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Abstract and Figures

Electronic fetal monitoring (EFM) entered clinical medical practice at the same time bioethics became reality. Bioethics changed the medical ethics landscape by replacing the traditional Hippocratic benign paternalism with patient autonomy, informed consent, beneficence, and nonmaleficence. But EFM use represents the polar opposite of bioethics' revered principles—it has been documented for half a century to be completely ineffectual, used without informed consent, and harmful to mothers and newborns alike. Despite EFM's ethical misuse, there has been no outcry from the bioethical world. Why? This article answers that question, discussing EFM's history and the reasons it was issued an ethics pass. And it explores the reason that even today mothers are still treated with blatant medical paternalism, deprived of autonomy and informed consent, and subjected to real medical risks under the guise that EFM is an essential safety device when in fact it is used almost solely to protect physicians and hospitals from cerebral palsy lawsuits.
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Perpetuating Myths, Fables, and Fairy Tales:
A Half Century of Electronic Fetal Monitoring
Thomas P. Sartwelle1James C. Johnston2Berna Arda3
1Beirne, Maynard and Parsons, LLP, Houston, Texas, United States
2Legal Medicine Consultants, Seattle, Washington, United States
3Department of Medical Ethics, University of Ankara, Ankara, Turkey
Surg J
Address for correspondence James C. Johnston, MD, JD, Legal
Medicine Consultants, 321 High School Road, Suite D3-750, Seattle,
WA 98110, United States (e-mail: johnston@GlobalNeurology.com).
Doctors are men who prescribe medicines of which they
know little, for dise ases about which they un derstand even
less, for people about whom they know nothing.
Voltaire
Every time a mother is hooked up to an electronic fetal
monitor (EFM), she subjects herself and her baby to potential
but undisclosed harm, including death, injury, disability, and
the very real possibility of chronic lifelong disease. These
potential consequences have been known to medicine since
the inception of EFM, yet remain undisclosed to millions of
mothers. Rather, EFM has been sold to patients as a necessary
safety device.
It has become popular for physicians today to concede that
EFM has been without evidence of clinical efciency for the
nearly half century of its use in monitoring the vast majority
of pregnant women in the industrialized world.16Conceding
EFMs uselessness, and even acknowledging EFMs potential
to cause some harmprimarily by compelling unnecessary
cesarean sectionsit has been equally popular for EFM
proponents to argue for continued clinical use of the modali-
ty. These arguments are consistently afrmed by birth-relat-
ed professional organizations (BRPOs) worldwide.16
These are prodigiously astounding arguments. Not only do
EFM proponents ignore the vast hoards of empirical evidence
of EFM-induced harm to mother and babies, but they ignore
logic and reason as well. Even more importantly, EFM pro-
ponents also purposely out the bedrock bioethical princi-
ples of autonomy, benecence, and nonmalecence by
advocating continued EFM use, in particular EFM use without
mothersinformed consent. And despite the arguments for
continued EFM use being totally devoid of ethics, there has
been no protest from organized medicine, BRPOs, clinicians,
or ethicists. EFM has received an ethics pass.
Why has the me dical world remained virtually s ilent while
a machine known to be junk science has been presented to
laboring mothers for nearly a half century cleverly disguised
as a device necessary for safe delivery that can predict the
babys future? Because the reason EFM is used in virtually
every labor is as a defense by physicians, nurses, and hospitals
Keywords
cerebral palsy
electronic fetal
monitoring
medical ethics
medical education
medical malpractice
Abstract Electronic fetal monitoring (EFM) entered clinical medical practice at the same time
bioethics became reality. Bioethics changed the medical ethics landscape by replacing
the traditional Hippocratic benign paternalism with patient autonomy, informed
consent, benecence, and nonmalecence. But EFM use represents the polar opposite
of bioethicsrevered principlesit has been documented for half a century to be
completely ineffectual, used without informed consent, and harmful to mothers and
newborns alike. Despite EFMs ethical misuse, there has been no outcry from the
bioethical world. Why? This article answers that question, discussing EFMs history and
the reasons it was issued an ethics pass. And it explores the reason that even today
mothers are still treated with blatant medical paternalism, deprived of autonomy and
informed consent, and subjected to real medical risks under the guise that EFM is an
essential safety device when in fact it is used almost solely to protect physicians and
hospitals from cerebral palsy lawsuits.
received
September 10, 2015
accepted after revision
October 9, 2015
DOI http://dx.doi.org/
10.1055/s-0035-1567880.
ISSN 2378-5128.
Copyright © by Thieme Medical
Publishers, Inc., 333 Seventh Avenue,
New York, NY 10001, USA.
Tel: +1(212) 584-4662.
THIEME
Perspective
against cerebral palsy (CP) lawsuits, another long-standing
birth myth. But the use of a scientically bankrupt machine
solely to benet physicians when it harms patients is simply
an egregious endorsement of obstetric defensive medicine
postmodern ethical relativism solely for the benet of physi-
ciansand is undeniable proof that bioethical principles are
nothing more than empty rhetoric.
A Medical Myth Is Born
In the 1950s and 1960s, amid the nascent technology revolu-
tion, space race, and medicines conquest of diseases that had
tormented the world for generations, several researchers
were independently inventing a computer-like fetal heart-
beat counter.5,79The invention was motivated by the per-
ceived need to replace humans at the heartbeat-counting task
of intermittent auscultation during labor.5,79Counting fetal
heartbeats emanated from an 18th-century unproven theory
that asphyxia during labor caused CP and other neurologic
birth maladies. That theory merged into the theory that an
abnormal fetal heart rate was a direct, accurate measure of
past and present fetal brain damage.5,7 The theory soon
became dogma. Quick delivery was the cure from the asphyx-
ia causing CP or any other neurologic birth injury. At rst,
interventions were with forceps and obstetric maneuvers, but
that quickly gave way to cesarean sections as surgical techni-
ques and anesthesia improved.5,7,8 The EFM inventors, rather
than questioning the theories that had been accepted by
generations of physicians before them that CPscausewas
asphyxia and that abnormal fetal heart rates accurately
reected brain damage, concentrated on counting heartbeats.
