HARM WORKSHEET

Citation:
Are the results of this harm study valid?
Were there clearly defined groups of
patients, similar in all important ways other
than exposure to the treatment or other
cause?
Were treatments/exposures and clinical
outcomes measured in the same ways in both
groups (was the assessment of outcomes
either objective or blinded to exposure)?
Was the follow-up of study patients
complete and long enough?
o the results satisfy some !diagnostic tests for causation"?
#s it clear that the exposure preceded the
onset of the outcome?
#s there a dose-response gradient?
#s there positive evidence from a
!dechallenge-rechallenge" study?
#s the association consistent from study to
study?
oes the association ma$e biological sense?
Are the valid results from this harm study important?
%dverse outcome
&otals
'resent (case) %bsent (control)
(xposed to
the treatment
)es
(cohort)
a a!
*o
(
c
o
h
o
rt
)
" d "!d
&otals a!" !d a!!"!d
#n a randomised trial or cohort study+ relative ris$ , -- , .a/(a/b)0/.c/(c/d)0
#n a case-control study+ odds ratio (or relative odds) , 1- , ad/bc
Should these valid# potentially important results "han$e the treatment of your
patient?
#s your patient so different from those in
the study that its results don2t apply?
What are your patient2s ris$s of the
adverse event?
&o calculate the **3 (number of patients
you need to treat to harm one of them) for
any odds ratio (1-) and your patient2s
expected event rate for this adverse event
if they were not exposed to this treatment
('((-)+
) 4 ( ) 4 (
4 ) 4 (
PEER OR PEER
OR PEER
NNH

+
=
What are your patient2s preferences,
concerns and expectations from this
treatment?
What alternative treatments are available?
Additional notes: