GRADE en el programa nacional de
Guías de Práctica Clínica
Pablo Alonso, Centro Cochrane Iberoamericano, IBB Sant Pau.
¿De qué hablaré?¿De qué hablaré?
• Las experiencias GRADE en el ámbito
internacional
• Las experiencias GRADE en nuestro
P...
Amplia aceptación internacionalAmplia aceptación internacional
Serie para usuarios en el BMJ (2008). Versión disponible en castellano.
Serie para elaboradores de GPC en el JCE (2011).
Contexto internacionalContexto internacional
• NICE (National Institute for Health and
Clinical Excellence)
• SIGN (Scotti...
NICENICE
• NICE utilizaba el sistema SIGN
• Piloto inicial con tres guías
• Introducción GRADE desde 2007
• Utiliza fundam...
NICENICE
• Necesidad de formación y requirió tiempo para cambiar
a un modelo más transparente y estructurado
• No más tiem...
indirectness
NICE: cáncer colorectalNICE: cáncer colorectal
Pantallazo SIGN
Metodología SIGNMetodología SIGN
BMJ 2001; 323:334-337
SIGN y GRADESIGN y GRADE
• Similitudes
– Priorizan el uso de revisiones sistemáticas
– Formato PICO
– Diferencian entre ca...
Systematic review
Guideline development
P
I
C
O
Outcome
Outcome
Outcome
Outcome
Formulate question
Rate importance
Critica...
Experiencia de SIGN conExperiencia de SIGN con
GRADEGRADE
• Dos guías en marcha
• Actualizaciones (osteoporosis y cáncer m...
Experiencia de SIGN conExperiencia de SIGN con
GRADEGRADE
• Coexistencia de dos sistemas potencial pero inevitable
problem...
Colaboración CochraneColaboración Cochrane
• Organización dedicada a la elaboración y
difusión de revisiones sistemáticas ...
heparin compared to no heparin for patients with cancer who have no other therapeutic or prophylactic indication for antic...
GRADEproGRADEpro
• Software de acceso libre
• Permite elaborar tablas resumen
• Para las GPC: Evidence Profile
• Para las ...
heparin compared to no heparin for patients with cancer who have no other therapeutic or prophylactic indication for antic...
Evidence profileEvidence profile
Quality assessment No of patients Effect
Qualit
y
ImportanceNo. of
studi
es
Design Limita...
GRADEproGRADEpro
Futuros desarrollos:
• Desarrollo módulo diagnóstico
• Desarrollo tabla para la formulación de
recomendac...
DECIDEDECIDE
Developing and Evaluating Communication Strategies to Support
Informed Decisions and Practice Based on Eviden...
Screen shot 3
Screen shot 2
¿Y en nuestro entorno?¿Y en nuestro entorno?
¿Y en nuestro¿Y en nuestro entornoentorno??
• Inicialmente SIGN
• Debate en el 2006
– GRADE todavía inmaduro
– Ambos, SIGN...
Métodos INTERVENCIÓN PARTICIPANTES VARIABLES COMENTARIOS
Autor/año:
Gelband 2000
País:
Objetivo:
Evaluar la eficacia
de re...
Quality assessment
Summary of findings
Importan
ce
No of patients Effect
QualityNo of
studi
es
Design
Limitat
ions
Inconsi...
Test findings
Range of sensitivity Best: 0.74 Worst: 0.09
Range of specificity Best: 1 Worst: 0.84
Consequences (number pe...
GPC TuberculosisGPC Tuberculosis
¿Es GRADE realmente¿Es GRADE realmente
necesario en Programa?necesario en Programa?
VirtudesVirtudes
• Transparente y estructurado
• Aborda limitaciones previas de otros sistemas
– Graduar la importancia de...
VirtudesVirtudes
• Adopción en el ámbito internacional
– Amplia difusión (sintonía con el resto) y experiencias
positivas
...
DificultadesDificultades
• Sistema en evolución
• Complejo, mayor tiempo (curva aprendizaje)
• ¿Mayor coste?
• ¿Mayor tiem...
En resumenEn resumen
• GRADE es un sistema riguroso, explícito y transparente
con amplia aceptación internacional
• Las ex...
