Elaboración de recomendaciones en GPC. Sistema GRADE
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Elaboración de recomendaciones en GPC. Sistema GRADE

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Presentación realizada por Nicola Magrini, Director del Centro de evaluación de efectividad de cuidados en salud del Sistema Nacional de Salud de Italia, sobre el uso del Sistema GRADE para la......

Presentación realizada por Nicola Magrini, Director del Centro de evaluación de efectividad de cuidados en salud del Sistema Nacional de Salud de Italia, sobre el uso del Sistema GRADE para la elaboración de 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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  • 1. Elaboración de recomendaciones en las GPC Sistema GRADE Nicola MagriniNHS CeVEAS, Centre for the Evaluation of the Effectiveness of Health Care, Modena, Italy WHO Collaborating Centre for Evidence Based Research Synthesis and Guideline Development
  • 2. Contents of the presentation• What are the defects of existing guidelines and systems of grading• Why GRADE could help …• A three pillar method: the GRADE system to evaluate quality of evidence and define the strength of a recommendation• Three examples• Conclusions
  • 3. Contents of the presentation• What are the defects of existing guidelines and systems of grading• Why GRADE could help …• A three pillar method: the GRADE system to evaluate quality of evidence and define the strength of a recommendation• Three examples• Conclusions
  • 4. http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp 2011
  • 5. Tendency of recent guidelines
  • 6. Trends in guideline production (AHA guidelines, Tricoci JAMA 2009)• Recommendations are increasing in size with every update (+48% form first version)• Quality of evidence: only a minority of recommendations are based on good evidence (11%) and half (48%) on low quality evidence• Recommendations with high quality evidence are mostly concentrated in class I (strong recommendation) but only 245 of 1305 class I recommendations have high quality evidence (median, 19%)
  • 7. Guidelines reassessment …• … in ACC/AHA guidelines with at least 1 revision, the number of recommendations increased 48% from the first guideline to the most recent version. If there is a main message in such guidelines, it is likely to be lost in the minutiae.• Within a guideline document, individual recommendations also need to be prioritized.• Finally, guidelines need flexibility. Recommendations should vary based on patient comorbidities, the health care setting, and patient values and preferences.• Physicians would be better off making clinical decisions based on valid primary data. Shaneyfelt TM, Centor RM. Reassessment of clinical practice guidelines JAMA 2009
  • 8. How to improve guideline qualityPresent limitations:• Governance and composition of the guideline committee (“what is to be decided is often already decided with the selection of the deciders”)• Unanimity in guideline (not a natural component in research)• Lack of independent review (outside the accepted procedures of scientific publications)• Suboptimal management of Conflicts of interests Sniderman AD, Furberg CD. Why guidelines making requires reform JAMA 2009
  • 9. Too many grading systems? Who is confused?Recommendation for use of oralanticoagulation in patients with atrialfibrillation and rheumatic mitral valvediseaseEvidence Recommendation OrganizationB Class I AHAC+ 1 ACCPIV C SIGN
  • 10. Contents of the presentation• What are the defects of existing guidelines and systems of grading• Why GRADE could help …• A three pillar method: the GRADE system to evaluate quality of evidence and define the strength of a recommendation• Three examples• Conclusions
  • 11. Why using GRADEGRADE is much more than a rating system• offers a transparent and structured process for developing and presenting summaries of quality of evidence• provides guideline developers with a comprehensive and transparent framework for carrying out the steps involved in developing recommendations• specifies an approach to framing questions, choosing outcomes of interest and rating their importance, evaluating the evidence, and incorporating evidence with considerations of values and preferences of patients and society to arrive at recommendations
  • 12. WHO guidelinedevelopment processesupdate 2010
  • 13. Title, responsible person, WHO Department - responsible of the clearance process, WHO Departments involved, CC involved,1. Scoping the document: reasons for choosing the topic, problems with existing guidelines, variations and gaps, Reporting standard and process 2. Group composition (or consultations) 3. Conflict of interest 4. Formulations of the questions and choice of the relevant outcomes 5. Evidence retrieval, evaluation and synthesis (balance sheet, evidence table) Standards for evidence: GRADE system6. Benefit/risk profile: integrating evidence with values and preferences, equity and costs 7. Formulation of the recommendations 8. Implementation and evaluation of impact 9. Research needs or areas of further research Reporting standard and process 10. Peer-review process and updating
  • 14. GRADE Working Group website and publicationswww.gradeworkinggroup.org
  • 15. Contents of the presentation• What are the defects of existing guidelines and systems of grading• Why GRADE could help …• A three pillar method: the GRADE system to evaluate quality of evidence and define the strength of a recommendation• Three examples• Conclusions
