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Guía de Práctica Clínica - Problema de Salud AUGE N°70

Cáncer Colorectal en personas de 15 años y más

Recomendación – Dg2 / Juicio del Panel y Evidencia

Dg.2.En personas con diagnóstico de cáncer de recto medio e inferior en proceso de etapificación local, el Ministerio de Salud SUGIERE realizar resonancia magnética pelvis por sobre tomografía computarizada de pelvis.
Comentarios del Panel de Expertos:
►En comparación con a la tomografía computarizada de pelvis, la resonancia magnética de pelvis en el proceso de etapificación local de cáncer de recto medio e inferior, permite una mejor planificación del tratamiento en cuanto a su secuencia y modalidades.

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 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 precisa es este test?
Muy imprecisa Imprecisa Precisa Muy precisa Varía No lo sé

Muy precisa: La prueba es capaz de diferenciar en forma confiable quienes padecen y no padecen la enfermedad o condición. La resonancia magnética es más precisa que la tomografía computarizada para evaluar el compromiso transmural, del meso recto y de los ganglios regionales

Evidencia de investigación

Resonancia magnética de pelvis comparado con tomografía computarizada de pelvis para etapificación de cáncer de recto medio e inferior.

 

Pacientes

Personas con diagnóstico de cáncer de recto medio e inferior en proceso de etapificación local.

 

Test

Resonancia magnética de pelvis.

 

Comparación

Tomografía computarizada de pelvis (ver nota en sección “estimación del efecto”)

 

Impacto diagnóstico

  

Desenlaces

Efecto

  

Morbilidad o mortalidad

No se identificaron estudios evaluando el impacto, por lo que el desenlace se estimó este en base a la exactitud diagnóstica del test, y de las consecuencias esperadas a partir de cada resultado.

  

Exactitud diagnóstica

  

Gold standard

Cirugía, biopsia y seguimiento clínico.

  

Desenlaces

Efecto por 1000 pacientes testeados

(IC 95%)

Prevalencia hipotética %*

Certeza de la evidencia

(GRADE)

Mensajes clave en términos sencillos

  
 

Resonancia magnética de pelvis.

Tomografía computarizada de pelvis.

  

Sensibilidad: 92% (IC 95% de 71 a 99%)

Especificidad: 72% (IC 95% de 37 a 91%)

LR (+): 3,29 (IC 95% de 2,13 a  5,06)

LR (-): 0,11 (IC 95% de 0,05 a 0,26)

Sensibilidad: 89% (IC 95% de 49 a 99%)

Especificidad: 75% (IC 95% de 54 a 86%)

LR (+): 3,56 (IC 95% de 2,23 a  5,68)

LR (-): 0,15 (IC 95% de 0,07 a 0,30)

  

121 pacientes (3 estudios [13, 86, 87])

Población hipotética de 1000 personas con 550 enfermos con compromiso transmural y 550 localizado.

  

Pacientes con compromiso transmural

(verdaderos positivos)

Resonancia

Al utilizar resonancia comparado con tomografía probablemente se diagnostican correctamente con compromiso transmural a 16 pacientes más de cada 1000 (o 550 enfermos)

  

506 (391 a 545)

⊕⊕⊕◯1 Moderada

  

Tomografía

  

490 (270 a 545)

⊕⊕⊕◯1 Moderada

  

Pacientes con compromiso transmural incorrectamente identificados como sin compromiso

(falsos negativos)

Resonancia

  

44 (5 a 159)

⊕⊕⊕◯1 Moderada

  

Tomografía

  

60 (5 a 280)

⊕⊕⊕◯1 Moderada

  

Pacientes sin  compromiso transmural correctamente identificados

(verdaderos negativos)

Resonancia

Al utilizar resonancia comparado con tomografía probablemente se diagnostican correctamente sin compromiso transmural a 13 pacientes menos de cada 1000 (o 450 sanos)

  

324 (166 a 410)

⊕⊕⊕◯1 Moderada

  

Tomografía

  

337 (243 a 387)

⊕⊕⊕◯1 Moderada

  

Personas sin compromiso transmural incorrectamente clasificadas como con compromiso

