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Practicing and Teaching Evidence-Based Health Care in Other Clinical

Specialties

4. Appendix: Critical appraisal worsheets
HA!" #O!$SHEET
Citation:
Cancer risk among users of oral contraceptives: cohort data from the Royal
College of General Practitioners oral contraception study.
Are the res%lts o& this har' st%d( valid)
Were there clearly
defined groups of
patients, similar in all
important ways other
than exposure to the
treatment or other
cause?
Ada
Di bagian method dijelaskan bahwa penelitian The Royal
ollege of !eneral "ractitioners# oral contraception
dimulai pada $ei %&'( selam %) bulan oleh %)** dokter
umum dengan merekruit sekitar +,*** wanita yang
mengunakan kontrasepsi oral dan sekitar +,*** wanita
yang tidak menggunakan oral kontrasepsi- .emunya
rata berumur +& tahun, sudah menikah, tinggal dalam
hubungan yang stabil- Dalam penelitian informasi
baseline yang dikumpulkan meliputi kebiasaan
merokok, kelas social/pekerjaan suami0, kesimbangan,
dan pentingnya medical history-
1The Royal College of General Practitioners oral
contraception study egan in !ay "#$%. &ver a "'
month period "'(( general practitioners throughout the
)nited *ingdom recruited aout +, ((( -omen -ho
-ere using oral contraceptives and +, ((( -omen -ho
had never used them."" The mean age at recruitment
-as +# .standard deviation $.$/. 0ll the -omen -ere
married or living in a stale relationship and most -ere
-hite. 1aseline information collected included smoking
haits2 social class .ased on husands occupation/2
parity2 and important medical history
Were
treatments2exposures
and clinical outcomes
measured in the same
ways in both groups
/was the assessment
of outcomes either
objecti3e or blinded
to exposure0?
4ya, ada pada bagian method 5
0fter recruitment the general practitioners supplied
information every si3 months aout any hormonal
preparations prescried2 any pregnancies and their
outcome2 all ne- episodes of illness .including cancer/2
and any surgery in -omen still under their oservation.
"ada method dijelaskan bahwa semua wanita yang
direkruitmen baik yang menggunakan kontrasepsi oral
maupun wanita yang tidak mengggunakan kontrasepsi
oral difollow up sama- $ereka setiap enam bulan diberi
2
informasi mengenai hormonal, macam6macam
kehamilan, dan outcome mereka penelitian, semua
episode penyakit/ termasuk kanker0 dan berbagai
operasi-
Was the follow6up of
study patients
sufficiently long and
complete?
Dari penelitian di atas follow up yang dilakukan panjang-
7al tersebut dilihat dari penyakit yang diteliti yaitu
apakah kontrasepsi oral menyebabkan resiko cancer-
Durasi rata6rata kontrasepsi oral yang digunakan untuk
penelitian antara lain )) bulan / range inter8uatil %&
sampai (, bulan , range %6 ,)) bulan0- "enelitian di
mulai $ei %&'( sampai Desember +**)- Dan follow up
yang dilakukan tidak komplet karena participant dan
dokter yang meningalkan lebih dari +*9 yaitu +)9
wanita tidak ditandai karena mereka dan dokter mereka
meninggalkan penelitian ini-
Do the results satisfy some 1diagnostic tests for causation:?
4s it clear that the
exposure preceded
the onset of the
outcome?
;a
Dijelaskan di table <low chart of Royal !eneral
"ractitioners# oral contraception study- =alues refer to
numbers of women unless stated otherwise- Tetapi
kontrasepsi oral bukan merupakan faktor langsung
kanker- "emeriksaan risiko absolute dan keuntungan
pada kanker dihubungkan dengan pemakaian
kontrasepsi oral tergantung pada model2type
kontrasepsi oral yang digunakan dan insiden dari
berbagai macam kanker-
Conclusion 4n this )* cohort2 oral contraception -as
not associated -ith an overall increased risk of cancer5
indeed it may even produce a net pulic health gain.
The alance of cancer risks and enefits2 ho-ever2 may
vary internationally2 depending on patterns of oral
contraception usage and the incidence of different
cancers.
4s there a dose>
response gradient?
Tidak dijelaskan-
4s there positi3e
e3idence from a
1dechallenge>
rechallenge: study?
Tidak dijelaskan-
4s the association
consistent from study
to study?
?onsisten bahwa penggunaan kontrasepsi
meningkatkan resiko kanker payudara, cer3ic, dan hati-
Does the association
make biological
sense?
?anker yang disebabkan secara tidak langsung oleh
penggunaan kontrasepsi oral, risiko kanker dan
keuntungannya tergantung pada model2type
kontrasepsi oral yang digunakan dan insiden dari
3
berbagai macam kanker-
Are the valid res%lts &ro' this har' st%d( i'portant)
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 outcome?


Ad3erse outcome
*nvasive cancer
Totals
"resent /case0 Absent /control0
@xposed to
the treatment
$ontrasepsi
Oral
;es
/cohort0
a
+4,-
b
./0+
aAb
.-1
Bo
/cohort0
c
+1
d
-42.
cAd
,401
Totals
aAc
/.33
bAd
---+
aAbAcAd
,1-+
4n a randomiCed trial or cohort study5
!elative !is4!!0
DEa2/aAb0F2Ec2/cAd0F
DEGH2%H'F2E,*+H2()&'F
D*,)(2*,,'
D%,,
Iadi Relati3e Risk penelitian ini adalah %,,
55T

4n a case>control study5 odds ratio /or relati3e odds0DJRDad2bc-
4
Sho%ld these valid6 potentiall( i'portant res%lts change the treat'ent o& (o%r
patient)
7o the res%lts appl( to o%r patient)
4s our patient so different from those in
the study that its results don#t apply?
6
What are our patient#s risks of the ad3erse
e3ent?
To calculate the BB7 /number of patients
we need to treat to harm one of them0 for
any odds ratio /JR0 and our patient#s
expected e3ent rate for this ad3erse e3ent
if they were not exposed to this treatment
/"@@R05
6
What are our patient#s preferences,
concerns and expectations from this
treatment?
6
What alternati3e treatments are a3ailable? 6
Additional notes:
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