  • 16. GRADE: a 3 pillars approach1. Formulate the question, choose and rate your outcomes of interest and perform a systematic review (quality of evidence)2. Risk benefit evaluation, consider patients values and preferences and also resource use and feasibility3. Direction (positive/negative) and strength (strong/weak) of the recommendation
  • 17. GRADE: a 3 pillars approach1. Formulate the question, choose and rate the outcomes of interest and perform a systematic review (quality of evidence)2. Risk benefit evaluation, consider patients values and preferences and also resource use and feasibility3. Strength of the recommendation
  • 18. Interpretation of quality of evidenceHigh quality— Further research is very unlikely tochange our confidence in the estimate of effectModerate quality— Further research is likely tohave an important impact on our confidence in theestimate of effect and may change the estimateLow quality— Further research is very likely to havean important impact on our confidence in theestimate of effect and is likely to change theestimateVery low quality— Any estimate of effect is veryuncertain
  • 19. Figure 1: Hierarchy of outcomes according to their patient-importance to assess the effect of enteral supplement nutrition for geriatric patients with bed sores Rating of Importance outcomes of endpoints Mortality 9 Critical Healing of the 8 for decision making bedsore … example: Quality of life 7patient with Function 6 Important, bed sores 5 but not critical for decision making Nutritional status 4 Energy supply 3 2 Not patient-important Microcirculation of the wound 1
  • 20. WHO Recommendations for the Prevention of PPH, 2007
  • 21. WHO Recommendations for the Prevention of PPH, 2007
  • 22. Study design is importantEarly systems of grading the quality of evidencefocused almost exclusively on study designRandomised trials provide, in general, strongerevidence than observational studies: –RCTs start at High Quality –Observational studies start at Low QualityHowever, other factors may decrease or increasethe quality of evidence
  • 23. Quality assessment criteria: the big start
  • 24. Factors that may decrease the quality of evidenceStudy limitations (risk of bias) well established – concealment – intention to treat principle observed – blinding – completeness of follow-up – Choice of comparator (standard/optimal treatment) more recent – early stopping for benefit – selective outcome reporting bias
  • 25. Factors that may decrease the quality of evidenceStudy limitations (risk of bias)Inconsistency among studiesIndirectness of evidenceImprecise resultsReporting bias
  • 26. of ion es s ile lity r est s ce om tudie e at e p rof ro ua e q ce fo e me tc RCT start high, qu tco or tan Ou oss s Cre denc ADEp t Ra den tcom te ula ct ou imp acr evi h GR evi h ou obs. data start low rm ele ate wit ea c Fo S R Grade down 1. Risk of bias P Outcome Critical High 2. Inconsistency I Outcome Critical Moderate 3. Indirectness Low 4. Imprecision C Outcome Important 5. Publication bias Very low O Outcome Not im po rta Summary of findings nt 1. Large effect Grade up & estimate of effect 2. Dose for each outcome responseEvidence synthesis (systematic review) 3. Confounders Rate overall quality of evidence across outcomes based on lowest quality of critical outcomes
  • 27. GRADE: a 3 pillars approach1. Formulate the question, choose and rate your outcomes of interest and perform a systematic review (quality of evidence)2. Risk benefit evaluation, consider patients values and preferences and also resource use and feasibility3. Strength of the recommendation
  • 28. Determining the benefit risk profile: positive/uncertain/unfavourableFactors Impact on the strength of a recommendationBalance between Larger the difference between the desirable and desirable and undesirable effects, more undesirable likely a favourable benefit But effects differences can arise depending on the severuty of adverse eventsValues and More variability in values and preferences preferences, or more uncertainty in values and preferences, more likely an unfavourable profile.Costs (resource Higher the costs of an intervention – that use) is, the more resources consumed – less likely a favourable profile.
  • 29. GRADE Step 2: risk benefit profile,values and preferences (1/3)
  • 30. GRADE Step 2: risk benefit profile,values and preferences (2/3)
  • 31. GRADE Step 2: risk benefit profile,values and preferences (3/3)
  • 32. GRADE: a 3 pillars approach1. Formulate the question, choose and rate your outcomes of interest and perform a systematic review (quality of evidence)2. Risk benefit evaluation, consider patients values and preferences and also resource use and feasibility3. Strength of the recommendation
  • 33. Strength of recommendationThe degree of confidence that the desirable effects of adherence to a recommendation outweigh the undesirable effects.Desirable effects Undesirable effects•health benefits •harms•less burden •more burden•savings •costs
  • 34. Categories of recommendationsAlthough the degree of confidence is a continuum, we suggest using two categories: strong and weak. Strong recommendation: the panel is Recommend confident that the desirable effects of adherence to a recommendation outweigh the undesirable effects. Weak recommendation: the panel Suggest concludes that the desirable effects of adherence to a recommendation probably outweigh the undesirable effects, but is not confident.
