Victories

There are victories of the soul and spirit.  Sometimes even if you lose you win.

                Elie Wiesel

It is amazing how victories can be small – even invisible to others – and can manifest in the darkest of situations and times, and yet still have a major impact.  This past week, that truth was brought home to me yet again, as I shared a stage with a number of very prominent women leaders in health.  I was fortunate enough to be part of a panel discussion at the Women’s Healthcare Innovation and Leadership Showcase sponsored by the Metro (NY/NJ/CT) chapter of the Healthcare Businesswomen’s Association .

On that panel were very smart women who are passionate about changing the world of healthcare. Two, in particular, spoke forcefully and eloquently about the seemingly small, individual efforts that—when multiplied—can change the world. 

Dr. Julie Gerberding, President of Merck Vaccines and the former Director of the Centers for Disease Control, spoke of scrubbing toilets in a small African village and realizing that clean water and empowered mothers in this village could change the world.  She talked about women who had nothing finding ways to fight cervical cancer by working together with community support.  In the midst of the poverty and squalor of a small village in Africa, Dr. Gerberding saw hope and strength in the women she met and worked with. 

Dr. Anne Beal, Deputy Executive Director and Chief Operating Officer for the Patient-Centered Outcomes Research Institute, remembered a poor single woman, who—upon discovering she was pregnant—spent weeks and weeks fighting her way through the system to obtain Medicaid coverage so she could receive the right prenatal care. Finally, at 24 weeks of pregnancy, she saw the doctor for the first time—and discovered she was carrying triplets. Dr. Beal spoke of that woman’s great strength, and of her ability to obtain care for herself and for her new family when she delivered prematurely. In a situation that some would find hopeless, Dr. Beal and that brave mother saw triumph. 

In both of these leaders’ stories, I could hear the satisfaction and joy each had in helping these women in the worst situations achieve small victories.  We were not talking about dramatic lifesaving surgery, but rather about the commonplace issues of clean toilets, routine exams, and Medicaid coverage. 

And the entire meeting was energized by their work and their words.  These moving stories made me think about my own personal journey and the fact that I was most inspired by playing a small role in helping someone find the “victories of the soul” as described by that great writer, Elie Wiesel.   While I was in college, I taught guitar to children with brain injuries. My talent at guitar was such that I could only teach someone who had physical disorders of coordination (which is why I am not playing guitar on stage these days, but talking instead).  When I saw a child’s satisfaction at mastering a note, I did not know that I was working to change the world, but helping those young people master motor control and gain confidence was earth- shaking. 

My sister has recounted her own experience as a special education teacher, helping a small child in a wheelchair at Halloween.  That little boy—dressed in his costume—came to her class in his wheelchair for their Halloween party.  He was so excited about the costume! When my sister greeted him and told him what a great costume it was, he asked, “How did you know it was me?”  He was not, at that moment, a sick child confined to a wheelchair; he was just a kid in a costume acting like any other kid. 

When I was in practice, I often treated patients who were terminally ill.  I was given the privilege of being with people at their time of greatest need, sharing their fears and their hopes, helping them communicate with their families, and helping them feel valued and heard by those they cared about in their last days and hours.  The victories I saw as they spent their last days with those they loved were inspiring. 

My wife (a specialist in clinical genetics) helps parents every day whose baby is born with a severe genetic illness, often terminal, as they struggle to accept that reality and create new hopes for their child—if that child survives—and for future children.  When she sees an older child with severe disabilities and greets the child playfully—as a child and not as a “specimen” with severe impairments—parents understand that she sees their son or daughter as a unique person.  Those are huge victories for the entire family. 

Good, experienced clinicians —and health policy leaders like Drs. Gerberding and Dr. Beal--know this secret almost instinctively: When you help people achieve small triumphs, victories of the soul and spirit, you help them achieve higher quality care—and you also save money for the entire healthcare system.  When that villager is able to help her community get clean water, the entire health of the community improves.  When the mother of triplets can advocate for herself in the confusing and difficult systems of healthcare and health benefits, the care her children will receive is better, and the chance of those triplets ending up in the hospital for prolonged stays drops dramatically.  When the family of a terminally ill child is able to avoid unnecessary, often uncomfortable tests and procedures--and the parents can hold their baby for those last precious hours instead, it is better for the parents, the child and the healthcare system.

