Transitions in an integrated model of renal replacement therapy in a regional health system.

INTRODUCTION AND OBJECTIVES: The choice of renal replacement therapy (RRT) is an important decision that determines the quality of life and survival. Most patients change from one RRT modality to another to adapt RRT to clinical and psychosocial needs. This has been called «integrated model of RRT¼ that implies new questions about the best sequence of techniques. MATERIAL AND METHODS: The study describes the impact of transitions between RRT modalities on survival using the Madrid Registry of Renal Patients (2008-2018). This study used the proportional hazards models and competitive risk models to perform an intention-to-treat (ITT), according to their 1st RRT modality and as-treated (AT) analysis, that consider also their 1st transition. RESULTS: A total of 8971 patients started RRT during this period in Madrid (6.6 Million population): 7207 (80.3%) on hemodialysis (HD), 1401 (15.6%) on peritoneal dialysis (PD) and 363 (4.2%) received a pre-emptive kidney transplantation (KT). Incident HD-patients were older (HD group 65.3 years (SD 15.3) vs PD group 58.1 years (SD 14.8) vs KTX group 52 years (SD 17.2); p < 0.001) and had more comorbidities. They presented higher mortality (HD group 40.9% vs PD group 22.8% vs KTX group 8.3%, p < 0.001) and less access to a transplant (HD group 30.4% vs PD group 51.6%; p < 0.001). Transitions between dialysis techniques define different groups of patients with different clinical outcomes. Those who change from HD to PD do it earlier (HD â†’ PD: 0.7 years (SD 1.1) vs PD â†’ HD: 1.5 years (SD 1.4) p < 0.001), are younger (HD â†’ PD: 53.5 years (SD 16.7) vs PD â†’ HD: 61.6 years (SD 14.6); p < 0.001), presented less mortality (HD â†’ PD: 24.5% vs PD â†’ HD: 32.0%; p < 0.001) and higher access to a transplant (HD â†’ PD: 49.4% vs PD â†’ HD: 31.7%; p < 0.001). Survival analysis by competitive risks is essential for integrated RRT models, especially in groups such as PD patients, where 51.6% of the patients were considered as lost follow-up (received a KTX after during the first 2.5 years on PD). In this analysis, survival of patients who change from one technique to another, is more similar to the destination modality than the origin one. CONCLUSION: Our data suggest that transitions between RRT-techniques describes different patients, who associate different risks, and could be analyzed in an integrated manner to define improvement actions. This approach should be incorporated into the analysis and reports of renal registries.

The hidden diabetic kidney disease in a university hospital-based population: a real-world data analysis.

Background: Correct identification of diabetic kidney disease (DKD) in type 2 diabetes mellitus (T2DM) patients is crucial to implement therapeutic interventions that may prevent disease progression. Methods: We compared the real prevalence of DKD in T2DM patients according to actual serum and urine laboratory data with the presence of the diagnostic terms DKD and/or CKD on the electronic medical records (EMRs) using a natural language processing tool (SAVANA Manager). All patients ˃18 years of age and diagnosed with T2DM were selected. DKD was defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 or a urinary albumin:creatinine ratio (UACR) >30 mg/g or a urinary protein:creatinine ratio (UPCR) >0.3 g/g after excluding acute kidney injury. Results: A total of 15 304 T2DM patients identified on EMRs were eligible to enter the study. A total of 4526 (29.6%) T2DM patients had DKD according to lab criteria. However, the terms CKD or DKD were only present in 33.1% and 7.5%, representing a hidden prevalence of CKD and DKD of 66.9% and 92.5%, respectively. Less severe kidney disease (lower UACR or UPCR, higher eGFR values), female sex and lack of insulin prescription were associated with the absence of DKD or CKD terms in the EMRs (P < .001). Conclusions: The prevalence of DKD among T2DM patients defined by lab data is significantly higher than that reported on hospital EMRs. This could imply underdiagnosis of DKD, especially in patients with the least severe disease who may benefit the most from optimized therapy.