It is unfortunate that the inventors overlooked proving the
dogma, because it is nothing more than myth, fable, and fairy
tale.6,824
Cerebral Palsys Nemesis
The EFM inventors did not rely on clinical trials. EFM efcacy
was proven by uncontrolled clinical assessments and anec-
dotes.5,7,8,16,20,23,24 Nevertheless, the clinical obstetric com-
munity received EFM with enthusiasm, because fetal
monitoring did not involve new concepts. EFM merely auto-
mated the critical task of heartbeat counting that previously
had been done manually.24 EFM inventors were even more
enthusiastic. They predicted that EFM alone would reduce by
half intrapartum deaths, mental retardation, and CP.25
A New Medical Phenomenon: Defensive
Obstetrics
In 1970, as EFM began revolutionizing clinical obstetrics, two
other seemingly unconnected simultaneous revolutions
gained momentum. One was the revolution in legal liability
theories and evidence law, which was exponentially expand-
ing medical malpractice lawsuits, causing the rst of many
malpractice insurance crises.6,9,11,26 The second was a slower
sea change collapsing the Hippocratic traditionthe physi-
cian chooses what is best for the patientto bioethics, a code
based on secular liberal political philosophythe physician
provides the patient with treatment option information,
thereby enabling the patient to make medical decisions
autonomously.2729 No one knew that these revolutions
would merge to create a maelstrom that put trial lawyers,
not physicians, in charge of labor room decisions and created
a phenomenon previously unknown in medical history
defensive medicine: treatments disguised as medical care
that are solely for the physiciansprotection from trial
lawyers.6,911
The Perfect Storm
Before EFM, there was little in the way of obstetric medical
malpractice. Intermittent auscultation resulted in recording
what the physician heard, and no amount of cross-examina-
tion could change a doctors recollection that the fetal heart
tones were normal during labor. EFM changed everything.
EFM provided a permanent second-by-second computer-like
graph of the entire labor, a graph that years or even decades
after birth could be critically analyzed by EFM expertswho
specialized in courtroom obstetrics. These experts could,
without fail, deliver neurologically perfect babies every
time by performing the just-in-time cesarean section that
saved the infant from certain devastation. Defendant physi-
cians, on the other hand, not as capable, well-educated, or
attentive as the courtroom experts, sentenced a child to the
lifelong neurologic devastation of CP, cognitive diminution,
seizures, and other conditions, all because of his or her
negligent EFM mismanagement and failure to perform a
simplecesarean section. Lawsuits multiplied exponentially,
as did the amount of the CP verdicts and settlements, many so
enormous they rivaled business litigation lawsuits.6,914,19,21
Forty years of the EFMCP punitive litigation cottage
industry have enriched trial lawyers and their experts, but
rarely the children with CP10,12,13,15,19,21; made physicians
and hospitals into a social welfare insurance scheme; driven
caregivers away from obstetrics; closed obstetric services to
the public; and for more than a generation diverted research
away from CPs true causes.6,1013,15,19,21
How? Because physicians, convinced that the birth dogma
accepted for multiple generations was the cause of CP, sought
to protect themselves by concentrating solely on a system
whose inventors promised would defeat CP and most other
birth defectsEFM. Ironically, the choice to make EFM the
deus ex machina led inevitably to more and bigger CP verdicts
and settlements, multiplying the anxiety level associated
with each birth and causing physicians to abandon true
patient care in favor of protecting themselves from harm,
rather than protecting their patients.20
Willful Ignorance
In 2013, thought leaders in the maternalfetal medicine
community conceded that ve decades of EFM research,
investigation, and clinical use had failed to reduce the inci-
dence of CP or any other neurologic malady.30 EFM had
resulted in an exponentially increased cesarean section
The Surgery Journal
Perpetuating Myths, Fables, and Fairy Tales Sartwelle et al.
rate, driven primarily by CP-related litigation as well as the
realization there was a consistent absence of scientic evi-
dence that interventions in labor based on any single or
combination EFM patterns did not prevent CP or other
neurologic impairment.30 These scholars conceded that it
was time to start over, because, despite a half century of
meetings, conferences, and task forces designed to make EFM
viable, EFM still lacked common language, standard inter-
pretations, and reasonable management principles and
guidelines.
All of the EFM faults outlined by these scholars had been
known for decades, but had remained secrets within the
medical community, never shared with the millions of moth-
ers undergoing EFM assessments. In fact, the secret EFM
faults, aws, imperfections, and weaknesses were even
more sweeping than the maternalfetal medicine scholars
admittedso sweeping that EFM should have been discarded
on the junk science trash heap after the rst real clinical trial
in 1976 found no EFM benet but signicantly increased
cesarean sections.6,9 BRPOswillful blindness and the desire
to protect doctors and hospitals from lawsuit are the reason
EFM survived. Nevertheless, there was a price to be paid. And
it was mothers and babies who paid the price.
