WORKSHEET CRITICAL APPRAISAL

CHECKLIST FOR AN ARTICLE ON TREATMENT

Adapted from:
Critical Appraisal Skills Programme (CASP), Public Health Resource Unit,Institute of Health Science, Oxford.
Guyatt GH, Sackett DL, Cook DJ. Users guides to the medical literature. II.How to use an article about therapy or prevention. A. Are the results of thestudy valid? JAMA 1993;
270: 2598-2601.
Guyatt GH, Sackett DL, Cook DJ. Users guides to the medical literature. II.How to use an article about therapy or prevention. B. What were the resultsand will they help me in
caring for my patients? JAMA 1993; 271: 59-63.

Title / Judul

Randomized, Controlled Trial of Ibuprofen Syrup Administered During Febrile Illnesses to Prevent
Febrile Seizure Recurrences
Author / Peneliti :
Margriet van Stuijvenberg, Gerarda Derksen-Lubsen; Ewout W. Steyerberg,; J. Dik F Habbema,; and
Henriette A. Moll
Publication by / Publikasi oleh :
PEDIATRICS Vol. 102 No. 5 November 1998, USA
DOES THIS STUDY ADDRESS A CLEAR
QUESTION? (PICO Question)
1. Were the following clearly stated:
Patients/ Pasien
Intervention/ Intervensi

Comparison
Intervention/
Intervensi
Outcome(s) / Keluaran atau hasil

Yes

No

Cant Tell

Recurent Febrile seizure

Ibuprofen syrup, 20 mg/mL, 0.25 mL (5 mg) perkilogram
of body weight per dose atau
5mg/KgBB/dosis
Pembanding Placebo
-

The first recurrence of a febrile seizure

Yes

Cant Tell

ARE THE RESULTS OF THIS SINGLE

TRIAL VALID?
A. The main questions to answer:
APAKAH HASIL PENELITIAN INI VALID?
A. Pertanyaan utama untuk menjawab:
2. Was the assignment of patients to
treatments randomised?
Apakah
penetapan
pasien
untuk
mendapatkan pengobatan secara acak?

No

Yes on page 2, 1st line second paragraph under

study medication:
According to a computergenerated
randomization
schedule,
which
was
stratified by center, each
child was assigned at study
entry to either the ibuprofen
or the placebo arm of the
study.

3. Was the randomisation list concealed? Can Yes on page 2, 3-4 line you tell?
second paragraph under
Apakah daftar pengacakan tersembunyi?
study medication:
Dapatkah Anda memberitahu?
According to a computergenerated
randomization
schedule,
which
was
stratified by center, each
child was assigned at study
entry to either the ibuprofen
or the placebo arm of the
study. Only the biostatistician
and the hospital pharmacists
knew the actual treatment
allocation.
4. Were all subjects who entered the trial Yes on page 2, Figure 1. accounted for at its conclusion?
Recruitment of the study
Apakah semua subjek yang masuk penelitian participants. and Figure 2.
diperhitungkan di kesimpulan?
Events terminating follow-up
time at risk (see Methods,
Statistical Analysis) And 1st
line under Result :

In total, 478 children were

considered for inclusion.
Between October 1, 1994,
and April 1, 1996, 230 of
these were randomized (Fig
1), 111 to the ibuprofen group
and 119 to the placebo group
to treat any fever episode
that might occur
5. Were they analysed in the groups to which
they were randomised, i.e. intention-to-treat
analysis?
Apakah mereka dianalisis dalam kelompokkelompok yang mereka diacak, yaitu
intention-to-treat analysis?

Yes on page 2, 1st line second paragraph Under

Statistical analysis:
Two
analyses
were
performed. In an intention-totreat analysis, all first
recurrent febrile seizures over
the follow-up time at risk
defined
earlier
were
considered, regardless of
study medication compliance
by the childs parents

6. Were subjects and clinicians blind to

which treatment was being received, i.e.
could they tell?
Apakah subjek dan klinisi 'buta' terhadap
pengobatan yang diterima, yaitu bisakah
mereka ceritakan?

Yes on page 2, 3-4 line second paragraph under

study medication:
Only the biostatistician and
the hospital pharmacists
knew the actual treatment
allocation.

7. Aside from the experimental treatment,

were the groups treated equally?
Selain dari pengobatan eksperimental,
apakah kelompok diperlakukan sama?

Yes on page 2, one

paragraph
under
Procedures:

8. Were the groups similar at the start of the

trial?
Apakah pengelompokanya sama pada awal
percobaan?

WHAT WERE THE RESULTS?

9. How large was the treatment effect?
How were the results expressed .
seberapa besar efek pengobatan?
Bagaimana hasil diungkapkan.

Parents were instructed to

record the precise timing of
study
medication
administration and the degree
of the temperature on a
standardized patient form.
For
measuring
rectal
temperature,
a
Philips
HP5316 digital thermometer
(Philips, Eindhoven, The
Netherlands)
was
distributed....
Yes on page 2-3, Figure 1. Recruitment of the study
participants. and Figure 2.
Events terminating follow-up
time at risk (see Methods,
Statistical Analysis) And
Table
1
Baseline
Characteristics by Treatment
Group.

