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OBJECTIVE: To assess the cost-effectiveness of emicizumab prophylaxis for patients having haemophilia A with inhibitors in the Indian context using an adaptive health technology assessment (aHTA) methodology. DESIGN: Economic evaluation using multiple approaches aimed at adjusting previously generated cost-effectiveness results based on (1) price differences only ('simple') and (2) differences in cost and expected treatment duration ('moderate') and differences in cost, inflation and life expectancy ('complex'). SETTING: Typical haemophilia care in India. PARTICIPANTS: Patients with haemophilia A and inhibitors. INTERVENTION: Emicizumab prophylaxis using two vial strengths (30 or 150 mg/mL) in comparison to no prophylaxis. MAIN OUTCOME MEASURES: Adjusted incremental cost-effectiveness ratio (ICERa), incremental costs and incremental quality-adjusted life years associated with emicizumab prophylaxis from both the health system and societal perspectives. RESULTS: Using the simple ICER adjustment method, emicizumab prophylaxis resulted in potential cost savings from the payers' perspective for both vial strengths in patients aged ≥12 and <12 years. However, from a societal perspective, emicizumab prophylaxis was not cost-effective. Using the moderate adjustment method, emicizumab prophylaxis showed potential cost saving from the health system perspective. The complex adjustment method also revealed cost savings for emicizumab prophylaxis from the health system and societal perspectives across different age groups. CONCLUSION: We found that implementing emicizumab prophylaxis for patients with haemophilia A and inhibitors in India has the potential to result in cost savings. This study highlights the feasibility of using the expanded aHTA methodology for rapid evidence generation in the Indian context. However, it is crucial to address certain research gaps, including data limitations, challenges in translating international evidence to Indian context and associated uncertainties. Additionally, conducting a comprehensive budget impact analysis is necessary. These findings hold significant implications for decision-making regarding the potential provision of emicizumab prophylaxis through federal or/and state government-funded programmes and institutions in India.
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BACKGROUND AND AIMS: This review aims to estimate the prevalence of undernutrition among migrants, refugees, internally displaced children, and children of migrated parents living in lower-middle-income countries. METHODS: PubMed, Scopus, Science-Direct, CINAHL-Plus, & Google Scholar were searched for peer-reviewed evidence published between January 2010 to March 2023. Two researchers independently examined the studies and retrieved the data. The internal and external validity of the studies was assessed using the NIH quality assessment tool, and a checklist adapted from Downs & Black, Bracht & Glass, and Del Siegle's guidelines. A random effect model was chosen to pool the estimates. Subgroup analysis, Meta-regression, and sensitivity analysis were done to explore the source of heterogeneity and the robustness of estimates. RESULTS: Among the 1978 records initially searched, 21 studies were selected for analysis. The pooled prevalence estimates for stunting, wasting, and underweight were estimated to be 29.39% (Confidence Interval [CI] 21.69-37.73; I2 99%; p < 0.01), 12.76% (CI 7.84-18.68; I2 99%; P < 0.01), and 24.05% (CI 16.17-32.94; I2 100%; p < 0.001) respectively. Among different WHO regions, all three undernutrition estimates were higher in LMICs belonging to the Southeast Asian region (Stunting 37.62%; wasting 14.28% and underweight 31.24%). Undernutrition among migrant Indian children was 43.55%, 18.71%, and 37.45% respectively. High heterogeneity was noted across all estimates with I2-value >90%. Sensitivity analysis across indicators showed the stability of our estimates. CONCLUSIONS: The extent of undernutrition, particularly wasting was high among migrant/refugee children living in lower-middle-income countries. Measures should be taken to strengthen the government-subsidized public food distribution system, increase healthcare outreach, and ensure public health insurance coverage among the migrant population.
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Países en Desarrollo , Desnutrición , Refugiados , Migrantes , Humanos , Refugiados/estadística & datos numéricos , Prevalencia , Desnutrición/epidemiología , Países en Desarrollo/estadística & datos numéricos , Migrantes/estadística & datos numéricos , Niño , PadresRESUMEN
Shikha YadavBackground Chronic diseases require more attention in terms of patient satisfaction due to their physically and mentally exhausting nature. Cancer burden in India for 2021 was 26.7 million disability-adjusted life years (DALYs), and is projected to rise to 29.8 million by 2025. The second most common cause of cancer DALYs among females was cervix uteri (98.6 per 100,000). Evaluation of factors that influence satisfaction can assist in finding solutions to improve the quality of services provided. Methods This study was conducted in the Regional Cancer Centre, Puducherry. One focused group discussion (FGD) was conducted among seven cervical cancer patients and eight key informant interviews (KII) with their healthcare providers (HCPs). The details collected included perceptions of patient satisfaction, difficulties they faced in achieving patient satisfaction, and possible recommendations for improvement. Thematic analysis was done after preparing transcripts. Results The major facilitating factors reported were proper information exchange, the approachability of staff, and assisting patients with transportation concession certificates. Obstacles highlighted by patients included lack of family support, side effects of treatment, inability to do routine work, and long travel time. HCP reported misalignment between and within departments, overworked staff, lack of equipment for smooth telemedicine services, and inadequate space for OPD, counseling, and waiting as barriers to providing satisfactory services to patients. Conclusions Most challenges were attributed to overworked staff, inequitable distribution of cancer center, and patients' knowledge and understanding of disease. Therefore, it is important to make patients aware of the disease, treatment, and value of the quality of life. It can enable them to make better use of resources, in addition to improvements in the health system.