At Accolade, I am privileged to have helped build a system that helps people every day in small ways. We help people get those small victories every single day—the victories that allow them to improve their health, live their lives, and maintain autonomy over their own bodies and their own decisions.  I get to play a part of the interactions our Health Assistants have daily. I know that as we help each of those people in small ways, we are changing their individual worlds and helping the broader health system and community, as well.   

 

 

Bad Habits or Critical Thinking?

Danielle Ofri, a physician at NYU Medical Center (in New York City) and a New York Times contributor, is one of my favorite medical commentators. Her insights and judgment into issues such as the use of the medical narrative are impeccable. However, I wonder if in this recent opinion piece she might have missed the mark a bit.

In this article, she takes herself to task for a “bad habit” of not following the ‘Choosing Wisely’ guideline from the Society of General Internal Medicine (SGIM) concerning routine visits. She still sees her patients routinely for health checks, even though this particular SGIM guideline states “Don’t perform routine general health checks for asymptomatic adults.” The guideline then goes on to explain:

 “Routine general health checks are office visits between a health professional and a patient exclusively for preventive counseling and screening tests. In contrast to office visits for acute illness, specific evidence-based preventive strategies, or chronic care management, such as treatment of high blood pressure, regularly scheduled general health checks without a specific cause including the ‘health maintenance’ annual visit, have not shown to be effective in reducing morbidity, mortality or hospitalization, while creating a potential for harm from unnecessary testing.”

And yet, while Ofri considers her own actions to be bad habits, I consider them good critical thinking—and good instincts. I believe this “bad habit” is really related to a deep understanding she has of the doctor-patient relationship—an understanding not reflected in the guideline.

While this guideline (and the many others that accompany it) is well-intentioned and an important step toward making us all wiser doctors and patients, it’s also important to think critically about it.

The guideline is based on scientific studies of populations and the population effect on reducing morbidity, mortality and hospitalization, but it doesn’t take into consideration other studies that have documented the eroding trust in physicians, as well as the studies that document the morbidity increases resulting from lifestyle diseases.

I find it difficult to separate these two issues. Patients must trust their doctors if they are to follow doctors’ advice concerning lifestyle, as well as the more immediate advice doctors give suggesting diagnostics and therapeutics. If patients are going to take medications as they were meant to be taken or undergo a diagnostic test that will ultimately help them better, they must have a relationship with the physician built on trust. That kind of relationship only happens when the doctor gets to know the patient as a person—not just his or her physiology and health risks—and that requires regular contact between a doctor and an individual.    

In today’s world, it is more important than ever to think about what happens outside of the doctor’s office as well as what happens inside it. Before the person ever sees the doctor, how does he or she decide whether to go in the first place? It often depends on how much trust a person has in that doctor—and how much value he or she thinks the visit will offer. In an absence of trust, a person may not even go to the visit—and miss an opportunity for early treatment.  Or, when that person leaves the office, will he or she act on the physician’s advice?  What if the physician wants to try “watchful waiting,” which requires a great deal of patience and confidence in that guidance?

We should ask ourselves if the guideline’s goal should also be related to trust. Shouldn’t trust be at least as important as the epidemiology of a borderline cholesterol level? Perhaps the real benefit is not just in treating that borderline cholesterol, but comes home to roost 1 or 2 years later, when—in an urgent situation—the person actually calls the doctor he or she trusts.

Many years ago, I ran a nutritional support service and made regular home visits to the patients we treated. I found I learned the truth about what patients were really doing when I went to their homes. I learned about the real-life barriers that prevented them from following the advice I gave. I formed a bond with them that was related to my willingness to meet them where they were, not just emotionally, but physically.

In healthcare, we are beginning to recognize the importance of shared decision- making—in which the doctor and the patient jointly decide the best course of action. This can only occur with trust. It only occurs when the doctor knows the person, and not only the patient. It only occurs when the patient believes the doctor has his or her best interest at heart--and not the best interest of the health system they work for, the government, or even society as a whole--no matter how “noble” that may seem from a population perspective.  