Análisis de las transiciones en el modelo integrado de tratamiento sustitutivo renal en un sistema regional de salud / Transitions in an integrated model of renal replacement therapy in a regional health system

Introducción y objetivos : La elección del tratamiento sustitutivo renal (TSR) es una decisión importante que determina la calidad de vida y la supervivencia. La mayoría de los pacientes cambiará de una modalidad de TSR a otra para adaptarla a sus necesidades dentro de lo que se conoce como modelo de TSR integrado. En estas circunstancias surgen nuevas preguntas sobre la mejor secuencia de técnicas o las consecuencias de las transiciones.Material y métodosDescribimos las transiciones entre técnicas de TSR y su impacto en la supervivencia a partir del Registro Madrileño de Enfermos Renales (REMER), durante un periodo de 11 años. Se utilizaron los modelos de riesgos proporcionales y de riesgos competitivos para realizar un análisis por intención de tratar (ITT) según su 1.er tratamiento y como tratado (AT) considerando la 1.ª transición.ResultadosUn total de 8.971 pacientes iniciaron su primer TSR durante este periodo en Madrid (6,6 millones habitantes): 7.207 (80,3%) en hemodiálisis (HD), 1.401 (15,6%) en diálisis peritoneal (DP) y 363 (4,1%) recibieron un trasplante renal anticipado (TXR). En el análisis ITT, los pacientes incidentes en HD eran mayores (HD 65,3 años (DE 15,3) vs. DP 58,1 años [DE 14,8] vs. TXR 52,0 años (DE 17,2); p<0,001) y tenían más comorbilidades. Presentaron mayor mortalidad (HD 40,9% vs. DP 22,8% vs. TXR 8,3%, p<0,001) y menor acceso a trasplante (HD 30,4% vs. DP 51,6%; p<0,001). Las transiciones entre las técnicas de diálisis identifican diferentes fenotipos de pacientes con diferentes resultados clínicos en el análisis AT. Los pacientes que cambiaban de HD a DP lo hacían más precozmente (HD→DP: 0,7 años (DE 1,1) vs. DP→HD: 1,5 años [(DE 1,4); p<0,001), eran más jóvenes (HD→DP: 53,5 años (DE 16,7) vs. DP→HD: 61,6 años, (DE 14,6) p<0,001), sufrían menor mortalidad (HD→DP: 24,5% vs. DP→HD: 32%, p<0,001) y tenían mayor acceso al TXR (HD→DP: 49,4% vs. DP→HD: 31,7%, p<0,001). ... (AU)

Introduction and objectives : The choice of renal replacement therapy (RRT) is an important decision that determines the quality of life and survival. Most patients change from one RRT modality to another to adapt RRT to clinical and psychosocial needs. This has been called «integrated model of RRT» that implies new questions about the best sequence of techniques.Material and methodsThe study describes the impact of transitions between RRT modalities on survival using the Madrid Registry of Renal Patients (2008–2018). This study used the proportional hazards models and competitive risk models to perform an intention-to-treat (ITT), according to their 1st RRT modality and as-treated (AT) analysis, that consider also their 1st transition.ResultsA total of 8971 patients started RRT during this period in Madrid (6.6 Million population): 7207 (80.3%) on hemodialysis (HD), 1401 (15.6%) on peritoneal dialysis (PD) and 363 (4.2%) received a pre-emptive kidney transplantation (KTX). Incident HD-patients were older (HD group 65.3 years (SD 15.3) vs PD group 58.1 years (SD 14.8) vs KTX group 52 years (SD 17.2); p<0.001) and had more comorbidities. They presented higher mortality (HD group 40.9% vs PD group 22.8% vs 8.3% KTX group, p<0.001) and less access to a transplant (HD group 30.4% vs DP group 51.6%; p<0.001). Transitions between dialysis techniques define different groups of patients with different clinical outcomes. Those who change from HD to PD do it earlier (HD→PD: 0.7 years (SD 1.1) vs PD→HD: 1.5 years (SD 1.4) p<0.001), are younger (HD→PD: 53.5 years (SD 16.7) vs PD→HD: 61.6 years (SD 14.6); p<0.001), presented less mortality (HD→PD: 24.5% vs PD→HD: 32.0%; p<0.001) and higher access to a transplant (HD→PD: 49.4% vs PD→HD: 31.7%; p<0.001). ... (AU)

