Table 5.

Summary of components to consider when evaluating the quality of evidence from research.

Components
Study Design:
Randomized
Allocation concealment
Blinding (if possible)*
Clinically important and objective primary outcome
Beta-error**
Multi-centre
Study Conduct:
Intention-to-treat analysis
Follow-up or attrition rate
Completion to planned numbers
Study Findings:
Biological plausibility
Strength of estimate of effect
Precision of estimate of effect
Observed event rate
Study Applicability:
Complex intervention
Consistency across similar studies
Generalizability
Cost of intervention

*Blinding may not be possible in device or protocol/process trials

**Adequately powered, appropriate estimate of control event rate and relative or absolute reduction in patient-centred and clinically important primary outcome.