Harlan Krumholz is a healthcare hero.  He has actively campaigned against the corruption of healthcare and has received attacks aimed at him personally and professionally.  He has formed a cadre of rigorous researchers in cardiovascular outcomes research who meet regularly. He is now the editor of the leading journal in this space.   He is an independent thinker, a productive researchers, and a supportive and loyal mentor to his peers and students.  The opportunity to express my admiration comes from the publication of Harlan’s op-ed in the Washington Post that directly relates to the topic of this blog.

For minimally disruptive medicine to take place, clinicians and patients need credible research evidence about what works, how much interventions are able to accomplish in terms of patient-important goals and outcomes, and what are the harms and costs to pay to get those benefits.  Both positive and negative trials (the latter referring to those who find conclusions of no difference between a new intervention and no intervention, placebo, or the standard of care) are essential to this mission.  However, negative trials are less likely to be published which furthers the notion that most of medicine’s treatments on average are effective.

Harlan’s Op-Ed makes a strong case for supporting, publishing, and celebrating negative trials.  And this is important for minimally disruptive medicine and to answer the question that patients ask: “is there something that we can stop doing?”  For many of my patients with diabetes taking pills this means that they can stop checking their blood sugars using finger sticks.  We know this from well conducted research showing marginal, if any, benefit.

Clinicians and patients in the US are enthusiastic tinkerers and are in the lookout for exciting new opportunities to improve their health.  As a result they are often attracted to new potentially effective therapies.  Publication of only positive trials contributes to sell those therapies; hiding of negative trials distorts the record, misleads clinicians and patients, and corrupts healthcare.

Thanks Harlan for raising this issue, and for all you do for patients.

A patient comes to see her diabetes doctor every 3 months at great burden to her (get a ride, company, time). When the MDM clinician seeks simplification of the follow up schedule with less intense schedule the patient feels abandoned. What is the role of e-health in this setting?

At a meeting of entrepreneurs in Minneapolis, MN I challenged them to consider patient disruption as a target for innovation and non disruption as a design criterion for new technologies for patients with chronic disease.

And the challenges of this new approach keep piling up…

The workload of a patient’s participation in self-care or treatment on his or her daily life has become known in our group as the Burden of Treatment (BoT). It is important to note that this does NOT include the ways in which the disease itself effects life, but is restricted to the ways in which the patient’s investment of time, money, effort, and social and other resources in treatment affects the patient.

I’d like to clarify and put this into perspective with my previous musings on “What is fit?”. Recall that a treatment that fits is one which meets the doctor and patient’s shared priorities and goals for treatment outcomes, and does not exceed the patient’s capacity to cope. In order to make a treatment to a patient, a healthcare provider can either attempt to increase the patient’s capacity in order to bear the burden of treatment, or decrease the burden to not exceed the patient’s capacity.

I recently had the opportunity to discuss these ideas on treatment fit, BoT, and MDM with Dr. Michael Seltzer, a medical anthropologist from Oslo, Norway. Dr. Seltzer has studied the effects on patients of medical and psychological treatment from an anthropological perspective and he gave me a paper (see citation) regarding the concept of “colonizer” family therapists. Such colonizer therapists can be viewed as an parable for other health care providers working to avoid “maximally disruptive medicine”, and are examples of how even well-intentioned professional helpers can give treatment that grossly does not fit.

Therapy and colonialism may seem to be highly contradictory activities. As Rober and Seltzer explain, “Indeed, colonialism refers to a complex of practices for oppressing and exploiting peoples, while therapy, on the other hand, refers to a set of ideas and practices aimed at helping them” (124). However, as a professional helper, it is possible that attempts to help alleviate the burdens and detriments of disease can feel overwhelming and even oppressive to a patient. Anyone who has attempted to comply with a complex treatment regimen, especially one that lasts indefinitely for a chronic condition, may feel that health care providers and their treatment consume significant personal, financial, and social resources. One patient described this phenomenon of BoT to me as “a hijacking of my life, my time, my activities, and my priorities from day to day”, echoing the “colonial” exploitation described by Rober and Seltzer. Rober and Seltzer also reference the argument of Aime Cesaire that “those conquered and exploited by imperial powers also suffer devastating psychological damage. Colonialism, he argued, not only stripped colonized peoples of their natural resources but, perhaps more destructively, robbed them of confidence in their own strengths and resources.” (124). In this way, the burden experienced by a patient whose capacity is overwhelmed or exceeded by treatment is confounded by decreased perceived self-efficacy or confidence in their capacity to cope, which in turn further decreases his or her capacity to cope with treatment. If this cycle of overburdening and decreasing capacity continues, a patient is sure to encounter not only unsatisfactory health outcomes but consequences in other aspects of life due to the burden of treatment.

