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The Scientific Method is Dead-Long Live the (New) Scientific Method

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 Surgical Innovation
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The Scientific Method is Dead-Long Live the (New) Scientific Method

Richard M. Satava
Surg Innov 2005; 12; 173
DOI: 10.1177/155335060501200218

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 Surgical Innovation, Vol 12, No 2 (June), 2005: pp 173-176
The Scientific Method is Dead-Long Live the
(New) Scientific Method
Richard M. Satava, MD
The scientific method has been the mainstay of scientific in-
quiry and clinical practice for nearly a century. A new method-
ology has been emerging from the scientific (nonmedical)
community: the introduction of modeling and simulation as an
integral part of the scientific process. Thus, after the hypoth-
esis is proposed and an experiment is designed, modern sci-
entists perform numerous simulations of the experiment. An
iterative optimization of the design of the experiment is per-
formed on the computer and is seen in virtual prototyping and
virtual testing and evaluation. After this iterative step, when
the best design has been refined, the actual experiment is con-
ducted in the laboratory. The value is that the modeling and
simulation step saves time and money for conducting the live
experiment. The practice of medicine should look to the tools
being used by the rest of the scientific community and con-
sider adopting and adapting those new principles.
Key words: scientific method, modeling and simulation, virtu-
al prototyping and testing.
edical and surgical practice derives its validity
through the scientific rigor with which the ob-
servations are made concerning the diagnosis and
treatment of patients. Over time, the proving of the
truth of these observations is what is referred to as
evidence-based medicine. This proof is valid only if it
adheres to the conduct of experimentation within
specific rigid guidelines. This is a very stringent
evaluation process that has resulted in the creation,
building, and verification of what is now defined as
the scientific method. The process can be summa-
rized as:
From the Department of Surgery, University of Washington
Medical Center, Seattle, WA.
The opinions or assertions contained herein are the private views
of the author(s) and are not to be construed as official, or as
reflecting the views of the Departments of the Army, Navy or Air
Force, the Defense Advanced Research Projects Agency, or the
Department of Defense.
This is a declared work of the United States Government and as
such is not subject to copyright protection in the United States.
Address reprint requests to Richard M. Satava, MD, FACS,
Department of Surgery, University of Washington Medical
Center, 1959 Pacific Street NE, Seattle, WA 98195 (e-mail:
rsatava@u.washington.edu).
©2005 Westminster Publications, Inc., 708 Glen Cove Avenue,
Glen Head, NY 11545, USA.
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173
1. observing a particular biologic or physical phe-
nomenon,
2. developing a hypothesis about the cause of the
phenomenon,
3. designing an experiment to prove the hypothesis,
4. conducting the experiment to collect data,
5. analysis of the data to determine if the results
prove or disprove the hypothesis, and
6. reporting the results.
The amount to which a particular basic science
or clinical research study adheres to this process
determines the level of credibility which the med-
ical community trusts the conclusions of the study
and thereby tacitly certifies the acceptance of the
conclusions as part of the practice of medicine.
Recent attention to evidence-based medicine has
derived the levels of credibility of the evidence
that is assigned to a given clinical or basic science
study (Oxford Centre for Evidence-based Medicine
Levels of Evidence).1 This is the current status of
using science to support our daily clinical practice
of medicine.
This methodology, the scientific method, is not
unique to medicine. As a matter of fact, the health-
care field has only recently fully embraced this
methodology, which has long been the cornerstone
of all of science-taking the many observations of
daily living (including sickness and health) and in-
tellectual curiosity through this academic exercise
to determine fundamental principles by which to
improve our lives and our understanding of the
world within which we live. However, the general
scientific community has been taking a new ap-
proach to scientific inquiry, once again leaving med-
icine and surgery well behind modern scientific
practice.
To understand the profound changes that are
occurring at the most fundamental levels, a moment
of historical perspective through the example of
medical research and practice will help explain
what appears to be an emerging trend in scientific
research.
174
174
Satava
Medicine in Antiquity
For the initial 2000 years or more (2500 BC to 300
BC) of recorded history, health care was provided
through mythology and "authoritative" proclama-
tion by the local medico-religious leader (shaman,
medicine man, physician). Classical Greece, with
Aristotle, Plato, Hippocrates, and Socrates, among
others, added observation and deduction but main-
tained the importance of tradition and religion
(with little formal methodology to observation or
evidence) in the teaching and practice of medicine.
This is the classical phenomenologic approach to
science: observe, describe, and record a specific
phenomenon. However, there was no further un-
derstanding of the underlying principles, nor
whether there was a cause-and-effect relationship
or correlation.
