As we grapple with provider shortages, the surge in chronic illness and the quality to price (QPR as they say in the wine business) challenge in US healthcare delivery, it’s hard to imagine a future that does not include some sort of guideline or algorithm-driven care.  As providers take on more financial risk, one common strategy involves team-based care, and the attendant increase in decision-making and care delivery by non-physician clinicians.  If the je ne sais quoi feature of a quintessentially great doctor is clinical judgment and instinct, one of the challenges of this transition to team-based care is how to harness that trait and use it efficiently.

Care decisions that are unassailable at a population level (e.g., women should have regular, routine PAP smears or smoking is bad for your health) or are algorithmic in nature (e.g., titration of treatment for uncomplicated hypertension or therapy for mild to moderate teenage acne) can all be effectively reduced to guidelines.  This, in turn, allows a physician to delegate certain therapeutic decisions to non-physician providers while maintaining a high degree of care quality.  It is also thought that this type of uniformity of care delivery will improve the QPR too, by decreasing variability.

How do we come up with guidelines?  Typically they are based on large-scale, randomized, controlled clinical studies.  As is nicely articulated in a recent JAMA opinion piece by Drs. Jeffrey Goldberg and Alfred Buxton (JAMA, June 26, 2013—Vol 309, No. 24, pg 2559), guidelines are formulated based on the inclusion criteria for these trials.  This process gives us comfort that guidelines are based on rigorous science — and that is a good thing.  The challenge arises when we realize that individuals do not reflect populations exactly.  Clinical research is much more complex than wet lab work because people are complex and indeed unique.  Every clinician has had the experience of prescribing a therapy to a patient who fit guideline criteria exactly and having the opposite outcome of what the guideline predicts.


Goldberg and Buxton point out the collision of this guideline-based care delivery model with the burgeoning area of personalized medicine.  I was immediately drawn to their definition of personalized medicine:

“The tailoring of medical treatment to the individual characteristics of each patient.  It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment.” I always felt like there was too much emphasis on the genetic components of personalized medicine.

Our vision at the Center for Connected Health (which is backed up by our experience to date) is that we will get far richer and complex data from multiple phenotypic inputs such as physiologic monitoring data, mood and motivation-related data than is represented by genomic data.  The genome is an incredibly important anchor for devising a personalized medicine profile, but the profile will change over an individual’s lifetime according to these phenotypic inputs.

We’ve done some preliminary work on this and found that indeed we can map individuals phenotypic data over time as they go through an intervention designed, for example, to improve activity level.  During a six month period of tracking activity and motivation, we have seen dynamic changes in these two variables.  Think about it over a lifetime.

The collision with guidelines is multifactorial.  We are all individuals and none of us are completely representative of the composite patient who is defined by the inclusion criteria for the clinical trial that lead to the guideline.  Thus, some of us are bound to be poor candidates for the prescribed intervention (I hate to mention it, but we’ve all seen examples of Uncle Harry who smoked two packs per day, lived into his 90s and died of causes unrelated to smoking).  If that wasn’t enough, there is the fact that we change over time and though we might fit a guideline today, we may not in a year.

Really, when you think about it, ‘clinical judgment and instinct’ is the 20th century (and earlier) embodiment of personalized medicine.  Those of us who are clinicians can all point to experiences where we’ve said, “I can’t tell you why, but I really think we should do it this way” (this way being contrary to conventional wisdom) and it has generated a positive outcome.  Of course we also have experiences where the outcome is not good or where we make mistakes that could have been prevented by adherence to guidelines.

How to make sense of this complex and contradictory situation? Here’s my take:

  1. Personalized medicine, however you define it, is still in the very early stages. We have decades to go, probably on both the genetic and phenotypic fronts, before we can comfortably replace guidelines.
  2. We should welcome the sharing of decision-making across the care team and maximize the use of non-physician clinicians. Guidelines give us the state-of-the-art way to do this.
  3. The best form of personalized medicine today is still clinician instinct and judgment.  This does not mean deferring all clinical decisions to the most senior or most highly trained person on the team. The care delivery culture can be modified to maximize appropriate personalization of care while adhering appropriately to guidelines. This requires an open culture where inquiry is encouraged.  Each care team member must be comfortable with what he or she doesn’t know, with spotting exceptions to norms and engaging other team members in a learning dialogue around these exceptions.

