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EBM, KP 1.12

Mar 06, 2016

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  • *INTRODUCTION EVIDENCE BASED MEDICINE

  • *Pendahuluan:Dalam pekerjaan sehari hari, dokter dihadapkan pada kebutuhan informasi tentangmasalah medis yg relevan (evidence-based)sementara arus informasi berubah dengan cepat.

    Tujuannya:Mencari bukti yang relevan dan bermanfaatuntuk meningkatkan kualitas perawatanpasien

  • * Dokter memerlukan informasi terbaru dan mempelajari keterampilan baru (learn new skills). Karena itu mahasiswa kedokteran harus menguasai: current information technique prepare for life long learning

  • *Aspek yg penting bagi mahasiswa dlmmempelajari EBM adalah:- Belajar mengidentifikasi kekurangan pengetahuan.- Menentukan pertanyaan klinik yg spesifik.- Menemukan artikel yg relevan dalam literatur medis.

    Suatu cara bagi mahasiswa menemukan deficitknowledge yg tersembunyi adalah selalumembawa buku saku (notebook) dalam sakunyakemana pergi, catat pertanyaan klinik yg muncul

  • * EBM

    . Pendekatan th/ empiris ditinggalkan. Start : awal 90s di Paris oleh ahli epidemiologi klinis. 1992 : hanya sedikit artikel EBM. 1998 : >1000 artikel. Indonesia : berawal pada thn 1997

  • * The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients Sackett DL et al

    Penggunaan bukti-bukti ilmiah yang terkini dan terpercaya dalam pengambilan keputusan tatalaksana pasien

  • *Previous practice:6 yrs medicaleducation40-50 yrsmedical practiceProblems with patients:Dx, Rx, PxConsultant, colleaguesTextbooksHandbooksLecture notesClinical guidelinesCME, seminars, etcJournalsUsu. see only Results section, or even worse, Abstract section

  • *Evidence Based Medicine is the integration of best research with clinical expertise and patient value

  • *.. Integrasi : 1.Best research evidence - penelitian yang terpercaya dan sesuai - penelitian ilmu dasar kedokteran maupun penelitian ttg klinis, test diagnostik , prognosis dll

    2. Clinical expertise - kemampuan klinis kompetensi dokter - identifikasi secara cepat tingkat kesehatan dan diagnosa , faktor resiko dan manfaat dari intervensi yang dilakukan serta pengenalan pasien dan harapan2nya

  • *3.Patient values -pemahaman terhadap keunikan pilihan, perhatian dan harapan pasien dan yang mana yang harus diintegrasikan dalam pengambilan keputusan saat menangani pasien

    bila ke 3 elemen ini terintegrasi dokter dan pasien diagnosa dan terapi outcome klinis dan kwalitas hidup yang baik

  • *WHY EBM?

    1.Selalu ada bukti ilmiah terbaru

    2.Ketidakmampuan untuk mengetahui adanya bukti ilmiah terbaru

    3.Setiap hari diperlukan informasi yang valid/ sah pada situasi klinis ( diagnosa, prognosa, therapi dan pencegahan)

  • *

    4.Kurangnyan informasi dari: sumber tradisional ( buku teks, tenaga ahli )

    5.Terdapat peningkatan kemampuan diagnostik dan keputusan klinis dengan waktu dan pengalaman, tetapi terdapat kemunduran dalam mengup-date pengetahuan

    6.Keterbatasan waktu untuk evaluasi dan pencarian informasi yang mendalam tentang hal-hal yang berhubungan dengan klinis

  • *Years after graduationRelative% ofremainingknowledge

    2 4 6 8 10 12$100%

  • * Diagnosis (Determination of disease or problem) Treatment (Intervention necessary to help the patient) Prognosis (Prediction of the outcome of the disease) Main area

  • *Steps in Practicing Evidence-Based MedicineLangkah 1: Membuat pertanyaan klinis yang baik dan dapat dipertanggungjawabkanLangkah 2: Pilih penelitian / bukti yang terbaik untuk menjawab pertanyaan Langkah 3: Nilai dengan kritis hasil penemuan Langkah 4: Integrasikan penemuan dengan keahlian klinis dan kebutuhan pasienLangkah 5: Evaluasi hasil yang diperoleh dan temukan cara untuk meningkatkannyaSackett DL et al. Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed. Churchill Livingstone; 2000.

  • *Step 1: Construct Well-Built Clinical QuestionsMembuat pertanyaan klinis yang baik dan dapat dipertanggungjawabkan

    Background questionsAsk for general knowledge about a disorder - Two componentsRoot (who, what, when, where, why)A disorder or aspect of a disorder

  • * -What is Kawasaki disease? -What is the cause? - What are symptoms & signs? -What is the treatment? -Cardiac involvement?

