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Evidence-Based Medicine,

tuntutan baru dalam profesionalismepengobatan seorang penderita

Dr. Moch. Maroef, SpOG

FK UMM

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Evidence BasedMedicine (EBM)

Menggunakan segala pertimbangan

bukti ilmiah (evidence) yang sahih yang

diketahui hingga kini untuk menentukanpengobatan pada penderita yang

sedang kita hadapi.

Merupakan penjabaran bukti ilmiahlebih lanjut setelah obat dipasarkan dan

seiring dengan pengobatan rasional.

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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!

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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/

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How is LoE implemented in

Recommendation Guidelines? (2)

Strength of Recommendation:

Class I:Conditions for which there is evidence/general agreementthat a given procedure/therapy is useful and effective.

Class II:Condition for which there is conflicting evidence ordivergence 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/

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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 controversialalthough 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 dataat all.

Disini conflict of interest dari penilai dijaga ketat!!

www.guidelines.gov/

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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 ofserious 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. (USInstitute of Medicine, 2001)

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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.

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The Knowledge Filter(H.H. Bauer, 1995)

Primary literature

How much is

incorrect?

Correction

of errors

Much of it is correct

(adapted)

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Untuk menunjang EBM, FDA telah

melakukan perubahan label indikasiobat 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.

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Bagaimana interpretasi hasil Lab

yg tidak pas? Nilai Widal yg dipakai untuk diagnosis tifus.

SGPT yg merupakan surrogate endpoint.

Hasil antibiogram yg mengikutsertakan AB ygtidak semestinya:

gentamicin (tidak pas) untuk kuman tifus,

tidak mengikutsertakan AB terpilih sepertiflukloksasilin, dikloksasilin atau penisilin G untuk

Staph. aureus atau stretokokkus, tapi

menyertakan berbagai sefalosporin,... dsb.

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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 untkgout, walaupun 65% merupakan masalah

ekskresi asam urat (alopurinol di-indikasikan

untk masalah pembentukan urat {35%}).

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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/

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Masalah

terbesar ialahbahwa

evidence

dapat diartikan

berbeda-beda

menurut

setiap orang

atau profesi.

FDA

Industri

Dokter

Spesialis

Farmasis

Herbalis

Naturo-

patis

Awam

dsb.

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EBM menjembatani

Ilmu Kedokteran dan Hukum ?

EBM mulai dibutuhkan juga oleh seorang

hakim menentukan apakah suatu

pengobatan tertentu sudah benar dalampersidangan. 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.

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Namun, masih akan dijumpai

berbagai kendala, karena ilmu

pengobatan dan EBM sendiritidak sesederhana itu.

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EBM is challenged by the very

presence of neutraceuticals While orthodox medicine is requiring

stricter use of drugs by scientific evidence,

unrestricted availability of alternativemethods and medicines are worldwide -

most without even any evidence of efficacy

and safety - at a price that surpass newpharmaceuticals.

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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.

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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.

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Terima Kasih !