Faults, Flaws, and Foibles
Clinical trials organized years after EFM use had already
become popular showed no EFM benet compared with
intermittent auscultation. Between 1976, when the rst trial
was reported, until 1995, 12 clinical trials found no EFM
benet but a substantially higher cesarean section
rate.6,9,11,31 Along the way, a few obser vers plainly told BRPOs
and the medical community that CP was not caused by
asphyxia,32 that EFM was a failure and a waste of
time,8,17,18,20,21,23 and that using EFM to deliver babies by
cesarean section in response to EFM patterns was causing
more harm than good,14,17,19,22 and some suggested early in
the process that EFM should be abandoned.24
But BRPOs and their members ignored that evidence and
the evidence that EFM pattern interpretation, even among
experts, was contradictory, highly unreliable, and difcult to
teach.9,11,31 And despite four decades of effort to improve
EFM pattern interpretation, it remained subjective, impossi-
ble to standardize, poorly reproducible, with inter- and intra-
observer contradictions even more problematic today than in
the past.20,3335
Protecting Doctors from Lawsuits: The
Undisclosed Price
EFM has consistently produced signicantly more cesarean
sections than any other method of fetal surveillance. In
1970, the cesarean section rate was 2%.31 In 2013, 33%.36
Much of that increase was driven by defensive obstetrics
cesarean sections in any case with a questionable EFM
pattern.6,914,17,19,2124 Far better to do a cesarean section
than be sued for acting slowly. But the plain truth is that
80% of the EFM patterns are category II, for which BRPOs
have no clinical management guidelines or recommenda-
tions.30,3739 Clinicians are on their own, with only a good
luck wish from their professional societiesthe organiza-
tions that should be advancing evidence-based medicine
and helping their members avoid specious litigation.39 But
instead BRPOs50 years of silence have done everything to
assist the plaintiff lawyers waiting on the sidelines for the
next physician or nurse perplexed by a machine that
confuses everyone in obstetrics, save and except the usual
courtroom experts, who never have difculty interpreting
any EFM pattern and know precisely what to do and when
to act.19,21,40
The act favored by courtroom experts is the cesarean
section. Multiple times per year in courtrooms around the
world and on thousands of trial lawyer Web sites, courtroom
experts save babies from CP with a simple, quick, safe
cesarean sectionthat never has complications or consequen-
ces. The defendant physician, if only he had done the same
thing, could have saved the child in the courtroom, wheel-
chair-bound, blind, deaf, or both, cognitively impaired, and
fed through a stomach tube. This testimony appeals to
laypeople, jurors, judges, and even many physicians, because
they do not perceive the serious risks associated with this
major abdominal surgery.41 The lay view of cesarean section
risks is perhaps best illustrated by the increase of the con-
cierge-like desire for cesarean sections on demand.42 And
although the attitude that a cesarean section is simple and
safe accounts for some of the dramatic cesarean section
increase, the primary driver of unnecessary cesarean sec tions
and, therefore, unnecessary risks for mothers and children, is
EFMs unbelievable 99% false-positive rate and physicians
litigation fears.6,915,19,21,39,41
But for almost half a century practitioners and their BRPOs
have ignored EFMsaws and the fact that nonemergency
cesarean sections have double the risk of complications com-
pared with vaginal birth43 (bleeding, infection, embolisms,
anesthesia reactions, surgical injuries41,44) and risks in subse-
quent pregnanciesrepeat cesarean sections for life, uterine
rupture, operative complications from previous surgery, and
placenta previa and accreta.41,44,45 Could it be mere coinci-
dence that placenta accrete quadrupled over the past 40 years
(1 in 2,000 in 1980 to the current 1 in 500 pregnancies, making
placenta accreta the most common reason for cesarean hys-
terectomies in industrialized countries) or is it the cause and
effect of mounting lawsuit fears and ethical compromise
growing out of unneeded EFM cesarean sections?45
But known cesarean section risks may not be all that
physicians and hospitals have to fear. A growing body of
substantial evidence suggests babies delivered by cesarean
section are exposed to risks of future chronic diseases and
neuropsychiatric disorders.4649 This risk may be the future
price to be paid for willfully ignoring EFM and its contribu-
tions to false-positive cesarean sectionsan avalanche of
suits claiming a childs chronic disease was induced by false
EFM signals causing the physician to perform an unnecessary
cesarean section.
A half century of research in CP and EFM has exposed the
myths, fables, and fairy tales forming the foundation for a
The Surgery Journal
Perpetuating Myths, Fables, and Fairy Tales Sartwelle et al.
continuing deceit foist upon mothers and babies by physi-
cians and BRPOs fearful of trial lawyersso fearful that
mothers are given no choice or informed consent about
EFM. This medical paternalism supposedly died decades
ago, but apparently the reports of its death were greatly
exaggerated. As a recent author observed, although EFM is
almost certainly fatally awed, the overwhelming majority
of labor ing patients will continue to receive EFM, b enecial or
not, in the foreseeable future.50
Electronic Fetal Monitor and Medical Ethics:
Back to the Future
EFM was born during a period of perhaps the most rapid
advances in medical history, including advances in surgery,
medications, organ transplants, genetic engineering, repro-
ductive manipulations, and hundreds of technical advances
unimagined even a decade before. At the same time, social
and cultural changes stimulated philosophy and theology
scholars to join scientists and physicians in questioning the
ethical concerns of these rapid medical advances.51 During
the early part of this period in the late 1960s, the word
bioethics was coined as a way of linking scientic advances to
human values.51 By the end of the 1970s, bioethics was a new,
distinctive discipline with its own literature and its own
research centers, with professors of bioethics scattered
throughout the worlds medical schools.51
EFMs birth and insertion into clinical practice occurred
before traditional deontology dramatically changed from the
revered Hippocratic-based benign paternalismthe physi-
cians duty to determine the best treatment for the patient
using only the physicians best judgmentto the new, unfa-
miliar bioethics of autonomythe patients freedom to decide
what is in her best interestsand autonomyspartner,in-
formed consent.11,2729,51 Side by side with autonomy
emerged two bioethics principles essentially similar to the
previous traditional medical ethicsbenecence (acting in
the patients best interest) and nonmalecence (do no harm).
Among the new principles, autonomy and informed consent
were the absolute heart of bioethics, replacing the long-
revered, ancient Hippocratic instruction to physicians to do
what they thought was best for the patient, whether the
patient agreed or not.2729,51 In fact, the Hippocratic tradition
was solely physician-centered, so much so that even such a
luminary as Oliver Wendell Holmes advised his 1871 medical
school graduate audience that patients had no right to the
medical truth of their condition.27 As jarring as that state-
ment may seem today, that was the mind-set of medical
ethics as EFM became popularno need to discuss EFM with
mothers, obstetricians know exactly what to do and how to
do it. Unfortunately, that attitude has not changed even
slightly since the inception of EFM 50 years ago. And this
attitudinal truculence is intentional and willful. Through the
decades, BRPOs were well aware and were reminded often
that EFM was inefcacious, ineffectual, and useless for pre-
dicting CP or any other neurologic malady. Moreover, BRPOs
were periodically reminded that mothers should be given an
informed choice about EFM. BRPOs simply did not respond.
Even today, there remains no BRPO response. Nor has there
been any outcry from ethicists.
