Problema de Salud AUGE N°37
Ataque Cerebrovascular Isquémico en personas de 15 años y más
Recomendación de tratamiento – Juicio del Panel y Evidencia
En personas de 15 años y más con diagnóstico de Ataque Cerebrovascular isquémico con indicación de trombólisis intravenosa, el Ministerio de Salud SUGIERE que esta sea realizada con un neurólogo que se encuentre presencialmente o que asista a través de telemedicina.
Comentarios del panel de expertos
►Debido a que ambas alternativas serían equivalentes, la elección de la alternativa dependerá según los recursos disponibles en cada centro.
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 problemade salud ha sido definido como prioritario de abordar a través de una Guía de Práctica Clínica por la División de Prevención y Control de Enfermedades del Ministerio de Salud. La pregunta ha sido priorizada por el equipo de esta Guía, ya sea porque existía variabilidad o incertidumbre.
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 trombólisis intravenosa asistida por neurólogo a través de telemedicina» en comparación a «realizar trombólisis intravenosa por neurólogo presencial» 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 señala que ambas alternativas podrian se equivalentes en efectividad. Sin embargo, la telemedicina para asistir la trombolisis aumentaría el acceso al tratamiento a nivel nacional al ser una patología tiempo dependiente.
Evidencia de investigación
Tabla de Resumen de Resultados (Summary of Findings)
|
Realizar trombolisis asistida neurólogo a través de telemedicina comparado con realizar trombolisis no asistida neurólogo a través de telemedicina para personas con diagnóstico de ataque cerebrovascular isquémico. |
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|
Población |
Personas con diagnóstico de ataque cerebrovascular (ACV) isquémico. |
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Intervención |
Realizar trombolisis asistida neurólogo a través de telemedicina. |
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|
Comparación |
Realizar trombolisis por neurólogo presencial. |
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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 telemedicina |
CON telemedicina |
Diferencia (IC 95%) |
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|
Mortalidad intrahospitalaria |
RR 1,10 (0,54 a 2,25) — 1 ensayo/ 420 pacientes [24] |
64 por 1000 |
70 por 1000 |
Diferencia: 6 más (29 menos a 80 más) |
⊕⊕◯◯1,2 Baja |
Realizar trombolisis asistida por neurólogo a través de telemedicina podría aumentar la mortalidad intrahospitalaria, pero la certeza de la evidencia es baja. |
|
Mortalidad a los 90 días |
RR 1,34 (0,84 a 2,15) — 1 ensayo/ 420 pacientes [24] |
123 por 1000 |
164 por 1000 |
Diferencia: 41 más (20 menos a 141 más) |
⊕⊕◯◯1,2 Baja |
Realizar trombolisis asistida por neurólogo a través de telemedicina podría aumentar la mortalidad a los 90 días, pero la certeza de la evidencia es baja. |
|
Mortalidad a partir de estudios observacionales |
Se estimó el efecto a partir de estudios observacionales, concluyendo para mortalidad intrahospitalaria un OR 1,21 (0,98 a 1,49) I2: 0% basado en 4907 personas y para mortalidad a los 90 días un OR de 1,08 (0,85 a 1,37) I2: 0% basado en 3193 pacientes. |
⊕⊕◯◯2,3 Muy baja |
— |
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Hemorragia intracraneal |
RR 2,65 (0,11 a 62,00) — 1 ensayo/ 420 pacientes [24] |
1 por 1000 |
1 por 1000 |
Diferencia: 0 (0 a 31 más) |
⊕◯◯◯1,2 Muy baja |
Realizar trombolisis asistida por neurólogo a través de telemedicina podría tener poco impacto en hemorragia intracraneal. 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 SIN telemedicina está basado en el riesgo del grupo control en los estudios. El riesgo CON telemedicina (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 el ensayo no estaba clara la generación de secuencia de aleatorización ni ocultamiento de ésta. Además, el ensayo no fue ciego.
2 Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente. En el caso de hemorragia intracraneal se decidió disminuir dos, ya que adicionalmente el evento fue poco frecuente en ambos grupos e intervalo de confianza muy amplio.