Perhitungan
EER Experimental event rate = 31/31+80 = 0,279
CER Control event rate = 36/36 + 83 = 0,302
RR = EER/CER = 0,924
OR odds ratio = 31X83/36x80 = 2573/2880 = 0,89
Experimental event rate = risk of outcome
RRR Relative risk reduction = CER-EER/ CER = 0,076
event in experimental group = EER = a/(a+b)
Atau RRR = 1- RR = 0,076
Control event rate = risk of outcome event in
ARR = 0,302 0,279 = 0,023
control group = CER = c/(c+d)
Relative risk (RR) = EER/CER
NNT = 1/ARR = 1 / 0,302 0,279 = 43,4
Odds ratio (OR) = ad/bc
Relative risk reduction (RRR) = (CER - ARR = 0,302 0,279 = 0,023, berarti selisih kegagalan
EER)/CER or 1 - RR
ibuprofen dibandingkan placebo sebesar 2,3 %
Absolute risk reduction (ARR) = CER - EER
Number needed to treat (NNT) = 1/ARR = 1/ NNT Penelitian ini adalah 43, Artinya setiap 43 (empat puluh

(CER - EER)
Penjelasan :
EXPERIMENTAL
EVENT
RATE/EER
Kejadian event/ penyakit pada kelompok
eksperimen
Rumusnya EER = a/(a+b)
CONTROL EVENT RATE/CER adalah
Kejadian event/penyakit pada kelompok
control
Rumusnya CER = c/(c+d)
RELATIVE RISK REDUCTION (RRR)
menunjukkan berapa persen obat (Penelitian
Ini adalah Ibuprofen) dapat menurunkan
kegagalan terapi, dihitung dengan rumus
RRR=(CER-EER)/CER,
ABSOLUTE RISK REDUCTION (ARR)
menunjukkan perbedaan kegagalan aktual
antara intervensi (Ibuprofen) dan pembanding
(placebo).
ARR
dihitung
dengan
menggunakan rumus ARR = CER-EER,
NNT merupakan rata-rata dari jumlah pasien
yang dapat diterapi dengan intervensi spesifik
dengan satu hasil positif.
Nilai sempurna : 1
Nilai untuk pengobatan paling efektif : 2-4
10. How precise were the results?
Were the results presented with confidence
intervals?
Bagaimana
ketepatan
hasilnya?
Apakah hasil yang disajikan dengan interval
kepercayaan?
CAN I APPLY THESE VALID, IMPORTANT
RESULTS TO MY PATIENT?
11. Do these results apply to my patient?
Is my patient so different from those in the
trial that
the results dont apply?
How great would the benefit of therapy be for
my
particular patient?
11. Apakah hasil ini dapat diaplikasikan untuk
pasien saya?
Apakah pasien saya begitu berbeda dengan
yang ada di percobaan yang hasil tidak

tiga) anak-anak yang mendapat ibuprofen, akan tampak

pengurangan satu kasus kekambuhan kejang demam.
Between October 1, 1994, and April 1, 1996, 230 children
were randomly assigned to ibuprofen syrup (111 children) or
placebo (119 children). Median follow-up time was 1.04 years
(25th75th percentiles; 0.71.8 years) in the ibuprofen group
and 0.98 years (0.71.6years) in the placebo group. Of all
children, 67 had a first febrile seizure recurrence, with 31 in the
ibuprofen groupand 36 in the placebo group. The 2-year
recurrence probabilities were 32% and 39%, respectively.The
recurrence risk in the ibuprofen group was 0.9 (95%
confidence interval: 0.6 1.5) times the recurrence risk in the
placebo group (intention to treat).Adjustment for baseline
characteristics did not affect the risk-reduction estimate. Of the
67 recurrences, 30 occurred in the context of study medication
compliance (13 ibuprofen, 17 placebo). The per-protocol
analysis, which was limited to these events, showed similar
results.

Ya. Hasil yang disajikan dengan interval kepercayaan di sub

bagian Effect of Ibuprofen on Febrile Seizure Recurrence
CI/Confident Interval pada tiap hasil statistik menunjukkan
angka yang sempit yaitu (CI: 0.4 1.7).. Hal ini menunjukkan
sampel penelitian ini mewakili populasi target atau populasi
umum. Namun karena CI melewati angka satu maka
menunjukkan bahwa tidak terdapat perbedaan yang signifikan
antara kelompok ibuprofen dan placebo
Yes
No
Cant tell
Ya. Karena hasil penelitian menunjukkan bahwa terapi
ibuprofen syr dengan dosis
5mg/KgBB
tidak
dapat
mencegah
kekambuhan
kejang demam. Pasien Kami
tidak berbeda dengan pasien
di penelitian,hal ini terlihat
pada kriteria inklusi dan
ekslusi penelitian

berlaku?
seberapa besar akan manfaat terapi bagi
pasien tertentu?
12. Are my patients values and
preferences satisfied by the intervention
offered?
Do I have a clear assessment of my patients
values
and preferences?
Are they met by this regimen and its potential
consequences?

12. Apakah nilai dan pilihan/keinginan pasien

dipuaskan dengan intervensi yang
ditawarkan?
Apakah saya memiliki penilaian yang jelas
dari nilai-nilai pasien saya dan keinginannya?
Apakah mereka dipenuhi oleh regimen ini
dan potensinya
konsekuensi?

Conclusions :
This Journal is Valid, Not Importance, Not applicable

Tidak.
Hasil penelitian
ini
belum
bisa
memuaskan
keinginan pasien
karena
terapi
ibuprofen syrup
belum
bisa
mengurangi
kemungkinan
kekambuhan
kejang
pada
pasien Kejang
demam.