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CHECKLIST FOR APPRAISING AN ARTICLE ON TREATMENT

CHECKLIST FOR APPRAISING AN ARTICLE ON TREATMENT

A. Are the results of the trial valid?

1. Did the trial address a clearly focused issue?

An issue can be focused in terms of


- the population studied
- the intervention given (and comparison)
- the outcomes considered

2. Was the recruitment of patients prone to bias?

-
-were consecutive patients recruited?
was there allocation “concealment” (NB this is NOT the same as
“blinding”)?

3. Was the assignment of patients to treatments


randomised (and was the method described)?
- beware “quasi-randomisation”

4. Was the randomisation process successful: were


the groups similar at the start of the trial?

- baseline characteristics in each group


(In terms of other factors that might effect the outcome such as
age, sex, social class, severity: this tells us if randomisation was
successful)

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CHECKLIST FOR APPRAISING AN ARTICLE ON TREATMENT

5. Were patients, health workers and study personnel


“blind” to treatment?

- were the patients


- were the health workers
- were the study personnel

6. Were all of the patients who entered the trial


properly accounted for at its conclusion?

- was follow up complete? (at least 80%)


- were patients analysed in the groups to which they were
randomised?(intention to treat analysis)

7. Aside from the experimental intervention, were the


groups treated equally?

B. Were the results important?

1. How large was the treatment effect?

What outcomes were measured?

If the outcomes were dichotomous, work out the absolute risk


reduction and NNT for side effects too

2. How precise was the estimate of the treatment


effect?

What are its confidence limits?


Remember to look at harmful effects too.

3. If the study was positive how likely is this to be a


statistical quirk (and clinically unimportant), and if
negative how likely is it that the study missed a
difference that is really there (and clinically important)?

This bit is about type I and II errors, P values and statistical


“power”

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CHECKLIST FOR APPRAISING AN ARTICLE ON TREATMENT

C. Are the results applicable – will they help me in caring for my patient?

1. Can the results by applied to my patient care?

Do you think that the patients covered by the trial are similar enough
to your patient and the setting similar enough to your place of work?
(“external validity” is the jargon sometimes used here)

2. Were all clinically important outcomes considered?


If not, does this affect the decision?
Studies sometimes are less good at telling us about adverse effects
of the new treatment.
3. Are the benefits worth the harms and the costs?

This is unlikely to be addressed by the trial. But what do you think?

4. Do your patients have a clear assessment of whether


their values and preferences that are met by this
regimen and its consequences?

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CHECKLIST FOR APPRAISING AN ARTICLE ON TREATMENT

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