Elaboración de recomendaciones en GPC. Sistema GRADE 2
Elaboración de recomendaciones en GPC. Sistema GRADE 2
Elaboración de recomendaciones en GPC. Sistema GRADE 2
Elaboración de recomendaciones en GPC. Sistema GRADE 2
Elaboración de recomendaciones en GPC. Sistema GRADE 2
Elaboración de recomendaciones en GPC. Sistema GRADE 2
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Elaboración de recomendaciones en GPC. Sistema GRADE 2

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Presentación realizada por Pablo Alonso Coello, miembro del Centro Cochrane Iberoamericano sobre la utilización del sistema GRADE para la elaboración de recomendaciones en guías de práctica clínica. Presentación realizada en la Jornada Cienfífica de GuíaSalud 2011 "Avances en el desarrollo de Guías de Práctica Clínica"
Portal GuíaSalud http://www.guiasalud.es

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  • It’s a wee bit difficult to separate out generic problems from those that are specific to our organisation / staff. One thing I think is important to note is that in some ways it is harder to get people to change if you have an established methodology than if they are starting something new. Anyway, here are the main issues that we have had to overcome as far as I can see.
     
    1.       I have found it very difficult to get people to understand that systematic reviews are not in themselves regarded as a level of evidence under GRADE, but the means by which evidence is collected and reviewed for any question we address. It is the shift from thinking about reviews as an entity to thinking about what they contain that seems to be the problem. This leads on to the next point.
    2.       Once you start looking at reviews in terms of their conclusions or outcomes, questions arise about what you do when there are multiple reviews either completely or partially answering your question. Unless you have the resources to do a full review of reviews, working out a solution to this problem is not easy. There are also issues about if / when / how you update existing reviews that are a few years old.
    3.       Getting people to think in terms of outcomes can be problematical. Either they can’t agree, or they come up with dozens of potential outcomes. This can be addressed through using more formal methods of reaching consensus, but even then it has not been easy getting people to understand the difference between critical and important outcomes.
    4.       The material that is coming out from GRADE, particularly the JCE series, is very useful but very heavy on detail. Some of the detail is essential, some of it is important only in some situations – even some rare situations. When working with practising healthcare workers who have little knowledge or experience of methodology, it is tricky deciding what they HAVE to know about, and what is just potentially useful information should the situation arise.
    5.       Getting guideline panel members to understand the process and why they are doing things at a particular stage is challenging. Either you try to explain the whole process, and risk getting them bogged down, or you just explain whatever stage they are currently at, in which case they start wondering where it is all leading... (Holger’s presentation at Cochrane included a really excellent slide setting out the process, BTW).
    6.       Overall, I think the problems can be overcome. At the end of the day we are not really trying to do anything that should not have been covered by our old methodology, just being more rigorous and transparent. Once people have worked through the complete process things get a lot clearer, and they can get to grips with the process and make it work. Certainly a major problem for our staff is envisaging what the end result will look like. We are working on that though.
    We have two groups working with GRADE – one updating our osteoporosis guideline, the other updating breast cancer. They will be published based on GRADE. Guidelines starting after they have reached the peer review stage (to give us time to digest lessons from these two) should all be using GRADE. (We are actually running an evaluation of GRADE using breast cancer and lung cancer. The groups are running in parallel and we plan to assess the impact of the new process. This work is being led by an external academic, who is a member of SIGN Council. The outcome will not be to abandon GRADE, but to apply lessons learned to future work).
     
    The use of Gradepro is still under debate. I think we should, at least to establish the quality of evidence, and that it will make the later stages of the process easier. Others have still to be convinced, but I think experience will suggest using Gradepro is a good idea. We are also planning to start using RevMan for our reviews as this will make it easier to develop evidence ready to feed into Gradepro.
     
    This is an interesting question! Once we have completed a guideline using GRADE, all guidelines starting thereafter will use GRADE as well. We will wind up that all guidelines from SIGN 1nn onwards will use it. There are more complex issues when we come to asthma, which we run along with the British Thoracic Society as a living guideline – ie it is constantly updated. Inevitable, we will wind up with some sections using GRADE and others based on our existing system during a transition period that might cover a few years. There is clearly scope for confusion there, and this is something we have yet to resolve. There will be a similar problem when we partially update some guidelines. I’m not sure yet how we will resolve that.
