Professionalism: Secondary Goals

Robert A. Raschke, MD

Banner Good Samaritan Medical Center

Phoenix, AZ

Please recall my lengthy disclaimer from Part 1 of this series.

In part two, we reviewed the Oath of Maimonides. We considered our profession as a sacred vocation. We defined professionalism: A good doctor can be trusted to always place his/her individual patient’s best interest first, with ability, good judgment, and a caring attitude. We determined that we should be willing to make sacrifices in our commitment to our primary goal (as critical care physicians) – getting our patients and their families through their illness with as little disability and suffering as possible.

Now, my second disclaimer – I am going to express my opinions from atop my Ivory Tower – as I am not in private practice, and protected a bit from the harsh reality of the business world. I am going to express my possibly somewhat naive perspective on secondary goals related to our profession. These are not necessarily bad, but they may distract from our primary goal. I personally feel that I have to de-prioritize these goals in order to do what’s best for my patients.

It is not your primary goal to run your business.  I’m employed in a teaching hospital - so I can speak to this issue without having to "pay the overhead". However this was a personal choice I made early in my career, at a time when it was an unpopular and poorly-paid career path. I was able to afford it because my wife and I kept modest personal finances. The small home we raised our children in for 20 years cost less than twice my starting salary of $65,000. We have been blessed by not having to worry much about money along the way.  

The good salary we make as doctors ought to be used to achieve financial security in a modest lifestyle, so that we are less vulnerable to financial incentives. Remember, we did NOT go into medicine for the money. I’ve observed that some of my colleagues who spend a lot of money in their personal lives get caught-up in business practices that are not the best for their patients. I’ve also observed that some of the highest-earning physicians are most likely to suffer financial anxiety or even personal bankruptcy. Separate physician and business duties as much as possible .  Don’t hang out with or take gifts from medical salespeople that you would be at-all ashamed to tell your patients about. If you find your actions as a doctor are being unduly influenced by financial incentives, consider whether you can simplify your personal finances.

It is not your primary goal to have your patients or colleagues like you, as long as you are acting with good judgment and good attitude, in the patient’s best interest. One of my partners recently had a very frank discussion with a patient who was strongly suspected of Munchausen’s disease. Her self-destructive behavior had resulted in numerous ICU admissions and over 20 unnecessary endotracheal intubations. It was crucial to the care of this patient that this diagnosis was confronted, to avoid other unnecessary and dangerous interventions, and so that the underlying psychiatric disease could be treated. But this confrontation prompted an angry response. The patient filed an official complaint. This complaint came at a very bad time for my partner, and actually threatened costing him his job – although thankfully this did not come to pass. I hope he is able to do the right thing again next time, but it can be hard in a system where incentives for universal patient satisfaction are strong.

Another of my partners recently expressed exasperation with the more common difficulty of properly communicating poor prognosis to overly-optimistic family members who are praying for a miracle. We agreed that we have an obligation to express the truth – withholding poor prognostic information is essentially a lie of omission. Sometimes family members misinterpret this as a pessimistic attitude rather than plain old-fashioned honesty, no matter how much compassion we bring to the topic.    

I have injured my friendship and working relationship with several of my colleagues over the years because of disagreements over what was best for the patient. Conversely, some of my most shameful actions as a doctor were committed in an attempt “smooth things over” with colleagues that appeared to be trying to achieve the impossible, usually in relation to what I perceived to be futile care.

Several years ago, I was called to the bone marrow transplant unit to intubate a young woman with recurrent acute leukemia. She had previously failed two allogeneic bone marrow transplants, and had just failed an investigational chemotherapy protocol. She was in blast crisis, and rapidly developing multisystem organ failure. Worst of all, she had grade IV graft-vs-host disease and suffered florid gastrointestinal symptoms and was covered in skin lesions. She was non-communicative due to multifactorial delirium. Her family trusted the transplant hematologist, having known him for years, and they believed him when he told them that he could still save her.  

The transplant hematologist and I had had many disagreements in the past in situations in which I felt that patients and their families had been subjected to unnecessary suffering in futile situations, but up to this point, we had always been able to find at least an uneasy alliance. This time though, I flat out refused perform the requested intubation, and instead strongly recommended comfort care. I explained by rational to the patient’s family, who reacted with anger.  The transplant hematologist consulted a critical care physician from another group who came and inbutated the patient. The patient died several days later, during infusion of stem cells as part of a third transplant attempt.

This conflict damaged the working relationship between our groups, and hurt everyone’s job satisfaction, because we all enjoyed supporting the good work done in our bone marrow unit. It also hurt our group’s billings. But as best I can tell, my partners understood and supported my decision.   

It is not your primary goal to avoid a lawsuit. It is an incredible blessing not to get sued in the course of your career. Besides the obvious drawbacks, the stress of a lawsuit can seriously degrade your capacity to concentrate on taking care of patients, and even lead to physical illness. A lawsuit may even be career-ending – several very good clinicians that I know have made drastic career changes as a result of lawsuits. One perinatologist became an acupuncturist after a lawsuit involving an unpredictable complication of a blood transfusion. Others dropped out of critical care to practice office medicine or take administrative jobs.

But our primary goal takes precedence over medical-legal concerns. The practice of defensive medicine often leads patients to suffer complications of medically unnecessary procedures. Honesty in disclosure of errors is an ethical facet of our profession that often conflicts with the desire to avoid lawsuits. I once disclosed a major error in anticoagulation therapy that led to potentially disfiguring complications of cosmetic facial surgery to a young woman and her husband – this motivated them to send a letter to the CEO of our hospital at the time (the guy who signs my paycheck). Another time, I disclosed to a family that a patient’s previously unexplained in-hospital mortality had been determined to be caused by a transfusion-related West Nile Virus infection. I had exerted a major effort to make this obscure post-mortem diagnosis, the discovery and disclosure of which led to a request for records from a law-firm retained by the family.

I very much appreciate the help of the lawyers and paralegal staff of our risk management department, but I purposely avoid asking them for advice in situations when I already know the right thing to do for the patient. 

It is not your primary goal to achieve external measures of “quality” or utilization. Recently, the idea of physician “report cards” has been popularly embraced, and many employed physicians now have financial incentives based on surrogate measures of quality-of-care. Unfortunately many of the pooled outcomes used to define quality are difficult to interpret in the care of an individual patient. Recall the story of the liver transplant patient who received prolonged futile care (related in part 2 of this series). Note that the initial, poorly-focused care of this patient benefitted the 12-month mortality statistic for the transplant program, while appropriate comfort-focused care of the patient worsened the ICU mortality statistic. This example shows how statistics that sound like very valid measures of quality can be very misleading.  

Other surrogate markers of “quality” are initially supported by what seems like high-level experimental evidence, but are later found to lack benefit, or in some cases even cause harm. Recent examples in our specialty include early goal-directed therapy for severe sepsis, tight glucose control and the use of drotrecogan-alpha (Xigris^®).

Even valid surrogate measures of quality are likely to greatly oversimplify what it means to be a good doctor, focusing excessively on a few particular elements of care, and distracting from aspects that might be more important to an individual patient.

I resist being incentivized to achieve any measure that may conflict with my primary goal, but also think we ought to analyze our “quality data” with open and self-critical minds. I do my best to use it to learn to how to make myself a better doctor, rather than concentrating solely on making my statistics improve. I think it is best to simply do the best job you can for each individual patient, prioritizing the things that are most important to that person, and let specific individual data points that others use to define quality fall where they may.

I don’t like being on committees, but I force myself to be involved in the process by which quality measures are chosen. I bring skepticism to the meetings, even in regards to practices that are currently “evidence-based” – because history proves that many of these will eventually be found to be erroneous. I try to champion quality improvement processes that make the most sense, such as hand-washing, and getting unnecessary invasive hardware (such as unneeded Foley catheters, and IV lines) out as soon as possible.

Unfortunately, the un-professional behavior of a few among us has damaged the trust that most people have for their doctors, providing a rationale for monitoring and incentivizing our behavior. But real professionals don’t need to be financially incentivized to do what’s right. It is my opinion that the people who most want to incentivize us (politicians and administrators) do not have the wisdom to pick the right actions to incentivize, and may not always have the individual patient’s best interests at heart.

Capacity: You have to be cognitively, psychologically and physically healthy to do your best work as a doctor. I studied medicine pretty hard during my training, but I am fundamentally intellectually (and all-around) lazy. Once I went into practice, I found I had trouble keeping current with medical literature, no longer having to worry about board exams. Trying to force myself to read worked about as well as most diets. Eventually the problem was solved when I started a monthly Critical Care journal club with our fellows. This forced me to review the current literature each month, and actually read the articles carefully. We each have our own ways to stay current, but having a teaching job is a big advantage. It justifies study as a job duty, and protects some time for you to work on it.

Happiness in your personal life will reflect on your ability to survive stress and maintain the right attitude at work. My wife Carolyn has been a wonderful blessing to me in this regard, and has helped me be a better doctor. Back in the days before we took night call, whenever my pager went off at night, it woke us both up. I would call in and try to figure out over the phone whether the patient was sick enough to warrant getting out of bed and driving in to the hospital in the middle of the night. It was pretty obvious to Carolyn that my ability to make good decisions when awoken from delta waves at 3 AM was questionable at best.  She suggested that I should just go in and see every ICU admit no matter how things sounded over the phone.  “You don’t do anything but toss and turn in bed anyway worrying that you should have gone in”.

This was a little extreme at the time for a teaching program, because we already had interns and residents in house all night. But it was endorsed by my wife, and it helped improve our patient care. The system was adopted by our entire group and practiced until we switched to 24-hour in-house coverage.  My happy marriage and supportive home life are an important counterbalance to the disappointments I often face in the ICU.      

Exercise regularly – you ought to be able to get some exercise even during your busiest work weeks. Whether you like running, yoga, weight-lifting or playing with your dog, your physical capacity and ability to concentrate will benefit from regular physical activity outside the hospital. I try to do some form of exercise at least twice a week, no matter how late I get home, even if it’s only for ten minutes.

Don’t take a job that will exceed your capacity to provide good care. I have seen hospitalists with a work list exceeding 50 patients for weekend rounds. No matter how efficient you are, no one can reliably do a good job with that magnitude of work load.

Feel free to comment if you disagree with part or all of the above. They are just the personal opinions of a confessed ex-altar-boy and boy scout!

END OF PART THREE  (next: part 4: “Attitude”)   

Reference as: Raschke RA. Professionalism: secondary goals. Southwest J Pulm Crit Care. 2014;8(6):349-53. doi: http://dx.doi.org/10.13175/swjpcc081-14 PDF

Professionalism: Definition and Qualities

Robert A. Raschke, MD

Banner Good Samaritan Medical Center

Phoenix, AZ

[Please recall my lengthy disclaimer from Part 1 of this series.]

Moses Maimonides (1135-1206 AD) was a Jewish rabbi, philosopher and physician who studied and practiced in northern Africa. The Oath of Maimonides expresses his attitude towards our shared profession, that is still applicable to the bedside in a modern ICU:

"The eternal providence has appointed me to watch over the life and health of Thy creatures.

May the love for my art actuate me at all time; may neither avarice nor miserliness, nor thirst for glory or for a great reputation engage my mind; for the enemies of truth and philanthropy could easily deceive me and make me forgetful of my lofty aim of doing good to Thy children.

May I never see in the patient anything but a fellow creature in pain.

Grant me the strength, time and opportunity always to correct what I have acquired, always to extend its domain; for knowledge is immense and the spirit of man can extend indefinitely to enrich itself daily with new requirements. Today he can discover his errors of yesterday and tomorrow he can obtain a new light on what he thinks himself sure of today.

Oh, God, Thou has appointed me to watch over the life and death of Thy creatures; here am I ready for my vocation and now I turn unto my calling."

I want to try to define professionalism, then call-out distinct qualities required to do the job right, as enumerated by Maimonides.

Definition of professionalism for a doctor: A good doctor can be trusted to always place his/her individual patient’s best interest first, with ability, good judgment, and a caring attitude.

Maimonides points out, first and last, that it is a privilege to be a doctor –not just a career (the word career implies that our main purpose is to make a living for ourselves).  Being a doctor is a sacred vocation. Our profession is first and foremost one of being a servant to others, not to ourselves. I personally can’t reliably maintain this attitude every minute of the day, but I try to remember it as often as I can. In addition to this proper attitude, Maimonides describes commitment, capacity, compassion and humility, which we will discuss shortly. But let’s start with “attitude” - just as Maimonides did.