Perhaps we could modify the Choosing Wisely guideline so that we avoid lab tests at those yearly visits, but maintain the yearly visit itself to help maintain the bond? Perhaps it should even be a yearly home visit (although I suspect that would not be warmly received by most doctors or health policy people) to really see all that the patient and the family unit has to deal with in order to try and stay healthy?  A modification in the guideline that fostered trust and relationship building could result in better care and even more cost savings.

I applaud Dr. Ofri’s instinct to follow her own path, rather than following the guideline in this case. Her voice will help SGIM and all those involved in setting guidelines better understand that healthcare needs trusting relationships as much as it needs science and epidemiology. I hope that she continues to use the critical thinking skills that are reflected in so much of her writing to build trust and motivate patients so they call when they are in need--and follow the sage advice I am sure Dr. Ofri gives.

Trust, Small Decisions, and Improving Health Care

Our lives are built on trust in others. We trust that the person in the car stopped by the red light will not suddenly hit the accelerator and run us over as we cross the street. We trust that the people upon whom we depend, whether they are family members, doctors, grocers, or plumbers, will do their jobs and meet their responsibilities in such a way to help us stay healthy, fed and safe. However, in an increasingly impersonal world, can we still trust? Can we depend on the right things happening, when we don’t know the nurse, the doctor, the plumber and the grocer?

I grew up the son of an immigrant who owned a small “mom-and-pop” grocery store in New York City. My father knew each of his customers, would physically give them the food, and would understand when they couldn’t pay at that moment in time and would try to help them. I vividly remember seeing lists of names—on the backs of envelopes and scraps of paper in the store—of people who owed money from when they needed food and couldn’t pay for it. My father felt he had a responsibility to his customers who needed the food; the fact that they couldn’t pay at that moment, he reasoned, should not stop them from having that food. There was no interest paid or collection agencies. There was simply trust. Sometimes, I would deliver the food to people’s homes when they could not leave the house because they were old or infirm. As a child, I was sometimes a little frightened going into strangers’ apartments in areas of New York that others would consider dangerous. Yet that, too, grew out of my father’s sense of responsibility—and the trust between my father and the people who needed the food.

So what does all this have to do with health decisions? Health is not only about what doctors, hospitals, or any healthcare providers decide. It is about the small decisions people make every day in thousands of ways, big and small. Here at Accolade, we tried to estimate the number of health decisions individuals make every year. We started with claims, as each claim represents a medical service that results from a decision. We added in over-the-counter medication use, gym use, and other “everyday” activities. We left out the decisions around food purchases--even though as a grocer’s son and a physician who is board certified in clinical nutrition, I believe food purchases to be among the most important health decisions. We also left out the decisions we all make around everyday activity, such as whether we park our car in a place far from our office entrance or as close as we can to avoid a long walk. The result: We estimated that the average person makes more than 2,500 health decisions a year. It is, admittedly, a poor estimate-- probably underestimating by a large factor; it also reflects the average person, not necessarily the sick person.

How are all these big and little decisions related to trust? If you want to improve healthcare decision-making, you have to be able to influence those thousands of small decisions—which means you must build trust with the decision-makers, who may or may not be the patient. In many families, the wife and mother is the main decision-maker for the family. It also means that health systems and health policy must support and facilitate good decisions by people even when those decisions are small, whether they are healthy or sick.

Let’s examine nutrition as an example. A recent Health Affairs article about nutrition highlighted the health consequences of an industrialized food industry that processes food—sometimes to increase affordability, sometimes to increase shelf life, and ultimately leads to obesity which leads to disease. Written by two former Secretaries of Agriculture, Dan Glickman and Ann Veneman, the article states:

“On the one hand, with obesity-related health costs rapidly rising, the federal government has encouraged people to make healthy dietary choices through efforts such as Let’s Move! and MyPlate. On the other hand, the federal government spends billions of dollars on traditional agricultural commodity programs that fail to reinforce the kind of healthy dietary choices outlined in federal dietary guidelines.”

