SS/EBM/IKA-UDIP-2010 (”Bringing research evidence into practice”) Evidence-Based Medicine...
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Transcript of SS/EBM/IKA-UDIP-2010 (”Bringing research evidence into practice”) Evidence-Based Medicine...
SS/EBM/IKA-UDIP-2010
(”Bringing research evidenceinto practice”)
Evidence-Based Medicine
Sudigdo Sastroasmoro
Clinical Epidemiology and Evidence-based Medicine Unit
FMUI – CMH, Jakarta
SS/EBM/IKA-UDIP-2010
5-day workshop3-day workshop2-day workshop
SS/EBM/IKA-UDIP-2010
Evidence-based Medicine
Opinion-based medicineExperience-based medicinePower-based medicineHope-based medicineLogic-based medicineErratic-based medicine
versus
SS/EBM/IKA-UDIP-2010
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)
SS/EBM/IKA-UDIP-2010
Evidence-based Medicine
Medicine-based evidencePragmatic researchOutcome research
Related with morbidity, mortality, quality
of life
SS/EBM/IKA-UDIP-2010
Value = Quality
Cost
MorbidityMortality
QoL
PatientSatisfaction
Health Status
SS/EBM/IKA-UDIP-2010
Diagnosis
Patient with complaintHistoryPhysicalSimple testSpecific test: If the test (+) what is the probability that the patient has the disease? Yes or no answer Predictive value is the most important
The spectrum of the presentations must resemble that in practice
SS/EBM/IKA-UDIP-2010
TreatmentPatient with certain diagnosis: best treatment?Is drug X more effective than Y?Focus on the clinical outcome, rather than its explanation (biomolecular markers, etc)Yes or no outcome most usefulNot in studies with “idealized” subjects Px with DM are frequently have
hypercholesterolemia, obese, hypertension, etc
SS/EBM/IKA-UDIP-2010
Prognosis
Usually in cohort studiesTo inform about the fate of the patient Absolute risk is more important than relative risk Absolute: 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)
SS/EBM/IKA-UDIP-2010
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
EBM & Clinical Epidemiology
SS/EBM/IKA-UDIP-2010
Previous practice:
6 yrs medical
education
40-50 yrsmedical practice
Problems with patients:
Dx, Rx, Px
Consultants, colleaguesTextbooksHandbooks
Lecture notesClinical
guidelinesCME, seminars,
etcJournals
Usu. see only Results section,
or even worse, Abstract section
SS/EBM/IKA-UDIP-2010
Trust meIn my experience ….LogicallyTextbook, handbook, capita selecta
SS/EBM/IKA-UDIP-2010
The results….“Opinion-based medicine”
Steroid inj. in prematures to prevent RDSRoutine episiotomyRoutine circumcisionAntibiotics for flu-like syndromeUse of immunomodulators“Skin test” before antibiotic injectionRoutine chest X-ray for pre-op preparationCT scan after minor head traumaetc ……
SS/EBM/IKA-UDIP-2010
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
SS/EBM/IKA-UDIP-2010
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 evidence• Meta-analyses, clinical trials, and all study results should be critically appraised
Keyword for EBM: Methodological skill to judge the validity of study reports (Re. Andersen B:
Methodo-logical errors in medical research, 1989)
SS/EBM/IKA-UDIP-2010
Y= a + b 1x 1
+ b 2X 2
+ b 3X 3
+ ……. + b ix i
εφlnΣδψ 2
$ 6,000
Yesss!!!
SS/EBM/IKA-UDIP-2010
SS/EBM/IKA-UDIP-2010
Dean, Harvard Medical School to students:
“We believe that 50% of what we are teaching to you now will prove to be false 5 years later; the problem is that we do not know which 50%”
SS/EBM/IKA-UDIP-2010
WHY EBM?1 Information overload 2 Keeping current with literature3 Our clinical performance deteriorates
with time (“the slippery slope”)4 Traditional CME does not improve
clinical performance
5 EBM encourages self directed learning process which should overcome the above shortages
SS/EBM/IKA-UDIP-2010
Years after graduation
Relative% ofremainingknowledge
2 4 6 8 10 12
$100%
THE SLIPPERY SLOPE
SS/EBM/IKA-UDIP-2010
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.
