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Problema de Salud AUGE N°01

Peritoneodiálisis

Juicio del Panel y Evidencia

En personas adultas mayores con enfermedad renal crónica en etapa 5, el Ministerio de Salud SUGIERE realizar peritoneodialisis por sobre hemodiálisis
Comentarios del panel:
►La decisión varía dependiendo de los valores y preferencias de cada adulto mayor, de la autovalencia y asistencia de la familia o cuidador.

El Panel de Expertos analizó y debatió cada uno de las preguntas de la “Tabla de la evidencia a la decisión”, considerando tanto la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de los pacientes. Una vez consensuada la postura del panel respecto a las preguntas, emitieron un juicio seleccionando la opción de respuesta que mejor representaba la opinión del conjunto (destacada con color). Finalmente cuando el panel emitió su juicio sobre todas las preguntas, se emitió la recomendación.

A continuación se presenta la “Tabla de la evidencia a la decisión” con el resumen de los juicios, la evidencia de investigación evaluada, consideraciones adicionales y comentarios planteados por el panel.

 1.- ¿El problema es una prioridad?
No Probablemente no Probablemente sí Varía No lo sé

El problema ha sido definido como prioritario en el marco de las Garantías Explícitas en Salud (GES), régimen integral de salud que prioriza un grupo de patologías o problemas de salud, garantizando el acceso a tratamiento oportuno y de calidad.

 2.- ¿Qué tan significativos son los efectos deseables anticipados?
Trivial Pequeño Moderado Grande Varía No lo sé

Grandes: El equipo elaborador de la Guía estimó que los efectos deseables de «usar peritoneodiálisis» en comparación a «usar hemodiálisis» son grandes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.

Consideraciones Adicionales

El panel de expertos considera que los adultos mayores presentan mayor tolerancia a la peritoneodiálisis y tienen mejor calidad de vida.

Evidencia de investigación

Tabla de Resumen de Resultados (Summary of Findings)

Diálisis peritoneal comparado con hemodiálisis para enfermedad renal crónica en etapa 5.

Pacientes

Personas adultas mayores con enfermedad renal crónica en etapa 5.

Intervención

Diálisis peritoneal.

Comparación

Hemodiálisis.

Desenlaces

Efecto relativo

(IC 95%)

Estudios/

pacientes

Efecto absoluto estimado*

Certeza de la evidencia

(GRADE)

Mensajes clave en términos sencillos

Hemodiálisis

Diálisis peritoneal

Diferencia

(IC 95%)

Mortalidad

RR 0,50

(0,21 a 1,22)

1 ensayo/ 38 pacientes [9]

500

 por 1000

250

 por 1000

Diferencia: 250 menos

(395 menos a 110 más)

⊕⊕◯◯1.2

Baja

Diálisis peritoneal comparado con hemodiálisis podría disminuir la mortalidad, pero la certeza de la evidencia es baja.

IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
DM: Diferencia de media.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo CON hemodiálisis está basado en el riesgo del grupo control en los estudios. El riesgo CON diálisis peritoneal (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
1 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que no estaba clara la generación de secuencia de aleatorización.
2 Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
Fecha de elaboración de la tabla: Octubre, 2018.

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Búsqueda y Síntesis de Evidencia

 3.- ¿Qué tan significativos son los efectos indeseables anticipados?
Grande Moderado Pequeño Trivial Varía No lo sé

Varía: El equipo elaborador de la Guía consideró que existen componentes que pueden afectar de distinta manera los efectos indeseables de «usar peritoneodiálisis» en comparación a «usar hemodiálisis».

Consideraciones Adicionales

El panel de expertos considera que la peritoneodiálisis requiere autovalencia y asistencia familiar o cuidador.

Evidencia de investigación

Tabla de Resumen de Resultados (Summary of Findings)

Diálisis peritoneal comparado con hemodiálisis para enfermedad renal crónica en etapa 5.

Pacientes

Personas adultas mayores con enfermedad renal crónica en etapa 5.

Intervención

Diálisis peritoneal.

Comparación

Hemodiálisis.

