Problema de Salud AUGE N°41
Tratamiento médico en personas de 55 años y más con artrosis de cadera y/o rodilla, leve o moderado
ETD-12-2018
En personas mayores de 55 años con diagnóstico clínico de artrosis de cadera o rodilla moderada, el Ministerio de Salud SUGIERE NO USAR inyecciones con ácido hialurónico.
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 formuló 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 significativos son los efectos deseables anticipados?
| Triviales | Pequeños | Moderados | Grandes | Varía | No lo sé |
|---|
No lo sé: El panel de expertos de la Guía consideró que no contaba con suficiente información para emitir un juicio respecto a la significancia de los efectos deseables de «usar inyecciones con ácido hialurónico» en comparación a «no usar», considerando que a la luz de la evidencia y de la experiencia clinica existe incertidumbre de que tan significativos son los efectos deseables del ácido hialurónico en esta población.
Evidencia de investigación
|
inyección con ácido hialurónico en personas mayores de 55 años con diagnóstico clínico de artrosis de cadera y/o rodilla moderada |
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|
Pacientes |
En personas mayores de 55 años con diagnóstico clínico de artrosis de cadera y/o rodilla moderada |
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|
Intervención |
Inyecciones con ácido hialurónico. |
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|
Comparación |
No usar. |
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|
Desenlaces |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
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|
SIN Inyecciones con ácido hialurónico |
CON Inyecciones con ácido hialurónico |
Diferencia (IC 95%) |
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|
Dolor (Evaluado con Índice WOMAC)** |
50 ensayos en una revisión sistemática [6] /7.273 pacientes |
40 puntos |
10 puntos |
DM: 29,44 menos (24,17 a 34,93 menos) |
⊕◯◯◯1,2,3 Muy baja |
Aplicar inyecciones de ácido hialurónico, podría disminuir el dolor. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
|
Funcionalidad (Evaluado con Índice WOMAC)** |
50 ensayos en una revisión sistemática [6]/ 7.273 pacientes |
DME***: 0,30 más (0,20 a 0,40 más) |
⊕◯◯◯1,2,3,4 Muy baja |
Aplicar inyecciones de ácido hialurónico, podría tener poco impacto en funcionalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
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|
Eventos adversos |
36 ensayos en una revisión sistemática [6] |
No reportaron eventos adversos serios en ninguno de los dos grupos. |
⊕◯◯◯1,3,4 Muy baja |
Aplicar inyecciones de ácido hialurónico podría tener pocos efectos adversos. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
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IC 95%: Intervalo de confianza del 95% // RR: Riesgo relativo //DME: Diferencia de media estándar.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo SIN inyección de ácido hialurónico está basado en el riesgo del grupo control en los estudios. El riesgo CON inyección de ácido hialurónico (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
**El índice WOMAC (Western Ontario McMaster Osteo-Arthritis Index) fue desarrollado para evaluar y cuantificar el dolor, la rigidez de las articulaciones y la discapacidad relacionada con la osteoartritis de la rodilla y la cadera. El índice está disponible en formatos de escala Likert de 5 puntos (LK), analógico visual de 100 mm (VA) y clasificación numérica de 11 puntos (NR). A las respuestas a las preguntas individuales se les asigna un puntaje entre 0 (extremo) y 4 (ninguno). Las puntuaciones de las preguntas individuales se suman para formar un puntaje bruto que va desde 0 (peor) a 96 (mejor). Finalmente, los puntajes brutos se normalizan al multiplicar cada puntaje por 100/96. Esto produce un puntaje WOMAC reportado entre 0 (peor) y 100 (mejor).
***La diferencia de medias estandarizada se utiliza cuando el desenlace ha sido medido en diferentes escalas y es difícil de interpretar clínicamente. Una regla general es que valores menores a 0,2 son de poca relevancia clínica, valores de 0,5 de relevancia moderada y 0,8 relevancia clínica importante.
1 Se disminuyó la certeza de la evidencia por riesgo de sesgo, ya que no estaba clara la generación de secuencia de aleatorización ni ocultamiento de ésta en la mayoría de los estudios incluídos.
2 Se disminuyó la certeza de la evidencia en un nivel por inconsistencia, ya que diferentes ensayos presentan diferentes conclusiones.
3 Se disminuyó la certeza de la evidencia en un nivel por sospecha de sesgo de publicación evidenciado en el funnel plot, de acuerdo a lo expuesto en la revisión Cochrane [7]. Sin embargo, en el desenlace reacción en sitio de punción se decidió no disminuir por este motivo ya que si bien puede cambiar el estimador, reforzaría la decisión.
4 Se disminuyó la certeza de la evidencia en un nivel por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente. En el desenlace efectos adversos severos se decidió disminuir por pocos eventos en ambos grupos.
