jk

• klkEvidence-Based Medicine

(”Bringing research evidence into practice”)

Evidence-based Medicine• Opinion-based medicine• Experience-based medicine• Power-based medicine• Hope-based medicine• Logic-based medicine• Erratic-based medicine• Obat berbasis Opini

Obat berbasis pengalaman Obat berbasis-Power Kedokteran berbasis Harapan Obat berbasis logika Obat menentu berbasis

• Medicine-based evidence• Pragmatic research• Outcome research

Evidence-based Medicine

Related with morbidity, mortality, & quality of life

MorbidityMortality

QoLPatient

SatisfactionHealt

h Statu

s

Value = Quality

Cost

Diagnosis• Patient with complaint• History• Physical• Simple test• Specific test

Yes or no answerPredictive value is the most important

The spectrum of the presentations must resemble that in practice

Treatment

• Patient with certain diagnosis• Does drug X more effective than Y?• Focus on the outcome, rather than its

explanation (biomolecular markers)• Yes or no outcome most useful

Prognosis• Usually in cohort studies• To inform the patient 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)

EBM• Started in early 90’s by clinical epidemiologists• 1992 : only few articles on EBM• 2000 : >1000 articles• Indonesia : started in 1997• Workshops : Yogya (2000)

IKA FKUI (2000, 2001, etc)• Group discussion on EBM / mailing list:

<ebm-f2000@yahoogroups.com>

EBM & Clinical Epidemiology• Fletcher & Fletcher: CE = The application of

epidemiologic principles in problems encountered in clinical medicine

• Sackett et al: CE = The basic science for clinical medicine

• Much resistance by experts• EBM: In principle – no one disagree• All major medical journals have adopted EBM• Centers for EBM all over the world

Previous Practice6 yrs medical

education

40-50 yrsmedical practice

Problems with patients:Dx, Rx, Px

Consultants, colleaguesTextbooks

HandbooksLecture notes

Clinical guidelinesCME, seminars, etc

JournalsUsu. see only Results section,

or even worse, Abstract section

Previous Practice

• Trust me• In my experience ….• Logically• Textbook, handbook, capita selecta

The results….“Opinion-based medicine”• Steroid inj. in prematures to prevent RDS• Routine episiotomy• Routine circumcision• Antibitotics for flu-like syndrome• Use of immunomodulators• “Skin test” before antibiotic injection• Routine chest X-ray for pre-op preparation• CT scan after minor head trauma• etc ……

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

• 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)

Years after graduation

Relative% ofremainingknowledge

2 4 6 8 10 12

$100% THE SLIPPERY SLOPE

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

performance5. EBM encourages self directed learning process

which should overcome the above shortages

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.

The Inevitable Consequence

• On average, the clinically-important knowledge of physicians deteriorates rapidly after we complete our training.

Steps in EBM practice1. Formulate clinical problems in answerable questions2. 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

VIA

Main AreaDiagnosis

(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?

Foregroundquestions

Backgroundquestions

Experience with condition

Other Examples• In 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 O• The Patient or Problem• The Intervention / Index• Comparative intervention (if relevant)• The Outcome

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

Relevance: Type of Evidence

• POE: Patient-oriented evidence –mortality, morbidity, quality of life

• DOE: Disease-oriented evidence–pathophysiology, pharmacology,

etiology

POEM

• Patient-Oriented• Evidence• Morbity, Mortality

E

Comparing DOES and POEMs

Example DOE POEM Comment

AntiarrhythmicTherapy

Prostatescreening

PSA screeningdetects prostate

Ca. early

? whether PSAscreening mortality

Antihypertens.Therapy

Drug A PVCOn ECG

Drug X BP Drug X mortality

Drug A > mortality

DOE & POEMcontradicts

POEM 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, etc

Importance: In Results section– characteristics of subjects, drop out, analysis, p

value, confidence intervals, etcApplicability: In Discussion section + our patient’s

characteristics, local setting

Example: Critical appraisal for therapy• 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?

Hierarchy of evidence

Weight ofScientific Scrutiny

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

Rec

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

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

Patient’s values

Physician’s competenceValid evidence

FormulateIn answerable

question

Search theevidence

Critically Appraise

The evidence

ApplyThe evidence

PatientWith problem

Criticism to EBM• EBM makes expensive medical care• EBM cannot be implemented in developing

countries• EBM is costly and time consuming• EBM ignore pathophysiology & reasoning• EBM ignore experience and clinical judgment• EB-guidelines etc interfere with professional

autonomy

Criticism to EBM

EBM makes expensive medical careCf:

– Routine antibiotics for ARTI & diarrhea– Liberal indication for C-section– Unnecessary sophisticated procedures /

exams– Unnecessary / harmful treatment:

steroid for recurrent cough

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

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

Criticism to EBM

EBM ignores pathophysiology & reasoning• EBM encourages clinical reasoning in the light

of valid and important evidence• Pathophysiology and reasoning should be

seen as hypothesis and should end-up in empirical evidence

Criticism to EBM

EBM ignore experience and clinical judgment

• Personal experience and clinical judgment are by no means can be eliminated

• EBM encourage detailed and systematic documentation of experience and judgment

• Subjective experience should be, whenever possible, translated into more objective measures

Criticism to EBM

EB-guidelines interfere with professional autonomy– Professional conduct (competence, altruism,

openness, collegiality, ethics) is encouraged in EBM– Every physician should develop their own practice

attitude based on his/her profess-ionalism, valid evidence, and patient’s values

– Development of clinical guidelines and other standards of care should be seen as a guide and implemented according to clinical setting

Advantages of EBM• Encourages reading habit• Improves methodological skill (and willingness

to do research?!)• Encourages rational & up to date management

of patients• Reduces intuition & judgment in clinical

practice, but not eliminates them• Consistent with ethical and medico-legal aspects

of patient management

End Result

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

Conclusion

• EBM is nothing more than a

• framework of systematic use of

• current valid study results

• relevant to our patient

Terima Kasih