Worksheet Critical Appraisal

Jurnal Terapi
Judul Jurnal : Asthma control in patients receiving inhaled corticosteroid and longacting beta2-agonist fixed combinations. A real-life study comparing dry powder
inhalers and a pressurized metered dose inhaler extrafine formulation.
Validitas
1a. Apakah alokasi pasien terhadap
terapi/perlakukan dilakukan secara
random?

Ya
[]

Alokasi

pasien

dilakukan

secara

random.
Male and female asthma patients aged
above 18 years were eligible for

Tidak
[

inclusion in the study if: 1) they had a

diagnosis

of

moderate

or

severe

persistent asthma confirmed by chest

physician; 2) diagnosis occurred at least
6 months before the beginning of the
study; 3) they were treated with fixed
combination of ICS and LABA as
maintenance therapy; 4) they did not
change their medication within the last 4
weeks prior to start of study; 5) they had
no asthmatic exacerbation within the last
6 weeks prior to start of study.
Terdapat dalam Methods halaman 2.

1b. Apakah randomisasi dilakukan

tersembunyi?

Ya
[ ]

Alokasi

pasien

dilakukan

secara

tersembunyi.
The study was approved by the

Tidak
[ ]

institutional Ethics Committee of the

Department

of

Pulmonology,

Semmelweis University. No consent was

obtained from the participants as it was

a non-interventional retrospective data

analysis of the real-life data collected on
the

usual

visits

of

patients.

No

intervention was done only for the sake

of the study.

1c. Apakah antara subyek penelitian

dan

peneliti

blind

terapi/perlakukan

terhadap

yang

akan

Ya
[]

diberikan ?

Terdapat dalam Methods halaman 2.

Subjek penelitian dan peneliti tidak
mengetahui

pengalokasian

kelompok

pasien.
The study included 111 patients (81

Tidak
[ ]

women and 30 men). For the purpose of

the study, patients were divided in two
groups depending on the inhaler device
they were using (pMDI or DPI). No
significant

difference

in

patient

characteristics between these two groups

was found. The severity of patients was
similar in both groups. Lung function
values

measured

at

the

time

of

diagnosis, on the basis of which patients

were characterized as moderate or
severe asthmatics, were not available.

2a. Apakah semua subyek yang ikut

serta

dalam

diperhitungkan

penelitian
dalam

kesimpulan?

hasil/

Ya
[]

(Apakah

pengamatannya cukup lengkap?)

Apakah

pengamatan

dilakukan cukup panjang?

yang

women and 30 men). For the purpose of

the study, patients were divided in two
groups depending on the inhaler device

Tidak
[

2b.

Terdapat dalam Results halaman 3.

The study included 111 patients (81

Ya
[ ]

they were using (pMDI or DPI).

Terdapat pada Results halaman 3.
This real-life study had a crosssectional design and involved a

group of asthmatic outpatients

Tidak
[ ]

from

the

Department

Pulmonology,

of

Semmelweis

University Budapest, Hungary.

Patients

were

consecutively

recruited during their regular

visits

to

the

outpatient

department from May 2008 until

August 2008.

2c. Apakah subyek dianalisis pada

kelompok di mana subyek tersebut
dikelompokkan dalam randomisasi?

Ya
[ ]

Terdapat dalam Methods halaman 2.

Asthma control was assessed by
patients using a questionnaire developed
on the basis of the GINA Guidelines.
Patients were asked to fill in the

Tidak
[
3a.
Selain
perlakuan
yang
dieksperimenkan, apakah subyek
diperlakukan sama?

questionnaire during their regular clinic

visits.

Ya
[ ]

Terdapat dalam Methods halaman 2.

Kedua kelompok mendapat perlakuan
yang sama.
Asthma

Tidak
[

control was assessed by

patients using a questionnaire developed

on the basis of the GINA Guidelines.
Patients were asked to fill in the
questionnaire during their regular clinic
visits.

3b. Apakah kelompok

penelitian
sama
pada
penelitian?

dalam
awal

Ya

Terdapat dalam Methods halaman 2.

The study included 111 patients (81

[ ]

women and 30 men). For the purpose of

the study, patients were divided in two
groups depending on the inhaler device

Tidak

they were using (pMDI or DPI

]
Terdapat pada Results halaman 3.

Importance
1. Berapa besar efek terapi?

2. Seberapa tepat estimasi efek

terapi ?
Applicable
1. Apakah pasien yang kita miliki
sangat berbeda dengan pasien
dalam penelitian?

Ya
[

Pasien yang kita miliki tidak berbeda

dengan pasien dalam penelitian.

Tidak
[ ]
2. Apakah hasil yang baik dari
penelitian dapat diterapkan dengan
kondisi yang kita miliki?

Ya
[ ]
Tidak
[

3. Apakah semua outcome klinis

yang penting dipertimbangkan (efek
samping yang mungkin timbul)?

Kriteria inklusi dan eksklusi sesuai

dengan kondisi yang kita miliki dan
outcome yang baik dapat diterapkan
dengan kondisi yang kita miliki.

Ya

Semua outcome klinis dipertimbangkan.

[]
Tidak
[

4. Apakah sudah memahami

Ya

Yang diharapkan dari pasien adalah

harapan dan pilihan pasien?

[]

mencapai dan mempertahankan kontrol

asma.

Tidak
5. Apakah intervensi yang akan
diberikan akan memenuhi harapan
pasien? Pasien siap akan
konsekuensinya?

[ ]
Ya
[]

Yang diharapkan dari pasien adalah

mencapai dan mempertahankan kontrol
asma.

Tidak
[

Simpulan : Dari hasi laporan penelitian, maka dapat disimpulkan bahwa laporan penelitian ini
belum tentu valid.
Level of evidence : IV.