Rober and Seltzer defined four characteristics of the colonizing family therapist (please see also the table below): “the therapist becoming overly responsible for the family, too much focus on change in the family, disrespect for the family’s pace, and most importantly, neglect of the resources that the family already possesses that could be used to make a positive change .” (125) These features correspond to aspects of disruptive medical practice: the physician assumes too much responsibility for decision making and/or care of the patient (instead of sharing such tasks with the patient), a focus on clinical goals that strays from patient goals and/or priorities, failure to evaluate, disregard for, or misunderstanding of patient’s capacity to cope with treatment, and neglect for the patient’s resources or assets for coping with the burden of treatment.

The Colonizing Family Therapist The Colonizing Healthcare Provider
Becomes overly responsible for the family Assumes too much responsibility for decision making and/or care of the patient (instead of sharing these to the extent that the patient’s ability)
Focuses too strongly on change Focuses too strongly on treatment goals that stray from the patient’s own goals or priorities
Disrespects the family Fails to evaluate or disregards or misunderstands the patient’s preferences or capacity
Neglects the family’s own resources Neglects the patient’s own resources or assets that can be used to cope with BoT

A conscientious clinician can avoid the “colonizer position” using minimally disruptive medicine as an approach to work with patients and implement a treatment that fits. In addition to emphasizing the importance of finding treatments that are effective within each patient’s goals and contexts, the Rober and Seltzer paper raises an important part about the patient’s capacity. Instead of looking only for the ways in which a patient falls short of being able to cope with a treatment burden, health care providers should find ways in which a patient’s strengths can support treatment with the aim of integrating the work of treatment into “normal” life. This idea of strengths-based design is neither new nor unique to MDM, and I think that this concept itself may yield interesting and valuable lessons on making care really fit. I have some further reading and investigating to do, but I look forward to discussing these issues with you in future posts.

Rober, P and Seltzer M. 2010. Avoiding colonizer positions in the therapy room: some ideas about the challenges of dealing with the dialectic misery and resources of families. J. Family Process: 49:1; 123-37.

What is Fit?

The single most important reason why it is important for a treatment to fit is that patients have the single largest stake in the treatment. It is the patient who will have to schedule the visits, take the medication, monitor his or her health, adjust his or her lifestyle, and deal with the effects of either the disease, the treatment, or both. These burdens of disease and burden of treatment must be managed using the resources of the patient and often his or her social community. The patient must have the capacity to cope with the demands of a treatment regimen in order for the treatment to help achieve a health goal. A good treatment fit with minimized treatment (and disease) burden are especially important for patients with at least one chronic disease, as the patient’s commitment to treatment can last a lifetime and the cumulative burden of disease and treatment can become very large.

The problem with many prescribed treatments is that the treatment must be used as directed in order to achieve the desired health outcome. Patient adherence, therefore, can be a major determining factor in whether a treatment will be able to achieve the doctor and patient’s goal. In addition to the decrease in benefit from treatment when adherence is low, additional side effects, complications, and doctor visits can result. Such consequences, which can result when disease management is poor, create an additional burden of disease and/or treatment for the patient, the community, and for society. Since adherence to treatments and the ability to cope with treatment burden can have a large effect on treatment outcomes, prescribed treatments should be chosen to fit a patient and to be minimally disruptive (or minimally burdensome) in order to allow for the best chance of reaching a health goal.

For a visual image of the way that I picture fit and minimally disruptive medicine, picture Venn diagram of three overlapping circles.

Each circle represents an important factor in choosing and implementing a treatment: on circle is the domain of the patient’s goals, on circle is the domain of the doctor’s goals, and one circle is the capacity of the patient to cope with or adhere to a treatment. At the intersection of all three domains is treatment that fits, and the practice of minimally disruptive medicine. In a perfect world, the doctor and patient would agree on all goals for treatment and disease management, and all of the possible treatments that would accomplish this goal would be within the capacity of the patient. In the real world, we must use different tools and ways of practicing medicine to determine the shared goal with as much agreement as possible between doctor and patient, and to find treatments that are within the capacity of the patient and can be accomplished using the patient’s available resources. This would mean working in the “zone” of treatment fit and minimally disruptive medicine, and allow the greatest chance of successfully achieving health goals.

Many different interventions have been developed which aim at improving health with the primary goal of increasing patient adherence and thus the efficacy of available treatment options. While many practices, including evidence-based and patient-centered medicine, include the aim to bring the doctor and patient to an agreed upon and effective treatment, specific tools have been developed to aid in setting these goals and prioritizing the characteristics of available treatments for the patient. These attributes include the efficacy of the treatment, various burdens of administration or monitoring of the treatment, side effects, cost in time, money, and resources, and access. Tools for helping to fit a treatment include decision aides, which give doctor and patient and systematic and inclusive approach.

Countless other interventions to improve treatment adherence address the issue of capacity by either increasing the patient’s resources available to use toward treatment (i.e. providing childcare, accompaniment to appointments, transportation, reminders) or by decreasing the burden of treatment to adjust for the patient’s capacity (i.e. scheduling fewer appointments, reducing costs, etc.) In some cases, treatment or outcome goals are adjusted so that the treatment necessary to accomplish them is within the capacity of the patient. Decisions to modify treatment or outcome goals must also take into account the possibility that while treatment burden may decrease as a result, the burden of disease increase in the short- or long-term as a result.

