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The Inexplicable Persistence
of EFM – Is the Law to Blame?
Julie D. Cantor, MD, JD
UCLA School of Law
Overview
• A Word on Systems
• The Story of EFM
• The Status Quo
• Explanations - Is the Law to Blame?
• Your Thoughts
• Closing Thoughts
What is EFM?
What is intermittent auscultation?
The Story of EFM
EFM: Solve Two Problems
1. Screening test for severe asphyxia
2. Allow for recognition of early asphyxia
On CP: Flawed Hypothesis
“Many lay people, and clinicians too, have come to
believe that birth abnormalities explain a variety of
neurologic and cognitive disorders in children.
In fact, there is little evidence to support this belief.”
- Paneth, NEJM 1986
On CP: Flawed Hypothesis
“The majority of cases of CP appear to be caused by
developmental defects, migrational defects, infections, toxins,
antepartum ischemic or asphyxial episodes in the fetus, and
other causes. Unfortunately, the prevalence of CP has not
decreased since the advent of FHR monitoring. . . . The hope that
FHR monitoring will abolish CP has proved to be an
unmeasurable and unrealistic goal.”
- Parer, AJOG 2000
Additional Concerns
• As a screening test (fetal death/CP), 99.8% false + rate
• Interpretation of the data is:
• subjective, difficult to standardize, poorly reproducible
• inter- and intra-observer variation
• Mobility, comfort measures
• Focus on machine, not patient
• Belief: Can prevent all perinatal mortality & neuro injury
• Abnormal pattern may reflect pre-existing condition
On EFM:
• Pseudodisease
• To prevent, intervene
• Dramatic increases in
• Rates of section
• M&M
• Cost of care
• Law suits
• Insurance costs
• No effect on incidence of CP
Rising Cesarean Rate
Status Quo
Prevalence of Use
• 85% of deliveries using continuous EFM
• #1 OB procedure
• 3.4 million US women at low risk screened annually
Structured IA is equivalent to continuous EFM in
screening for fetal compromise in low-risk patients.
An admission tracing of electronic FHR in low-risk
pregnancy increases intervention without improved neonatal
outcomes . . . routine admission tracings should not be
used to determine monitoring technique.
“the method of choice for the
monitoring of the fetus during normal
labour is intermittent auscultation”
“IA is the preferred method for monitoring the FHR
during labor for women at term who at the onset of
labor are low risk for developing fetal acidemia.”
“Given that the available data do not show a clear
benefit for the use of electronic fetal monitoring
over intermittent auscultation, either option is
acceptable in a patient without complications.”
“ineffective, but
nonetheless persistent”
- Michael Greene, MD
Mass. General Hospital
“Routine intrapartum EFM is not recommended for
low risk women. There is insufficient evidence
regarding its routine use in high risk pregnancies.”
“[T]he USPSTF believes that updating its 1996 recommendation
would have limited potential impact on clinical practice.
The USPSTF will not update its 1996 recommendation.”
Explanations
(Is the law to blame?)
Explanations
• No problem
• Psychology
• Economics
• Education
• Law
Your Thoughts
“The story of electronic fetal monitoring also
illustrates the need for proper randomized
clinical trials before new forms of technology are
introduced that may become the standard of
practice without clearly demonstrated benefit.”
The Inexplicable Persistence of EFM – Is the Law to Blame?

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The Inexplicable Persistence of EFM – Is the Law to Blame?

  • 1. The Inexplicable Persistence of EFM – Is the Law to Blame? Julie D. Cantor, MD, JD UCLA School of Law
  • 2. Overview • A Word on Systems • The Story of EFM • The Status Quo • Explanations - Is the Law to Blame? • Your Thoughts • Closing Thoughts
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  • 7. What is intermittent auscultation?
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  • 10. EFM: Solve Two Problems 1. Screening test for severe asphyxia 2. Allow for recognition of early asphyxia
  • 11. On CP: Flawed Hypothesis “Many lay people, and clinicians too, have come to believe that birth abnormalities explain a variety of neurologic and cognitive disorders in children. In fact, there is little evidence to support this belief.” - Paneth, NEJM 1986
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  • 13. On CP: Flawed Hypothesis “The majority of cases of CP appear to be caused by developmental defects, migrational defects, infections, toxins, antepartum ischemic or asphyxial episodes in the fetus, and other causes. Unfortunately, the prevalence of CP has not decreased since the advent of FHR monitoring. . . . The hope that FHR monitoring will abolish CP has proved to be an unmeasurable and unrealistic goal.” - Parer, AJOG 2000
  • 14. Additional Concerns • As a screening test (fetal death/CP), 99.8% false + rate • Interpretation of the data is: • subjective, difficult to standardize, poorly reproducible • inter- and intra-observer variation • Mobility, comfort measures • Focus on machine, not patient • Belief: Can prevent all perinatal mortality & neuro injury • Abnormal pattern may reflect pre-existing condition
  • 15. On EFM: • Pseudodisease • To prevent, intervene • Dramatic increases in • Rates of section • M&M • Cost of care • Law suits • Insurance costs • No effect on incidence of CP
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  • 19. Prevalence of Use • 85% of deliveries using continuous EFM • #1 OB procedure • 3.4 million US women at low risk screened annually
  • 20. Structured IA is equivalent to continuous EFM in screening for fetal compromise in low-risk patients. An admission tracing of electronic FHR in low-risk pregnancy increases intervention without improved neonatal outcomes . . . routine admission tracings should not be used to determine monitoring technique. “the method of choice for the monitoring of the fetus during normal labour is intermittent auscultation”
  • 21. “IA is the preferred method for monitoring the FHR during labor for women at term who at the onset of labor are low risk for developing fetal acidemia.” “Given that the available data do not show a clear benefit for the use of electronic fetal monitoring over intermittent auscultation, either option is acceptable in a patient without complications.”
  • 22. “ineffective, but nonetheless persistent” - Michael Greene, MD Mass. General Hospital
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  • 24. “Routine intrapartum EFM is not recommended for low risk women. There is insufficient evidence regarding its routine use in high risk pregnancies.” “[T]he USPSTF believes that updating its 1996 recommendation would have limited potential impact on clinical practice. The USPSTF will not update its 1996 recommendation.”
  • 26. Explanations • No problem • Psychology • Economics • Education • Law
  • 28. “The story of electronic fetal monitoring also illustrates the need for proper randomized clinical trials before new forms of technology are introduced that may become the standard of practice without clearly demonstrated benefit.”