Assessing the Burden of Treatment

As healthcare becomes more standardized, there has been a proliferation of measures to track population health and appraise healthcare delivery. These measures are often used to report on disease prevalence and healthcare quality as defined by clinical practice guidelines or metrics imposed by health insurance providers. However, one crucial aspect of healthcare has been largely absent in these surveys; the burden of the work that patients endure to access and use care and enact self-care. This work is often time-consuming and complex. It includes learning about healthcare problems and treatments; enrolling in health insurance plans and affording medical costs; and daily medication-taking and health behaviors. The work is amplified by unregulated medication pricing, and delegation of work and costs to patients because they have more “skin in the game”. Those who are not excluded from healthcare by prohibitive costs and demands may have to spend multiple hours weekly on healthcare. But, high-value, high-quality, just healthcare should result in improved health outcomes with the least possible burden to patients and their caregivers.

In our recent publication, Assessing the Burden of Treatment,[1] published in the Journal of General Internal Medicine (, we describe how we can start making the work of being a patient visible and useful. We report on two available measures that can be used to assess the burden of treatment and healthcare for patients with any or multiple health conditions.[2, 3] These measures vary in their lengths, properties and domains. Uncovering the burden of treatment can be used to track and improve healthcare services at the clinician, institution and national level. Consider the case of Carlos, a 52-year-old male Puerto Rican patient with diabetes who after a decade with reasonable glycemic control presents to his primary care physician with elevated blood glucose levels. The doctor assumes this is part of the natural history of disease and adjusts the insulin dosing accordingly.  After some conversation, however, Carlos shares that he recently saw a four-fold surge in insulin prices at his local pharmacy that makes paying for insulin impossible on his budget. He is therefore awaiting an informal shipment of affordable insulin from a neighboring Caribbean island. He feels frustrated and disappointed but sees no other recourse. Carlos has taken on emotional and existential work to accept the loss of access to a life-saving medication which he had integrated into his daily life for years. He has done the work of searching among family, friends and acquaintances for alternative insulin sources. Carlos’ HbA1c readings may not be as consistent anymore; he must await inconsistent shipments and ration doses to manage his insulin supply. Uncovering the work that Carlos is doing to care of his health creates the space for a practical and productive relationship with his clinician.[4] She may offer strategies for assessing the integrity of the product and adjusting carbohydrate intake. She can also share the information with colleagues who may be caring for patients in similar situations. If treatment burden was assessed on a large scale, with standardized measures, policy-makers can respond with price regulation and government agencies can offer subsidies and emergency supplies.

Assessing the burden that healthcare imposes on patients and finding ways to reduce patient workload can support a transition towards more holistic and practical models of care. Minimally Disruptive Medicine (MDM) is one such model that acknowledges that patients have life goals and responsibilities and finite resources (materials, energy, time and attention) with which to accomplish them.[5] Therefore, MDM seeks to create healthcare that aligns with and fits in patients’ lives and goals.  Collecting and tracking national information on patient treatment burden would make the work that patients do to manage their chronic illness much more visible to policymakers and clinicians alike. Ultimately, knowing the burden patients bear and the constraints they are under will guide providers in the treatment recommendations they make and partnerships they forge with patients to support health and well-being.

How does your organization uncover and track the work that is delegated to patients? How could you use these tools in your setting? We welcome discussion and questions! Comment below or tweet us @vmontori and @gabrielamabel12.

  1. Spencer-Bonilla, G., et al., Assessing the Burden of Treatment. J Gen Intern Med, 2017.
  2. Eton, D.T., et al., Development and validation of the Patient Experience with Treatment and Self-management (PETS): a patient-reported measure of treatment burden. Qual Life Res, 2017. 26(2): p. 489-503.
  3. Tran, V.T., et al., Adaptation and validation of the Treatment Burden Questionnaire (TBQ) in English using an internet platform. BMC Med, 2014. 12: p. 109.
  4. Boehmer, K.R., et al., Patient capacity and constraints in the experience of chronic disease: a qualitative systematic review and thematic synthesis. BMC Fam Pract, 2016. 17: p. 127.
  5. May, C., V.M. Montori, and F.S. Mair, We need minimally disruptive medicine. BMJ, 2009. 339: p. b2803.

Submitted by Gabriela Spencer Bonilla, Ana Quinones, and Victor Montori.

