The role of registries and audit in implementing quality standards

Prof Mark Baker
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  Guidance, Registries and Audit Squaring the Circle Professor Mark R Baker Director, Centre for Clinical Practice, NICE  Evidence and Registries Chicken or egg? ã Registries and observational databases are hypothesis-forming tools ã Research studies test the hypotheses ã Evidence from research informs guidance ã Guidance implementation needs to be audited ã Registries (can) provide the means of monitoring implementation and revisit hypotheses  How NICE perceives observational data ã GRADE tool used to assess the quality of the evidence  –  not the research ãRCTs start at ‘good’; observational studies start at ‘low quality’   ã  Adjustment for quality of investigation, completeness of data, reliability of the findings etc can lead to RCTs being ‘very low’ and observations being ‘good’!    What is guidance based on? ã‘The best available evidence’   ã NICE does not create magic out of uncertainty but does try to reduce unjustified variation in practice ã Typically 20 systematic reviews of the evidence  –   we don’t use others’ reviews and we don’t copy guidelines from other sources
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