Box 1. 12 questions to help you make sense of a trial.

Adapted from Guyatt

et al
A. Are the results of the study valid?
Screening questions
1. Did the trial address a clearly focused research question?
Tip: a research question should be focused in terms of:
The population studied
The intervention given
The outcomes considered.
2. Did the authors use the right type of study?
Tip: the right type of study would:
Address the research question
Have an appropriate study design.
Is it worth continuing?
Detailed questions
3. Was the assignment of patients to treatments randomised?
Tip: consider if this was done appropriately.
4. Were all of the patients who entered the trial properly accounted for at its
conclusion?
Tip: look for:
The completion of follow-up
Whether patients were analysed in the groups to which they were randomised.
5. Were patients, health workers and study personnel blind to treatment?
Tip: this is not always possible, but consider if it was possible was every effort made
to ensure blinding?
6. Were the groups similar at the start of the study?
Tip: think about other factors that might effect the outcome such as age, sex, social
class.
7. Aside from the experimental intervention, were the groups treated equally?
Tip: for example, were they reviewed at the same time intervals.
B. What are the results?
8. How large was the treatment effect?
9. How precise was the estimate of the treatment effect?
Tip: look for the confidence limits.
C. Will the results help locally?
10. Can the results be applied to the local population?
Tip: consider whether the patients covered by the trial are likely to be very different
from your population.
11. Were all clinically important outcomes considered?
12. Are the benefits worth the harms and costs?