  • 35. Why Grade Recommendations?Strong recommendations– strong methods– large precise effect– few down sides of therapyWeak recommendations– weak methods– imprecise estimate– small effect– substantial down sides
  • 36. of ion es s ile lity r est s ce om tudie e at e p rof ro ua e q ce fo e me tc RCT start high, qu tco or tan Ou oss s Cre denc ADEp t Ra den tcom te ula ct ou imp acr evi h GR evi h ou obs. data start low rm ele ate wit ea cFo S R Grade down 1. Risk of bias P Outcome Critical High 2. Inconsistency I Outcome Critical Moderate 3. Indirectness Low 4. Imprecision C Outcome Important 5. Publication bias Very low O Outcome Not im po rta Summary of findings nt 1. Large effect Grade up & estimate of effect 2. Dose for each outcome responseEvidence synthesis (systematic review) 3. Confounders Making recommendations (guidelines) RateFormulate recommendations: overall quality of evidence•For or against (direction) across outcomes based on•Strong or weak (strength) lowest quality By considering: of critical outcomes Quality of evidence Balance benefits/harms • “We recommend using…” Values and preferences • “We suggest using…”Revise if necessary by considering: • “We recommend against using…” Resource use (cost) • “We suggest against using…”
  • 37. Contents of the presentation• What are the defects of existing guidelines and systems of grading• Why GRADE could help …• A three pillar method: the GRADE system to evaluate quality of evidence and define the strength of a recommendation• Three examples• Conclusions
  • 38. Recommendations using GRADE: Example 1 A flexible method: quality of evidence independentfrom strength of recommendation
  • 39. WHO avian flu guideline 2006 Schünemann HJ et al. Lancet Infect Dis 2007;7:21-31
  • 40. WHO Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence (2009)For opioid agonist maintenance treatment, most patients should be advised to use methadone in adequate doses in preference to buprenorphine. – Strength of recommendation – Strong – Quality of evidence – HighOn average, methadone maintenance doses should be in the range of 60–120 mg per day. – Strength of recommendation – Strong – Quality of evidence – Low
  • 41. Recommendations using GRADE: Example 2Taking into account values andpreferences … and local context
  • 42. Values and preferencesStroke guideline: patients with TIA clopidogrel over aspirin (Grade 2B).Underlying values and preferences: This recommendation to use clopidogrel over aspirin places a relatively high value on a small absolute risk reduction in stroke rates, and a relatively low value on minimizing drug expenditures.
  • 43. Values and preferencesperipheral vascular disease: aspirin be used instead of clopidogrel (Grade 2A).Underlying values and preferences: This recommendation places a relatively high value on avoiding large expenditures to achieve small reductions in vascular events.
  • 44. Recommendations using GRADE: Example 3 Weak recommendations …a blurred vision or a clear one?
  • 45. Recommendations and expected adoption rate Strength Expected Definition and implications adoption rateStrong The drugs/interventions should offered to the vast majority of > 60-70%positive patients and could be used as an indicator of good quality of care It has the wider range of uncertainty since it could mean only for a minority of patients (30%) or for a good proportion of them (50-Weak 60%). It is necessary to inform patients of the expected benefits 30-60%positive and risks (and their magnitude), explore patients values and discuss potential alternative treatments In selected cases or a defined minority. The decision should goWeak along with a detailed information to patient of the benefit risk profile 5-30%negative (magnitude), patients values and expectations and the presentation of potential alternative treatments It should not be used neither routinely nor for a subgroup. Only inStrong few very selected (and documented) cases can be used since the < 5%negative benefit/risk balance is negative/unknown and available alternative are preferable
  • 46. Contents of the presentation• What are the defects of existing guidelines and systems of grading• Why GRADE could help …• A three pillar method: the GRADE system to evaluate quality of evidence and define the strength of a recommendation• Three examples• Conclusions
  • 47. GRADE … in short• Have an overall view of the process (see WHO), a good- enough mandate and some governance of relevant CoI• Make just a few (a reasonable number of) recommendations• Use systematic reviews (if not available, review key, accessible evidence) – DO NOT meta-analyse if not done• Use GRADE criteria for quality of evidence• Explain the reasons supporting the strength of recommendations, including the benefit/risk profile and values and preferences• … just be (more) transparent
  • 48. Because what you told me is Yes, absolutely how did You must but correct Whereyou be a completely amknow? I? Because you researcher useless don’t know where you are, you 30 You’re You must Yes. don’t knowmetres where be a policy How you’re going, and above the maker you did now you’re in a ground know? blaming me balloonfrom: Jonathan Lomas, 2008