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.


Assuntos
Transplante de Rim , Adesão à Medicação , Projetos de Pesquisa , Humanos , Tecnologia da Informação , Rim , Ensaios Clínicos Controlados Aleatórios como Assunto , Transplantados
16.
Hepatology ; 73(3): 998-1010, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32416631

RESUMO

BACKGROUND AND AIMS: Radioembolization (yttrium-90 [Y90]) is used in hepatocellular carcinoma (HCC) as a bridging as well as downstaging liver-directed therapy to curative liver transplantation (LT). In this study, we report long-term outcomes of LT for patients with HCC who were bridged/downstaged by Y90. APPROACH AND RESULTS: Patients undergoing LT following Y90 between 2004 and 2018 were included, with staging by United Network for Organ Sharing (UNOS) tumor-node-metastasis criteria at baseline pre-Y90 and pre-LT. Post-Y90 toxicities were recorded. Histopathological data of HCC at explant were recorded. Long-term outcomes, including overall survival (OS), recurrence-free survival (RFS), disease-specific mortality (DSM), and time-to-recurrence, were reported. Time-to-endpoint analyses were estimated using Kaplan-Meier. Univariate and multivariate analyses were performed using a log-rank test and Cox proportional-hazards model, respectively. During the 15-year period, 207 patients underwent LT after Y90. OS from LT was 12.5 years, with a median time to LT of 7.5 months [interquartile range, 4.4-10.3]. A total of 169 patients were bridged, whereas 38 were downstaged to LT. Respectively, 94 (45%), 60 (29%), and 53 (26%) patients showed complete, extensive, and partial tumor necrosis on histopathology. Three-year, 5-year, and 10-year OS rates were 84%, 77%, and 60%, respectively. Twenty-four patients developed recurrence, with a median RFS of 120 (95% confidence interval, 69-150) months. DSM at 3, 5, and 10 years was 6%, 11%, and 16%, respectively. There were no differences in OS/RFS for patients who were bridged or downstaged. RFS was higher in patients with complete/extensive versus partial tumor necrosis (P < 0.0001). For patients with UNOS T2 treated during the study period, 5.2% dropped out because of disease progression. CONCLUSIONS: Y90 is an effective treatment for HCC in the setting of bridging/downstaging to LT. Patients who achieved extensive or complete necrosis had better RFS, supporting the practice of neoadjuvant treatment before LT.


Assuntos
Braquiterapia/métodos , Carcinoma Hepatocelular/radioterapia , Neoplasias Hepáticas/radioterapia , Transplante de Fígado , Terapia Neoadjuvante/métodos , Idoso , Carcinoma Hepatocelular/mortalidade , Carcinoma Hepatocelular/cirurgia , Intervalo Livre de Doença , Feminino , Humanos , Estimativa de Kaplan-Meier , Neoplasias Hepáticas/mortalidade , Neoplasias Hepáticas/cirurgia , Transplante de Fígado/mortalidade , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Análise de Sobrevida , Radioisótopos de Ítrio
18.
JAMA Surg ; 156(3): 256-262, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33377947

RESUMO

Importance: Female liver transplant candidates experience higher rates of wait list mortality than male candidates. Frailty is a critical determinant of mortality in patients with cirrhosis, but how frailty differs between women and men is unknown. Objective: To determine whether frailty is associated with the gap between women and men in mortality among patients with cirrhosis awaiting liver transplantation. Design, Setting, and Participants: This prospective cohort study enrolled 1405 adults with cirrhosis awaiting liver transplant without hepatocellular carcinoma seen during 3436 ambulatory clinic visits at 9 US liver transplant centers. Data were collected from January 1, 2012, to October 1, 2019, and analyzed from August 30, 2019, to October 30, 2020. Exposures: At outpatient evaluation, the Liver Frailty Index (LFI) score was calculated (grip strength, chair stands, and balance). Main Outcomes and Measures: The risk of wait list mortality was quantified using Cox proportional hazards regression by frailty. Mediation analysis was used to quantify the contribution of frailty to the gap in wait list mortality between women and men. Results: Of 1405 participants, 578 (41%) were women and 827 (59%) were men (median age, 58 [interquartile range (IQR), 50-63] years). Women and men had similar median scores on the laboratory-based Model for End-stage Liver Disease incorporating sodium levels (MELDNa) (women, 18 [IQR, 14-23]; men, 18 [IQR, 15-22]), but baseline LFI was higher in women (mean [SD], 4.12 [0.85] vs 4.00 [0.82]; P = .005). Women displayed worse balance of less than 30 seconds (145 [25%] vs 149 [18%]; P = .003), worse sex-adjusted grip (mean [SD], -0.31 [1.08] vs -0.16 [1.08] kg; P = .01), and fewer chair stands per second (median, 0.35 [IQR, 0.23-0.46] vs 0.37 [IQR, 0.25-0.49]; P = .04). In unadjusted mixed-effects models, LFI was 0.15 (95% CI, 0.06-0.23) units higher in women than men (P = .001). After adjustment for other variables associated with frailty, LFI was 0.16 (95% CI, 0.08-0.23) units higher in women than men (P < .001). In unadjusted regression, women experienced a 34% (95% CI, 3%-74%) increased risk of wait list mortality than men (P = .03). Sequential covariable adjustment did not alter the association between sex and wait list mortality; however, adjustment for LFI attenuated the mortality gap between women and men. In mediation analysis, an estimated 13.0% (IQR, 0.5%-132.0%) of the gender gap in wait list mortality was mediated by frailty. Conclusions and Relevance: These findings demonstrate that women with cirrhosis display worse frailty scores than men despite similar MELDNa scores. The higher risk of wait list mortality that women experienced appeared to be explained in part by frailty.