This article was published at about the same time Sequoia Capital invested in a rapidly growing start-up company, Good Eggs.  Good Eggs is making locally sourced healthier food more available, offering a communication platform and delivery service for consumers with the farmers, bakers, and other food providers that is personal and easy. (Full disclosure: My son Rob Spiro is co-founder and CEO of Good Eggs; my goal is to someday bag and deliver groceries for them so I can go full circle from my youth.)

Good Eggs realizes that the answer is less about programs and more about fostering a personal system in which the local person who advises people and helps them is right there, helping them make better decisions. We need to replace the emphasis on an industrial system that is focused on large production and bulk delivery. We need to foster a trust based on the fact that you know the person who produces your food, that they know you and that you each have the other’s best interests in mind. You meet your local farmer on Good Eggs, can speak to him or her and end up eating healthier foods as a result of that personal trust. This trust, simplification and facilitation of smart, small decisions leads to better eating, lower rates of obesity and lower healthcare costs than any forced weight loss program. It is really about trust and people-to-people communication.

Technology can help facilitate this communication, but can never be the only answer. The folks at Good Eggs have found that they had to use creative and imaginative apps and technology, but that they also had to deliver the food and actually “touch” their customers, person to person. Bryan Shreier from Sequoia Capital in an article linked here talks about the need for tech firms to embrace operations and not assume the tech alone will be the answer. He uses the examples of Good Eggs, as well as Uber, the limousine service, as companies using technology to simplify and personalize a human interaction.

In healthcare, specifically, that need to facilitate the person-to-person interaction, which leads to better decision-making and better health and sickness care is even more urgent—and is our approach at Accolade.

Unfortunately, the health technology industry often seems to only focus on the "big data" and the “apps.” In an article in Fortune Magazine entitled, “Health Apps Don’t Save People, People Do,”, Ryan Bradley reviews a number of studies that show, when it comes to the treatment of obesity and diabetes, apps alone--no matter how enticing and technologically simple--are never as effective as person-to-person interactions. Bringing people together with each other and with educators and professionals on a regular basis positively influences their decision-making, and ultimately, their activities and the choices they make.

At Accolade, we see that every day in the small decisions that our Health Assistants help people make as they live their lives. The people we serve are trying to make a living, feed their families, and choose what to do about their ailments and lifestyle. No matter how big or small those choices are, the answer always lies in the trust and help we give each other. That social interaction gives strength to our fellow  human being, helps them through tough times, shares and celebrates good times—and creates the positive decisions and outcomes that bring better health and better life to people. While we use "big data" and "apps", ultimately we know that Angry Birds alone can’t do that. We know that technology can only be the answer when it is facilitating human interactions. 

Laura's Story

Recently, Laura Stout, a Health Assistant I work with at Accolade shared a story with me that has been passed down in her family.   I share it here exactly as she shared it with me, with her permission of course. 

“I have an interesting story about my Great Grandmother… 

She was working on the Family farm and had a serious farming accident during harvest.  A corn stalk punctured her lower leg and continued through her leg until it reached her knee.  She was 26 years old and had two kids under the age of five years old and a dairy farm to sustain.This wound was enormous and became infected which considering what they use as fertilizer, is no surprise. 

The shocking part of the story is that due to the “blood poisoning” caused by the infection in her injury, the small town doctor gave my great grandmother two options for treatment, “You can have your entire leg amputated, or you can die”.   

Well, this seems like an obvious course of treatment in the pre-antibiotic era, but what was not considered is that for a Mennonite woman in rural PA working a dairy farm and raising a young family, the loss of her entire leg was a worse option than death itself.  So, she said… give me death…. 

Well, my Great Grandfather was not as on board with this as an option, so he took my Great Grandmother from her “death bed,” to an Indian Medicine man who made a wash using unknown ingredients (in the story it was some type of ash water) and instructed her to rinse her leg day and night changing its wrap continuously.  

Long story short… My Grandmother was her fourth child.  My Grandmother talks about reaching up her Mother’s leg and feeling the scar and hearing the story as a warning during the harvest every year.”

This is a wonderful parable that illustrates a number of universal truths that we in health care see every day. 