I once very briefly took care of a 57 year old woman with a past medical history of short bowel syndrome, dependent on intravenous feeding. She had acutely developed Klebsiella pneumoniae sepsis of unclear origin and acute renal failure. She was receiving antibiotics, stress-dose steroids and dialysis. During her hospital course, she developed belly pain, and a CT showed pneumatosis intestinalis. The surgeon initially recommended conservative medical care, but after 72 hours, her condition deteriorated and he decided to operate. I saw her in the early afternoon on that day, just before the operating room technicians arrived to take her down to the OR. By this point, the proper course of action was already decided, and nothing I was likely to find on physical examination was likely to change it. So I looked her over briefly - put my stethoscope on her chest without listening very carefully - already thinking of the list of other patients I had left to see that afternoon. But as I straightened and prepared to leave her room, she told me that she was scared she was going to die.

Fortunately for me, I wasn’t terribly inpatient that day. My work list wasn’t too long.  I decided to mentally put my work aside*, and spend a little time with her [in retrospect, this thought that it was not “my work” to spend some time talking with this patient was obviously incorrect]. I brought a chair into the room and sat at her bedside. She told me some things about her life that I previously had no idea about – personal goals that her illness had prevented her from fulfilling. Now she felt she might never have another chance. I actually believed that she would come through the surgery OK.  I listened, and was able to comfort her a little. We ended up holding hands and saying a prayer together. The transport personal showed up to take her to the OR, interrupting us a little, but we had had a nice quiet moment together. I told her I would check in on her after her surgery. But she developed intraoperative complications and died in the OR, never again regaining consciousness.

This surprised and deflated me when I was notified shortly thereafter. Then it struck me more deeply that I was the last person on earth to talk with her before she died - perhaps with the exception of the anesthesiologist asking her to count backwards from 100. What would this patient’s sister, or best friend have given to trade places with me in that quiet moment we had together? The privilege that this represents is astounding. Whether you believe in God or providence, there was a reason that we are given such opportunities that goes way beyond simply making a living. The great opportunities we share demand our commitment.

Commitment: being willing to make sacrifices in an unswerving effort to achieve a single goal. Our primary goal, as taught to me by my friend and mentor, Tom Bajo, is to get the patient and their family through their illness with as little disability and suffering as possible. This sounds very straightforward on paper, but it can be hard to keep your eye on the ball in complicated clinical situations.

Consider the following story:

A 54-year-old patient who was admitted to the hospital with a chief complaint of “I feel terrible”. He underwent a liver transplant 12 months before, but was suffering transplant rejection despite treatment with tacrolimus and rapammune - drugs that had inflicted significant side effects. Over these past 2 months he suffered progressive severe liver failure, and had been turned-down for a salvage transplant. He had suffered recurrent episodes of acute renal failure, severe nosebleeds, unremitting diarrhea, encephalopathy, and depression.

In his admission history, his symptoms included nausea, anorexia, muscle pain, headaches, weakness, belly ache, recurrent nose bleeds, general debilitation and vomiting-up bile and all his medications. He had been admitted 3 times in the prior 2 months for similar complaints, only going home for a few days in between admissions.

At the time of his physical examination it was noted that he was cachectic, somnolent and deeply jaundiced. When the nurses tried to place a Foley catheter, the patient refused – the nurse quoted him in the chart as despairing: “I’ve been through so much.”

The patient expressed his wish to be made DNR to multiple physicians, and an order to that effect was written. But he was incredibly debilitated, and his ability to defend his decision was weak. A few hours later, a specialist spoke with him and rescinded the DNR order.

The primary managing physicians made the following assessment of the patient:

1. pancytopenia secondary to liver failure
2. volume depletion causing acute renal failure
3. hypercalcemia partially related to immobility
4. rhinorrhea, possibly secondary to CSF leak

(this later diagnosis seems odd, but was influenced by the patient’s complaint of a persistent runny nose after treatment of the patient by an ENT doc who was consulted to treat his nosebleeds – it was hypothesized that the treatment might have been complicated by a fracture of the patient’s cribiform plate, resulting in a cerebral spinal fluid leak)

I want to pause the story here for a moment to consider this assessment. It strikes me that it is almost unrecognizable in relation to the patient lying in the hospital bed. The assessment that lays more closely to the truth, and that would have better guided appropriate therapy is:

1. the patient is dying.
2. the patient is suffering.

The following management was ordered:

CT scan of brain and sinuses, spinal tap, neurosurgery consultation, ENT consultation, cefepime and vancomycin antibiotics, lab tests including TSH, free T4, iPTH, 1-25 vitamin D, 25-hydroxy vitamin D, SPEP, UPEP, Beta-2 transferrin of nasal secretions, Fe, TIBC, ferritin, methylmalonic acid level, homocystiene and fractionated bilirubin (looking for hemolysis).

I can’t say what thoughts were in other people’s minds, but their actions speak about the goals they were committed to achieving. Some appeared to be committed to merely keeping the patient alive. Some appeared to be committed to making obscure diagnoses that were highly unlikely to bring any relief to the patient. Some who privately felt the reversal of the DNR was wrong, seemed committed to preserving their working relationship with the specialist, who is a highly respected physician. Many doctors felt that what the patient really needed was comfort care, but nobody committed to that as their primary goal.

The patient suddenly lost consciousness, was found to have suffered a massive intracranial hemorrhage, and was transferred to the ICU – astoundingly for "a higher level of care”! By this, they meant more intervention – possibly endotracheal intubation. But now, my partner Jennie assumed authority for his care, and she immediately re-established DNR status and initiated comfort care.

If you are going to commit yourself to a single goal, pick the one that is achievable and most important to your patient, then chase it to the best of your ability with a caring attitude.

There are many false primary goals in medicine – not necessarily bad goals, but distractions from the best goal. We all need to de-prioritize these in order to be better doctors. In part 3 of this series, I will review some of these (likely getting myself in further trouble).

Reference as: Raschke RA. Professionalism: definition and qualities. Southwest J Pulm Crit Care. 2014;8(5):291-6. doi: http://dx.doi.org/10.13175/swjpcc071-14 PDF

Professionalism: Introduction

Robert A. Raschke, MD

Banner Good Samaritan Medical Center

Phoenix, AZ

Editor's note: This is the first of a multi-part series on professionalism. The remaining parts will be posted over the next few weeks.

An important event in my career occurred about 20 years ago, late on a Friday afternoon. I was scheduled on call in the ICU for the entire 72-hour weekend, and even though I was just getting started, I was already tired and in a lousy mood. At 5 PM, I got a consult to see a patient in the neuro ICU. He was a 34-year-old man who had attempted suicide by drinking ethylene glycol antifreeze after an argument with his girlfriend. He had initially stabilized from a medical standpoint, but then developed delayed-onset cerebral edema. The team that was taking care of him had unsuccessfully pursued all treatment options. After 8 days of effort, he remained in a deep coma, near brain death. Now, with nothing left to try, and no hope left for a good outcome, they were dumping responsibility onto me just in time for the weekend.

I considered this unhappily as I began to page through his thick chart, trying to suppress my frustration so that I could concentrate, but I was interrupted by the patient's nurse – Terry - before I could get very far. She told me that the patient's mom had just stormed into the unit, and was demanding to talk with her son’s doctor - which as of the last 10 minutes was now me.  She warned me that the patient’s mother was inpatient, accusatory and totally unrealistic about her son's prognosis, but despite all this, Terry acted somewhat relieved that I was there. The impression that she was somehow happy about the situation made me even more angry than I already was. 

I had had enough. I really gave Terry an earful– outlining all my suspicions about the bad motivations of the referring team and concluding with my refusal to do their dirty work. Somehow, in my self-centeredness, I expected her to empathize with me. But she didn't. Instead, she appeared to be somewhat shocked and deflated. She listened silently to my rant, then turned and walked away without saying anything.

It took me a few minutes to realize that she had a higher opinion of me than I had of myself. She had thought I was a good doctor– strong enough to shoulder a tough situation– compassionate and empathic for a bereaved mother - ready to take on this challenge and make a bad situation a little better. I had proved her wrong.

I always thought of myself as a good doctor, but I realized then that I really wasn't all that good. I composed myself and tried to reset my thinking. I introduced myself to the patient’s mother briefly after explaining that I hadn't had time to review all the records– later, we would sit down and really talk. She actually wasn’t as unreasonable as I imagined she might be. It turned out I did have an important job to do in this case– to help a grieving mother come to terms with the death of her beloved son. The next day I apologized to Terry– this turned out to be a good long-term investment, since we continue to work together to this day.

This was an experience that got me thinking about how I could try to become a better doctor. Not by studying in order to get smarter, but by having the proper goals and attitude– the things this series is about.  Recounting this story also gives me the opportunity to admit that I claim no special personal legitimacy to write a series for SWJPCC on professionalism. I am pretty lazy at times. I have a temper when I’m under pressure. I can sometimes be hurtful to nurses and residents. There are even a few people who would consider it the height of hypocrisy for me to come off like I know anything about being good.  During the week in which I first began writing this section, I did a bunch of very unprofessional things– things I was ashamed of them even as I was proceeding forward with them:

1. I got a page about a patient that was deteriorating just as I sat down to a very nice lunch. The patient was a young, otherwise– healthy alcoholic. I decided to relax and finish my lunch before heading up to see him. By time I finished dessert, he had deteriorated and was extremely unstable. 
2. I had misgivings about a patient’s DNR status. I thought the family might rescind the DNR order if they fully understood the clinical situation. But I didn’t want them to rescind DNR status, so I purposely avoided talking to them. 
3. I missed the essential (and not obscure) physical finding of abdominal pain in a patient with septic shock on steroids– a clinical mistake that I’ve repeatedly lectured others about during Mortality and Morbidity conference. This error delayed diagnosis of a life-threatening bowel perforation.
4. I declined a personal invitation to attend the memorial service of a patient that I felt very close to– who had in fact asked me for a hug the last time I had seen her before she died. Instead, I sat at home and watched TV.

So no, I am not an expert at professionalism. But I do care about it. So I am not going to write about the doctor I am, but about the doctor I want to be. Please look at this series in that spirit and do not allow my personal shortcomings to undermine our consideration of this topic.

Why discuss professionalism in medicine? I've considered the possibility that the age of professionalism is over– that talking about it is like trying to get your kids interested in playing the board-game Monopoly. Technology is the thing nowadays. It’s incredibly satisfying to help save a patient’s life with ECMO in the ICU. Yet some technological advances increasingly distance us from our patients.     

I have heard that when Laennec invented the stethoscope in 1816, there was widespread concern about the negative effect it might have on the doctor-patient relationship. Prior to the invention of the stethoscope, doctors placed their ear directly upon the patient's chest to listen to the heart and lungs. At this point in history, the stethoscope actually came between the doctor and patient– a barrier to the intimacy of the physical examination.

In a modern ICU, all patients are under "standard precautions" for infectious disease control– this means doctors and nurses are supposed to wear gloves when we shake their hand. Other infection control precautions require that masks, eye-shields and gowns be worn inside patient rooms. When we employ a proning bed, the patient is totally cocooned– it’s is difficult to even see a patient inside a prone bed, much less touch them.

Telemedicine is increasingly incorporated into patient care– this allows a physician anywhere in the world to take care of patients in our hospital remotely, utilizing video cameras. Mobile devices– almost like robots– with a face display video screen for a head, can be wheeled into a patient’s room to facilitate electronic interactions between doctors and patients.

The advent of the hospitalist has all but destroyed the traditional continuity of the doctor patient relationship. Patients who are sick enough to land in the hospital are rarely seen by their family doctor. Within the hospital, many doctors (including myself) work shifts– taking care of individual patients only within the time slots of their work schedule. Technically, my responsibility for my patients ends at "quitting time”.

More physicians are employed by healthcare systems than ever before. The choices that patients and doctors once made together are thereby increasingly influenced by non-physician administrators. Politicians have increasingly attempted to create financial incentives for doctors to behave as they think we should behave. The very semantics of related constructs such as the “physician report card” diminishes us as a profession, turning us back to a time before we could be trusted to know and do what was best for our patients.

I think it's fair to say that the risk that might lose our professionalism, our humanism, has never been greater than it is at this point in the history of medicine. So there has probably never been a better time to reconsider professionalism as an essential part of being a doctor.

Many of us were taught in medical school about how to “act professional” – maintaining a detached demeanor, not allowing yourself to get emotionally-involved, appearing confident in all situations, etc. That’s not the kind of professionalism I’m going to talk about. Sir William Osler once said “the secret to the care of the patient is in caring for the patient” I think that’s a much better place to start our consideration of professionalism.

In the next installment we will consider the Oath of Maimonides and how it applies to the practice of medicine in a modern ICU:

"The eternal providence has appointed me to watch over the life and health of Thy creatures.

May the love for my art actuate me at all time; may neither avarice nor miserliness, nor thirst for glory or for a great reputation engage my mind; for the enemies of truth and philanthropy could easily deceive me and make me forgetful of my lofty aim of doing good to Thy children.

May I never see in the patient anything but a fellow creature in pain.

Grant me the strength, time and opportunity always to correct what I have acquired, always to extend its domain; for knowledge is immense and the spirit of man can extend indefinitely to enrich itself daily with new requirements. Today he can discover his errors of yesterday and tomorrow he can obtain a new light on what he thinks himself sure of today.