Transitions in an integrated model of renal replacement therapy in a regional health system. / Análisis de las transiciones en el modelo integrado de tratamiento sustitutivo renal en un sistema regional de salud.

INTRODUCTION AND OBJECTIVES: The choice of renal replacement therapy (RRT) is an important decision that determines the quality of life and survival. Most patients change from one RRT modality to another to adapt RRT to clinical and psychosocial needs. This has been called «integrated model of RRT¼ that implies new questions about the best sequence of techniques. MATERIAL AND METHODS: The study describes the impact of transitions between RRT modalities on survival using the Madrid Registry of Renal Patients (2008-2018). This study used the proportional hazards models and competitive risk models to perform an intention-to-treat (ITT), according to their 1st RRT modality and as-treated (AT) analysis, that consider also their 1st transition. RESULTS: A total of 8971 patients started RRT during this period in Madrid (6.6 Million population): 7207 (80.3%) on hemodialysis (HD), 1401 (15.6%) on peritoneal dialysis (PD) and 363 (4.2%) received a pre-emptive kidney transplantation (KTX). Incident HD-patients were older (HD group 65.3 years (SD 15.3) vs PD group 58.1 years (SD 14.8) vs KTX group 52 years (SD 17.2); p<0.001) and had more comorbidities. They presented higher mortality (HD group 40.9% vs PD group 22.8% vs 8.3% KTX group, p<0.001) and less access to a transplant (HD group 30.4% vs DP group 51.6%; p<0.001). Transitions between dialysis techniques define different groups of patients with different clinical outcomes. Those who change from HD to PD do it earlier (HD→PD: 0.7 years (SD 1.1) vs PD→HD: 1.5 years (SD 1.4) p<0.001), are younger (HD→PD: 53.5 years (SD 16.7) vs PD→HD: 61.6 years (SD 14.6); p<0.001), presented less mortality (HD→PD: 24.5% vs PD→HD: 32.0%; p<0.001) and higher access to a transplant (HD→PD: 49.4% vs PD→HD: 31.7%; p<0.001). Survival analysis by competitive risks is essential for integrated RRT models, especially in groups such as PD patients, where 51.6% of the patients were considered as lost follow-up (received a KTX after during the first 2.5 years on PD). In this analysis, survival of patients who change from one technique to another, is more similar to the destination modality than the origin one. CONCLUSION: Our data suggest that transitions between RRT-techniques describes different patients, who associate different risks, and could be analyzed in an integrated manner to define improvement actions. This approach should be incorporated into the analysis and reports of renal registries.

Impacto del primer año de tratamiento sustitutivo renal en la hospitalización de una comunidad autónoma / Impact of first year renal replacement therapy on the hospital admissions of a regional public health system