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BACKGROUND: Globally, one in ten pregnant women have diabetes; out of which, 90% contribute to gestational diabetes mellitus (GDM). Medical Nutrition Therapy (MNT) is the cornerstone for GDM treatment yet adherence to MNT among the masses is not adequately monitored as part of the routine antenatal services. The study aimed to estimate the proportion of adherence to MNT and determine the factors related toadherence among antenatal women with GDM. This study also explores the facilitators, barriers, and possible suggestions for improving adherence. MATERIALS AND METHODS: This facility-based sequential explanatory mixed-method study was conducted among 341 antenatal women with GDM at, Puducherry. The study was conducted in 2021. Dietary adherence was evaluated using Perceived Dietary Adherence Questionnaire and based on the scores obtained they were selected for in-depth interviews to explore the facilitators and barriers. Collected data wereanalysed by Chi-square test using STATA version 16. RESULTS: Out of 341 participants, the proportion of participants adherent to MNT was 135 (39.6%) with 95% CI of 34%-44%. Thepredictors for poor adherence were unemployment (PR: 0.65; 95%CI: 0.48-0.88) and good adherence was antenatal women in the 2nd trimester (PR: 1.541; 95%CI: 1.18-2.025). Barrierstonon-adherence were financial crisis, lack of awareness ofthe need for MNT, and joint family pressure. CONCLUSIONS: About two-thirds of antenatal women with GDM are non-adherent to MNT. Unemployment and period of gestation were found to be theirdeterminants. Appropriate action has to be implemented for improving the adherence rate.
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OBJECTIVE: The impact of glycemic control in diabetic patients with chronic kidney disease (CKD) who may or may not transition to dialysis remains uncertain, given recent interest in the conservative management of advanced CKD without dialysis therapy, which may benefit from alternative glycemic control strategies. DESIGN AND METHODS: Among a national cohort of US Veterans, we examined the association of glycemic status, defined by averaged random blood glucose and hemoglobin A1c (HbA1c), with mortality after transitioning to dialysis over 2007-2011 (Transition Cohort) compared with patients in a one-to-one matched cohort of CKD patients with diabetes who did not transition to dialysis (Nontransition Cohort). RESULTS: Among 17,121 patients in the Transition Cohort, averaged random glucose ≥200 mg/dL was associated with higher mortality in expanded case-mix analyses (reference: 100-<120 mg/dL): adjusted hazard ratio (95% confidence interval) 1.26 (1.13-1.40). In the transition cohort, HbA1c 8-<10% and ≥10% were associated with higher mortality (reference: 6-<8%): adjusted hazard ratios (95% confidence interval) 1.21 (1.11-1.33) and 1.43 (1.21-1.69), respectively. Among 8,711 patients in the Nontransition Cohort, averaged random glucose <100 mg/dl and ≥160 mg/dl were associated with higher death risk, whereas HbA1c was not associated with mortality. CONCLUSION: In diabetic CKD patients transitioning to dialysis, higher averaged random glucose and HbA1c were associated with early dialysis mortality, whereas in matched CKD patients who did not transition, both lower and higher glucose levels were associated with higher mortality. These data suggest the need for different glycemic strategies based on whether there are plans to transition to dialysis versus pursue conservative management among diabetic patients with CKD.
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Glucemia/análisis , Diálisis Renal/mortalidad , Insuficiencia Renal Crónica/terapia , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Nefropatías Diabéticas/sangre , Nefropatías Diabéticas/mortalidad , Nefropatías Diabéticas/terapia , Etnicidad , Femenino , Hemoglobina Glucada/análisis , Humanos , Fallo Renal Crónico/sangre , Fallo Renal Crónico/mortalidad , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Insuficiencia Renal Crónica/sangre , Insuficiencia Renal Crónica/mortalidad , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Estados Unidos , United States Department of Veterans Affairs , VeteranosRESUMEN
OBJECTIVE: Given that patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) have a disproportionately higher prevalence of hypothyroidism compared with their non-CKD counterparts, we sought to determine the association between thyroid status, defined by serum thyrotropin (TSH) levels, and mortality among a national cohort of patients with NDD-CKD. PATIENTS AND METHODS: Among 227,422 US veterans with stage 3 NDD-CKD with 1 or more TSH measurements during the period October 1, 2004, to September 30, 2012, we first examined the association of thyroid status, defined by TSH categories of less than 0.5, 0.5 to 5.0 (euthyroidism), and more than 5.0 mIU/L, with all-cause mortality. We then evaluated 6 granular TSH categories: less than 0.1, 0.1 to less than 0.5, 0.5 to less than 3.0, 3.0 to 5.0, more than 5.0 to 10.0, and more than 10.0 mIU/L. We concurrently examined thyroid status, thyroid-modulating therapy, and mortality in sensitivity analyses. RESULTS: In expanded case-mix adjusted Cox analyses, compared with euthyroidism, baseline and time-dependent TSH levels of more than 5.0 mIU/L were associated with higher mortality (adjusted hazard ratios [aHRs] [95% CI], 1.19 [1.15-1.24] and 1.23 [1.19-1.28], respectively), as were baseline and time-dependent TSH levels of less than 0.5 mIU/L (aHRs [95% CI], 1.18 [1.15-1.22] and 1.41 [1.37-1.45], respectively). Granular examination of thyroid status showed that incrementally higher TSH levels of 3.0 mIU/L or more were associated with increasingly higher mortality in baseline and time-dependent analyses, and TSH categories of less than 0.5 mIU/L were associated with higher mortality (reference, 0.5-<3.0 mIU/L) in baseline analyses. In time-dependent analyses, untreated and undertreated hypothyroidism and untreated hyperthyroidism were associated with higher mortality (reference, spontaneous euthyroidism), whereas hypothyroidism treated-to-target showed lower mortality. CONCLUSION: Among US veterans with NDD-CKD, high-normal TSH (≥3.0 mIU/L) and lower TSH (<0.5 mIU/L) levels were associated with higher death risk. Interventional studies identifying the target TSH range associated with the greatest survival in patients with NDD-CKD are warranted.
