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From evidence to Policy: Paediatric guideline development in Kenya Mercy Mulaku
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Outline Hierarchy of clinical evidence GRADE system Evidence to recommendations Kenyan Experience
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Hierarchy of clinical evidence Systematic reviews Randomised controlled trials Observational studies Clinical experience High Low Quality of evidence: the extent to which one can be confident that an estimate of effect or association is correct
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Traditional way of formulating guidelines Based on expert opinion
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3. Variable capacity to implement the new standard
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What is GRADE? G rading of R ecommendations; A ssessment, D evelopment, and E valuation.
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Who uses GRADE?
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Certainty of evidence GRADE system – a robust system for: 1.Assessing the certainty of evidence – How confident are we that the research is correct? 2.Moving from evidence to making recommendations – Consider other factors: balance of benefits and harms, feasibility, costs, values and preferences Grading of Recommendation, Assessment, Development and Evaluation
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Levels of quality of evidence HIGH MODERATE LOW VERY LOW
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Components determining quality Randomised controlled trials start high Observational studies start low Methodological limitations Inconsistency of results Indirectness of evidence Imprecision of results Publication bias What lowers certainty of evidence? 5 factors:
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Linking evidence to recommendations Research evidence alone never sufficient to make a clinical decision Evidence + Judgement recommendations – Balance of benefits, risks – to patients, staff? – Costs? – Feasibility? – Acceptability, preferences – to patients, staff?
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Approach to developing Kenyan National Guidelines (1) Topic identification – Informal process Systematic review – Contextualised SR and narrative – GRADE summary of findings tables – Panels provided with SR and key publications 4 weeks before the panel meeting
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Guideline Panel Meeting, April 2013 Three multidisciplinary panel (N~~20) – Policymakers, topic experts, researchers, clinicians – Guideline methodologists, external observers Panels invited by Ministry of Health (MoH) & KPA 12 weeks before event and tasks explained
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Summarised evidence – 2 systematic reviews and 8 randomised controlled trials; – Moderate to high quality evidence indicate that cord cleansing with 4% chlorhexidine may reduce the risk of neonatal mortality and sepsis in low-resource settings
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Evidence to recommendation Chlorhexidine for cord care: For hospital births (gestation >28 weeks, birth weight >1000 g) – Apply 4% active Chlorhexidine to the umbilical cord immediately after birth and thereafter daily till the cord separates; – Recommendation based on moderate quality evidence
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Summarised evidence – 1 systematic review (n=26 studies), 2 randomised controlled trials (n=354 children), 14 observational studies and 2 National Institute of Health reports; – Hydroxyurea may improve morbidity and haematological outcomes in childhood sickle cell disease and appears safe in settings able to provide consistent haematological monitoring
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Evidence to recommendation Hydroxyurea should be considered for use in children below 5 years with severe form of sickle cell disease where minimum monitoring conditions and appropriate formulation are available; Recommendation based on low quality of evidence
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Summarised evidence – 6 studies were included (2 RCTs, 4 observational studies); – Only one study was from a low-income country (FEAST 2011 trial, N=3141 children); – This large study provides robust evidence that in low-income settings fluid boluses increase mortality in children with severe febrile illness and impaired circulation
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Evidence to recommendation In children with severe febrile illness and impaired circulation without signs of severely impaired circulation maintain hydration with appropriate maintenance fluids – Do not give a rapid fluid bolus; – Recommendation based on high quality evidence
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Acknowledgement Prof. Mike English Prof. Paul Garner Dr. Dave Sinclair
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