Evidence-Based Medicine,

tuntutan baru dalam profesionalisme

pengobatan seorang penderita
Dr. Moch. Maroef, SpOG
FK UMM
Evidence Based Medicine (EBM)
Menggunakan segala pertimbangan
bukti ilmiah (evidence) yang sahih yang
diketahui hingga kini untuk menentukan
pengobatan pada penderita yang
sedang kita hadapi.
Merupakan penjabaran bukti ilmiah
lebih lanjut setelah obat dipasarkan dan
seiring dengan pengobatan rasional.
What is the level (L)
of evidence ? (TGA)
L1a. Randomized controlled trial (best evidence)
L1b. Meta-analysis (pros and cons)
L2. Retrospective analysis (case-control studies)
L2. Prospective follow-up (cohort studies)
Cross-sectional population (prevalence studies)
Previous reviews (position statements)
Clinical interventions (non-randomized)

Safety data (important element !)
A comprehensive evaluation of all data is the best approach!
How is LoE implemented in
Recommendation Guidelines? (1)
Levels of Evidence for Heart Failure:

A. Data derived from multiple RCTs.
B. Data derived from a single randomized trial or
non-randomized studies.
C. Consensus opinion of experts was the primary
source of recommendation.
www.guidelines.gov/
How is LoE implemented in
Recommendation Guidelines? (2)
Strength of Recommendation:
Class I: Conditions for which there is evidence/general agreement
that a given procedure/therapy is useful and effective.
Class II: Condition for which there is conflicting evidence or
divergence of opinion about the usefulness /efficacy of performing the
procedure /therapy.
Class IIa: in favor of usefulness
Class IIb: usefulness is less well established
Class III:Condition for which there is evidence/general agreement
that a procedure/therapy is not useful/effective and may be harmful.
www.guidelines.gov/
How is LoE implemented in
Recommendation Guidelines? (3)
The strength of evidence does not necessarily
reflect the strength of recommendation. A
treatment may be considered controversial
although it has been evaluated in CTs;
conversely, a strong recommendation may be
based on years of clinical experience and be
supported only by historical data or by no data
at all.
Disini conflict of interest dari penilai dijaga ketat!!
www.guidelines.gov/
Drug Safety in increased focus
around the world
Increasing number of drug withdrawals
because of harmful effects (recently: Prepulsid,
Posicor, Hismanal, Rezulin, Lipobay, etc).
Scientific report on epidemic proportions of
serious ADRs in hospitalized patients.
(Lazarou, JAMA 1998)
Medical mistakes (45.000 deaths/annually)
and medication errors (28%) are reported,
including under-utilization of proven drug
therapies. (US Institute of Medicine, 2001)
Bagaimana dokter bisa mengerti
EBM ?
Evidence perlu diterapkan pada penderita
dg segala penyakit/komplikasi-nya.
Evidence berubah menurut perkem-
bangan ilmu.

Perlu CME model baru untuk men-
sosialisasikan pengetahuan baru ini.
Forum seminar biasa tidak lagi adekuat.
Pengobatan profesional membutuhkan
paradigma baru dalam CME.
The Knowledge Filter
(H.H. Bauer, 1995)
Primary literature
How much is
incorrect?
Correction
of errors
Much of it is correct
(adapted)
Untuk menunjang EBM, FDA telah
melakukan perubahan label indikasi
obat sewaktu ijin pemasaran melalui
undang-undang.
Misalnya: Indikasi antibiotik yang luas,
seperti untuk
upper respiratory tract infection,
terdiri dari banyak lokasi yang kuman
penyebab maupun antibiotiknya berbeda.
Bagaimana interpretasi hasil Lab
yg tidak pas?
Nilai Widal yg dipakai untuk diagnosis tifus.
SGPT yg merupakan surrogate endpoint.
Hasil antibiogram yg mengikutsertakan AB yg
tidak semestinya:
gentamicin (tidak pas) untuk kuman tifus,
tidak mengikutsertakan AB terpilih seperti
flukloksasilin, dikloksasilin atau penisilin G untuk
Staph. aureus atau stretokokkus, tapi
menyertakan berbagai sefalosporin,... dsb.
Lalu, bagaimana dg evidence
pengobatan empirik yg tidak ada uji
klinik formal, tetapi sangat berguna?
Varisella: cukup mandi teratur, tidak perlu AB
rutin
Parotitis epidemika: cukup permen karet.
Dikloksasilin atau flukloksasilin untuk staph.
resisten, juga penisilin prokain tidak dipakai lagi.
Probenesid (dosis kecil) telah dilupakan untk
gout, walaupun 65% merupakan masalah
ekskresi asam urat (alopurinol di-indikasikan
untk masalah pembentukan urat {35%}).
Case: Yn. 18 yrs with Grand Mal
for 14 years since 4 yrs old.
2-4 convulsions a day with coma now
and then, but now controlled. Evidence?
Anticonvulsant blood levels were:
daily dose blood l. norm. range
(mcg/ml)
- Dilantin 400 mg 1.57 /10-20/
- Luminal 200 mg 30.19 /15-40/
- Carbzepine 200 mg 1.97 /4-10/
Masalah
terbesar ialah
bahwa
evidence
dapat diartikan
berbeda-beda
menurut
setiap orang
atau profesi.

FDA
Industri
Dokter
Spesialis
Farmasis
Herbalis
Naturo-
patis
Awam
dsb.
EBM menjembatani
Ilmu Kedokteran dan Hukum ?
EBM mulai dibutuhkan juga oleh seorang
hakim menentukan apakah suatu
pengobatan tertentu sudah benar dalam
persidangan. Diperlukan ilmu (evidence)
di belakang pertimbangan suatu testimoni
seorang saksi ahli. (JAMA Vol. 283 No.21, June 2000)
Juga, EBM menentukan harga saham
pabrik obat, yang disebarkan mass media
ekonomi.
Namun, masih akan dijumpai
berbagai kendala, karena ilmu
pengobatan dan EBM sendiri
tidak sesederhana itu.
EBM is challenged by the very
presence of neutraceuticals
While orthodox medicine is requiring
stricter use of drugs by scientific evidence,
unrestricted availability of alternative
methods and medicines are worldwide -
most without even any evidence of efficacy
and safety - at a price that surpass new
pharmaceuticals.
EBM is perhaps not always
applicable for many reasons:
Some times we cannot treat just the numbers.
Other times we cannot use statistics to treat a specific patient.
Large outcome studies includes patients with uncontrollable
variables.
Controlled clinical trials are not always flawless.
Pediatric CTs have not been required until 1998, although
compulsory for adults since 1962.
Dose-finding studies are rare, not the least in pediatrics.
Ultimately: ask 3 specialists and you will get 2-3 different
answers. Equipoise of opinions should perhaps be set at
around 70 : 30, or more.
Conclusion
Proper drug use should be promoted nationally.
Education on drugs and EBM must take a
different approach (not education by coercive,
pharmaceutical marketing needs).
The cause of irrationalism is linked with a
perpetuating error in a larger (health) system.
Health and DrugUsePolicy must be established.
If the Health Department is failing, universities
and the profession should - morally - take
initiative.



Terima Kasih !