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Hipertiroidismo/mortalidad , Hipotiroidismo/mortalidad , Fallo Renal Crónico/mortalidad , Diálisis Peritoneal/mortalidad , Veteranos/estadística & datos numéricos , Anciano , Estudios de Cohortes , Femenino , Humanos , Hipertiroidismo/sangre , Hipotiroidismo/sangre , Masculino , Persona de Mediana Edad , Diálisis Renal/mortalidad , Factores de RiesgoRESUMEN
BACKGROUND/AIMS: Ultrafiltration rate (UFR) appears to be associated with mortality in prevalent hemodialysis (HD) patients. However, the association of UFR with mortality in incident HD patients remains unknown. METHODS: We examined a US cohort of 110,880 patients who initiated HD from 2007 to 2011. Baseline UFR was divided into 5 groups (<4, 4 to <6, 6 to <8, 8 to <10, and ≥10 mL/h/kg body weight [BW]). We examined predictors of higher baseline UFR using logistic regression and the association of baseline UFR and all-cause and cardiovascular (CV) mortality using Cox proportional hazard models with adjustments for demographics, comorbidities, and markers of malnutrition-inflammation-cachexia syndrome. RESULTS: Patients were 63 ± 15 years, with 43% women, 32% African Americans, and had a mean baseline UFR of 7.5 ± 3.1 mL/h/kg BW. In the fully adjusted logistic regression models, factors associated with higher UFR (≥7.5 mL/h/kg BW) included Hispanic ethnicity, diabetes, and higher dietary protein intake. There was a linear association between UFR and all-cause and CV mortality, where UFR ≥10 mL/h/kg BW (reference UFR 6-<8 mL/h/kg BW) conferred the highest risk in both unadjusted (HR 1.15 [95% CI 1.10-1.19]) and adjusted models (HR 1.23 [95% CI 1.16-1.31]). The linear association with all-cause mortality remained consistent across strata of age, urine volume, and treatment time. CONCLUSIONS: Higher UFR is independently associated with higher all-cause and CV mortality in incident HD patients. Clinical trials are warranted to examine the effects of lowering UFR on outcomes.
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Fallo Renal Crónico/mortalidad , Fallo Renal Crónico/terapia , Diálisis Renal/mortalidad , Ultrafiltración , Adulto , Factores de Edad , Anciano , Peso Corporal , Enfermedades Cardiovasculares/mortalidad , Estudios de Cohortes , Neuropatías Diabéticas/mortalidad , Neuropatías Diabéticas/terapia , Proteínas en la Dieta , Etnicidad , Femenino , Hemodiafiltración , Humanos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Resultado del Tratamiento , Estados Unidos/epidemiología , UrodinámicaRESUMEN
BACKGROUND AND OBJECTIVES: Patients undergoing hemodialysis with a frequency other than thrice weekly are not included in current clinical performance metrics for dialysis adequacy. The weekly standard Kt/Vurea incorporates treatment frequency, but there are limited data on its association with clinical outcomes. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used multivariable regression to examine the association of dialysis standard Kt/Vurea with BP and metabolic control (serum potassium, calcium, bicarbonate, and phosphorus) in patients incidental to dialysis treated with home (n=2373) or in-center hemodialysis (n=109,273). We further used Cox survival models to examine the association of dialysis standard Kt/Vurea with mortality, hospitalization, and among patients on home hemodialysis, transfer to in-center hemodialysis. RESULTS: After adjustment for potential confounders, patients with dialysis standard Kt/Vurea <2.1 had higher BPs compared with patients with standard Kt/Vurea 2.1 to <2.3 (3.4 mm Hg higher [P<0.001] for home hemodialysis and 0.9 mm Hg higher [P<0.001] for in-center hemodialysis). There were no clinically meaningful associations between dialysis standard Kt/Vurea and markers of metabolic control, irrespective of dialysis modality. There was no association between dialysis standard Kt/Vurea and risk for mortality, hospitalization, or transfer to in-center hemodialysis among patients undergoing home hemodialysis. Among patients on in-center hemodialysis, dialysis standard Kt/Vurea <2.1 was associated with higher risk (adjusted hazard ratio, 1.11; 95% confidence interval, 1.07 to 1.14) and standard Kt/Vurea ≥2.3 was associated with lower risk (adjusted hazard ratio, 0.97; 95% confidence interval, 0.94 to 0.99) for death compared with standard Kt/Vurea 2.1 to <2.3. Additional analyses limited to patients with available data on residual kidney function showed similar relationships of dialysis and total (dialysis plus kidney) standard Kt/Vurea with outcomes. CONCLUSIONS: Current targets for standard Kt/Vurea have limited utility in identifying individuals at increased risk for adverse clinical outcomes for those undergoing home hemodialysis but may enhance risk stratification for in-center hemodialysis.