Fecha de elaboración de la tabla: Diciembre, 2018
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Búsqueda y Síntesis de Evidencia
Informe de búsqueda y síntesis de evidencia de los efectos deseables e indeseables
3.- ¿Qué tan significativos son los efectos indeseables anticipados?
| Grandes | Moderados | Pequeños | Triviales | Varía | No lo sé |
|---|
Pequeños: El panel de expertos de la Guía estimó que los efectos indeseables de «usar inyecciones con ácido hialurónico» en comparación a «no usar» son pequeños, considerando la evidencia y experiencia clínica. El panel señala que la intervención debiera ser aplicada por profesionales entrenados en artrocentesis, ya que disminuye los riesgos de eventos adversos por punciones extrarticulares.
Evidencia de investigación
|
inyección con ácido hialurónico en personas mayores de 55 años con diagnóstico clínico de artrosis de cadera y/o rodilla moderada |
||||||
|
Pacientes |
En personas mayores de 55 años con diagnóstico clínico de artrosis de cadera y/o rodilla moderada |
|||||
|
Intervención |
Inyecciones con ácido hialurónico. |
|||||
|
Comparación |
No usar. |
|||||
|
Desenlaces |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
||
|
SIN Inyecciones con ácido hialurónico |
CON Inyecciones con ácido hialurónico |
Diferencia (IC 95%) |
||||
|
Dolor (Evaluado con Índice WOMAC)** |
50 ensayos en una revisión sistemática [6] /7.273 pacientes |
40 puntos |
10 puntos |
DM: 29,44 menos (24,17 a 34,93 menos) |
⊕◯◯◯1,2,3 Muy baja |
Aplicar inyecciones de ácido hialurónico, podría disminuir el dolor. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
|
Funcionalidad (Evaluado con Índice WOMAC)** |
50 ensayos en una revisión sistemática [6]/ 7.273 pacientes |
DME***: 0,30 más (0,20 a 0,40 más) |
⊕◯◯◯1,2,3,4 Muy baja |
Aplicar inyecciones de ácido hialurónico, podría tener poco impacto en funcionalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
||
|
Eventos adversos |
36 ensayos en una revisión sistemática [6] |
No reportaron eventos adversos serios en ninguno de los dos grupos. |
⊕◯◯◯1,3,4 Muy baja |
Aplicar inyecciones de ácido hialurónico podría tener pocos efectos adversos. 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 //DME: Diferencia de media estándar.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo SIN inyección de ácido hialurónico está basado en el riesgo del grupo control en los estudios. El riesgo CON inyección de ácido hialurónico (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
**El índice WOMAC (Western Ontario McMaster Osteo-Arthritis Index) fue desarrollado para evaluar y cuantificar el dolor, la rigidez de las articulaciones y la discapacidad relacionada con la osteoartritis de la rodilla y la cadera. El índice está disponible en formatos de escala Likert de 5 puntos (LK), analógico visual de 100 mm (VA) y clasificación numérica de 11 puntos (NR). A las respuestas a las preguntas individuales se les asigna un puntaje entre 0 (extremo) y 4 (ninguno). Las puntuaciones de las preguntas individuales se suman para formar un puntaje bruto que va desde 0 (peor) a 96 (mejor). Finalmente, los puntajes brutos se normalizan al multiplicar cada puntaje por 100/96. Esto produce un puntaje WOMAC reportado entre 0 (peor) y 100 (mejor).
***La diferencia de medias estandarizada se utiliza cuando el desenlace ha sido medido en diferentes escalas y es difícil de interpretar clínicamente. Una regla general es que valores menores a 0,2 son de poca relevancia clínica, valores de 0,5 de relevancia moderada y 0,8 relevancia clínica importante.
1 Se disminuyó la certeza de la evidencia por riesgo de sesgo, ya que no estaba clara la generación de secuencia de aleatorización ni ocultamiento de ésta en la mayoría de los estudios incluídos.
2 Se disminuyó la certeza de la evidencia en un nivel por inconsistencia, ya que diferentes ensayos presentan diferentes conclusiones.
3 Se disminuyó la certeza de la evidencia en un nivel por sospecha de sesgo de publicación evidenciado en el funnel plot, de acuerdo a lo expuesto en la revisión Cochrane [7]. Sin embargo, en el desenlace reacción en sitio de punción se decidió no disminuir por este motivo ya que si bien puede cambiar el estimador, reforzaría la decisión.
4 Se disminuyó la certeza de la evidencia en un nivel por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente. En el desenlace efectos adversos severos se decidió disminuir por pocos eventos en ambos grupos.
Fecha de elaboración de la tabla: Diciembre, 2018
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Búsqueda y Síntesis de Evidencia
Informe de búsqueda y síntesis de evidencia de los efectos deseables e indeseables
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 inyecciones con ácido hialurónico» en comparación a «no usar». La certeza de la evidencia se basó en los desenlaces de salud establecidos como críticos para los pacientes, en este caso dolor.
Evidencia de investigación
|
Desenlaces |
Importancia |
Certeza en la evidencia (GRADE) |
|
Dolor |
CRÍTICO |
⊕◯◯◯1,2,3 Muy baja |
|
Funcionalidad |
IMPORTANTE |
⊕◯◯◯1,2,3,4 Muy baja |
|
Efectos adversos |
IMPORTANTE |
⊕◯◯◯1,3,4 Muy baja |
1 Se disminuyó la certeza de la evidencia por riesgo de sesgo, ya que no estaba clara la generación de secuencia de aleatorización ni ocultamiento de ésta en la mayoría de los estudios incluídos.
