Worksheet Critical Appraisal

Jurnal Terapi

Judul Jurnal : Asthma control in patients receiving inhaled corticosteroid and long-
acting 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 Ya Alokasi pasien dilakukan secara

terapi/perlakukan dilakukan secara random.
[]
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 Ya Alokasi pasien dilakukan secara

tersembunyi? tersembunyi.
[ ]

The study was approved by the

institutional Ethics Committee of the
Tidak
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.

Terdapat dalam Methods halaman 2.

1c. Apakah antara subyek penelitian Ya Subjek penelitian dan peneliti tidak
dan peneliti blind terhadap mengetahui pengalokasian kelompok
[]
terapi/perlakukan yang akan pasien.
diberikan ?
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.

Terdapat dalam Results halaman 3.

2a. Apakah semua subyek yang ikut Ya The study included 111 patients (81
serta dalam penelitian women and 30 men). For the purpose of
[]
diperhitungkan dalam hasil/ the study, patients were divided in two
kesimpulan? (Apakah groups depending on the inhaler device
pengamatannya cukup lengkap?) they were using (pMDI or DPI).
Tidak

[ ] Terdapat pada Results halaman 3.

2b. Apakah pengamatan yang Ya This real-life study had a cross-
dilakukan cukup panjang? sectional design and involved a
[ ]
 group of asthmatic outpatients
from the Department of
Tidak
Pulmonology, Semmelweis
[ ] University Budapest, Hungary.
Patients were consecutively
recruited during their regular
visits to the outpatient
department from May 2008 until
August 2008.

Terdapat dalam Methods halaman 2.

2c. Apakah subyek dianalisis pada Ya Asthma control was assessed by
kelompok di mana subyek tersebut patients using a questionnaire developed
[ ]
dikelompokkan dalam randomisasi? on the basis of the GINA Guidelines.
Patients were asked to fill in the
questionnaire during their regular clinic
Tidak
visits.
[ ]
Terdapat dalam Methods halaman 2.
3a. Selain perlakuan yang Ya Kedua kelompok mendapat perlakuan
dieksperimenkan, apakah subyek yang sama.
diperlakukan sama? [ ]
Asthma control was assessed by
patients using a questionnaire developed
Tidak
on the basis of the GINA Guidelines.
[ ]
Patients were asked to fill in the
questionnaire during their regular clinic
visits.

Terdapat dalam Methods halaman 2.

3b. Apakah kelompok dalam Ya The study included 111 patients (81
penelitian sama pada awal women and 30 men). For the purpose of
penelitian? [ ]
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 Ya Pasien yang kita miliki tidak berbeda
sangat berbeda dengan pasien dengan pasien dalam penelitian.
[ ]
dalam penelitian?
Tidak

[ ]

2. Apakah hasil yang baik dari Ya Kriteria inklusi dan eksklusi sesuai
penelitian dapat diterapkan dengan dengan kondisi yang kita miliki dan
[ ]
kondisi yang kita miliki? outcome yang baik dapat diterapkan
Tidak dengan kondisi yang kita miliki.

[ ]

3. Apakah semua outcome klinis Ya Semua outcome klinis dipertimbangkan.

yang penting dipertimbangkan (efek
[]
samping yang mungkin timbul)?
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 Ya Yang diharapkan dari pasien adalah
diberikan akan memenuhi harapan mencapai dan mempertahankan kontrol
[]
pasien? Pasien siap akan asma.
konsekuensinya?
 Tidak

[ ]

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

Level of evidence : IV.