     
  • Debate con los responsables de elaboración de las guías de las agencias que participan en el Programa de Guías del SNS y como resultado de este debate presentamos las siguientes reflexiones
  • Elaboración de recomendaciones en GPC. Sistema GRADE 2

    1. 1. GRADE en el programa nacional de Guías de Práctica Clínica Pablo Alonso, Centro Cochrane Iberoamericano, IBB Sant Pau.
    2. 2. ¿De qué hablaré?¿De qué hablaré? • Las experiencias GRADE en el ámbito internacional • Las experiencias GRADE en nuestro Programa • Necesidad de GRADE en el Programa Nota: como conflicto de interés, soy miembro del grupo GRADE.
    3. 3. Amplia aceptación internacionalAmplia aceptación internacional
    4. 4. Serie para usuarios en el BMJ (2008). Versión disponible en castellano.
    5. 5. Serie para elaboradores de GPC en el JCE (2011).
    6. 6. Contexto internacionalContexto internacional • NICE (National Institute for Health and Clinical Excellence) • SIGN (Scottish Intercollegiate Guidelines Network): sistema propio • Colaboración Cochrane
    7. 7. NICENICE • NICE utilizaba el sistema SIGN • Piloto inicial con tres guías • Introducción GRADE desde 2007 • Utiliza fundamentalmente para evaluar la calidad de la evidencia • Todavía no en preguntas diagnósticas
    8. 8. NICENICE • Necesidad de formación y requirió tiempo para cambiar a un modelo más transparente y estructurado • No más tiempo que el sistema narrativo habitual que usaban • Evaluación interna: – Experiencia positiva para metodólogos y miembros de los grupos – Transparente, estructurado y sistemático – Tablas fáciles de interpretar (tras recibir formación) y más útiles que el texto. • Identifican áreas de mejora (Imprecisión, network metanálisis, estudios no aleatorizados/Dcos)
    9. 9. indirectness NICE: cáncer colorectalNICE: cáncer colorectal
    10. 10. Pantallazo SIGN
    11. 11. Metodología SIGNMetodología SIGN BMJ 2001; 323:334-337
    12. 12. SIGN y GRADESIGN y GRADE • Similitudes – Priorizan el uso de revisiones sistemáticas – Formato PICO – Diferencian entre calidad y fuerza • Diferencias • Graduación importancia de variables de resultado • Evaluación de la calidad por variable de resultado • En GRADE diseño no determina completamente la calidad • Juicios secuenciales, estructurados y explícitos
    13. 13. Systematic review Guideline development P I C O Outcome Outcome Outcome Outcome Formulate question Rate importance Critical Important Critical Not important Create evidence profile with GRADEpro Summary of findings & estimate of effect for each outcome Grade overall quality of evidence across outcomes based on lowest quality of critical outcomes Randomization increases initial quality 1. Risk of bias 2. Inconsistency 3. Indirectness 4. Imprecision 5. Publication bias GradedownGradeup 1. Large effect 2. Dose response 3. Confounders Rate quality of evidence for each outcome Select outcomes Very low Low Moderate High Formulate recommendations: •For or against (direction) •Strong or conditional/weak (strength) By considering: Quality of evidence Balance benefits/harms Values and preferences Revise if necessary by considering: Resource use (cost) • “We recommend using…” • “We suggest using…” • “We recommend against using…” • “We suggest against using…” Outcomes across studies
    14. 14. Experiencia de SIGN conExperiencia de SIGN con GRADEGRADE • Dos guías en marcha • Actualizaciones (osteoporosis y cáncer mama) • Después todas con GRADE • Proceso evaluado internamente • Dificultad intrínseca de cambiar teniendo sistema previo • Al evaluar por variable de resultado hay que realizar RS propias (más tiempo!) • Dificultades graduando las variables de resultado
    15. 15. Experiencia de SIGN conExperiencia de SIGN con GRADEGRADE • Coexistencia de dos sistemas potencial pero inevitable problema • A menudo demasiado complejo para los clínicos (ellos se implican a todos los niveles) • Algunas dificultades con GRADEpro pero piensan que es necesario • Van a utilizar RevMan para sus RS • GRADE incluye factores similares a SIGN pero de forma más estructurada y explícita
    16. 16. Colaboración CochraneColaboración Cochrane • Organización dedicada a la elaboración y difusión de revisiones sistemáticas (RS) – Las RS son un ingrediente fundamental de las guías – Adoptó GRADE para evaluar la calidad de la evidencia • Incluye tabla de síntesis GRADE (Summary of Findings) • Sinergia clara con los elaboradores de guías
