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    Evidence Based Medicine

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    Putri Intan
    This document summarizes a randomized controlled trial that compared the efficacy of naltrexone implants versus oral naltrexone for treating heroin dependence. The summary critically appraises the validity, importance, and applicability of the trial. It finds that the trial had some methodological weaknesses like insufficient follow-up duration. It also determines that the trial results were not statistically significant and not applicable to the patient scenario described. So overall, the summary concludes that the trial evidence is not valid, important, or applicable to help answer the clinical question.

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    Evidence Based Medicine

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    Putri Intan
    75 views55 pages
    This document summarizes a randomized controlled trial that compared the efficacy of naltrexone implants versus oral naltrexone for treating heroin dependence. The summary critically appraises the validity, importance, and applicability of the trial. It finds that the trial had some methodological weaknesses like insufficient follow-up duration. It also determines that the trial results were not statistically significant and not applicable to the patient scenario described. So overall, the summary concludes that the trial evidence is not valid, important, or applicable to help answer the clinical question.

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    This document summarizes a randomized controlled trial that compared the efficacy of naltrexone implants versus oral naltrexone for treating heroin dependence. The summary critically appraises the validity, importance, and applicability of the trial. It finds that the trial had some methodological weaknesses like insufficient follow-up duration. It also determines that the trial results were not statistically significant and not applicable to the patient scenario described. So overall, the summary concludes that the trial evidence is not valid, important, or applicable to help answer the clinical question.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    75 views55 pages

    Evidence Based Medicine

    Uploaded by

    Putri Intan
    This document summarizes a randomized controlled trial that compared the efficacy of naltrexone implants versus oral naltrexone for treating heroin dependence. The summary critically appraises the validity, importance, and applicability of the trial. It finds that the trial had some methodological weaknesses like insufficient follow-up duration. It also determines that the trial results were not statistically significant and not applicable to the patient scenario described. So overall, the summary concludes that the trial evidence is not valid, important, or applicable to help answer the clinical question.

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    of 55

    EVIDENCE BASED

    MEDICINE

    dr. Kartini Lidia, M.Sc

    FAKULTAS
    KEDOKTERAN
    UNDANA
    2016
    Definition of EBM

    Evidence Based Medicine


    (EBM) is the integration of
    clinical expertise, patient
    values, and the best
    research evidence into
    the decision making
    process for patient care.

    EBM always begins and


    ends with the patient.
    CRITICAL APPRAISAL :
    Apakah Penelitiannya Valid?
    Apakah Important?
    Apakah applicable?
    EVIDENCE BASED MEDICINE

    CRITICAL APPRAISAL OF
    THERAPY STUDY
    ANSWERABLE CLINICAL QUESTION

    Jenny 52 tahun adalah ibu dari Jon 23 tahun yang


    merupakan penderita ketergantungan heroin yang sedang
    menjalani terapi harian Naltrexon oral. Jenny mendapat
    informasi kalau terdapat obat Naltrexon dalam bentuk
    implant. Jenny bertanya kepada dokter apakah Naltrexon
    implant memiliki efficacy yang lebih baik dibanding oral
    Naltrexon?
    P I C O

    PATIENTS
    Patient with heroin dependence
    INTERVENTION Naltrexon Implant

    COMPARISON Naltrexon Oral

    OUTCOME
    Abstinence (efficacy)
    Searching evidence

    ARCH GEN PSYCHIATRY/VOL 66 (NO.10),


    OCT 2009
    CRITICAL APPRAISAL
    Consort
    study
    CONSORT CHECKLIST

    Title &
    Abstract
    CONSORT CHECKLIST

    Scientific
    Background
    Page 1
    CONSORT CHECKLIST

    Methods
    Participant
    Eligibility
    criteria
    Setting
    and
    location
    CONSORT CHECKLIST

    Precise details
    Intervention
    Page 2
    CONSORT CHECKLIST

    Objective
    and
    Outcome
    Page 2
    CONSORT CHECKLIST

    Sample Size
    Page 3
    CONSORT CHECKLIST

    Randomization Randomization codes were generated by


    Sequence generation computer with a variable block size and a
    Page 2 1:1 allocation ratio

    Packs (active implant +placebo tablets or placebo


    implant + active tablets) were labeled with these
    Randomization codes.
    Allocation concealment Personnel generating the codes and handling the
    researchmedications did not have contact with
    Page 2 participants. Study research officers undertaking
    assessment, recruitment, and patient follow-up had
    no access to the codes.