Gabriela Spencer Bonilla

Gabriela Spencer-Bonilla is a 4th year medical student at the University of Puerto Rico and Mayo Graduate School alumnus. She works with the KER unit to describe patient work in diabetes care with a mission of just and kind healthcare.



Quinones (high)

Ana Quiñones, PhD MS, is an Associate Professor of Family Medicine at Oregon Health & Science University (OHSU) with affiliate appointments in the OHSU-PSU School of Public Health, and the Portland Veterans Affairs (VA) Health Care System. She is a gerontologist trained in health services organization and policy from the University of Michigan’s School of Public Health. Her research interests address four main areas: (1) age-related changes in health, (2) racial and ethnic disparities in health, (2) co-existing chronic disease (multimorbidity), and (4) health care delivery changes designed to improve the management of chronic conditions for vulnerable older adults.

Throughout her training, she has aimed to understand disparities in health stemming from differential access to resources for disadvantaged populations and subsequent effects on health and wellbeing throughout the life course. In this stage of her career, her work focuses on the development of and intersection between multimorbidity and disability—and the role that specific multimorbidity combinations play in accelerating poor health outcomes among older adults.



In the face of complexity, do we choose the right action for the patient?

Often, when we take the time to understand a person’s context, we find that a raft of problems are tangled at their roots, and that addressing one causes a shift in another, a sort of game of pickup sticks in which piles vibrate easily. It can then be easy to lapse into nonaction, to let inertia determine the course of future events rather than to choose them actively. How, in the face of complexity, do you choose the next right action for your patient?

 Maybe I’m taking it too far, or that the sentimental and idealistic mindset I felt when applying to medical school hasn’t quite warn off yet, but possibly the way to create a care plan for a patient is to step back and see his or her humanity. St. Augustine captures this well, encouraging us to “love human beings in a human way” – recognizing that we all have our faults, gifts, sources of joy and fear, and, most of all, are fragile. Taking the time to know a patient in this way, to create a type of filial love, opens us up to the real risk of disappointment. Our rational and scientific minds want to boil down sets of variables that can be easily manipulated in equations, quickly derived to maximize the functions we create. But we’re messy beings and even the body of our scientific knowledge about the human body falls well short of explaining the complex interworking’s of even an isolated human not burdened by the complexities of life and its web of connections with others.

Having a strong foundation of knowledge, both of basic science and optimal treatment plans, is an important place to start. Learning from those with more time in medicine and those who best understand the condition at hand (the patient and caregiver) fill in the gaps in our “book knowledge”. This clinical training seems to be a process of building what Daniel Kahneman calls “System 1 thinking.” We’ve spent the first two years of medical school building up “System 2” – facts we can logically, deliberately apply in a perfect setting. But we’re never in that setting and so our instinct, biases, and the heuristics we’ve collected through life and the early part of medical school take over, not because we’re lazy but because our minds have evolved to be efficient especially in the face of complexity – Kahneman’s System 1. We refine these heuristics, discarding some and collecting others, and, more importantly, being to learn to recognize those instances when “optimal care plans” — the way it’s always done — are inadequate. It is then that we need to engage our critical thinking skills (kind of sounds like something my 5th grade teacher would say, but still important). And eventually we begin to understand those words made famous by Kenny Rogers: “You’ve got to know when to hold ’em, know when to fold ’em, know when to walk away, and know when to run”.   Still we will  sometimes fail to change the course of a disease at all, but during our time with the patient we were able to join them on their journey and hopefully provide some benefit. Not to rationalize or take an overly game theoretic approach to modern health care, but maybe the measure of success is did we help make a patient better off than the she or he would have been had there been no encounter with health care – is this what is meant by “do no harm”?

I’m sure there will be times in medicine when throwing up our hands and letting it all play out  doesn’t seem like such a bad option and yet we’re hopefully able to provide healing sometimes and comfort always.


Benjamin Mundell is a student at the Mayo Clinic School of Medicine, where he wrote the following response to a prompt from his family medicine clerkship.

Minimally Disruptive Medicine Meets Disruptive Innovation

When a patient comes to us, he or she is hiring our services to accomplish something in his or her life. I always find it an intriguing question to wonder, “What is this patient hiring us to do?” In other words, “What is the patient’s job to be done?”

To me, the concepts of Minimally Disruptive Medicine, Contextualizing Care, Shared Decision-Making, Patient-Centered Care, Individualized Medicine, etc. are all different but similar ways of helping us understand the patient’s “job to be done” and customizing our arsenal of tools, skills, and knowledge to help him or her fulfill that job.