    17. 17. heparin compared to no heparin for patients with cancer who have no other therapeutic or prophylactic indication for anticoagulation Patient or population: patients with cancer who have no other therapeutic or prophylactic indication for anticoagulation Settings: outpatient Intervention: heparin Comparison: no heparin Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) No of Participants (studies) Quality of the evidence (GRADE) Comments Assumed risk Corresponding risk No heparin Heparin Mortality Follow-up: 12 months Medium risk population RR 0.93 (0.85 to 1.02) 2531 (8 studies) ⊕⊕⊕⊝ moderate1,2,3 649 per 1000 604 per 1000 (552 to 662) Symptomatic VTE Follow-up: 12 months Medium risk population RR 0.55 (0.37 to 0.82) 2264 (7 studies) ⊕⊕⊕⊕ high1 29 per 1000 16 per 1000 (11 to 24) Major bleeding Follow-up: 12 months Medium risk population RR 1.3 (0.59 to 2.88) 2843 (9 studies) ⊕⊕⊕⊝ moderate1,4 7 per 1000 9 per 1000 (4 to 20) Minor bleeding Follow-up: 12 weeks Medium risk population RR 1.05 (0.75 to 1.46) 2345 (7 studies) ⊕⊕⊕⊝ moderate1,4 27 per 1000 28 per 1000 (20 to 39) Health related quality of life the Uniscale and the Symptom Distress Scale (SDS); Better indicated by lower values Follow-up: 12 months See comment See comment Not estimable5 138 (1 study) ⊕⊕⊝⊝ low6 *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 Vast majority of studies had allocation concealment , and used blinded outcome and adjudication. We did not downgrade although there was some concern about lack of blinding in some studies; the overall risk of bias was felt to be very low. 2 There is moderate heterogeneity among studies included in the analysis of death at 12 months (I2=41%). The subgroup analysis for mortality at 12 months was statistically significant and suggested survival benefit in patients with SCLC but not in patients with advanced cancer. Overall we decided to downgrade by one level when considering these issues along with imprecision. 3 CI interval includes effects suggesting benefit as well as no benefit. 4 CI includes possibility of both harms or benefits. 5 The scores for the 2 scales were similar for the 2 study groups, both at baseline and at follow-up 6 High risk of bias and only 138 patients enrolled.
    18. 18. GRADEproGRADEpro • Software de acceso libre • Permite elaborar tablas resumen • Para las GPC: Evidence Profile • Para las RS: Tabla Summary of Findings • Puede importar automáticamente la información de RS Cochrane (variables y resultados) • Permite optimizar la actualización
    19. 19. heparin compared to no heparin for patients with cancer who have no other therapeutic or prophylactic indication for anticoagulation Patient or population: patients with cancer who have no other therapeutic or prophylactic indication for anticoagulation Settings: outpatient Intervention: heparin Comparison: no heparin Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) No of Participants (studies) Quality of the evidence (GRADE) Comments Assumed risk Corresponding risk No heparin Heparin Mortality Follow-up: 12 months Medium risk population RR 0.93 (0.85 to 1.02) 2531 (8 studies) ⊕⊕⊕⊝ moderate1,2,3 649 per 1000 604 per 1000 (552 to 662) Symptomatic VTE Follow-up: 12 months Medium risk population RR 0.55 (0.37 to 0.82) 2264 (7 studies) ⊕⊕⊕⊕ high1 29 per 1000 16 per 1000 (11 to 24) Major bleeding Follow-up: 12 months Medium risk population RR 1.3 (0.59 to 2.88) 2843 (9 studies) ⊕⊕⊕⊝ moderate1,4 7 per 1000 9 per 1000 (4 to 20) Minor bleeding Follow-up: 12 weeks Medium risk population RR 1.05 (0.75 to 1.46) 2345 (7 studies) ⊕⊕⊕⊝ moderate1,4 27 per 1000 28 per 1000 (20 to 39) Health related quality of life the Uniscale and the Symptom Distress Scale (SDS); Better indicated by lower values Follow-up: 12 months See comment See comment Not estimable5 138 (1 study) ⊕⊕⊝⊝ low6 *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 Vast majority of studies had allocation concealment , and used blinded outcome and adjudication. We did not downgrade although there was some concern about lack of blinding in some studies; the overall risk of bias was felt to be very low. 2 There is moderate heterogeneity among studies included in the analysis of death at 12 months (I2=41%). The subgroup analysis for mortality at 12 months was statistically significant and suggested survival benefit in patients with SCLC but not in patients with advanced cancer. Overall we decided to downgrade by one level when considering these issues along with imprecision. 3 CI interval includes effects suggesting benefit as well as no benefit. 4 CI includes possibility of both harms or benefits. 5 The scores for the 2 scales were similar for the 2 study groups, both at baseline and at follow-up 6 High risk of bias and only 138 patients enrolled.
