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Validity of Harm Study on Arthritis Treatments

This study compared the risks of recurrent ulcer bleeding in arthritis patients taking celecoxib versus diclofenac plus omeprazole. Patients were randomly assigned to celecoxib twice daily plus placebo or diclofenac twice daily plus omeprazole daily for six months. Treatments and outcomes were measured the same way between groups. The follow up time was sufficient. The results show celecoxib is associated with a lower risk of rebleeding compared to diclofenac/omeprazole. The valid results could change the treatment of patients similar to those in the study who have no preference between treatments.

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Elisa Mai Sarah
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7 views4 pages

Validity of Harm Study on Arthritis Treatments

This study compared the risks of recurrent ulcer bleeding in arthritis patients taking celecoxib versus diclofenac plus omeprazole. Patients were randomly assigned to celecoxib twice daily plus placebo or diclofenac twice daily plus omeprazole daily for six months. Treatments and outcomes were measured the same way between groups. The follow up time was sufficient. The results show celecoxib is associated with a lower risk of rebleeding compared to diclofenac/omeprazole. The valid results could change the treatment of patients similar to those in the study who have no preference between treatments.

Uploaded by

Elisa Mai Sarah
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

HARM WORKSHEET

Citation: CELECOXIB VERSUS DICLOFENAC AND OMEPRAZOLE IN


REDUCING THE RISK OF RECURRENT ULCER BLEEDING IN PATIENTS WITH
ARTHRITIS

Are the results of this haerm study valid?


Were there clearly defined groups of
patients, similar in all important ways
other than exposure to the treatment or
other cause?

Yes, (Study Design, 2105)


Eligible patients were randomly assigned
to receive either 200 mg of celecoxib
(Celebrex, Pharmacia) twice daily plus
omeprazole placebo daily or 75 mg of
extended-release diclofenac (Voltaren XR,
Novartis) twice daily plus 20 mg of
omeprazole (Losec, AstraZeneca) daily
for six months.

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)?

Yes,

Was the follow-up of study patients


sufficiently long and complete?

Yes,

Do the results satisfy some diagnostic


tests for causation?

Yes,

Is it clear that the exposure


preceded the onset of the
outcomes?

Yes,

Is there a dose-response
gradients?

Cant tell

Is there positive evidence from a


dechallenge-rechallenge study?
Is the association consistent from
study to study?
Does the association make
biological sense?

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
outcomes?

Adverse outcomes
Present (case)
Exposed to the
treatment

Totals

Absent
(control)

Yes
(cohort)

a. 9

b. 134

a+b

No
(cohort)

c. 7

d. 137

c+d

a+c

b+d

a+b+c+d

Totals

Should these valid, potentially important results


change the treatment
ofDoyour
patient?
the results apply to our patient?
Yes,
Is our patient so different from those in
the study that its results dont apply?

No, our patient similiar to the patient in


the study

What are out patients risks of the


adverse event?

Berapa orang yang diobati untuk


menghasilkan 1 orang yang berisiko NNH
= -69,9

To calculate the NNH (number of patients


we need to treat to harm one of them) for
any oods ratio (OR) and our patients
expected event rate for this adverse
event if they were not exposed to this
treatment (PEER):
What are our patients preferences,
concerns and expectations from this
treatment?
What alternative treatments are
available?

The treatment doesnt move any adverse


to the patient

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