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The Promise
(the Tyranny?): Some Observations on the Evolution of Evidence-Based Medicine
By Elizabeth Bogdan-Lovis
She
dont lie, she dont lie,
she dont lieCOCHRANE!
(Refrain from the song Cochrane performed
by Argentinean physician and Cochrane reviewer, Agustín Ciapponi,
at the 2003 Cochrane Colloquium end-of-conference social event.)
A little more than
ten years ago a working group at Canadas McMaster University suggested
evidence-based medicine (EBM) as a new approach to teaching and practicing
medicine (Evidence-Based Medicine Working Group 1992). EBM is defined
as the conscientious, explicit, and judicious use of the best evidence
in making decisions about the care of individual patients (Sackett
1996: 312). That foundational quote illustrates why EBM carries legitimized
political and professional capital among all health care stakeholders,
including medical educators, clinicians, patients, governments, and third
party payers. EBM is anchored in the grand narrative of modernist scientific
medicine. Under the best circumstances, EBM employs sciences empirical
testing and measuring tools to free humankind from old fogyism, all the
while remaining firm in the belief that this numbered knowledge of the
world produces tangible benefits. Lured by this sirens song of modernity,
who can resist the seduction of applying the best science to effectively
and efficiently address health needs?
EBM is indeed a new
medical paradigm. Although there remain outliers still dubious of its
utility, my reliable crystal ball tells me that there is a very promising
future for the EBM endeavor, especially for high quality EBM work such
as that produced by the Cochrane Collaboration, the ACP Journal Club,
the Journal of Evidence-Based Health Care, and the like. That being said,
its not surprising that relatively rapid, large-scale implementation
of EBM has exposed contextual application issues requiring attention.
These issues include
the ongoing problem of phronesis, i.e., how to best wed patient-oriented
evidence to clinical expertise and judgment; how to effectively extrapolate
information from population-based randomized clinical trials and apply
it to the individual patient; how to steer the international biomedical
research agenda and associated EBM to effectively address prioritized
international health needs; and how to incorporate qualitative data into
the EBM equation (a task that is being undertaken by the nascent the Campbell
Collaboration). In an effort to continually improve EBM, those physicians,
biomedical researchers, biomedical statisticians, medical librarians,
and policymakers who enthusiastically promote diffusion of this innovation
have addressed these and related dilemmas as they emerge; as such it is
not my intent to speak to those issues here.
Instead, I will consider
the evolution of EBM from the dual perspectives of anthropology and my
past life of birth activism. The first (anthropological) perspective allows
me to critically examine influential social dynamics within the health
care delivery system, paying close attention to the distribution of power
in social relations, in clinical authority, and in knowledge production.
The complexities of social location and social interactions shape our
perspectives and perceptions of the world around us, influencing what
we see as risks, as problems, and as solutions. Here, I examine the influence
of social context on the evolving practice of EBM.
My
second reflexive perspective draws on my long history of birth activismsubtitled
Everything I know today I learned in childbirth preparation classes.
In the 1980s I taught a renegade style of childbirth preparation class.
In place of teaching the customary (for the day) Lamaze-style breathing
gymnastics, which taught women to be obedient patients, I instead instructed
pregnant clients on rebellious strategies to minimize their chances of
having an unnecessarily medicalized birth experience. I should add here
that I retrospectively view that goal as simplistic and naïve. My
clientele included a demographically-skewed, disproportionately large
number of physicians, medical residents, medical students, and nurses.
As a consequence of their professional orientation, this group was notably
conversant with what might be considered rather esoteric medical knowledge.
In short, while their social location did not quite equalize the usual
provider/patient power differential, it certainly influenced their relationships
with their chosen physicians. A curious dynamic emerged.
Not uncommonly, my
medical-professional clientele desired a manner of demedicalized birth
management that differed from standard institutional hospital faresuch
as a desire to avoid an episiotomy, or to birth in something other than
the flat on your back lithotomy position. Given their relatively
privileged insights into the medical world, and knowing that they faced
likely resistance from their provider, these pregnant professional women
recognized the need to support their unconventional protocol requests
in a conventional fashion. They thus armed themselves with supporting
medical research, practicing a nascent sort of evidence-based patient
choice (Edwards & Elwyn 2001).
They
guessed correctly. Their providers did indeed often respond defensively,
manifesting a biased assimilation effectdescribed by
psychologists as ones tendency to look harder for flaws in research
with which one disagrees. Seeking weaknesses in the womens proffered
research articles, their providers would cite medical research to support
their own routinized medical protocols. A patterned thrust and parry of
data vs. data ensued. The metaphorical duel was usually called to a draw
when the provider successfully assumed authoritative power with statements
such as if youd seen what Ive seen illustrated
with a sufficiently convincing worst-case scenario, or more simply this
is the way I do it.
