Critical Appraisal of

therapy
Dr.Nadira Abbas AL-Baghli
Therapy: fundamental
concept
 You want to know if new
treatment works in the prognosis
of your patients.

 How you decide?

steps in using An 4
article from medical
literature
 Relevance assessment
 Is it address question need?
 Are the results of study valid?
 true
 What are the results?
 important
 How can I apply these results to patients
care?
 Can I apply it to my pt ( is it similar to him, have
all outcome of importance to the pt were
measured
What is the appropriate
study design for
treatment
 Randomized controlled trials
?Are the results valid

 Were patients randomized?

 Was randomization concealed
(blinded or masked)
 Were pts analyzed in the groups to
which they were randomized
 Were pts in the treatment gp similar
with respect to known prognostic
factors?
Did experimental &control gps
retain a similar prognosis after
?the study started

 Were pts aware of gp allocation?

 Were clinician aware of group
allocation?
 Were outcome assessors aware of
group allocation?
 Was follow-up complete?
Randomization

 Methods to allocate person who

accepted for a study into one of the
groups (called arm of the study)
 Why we do randomization?
 ?
 to create two prognostically similar
group
Was randomization concealed

 The group to which the next pt goes is kept

undisclosed from the investigator who is
recruiting the pt.
 It is the processes ensures that the recruiting
physician cannot anticipate the group to w the
next pt goes and thus cannot consciously or
subconsciously tamper with the randomization
process.
Were pt analyzed in the group
to which they were randomized
Were pts in the treatment and
control gps similar with respect
?to prognostic factors
Were pt aware of group
allocation
Were clinicians aware of gp
?allocation
Were outcome assessors aware
?of group allocation
?Was fu complete

 Lost to follow-up
 Affect validity
 Pt may disappear may either
suffer adverse effect, or improved
Summery
?What are the results

 How large was the treatment

effect?
 How precise was the estimate of
the treatment effect?
How large the treatment effect

 Consider a study in w 20% of a

control died, but only 15% of
those receiving treatment died
how might these results
expressed?
Absolute difference

 Absolute risk reduction

 The proportion who died in the
control gp (X)- the proportion who
died in the treatment group (Y)
Absolute risk reduction

 X-Y= 0.2-0.15=0.05
Relative risk

 RR= the risk of events among pt

on the new treatment, relative to
that risk among pts in control gp
 Y/X
RR
 0.15/0.2=0.75
Relative risk reduction

 RRR= (1-Y/X)
 =1-0.75 ×100=25%
 It means the new treatment
reduced the risk of death by 25%
relative to that occurring among
control pts
 The more the RRR the more
effective the treatment
Number needed to treat

 Number needed to treat to

prevent one outcome
 1/Absolute risk difference

 How much NNT is good?

Odds ratio

 Odds of events in the Rx gp/Odds

of events in the control gp
How precise was the estimate
?of the Rx effect

 Treatment effect observed in the

study is called point estimate
 It is unlikely to be precisely
correct
P value

 The probability that the result

observed could have occurred by
chance.
Confidence interval

 The range within which you are

sure to a specified (95%) level that
the actual (true) values lies
 The width is directly proportional
to the specified level of confidence
 A point denotes the point estimate
and a line on either side of the
point denotes the range.
Amiodarone versus placebo showing no efficacy for return to
sinus rhythm at 1 to 2 h and efficacy at 24 h (right). (left)
Graphical representation shows relative risk and 95%

confidence interval
How can I apply the results to
?pt care

 Were the study similar to my pt?

 Is the treatment feasible in our sitting?
 Were all clinically important outcomes
considered?
 Are the likely treatment benefits worth
the potential harm and cost?
 What are our pt values and preferences
for both the outcome we are trying to
prevent and the side-effect we may
cause?
Were the study pts similar
?to the pts in my practice
 Sicker
 Have another co morbidity
excluded from the study
Were all important
?outcomes considered
Are the likely treatment
benefits worth the potential
?harm &cost