The main questions to answer
- Was the assignment of patients to treatment randomised?
And was the randomisation list concealed?
- Were all the patients who entered the trial accounted for at its conclusion?
And were they analysed in the groups to which they were randomised?
And some finer points to address
- Were the patients and the clinicians kept “blind” to which treatment was being received?
- Aside from the experimental treatment, were the groups treated equally?
- Were the groups similar at the start of the trial?
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Reference: Evidence-based Medicine – Sackett, Richardson, Rosenberg and Haynes.