I offer this dated
description of such fractious confrontations to illustrate the dynamic,
complex, and relational nature of knowledge production, the subjectivity
of scientific medical research in the clinical context, and the socially-located
trump card of professional authority. In this 1980s climate, the parallel
knowledge base, summarized here as birth works was
considered by providers to be woefully ignorant of real medical matters.
Social theorist Pierre Bourdieu (1980) would use the term habitus to describe
the function of power relationships within this state of affairs. According
to Bourdieu, habitus is the social location, the social lens, and the
accompanying social structure, that enables an individual to perceive
activities in a particular order and in a particular way, and to evaluate
them accordingly. The more one is enmeshed within ones habitus,
the more they then conceptualize, interpret, and make sense of surrounding
structured activities through that lens. Habitus subtly shapes a tacit
tolerance for the status quo and is in turn structured by it (Callinicos
1999: 292-3).
In truth, at the
time, neither the birth works nor the standard medical model had
been sufficiently evaluated by a systematic review of medical research
to adequately establish where the weight of the evidence lay. Fast forward
to the end of that decade and enter the EBM research data organization
and application tool.
EBM disciples will
be familiar with the following piece of the EBM origin myth. Epidemiologist
and visionary founding father of EBM, Archie Cochrane, suggested that
modern obstetrics in particular deserved the Wooden Spoon Award
for including a multitude of routine clinical interventions lacking a
sufficient, scientifically tested, evidentiary base to justify their practice,
and whose hazards were unknown (Cochrane 1979). As a response to Archies
clarion call, a collaborative multinational working group set about the
task of systematically identifying and evaluating research on childbirth
management. The results of their work, published in the two-volume Effective
Care in Pregnancy and Childbirth (Chalmers, Enkin, & Kierse 1989),
demonstrated that critically appraised research supported a social model
of childbirth management (birth works) over the standard medical
model. Yet, as we know, standard medical management continues to define
and shape hospital birth.
Equally relevant
to this discussion is the observation that most pregnant women actively
seek medically managed hospital birth. Advocates of patient-oriented evidence-based
decision-making suggest that patients can and should be effectively engaged
in certain aspects of clinical decision-making (Edwards & Elwyn 2001).
Available access to EBM databases might potentially lead to increased
democratization of what was formerly professionally-owned esoteric medical
knowledge. But habitus also influences socially embedded patient consideration
of what constitutes best care.
To illustrate, in
an attempt to minimize unnecessary and costly routine pregnancy and childbirth
intervention, a government-subsidized pilot project in the United Kingdom
made EBM-based pregnancy and childbirth decision-aide leaflets available
both to pregnant women and to their midwife providers. The leaflets encouraged
a balanced consideration of routine interventions. End-of-project evaluation
concluded that these decision aides were ineffective in deterring an escalating
reliance on technological intervention. At a fundamental level, the information
leaflets convinced neither midwives nor consumers that less, in the form
of technologically-mediated medical management, might be equally good
if not in some cases, better (Stapleton, Kirkham, & Thomas 2002).
Like the aforementioned knowledge production, the clinical encounter is
equally dynamic, relational, and complex. While EBM has the potential
to democratize medical decision-making, resultant EBM patient choice is
profoundly manufactured and shaped by habitus including, especially, the
influence of popular culture.
So what are we to
make of such disconnects? Perhaps modern society's relationship to health
care services is similar to its relationship with shopping. In his book
I Want That! How We All Became Shoppers (2002), cultural historian Thomas
Hine observes that shopping practices reflect our sense of entitlement
for increasingly sophisticated commodities. Hine tells us "Shopping
is a responsibility, an exercise of power
the choices that we make
about these things play a big role in determining who we are. We don't
want to surrender such power to a computer program . . ." (p. 208).
By comparison, perhaps media-steered health care consumers, and industry-influenced
health care providers alike, perceive the most recent medical technologies
as delivering optimal care. Encouraged by popular representations which
equate "newer, bigger and more" with better, perhaps we selectively
view ourselves as entitled to pick and choose among various health services
- health care resource thresholds not withstanding. Quite possibly, we
will be unwilling to surrender such consumer power to the vagaries of
EBM number crunchers. Patient-oriented EBM be damned?