Oh, God, Thou has appointed me to watch over the life and death of Thy creatures; here am I ready for my vocation and now I turn unto my calling."

Reference as: Raschke RA. Professionaism: introduction. Southwest J Pulm Crit Care. 2014;8(5):284-7. doi: http://dx.doi.org/10.13175/swjpcc067-14 PDF

The Unfulfilled Promise of the Quality Movement

Richard A. Robbins, MD

Phoenix Pulmonary and Critical Care Research and Education Foundation

Gilbert, AZ

Abstract

In the latter half of the 20^th century efforts to improve medical care became known as the quality movement. Although these efforts were often touted as “evidence-based”, the evidence was often weak or nonexistent. We review the history of the quality movement. Although patient-centered outcomes were initially examined, these were replaced with surrogate markers. Many of the surrogate markers were weakly or non-evidence based interventions. Furthermore, the surrogate markers were often “bundled”, some evidence-based and some not. These guidelines, surrogate markers and bundles were rarely subjected to beta testing, and when carefully scrutinized, rarely correlated with improved patient-centered outcomes. Based on this lack of improvement in outcomes, the quality movement has not improved healthcare. Furthermore, the quality movement will not likely improve clinical performance until recommended or required interventions are tested using randomized trials.

Introduction

The quality movement has been touted as improving patient care at lower costs. However, there are very little data available that “clinically meaningful” outcomes have improved as a result of the quality movement. This manuscript will examine some of the major quality improvement efforts (Table 1).

Table 1. Major quality programs examined in this manuscript.

In addition, the manuscript will point out that some of the key issues with quality improvement measures particularly relevant to pulmonary/critical care physicians such as pneumococcal vaccination in adults, ventilator-associated pneumonia (VAP) and central line associated bloodstream infection (CLABSI) bundles.

Early History of the Quality Movement

Origins of the quality-of-care movement can be traced back to the nineteenth century. An early study assessing the efficacy of hospital care was the work of the British nurse, Florence Nightingale (1). She reported that the hospital in Scutari during the Crimean War had an exceedingly high mortality rate.

In 1910, Flexner issued a critical report of the U.S. medical educational system and called for major reforms. In addition to reforms in education, the report called for full time faculty who held appointments in a teaching hospital with adequate space and equipment (2). Shortly after the Flexner report, Codman developed the medical audit, a process for evaluating the overall practice of a physician including the outcomes of surgery (3).

A survey conducted by the American College of Surgeons of 700 hospitals in 1919 concluded that few were equipped to provide patients with even a minimal level of quality of care. The College went on to establish a program of minimum hospital standards (4). Later the program was transferred to the Joint Commission on Accreditation of Hospitals (now the JCAHO or Joint Commission). However, the Joint Commission was largely ineffective until 1965. At that time, the Joint Commission became one of the most powerful accrediting groups through its role in certifying eligibility for receipt of federal funds from Medicare and Medicaid.

As the role of government in paying for medical care has grown, so has the demand for assurance of the quality of the healthcare services. In the mid-1960s, utilization review activities were required to receive reimbursement for in-patient services from Medicare and Medicaid. Despite utilization review, increasing concern for accountability in healthcare arose from two sources. One was the consumer movement (5). This was fueled by continual reports of variation in services offered by different physicians and by different health care institutions. Usually the reports implied or stated that the care was substandard. The second was a dramatic increase in medical malpractice suits further eroding the public confidence in the medical profession.

The most common definition of quality of care used in the later twentieth century was authored by Donabedian in 1966 (6). He identified three major foci for the evaluation of quality of care­ outcome, process and structure. Outcome referred to the condition of the patient and the effectiveness of healthcare including traditional outcome measures such as morbidity, mortality, length of stay, readmission, etc. Process of care represented an alternative approach which examined the process of care itself rather than its outcomes. These processes are often referred to as surrogate markers. The structural approach involved examining the physical aspects of health care, including buildings, equipment, and supplies.

Joint Commission (JCAHO)

The structural approach was often emphasized in the Joint Commission surveys in the 1960’s and 70’s. Beginning in the 1970’s the Joint Commission began to address outcomes by requiring hospitals to perform medical audits. However, the Joint Commission soon realized that the audit was “tedious, costly and nonproductive” (7). Efforts to meet audit requirements were too frequently “a matter of paper compliance, with heavy emphasis on data collection and few results that can be used for follow-up activities. In the shuffle of paperwork, hospitals often lost sight of the purpose of the evaluation study and, most important, whether change or improvement occurred as a result of audit”. Furthermore, survey findings and research indicated that patient care and clinical performance had not improved (7).

In response to the ineffectiveness of the audit and the call to improve healthcare, the Joint Commission introduced a new quality assurance standard in 1980. The standard consisted of five elements:

• The integration or coordination of all quality assurance activities into a comprehensive program;
• A written plan for the program;
• A problem-focused approach to review;
• Annual reassessment of the program;
• Measurable improvement in patient care or clinical performance.

Hospitals complied with most aspects of these five elements. Over 90% had a written plan, annual reassessment, and integration of the quality assurance activities under the hospital administration by mid-1982 (8). However, the other elements remained largely ignored. Physician involvement was often perfunctory either because of their reluctance to be involved or because of hospital administration reluctance to have them involved. Hospital boards and administrators had little idea of which problems were most important and little idea of how to proceed with evaluation and interpretation of the results. Given these limitations it is not surprising that data demonstrating measurable improvement in patient care was lacking.

A number of superficial name changes occurred over the next few years. These included quality improvement, total quality improvement, risk management, quality management and total quality improvement. Although each was touted as an improvement in quality assurance, none were fundamentally different than the original concept and none demonstrated a convincing improvement in any patient-centered outcomes.

Institute of Healthcare Improvement (IHI)

Recognizing weaknesses in the Joint Commission processes, private organizations attempted to develop programs that enhanced quality. One was the Institute for Healthcare Improvement (IHI). Founded by Donald Berwick in 1989, IHI was quite successful in attracting funding from a number of charitable organizations such as Kaiser Permanente Community Benefit, the Josiah Macy, Jr. Foundation, the Rx Foundation,​the MacArthur Foundation, the Robert Wood Johnson Foundation, the Bill & Melinda Gates Foundation, the Health Foundation, and the Izumi Foundation. Additional funding was obtained from insurance companies such as the Blue Cross and Blue Shield Association, the Cardinal Health Foundation, the Aetna Foundation, the Blue Shield of California Foundation. Some pharmaceutical funding was also obtained from​ Baxter International, Inc. and the Abbott Fund. In addition, through the IHI “Open School” many hospitals, both academic and private, supported IHI activities. These included the Mayo Clinic, Banner Good Samaritan Medical Center, St. Joseph's Hospital and Medical Center, the University of Arizona Medical Center, the University of Colorado at Denver, and University of New Mexico - Albuquerque (9).

Under Berwick’s leadership, IHI launched a number of proposals to improve healthcare. A noteworthy initiative from the IHI was the 18 month 100,000 Lives Campaign which began in January 2005. This campaign encouraged hospitals to adopt six best practices to reduce harm and deaths. The interventions included deployment of rapid response reams, a medication reconciliation process, interventions for acute myocardial infarction, a central line management process, administering antibiotics at a specific time to prevent surgical site infections, and using a ventilator protocol to minimize ventilator associated-pneumonia. Review of the evidence basis for at least 3 of these interventions reveals fundamental flaws. A large cluster-randomized, controlled trial demonstrated that medical response teams greatly increased medical response team calling, but did not substantially affect the incidence of cardiac arrest, unplanned ICU admissions, or unexpected death (10). Furthermore, the interventions to prevent central line infections and ventilator-associated pneumonia were either non- or weakly evidence-based and unlikely to improve patient outcomes (11,12)

Despite these limitations, IHI announced in June 2006 that the campaign prevented 122,300 avoidable deaths (13). Interestingly, the methodology and sloppy estimation of the number of lives saved were pointed out by Wachter and Pronovost (14), in the Joint Commission’s Journal of Quality and Safety. IHI failed to adjust their estimates of lives saved for case-mix which accounted for nearly three out of four "lives saved." The actual mortality data were supplied to the IHI by hospitals without audit, and 14% of the hospitals submitted no data at all. Moreover, the reports from even those hospitals that did submit data were usually incomplete. The most striking example of this is the fact that the IHI announcement of lives saved in 18 months was based on submissions through March, not June, 2006, accounting for only 15 months. The final three months were also extrapolated from hospitals’ previous submissions. Although not reported by IHI, it seems likely that there were even more missing data beyond that described above. One important confounder is the fact that the campaign took place against a background of declining inpatient mortality rates (14).

Whether this decline was a result of some of the quality improvement efforts promoted by IHI and others or other factors is unclear. Undeterred, the IHI proceeded with the 5,000,000 Lives Campaign claiming that over 80% of US hospitals were participants (15). However, this campaign ended in 2008 and was apparently not successful (16). Although IHI promised to publish results in major medical journals, a literature search revealed no published outcomes.

Department of Veterans Affairs (VA)

The Department of Veterans Affairs (VA) has played a pivotal role in the quality movement. Although VA hospitals have been required to be Joint Commission approved since the Regan Administration, the quality movement began with the appointment of Kenneth W. Kizer as the VA's undersecretary of health in 1994. An emergency room physician, Kizer was Director of California Emergency Medical Services, Chief of Public Health for California and Director of the California Department of Health Services before coming to the VA (18).

Kizer mandated several interventions. One was the installation and utilization of an electronic healthcare record. The second was a set of performance measures which became known as the chronic disease indicators (19). In order to encourage performance of these interventions, Kizer initiated pay-for-performance, not to the doctors and nurses doing the interventions, but to the top administration of the hospital. The focus changed from meeting the needs of the patient to meeting the performance measures so the administrators could receive their bonuses. From 1994 to 2000 nearly all the performance measures improved. Three improved dramatically-pneumococcal vaccination, annual measurement of hemoglobin A1C, and smoking cessation (19). However, the evidence basis that these interventions improved patient outcomes was questionable (20). Furthermore, there was no outcome data such as morbidity, mortality, admission rates, length of stay, etc. that supported the contention that the health of veterans improved.

Although politics forced Kizer’s resignation in 1999, he was followed by his deputy, Thomas L. Garthwaite and eventually by his Chief Quality and Performance Officer, Jonathan B. Perlin. Perlin realized that outcome data was needed and promised that this would be forthcoming. On August 11, 2003 at the First Annual VA Preventive Medicine Training Conference in Albuquerque, NM, Perlin claimed that the increase in pneumococcal vaccination saved 3914 lives between 1996 and 1998 (21) (For a copy of the slides used by Perlin click here). Furthermore, he claimed pneumococcal vaccination resulted in 8000 fewer admissions and 9500 fewer days of bed care between 1999 and 2001. However, this data was not measured but based on extrapolation from a single, non-randomized, observational study (22). Although no randomized study examining patient outcomes with the 23-polyvalent pneumococcal vaccine has been performed, other studies do not support the efficacy of the vaccine in adults (23-25). Furthermore, there was an overall downward trend in hospital admissions. The reduction in hospital admissions for pneumonia appeared to be nothing more than part of this trend since the number of outpatient visits for pneumonia increased (26).

Institute of Medicine (IOM)

The Institute of Medicine (IOM) is a non-profit, non-governmental organization founded in 1970, under the congressional charter of the National Academy of Sciences (27). Its purpose is to provide national advice on issues relating to biomedical science, medicine, and health, and its mission to serve as adviser to the nation to improve health.

The IOM attracted little attention until publication of “To Err is Human” in 1999 (28). This report was authored by the IOM’s committee on quality of health care in America whose members included Donald Berwick from the Institute of Healthcare Improvement and Mark Chassin, now president and chief executive officer of the Joint Commission. The report estimated that 44,000 to 98,000 deaths occur annually in the US due to medical errors. It was presented with drama and an assertion of lack of previous attention. This was followed by a plea to the medical profession to remember its promise to "do no harm" and that "at a very minimum, the health system needs to offer that assurance and security to the public." The clear implication was that doctors were killing their patients at a terrible rate and needed oversight and direction. The Clinton administration clearly heard this message and issued an executive order instructing government agencies that conduct or oversee health-care programs to implement proven techniques for reducing medical errors, and creating a task force to find new strategies for reducing errors. Congress soon launched a series of hearings on patient safety, and in December 2000 it appropriated $50 million to the Agency for Healthcare Research and Quality to support a variety of efforts targeted at reducing medical errors.

Examination of the two studies on which the IOM based their mortality estimates both came from the Harvard School of Public Health where Harvey Fineberg, president of the IOM, had been dean. The higher estimate was based on a 1991 study published in the New England Journal of Medicine (29). In this study, 30,121 medical records from 51 randomly selected acute care hospitals in New York State were reviewed. Population estimates of injuries were made. To do this the records were screened by trained nurses and medical-records analysts; if a record was screened as positive for a potentially adverse event, two physicians independently reviewed the record. The second study on which the lower mortality estimate was made was published in Medical Care in 2000 (30). The same group from the Harvard School of Public Health used a similar strategy and examined 15,000 records from acute care hospitals in Utah and Colorado from 1992.

