PENANG MEDICAL COLLEGE EVIDENCE BASED MEDICINE

Critical Appraisal Worksheet

Therapy
A. Are the results of the trial valid?
Citation:

1. How were patients assigned to treatment groups?

HINTS: Was the
allocation to
intervention and
control truly
random? Check that
the method of
allocation is
described. Consider
if any differences
between groups
could have altered
the outcome
(confounding). Are
any differences
reported? In a small
trial was a method
used to balance the
randomisation?

2. Were participants, staffs and study personnel ‘blind’ to treatment?

HINT: Blinding is not
always possible, but
was every effort
made to ensure
blinding? What effect
could this have had?
How much do you
think it matters in
this study? We are
looking for ‘observer
blas’ amd ‘Hawthorne
effects’

3. Were all the participants who entered the trial properly accounted for at its conclusion?
HINT: We are looking
for bias caused by
incomplete follow up
and inappropriate
analysis (participants
should be analysed
in the groups to
which they were
randomised in an
‘intention-to-treat
analysis’)
PENANG MEDICAL COLLEGE EVIDENCE BASED MEDICINE
4. Aside from the experimental intervention were the groups treated in the same way?
HINT :for example
were they reviewed at
the same time
intervals and did they
receive the same
amount of attention
from researchers and
health workers? Any
differences may
introduce
performance bias.

5. Did the study have enough participants to minimize the play of chance?
HINT: Look for a
power calculation –
This will estimate
how many patients
are needed to be
reasonable sure of
finding something
important (if it really
exists and for a given
level of uncertainty
about the final
result).

B. What are the results?

6a. How are the results presented?

HINT:
1. As a proportion of
people experiencing
an outcome – Risks
2. As a measurement
– mean or median
differences
3. As survival curves
– Hazards

6b. What is the main result?

HINT: Try to sum up
the bottom line
results of the trial in
one sentence.
How important is this
size of result?
What would it mean
for a patient?
PENANG MEDICAL COLLEGE EVIDENCE BASED MEDICINE
7. How precise are these results?
HINT: Is the result
precise enough to
make a decision? If a
confidence interval is
reported would you
decision about
whether to use this
treatment be the
same at the upper
confidence interval
as at the lower
confidence interval?
If confidence
intervals are
unavailable is there a
p value reported?

C. How might these results be applied?

8. Can the results be applied to the local population?
HINT: Consider
whether:
- the population
sample covered by
the trial could be
sufficiently different
from your population
in ways that would
produce different
results.
- your local setting is
likely to differ much
from that of the trial

9. Were all important outcomes considered?

HINT: Often not
covered in trials as
they are designed to
test a particular
hypothesis. Consider
outcomes from the
point of view of the:
- individual
- policy maker and
professionals
- family/carers
- wider community
10. Should policy or practice change as a result of the evidence contained in this
trial?
HINT: Consider
whether the benefits
are worth the harms
and costs. If this
information is not
reported can it be
filled in from
elsewhere.