CRITICAL APPRAISAL

The comparison of propofol and midazolam

for bronchoscopy : A meta-analysis of randomized
controlled studies

Disusun Oleh:
Citra Septiani (406172038)

Pembimbing:

dr. Lukas Handoko, Sp.An

KEPANITERAAN KLINIK ILMU ANESTESI

RUMAH SAKIT SUMBER WARAS
PERIODE 31 DESEMBER 2018 – 03 FEBUARI 2019
FAKULTAS KEDOKTERAN
UNIVERSITAS TARUMANAGARA
JAKARTA
Critical Appraisal – RCTs

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What question did the study ask?
(P) Patients
Tujuh puluh lima pasien yang akan menjalani bronchoscopy dengan kriteria
eksklusi: penolakan tindakan, ASA lebih dari 2, umur kurang dari 60 tahun, dan
membandingkan antara propofol dan midazolam.
(I) Intervention
Pasien dipuasakan 8 jam sebelum tindakan dan tidak diberikan premedikasi.
Setelah semua pasien dibagi secara acak menggunakan computer dimana
Kelompok M akan menerima sedasi midazolam dengan BIS (bispectral index)
index reached dan Kelompok P akan menerima propofol dengan BIS (bispectral
index) index reached . Saat pasien telah sampai di ruangan bronchoscopy.
(C) Comparison
Kelompok M akan menerima sedasi midazolam dengan BIS (bispectral index)
index reached dan Kelompok P akan menerima propofol dengan BIS (bispectral
index) index reached.
(O) Outcome(s)
Pasien yang dapat mengkontrol analgesi sedasi dengan propofol mendapatkan
hasil yang efektif dan aman untuk prosedur bronchoscopy pada saluran cerna atas
dan memiliki tingkat kepuasan yang lebih tinggi dan menjadi rekomendasi untuk
pasien dan operator.

Validasi Internal

1a. R- Was the assignment of patients to treatments randomized?

What is best? Where do I find the information?
Centralised computer The Methods should tell you how
randomisation is ideal and often patients were allocated to groups and
used in multi-centred trials. whether or not randomisation was

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Smaller trials may use an concealed.
independent person (e.g, the
hospital pharmacy) to “police” the
randomization.
This paper: Yes

Comment:

Pasien pada penelitan ini dibagi menjadi ke dalam 2 kelompok: Kelompok M

dan Kelompok P dibagi oleh computer secara acak. Kelompok M akan
menerima sedasi midazolam dengan BIS (bispectral index) index reached dan
Kelompok P akan menerima propofol dengan BIS (bispectral index) index
reached.
1b. R- Were the groups similar at the start of the trial?
What is best? Where do I find the information?

If the randomisation process The Results should have a table of

worked (that is, achieved
comparable groups) the groups
should be similar. The more similar
the groups the better it is.
There should be some indication of
whether differences between
groups are statistically significant
(ie. p values).
This paper: Yes
"Baseline Characteristics" comparing the
randomized groups on a number of
variables that could affect the outcome
(ie. age, risk factors etc). If not, there
may be a description of group similarity
in the first paragraphs of the Results
section.

Comment:

Sebanyak 75 pasien dipilih sebagai sample dibagi ke dalam 2 kelompok

(Kelompok M dan P) dengan masing-masing 35 pasien dan mengikuti
penelitian dari awal hingga selesai. Kedua kelompok memiliki rentang umur,
berat badan, jenis kelamin, baseline anxiety level dan baseline systolic arterial
pressure dan detak jantung yang mirip. Dapat dilihat pada Tabel 1.
2a. A – Aside from the allocated treatment, were groups treated equally?
What is best? Where do I find the information?
Apart from the intervention the Look in the Methods section for the
patients in the different groups follow-up schedule, and permitted
should be treated the same, eg., additional treatments, etc and in Results
additional treatments or tests. for actual use.
This paper: Yes

Comment:

Kedua kelompok diperlakukan secara sama dimana kedua kelompok

dipuasakan selama 8 jam dan tidak diberikan premedikasi sebelum tindakana.
Saat tiba di ruangan bronchoscopy, semua pasien dilakukan penilain dengan
skala VAS 100mm dan dipasangankan kanul intravena berukuran 18 di lengan

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dan diberikan 10 ml/kg ringer lactate.

2b. A – Were all patients who entered the trial accounted for? – and were
they analyzed in the groups to which they were randomized?
What is best? Where do I find the information?
Losses to follow-up should be The Results section should say how
minimal – preferably less than many patients were andomised (eg.,
20%. However, if few patients Baseline Characteristics table) and how
have the outcome of interest, then many patients were actually included in
even small losses to follow-up can the analysis. You will need to read the
bias the results. Patients should results section to clarify the number and
also be analysed in the groups to reason for losses to follow-up.
which they were randomised –
‘intention-to-treat analysis’.
This paper: Yes

Comment:
Terdapat 54 pasien yang dipilih untuk penelitian ini. Pasien terbagi ke dalam 2
kelompok, yaitu kelompok M dan kelompok P. Kelompok pasien dibagi secara
acak oleh computer. Seluruh pasien mengikuti penelitian ini dari awal hingga
akhir.