3 Diseño observacional.
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
3.- ¿Qué tan significativos son los efectos indeseables anticipados?
| Grande | Moderado | Pequeño | Trivial | Varía | No lo sé |
|---|
Pequeños: El equipo elaborador de la Guía estimó que los efectos indeseables de «realizar trombolisis intravenosa asistida por neurólogo a través de telemedicina» en comparación a «realizar trombolisis intravenosa por neurólogo presencial» son pequeños, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Evidencia de investigación
Tabla de Resumen de Resultados (Summary of Findings)
|
Realizar trombolisis asistida neurólogo a través de telemedicina comparado con realizar trombolisis no asistida neurólogo a través de telemedicina para personas con diagnóstico de ataque cerebrovascular isquémico. |
||||||
|
Población |
Personas con diagnóstico de ataque cerebrovascular (ACV) isquémico. |
|||||
|
Intervención |
Realizar trombolisis asistida neurólogo a través de telemedicina. |
|||||
|
Comparación |
Realizar trombolisis por neurólogo presencial. |
|||||
|
Desenlaces |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
||
|
SIN telemedicina |
CON telemedicina |
Diferencia (IC 95%) |
||||
|
Mortalidad intrahospitalaria |
RR 1,10 (0,54 a 2,25) — 1 ensayo/ 420 pacientes [24] |
64 por 1000 |
70 por 1000 |
Diferencia: 6 más (29 menos a 80 más) |
⊕⊕◯◯1,2 Baja |
Realizar trombolisis asistida por neurólogo a través de telemedicina podría aumentar la mortalidad intrahospitalaria, pero la certeza de la evidencia es baja. |
|
Mortalidad a los 90 días |
RR 1,34 (0,84 a 2,15) — 1 ensayo/ 420 pacientes [24] |
123 por 1000 |
164 por 1000 |
Diferencia: 41 más (20 menos a 141 más) |
⊕⊕◯◯1,2 Baja |
Realizar trombolisis asistida por neurólogo a través de telemedicina podría aumentar la mortalidad a los 90 días, pero la certeza de la evidencia es baja. |
|
Mortalidad a partir de estudios observacionales |
Se estimó el efecto a partir de estudios observacionales, concluyendo para mortalidad intrahospitalaria un OR 1,21 (0,98 a 1,49) I2: 0% basado en 4907 personas y para mortalidad a los 90 días un OR de 1,08 (0,85 a 1,37) I2: 0% basado en 3193 pacientes. |
⊕⊕◯◯2,3 Muy baja |
— |
|||
|
Hemorragia intracraneal |
RR 2,65 (0,11 a 62,00) — 1 ensayo/ 420 pacientes [24] |
1 por 1000 |
1 por 1000 |
Diferencia: 0 (0 a 31 más) |
⊕◯◯◯1,2 Muy baja |
Realizar trombolisis asistida por neurólogo a través de telemedicina podría tener poco impacto en hemorragia intracraneal. 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 SIN telemedicina está basado en el riesgo del grupo control en los estudios. El riesgo CON telemedicina (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 el ensayo no estaba clara la generación de secuencia de aleatorización ni ocultamiento de ésta. Además, el ensayo no fue ciego.
2 Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente. En el caso de hemorragia intracraneal se decidió disminuir dos, ya que adicionalmente el evento fue poco frecuente en ambos grupos e intervalo de confianza muy amplio.
3 Diseño observacional.
Fecha de elaboración de la tabla: Octubre, 2018.
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171. Wiborg A, Widder B, Telemedicine in Stroke in Swabia Project. Teleneurology to improve stroke care in rural areas: The Telemedicine in Stroke in Swabia (TESS) Project. Stroke; a journal of cerebral circulation. 2003;34(12):2951-6.
172. Wiegand N, Lüthy R, Vogel B, Straumann E, Beynon C, Bertel O, Oelz O, Caspar CB. Intravenous thrombolysis for acute ischaemic stroke in a hospital without a specialised neuro-intensive care unit. Swiss medical weekly. 2004;134(1-2):14-7.
173. Wojner-Alexandrov AW, Alexandrov AV, Rodriguez D, Persse D, Grotta JC. Houston paramedic and emergency stroke treatment and outcomes study (HoPSTO). Stroke; a journal of cerebral circulation. 2005;36(7):1512-8.
174. Wu TC, Nguyen C, Ankrom C, Yang J, Persse D, Vahidy F, Grotta JC, Savitz SI. Prehospital utility of rapid stroke evaluation using in-ambulance telemedicine: a pilot feasibility study. Stroke. 2014;45(8):2342-7.
175. Yaghi S, Rayaz S, Bianchi N, Hall-Barrow JC, Hinduja A. Thrombolysis to stroke mimics in telestroke. Journal of telemedicine and telecare. 2012;
176. Yoneda Y, Mori E, Uehara T, Yamada O, Tabuchi M. Referral and care for acute ischemic stroke in a Japanese tertiary emergency hospital. European journal of neurology : the official journal of the European Federation of Neurological Societies. 2001;8(5):483-8.
