Balancing Consistency and Innovation in Healthcare

Our healthcare system is now facing a problem that has plagued business leaders for years: how do you  balance consistency and innovation?

The drive for consistency in healthcare is based upon the fundamental observation that physicians across the country treat similar medical conditions in dramatically different fashions.  Sometimes, these different approaches are costly, such as using a more expensive treatment when a less expensive approach might be as effective.  In other cases, these practice variations are dangerous – failing to provide patients with treatment the evidence suggests is best.

Standardizing the delivery of care — identifying “best practices,” and then insisting physicians follow these guidelines – could, in theory, save money while improving quality, and is the basis of Obama’s healthcare proposal.

Businesses have long known about the benefits of standardization – lower costs, higher baseline quality — and have aspired to achieve it.  The ability to make the same product in the exact same way every single time has contributed materially to the success of companies from McDonalds to Intel.  The global adoption of the “Six Sigma” program, an initiative originally developed by Motorola to reduce variability and ensure consistency, is perhaps the most visible example of the value most industries place upon achieving uniformity.

For many managers, one of the great attractions of consistency initiatives is that they offer instant metrics, quantitative methods of evaluating how well you are doing simply by measuring how close you are adhering to the established standard.

Yet, these exact metrics are also what most concern many physicians, as the drive for standardization seems to have far outstripped our ability to identify appropriate standards.  Many practice guidelines are based on limited data, and in many cases, it’s not clear that strict adherence to these guidelines actually improves patient outcomes.  (The ubiquitous use of “best practice” benchmarks in the corporate world likely rests on an even shakier foundation.)

The administration hopes that through improved communication, and aided by modernized information technology systems, physicians can be nudged to standardize themselves, motivated by a professional desire to provide the best care at the cheapest cost.  However, given both the profound challenges of defining what “best” is, and the complexity of physician motivation, the only way to achieve the required cost-savings may be to mandate strict adherence to practice guidelines.

At some level, standardized algorithms might be good for medicine, reducing the blatant mismanagement of patients by physicians who have not stayed current, and discouraging doctors from reflexively selecting expensive procedures or medications that have been shown to offer little benefit.  In simplifying the physician’s decision tree, such guidelines may also enable doctors to spend more time listening to patients, and less time running through a confusing litany of therapeutic alternatives.

At the same time, if medicine lurches in the direction of guidelines and algorithms, two important opportunities may be lost:

– First, we may lose the chance to individualize care; as Steven J. Gould famously wrote, “The median isn’t the message,” and a treatment ineffective for most patients may be enormously useful for some.  A key driver of personalized medicine is the urgent clinical need to identify just which patients are most likely to benefit from a particular drug or intervention.

– Second, we may lose the opportunity to tinker and innovate – so many powerful discoveries originated with a clinician’s chance observation or slight deviation from standard treatment.  If the role of physicians is dumbed down to the point where they are simply expected to mechanically execute on established protocols, the ability to intelligently improvise may be curtailed, thwarting medical progress.

Regrettably, the current fashion for standards has consumed not only medical practice but also medical training, as young doctors, nurses, and other healthcare providers are continously compelled to demonstrate “proficiency” in a series of expensive (and, for the sponsors, quite lucrative) certification examinations, despite minimal evidence that the score produced by this testing correlates in any meaningful way with the care subsequently delivered to patients.   In a healthcare system fixated on metrics, the proliferation of such unvalidated testing instruments will only get worse.

Is there an intelligent way to harness the cost and quality benefits of standardization in a fashion that doesn’t lead to the dangers of guidance creep and preserves innovation?

One approach is to clearly differentiate between guidelines based on the most robust evidence – strong recommendations that truly deserve to guide clinical practice – from all other guidance, which can inform care, but should not dictate it.  This will require from clinical leaders who develop guidelines a measure of humility – something often in short supply.

A second approach is to ensure that to the extent standardized treatment protocols are employed, they are routinely used to evaluate and improve care, not just deliver it.  Treatment algorithms could enable the rigorous comparison of different therapeutic approaches when there are several reasonable alternatives, potentially providing more actionable conclusions than an army of tinkering practitioners.  Success in this research endeavor would require planning, expertise, commitment, and funding (presumably also in short supply).

My own experience working with a range of companies suggests that balancing consistency and creativity can represent an overwhelming challenge.  While many managers harbor a genuine desire to promote innovation, ultimately, the allure of standardization, and the seductive comfort of quantitative metrics (however meaningless) and rigid processes (however cumbersome) is often too powerful to resist. Our healthcare system is too important to suffer this same fate.