Alternatively,
perhaps the aforementioned blindness is caused by "cognitive bias"
which gives an illusion of validity - discounting information that goes
against one's preferred conclusion. One can hypothesize that EBM might
offer a valuable corrective here - it has the potential to objectively
assess the cumulative merit of the research, and with such an objective
assessment, produce robust knowledge to counter cognitive bias. And in
certain cases, EBM has done just that. My colleague Howard Brody reminds
me that located within EBM's lore there is the pivotal Cardiac Arrhythmia
Suppression Trial (CAST). Here, despite plausible pathophysiological reasoning
on the soundness of administering antiarrhythmia drugs encainide and flecainide
for survivors of myocardial infarction, definitive outcome evaluation
demonstrated otherwise. The CAST study found that even though such therapy
successfully suppressed asymptomatic or mildly symptomatic ventricular
arrhythmias, it ultimately accounted for a higher total mortality (CAST
1989). In this case, outcome data clearly impacted treatment; it triumphed
over cognitive bias and successfully influenced subsequent clinical management.
So just why is it
that doctors and patients sometimes capriciously discard a working hypothesis
because of new data, while at other times they cling to a hypothesis despite
evidence to the contrary? Nineteenth-century philosopher William James
posited that one set of looks can indeed overcome another way of looking.
But he also noted the countervailing tendency. "Most of us grow more
and more enslaved to the stock conceptions with which we have once become
familiar, and less and less capable of assimilating impressions in any
but the old ways. Old fogyism, in short is the inevitable terminus to
which life sweeps us on. Objects which violate our established habits
of 'apperception' are simply not taken account of at all; or, if on some
occasion we are forced by dint of argument to admit their existence, twenty-four
hours later the admission is as if it were not, and every trace of the
unassimilable truth has vanished from our thought" (James 1950, c
1918).
In the case of childbirth
management, EBM-supported reasoning is sacrificed to pragmatic reasoning
that sees truth in its consequences. Returning to my birth works
example, it is casually observed that medicalized childbirth results in
healthy mothers and healthy babies, so it is concluded that medicalizing
birth works. The prevailing medical gaze interprets childbirth
as risky; the resultant cultural prescription then views birth as in need
of precautionary "just in case, just to be safe
" medicalization.
According to this popular cultural metanarrative birth does not work;
it is instead an untidy experience that predictably flirts with disaster,
and only when aided by bigger and presumably better medical technologies
and more intervention does it then emerge triumphant.
Problematically,
reliance on the body of systematic reviews of relevant research argues
more convincingly for how to proceed with medical interventions than whether
to proceed with them in the first place. This curious paradox is linked
in part to human nature, and human perception. "If people want to
believe there is an effect, it can be very hard to persuade them that
any effect is too small to be important" (Alderson & Groves 2004:
473).
Yet
another confounding obstacle to implementing effective and efficient EBM
policy is the powerful influence of stories - especially those stories
with "tragic outcomes
[that] seem to offer a solution"
(Newman 2003: 1426). In his article "The Power of Stories Over Statistics"
epidemiologist and biostatistician Thomas Newman describes the compelling
power of stories, noting how an especially poignant story might make statistical
probabilities excessively vivid, and in so doing, inadvertently distort
the appropriate application of the statistical data (Newman 2003: 1426).
This dynamic might partially explain why the American College of Obstetricians
and Gynecologists has recently been willing to entertain the notion of
patient choice for elective primary cesarean section (Bump 2002: 823).
The 2003 Institute
of Medicine report Health Professions Education: A Bridge to Quality suggests
that "it is critical for interdisciplinary health teams and each
of the disciplines to be able to tap this evidence base effectively at
the point of patient care, determining whether an intervention, such as
a preventive service, diagnostic test, or therapy, can be expected to
produce better outcomes than alternatives - including the alternative
of doing nothing (emphasis mine)" (Institute of Medicine 2003: 56).
Ironically, EBM's pattern of reliance on the results of randomized controlled
trials focuses the discourse more on doing something than on doing nothing.
Thus, it is the case that the medical management model as well as societal
opinion are equally biased towards action over inaction.
Returning to my example,
childbirth management screening, testing, and measuring are socially and
medically reified as the best way to know birth, and within this empirical
model a parallel birth works model lacks equivalent authority;
it is viewed as backward, less desirable, and unsafe. As two general practitioners
cogently point out "perhaps it is societal opinion (for which one
ear of the medical profession is always pricked) that sins of omission
are more reprehensible than errors of commission that is at fault. Is
missing a rare diagnosis so much worse than harm from over-testing?"
(Doust & Del Mar 2004: 474). The social response appears to be a deafening
"yes."
While early EBM argued
for a social model of childbirth management, a review of current childbirth
management practices demonstrates that EBM failed to effectively challenge
societal opinion. Paradoxically, expanding reliance on randomized controlled
trials to empirically know birth, such as is required by EBM, now subtly
but surely steers birth towards an increasingly medicalized model - the
tyranny?
Perhaps
my concerns about the evolution of EBM are accurate only when considering
unnecessarily medicalized aspects of life and quite possibly EBM is the
very best corrective that we have to offer in that epistemological regard;
but in today's increasingly medicalized world I simply don't trust that
we can accurately distinguish the difference. Medical facts and social
values are intimately intertwined. Medical science is dialectical, structuring
societal opinion while in turn being structured by it.