A Prophet Is Not without Honor
Only once in EFMsandautonomys life, 1979, were serious
concerns raised in a high-prole National Institute of Child
Health (NICH) Task Force formed to investigate antenatal
diagnoses, including hereditary disease, congenital defects,
and intrapartum fetal distress predictors, one of which was
EFM. In its report, the task force emphasized that EFM was
unproven and had discernible risks and that data interpreta-
tion was problematic at best and likely responsible for the
already signicant increa se in cesarean section. The task force
concluded that before EFM use, mothers were entitled to a
thorough discussion of benets,limitations,andrisks,anda
choice of alternative forms of monitoring. The task force
pointedly observed that such discussions should occur during
prenatal care and again on admission to the labor suite.52,53
Nothing changed.
By 1984, the EFM lack of informed consent controversy
was prominent in the legal literature. The medical and legal
EFM issues were elegantly elucidated including EFMs futility
and medicines failure to live up to the informed consent
autonomy where EFM use was concerned.54 Nothing
changed.
In 1987, the International Federation of Gynecology and
Obstetrics (IFGO), comprised of worldwide obstetricsgyne-
cologic societies, published its guidelines for the use of fetal
monitoring. Echoing the 1979 NICH Task Force, the IFGO also
opined that mothers should have informed consent about
EFM use, both during antepartum care and again on admis-
sion to the labor suite.55 Nothing changed.
In 1987, the legal literature again emphasized obstetrics
complete and total failure to include mothers in the EFM
discussion matrix, concluding that informed consent in ob-
stetrics was an illusion.56 Nothing changed.
Through the ensuing years, the same questions have been
raised and discussed and the same conclusions reached.57,58
Nothing changed. And because nothing has changed for half a
century, the questions continue to be raised even to this
day.59
Egregious Failure
This documented EFM ethical failure is egregious. There
have been failures of medical ethics in the pastthe Tuske-
gee experiment, plutonium injections, mental health treat-
mentsand all had at least one common theme: the
subjects were not told about the experiment. Analogously,
mothers are not routinely told about the EFM experiment
inicted in childbirth. And experiment is not too strong a
word. What word would accurately describe a medical
procedure indicted by its contemporaries for 50 years as
being a failure in every decade of its existence? EFM use has
done more harm than good and cost more in terms of
maternal morbidity and mortality than it has beneted
babies14,22; EFM interpretation today and in the past, even
The Surgery Journal
Perpetuating Myths, Fables, and Fairy Tales Sartwelle et al.
among experts, is subjective, impossible to standardize,
poorly reproducible, and contradictory20,3335,3739;there
are no long-term benets of EFM1; fetal heart rate is a poor
measure of past and present fetal brain function and
damage10; 50 years of EFM and EFM-induced cesarean
sections have not changed the rate of CP or
encephalopathy1,8,10,1215,1724; as a screening test for
absence of injury, EFM is no better than a coin toss14;
EFM has a huge false-positive rate, a fact known since at
least 1979,52 and quantied at 99% in 1994, a percentage
never challenged since then6,9,11;nodataexistsinthe
entire medical literature demonstrating that any interven-
tion based on any single or combination of fetal heart rate
patterns reduces the risk of CP1,22,30;atestleadingtoan
unnecessary major abdominal surgery in 99.5% of cases
should be regarded by the medical community as absurd at
best22; an evolving consensus in the maternalfetal medi-
cine community concludes it is time to start over with EFM
and establish common EFM language, standard EFM inter-
pretations, and EFM management principles and guilde-
lines30; EFM does not predict CP, neonatal neurologic
injury, stillbirth, or neonatal encephalopathy1,10;EFM
harms women,”“wastes time and money,and offers
no lasting benetto children; and few physicians would
use a pregnancy test (or a home smoke detector) that is
wrong almost every time a positive signal appears.17
Homer Nods; Atlas Shrugs
The EFM experiment must end. It is past time to recognize
that EFM in labor is as much of a medical procedure with
potential, real life-and-death choices as any other signicant
health care treatment. And it is far past time that mothers be
told the truth about EFMit is still experimental. Many may
choose EFM. But the choice belongs to mothers, not physi-
cians and hospitals. The few voices from the distant and
recent past revealing EFM as an imposter and those calling
for informed consent have been intentionally disregarded by
BRPOs, physicians, and hospitals because they fear trial
lawyers and lawsuits more than they respect their ethical
obligations to mothers and babies. And although such fear is
neither rational, reasonable, nor ethical,6,9,11 at least it is a
discernible excuse for 50 years of medical paternalism. Eth-
icists, on the other hand, have no excuse whatsoever for their
silence.
Inthehalfcenturysincebioethicsbecameaconcept,
then a word, and nally reality, millions of spoken and
written words have championed autonomythe individu-
als right to self-determinationas the heartbeat of bioeth-
ics. But, as so many point out, autonomy cannot possibly
exist without timely information.2729,5261 So the ques-
tion is, where have the ethicists been for almost a half
century as the EFM controversies over efcacy and in-
formed consent played out in the literature and in the
real world of childbirth? It is in that real world that
physicians and hospitals simply impose their modern-day
brand of medical paternalism. Did ethics sleep while the
medical world tilted on its axis?
Conclusion
Myths, fables, and fairy tales aside, medi cine has continued its
50-year use of a known scientically bankrupt machine
under the banner that it is a reliable safety device monitoring
mothersand babieshealth. But EFMs true purpose is
primarily to protect health care providers from trial lawyers;
with full knowledge that the machine causes harm to unsus-
pecting patients, its use is a shocking, agrant, egregious
deception. The fact that only a handful of caregivers who
knew about the EFM deception tried over the years to change
the paradigm is equally shocking, but not nearly as appalling
as the fact that the entire medical ethics eld did not listen,
much less endeavor to stop the open and obvious EFM patient
exploitation and duplicity. EFMs half-century histor y is
simply undeniable proof that defensive medicinepostmod-
ern ethical relativism for physicianssole beneteasily
trumps the empty rhetoric of bioethics. Today is the day
that should end. If not now, when?
