TUGAS EBM:

FORMULASI PERTANYAAN KLINIS

DAN SEARCH STRATEGY

Disusun oleh:
Prodi Sp1 Obstetri dan Ginekologi

Pembimbing:
dr. Achmad Ridwan, MO, M.Sc

PROGRAM PENDIDIKAN DOKTER

SPESIALIS I FAKULTAS KEDOKTERAN
UNIVERSISTAS SRIWIJAYA PALEMBANG
2024
Daftar nama Mahasiswa Prodi Sp1 Obstetri dan Ginekologi:

dr. Diani Wulan dona 04052722428001

dr. Beby Dwi Lestari 04052722428002
⁠dr. Rina Novitriani 04052722428003
dr. Dewi Zartika 04052722428004
⁠dr. Alman P Manalu 04052722428005
dr. Egyd Tradiga 04052722428006
dr. Dimas Djiwandono Daryanto 04052722428007
dr. Elmo Saviro Herprananda 04052722428008
dr. Leonardus Yogie Ricardo 04052722428009
dr. M. Alfadilla Akbar 04052722428010
dr. Habibi Adhi Pratama Duarsa 04052722428011
dr. Mohamad Reihansyah Deswindra 04052722428012
dr. Muhammad Vary Pramadezta 04052722428013
dr. Nopan Rahmat Dermawan 04052722428014
Skenario 1
A 24-years old woman in 34 weeks of gestation presents to emergency room
after being referred from local clinic due to severe hypertension. This is her
first gestation. Her referral letter said that her blood pressure was 162/108
mmHg and measurement in emergency room revealed her blood pressure to be
172/114 mmHg. She also has proteinuria. In the emergency room, you have
oral nifedipine and intravenous labetalol and you wonder what’s more
effective between oral nifedipine and intravenous labetalol in
preeclampsia.

1. Formulating Question? Background question

- What is the most dangerous outcome of preeclampsia?
- What the approved drugs to treat preeclampsia in emergency settings?
- Which choice is the safest and the most efficacious: oral nifedipine or
intravenous labetalol to treat preeclampsia?

Foreground question
Is there any randomized controlled trial to compare oral nifedipine better
than intravenous labetalol to treat severe preeclampsia?
Question Terminology(ies) Alternate terms(s)
segment
P:Patient Pregnant Late trimester, third
trimester
I: Intervention Randomized controlled trial RCT
C: Comparison Nifedipine Labetalol
O: Outcome Effectiveness Efficacy, control
2. Keyword and Search Strategy
a. Identify terms to fit PICO question
P I C O

#1 Pregnant #3 Randomized #6 Nifedipine #8 Effectiveness

controlled trial
#2 Late trimester #4 RCT #7 Labetalol #9 Efficacy
# Third trimester - #10 Control
#1 OR #2 OR #3 #3 OR #4 #6 AND #7 #8 OR #9 OR #10
Seleksi artikel yang relevan:
pregnant AND randomized controlled trial AND nifedipine AND labetalol
AND effectiveness

b. History and Search Details

3. Download abstract dan Full text Journal
 Skenario 2
A 26-years old, 10-weeks pregnant mother is worried when a friend of her died
after suffering eclampsia. She wondered whether it’s a good idea to take
vitamin D as one of supplementation in pregnancy. She heard that vitamin D
deficiency is common in Indonesia and she wondered whether vitamin D is
beneficial to prevent preeclampsia. She asked your professional opinion.

1. Formulating Question?
Background question
- What is preeclampsia?
- What is the risk factors of preeclampsia?
- What is vitamin D and why is it important in pregnancy?

Foreground question
Is vitamin D supplementation beneficial to prevent preeclampsia?
Question Terminology(ies) Alternate term(s)
segment
P=Patient Primigravid Pregnant