In a way, a patient encounter is a negotiation. In negotiations, people often make the mistake of immediately trying to gain as big a possible piece of a fixed pie that they can. In reality, however, it is usually far more beneficial to first ask questions of one another to grow the pie before divvying it up. Growing the pie, however, requires the patience, dialogue, and trust to understand one another’s priorities as well as the ability to align those priorities to create maximum value for each party. It requires debunking an often innate assumption that the pie is fixed in the first place.

Furthermore, in medicine the negotiations are rigged. As providers, we wield all the authority in making the plans but we often forget that we have none of the power in implementing them.

Each of us, as providers, has a default set of assumptions at baseline. Baseline assumptions, however, are often overlooked even though they have profound influences on results. A look back to the launch of Space Shuttle Challenger on January 28, 1986 reveals a painful lesson about default assumptions.  In an emergency conference call on the night of January 27, engineers and executives of Morton Thiokol (manufacturers of the solid rocket boosters) told NASA managers and flight controllers that they were concerned because the overnight temperatures were going to be colder than they had ever planned for or had data about and they were concerned that elastic o-ring seals on their boosters may not function properly during liftoff at such cold temperatures.

NASA leaders, however, had already made “launch” the default assumption in their mind. George Hardy, Manager of the Solid Rocket Booster Project, reportedly responded to Thiokol’s request to delay the launch with, “I am appalled. I am appalled by your recommendation”. Millions of people watched on TV the next morning as the Challenger exploded a little over one minute into flight, later determined to be a result of the failure of the elastic o-ring seals.

In medicine, “launch” is often our default. With a few easy clicks of the computer, we can engage sophisticated technologies, armies of staff and services, novel treatments from around the world, and cash flows that can bury our patients in economic turmoil, none of which we have to pay for or experience ourselves. The pain, inconvenience, and expense of what we enact we rarely see or even have time in clinic to ponder. Furthermore, when the rocket explodes, we aren’t in the cockpit.

Minimally Disruptive Medicine is, from my understanding, an umbrella term that encapsulates a number of focused and targeted strategies for providing services and treatments that are aligned with our patient’s own unique “job to be done” and are simple, easy, and convenient for that particular patient to participate in and adhere to.

Contextualizing care is a process of empathizing with each patient to understand where our assumptions as providers may be false and to attempt to determine that individual patient’s expressed and even unexpressed needs, desires, and limitations. Knowing an individual’s context and status in life helps us remedy our false assumptions and thereby gain a more accurate understanding of a patient’s priorities and how our care can be optimally aligned with those priorities.

The very name “Minimally Disruptive Medicine” starts with the assumption that care will be disruptive and that our job as providers is to minimize that disruption. However, Ritz-Carlton’s mission is not, “Avoid bothering our guests too much.” Their mission is actually quite long, but the final line is, “The Ritz-Carlton experience enlivens the senses, instills well-being, and fulfills even the unexpressed wishes and needs of our guests.” It is ambitious but inspiring for employees. I am not sure I am inspired by making something less awful for my patients; I think we have a long way to go in how we frame the care we provide. I believe in the pursuit of MDM and respect and look up to Dr. Montori and the entire KER team. MDM has obviously been highly successful at getting out the message that care, especially chronic care, is extremely disruptive to patients and needs to be redesigned. Moving this from discovery to translation to application at large scale, however, is another story. A 2015 “Minnesota Physician” article on MDM discussed that a 22-chapter implementation guide for MDM was in the works. I haven’t found that manual yet, but a 22-chapter implementation guide sounds frighteningly complex when the overall goal is to reduce complexity.

Every time I hear or read Minimally Disruptive Medicine, it is impossible for me not to also think about a completely different but similarly-named and ironically applicable theory, that of Disruptive Innovation. Disruptive Innovation is a theory that “explains the process by which complicated, expensive products and services [such as medicine] are transformed into simple, affordable ones. It also shows why it is so difficult for the leading companies or institutions [like Mayo Clinic] in an industry to succeed at disruption. Historically, it is almost always new companies or totally independent business units of existing firms that succeed in disrupting an industry.” (From Innovator’s Prescription by Clayton Christensen, page 3).