This should enable guidelines to be appropriately applied while surfacing exceptions for discussion.  In the meantime, we and others will be working as fast as we can to create the framework for personalized medicine from both the genetic and phenotypic perspective.

Dr. Joseph Kvedar is the Director of the Center for Connected Health at Partners Healthcare. This post originally appeared at cHealth Blog.

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22 Responses for “Guidelines vs. Personalized Medicine: the Battle for the Future of Healthcare”

  1. Excellent article, Dr.Kvedar. I, too, think that a combination of personalized and guideline medicine- as mentioned in your third point- is required for healthcare to be more efficient.

  2. Dr. Kvedar – nice piece. A very eloquent argument for the collaborative use of mid-levels to help increase access to care. Since money runs the world, I will say that clinical judgement and instinct tends to be expensive, while protocols and guidelines are supposed to be cheaper. While I think clinical judgement on a patient-by-patient is real medicine, I’m afraid we are going the way of guideline-based decisions. It’s easier to study, easier to quantify, and most importantly, easier to code and bill on EMR.

  3. I agree with Dr. Leng. And add that personalized medicine should also include the patient/family perspective to generate the plan of treatment. Engaging them through certain conversational skills (whether in the exam room, internet video, or email) can “personalize” a clinical guideline and judgment that can also decrease costs even further. This approach doesn’t take more time, it can actually take less.
    This goes beyond asking the pt/family if they agree with the practitioner’s plan or if they have any questions about it. Engaging the patient to help devise their plan, along with the use of a guideline and clinical judgment is worthy to note.

  4. Anonymous says:

    Thank you for this article! As a person who, for no known reason, does not fit the guidelines (the “usual” medications tend not to work, but those medications with “conflicting results” tend to work), it is great to hear this voiced. Physicians and insurance companies often come into conflict in this area, as insurance can stick to guidelines. And in working in healthcare, I see too much stringent sticking to guidelines. Yes, for the most part guidelines are appropriate. But they are guidelines, not set in stone requirements.

  5. Outcomes happen to people and statistics happen to cohorts. The opportunity exists for a new approach to clinical pathways or guidelines. Clinicians have domain expertise that should never be ignored and algorithms allow vast amounts of information to be harnessed. It is possible to combine both quantitative and qualitative data in order to model and provide appropriate decision support to both the consumer and clinician. Thanks again Dr. K for the action inquiry!

  6. Mighty Casey says:

    Personalized medicine has as much to do with patient culture as it does with clinical culture. The sad part is that the patient is asked so very rarely what his/her preferences are. All the talk of “patient engagement” in the world will stay in the lip-service column until patients are *empowered* to fully participate in shared decision-making. I’ve been asking “where’s my snowflake medicine” at pharma conferences to encourage that sort of culture/thinking shift. Guidelines are great, but only *after* all the data is in. Including patient outcome goals …

  7. Dr. Pullen says:

    As much as pathways or guidelines seem to limit our individual input into care, my experience, mostly with hospital pathways, has been that far fewer major errors of ommission and comission occur by following pathways. I also agree that having the authority to vary when our judgement suggests a pathway is not best may be best at times, but if that is a conscious decision it is less likely to lead us astray.

  8. Thank you for providing a lot of information on this topic for your readers.

  9. Dr. Rick Lippin says:

    Contemporary bio-medicine needs a heavy prolonged dose of humility and purging the excesses of the profit motive out of the “former” profession of medicine.

    If I start with those premises I default to the position of not trusting any so called “experts” to set guidlines (the word “guidlines” is also dishonest in the real world). Hence right now I lean toward Oslerian very personalized medicine. To me there is no other medicine?

    Dr. Rick Lippin
    Southampton,Pa

  10. It does seem unfair that generally guidelines are based off of a population of people, when in reality we are all different and respond differently to the same treatments.

