Nama :Okta Kurniawan Saputra

NIM :04032711822001
P. Studi :Kesehatan Mata

HARM WORKSHEET

Citation:
Silverman S, Watts N.B, Delmas P.D, Lange J.LEffectiveness of bisphosphonates on nonvertebral and
hip fractures in the first year of therapy: The risedronate and alendronate (REAL) cohort study. Journal
of Osteoporosis Int 2007;18:25-34

Are the results of this harm study valid?

Were there clearly defined groups of Yes. Patient devide to 2 group,

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?
Do the results satisfy some “diagnostic tests for causation”?
Is it clear that the exposure preceded the
onset of the outcome?
Is there a dose-response gradient?
Is there positive evidence from a
“dechallenge-rechallenge” study?
Is the association consistent from study to
study?
Does the association make biological sense? Yes, because this study assesses the
exposed and not-exposed with
treatment and they treated in same
way.
Yes it was measure with same method
yes. Its was follow up for 12 months
coresponding to drugs mechanism
No. its not describe the onset of the
outcome
No. there is no gradient
No. theres no discription
No. It’s the primary study to measure
the risk of fracture on osteoporosis
patient that consume risedronate
patient based on clinical parameter

Are the valid results from this harm study important?

Adverse outcome
Present Absent Totals
Yes 12.051 12.022 164 193 12.215
(cohort)
 Exposed to No 21.272 21192 343 423 21.615
the treatment (
c
o
h
o
rt
)
Totals

RR = {a/(a+b)}/{c/(c+d)}
= (12.051/12.215)/21.272/21.615)
= 0.986/0.984
= 1.004

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

Is your patient so different from those in No. the patient is not so different so its
the study that its results don’t apply? result can apply
What are your patient’s risks of the
adverse event?
To calculate the NNH (number of patients
you need to treat to harm one of them) for
any odds ratio (OR) and your patient’s
expected event rate for this adverse event
if they were not exposed to this treatment
(PEER):
PEER (OR  1)  1
NNH 
PEER (OR  1)  (1  PEER )
What are your patient’s preferences, The patient’s preferences, concerns and
concerns and expectations from this expectations from this treatment are to get
treatment? drugs that minimize fracture insiden on
osteoporosis
What alternative treatments are available? There is some alternative treatment

Additional notes: