Memanfaatkan
Menyediakan
bukti, menerapkan
Menghasilkan bukti
dlm praktek
bukti Utk pasien scr
Utk populasi &
perorangan
kel pasien
Langkah-langkah dalam proses EBM
http://www.cochrane.org
Package Insert
Review obat baru
Menunjukkan berapa penelitian yg digunakan
dalam review dan drug approval
AMCP Dossier Format
Sumber informasi penelitian yg tdk dipublikasikan
Memuat analisis ekonomi
http://clinicalstudyresults.org
Step 3: Critical Appraisal
Sample size yg
Lama follow upadekuat
adekuatdg statistical power
Randomization
Blind assessment
Comparable groups pada baseline
Equal assessment
Equal co-treatment
Intention-to-treat analysis
Compliance
Post-hoc analysis
Angka drop out rendah
External Validity dari RCTs
Bagaimana relevansi penelitian ?
Apakah endpoint secara klinik berarti?
Apakah efek terapi yg penting dan signifikan scr klinik?
Bagaimana generalisasi hasil?
Apakah bisa diperbandingkan utk praktek kita?
Apakah penelitian menggambarkan kenyataan dlm
praktek?
Jika internal validity tdk bisa diterima, Aplikasi tdk
relevan
Pharmaceutical Industry Sponsored Studies
NNT: 100%
ARR
tekanan darah
Rata-rata perubahan HbA1c vs. % HbA1c dibawah 7
Contoh perhitungan
95% of patients with AOM are improved after
10days with gorillacillin vs. 85% on placebo
(p<.05)
What is the:
ARR = ?
NNT = ?
Example: Amitiza for IBS-C
“patients receiving Amitiza were nearly twice as likely to
acheive a statistically significant overall response
compared to those given placebo” (from the monthly
prescribing reference)
Study 1: 13.8% respond to Amitiza vs 7.8% P
Study 2: 12.1% Amitiza vs. 5.7% P
Response = responded 2 out of 3 months
ARR = about 6% will respond 2 out of 3 months
NNT= For every 16 patients treated for 12 weeks, one
will respond two out of three months
Step 5: Form kesimpulan dan aplikasi bukti