Ensuring good data are translated into clinical practice is essential, but replacing true uncertainty with false precision will only hurt patients, inhibiting innovation while obscuring the relatively few well-established standards that have clearly been shown to make a difference.

David Shaywitz, MD, PhD, is a management consultant in New Jersey, and co-founder of Harvard’s PASTEUR program in translational research. This essay originally appeared in abridged form in the Second Opinions Forum of the Washington Post.

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  1. Insurance is the fox guarding the hen house.
    Take insurance out of my healthcare decisions. They interfere. They don’t reduce cost at all. They cause a lot of bickering about what they should and don’t cover. Paperwork is horrendous. It’s a mess hardly any lay person understands and it ends up costing us all more. How can we expect someone (Insurance) to cut costs that they are creating by their existence and for which they stand to gain? This is just stupid. (I know they employ a lot of people who would lose their jobs, and that would need attention, but that is a totally different matter, and a problem that they also created.)
    My insurance doesn’t pay for most of what I do to maintain my health and to remedy my illness. This is not my idea of Healthcare. It’s more like Health-No-Care. So, how can you IMPOSE insurance and infringe on my freedoms. I do not want to pay for Insurance at all. I personally do not want insurance. But, I also don’t want insurance to drive up the cost of treatment for those without insurance (like it is now). I do not want to pay for someone else’s poor life style or indiscretions. I want the rewards and consequences of my lifestyle to be mine. (I know there are those who are hurting and need our help. And we need to address this serious problem. But, insurance for all is not the answer. There are lots of other ways to solve this.)
    Currently I have health care insurance and they pay very little of what I determine I need for my own care. I am motivated to stay away from pills and conventional doctors and most especially hospitals. My healthcare includes Chinese Herbal medicine, Homeopathy, Visual Imaging, Physical Therapies, Vitimine therapy, and other effective forms. And these are very inexpensive and effective for me. At 65 I am healthy and taking no regular pills or medicine. I understand this to be quite a rarity these days.
    But insurance decides my practices do not qualify for their coverage- that “these are not effective.” So, I am left out- that is, I pay for insurance but cannot collect. And when insurance has great numbers (esp helped by legislation) behind them it tends to drive my healthcare practicioners out of business. What gives Insurance this right?
    In reality, the interests of Insurance, or any business, or any government, are not in the personal, nor the moral. And governments must take care to protect the minority. Even with good intentions, profit making, promotion of power and position, no one else can or should ever make my health decisions for me– not even in the name of money!
    So, I will refuse any mandated insurance and tax payers will spend their resources on enforcement of innocent citizens like me who will stand up for ourselves. I will say “show me where in the Constitution it says to be a citizen I must buy insurance.”
    Abraham Lincoln reminds us that Democracy is NOT rule by majority. It is manifested in the protection of the minority.
    see also my blog: http://HealthcareHurts.blogspot.com

  2. 1) How much is this IT gonna cost everybody and who is gonna pay for it?. More government grants? I doubt that with the state of our financial status. It seems everywhere I read IT is needed to deliver better healthcare. Technology isnt cheap and with all the new changes it looks like the one big winner here is gonna be the IT sector. No wonder its being pushed so hard.
    2) There is not a whole lot of EBM out there. The EBM that does exist is good and should be followed. But there a lot of gray areas, for example, there is no good data on the dose of steroids (a commonly prescribed medication) that you should give in say a COPD exacerbation. The dose that is given is usually decided upon by the physician, there past experiences and each patients presentation and stage of disease, what precipitated it and their other comorbid diseases. To start putting algorithims in place and say everyone with a COPD exacerbation gets 40mg of steroids every 12 hours is wrong. Every patient is different and we as doctors need to be able to have the power of decision making when it comes to this. By putting in guidelines and algorithims without taking into account our interpretation of the facts and clinical scenario is useless. All it will do is make for inferior care and line the pockets of lawyers because now if we have to do something that the guidelines dont call for we are not practicing “proper medicine”. Practicing medicine is not something you can plug into a computer and get an answer, none of these patients conditions exist in a vacuum, everything is intertwined and it takes a lot of critical thinking and decision making to decide exactly how you are gonna treat each patient without doing harm.

