1. Evidence Based Fertility Practice Dr. Priya Bhave Chittawar

2. SCOPE OF THE PRESENTATION Need for information Sources EBM: the steps Examples Towards wisdom based medicine

3. What should I do? What should I not do? What is the correct way to treat/diagnose/operate/correct What is the incorrect way to treat/diagnose/operate/correct

4. Ask Mom….

5. Ask the Teacher…

6. Read a book….

7. Ask a friend…

8. Turn to God?

10. It is important to ask. It is important to ask the right questions It is important to ask the right person “Seek and you shall find……………”

11. Need for Information Our daily need for valid information regarding diagnosis, prognosis , therapy and prevention Three times per day for outpatients Upto five times per day for inpatients. ( Osheroff et all:Physicians information needs: Analysis of questions posed during clinical teaching. Ann Int Med 1991; 114:576-8)

12. INFORMATION OVERLOAD

13. Alternatives to EBM Eminence based medicine Vehemence based medicine Eloquence based medicine Providence based medicine Diffidence based medicine Nervousness based medicine Confidence based medicine Seven alternatives to evidence based medicine BMJ. 1999 December 18; 319(7225): 1618.

15. Why Evidence Based Fertility Practice? Infertility treatments have limited success Costly Most choices are based on statistical probabilities Female age is a critical factor Ethnic differences

16. EXAMPLE 1 Metformin in Polycystic Ovarian Syndrome Insulin resistance Metformin is an insulin sensitizer Large number of small trials recommended use to improve insulin sensitivity, ovulation rates, pregnancy rates Cochrane review( Lord 2003): Metformin is an effective intervention in women with PCOS

17. Larger RCTs by Legro( 2007), Moll (2006) and Tang( 2007) Updated Cochrane review ( Tang 2009): “Adding Metformin to Clomiphene or Metformin alone does not improve Live birth rates”

18. How to practice EBM Ask: an answerable question Acquire: the best evidence to answer that question Appraise: critically the evidence for its validity, impact, size of effect and applicability Apply: integrate the clinical scenario, evidence with the patients expectations and background Asses : the outcome

19. Ask P: Who is the Patient or problem being addressed? I: What is the intervention or exposure? C: What is the comparison group? O: What is the outcome?

20. EXAMPLE 2 In ovulation induction for anovulatory infertility, HCG is routinely given as ovulation trigger Better timing? Preventing Luteinized unruptured follicle syndrome? Better luteal phase? What is the evidence?

21. Ask Does triggering ovulation with HCG help get more pregnancies? In anovulatory women with PCOS, does triggering ovulation with HCG result in better pregnancy rate compared to spontaneous ovulation?

22. Ask Acquire Appraise Apply Analyze

23. Acquire Journals : Human Reproduction, Human Reproduction update, Fertility Sterility MEDLINE Pubmed Cochrane database

24. Acquire Two randomized controlled trials George et al: Compared spontaneous ovulation versus hCG triggered ovulation in anovulatory women treated with Clomiphene citrate. No statistically significant difference in ovulation and pregnancy rates. ( FertStert April 2007)

25. Yilmaz et al : No difference in pregnancy rate or ovulation rate in the two groups. ( FertStert 2006)

26. Ask Acquire Appraise Apply Analyze

27. Appraise

28. Appraise

29. Chance: Bias: Systematic error that deviates results from the truth Type 1: shows a difference when there is none Type 2: Shows no difference when there is one.

30. Reducing bias and random errors Adequate sample size Having a control group Randomization Allocation concealment Blinding

32. Internal Validity: If the conclusions are reliable External validity: If the conclusions are applicable to a different population

33. Synthesize the evidence: Reviews Meta analysis

34. How to interpret a meta analysis? Graphical display in the form of a Forrest plot All the contributing trials mentioned with the number of subjects

37. There is inadequate evidence to recommend or refute the use of urinary hCG as an ovulation trigger, in anovulatory women being treated with Clomiphene Citrate

38. Absence of evidence or evidence of absence?

39. There is absence of evidence to recommend giving HCG as ovulation trigger. Financial aspect

40. Ask Acquire Appraise Apply Analyze

41. Apply results to your clinical practice. Find more evidence Generate more evidence Financial aspect

42. Ask Acquire Appraise Apply Analyze

43. Should I use the latest treatment on the block? Wont I be depriving my patients of the ‘Benefits’ of this new magical drug/intervention if I dally?

46. Innocent until proved guilty? Guilty until proved innocent?

47. Primum Non Nocere……. First do no harm!

49. What is Evidence based healthcare? Integration of research evidence, clinical expertise and patient values.

50. When you know a thing, to hold that you know it; And when you don’t know a thing, To allow that you don’t know a thing, That is wisdom Confucious

52. "From inability to let well alone,From too much zeal for what is new, and contempt for what is old,From putting knowledge before wisdom, science before art,and cleverness before common sense,...From treating patients as cases, andFrom making the cure of a disease more grievous than its enduranceGood Lord deliver us."

53. Thank You….