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Table 5 Summary of components to consider when evaluating the quality of evidence from research.

From: The need to reform our assessment of evidence from clinical trials: A commentary

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

  1. *Blinding may not be possible in device or protocol/process trials
  2. **Adequately powered, appropriate estimate of control event rate and relative or absolute reduction in patient-centred and clinically important primary outcome.