2 Se disminuyó la certeza de la evidencia en un nivel por inconsistencia, ya que diferentes ensayos presentan diferentes conclusiones.
3 Se disminuyó la certeza de la evidencia en un nivel por sospecha de sesgo de publicación evidenciado en el funnel plot, de acuerdo a lo expuesto en la revisión Cochrane [7]. Sin embargo, en el desenlace reacción en sitio de punción se decidió no disminuir por este motivo ya que si bien puede cambiar el estimador, reforzaría la decisión.
4 Se disminuyó la certeza de la evidencia en un nivel por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente. En el desenlace efectos adversos severos se decidió disminuir por pocos eventos en ambos grupos.
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 |
|---|
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 panel de expertos de la Guía consideró que existe incertidumbre o variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «usar inyecciones con ácido hialurónico» y «no usar».
Evidencia de investigación
Un estudio que contó con la participación de 162 personas con artrosis de rodilla observó que el grupo de inyección intra-articular de ácido hialurónico (n=44), el 64,1% estaban satisfechos, el 23,1% estaba parcialmente satisfecho y el 12,8% no estaba satisfecho al final del procedimiento. En el grupo de control, inyección con solución salina (n=40), el 5% de los pacientes estaban satisfechos, el 15% estaba parcialmente satisfecho y el 80% no estaba satisfecho con el procedimiento de inyección (1).
Referencias
1. Görmeli G, Görmeli CA, Ataoglu B, Çolak C, Aslantürk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surgery, Sport Traumatol Arthrosc [Internet]. 2017 Mar 2 [cited 2019 Jan 8];25(3):958–65. Available from: http://link.springer.com/10.1007/s00167-015-3705-6
Búsqueda y Síntesis de Evidencia
Informe de búsqueda y síntesis de evidencia de las preferencias de los pacientes
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 |
|---|
Probablemente favorece la comparación: Considerando que la intervención es «usar inyecciones con ácido hialurónico» y la comparación es «no usar», el panel de expertos de la Guía opinó que el balance entre efectos deseables e indeseables probablemente favorece «no usar», en base a que no es posible determinar los efectos deseables, los indeseables son pequeños, que la certeza de la evidencia es muy baja y que hay variabilidad o incertidumbre importante en lo que escogerían las personas.
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 panel de expertos de la Guía consideró que los costos de «usar inyecciones con ácido hialurónico» son moderados si se compara con los costos de «no usar», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.
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: usar inyecciones con ácido hialurónico |
|
Consulta médica de especialidad en traumatología y ortopedia1 |
$ 14.340 |
|
Infiltración local medicamentos (bursas, tendones, yuxtaarticulares y/o intraarticulares), y/o punción evacuadora c/s toma de muestra (en interfalangicas comprende hasta dos por sesión)1 |
$ 9.500 |
|
Ácido Hialurónico 6ml JER 1 2 |
$ 154.700 |
|
Total |
$ 182.390 |
Referencias
1. Precio total para prestador nivel 3 de la base de datos Modalidad de Libre Elección 2018, FONASA.
2. Precio obtenido de la base de datos con los precios de fármacos adquirido en el retail en Chile. Se consideró el promedio del precio de venta de los últimos 6 meses y se inflactó al 2018 (IQVAI, 2017)
2. Precio obtenido de la base de datos con los precios de fármacos adquirido en el retail en Chile. Se consideró el promedio del precio de venta de los últimos 6 meses y se inflactó al 2018 (IQVAI, 2017)
Búsqueda y Síntesis de Evidencia
Informe de búsqueda de costos referenciales de las intervenciones
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 |
|---|
Probablemente favorece la comparación: Considerando que la intervención es «usar inyecciones con ácido hialurónico» y la comparación es «no usar», el panel de expertos de la Guía opinó que probablemente la alternativa más costo-efectiva es «no usar», en base que el costo del tratamiento es considerable y que no hay certeza de la efectividad.
No se realizó la búsqueda de evidencia que abordaran la costo-efectividad ya que las intervenciones evaluadas no es consideraron 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».
9.- ¿Cuál sería el impacto en equidad en salud?
| Reducido | Probablemente reducido | Probablemente ningún impacto | Probablemente aumentado | Aumentado | Varía | No lo sé |
|---|
Reducida: El panel de expertos de la Guía consideró que la equidad en salud se reduciría si se recomendase «usar inyecciones con ácido hialurónico», dado que identificó grupos o contextos que actualmente tienen 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 | Sí | Varía | No lo sé |
|---|
Probablemente no: El panel de expertos de la Guía consideró que «usar inyecciones con ácido hialurónico» probablemente NO 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 | Sí | Varía | No lo sé |
|---|
Probablemente sí: El panel de expertos de la Guía consideró que «usar inyecciones con ácido hialurónico» probablemente SÍ es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.