Guía de Práctica Clínica - No GES
Influenza
Recomendación – Dg2 / Juicio del Panel y Evidencia
Dg2.- En adultos, niños y niñas en que se plantea realizar un examen para determinar la presencia de influenza, el Ministerio de Salud sugiere realizar PCR (reacción de polimerasa en cadena) por sobre realizar inmunofluorescencia o test rápidos
Comentarios del Panel de Expertos:
►Si los clínicos y pacientes consideran necesario el tratamiento antiviral, como por ejemplo en pacientes de alto riesgo de complicación o pacientes con manifestaciones graves de la enfermedad, la realización de la PCR no debe retrasar el inicio de oseltamivir.
►El panel considera que la información al paciente debiera incluir las consecuencias del resultado del test (por ejemplo un resultado negativo puede no implicar un cambio en el tratamiento) y sus potenciales costos
►En la actualidad existe una disponibilidad limitada de PCR en los centros asistenciales, especialmente fuera de los núcleos urbanos. Esto pudiera limitar la implementación de esta recomendación.
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 |
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El problema ha sido definido como prioritario del Departamento de Enfermedades Transmisibles del Ministerio de Salud.
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 «realizar examen de PCR» en comparación a «realizar inmunofluorescencia o test rápidos» 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 considera que en cuadros graves la certeza diagnóstica es mayor.
Es importante no retrasar el tratamiento en espera del diagnóstico.
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Realizar IFI/IFD en comparación a realizar examen PCR para pacientes graves con sospecha de influenza |
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Pacientes |
Pacientes graves con sospecha de influenza. |
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Test |
Realizar IFI/IFD. |
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Comparación |
Realizar examen PCR. |
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Impacto diagnóstico |
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Desenlaces |
Efecto |
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Morbilidad o mortalidad |
No se identificaron estudios evaluando el impacto, por lo que el desenlace se estimó en base a la exactitud diagnóstica del test, y de las consecuencias esperadas a partir de cada resultado. |
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Exactitud diagnóstica |
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Gold standard |
Resultado positivo de PCR |
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Desenlaces |
Prevalencia hipotética 45%* |
Certeza de la evidencia (GRADE)** |
Mensajes clave en términos sencillos |
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Sensibilidad: 57,2% (IC 95% de 60,7 a 53,7%) Especificidad: 98,5% (IC 95% de 94,7 a 99,3%) LR (+): 38 (IC 95% de 23 a 65) LR (-): 0,43 (IC 95% de 0,40 a 0,47) 1689 muestras (1 estudio [1]) |
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Pacientes con influenza (verdaderos positivos) |
257 (242 a 737) |
⊕⊕⊕◯1 Moderada |
El test de IFD probablemente detecta correctamente a 257 de los 450 pacientes con influenza (verdaderos positivos). |
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Pacientes enfermos incorrectamente clasificados como sanos (falsos negativos) |
193 (177 a 208) |
⊕⊕⊕◯1 Moderada |
El test de IFD probablemente detecta incorrectamente a 193 de los 450 pacientes con influenza (falsos negativos). |
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Pacientes sanos (verdaderos negativos) |
542 (521 a 546) |
⊕⊕⊕◯1 Moderada |
El test de IFD probablemente detecta correctamente a 542 de los 550 pacientes sanos (verdaderos negativos). |
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Pacientes sanos incorrectamente clasificados como enfermos (falsos positivos) |
8 (4 a 29) |
⊕⊕⊕◯1 Moderada |
El test de IFD probablemente detecta incorrectamente a 8 de los 550 pacientes sanos (falsos positivos). |
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IC: Intervalo de confianza del 95%.
GRADE: grados de evidencia del GRADE Working Group.
*La prevalencia corresponde a la prevalencia aproximada del estudio [1]
** Certeza de exactitud diagnóstica.
1 Se disminuyó un nivel de certeza de evidencia por indirecto, ya que son muestras diversas y no solo pacientes graves.
Fecha de elaboración de la tabla: Octubre, 2018.
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76. Li M, Brenwald N, Bonigal S, Chana K, Osman H, Oppenheim B. Rapid diagnosis of influenza: an evaluation of two commercially available RT-PCR assays. The Journal of infection. 2012;65(1):60-3.
77. Noh JY, Choi WS, Lee J, Kim HL, Song JY, Cheong HJ, Kim WJ. Clinical performance of the Sofia™ Influenza A+B FIA in adult patients with influenza-like illness. Diagnostic microbiology and infectious disease. 2015;83(2):130-2.