Although examples were given of what constituted an adverse event and whether it was due to negligence, it is “difficult to judge whether a standard of care has been met” leading to a “relatively low level of reliability…” according to the first article.  In both articles, negligence remained undefined which ultimately means that the determination of negligence relied on judgment. Unexplained is why the second article showed deaths due to negligence in Utah and Colorado at half the rate of New York.

Hofer et al. (31) examined medical errors in large part as a response to “To Err is Human” and the Harvard School of Public Health studies on which the IOM based their mortality estimates. They made four principal observations. “First, errors have been defined in terms of failed processes without any link to subsequent harm. Second, only a few studies have actually measured errors, and these have not described the reliability of the measurement. Third, no studies directly examine the relationship between errors and adverse events. Fourth, the value of pursuing latent system errors (a concept pertaining to small, often trivial structure and process problems that interact in complex ways to produce catastrophe) using case studies or root cause analysis has not been demonstrated in either the medical or nonmedical literature”.

Patient Safety

The IOM report, “To Err is Human”, resulted in yet another name change for the quality movement, the patient safety movement. An article in JAMA by Leape, Berwick and Bates (32) in 2005 entitled “What Practices Will Most Improve Safety? Evidence-Based Medicine Meets Patient Safety” examined what the authors considered evidence-based practices that might improve patient safety. They examined patient safety targets and listed patient safety practices to reduce or eliminate any adverse outcomes. The evidence of each practice was graded greatest, high, medium, low and lowest. Unfortunately, mistakes were made and some would disagree with the strength of evidence. For example, the ventilator bundle from 2011 used by IHI lists 5 interventions:

• Elevation of the Head of the Bed
• Daily "Sedation Vacations" and Assessment of Readiness to Extubate
• Peptic Ulcer Disease Prophylaxis
• Deep Venous Thrombosis Prophylaxis
• Daily Oral Care with Chlorhexidine

However, in their JAMA article the intervention with the greatest evidence for prevention of ventilator-associated pneumonia was continuous aspiration of subglottic secretions. Semirecumbent positioning and elective decontamination of the digestive tract were listed as having a high strength of evidence. Continuous oscillation was listed as medium strength evidence. Use of sucralfate was listed as lowest strength of evidence. Sedation vacations and oral care with chlorhexidine were not listed. Deep venous prophylaxis was listed as prevention of venous thromboembolism, which it clearly does but does not reduce mortality or prevent pneumonia (33). Peptic ulcer disease prophylaxis with H2 antagonists was listed as medium strength of evidence. The possibility that H2 antagonists might increase pneumonia rather than prevent it was not raised (34).

Similarly, practices listed in the 2005 JAMA article to prevent central line-associated bloodstream infection listed antibiotic-impregnated catheters (greatest strength of evidence); chlorhexidine, heparin and catheter tunneling (lower strength of evidence); and routine antibiotic prophylaxis and changing catheters routinely (lowest strength of evidence). However, the IHI central line bundle include:

• Hand Hygiene
• Maximal Barrier Precautions Upon Insertion
• Chlorhexidine Skin Antisepsis
• Optimal Catheter Site Selection, with Avoidance of the Femoral Vein for Central Venous Access in Adult Patients
• Daily Review of Line Necessity with Prompt Removal of Unnecessary Lines

Although disagreement about the level of evidence may be appropriate, the IHI bundles are clearly discordant with the evidence basis of the interventions as listed in the JAMA article. Furthermore, IHI mixed practices with various levels of evidence into a single bundle and encouraged the performance of all in order to receive “credit” for compliance with the bundle.

Department of Health and Human Services (HHS)

When Berwick became director of HHS’ Center for Medicare and Medicaid Services (CMS) the IHI’s bundles moved with him. With the Agency for Healthcare Quality and Research (AHRQ), another division of HHS, CMS initiated a vigorous program to prevent hospital-acquired infections backed up with financial penalties for noncompliance. This included bundles mixing practices with various levels of evidence (or no evidence) and requiring compliance with all to receive “credit”, or in this case, avoid financial penalties for noncompliance. CMS referred to this as “value-based performance”.

In an increasingly familiar scenario, AHRQ issued a press release on September 20, 2012 touting the remarkable success of the program to reduce central line-associated bloodstream infections (CLABSIs) (35). The program “…reduced the rate [of CLABSI] … in intensive care units by 40 percent…saving more than 500 lives and avoiding more than $34 million in health care costs” (35). Although the methodology used to determine these numbers was not stated, it seems likely that it followed the model of IHI’s 100,000 Lives Campaign.  A program was initiated based on a dubious intervention(s)-in this case a 2 page checklist for central line insertion (36). Data on the incidence of infection was determined by billing, another form of self-reporting. The dollars and lives saved were then extrapolated from other publications.

There are several problems with this approach. First, Meddings et al. (37) determined that data on self reported urinary tract infections were “inaccurate” and “are not valid data sets for comparing hospital acquired catheter-associated urinary tract infection rates for the purpose of public reporting or imposing financial incentives or penalties”. The authors proposed that the nonpayment by Medicare for “reasonably preventable” hospital-acquired complications resulted in this discrepancy. There is no reason to assume that data reported for CLABSI is any more accurate. Further evidence comes from the observation that compliance with most of these bundles does not appear to correlate with outcomes such as mortality or readmission rates (38).

Second, choosing a single article which does not represent the overall body of evidence can be deceiving. In the pneumococcal vaccine example cited earlier, Perlin chose the only article to show a beneficial effect of the 23-polyvalent pneumococcal vaccine in adults (22). Most reviews and meta-analyses do not support the vaccine’s efficacy (23-25).

Third, many of the articles used for calculation of the mortality and cost savings are not risk adjusted. It may seem obvious, but saying that CLABSIs are associated with higher mortality and costs is not the same as saying the mortality and costs were caused by the CLABSI. Central lines are placed in sicker, more unstable patients and their underlying disease and not the CALBSI could account for the higher mortality and costs. These extrapolated conclusions are not the same as measurement of the mortality and costs in carefully planned and controlled randomized trials.

Discussion

Review of the quality movement reveals a dizzying array of pseudo-regulatory organizations and ever-changing programs and guidelines. The National Guidelines Clearinghouse lists in excess of 15,000 guidelines (39). This explosion of directives appears to undergo little to no oversight with no checks to ensure that these guidelines are evidence-based.

This manuscript reviewed some of the more prominent programs to improve healthcare and have found them sadly wanting (Table 1). Overall the science has been poor and evidence of improvement in patient outcomes lacking. It is unclear if the present programs have improved on the tedious, costly and nonproductive medical audits of the 1970’s (7). Like the audits, present quality programs appear to be more a matter of paper compliance. In the shuffle of paperwork, hospitals and regulatory agencies seem to have lost sight of that the purpose is to improve healthcare and not fulfill a political or financial goal.

As hospitals struggle to decrease complication rates in order to receive better reimbursement for “value-based performance” several likely strategies may evolve. One is to lie about the data. According to Meddings (37) this is apparently happening with urinary tract infections and clearly was happening with ventilator-associated pneumonia (12). The accuracy of the data submitted by a hospital’s quality manager, under intense scrutiny from the CEO or board to demonstrate the hospital’s success in quality improvement, is rarely questioned if it shows an improvement. This may be particularly true now that many CEOs and managers are operating under incentive systems that tie bonuses to quality performance (14). Tying hospital reimbursement may induce similar discrepancies. Another rather obvious strategy to increase reimbursement would be to prevent complications by not performing interventions such as urinary tract catheters or central lines. Whether this is happening is not clear but seems likely. It is also unclear whether this will be beneficial or harmful to patients.

It is difficult to argue that a complication might be good for a patient. However, some of the hospital-acquired infections and readmission rates correlate with improved mortality (38). The reason for this is not clear but could represent a minor complication of what are best practices that benefit the majority of patients.

According to Patrick Conway, CMS Chief Medical Officer and Deputy and Administrator for Innovation and Quality, CMS will be reorienting and aligning measures around patient-centered outcomes (40). Readmission rates for certain disorders are already part of CMS’ formula for reimbursement adjustments based on readmissions for COPD will begin in 2014. It is unclear at this juncture if other traditional outcome measures such as mortality, morbidiy, hospital length of stay and cost will also be considered. These would likely be an improvement over the “value-based performance” measures, many of which either do not or inversely correlate with outcomes.

The explosion in the number of groups attempting to improve quality and safety raises the question of how should target practices be selected. It is unclear if private organizations be setting a national agenda for change. The 100,000 Lives Campaign allowed IHI to receive credit for many things that would have happened anyway (14). The campaign created a landslide of “brand recognition” for IHI, and undoubtedly led to substantial new revenues and philanthropic dollars. A conflict (or, at very least, appearance of conflict) is unavoidable. A federal agency or regulator would not be vulnerable to such concerns.

Professional organizations need to do their part in improving the quality of medical care. Many, if not most, professional organizations have rushed to publish guidelines. Unfortunately, the evidence basis for these guidelines have been little better than the IHI, Joint Commission or IOM’s recommendations. Lee and Vielemeyer (41) found that only 14% of the Infectious Disease Society of America (IDSA) guidelines are based on level I evidence (data from >1 properly randomized controlled trial). Much of this 14% and the 86% that are below level I evidence will eventually be proven wrong (42,43). It is doubtful that other medical societies are performing much better.

Medical journals also need to do their part. Reviewers and editors need to evaluate manuscripts regarding “quality medical care” with the same scientific skepticism applied to other articles. Randomized trials should not only be applied to diagnostic and therapeutic interventions but just as vigorously applied to formulation and implementation of guidelines and other interventions designed to improve medical care quality. Too often interventions based on either weak or no evidence become ingrained in medical practice when papers with questionable methods and/or outcomes are published. Journals should not allow authors to call an intervention as improving quality of medical care without definition of quality and without accompanying demonstration of an improvement in patient-centered outcomes.

Lastly, physicians need to do their part. Physicians should reevaluate their participation and financial support of medical societies that author or support non- or weakly evidenced guidelines. They should oppose quality programs introduced into medical practice that are not based on level I evidence (at least one randomized trial). That the IHI was able to introduce a program such as the 100,000 Lives Campaign into hospital practice based on weak or non-evidence based interventions such as rapid response teams, central-line insertions guidelines and ventilator-associated guidelines is disturbing. That the IHI was able to declare that implementation of their interventions saved 123,000 lives based on the sloppy collection of self-reported data is equally disturbing. That these interventions persist to this day is perhaps most disturbing of all. As taught by Flexner nearly a century ago, only through application of scientific principles and vigorous review of interventions will the quality of medical care improve.