3. M - Were measures objective or were the patients and clinicians kept

“blind” to which treatment was being received?
What is best? Where do I find the information?
It is ideal if the study is ‘double- First, look in the Methods section to see
blinded’ – that is, both patients and if there is some mention of masking of
investigators are unaware of treatments, eg., placebos with the same
treatment allocation. If the appearance or sham therapy. Second, the
outcome is objective (eg., death) Methods section should describe how the
then blinding is less critical. If the outcome was assessed and whether the
outcome is subjective (eg., assessor/s were aware of the patients'
symptoms or function) then treatment.
blinding of the outcome assessor is
critical.
This paper: No
Comment:
Pada penilitian ini terdapat 3 pihak yang terlibat, yaitu: pasien, ahli
pulmonology dan dokter anestesi. Pasien dan ahli Pulmonology tidak tahu
mengenai obat yang diberikan namun dokter anestesi mengetahuinya dengan
alasan agar penggunaan obat dapat lebih dipantau.

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What were the results?

1. How large was the treatment effect?

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Most often results are presented as dichotomous outcomes (yes or not
outcomes that happen or don't happen) and can include such outcomes as
cancer recurrence, myocardial infarction and death. Consider a study in which
15% (0.15) of the control group died and 10% (0.10) of the treatment group
died after 2 years of treatment. The results can be expressed in many ways as
shown below.

 Kedua kelompok memiliki baseline yang serupa (dapat dilihat pada

tabel 1)
 Tidak terdapat perbedaan statistik secara signifikan pada data
intraoperative (dapat dilihat pada tabel 2) dan data post operatif (dapat
dilihat pada tabel 3)
 Durasi prosedur pada kelompok P (59.9±11, p = 0.87) lebih singkat
dibandingkan dengan kelompok M (59.9 ± 11, p = 0.06). Dapat dilihat
di tabel 3.

What is the measure? What does it mean?

Relative Risk (RR) = risk of the
outcome in the treatment group / risk
of the outcome in the control group.
The relative risk tells us how many
times more likely it is that an event
will occur in the treatment group
relative to the control group. An RR
of 1 means that there is no difference
between the two groups thus, the
treatment had no effect. An RR < 1
means that the treatment decreases
the risk of the outcome. An RR > 1
means that the treatment increased
the risk of the outcome.

Tidak dinilai Since the RR < 1, the treatment

decreases the risk of death.

Absolute Risk Reduction (ARR) = The absolute risk reduction tells us

risk of the outcome in the control
group - risk of the outcome in the
treatment group. This is also known as
the absolute risk difference.
the absolute difference in the rates of
events between the two groups and
gives an indication of the baseline
risk and treatment effect. An ARR of
0means that there is no difference
between the two groups thus, the
treatment had no effect.

Tidak dinilai The absolute benefit of treatment is a

5% reduction in the death rate.

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Relative Risk Reduction (RRR) =
absolute risk reduction / risk of the
outcome in the control group. An
alternative way to calculate the RRR is
to subtract the RR from 1 (eg. RRR =
1 - RR)
Tidak dinilai
The relative risk reduction is the
complement of the RR and is
probably the most commonly
reported measure of treatment
effects. It tells us the reduction in the
rate of the outcome in the treatment
group relative to that in the control
group.
The treatment reduced the risk of
death by 33% relative to that
occurring in the control group.

Number Needed to Treat (NNT) = The number needed to treat

inverse of the ARR and is calculated
as 1 / ARR.
represents the number of patients we
need to treat with the experimental
therapy in order to prevent 1 bad
outcome and incorporates the
duration of treatment. Clinical
significance can be determined to
some extent by looking at the NNTs,
but also by weighing the NNTs
against any harms or adverse effects
(NNHs) of therapy.

Tidak dinilai We would need to treat 20 people for

2 years in order to prevent 1 death.

2. How precise was the estimate of the treatment effect?

The true risk of the outcome in the population is not known and the best we
can do is estimate the true risk based on the sample of patients in the trial.
This estimate is called the point estimate. We can gauge how close this
estimate is to the true value by looking at the confidence intervals (CI) for
each estimate. If the confidence interval is fairly narrow then we can be
confident that our point estimate is a precise reflection of the population value.
The confidence interval also provides us with information about the statistical
significance of the result. If the value corresponding to no effect falls outside
the 95% confidence interval then the result is statistically significant at the
0.05 level. If the confidence interval includes the value corresponding to no
effect then the results are not statistically significant.
Hasil penelitian ini akan dapat dipercaya, karena metode pengukuran pre dan
paska intervensi menggunakan metode-metode yang jelas dan tervalidasi
secara klinis. Efek penelitian ini juga dinyatakan dalam bentuk kemaknaan
statistik dengan power 90% dan standar kemaknaan < 0.05, sehingga
hasil/efek penelitian ini dapat dipercaya.

