Laporan Critical Appraisal

Analisis PICO
Problem/Patien
t
Intervention
Comparison
Outcome
Type of
Question
Type of Study

Wanita, 50 tahun, faringitis

Tonsilektomi
Tidak dilakukan tonsilektomi
Mencegah kekambuhan infeksi Streptokokus
pada faring
Terapi
RCT

Teknik Pencarian
Menuliskan keyword pada situs pencarian Google Scholar
Kata kunci yang digunakan adalah : pharyngitis + therapy
+ randomized controlled trial
Jurnal yang didapat
Judul Tulisan
Tonsillectomy Versus Watchful Waiting in Recurrent
Streptococcal Pharyngitis in Adults: Randomised Controlled
Trial
Penulis
Olli-Pekka Alho, Petri Koivunen, Tomi Penna, Heikki Teppo,
Markku Koskela,
Jukka Luotonen
Nama jurnal dan tahun terbit
BMJ, doi:10.1136/bmj.39140.632604.55 (published 8 March
2007)
Validitas
Pertanyaan
1a. Apakah alokasi pasien
terhadap terapi /
perlakuan dilakukan
secara random?

Jaw
ab
Ya

Jelaskan dan sebutkan di

mana penjelasan tersebut
dituliskan
Pada halaman 1, dalam bahasan
Abstract baris ke-4.
Design : Randomised
controlled trial.
Halaman 1, dalam bahasan
Methods Study Design

1b. Apakah randomisasi

dilakukan tersembunyi?

1c. Apakah antara subjek

penelitian dan peneliti
blind terhadap
terapi/perlakuan yang
akan diberikan?

Ya

Tida
k

... To avoid disparity between

group sizes,
we used replacement
randomisation
Baris ke-4 halaman 2 dalam
bahasan Methods Study
Design.
... A research assistant not
involved in the assignment or
care of the trial patients
generated the randomisation
sequence with a computer
random number generator. The
assistant concealed the
allocation sequence from the
investigators who enrolled the
participants by putting the
assigned treatments in
sequentially numbered, opaque,
sealed envelopes.
Karena salah satu grup
(tonsillectomy group) dipastikan
menerima perlakuan
pembedahan, maka subjek tahu
perlakuan yang akan diberikan
kepadanya. Sedangkan peneliti
(investigator) maupun asisten
peneliti tidak ikut dalam
perlakuan/operasi (asisten juga
tidak ikut dalam penilaian).
Peneliti
Baris ke-4 halaman 2 dalam
bahasan Methods Study
Design.
... A research assistant not
involved in the assignment or
care of the trial patients
generated the randomisation
sequence with a computer

random number generator. The

assistant concealed the
allocation sequence from the
investigators who enrolled the
participants by putting the
assigned treatments in
sequentially numbered, opaque,
sealed envelopes.
Subjek penelitian
Baris ke-10 halaman 2 dalam
bahasan Methods Study
Design.

2a. Apakah semua subjek

yang ikut serta dalam
penelitian diperhitungkan
dalam hasil/kesimpulan?

Ya

... These were opened

sequentially only after an
eligible participant had been
found and informed consent
obtained ...
Pada skema Enrolment and
allocation of patients in study di
halaman 3, sub judul Results
Patients tertulis :
Analysed (intention to treat)
(n=34)
Analysed (intention to treat)
(n=36)

2b. Apakah pengamatan

yang dilakukan cukup
panjang?

Ya

dimana jumlahnya sama

dengan jumlah subjek yang
dipakai dari awal (n=70)
Terdapat pada halaman 3 dalam
pembahasan Results
All patients were seen at followup visits and were followed up
for at least the scheduled 90
days, the mean lengths of
follow-up being 164 days (SD
63) in the control group and 170
days (SD 12) in the
tonsillectomy
group.
3

2c. Apakah subjek

dianalisis pada kelompok
di mana subjek tersebut
dikelompokkan dalam
randomisasi?

3a. Selain perlakuan yang

dieksperimenkan, apakah
subjek diperlakukan
sama?

Ya

Pada
bahasan
Methods

Statistical Analysis halaman 2

dan 3.
... For the primary and
secondary end points, all
participants were analysed
on an intention to treat
basis.

Ya

All data analyses were done

according to a pre-established
plan. Descriptive data are given
as means (SD) or as medians
with interquartile ranges. We
used the
Mann-Whitney U test to
compare continuous variables.
We constructed survival curves,
as they related to the
treatment group, according to
the Kaplan-Meier method,
starting from the date of the
randomisation. The differences
between the groups were tested
with the log rank test.
Pada bahasan Methods
Surveillance Protocol halaman
2.
... Patients were given a
prepaid microbiological postal
package and the phone number
of the study nurse with
instructions to order a new
package immediately after using
one. The package included
equipment for
taking a specimen (Transpocult,
Orion Diagnostica, Helsinki,
Finland).

... All participants were

advised to visit their own
general practitioner whenever
they had acute symptoms
suggestive of pharyngitis.
Patients used diaries to record
their acute symptoms (fever,
throat pain, cough, and rhinitis),
episodes of pharyngitis, and
visits to a doctor.

3b. Apakah kelompok

dalam penelitian sama
pada awal penelitian?

Ya

... Patients in the tonsillectomy

group also documented the
duration of postoperative throat
pain. At the follow-up visit, we
collected the diaries and
checked them for
completeness.
Dalam bahasan Results
Patients halaman 3.
The first patient underwent
randomisation in October 2001,
and the last participant
completed the study in
December 2005. We screened
298 candidates, 226 of whom
were excluded, and two declined
to participate. Most of those
excluded had too few episodes
of pharyngitis or had
undocumented or nonstreptococcal episodes or
chronic tonsillitis. Of the 70
remaining patients who we
enrolled, 34 were randomly
assigned to the control group
and 36 to the tonsillectomy
group. All patients were seen at
follow-up visits and were

followed up for at least the

scheduled 90 days ...