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EBM therapy
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Skenario Klinis
Seorang pasien berusia 4 tahun datang bersama ibunyake tempat praktek pribadi dengan keluhan demam.Gejala demam disertai sakit perut, muntah, dan lemas.Pasien tidak mengalami kejang. Pasien tinggal di
daerah endemis malaria. Hasil pemeriksaan apusandarah didapatkan plasmodium falciparum. Doktermenyarankan untuk mendapatkan pengobatan terkinimenggunakan Artemisinin-based combination therapy(ACT) yang hanya tersedia di puskesmas dan diperoleh
secara cuma-cuma. Namun ibu pasien menolak daningin mendapatkan terapi dari dokter yangbersangkutan .
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Dokter berfikir terdapat sediaan ACT di luar
program pemerintah. Namun dokter belum
begitu yakin efektifitas obat tersebut
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Steps in Practicing EBM
1. Convertthe need for information into ananswerable question.
2. Track down the best evidence with which to
answer that question.3. Critically appraise the evidence for itsvalidity, impact, and applicability.
4. Integrate the evidence with our clinicalexpertise and our patients characteristicsand values.
5. Evaluating our effectiveness and efficiency inexecuting steps 14 and seeking ways toimprove them both for next time.
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Pertanyaan klinis
Patient and the
problem:
Intervention: Comparison: Outcome of
interest:
Pasien dengan
sarkaidosis
kutaneus
CLEAR
(concomitant,
Levofloxacin,
Ethambutol,Azitromisin,
Rifampin)
Placebo Reduksi diameter
lesi sarkaidosis
kutaneus
Components of foreground question (PICO):
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Pertanyaan klinis
Pada pasien dengan sarkaidosis kutaneus,
apakah pemberian CLEAR (concomitnan,
Levofloxasin, Ethambutol, Azitromisin,
Rifampin) sama efektifnya dengan pemberian
placebo dalam mempengaruhi kesembuhan?
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Steps in Practicing EBM
1. Convert the need for information into ananswerable question.
2. Track down the best evidence with which to
answer that question.3. Critically appraise the evidence for itsvalidity, impact, and applicability.
4. Integrate the evidence with our clinicalexpertise and our patients characteristicsand values.
5. Evaluating our effectiveness and efficiency inexecuting steps 14 and seeking ways toimprove them both for next time.
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Search Strategy
Medline database:
http://www.ncbi.nlm.nih.gov/pubmed/
Using the Clinical Queries function ofPubMed:
Key words:
coartemAND
malaria
Clinical Study Categories: Therapy
Scope: Narrow
http://www.ncbi.nlm.nih.gov/pubmed/http://www.ncbi.nlm.nih.gov/pubmed/8/10/2019 sarkaidosis
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The evidence
Efficacy of artesunate-amodiaquine and artemether-lumefantrine fixed-dose combinations for thetreatment of uncomplicated Plasmodium falciparummalaria among children aged six to 59 months inNimba County, Liberia: an open-label randomized non-
inferiority trial
Schramm B, Valeh P, Baudin E, Mazinda CS, Smith R,Pinoges L, Dhorda M, Boum Y, Sundaygar T, Zolia YM,Jones JJ, Comte E, Houze P, Jullien V, Carn G, Kiechel J,Ashley EA, Guerin PJ.
http://www.malariajournal.com/content/12/1/251
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Steps in Practicing EBM
1. Convert the need for information into ananswerable question.
2. Track down the best evidence with which to
answer that question.3. Critically appraise the evidence for itsvalidity, impact, and applicability.
4. Integrate the evidence with our clinicalexpertise and our patients characteristicsand values.
5. Evaluating our effectiveness and efficiency inexecuting steps 14 and seeking ways toimprove them both for next time.
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ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?
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ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?
1. Was the assignment of patients to treatment
randomized? Lihat di judul
Ya, pada jurnal yang kami temukan di juduldikemukakan bahwa penelitain ini merupakan
Randomizeddan hal tersebut juga dinyatakan dalam
metode.
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2. Was the randomization concealed ?
- Ya
ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?
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3. Were the groups similiar at the start of the
trial ?
- Ya
pada methodde kalimat berdua, dan kriteria
inklusi eklusi pada paragraf kedua, pada
interventions
ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?
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ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?
2. Was the randomization concealed? Bukti
randomizedny mana?
ya
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ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?
3. Were the groups similar at the start of the trial?carikriteria inklusinya sama (orang, waktu, cara
pengambilan)
Ya + tbel 1
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ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?4. Was follow-up of patients sufficiently long and complete?
Pada penelitian ini follow-up pasien dilakukan selama 180 hari mulai
dari awal
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ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?
5. Were all patients analyzed in the groups to which
they were randomized?
Ya, penelitian ini menganalisis masing-masing kelompok
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ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?
6. Were patients, clinicians, and study personnelkept blind to treatment?
Tidak
Pasien diberikan inform consent sebelumdilakukan penelitian
Clinicians tidak mengetahui tujuan dari penelitian
ini (single blind)
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ARE THE RESULTS OF THIS INDIVIDUAL STUDY
VALID?
