Chain of Care: Where does Research Evidence Fit? Eileen K. Hutton RM PhD McMaster University

1. Chain of Care: Where does Research Evidence Fit? Eileen K. Hutton RM PhD McMaster University Hamilton, Canada

2. Research “The very reason for the research enterprise in a practice discipline is to inform practice.” Stevens K. Systematic reviews:the heart of evidence-based practice . AACN Clinical Issues;12(4):529-38.

3. Midwives and Research • midwives were among the first practitioners to document their practice methods

4. Midwives and Research Catharina Schrader

5. Midwives and Research • however, there is not a longstanding culture of research within the profession

6. Practitioners and Research • Practice is shaped by observation • However observation alonelacks systematic analysis due to: • Small sample size • Inability to make inferences that reflect truth

7. Questions Practice Research Evidence

8. Questions Practice Research Evidence

9. Questions Practice Research Evidence

10. Questions Practice Research Evidence

11. Questions Practice Research Evidence

12. Evidence based practice What is it? “Integration of research evidence with clinical expertise and patient values” * * From Sackett et al. Evidenced Based Medicine, 2000

13. Evidence based practice • A practical way to apply research findings to clinical practice • Getting the right information • Critical appraisal • Understanding the research literature • Interpreting the findings • Considered application in practice

14. Evidence based practice Where did it come from? • McMaster University group in Hamilton, Ontario Canada • Critical appraisal (1981) • EBM (1990) • JAMA “users guide” series (1993-2000)

15. Evidence based practice Why do we need it? Without evidence, we practice by: • Rote • Personal or “expert opinion” • Intuition or “best guess” • Common sense • Info from external sources Greenhalgh T. How to read a paper. BJM Books, 2001.

16. Developing research evidence • Purpose of research is to begin to understand “the truth” • Arriving at the truth is a slow and painstaking process • Our understanding today, may change in the future

18. Breech • 3-4% of term infants present by the breech • Breech born babies >birth trauma, asphyxia, longer term morbidity

19. Term Breech Trial • Large multi-centred RCT • Enrolled >2000 women • Randomised: • 1041 planned CS • 1042 planned Vaginal birth Hannah ME et al Lancet 2000

20. Term Breech Trial • 0f 1041 planned CS • 90% had CS • Of 1042 planned vaginal birth • 57% gave birth vaginally Hannah ME et al Lancet 2000

21. Term Breech Trial • Perinatal mortality and neonatal mortality and severe morbidity rates: Lower in CS group • 1.6% compared to 5.0% • RR 0.33 (0.19, 0.56) • No differences in maternal morbidity or mortality Hannah ME et al Lancet 2000

22. How should these findings be used? • Practitioners? • Women? • Policy makers?

23. Term Breech Trial • Unprecedented shift in practice • Survey data • National data – Netherlands, France, Belgium

24. Survey of TBT collaborators • Of 80 centres in >20 countries • 92.5% indicate change to policy of Caesarean section for most or all breech fetuses Hogel K. JOGC, 2003

25. Goffinet - France, Belgium • 2006, prospective cohort study • All breech pregnancies at 172 centres over 12 month Goffinet F. ACOG, 2003

26. Goffinet - France, Belgium • Primary outcome – composite neonatal / perinatal mortality & morbidity • Similar to Term Breech Trial

27. Goffinet - France, Belgium • N = 8105 • 2526 Planned vaginal birth • 5579 Planned caesarean section • No difference between groups • 1.60% vs 1.45% composite fetal & neonatal morbidity and mortality

28. Goffinet – France, Belgium “Under the conditions discussed here, singleton fetuses in breech presentation at term remains a safe clinical option that can be offered to women after providing them with clear, objective, and complete information.”

29. Goffinet – France, Belgium “There may be a slightly higher neonatal risk associated with planned vaginal delivery but it is very different from that reported in the only published large randomized trial.”

