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Beyond Evidence: The Complexity of Maternity Care

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BIRTH 33:4 December 2006 265

GUEST EDITORIAL

Beyond Evidence: The Complexity of

Maternity Care
Preface: This paper has been gestating for a long time–the sixty years that I have been associated
with maternity care. It was conceived during an era of medical authoritarianism, born in a time of
nascent childbirth education and family-centered maternity care, matured in a period of enthusiastic
(but not unquestioning) homage to evidence-based obstetrics, and culminated in a reluctant but
comforting acceptance of uncertainty. It has passed through stages of enthusiasm, of disillusionment,
and of reevaluation. It is, to use an ancient word I only recently learned, a clinamen, a swerve,
a point of intellectual revision. Others in the Clinamen Collaboration share the authorship of this
paper with me.
Murray Enkin

Lest anyone yearn for the good old days, the halcyon
days of yore, they weren’t. My father’s mother was
one of the many women who died in childbirth.
Although maternal mortality, which in the 1930s
was still as high as it had been a century before (1),
began to fall precipitously in the 1940s (at least in the
West), it left its residue of fear. When I began practice
in the late 1940s, pregnancy was still seen as a time of
danger, and maternity care was enmeshed in a tangle
of enshrined do’s and don’ts, prescriptions and pro-
scriptions, dictated by medical tradition. Companions
(witnesses?) were excluded from accompanying, help-
ing, or even seeing laboring women. The pain of labor
was controlled by massive narcosis, and that of child-
birth by general anesthesia. But growing obstetrical
expertise also brought great benefits. Care became
more effective, childbirth both more comfortable
and safer. It was a win-win situation. Women were
pleased, and doctors gratified. It was a time of great,
and justified, optimism.
Nevertheless some disturbing problems remained.
Experts did not agree either with women’s demands
or with each other. Different interventions were used,
Address correspondence to Dr. Murray W. Enkin, 1001 Bay Street, Apt.
2404, Toronto, ON M5S 3A6, Canada.
Ó 2006, Copyright the Authors
Journal compilation Ó 2006, Blackwell Publishing, Inc.
in different ways, and often with differing results.
Expectations grew; as more was achieved, still more
was demanded. Something new was needed.
A New Approach to Evidence
Something new came along. At first largely unknown
and ignored, randomized clinical trials were intro-
duced to medicine in the 1950s as an unbiased way
to determine the real effects of medical interventions.
The medical profession was slow to recognize their
value, and obstetrics was one of the slowest specialties
to make use of this new approach to evidence. In his
1979 review of the medical profession, Archie
Cochrane, after first considering the abysmal record
of psychiatrists, surgeons, and cardiologists, decided
to award the ‘‘wooden spoon’’ to the obstetricians for
the poorest record in evaluating their practices. He
justified his ranking by pointing out that
The specialty missed its first opportunity in the sixties, when
it failed to randomise the confinement of low risk pregnant
women at home or hospital. . . . Then, having filled the emp-
tying beds by getting nearly all pregnant women into hospi-
tal, the obstetricians started to introduce a whole series of
expensive innovations into the routines of pre and postnatal
care and delivery, without any rigorous evaluation. The list is
long, but the most important were induction, ultra-sound,
fetal monitoring, and placental function tests. The specialty
reached its apogee in 1976 when they produced 20 per cent
fewer babies at 20 per cent more cost (2).
266
Cochrane was, however, cautiously optimistic. He
presciently went on to ‘‘admit that my spies tell me
there will soon be a torrent of evaluations in this
field.’’ His spies were right; obstetrics indeed rose to
his challenge. Iain Chalmers, director of the fledgling
National Perinatal Epidemiology Unit in Oxford, set
about the monumental task of finding, analyzing, sys-
tematically reviewing, and synthesizing the data from
all controlled trials in perinatal medicine. One of us
(MWE) was able to join him early in his endeavors,
when he first embarked on his massive international
search, at first without the benefit of computers. The
result, 10 years later, was the electronic Oxford Data-
base of Perinatal Trials (3), and then an encyclopedic,
multi-authored, two-volume text (4), the first system-
atic review of controlled trials in any entire medical
specialty. This was shortly followed by a paperback
synopsis of the larger work (5), which could make the
findings more generally available to a wider audience.