The practice and pursuit of finding a treatment that fits by shifting the doctor and patient goals as well as by addressing the patient’s capacity to cope with or adhere to a treatment is the practice of minimally disruptive medicine.  In minimally disruptive medicine, the most important objective should be to treat or manage disease so that the patient has the best chance of leading the life that he or she wants with minimal disruption due to disease or treatment. I recently began the long journey of medical school because I want to spend my life helping others to address health problems in order to use time an energy towards other priorities, and in minimally disruptive medicine, I hope to find a fit.

– Hannah Fields, Mayo Medical School

The role of innovation in reducing treatment burden seems central to the quest for minimally disruptive medicine.   This year, the competition has built in, for the winners, opportunities to really take concepts to market thru key partnerships like Ideo.  Let’s hope that opportunities like this continue to contribute to effective patient-centered solutions to reduce treatment burden.  Healthcare policymakers and professionals should do their part to change goals, treatment and monitoring schedules, and visits to assist further with that goal.  Maybe we need another competition to spark an innovation in healthcare delivery aimed at reducing treatment burden.

With very thin data to support this recommendation, many diabetologists are promoting the early use of insulin in patients with type 2 diabetes, the most common form of diabetes.  Since insulin use requires closer monitoring of blood sugars to manage the dose of insulin and avoid and manage low blood sugars, insulin-containing programs may be quite disruptive.  This paper adds that injecting the insulin can also be disruptive (in terms of effort and schedule I suspect given the correlation with more frequently prescribed injections) and embarrassing to some.

In my practice, I tried to address this with my patients, particularly those who need insulin to avoid symptoms of high blood sugars.  For these patients, I suggest the use of insulin pens and, when appropriate, insulin pumps.  However, the cost of these technologies has made them less accessible to my patients in these times of economic crises.  Thus, clinicians would have to review with patients their goals of care to determine whether, when, and how should insulin be used to manage their diabetes.  Calls for early use to protect the beta cell seem to ignore or at best place a lower value on avoiding or minimizing these challenges.

“He did cut back on energy drinks, quite a bit from what he’d usually do,” Josh said, “but [doctors] have determined that smoking was the cause of this, and that was always his biggest habit. He had changed a lot of his habits but just could never kick the smoking. He started working with that electronic cigarette but, not used to it, he didn’t know how to charge it. He just kept smoking.”

What does it feel for a patient with multiple medical conditions to experience healthcare that fits?  By fit we mean healthcare that pursues the goals of the patients in manners that are consistent with her preferences while demanding work, time, and attention that can easily be integrated with all the other roles the patient plays in their lives: mother, sister, wife, worker, friend, etc.

For some it means technologies that are placed at the ‘point of life’, i.e., at home, at work, in between.  These technologies, ubiquitous technologies, can monitor signs of health and disease and use of treatment and communicate this information to algorithms and caregivers who in turn act on this information to deploy a tailored treatment.  This treatment (which could be advice, support, education, or medicines) accesses the patient with minimal requirements from the patient and acts on the patient with minimal to no involvement or at times of the patient choosing.

There is out there the belief that patients with chronic conditions need to be aware of their disease in order to manage the disease effectively.  Putting the condition and the necessary treatments in the back burner without due attention leads to disease progression and loss of health (so-called denial state).  But what if treatments just worked without calling attention from the patient?  Will this be progress?  What do the “personal responsibility” crowd feel about such development?

What are the implications for diagnostics and monitoring?  Can these take place in ways that do not require patients to act on them to activate or submit for analyses?  What are the implications for treatment design?  What are the implications for direct patient examination (make an appointment and meet with the clinician taking time away — in time and space — from usual routines)?  What role may indirect patient examinations (asynchronous? at the point of life?  without patient participation?) play?

In the minimally disruptive medicine utopia, are patients allowed to forget they have multiple chronic conditions?  If so, what happens with the behaviors and actions, the ways in which the patient interacts with the environment, that are necessary to prevent further progression of these conditions or the appearance of new ones?  Isn’t being sick a motivator to avoid getting sicker?  If treatments become “not a big a deal”, will individuals loose the motivation to prevent chronic disease?

We welcome your wildest dreams and most careful consideration.  What does a life of chronic disease looks like when treatments just fit?

Montori notes that a good-enough blood sugar strategy would also ease the sheer time and energy it takes to manage diabetes. Treatment regimens — with frequent doses of pills or insulin, blood-sugar monitoring and doctor visits — are complicated and burdensome, particularly in patients who may be elderly and have other chronic conditions, such as high blood pressure and high cholesterol. One estimate of the time patients spend taking care of their condition, if they follow all the advice of their doctors, is 143 minutes per day. “That’s as much as a part-time job,” Montori says.

The link to the full article (LA Times, Oct 26 2009) is here