To me, a more rapid and effective approach to achieve the goals of MDM would be a Disruptive Innovation approach, something that would seem radical and unviable to the “leading companies and institutions” like Mayo Clinic. A Disruptive Innovation solution may likely be centered around a new baseline, one where the default assumption will be that a patient does not want any healthcare services or treatments and only through discussion of each patient’s unique priorities would you begin to build a thorough and individualized plan from scratch that encompassed every aspect of a person’s life. I can quickly envision a vertically integrated approach to “healthcare” that coordinates and organizes all the important elements of people’s lives, including food, fitness, financial services, education, career navigation, child care, etc.

Of course, doing something like this requires fundamentally restructuring the entire way in which we deliver and ensure “health”, “healthcare”, and “medicine.” This is why I am an advocate for Disruptive Innovation as a “build from scratch” rather than “rebuild what we’re already doing” model. In healthcare, we must sit in the cockpit with our patients. To do that, however, we must restructure everything, including, and perhaps most importantly, who pays us, when they pay us, why they pay us, how they pay us, what they pay us, and what they pay us for.

John Schupbach

John Schupbach is a student at the Mayo Clinic School of Medicine, recent graduate of Harvard Business School, and Founder and CEO of Squalor to Scholar. He plans to complete his residency in Emergency Medicine and eventually to engage in practice redesign efforts globally. He wrote this response to a writing prompt as part of his Family Medicine clerkship.


What cultural differences can you name, comparing “acute” and “primary” care?

What cultural differences can you name, comparing “acute” and “primary” care?

Patience is a major cultural difference between acute/rescue and primary care.  After reading Atul Gawande’s “The Heroism of Incremental Care” (New Yorker, Jan 23 2017)  it is obvious that patience is a major component to primary care, which is often not seen in rescue medicine.  I enjoyed his statement “most of the time people will get better on their own, without intervention or extensive workup. And, if they don’t get better, then usually more clues to the diagnosis will emerge.”  This is a perfect example of many of the patients we see in clinic.  By employing incremental care, patient can avoid unnecessary procedures and save healthcare dollars.

But why are rescue specialties attractive?  They are attractive in today’s society because of the immediate gratification patients and clinicians expect.  Patients want results now, they want treatment now, and they want to feel better now.  We all want a special pill to solve problems right away.  If you tell a patient their condition will resolve in a couple months by itself or they can pay to get it fixed now, many will probably pay if they can afford it.  The  culture has shaped patients’ expectations as well as influenced the political aspects of reimbursement.  “Construction produces immediate and visible success” and everyone loves a shiny new bridge.  But we often forget that maintenance is needed to prevent that shiny new bridge from becoming just like others that are rotting away or on the brink of collapse.  It is our job as clinicians to be those maintenance workers and encourage those funding the construction to focus on constant upkeep, known as preventative medicine.

 What attracts you to, or repels you from, incrementalism?

I partly choose the field of anesthesia because of the immediate feedback one receives when pushing drugs like propofol or phenylephrine.  I enjoy seeing results right away, and being able to react quickly to new data points constantly streaming my way.

In medicine there are people who have personalities designed for incrementalism.  These individuals are in the ideal position to discuss factors such as living situation, family dynamics, stress levels, and how intricate parts of their lives impact health.  In an ideal situation we would all do this.  However, our healthcare system is not set up this way.  We have a fragmented healthcare system both practically and economically.  Often, even in Gawande’s article, fields of medicine are compared to each other as if we are individual teams fighting to be the ones that have the biggest impact on our patient’s lives.  We are competing and making statements to justify why a specific –ologist or family medicine physician is doing better than someone else.  This culture sets us up for failure.  Gawande elegantly stated, “in his first days rescue medicine was what he needed…. but incremental medicine is what he has needed ever since.”  Our focus in medicine should be to treat patients as a team.  To incrementally address patients concern and transition to rescue care when absolutely needed.  When these transitions occur, they should be done in a collegial, appreciative, and team-based fashion, rather than the often hierarchical attitude that is often seen in medicine.  Although I enjoy the immediate results of anesthesia, I also appreciate the work my teammates will put in to prevent surgical procedures and keep patients out of the hospital.  But when that time comes that rescue medicine is needed, I will be there to get patients through whatever it is they need, in order to transition them back to my teammates in the outpatient setting who can continue to provide maintenance to prevent their ultimate collapse.

Chris Aiudi

Christopher Aiudi is a student of the Mayo Clinic School of Medicine who writes as part of his family medicine clerkship.