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Instituciones de Atención Ambulatoria , Soluciones para Diálisis/química , Hemodiálisis en el Domicilio , Hospitalización/estadística & datos numéricos , Transferencia de Pacientes/estadística & datos numéricos , Urea/análisis , Adulto , Anciano , Anciano de 80 o más Años , Bicarbonatos/sangre , Presión Sanguínea , Calcio/sangre , Femenino , Humanos , Fallo Renal Crónico/terapia , Masculino , Persona de Mediana Edad , Fósforo/sangre , Potasio/sangre , Modelos de Riesgos Proporcionales , Tasa de SupervivenciaRESUMEN
BACKGROUND: Among the general population, low circulating testosterone levels are associated with higher risk of cardiovascular disease and death. While testosterone deficiency is common in dialysis patients, studies of testosterone and mortality in this population are ambiguous and overlapping. We hypothesized that lower testosterone levels are associated with higher mortality in male dialysis patients. METHODS: We examined a nationally representative cohort of male dialysis patients from a large US dialysis organization who underwent one or more total testosterone measurements from 1/2007 to 12/2011. The association between total testosterone categorized as quartiles and all-cause mortality was studied using Cox models adjusted for expanded case-mix and laboratory covariates. We also examined total testosterone as a continuous predictor of all-cause mortality using restricted cubic splines. RESULTS: Among 624 male dialysis patients, 51% of patients demonstrated testosterone deficiency (total testosterone <300 ng/dL); median (IQR) total testosterone levels were 297 (190-424) ng/mL. In expanded case-mix + laboratory adjusted Cox analyses, we observed a graded association between lower testosterone levels and higher mortality risk (ref: quartile 3): adjusted hazard ratios (95% CI) 2.32 (1.33-4.06), 1.80 (0.99-3.28), and 0.68 (0.32-1.42) for Quartiles 1, 2, and 4, respectively. In adjusted spline analyses, the lower testosterone-higher mortality risk association declined with higher testosterone levels until the value reached a threshold of 400 ng/dL above which risk plateaued. CONCLUSION: Lower testosterone levels were independently associated with higher mortality risk in male dialysis patients. Further studies are needed to determine underlying mechanisms, and whether testosterone replacement ameliorates death risk in this population.
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Enfermedades Cardiovasculares/mortalidad , Fallo Renal Crónico/terapia , Diálisis Renal , Testosterona/sangre , Adulto , Anciano , Enfermedades Cardiovasculares/sangre , Causas de Muerte , Estudios de Cohortes , Humanos , Fallo Renal Crónico/sangre , Fallo Renal Crónico/mortalidad , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Factores de Riesgo , Testosterona/deficiencia , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND AND OBJECTIVES: Depression in patients with nondialysis-dependent CKD is often undiagnosed, empirically overlooked, and associated with higher risk of death, progression to ESRD, and hospitalization. However, there is a paucity of evidence on the association between the presence of depression in patients with advanced nondialysis-dependent CKD and post-ESRD mortality, particularly among those in the transition period from late-stage nondialysis-dependent CKD to maintenance dialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: From a nation-wide cohort of 45,076 United States veterans who transitioned to ESRD over 4 contemporary years (November of 2007 to September of 2011), we identified 10,454 (23%) patients with a depression diagnosis during the predialysis period. We examined the association of pre-ESRD depression with all-cause mortality after transition to dialysis using Cox proportional hazards models adjusted for sociodemographics, comorbidities, and medications. RESULTS: Patients were 72±11 years old (mean±SD) and included 95% men, 66% patients with diabetes, and 23% blacks. The crude mortality rate was similar in patients with depression (289/1000 patient-years; 95% confidence interval, 282 to 297) versus patients without depression (286/1000 patient-years; 95% confidence interval, 282 to 290). Compared with patients without depression, patients with depression had a 6% higher all-cause mortality risk in the adjusted model (hazard ratio, 1.06; 95% confidence interval, 1.03 to 1.09). Similar results were found across all selected subgroups as well as in sensitivity analyses using alternate definitions of depression. CONCLUSION: Pre-ESRD depression has a weak association with post-ESRD mortality in veterans transitioning to dialysis.