Assuntos
Fragilidade/complicações , Fragilidade/mortalidade , Cirrose Hepática/complicações , Cirrose Hepática/mortalidade , Transplante de Fígado , Listas de Espera/mortalidade , Estudos de Coortes , Feminino , Fragilidade/diagnóstico , Força da Mão , Humanos , Cirrose Hepática/terapia , Masculino , Pessoa de Meia-Idade , Atividade Motora , Equilíbrio Postural , Modelos de Riscos Proporcionais , Fatores de Risco , Fatores Sexuais
19.
Sleep ; 44(6)2021 06 11.
Artigo em Inglês | MEDLINE | ID: mdl-33367862

RESUMO

Cognitive impairment and disturbed sleep-wake rhythms are disabling complications of liver cirrhosis, yet there is limited understanding of how they are related. We tested the hypothesis that alterations of sleep, rest-activity, and light exposure patterns are associated with worse cognition in cirrhosis. A total of 54 ambulatory adult patients with cirrhosis and 41 age-/gender-matched healthy controls wore wrist actigraphy for rest-activity and light measurements and completed Patient-Reported Outcomes Measurement Information System sleep instruments for self-reported sleep quality. We used standard nonparametric descriptors to characterize rest-activity and light patterns, and wake after sleep onset and sleep efficiency to assess objective sleep quality. The NIH Toolbox cognition battery was used for objective cognitive evaluation using T-scores from a demographically adjusted population reference. Spearman's correlation and multivariable models were used to explore associations between measures of cognition, sleep, rest-activity, and light. Cognition was significantly impaired in cirrhosis patients. Sleep quality was worse in cirrhosis patients by subjective and objective measures compared with controls. Cirrhosis patients exhibited fragmented and dampened rest-activity rhythms, lower daytime and higher nighttime light exposure compared with controls. Worse working memory and processing speed was associated with lower daytime activity level, higher rest-activity fragmentation, lower day-to-day stability, and greater nocturnal light exposure. No association was found between cognition and sleep quality. Rest-activity fragmentation and abnormal light exposure patterns are common in patients with liver disease and are associated with the severity of cognitive impairment. Further research is needed to investigate the effects of timed bright light and exercise intervention on cognitive function in patients with liver disease.


Assuntos
Disfunção Cognitiva , Transtornos do Sono-Vigília , Actigrafia , Adulto , Ritmo Circadiano , Disfunção Cognitiva/complicações , Humanos , Cirrose Hepática/complicações , Descanso , Sono
20.
J Vasc Interv Radiol ; 32(2): 211-219, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33349507

RESUMO

PURPOSE: To evaluate safety and efficacy of segmental yttrium-90 (Y90) radioembolization for hepatocellular carcinoma (HCC) after transjugular intrahepatic portosystemic shunt (TIPS) placement. The hypothesis was liver sparing segmental Y90 for HCC after TIPS would provide high antitumor response with a tolerable safety profile. MATERIALS AND METHODS: This single-arm retrospective study included 39 patients (16 women, 23 men) with ages 49-81 years old who were treated with Y90. Child-Pugh A/B liver dysfunction was present in 72% (28/39) with a median Model for End-stage Liver Disease score of 18 (95% confidence interval, 16.4-19.4). Primary outcomes were clinical and biochemical toxicities and antitumor imaging response by World Health Organization (WHO) and European Association for the Study of the Liver (EASL) criteria. Secondary outcomes were orthotopic liver transplantation (OLT), time to progression (TTP), and overall survival (OS) estimates by the Kaplan-Meier method. RESULTS: The 30-day mortality was 0%. Grade 3+ clinical adverse events and grade 3+ hyperbilirubinemia occurred in 5% (2/39) and 0% (0/39), respectively. Imaging response was achieved in 58% (22/38, WHO criteria) and 74% (28/38, EASL criteria), respectively. Median TTP was 16.1 months for any cause and 27.5 months for primary index lesions. OLT was completed in 88% (21/24) of listed patients at a median time of 6.1 months (range, 0.9-11.7 months). Median OS was 31.6 months and 62.9 months censored and uncensored to OLT, respectively. CONCLUSIONS: Segmental Y90 for HCC appears safe and efficacious in patients after TIPS. Preserved transplant eligibility suggests that Y90 is a useful tool for bridging these patients to liver transplantation.


Assuntos
Carcinoma Hepatocelular/terapia , Embolização Terapêutica , Neoplasias Hepáticas/terapia , Derivação Portossistêmica Transjugular Intra-Hepática , Compostos Radiofarmacêuticos/administração & dosagem , Radioisótopos de Ítrio/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/mortalidade , Bases de Dados Factuais , Progressão da Doença , Embolização Terapêutica/efeitos adversos , Embolização Terapêutica/mortalidade , Feminino , Humanos , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/mortalidade , Masculino , Pessoa de Meia-Idade , Derivação Portossistêmica Transjugular Intra-Hepática/efeitos adversos , Derivação Portossistêmica Transjugular Intra-Hepática/mortalidade , Compostos Radiofarmacêuticos/efeitos adversos , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Radioisótopos de Ítrio/efeitos adversos
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