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Harm Worksheet

This harm study validly assessed the risk of nonvertebral and hip fractures in the first year of therapy with bisphosphonates risedronate and alendronate. The study divided patients into exposed and unexposed groups that were similar in important characteristics other than treatment. Clinical outcomes were objectively measured in both groups. However, the results do not satisfy tests for causation as the timing of outcomes relative to exposure is unclear and there is no evidence of a dose-response or from rechallenge. While the association of reduced fractures makes biological sense, the results of this primary study may not apply to the patient given without more details about their risks and preferences. Alternative treatments should be considered.

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Okta Kurniawan Saputra
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167 views2 pages

Harm Worksheet

This harm study validly assessed the risk of nonvertebral and hip fractures in the first year of therapy with bisphosphonates risedronate and alendronate. The study divided patients into exposed and unexposed groups that were similar in important characteristics other than treatment. Clinical outcomes were objectively measured in both groups. However, the results do not satisfy tests for causation as the timing of outcomes relative to exposure is unclear and there is no evidence of a dose-response or from rechallenge. While the association of reduced fractures makes biological sense, the results of this primary study may not apply to the patient given without more details about their risks and preferences. Alternative treatments should be considered.

Uploaded by

Okta Kurniawan Saputra
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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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 exposed and not-exposed with
than exposure to the treatment or other treatment and they treated in same
cause? way.
Were treatments/exposures and clinical Yes it was measure with same method
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 yes. Its was follow up for 12 months
complete and long enough? coresponding to drugs mechanism
Do the results satisfy some “diagnostic tests for causation”?
Is it clear that the exposure preceded the No. its not describe the onset of the
onset of the outcome? outcome
Is there a dose-response gradient? No. there is no gradient
Is there positive evidence from a No. theres no discription
“dechallenge-rechallenge” study?
Is the association consistent from study to No. It’s the primary study to measure
study? the risk of fracture on osteoporosis
patient that consume risedronate
Does the association make biological sense? Yes, because this study assesses the
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:

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