We CAN’T change healthcare but we CAN make the difference

PictureThis is an introduction to DocRocks, a new blog with a goal to provide opinions, hacks, and answer to your questions. Everything you need to enhance your Doctor Awesomeness. If you find this interesting, click here to subscribe to future posts.

Does this sound familiar?

You just became a doctor and the future looks bright.

You are excited to save lives and leave a positive mark on the world, guided by your own principles and ideas on how things should work.

Everyone talks about the downsides of being a doctor but it doesn’t bother you too much. You clearly know what you want and that is helping patients and providing exceptional care.

Two years later, it all starts to fade…

Despite the wish to make great clinical judgments and show compassion for your patients your hands are tied. After feeding the electronic beast and doing all manner of administrative things, you get less than 5 minutes to actually speak with patients.

In those five minutes, patients are confused, afraid, and oftentimes angry. They are frustrated with the broken system and you are the front line representative of it.

You take blame and responsibility and someone else takes your money.

Every time when you want to reverse your wheel and come one step closer to your dream, you get the same answer, “It’s Impossible,” over and over again.

But still, you don’t stop believing. The other side of “impossible” still fuels your motivation.

You never wanted to become a falsely glorified “prescriptioner,” you have slightly different picture of yourself for the future.

Deep inside, you know it’s possible and only one question remains.


The Other Side of Impossible

This blog is about “How”.

In the last 7 years, we met doctors who hacked the system. Some found the ways to go above and beyond for their patients. Others made perfect micro-environments, where almost everything worked as intended.

And guess what?

It works for everyone.

When I look at my patient experience with those special kinds of doctors, “AMAZING” is the only word that fits. It made me share positive vibes about them, refer them to other patients, and in the end, it inspired me to start this blog.

Several doctors enter medicine because it is worthwhile and noble. However, only the rare ones have found effective ways to transform good intentions into good practices.

These ways aren’t taught in medical school and aren’t part of some big governmental initiative. They are the result of courage and a lot of trying. Best of all; from today until the end of time, we are going to cover them here.

DocRocks is blog about opinions, tactics, and answer to questions; everything that can give you immediate value. Things you can read or watch and use to improve your doctor awesomeness.

You will find no armchair analysis here; just hard earned lessons from our own experiences, mixed with practical advice from awesome doctors.

Starting With Doctor – Patient Communication

Over the next few posts, we are going to cover doctor-patient communication.

This is a field where doctors rarely look for improvement. Most doctors rely on abstract advice like “be emphatic,” “smile at patients,” or “watch out for yourself.”

Instead of abstract advice, we will show you the exact moves step by step, to make your patients healthier and your private life happier.

For example, we will feature posts about:

  • How to make yourself available to patients without ruining your personal life.
  • Why my doctor didn’t want to schedule a physical exam because he cared about me.
  • How to track patients’ outcomes without long and fancy questionnaires.

These posts will be packed with explanations and real life examples. “Small skills” that make big differences.

Pairing courage and medical knowledge with these skills made the special kinds of doctors I wrote about above. It helped them become the doctors they wanted to be, and I hope it can help you too.

Are You With Us?

Hopefully, you will join us on the road to build an awesome DocRocks community.

We will release a new post every 10 days, starting with those outlined above. To get each post emailed to you as soon as it’s published, sign up for our blog’s mailing list.

See you next week! Have something you want to learn more about? Let me know in the comments below or hit me up on Twitter.



Submitted by Selver Maric. Father of twins, a healthcare entrepreneur and writer, he speaks internationally about the doctor-patient revolution. After 7 years of fighting against illness, searching for solutions, and interacting with doctors – his passion to improve relationships between doctor and patient is the strongest driving force in his life.


Registration now open

Friends of Minimally Disruptive Medicine and Shared Decision Making,

Registration is now open for our 2nd annual Minimally Disruptive Medicine Workshop! We welcome all including, clinicians, health professionals, researchers, advocates, and patients to our home base in Rochester, Minnesota to join in sessions of conversations and learning to move kind and careful healthcare forward. For those who joined us last year, we have a great deal of new content, and hope you join us again this year!

Link to schedule and registration:
Hope to see you there!

Risks and Benefits of Adopting Guideline-Driven Care

What is your opinion of the Minnesota Community Measures’ “D5” criteria for diabetes management? What are the risks and benefits of adopting guideline-driven care? Do the D5 measures reflect a friendly contextualization of care?

