HARM WORKSHEET

Citation:

Are the results of this harm study valid?

Were there clearly defined groups of patients, Yes. The patient was defined by two
similar in all important ways other than group such as vascular disease and
exposure to the treatment or other cause? ulcer bleeding. The study was
randomized, and has eligible criteria.

Were treatments/exposures and clinical Yes. Because the treatment were

outcomes measured in the same ways in both randomly given. Each patient received
groups (was the assessment of outcomes different drugs. The drugs was split into
either objective or blinded to exposure)? different colors after that and entered
into a envelope.

Was the follow-up of study patients sufficiently Yes. The patient returned at month 1,
long and complete? month 3, and every 3 months in 12
month.

Do the results satisfy some “diagnostic tests for causation”?

Is it clear that the exposure preceded the onset Yes. Because the study used cohort
of the outcome? methods

Is there a dose–response gradient? No.

Is there positive evidence from a “dechallenge– Can not tell, because both of the study
rechallenge” study? were given drugs

Is the association consistent from study to Can not tell, because the previous
study? study of this association did not
mention in this study

Does the association make biological sense? No. Because the mechanism of the
characteristic of the drugs to the ulcer
bleeding not fit into pathological
framework.

Are the valid results from this harm study important?

What is the magnitude of the association

between the exposure and outcome?

What is the precision of the estimate of the

association between exposure and outcome?
 Adverse outcome Totals

Present (case) Absent (control)

Yes
13 148 161
(cohort)
Exposed to
the treatment
No
1 158 159
(cohort)

Totals a+c b+d a+b+c+d

In a randomized trial or cohort study: relative risk

RR=[a/(a+b)]/[c/(c+d)]

RR = [13/161]/[1/159]

RR = 12,84

In a case–control study: odds ratio (or relative odds)

OR=ad/bc

OR = 13(158)/148(1)

OR = 13,88

Should these valid, potentially important results change the treatment of your
patient?

Do the results apply to our patient? Yes

Is our patient so different from those in the
study that its results don’t apply?
What are our patient’s risks of the adverse
event?
To calculate the NNH (number of patients
we need to treat to harm one of them) for
any odds ratio (OR) and our patient’s
expected event rate for this adverse event if
they were not exposed to this treatment
(PEER):
No. Because the patients were same.
Because clopidogrel has an NNH of 13,5, it
means you have to treat 13 people with the drug
to prevent one additional bad outcome
NNH : 1/EER – CER
NNH : 1/0,008 – 0,006
NNH : 13,5 (Harmful)
What are our patient’s preferences, To reduce ulcer bleeding event
concerns and expectations from this
treatment?

What alternative treatments are available? Can not tell

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