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BACKGROUND: For chronic kidney disease patients who progress to end-stage renal disease, survival is dependent on renal replacement therapy in the form of kidney transplantation or chronic dialysis. Peritoneal dialysis (PD), which can be performed at home, is both more convenient and less costly than hemodialysis that requires three 4-h visits per week to the dialysis facility and complicated equipment. Remote therapy management (RTM), technologies that collect medical information and transmit it to healthcare providers for patient management, has the potential to improve the outcomes of patients receiving automated peritoneal dialysis (APD) at home. OBJECTIVE: Estimate through a simulation study the potential impact of RTM on APD patients use of healthcare resources and costs in the United States, Germany, and Italy. METHODS: Twelve APD patient profiles were developed to reflect potential clinical scenarios of APD therapy. Two versions of each profile were created to simulate healthcare resource use, one assuming use of RTM and one with no RTM. Eleven APD teams (one nephrologist, one nurse) estimated resources that would be used. RESULTS: Results from U.S., German, and Italian clinicians found that RTM could avoid use of 59, 49, and 16 resources over the 12 profiles, respectively. Estimated reduced utilization across the three countries ranged from one to two hospitalizations, one to four home visits, two to five emergency room visits, and four to eight unplanned clinic visits. Total savings across all scenarios were $23,364 in the United States, $11,477 in Germany, and $7,088 in Italy. CONCLUSION: In a simulated environment, early intervention enabled by RTM reduced healthcare resource utilization and associated costs.
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Serviços de Assistência Domiciliar/organização & administração , Falência Renal Crônica/terapia , Monitorização Ambulatorial/métodos , Diálise Peritoneal/métodos , Telemedicina/métodos , Simulação por Computador , Feminino , Gastos em Saúde/estatística & dados numéricos , Serviços de Assistência Domiciliar/economia , Humanos , Masculino , Monitorização Ambulatorial/economia , Equipe de Assistência ao Paciente/organização & administração , Telemedicina/economia , Adulto JovemRESUMO
BACKGROUND: Patient registries have great potential for providing data that describe disease burden, treatments, and outcomes; which can be used to improve patient care. Many renal registries exist, but a central repository of their scope, quality, and accessibility is lacking. The objective of this study was to identify and assess worldwide renal registries reporting on renal replacement therapy and compile a list of those most suitable for use by a broad range of researchers. METHODS: Renal registries were identified through a systematic literature review and internet research. Inclusion criteria included information on dialysis use (yes/no), patient counts ≥300, and evidence of activity between June 2007 and June 2012. Public availability of information on dialysis modality, outcomes, and patient characteristics as well as accessibility of patient-level data for external research were evaluated. RESULTS: Of 144 identified renal registries, 48 met inclusion criteria, 23 of which were from Europe. Public accessibility to annual reports, publications, or basic data was good for 17 registries and moderate for 22. Patient-level data were available to external researchers either directly or through application and review (which may include usage fees) for 13 of the 48 registries, and were inaccessible or accessibility was unknown for 25. CONCLUSIONS: The lack of available data, particularly in emerging economies, leaves information gaps about health care and outcomes for patients with renal disease. Effective multistakeholder collaborations could help to develop renal registries where they are absent, or enhance data collection and dissemination for currently existing registries to improve patient care.
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Saúde Global , Falência Renal Crônica/epidemiologia , Falência Renal Crônica/terapia , Sistema de Registros , Feminino , Humanos , Falência Renal Crônica/diagnóstico , Masculino , Diálise Peritoneal/métodos , Diálise Peritoneal/estatística & dados numéricos , Prevalência , Diálise Renal/métodos , Diálise Renal/estatística & dados numéricos , Análise de SobrevidaRESUMO
BACKGROUND: There is growing evidence of the benefits of intravenous fluid therapy with balanced crystalloids over 0.9% 'normal' saline. This analysis evaluated the economic impact of increasing usage of a calcium-free balanced crystalloid solution (BAL) in patients with systemic inflammatory response syndrome (SIRS) on an annual hospital budget. METHODS: An Excel®-based economic model was developed to estimate costs associated with increased BAL usage (i.e., use in a greater proportion of patients), from the US hospital perspective, over a 5-year time horizon. Clinical inputs were based on the results of a retrospective Electronic Health Record (EHR) database analysis identifying significantly fewer complications among SIRS patients receiving predominantly BAL versus saline. Complication-associated costs, adjusted to 2015, were obtained from published reports. Scenario analyses examined cost impacts for hospitals of various sizes, with different BAL adoption levels and rates. RESULTS: Base-case scenario analysis (300-bed hospital, 80% occupancy, current and year 5 BAL usage in 5 and 75% of SIRS patients, respectively, exponential year-over-year adoption) showed year 1 hospital savings of US$29,232 and cumulative 5-year savings of US$1.16M. Cumulative 5-year pharmacy savings were US$172,641. Scenario analyses demonstrated increasing cumulative 5-year savings with increasing hospital size, year 5 BAL usage in greater proportions of patients, and rapid/early BAL adoption. CONCLUSIONS: Increased BAL usage represents an opportunity for hospitals and pharmacy departments to reduce complication-related costs associated with managing SIRS patients. The model suggests that savings could be expected across a range of scenarios, likely benefiting hospitals of various sizes and with different adoption capabilities.