78. Yasuda C, Sovann L, Kasper M, Williams M, Wierzba TF. Epidemiological characteristics, clinical presentation and diagnosis at point-of-care during the first wave of the H1N1 influenza pandemic in Cambodia. The Southeast Asian journal of tropical medicine and public health. 2012;43(1):68-77.
79. Kasper MR, Putnam SD, Sovann L, Yasuda CY, Blair PJ, Wierzba TF. Short report: Rapid-test based identification of influenza as an etiology of acute febrile illness in Cambodia. The American journal of tropical medicine and hygiene. 2011;85(6):1144-5.
80. Kenmoe S, Tchendjou P, Moyo Tetang S, Mossus T, Njankouo Ripa M, Guillet M, Kfutwah A, Njouom R. Evaluating the performance of a rapid antigen test for the detection of influenza virus in clinical specimens from children in Cameroon. Influenza and other respiratory viruses. 2014;8(2):131-4.
81. Hazelton B, Nedeljkovic G, Ratnamohan VM, Dwyer DE, Kok J. Evaluation of the Sofia Influenza A + B fluorescent immunoassay for the rapid diagnosis of influenza A and B. Journal of medical virology. 2015;87(1):35-8.
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83. Eggers M, Enders M, Terletskaia-Ladwig E. Evaluation of the Becton Dickinson Rapid Influenza Diagnostic Tests in Outpatients in Germany during Seven Influenza Seasons. PloS one. 2015;10(5):e0127070.
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86. Simmerman JM, Chittaganpitch M, Erdman D, Sawatwong P, Uyeki TM, Dowell SF. Field performance and new uses of rapid influenza testing in Thailand. International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases. 2007;11(2):166-71.
87. Faix DJ, Sherman SS, Waterman SH. Rapid-test sensitivity for novel swine-origin influenza A (H1N1) virus in humans. The New England journal of medicine. 2009;361(7):728-9.
88. Kwon D, Shin K, Kwon M, Oh HB, Kang C, Lee JY. Development and evaluation of a rapid influenza diagnostic test for the pandemic (H1N1) 2009 influenza virus. Journal of clinical microbiology. 2011;49(1):437-8.
89. Jokela P, Vuorinen T, Waris M, Manninen R. Performance of the Alere i influenza A&B assay and mariPOC test for the rapid detection of influenza A and B viruses. Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 2015;70:72-76.
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
3.- ¿Qué tan significativos son los efectos indeseables anticipados?
| Grande | Moderado | Pequeño | Trivial | Varía | No lo sé |
|---|
Triviales: El equipo elaborador de la Guía estimó que los efectos indeseables de «realizar examen PCR » en comparación a «realizar diagnóstico clínico» 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
|
Realizar IFI/IFD en comparación a realizar examen PCR para pacientes graves con sospecha de influenza |
|
|||
|
Pacientes |
Pacientes graves con sospecha de influenza. |
|
||
|
Test |
Realizar IFI/IFD. |
|
||
|
Comparación |
Realizar examen PCR. |
|
||
|
Impacto diagnóstico |
||||
|
Desenlaces |
Efecto |
|||
|
Morbilidad o mortalidad |
No se identificaron estudios evaluando el impacto, por lo que el desenlace se estimó en base a la exactitud diagnóstica del test, y de las consecuencias esperadas a partir de cada resultado. |
|||
|
Exactitud diagnóstica |
||||
|
Gold standard |
Resultado positivo de PCR |
|||
|
Desenlaces |
Prevalencia hipotética 45%* |
Certeza de la evidencia (GRADE)** |
Mensajes clave en términos sencillos |
|
|
Sensibilidad: 57,2% (IC 95% de 60,7 a 53,7%) Especificidad: 98,5% (IC 95% de 94,7 a 99,3%) LR (+): 38 (IC 95% de 23 a 65) LR (-): 0,43 (IC 95% de 0,40 a 0,47) 1689 muestras (1 estudio [1]) |
||||
|
Pacientes con influenza (verdaderos positivos) |
257 (242 a 737) |
⊕⊕⊕◯1 Moderada |
El test de IFD probablemente detecta correctamente a 257 de los 450 pacientes con influenza (verdaderos positivos). |
|
|
Pacientes enfermos incorrectamente clasificados como sanos (falsos negativos) |
193 (177 a 208) |
⊕⊕⊕◯1 Moderada |
El test de IFD probablemente detecta incorrectamente a 193 de los 450 pacientes con influenza (falsos negativos). |
|
|
Pacientes sanos (verdaderos negativos) |
542 (521 a 546) |
⊕⊕⊕◯1 Moderada |
El test de IFD probablemente detecta correctamente a 542 de los 550 pacientes sanos (verdaderos negativos). |
|
|
Pacientes sanos incorrectamente clasificados como enfermos (falsos positivos) |
8 (4 a 29) |
⊕⊕⊕◯1 Moderada |
El test de IFD probablemente detecta incorrectamente a 8 de los 550 pacientes sanos (falsos positivos). |
|
IC: Intervalo de confianza del 95%.