Recommendations
We recommend that an international task force similar to
the Neonatal Encephalopathy Task Force1publish a con-
sensus report stating the following: EFM cannot detect the
onset of neuropathology,10 cannot determine when neuro-
pathology would be reversible or irreversible,10 cannot
ascertain when earlier delivery by cesarean section would
prevent CP,10 and that except for obstetric catastrophes
(such as maternal cardiac arrest or uterine rupture), EFM
pattern interpretation does not reduce the risk of CP in any
population.6,10,11,22 Such a report would mark the begin-
ning of the end of using EFM pattern interpretation as the
standard of care in the worlds courtrooms.6,10,11,26 More
importantly, it would propel EFM clinical pattern interpre-
tation into the medical experimental category where it
belongs, thus requiring that mothersgive informed consent
before EFM use. Physicians would be able to continue using
EFM as a labor-saving device over one-on-one auscultation,
without the pressure to quickly deliver every baby with a
worrisome EFM pattern.
Funding
The authors received no nancial support for the research,
authorship, or publication of this article.
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The Surgery Journal
Perpetuating Myths, Fables, and Fairy Tales Sartwelle et al.
... Later, however, the caregivers, motivated by paralysing fear of CP lawsuits, and ignoring science and medical ethics, sought self-protection in EFM use rather than exposing and extinguishing the hoaxes (4,6,9). Thus, the CP-EFM hoaxes continue flourishing today, giving CP victims and their families false information and false hope of a safe birth (4,7,9), costing society huge amounts of money (2,4,6,7,10,11) misdirected to CP litigation instead of CP research, and CP care, costing physicians their ethical integrity (9), and costing mothers and children permanent physical and potential future harms from unnecessary EFM-induced caesarean sections (C-sections) (2,4,7,(11)(12)(13)(14)(15)(16)(17). ...
... And while money in a limited resource endeavour like healthcare is of notable concern, the billions lost to the hoaxes are insignificant when compared to physicians' dishonouring the key ethical principles of autonomy¾informed consent, non-maleficence and beneficence (9,12,16), and causing harm to mothers and babies by the continued knowing use of a scientifically destitute machine disguised as a safety device primarily for their own protection from lawsuits (2,4,7,(9)(10)(11)(12). ...
... Banishing these hoaxes is an uncomplicated endeavour because the research and literature conclusively proving physician related birth events rarely cause CP and EFM does not predict or prevent CP, has existed for decades and has recently been accumulating rapidly (2,6,10,17,(20)(21)(22)(23)(24)(25)(26)(27). But, while physicians have long had the ability to dispel the CP-EFM hoax they have mysteriously refused to use it (4,11,16). And that is one of the questions answered here: Why not? ...
Article
Full-text available
The worldwide cerebral palsy (CP) litigation crisis is predicated on the hoax that electronic fetal monitoring (EFM) predicts and prevents CP. There are decades of research disproving this hoax, yet EFM continues to be performed in the vast majority of labors in developed countries with resultant harm to mothers and babies alike through unnecessary caesarean sections with all of the attendant complications and ramifications of that procedure. This article reviews the history and evolution of EFM, explores the reasons for its misuse, discusses how obstetricians have abandoned their ethical mandate by failing to obtain informed consent for EFM, and proposes a realistic, practical solution that would effectively change the standard of care.
... (Max Planck) Five decades of scientific research has exposed the use of electronic fetal monitoring (EFM) and just-in-time cesarean sections (C-sections) to prevent cerebral palsy (CP) and other neurologic injury, to be merely myth, fable, and fairy tale. [1][2][3][4][5][6] More importantly, EFM use has actually done more harm than good to mothers and babies through needless C-sections. [7][8][9] This half century expose has produced scientific light so piercing that it should have utterly blinded the vast majority of physicians who continue to insist on EFM use for every labor regardless of the known unpropitious, direful, consequences. ...
... The EFM story is full of deceit, avarice, arrogance, conflicts of interest, fear, medical paternalism, disregard of patient consent, unscientific optimism, rejection of proven science, and postmodern ethical relativism. 5,6,9,16 The development of the machine is well chronicled in various books and articles. 11,16 Our interest here is the development of the physiologic basis of fetal monitoring which has turned out to be so wrong, but which is held sacrosanct by so many even today, and has caused more harm than help to mothers and babies for the last half century. ...
... [7][8][9] EFM's purpose was to prevent fetal asphyxia. 2,3,5-9 Asphyxia, according to long held but scientifically unsubstantiated belief, was thought to be the primary cause of CP. 2,3,[5][6][7][8][9] If identified early and with early intervention, primarily by C-section, the prevailing conventional wisdom taught that death and long term neurologic morbidity, in particular CP, would be mostly eliminated. 2,3,5,17 The goal was perhaps noble in purpose, but the methods used for proof of concept were anything but. ...
Article
Full-text available
A half century ago electronic fetal monitoring was rushed into clinical use with the promise that the secrets of fetal heart rate decelerations had been discovered and that the newly discovered knowledge would prevent cerebral palsy with just in time cesarean sections (C-sections) preventing babies from experiencing asphyxia, which was thought to be the primary cause of cerebral palsy. In the years since electronic fetal monitoring's debut, it has been discovered that asphyxia is a rare cause of cerebral palsy. At the same time electronic fetal monitoring use increased to 85% of all labors, the C-section rate increased to 33% without an attributable decrease in the rate of cerebral palsy. What went wrong with electronic fetal monitoring? The answer lies in a new analysis of the physiologic theories concerning fetal heart rate decelerations, demonstrating that the earlier electronic fetal monitoring theories were wrong. This revelation is only the latest evidence that electronic fetal monitoring use today is harming mothers and babies with useless C-sections. Yet electronic fetal monitoring use continues unabated. Why? This article explores the complex answers and bioethical concerns, through a review of the new evidence underlying fetal heart rate decelerations in labor.
... 1,3-7,10-12,18 CP litigation, in turn, inspired physicians to compromise their ethical principles, using EFM without informed consent as protection from CP lawsuits despite the evidence that EFM has caused more harm than good. 9,11,18,19 Widely Used in the Obstetrics Community Wiznitzer's first argument is known by many names-argumentum ad populum, bandwagon fallacy, appeal to popularity, consensus fallacy-but is a poor substitute for medical evidence. One may as well argue that since millions of people worldwide still smoke, smoking must be healthy despite the contrary medical evidence. ...