• ·      Every family has their own stories, their own “mythology” that helps define the family’s values, beliefs and strengths.  Those stories help pass on from generation to generation core aspects of that family’s approach to health, illness, adversity and life itself.  Whenever you work in a helping field, the ability to have a person share their family story is extremely valuable in enhancing the professional’s ability to help that person and their family.
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•       Based on a person’s values, death may not be the most negative outcome.  In this story, the thought of being an added burden for the family that needed her was worse than death for Laura’s great-grandmother.  When health professionals help others, they have to understand that there are certain things that may be more important than health such as caring for a family and being true to one’s beliefs and values. 

• ·      Everyone can be totally open, and be totally correct and yet be incomplete in their “truth”.  Thus the country doctor was absolutely correct from his training and perspective that the only choices were amputation or death.  The medicine man’s knowledge of what were certainly antibacterial substances was unknown to the doctor and therefore the doctor’s knowledge was incomplete.  Even in today’s advanced medical world, an expert in a narrow area of medicine can easily miss options that are available outside of his or her area of expertise. 
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•       Lastly the power of a narrative, a story used to communicate, should be strongly valued.  We are truly fortunate to have narratives before us daily and we should always strive to capture them, learn from them and use them to teach others.  

Disease, Illness and Suffering

Health policy tends to focus on population issues such as costs, access, and outcomes and in recent times has developed strong interest in evidence based medicine, changing behavior within communities, insurance exchanges, and encouraging consumerism.  These are all important concerns however I fear we all lose when we focus too much on the policy and not enough on what that policy means to the individual in need.  We may be missing critical components of the nature of disease, illness and suffering as we push to redefine patients as consumers of health care services in order to lower costs and broaden access.  While those policy efforts bring benefits, they also have the potential to harm individual patients and their families.  For me as a physician and for most health professionals, patients are more than consumers and illness and suffering are more than the biology of disease.  For clarity, we need to define disease, illness and suffering.  

• Disease: Any impairment of normal physiological function affecting all or part of an organism, especially a specific pathological change caused by infection, stress, etc., producing characteristic symptoms. 
• Illness: The experience of a person who has a disease including the psychological, the social, the financial and the spiritual.  Different people experience diseases differently and that difference makes illness unique for each person. 
• Suffering: The feeling of pain, loss, fear, loneliness, stress and even spiritual angst that can be associated with disease and illness however may also be present in the absence of any biological stress. 

These distinctions are important for individuals and for policy.  People want to be understood as unique and autonomous when they are in a time of need.  Evidence based medicine which is solely focused on the physiology of the disease may not fit the experience of the illness they have and they feel.  An evidence based disease protocol that calls for medications that are too expensive for a particular patient or for advanced diagnostics that are not available in a certain community and requires travel and time away from work and family do not fit the patient’s illness which is their reality of the disease.

 

Recently at Accolade, we assisted a woman who has a disease called pseudotumor cerebri.  She lives in an area in which the best physicians and facilities to treat her disease are about four hours away by car at a renowned academic medical center. We had originally helped arrange for her initial care at that academic center.   The reality of her illness, as opposed to her disease, includes the fact that she cannot drive four hours and her husband cannot take time off to drive her as he is at risk of losing his job if he takes more time off of work.  So she will not go back to that academic center even though she had her initial successful treatment there.  We are now helping her get the best possible care for her disease and her illness closer to home by marshaling local resources for her.   The risk of receiving care that is potentially not as good as the care at that academic medical center is worth it to her to maintain her way of life and to avoid further work stress for her husband.  We are helping her with her illness not only her disease. 

In health care and in health policy, we tend to focus on suffering in situations in which someone has a terminal disease that is beyond our abilities to cure however suffering is seen in any number of illnesses and even in the absence of an illness.  A person who has lost a job and cannot care for their family is suffering without an illness.  We recently had the occasion to help a woman whose husband died after he saved her from a riptide when they were swimming in the ocean.  That woman was not sick but was profoundly suffering.  On her third call with an Accolade Health Assistant, this woman spent time crying with her Health Assistant and grieving at her great loss.  She needed someone she trusted to just listen and be that shoulder to cry on.  She needed someone to be with her through her suffering.  