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Will the results help me in caring for my patient? (External
Validity/Applicability)
The questions that you should ask before you decide to apply the results of the study
to your patient are:

 Is my patient so different to those in the study that the results cannot apply? NO
 Is the treatment feasible in my setting? NO
 Will the potential benefits of treatment outweigh the potential harms of treatment
for my patient? YES

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Check List Umum Struktur dan Isi Makalah

Ya (Y)
No Kriteria Tidak Ada (N)
Tidak Relevan (TR)
Judul Makalah
1 Tidak terlalu panjang atau terlalu pendek Y
2 Menggambarkan isi utama penelitian Y
3 Cukup menarik Y
4 Tanpa singkatan selain yang baku Y
Pengarang dan Institusi
5 Nama-nama ditulis sesuai dengan aturan Y
jurnal
Abstrak
6 Abstrak satu paragraph atau terstruktur Y
7 Mencakup komponen IMRAD Y
8 Secara keseluruhan informative Y
9 Tanpa singkatan selain yang baku Y
10 Kurang dari 250 kata N
Pendahuluan
11 Ringkas, terdiri dari 2-3 paragraf N
12 Paragraf pertama mengemukakan alasan N
dilakukan penelitian
13 Paragraf berikut menyatakan hipotesis atau Y
tujuan penelitian
14 Didukung oleh pustaka yang relevan Y
15 Kurang dari 1 halaman Y
Metode Penelitian
16 Disebutkan desain, tempat, dan waktu Y
penelitian
17 Disebutkan populasi sumber (populasi Y
terjangkau)
18 Dijelaskan kriteria inklusi dan eksklusi Y
19 Disebutkan cara pemilihan subyek (teknik Y
sampling)
20 Disebutkan perkiraan besar sampel dan N
alasannya
21 Besar sampel dihitung dengan rumus yang TR
sesuai
22 Komponen-komponen rumus besar sampel TR
masuk akal
23 Observasi, pengukuran, serta intervensi dirinci TR
sehingga orang lain dapat mengulanginya
24 Ditulis rujukan bila teknik pengukuran tidak TR
dirinci
25 Pengukuran dilakukan secara tersamar TR

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26 Dilakukan uji keandalan pengukuran (kappa) TR

27 Definisi istilah dan variable penting Y

dikemukakan
28 Ethical clearance diperoleh TR

29 Persetujuan subyek diperoleh Y

30 Disebut rencana analisis, batas kemaknaan dan TR

power penelitian
31 Disebutkan program computer yang dipakai N

32 Disertakan table karakteristik subyek Y

penelitian
33 Karakteristik subyek sebelum intervensi Y
dideskripsi
34 Tidak dilakukan uji hipotesis untuk kesetaraan TR
pra-intervensi
35 Disebutkan jumlah subjek yang diteliti Y

36 Dijelaskan subyek yang drop out dengan N

alasannya
37 Ketepatan numeric dinyatakan dengan benar Y

38 Penulisan table dilakukan dengan tepat Y

39 Tabel dan ilustrasi informative dan memang Y

diperlukan
40 Tidak semua hasil di dalam table disebutkan N
pada naskah
41 Semua outcome yang penting disebutkan N
dalam hasil
42 Subjek yang drop-out diikutkan dalam analisis N

43 Analisis dilakukan dengan uji yang sesuai Y

44 Ditulis uji hasil statistika, degree of freedom N

dan nilai p
45 Tidak dilakukan analisis yang semula tidak Y
direncanakan
46 Disertakan interval kepercayaan Y

47 Dalam hasil tidak disertakan komentar atau N

pendapat

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 Diskusi
48 Semua hal yang relevan dibahas Y

49 Tidak sering diulang hal yang dikemukakan Y

pada hasil
50 Dibahas keterbatasan penelitian, dan Y
dampaknya terhadap hasil
51 Disebut penyimpangan protocol dan N
dampaknya terhadap hasil
52 Diskusi dihubungkan dengan pertanyaan Y
penelitian
53 Dibahas hubungan hasil dengan Y
teori/penelitian terdahulu
54 Dibahas hubungan hasil dengan praktek klinis Y

Ucapan Terima Kasih

55 Ucapan Terimakasih ditujukan kepada orang N
yang tepat
56 Ucapan Terimakasih dinyatakan secara wajar N

Daftar Pustaka
57 Daftar Pustaka disusun sesuai dengan aturan Y
jurnal
58 Kesesuaian sitasi pada naskah dan daftar Y
pustaka
Lain-lain
59 Bahasa yang baik dan benar, enak dibaca, Y
informative, dan efektif
60 Makalah ditulis dengan ejaan yang taat asas Y

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