1. Evidence Based Medicine Diagnostic - in getting close & Novel Therapy bringing hopes
Seminar&Workshop Case
By Naldo Sofian, MD
Lembaga Pengkajian dan Penelitian
BEM IKM FKUI
RSCM

2. Agenda Brief Introduction on EBM Usefullness
Decision into a Clinical Practice
Value of Truth in a Validation
Search According to Cases
How to Decide for Novel Therapy
Diagnostic Procedure Comparison
Quick
Critical Appraisal

3. Brief Introduction on EBM Usefullness

4. Brief Introduction on EBM UsefullnessVs

5. Search According to Cases
A 29-year-old low-economic, tailor, woman (P2A1) come to your Antenatal Department due to 6-weeks amenorrhea and intermittent pelvic pain. She would like to know whether she has ectopic pregnancy or not at that time in order to save some money for her management.
No other complains, except mild nausea. Her medical history is unremarkable. You found no abnormalities in any physical examination except mild illiac pain in abdominal palpation and upon shaking of her cervix portio.
For diagnosis,including pregnancy confirmation, you have pregnancy test as follows in your Antenatal Department:
ß-HCG serum Quantification
Pregnancy Rapid Test (ß-HCG Marker)
Transabdominal USG
Transvaginal USG
MRI

6. Search According to Cases

7. Value of Truth in a Validation
Method
“Gold Standard”
Medical Science Based
Randomized
Blinded
Updated
Appropriate
Acceptable

8. Diagnostic Procedure Comparison

9. Diagnostic Procedure Comparison

10. What is your diagnostic tool decision?
See your result on importancy and applicability!

11. How to Decide for Novel Therapy
Ectopic pregnancy has been definitively diagnosed by your supporting examination. Treatment is going to be proposed in your discussion to this patient.
Further discussion reveals that:
She is a tailor with minimum regional payment. No additional income and no insurance
She has only 14 days off in a month for bearing her child
Due to two considerations above, she hope that she could delay her treatment

12. How to Decide for Novel Therapy

13. How to Decide for Novel Therapy
Hasil
Terapi
Tindakan
Obat A (100 Subjek)
Sembuh: 60 Subjek
Tidak Sembuh:
30 Subjek
Obat B (100 Subjek)
Sembuh: 45 Subjek
Tidak Sembuh: 45 Subjek
How to Decide for Novel Therapy
Randomization
Per Protocol
Intention to Treat
Worst Case Analysis
N-of-1 Trial 10
Drop- Out 10
Drop-Out
Analysis A B
Sembuh
Tidak Sembuh
Per Protocol
60/90
30/90
45/90
Intention to Treat
60/100
30/100
45/100
Worst-Case Analysis
40/100
55/100

14. Follow-Up in Suitable Time!
Hasil
Terapi
Tindakan
Obat A (100 Subjek)
Sembuh: 60 Subjek
Tidak Sembuh:
30 Subjek
Obat B (100 Subjek)
Sembuh: 45 Subjek
Tidak Sembuh: 45 Subjek
How to Decide for Novel Therapy
Control Event Rate
Experimental Event Rate
Absolute Risk Reduction
Relative Risk Reduction
Number Needed to Treat/Harm
Decimal Fraction 10
Drop- Out 10
Drop-Out
CER
EER
ARR
RRR
NNT
45/100
45%
30/100
30%
45%-30% = 15%
15/45 = 1/3
1/(15%) = 7
0.0045%
0.0030%
0.0015%
0.0015/ = 1/3
1/(0.0015%) = 70000
Follow-Up in Suitable Time!

15. Decision Into a Clinical Practice
DISCUSSION
Positive Predictive Value (PPV)
Negative Predictive Value (NPV)
NOT SENSITIVITY and SPECIFICITY
Diagnostic
Number Needed to Treat (NNT)
Number Needed to Harm (NNH)
Quality of Life (QoF)
Therapy
Comorbid
Cost-Effectiveness
Risk Factor Influence
Suitable Situation
Other

16. Finish your discussion!
Share your result! Attention for other group
Finish your discussion!

17. Magnitude of Importancy
Skrining
Focused Issue
Randomize
Blinded Controlled
P-value & CI
Magnitude of Importancy
Quick Appraisal

18. Conclusion Evidence Based Medicine needs your:
Cases Needs
Valid, Important, and Applicable Studies
Clinical Judgement

19. Thank You^^
By: Naldo Sofian, MD
Rs Tc Hillers; Kab. Sikka,
Maumere – Nusa Tenggara Timur