This persisted even into the 17th century until
Bacon, Galileo, Tycho Brahe, and others who were
unhappy with the Aristotelian approach ushered
in the Age of Enlightenment and proposed the sci-
entific method. This introduced the important
principle of establishing an inductive method of
meticulously observing events and basing research
and clinical practice on a structured approach that
is evidence driven. It would take more than 300
years to untangle the enormous religions and tra-
ditional trappings that continued to intertwine
with science.
Medicine in the Industrial Age
While the final rigorous formal scientific method of
hypothesis-driven research was emerging for non-
medical science, it was not until well into the late 19th
century Industrial Age that medicine began to em-
brace this approach. One of the early advocates was
the surgeon Nicholas Senn,2 who espoused these prin-
ciples for the medical community in 1908; the metic-
ulous description of wounds and diseases became the
basis (evidence) upon which diagnostic and thera-
peutic decisions were made and "... the blind faith in
ancient authorities and the handmaiden of ignorance,
superstition, ..." was relinquished to empirical science
to deduce a logical approach to therapy. This was an
enormous step forward for medicine-from mysticism
and apprenticeship to science-and presaged the
transition to the hypothesis-driven scientific method
with experiments and clinical trials that are specifi-
cally designed to prove a cause-and-effect relation-
ship between treatment and results.3
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The (New) Scientific Method
There are two interesting aspects of this microhis-
tory:
1. Although a preceding approach to science was
replaced, it usually took some of the older prin-
ciples and extended them into a powerful new
tool: the scientific method did not discard obser-
vation of phenomenon but instead incorporated
the empirical method (evidence) as a component
of the formal methodology, and
2. The new method existed in nonmedical science
long before it emerged in medicine.
Hence, this immediately prompts the question
"what are the other scientific disciplines doing in
their approach to research today?"
The process of the new scientific method has
been alluded to by scientific savant Stephen
Wolfram in his book A New Kind of Science.4 The au-
thor repeatedly refers to the power of modeling and
simulation and the importance of an iterative opti-
mization of the model. Build the computer model,
add the data from a real world experiment, see if
the results match real-world expectations, change
the input data to more closely approximate the
model, and run the next iteration. This is continued
until there is concurrence with the evidence of real-
world results.
Stefan Thomke also emphasized this process of
iterative optimization by his hero, Thomas Edison,
in his book Experimentation Matters.5 Like Clayton
Christensen, his colleague in the Harvard Business
School who defined the term disruptive technologies
in his book The Innovators Dilemma,6 Thomke has
focused upon the importance of not only the cre-
ativity of new technologic ideas but also the itera-
tive proof of the scientific method that gains the ac-
ceptance by the scientific community and public at
large.
The result is that world of science has (un-
knowingly) changed the scientific method to in-
clude an additional step between designing the ex-
periment (step 3) and conducting the experiment
(step 4). This step is 3A: model and simulate, by re-
peated iteration to optimize the design of the ex-
periment, and then proceed to conduct the experi-
ment (Figure 1). This appears to be the (new) sci-
entific method, or perhaps it should be designated
the simulation method of science. However, to what
practical ends should this new idea be embraced is
a matter of opinion.
 The Scientific Method is Dead-Long Live the (New) Scientific Method
Medicine in the Computer Age
In every industry except health care, the researchers
(and frequently designers, manufacturers, and other
practitioners) are taking this additional step to any
idea or problem by creating a computer model of
the device, service, process, or even concept and
simulating the results on the computer through it-
erative optimization. This is most commonly re-
ferred to as modeling and simulation and includes
virtual prototyping, computer-assisted design and
computer-assisted manufacturing, virtual testing
and evaluation, predeployment planning, and mis-
sion rehearsal. The purpose is to conserve the con-
sumption of expensive resources that occurs with
the creation of many intermediate physical products
as well as to drastically reduce the time for the test-
ing and evaluation of every physical product or ser-
vice that has been constructed. Of course, the con-
ventional wisdom "time is money" is very applicable
here. Only after the computer is used to optimize
the best design is the product built or the service
provided.
Health care has no computer representation of
its "product," the patient, although the emergence
of total body scanning provides the first step into
The Simulation Method
Hypothesis l Study Design
3A
Hypothesis Study Design odelng &
Simulation
Figure 1. The simulation method or the (new) scientific method.
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175
this area of computer representation of our patients.
The military has a research project, the Virtual
Soldier, which is taking the first steps toward creat-
ing such a computerized patient (or soldier). This
computer model, called a holographic medical elec-
tronic representation or holomer, actually exists in
the computer (and on the soldier's electronic dog
tag) as an information surrogate for the soldier. The
holomer is also a visual electronic health record.
