CRITICAL APPRAISAL IN

HARM
Rina Amalia C. Saragih

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Clinicians often encounter patients who face
potentially harmful exposures either to
medical interventions or environmental
agents
Are pregnant women at increased risk of
miscarriage if they work in front of video
display terminals?
Do vasectomies increase the risk of
prostate cancer?
Do changes in health care policies lead to
harmful outcomes?

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In assessing an interventions potential for harm, we are usually looking at
prospective cohort studies or retrospective casecontrol studies. This is
because RCTs may have to be very large indeed to pick up small adverse
reactions to treatment. 3
Critical appraisal

V = valid?
I =
important?
A = applicable?

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 Is this study valid?
1. Was there a clearly defined question?
Consider:
Patients
Exposure
Outcome
2. Were there clearly defined, similar groups of patients?
3. Were exposures and clinical outcomes measured the same way
in both groups?
4. Was the follow up complete and long enough?
5. Does the suggested causative link make sense?

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Does the suggested causative link make sense?

Is it clear the exposure preceded the onset of the

outcome?
Is there a doseresponse gradient?
Is there evidence from a dechallenge
rechallengestudy?
Is the association consistent from study to study?
Does the association make biological sense?

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Are the results important?

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Statistical significance
As with other measures of efficacy, we would be
concerned if the 95% CI around the results, whether
relative risk or odds ratio, crossed the value of 1, meaning
that there may be no effect (or the opposite)

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HOW CAN I APPLY THE RESULTS TO PATIENT CARE?
Were the Study Patients Similar to the Patient in My Practice?
Was Follow-up Sufficiently Long?
Is the Exposure Similar to What Might Occur in My Patient?
What Is the Magnitude of the Risk?
Are There Any Benefits That Offset the Risks Associated With
Exposure?

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Thank you
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