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Evidence-Based Medicine(Bringing research evidence into practice)

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Evidence-based MedicineOpinion-based medicineExperience-based medicinePower-based medicineHope-based medicineLogic-based medicineErratic-based medicineObat berbasis Opini Obat berbasis pengalaman Obat berbasis-Power Kedokteran berbasis Harapan Obat berbasis logika Obat menentu berbasis

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Medicine-based evidencePragmatic researchOutcome researchEvidence-based MedicineRelated with morbidity, mortality, & quality of life

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MorbidityMortalityQoLPatientSatisfactionHealth StatusValue = QualityCost

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DiagnosisPatient with complaintHistoryPhysicalSimple testSpecific testYes or no answerPredictive value is the most importantThe spectrum of the presentations must resemble that in practice

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TreatmentPatient with certain diagnosisDoes drug X more effective than Y?Focus on the outcome, rather than its explanation (biomolecular markers)Yes or no outcome most useful

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PrognosisUsually in cohort studiesTo inform the patient about the fate of the patient Absolute risk is more important than relative riskAbsolute: Your risk of having second stroke in 1 year is 30%Relative: Your risk of having second stroke in 1 year is 2 times than in non-smokers (RR = 2)

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EBMStarted in early 90s by clinical epidemiologists1992: only few articles on EBM2000: >1000 articlesIndonesia: started in 1997Workshops: Yogya (2000) IKA FKUI (2000, 2001, etc)Group discussion on EBM / mailing list:

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EBM & Clinical EpidemiologyFletcher & Fletcher: CE = The application ofepidemiologic principles in problems encountered in clinical medicineSackett et al: CE = The basic science for clinical medicineMuch resistance by expertsEBM: In principle no one disagreeAll major medical journals have adopted EBMCenters for EBM all over the world

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Previous Practice6 yrs medicaleducation40-50 yrsmedical practiceProblems with patients:Dx, Rx, PxConsultants, colleaguesTextbooksHandbooksLecture notesClinical guidelinesCME, seminars, etcJournalsUsu. see only Results section, or even worse, Abstract section

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Previous PracticeTrust meIn my experience .LogicallyTextbook, handbook, capita selecta

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The results.Opinion-based medicineSteroid inj. in prematures to prevent RDSRoutine episiotomyRoutine circumcisionAntibitotics for flu-like syndromeUse of immunomodulatorsSkin test before antibiotic injectionRoutine chest X-ray for pre-op preparationCT scan after minor head traumaetc

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What is Evidence-based Medicine?

The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patientsPemanfaatan bukti mutakhir yang sahih dalam tata laksana pasienIntegration of (1) physicians competence(2) valid evidence from studies(3) patients preference

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Pros : New paradigm in medicine Extraordinary innovations, only 2nd to Human Genome Project Cons : New version of an old song Fair : Nothing wrong with EBM, but:Be careful in searching evidenceMeta-analyses, clinical trials, and all study results should be critically appraisedKeyword for EBM: Methodological skill to judge the validity of study reports (Re. Andersen B: Methodo-logical errors in medical research, 1989)

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Years after graduationRelative% ofremainingknowledge

2 4 6 8 10 12$100%THE SLIPPERY SLOPE

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WHY EBM?

Information overload Keeping current with literature3.Our clinical performance deteriorates with time (the slippery slope)4. Traditional CME does not improve clinical performance5. EBM encourages self directed learning process which should overcome the above shortages

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Our textbooks are out-of-dateFail to recommend Rx up to ten years after its been shown to be efficacious.Continue to recommend therapy up to ten years after its been shown to be useless.

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The Inevitable ConsequenceOn average, the clinically-important knowledge of physicians deteriorates rapidly after we complete our training.

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Steps in EBM practice

Formulate clinical problems in answerable questionsSearch the best evidence: use internet or other on-line database for current evidence 3. Critically appraise the evidence for Validity (was the study valid?) Importance (were the results clinically important?) Applicability (could we apply to our patient?)4. Apply the evidence to patient5. Evaluate our performanceVIA

Main Area

Diagnosis(Determination of disease or problem)

Treatment(Intervention necessary to help the patient)

Prognosis(Prediction of the outcome of the disease)

A 2-year old boy diagnosed presented with 6-day high fever, conjunctival injection without secretion, skin rash> blood test shows leukocytosis, high ESR, CRP +++. He was suspected to have Kawasaki disease. The pediatrician is aware of the use of immunoglobulin to prevent coronary involvement, but uncertain about the dosage.

Medical students:(Background question)What is Kawasaki disease? What is the etiology?How it is diagnosed?What is the treatment of choice?Complications?

House Officers(Foreground Question)

In a child with KD, would immuno -globulin treatment, compared with no immunoglobulin, reduce the chance to develop coronary complication?

