(A) Are the results of the trial valid?
Screening Questions
1. Did the trial address a clearly focused issue?
HINT: An issue can be ‘focused’ In terms of
- The population studied
- The intervention given
- The comparator given
- The outcomes considered
Yes Can’t tell No
2. Was the assignment of patients to treatments randomised?
HINT: Consider
- How was this carried out?
- Was the allocation sequence concealed from researchers and patients?
Yes Can’t tell No
3. Were all of the patients who entered the trial properly accounted for at its conclusion?
HINT: Consider
- Was the trial stopped early?
- Were patients analysed in the groups to which they were randomised?
Yes Can’t tell No
Is it worth continuing?
Detailed questions
4. Were patients, health workers and study personnel ‘blind’ to treatment?
HINT: Think about
- Patients?
- Health workers?
- Study personnel?
Yes Can’t tell No
5. Were the groups similar at the start of the trial?
HINT: Look at
- Other factors that might affect the outcome such as age, sex, social class
Yes Can’t tell No
6. Aside from the experimental intervention, were the groups treated equally?
Yes Can’t tell No
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(B) What are the results?
7. How large was the treatment effect?
HINT: Consider
- What outcomes were measured?
- Is the primary outcome clearly specified?
- What results were found for each outcome?
Yes Can’t tell No
8. How precise was the estimate of the treatment effect?
HINT: Consider
- What are the confidence limits?
Yes Can’t tell No
(C) Will the results help locally?
9. Can the results be applied in your context? (or to the local population?)
HINT: Consider whether
- Do you think that the patients covered by the trial are similar enough to the patients to whom you will apply this?, if not how to they differ?
Yes Can’t tell No
10. Were all clinically important outcomes considered?
HINT: Consider
- Is there other information you would like to have seen?
- If not, does this affect the decision?
Yes Can’t tell No
11. Are the benefits worth the harms and costs?
HINT: Consider
- Even if this is not addressed by the trial, what do you think?
Yes Can’t tell No