GRADE: grados de evidencia del GRADE Working Group.
*La prevalencia corresponde a la prevalencia aproximada del estudio [1]
** Certeza de exactitud diagnóstica.
1 Se disminuyó un nivel de certeza de evidencia por indirecto, ya que son muestras diversas y no solo pacientes graves.
Fecha de elaboración de la tabla: Octubre, 2018.
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
4.- ¿Cuál es la certeza general de la evidencia sobre efectos?
| Muy baja | Baja | Moderada | Alta | Ningún estido incluído |
|---|
Baja:Existe cierta incertidumbre respecto del efecto de «realizar examen de PCR» en comparación a «realizar inmunofluorescencia o test rápidos».
Evidencia de investigación
|
Desenlaces |
Importancia |
Certainty of the evidence |
|
Mortalidad – no reportado |
CRITICAL |
– |
|
Prescripción de antibióticos |
IMPORTANT |
⨁◯◯◯ |
|
Duración de hospitalización (Días) |
CRITICAL |
⨁⨁◯◯ |
a. 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 |
|---|
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 equipo elaborador 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 examen de PCR» y «realizar inmunofluorescencia o test rápidos». Todas o casi todas las personas escogerían realizar examen PCR.
Evidencia de investigación
No se identificaron estudios de valores y preferencias de las personas para responder la pregunta.
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 «realizar examen de PCR» y la comparación es «realizar inmunofluorescencia o test rápidos», el equipo elaborador de la Guía opinó que el balance entre efectos deseables e indeseables claramente favorece «realizar examen de PCR».
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 |
|---|
Varía: El equipo elaborador de la Guía considera que existen componentes que pueden afectar de distinta manera la magnitud de los costos o ahorros asociados a «realizar examen de PCR» versus «realizar inmunofluorescencia o test rápidos».
Consideraciones Adicionales
El panel considera en términos de la población global los costos serían extensos. Sin embargo en pacientes más graves no.
Evidencia de investigación
A continuación se muestran los precios referenciales de las prestaciones sanitarias de “realizar examen reacción en cadena de la polimerasa (PCR) y no realizar examen”, de modo que el equipo elaborador de la Guía se pudiese pronunciar al respecto.
|
Ítem |
INTERVENCION |
PRECIO |
|
Examen |
1Reacción en cadena de la polimerasa (PCR) |
$77.611.- |
|
Examen |
Inmunofluorescencia Indirecta (IFI) A o B |
$18.889.- |
Referencias:
1. Instituto de Salud Pública – Chile
Búsqueda y Síntesis de Evidencia
Búsqueda de costos
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 intervención: Considerando que la intervención es «realizar examen de PCR» y la comparación es «realizar inmunofluorescencia o test rápidos», el equipo elaborador de la Guía opinó que probablemente la alternativa más costo-efectivo
Consideraciones Adicionales
El panel considera que podría variar de acuerdo al contexto: presencia de gravedad y factores de riesgo de los pacientes, favoreciendo la costó efectividad en aquellos pacientes con mayor riesgo.
Evidencia de la investigación
No se identificaron estudios nacionales sobre la costó efectividad de realizar diagnóstico clínico versus realizar examen PCR en adultos con sospecha de influenza.
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 «realizar examen de PCR», 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 informa que solo 7 hospitales cuentan con el examen PCR en el contexto de la vigilancia.
10.- ¿La intervención es aceptable para las partes interesadas?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
Sí: El equipo elaborador de la Guía consideró que «realizar examen de PCR» 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 | Sí | Varía | No lo sé |
|---|
Probablemente no: El equipo elaborador de la Guía consideró que «realizar examen de PCR» probablemente NO es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.
Consideraciones Adicionales
El panel informa que actualmente no se cuentan con los recursos para la implementación del examen PCR.