Académique Documents
Professionnel Documents
Culture Documents
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
Yes
Cant Tell
No
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 :
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
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?
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.