(falsos positivos)

Resonancia

  

126(40 a 284)

⊕⊕⊕◯1 Moderada

  

Tomografía

  

113 (63 a 207)

⊕⊕⊕◯1 Moderada

  

IC: Intervalo de confianza del 95%.
GRADE: grados de evidencia del GRADE Working Group
*La prevalencia corresponde a la prevalencia del estudio con más peso [13]
**Certeza de exactitud diagnóstica
1 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 deseables anticipados?
Triviales Pequeños Moderados Grandes Varía No lo sé

Grandes: El panel de expertos de la Guía estimó que los efectos deseables de «realizar resonancia magnética pelvis» en comparación a «realizar tomografía computarizada de pelvis» son grandes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud. Argumentando, principalmente, que permite la planificación del tratamiento en cuanto a su secuencia y modalidades.

Evidencia de investigación

De una población hipotética de 1.000 personas con 550 enfermos con compromiso transmural y 550 localizado, se estima que al utilizar resonancia comparado con tomografía probablemente se diagnostican correctamente con compromiso transmural a 16 pacientes más de cada 1000 (o 550 enfermos) [13, 86, 87].

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Búsqueda y Síntesis de Evidencia

 4.- ¿Qué tan significativos son los efectos indeseables anticipados?
Grandes Moderados Pequeños Triviales Varía No lo sé

Triviales: El panel de expertos de la Guía estimó que los efectos indeseables de «realizar resonancia magnética pelvis» en comparación a «realizar tomografía computarizada de pelvis» son triviales o no relevantes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.

Evidencia de investigación

De una población hipotética de 1.000 personas con 550 enfermos con compromiso transmural y 550 localizado, se estima que al utilizar resonancia comparado con tomografía probablemente se diagnostican correctamente sin compromiso transmural a 13 pacientes menos de cada 1000 (o 450 sanos).

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Búsqueda y Síntesis de Evidencia

 5.- ¿Cuál es la certeza general de la evidencia sobre la precisión de la prueba?
Muy baja Baja Moderada Alta Ningún estudio incluído

Moderada: Existe confianza respecto del efecto de «realizar resonancia magnética pelvis» en comparación a «realizar tomografía computarizada de pelvis».

Evidencia de investigación

Desenlaces

Certeza de la evidencia

(GRADE)

Pacientes con compromiso transmural(verdaderos positivos)

⊕⊕⊕◯1
Moderada

Pacientes con compromiso transmural incorrectamente identificados como sin compromiso(falsos negativos)

⊕⊕⊕◯1
Moderada

Pacientes sin compromiso transmural correctamente identificados(verdaderos negativos)

⊕⊕⊕◯1
Moderada

Personas sin compromiso transmural incorrectamente clasificadas como con compromiso (falsos positivos)

⊕⊕⊕◯1
Moderada

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

Muy Baja: Existe considerable incertidumbre respecto del efecto de «inactivo» en comparación a «inactivo». Se baja dos nivel de certeza de la evidencia respecto al ítem anterior, dado que no se identificaron estudios que evaluaran el efecto de realizar resonancia magnética en los desenlaces de salud para los pacientes con cáncer de recto medio e inferior (impacto diagnóstico).

 7.- ¿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

No hay variabilidad o incertidumbre importante: 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 panel de expertos de la Guía consideró que no existe incertidumbre o variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «realizar resonancia magnética pelvis» y «realizar tomografía computarizada de pelvis». Todas o casi todas las personas escogerían resonancia magnética pelvis.