I think the topic of guideline-driven care is an important one, and I find myself having mixed feelings about it.  As a medical student and learner faced with a new or complex problems, I think guidelines can serve as a starting point for reading or from which to build a care plan. In the context of the D5, for example, the guideline gives me an idea of what aspects of evidence-based care I should be thinking about when I am beginning to get to know a new patient with diabetes.  However, I think solely utilizing guidelines comes with risks. They assume every patient is similar and therefore can be managed in a similar manner.  A guideline can put patients into boxes, and can quickly take away from personalized clinical reasoning.  It would be easy to go throughout your day just checking boxes and following algorithms, but this approach may often miss the bigger picture of looking at the patient as a human with a host of social, behavioral, and economic challenges that all play into their health.

I remember my preceptor mentioning the D5 guidelines to me before going into a patient room last week, asking to make sure the patient was taking their aspirin and if they were still smoking, as those are aspects we are now evaluated upon.  In one sense I think the D5 guidelines are helpful as they do aim to improve health outcomes and have been shown to reduce the risks for diabetes complications including heart attack and stroke.  They provide a guide for patients, outlining a clear set of key action items that a patient can work on together with their health care team.  However, I think it’s important to realize these shouldn’t be the sole focus of patient care and can/should be adapted to fit the individual needs of the patient at hand.  I think it’s also difficult to assess a physician based on how many of their patients are meeting specific guidelines.   Each patient and patient population is different.  Having good control of blood pressure or blood sugar may lRolfesook different in a completely healthy person versus a patient with multiple other comorbidities, and guidelines or evaluations may need to be adapted to reflect this.

Mary Rolfes wrote the following as part of her 3rd-year family medicine clerkship at the Mayo Clinic School of Medicine.

Views from a Mayo Clinic School of Medicine Student

Prior to starting the clinical portion of my training, I often wondered what it would be like to be the provider for a patient who is not able to manage their disease as advised. My goal was to have an approach to the patient that was not paternalistic, but I find this to be easier said than done. Mainly, the difficulty arises from the role placed automatically upon the physician, whose counsel is sought by patients because that physician is perceived to be an expert in his or her field. It’s a challenge to rise to this role, to speak confidently (as we are taught to do early on in third year), and yet to balance this with humility — the quality that patients actually need.

Recently, I was expected to discuss a patient’s case with a team, in front of the patient, in the patient’s hospital room. I was to have a plan and sound “confident and unwavering.” But, honestly, I struggled — because there is so much at this stage, and will be at every stage of my career, that I do not and cannot know. Even if I was already the world’s expert on a limited subset of disease in one specialty, I still would not know the details of this patient’s life, the detail that will cause this patient to not be able to adhere to a plan, unless I begin a conversation with them from the standpoint that only they can teach me about themselves. I can be truly confident of what I know if I humbly gather that information and tailor disease-related advMontenegroice to the patient’s context.

Ms. Montenegro is a third-year Mayo Clinic School of Medicine student, writing as part of her family medicine clerkship.

Minimally Disruptive Research: a respectful approach to conducting clinical studies

As a study coordinator at the Knowledge and Evaluation Research (KER) Unit, I have over 10 years of experience in conducting research across a broad array of contexts and designs. Most often, we evaluate patient-centered interventions and their impact in the clinical encounter. These interventions are not drugs or devices, in which participants are often extracted from their personal and clinical care contexts to participate in strict protocols, but rather are tools to support clinicians and patients in improving their conversations and decisions. To see the effects of our tools, we record the clinical encounters and ask users (clinicians and patients) for their experiences. Because our recruitment and data collection takes place in the context of clinical practice without time deliberately allocated for research effects, often in a tightly scheduled and carefully choreographed setting (or in a chaotic mess, depending on the clinic), and because clinicians and patients may be overwhelmed or anxious, it is important that all protocols for recruitment and data collection are designed and implemented with minimal disruption to the clinical workflow and to the patient agenda.