    20. 20. Evidence profileEvidence profile Quality assessment No of patients Effect Qualit y ImportanceNo. of studi es Design Limitations Inconsistenc y Indirectness Imprecision Other Cryotherapy LEEP Relative (95% CI) Absolute effect at 1 year (95% CI) Recurrence CIN2–3 (follow-up 12 months randomized trials; 3–85 months observational studies) 1 randomized trials no serious limitations no serious inconsistency no serious indirectness seriousa,b none 12/161 (7.5%) 4/168 (2.4%) OR 3.3 (1.04 to 10.46) 51 more per 1000 (from 1 to 179 more) ⊕⊕⊕Ο CRITICAL 3 observational studies no serious limitations no serious inconsistency no serious indirectness no serious imprecision none 2227/14 387 (15.5%) 319/7454 (4.3%) OR 2.66 (1.89 to 3.75) — ⊕⊕ΟΟ CRITICAL 2.4%c 37 more per 1000 (from 20 to 60 more) Cervical cancer (follow-up 12 months randomized trials; 3–85 months to 26 years observational studies) 1 randomized trials no serious limitations no serious inconsistency no serious indirectness very seriousa none 0/200 (0%) 0/200 (0%) — 0 fewer per 1000d ⊕⊕ΟΟ CRITICAL 2 observational studies no serious limitations no serious inconsistency no serious indirectness no serious imprecision none 2/679 (0.3%) 3/3350 (0.1%) — 0 fewer per 1000e ⊕⊕ΟΟ CRITICAL Treatment unacceptable to women (follow-up 2 weeks; acceptability question) 1 randomized trials no serious limitations no serious inconsistency no serious indirectness very seriousf none 15/170 (8.8%) 8/186 (4.3%) OR 2.15 (0.89 to 5.22) 45 more per 1000 (from 5 fewer to 147 more) ⊕⊕ΟΟ CRITICAL All severe adverse events (follow-up mean 12–16 months; stenosis and PID) 2 randomized trials no serious limitations no serious inconsistency no serious indirectness very seriousf none 3/300 (1%) 2/298f (0.67%) — 0.4 more per 1000 (from 8 fewer to 9 more) ⊕⊕ΟΟ CRITICAL All severe adverse events (follow-up 33 months; PID, plug syndrome, stenosis, blood transfusion) 5 randomized trials no serious limitations no serious inconsistency serioush serioush none 136 480 OR 0.53 (0.1 to 2.88) — ⊕⊕ΟΟ CRITICAL   4%i 18 fewer per 1000 (from 36 fewer to 67 more) All severe adverse events (follow-up 12 months; PID, stenosis, major bleeding) 9 observational studies serious limitationsj no serious inconsistency seriousi seriousf none 1/2233 (0%) 38/960 (4%)a — 10 fewer per 1000 (from 20 fewer to 0) ⊕ΟΟΟ CRITICAL Should cryotherapy versus LEEP be used in women with histologically confirmed CIN?
    21. 21. GRADEproGRADEpro Futuros desarrollos: • Desarrollo módulo diagnóstico • Desarrollo tabla para la formulación de recomendaciones • Compatible con ordenadores Mac • Herramienta de elaboración de GPC
    22. 22. DECIDEDECIDE Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence • Proyecto europeo sobre como optimizar la presentación de las recomendaciones (2010-2015) – Profesionales de la salud, pacientes, gestores (policy maker) • Objetivo es mejorar la diseminación de las GPC – Múltiples formatos (papel, móviles, tabletas, vídeos) • GRADEpro proporcionará diferentes formatos
    23. 23. Screen shot 3
    24. 24. Screen shot 2
    25. 25. ¿Y en nuestro entorno?¿Y en nuestro entorno?