30. Goffinet - France, Belgium • Noted: • Rate of CS for breech, following Term Breech Study and prior to Goffinet study • 49% in 1998 • 75% in 2003

31. Rietberg - Netherlands • Retrospective observational study • Breech presentation 1998 – 2002 • < 4000 g (n = 33,024) • > 4000 g (n = 2,429) • Exclude: multiples, antenatal death, major anomalies Rietberg C et al. BJOG, 2005

32. Rietberg - Netherlands Compared • mode of delivery, neonatal outcomes • Cohort 33 months prior to TBT publication • 25 months following

33. Rietberg - Netherlands Results (< 4000 g) • Within 2 months CS rate: 50% to 80% • Perinatal mortality decreased • 0.35% to 0.18% • ( 3.5 per 1000 to 1.8 per 1000 ) • (OR = 0.53; CI 0.33 – 0.83)

34. Rietberg - Netherlands Results (< 4000 g) • Apgar at 5 minutes <7 • 2.4% to 1.1% • (OR = 0.43; CI 0.36 – 0.52) • Trauma • 0.29% to 0.08% • (OR = 0.26; CI 0.14 – 0.5)

35. Rietberg - Netherlands • Number Needed to Treat • 175 additional CS to prevent 1 perinatal death • Balance this with increase risk: • Maternal morbidity, mortality • Subsequent pregnancy (fetal & maternal)

36. Maternal outcomes with breech CS • TBT secondary analysis: • Lowest rate of maternal morbidity associated with vaginal birth • highest following CS during active labour • OR = 3.33; 95% CI 1.75 – 6.33

37. Maternal outcomes with breech CS • Canadian data base study • Data from 1991-2005 • Compared women with planned CS (46,766) for breech with low risk vaginal birth (2,292,420) Liu S et al. CMAJ,2008

38. Maternal outcomes with breech CS • Outcome: maternal mortality & severe morbidity • 2.7 vs 0.9% • OR = 5.1; 95% CI, 4.6, 5.5 • Hysterectomy • OR = 3.2; 95% CI, 2.2, 4.8 Liu S et al. CMAJ,2008

39. Maternal outcomes with breech CS • Cardiac arrest • 2.7 vs 0.9% • OR = 5.1; 95% CI, 4.1, 6.3 • Wound haematoma • OR = 5.1; 95% CI, 4.6, 5.5 Liu S et al. CMAJ,2008

40. Maternal outcomes with breech CS “Although the absolute difference is small, the risks of severe maternal morbidity associated with planned cesarean delivery are higher than those associated with planned vaginal delivery.” Liu S et al. CMAJ,2008

41. Maternal outcomes with breech CS “These risks should be considered by women contemplating an elective cesarean delivery and by their physicians.” Liu S et al. CMAJ,2008

42. Evidence based practice “Integration of research evidence with clinical expertise and patient values” * * From Sackett et al. Evidenced Based Medicine, 2000

43. Evidence based practice “Integration of research evidence with clinical expertise and patient values” * * From Sackett et al. Evidenced Based Medicine, 2000

44. Evidence Based Practice and patient decision making: are they compatible?

45. Individualization: a challenge for EBP “The individual in the twenty-first century expects, and has a right to be offered, information about the probability of risk and benefit as it affects them as an individual” Muir Gray 2001; Evidence Based Medicine for Professionals

46. Risk • Cannot be eliminated • Concept of risk is often misunderstood • Must be placed in the social and cultural contexts of everyday life to be understood

47. Communicating Risk “evidence is growing that decisions … can be influenced by the way in which information on risk is presented, and that this may not necessarily be evidence of informed decision making” - Cochrane Review

48. Communicating Risk “Uninformed participants leads to anger, bitterness and potentially litigation”

49. Communicating Risk • “ how best to present and discuss risks and benefits of health care… for an individual is still limited” - Cochrane Review • Average risk vs. individualized risk communication

50. Contribution to individual decisions Choices options Decision Evidence