When we conduct our research, we immerse ourselves in the clinical settings to understand the clinical workflow and identify patients while being as visible (as to keep staff aware of our study) and invisible (as to avoid disrupting the staff) as possible. We consent patients in the exam rooms (a private location) during the wait time between being roomed and seeing the clinician, which has led to higher enrollment than calling the patient ahead of time. Importantly, by assessing eligibility prior to the encounter and by finishing data collection (i.e. surveys) at the same visit, we prevent scheduling extra patient visits to the medical center for the study (with its associated interruption to patients’ daily routines, time away from work and family, parking woes, and other burdens). This means that everything, from informed consent documents to post-intervention surveys, must be succinct. Our researchers must give up “nice-to-have” items in the surveys, for example, that can be omitted as nonessential. This means briefer study time and less effort for the research participants and a faster flow of study patients through the clinic. The purpose of our research is to learn how to support kind and careful medical encounters.  In order to observe clinical conversations, we use a small camera that, while unobtrusive, stays evident in the room, and has a clear and easy way to be turned off or to be reoriented (e.g., toward the ceiling or the floor to capture audio only) if any of the participants prefer not to be recorded at any time. The recorder reduces the research presence in the encounter as the researcher does not need to be in the room observing the discussion or taking notes. As patients and clinicians engage, it is evident that the small camera becomes ignored or forgotten as the visit progresses.  This is as close to the real world as we can get while minimizing the research imprint.

Our experience in conducting single and multi-site studies- for examples, conducting Chest Pain Choice in the emergency department, Depression Medication Choice and Diabetes Medication Choice in primary care, Graves Disease Treatment Choice and PCI Choice in specialty ambulatory clinics, and AMI Choice in hospital care- is that research can be designed and implemented in this fashion across a wide range of clinical settings and in urban, suburban, and rural settings.

Along with colleagues at the KER UNIT, we are working toward a new standard.  In our view, the design and conduct of clinical studies must achieve the research goals while minimizing the work allocated to participants.  Protocols are not only reviewed to meet ethical standards, but also to maximally collect information (about outcomes that matter to patients and clinicians), while imposing the smallest possible footprint on clinical care activities.  Importantly, by minimally disrupting practice, our outcomes best reflect the effect of the intervention in daily routine.

I recognize that other projects (i.e. FDA regulated) may have more stringent protocols that cannot be bent to fit the context of care.  They could still benefit however, from review that ensures their protocols meet ethical standards, and impose on participants the smallest possible burden necessary to effectively answer the research question.   This may require extra effort and conversations with funders and designers but is crucial to conduct research that is respectful of patients and clinicians time and energy.

Our adherence to this new standard, Minimally Disruptive Research, requires participants (both patients and clinicians) as research partners to engage with investigators at every step of the research process to ensure that all procedures are as easy as possible. The test the implemented protocol must pass in all eyes is that it results in CAREFUL and KIND RESEARCH.

What strategies does your team use to be kind and careful when conducting research about the experience and delivery of clinical care?

Submitted by Sara Dick, MSc, CCRP

Contributing Authors: Gabriela Spencer Bonilla, BA, and Marleen Kunneman, PhsaraD

Annals of minimally disruptive medicine: Presence


Restoring coherence amid uncertainty

Submitted by Ronald Epstein, M.D.

A couple of months ago I was awakened with abdominal pain. I couldn’t sleep. The pain was unfamiliar, different from my prior kidney stones. It was more in the front of my abdomen, not the side; it didn’t wax and wane.

The pain got worse and my wife drove me to the emergency room. As a doctor who is no stranger to the emergency room as a patient, I took the opportunity to note the quality of attention I received from each person I encountered, and the degree to which they were present, seemed interested in me as a person and expressed caring.

The first thing I learned is that attentive presence has nothing to do with role. The clerk at the front desk first asked for my name, date of birth and insurance information; he made eye contact with a knowing look. That look made me feel more attended to, even before he said he’d get me seen right away. The person who transported me in a stretcher to the CT scanner asked how I was doing and she seemed interested in the answer. Both the clerk and the transporter were part of the healing enterprise. On the other hand, the tech, obviously harried, took my blood pressure without sharing any of her presence. I found her lack of presence disruptive; for her I was merely a task to be completed, not a person to be known. It was disruptive to a fragile sense of coherence in a moment of vulnerability. The same blood pressure check with some expression of human connection would have been more healing, less jarring.