    26. 26. ¿Y en nuestro¿Y en nuestro entornoentorno?? • Inicialmente SIGN • Debate en el 2006 – GRADE todavía inmaduro – Ambos, SIGN y GRADE, coexistirían en el manual metodológico • Escasa experiencia todavía – Tres guías con evidence profiles (un solo centro) – Satisfacción de los metodólogos y profesionales de la salud – Complejo (diagnóstico) y necesidad de atención al detalle
    27. 27. Métodos INTERVENCIÓN PARTICIPANTES VARIABLES COMENTARIOS Autor/año: Gelband 2000 País: Objetivo: Evaluar la eficacia de regímenes de corta duración para el tratamiento de la tuberculosis pulmonar activa Financiación: Pública (UK) y OMS. Diseño: Revisión sistemática de la literatura con metanàlisis (ECA) Búsqueda (años): Sin riesgo de sesgo Mayo 2004 (sin cambios desde 1999) Calidad global: ++ Grupos de comparación: Tratamientos de corta duración (< 6 meses) versus tratamientos de más duración Tipos de intervención: Estreptomicina Isoniazida Rifampicina Piracinamida (en diferentes combinaciones, dosis i pautas) Comparación: Pauta más corta con más larga. Duración de los estudios: de 3 a 12 meses Duración del seguimiento: De 1 a 5 años Estudios incluidos: ECA controlats amb tractament actiu. Criterios de inclusión: ECA que comparen 2 o más regímenes (uno de ellos de <6 meses de duración) de diferente duración. En pacientes con TB activa (baciloscopia, cultivo o Rx compatible). Criterios de exclusión: Regímenes de idéntica duración. N. de pacientes: 2200: tratamientos cortos 1900: tratamientos largos 2m vs >2m:529 3m vs >3m: 2588 4m vs >4m: 887 5m vs >5m: 390 Edad: La mayoría adultos (1 ECA > 15 años) Sexo: N.E Entre un 9% y un 16% de los pacientes presentaban TB resistente. AC incluidos: 7 ECA Principales: Recurrencia: (relapse) presencia de un cultivo de esputo positivo o baciloscopia con síntomas, tras los 12 meses de un tratamiento completo (u otro periodo más largo) Toxicidad: RAM que implique alteración del tratamiento Secundarias: Esterilización: cultivo negativo inmediatamente tras tratamiento Muerte DE LOS AUTORES: Las recurrencias tras los regímenes de corta duración fueron superiores de una forma consistente, en comparación a los de larga duración. Las tasas de esterilizaciones fueron muy elevadas en todos los casos. No hubo diferencias globales para la toxicidad. Los resultados son sobre los pacientes con un buen cumplimiento (superior al 75%), los resultados por ITT podrían favorecer los tratamiento de corta duración. DE LOS REVISORES: Son estudios antiguos y no todos comparan con el régimen corto más aceptado de 6 meses. Se usaron las pautas más comunes en ese momento. La revisión apunta que como más prolongada la pauta mejor. Las pérdidas son elevadas: del 10 al 23%. RESULTADOS GRADE Calidad de la evidencia Diseño y ejecución (sesgo): Alto riesgo de sesgo: ocultación de la secuencia no clara, no ciego, elevadas pérdidas, no ITT Consistencia: Evidencia directa: SI Sesgo de publicación: Improbable. Referencia: Gelband H. Regimens of less than six months for treating tuberculosis. Cochrane Database of Systematic Reviews 1999, Issue 4. Art. No.: CD001362. DOI: 10.1002/14651858.CD001362. Tabla síntesis de características principales de una RS GPC TuberculosisGPC Tuberculosis