At first all went well. Most of the time the results
came out as we had predicted, and they provided good
rationale for the changes we wanted to see in existing
practices. When controlled trials failed to show any
benefits from traditional practices like predelivery
shaving (6,7) and enemas (8), we could convincingly
recommend that such uncomfortable practices be dis-
continued. We were happy when trials of labor sup-
port from either companions or professionals showed
clear improvements in outcome (9) for the mothers, as
we knew it would. We were excited when randomized
trials demonstrated effective ways to prevent serious
disorders (10), or clearly resolved controversies about
the best treatment for dangerous pregnancy compli-
cations (11). We believed we had the answer.
This pioneering approach received academic acco-
lades (12), but seemed to have little influence on
obstetrical practice. It took what seemed to us to be
ages before the profession and the public began to
appreciate how effective randomized trials could be
as a way to choose between alternative forms of care.
We should have been more patient; shifts in para-
digms do not occur quickly. The age of Galenic med-
icine lasted 1,200 years, the preeminence of pathology
in medical thinking continued for over 300 years, and
the deference to obstetrical expertise predominated
for most of the last century.
But the status quo shifted, in what seemed to be
overnight. Only history can tell us who or what will
receive the credit (or blame) for the meteoric rise of
what came to be called evidence-based medicine. The
term was coined by Gordon Guyatt, of McMaster
University in Hamilton, Ontario, only in 1991 (13),
and achieved widespread acceptance the following
year (14). Over a period of years rather than decades
or centuries the paradigm changed. The Cochrane
BIRTH 33:4 December 2006
Collaboration began as a single center in the United
Kingdom, then became an immense multinational
organization (15). The Oxford Database of Perinatal
Trials became only a tiny part of the Cochrane
Library, which systematically reviewed randomized
trials of health care in almost all health disciplines.
‘‘Evidence-based medicine’’ became the new mantra,
the new authority.
Authority Can Be Wrong
And therein lies the rub. Any authority can be wrong,
and can mislead even when it is right. Just as clinical
expertise had contributed so tremendously to the
improvement in health care and in health but was
sometimes mistaken, so evidence-based obstetrics
has answered many important questions about ‘‘best’’
care in pregnancy and childbirth, but by no means all.
When the results of trials do not conform to what we
believe from other evidence, we had to devise ad hoc
rationalizations to explain the discrepancies. A sys-
tematic review of trials of antenatal education for
labor or parenthood failed to demonstrate any clear-
cut benefits from our intervention. The authors con-
cluded only that ‘‘No recommendations for practice
changes can be made at this time since there exists
insufficient evidence to determine the effects of per-
son-to-person antenatal education for childbirth
and/or parenthood’’ (16). Yet women obviously get
something from prenatal classes, because they con-
tinue to attend them.
A Cochrane review of programs offering compre-
hensive social support for pregnant women at high
risk of having an overly small baby failed to demon-
strate improvements in any measurable perinatal out-
comes (17). The authors of this review explained their
unexpected results with the comment, ‘‘Pregnant
women need and deserve to have the help and support
of caring family members, friends, and health profes-
sionals. However, such support is unlikely to be pow-
erful enough to overcome the effects of a lifetime of
poverty and disadvantage, or a longstanding preg-
nancy complication, and thereby influence the
remaining course of a pregnancy’’ (17).
Electronic fetal heart rate monitoring has been
extensively studied, and the only clinically significant
benefit demonstrated from its use is a reduction of
neonatal seizures (18), which was subsequently shown
to have no long-term adverse effects (19). The
counter-intuitive results of these trials were largely
ignored. Electronic fetal monitoring is still almost
routinely practiced in many hospitals.
Sometimes, of course, the way a trial is conceived or
carried out is not perfect. Questions can be, and have
BIRTH 33:4 December 2006
been, raised about the methodology of even some
recent, major, large-scale, highly influential trials
(20-23). More fundamentally, however, questions
have been, and increasingly are being, raised about
the types of question that trials can address, and the
extent to which they should influence our care (24).
Even good evidence can lead to bad practice if applied
in an unthinking way. Moreover, there are biases
inherent in even the best trials.