  3. The human body is too complex in its inner workings for one person to understand it completely. The doctor must rely on his experience to make a best guess (diagnosis).
    Two Different doctors with different backgrounds can have wide variation in diagnoses and treatments based on experience. If either doctor used the others method of treatment, it would have less chance of success because he lacks the prerequisite experience.
    Guidelines are useful and well documented methods of treatment can improve quality of care. IT can help by organizing and presenting more useful information to a doctor so that he can become more informed/educated/experienced more quickly.
    In relatively few cases is there one best practice. The best approach is to deliver quality information in a succinct package with access to vast amounts of supporting documentation.
    The system is there to support doctors not to dictate to them with hard protocols.
    Innovation and creativity are useful but can be risky. Leave the risk to the researchers. Innovate and create in ways that improve quality of care without taking risks with the patient’s well-being.

  4. jd’s example of assemply line decision making must take into account why modern manufacturing is so efficient; it’s because of Industrial Engineers (http://en.wikipedia.org/wiki/Industrial_engineering)constantly assessing processes and applying their training, observations and real life application to an already controlled environment. I don’t know if their is a branch of medicine equal to an Industrial Engineer and if hosptials now have some system of similar evaluation and process application to give us intellengent treatment consistency. I don’t want a doctor to be a robot of assembly line mentallity, but I do want a doc that is an intelligent problem solver.
    Mark, I have yet to encounter a doc that is an independent or creative thinker given my medical history. I see the problem as them being to highly trained to think inside the medical box and not look for causes outside their ability to prescribe a pill to “fix” or coverup the underlying problem. I have always done better experimenting with alternate therapy and causes that docs are not trained to consider.

  5. Mark,
    Excellant post. The worried well are whom we spend a lot of money on and who themselves spend a lot of money on health care. All this of course because we can’t just tell them they are well and be done with it. We have to show it; not just once, but over and over again, whenever their anxiety reaches fever itch.
    The doctor of today will not exist in ObamaCare. The doctor of tomorrow is not going to go to medical school to be a “provider”.

  6. POOKIEMD: is right on the issue, well said!
    Dale Halling: agree completely
    Margalit: I again agree with you,
    There are several very big problems with this protocol line of thinking. There seems to be a belief that physician aren’t practicing most efficiently or safely if a guideline isn’t followed, that they require some motivator to make the best decisions. This shows a total misunderstanding of how and why people get well and why physicians do a job that no studies will ever approximate. We must not forget that physicians are good at their job because we select for intelligent, complex thinkers with many necessary qualities.The fact is that good physicians are:
    1. Independent, creative thinkers. Why would a good thinker who deals with problems want to go into a field guided by protocols?
    2. Highly Intelligent. Why would these men and women go into medicine if their intelligence is not challenged?
    3. Good problem solvers. Why would a problem solver enter a field controlled by algorithms?
    4. Highly educated. Why go through the grueling educational process if it won’t be used much anyway, or if it is used, it will be so infrequent, it will be lost.
    5. Trustworthy and Empathic. There is much to be said for good and heartfelt advice. A protocol is a weak, cold tool in this regard.
    7. Decisive and confident when needed. Why should a physician be a good decisionmaker if a protocol will call the shots? Might as well do something which fits these qualities.
    My first point being, don’t we value having physicians most of whom have the qualities above? If we seek uniformity, we will clearly lose the physicians who we expect and deserve to have caring for us.
    My second point, protocols and uniform practices do not treat patients and make them well.
    Uniformity will necessarily lead to routine and thus omissions and dangerous errors. If a treater is thinking through a problem, less will be missed or underemphasized. Systems which are made uniform have this quality.
    Uniformity is not congruent with the world of real patients. In reality, very few patients are typical in their presentation. Comorbid conditions are the rule, unexpected side effects or contraindications or confounding enigmatic symptoms occur. Sometimes a decision must be made which is clearly a risk to the patient and may worsen one condition while favoring another. We want a physician to help us with these decisions, not even a well-studied,touted-to-be- theoretically)-efficient, uniform practice protocol will come close. The protocol will always be inferior. Situations ARE grey most of the time. Otherwise it would be quite an easy job.
    It is likely man will never find any protocol or any IT application that will ever achieve what some of you believe is a realistic goal. We need to allow the human treater to make judgments. It is clear to me many times every day. We should be careful what we dissemble for unproven and (in my opinion) unreachable efficiencies. The world is complex. We have to get over it. I plan to. Does anyone else out there agree?