References

1. John Maindonald J, Richardson AM. This passionate study: a dialogue with Florence Nightingale. Journal of Statistics Education 2004: 12(1). Available at: www.amstat.org/publications/jse/v12n1/maindonald.html (accessed 12/5/13).
2. Flexner A. Medical Education in the United States and Canada: A Report to the Carnegie Foundation for the Advancement of Teaching. Bulletin 4. 1910. New York: Carnegie Foundation.
3. Lembcke PA. Evolution of the medical audit. JAMA. 1967;199(8):543-50. [CrossRef] [PubMed]
4. Borus ME, Buntz CG, Tash WR. Evaluating the Impact of Health Programs: A Primer. 1982. Cambridge, MA: MIT Press.
5. Baker F. Quality assurance and program evaluation. Eval Health Prof. 1983;6(2):149-60. [PubMed]
6. Donabedian A. Evaluating the quality of medical care. 1966. Milbank Q. 2005;83(4):691-729. [PubMed]
7. Affeldt JE. The new quality assurance standard of the Joint Commission on Accreditation of Hospitals. West J Med. 1980;132:166-70. [PubMed]
8. Affeldt JE, Roberts JS, Walczak RM. Quality assurance. Its origin, status, and future direction--a JCAH perspective. Eval Health Prof. 1983;6(2):245-55. [PubMed]
9. Institute for Healthcare Improvement Open School. US Directory. Available at: http://www.ihi.org/offerings/IHIOpenSchool/Chapters/Pages/ChapterDirectoryUnitedStates.aspx (accessed 12/7/13).
10. Hillman K, Chen J, Cretikos M, Bellomo R, Brown D, Doig G, Finfer S, Flabouris A; MERIT study investigators. Introduction of the medical emergency team (MET) system: a cluster-randomised controlled trial. Lancet. 2005;365(9477):2091-7. [PubMed]
11. Hurley J, Garciaorr R, Luedy H, Jivcu C, Wissa E, Jewell J, Whiting T, Gerkin R, Singarajah CU, Robbins RA. Correlation of compliance with central line associated blood stream infection guidelines and outcomes: a review of the evidence. Southwest J Pulm Crit Care 2012;4:163-73.
12. Padrnos L, Bui T, Pattee JJ, Whitmore EJ, Iqbal M, Lee S, Singarajah CU, Robbins RA. Analysis of overall level of evidence behind the Institute of Healthcare Improvement ventilator-associated pneumonia guidelines. Southwest J Pulm Crit Care 2011;3:40-8.
13. Institute for Healthcare Improvement. IHI announces that hospitals participating in 100,000 lives campaign have saved an estimated 122,300 lives. Available at: http://www.ihi.org/about/news/documents/ihipressrelease_hospitalsin100000livescampaignhavesaved122300lives_jun06.pdf (accessed 12/7/13).
14. Wachter RM, Pronovost PJ. The 100,000 Lives Campaign: A scientific and policy review. Jt Comm J Qual Patient Saf. 2006;32(11):621-7. [PubMed]
15. Institute for Healthcare Improvement. 5 million lives campaign. Available at: http://www.ihi.org/about/Documents/5MillionLivesCampaignCaseStatement.pdf (accessed 12/7/13).
16. DerGurahian J. IHI unsure about impact of 5 Million campaign. Available at: http://www.modernhealthcare.com/article/20081210/NEWS/312109976 (accessed 12/7/13).
17. Ken Kizer transforming the VA. Available at: http://www.medsphere.com/transforming-the-va (accessed 12/19/13).
18. Robbins RA. Profiles in medical courage: of mice, maggots and Steve Klotz. Southwest J Pulm Crit Care. 2012;4:71-7.
19. Jha AK, Perlin JB, Kizer KW, Dudley RA. Effect of the transformation of the Veterans Affairs Health Care System on the quality of care. N Engl J Med. 2003;348(22):2218-27 [CrossRef] [PubMed]
20. Robbins RA, Klotz SA. Quality of care in US hospitals. N Engl J Med 2005; 353(17):1860-1861 [CrossRef] [PubMed]
21. Perlin JB. Prevention in the 21st century: using advanced technology and care models to move from the hospital and clinic to the community and caring. Presented at the First Annual VA Preventive Medicine Training Conference, Albuquerque, NM , August 11, 2003. For a copy of the slide presentation click here.
22. Nichol KL, Baken L, Wuorenma J, Nelson A. The health and economic benefits associated with pneumococcal vaccination of elderly persons with chronic lung disease. Arch Intern Med. 1999;159(20):2437-42. [CrossRef] [PubMed]
23. Fine MJ, Smith MA, Carson CA, Meffe F, Sankey SS, Weissfeld LA, Detsky AS, Kapoor WN. Efficacy of pneumococcal vaccination in adults. A meta-analysis of randomized controlled trials. Arch Int Med 1994;154:2666-77. [CrossRef] [PubMed]
24. Dear K, Holden J, Andrews R, Tatham D. Vaccines for preventing pneumococcal infection in adults. Cochrane Database Sys Rev 2003:CD000422. [PubMed]
25. Huss A, Scott P, Stuck AE, Trotter C, Egger M. Efficacy of pneumococcal vaccination in adults: a meta-analysis. CMAJ 2009;180:48-58. [CrossRef] [PubMed]
26. Robbins RA. August 2013 pulmonary journal club: pneumococcal vaccine déjà vu. Southwest J Pulm Crit Care. 2013;7(2):131-4.[CrossRef]
27. Institute of Medicine. Available at: http://www.iom.edu/About-IOM.aspx (accessed 12/20/13).
28. Kohn LT, Corrigan J, Donaldson MS, Institute of Medicine (U.S.) Committee on Quality of Health Care in America. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Pr; 1999.
29. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370-6. [CrossRef] [PubMed] 
30. Thomas EJ, Studdert DM, Burstin HR, Orav EJ, Zeena T, Williams EJ, Howard KM, Weiler PC, Brennan TA. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care. 2000;38(3):261-71. [CrossRef] [PubMed] 
31. Hofer TP, Kerr EA, Hayward RA. What is an error? Eff Clin Pract. 2000;3(6):261-9. [PubMed]
32. Leape LL, Berwick DM, Bates DW. What practices will most improve safety? Evidence-based medicine meets patient safety. JAMA. 2002;288(4):501-7. [CrossRef] [PubMed] 
33. Dentali F, Douketis JD, Gianni M, Lim W, Crowther MA. Meta-analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med. 2007;146(4):278-88. [CrossRef] [PubMed] 
34. Marik PE, Vasu T, Hirani A, Pachinburavan M. Stress ulcer prophylaxis in the new millennium: a systematic review and meta-analysis. Crit Care Med. 2010;38(11):2222-8. [CrossRef] [PubMed] 
35. AHRQ Patient Safety Project Reduces Bloodstream Infections by 40 Percent. September 2012. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http://www.ahrq.gov/news/newsroom/press-releases/2012/20120910.html  (accessed 12/23/13).
36. Central Line Insertion Care Team Checklist. May 2009. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http://www.ahrq.gov/professionals/quality-patient-safety/patient-safety-resources/resources/cli-checklist.html (accessed 12/23/13).
37. Meddings JA, Reichert H, Rogers MA, Saint S, Stephansky J, McMahon LF. Effect of nonpayment for hospital-acquired, catheter-associated urinary tract infection: a statewide analysis. Ann Intern Med. 2012;157:305-12. [CrossRef] [PubMed]
38. Robbins RA, Gerkin RD. Comparisons between Medicare mortality, morbidity, readmission and complications. Southwest J Pulm Crit Care. 2013;6(6):278-86. 
39. National Guideline Clearinghouse. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http://www.guideline.gov/browse/by-topic.aspx (accessed 12/23/13).
40. Conway PH, Mostashari F, Clancy C.The future of quality measurement for improvement and accountability. JAMA. 2013;309(21):2215-6. [CrossRef] [PubMed] 
41. Lee DH, Vielemeyer O. Analysis of overall level of evidence behind infectious diseases society of America practice guidelines. Arch Intern Med. 2011;171:18-22.  [CrossRef]  [PubMed]
42. Prasad V, Vandross A, Toomey C, et al. A decade of reversal: an analysis of 146 contradicted medical practices. Mayo Clin Proc. 2013;88(8):790-8. [CrossRef] [PubMed] 
43. Villas Boas PJ, Spagnuolo RS, Kamegasawa A, et al. Systematic reviews showed insufficient evidence for clinical practice in 2004: what about in 2011? The next appeal for the evidence-based medicine age. J Eval Clin Pract. 2013;19(4):633-7. [CrossRef] [PubMed] 

Reference as: Robbins RA. The unfulfilled promise of the quality movement. Southwest J Pulm Crit Care. 2014;8(1):50-63. doi: http://dx.doi.org/10.13175/swjpcc181-13 PDF

A Comparison Between Hospital Rankings and Outcomes Data

Richard A. Robbins, MD*

Richard D. Gerkin, MD ^‡ 

*Phoenix Pulmonary and Critical Care Research and Education Foundation, Gilbert, AZ

^‡Banner Good Samaritan Medical Center, Phoenix, AZ

Abstract

Hospital rankings have become common but the agreement between the rankings and correlation with patient-centered outcomes remains unknown. We examined the ratings of Joint Commission on Healthcare Organizations (JCAHO), Leapfrog, and US News and World Report (USNews), and outcomes from Centers for Medicare and Medicaid Hospital Compare (CMS) for agreement and correlation. There was some correlation among the three “best hospitals” ratings.  There was also some correlation between “best hospitals” and CMS outcomes, but often in a negative direction.  These data suggest that no one “best hospital” list identifies hospitals that consistently attain better outcomes.

Introduction

Hospital rankings are being published by a variety of organizations. These rankings are used by hospitals to market the quality of their services. Although all the rankings hope to identify “best” hospitals, they differ in methodology. Some emphasize surrogate markers; some emphasize safety, i.e., a lack of complications; some factor in the hospital’s reputation; some factor in patient-centered outcomes.  However, most do not emphasize traditional outcome measures such as mortality, mortality, length of stay and readmission rates. None factor cost or expenditures on patient care.

We examined three common hospital rankings and clinical outcomes. We reasoned that if the rankings are valid then better hospitals should be consistently on these best hospital lists. In addition, better hospitals should have better outcomes.

Methods

CMS

Outcomes data was obtained from the CMS Hospital Compare website from December 2012-January 2013 (1). The CMS website presents data on three diseases, myocardial infarction (MI), congestive heart failure (CHF) and pneumonia. We examined readmissions, complications and deaths for each of these diseases. We did not examine all process of care measures since many of the measures have not been shown to correlate with improved outcomes and patient satisfaction has been shown to correlate with higher admission rates to the hospital, higher overall health care expenditures, and increased mortality (2). In some instances actual data is not presented on the CMS website but only higher, lower or no different from the National average. In this case, scoring was done 2, 0 and 1 respectively with 2=higher, 0=lower and 1=no different.

Mortality is the 30-day estimates of deaths from any cause within 30 days of a hospital admission, for patients hospitalized with one of several primary diagnoses (MI, CHF, and pneumonia). Mortality was reported regardless of whether the patient died while still in the hospital or after discharge. Similarly, the readmission rates are 30-day estimates of readmission for any cause to any acute care hospital within 30 days of discharge. The mortality and readmission measures rates were adjusted for patient characteristics including the patient’s age, gender, past medical history, and other diseases or conditions (comorbidities) the patient had at hospital arrival that are known to increase the patient’s risk of dying or readmission.

The rates of a number of complications are also listed in the CMS data base (Table 1).

Table 1. Complications examined that are listed in CMS data base.

CMS calculates the rate for each serious complication by dividing the actual number of outcomes at each hospital by the number of eligible discharges for that measure at each hospital, multiplied by 1,000. The composite value reported on Hospital Compare is the weighted averages of the component indicators.  The measures of serious complications reported are risk adjusted to account for differences in hospital patients’ characteristics. In addition, the rates reported on Hospital Compare are “smoothed” to reflect the fact that measures for small hospitals are measured less accurately (i.e., are less reliable) than for larger hospitals.

Similar to serious infections, CMS calculates the hospital acquired infection data from the claims hospitals submitted to Medicare. The rate for each hospital acquired infection measure is calculated by dividing the number of infections that occur within any given eligible hospital by the number of eligible Medicare discharges, multiplied by 1,000. The hospital acquired infection rates were not risk adjusted.

JCAHO

The JCAHO list of Top Performers on Key Quality Measures™ was obtained from its 2012 list (3). The Top Performers are based on an aggregation of accountability measure data reported to The JCAHO during the previous calendar year.

Leapfrog

Leapfrog’s Hospital Safety Score were obtained from their website during December 2012-January 2013 (4). The score utilizes 26 National performance measures from the Leapfrog Hospital Survey, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS) to produce a single composite score that represents a hospital’s overall performance in keeping patients safe from preventable harm and medical errors. The measure set is divided into two domains: (1) Process/Structural Measures and (2) Outcome Measures. Many of the outcome measures are derived from the complications reported by CMS (Table 1). Each domain represents 50% of the Hospital Safety Score. The numerical safety score is then converted into one of five letter grades. "A" denotes the best hospital safety performance, followed in order by "B", "C", “D,” and “F.” For analysis, these letter grades were converted into numerical grades 1-5 corresponding to letter grades A-F.

US News and World Report

US News and World Report’s (USNews) 2012-3 listed 17 hospitals on their honor roll (5). The rankings are based largely on objective measures of hospital performance, such as patient survival rates, and structural resources, such as nurse staffing levels. Each hospital’s reputation, as determined by a survey of physician specialists, was also factored in the ranking methodology. The USNews top 50 cardiology and pulmonology hospitals were also examined.

Statistical Analysis

Categorical variables such as JCAHO and USNews best hospitals were compared with other data using chi-squared analysis. Spearman rank correlation was used to help determine the direction of the correlations (positive or negative). Significance was defined as p<0.05.

Results

Comparisons of Hospital Rankings between Organizations

A large database of nearly 3000 hospitals was compiled for each of the hospital ratings (Appendix 1). The “best hospitals” as rated by the JCAHO, Leapfrog and USNews were compared for correlation between the organizations (Table 2).

Table 2. Correlation of “best hospitals” between different organizations

There was significant correlation between the JCAHO and Leapfrog and Leapfrog and USNews but not between JCAHO and USNews.

JCAHO-Leapfrog Comparison

The Leapfrog grades were significantly better for JCAHO “Best Hospitals” compared to hospitals not listed as “Best Hospitals” (2.26 + 0.95  vs. 1.85 + 0.91, p<0.0001). However, there were multiple exceptions. For example, of the 358 JCAHO “Best Hospitals” with a Leapfrog grade, 84 were graded “C”, 11 were graded “D” and one was graded as “F”.

