TELAAH KRITIS JURNAL

Effect of intravenous -2 agonist treatment on clinical outcomes

in acute respiratory distress syndrome (BALTI-2): a multicentre,
randomised controlled trial

Pembimbing:
J. Eko Wahono, dr., Sp.S., M.Kes
Peserta Pendidikan Dokter Spesialis I:
Kelompok 9
No.
1.
2.
3.
4.
5.

Nama

NIM

Program Studi

FAKULTAS KEDOKTERAN UNAIR/RSUD Dr. SOETOMO

AGUSTUS 2016

I.

Pendahuluan.

II.

Pertanyaan Klinis.
Apakah terdapat perbaikan outcome klinis penggunaan beta-2 agonis intravena pada
pasien Acute Respiratory Distress Syndrome (ARDS) dewasa dibandingkan yang tidak?

III. Formulasi Pertanyaan Klinis dalam PICO Penelusuran Bukti.

Patient / Problem /
Population
Pasien ARDS dewasa

IV.

Intervention/
Indicator/

Comparison

Outcome

Index
Pemberian beta-2

Pemberian

Perbaikan klinis pasien

agonis intravena

placebo

dan mortalitasnya

Penyusunan Struktur Umum PICO untuk Penelusuran Bukti.

Struktur Umum Penelusuran Bukti:
(Patient Acute Respiratory Distress Syndrome AND adult AND beta-2 agonist OR
salbutamol AND clinical outcome OR mortality)

V.

Bukti (Jurnal) Terbaik yang Diperoleh

Penulis : Fang Gao Smith, Gavin D Perkins, Simon Gates, Duncan Young, Daniel F
McAuley, William Tunnicliff e, Zahid Khan, Sarah E Lamb
Judul

: Effect of intravenous -2 agonist treatment on clinical outcomes in acute

respiratory distress syndrome (BALTI-2): a multicentre, randomised controlled

trial
Nama & Tahun Jurnal : www.thelancet.com Vol 379 January 21, 2012

PICO

PertanyaanKlinis

Pasien ARDS dewasa

Jurnal yang Diperoleh

Pasien ARDS terintubasi dan terpasang
ventilasi mekanis, dewasa >16 tahun
Pemberian beta-2 agonis: Salbutamol

Pemberian beta-2 agonis

sulphate BP 5 ml (1 mg/ml) setara dosis

intravena

15 microgram salbutamol per kg BBI

Pemberian placebo

perjam intravena
Placebo 5 ml (0.9% saline)
Primer: mortalitas dalam 28 hari post
randomisasi.
Sekunder: mortalitasdi ICU atau RS
sebelum kepulangan pertama kali, hari

Perbaikan klinis pasien dan atau

bebas ventilator, dn hari bebas gagal

angka mortalitasnya

organ dalam 28 hari post randomisasi;

lama perawatan di ICU dan RS;
takikardia, aritmia baru, dan timbulnya
efek samping yang memberikan cukup
alasan untuk menghentikan pengobatan.

Relevansi PICO Pertanyaan Klinis dengan PICO Jurnal

VI.

Desain Penelitian, Fokusdan Worksheet yang digunakan untuk telaah kritis dari
Jurnal yang diperoleh.
Desain Penelitian
: Eksperimental
Fokus Jurnal
: Terapi
Worksheet yang digunakan pada telaah kritis : Terapi
VALIDITY
RAMMBO
1. Recruitment

Telaah Validity
Worksheet
Terapi
Apakah subjek
mewakili?

Jawabansesuai Worksheet
Ya,
(Methods, pg. 36-37 )
Study design and participants
We undertook a multicentre, pragmatic, doubleblind,
placebo-controlled, parallel-group, randomised
trial at
46 UK intensive-care units between December,
2006,
and March, 2010. Eligible participants were
intubated
and mechanically ventilated adults aged 16
years and
older within 72 h of ARDS onset. Patients were
identifi ed
and recruited by local investigators at each
site. We
defi ned ARDS in accordance with the American
European Consensus criteria: 14 a pressure of
arterial
oxygen to fractional inspired oxygen
concentration
(PaO2/FIO2) ratio of 200 mm Hg or less, bilateral
pulmonary infi ltrates consistent with oedema,
and the
absence of clinically evident left atrial
hypertension.
Exclusion criteria were pregnancy; current
treatment with intravenous -2 agonist or need
for continuous,
regular, aerolised -2 agonists; current
treatment with
-adrenergic antagonists; imminent withdrawal
of
medical treatment; chronic liver disease, defi
ned as
Child-Pugh grade C; and enrolment in another
clinical
trial of an investigational medicinal product
within the
previous 28 days.

2. Allocation

Apakah penempatan I & C diacak

dan
disembunyikan?

Ya,

Sehingga
kelompokkelompok I & C
sebanding pada
awal percobaan?

3. Maintenance

4. Measurement
Blinding
Outcome

Apakah kelompokkelompok
memperoleh
kointervensi yang
sama? Apakah ada
kecukupan tindak
lanjut?

