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The electronic medical record could save the clinical trial, cut health care costs, and improve the value of research.
With these words, President Barack Obama not only demonstrated his hip sci-fi credentials—Morpheus’s choice to Neo was either to take the blue pill and remain happy but ignorant of the truth, or the red pill, which would reveal to him a sometimes-painful reality and also launch the lucrative “Matrix” trilogy of movies—but also his desire to take a 21st-century, data-driven approach to clinical decision making and health care policy.
The Affordable Care Act, better known as Obamacare, has implemented a number of initiatives to address this problem. The fundamental problem is that the gold standard for studying comparative effectiveness, the randomized controlled trial, or RCT, is too costly and disruptive to be done for every important comparative effectiveness question.
Fundamental questions—such as “Does drug A or drug B have a better chance at keeping a diabetic patient from needing insulin? The RCT is a 20th century method that worked well for acute, serious diseases such as infectious diseases, heart attacks, and pediatric cancers, where entry criteria were simple, options in clinical care were few, and results could be obtained relatively quickly.
President Obama’s call for a trial to compare the blue pill to the red pill would mean mustering millions of dollars and recruiting thousands of patients as research subjects to be followed for many years. Just as the RCT was made possible by 20th-century advances in statistics and research technologies, 21st-century advances now present an alternative to the large, expensive, and cumbersome clinical trial. Most proposals to use EMR as a tool for comparative effectiveness research simply use the EMR as a large database for a traditional observational study.  This possibility has received deserved attention, but has also been appropriately criticized, because such traditional observational studies are not nearly as reliable as RCTs in distinguishing true causal effects of drugs from non-causal associations. The same technology can be used to introduce one of the RCT’s essential features, the “flip of a coin,” where the computer can choose whether the patient receives the red pill or the blue pill.
If, for example, a physician orders the blue pill, 50 percent of the time the computer will also choose the blue pill. A PORTS study design makes sense when the red pill and the blue pill are both used interchangeably in clinical practice, but physicians truly do not know which one is safer or more effective. Crucially, that difference will reflect the properties of the pills themselves, not subtle differences between the kinds of patients who choose red and those who would rather have blue. Electronic systems, prompts, and other tools can introduce small probabilistic changes in care, changes that can yield the kind of unbiased quality improvement data that to date has been available only at the high cost of the RCT.
We just have to summon the will to take the red pill and discover the innovative ways to interact with the new matrix of medical data. By clicking and submitting a comment I acknowledge the Science Progress Privacy Policy and agree to the Science Progress Terms of Use. Science Progress proceeds from the propositions that scientific inquiry is among the finest expressions of human excellence, that it is a crucial source of human flourishing, a critical engine of economic growth, and must be dedicated to the common good. We’ve been promising for some time to explain why in the choice between power and leadership, leadership is fundamentally the only option to take. Those of you who have seen the movie The Matrix may recall the scene where the hero, Neo, experiences his awakening. For us, this movie has its place not only in the realms of science fiction but is central to understanding leadership itself. Yet many of the relationships in the business world are based on power relationships that are probably succoured by the power structures within organisations.
We’ve seen in a previous post, how there is a fundamental tension in us as to what we want. Those of you who have been following this blog will be familiar with our Strategic Thinking Model that captures all the variables we can possibly face in almost any situation. Following a discipline of using the strategic thinking model helps you avoid the biases created by power and stay, as far as possible, within the cycle of reality and truth – which is critical in business but something that is strangely lacking in the workplace. If you would like to boost your own leadership skills, then why not have a look at The Leadership Challenge Workshop, where the skill described above is brought to life.
If you are one of the millions of people who have seen the Matrix, then you would remember that Neo was given a choice to take either the red pill – which would open his eyes to reality, or the blue pill – which would keep him living behind rose-colored lenses. Awareness without appropriate action creates anxiety, which we have all been guilty of at one point or another. Remember awareness generates relief and power, while avoidance leads to anxiety and suffering.
At the RCT’s core is the assignment of an intervention to each subject by a “flip of a coin,” meaning that some patients receive drug A, and some patients receive drug B. Special procedures such as using a “flip of a coin” at a central study site to assign each patient to an intervention are so different from routine clinical practice that trials must hire expert clinical investigators and take place at special study sites.
The major pharmaceutical companies are among the few institutions that can single-handedly muster the resources to implement large RCTs, and they use them to get their drugs approved, typically by comparing the drug to a placebo.