  11. maithri says:

    Great, great responses to an excellent piece.

    Wonder what Joseph–and readers of this piece-think about the sequestration-induced cuts set in place for the Framingham Heart Study beginning in August…

    http://commonhealth.wbur.org/2013/07/framingham-heart-study-cuts

  12. Your second point is fantastic. Could not agree more.

  13. lewesjoan says:

    In oncology, we have begun to develop guidelines based on biology where data exist. The hematologic malignancies have led the way, in part because tissue for testing is more readily available for molecular studies. However, in recent years, solid tumors have begun to catch up. Agents targeted to specific abnormalities in various diseases have been approved for marketing. The challenges are to first, find out whether a target in one disease is also responsive in others, and second how to combine targeted therapies for optimal results. As the information base expands, the branches of the decision trees will as well.

  14. Hi,

    Thanks for providing such a nice information on personalization and guideline medicine.I agree with your points.Guidelines are based of individuals , clinical research and population of people.

  15. Have to agree with BobbyG above: Larry Weed’s work in Medicine in Denial is very relevant to this post and the question of how to better personalize medicine, in a way that is truly patient-centered and patient empowering.

    20th century clinical insight and judgment was all very heavily weighted towards the clinician’s habits and judgments, and often neglected to consider what was preferable or feasible or even more physiologically effective for the patient and family. (Clinicians often have difficulty following on symptoms such as depression, pain, wellbeing. Plus we have been known to let anemia and other lab abnormalities fall through the cracks.)

    I like Weed’s idea that guidelines, algorithms, and knowledge couplers should be used as a starting point. (He also advocates for a really rigorous method of documenting symptoms/findings, but that’s another story.) And then we personalize…based on the patient’s preferences and instincts, with expert input, guidance, and judgement from the clinical team. And good followup. That in itself will make a big difference.

  16. Eugenio says:

    Buenas Sólo quería decirte que algunas de las imágenes no se cargan adecuadamente.

    He probado en 3 navegadores de Internet diferentes y todos muestran los mismos resultados
    .

  17. Dr. Mike says:

    You can’t really come to an understanding about the balance between guidelines and personalized medicine until you understand this:
    http://www.newyorker.com/online/blogs/elements/2013/07/when-doctors-tell-patients-what-they-dont-want-to-hear.html
    “Consider, for example, a recent study among patients with chronic kidney disease: the more knowledge patients had about their illness, the less satisfied they were with their doctors’ communication. Another study’s title asks, “How does feeling informed relate to being informed?” The answer: it doesn’t. The investigators surveyed over twenty-five hundred patients about decisions they had made in the previous two years, and found no over-all relationship between how informed patients felt and what they actually knew.”
    ” A recent study examined patient satisfaction among more than fifty thousand patients over a seven-year period, and two findings were notable. The first was that the most satisfied patients incurred the highest costs. The second was that the most satisfied patients had the highest rates of mortality.”

  18. HealthCare says:

    I agree with you. There is opportunity for a new approach to clinical guidelines. No doubt whatsoever that physicians have expertise and formulas allows anyone to interpret large amount of information. It is possible to provide appropriate decision support to both the consumer and clinician if quantitative and qualitative aspects are combined. Thanks for this insightful post, again.

  19. Very good article. However let us not lose sight of the fact that many “guidelines” are political, often compromises that come associated with personal and individual agendas. Guidelines apply to populations as just that “guidelines”, individual patients and their complex milieu often do not nearly fit into guidelines.

  20. HealthCare says:

    ” The most satisfied patients had the highest rates of mortality”- now that is the point from the study to watch out for from the comment Dr. Mike . Does that mean the lesser the patient know about their diseases , the better ? I don’t know why but I tend to agree with it.

  21. RN Suzey says:

    The nursing shortage is a JOBS shortage. But new nursing schools are popping up on every corner. I’m working towards my BSN now (ADN RN) – where’s the financial aid for that? still paying off student loans after 8 years and trying to find enough work to buy groceries. I feel like I was sold a bill of good and bought it hook line and sinker

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