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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 The online version of this article can be found at: http://sri.sagepub.com/cgi/content/abstract/12/2/173
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Surgical Innovation, Vol 12, No 2 (June), 2005: pp 173-176
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The Scientific Method is Dead-Long Live the (New) Scientific Method Richard M. Satava, MD The scientific method has been the mainstay of scientific inquiry and clinical practice for nearly a century. A new methodology 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 hypothesis is proposed and an experiment is designed, modern scientists perform numerous simulations of the experiment. An iterative optimization of the design of the experiment is performed 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 conducted 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 consider adopting and adapting those new principles.
Key words: scientific method, modeling and simulation, virtual prototyping and testing.
edical and surgical practice derives its validity through the scientific rigor with which the observations 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 summarized 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:
[email protected]). ©2005 Westminster Publications, Inc., 708 Glen Cove Avenue, Glen Head, NY 11545, USA.
1. observing a particular biologic or physical phenomenon, 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 medical 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 healthcare 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 intellectual 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 approach to scientific inquiry, once again leaving medicine 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.
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Medicine in Antiquity
The (New) Scientific Method
For the initial 2000 years or more (2500 BC to 300 BC) of recorded history, health care was provided through mythology and "authoritative" proclamation 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 maintained 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 understanding 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 scientific 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 traditional trappings that continued to intertwine with science.
There are two interesting aspects of this microhistory: 1. Although a preceding approach to science was replaced, it usually took some of the older principles and extended them into a powerful new tool: the scientific method did not discard observation of phenomenon but instead incorporated the empirical method (evidence) as a component of the formal methodology, and
Medicine in the Industrial Age While the final rigorous formal scientific method of hypothesis-driven research was emerging for nonmedical science, it was not until well into the late 19th century Industrial Age that medicine began to embrace this approach. One of the early advocates was the surgeon Nicholas Senn,2 who espoused these principles for the medical community in 1908; the meticulous description of wounds and diseases became the basis (evidence) upon which diagnostic and therapeutic 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 specifically designed to prove a cause-and-effect relationship between treatment and results.3
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 author repeatedly refers to the power of modeling and simulation and the importance of an iterative optimization 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 realworld 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 creativity of new technologic ideas but also the iterative proof of the scientific method that gains the acceptance by the scientific community and public at large. The result is that world of science has (unknowingly) changed the scientific method to include an additional step between designing the experiment (step 3) and conducting the experiment (step 4). This step is 3A: model and simulate, by repeated iteration to optimize the design of the experiment, and then proceed to conduct the experiment (Figure 1). This appears to be the (new) scientific 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.
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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 iterative optimization. This is most commonly referred to as modeling and simulation and includes virtual prototyping, computer-assisted design and computer-assisted manufacturing, virtual testing and evaluation, predeployment planning, and mission rehearsal. The purpose is to conserve the consumption of expensive resources that occurs with the creation of many intermediate physical products as well as to drastically reduce the time for the testing and evaluation of every physical product or service that has been constructed. Of course, the conventional 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
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this area of computer representation of our patients. The military has a research project, the Virtual Soldier, which is taking the first steps toward creating such a computerized patient (or soldier). This computer model, called a holographic medical electronic 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 beyond the traditional scientific method to the new simulation method and rapidly expand our capabilities. 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-
The Simulation Method
Hypothesis
l
Study Design
Experiment
Results
Reporting
3A
Hypothesis
Study Design
odelng & Simulation
m
Experimentw- Results Reporting
Figure 1. The simulation method or the (new) scientific method.
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rhythmia would resolve, and if not, the dose could be adjusted until the holomer's arrhythmia ceased. Or for a complicated surgical procedure, the surgeon could rehearse the simulated surgical procedure 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 create 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 devoted to conducting numerous experiments on the road to a final experiment that provides the conclusive 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 community can leverage off the traditional scientific method to the simulation method and elevate scientific inquiry to an even more productive plateau. If the remainder of the scientific community embraces modeling and simulation, so too should medicine, whether in daily practice or in rigorous clinical research. The use of modeling and simulation in medical education and training has not been addressed because 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 procedural simulators have been developing over the past 2 decades. Flight simulators have been around for more than 70 years, and now the surgical community is learning of their importance and has developed technology to adapt simulation for surgical education and training. As already indicated, simulation can be introduced into the daily practice of medicine, so too should education, training, and assessment become a continuum with medical practice. In the future, life-long learning and maintenance of certification will be transparent as part of clinical practice, in a great part due to the power of
simulation. Although this is not directly part of the scientific method, it simply illustrates the broad application 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 research and therefore gets very little support or attention 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 electronic 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 management. The time will eventually come, it is simply a matter of how long does medicine wait until it rejoins 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):316320, 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.
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