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Depresión/mortalidad , Fallo Renal Crónico/mortalidad , Fallo Renal Crónico/terapia , Riñón/fisiopatología , Transferencia de Pacientes , Diálisis Renal , Insuficiencia Renal Crónica/mortalidad , Insuficiencia Renal Crónica/terapia , Anciano , Anciano de 80 o más Años , Distribución de Chi-Cuadrado , Comorbilidad , Depresión/diagnóstico , Depresión/psicología , Progresión de la Enfermedad , Femenino , Humanos , Estimación de Kaplan-Meier , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/fisiopatología , Masculino , Persona de Mediana Edad , Análisis Multivariante , Modelos de Riesgos Proporcionales , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/fisiopatología , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Estados Unidos/epidemiología , Salud de los VeteranosRESUMEN
OBJECTIVE: Although early trials suggested that intensive glycemic targets reduce the number of complications with diabetes, contemporary trials indicate no cardiovascular benefit and potentially higher mortality risk. As patients with advanced chronic kidney disease (CKD) transitioning to treatment with dialysis were excluded from these studies, the optimal glycemic level in this population remains uncertain. We hypothesized that glycemic status, defined by hemoglobin A1c (HbA--1c) and random glucose levels, in the pre-end-stage renal disease (ESRD) period is associated with higher 1-year post-ESRD mortality among patients with incident diabetes who have ESRD. RESEARCH DESIGN AND METHODS: Among 17,819 U.S. veterans with diabetic CKD transitioning to dialysis from October 2007 to September 2011, we examined the association of mean HbA--1c and random glucose levels averaged over the 1-year pre-ESRD transition period with mortality in the first year after dialysis initiation. All-cause mortality hazard ratios (HRs) were estimated using multivariable survival models. Secondary analyses examined cardiovascular mortality using competing risks methods. RESULTS: HbA--1c levels ≥8% (≥64 mmol/mol) were associated with higher mortality in the first year after dialysis initiation (reference value 6% to <7% [42-53 mmol/mol]): adjusted HRs [aHRs] 1.19 [95% CI 1.07-1.32] and 1.48 (1.31-1.67) for HbA--1c 8% to <9% [64-75 mmol/mol] and ≥9% [≥75 mmol/mol], respectively). Random glucose levels ≥200 mg/dL were associated with higher mortality (reference value 100 to <125 mg/dL): aHR 1.34 [95% CI 1.20-1.49]). Cumulative incidence curves showed that incrementally higher mean HbA--1c and random glucose levels were associated with increasingly higher cardiovascular mortality. CONCLUSIONS: In patients with diabetes and CKD transitioning to dialysis, higher mean HbA--1c and random glucose levels during the pre-ESRD prelude period were associated with higher 1-year post-ESRD mortality. Clinical trials are warranted to examine whether modulating glycemic status improves survival in this population.
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Glucemia/análisis , Nefropatías Diabéticas/mortalidad , Diálisis Renal/mortalidad , Insuficiencia Renal Crónica/mortalidad , Anciano , Anciano de 80 o más Años , Progresión de la Enfermedad , Femenino , Hemoglobina Glucada/análisis , Humanos , Incidencia , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Insuficiencia Renal Crónica/sangre , Factores Socioeconómicos , Estados Unidos/epidemiología , VeteranosRESUMEN
BACKGROUND: Hyperkalemia is observed in chronic kidney disease patients and may be a risk factor for life-threatening arrhythmias and death. Race/ethnicity may be important modifiers of the potassium-mortality relationship in maintenance hemodialysis (MHD) patients given that potassium intake and excretion vary among minorities. METHODS: We examined racial/ethnic differences in baseline serum potassium levels and all-cause and cardiovascular mortality using Cox proportional hazard models and restricted cubic splines in a cohort of 102,241 incident MHD patients. Serum potassium was categorized into 6 groups: ≤3.6, >3.6 to ≤4.0, >4.0 to ≤4.5 (reference), >4.5 to ≤5.0, >5.0 to ≤5.5, and >5.5 mEq/L. Models were adjusted for case-mix and malnutrition-inflammation cachexia syndrome (MICS) covariates. RESULTS: The cohort was composed of 50% whites, 34% African-Americans, and 16% Hispanics. Hispanics tended to have the highest baseline serum potassium levels (mean ± SD: 4.58 ± 0.55 mEq/L). Patients in our cohort were followed for a median of 1.3 years (interquartile range 0.6-2.5). In our cohort, associations between higher potassium (>5.5 mEq/L) and higher mortality risk were observed in African-American and whites, but not Hispanic patients in models adjusted for case-mix and MICS covariates. While in Hispanics only, lower serum potassium (<3.6 mEq/L) levels were associated with higher mortality risk. Similar trends were observed for cardiovascular mortality. CONCLUSIONS: Higher potassium levels were associated with higher mortality risk in white and African-American MHD patients, whereas lower potassium levels were associated with higher death risk in Hispanics. Further studies are needed to determine the underlying mechanisms for the differential association between potassium and mortality across race/ethnicity.