ForegroundquestionsBackgroundquestionsExperience with condition

Other ExamplesIn women with history of eclampsia, would administration of low-dose aspirin during pregnancy prevent eclampsia? (Prevention) In young women with solitary thyroid nodule, can USG, compared with biopsy, differentiate between benign from malignant? (Diagnosis)In women systemic lupus erythematosus, is history of congestive heart failure, compared with no heart failure, worsen the prognosis? (Prognosis)

1Four elements of good clinical question: P I C OThe Patient or ProblemThe Intervention / IndexComparative intervention (if relevant)The Outcome

Four elements of a well constructed clinical question: PICO

P I C OThe maininterventionconsideredThe alternativeto comparewith theinterventionOutcomeexpected from this intervention?Descriptionof patientor problemB e b r i e f a n d s p e c i f i c

Relevance: Type of EvidencePOE: Patient-oriented evidence mortality, morbidity, quality of lifeDOE: Disease-oriented evidencepathophysiology, pharmacology, etiology

POEMPatient-OrientedEvidenceMorbity, Mortality

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Comparing DOES and POEMsExample

DOE

POEM

Comment

AntiarrhythmicTherapyProstatescreeningPSA screeningdetects prostateCa. early? whether PSAscreening mortalityAntihypertens.TherapyDrug A PVCOn ECGDrug X BP

Drug X mortalityDrug A > mortalityDOE & POEMcontradictsPOEM agreesWith DOE

3Appraising the evidence:VIA

VIAValidity: In Methods section:design, sample, sample size, eligibility criteria (inclusion, exclusion), sampling method, randomization method, intervention, measurements, methods of analysis, etcImportance: In Results sectioncharacteristics of subjects, drop out, analysis, p value, confidence intervals, etcApplicability: In Discussion section + our patients characteristics, local setting

Example: Critical appraisal for therapyWere the subjects randomized?Were all subjects received similar treatment?Were all relevant outcomes considered?Were all subjects randomized included in the analysis?Calculate CER, EER, RRR, ARR, and NNTWere study subjects similar to our patients in terms of prognostic factors?

Hierarchy of evidenceWeight ofScientific ScrutinyMeta-analysis of RCT

Large RCT

Small RCT

Non-Randomized trials

Observational studies

Case series / reports

Anecdotes, expert, consensusLevel 1Level 2Level 3Level 4ABCRec

Implementation of EBM practice:How to get started1. Teaching EBM in medical schools / PPDS Easier than to change the already existing attitude Most important May be included in formal curricula or integrated in existing activities: ward rounds, on calls, case presentations, group discussions, journal clubs, etc2. Workshop for teaching staff 3. Workshop for practitioners, incl. nurses

Resistance to EBM teaching & learning Rudimentary skill in critical appraisal / methodological skill Limited resources, esp. time factor Lack of high quality evidence Skepticism toward evidence-based practice Happy with current practice

FormulateIn answerablequestionSearch theevidenceCritically AppraiseThe evidenceApplyThe evidencePatientWith problem

Criticism to EBMEBM makes expensive medical careEBM cannot be implemented in developing countriesEBM is costly and time consumingEBM ignore pathophysiology & reasoningEBM ignore experience and clinical judgmentEB-guidelines etc interfere with professional autonomy

Criticism to EBMEBM makes expensive medical careCf:Routine antibiotics for ARTI & diarrheaLiberal indication for C-sectionUnnecessary sophisticated procedures / examsUnnecessary / harmful treatment: steroid for recurrent cough

Criticism to EBMEBM cannot be implemented in developing countriesBy definition EBM is implemented if it is implementable (patients preference and local condition) for the benefit of the patients and the community

Criticism to EBMEBM is costly and time consumingEBM does requires facilities at the cost of quality medical care!Cost benefit ratio should be assessed in individual and community levels

Criticism to EBMEBM ignores pathophysiology & reasoningEBM encourages clinical reasoning in the light of valid and important evidencePathophysiology and reasoning should be seen as hypothesis and should end-up in empirical evidence

Criticism to EBMEBM ignore experience and clinical judgmentPersonal experience and clinical judgment are by no means can be eliminatedEBM encourage detailed and systematic documentation of experience and judgmentSubjective experience should be, whenever possible, translated into more objective measures

Criticism to EBMEB-guidelines interfere with professional autonomyProfessional conduct (competence, altruism, openness, collegiality, ethics) is encouraged in EBMEvery physician should develop their own practice attitude based on his/her profess-ionalism, valid evidence, and patients valuesDevelopment of clinical guidelines and other standards of care should be seen as a guide and implemented according to clinical setting

Advantages of EBMEncourages reading habitImproves methodological skill (and willingness to do research?!)Encourages rational & up to date management of patientsReduces intuition & judgment in clinical practice, but not eliminates themConsistent with ethical and medico-legal aspects of patient management

End Result

Self directed, life-long learning attitudefor high quality patient care

ConclusionEBM is nothing more than a

framework of systematic use of

current valid study results

relevant to our patient

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