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Problema de Salud AUGE N°01

Peritoneodiálisis

Juicio del Panel y Evidencia

En personas con enfermedad renal cronica en etapa 5 con obesidad el Ministerio de Salud sugiere no usar peritoneodialisis por sobre hemodiálisis
Comentarios del panel:
►La peritoneodiálisis no esta contraindicada en personas obesas, sin embargo la presencia de comorbilidad y complicaciones podría ser reservada para pacientes que no tienen otra opción de terapia de reemplazo renal.

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

No lo sé: El equipo elaborador de la Guía consideró que no contaba con suficiente información para emitir un juicio respecto a la significancia de los efectos deseables de «usar peritoneodiálisis» en comparación a «usar hemodiálisis».

Evidencia de investigación

Tabla de Resumen de Resultados (Summary of Findings)

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

Pacientes

Personas con enfermedad renal crónica en etapa 5 con obesidad.

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

Desde ensayo aleatorizado

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)

⊕  ◯  ◯    ◯  1.2,3

Muy baja

Diálisis peritoneal comparado con hemodiálisis podría disminuir la mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Desde estudios observacionales

RR 1,12 

(1,06 a 1,17)

2 estudios observacionales

 / 30.297 pacientes [124, 125]

138

 por 1000

154

 por 1000

Diferencia:

 16 más 

(8 a 23 más)

⊕  ◯  ◯    ◯  1,4

Muy baja

Diálisis peritoneal comparado con hemodiálisis podría aumentar la mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Desde comparación indirecta en revisión sistemática de observacionales

En una revisión sistemática [128], se observó que por cada aumento de 1 kg/m2 en el IMC hubo una reducción en el riesgo de mortalidad por todas las causas [HR 0,97 (IC del 95%: 0,96 a 0,98)] en pacientes en hemodiálisis (22 estudios observacionales, n = 89.322), mientras que en

 pacientes en diálisis peritoneal hubo un aumento del riesgo [HR 1.05 (IC del 95%: 0,95–1,17)] (4 estudios observacionales, n=782).

⊕  ◯  ◯    ◯  1,4,5

Muy baja

Diálisis peritoneal comparado con hemodiálisis podría aumentar la mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
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. En el caso de los estudios observacionales, estos no fueron ciegos.
2 Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
3 Se disminuyó un nivel de certeza de evidencia por ser indirecta, ya que la evidencia proviene de una población más amplia (cualquier paciente en elección de modalidad de diálisis) y no solamente obesos/sobrepeso.
4 Diseño observacional.
5 Se disminuyó dos niveles de certeza de evidencia por ser indirecta, ya que la estimación proviene de la asociación entre el valor del índice de masa corporal y la mortalidad total en pacientes con enfermedad renal crónica etapa 5. Además, no se realizó una comparación directa entre diálisis peritoneal y hemodiálisis.
Fecha de elaboración de la tabla: diciembre, 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

No lo sé: El equipo elaborador de la Guía consideró que no contaba con suficiente información para emitir un juicio respecto a la significancia de los efectos indeseables de «usar peritoneodiálisis» en comparación a «usar hemodiálisis».

Consideraciones Adicionales

El panel de expertos clínicos considera que basado en su experiencia el riesgo añadido corresponde a los riesgos inherentes a la técnica.

Evidencia de investigación

Tabla de Resumen de Resultados (Summary of Findings)

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

Pacientes

Personas con enfermedad renal crónica en etapa 5 con obesidad.

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

Desde ensayo aleatorizado

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)

⊕  ◯  ◯    ◯  1.2,3

Muy baja

Diálisis peritoneal comparado con hemodiálisis podría disminuir la mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Desde estudios observacionales

RR 1,12 

(1,06 a 1,17)

2 estudios observacionales

 / 30.297 pacientes [124, 125]

138

 por 1000

154

 por 1000

Diferencia:

 16 más 

(8 a 23 más)

⊕  ◯  ◯    ◯  1,4

Muy baja

Diálisis peritoneal comparado con hemodiálisis podría aumentar la mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Desde comparación indirecta en revisión sistemática de observacionales

En una revisión sistemática [128], se observó que por cada aumento de 1 kg/m2 en el IMC hubo una reducción en el riesgo de mortalidad por todas las causas [HR 0,97 (IC del 95%: 0,96 a 0,98)] en pacientes en hemodiálisis (22 estudios observacionales, n = 89.322), mientras que en

 pacientes en diálisis peritoneal hubo un aumento del riesgo [HR 1.05 (IC del 95%: 0,95–1,17)] (4 estudios observacionales, n=782).

⊕  ◯  ◯    ◯  1,4,5

Muy baja

Diálisis peritoneal comparado con hemodiálisis podría aumentar la mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
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. En el caso de los estudios observacionales, estos no fueron ciegos.
2 Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
3 Se disminuyó un nivel de certeza de evidencia por ser indirecta, ya que la evidencia proviene de una población más amplia (cualquier paciente en elección de modalidad de diálisis) y no solamente obesos/sobrepeso.
4 Diseño observacional.
5 Se disminuyó dos niveles de certeza de evidencia por ser indirecta, ya que la estimación proviene de la asociación entre el valor del índice de masa corporal y la mortalidad total en pacientes con enfermedad renal crónica etapa 5. Además, no se realizó una comparación directa entre diálisis peritoneal y hemodiálisis.
Fecha de elaboración de la tabla: diciembre, 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

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

 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».

Evidencia de investigación

No se identificó evidencia sobre valores y preferencias en población con obesidad con enfermedad renal crónica.

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

No lo sé: El equipo elaborador de la Guía consideró que no contaba con suficiente información para emitir un juicio respecto al balance entre efectos deseables e indeseables.

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

Evidencia de investigación

A continuación se muestran los precios referenciales de las prestaciones sanitarias de realizar peritoneodiálisis en comparación a realizar hemodiálisis, 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

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

referencia

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

Ningún estudio incluido: No se encontraron estudios que respondieran la preguntan de interés.

Comentarios adicionales

El panel de expertos considera que personas obesas con enfermedad renal crónica generarían más costos al Sistema de salud

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

Probablemente reducida: El equipo elaborador de la Guía consideró que la equidad en salud se probablemente 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.

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

Varía: El equipo elaborador de la Guía considera que existen componentes que pueden afectar de distinta manera la aceptación de la intervención “usar peritoneodiálisis» por las partes interesadas (profesionales de la salud, gestores de centros de salud, directivos servicios de salud, pacientes, cuidadores, seguros de salud, otros).

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

Varía: El equipo elaborador de la Guía considera que existen componentes que pueden afectar de distinta manera la factibilidad de implementación de «usar peritoneodiálisis» (la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.).

Consideraciones Adicionales

El panel de expertos considera que hay variabilidad en el RR.HH que maneja la técnica de inserción del catéter a nivel nacional.