Desenlaces

Efecto relativo

(IC 95%)

Estudios/

pacientes

Efecto absoluto estimado*

Certeza de la evidencia

(GRADE)

Mensajes clave en términos sencillos

Hemodiálisis

Diálisis peritoneal

Diferencia

(IC 95%)

Mortalidad

RR 0,50

(0,21 a 1,22)

1 ensayo/ 38 pacientes [9]

500

 por 1000

250

 por 1000

Diferencia: 250 menos

(395 menos a 110 más)

⊕⊕◯◯1.2

Baja

Diálisis peritoneal comparado con hemodiálisis podría disminuir la mortalidad, pero la certeza de la evidencia es baja.

IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
DM: Diferencia de media.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo CON hemodiálisis está basado en el riesgo del grupo control en los estudios. El riesgo CON diálisis peritoneal (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
1 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que no estaba clara la generación de secuencia de aleatorización.
2 Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
Fecha de elaboración de la tabla: Octubre, 2018.

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Búsqueda y Síntesis de Evidencia

 4.- ¿Cuál es la certeza general de la evidencia sobre efectos?
Muy baja Baja Moderada Alta Ningún estudio incluido

Baja: Existe cierta incertidumbre respecto del efecto de «usar peritoneodiálisis» en comparación a «usar hemodiálisis».

Evidencia de investigación

Desenlaces

Importancia

Certainty of the evidence
(GRADE)

Mortalidad

CRÍTICO

⨁⨁◯◯
BAJA
a,b

a. Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que no estaba clara la generación de secuencia de aleatorización.
b. Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente.

 5.- ¿Hay incertidumbre importante o variabilidad sobre qué tanto valora la gente los desenlaces principales?
Incertidumbre o variabilidad importantes Posiblemente hay incertidumbre o variabilidad importantes Probablemente no hay incertidumbre ni variabilidad importantes No hay variabilidad o incertidumbre importante

Posiblemente hay incertidumbre o variabilidad importantes: En función de la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud, el equipo elaborador de la Guía consideró que posiblemente existe incertidumbre o variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «usar peritoneodiálisis» y «usar hemodiálisis».

Consideraciones Adicionales

El panel de expertos resalta que la decisión debe ser bien informada.

Evidencia de investigación

El objetivo de un estudio fue cuantificar los atributos de la atención de diálisis y las compensaciones que los pacientes consideran al tomar decisiones sobre las modalidades de diálisis.(1)
Se llevó a cabo una encuesta prospectiva para cuantificar preferencias sobre tratamiento de diálisis en 143 pacientes adultos con ERC (en etapa pre diálisis), en quienes se esperaba que requirieran terapia de sustitución renal dentro de los 12 meses siguientes. Se evaluaron aspectos relacionados con flexibilidad de horarios, costos de bolsillo, subvención en servicios de transporte, nivel de apoyo de enfermería, esperanza de vida, tiempo de entrenamiento de diálisis, bienestar en diálisis y programa de diálisis (frecuencia y duración).
Las terapias en el hogar tuvieron significativamente mayor preferencia en los atributos: mayor supervivencia (OR:1,63; IC 95%: 1,25-2,12), mayor flexibilidad de tratamiento (OR: 9,22; IC 95%:2,71-31,3), mayor bienestar (OR:210; IC95%:15-2489) y más apoyo de enfermería (OR:87.3; IC95%:3.8-2014).
Los encuestados prefirieron diálisis domiciliaria frente a asistencia hospitalaria y estaban dispuestos a aceptar gastos de bolsillo adicionales por mes para recibir mayor apoyo de enfermería y por mayor flexibilidad en el tratamiento

Referencia
(1). Walker RC, Morton RL, Palmer SC, Marshall MR, Tong A, Howard K. A Discrete Choice Study of Patient Preferences for Dialysis Modalities. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):100-108.

Búsqueda y Síntesis de Evidencia

 6.- El balance entre efectos deseables e indeseables favorece la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía No lo sé

Favorece la intervención: Considerando que la intervención es «usar peritoneodiálisis» y la comparación es «usar hemodiálisis», el equipo elaborador de la Guía opinó que el balance entre efectos deseables e indeseables claramente favorece «usar peritoneodiálisis».