  • *Foreground questions

    Ask for specific knowledge about managing patients with a disorder-Have four essential component In a child with Kawasaki disease, will repeated echo examination necessary for early detection of cardiac involvement? (Dx)

  • *Formulate a focused clinical questionP- PatientI- InterventionC- ComparisonO- Outcome

  • *Asking answerable clinical questions (CEBM- Oxford)

  • *Step 2: Locate the Best EvidencePilih penelitian / bukti yang terbaik untuk menjawab pertanyaan

    Sources of information and evidence may include:Colleagues Textbooks Journals (e.g., evidence-based) Systematic reviews Guidelines Electronic databases Where to start searching may depend on: Available time Available databases Foreground versus background knowledge requiredSackett DL et al. Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed. Churchill Livingstone; 2000. .

  • *Evidence Pyramid

    Type of Study

    Meta-Analysis

    Systematic Review

    Randomized Controlled Trial

    Cohort studies

    Case Control studies

    Case Series/Case Reports

    Animal research

  • *Levels of Evidence

    Level of EvidenceType of Study1aSystematic reviews of randomized clinical trials (RCTs)1bIndividual RCTs2aSystematic reviews of cohort studies2bIndividual cohort studies and low-quality RCTs3aSystematic reviews of case-controlled studies3bIndividual case-controlled studies4Case series and poor-quality cohort and case-control studies5Expert opinion based on clinical experience

  • *Levels of EvidenceLevel 1: Highest: Level 2: Level 3:Level 4:Level 5: Lowestbut still evidence

  • *Step 3: Critically Appraise the EvidenceVALIDITY: In Methods section:

    -design, sample, sample size, eligibility criteria (inclusion, exclusion) sampling method, randomization method, intervention,measurements, methods of analysis, etcCan I trust this information?

  • *IMPORTANCE: In Results section-characteristics of subjects, drop out, analysis, p value, confidence intervals, etcAre the valid results of the study important?

    APPLICABILITY: In Discussion section + our patients characteristics, local settingCan the results be applied to my patient?

  • *Step 4: Integrate Findings With Clinical Expertise and Patient NeedsCriticalAppraisalClinicalDecisionPatientAdapted from: Sackett DL et al. Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed. Churchill Livingstone; 2000.

    Preferences Concerns Expectations

  • *Step 5: Evaluate Performance and Seek Ways to ImproveAm I asking well-formulated clinical questions? Am I searching at all? Do I know the best sources of current external evidence?Am I critically appraising external evidence?Am I integrating my critical appraisal into my practice?Examples of Self-Evaluation Questions:

  • *Limitations of EBMKurangnya bukti bukti (penelitian )ilmiah Sumber biaya membatasi tipe dan ruang lingkup penelitianAkses ke sumber informasi terbatas (pada situasi klinik )Tidak adekuatnya contoh penelitian yang ada untuk menilai kompleksitas yang terdapat dala sistem kehidupan Kurangnya keterampilan untuk memanfaatkan sumber informasi yang adaaKesulitan dalam menerapkan bukti ilmiah tsb dalam menangani pasien

  • *

    ************Steps in Practicing Evidence-Based MedicineSackett et al. has streamlined the practice of evidence-based medicine into 5 steps. Step 1: Start with the patient. Convert the need for information (e.g., about diagnosis, treatment, or prevention) into an answerable question.Step 2: Track down the best evidence with which to answer that question.Step 3: Critically appraise that evidence for its validity, impact, and applicability.Step 4: Integrate the critical appraisal with our clinical expertise and with our patients concerns, preferences, expectations and circumstances.Step 5: Evaluate our effectiveness and efficiency in executing Steps 1-4 and seek ways to improve. This step emphasizes the need for lifelong learning through the self-evaluation process.**Step 1: Construct Well-Built Clinical QuestionsThe practice of evidence-based medicine is usually initiated by a patient encounter that generates questions about the effects of therapy, the utility of diagnostic tests, the prognosis of diseases, or the etiology of disorders. The first step is to convert the need for information into a well-built and answerable question. The inability to ask a focused and specific question can be a major impediment to the practice of evidence-based medicine. Clinical questions may include both background and foreground knowledge questions.

    Background knowledge questions are general questions about conditions, illnesses, syndromes, or pathophysiology.

    Foreground questions are more often about issues of care. The answers to these questions provide specialized and distinct knowledge needed for specific and relevant clinical decision-making.

    As clinicians, we all have needs for both background and foreground knowledge, in proportions that vary over time depending primarily on our clinical experience.

