Critical appraisal of RCTs
Critical appraisal
- Systematically examining research evidence to determine trustworthiness, value and relevance
- Necessary for evidence-based medicine
- Apply suitable list of questions related to quality
- Formulate an overall opinion of quality and relevance of given research
Validity
- Internal: strength of evidence for causality, degree to which results attributable to intervention rather than other factors
- External: generalisability, degree to which study results apply to wider populations/settings
ROSSINI trial
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Research question
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Appropriate design
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Randomisation
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Allocation concealment
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Baseline balance
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Blinding
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Follow-up
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Outcome reporting
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Applicability
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Clinical significance
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Good internal validity
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Broadly generalisable
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Low risk of major bias
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No meaningful evidence of benefit
Bias
- Selection: differences between groups from when participants enter trial
- Performance: difference in care or behaviour of participants between groups
- Detection: differences in how outcomes are assessed
- Attrition: differences caused by withdrawals
Tools
- Formalising critical appraisal
- Critical Appraisal Skills Programme (CASP) checklists
- Cochrane risk of bias 3 (RoB 2)
- Answer series of questions
- Apply algorithms to judge risk of bias overall on specific domains
- SIGN and NICE checklists