Medicine and the Simulation Method
Once it is learned how to approach our patients
from this radically new perspective-viewing their
holomer representations in "information space" on
a computer-it will be possible to catch up with
the rest of the scientific community and extend be-
yond the traditional scientific method to the new
simulation method and rapidly expand our capabil-
ities. Today in patient care, if each person had his or
her own holomer, it would be possible to simulate a
treatment option before prescribing a medication.
For example, a patient with an arrhythmia could be
given a virtual dose of digitalis to see if the ar-
Experiment Results Reporting
m Experimentw- Results Reporting
 176
176
Satava
Satava
rhythmia would resolve, and if not, the dose could
be adjusted until the holomer's arrhythmia ceased.
Or for a complicated surgical procedure, the sur-
geon could rehearse the simulated surgical proce-
dure on the patient's holomer before operating on
the patient. Any errors in drug dosage or surgical
technique would occur to the holomer, not to the
actual patient.
Today in clinical trials of a new drug, device,
or procedure, hundreds of patients are subjected
to a new, unproven treatment and compared with
controls over a short fixed time of usually 3 to 10
years. In an analogy to other disciplines such as
weather, aviation, and manufacturing, why not cre-
ate a database of deidentified models (holomers) of
a million different patients, conduct a clinical trial
over 50 years of time, and simulate the results in
one weekend on a supercomputer, with no risk to
any patient? The purpose is not to do away with
clinical trials or basic scientific research but rather
to dramatically decrease the resources and time de-
voted to conducting numerous experiments on the
road to a final experiment that provides the conclu-
sive results.
The principles of the scientific method have
served us well for long period of time; however, the
new technology and methodology that exists today
and is being used by others in the scientific com-
munity can leverage off the traditional scientific
method to the simulation method and elevate sci-
entific inquiry to an even more productive plateau.
If the remainder of the scientific community em-
braces modeling and simulation, so too should med-
icine, whether in daily practice or in rigorous clini-
cal research.
The use of modeling and simulation in medical
education and training has not been addressed be-
cause it is not traditionally considered part of the
direct practice of medicine; however, simulation has
been critical to all other industries in training their
personnel (especially military, transportation, etc).
Surgical simulators and other medical and proce-
dural simulators have been developing over the past
2 decades. Flight simulators have been around for
more than 70 years, and now the surgical commu-
nity is learning of their importance and has devel-
oped technology to adapt simulation for surgical ed-
ucation and training. As already indicated, simula-
tion can be introduced into the daily practice of
medicine, so too should education, training, and as-
sessment become a continuum with medical prac-
tice. In the future, life-long learning and mainte-
nance of certification will be transparent as part of
clinical practice, in a great part due to the power of
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simulation. Although this is not directly part of the
scientific method, it simply illustrates the broad ap-
plication of modeling and simulation and attests to
the profound changes that are occurring.
There is a growing awareness in the medical
community of the power of simulation, but this
awareness remains mainly within the realm of re-
search and therefore gets very little support or at-
tention by clinicians. Research projects such as the
Digital Human, Medical Simulation and Training,
and Virtual Autopsy have yet to catch the attention
of policymakers and instill an enthusiasm for this
emerging revolution in science. Even as the elec-
tronic health record slowly inserts into the daily
practice of medicine, so too will the other powerful
new information and business tools migrate.
Modeling and simulation (the simulation method)
will gently merge into clinical practice just as supply
chain management and just-in-time-inventory have
become critical processes in efficient medical man-
agement. The time will eventually come, it is simply
a matter of how long does medicine wait until it re-
joins the rest of science.
References
1. Anon: Oxford Centre for Evidence-based Medicine: levels
of evidence. http://www.cebm.net/levels of evidence.asp;
http://www.cebm.net/index.asp. Last accessed May 15,
2005.
2. Senn N: The dawn of modern military surgery. Surgery,
Gynecology and Obstetrics, 477-482, 1908.
3. Satava RM: Days 2 and 3 of the dawn of modern military
surgery: the sequel to Senn. J Am Coll Surg 200(3):316-
320, 2005.
4. Wolfram S. A New Kind of Science. Champaign, IL:
Wolfram Media, Inc, 2002.
5. Thomke S. Experimentation Matters: Unlocking the
Potential of New Technologies for Innovation. Boston:
Harvard Business School Press, 2003.
6. Christensen C. Innovator's Dilemma: When Technologies
Cause Great Firms to Fail. Boston: Harvard Business School
Press, 1997.