INTRODUCCIÓN Y OBJETIVOS: La enfermedad renal crónica tiene una alta prevalencia y coste, así como un mayor riesgo de ingreso. Disponemos de registros públicos y obligatorios, pero no hay referencias recientes para estimar el impacto que el tratamiento sustitutivo renal (TSR) tiene en la actividad hospitalaria. MÉTODOS: Tras las autorizaciones pertinentes, hemos integrado las bases de datos REMER (2013-2014) y CMBDH (2013-2015) para analizar la actividad hospitalaria durante el primer año de TSR. RESULTADOS: Un total de 767 pacientes iniciaron TSR en los 7 hospitales de tercer nivel de la Comunidad de Madrid. Más de una tercera parte lo hicieron de forma no programada durante un ingreso. Este inicio es más frecuente en HD que en DP, pero existen diferencias clínicas relevantes en edad y en comorbilidad. Descartando este primer episodio, casi el 60% de pacientes ingresan durante el primer año. La tasa de ingreso es de 1,2 ingresos/paciente, más alta en HD que en TX y DP; la estancia media es de 8,6días. El coste agregado de los ingresos del primer año es de 12.006 €/paciente. Nuestro análisis asegura la inclusión exhaustiva de todos los episodios y la estimación precisa de costes. CONCLUSIONES: El impacto del TSR en la actividad hospitalaria ha sido infraestimado y es una parte importante del coste global del TSR. Los resultados de la literatura internacional no pueden extrapolarse a nuestro país por las diferencias en el modelo sanitario y perfil de paciente. La integración de bases de datos clínicas es técnicamente viable y podría abrir una vía inmensa de información que solo requiere apoyo institucional para su desarrollo

INTRODUCTION AND OBJECTIVES: Chronic kidney disease has a high prevalence and economic impact, and an increased risk of hospitalization. Although there are public regional and country registries, we have not found references to estimate the impact of renal replacement therapy (RRT) on hospital admissions. METHODS: We obtained authorization from the ethics committee and health authorities to integrate the REMER [Madrid Kidney Disease Registry] (2013-2014) and Minimum Basic Data Set (2013-2015) databases and to analyze the admissions during the first year of RRT. RESULTS: 767 patients started RRT in all the hospitals of our region across all RRT modalities. More than a third of the patients start dialysis during a hospital admission. This unplanned start, more common in HD than PD, shows relevant differences in patient profile or admission characteristics. Without considering this initial episode, almost 60% of patients were admitted during their first year. The hospitalization rate was 1.2 admissions/patient, higher in HD than in TX or PD; the mean length of stay was 8.6 days. The estimated cost of admissions during the first year is €12,006/patient. Our analysis ensures the exhaustive inclusion of all episodes and accurate estimation based on the discharge form. CONCLUSION: The impact of RRT on hospitals has been underestimated and is very relevant when calculating the total cost of RRT. Results from other countries cannot be extrapolated due to differences in the health system and patient profile. The integration of clinical databases could open up an opportunity that needs only institutional support for its development

Impact of first year renal replacement therapy on the hospital admissions of a regional public health system. / Impacto del primer año de tratamiento sustitutivo renal en la hospitalización de una comunidad autónoma.

INTRODUCTION AND OBJECTIVES: Chronic kidney disease has a high prevalence and economic impact, and an increased risk of hospitalization. Although there are public regional and country registries, we have not found references to estimate the impact of renal replacement therapy (RRT) on hospital admissions. METHODS: We obtained authorization from the ethics committee and health authorities to integrate the REMER [Madrid Kidney Disease Registry] (2013-2014) and Minimum Basic Data Set (2013-2015) databases and to analyze the admissions during the first year of RRT. RESULTS: 767 patients started RRT in all the hospitals of our region across all RRT modalities. More than a third of the patients start dialysis during a hospital admission. This unplanned start, more common in HD than PD, shows relevant differences in patient profile or admission characteristics. Without considering this initial episode, almost 60% of patients were admitted during their first year. The hospitalization rate was 1.2admissions/patient, higher in HD than in TX or PD; the mean length of stay was 8.6days. The estimated cost of admissions during the first year is €12,006/patient. Our analysis ensures the exhaustive inclusion of all episodes and accurate estimation based on the discharge form. CONCLUSION: The impact of RRT on hospitals has been underestimated and is very relevant when calculating the total cost of RRT. Results from other countries cannot be extrapolated due to differences in the health system and patient profile. The integration of clinical databases could open up an opportunity that needs only institutional support for its development.