    Randomization The study was overseen by an independent monitoring


    committee (IMC) consisting of 4 senior physicians
    Implementation experienced
    Data collected were audited for Good Clinical Practice
    Who? compliance by an independent study monitor and were
    double entered with computerized verification.
    Page 3
    Study research officers undertaking
    assessment, recruitment, and patient
    BLINDING follow-up had no access to the codes.

    CONSORT CHECKLIST

    Differences in proportions were assessed with


    Fisher exact tests, and continuous variables were
    compared with t tests or Mann-Whitney tests, as
    appropriate. Hazard ratios for drug related
    outcomes were computed via Cox proportional
    STATISTICAL hazards regression models with age, sex, years of
    regular heroin use, body mass index (calculated as
    METHODE weight in kilograms divided by height in meters
    squared), and group as covariates.
    Time to return to heroin use 4 or more days per
    week or unavailable for follow-up was evaluated
    with Kaplan-Meier survival analysis and log-rank
    tests
    RESULT
    PARTICIPANT FLOW
    RESULT
    CRITICAL
    APPRAISAL

    Are the results of therapeutic trial valid?

    Are the valid results of this randomised


    trial important?

    Can you apply this valid, important evidence


    about therapy in caring for your patient?
    ARE THE RESULTS
    VALID?
    Was the assignment of patients to treatments randomised?

    Were the groups similar at the start of the trial?

    Was follow-up of patients sufficiently long and complete?

    Were all patients analysed in the groups to which they were


    randomised?

    Were the patients and clinicians kept blind to the treatment?

    Were the groups treated equally, apart from the experimental


    treatment?
    ARE THE RESULT
    VALID

    Was the assignment


    of patients to Yes.
    treatments A randomized, double-blind,
    randomised? double-placebo controlled trial

    Yes
    Randomization codes were generated by
    computer with a variable block size and a 1:1
    Was the allocation ratio. Packs (active implant plus
    randomization list placebo tablets or placebo implant plus active
    tablets) were labeled with these codes.
    concealed? Personnel generating the codes and handling the
    research medications did not have contact with
    participants.
    ARE THE RESULT VALID?

    Was follow-up of No it wasnt .Follow-up


    patients sufficiently during 6 months was not
    long and complete?
    sufficient long

    Were all patients


    analyzed in the Yes.
    groups to which they
    were randomized?
    Analyses used an
    intention to treat approach
    ARE THE RESULT VALID?

    Yes.
    Were patients, Pasien tidak tau mana yang obat/implant aktif dan
    mana yang placebo
    clinicians, and Study research officers undertaking as-sessment,
    study personnel recruitment, and patient follow-up had no access to
    kept blind to the codes (Randomization codes were generated by
    computer with a variable block size and a 1:1
    treatment? allocation ratio).
    Personnel generating the codes and handling the
    research medications did not have contact with
    participants

    Were the groups


    treated equally, Yes
    apart from the All participants received treatment
    experimental with either oral or implant nalterxon
    treatment? while also receiving a placebo
    implant or tablet.
    ARE THE RESULT VALID?

    Were the
    groups
    similar at the
    start of the
    trial apart
    from the
    experimental
    therapy?
    Are the valid results of this
    randomized trial important?

    What is the
    Abstinence & returned to regular
    magnitude of the
    heroin use
    treatment effect?

    How precise is the The self reported of abstinence and


    estimate of the regular heroin use verification by
    treatment effect? urynalisis
    Can you apply ?

    Is your patient so
    different from
    Ya, berbeda dari segi ras, tingkat
    those in the study ekonomi, dan pendidikan
    that its results
    cannot apply?

    Is the treatment
    feasible in your May be not feasible
    setting?
    CONCLUSION

    Studi tidak valid karena 95%CI untuk


    outcome opioid abstinence (tabel 3) tidak
    bermakna karena melewati angka 1 (0,90-
    3,28) demikian juga dalam perhitungan
    didapatkan 95% CI (0,007-0,49) juga tidak
    bermakna.
    Studi not important
    Studi Not applicable karena tidak sesuai
    dengan value dan preference pasien saya

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