Presentation on theme: "(”Bringing research evidence"— Presentation transcript:
1 (”Bringing research evidence B asedM edicine(”Bringing research evidenceinto practice”)Sudigdo SastroasmoroMedical School University of Indonesia
2 Dr. Benjamin Spock: Baby and Child Care “I think it is preferable to accustom a baby to sleeping on his stomach from the start of he is willing. He may change later when he learns to turn over”.Later evidence indicates that prone position is aan significant risk factor for SIDS(sudden infant death syndrome)2
3 EBM & Clinical Epidemiology Fletcher & 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
4 Previous practice: 6 yrs medical education Problems with patients: Dx, Rx, Px40-50 yrsmedical practiceConsultants, colleaguesTextbooksHandbooksLecture notesClinical guidelinesCME, seminars, etcJournalsUsu. see only Results section,or even worse, Abstract section
5 Trust meIn my experience ….LogicallyTextbook, handbook, capita selecta
6 What is Evidence-based Medicine? “The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients”“Pemanfaatan bukti mutakhir yang sahih dalam tata laksana pasien”Integration of (1) physician’s competence (2) valid evidence from studies (3) patient’s preference
7 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, etc. should be critically appraisedKeyword for EBM:Methodological skill to judge the validityof study reports (Re. Andersen B: Methodological errors in medical research, 1989)
8 “Hierarchy of Lies”StatisticsDamn lies.....Lies.....(Mark Twain)
9 WHY EBM? 1. Information overload Keeping current with literature Our clinical performance deteriorates with time (“the slippery slope”)4. Traditional CME does not improve clinicalperformance5. EBM encourages self directed learning process which should overcome the above shortages
11 The Flora and Fauna of the Medical Jungle Original ResearchAcademic ReviewsDecision/Cost AnalysisMedical Cookbooks (Practice Guidelines)Translation JournalsCMEClinical ExperienceExpertsNewsletters and Survey ServicesPharmaceutical RepresentativesComputer sourcesAudiotapesQualitative Research
12 Our textbooks are out-of-date Fail to recommend Rx up to ten years after it’s been shown to be efficacious.Continue to recommend therapy up to ten years after it’s been shown to be useless.Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC: A comparison of results of meta-analyses of randomised control trials and recommendations of clinical experts. JAMA 1992;268:240-8.Then I show two slides from their article, showing the lag in recommending thrombolytics and the lag in de-recommending lidocaine for myocardial infarction.
13 The inevitable consequence: On average, the clinically-important knowledge of physicians deteriorates rapidly after we complete our training.We have a nice slide from the late Ted Evans, but also include a jazzier version of it from Brian Haynes, and it follows here.Evans CE, Haynes RB, Birkett NJ et al: Does a mailed continuing education program improve clinician performance? Results of a randomised trial in antihypertensive care. JAMA 1986:255:501-4.
14 $ THE SLIPPERY SLOPE 100% Relative % of remaining knowledge Years after graduationTHE SLIPPERY SLOPE
15 Steps in EBM practice VIA Formulate clinical problems in answerable questionsSearch the best evidence: use internet or other on-line database for current evidence3. Critically appraise the evidence forValidity (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
16 Main areaDiagnosis (Determination of disease or problem) Treatment (Intervention necessary to help the patient) Prognosis (Prediction of the outcome of the disease)
17 Others:Meta-analysis Clinical guidelines Economic analysis Clinical decision making Cost-effectiveness analysis Qualitative research
19 A 2-month old infant with large VSD Birth weight 3.1 kgWeight 3.8 kg, HR=132, RR 68Retractions (+)Systolic murmur, gallop rhythmHepatomegalyDx: Large VSD, Heart failure, Failure to thriveDefinite Rx: early surgeryAlternative Rx: Drugs first?
20 Medical students: (Background question) What is VSD?How to Dx?What are symptoms & signs of CHF in infants with L-R shunt?What is the treatment?
21 House officers (Foreground question) In infants with large VSD and CHF, would administration of digoxin or other inotropic agent delay the need for surgery?
22 ForegroundquestionsBackgroundExperience with condition
23 Other exampleIn neonates born to mothers with history of herpes simplex infection, does the administration of IVIG (intravenous immunoglobulin) reduce the possibility of neonatal herpes?
24 Other exampleIn women with history of eclampsia, would administration of low-dose aspirin (compared with no aspirin) during pregnancy prevent eclampsia?
26 …a risk factor for the developmnt HMD? Example: EtiologyP I C O…a risk factor for the developmnt HMD?“Inprematureinfants ……is modeof delivery…
27 …comparedwith microscope Example: DiagnosisP I C O“In patientswith suspectedmalaria…canrapid test…comparedwith microscopeexam…effectivelyestablishdiagnosis?
28 Example: Therapy P I C O “For px with Stevens Johnson syndrome will earlyIVImmuno-globulin(IVIG)…whencomparedwithno IVIG…preventseverecomplica-tions?