As I ponder my benefit-burden, promise-tyranny misgivings about EBM,
I realize that my reservations resemble those presented by Susan Sontag
in her essays On Photography (1966). I conclude with the following pastiche,
lifted - and ever so slightly twisted - from Sontag's essays.
·Like photography, EBM is "a way of depersonalizing our relation
to the" patient (p.167).
·Like
photography, "it is a way of appropriating the objective world"
(p.122).
·Like photography, EBM "can be seen as a faithful recording
of what is evident" (p.118).
·Like photography, "it is a way of finding a place in the
world
to relate to it with detachment" (p.167).
·Just as photography turns living beings into things, so, too,
EBM turns embodied processes of the doctor-patient interaction into commodified
things, things to be measured and recorded (p.98).
·EBM "creates another habit of seeing - both intense and cool,
solicitous and detached, charmed by the insignificant details, addicted
to incongruity/congruity" (p.99).
·In photography it is only by looking at reality in the form of
an object does it become real. So too, EBM requires that aspects of a
healing encounter be subjected to testing, measuring, and within such
a robust numbered equation, the option of "doing nothing" pales
by comparison (p.168).
·Like photography, EBM "cannot create a moral position, but
[it] can reinforce one and can help build a nascent one" (p.17).
·Like photography, EBM "may be more memorable than moving
images, real people, because [it is] a neat slice of time, not a flow"
(p.17).
·EBM is in "a chronic voyeuristic relation to the world which
levels the meaning of all events" (p.11).
·To reduce an aspect of the healing encounter to the level of a
systematic review is to "appropriate" [it]
It means putting
[it] into a certain relation to the world that feels like knowledge-and,
therefore, like power" (p.4).
·EBM "alters and enlarges our notions of what is worth looking
at and what we have a right to observe. [It is] a grammar and, even more
importantly, an ethics of seeing" (p.3).
· EBM "can convey some kind of stable meaning, [it] can reveal
truth" (p.106).
Elizabeth
Bogdan-Lovis, MA
Assistant Director, the Center for Ethics and
Humanities in the Life Sciences
Citations
Alderson, P. and
T. Groves. (2004) What doesn't work and how to show it: Ineffectiveness
is hard to prove and accept. BMJ 328: 473.
Bourdieu, P. (1990) The Logic of Practice (Translated by Richard Nice).
Cambridge: Polity Press.
Bump, R. (2002) Advising prospective mothers about the maternal morbidity
of vaginal childbirth. Am J of Obstet and Gynecol 187: 823.
Callinicos, A. (1999) Social Theory: A Historical Introduction. New
York: New York University Press.
Campbell Collaboration http://www.campbellcollaboration.org/index.html
CAST (1989) Preliminary report: effect of encainide and flecainide on
mortality in a
randomized trial of arrhythmia suppression after myocardial infarction.
The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. N Engl
J Med 321: 406-412.
Chalmers, I., M. Enkin, M.J.N.C. Keirse. (1989) eds. Effective Care
in Pregnancy and
Childbirth. Oxford: Oxford University Press.
Cochrane, A. L. (1979) 1931-1971: A critical review, with particular
reference to the
medical profession. In Medicines for the Year 2000, pp.1-11. Office
of Health Economics London.
Cochrane Collaboration http://www.cochrane.org/index1.htm
Doust, J. and C. Del Mar. (2004) Why do doctors use treatments that
do not work? (Editorial) BMJ 328: 474.
Edwards, A. and G. Elwyn. (2001) Evidence-based Patient Choice: Inevitable
Impossible? New York: Oxford University Press.
Evidence-Based Medicine Working Group. (1992) Evidence-based medicine.
A new
approach to teaching the practice of medicine. JAMA 268: 2420-5.
Hine, T. (2002) I Want That! How We All Became Shoppers. New York: Harper
Collins.
Institute of Medicine. (2003) Health Professions Education: A Bridge
to Quality.
Washington DC: National Academy Press.
James, W. (1950, c 1918) The Principles of Psychology. New York: Dover
Publications.
Newman, T. (2003) The power of stories over statistics. BMJ 327: 1424-27.
Sackett, D.L., W. Rosenberg, M. Gray, B. Haynes, & S. Richardson.
(1996).
Evidence-based medicine: What it is and what it isn't. BMJ 312: 71-72.
Sontag, S. (1973) On Photography. New York: Farrar, Straus & Giroux.
Stapleton H, Kirkham M, Thomas G. (2002) Qualitative study of evidence
based leaflets
in maternity care. BMJ 324: 639.
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