Ya,

Apakah subjek dan

penilai disamarkan
terhadap perlakuan
yang diterima dan/

Ya

All analyses were based on intention-to-treat

analyses.
We compared the primary outcome and other
dichot omous
outcomes using RRs and 95% CIs. We
compared
continuous outcomes with mean diff erences
and their
95% CIs. We analysed 28-day mortality with
survival
analysis, and by comparison of the two groups
with hazard
ratios and 95% CIs and the KaplanMeier curve.
All
reported p values are two-sided and were not
adjusted for
multiple comparisons. We used prespecifi ed
sub group
analyses to investigate the eff ects of age,
severity of
hypoxaemia at study entry, cause (direct vs
indirect causes
of ARDS), and the APACHE II mortality risk, on
the eff ect
of salbutamol. All subgroup analyses used
interaction tests;
we either calculated the ratio of RRs between
the subgroups,
or used interaction terms in logistic regression
models. We
did a post-hoc analysis for the main causes of
death as
recorded on the death certifi cates of
participants who died
within 28 days of randomisation.

Randomisation and masking

Study drug packs were prepared by Bilcare
Global
Clinical Supplies (Europe; Powys, UK). The
active and

atau apakah
pengukurannya
objektif?

placebo drug components of the infusions were

packaged identically into numbered treatment
packs,
each containing 5 mL of either salbutamol
sulphate BP
(1 mg/mL
in a sterile isotonic solution, GlaxoSmithKline,
Middlesex, UK) or placebo (09% sterile
sodium
chloride). We used a computer-generated
randomisation
sequence with a block size of eight. Patients
were randomly assigned in a 1:1 ratio by a
centralised
24 h telephone or web-based randomisation
service
(Uni versity of Aberdeen, UK). Randomisation
was
minimised by centre, PaO2/FIO2 ratio (50, 51
99, or
100 mm Hg), and age (<64, 6584, 85
years).
Participants, care providers, and investigators
were
masked to group assignment.

IMPORTANCY
TelaahImportancy
Worksheet
Terapi
Apakahkemaknaanstatistik&ke
maknaanklinisdarihasilpeneliti
antergambardenganbaik?

Jawabansesuai Worksheet
Ya,
(Abstract(Result), pg. 35 )
The patients (61.79.9 yearsold, 163 males) who
underwent successful stenting were randomized to
aspirin and cilostazol (group I, n=141,61.29.6
years old) vs aspirin and clopidogrel (group II,
n=139, 62.010.0 years old) after 1 month of
aspirin,cilostazol, and clopidogrel combination
treatment. There were no significant differences in
baseline characteristicsof the groups. The type of
DES implanted did not differ between the groups.
There were no differences inangiographic and
procedural characteristics of the groups. Major
adverse cardiac events, including acute andsubacute stent thrombosis within 1 month, did not
occur in either group. Cases of angiographic late
stent thrombosiswere 1 (0.9%) in group I and 1
(0.8%) in group II. Follow-up coronary
angiography was performed in 237patients
(84.6%). Mean follow-up duration was 7.1
months. The rate of angiographic restenosis (stent
plus 5-mmborders) was 9 (8.0%) in group I and 20
(16.1%) in group II, p=0.041). The minimal
6

luminal diameter at followupperiod in group I was

2.550.63 mm compared with 2.410.83 mm in
group II (p=NS).
Pengukuranapa yang
KejadianRestenosis :
EER
: 0.08
digunakandanseberapadampak
CER
: 0,161
perlakuannya?
RR
: 0,422
(EER.CER,RRR,ARR,danNNT
ARR
: 0,081
?)
RRR
: 50%
NNT
: 12
Mungkinkahdampakterjadikare TidakKebetulan,
p = 0,041
nakebetulan?
CI 95%
P-value?
Interval kepercayaan (CI)?
(Statistical Analysis, pg. 37)
Continuous variables are shown as
meanstandard deviation and categorical variables
as proportions. Continuous variables were
compared by unpaired t-test or analysis of
variance as appropriate. Categorical variables
were compared by chi-square. All data was
analyzed by intention-to-treat. A p value <0.05
was considered to be significant.

APPLICABILITY
No
1.
2.

3.

4.

Telaah Applicability
Apakah PICO jurnal yang diperolehsesuai PICO

Jawaban
Ya

pertanyaanklinis?

Ya

Apakahpasienandacukupmiripdenganpasiendalampenelitian?
Apakahintervensi/Indicator/indeksdalampenelitianinidapatditerap
kanuntukmanajemenpasien di lingkungananda?
Karenaobat yang digunakandalaminterversisudahtersedia
hanyabelumdimasukkandalam guideline
Apakahoutcomes penelitianinipentingbagipasienanda?
Karenadapatmenurunkaninsiden restenosis
Akankahpotensimanfaatlebihbesar/ Indicator /

di

Ya
Indonesia
Ya

5.

potensimerugikanbilaintervensi/Indicator/indeksinidiaplikasikan

Ya

6.

padapasienanda?
Karenadapatmenurunkaninsiden restenosis
Apakahhasilpenelitianinidapatdiintegrasikandengannilai-

Ya

nilaisertaharapanpasienanda?
Karenahalinidapatmenurunkankebutuhanuntuk

stenting

ulangpadapasien post DES

VII.

Kesimpulan
1. Penelitian yang dilaporkan dalam jurnal tersebut VALID
2. IMPORTANCY dalam penelitian tersebut tergambar dalam jurnal.
3. Hasil penelitian yang dilaporkan dalam jurnal tersebut bersifatAPPLICABLE
untuk pasien.