... 4,24,25 The obstetrical community ignored these studies, purposely using unproven EFM technology in an age when medical technology seemed to have bypassed obstetrics in favor of every other medical specialty. 9,11,18,24,25 For the next half century, the scientific and medical evidence related to CP and EFM accumulated at a rapid pace. At the same time, EFM use increased to 85% of all labors in the United States and similar numbers in other industrialized countries. ...
... The accumulated CP-EFM evidence did not prove asphyxia as a prominent CP cause or that EFM was efficacious. Rather, the evidence proved exactly what Benson 27 and others said about EFM in the beginning: birth asphyxia was a rare cause of CP; [1][2][3][4][5][6][7][9][10][11][12][17][18][19] EFM as a predictor of CP was a myth; [1][2][3][4][5][6][7][9][10][11][12][17][18][19] EFM inspired Csections caused more harm than good; 4,5,9 and the rate of CP, despite EFM and C-sections, was unchanged, as were rates of perinatal death, intrapartum stillbirth, neonatal death, low or very low Apgar scores, need for special neonatal care, and neonatal deaths. [1][2][3][4][5]7,[9][10][11][12] The more incredible part of this O. Henry ending is the fact that this accumulated evidence is virtually unchallenged by any substantial contemporary medical or scientific evidence. ...
Article
Full-text available
A half century after continuous electronic fetal monitoring (EFM) became the omnipresent standard of care for the vastmajority of labors in the developed countries, and the cornerstone for cerebral palsy litigation, EFM advocates still do not have any scientific evidence justifying EFM use in most labors or courtrooms. Yet, these EFM proponents continue rationalizing the procedure with a rhetorical fog of meaningless words, misleading statistics, archaic concepts, and a complete disregard for medical ethics. This article illustrates the current state of affairs by providing an evidence-based review penetrating the rhetorical fog of a prototypical EFM advocate.
... 3 EFM is used in the world's industrialized countries in a great majority of births based on the unproven assumption that EFM can predict and prevent CP by providing caregivers a window of opportunity in which to intervene in labor-mostly by cesarean section (C-section)-and rescue the fetus before irreversible brain damage occurs. [4][5][6][7][8][9][10][11][12][13][14][15][16] This erroneous concept is rooted and grounded in a 19th century birth myth, still prevalent today, that CP and other neurologic birth maladies are caused by oxygen deprivation during labor or delivery. [5][6][7][8][9][10][11][12][13][14][15][16] EFM was conceived in the 1960s based on this birth myth, and that myth is still EFM's foundation today despite decades of research revealing that CP is rarely caused solely by asphyxia, that fetal heart rate is an indirect and poor measure of past and present fetal brain function and damage, that EFM's positive signals are frequently misinterpreted and are wrong 99 times out of 100, and that EFM has caused more harm than good for mothers and babies through unnecessary C-sections. ...
... [4][5][6][7][8][9][10][11][12][13][14][15][16] This erroneous concept is rooted and grounded in a 19th century birth myth, still prevalent today, that CP and other neurologic birth maladies are caused by oxygen deprivation during labor or delivery. [5][6][7][8][9][10][11][12][13][14][15][16] EFM was conceived in the 1960s based on this birth myth, and that myth is still EFM's foundation today despite decades of research revealing that CP is rarely caused solely by asphyxia, that fetal heart rate is an indirect and poor measure of past and present fetal brain function and damage, that EFM's positive signals are frequently misinterpreted and are wrong 99 times out of 100, and that EFM has caused more harm than good for mothers and babies through unnecessary C-sections. [5][6][7][8][9][10][11][12][13][14][15][16] These facts have been known to medicine for decades. ...
... [5][6][7][8][9][10][11][12][13][14][15][16] EFM was conceived in the 1960s based on this birth myth, and that myth is still EFM's foundation today despite decades of research revealing that CP is rarely caused solely by asphyxia, that fetal heart rate is an indirect and poor measure of past and present fetal brain function and damage, that EFM's positive signals are frequently misinterpreted and are wrong 99 times out of 100, and that EFM has caused more harm than good for mothers and babies through unnecessary C-sections. [5][6][7][8][9][10][11][12][13][14][15][16] These facts have been known to medicine for decades. 4,6-18 Yet the myth is still taught today as gospel in the form of EFM. ...
Article
Full-text available
Permissions and Reprints Abstract Electronic fetal monitoring (EFM) does not predict or prevent cerebral palsy (CP), but this myth remains entrenched in medical training and practice. The continued use of this ineffectual diagnostic modality increases the cesarean section rate with concomitant harms to mothers and babies alike. EFM, as it is used in defensive medical practice, is a violation of patient autonomy and raises serious ethical concerns. This review addresses the need for improved graduate medical education so that physicians and medical residents are taught both sides of the EFM–CP story. Keywords electronic fetal monitoring - cerebral palsy - medical ethics - medical education * The Rest of The Story was a Monday-Friday radio program featuring Paul Harvey. Beginning in WWII, Harvey would narrate a little known or forgotten story of history, leaving a key element, like the name of a well-known person, until the very end of the narration, concluding with the now famous tag line “And now you know the rest of the story.”[1]
... Commonly, in cerebral palsy litigation cases, fetal monitor tracings are utilized by both plaintiff and defense experts as the basis for opinions. However, the sensitivity, specificity and reproducibility of opinions of electronic fetal monitoring are limited [8][9][10]. ...
Article
Full-text available
Cerebral palsy litigation cases account for the highest claims involving obstetricians/gynecologists, a specialty that ranks among the highest liability medical professions. Although epidemiologic studies indicate that only a small proportion of cerebral palsy (10–20%) is due to birth asphyxia, negligent obstetrical care is often alleged to be the etiologic factor, resulting in contentious medical-legal conflicts. Defense and plaintiff expert opinions regarding the etiology and timing of injury are often polarized, as there is a lack of established methodology for analysis. The objective results provided by umbilical cord and newborn acid/base and blood gas values and the established association with the incidence of cerebral palsy provide a basis for the forensic assessment of both the mechanism and timing of fetal neurologic injury. Using established physiologic and biochemical principles, a series of case examples demonstrates how an unbiased expert assessment can aid in both conflict resolution and opportunities for clinical education.