I think about these cases because we cannot “fix” healthcare, making it affordable and accessible until we acknowledge and address illness and suffering and not only disease.  That means realizing what is important to families and not only the important biological facts.  Daniel Sulmasy, a Franciscan monk and a physician who is on the faculty of the University of Chicago Medical School and the University  of Chicago Divinity School has written eloquently for years about the need for patients' illnesses and suffering to be recognized and “treated” as effectively and diligently as their disease. 

In his books, Sulmasy points out that the role of a health professional is not merely to cure and treat disease, but to address illness, and perhaps most of all to relieve suffering.  He points out, “the need for medical care is not like the need for automobile repairs or a haircut”.  He quotes Robert Sokolowski, the eminent Catholic theologian and professor of Philosophy as saying, “The medical need is special not because my body is at issue but because I am at issue.” 

Sulamsy writes, “They (People) want a form of medicine that can heal them in body and soul.”  “They seek a form of medicine that treats them as persons – a form of medicine that acknowledges what science cannot see or hear or accomplish.”  He goes on to say in describing the limitations of purely science based medicine, “Patients came to feel like scientific specimens rather than human beings.  Iatrogenic (illnesses caused by medical practice) grew steadily more prominent with every scientific success.  Some side effects have been even more social than biophysical…..The solutions to these problems…have been diagnostic of its affliction – more nursing homes, more neonatal intensive care units….Empathy and mutual acceptance of the frailty of our common humanity have come to be considered anachronistic.” 

Sulmasy knows that the pain of being alone when you are sick is not eased by having an MRI.  The suffering of something as simple and “minor” as an upper respiratory viral infection is not eased by antibiotics that won’t cure a virus but will make it feel as though someone cares enough to take action.  We need more caring and less unnecessary testing and medications.  We need more caring and fewer interventions that do not contribute to improvement in life.  We need more treatment of the illness and easing of the suffering while we treat the disease. 

The irony is that modern health policy, by focusing only on disease increases costs as people try to find solace and understanding through the lab and the pharmacy.  It is only by caring for people through their illnesses and their suffering that we can achieve true savings as people stop trying to find answers and solutions where none exist.  To paraphrase Professor Robert Sokolowski, we must always keep sight of the person, the “I” and not only the body.

What is “Best” Care and How is it Determined

In medicine, randomized controlled studies have long been the gold standard in defining the “best” care. In these types of studies, usually two large groups of patients, the larger the better, receive the same care except for one intervention that is different for each group and the results are compared. This defines the best care medical science has to offer. No one disputes the usefulness of these types of studies, however, are they enough? Do they really tell us all we need to know about the care of an individual? 

A recent article in the journal “Medical Decision Making” by Bruce Barrett M.D. entitled Sufficiently Important Difference: Concepts, Caveats, and Challenges questions whether our approach to using and interpreting these studies is adequate. The article looks at randomized controlled studies and the facts that they define in light of a new reality in health care. The new reality is that the value from the patient’s point of view is the key factor that must be taken into consideration when doctors and patients make decisions about care. That patient point of view has rarely been used as an end point in randomized controlled studies and the evidence based medicine that results. Dr. Barrett defines this focus on value from the patient’s point of view for clinical research design purposes as the “sufficiently important difference” (SID) or the “smallest worthwhile effect” which he defines as “the smallest amount of patient-valued benefit that an intervention would require to justify associated costs, risks and other harms.” He then adds, “SID is understood in the context of existing evidence and is measured at the individual level.” Measuring at the individual level is earthshaking for clinical researchers and for those who apply clinical research to the practice of medicine because when randomized controlled studies are done, the gold standard for results is always population based. While individual decisions must be informed by population statistics, the real impact of a particular intervention on an individual may not perfectly fit a population fact found by study. By telling us that the way to do clinical research is by measuring at the individual level and that it be “patient-valued” Dr. Barrett is telling us that we have to look anew at the outcomes of studies and as a result, many of our favorite “facts” and “goals” in population health and in the diagnosis and treatment of disease. A recent case in the news illustrates this point. As I write this an 11 year old girl is going home from the hospital after receiving a double lung transplant. The standard of care based on population evidence and expert consensus is that this lung transplant should not have been allowed to happen since this child was considered too young to receive adult lungs. A persistent legal and public relations fight by her parents forced the circumvention of this rule and this child is going home now with new lungs. The population facts were not disproved and remain helpful; they just did not perfectly apply to this young girl.