JCAHO-USNews Comparison

Of the JCAHO “Top Hospitals” only one was listed on the USNews “Honor Roll”. Of the cardiology and pulmonary “Top 50” hospitals only one and two hospitals, respectively, were listed on the JCAHO “Top Hospitals” list.

Leapfrog-USNews Comparison

The Leapfrog grades of the US News “Honor Roll” hospitals did not significantly differ compared to the those hospitals not listed on the “Honor Roll” (2.21 + 0.02 vs. 1.81 + 0.31, p>0.05). However, Leapfrog grades of the US News “Top 50 Cardiology” hospitals had better Leapfrog grades (2.21 +  0.02 vs. 1.92 + 0.14, p<0.05). Similarly, Leapfrog grades of the US News “Top 50 Pulmonary” hospitals had better Leapfrog grades (2.21 + 0.02 vs. 1.91 + 0.15, p<0.05).

“Best Hospital” Mortality, Readmission and Serious Complications

The data for the comparison between the hospital rankings and CMS’ readmission rates, mortality rates and serious complications for the JCAHO, Leapfrog, and USNews are shown in Appendix 2, Appendix 3, and Appendix 4 respectively. The results of the comparison of “best hospitals” compared to hospitals not listed as best hospitals are shown in Table 3.

Table 3. Results of “best hospitals” compared to other hospitals for mortality and readmission rates for myocardial infarction (MI), congestive heart failure (CHF) and pneumonia.

Red:  Relationship is concordant (better rankings associated with better outcomes)

Blue:  Relationship is discordant (better rankings associated with worse outcomes)

Note that of 21 total p values for relationships, 12 are non-significant, 6 are concordant and significant, and 6 are discordant and significant.  All 4 of the significant readmission relationships are discordant. All 5 of the significant mortality relationships are concordant. This underscores the disjunction of mortality and readmission. All 3 of the relationships with serious complications are significant, but one of these is discordant. Of the 3 ranking systems, Leapfrog has the least correlation with CMS outcomes (5/7 non-significant).  USNews has the best correlation with CMS outcomes (6/7 significant).  However, 3 of these 6 are discordant.

The USNews “Top 50” hospitals for cardiology and pulmonology were also compared to those hospitals not listed as “Top 50” hospitals for cardiology and pulmonology. Similar to the “Honor Roll” hospitals there was a significantly higher proportion of hospitals with better mortality rates for MI and CHF for the cardiology “Top 50” and for pneumonia for the pulmonary “Top 50”. Both the cardiology and pulmonary “Top 50” had better serious complication rates (p<0.05, both comparisons, data not shown).

Discussion

Lists of hospital rankings have become widespread but whether these rankings identify better hospitals is unclear. We reasoned that if the rankings were meaningful then there should be widespread agreement between the hospital lists. We did find a level of agreement but there were exceptions. Hospital rankings should correlate with patient-centered outcomes such as mortality and readmission rates. Overall that level of agreement was low.

One probable cause accounting for the differences in hospital rankings is the differing methodologies used in determined the rankings. For example, JCAHO uses an aggregation of accountability measures. Leapfrog emphasizes safety or a lack of complications. US News uses patient survival rates, structural resources, such as nurse staffing levels, and the hospital’s reputation. However, the exact methodolgical data used to formulate the rankings is often vague, especially for JCAHO and US News rankings. Therefore, it should not be surprising that the hospital rankings differ.

Another probable cause for the differing rankings is the use of selected complications in place of patient-centered outcome measures. Complications are most meaningful when they negatively affect ultimate patient outcomes. Some complications such as objects accidentally left in the body after surgery, air bubble in the bloodstream or mismatched blood types are undesirable but very infrequent. Whether a slight, but significant, increase in these complications would increase more global measures such as morality or readmission rates is unlikely. The overall poor correlation of these outcomes with deaths and readmissions in the CMS database is consistent with this concept.

Some of the surrogate complication rates are clearly evidence-based but some are clearly not. For example, many of the central-line associated infection and ventilator-associated pneumonia guidelines used are non-evidence based (6.7). Furthermore, overreaction to correct some of the complications such as “signs of uncontrolled blood sugar” may be potentially harmful. This complication could be interpreted as tight control of the blood sugar. Unfortunately, when rigorously studied, patients with tight glucose control actually had an increase in mortality (8).

In some instances a complication was associated with improved outcomes. Although the reason for this discordant correlation is unknown, it is possible that the complication may occur as a result of better care. For example, catherization of a central vein for rapid administration of fluids, drugs, blood products, etc. may result in better outcomes or quality but will increase the central line-associated bloodstream infection rate. In contrast, not inserting a catheter when appropriate might lead to worse outcomes or poorer quality but would improve the infection rate.

Many of the rankings are based, at least in part, on complication data self-reported by the hospitals to CMS. However, the accuracy of this data has been called into question (9,10). Meddings et al. (10) studied urinary tract infections which were self-reported by hospitals using claims data. According to Meddings (10), the data were “inaccurate” and not were “not valid data sets for comparing hospital acquired catheter-associated urinary tract infection rates for the purpose of public reporting or imposing financial incentives or penalties”. The authors proposed that the nonpayment by Medicare for “reasonably preventable” hospital-acquired complications resulted in this discrepancy. Inaccurate data may lead to the lack of correlation a complication and outcomes on the CMS database.

The sole source of mortality and readmission data in this study was CMS. This is limited to Medicare and Medicaid patients but is probably representative of the general population in an acute care hospital. However, also included on the CMS website is a dizzying array of measures. We did not analyze every measure but analyzed only those listed in Table 1. Whether examination of other measures would correlate with mortality and readmission rates is unclear.

There are several limitations to our data. First and foremost, the CMS data is self-reported by hospitals. The validity and accuracy of the data has been called into question. Second, data is missing in multiple instances. For example, much of the data from Maryland was not present. Also, there were multiple instances when the data was “unavailable” or the “number of cases are too small”.  Third, in some instances CMS did not report actual data but only higher, lower or no different from the National average. This loss of information may have led to inaccurate analyses. Fourth, much of the data are from surrogate markers, a fact which is important since surrogate markers have not been shown to predict outcomes. This is also puzzling since patient-centered outcomes are available.  Fifth, much of the outcomes data is derived from CMS which to a large extent eliminates Veterans Administration, pediatric, mental health and some other specialty facilities.

It is unclear if any of the hospital rankings should be used by patients or healthcare providers when choosing a hospital. At present it would appear that the rankings have an over reliance on surrogate markers, many of which are weakly evidence-based. Furthermore, categorizing the data as average, below or above average may lead to an inaccurate interpretation of the data. Lastly, the accuracy of the data is unclear. Finally, lack of data on length of stay and some major morbidities is a major weakness. We as physicians need to scrutinize these measurement systems and insist on greater methodological rigor and more relevant criteria to choose. Until these shortcomings are overcome, we cannot recommend the use of hospital rankings by patients or providers.

References

1. http://www.medicare.gov/hospitalcompare/ (accessed 6/12/13).
2. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med. 2012;172(5):405-11. [CrossRef] [PubMed]
3. http://www.jointcommission.org/annualreport.aspx (accessed 6/12/13).
4. http://www.hospitalsafetyscore.org (accessed 6/12/13).
5. http://health.usnews.com/best-hospitals (accessed 6/12/13).
6. Padrnos L, Bui T, Pattee JJ, Whitmore EJ, Iqbal M, Lee S, Singarajah CU, Robbins RA. Analysis of overall level of evidence behind the Institute of Healthcare Improvement ventilator-associated pneumonia guidelines. Southwest J Pulm Crit Care. 2011;3:40-8.
7. Hurley J, Garciaorr R, Luedy H, Jivcu C, Wissa E, Jewell J, Whiting T, Gerkin R, Singarajah CU, Robbins RA. Correlation of compliance with central line associated blood stream infection guidelines and outcomes: a review of the evidence. Southwest J Pulm Crit Care. 2012;4:163-73.
8. NICE-SUGAR Study Investigators. Intensive versus conventional insulin therapy in critically ill patients. N Engl J Med. 2009;360:1283-97. [CrossRef] [Pubmed]
9. Robbins RA. The emperor has no clothes: the accuracy of hospital performance data. Southwest J Pulm Crit Care. 2012;5:203-5.
10. Meddings JA, Reichert H, Rogers MA, Saint S, Stephansky J, McMahon LF. Effect of nonpayment for hospital-acquired, catheter-associated urinary tract infection: a statewide analysis. Ann Intern Med. 2012;157:305-12. [CrossRef] [PubMed]

Reference as: Robbins RA, Gerkin RD. A comparison between hospital rankings and outcomes data. Southwest J Pulm Crit Care. 2013;7(3):196-203. doi: http://dx.doi.org/10.13175/swjpcc076-13 PDF

Profiles in Medical Courage: John Snow and the Courage of Conviction

Richard A. Robbins, M.D.¹

Stephen A. Klotz, M.D.² 

¹Phoenix Pulmonary and Critical Care Research and Education Foundation, Gilbert, AZ

²Division of Infectious Diseases, University of Arizona, Tucson, AZ

Abstract

The story of John Snow’s removal of the handle of the Broad Street pump stopping the London cholera outbreak of 1854 has reached near legendary status. In this review we examine Snow’s life and conclude that the removal of the pump handle causing the end of the epidemic is largely myth. However, Snow was a clever man with eclectic medical interests. He not only founded the field of epidemiology but did early pioneering work in resuscitation and anesthesia. It is likely that his self-experimentation with anesthetic gases may have contributed to his early death at age 45. Largely forgotten during his own time, he is now correctly remembered as a smart physician and scientist with the conviction to pursue what he believed to be right.

Introduction

A poll taken by a UK medical magazine for hospital doctors named John Snow (Figure 1) the greatest physician of all time (1).

Figure 1. John Snow in 1857.

Hippocrates was second. However, a recent equally unscientific poll of medical students revealed that none had heard of Snow (Robbins RA, unpublished observations) prompting the writing of this Profile in Medical Courage. Snow’s work was largely ignored in his own time (2). The 19th century British medical establishment was in general fiercely opposed to his views on cholera and favored the “miasma” or bad air theory of how cholera was spread (2,3). His somewhat less than friendly personality and early death contributed to his lack of recognition. However, starting in the 1930’s with republication of Snow’s most famous text, “On the Mode of Communication of Cholera” the story of John Snow and cholera has become a founding chronicle of public health (4). Snow’s contributions have been so important that he has been termed the founder of epidemiology (2-4).

Many have heard the famous story of the Broad Street pump and how the removal of the pump handle stopped the cholera epidemic of 1854, although apparently not our medical students. Snow's rise to iconic status originated not only because of his founding the science of epidemiology, but also his pioneering work on resuscitation and anesthesia (2). During his short lifetime, Snow contributed 107 publications to the scientific literature (2). In this review, we examine the life of Snow, his publications and his work on cholera, anesthesia and resuscitation.

Early Years

John Snow was born into a family of modest means on March 15, 1813 in York, England (2). His father was a laborer in the neighboring coal yard. Beginning about age 6, Snow attended a private, common day school in York. There were few public schools and common day schools were intended to educate the poor. He attended school until he was 14 and received basic education in reading, writing, arithmetic and the Scriptures. He was noted to be a good student with mathematics and natural history his favorite subjects.

Usually the children of poor families left home as early as possible to earn their own livings. How Snow’s family afforded to send him to a private school, even one intended for the poor, remains a mystery. Some suggest that money may have come from his maternal uncle, Charles Empson, a prosperous book merchant first in Newcastle-upon-Tyne and later in Bath (2).  However, others suggest Snow's ambitious father, William, was the likely source (2). At about the time he began school, his father began delivering goods by horse-drawn carriage that arrived by river. He saved his money and purchased rental property and eventually a farm.  Such upward financial mobility was unusual in 19^th century England.

Medical Apprenticeships

Medical education in the early 1800’s was markedly different from today (2). Only two universities, Oxford and Cambridge, granted medical degrees leading to licensure. Snow’s modest means meant he could attend neither. The other route to licensure, and the one taken by Snow, was to apprentice with a surgeon and apothecary (pharmacist). Eventually the apprentice could take the licensing test given by the Royal Colleges of Physicians and of Surgeons and the Worshipful Society of Apothecaries to obtain medical licensure. 

Snow did 3 apprenticeships beginning at age 14 that lasted 9 years. His first was in Newcastle- upon-Tyne with William Hardcastle, a general practitioner. Newcastle was 90 miles from York, a fair distance in the first half of the 19^th Century. Why Snow was sent so far from home for his first apprenticeship is likely explained by Hardcastle’s friendship with Snow's uncle, Charles Empson. Empson was a witness at Hardcastle’s wedding and executor of his will. Hardcastle was an established practitioner of good reputation in the Newcastle area who was thirty-one years old at the outset of Snow's apprenticeship.  