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Hiperpotasemia/mortalidad , Fallo Renal Crónico/mortalidad , Fallo Renal Crónico/terapia , Mortalidad/etnología , Potasio en la Dieta/efectos adversos , Diálisis Renal/efectos adversos , Negro o Afroamericano/estadística & datos numéricos , Anciano , Femenino , Estudios de Seguimiento , Hispánicos o Latinos/estadística & datos numéricos , Humanos , Hiperpotasemia/sangre , Fallo Renal Crónico/sangre , Masculino , Persona de Mediana Edad , Potasio en la Dieta/sangre , Modelos de Riesgos Proporcionales , Medición de Riesgo , Población Blanca/estadística & datos numéricosRESUMEN
BACKGROUND: Mortality is extremely high immediately after the transition to dialysis therapy, but the association of blood pressure (BP) before dialysis therapy initiation with mortality after dialysis therapy initiation remains unknown. STUDY DESIGN: Observational study. SETTING & PARTICIPANTS: 17,729 US veterans transitioning to dialysis therapy in October 2007 to September 2011, with a median follow-up of 2.0 years. PREDICTOR: Systolic (SBP) and diastolic BP (DBP) averaged over the last 1-year predialysis transition period as 6 (<120 to ≥160mmHg in 10-mmHg increments) and 5 (<60 to ≥90mmHg in 10-mmHg increments) categories, respectively, and as continuous measures. OUTCOMES & MEASUREMENTS: Postdialysis all-cause mortality, assessed over different follow-up periods (ie, <3, 3-<6, 6-<12, and ≥12 months after dialysis therapy initiation) using Cox regressions adjusted for demographics, comorbid conditions, medications, cardiovascular medication adherence, body mass index, estimated glomerular filtration rate, and type of vascular access. RESULTS: Mean predialysis SBP and DBP were 141.2±16.1 (SD) and 73.7±10.6mmHg, respectively. There was a reverse J-shaped association of SBP with all-cause mortality, with significantly higher mortality seen with SBP<140mmHg. Mortality risks associated with lower SBP were greatest in the first 3 months after dialysis therapy initiation, with multivariable-adjusted HRs of 2.40 (95% CI, 1.96-2.93), 1.99 (95% CI, 1.66-2.40), 1.35 (95% CI, 1.13-1.62), 0.98 (95% CI, 0.78-1.22), and 0.76 (95% CI, 0.57-1.00) for SBP <120, 120 to <130, 130 to <140, 150 to <160, and ≥160 (vs 140-<150) mmHg, respectively. No consistent association was observed between predialysis DBP and postdialysis mortality. LIMITATIONS: Results cannot be inferred to show causality and may not be generalizable to women or the general US population. CONCLUSIONS: Lower predialysis SBP is associated with higher all-cause mortality in the immediate postdialysis period. Predialysis DBP showed no consistent association with postdialysis mortality. Further studies are needed to clarify ideal predialysis SBP levels among incident dialysis patients as a potential means to improve the excessively high early dialysis mortality.
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Presión Sanguínea , Diálisis Renal/mortalidad , Anciano , Determinación de la Presión Sanguínea , Femenino , Humanos , Fallo Renal Crónico/mortalidad , Fallo Renal Crónico/terapia , Masculino , Estudios Retrospectivos , Factores de Tiempo , Estados Unidos , Salud de los VeteranosRESUMEN
BACKGROUND: Seasonal variations may exist in transitioning to dialysis, kidney transplantation and related outcomes among end-stage renal disease (ESRD) patients. Elucidating these variations may have major clinical and healthcare policy implications for better resource allocation across seasons. METHODS: Using the United States Renal Data System database from 1 January 2000 to 31 December 2013, we calculated monthly counts of transitioning to dialysis or first transplantation and deaths. Crude monthly transition fraction was defined as the number of new ESRD patients divided by all ESRD patients on the first day of each month. Similar fractions were calculated for all-cause and cause-specific mortality and transplantation. RESULTS: The increasing trend of the annual transition to ESRD plateaued during 2009-2012 (n = 126 264), and dropped drastically in 2013 (n = 117 372). Independent of secular trends, monthly transition to ESRD was lowest in July (1.65%) and highest in January (1.97%) of each year. All-cause, cardiovascular and infectious mortalities were lowest in July or August (1.32, 0.58 and 0.15%, respectively) and highest in January (1.56, 0.71 and 0.19%, respectively). Kidney transplantation was highest in June (0.33%), and this peak was mainly attributed to living kidney transplantation in summer months. Transplant failure showed a similar seasonal variation to naïve transition, peaking in January (0.65%) and nadiring in September (0.56%). CONCLUSIONS: Transitioning to ESRD and adverse events among ESRD people were more frequent in winter and less frequent in summer, whereas kidney transplantation showed the reverse trend. The potential causes and implications of these consistent seasonal variations warrant more investigation.
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Fallo Renal Crónico/mortalidad , Fallo Renal Crónico/terapia , Adulto , Anciano , Femenino , Humanos , Trasplante de Riñón/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Diálisis Renal/estadística & datos numéricos , Estaciones del Año , Insuficiencia del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Prior studies have suggested that arteriovenous fistula (AVF) or graft (AVG) creation may be associated with slowing of estimated glomerular filtration rate (eGFR) decline. It is unclear if this is attributable to the physiological benefits of a mature access on systemic circulation versus confounding factors. METHODS: We examined a nationwide cohort of 3026 US veterans with advanced chronic kidney disease (CKD) transitioning to dialysis between 2007 and 2011 who had a pre-dialysis AVF/AVG and had at least three outpatient eGFR measurements both before and after AVF/AVG creation. Slopes of eGFR were estimated using mixed-effects models adjusted for fixed and time-dependent confounders, and compared separately for the pre- and post-AVF/AVG period overall and in patients stratified by AVF/AVG maturation. In all, 3514 patients without AVF/AVG who started dialysis with a catheter served as comparators, using an arbitrary 6-month index date before dialysis initiation to assess change in eGFR slopes. RESULTS: Of the 3026 patients with AVF/AVG (mean age 67 years, 98% male, 75% diabetic), 71% had a mature AVF/AVG at dialysis initiation. eGFR decline accelerated in the last 6 months prior to dialysis in patients with a catheter (median, from -6.0 to -16.3 mL/min/1.73 m2/year, P < 0.001), while a significant deceleration of eGFR decline was seen after vascular access creation in those with AVF/AVG (median, from -5.6 to -4.1 mL/min/1.73 m2/year, P < 0.001). Findings were independent of AVF/AVG maturation status and were robust in adjusted models. CONCLUSIONS: The creation of pre-dialysis AVF/AVG appears to be associated with eGFR slope deceleration and, consequently, may delay the onset of dialysis initiation in advanced CKD patients.