One such bias is in the choice of outcomes to be
studied. These must be specified in advance, and
hence reflect the values (and biases) of the investiga-
tors. They must be limited in number; if we choose too
many outcomes to study, some will be statistically
significant by chance; if we choose too few, how can
we tell if we really chose the right ones? We are limited
by cost and feasibility. We have to study the outcomes
that we can study, rather than the outcomes we would
like to study. We tend to use surrogate rather than
clinical outcomes, short-term outcomes rather than
long term, in the necessary interest of feasibility.
Perhaps the most significant and ubiquitous bias is
in the choice of what to study. Evidence-based obstet-
rics pays attention to the interventions that have been
studied in randomized trials. Other, potentially more
useful interventions that have not been studied by
randomized trials, tend to be ignored. Sometimes
the determining factor is the commercial importance
of the intervention studied, or a vested interest of
either the researcher or the funding agency. And some
things just cannot be studied by randomized trials.
Randomized trials, currently at the top of the
evidence-based hierarchy, are perfectly suited to eval-
uate the (average) relative effects of alternative forms
of care, for both simple and complicated problems,
where the form of care used is the principal cause of
the outcome found. They are less suitable, and often
seriously misleading, for complex problems, where the
outcomes depend more on the web of interactions
between the care, the individuals concerned, and the
context in which they occur.
From Complicated to Complex
It is well, at this point, to try to clarify the differences
among simple, complicated, and complex issues (25)
(Table 1). Some problems, such as how to bake a cake,
or how to suture an episiotomy, are pretty straightfor-
ward. You get a good recipe, and you follow it. We
have lots of good recipes in maternity care: cortico-
steroids for lung maturation with preterm birth; cesar-
ean section for placenta previa; transfusions for
women who have lost excessive blood; magnesium
sulphate for eclampsia. There is a direct, linear rela-
267
tionship between what is done and what results. Prop-
erly used, the results will be as expected. A recipe must
be tested. When an effect is sufficiently large, it can be
tested by simple observation. For smaller, but still
important effects, these recipes can only be adequately
tested by randomized trials.
Other basically linear problems are more compli-
cated. You need much more than a simple recipe to
put a space ship in orbit, or manage a brittle diabetes.
You need sophisticated equipment and a highly trained
team. But if you make your preparations carefully,
have everything in place, and take meticulous care at
every step, you can be reasonably confident that you
will likely succeed. With specialized skills, advanced
technology, and coordinated teamwork, many compli-
cated problems in maternity care can now be confi-
dently addressed. Severe diabetes can be managed
successfully, genetic deviations from normal can be
anticipated, fetal growth can be monitored. Random-
ized trials play a major role in the evaluation of these
complicated recipes
But when a problem is complex, rather than just
complicated, we can never be entirely sure of what is
going to happen. There is no direct, linear effect
between what we do, and what results. Perhaps the
best, or the most familiar, example of a complex prob-
lem is how to raise one’s child. Formulas, recipes,
guidelines, have a limited application. Expertise in
parenting can help, but is not enough. Every child is
unique, and an approach that results in a successful
outcome for one child may be disastrous for another.
Many of the influences that determine how your child
will grow up are beyond your control. Chance events
can have far-reaching consequences: a meeting with
a friend, or with a bully; a teacher who fosters your
child’s talents, or one who blunts her curiosity.
Despite all this, the birth of a child is a time for opti-
mism. We look forward to raising that child as both
a challenge and an opportunity.
We have solved, or are well on the way to solving,
many of our complicated problems in maternity care.
These respond to the well-established toolkit of the
evidence-based paradigm. How can we dare to even
think of challenging this paradigm that has served us
so well, that has proved so successful, that has helped
us to cure some of our most serious diseases, to solve
so many ‘‘insoluble’’ problems, to answer so many
‘‘unanswerable’’ questions?
Breaking Through the Tangle
Because we must dare, we must think. Many, if not
most, of our remaining problems are complex ones,
rather than merely complicated. They have multiple,
268 BIRTH 33:4 December 2006