SS/EBM/IKA-UDIP-2010
1. Formulate clinical problems in answerable questions
2. Search 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 performance
Steps in EBM practice
VIA
SS/EBM/IKA-UDIP-2010
Diagnosis(Determination of disease or problem)
Treatment(Intervention necessary to help the patient)
Prognosis(Prediction of the outcome of the disease)
Main area
SS/EBM/IKA-UDIP-2010
(I)Formulating clinical questions
SS/EBM/IKA-UDIP-2010
A 2-year old boy 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 or recent developments.
SS/EBM/IKA-UDIP-2010
Medical students:(Background question)
What is Kawasaki disease? What is the etiology?How it is diagnosed?What is the treatment of choice?Complications?
SS/EBM/IKA-UDIP-2010
House officers(Foreground question)
In a child with KD, would immunoglobulin treatment, compared with no immunoglobulin, reduce the chance to develop coronary complication?
SS/EBM/IKA-UDIP-2010
Foregroundquestions
Backgroundquestions
Experience with condition
SS/EBM/IKA-UDIP-2010
In women with history of eclampsia, would administration of low-dose aspirin during pregnancy prevent eclampsia? (Prevention)
Other examples
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)
SS/EBM/IKA-UDIP-2010
Four elements of good clinical
question: PICOThe Patient or ProblemThe Intervention / IndexComparative intervention (if relevant)The Outcome
SS/EBM/IKA-UDIP-2010
Four elements of a well constructed clinical
question: PICO
P I C O
The maininterventionconsidered
The alternativeto compare
with theintervention
Outcomeexpected from this
intervention?
Descriptionof patient
or problem
B e b r i e f a n d s p e c i f i c
SS/EBM/IKA-UDIP-2010
Do all clinical questions contain 4 elements of
PICO?NoThe C implies in the question - PIO
Does temulawak increase appetite in undernourished children?
Asking prevalence – POWhat is the prevalence of abnormal gene XYZ in patients with -thalassemia?
SS/EBM/IKA-UDIP-2010
Relevance: Type of Evidence
POE: Patient-oriented evidence mortality, morbidity, quality of life
DOE: Disease-oriented evidencepathophysiology, pharmacology, etiology
SS/EBM/IKA-UDIP-2010
POEM
Patient-OrientedEvidence
SS/EBM/IKA-UDIP-2010
Comparing DOES and POEMs
Prostatescreening
PSA screeningdetects prostate
Ca. early
? whether PSAscreening mortality
DOE exists, butPOEM unknown
AntiarrhythmicTherapy
Antihypertens.Therapy
Drug A PVCOn ECG
Drug X BP Drug X mortality
Drug A > mortality
DOE & POEMcontradicts
POEM agreesWith DOE
Example DOE POEM Comment
SS/EBM/IKA-UDIP-2010
IISearching the evidence
SS/EBM/IKA-UDIP-2010
IIIAppraising the evidence:
VIA
SS/EBM/IKA-UDIP-2010
Validity: In Methods section:design, sample, sample size, eligibility criteria (inclusion, exclusion), sampling method, randomization method, intervention, measurements, methods of analysis, etc
Importance: In Results sectioncharacteristics of subjects, drop out, analysis, p value, confidence intervals, etc
Applicability: In Discussion section + our patient’s characteristics, local setting
VIA
SS/EBM/IKA-UDIP-2010
Were 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 NNT
Were study subjects similar to our patients in terms of prognostic factors?
Example: Critical appraisal for therapy
SS/EBM/IKA-UDIP-2010
Hierarchy of evidence
Meta-analysis of RCT
Large RCT
Small RCT
Non-Randomized trials
Observational studies
Case series / reports
Anecdotes, expert, consensus
Level 1
Level 2
Level 3
Level 4
A
B
C
RecWeight ofScientific Scrutiny
For complete description see www.cebm.net
SS/EBM/IKA-UDIP-2010
Implementation of EBM practice:
How to get started 1. 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, etc
2. Workshop for teaching staff 3. Workshop for practitioners, incl. nurses
SS/EBM/IKA-UDIP-2010
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
SS/EBM/IKA-UDIP-2010
Physician’s competence
Valid evidencePatient’s values
SS/EBM/IKA-UDIP-2010
TheEBMCycle
PatientWith problem
FormulateIn answerable
question
Search theevidence
AppraiseThe
evidence
ApplyThe
evidence
SS/EBM/IKA-UDIP-2010
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
SS/EBM/IKA-UDIP-2010
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
SS/EBM/IKA-UDIP-2010
End result
Self directed, life-long learning attitude
for high quality patient care
SS/EBM/IKA-UDIP-2010
Conclusion
EBM is nothing more than aframework of systematic use ofcurrent valid study results relevant to our patient