Snow's apprenticeship with Hardcastle lasted six years. Not only were the foundations of his medical training developed but the first indications of his independent nature became evident. During the third year of his apprenticeship when he was 17 years old, he became a vegetarian and teetotaler. Snow found time to attend classes at what would eventually become a modern medical school. He also developed his interest in cholera. In 1831, when he was 18 years old, Hardcastle sent Snow to provide medical assistance to the local coal miners and their families who were victims of a cholera outbreak. Years later Snow wrote, "That the men [who work in coal pits] are occasionally attacked whilst at work I know, from having seen them brought up from some of the coal-pits ... after having had profuse discharges from the stomach and bowels, and when fast approaching to a state of collapse” (2).

At age 20 Snow went to Burnop Field, a neighboring village near Newcastle and became an assistant to John Watson, a rural apothecary.  He apparently had little in common with Mr. Watson and considered his wages very low. He left Burnop Field after only a year and did his next apprenticeship at Pateley Bridge with Joseph Warburton, also a licensed apothecary. Pateley Bridge was and is a small village in a remote region about 30 miles west of York. Snow lived in the large house that served as both home and surgery to Warburton and his family. Snow viewed Warburton with great respect and friendship, later referring to him as his "old master” (2). He remained with Warburton for 18 months.

Formal Medical Education

At the age of 23 Snow began his formal education by enrolling for a year in the Hunterian School of Medicine located on Great Windmill Street in the Soho region of east London (2). During this time Snow rented an inexpensive room at 11 Bateman's Buildings, a narrow alleyway several blocks north of the Hunterian Medical School and just south of Soho Square. In the 19^th century Soho could be best described as “dodgy” (5). Respectable families had moved away, and prostitutes, music halls and small theatres had moved in. The Hunterian school was privately run and provided lectures, demonstrations and dissections.  Shortly after Snow completed his year at Hunterian, the school closed.  

In October 1837 at the age of 24, Snow became a registrar at the Westminster Hospital, thereby gaining experience in a hospital setting (2). The hospital was nearly a mile south of his home on Bateman's Buildings, to which he walked most days. The hospital had been reconstructed and enlarged in 1834, and had a good reputation in surgery. After about 18 months, Snow passed his examination to become a Member of the Royal College of Surgeons of England (MRCS), permitting him to practice general medicine. He ranked 7th among the 114 candidates who passed the examination. Snow also passed his Licentiate of the Society of Apothecaries (LSA), ranking 8th on a list of 10, allowing him to prepare and sell drugs and other medicines.  After 12 years of apprenticeship and education he was certified as a general practitioner.

In the mid-1800s, neither the MB nor MD was necessary to practice general medicine. However, Snow's curiosity along with a desire for wealthier, more discerning patients led him to enroll at the newly created University of London Medical School in 1838. While active as a general practitioner, Snow attended the University of London for five years. When he was 30 years old Snow received the Bachelor of Medicine (MB) degree. A year later in December 1844, he obtained the Doctorate of Medicine (or MD), also from the University of London. 

Early Practice and Academic Pursuits

Snow continued his general practice in Soho and was now located at a new address about a block south of Soho Square (2). In 1846 he took a position as lecturer in forensic medicine at the Aldersgate School of Medicine, a private medical school in central London.  He remained at the school as Lecturer from 1846 to 1849 when the institution closed for lack of funding. In 1850 he passed the examination to become a Licentiate of the Royal College of Physicians (LRCP) of London.  The LRCP was the most elite of the medical profession.

Resuscitation

Beginning in about 1837, Snow joined the Westminster Medical Society. Although not a particularly sociable man, Snow was able to interact with his medical colleagues and to present his scientific theories. Snow regarded membership in this organization as the most influential in his professional growth (2).

In the 1840’s Snow developed an interest in resuscitation. One of the first communications to the Westminster Medical Society described a device for resuscitation of the newborn (6). The instrument was based on the concept of the “pulmotor”. Snow assumed that the stimulus for respiration, including newborns, was hypoxemia. He also speculated that the pulsive action of the blood was in part due to the capillaries, since it seemed unlikely that heart was sufficiently strong to propel the blood through the arteries, capillaries and veins.

Anesthesia

Snow’s early practice was not particularly successful, at least in part, because he was not very personable (2). During his time at the University of London, Snow became increasingly interested in anesthetics. He conducted numerous experiments, both on animals and himself and invented an improved ether inhaler (2).  Air and ether were mixed as vapor at one side of the apparatus and drawn over and round the spiral chamber, to be inhaled by the patient through a mouth-tube fitted with cedarwood ball valves. His work attracted the attention of Robert Liston, the best known surgeon of the day. Liston, who performed the first operation in Europe using ether, was impressed with the difference between the result of anesthesia administered by Snow, and that of less cautious anesthetists. Liston put his ether practice almost entirely into Snow’s hands (2). Soon Snow was recognized as the premier anesthetist in London. Although he had practically introduced the use of ether into English surgery, Snow balanced ether against other anaesthetizing agents, particularly chloroform. He administered the later to Queen Victoria during the birth of her last 2 children in 1853 and 1857 (2). Snow published the results of his experience with ether in 1847, including the definition of four anesthesia stages which continue to be recognized in modern times (7).

Epidemiology and the Broad Street Pump

By the middle of the 19th century, London along the Thames was a cesspool (Figure 2).

Figure 2. Cartoon of famous English scientist Michael Faraday who wrote a letter to The Times in 1855 complaining of the foul condition of the Thames, which resulted in this cartoon in Punch.

Both human and animal excrement and garbage were placed in cesspits if not thrown directly into the river. However, the cesspits eventually filled and overflowed draining into the river. Disposal of waste in the river was further complicated in that London is close enough to the North Sea that the river level is affected by the tides. Sewage flowed downriver at low tide but twice a day a wall of water would carry it back upstream. Snow’s neighborhood of Soho was especially bad (5). It had become an insanitary place of cow-sheds, slaughterhouses, grease-boiling dens and primitive, decaying sewers.

When cholera first hit England in late 1831, it was thought to be spread by "miasma in the atmosphere” or bad air (2). The cholera outbreaks seemed to occur where the stench was worst, which was often next to water sources. This is hardly surprising since acceptance of the germ theory would wait the discoveries of Pasteur and Koch in the later part of the century (Figure 3).

Figure 3. Timeline for some of seminal infectious disease discoveries of the 19^th century. A: 1847-Semmelweis discovers that hand washing decreases the incidence of puerperal fever. B: 1855-Snow publishes On the Mode of Communication of Cholera. C: 1878-Pasteur publishes Microbes Organized, Their Role In Fermentation, Putrefaction and the Contagion. D: 1883-Koch identifies the bacterial cause of cholera.

England had suffered numerous cholera outbreaks during the 19^th century. Whenever cholera broke out nothing could be done to contain it. The disease rampaged through the industrial cities, leaving tens of thousands dead in its wake. At the beginning of the 1854 London epidemic Soho suffered only a few, isolated cases. However, on the night of August 31^st what Dr Snow later called "the most terrible outbreak of cholera which ever occurred in the kingdom" broke out (8). During the next three days, 127 people living in or around Broad Street died. Within a week, most residents had fled their homes, leaving the shops shuttered, the houses locked and the streets deserted. Only those who could not afford to leave remained there.

By September 10^th, the number of fatal attacks had reached 500. Snow’s previous researches had convinced him that cholera, "always commences with disturbances of the functions of the alimentary canal” (2). This led him to conclude that it was spread by sewage-tainted water. Snow had traced a recent outbreak in South London to contaminated water supplied by the Southwark and Vauxhall Water Company (9,10). However, no one believed his theory. The water company pooh-poohed his theories and the authorities were reluctant to believe in a theory of fecal-oral contamination.

From the beginning Snow interviewed the families of the victims. His research led him to a pump on the corner of Broad Street and Cambridge Street, at the epicenter of the epidemic. He mapped the deaths of each of the victims (Figure 4).

Figure 4. Panel A. Snow’s map from his 1855 publication (8). Squares indicate deaths from cholera. The pump is indicated by the red arrow and Snow’s residence on Frith Street by the blue arrow (5). Panel B. Enlargement of the green square from Panel A showing the clustering of the deaths surrounding the Broad Street pump.

Snow would write that “… nearly all the deaths had taken place within a short distance of the pump" (8).  He took a sample of water from the pump, and, on examining it under a microscope, found that it contained "white, flocculent particles” (8). By September 7^th, he was convinced that these were the source of infection.

Snow was a prominent physician and considered somewhat an expert on cholera having published several articles on the disease (9,10). He came uninvited to a meeting of the Board of Guardians of St James's Parish, the region serviced by the Broad Street pump on September 7^th. In England, the parish is the fundamental tier of local government. Dr. Edwin Lankester, a member of a local group that looked into the causes of the Broad Street outbreak and the first medical officer for the St. James's district, later wrote, "The Board of Guardians met to consult as to what ought to be done. Of that meeting, the late Dr. Snow demanded an audience. He was admitted and gave it as his opinion that the pump in Broad Street, and that pump alone, was the cause of all the pestilence.  He was not believed -- not a member of his own profession, not an individual in the parish believed that Snow was right.  But the pump was closed nevertheless and the plague was stayed” (2). The pump handle was famously removed.

Aftermath of the 1854 Cholera Outbreak

By the end of September the outbreak was over leaving 616 residents of Soho dead. However, there were several unexplained deaths from cholera that could not be linked to the Broad Street pump water -- notably, Susannah Eley, a widow living in Hampstead on London’s West End, who had died of cholera on September 2^nd, and her niece who had succumbed the following day (8). Neither of these women had been near Soho. Dr Snow traveled to Hampstead to interview the Eley's son. Snow learned that the widow had once lived on Broad Street, and that she had liked the taste of the well-water there so much that she had sent her servant down to Soho every day to bring back a large bottle for her by cart. The last bottle of had been brought to Hampstead on August 31^st, at the very start of the epidemic.

Snow’s persistence in obtaining as much data as was possible is a remarkable trait demonstrated by the following incidents (8). Only 5 of the 530 inmates of the Poland Street workhouse, which was just around the corner from the pump, contracted cholera. Snow discovered that few drank the pump water, since the workhouse had its own well. Similarly, among the 70 workers in a brewery on Broad Street there were no fatalities at all. It was discovered that the workers were given a beer allowance and never drank from the well.

Snow’s “Grand Experiment,” compared cholera in the 1854 epidemic in neighborhoods receiving water from two different companies (8). The Lambeth Company delivered water from the upper Thames away from the Broad Street pump and urban pollution. On the other hand, the Southwark and Vauxhall Company relied on inlets in the heart of London, where the contamination of water with sewage was common. Snow showed the harmful effect of contaminated water in two nearly equivalent populations, and he suggested intervention strategies to control the epidemic. His ideas and observations, including innovative disease maps, were published in his book On the Mode of Communication of Cholera (8). Later, beginning in the 1930s, Snow’s work was republished as a classic work in epidemiology, resulting in his lasting recognition (4).

Snow wrote, "The experiment, too, was on the grandest scale. No fewer than three hundred thousand people of both sexes, of every age and occupation, and of every rank and station, from gentlefolks down to the very poor, were divided into two groups without their choice, and, in most cases, without their knowledge; one group being supplied with water containing the sewage of London, and, amongst it, whatever might have come from the cholera patients, the other group having water quite free from such impurity” (8).

Using a classic 2X2 set up, Snow obtained data on the two sets of London households and found that during an 1854 epidemic there were 315 deaths from cholera per 10,000 homes among those supplied by Southwark-Vauxhall but only 37 deaths per 10,000 supplied by Lambeth (2). Snow had gotten his numbers from a less than precise Parliamentary report leading to criticism and Snow’s own admission that the results were not strong enough to establish that cholera was related to water supply.

Still no one believed Snow. A report by the Board of Health a few months later concluded, "We see no reason to adopt this [Snow’s] belief” (2).  The pump handle was replaced. However, about a year after the epidemic Snow’s theories received support from an unexpected source. The Reverend Henry Whitehead, vicar of St Luke's Church, Berwick Street, did his own investigation (2). Although originally a believer in the miasma theory, Snow’s data convinced him that the pump was the source. Furthermore, Whitehead helped Snow to determine the probable cause of the cholera outbreak. Just before the Soho epidemic, a child living at number 40 Broad Street had been taken ill with cholera symptoms. Its diapers had been steeped in water which was subsequently disposed of in a leaking cesspool situated only three feet from the Broad Street well.

Whitehead's findings were published in the architectural journal, The Builder, along with a report on living conditions in Soho (2). "Even in Broad-street it would appear that little has since been done... In St Anne's-Place, and St Anne's-Court, the open cesspools are still to be seen; in the court, so far as we could learn, no change has been made; so that here, in spite of the late numerous deaths, we have all the materials for a fresh epidemic... In some [houses] the water-butts were in deep cellars, close to the undrained cesspool... The overcrowding appears to increase..."  The Builder went on to recommend "the immediate abandonment and clearing away of all cesspools -- not the disguise of them, but their complete removal”.

