Sunday, February 18, 2007

Mass Customization & Evidence Based Medicine

Mass Customization

A couple of weeks ago I became reacquainted with the concept of mass customization. Mass customization "is the use of flexible computer-aided manufacturing systems to produce custom output. Those systems combine low unit costs of mass production processes with the flexibility of individual customization." Raised the son of a car dealer I spent my youth on the showroom floor and saw for myself how a basic model of automobile could be customized with options to suit the needs and wishes of the customer. Most of the components of that vehicle were the same as any other of that model year. Details such as the color of the car or type of wheels were customized and that is what was used to close the deal and sell the vehicle. Today industry leaders such as Toyota have worked continuous quality improvement into the process of automobile manufacturing with stunning success. The computer industry has capitalized on this concept as well, most notably Dell Computers. Any individual can order a model of computer and customize it with the options that they want. The computer, just like a vehicle at Toyota is then built with "just in time" manufacturing processes that improve the efficiency of the process and decrease the cost. The idea is to get "the right material, at the right time, at the right place, and in the exact amount." It got me wondering if a variant of this concept could be used in the development and implementation of evidence based medicine.

Evidence Based Medicine

Evidence based medicine (EBM) is the idea of using the best available evidence to guide the clinical practice of medicine. While this may seem obvious it is not always as standardized as we may think. There still remains a significant bench to bedside gap. What this means is that medical research discoveries may take years to decades to find their way into the textbooks and everyday practice of clinicians. EBM is a movement in medicine to reduce that time period and bring the best available medical treatments into the care of patients today. It is easier said then done. While physicians are some of the greatest champions of this movement they are also one of the biggest obstacles. The development of EBM typically distills a large mass of evidence down to a single standard or guideline. Physicians tend to be suspicious of guidelines and consider them too rigid when applied universally. They see it as a "one size fits all" approach to the care of patients which is contrary to their every day experience. Most physicians see their value, not only as gatekeepers to the health care system but as the ones who will customize and tailor the treatments available in medicine to the individual patient. EBM and its guidelines removes this customization process and therefore one of the roles of the traditional physician. EBM then becomes a threat to the livelihood of the physician. There has to be a better way and I think there is.

"The only thing we have to fear is fear itself."
Franklin Delano Roosevelt

The idea of improving the process of how we deliver health care is not new. Total Quality Management has been around for years but not exactly embraced by physicians. Again there is a deep suspicion that this will remove any customization the physician will provide but more importantly may introduce an element of risk for the physician. The transparency advocated by this process and the emphasis on exposing errors brings with it the fear of medical liability litigation which has become such a dominant part of the health care landscape over the last several decades. How do we overcome this barrier and create a process that decreases or even eliminates this all to real fear? I think it may come in the form of a variant to mass customization which could be called "evidence based mass customization". I think it will take courage to implement because it depends on the process of error reduction advocated by supporters of Root Cause Analysis and Six Sigma. With the focus on error reduction comes the hazards of error exposure but in this case the benefit is worth the risk. It can be argued that reducing error will ultimately contribute to the reduction of medical liability risk. Staying within the guidelines may decrease the freedom of physicians to customize what treatments they prescribe but should also bring with it the decreased likelihood of lawsuits. This remains to be seen but it is the hope of those who believe in guidelines. So how do we get physicians to buy into this when there is no guarantee that they will reduce medical liability?

Evidence Based Mass Customization

In medicine we know that when a specific practice pattern has increased variability it also carries with it an increased likelihood of error. We also know that as we reduce the heterogeneity of our practice patterns and focus on a "best practice" we reduce the likelihood of error. Health care guidelines are, in essence, a set of rules for how to approach a specific medical problem. They are evidenced based rules and have been shown to reduce variability in practice patterns and to reduce errors. It seems like the perfect solution and yet there is resistance. Physicians all to often see the exceptions to the rules and therefore are hesitant to endorse the broad application of guidelines. What we need then is a way to customize guidelines in the daily practice of medicine. Most of the time guidelines, when properly designed, work for most of the patients. Mass customization would mean creating guidelines that would have universal application for 90-95% or more of the time they are needed. The remaining 5-10% of the time would default to a physician who would tailor the treatment to the specific need of their patient. Another way to design them is to create guidelines that could be used, as written, at all health care institutions. Variations to the guideline would depend on local health care resources. An example would be of a guideline that results in the prescription for a specific class of a medication. The specific medication prescribed in that class would depend on things such as local prescribing habits, approved hospital formulary medications and insurance limitations. The way to sell guidelines is to leave room for the options. Most physicians are willing to work with guidelines as long as they believe they can customize them in a way that meets the needs of their patients. The key is to design guidelines that create a feedback loop back to both the creators of the guidelines as well as those modifying them at the patient level. Without a feedback loop neither will be able to continuously improve the guidelines or the way they are being modified. The advantage of leaving room for minor variations is that these variations will inevitably identify further modifications and improvements to the original guidelines. The goal is to get the right treatment, at the right time, to the right patient with the best possible outcome.

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