Does drug A or drug B prolong life more in heart failure patients?”—go unanswered because, outside of the big pharmaceutical companies, few institutions have the resources to do an RCT to answer these questions.
Since the middle of the 20th century when the debt-weary post-war British National Health Service used it to inform whether streptomycin therapy was worth the cost for the treatment of tuberculosis, it has been the court system that decides which promising therapies are in fact safe and effective and which are not.
Even then, the results will likely be subject to a fusillade of questions because patients who participate in an RCT are typically not like the usual patient, the protocols often limit usual care, and treatment options may have changed in the years it took to execute the trial.
The critical change happening now is the linking of fast, user friendly, networked computers into large databases replete with medical information—the so-called electronic medical record, or EMR. We propose a complementary way to use EMR that will retain some of the special advantages of RCTs at much lower cost and with fewer ethical problems. It can, for example, prompt a physician to reconsider or even change a medication that is linked to a documented patient allergy, interacts with another medication, or is not on formulary.
Whenever a physician order one of these colorful pills, the computer can make its own random choice between the drugs.
This design increases the probability that a patient will receive the randomly assigned treatment. A relatively simple technique called instrumental variable analysis formalizes this intuition and makes it possible to take these data and uncover the difference in effectiveness between the red pill and the blue pill. Some patients will get a treatment different from what they and their doctor would have otherwise selected. The PORTS proposal is just one example of the more general but untapped promise of the EMR in medicine, a promise that could be as revolutionary as the RCT, and before that, the stethoscope. Small, benign random variations in practice could gradually develop a far more comprehensive picture of what works and what does not. Jason Karlawish is a professor of medicine, medical ethics and health policy at the University of Pennsylvania. His awakening comes in the form of a choice offered him by his mentor-to-be, Morpheus – a choice between a red pill, and a blue pill.
We have made up excuses to avoid taking action – “But I have no time” or “This small dessert won’t really hurt me”.
What do you think happens when you avoid certain fearful or uncomfortable situations, emotions, or sensations?
A core mission of PCORI is to conduct comparative effectiveness research that gives patients and their health care providers the best evidence to help make more informed decisions. Meanwhile, patients and physicians alike can be reluctant to engage in an activity so potentially disruptive to routine clinical care. Even if multiple competing drugs are available for a disease, drug companies rarely conduct comparative effectiveness studies. Part of the answer may be for the Food and Drug Administration to ask for more RCTs to address comparative effectiveness questions, but we also need new methods to do comparative effectiveness research more efficiently. For complex, common, and chronic diseases such as diabetes that can require lifelong treatment, however, the RCT is a large and costly enterprise akin to moving an armada across an ocean. We call it Prompted Optional Randomization Trial, or PORTS, a design impossible in the days of paper charts but easily implemented [subscription required] using an EMR. These prompts sometimes result in rapid, appropriate adjustment of medications, but perhaps more often the physician finds the suggested change inappropriate and overrides the prompt with the click of a button.
The computer can then prompt a physician to consider changing his or her prescription, but only when a physician’s order and the computer’s random choice are discordant. If the computer chooses red instead, it displays a prompt to consider prescribing the red pill instead of the blue pill.
The association will not be perfect, since in many cases the patient and physician will prefer a drug and appropriately ignore a prompt that conflicts with that preference. It turns routine clinical practice into an efficient and low-cost engine of discovery that will tell Americans whether we should take the red pill or the blue pill. You will experience discomfort and anxiety because you are mindful of the limitations that exist. If you are mindful and acknowledging of your excuses and their potential consequences, then you have taken attempted action to minimize experiencing anxiety. You are actually evaluating the situation, emotion, or sensation with more meaning than what it deserves. This means that you fear experiencing the physiological sensations of your biological fight-or-flight response – heart palpitations, shortness of breath, chills, sweatiness, nausea, etc.


Yip’s experiences with Obsessive-Compulsive Disorder (OCD) began long before her current position as Executive Director of the Renewed Freedom Center.  Since childhood, Dr. Half of insured patients in the United States are on chronic medications for conditions such as diabetes, hypertension, and high cholesterol. As promising and common sense as this mission is—because why not pay half price?—solid gold evidence to answer a patient’s question “Should I take the red pill or blue pill?” is hard to obtain. Ethical oversight helps ensure that clinical care is not truly compromised, but this oversight is intensive, costly, and time-consuming too. A physician who prefers the blue pill for the particular patient dismisses the prompt with a single click and prescribes the blue pill. Intuitively, however, if the blue pill is in fact a little better than the red and a prompt for blue makes patients more likely to get blue, the patients who do get a prompt for blue will on average do a little better than patients who get a prompt for red.
We would argue that it is not, because the physician can override the prompt if there is any reason to suspect one drug is worse than the other.
However, you will also have the awareness to take appropriate action when necessary to minimize potential harm. If your awareness and action (or lack of) contradict, then you are not doing what it takes to minimize anxiety and suffering. Sufferers will usually avoid feeling these sensations at all costs, which keep them safe and comfortable in a box. Yip has fought her own personal battle with OCD.  Inspired by her struggles and motivated to helping others overcome theirs, Dr.
Patients, physicians, and policymakers need reliable data to know what to take, what to recommend, and what is worth paying for. A physician with no preference between treatments, however, can endorse the change with a single click and prescribe the red pill.
However, this also means that you won’t be aware of all the potential dangers that may harm you. Better yet, if you have the awareness and take appropriate action to reduce the potential risks, then you are eliminating worry and anxiety.
Yip has dedicated her professional career to treating families and individuals with severe OCD, performance and sports anxiety, body image issues, and related anxiety disorders. Would they need to give it every time, or just once when they establish care at a practice that uses this method? By refusing to step outside this box, you actually become weaker while the anxiety monster gains power waiting to attack at the next opportunity. If a company does a comparativeness effectiveness trial, the study design often uses clever design features that, unsurprisingly, stack the data to show their that drug is more effective.
These are questions that need to be addressed, but they are mere shadows compared to the glare of the serious ethical concerns traditional RCTs raise. Although this awareness may trigger anxiety and guilt for some of you, for others, learning what constitutes healthy food and exercise gives you direction to take appropriate action. To take back this power means that you will have to step outside of your comfort zone, face your dreaded fear, and fight the anxiety monster.
Yip has developed her own innovative treatment modality integrating Mindfulness Training and Strategic Paradoxical Techniques with CBT in the treatment of children and adolescents.  She’s published numerous articles, presented at more than 35 national and international conferences, and worked to train other professionals in the field to be effective clinicians.
To grow stronger means that you will have to behave in ways that are counterintuitive to your fears by becoming very familiar with those panic sensations.
Toddlers who have yet to experience a burning stove will not know that touching it will hurt. To be resilient means that you will have to expose yourself to those uncomfortable sensations, so that you learn they are harmless. If you are willing to endure these challenges, then you will overcome anxiety and irrational fears.



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