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

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):

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

Midwives and Research Catharina Schrader

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

Practitioners and Research Practice is shaped by observation However observation alone lacks systematic analysis due to:  Small sample size  Inability to make inferences that reflect truth

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

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

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

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.

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

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

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

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

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

How should these findings be used? Practitioners? Women? Policy makers?

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

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

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

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

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

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.”

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.”

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

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

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

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)

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)

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Contribution to individual decisions Evidence Choices options Decision

Contribution to individual decisions Baseline Risk Evidence Choices options Decision

Contribution to individual decisions Baseline Risk Individual’s values & expectations Evidence Choices options Decision Muir Gray 2001; Evidence-based medicine for professionals

Women’s decisions “ challenge to authority, including the authority of science, should be expected in a healthy democracy ” Practitioner as advocate Peer support when alternate decisions are made Bellaby 2003; Communication and miscommunication of risk. BJM

Low Resource settings Justus Hofmeyr: Is breech pregnancy a problem?

Perinatal Problem Identification Program sample : 107 South African hospitals Oct 99 to Sep 02 (RC Pattinson) PPIP sampleAnnually in SA Births Term Breech Deaths from traumatic breech deliveries HIV infected babies

Perinatal Problem Identification Program sample : 107 South African hospitals Oct 99 to Sep 02 (RC Pattinson) PPIP sampleAnnually in SA Births Term Breech Deaths from traumatic breech deliveries HIV infected babies

Perinatal Problem Identification Program sample : 107 South African hospitals Oct 99 to Sep 02 (RC Pattinson) PPIP sampleAnnually in SA Births Term Breech Deaths from traumatic breech deliveries HIV infected babies

Perinatal Problem Identification Program sample : 107 South African hospitals Oct 99 to Sep 02 (RC Pattinson) PPIP sampleAnnually in SA Births Term Breech Deaths from traumatic breech deliveries 53 (0.7%)+176 HIV infected babies

Perinatal Problem Identification Program sample : 107 South African hospitals Oct 99 to Sep 02 (RC Pattinson) PPIP sampleAnnually in SA Births Term Breech Deaths from traumatic breech deliveries 53 (0.7%)+176 HIV infected babies

Perinatal Problem Identification Program sample : 107 South African hospitals Oct 99 to Sep 02 (RC Pattinson) PPIP sampleAnnually in SA Births Term Breech Deaths from traumatic breech deliveries 53 (0.7%)+176 HIV infected babies

Perinatal Problem Identification Program sample : 107 South African hospitals Oct 99 to Sep 02 (RC Pattinson) PPIP sampleAnnually in SA Births Term Breech Deaths from traumatic breech deliveries 53 (0.7%)+176 HIV infected babies