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Background: Patients developing acute kidney injury (AKI) during critical illness or major surgery are at risk for renal sequelae such as costly and invasive acute renal replacement therapy (RRT) and chronic dialysis (CD). Rates of renal injury may be reduced with use of chloride-restrictive intravenous (IV) resuscitation fluids instead of chloride-liberal fluids. Objectives: To compare the cost-effectiveness of chloride-restrictive versus chloride-liberal crystalloid fluids used during fluid resuscitation or for the maintenance of hydration among patients hospitalized in the US for critical illnesses or major surgery. Methods: Clinical outcomes and costs for a simulated patient cohort (starting age 60 years) receiving either chloride-restrictive or chloride-liberal crystalloids were estimated using a decision tree for the first 90-day period after IV fluid initiation followed by a Markov model over the remainder of the cohort lifespan. Outcomes modeled in the decision tree were AKI development, recovery from AKI, progression to acute RRT, progression to CD, and death. Health states included in the Markov model were dialysis free without prior AKI, dialysis-free following AKI, CD, and death. Estimates of clinical parameters were taken from a recent meta-analysis, other published studies, and the US Renal Data System. Direct healthcare costs (in 2015 USD) were included for IV fluids, RRT, and CD. US-normalized health-state utilities were used to calculate quality-adjusted life years (QALYs). Results: In the cohort of 100 patients, AKI was predicted to develop in the first 90 days in 36 patients receiving chloride-liberal crystalloids versus 22 receiving chloride-restrictive crystalloids. Higher costs of chloride-restrictive crystalloids were offset by savings from avoided renal adverse events. Chloride-liberal crystalloids were dominant over chloride-restrictive crystalloids, gaining 93.5 life-years and 81.4 QALYs while saving $298 576 over the cohort lifespan. One-way sensitivity analyses indicated results were most sensitive to the relative risk for AKI development and relatively insensitive to fluid cost. In probabilistic sensitivity analyses with 1000 iterations, chloride-restrictive crystalloids were dominant in 94.7% of iterations, with incremental cost-effectiveness ratios below $50 000/QALY in 99.6%. Conclusions: This analysis predicts improved patient survival and fewer renal complications with chloriderestrictive IV fluids, yielding net savings versus chloride-liberal fluids. Results require confirmation in adequately powered head-to-head randomized trials.
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Differences in dialyzer design may have consequences for patient outcomes. We evaluated the comparative effectiveness of commonly used dialyzers with respect to measures of dialysis treatment, anemia management, inflammation, and dialyzer clotting. Patients receiving hemodialysis between January 1, 2009, and December 31, 2013, and using polyarylethersulfone-polyvinylpyrrolidone (PAS-PVP; Polyflux Revaclear) or polysulfone (PS; Optiflux 160 or Optiflux 180) dialyzers were followed for 1 year or until end of study or censoring for dialyzer switch, modality change, or loss to follow-up. For each comparison, eligible patients were propensity score-matched 1:1 on a range of baseline characteristics. Outcomes were assessed using generalized linear mixed models. Dialysis adequacy was similar in both dialyzer groups. Erythropoiesis-stimulating agent (ESA) doses were lower for patients using PAS-PVP versus patients using PS-160 (difference range: 75-589 units/treatment; statistically significant in months 1-5 and 7) and for patients using PAS-PVP versus patients using PS-180 (difference range: 27-591 unit/treatment; statistically significant in months 1-9). Intravenous iron doses trended lower for patients using PAS-PVP versus patients using PS, but hemoglobin concentrations were equivalent. In conclusion, use of PAS-PVP versus PS dialyzers was associated with equivalent dialysis adequacy, lower ESA doses, modestly lower Intravenous iron doses, and equivalent hemoglobin concentrations.
