From evidence to Policy: Paediatric guideline development in Kenya Mercy Mulaku

Outline Hierarchy of clinical evidence GRADE system Evidence to recommendations Kenyan Experience

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

Traditional way of formulating guidelines Based on expert opinion

3. Variable capacity to implement the new standard

What is GRADE? G rading of R ecommendations; A ssessment, D evelopment, and E valuation.

Who uses GRADE?

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

Levels of quality of evidence HIGH MODERATE LOW VERY LOW

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:

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?

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

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

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

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

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

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

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

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

Acknowledgement Prof. Mike English Prof. Paul Garner Dr. Dave Sinclair