7. Were groups treated equally, apart from the
experimental therapy?Apakah kelompok
pasien yang diteliti dipilih secara acak,
terlepas dari riwayat terapiny?
Ya, sampel penelitian diacak menggunakan
random sampling dengan perbandingan 1:1
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ARE THE VALID RESULTS OF THIS INDIVIDUAL
STUDY IMPORTANT?
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1. What is the magnitude of the treatment
effect? Cari ditabel ttg perlakuan
event Time to
event
Kel. Control
Total pasien : 150Total yg dianalisis: 149
Kel. perlakuan
Total pasien : 150Total yg dianalisis: 150
cure 28 days Number of
event
CER
99
0.66
Number of
event
EER
108
0.720
cure 42 days Number of
event
CER
75
0.50
Number of
event
EER
71
0.473
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2. How precise is this estimate of the
treatment effect?Cari ditabel juga ttg
besarnya pengaruh obat trhp lesi
CER EER RRR
|CER-EER|/CER
ARR
|CER-EER|
NNT
1/ARR
Cure 28 days 66 72 -9%-25%-7%
0.06-0.164-0.044
17NNT: 22 to INF
NNH: 6 to INF
Cure 42 days 50 47.3 5%
-17%-28%
0.027
-0.086-0.14
37
NNT: 7 to INF
NNH: 12 to INF
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ARE THE VALID, IMPORTANT RESULTS OF THIS INDIVIDUAL STUDY
APPLICABLE TO OUR PATIENT?
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ARE THE VALID, IMPORTANT RESULTS OF THIS INDIVIDUAL STUDY
APPLICABLE TO OUR PATIENT?
1. Is our patient so different from those in the
study that its results cannot apply?
Tidak, pasien sesuai kriteria inklusi penelitian,
namun menurut American Lung Association Stateof Lung Disease in Diverse Communities (2010)
menyebutkan bahwa Indonesia bahwa penyakit
sarkaidosis jarang terjadi di Asia Selatan (Korea,
Cina dan Indonesia)
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ARE THE VALID, IMPORTANT RESULTS OF THIS INDIVIDUAL STUDY
APPLICABLE TO OUR PATIENT?
2. Is the treatment feasible in our setting?
(harga, ready stok)
Tidak
Untuk metode CLEAR (concominant, levofloxacin,
ethambutol, azitromycin dan rifampin),
concominanttidak tersedia di Indonesia
Sedangkan rifampin biasa dikenal di Indonesiadengan sebutan rifampicin
(ISO Indonesia, 2010)
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ARE THE VALID, IMPORTANT RESULTS OF THIS INDIVIDUAL STUDY
APPLICABLE TO OUR PATIENT?
3. What are our patients potential benefits and harmsfrom the therapy?Bukti bahwa potensi kesembuhan dankesakitan dari terapi?
Penelitian ini melaporkan nilai NNT pada akhir pengamatan: 37,
artinya kita membutuhkan 37 pasien yang mendapatkan terapicoartem selama 42 hari untuk mendapatkan hasil tambahan 1orang yang sembuh dari malaria
Pasien ini tidak memerlukan analog peningkatan risiko karenapasien tinggal di daerah endemis ( sesuai dengan setting
penelitian) Dengan ACT Program biaya yang dikeluarkan lebih sedikit,
bahkan bisa diperoleh secara gratis, sedangkan untuk AL biayayang diperlukan lebih besar/mahal
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ARE THE VALID, IMPORTANT RESULTS OF THIS INDIVIDUAL STUDY
APPLICABLE TO OUR PATIENT?
4. What are our patients values and expectationsfor both the outcome we are trying to preventand the treatment we are offering?Bagaimanaekspektasi dari pasien kita thdp terapi yang kitaanjurkan?
Penggunaan ACT maupun coartem memilikikesamaan efektifitas dalam kesembuhan pasien
Jadi ada kesesuaian antarapatients values andexpectationsdengan pengobatan yang akandiberikan berdasarkan evidence tersebut
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Steps in Practicing EBM
1. Convert the need for information into ananswerable question.
2. Track down the best evidence with which toanswer that question.
3. Critically appraise the evidence for itsvalidity, impact, and applicability.
4. Integrate the evidence with our clinicalexpertise and our patients characteristics
and values.5. Evaluating our effectiveness and efficiency in
executing steps 14 and seeking ways toimprove them both for next time.
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Resolution of The Case Scenario
Dokter bisa menggunakan coartem sebagai
terapi alternatif pada pengobatan malaria
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Steps in Practicing EBM
1. Convert the need for information into ananswerable question.
2. Track down the best evidence with which toanswer that question.
3. Critically appraise the evidence for itsvalidity, impact, and applicability.
4. Integrate the evidence with our clinicalexpertise and our patients characteristics
and values.5. Evaluating our effectiveness and efficiency in
executing steps 14 and seeking ways toimprove them both for next time.
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Terimakasih
Alhamdulillah