  7. David, excellent post. JD is right on the money…your analysis is much more intelligent than the typical argument usually made by the growing anti-quality measurement movement (Dr. Jerome Groopman is probably the worst and most cynical of the lot).
    The central problem here is that for the vast majority of medical scenarios, we just don’t have scientific evidence to guide us. My medical education socialized me to believe that a reductionist understanding of biology would provide me with a scientific basis for treating disease, but my residency and fellowship proved just how misleading this mindset is. After all, how many times have you seen an attending provide an eloquent biochemical explanation for a patient’s change in condition, only to the discover that (oops!) the results he was explaining actually belonged to the wrong patient. Or take the case of the patient with chronic low back pain who then has an MRI showing a herniated disc. Never mind that the herniation doesn’t correspond to the current symptom pattern. It’s from the fancy scifi-looking MRI scanner, so it must be the cause!
    Looking for basic biological explanations for changes in condition is like looking for predictions of current events in the writings of Nostradamus.
    So we’re left with the only truly scientific bases for clinical carei: clinical trials and well-done epidemiological studies. These barely cover anything we do, apply to only a subset of the patients we see, and of course exhibit an array of design flaws. Without an evidence base, there can be no guidelines, no measurement, and no accountability. We do our best, but as JD says, we’re mostly shooting from the hip. When we do, are we fundamentally any different from the neighborhood chelationist? The village shaman? Not really.
    What I would love to see would be standardization of care processes _with_ monitoring and purposeful variation in the vast areas of evidence-free care. Pick any reasonable-sounding standard as a starting point. Who can rationally object? After all, we have no idea what we’re doing.
    In the current policy discussion, ACOs would be the ideal entities to accomplish and monitor this standardization. The point would be to incrementally create new evidence outside the scientific establishment. You don’t see Motorola publishing a paper every time it improves the chip manufacturing process. Why shouldn’t we expect the same degree of silent, speedy, and responsible innovation from, say, MGH?

  8. Physicians do not innovate. That is not to say that some have not done. Have you ever talked to one..they will quote and research, and statistics.
    I am not sure if it is training issue or competence…but it is what i have observed.
    Healthcare innovations are away from clinics most of the time. I once had the urge to work on cancer research – I have always beleived that the solution to cancer is not as difficult as people have made it out to be and wanted to prove. I even negotiated with John Hopkins to give me a platform….and yes I was willing to take 50% paycut. But we could never reach an agreement…that was 10 yrs ago.
    Why did I do that besides the fact I wanted to…I believe if you introduce innovative and analytical minds in clinical research, you will find greater result. The healthcare industry is still struggling with even half decent process and IT, it would be stretching the limit to expect too much innovation.

  9. What I don’t understand is what would make a doctor feel like it’s ok to go against established science when treating a patient. It seems like doctors often think back to something that’s worked in the past, which is susceptible to anecdote effects that aren’t based on actual data.
    I understand there is a lot of gray in medicine, but I also understand there’s a lot of black and white. I’ve never heard someone complain about any of the measures CMS has issued for hospitals on AMI, pneumonia, etc., it seems like those are pretty well-established, and yet many hospitals haven’t taken steps to ensure they happen. When people talk about evidence-based medicine, I don’t think they’re talking about turning doctors into mindless automatons, they’re saying that when we know something, when it’s been proven, we need to make sure everyone’s on board with doing what works, not doing what they feel like.
    That’s what Intermountain said at the HFMA conference this year. They’re not overstepping. They’re ensuring the things we know work get done.
    It seems a lot of physicians create straw men out of those proposing more consistent care because they don’t want to sacrifice any autonomy to anything, even established scientific fact.

  10. There are excellent examples working right now in real healthcare settings of approaches that address all of these concerns. These programs are simultaneously reducing unnecessary variability in care, preventing harm, improving patient outcomes, testing innovations, AND systematically identifying new standards of care where no standard or guideline currently exists. Guidelines alone — no matter how strong the evidence base — cannot accomplish this. Improvement science, which addresses both standardization and innovation, can accomplish this. I’m most familiar with pediatric examples, all of which are national networks of clinicians collaboratively implementing systematic improvement programs and making remarkable progress: 61 pediatric intensive care units working together to eliminate one type of hospital-acquired infection have saved 100 lives, prevented 850 infections, and saved $29 million. 16 peds gastroenterology clinics working together have increased remission rates for kids with Crohn’s Disease by 25%. Cystic fibrosis centers have extended life expectancy by 9 years. Ohio pediatricians have reduced asthma hospitalizations and ED visits by over 40%. So there is no mystery about how this can be done; we need the WILL to do it.

