TUTORIAL CRP

KELOMPOK TUTORIAL
B4

Skenario :
Pak J 60 tahun, sudah 5 tahun menderita
osteoarthritis. Selama ini dokter sering
memberikan anti inflamasi untuk mengatasi
keluhannya tersebut. Namun akhir akhir ini
Pak J sering mengeluh nyeri ulu hati, bahkan 1
bulan lalu pak J harus di rawat di Rumah Sakit
karena perdarahan lambung. Keluarga berharap
Pak J mendapatkan obat anti hematik tapi
tidak memperberat keluhan pada perutnya.

HARM WORSHEET

Citation :
Celecoxib
Versus
Diclofenac
and
Omeprazole in Reducing the Risk of
Recurrent Ulcer Bleeding in Patients
With Arthritis

Are the results of this harm

study valid?
1.

Were there clearly defined groups of

patients, similar in all important ways other
than exposure to the treatment or other
cause?
Ans
: Yes, karena terdapat kriteria inklusi
dan eksklusi. Selain itu juga dapat dilihat dari
baseline characteristic nya yang tidak jauh
berbeda.

Pg. 2105; Methods; Study Population

Pg. 2106

2. Were treatments/ exposures and clinical

outcomes measured in the same ways in both
groups ( was the assessment of outcomes
either objective or blinded to the exposure )?
Ans : Yes, (1) Sealed enveloped ; (2) Double
blinding ; (3) Endoscopy was performed in a
treatment-blind fashion

Pg. 2105; Methods; Study Design

Pg. 2105; Methods; Study End Points

3. Was the follow-up of study patients

sufficiently long and complete?
Ans : Yes
a. Long : karena dalam 6 bulan sudah ada yang
muncul outcome (recurrent bleeding).
b. Complete : Total 290 patients. 1 in each group
died, 1 in each group lost to follow up. Jadi
lost to follow up nya <20%. Berarti complete.

Pg. 2106; Results; Patients

Pg. 2107; Results; Patients

Do the results satisfy some diagnostic tests

for causation ?
4. Is it clear that the exposure preceded the
onset of the outcome?
Ans : Yes, berdasarkan landasan teori
yang
memang ada pada NSAID.
4. Is there a dose-response gradient?,
Ans : No, karena tidak ada variasi dosis obat.

Pg. 2105; Methods; Study Design

6. Is there positive evidence from

dechallenge - rechallenge study?
Ans : No, karena tidak ada kelompok kontrol
sebagai pembanding.
6. Is the association consistent from study to
study?
Ans : Yes, CLASS menyatakan celecoxib tidak
beda jauh dengan diclofenac.
6. Does the association make biological sense?
Ans : Yes, memang sesuai dengan mekanisme
obatnya.

Pg. 2108; Discussion

Are the valid results from this

harm study important?
9. What is the magnitude of the association
between the exposure and outcome?
Ans : RR = 0,77 ; NNH = 69,8
Pg. 2107;
Results;
Patients

Pg. 2107;
Results; Serious
Gastrointestinal
Events

Adverse Outcome

Exposed to
the
treatment

Diclofenac +
Omeprazole
Celecoxib

Totals

Totals

Yes

No

134

143

137

144

16

271

287

Cohort Study : Relative Risk

RR = [a/(a+b)]/[c/(c+d)]
= [9/143] / [7/144]
= 1,294--> mempunyai FR, tapi tidak terlalu
bermakna ( RR>3 baru bermakna )

NNH

= 1/ [(a/a+b)-(c/c+d)]
= 1/ [(9/143)-(7/144)]
= 69,8 --> NNH tidak bermakna ( NNH < 10 b
bermakna )

10. What is the precision of the estimate of

the association between exposure and
outcome?
Ans : 95%CI --> signifikan

Should these valid, potentially important

results change the treatment of your
patient?
Do the results apply to our patient?

11.
Is our patient so different from those in
the
study that its results don't apply?
Ans : No, pasien sesuai dengan kriteria inklusi.
12. What are our patient's risks of the
adverse event?
Ans : Resiko recurrent ulcer bleeding

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) :
Ans : NNH = 69,8
13.
and

What are our patient's preferences, concerns

expectations from this treatment?
Ans : Yes, karena penelitian ini fokus mengenai
apakah ini bisa timbul ulcer bleeding atau tidak,
bukan
ke hal yang lain ( Mis : renal
bleeding, etc )
14.

What alternative treatments are available?

Ans : Yes, celecoxib

Kesimpulan :
Diantara pasien dengan riwayat ulcer bleeding.
Pengobatan celecoxib sama efektifnya dengan
Dicofenac + Omeprazole ( karena RR < 3 --> tidak
impressed) dalam hal mencegah recurrent ulcer
bleeding pada pasien arthritis.