    28. 28. Quality assessment Summary of findings Importan ce No of patients Effect QualityNo of studi es Design Limitat ions Inconsistency Indirectness Imprecision Other consideration s regimens of less than six months longer Relative (95% CI) Absolute relapse (3 months vs longer) (follow-up 12 to 70 months; bacteriológica y/o clínica3 ) 5 randomis ed trials serious1 no serious  inconsistency no serious  indirectness no serious  imprecision none 71/1290 (5.5%) 39/1298  (3%) RR 3.67  (2.42 to  5.58) 80 more per 1000  (from 43 more to  137 more) ⊕⊕⊕Ο MODER ATE CRITICA L toxicity (3 months or longer) (AE que requiere alteración o cese del tratamiento) 5 randomis ed trials serious1 serious4 no serious  indirectness no serious  imprecision none 178/1418  (12.6%) 200/1500  (13.3%) RR 1.09  (0.87 to  1.38) 12 more per 1000  (from 17 fewer to 51  more) ⊕⊕ΟΟ LOW IMPORT ANT relapse (4 months vs longer) (follow-up 5 to 8 years; bacteriológica y/o clínica3 ) 2 randomis ed trials serious1 no serious  inconsistency no serious  indirectness no serious  imprecision2 none 25/530 (4.7%) 4/357  (1.1%) RR 3.64  (1.71 to  7.75) 29 more per 1000  (from 8 more to 74  more) ⊕⊕⊕Ο MODER ATE CRITICA L toxicity (4 months vs longer) (AE que requiere alteración o cese del tratamiento) 1 randomis ed trials serious1 no serious  inconsistency no serious  indirectness serious5 none 113/879 (12.9%) 31/235  (13.2%) RR 0.97  (0.63 to  1.49) 4 fewer per 1000  (from 49 fewer to 65  more) ⊕⊕ΟΟ LOW IMPORT ANT relapse (5 months vs longer) (follow-up mean 24 months; bacteriológica y/o clínica3 ) 1 randomis ed trials serious1 no serious  inconsistency no serious  indirectness no serious  imprecision2 none 11/129 (8.5%) 11/261  (4.2%) RR 2.24  (0.9 to  5.59) 52 more per 1000  (from 4 fewer to 193  more) ⊕⊕⊕Ο MODER ATE CRITICA L Author(s): Gelband H. Date: 2008-07-02 Question: Should regimens of less than six months vs longer be used for tuberculosis treatment Bibliography: Regimens of less than six months for treating tuberculosis. The Cochrane Library 1999;(4):CD001362. GPC TuberculosisGPC Tuberculosis
    29. 29. Test findings Range of sensitivity Best: 0.74 Worst: 0.09 Range of specificity Best: 1 Worst: 0.84 Consequences (number per 1000) Baseline risk 38.7% Importance Best: Worst: True Positives 29 3 Critical Treu Negatives 961 807 Critical False Positives 0 154 Critical False Negatives 10 35 Critical GPC TuberculosisGPC Tuberculosis
    30. 30. GPC TuberculosisGPC Tuberculosis
    31. 31. ¿Es GRADE realmente¿Es GRADE realmente necesario en Programa?necesario en Programa?
    32. 32. VirtudesVirtudes • Transparente y estructurado • Aborda limitaciones previas de otros sistemas – Graduar la importancia de las variables de resultado – Evaluar la calidad por variable de resultado – Proceso estructurado para clasificar calidad y fuerza • Sistema vivo que va incorporando los avances en el campo metodológico – Diagnóstico – Network metanálisis
    33. 33. VirtudesVirtudes • Adopción en el ámbito internacional – Amplia difusión (sintonía con el resto) y experiencias positivas – El propio SIGN lo ha adoptado – Las RS Cochrane también • Software libre para elaborar materiales de trabajo (GRADEpro) – Tablas de síntesis útiles para la elaboración y actualización de las GPC – Importación automática de archivos Revman
    34. 34. DificultadesDificultades • Sistema en evolución • Complejo, mayor tiempo (curva aprendizaje) • ¿Mayor coste? • ¿Mayor tiempo de elaboración?
    35. 35. En resumenEn resumen • GRADE es un sistema riguroso, explícito y transparente con amplia aceptación internacional • Las experiencias actuales son positivas • Es más complejo por lo que requiere más tiempo y recursos • Es necesaria una implantación progresiva en el marco del Programa de GPC en el SNS – Mayor formación y quizás más recursos (quizás solo tiempos) – Cambio en la filosofía de las guías • Abordaje con preguntas clave • Plazos para su elaboración
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