Table 1. Differences Among Simple, Complicated, and Complex Issues*

Linear

Simple Complicated Complex

Baking a Cake or Suturing Sending a Rocket into Orbit or Raising a Child or

an Episiotomy
Recipe is essential
Recipe is tested to assure easy
replication
No particular expertise is required,
but expertise increases success rate
Recipes produce standard products
Direct causal relationship between
what is done and what occurs
Best recipes give good results
every time
Test with randomized trial
An optimistic approach to the
problem is possible
Managing a Brittle Diabetes
Recipe is critical
Doing once increases assurance
that the next will be OK
High levels of expertise in a variety
of fields are necessary for success
Rockets, like surgical procedures,
are similar in critical ways
Direct causal relationship between
what is done and what occurs
There is a high degree of certainty
about the outcome
Test with randomized trial
An optimistic approach to the
problem is possible
Delivering a Baby
Recipes have limited application
Raising one child provides
experience, but no assurance
of success with the next
Expertise can contribute, but is
neither necessary nor sufficient
to assure success
Every child, like every birth, is
unique, and must be understood
as an individual
Results are contingent on factors
beyond the control of the operator
Uncertainty of the outcome remains
Test with appropriate methodology;
qualitative, quantitative, narrative,
innovative
An optimistic approach to the
problem is possible

*Modified from Glouberman and Zimmerman (25).

interrelated, interconnected, interwoven, hopelessly
tangled causes. They respond in unexpected ways to
well-intentioned interventions, even ones based on
good evidence. They are not tidy, like respectable
problems should be. They demand a new approach.
The fundamental mistake of evidence-based medi-
cine, evidence-based obstetrics, is to treat complex
problems as if they were merely complicated. We have
hoped, even expected, that medical research would
reduce our apparently complex problems to their sim-
ple components, so that we could address them with
our current paradigm. But clinical problems, like pre-
term labor or small-for-gestational-age babies, do not
fit into our predefined slots. Neither do more broadly
based problems like overextended facilities, shortage
of maternity care practitioners, the current epidemic
of cesarean sections, or the specter of medicolegal lia-
bility that frightens and constrains us.
Our growing understanding of the nature of com-
plex systems, from the physical to the social, can
help us understand the changes that are taking place
in maternity care. The strength and acceptance of
family-centered over practitioner-centered care, the
resurgence of midwifery as an honored profession, all
speak to the power of self-organization within complex
systems. Naı̈ve efforts to simplify the management of
pregnancy and childbirth through standardized formu-
las, evidence-based protocols, are failing, and we are
beginning to recognize anew the complexity of preg-
nancy and birth as life events to be experienced, rather
than diseases to be managed. The present evidence-
based paradigm, while giving lip service to women
and their partners, and the context of each pregnancy
and birth, fails to fully appreciate that it is not simply
the woman or the setting, the attendant or the policies,
that influence the outcome. Rather, it is the complex
interrelationships among these separate elements.
Although not new, this renewed understanding can
guide us in our search to constantly improve care, at all
levels. It cannot provide us with the comforting proto-
cols that we have come to expect, but it can point us to
the steps we can take to move forward. First and fore-
most, we need to accept the uncomfortable reality that
there are no comprehensive formulas. A cookbook for
maternity care is not in the cards. The fruitless search
for the magic bullet can only lead to frustration.
Second, we must learn to think of the relationships
among the disparate factors that influence each birth,
each setting, each situation, rather than of the factors
in isolation. We must allow new forms of research to
evolve, to produce new kinds of evidence (26), and to
accept the value of this new evidence.
Third, we must advance quickly by moving slowly. A
revolution is neither needed nor desirable. Many
aspects of current understanding, current approaches,
and many current practices work very well. We must be
 BIRTH 33:4 December 2006
careful not to discard them, but to nourish them, adapt
them, and build on them. We can, we have, and we will.
Murray W. Enkin, MD, FRCSC, LLD(Hon), DSc(Hon)
Sholom Glouberman, PhD
Philip Groff, PhD
Alejandro R. Jadad, MD, DPhil, FRCPC
Anita Stern, RN*
Murray Enkin is Professor Emeritus, McMaster University,
Hamilton, Ontario; Sholom Glouberman is Philosopher in
Residence, Baycrest Centre for Geriatric Care, Toronto;
Philip Groff is Director, Research and Evaluation,
Smartrisk, Toronto; Alejandro R. Jadad is Professor, Chair,
Chief Innovator, Centre for Global eHealth Innovation,
Toronto; and Anita Stern is a Doctoral candidate,
McMaster University, Hamilton, Ontario, Canada.
*For the Clinamen Collaboration: The Clinamen Collab-
oration is a small study group from various parts of the
health care field, who are trying to understand more
about the complex nature of health. It includes a philos-
opher, a psychologist, a nurse, and several physicians.
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