29 Example: Prognosis P I C O “For px with SLE …worsen the prognosis? …wouldhistoryofheart failure…comparedwith nohistoryof HF
30 Four elements of good clinical question: PICO The Patient or ProblemThe InterventionComparative interventionThe OutcomeDomainDeterminantsOutcome
31 Four elements of a well constructed clinical question: PICO The maininterventionconsideredThealternativeto comparewith theOutcomeexpectedfrom thisintervention?Descriptionof patientor problemB e b r i e f a n d s p e c i f i c
32 Remember (1)Not all clinical questions contain 4 elements, depending on the nature of the condition being asked.Examples:In post-menopausal women on hormone replacement therapy, does addition of vitamin X reduce the likelihood of developing hip fracture? (PIO)In patients with thalassemia HbE disease, what is the prevalence of single gene mutation? (PO)
33 Remember (2)In the PICO context, Intervention does not necessarily mean TREATMENT or PREVENTION, but may be:A diagnostic test (for diagnosis)In a patient with solitary thyroid nodule, does ultrasound exam, compared with needle biopsy, differentiate malignant from benign tumor?A risk factor (for etiology, prognosis)Is poor fiber diet a risk factor for the development of colo-rectal cancer?A condition in the patient himself (for prognosis)In patient with SLE, would the history of cardiac failure, compared with no failure, worsen the long-term prognosis?
34 Relevance: Type of Evidence POE: Patient-oriented evidencemortality, morbidity, quality of lifeDOE: Disease-oriented evidencepathophysiology, pharmacology, etiology
35 Comparing DOEs and POEMs ProstatescreeningPSA screeningdetects prostateCa. early? whether PSAscreening mortalityDOE exists, butPOEM unknownAntiarrhythmicTherapyAntihypertens.Drug A PVCOn ECGDrug X BPDrug X Drug A >DOE & POEMcontradictsPOEM agreesWith DOEExampleDOEPOEMComment
38 Use keywords for searching Note:Spelling (American / British), terminologyFollow rigidly the instructions of each websiteExamples:“Host vs graft reaction” AND managementhemosiderosis AND thalassemia OR thalassaemia“breast cancer” OR “Ca mammae” AND immunoglobulin OR IVIG
40 VIA Validity: 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 patient’s characteristics, local setting
41 Validity - other approach: RAMMbo Recruitment: sampling methods, eligibility criteria, sample sizeAllocation: randomization? concealment?Maintenance: many drop outs?Measurementblinded – RCT, Dx testobjective – validity & reliabilityCan be applied for all designs with necessaryAdjustment according to nature of the design
42 Critical appraisal for therapy 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?
43 Hierarchy of evidence Rec Meta-analysis of RCT Level 1 Large RCT A BCRecWeight ofScientificScrutinyMeta-analysis of RCTLarge RCTSmall RCTNon-Randomized trialsObservational studiesCase series / reportsAnecdotes, expert, consensusLevel 1Level 2Level 3Level 4
44 Implementation of EBM practice: How to get started 1. Teaching EBM in medical schools / PPDSEasier than to change the already existing attitudeMost importantMay be included in formal curricula or integrated inexisting activities: ward rounds, on calls, casepresentations, group discussions, journal clubs, etc2. Workshop for teaching staff3. Workshop for practitioners, incl. nurses
45 Resistance to EBM teaching & learning Rudimentary skill in critical appraisal / methodological skillLimited resources, esp. time factorLack of high quality evidenceSkepticism toward evidence-based practice‘Happy’ with current practice
46 Development of EBM practice Passive diffusion modelActive dissemination modelCoordinated implementation model:Patients & communityHealth administratorsPublic policy makersClinical policy makers
49 The EBM Cycle Patient With problem Apply Formulate In answerable questionApplyThe evidenceCriticallyAppraiseThe evidenceSearch theevidence
50 Your patient is here! Usu. Based on practical purposes Target population(Domain)Accessiblepopulation(time, place)(demographic, clinical)AppropriatesamplingtechniqueYour patient is here!ActualstudysubjectsSubjectscompletedthe studyIntendedSample[Non-response, drop outs,withdrawals, loss to follow-up][Subjects selectedfor study]
51 Criticism to EBM EBM makes expensive medical care EBM 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
52 Criticism to EBM EBM makes expensive medical care Cf: Routine antibiotics for ARTI & diarrheaLiberal indication for C-sectionUnnecessary sophisticated procedures / examsUnnecessary / harmful treatment: steroid for recurrent cough
53 Criticism to EBM EBM cannot be implemented in developing countries By definition EBM is implemented if it is implementable (patient’s preference and local condition) – for the benefit of the patients and the community
54 Criticism to EBM EBM is costly and time consuming EBM does requires facilities at the cost of quality medical care!Cost benefit ratio should be assessed in individual and community levels
55 Criticism to EBM EBM ignores pathophysiology & reasoning EBM 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
56 Criticism to EBM EBM ignore experience and clinical judgment Personal 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
57 Criticism to EBM EB-guidelines etc 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 patient’s valuesDevelopment of clinical guidelines and other standards of care should be seen as a guide and implemented according to clinical setting
58 Barriers to the implementation of Evidence-Based Medicine “It takes too long.”“Possibly a limitation to my clinical freedom.”“It questions my professional autonomy.”
59 Advantages of EBM Encourages reading habit Improves 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
60 End result Self directed, life-long learning attitude for high quality patient care
61 Conclusion EBM is nothing more than a framework of systematic use of current valid study resultsrelevant to our patient
62 Evidence-based Cardiology Evidence-based PediatricsEvidence-based Ob-GynEvidence-based DentistryEvidence-based NursingEvidence-based Health PolicyEvidence-based Health Technology AssessmentEvidence-based Decision MakingEvidence-based Health Performance IndicatorsEvidence-based Clinical AuditEvidence-based Risk Management …….Evidence-based Everything!!!
63 All others must have evidence In God we trustAll others must have evidence
64 Medicine is the science of uncertainty and the art of probabilities Remember, however …...Medicine is the science of uncertaintyand the art of probabilities