For those who were engaged with me as a suffering person, I encountered different types of responses during my short stay. Some were interested in fixing my problem. Dr L, who attended me, did not waste any time getting me medicine for the pain and nausea. The pain resolved quickly and after a while I felt less nauseous. But it wasn’t just the pain and the nausea; there was more. I was worried. He inquired. Perhaps, he said, we should wait to see what the blood and urine tests show before ordering a CT scan. That could save you an unnecessary test and some radiation exposure if you really don’t need it. I agreed. More importantly, I was part of the plan, part of a collective effort to make sense of this unexpected event. Later, tests unrevealing, he explained, Would be an hour to drink the contrast solution slowly, and another hour to get the interpretation after the scan, and then we’ll see. I wanted to know why I was having pain and agreed to the scan. I didn’t get the sense that he was treating me specially because I’m also a doctor. He addressed me as a person first, a patient second. He communicated his interest in me as well as the illness, that he’d accompany me along the way, that I’d have a say.

There was a lot of waiting, first, to drink the contrast solution, then get the scan, then wait for the result. Then, a surprise. Not another kidney stone (I knew that), not diverticulitis (the ED doc thought it would be). The scan showed some thickening of the stomach lining, probably an ulcer, he said. Could be gastritis, could be an ulcer, could be something else, he said. In retrospect, I realize that he was preparing me for something, treading softly. The report from the radiologist said, possible infiltrative process, he said. I did not like the sound of that. I imagine that if I wasn’t a doctor he would have explained that he needed to make sure it wasn’t cancer. Now we were both in uncertain terrain. The pain gone, I felt fixed in a physical sense, but I was far from back to normal. I was anxious. Dr L suggested a call to GI, an endoscopy. No alcohol were his parting words.

Illness is a disruption of what we take for granted. Bodies hum along quietly, out of awareness, then “something” happens. For those who are relatively healthy, that something, fortunately, is an exceptional occurrence. For those who are chronically and seriously ill, some somethings are part of the fabric of life. However trivial or monumental a something might be, the resulting disruption is physical, psychological and existential; we experience it as suffering. Physicians normally respond to suffering by trying to fix a problem, to diagnose and treat, to remove the threat. But often the threat cannot be removed completely. There is a residual, a fear, a not-knowing. With the advances in CT and MRI scanners and ultrasound, it is now possible to see in ever more exquisite detail what previously would have evaded detection – usually a good thing, but this increased precision comes at the price of finding more lumps and bumps that are meaningless, harmless. Increasingly, we all become acquainted with these “guests” — who reside in our livers, our kidneys, our brains — and try to determine if they are innocent or nefarious.

I had entered that field of uncertainty, together with Dr L. In few words, he communicated that he wasn’t confusing the prescribing of treatment with the relief of suffering. Presence makes suffering tolerable, less disruptive. Presence can restore a sense of coherence. Even transient illnesses involve a sense of loss or threat, but in more serious, chronic or life-threatening illnesses that sense of loss can become so wrapped up with a person’s identity that they feel that they’re no longer whole. Helping patients reclaim their identity – that which defines who they are as a person regardless of the ravages of disease – is essential when patients are seriously or terminally ill, but it can be just as important at other times. Whatever transpires, whatever the diagnosis, and whatever uncertainties remain, physicians can support the integrity of the person. For patients whose illnesses don’t go away, sometimes the most important thing a doctor can to is to let them know that she is there not only to solve a problem but to help them discover that illness does not have to diminish them.

For me, in those few minutes in which the uncertainty about diagnosis emerged, Dr L was able to give me choices and help me be in control, at least to some degree. What transpired the next day – the endoscopy – suggested something benign but unusual-looking. A week later, Dr K, the endoscopist, called with the biopsy result. Here was another opportunity to address the person and the patient. It was certainly benign, he said, but some uncertainty remained whether the inflammation was acute or chronic. I felt fine. I opted out of another endoscopy, offered “just to make sure.” I knew better. Often more tests muddy things as much they clarify. The kind of reassurance I was looking for was knowing that I’d be accompanied, and that’s what I had.

It’s strange to write about a health care episode that went well. There’s so much wrong with health care. But patients know when health care is about people first then diseases. They feel seen, recognized, accompanied. It doesn’t take much. A quality of gaze, a warm inflection of speech, a momentary pause. Words that bring us together, human to human, rather than words that create distance. Gestures to honor a wholeness that would otherwise remain unseen.

Iconic portraits for the commercial and editorial industry by Stephen S Reardon Rochester, NYDr Epstein is a professor of Family Medicine, Psychiatry, Oncology and Medicine and Director of the Center for Communication and Disparities Research at the University of Rochester School of Medicine and Dentistry. His book, Attending: Medicine, Mindfulness and Humanity (Scribner, 2017), will be released in January 2017.

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