I: Intervention Randomized controlled trial RCT

C: Comparison Vitamin D Placebo
O: Outcome Preeclampsia -

2. Keyword and Search Strategy

a. Identify terms to fit PICO question
P I C O

#1 Primigravid #3 Randomized #6 Vitamin D #8 Preeclampsia

controlled trial
#2 Pregnant #4 RCT #7 Placebo -
- - - -
#1 OR #2 OR #3 #3 OR #4 #6 AND #7 #8
Seleksi artikel yang relevan:
primigravid AND vitamin D AND preeclampsia AND randomized
b. History and Search Details
c. Selected Journal full text dan Abstract
 d. Critical Appraisal of Randomized Clinical Trial
Judul Jurnal : Effect of early vitamin D supplementation on the incidence
of preeclampsia in primigravid women : a randomised clinical trial in
Eastern Democratic Republic of the Congo.
SCREENING
Does the study question match your
question?
Was the study design appropriate?
VALIDITY
F: Patient Follow-Up
 Were all patients who entered
the trial properly accounted
for at its conclusion? Losses to
follow-up should be less than
20% and reasons for drop-out
given.
 Was follow-up long enough?
R: Randomization
 Were the recruited patients
representative of the target
population?
 Was the allocation
(assignment) of patients to
treatment randomized and
concealed?
I: Intention to Treat Analysis
 Were patients analyzed in the
groups to which they were
randomized?
S: Similar Baseline Characteristics of
Patients
Were groups similar at the start of
the trial?
B: Blinding
 Were patients, health workers,
and study personnel “blind” to
treatment?
 If blinding was impossible,
Ya. Pertanyaan penelitian menjawab
pertanyaan yang telah diajukan. Desain
penelitian dipilih dengan tepat dan telah
diajukan dalam registry untuk clinical trial
dengan nomor ISRCTN46539495.
Follow-up dilakukan hingga persalinan
sehingga kebutuhan follow-up tercapai.
Angka loss-to-follow-up kurang dari 10%
pada kedua lengan penelitian (61/649 di
kelompok kontrol, 56/651 di kelompok
perlakuan). Alasan drop-out adalah
mengundurkan diri, abortus, atau clear egg.
Ya. Populasi pasien mencakup seluruh
perempuan primigravida dengan kehamilan
tunggal dengan usia kehamilan kurang dari
16 minggu tanpa komorbiditas. Usia kurang
dari 16 minggu dipilih karena ada proses
invasi trofoblas yang sedang terjadi.
Pengacakan dilakukan dengan cara single-
blind di mana hanya subjek yang tidak tahu
jenis perlakuan yang diperoleh.
Ya. Terdapat analisis intention-to-treat
terhadap pengurangan angka kejadian
preeklamsia.
Ya. Pada data baseline tidak terdapat
perbedaan statistik yang bermakna kecuali
pada kadar kalsium di mana kelompok
kontrol lebih tinggi secara bermakna.
Subjek menjalani blinding tetapi para
peneliti tidak mendapat blinding.
 were blinded raters and/or
objective outcome measures
used?
E: Equal Treatment Seluruh subjek pada kedua kelompok
 Aside from the experimental penelitian diperlakukan dengan setara
dalam follow-up dan proses persalinan.
intervention, were the groups treated
equally?
Conflict of Interest Penelitian tidak disponsori pihak manapun.
 Are the sources of support and Tidak ada konflik kepentingan yang
other potential conflicts of dilaporkan.
interest acknowledged and
addressed?
Summary of Article’s Validity Secara umum penelitian ini memiliki desain
 Notable study strengths or yang baik. Kelemahan yang menjadi
weaknesses or concerns? perhatian adalah desain single-blind tetapi
tidak terdapat kendala serius dalam
 How serious are the threats to pengumpulan hasil penelitian. Kelemahan
validity and in what direction lain adalah tidak ada data aktivitas fisik dan
could they bias the study makanan sehari-hari yang dikumpulkan.
outcomes?
IMPORTANCE
Kel. Preeklamsia Normal Total
Suplemen 12 571 583
Tanpa 33 543 576
suplemen
Total 45 1114 1159
Control Event Rate 5,7%
Experimental Event Rate 2,1%
Relative Risk 0,36
Absolute Benefit Increase 3,6%
Relative Benefit Increase 63,2%
Number Needed to Treat 1,58
Importance RR preeklamsia 0,36 (95%CI 0,19-0,69; p =
0,001). RR persalinan preterm 0,56 (95%CI
0,32-0,78; p = 0,002).
Overall Importance Penelitian ini bermakna secara statistik dan
memiliki makna secara klinis.
APPLICABILITY
Similar patient Ya. Usia pasien pada penelitian ini berkisar
1. Are your patients similar to those in antara 14-40 tahun dengan median 21
tahun. Tingkat pendidikan tinggi pada
the study?
2. Are they so different that the results Tidak ada. Suplementasi vitamin D dapat
can’t help you? Is there any drugs,
skills, facilities, and cost that are not
available?
3. How much of the study effect can
you expect for your patients? Will
patients and/or family accept
treatments based on their social,
cultural, and religious values?
Realistic Interventions
4. Is the intervention realistic in your disarankan pada hamper seluruh pasien
setting?
5. Does the comparison intervention
reflect your current practice?
6. What alternatives are available?
RIGHT OUTCOMES
7. Have all the right outcomes been
considered?
8. Are the outcomes appropriate to
your patient?
9. Does the intervention meet their
values and preferences?
OVERALL CONCLUSION
penelitian ini adalah 18,7% yang serupa
dengan Indonesia. Perbedaan dengan
Indonesia adalah tingkat konsumsi alkohol
di penelitian ini yang mencapai 9,5% dan
kadar vitamin D rerata pada baseline yang
lebih tinggi dari Indonesia.
diperoleh di Indonesia.
Ya. Pasien diharapkan dapat menerima
suplementasi vitamin D selama kehamilan.
Ya. Suplementasi vitamin D dapat
hamil.
Tidak. Suplementasi vitamin D pada
penelitian ini diberikan satu kali per bulan
pada dosis 60 ribu IU per pemberian di
kunjungan antenatal.
Suplementasi vitamin D diberikan setiap
hari dalam bentuk suplemen harian.
Ya. Tujuan penelitian ini telah terjawab
pada hasil dan kesimpulan penelitian.
Ya. Mengingat defisiensi vitamin D umum
terjadi di Indonesia dan pencegahan
preeklamsia penting untuk menurunkan
mortalitas serta morbiditas ibu,
suplementasi vitamin D dapat menjadi
alternatif yang murah dan bermanfaat untuk
meningkatkan kesehatan ibu secara
keseluruhan.
Ya. Suplementasi vitamin D selama
kehamilan tidak bertentangan dengan nilai-
nilai sosial maupun agama yang dianut di
Indonesia.
Penelitian ini dapat diaplikasikan di
Indonesia dan diharapkan mendatangkan
manfaat yang luas bagi kesehatan ibu dan
perempuan secara keseluruhan.