177. Zaidi SF, Jumma MA, Urra XN, Hammer M, Massaro L, Reddy V, Jovin T, Lin R, Wechsler LR. Telestroke-guided intravenous tissue-type plasminogen activator treatment achieves a similar clinical outcome as thrombolysis at a comprehensive stroke center. Stroke; a journal of cerebral circulation. 2011;42(11):3291-3.
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 estudio incluido |
|---|
Baja: Existe cierta incertidumbre respecto del efecto de «realizar trombólisis intravenosa asistida por neurólogo a través de telemedicina» en comparación a «realizar trombólisis intravenosa por neurólogo presencial».
Evidencia de investigación
|
Desenlaces |
Importancia |
Certeza de la Evidencia |
|
Mortalidad intrahospitalaria |
CRÍTICO |
⨁⨁◯◯ |
|
Mortalidad a los 90 días |
CRÍTICO |
⨁⨁◯◯ |
|
Mortalidad a partir de estudios observacionales |
———- |
⊕◯◯◯2,3 Muy baja |
|
Hemorragia intracraneal |
IMPORTANTE |
⨁◯◯◯ |
1 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que el ensayo no estaba clara la generación de secuencia de aleatorización ni ocultamiento de ésta. Además, el ensayo no fue ciego.
2 Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente. En el caso de hemorragia intracraneal se decidió disminuir dos, ya que adicionalmente el evento fue poco frecuente en ambos grupos e intervalo de confianza muy amplio.
3 Diseño observacional.
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 |
|---|
Probablemente no hay incertidumbre ni 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 probablemente no hay incertidumbre o ni variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «realizar trombólisis intravenosa asistida por neurólogo a través de telemedicina» y «realizar trombólisis intravenosa por neurólogo presencial».
Consideraciones Adicionales
El panel señala bajo nuestro contexto nacional la telemedicina se usará para suplir una carencia de neurólogo presencial que realice trombólisis con el objetivo de mejorar la equidad territorial. Por lo tanto, las personas no tendrian posibilidad de elección.
Evidencia de investigación
Se identificó un estudio realizado con el objetivo de explorar los puntos de vista de pacientes y cuidadores sobre sus experiencias con el uso de un sistema de telemedicina en Ataque Cerebrovascular, para contribuir al desarrollo de sistemas de telemedicina confiables y a la capacitación del personal de salud al respecto.
El estudio1, con el conocimiento previo sobre el beneficio de la telemedicina en facilitar la administración de trombólisis en el Ataque Cerebrovascular agudo, reclutó pacientes y cuidadores que habían estado presentes en consultas recientes de telemedicina para accidente cerebrovascular en tres hospitales en el noroeste de Inglaterra. Se realizaron 24 entrevistas semiestructuradas con 29 participantes (16 pacientes y 13 cuidadores) y un análisis temático. Factores relacionados con “coherencia” (encontrar sentido) incluyeron conocimiento y comprensión de la telemedicina. “Participación cognitiva” (trabajo relacional) incluyó la interacción entre el personal con pacientes y cuidadores. El aspecto “acción colectiva” (trabajo operativo) incluyó intercambio de información, apoyo y asuntos técnicos. Los hallazgos relacionados con “monitoreo reflexivo” (evaluación) consideraron impresiones positivas y negativas del proceso de telemedicina y reacciones emocionales (1).
Telemedicina se comparó favorablemente con una consulta telefónica (n = 5), porque permitió la participación del paciente y la evaluación directa de la condición del paciente, en lugar de confiar en una descripción verbal del problema del paciente a través de un intermediario1.
Otros (n = 8) declararon que una consulta cara a cara habría sido preferible o superior, porque el proceso de telemedicina no permitió el mismo grado de interacción personal, con respecto a si el paciente o cuidador tenía alguna pregunta (1).
Se consideró que el “asesor remoto” (médico consultor) tomaba la iniciativa en el proceso de telemedicina (n=7), hecho relacionado con su antigüedad y experiencia, a pesar de no estar presente físicamente (1).
Los autores concluyen que, aunque la telemedicina fue bien aceptada por muchos participantes, su uso añadió una capa adicional de complejidad a la consulta por accidente cerebrovascular agudo. Describen que la naturaleza «remota» de la consulta planteó desafíos para algunos pacientes y que estos problemas se pueden mejorar con información clara para pacientes y cuidadores, habilidades interpersonales del personal y trabajo en equipo (1).