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Fístula Arteriovenosa/complicaciones , Derivación Arteriovenosa Quirúrgica/efectos adversos , Tasa de Filtración Glomerular , Fallo Renal Crónico/patología , Insuficiencia Renal Crónica/cirugía , Dispositivos de Acceso Vascular/efectos adversos , Anciano , Desaceleración , Femenino , Humanos , Fallo Renal Crónico/etiología , Masculino , Diálisis Renal , Estudios RetrospectivosRESUMEN
BACKGROUND: Most current scoring tools to predict allograft and patient survival upon kidney transplantion are based on variables collected posttransplantation. We developed a novel score to predict posttransplant outcomes using pretransplant information including routine laboratory data available before or at the time of transplantation. METHODS: Linking the 5-year patient data of a large dialysis organization to the Scientific Registry of Transplant Recipients, we identified 15 125 hemodialysis patients who underwent first deceased transplantion. Prediction models were developed using Cox models for (a) mortality, (b) allograft loss (death censored), and (c) combined death or transplant failure. The cohort was randomly divided into a two thirds set (Nd = 10 083) for model development and a one third set (Nv = 5042) for validation. Model predictive discrimination was assessed using the index of concordance, or C statistic, which accounts for censoring in time-to-event models (a-c). We used the bootstrap method to assess model overfitting and calibration using the development dataset. RESULTS: Patients were 50 ± 13 years of age and included 39% women, 15% African Americans, and 36% persons with diabetes. For prediction of posttransplant mortality and graft loss, 10 predictors were used (recipients' age, cause and length of end-stage renal disease, hemoglobin, albumin, selected comorbidities, race and type of insurance as well as donor age, diabetes status, extended criterion donor kidney, and number of HLA mismatches). The new model (www.TransplantScore.com) showed the overall best discrimination (C-statistics, 0.70; 95% confidence interval [95% CI], 0.67-0.73 for mortality; 0.63; 95% CI, 0.60-0.66 for graft failure; 0.63; 95% CI, 0.61-0.66 for combined outcome). CONCLUSIONS: The new prediction tool, using data available before the time of transplantation, predicts relevant clinical outcomes and may perform better to predict patients' graft survival than currently used tools.
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Técnicas de Apoyo para la Decisión , Fallo Renal Crónico/cirugía , Trasplante de Riñón , Evaluación de Procesos, Atención de Salud , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Aloinjertos , Toma de Decisiones Clínicas , Minería de Datos , Femenino , Supervivencia de Injerto , Humanos , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/mortalidad , Trasplante de Riñón/efectos adversos , Trasplante de Riñón/mortalidad , Modelos Lineales , Masculino , Persona de Mediana Edad , Selección de Paciente , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Valor Predictivo de las Pruebas , Modelos de Riesgos Proporcionales , Sistema de Registros , Reproducibilidad de los Resultados , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Adulto JovenRESUMEN
BACKGROUND: Sodium disarrays are common in peritoneal dialysis (PD) patients, and may be associated with adverse outcomes in this population. However, few studies of limited sample size have examined the association of serum sodium with mortality in PD patients, with inconsistent results. We hypothesized that both hypo- and hypernatremia are associated with higher death risk in a nationally representative cohort of US PD patients. METHODS: We sought to examine the association of serum sodium over time and mortality among 4687 adult incident PD patients from a large US dialysis organization who underwent one or more serum sodium measurements within the first 3 months of dialysis over January 2007 to December 2011. We examined the association of time-dependent and baseline sodium with all-cause mortality as a proxy of short- and long-term sodium-mortality associations, respectively. Hazard ratios were estimated using Cox models with three adjustment levels: minimally adjusted, case-mix adjusted, and case-mix + laboratory adjusted. RESULTS: In time-dependent analyses, sodium levels <140 mEq/L were associated with incrementally higher death risk in case-mix models (ref: 140 to <142 mEq/L); following laboratory covariate adjustment, associations between lower sodium and higher mortality remained significant for levels <136 mEq/L. In analyses using baseline values, sodium levels <140 mEq/L were associated with higher mortality risk across all models (ref: 140 to <142 mEq/L). CONCLUSIONS: In PD patients, lower time-dependent and baseline sodium levels were independently associated with higher death risk. Further studies are needed to determine whether correction of dysnatremia improves longevity in this population.