Evidencia de investigación

Se identificó un estudio que comparó el tiempo de recuperación, aceptabilidad, satisfacción y carga entre resonancia magnética de cuerpo entero y tomografía computarizada, en 61 pacientes recién diagnosticados con cáncer colorrectal o con alta sospecha en etapificación. La aceptabilidad del escaneo fue significativamente más baja para resonancia magnética de cuerpo entero que para tomografía computarizada (“muy aceptable” 65,5% versus 80,4%; p< 0,05). No hubo diferencias entre el tiempo de recuperación después de las pruebas o satisfacción respecto al procedimiento (comunicación, instalaciones, información recibida)(1). Aunque los pacientes toleraron bien ambas modalidades y reportaron bajos niveles de carga (incomodidad, preocupación y satisfacción) en general, la resonancia magnética involucró una carga significativa mayor. Dentro de la sub-escala de incomodidad, la resonancia magnética destacó por la sensación claustrofobia e incomodidad por el ruido (1). Factores como comorbilidades y angustia preexistente fueron predictores de mayores niveles de “carga”, no así edad, sexo, origen étnico (1). Es decir, la resonancia magnética es marginalmente menos aceptable que la tomografía computarizada para pacientes con cáncer colorrectal.

Referencias

1. Evans RE, Taylor SA, Beare S, Halligan S, Morton A, Oliver A, et al. Perceived patient burden and acceptability of whole body MRI for staging lung and colorectal cancer; comparison with standard staging investigations. Br J Radiol [Internet]. 2018 Mar 20 [cited 2018 Aug 9];20170731. Available from: http://www.birpublications.org/doi/10.1259/bjr.20170731

Búsqueda y Síntesis de Evidencia

 8.- 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 «realizar resonancia magnética pelvis» y la comparación es «realizar tomografía computarizada de pelvis», el panel de expertos de la Guía opinó que el balance entre efectos deseables e indeseables claramente favorece «realizar resonancia magnética pelvis».

 9.- ¿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 panel de expertos de la Guía consideró que los costos y ahorros de «realizar resonancia magnética pelvis» son despreciables si se compara con «realizar tomografía computarizada de pelvis», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes. Los costos se estiman despreciables en el contexto del tratamiento de cáncer.

Evidencia de investigación

A continuación se muestran los costos referenciales, es preciso considerar que estos costos fueron recogidos con el único objetivo de constituir un antecedente aproximado.

El porcentaje de cobertura del seguro de salud sobre el precio de las prestaciones sanitarias, dependerá del tipo de seguro de cada paciente.

ítem

Intervención: resonancia magnética de pelvis

Comparación: TAC de pelvis

Resonancia magnética de pelvis (incluye medio de contraste). 1

$ 71.920

–

Tomografía computarizada de pelvis (además incluye sacro, coxis, caderas, huesos pélvicos, articulaciones sacroIliacas). Bilateral1

–

$ 161.870

Optiray 320 125 ML2

–

$ 24.812

 

$ 71.920

$ 186.682

Referencias:
1. Precio total para prestador nivel 3 de la base de datos Modalidad de Libre Elección 2018, FONASA.
2. Precio de compra por Establecimientos de Salud Públicos a través de plataforma Mercado Público, al 2018. Precio incluye IVA.

Búsqueda y Síntesis de Evidencia

 10.- ¿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 incluído

Probablemente favorece la intervención: Considerando que la intervención es «realizar resonancia magnética pelvis» y la comparación es «realizar tomografía computarizada de pelvis», el panel de expertos de la Guía opinó que probablemente la alternativa más costo-efectiva es «realizar resonancia magnética pelvis». Esto, en función de que se estimó que los costos eran relativamente despreciables y se considera que existen grandes efectos deseables.

No se realizó la búsqueda de evidencia que abordaran la costo-efectividad ya que las intervenciones evaluadas no es considerado de alto costo, según el Decreto 80 «Determinar umbral nacional de costo anual al que se refiere el artículo 6° de la Ley 20.850».

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

Probablemente reducida: El panel de expertos de la Guía consideró que la equidad en salud se probablemente se reduciría si se recomendase «realizar resonancia magnética pelvis», dado que identificó grupos o contextos que actualmente tiene barreras de acceso, ya sea en términos económicos, geográficos u otros. Existe una brecha en cuanto a la disponibilidad de resonancia magnética en compraración a la tomografía computarizada.

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

Sí: El panel de expertos de la Guía consideró que «realizar resonancia magnética pelvis» 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).

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

Probablemente sí: El panel de expertos de la Guía consideró que «realizar resonancia magnética pelvis» probablemente SÍ es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc. Dado que habría que aumentar la disponibilidad de resonadores y personal capacitado.