Referencia
1. Gibson J, Lightbody E, McLoughlin A, McAdam J, Gibson A, Day E, Fitzgerald J, May C, Price C, Emsley H, Ford GA, Watkins C. ‘It was like he was in the room with us’: patients’ and carers’ perspectives of telemedicine in acute stroke. Health Expect. 2016 Feb; 19(1):98-111.
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de valores y 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 |
|---|
No favorece la intervención ni la comparación: Considerando que la intervención es «realizar trombólisis intravenosa asistida por neurólogo a través de telemedicina» y la comparación es «realizar trombólisis intravenosa por neurólogo presencial», el equipo elaborador de la Guía opinó que la costo-efectividad no favorece ninguna de las dos alternativas.
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 |
|---|
Ahorros extensos: El equipo elaborador de la Guía consideró que al «realizar trombólisis intravenosa asistida por neurólogo a través de telemedicina» se generan ahorros grandes si es que se compara con los costos de «realizar trombólisis intravenosa por neurólogo presencial», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.
Evidencia de investigación
Tabla. Precios referenciales*
|
Ítem |
Trombólisis asistida neurólogo a través de telemedicina |
Trombólisis (Sin asistencia por neurólogo a través de telemedicina) |
|
TROMBÓLISIS |
$ 2.632.0301
|
$ 2.632.0301
|
|
Trombólisis intravenosa: Alteplase 50 mg (Actilyse) $1.046.5942 (Caja con 2 sets completos para el tratamiento fibrinolítico. Cada set contiene: 1 vial con 50 mg de alteplasa+ 1 vial con 50 cc de agua estéril para inyectables + 1 cánula de transferencia). Otros ítems trombólisis: $ 1.585.436 |
||
|
Evaluación por Neurólogo vía “Tele Accidente cerebrovascular “(Tele ACV)4 |
$ 76.9333** |
—– |
|
Total |
$ 2.708.963 |
$ 2.632.0301 |
*El porcentaje de cobertura del seguro de salud sobre el precio de la(s) prestación (es) sanitaria(s), dependerá del tipo de seguro de cada paciente.
**Sumatoria de costos directos de cada evaluación (RRHH, insumos, equipos) más costos indirectos.
Referencias
1. Arancel PPV 2018
2. Mercado público. Precio más IVA.
3. Matute J. Evaluación económica de la telemedicina en pacientes con ACV isquémico agudo en el Servicio de Urgencia Adulto del Hospital El Pino. Enero, 2017
4. Matute J, Medina V, Mansilla E, Figueroa T. Tele ACV en el Servicio de Salud Metropolitano Sur: Servicio de Urgencia Adulto del Hospital el Pino. Proyecto piloto pionero en búsqueda de la equidad en salud. Revista Chilena de Medicina Intensiva 2016; Vol 31(2): 82-83
2. Mercado público. Precio más IVA.
3. Matute J. Evaluación económica de la telemedicina en pacientes con ACV isquémico agudo en el Servicio de Urgencia Adulto del Hospital El Pino. Enero, 2017
4. Matute J, Medina V, Mansilla E, Figueroa T. Tele ACV en el Servicio de Salud Metropolitano Sur: Servicio de Urgencia Adulto del Hospital el Pino. Proyecto piloto pionero en búsqueda de la equidad en salud. Revista Chilena de Medicina Intensiva 2016; Vol 31(2): 82-83
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 |
|---|
Ningún estudio incluido: No se encontraron estudios que respondieran la preguntan de interés.
Consideraciones Adicionales
La evidencia que existe respecto a la telemedicina para personas con ACV es en el manejo integral y no para la asistencia a la trombólisis, por lo tanto, el panel la descarta ya que no responde a la pregunta.
9.- ¿Cuál sería el impacto en equidad en salud?
| Reducido | Probablemente reducido | Probablemente ningún impacto | Probablemente aumentado | Aumentado | Varía | No lo sé |
|---|
Aumentada: El equipo elaborador de la Guía consideró que la equidad en salud aumentaría si se recomendase «realizar trombólisis intravenosa asistida por neurólogo a través de telemedicina», 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 | Sí | Varía | No lo sé |
|---|
Sí: El equipo elaborador de la Guía consideró que «realizar trombólisis intravenosa asistida por neurólogo a través de telemedicina» 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 |
|---|
Sí: El equipo elaborador de la Guía consideró que «realizar trombólisis intravenosa asistida por neurólogo a través de telemedicina» SÍ es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.