... EFM provides that record-which can then be interpreted, after the birth, by appointed experts on both sides of the trial. 36 An EFM monitor strip can be introduced as exculpatory evidence, showing that a reasonable practitioner had no cause to be concerned about fetal distress or ordered a cesarean section at the appropriate time. But it can also be used as evidence of malpractice. ...
Article
The “best interests of the patient” standard—a complex balance between the principles of beneficence and autonomy—is the driving force of ethical clinical care. Clinicians’ fear of litigation is a challenge to that ethical paradigm. But is it ever ethically appropriate for clinicians to undertake a procedure with the primary goal of protecting themselves from potential legal action? Complicating that question is the fact that tort liability is adjudicated based on what most clinicians are doing, not the scientific basis of whether they should be doing it in the first place. In a court of law, clinicians are generally judged based on the “reasonably prudent” standard: what a reasonably prudent practitioner in a similar situation would do. But this legal standard can have the effect of shifting the medical standard of care—enabling a standard-of-care sprawl where actions undertaken for the primary purpose of avoiding liability reset the standard of care against which clinicians will be adjudicated. While this problem has been recognized in the legal literature, neither current ethical models of care nor legal theory offer workable solutions.
... Ethicists defaulted in the EFM debate by their overwhelming silence. The use of a scientifically bankrupt machine solely to protect healthcare providers from trial lawyers and lawsuits when the machine is known to be harming mothers and babies is an egregious conflict of interest and outrageous endorsement of obstetrical defensive medicine-post-modern ethical relativism solely to benefit healthcare providers-and is undeniable proof that evidence-based standard of care and bioethical principles are nothing more than empty rhetoric [79,80]. ...
Article
Full-text available
Bioethics abolished the prevailing Hippocratic tenet instructing physicians to make treatment decisions, replacing it with autonomy through informed consent. Informed consent allows the patient to choose treatment after options are explained by the physician. The appearance of bioethics in 1970 coincided with the introduction of electronic fetal monitoring (EFM), which evolved to become the fetal surveillance modality of choice for virtually all women in labor. Autonomy rapidly pervaded all medical procedures, but there was a clear exemption for EFM. Even today, EFM remains immune to the doctrine of informed consent despite continually mounting evidence which proves the procedure is nothing more than myth, illusion and junk science that subjects mothers and babies alike to increased risks of morbidity and mortality. And ethicists have remained utterly silent through a half century of EFM misuse. Our article explores this egregious ethical failure by reviewing EFM's lack of clinical efficacy, discussing the EFM related harm to mothers and babies, and focusing on the reasons that this obstetrical procedure eluded the revolutionary change from the Hippocratic tradition to autonomy through informed consent.
... Ethicists defaulted in the EFM debate by their overwhelming silence. The use of a scientifically bankrupt machine solely to protect healthcare providers from trial lawyers and lawsuits when the machine is known to be harming mothers and babies is an egregious conflict of interest and outrageous endorsement of obstetrical defensive medicine-post-modern ethical relativism solely to benefit healthcare providers-and is undeniable proof that evidence-based standard of care and bioethical principles are nothing more than empty rhetoric [79,80]. ...
Article
Full-text available
Bioethics abolished the prevailing Hippocratic tenet instructing physicians to make treatment decisions, replacing it with autonomy through informed consent. Informed consent allows the patient to choose treatment after options are explained by the physician. The appearance of bioethics in 1970 coincided with the introduction of electronic fetal monitoring (EFM), which evolved to become the fetal surveillance modality of choice for virtually all women in labor. Autonomy rapidly pervaded all medical procedures, but there was a clear exemption for EFM. Even today, EFM remains immune to the doctrine of informed consent despite continually mounting evidence which proves the procedure is nothing more than myth, illusion and junk science that subjects mothers and babies alike to increased risks of morbidity and mortality. And ethicists have remained utterly silent through a half century of EFM misuse. Our article explores this egregious ethical failure by reviewing EFM's lack of clinical efficacy, discussing the EFM related harm to mothers and babies, and focusing on the reasons that this obstetrical procedure eluded the revolutionary change from the Hippocratic tradition to autonomy through informed consent.
Article
PurposeThe two major components of a cardiotocograph (CTG) are uterine contraction (UC) and fetal heart rate (FHR) signals. CTG has been widely used to monitor fetal well-being in the past 50 years. The guideline provided by the National Institute of Child Health and Human Development (NICHD) classifies CTG patterns into three categories (I, II, and III) in evaluating the status of a fetus. However, manual interpretation of CTG is time-consuming and is subjected to inter-personal bias.Methods In this study, we combined the rule-based method and eXtreme Gradient Boosting (XGBoost) analysis in classifying CTG patterns. Because of the persistent controversies about the Category II of NICHD, XGBoost analysis was used to classify it into IIa and IIb. A total of 68 pregnant women were enrolled in this study.ResultsThree categories (I, II, and III) were consistent in both manual interpretation by clinicians and our algorithm across all categories, and the average Kappa was about 0.72. The probability of fetal distress (FD) was 28.8% and 71.2% in the categories IIa and IIb, respectively.Conclusion These findings show the proposed method has the potential to provide a clinical assistant tool to monitor fetal well-being and has high potential to be an assistive and warning system to reduce the burden of medical staff.
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This article investigates qualitatively the value profile of the da Vinci® surgical robot after almost two decades of extensive clinical use and research. We aimed to understand whether the swiftly growing body of published studies on robotic prostate surgery can now, that is, beyond an early stage, guide decisions on the acquisition, procurement, and public provision of this innovation. We explored both published studies and the perspectives of diverse stakeholders in the Netherlands. Both arenas represent conflicting, often polarised arguments on the (added) value of da Vinci surgery. What was unclear a decade ago due to lack of evidence is now unclear because of controversies about evidence. The article outlines controversial value issues and indicates the unlikelihood that awaiting more research - amid the mantra "further studies are needed" - will resolve the controversy. The study underscores multi-stakeholder deliberation to resolve controversies regarding the value of advanced medical innovations.