Cómo debemos analizar y describir la mortalidad de nuestros pacientes: experiencia del Grupo Centro Diálisis Peritoneal / How should we analyze and present mortality in our patients?: A multicentre GCDP experience

Introducción: Existen distintas estrategias para analizar la mortalidad en diálisis peritoneal (DP), con diferentes definiciones de caso, evento, tiempo en riesgo y análisis estadístico. Un método común entre los distintos registros permitiría compararlos adecuadamente y entender mejor las diferencias reales de mortalidad de nuestros pacientes. Métodos: Revisamos y describimos las estrategias de análisis de los registros autonómicos, nacional e internacionales. Incluimos análisis de supervivencia actuarial, Kaplan-Meier (KM) y riesgos-competitivos (RC). Aplicamos los diferentes enfoques a la misma base de datos (GCDP), lo que permite mostrar las diferencias aparentes con cada método. Resultados: Se incluyeron 1.890 pacientes incidentes en DP en el periodo 2003-2013 (55 años; 64,2% varones), con FRR inicial de 7ml/min; el 25% presentaba diabetes y un índice de Charlson de 3 [2-4]. Fallecieron 261 pacientes, 380 pasaron a hemodiálisis (HD) y 682 recibieron trasplante. Las tasas de mortalidad anual llegan a variar hasta un 20% en números relativos (6,4 vs. 5,2%) según el sistema aplicado. La estimación de probabilidad de mortalidad por RC es inferior a KM en todos los años: 3,6 vs. 4,0% el 1.er año; 9,0 vs. 11,9%; 15,6 vs. 28,3% y 18,5 vs. 43,3% los siguientes. Conclusiones: Aunque cada método pueda ser correcto en sí mismo y expresar diferentes enfoques, la impresión final que queda en el lector es un número que sobrestima la mortalidad. El modelo de RC expresa mejor la realidad en DP, donde el número de pacientes que pierden seguimiento (trasplante, paso a HD) cuadruplica al de los fallecidos y solo una cuarta parte continúa en DP al final del seguimiento (AU)

Introduction: There are different strategies to analyse mortality in peritoneal dialysis (PD) with different definitions for case, event, time at risk, and statistical tests. A common method for the different registries would enable proper comparison to better understand the actual differences in mortality of our patients. Methods: We review and describe the analysis strategies of regional, national and international registries. We include actuarial survival, Kaplan-Meier (KM) and competitive risk (CR) analyses. We apply different approaches to the same database (GCDP), which show apparent differences with each method. Results: A total of 1,890 incident patients in PD from 2003-2013 were included (55 years; men 64.2%), with initial RRF of 7 ml/min; 25% had diabetes and a Charlson index of 3 [2-4]; 261 patients died, 380 changed to haemodialysis (HD) and 682 received a transplant. Annual mortality rates varied up to 20% in relative numbers (6.4 vs. 5.2%) depending on the system applied. The estimated probability of mortality measured by CR progressively differs from the KM over the years: 3.6 vs. 4.0% the first year, then 9.0 vs. 11.9%, 15.6 vs. 28.3%, and 18.5 vs. 43.3% the following years. Conclusions: Although each method may be correct in themselves and express different approaches, the final impression left on the reader is a number that under/overestimates mortality. The CR model better expresses the reality of PD, where the number of patients lost to follow-up (transplant, transfer to HD) it is 4 times more than deceased patients and only a quarter remain on PD at the end of follow up (AU)

How should we analyze and present mortality in our patients?: A multicentre GCDP experience.

INTRODUCTION: There are different strategies to analyse mortality in peritoneal dialysis (PD) with different definitions for case, event, time at risk, and statistical tests. A common method for the different registries would enable proper comparison to better understand the actual differences in mortality of our patients. METHODS: We review and describe the analysis strategies of regional, national and international registries. We include actuarial survival, Kaplan-Meier (KM) and competitive risk (CR) analyses. We apply different approaches to the same database (GCDP), which show apparent differences with each method. RESULTS: A total of 1,890 incident patients in PD from 2003-2013 were included (55 years; men 64.2%), with initial RRF of 7ml/min; 25% had diabetes and a Charlson index of 3 [2-4]; 261 patients died, 380 changed to haemodialysis (HD) and 682 received a transplant. Annual mortality rates varied up to 20% in relative numbers (6.4 vs. 5.2%) depending on the system applied. The estimated probability of mortality measured by CR progressively differs from the KM over the years: 3.6 vs. 4.0% the first year, then 9.0 vs. 11.9%, 15.6 vs. 28.3%, and 18.5 vs. 43.3% the following years. CONCLUSIONS: Although each method may be correct in themselves and express different approaches, the final impression left on the reader is a number that under/overestimates mortality. The CR model better expresses the reality of PD, where the number of patients lost to follow-up (transplant, transfer to HD) it is 4 times more than deceased patients and only a quarter remain on PD at the end of follow up.