Dr. Barrett in this article points out that evidence based decisions, which are usually based on randomized controlled studies are not perfect in their design and suffer from their own limitations including “1) difficulties in forecasting individual outcomes from observed group effects; 2) the fact that negative outcomes are underassessed and underrepresented; and 3) the high degree of variability in how individuals value and weigh various positive and negative outcomes.” 

He does not say this in a policy journal or in a popular magazine. He makes these statements in a journal that only a statistician can really love. The science of medical decision making and the articles written in this journal are more geared to statistical researchers than to clinicians. In this same issue, there is an article entitled, “Development of a Framework for Cohort Simulation in Cost-Effectiveness Analyses Using a Multistep Ordinary Differential Equation Solver Algorithm in R”. For the journal Medical Decision Making, that is a relatively common type of title. I mention that only to make the point that Dr. Barrett is making these pronouncements as a way to improve analytics and as someone who believes in scientific and even mathematical approaches rather than as a moral argument. 

However he does realize that there is a moral dimension to his argument. After making a convincing case that “Patient-oriented evidence that matters (POEM) is superior to disease-oriented evidence (DOE), such as biomarkers or surrogate markers” on analytic grounds he goes on to say,

“Given this background, I would hazard the contention that the current system may to some extent be both unethical and irrational. Difficult questions must be asked: Is it rational to implicitly value benefits more than comparable harms? Should we continue to design and interpret trials based on benefit effect size only, ignoring harms? Is it ethical to take decision making away from individuals (guided by their clinicians) and to instead give that power to medical scientists, insurance companies, technocrats, and policy makers who set guidelines and formularies that determine care? I don’t believe that any of these questions should be answered in the affirmative.”

Thus he defines the challenge to the good, ethical clinical researcher and to the practitioner trying to follow evidence based medicine and best medical care. The challenge is at the least, to interpret randomized controlled studies with outcomes that are defined by patient values not only population metrics. It may mean moving to a whole new paradigm of clinical study that builds upon randomized controlled studies in new ways to measure these important patient-oriented outcomes that matter. He argues that until we understand how individuals value various benefits and harms we cannot really say what the best course is for a patient who is ill. For the practitioner that means knowing who your patient is as a person and not only knowing the biology of their disease. Ultimately, his scholarly analytic approach supports the contention that each individual is unique and autonomous with his or her own values that must be supported and respected.