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Biomarcadores/sangre , Hipernatremia/mortalidad , Hiponatremia/mortalidad , Mortalidad/tendencias , Diálisis Peritoneal/mortalidad , Sodio/sangre , Estudios de Cohortes , Femenino , Humanos , Hipernatremia/sangre , Hipernatremia/etiología , Hiponatremia/sangre , Hiponatremia/etiología , Masculino , Persona de Mediana Edad , Diálisis Peritoneal/efectos adversos , Pronóstico , Tasa de SupervivenciaRESUMEN
BACKGROUND: Previous studies in adult hemodialysis patients have shown that African-American and Hispanic patients have a lower risk of mortality in addition to a lower likelihood of kidney transplantation. However, studies of the association between race and outcomes in pediatric dialysis are sparse and often do not examine outcomes in Hispanic children. The objective was to determine if racial-ethnic disparities in mortality and kidney transplantation outcomes exist in pediatric dialysis patients. METHODS: This was a retrospective cohort analysis of 2,697 pediatric dialysis patients (aged 0-20 years) from a large national dialysis organization (entry period 2001-2011) of non-Hispanic white, African-American, and Hispanic race-ethnicity. Associations between race-ethnicity with mortality and kidney transplantation outcomes were examined separately using competing risks methods. Logistic regression analyses were used to examine the association between race-ethnicity, with outcomes within 1 year of dialysis initiation. RESULTS: Of the 2,697 pediatric patients in this cohort, 895 were African-American, 778 were Hispanic, and 1,024 were non-Hispanic white. After adjusting for baseline demographics, competing risk survival analysis revealed that compared with non-Hispanic whites, African-Americans had a 64 % higher mortality risk (hazards ratio [HR] = 1.64; 95 % CI 1.24-2.17), whereas Hispanics had a 31 % lower mortality risk (HR = 0.69; 95 % CI 0.47-1.01) that did not reach statistical significance. African-Americans also had higher odds of 1-year mortality after starting dialysis (odds ratio [OR] = 2.08; 95 % CI 0.95-4.58), whereas both African-Americans and Hispanics had a lower odds of receiving a transplant within 1 year of starting dialysis (OR = 0.28; 95 % CI 0.19-0.41 and OR = 0.43; 95 % CI 0.31-0.59 respectively). CONCLUSION: In contrast to adults, African-American pediatric dialysis patients have worse survival than their non-Hispanic white counterparts, whereas Hispanics have a similar to lower mortality risk. Both African-American and Hispanic pediatric dialysis patients had a lower likelihood of kidney transplantation than non-Hispanic whites, similar to observations in the adult dialysis population.
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Trasplante de Riñón/mortalidad , Diálisis Renal/estadística & datos numéricos , Adolescente , Negro o Afroamericano , Niño , Preescolar , Estudios de Cohortes , Etnicidad , Femenino , Hispánicos o Latinos , Humanos , Lactante , Recién Nacido , Fallo Renal Crónico/cirugía , Pruebas de Función Renal , Masculino , Grupos Raciales , Estudios Retrospectivos , Factores Socioeconómicos , Resultado del Tratamiento , Estados Unidos/epidemiología , Población Blanca , Adulto JovenRESUMEN
OBJECTIVES: To compare the mortality of elderly adults with end-stage renal disease (ESRD) treated with home hemodialysis (HD) with that of those receiving a kidney transplant (KTx). DESIGN: Prospective cohort. SETTING: Pertinent data for the two groups were obtained from electronic medical records from a large dialysis provider and the U.S. Renal Data System. PARTICIPANTS: Using data from elderly adults (aged ≥65) who started home HD and underwent KTx in the US between 2007 and 2011, a 1:1 propensity score (PS)-matched cohort of 960 elderly adults was created, and the association between treatment modality and all-cause mortality was examined using Cox proportional hazards and competing risk regression survival models using modality failure as a competing event. MEASUREMENTS: Modality of renal replacement therapy. RESULTS: The baseline mean age ± standard deviation of the PS-matched individuals undergoing home HD was 71 ± 6, and that of KTx recipients was 71 ± 5, 69% of both groups were male, 81% of those undergoing home HD and 79% of KTx recipients were white, and 11% and 12%, respectively, were African American. Median follow-up time was 205 days (interquartile range (IQR) 78-364 days) for those undergoing home HD and 795 days (IQR 366-1,221 days) for KTx recipients. There were 97 deaths (20%, 253/1,000 patient-years, 95% confidence interval (CI) = 207-309/1,000 patient-years) in the home HD group and 48 deaths (10%, 45/1,000 patient-years, 95% CI = 34-60/1,000 patient-years) in the KTx group. Elderly adults undergoing home HD had a risk of mortality that was almost five times as high as that of KTx recipients (hazard ratio = 4.74, 95% CI = 3.25-6.91). Similar results were seen in competing risk regression analyses (subhazard ratio = 4.71, 95% CI = 3.27-6.79). Results were consistent across different types of kidney donors and subgroups divided according to various recipient characteristics. CONCLUSION: Elderly adults with ESRD who receive a KTx have greater survival than those who undergo home HD. Further studies are needed to assess whether KTx receipt is associated with other benefits such as better quality of life and lower hospitalization rates.