Cinacalcet treatment for secondary hyperparathyroidism in dialysis patients: an observational study in routine clinical practice.

BACKGROUND: Cinacalcet reduces intact parathyroid hormone (iPTH), Ca and P serum levels in patients with secondary hyperparathyroidism (SHPT). METHODS: This Spanish, multicenter, observational, retrospective study collected data from SHPT dialysis patients 12 weeks before and up to 72 weeks after starting cinacalcet in clinical practice. RESULTS: Data from 428 patients with uncontrolled SHPT despite receiving standard of care (29% with baseline iPTH 501-800 pg/ml; 51% with >800 pg/ml) were collected. Percentages of patients within National Kidney Foundation Kidney Disease Outcomes Quality Initiative targets at baseline and 72 weeks were: iPTH, 0 versus 32.5% (p < 0.05); Ca, 40.1 versus 50% (p < 0.05); P, 47.7 versus 53.8% (p = 0.162). Vitamin D sterol use decreased from 53.3% at baseline to 36.7% at 72 weeks (p < 0.05). The mean ± SD cinacalcet dose at 72 weeks was 44.0 ± 25.8, 51.7 ± 31.3 and 57.1 ± 37.0 mg for patients with baseline iPTH 301-500, 501-800 or >800 pg/ml, respectively. The main adverse reactions were nausea (5.4%), dyspepsia (5.1%) and vomiting (3.7%). CONCLUSIONS: The introduction of cinacalcet improved the routine clinical management of SHPT in a large cohort of Spanish dialysis patients. Cinacalcet is effective and well tolerated regardless of disease severity, and maintains its efficacy over 72 weeks.

Comorbidity and mortality in peritoneal dialysis: a comparative study of type 1 and 2 diabetes versus nondiabetic patients. Peritoneal dialysis and diabetes.

We conducted a retrospective study with 750 peritoneal dialysis (PD) patients in a Spanish multicenter registry between 1993 and 1999 to analyze comorbidity and mortality in type 1 diabetes (T1D), type 2 diabetes (T2D) and nondiabetic (ND) patients. 163 patients (21.7%) were diabetic--96 T1D (58.8%) and 67 T2D (42.2%)--while 587 were not (78.3%). Different comorbidity factors such as the presence of cardiovascular disease, age over 70 and dyslipidemia at the start of PD were analyzed as well as the incidence of peritonitis, the peritonitis-free interval, need for hospitalization, mortality rate, early mortality rate, survival curves (log rank) and the impact factor (Cox) on mortality for the different variables. The comorbidity index (number of comorbidity factors when starting the treatment) and the peritonitis incidence were higher for T2D. Hospitalization rates were similar, but mortality rates were higher for T2D and early mortality rates (death during the 1st year of treatment) were higher for T1D. The actuarial survival curves showed a higher mortality for T2D with no differences between ND and T1D after adjustment for age. The mortality odds ratio was 1.78 for T2D and 1.13 for T1D, differences which were not significant after adding age over 70 and cardiovascular disease to the variables analyzed. Our results show that associated comorbidity is the most important difference between ND, T1D and T2D. While cardiovascular comorbidity is responsible for the higher percentage of early mortality found in T1D when compared to ND, both age and cardiovascular disease are responsible for the higher comorbidity and mortality found in T2D.