  11. I agree with David that there is a critical need to ensure our health care system balances the provision of consistent medical care (some would call ‘quality’) with the inclusion of innovative products and services. The ideal process, to better ensure this goal is met, is for doctors, practitioners, researchers and administrators to have a ‘whole-of-system’ perspective. This is defined as a comprehensive 360 degree view of existing medical practices and devices, hospital care developments and over-the-horizon products and services. The Health Care Group Purchasing Organizations, or GPOs provide our heath care system with this type of information and ‘creative tension’ needed to produce both great efficiencies and product innovation. GPOs work with hospitals and heath care facilities across the country, to ensure that patients and providers benefit from both proven medical technologies and ‘on the cusp’ medical innovations. GPOs also work for hospitals to contract for ‘best value’ in supplies and improve quality by partnering with clinicians to evaluate products. http://www.GPOsSaveMoney.org

  12. Compulsory standards inherently limit innovation, by freezing the art at a point in time and abdicating a physician’s and patient’s judgment for a panel of experts. When confronted with this standardized treatment as a patient, I am unimpressed with my physician, who do not seem to be able to think for themselves. I also suspect that the panel of experts is less interested in my health than their own agenda.
    The reason why the US has the most advanced medical treatments in the world is because of innovation. President Obama’s proposals would exacerbate medicine by standards, for more information see http://hallingblog.com/2009/08/28/medical-innovation/

  13. We have to find a balance between “trust me – I’m a doctor” and rigid guidelines that punish physician’s for showing good clinical judgement. A focus on outcomes more than process is one way to do this. A focus on assessing care for populations is another, including assessing “system” performance instead of just individual performance. Fundamentally though, physicians must step up and lead these efforts, instead of sitting on the sidelines and complaining about standards pushed upon them.

  14. Don’t get hung up on the word “implementer.” I just used it as a placeholder. As I said, the front-line practicing physician basically does this right now, just in a less systematic way. You already are seeing an “implementer” most likely.

  15. Hmmm…. jd, I don’t know that I would want to see an “implementer” if I had a serious condition, or I thought I may have a serious condition.
    If medicine is all about implementing protocols then why can’t I just access those on-line and treat myself?
    I’m not at all opposed to guidelines. I think they are necessary, but I’d prefer that they are just that, guidelines. There’s got to be some decision making process ability required for a profession that takes over a decade to learn.

  16. I have heard arguments worrying about standardization before, but Dr. Pandey is right: there need be no conflict between innovation and standardization.
    Much innovation can be retained through specialized roles: some physicians are the research scientist innovators, while most are the implementers who take what has been learned and implement it as well as possible.
    But even the implementers should continue to pay attention to the cases where the treatment/protocol works well and not so well, to identify opportunities for experiments and improvements. A practicing physician should be on the lookout for new reasons why some patients who take drug X seem to do better than others, and there should be a way to share any insights for discussion and possible further research.
    Take an assembly line. Even in that most routinized circumstance (which medicine is a long way from imitating, since it operates 1-on-1) good companies tell line workers to think of ways in which the process could be improved. They provide concrete suggestions from their experience on the line. True, line workers aren’t doing basic research, but then even today neither are a large majority of practicing physicians.
    There are really two questions: how can we get this process (treatment, etc.) as good as it can be, and can we rethink our current process to get a whole new way to achieve the result we want in a more efficient or effective manner. This is incremental innovation vs. disruptive innovation.
    I don’t see any reason at all to think that incremental innovation is discouraged in a six sigma type approach…just the opposite. And once you distinguish between roles (research vs. implementation) I don’t see a good case for disruptive innovation being discouraged when six sigma type practices are widely adopted by the implementers. The basic researcher isn’t doing six sigma.
    I’m not suggesting that David Shaywitz is one of them, but usually when I’ve heard objections to standardization in the past, what is really happening is that a physician is rejecting the idea that anyone should control how he practices medicine. It is the romantic vision of shoot-from-the-hip and trust my gut medical practice, and it is also, often, tied up with ego and power. It’s also a remarkably unscientific attitude for a discipline that is an applied science.

  17. I think best practices are helpful, but limiting. Most patients in the hospital (I am a hospitalist) have multiple meadical problems that we are treating simultaneously. A simple guideline for pneumonia and sepsis may not apply when a patient is also in heart failure. I think guidelines are a good start, but must be viewed in the light that many patients are more complicated than a simple guideline provides for.

  18. David,
    I am not sure if I agree with your view. Innovation does not have any impact on consistency. In fact, this is the first time in my life I am hearing the negativity.
    If one understands the new product introduction process, it is quite easy to innovate and be consistent.
    I think the issue is not of consistency versus innovation. We all agree that healthcare industry has tons of opportunities to create good and robust processes to catch up to the latest knowledges.
    I have spent a significant portion of my life in innovation and NPI, we do not see these two as competing concepts.

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