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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/
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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