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The Task Force Study on Neonatal Encephalopathy Second Edition 2014 failed to address Electronic Fetal Monitoring (EFM) and its forty years of clinical futility, failed to condemn EFM’s continued use against physicians in the world’s courtrooms and ignored the ethical breaches EFM’s use compels physicians to commit daily. This article considers why these critical points were overlooked and asks why the Task Force recommended continued EFM use for all women in labor while simultaneously acknowledging EFM’s impotency. This paradox is explored among the background of trial lawyers’ involvement in cerebral palsy and the failure of birthrelated professional organizations to recognize that the Daubert doctrine may be used to exclude EFM junk science from the world’s courtrooms.
Article
Full-text available
The cardinal driver of cerebral palsy litigation is electronic fetal monitoring, which has continued unabated for 40 years. Electronic fetal monitoring, however, is based on 19th-century childbirth myths, a virtually nonexistent scientific foundation, and has a false positive rate exceeding 99%. It has not affected the incidence of cerebral palsy. Electronic fetal monitoring has, however, increased the cesarian section rate, with the expected increase in mortality and morbidity risks to mothers and babies alike. This article explains why electronic fetal monitoring remains endorsed as efficacious in the worlds’ labor rooms and courtrooms despite being such a feeble medical modality. It also reviews the reasons professional organizations have failed to condemn the use of electronic fetal monitoring in courtrooms. The failures of tort reform, special cerebral palsy courts, and damage limits to stem the escalating litigation are discussed. Finally, the authors propose using a currently available evidence rule—the Daubert doctrine that excludes ‘‘junk science’’ from the courtroom—as the beginning of the end to cerebral palsy litigation and electronic fetal monitoring’s 40-year masquerade as science.
Article
Maintaining maternal oxygen supply is essential for foetal life, and labour constitutes an increased challenge to this. Good clinical judgement is required to evaluate the signs of reduced foetal oxygenation, to diagnose the underlying cause, to judge the reversibility of the condition and to determine the best timing for delivery. The main aim of intrapartum foetal monitoring is to identify foetuses that are being inadequately oxygenated, enabling appropriate action before the occurrence of injury. It is also to provide reassurance in cases of adequate foetal oxygenation, and thus to avoid unnecessary obstetric intervention. Poor foetal oxygenation is diagnosed by documenting metabolic acidosis in the umbilical cord immediately after birth or in the newborn circulation during the first minutes of life. However, most newborns recover quickly, and they do not develop relevant short- or long-term complications. Hypoxic-ischaemic encephalopathy is the short-term neurological dysfunction caused by inadequate intrapartum foetal oxygenation, and cerebral palsy of the spastic quadriplegic or dyskinetic types is the long-term neurological complication most commonly associated with it. Although there is insufficient evidence from randomised controlled trials to demonstrate that any form of intrapartum foetal monitoring reduces the incidence of adverse outcomes, reports from the clinical setting have documented a decrease in metabolic acidosis, hypoxic-ischaemic encephalopathy and intrapartum death over the last decades. It may be difficult to demonstrate the benefit of diagnostic techniques in complex environments such as the labour ward, but a reduction in the incidence of adverse clinical outcomes constitutes important evidence that intrapartum foetal monitoring makes a difference. Copyright © 2015 Elsevier Ltd. All rights reserved.
Article
Rationale, aims and objectivesTo evaluate obstetricians' inter- and intra-observer agreement on intrapartum cardiotocogram (CTG) recordings and to examine obstetricians' evaluations with respect to umbilical artery pH and base deficit.Methods Nine experienced obstetricians annotated 634 intrapartum CTG recordings. The evaluation of each recording was divided into four steps: evaluation of two 30-minute windows in the first stage of labour, evaluation of one window in the second stage of labour and labour outcome prediction. The complete set of evaluations used for this experiment is available online. The inter- and intra-observer agreement was evaluated using proportion of agreement and kappa coefficient. Clinicians' sensitivity and specificity was computed with respect to umbilical artery pH, base deficit and to Apgar score at the fifth minute.ResultsThe overall proportion of agreement between clinicians reached 48% with 95% confidence intervals (CI) (CI: 47–50). Regarding the different classes, proportion of agreement ranged from 57% (CI: 54–60) for normal to 41% (CI: 36–46) for pathological class. The sensitivity of clinicians' majority vote to objective outcome was 39% (CI: 16–63) for the umbilical artery base deficit and 27% (CI: 16–42) for pH. The specificity was 89% (CI: 86–92) for both types of objective outcome.Conclusions The reported inter-/intra-observer variability is large and this holds irrespective of clinicians' experience or work place. The results support the need of modernized guidelines for CTG evaluation and/or objectivization and repeatability by introduction of a computerized approach that could standardize the process of CTG evaluation within the delivery ward.
Article
Cerebral palsy (CP) is heterogeneous with different clinical types, co-morbidities, brain imaging patterns, causes and now also heterogeneous underlying genetic variants. Few are solely due to severe hypoxia or ischemia at birth. This common myth has held back research in causation. The cost of litigation has devastating effects on maternity services with unnecessarily high cesarean delivery rates and subsequent maternal morbidity and mortality. CP rates have remained the same for 50 years despite a sixfold increase in cesarean birth. Epidemiological studies have shown that the origins of most CP are prior to labor. Increased risk is associated with preterm delivery, congenital malformations, intrauterine infection, fetal growth restriction, multiple pregnancy and placental abnormalities. Hypoxia at birth may be primary or secondary to pre-existing pathology and international criteria help to separate the few cases of CP due to acute intrapartum hypoxia. Until recently 1-2% of CP (mostly familial) had been linked to causative mutations. Recent genetic studies of sporadic CP cases using new generation exome sequencing show that 14% of cases have likely causative single gene mutations and up to 31% have clinically relevant copy number variations. The genetic variants are heterogeneous and require function investigations to prove causation. Whole genome sequencing, fine scale copy number variant investigations and gene expression studies may extend the percentage of cases with a genetic pathway. Clinical risk factors could act as triggers for CP where there is genetic susceptibility. These new findings should refocus research about the causes of these complex and varied neurodevelopmental disorders. Copyright © 2015 Elsevier Inc. All rights reserved.