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Diálise Renal/instrumentação , Idoso , Feminino , Humanos , Estudos Longitudinais , Masculino , Membranas Artificiais , Pessoa de Meia-Idade , Polímeros , Povidona , Pontuação de Propensão , Diálise Renal/efeitos adversos , SulfonasRESUMO
BACKGROUND: Remote monitoring (RM) is defined as the surveillance of device-transmitted outpatient data. RM is expected to enable better management of chronic diseases. The objective of this research was to identify public policies concerning RM in four European countries. METHODS: Searches of the medical literature, the Internet, and Ministry of Health websites for the United Kingdom (UK), Germany, Italy, and Spain were performed in order to identify RM policies for chronic diseases, including end stage renal disease (ESRD), chronic pulmonary obstructive disease (COPD), diabetes, heart failure, and hypertension. Searches were first performed in Q1 2014 and updated in Q4 2015. In addition, in depth interviews were conducted with payers/policymakers in each country. Information was obtained on existing policies, disease areas and RM services covered and level of reimbursement, other incentives such as quality indicators, past/current assessments of RM technologies, diseases perceived to benefit most from RM, and concerns about RM. RESULTS: Policies on RM and/or telemedicine were identified in all four countries. Pilot projects (mostly in diabetes, COPD, and/or heart failure) existed or were planned in most countries. Perceived value of RM was moderate to high, with the highest rating given for heart failure. Interviewees expressed concerns about sharing of medical information, and the need for capital investment. Patients recently discharged from hospital, and patients living remotely, or with serious and/or complicated diseases, were believed to be the most likely to benefit from RM. Formal reimbursement is scarce, but more commonly available for patients with heart failure. CONCLUSIONS: In the four European countries surveyed, RM has attracted considerable interest for its potential to increase the efficiency of healthcare for chronic diseases. Although rare at this moment, incentives to use RM technology are likely to increase in the near future as the body of evidence of clinical and/or economic benefit grows.
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Política de Saúde , Monitorização Fisiológica/métodos , Consulta Remota/métodos , Telemedicina/métodos , Doença Crônica , Diabetes Mellitus/diagnóstico , Alemanha , Insuficiência Cardíaca/diagnóstico , Humanos , Hipertensão/diagnóstico , Itália , Falência Renal Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Espanha , Reino UnidoRESUMO
PURPOSE: To compare in a phase III study the safety and efficacy of fludarabine to that of cyclophosphamide, vincristine, and prednisone (CVP) in recurrent, low-grade, non-Hodgkin's lymphoma after previous response to systemic treatment. PATIENTS AND METHODS: Patients were randomized to fludarabine (25 mg/m(2) intravenously on days 1 to 5, every 28 days) or CVP (cyclophosphamide 750 mg/m(2) and vincristine 1.2 mg/m(2) both intravenously on day 1 and prednisone 40 mg/m(2) orally on days 1 to 5, every 21 days). The primary outcome assessed was progression-free survival (PFS); secondary outcomes included treatment-free survival (TFS), overall survival (OS), treatment-related toxicity, and quality of life (QoL) according to the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C-30 version 1.0 instrument. RESULTS: Ninety-one patients were randomized, 47 to fludarabine and 44 to CVP. There was no difference in response rates, with 64% (complete response [CR], 9%) for fludarabine versus 52% (CR, 7%) for CVP (P =.72). With a median follow-up of 42 months, median PFS (11 months v 9.1 months; P =.03) and TFS (15 months v 11 months; P =.02) were superior in patients receiving fludarabine. No difference in median overall survival was detected (57 months for fludarabine v 44 months for CVP; P =.95). Three patients receiving fludarabine died of treatment-related toxicity compared with none of the patients receiving CVP. Peripheral neuropathy and alopecia were more common with CVP. Patients receiving fludarabine had higher scores for social function (P =.008); no other differences in QoL were detected. CONCLUSION: In recurrent low-grade lymphoma, fludarabine improves PFS, TFS, and social function scores in comparison with CVP but does not improve OS.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Ciclofosfamida/uso terapêutico , Linfoma não Hodgkin/tratamento farmacológico , Prednisona/uso terapêutico , Vidarabina/análogos & derivados , Vidarabina/uso terapêutico , Vincristina/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prednisona/administração & dosagem , Prednisona/efeitos adversos , Qualidade de Vida , Taxa de Sobrevida , Resultado do Tratamento , Vidarabina/administração & dosagem , Vidarabina/efeitos adversos , Vincristina/administração & dosagem , Vincristina/efeitos adversosRESUMO
BACKGROUND: With the Dutch population aging, the number of individuals 75 years old or more needing dialysis is growing. This analysis assessed the cost-effectiveness of adding nurse-assisted peritoneal dialysis (aPD) to the usual care pathway in frail Dutch end-stage renal disease (ESRD) patients. METHODS: THE CURRENT DUTCH TREATMENT PATHWAY (CONSERVATIVE MANAGEMENT, CM: 40% and PD in nursing home, nhPD: 60%) was compared in a decision-tree model with a new approach where the proportion of patients on dialysis would increase to 80% (i.e. CM: 20%; nhPD: 20%; and aPD: 60%). In-center hemodialysis was added in a secondary analysis. Inputs included survival (from literature), utility (from literature), and costs (2009 official tariffs). A healthcare payer's perspective was used with a 5-year horizon. RESULTS: The new approach was almost cost neutral in the primary analysis (despite more patients on dialysis) and dominant (more effective and less expensive) in the secondary analysis. The incremental cost-effectiveness ratio was only 52/QALY. In the sensitivity analyses (primary and secondary analyses), the new approach was either dominant or cost-effective in approximately 75% of the simulations. CONCLUSIONS: Despite the investment required, offering aPD to frail elderly ESRD patients is a cost-effective alternative to the current pathway for Dutch healthcare payers.