1. EBM
R1張舜凱

2. Clinical Scenario
是抗生素出場的時候?對於急性壞死性胰臟炎病患有需要使用抗生素治療嗎?

3. Background Question
Acute necrotizing pancreatitis

4. EBM 5 步驟

5. Asking-Foreground question
P: Patient with acute necrotizing pancreatitis
I: Prophylactic antibiotic therapy
C: No prophylactic treatment
O: Septic complications and the mortality rate

6. Asking-Determine question type
▓ Treatment/Prevention
□ Harm
□ Diagnosis
□ Prognosis

7. Asking-Suggested best type of study
Type of question
Suggested best type of study
Therapy/Prevention
RCT > Cohort > Case Control > Case Series
Diagnosis
Prospective, blind comparison to gold standard
Etiology/Harm
Prognosis
Cohort Study > Case Control > Case Series
Clinical Exam
Cost analysis
Economic analysis

8. Accessing

9. Key word: acute necrotizing pancreatitis, prophylactic antibiotic therapy
Search database:

11. 6 RCT studies
Review: Antibiotic prophylaxis of pancreatic necrosis in acute pancreatitis reduces mortality and sepsis ACP Journal Club Jul-Aug;141:11.
Antibiotic therapy for prophylaxis against infection of pancreatic necrosis in acute pancreatitis The Cochrane Library 2010, Issue 5
Effect of antibiotic prophylaxis on acute necrotizing pancreatitis: results of a randomized controlled trial J Gastroenterol Hepatol May;24(5):
A double-blind, placebo-controlled trial of ciprofloxacin prophylaxis in patients with acute necrotizing pancreatitis J Gastrointest Surg Apr;13(4):  
Early antibiotic treatment for severe acute necrotizing pancreatitis: a randomized, double-blind, placebo-controlled study Ann Surg May;245(5):
Prophylactic antibiotic treatment in patients with predicted severe acute pancreatitis: a placebo-controlled, double-blind trial Gastroenterology Apr;126(4):

12. Appraising
Early antibiotic treatment for severe acute necrotizing pancreatitis: a randomized, double-blind, placebo-controlled study Ann Surg May;245(5):

13. Method
A multicenter, prospective, double-blind, placebo-controlled randomized study set in 32 centers within North America and Europe.
100 patients with clinically severe, confirmed necrotizing pancreatitis:
50 received meropenem (1 g q8h)
50 received placebo
within 5 days of the onset of symptoms for 7 to 21 days

14. Pancreatic or peripancreatic infections
Result
Pancreatic or peripancreatic infections
18% (9 of 50) in the meropenem group
12% (6 of 50) in the placebo group (P = 0.401)
Overall mortality rate
20% (10 of 50) in the meropenem group
18% (9 of 50) in the placebo group (P = 0.799)
Surgical intervention
26% (13 of 50) in the meropenem group
20% (10 of 50) in the placebo group (P = 0.476)

15. Conclusions
No statistically significant difference between the treatment groups
Not support early prophylactic antimicrobial use in patients with severe acute necrotizing pancreatitis

16. Are the results of the trial valid? (Internal Validity)
Was the assignment of patients to treatments randomised?

17. Were the groups similar at the start of the trial?

18. Aside from the allocated treatment, were groups treated equally?
Were all patients who entered the trial accounted for? – and were they analysed in the groups to which they were randomised?
Were measures objective or were the patients and clinicians kept “blind” to which treatment was being received? Yes

19. What were the results?
How large was the treatment effect?

20. Pancreatic or peripancreatic infections
Relative Risk (RR)= 1.5
RR > 1:the treatment increased the risk of the outcome
Absolute Risk Reduction (ARR)= -6%
absolute benefit of treatment is a -6% reduction in infection rate
Relative Risk Reduction (RRR)= -50%
The treatment reduced the risk of infection by -50% relative to that occurring in the control group
Number Needed to Treat (NNT)= -16.7
We would need to treat people to prevent 1 infection

21. Overall mortality rate
Relative Risk (RR)= 1.11
RR > 1:the treatment increased the risk of the outcome
Absolute Risk Reduction (ARR)= -2%
absolute benefit of treatment is a -2% reduction in mortality rate
Relative Risk Reduction (RRR)= -11%
The treatment reduced the risk of mortality by -11% relative to that occurring in the control group
Number Needed to Treat (NNT)= -50
We would need to treat -50 people to prevent 1 mortality

22. Surgical intervention
Relative Risk (RR)= 1.3
RR > 1:the treatment increased the risk of the outcome
Absolute Risk Reduction (ARR)= -6%
absolute benefit of treatment is a -6% reduction in surgical intervention
Relative Risk Reduction (RRR)= -30%
The treatment reduced the risk of surgical intervention by -30% relative to that occurring in the control group
Number Needed to Treat (NNT)= -16.7
We would need to treat people to prevent 1 surgical intervention

23. How precise was the estimate of the treatment effect?
confidence intervals (CI) for each estimate
If the confidence interval includes the value corresponding to no effect then the results are not statistically significant

25. Applying Will the results help me in caring for my patient?
Is my patient so different to those in the study that the results cannot apply? No
Is the treatment feasible in my setting? Yes
Will the potential benefits of treatment outweigh the potential harms of treatment for my patient?

26. Auditing
評估執行EBM成果

27. Thanks for listening
Happy new year!!