 7.- ¿Qué tan grandes son los recursos necesarios (costos)?
Costos extensos Costos moderados Costos y ahorros despreciables Ahorros moderados Ahorros extensos Varía No lo sé

Costos y ahorros despreciables: El equipo elaborador de la Guía consideró que los costos y ahorros de «usar peritoneodiálisis» son despreciables si se compara con «usar hemodiálisis», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.

Consideraciones Adicionales

El panel informa que en los niños se ocupa menos volumen de solución y que la diferencia de costos respecto de los adultos es moderada.
En adultos el costo varía según la modalidad de la técnica a utilizar.

Evidencia de investigación

A continuación se muestran los precios referenciales de las prestaciones sanitarias de usar soluciones biocompatibles (soluciones basadas en bicarbonato) y usar soluciones estándar en personas adultas y niños con enfermedad renal crónica en peritoneo diálisis, de modo que el equipo elaborador de la Guía se pudiese pronunciar respecto y no debe ser utilizado para otros fines.

Peritoneodiálisis

Arancel FONASA (MAI)1

Arancel FONASA (MLE)2

Peritoneodiálisis por sesión (incluye insumos)

$30.420

$30.420

Peritoneodiálisis continua en paciente crónico (adulto o niños) (tratamiento mensual)

$912.970

$912.970

Anual: $10.955.640

Referencia:
1. FONASA. Arancel de prestaciones de Salud. Modalidad Institucional 2018.
2. FONASA. Arancel de prestaciones de Salud. Modalidad Libre Elección, 2018.

Hemodiálisis

Arancel FONASA (MAI)1

Arancel FONASA (MLE)2

Mensual

Anual

Hemodiálisis con bicarbonato con insumos (por sesión)

$57.170

$57.170

$743.240*

$8.918.880

*precio disponible para hospitales públicos
Referencia:
1. FONASA. Arancel de prestaciones de Salud. Modalidad Institucional 2018.
2. FONASA. Arancel de prestaciones de Salud. Modalidad Libre Elección, 2018.

Búsqueda y Síntesis de Evidencia

 8.- ¿La costo-efectividad de la intervención beneficia la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía Ningún estudio incluido

Favorece la intervención. Considerando que la intervención es «usar peritoneodiálisis» y la comparación es «usar hemodiálisis», el equipo elaborador de la Guía opinó que claramente la alternativa más costo-efectiva es «usar peritoneodiálisis».

Evidencia de investigación

Se descartan todos los artículos porque su metodología difiere de caso de referencia nacional (considera la perspectiva social) y los pacientes son crónicos y no agudos como solicita la pregunta.

Búsqueda y Síntesis de Evidencia

 9.- ¿Cuál sería el impacto en equidad en salud?
Reducido Probablemente reducido Probablemente ningún impacto Probablemente aumentado Aumentado Varía No lo sé

Reducida: El equipo elaborador de la Guía consideró que la equidad en salud se reduciría si se recomendase «usar peritoneodiálisis», dado que identificó grupos o contextos que actualmente tiene barreras de acceso importantes, ya sea en términos económicos, geográficos u otros.

Consideraciones Adicionales

El panel d expertos considera que existe menor disponibilidad de centros de peritoneodiálisis en comparación con centros de hemodiálisis, principalmente en regiones.

 10.- ¿La intervención es aceptable para las partes interesadas?
No Probablemente no Probablemente sí Varía No lo sé

Probablemente sí: El equipo elaborador de la Guía consideró que «usar peritoneodiálisis» probablemente SÍ es aceptable para las partes interesadas (profesionales de la salud, gestores de centros de salud, directivos de centros de salud, pacientes, cuidadores, seguros de salud, otros).

 11.- ¿Es factible implementar la intervención?
No Probablemente no Probablemente sí Varía No lo sé

Probablemente sí: El equipo elaborador de la Guía consideró que «usar peritoneodiálisis» probablemente SÍ es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.