    ***P-Who am I interested in?I- What is the intervention?C- How is the intervention being compared?O- What are the outcomes of the intervention?***Step 2: Locate the Best EvidenceThe next step is to locate the best evidence to answer these questions.There are many sources of information that can support clinical decisions. Textbooks may become rapidly out of date and thus may not be the best source for establishing the cause, diagnosis, prognosis, prevention, or treatment of a disease. A growing number of periodicals summarize the best evidence found in traditional journals (e.g., ACP Journal Club). Because systematic reviews summarize and combine the results of several studies, they may be ideal sources of evidence for busy clinicians. Good guidelines come from the practice of evidence-based medicine. Evidence-based guidelines describe the strength of the evidence and try to separate opinion from evidence. Current best evidence from specific studies of clinical problems can be found in an increasing number of electronic databases, some with explicit evidence processing (e.g., Cochrane Library, Evidence-based Medicine Reviews). Where to start searching depends on the amount of time you have, the databases you have available to you, and the type of question you are asking.Instead of routinely reviewing the contents of dozens of journals for interesting articles, evidence-based medicine suggests that you target your reading to issues related to specific patient problems. Developing clinical questions and then searching current databases may be a more productive way of staying current with the literature.*This is often referred to as the "evidence pyramid". It is used to illustrate the evolution of the literature. The base of the pyramid is where information usually starts with an idea or laboratory research. As these ideas turn into drugs and diagnostic tools they are tested in laboratories models, then in animals, and finally in humans. The human testing may begin with volunteers and go through several phases of clinical trials before the drug or diagnostic tool can be authorized for use within the general population. Randomized controlled trials are then done to further test the effectiveness and efficacy of a drug or therapy. As you move up the pyramid the amount of available literature decreases, but increases in its relevance to the clinical setting. Meta-Analysis takes the systematic review (see below) a step further by using statistical techniques to combine the results of several studies as if they were one large study. Systematic Reviews usually focus on a clinical topic and answer a specific question. Extensive literature searches are conducted to identify studies with sound methodology. The studies are reviewed, assessed, and summarized according to the predetermined criteria of the review question.Randomized Controlled Trials are carefully planned projects that study the effect of a therapy or test on real patients. They include methodologies that reduce the potential for bias and that allow for comparison between intervention groups and control groups (no intervention). Evidence for questions of diagnosis is found in prospective trials which compare tests with a reference or "gold standard" test. Cohort Studies take a large population and follow patients who have a specific condition or receive a particular treatment over time and compare them with another group that is similar but has not been affected by the condition being studied. Cohort studies are not as reliable as randomized controlled studies, since the two groups may differ in ways other than in the variable under study. Case Control Studies are studies in which patients who already have a specific condition are compared with people who do not. These types of studies are often less reliable than randomized controlled trials and cohort studies because showing a statistical relationship does not mean than one factor necessarily caused the other. Case Series consist of collections of reports on the treatment of individual patients. Case Report is a report on a single patient. Because they are reports of cases and use no control groups with which to compare outcomes, they have no statistical validity . Practice Guidelines are systematically developed statements to assist practitioner and patient make decisions about appropriate health care for specific clinical circumstances. Guidelines review and evaluate the evidence and then make explicit recommendations for practice. The pyramid serves as a guideline to the hierarchy of evidence available. You may not always find the best level of evidence to answer your question. In the absence of the best evidence, you then need to consider moving down the pyramid to other types of studies.**Levels of EvidenceTo help clinicians critically review the external evidence they locate, Sackett et al. developed a hierarchical model to categorize most studies. It is important to note that these levels of evidence are not a rigid set of rules, but serve only as a set of guidelines for the critical appraisal of the literature.According to Sackett (BMJ 1996;312:71-2), the randomized trial (especially the systematic review of randomized trials) has become the gold standard for judging whether or not a particular treatment is beneficial. The practice of evidence-based medicine is not restricted to randomized trials. Studies from other levels may be better meet you needs for information or may be better in terms of quality. For example, although the cohort study design ranked lower than that of the randomized controlled trial, it may be the highest level of evidence (excluding systematic reviews) for other aspects of patient care (e.g., validity of diagnostic tests, assessing prognosis) or when randomized controlled clinical trials cannot be performed due to ethical concerns (e.g., study of harmful interventions or exposures).

    *****Step 4: Integrate Findings With Clinical Expertise and Patient NeedsAccording to Sackett et al., the fourth step in practicing evidence-based medicine requires the integration of the findings from the critical appraisal with clinical expertise and patient needs.Evidence-based medicine is the integration of clinical expertise, patient values, and the best evidence into the decision-making process for patient care. Clinical expertise refers to the clinicians cumulated experience, education, and clinical skills. By patient values we mean the unique preferences, concerns, and expectations each patient brings to a clinical encounter which must be integrated into clinical decisions if they are to serve the patient. The best evidence is usually found in clinically-relevant research that has been conducted using sound methodology.The evidence, by itself, does not make a decision for you, but it can help support the patient care process. The full integration of these three components into clinical decisions enhances the opportunity for optimal clinical outcomes.

    **Step 5: Evaluate Performance and Seek Ways to ImproveThe fifth step in practicing evidence-based medicine is often overlooked. Self-evaluation allows physicians to identify areas that need improvement and reinforces strengths. Asking the right questions, tracking down solid evidence, ensuring that evidence is applicable to a particular patient, and doing this on an everyday basis will serve to help the physician provide patients with the highest quality of care.

    **