Review, Quality Control and Arrogance

In 2002, I had an 80% right coronary artery narrowing that resulted in my having an angioplasty and a stent placement.   I thought of my procedure when I first read of the coronary artery stent placement performed on former President Bush and when I subsequently read the Washington Post opinion piece entitled “President Bush’s Unnecessary Heart Surgery” written by Drs. Vinod Prasad and Adam Cifu.   While I understand the authors concern that people who are asymptomatic will mistakenly interpret President Bush’s stress test and subsequent stent placement as meaning that this sort of approach should be taken for everyone, I am even more concerned about their strong statements that the former President’s care was wrong.   In their zeal to prevent unnecessary and potentially dangerous care, the article crossed a line by proclaiming judgments on medical care based on limited facts and incomplete information.    They presented as absolutes, decisions made daily by caring physicians and informed patients that are often more nuanced than they appear.  Medicine exists in the realm of uncertainty and consists of the constant balancing of risks and benefits for individuals.  Within this realm of uncertainty there still must be quality control to protect the public from dangerous and unnecessary care since doctors are human and make mistakes.  However, there is a difference between careful and thoughtful quality control and Monday morning quarterbacking.  There are four major factors that cause me to pause before I make the kinds of absolute statements that are made in this article.  These same factors also cause me to hesitate before endorsing many of the decisions that insurance carriers and regulators can be too quick to make about payment for services and quality of medical providers. These factors are:
Facts Change:
Back to my angioplasty and stent in 2002.  At that time, I had what was considered to be the correct standard of care.  The cardiology department at the Harvard teaching hospital where my procedure was done was steeped in the academic studies that rigorously followed the facts in the medical literature.  Today the facts are different as pointed out by Drs. Prasad and Cifu because as more information and different studies are done, facts change.  In an article published in the October 2012 issue of the American Journal of Medicine, Dr. Joseph Alpert points this out quite eloquently.  He states in the article entitled, “What Is True Today Is Often Not True Tomorrow”, “In fact, it is likely that many of our current medical beliefs will turn out to be untrue or only half true as a result of information obtained through subsequent scientific investigation.”
Populations Change:
When studies are done, the population is often defined in one way; however as more facts become available, certain subpopulations are defined that do not necessarily follow the lessons learned from the broader population.  Thus, as an example, women with breast cancer as a population do not benefit from removing the unaffected breast.  The smaller subpopulations of women with breast cancer who are positive for the BRCA gene however do benefit. 
Context Matters:
If someone cannot afford medication, then prescribing a medication that they will not take is not good care, even if the care pathway says it is.  Context is any factor that may make the “correct” approach or therapy not be applicable.  Every few months, I get the obligatory letter from my health plan saying that I should be on an ACE inhibitor due to my history of heart disease.  With my history, taking an ACE inhibitor every day is a good idea and is a part of many care guidelines and standards.  The health plan does not see my context which is that I don’t tolerate ACE inhibitors because they cause me to cough.   Context can be medical issues, social issues, even religious issues.  When I was in practice I cared for a number of people who were Jehovah’s Witnesses.  As part of their religious beliefs they often refused blood transfusions which, as a gastroenterologist treating them for bleeding from their GI tract caused me to modify my approach in order to respect their religious belief.  I found that they could be treated successfully even while being sensitive to their culture and their beliefs, however, the treatment often was not in keeping with the standard care approaches.  Context can be related to issues of culture or simply related to issues of communication and trust.  Dr. Saul Weiner and his group at the University of Illinois have studied context in medical care and have found that care quality is compromised and care outcomes are worse if doctors and nurses do not actively ask about contextual issues and change their approach based on the answers to those questions.
We don’t know the context of the former President’s procedure (although I suspect it was not a financial issue).
Real, Pertinent Information is Often Limited Outside of the Patient and Caregiver:
Perhaps the most intelligent statement made in the Washington Post piece by Prasad and Cifu is “Few facts are known about the case”.  In the case of the former President, we don’t have all the facts about what was said between doctor and patient.  We don’t know if President Bush had mild jaw pain that was considered to possibly be atypical cardiac pain during the long bike ride that was noted.  We don’t know if his ability to do other activities had been affected in small ways that his physician believed to be a warning sign.  The fact is that both media reports, and also the claims data that health plans depend on, are very limited and usually do not include the small clues that may lead a physician and patient in partnership to decide on a specific course of action.  Even electronic medical records may not have all the necessary facts.  It is the height of arrogance to think that through media reports we have enough information to make these types of statements.   We also can be misguided if we make payment decisions and judgments on the quality of care a physician is providing for an individual patient solely on claims data. 
I think there is another way.  I think there is a way to encourage good individualized medical care without the second guessing that is becoming even more prevalent in medicine, insurance and in public policy.  There is a way to include context in care pathways and guidelines; to develop quality systems that review patient physician interactions based both on outcomes (and right now the former President’s outcome looks pretty good) and on the process of individualized care.  That will require more communication and integration within medicine, that goes beyond system integration and back to physicians and nurses actually talking to one another and talking more with their patients.  It will also require that we acknowledge that medicine is really about uncertainty and that includes uncertainty about applying the ever evolving science of pathophysiology to the individual patient to maximize the value to that patient.  It will require a rethinking of our belief that every person fits neatly into a care guideline or insurance medical policy and that claims data can adjudicate every medical interaction easily.  It will require less arrogance and more cooperation and coordination in the pursuit of the best result for every patient.