Nothing was done. The pump handle was replaced. The cesspools were not drained. It was likely “The Great Stink of 1858” that prompted action (11). During the summer warm weather combined with a series of low tides to cause such a stench that Parliament was adjourned for a week. Finally in 1859 the Metropolitan Board of Works, after rejecting many schemes to diminish the Thames’ smell, accepted the proposal of Joseph Bazalgette. The intention of this very expensive scheme was to resolve the epidemic of cholera by eliminating the stench (miasma) which was believed to cause it. Over the next six years the main elements of the London sewerage system were created. As an unintended consequence the water supply ceased to be contaminated and resolved the repeated episodes of cholera epidemics.

Later Years and Death

Snow’s health had never been the best.  After receiving his MD from the University of London, Snow had suffered from tuberculosis (2). He recovered by spending a good deal of time in the fresh air away from Soho and the Thames. In 1845 he had an acute attack of renal disease. His physician told him to abandon his strict vegetarian diet and to take wine in small quantities. He improved. 

Likely of greater significance regarding was his self-experimentation with anesthesia (2).  He was the first to carry out experiments on the physiology of anesthesia, and did not spare himself in investigating every possible substance that might be employed as an anesthetic. The pathologic effect of most of these agents was not known in Snow's time. 

A clue to the Snow’s ill health is a photo showing the swelling of the index finger of his right hand (Figure 5).

Figure 5. Close up of Snow’s right hand taken from Figure 1 showing a swollen index finger.

Such swelling of the fingers has been associated with chronic renal failure. Exposure to anesthetic gases is now known to have numerous adverse health effects, including severe renal damage. In Snow's case, his swollen fingers were likely due to extensive self-experimentation over nearly a decade with a variety of anesthetic agents.

On the evening of June 9, 1858, John Snow joined a group of colleagues to discuss a new bi-aural (i.e., two ear pieces) stethoscope and the cause of the first Korotkoff sound when measuring blood pressure (2). The next morning, he suffered a slight stroke while working on, “On Chloroform and other Anesthetics”.  He recovered but a few days later suffered another cerebral accident. His housekeeper found him on the floor. He died a few days later. 

At autopsy, Snow's kidneys were found to be "shrunken, granular and encysted” (2). While there was also scar tissue in the kidney from old bouts of tuberculosis, it seems likely that his kidney problems arose from anesthetic experimentation.

On June 26, 1858, the following short notice of death appeared in The Lancet (Figure 6).

Figure 6. Snow’s death notice in the Lancet.

A humble obituary for so great a physician.

Legacy

Snow’s work in so many fields is well documented although he was not always right. Snow’s life is now commemorated in such an English way-a pub near the original site of the Broad Street pump. The pub was renamed for him in 1955 on the centenary of the Snow’s publication of “On the Mode of Communication of Cholera” (Figure 7).

Figure 7. John Snow pub on Broadwick (formerly Broad) Street in modern London.

It is ironic that Snow, who did not drink alcohol or eat meat for most of his life, should be commemorated by a public house where the menu is not vegetarian and the libations are alcoholic.

It is difficult to underestimate the historical importance of Snow’s work. Gro Harlem Brundtland, former Director-General of the World Health Organization has said, "In historic terms the marriage between science and health is a relatively recent event. Not long ago superstition, magic and astrology were the only weapons our ancestors had to fight diseases and epidemics that haunted the world. They were seen as divine punishments or unfavorable influence of the heavenly bodies. We owe that marriage to the creators of modern bacteriology, epidemiology and therapeutics - to scientists such as Louis Pasteur, Robert Koch, John Snow, Alexander Fleming and Paul Erlich - and their discoveries that shaped modern medicine and public health policies. They helped rescue our civilization from the dark ages of the unknown - and the unknown had names such as plagues, cholera or syphilis" (2).

When David Satcher, the former Surgeon General, was faced with a complex public health issue, he would frequently ask, “Where is the handle on this Broad Street pump?” (2).

We celebrate Snow for not “caving in” to popular opinion, even against his more illustrious colleagues, a persistence in getting at the truth of the matter, and the courage to put it in print. Yet, his real excellence, lies in his creativity to look at an event as all his contemporaries did and come up with the novel (and correct) solution and his conviction to that solution when he believed he was right.

References

1. http://www.ph.ucla.edu/epi/snow.html (accessed 5/7/13).
2. http://www.ph.ucla.edu/epi/snow.html (accessed 5/7/13).
3. http://madisonleighrose.wordpress.com/2012/08/27/john-snow-and-the-cholera-myth/ (accessed 5/7/13).
4. Snow J. Snow on Cholera -- A Reprint of Two Papers by John Snow, M.D. together with A Biographical Memoir by B.W. Richardson, M.D., and an Introduction by Wade Hampton Frost, M.D., Hafner Publishing Company, London, 1965.
5. Summers J. Soho -- A History of London's Most Colourful Neighborhood, Bloomsbury, London, 1989, pp. 113-117.
6. Snow J. On asphyxia and on the still-born. London Med Gaz. 1842;1:222-7.
7. Snow J. On the inhalation of the vapour of ether in surgical operations Br. J. Anaesth. 1953;25: 53-4. [CrossRef]
8. Snow J. On the Mode of Communication of Cholera. London: John Churchill,  New Burlington Street, England, 1855
9. Snow J. On the pathology and mode of communication of cholera: part 1. London Medical Gazette. 1849;44:745-52.
10. Snow J. On the pathology and mode of communication of cholera: part 2. London Medical Gazette. 1849;44:923-29.
11. http://en.wikipedia.org/wiki/Great_Stink (accessed 5/7/13).

Reference as: Robbins RA, Klotz SA. Profiles in medical courage: John Snow and the courage of conviction. Southwest J Pulm Crit Care. 2013;7(2):87-99. doi: http://dx.doi.org/10.13175/swjpcc063-13 PDF

Comparisons between Medicare Mortality, Readmission and Complications

Richard A. Robbins, MD*

Richard D. Gerkin, MD ^‡ 

*Phoenix Pulmonary and Critical Care Research and Education Foundation, Gilbert, AZ

^‡Banner Good Samaritan Medical Center, Phoenix, AZ

Abstract

The Center for Medicare and Medicaid Services (CMS) has been a leading advocate of evidence-based medicine. Recently, CMS has begun adjusting payments to hospitals based on hospital readmission rates and “value-based performance” (VBP). Examination of the association of Medicare bonuses and penalties with mortality rates revealed that the hospitals with better mortality rates for heart attacks, heart failure and pneumonia had significantly greater penalties for readmission rates (p<0.0001, all comparisons). A number of specific complications listed in the CMS database were also examined for their correlations with mortality, readmission rates and Medicare bonuses and penalties. These results were inconsistent and suggest that CMS continues to rely on surrogate markers that have little or no correlation with patient-centered outcomes.

Introduction

Implementation of the Affordable Care Act (ACA) emphasized the use of evidence-based measures of care (1). However, the scientific basis for many of these performance measures and their correlation with patient-centered outcomes such as mortality, morbidity, length of stay and readmission rates have been questioned (2-6). Recently, CMS has begun adjusting payments based on readmission rates and “value-based performance” (VBP) (7). Readmission rates and complications are based on claims submitted by hospitals to Medicare (8).

We sought to examine the correlations between mortality, hospital readmission rates, complications and adjustments in Medicare reimbursement. If the system of determining Medicare reimbursements is based on achievement of better patient outcomes, then one hypothesis is that lower readmission rates would be associated with lower mortality.  An additional hypothesis is that complications would be inversely associated with both mortality and readmission rates. 

Methods

Hospital Compare

Data was obtained from the CMS Hospital Compare website from December 2012-January 2013 (8). The data reflects composite data of all hospitals that have submitted claims to CMS. Although a number of measures are listed, we recorded only readmissions, complications and deaths since many of the process of care measures have not been shown to correlate with improved outcomes. Patient satisfaction was not examined since higher patient satisfaction has been shown to correlate with higher admission rates to the hospital, higher overall health care expenditures, and increased mortality (9). In some instances data are presented in Hospital Compare as higher, lower or no different from the National average. In this case, scoring was done 2, 0 and 1 respectively with 0=higher, 2=lower and 1=no different.

Mortality

Mortality was obtained from Hospital Compare and is the 30-day estimates of deaths from any cause within 30 days of a hospital admission for patients hospitalized for heart attack, heart failure, or pneumonia regardless of whether the patient died while still in the hospital or after discharge. The mortality and rates are adjusted for patient characteristics including the patient’s age, gender, past medical history, and other diseases or conditions (comorbidities) the patient had at hospital arrival that are known to increase the patient’s risk of dying.

Readmission Rates

Similarly, the readmission rates are 30-day estimates of readmission for any cause to any acute care hospital within 30 days of discharge. These measures include patients who were initially hospitalized for heart attack, heart failure, and pneumonia. Similar to mortality, the readmission measures rates are adjusted for patient characteristics including the patient’s age, gender, past medical history, and other diseases or conditions (comorbidities) the patient had at hospital arrival that are known to increase the patient’s risk for readmission.

Complications

CMS calculates the rate for each complication by dividing the actual number of self-reported outcomes at each hospital by the number of eligible discharges for that measure at each hospital, multiplied by 1,000. The composite value reported on Hospital Compare is the weighted averages of the component indicators.  The measures of serious complications reported are risk adjusted to account for differences in hospital patients’ characteristics. In addition, the rates reported on Hospital Compare are “smoothed” to reflect the fact that measures for small hospitals are measured less accurately (i.e., are less reliable) than for larger hospitals.

CMS calculates the hospital acquired infection data from the claims hospitals submit to Medicare. The rate for each hospital acquired infection measure is calculated by dividing the number of infections that occur within any given eligible hospital by the number of eligible Medicare discharges, multiplied by 1,000. The hospital acquired infection rates were not risk adjusted by CMS.

In addition to the composite data, individual complications listed in the CMS database were examined (Table 1).

Table 1. Complications examined that are listed in CMS data base.

Objects Accidentally Left in the Body After Surgery

Air Bubble in the Bloodstream

Mismatched Blood Types

Severe Pressure Sores (Bed Sores)

Falls and Injuries

Blood Infection from a Catheter in a Large Vein

Infection from a Urinary Catheter

Signs of Uncontrolled Blood Sugar

Medicare Bonuses and Penalties

The CMS data was obtained from Kaiser Health News which had compiled the data into an Excel database (10).

Statistical Analysis

Data was reported as mean + standard error of mean (SEM). Outcomes between hospitals rated as better were compared to those of hospitals rated as average or worse using Student’s t-test. The relationship between continuous variables was obtained using the Pearson correlation coefficient. Significance was defined as p<0.05. All p values reported are nominal, with no correction for multiple comparisons.

Results

A large database was compiled for the CMS outcomes and each of the hospital ratings (Appendix 1). There were over 2500 hospitals listed in the database.

Mortality and Readmission Rates

A positive correlation for heart attack, heart failure and pneumonia was found between hospitals with better mortality rates (p<0.001 all comparisons). In other words, hospitals with better mortality rates for heart attack tended to be better mortality performers for heart failure and pneumonia, etc.  Surprisingly, the hospitals with better mortality rates for heart attack, heart failure and pneumonia had higher readmission rates for these diseases (p<0.001, all comparisons).

Examination of the association of Medicare bonuses and penalties with mortality rates revealed that the hospitals with better mortality rates for heart attacks, heart failure and pneumonia received the same compensation for value-based performance as hospitals with average or worse mortality rates (Appendix 2, p>0.05, all comparisons). However, these better hospitals had significantly larger penalties for readmission rates (Figure 1, p<0.0001, all comparisons). 

Figure 1.  Medicare bonuses and penalties for readmission rates of hospitals with better, average or worse mortality for myocardial infarction (heart attack, Panel A), heart failure (Panel B), and pneumonia (Panel C).

Because total Medicare penalties are the average of the adjustment for VBP and readmission rates, the reduction in reimbursement was reflected with higher total penalty rates for hospitals with better mortality rates for heart attacks, heart failure and pneumonia (Figure 2 , p<0.001, all comparisons).

Figure 2.  Total Medicare bonuses and penalties for readmission rates of hospitals with better, average or worse mortality for myocardial infarction (heart attack, Panel A), heart failure (Panel B), and pneumonia (Panel C).

Mortality Rates and Complications

The rates of a number of complications are also listed in the CMS database (Table 1). A correlation was performed for each complication compared to the hospitals with better, average or worse death and readmission rates for heart attacks, heart failure and pneumonia (Appendix 3). A positive correlation of hospitals with better mortality rates was only observed for falls and injuries in the hospitals with better death rates from heart failure (p<0.02). However, severe pressure sores also differed in the hospitals with better mortality rates for heart attack and heart failure, but this was a negative correlation (p<0.05 both comparisons). In other words, hospitals that performed better in mortality performed worse in severe pressure sores. Similarly, hospitals with better mortality rates for heart failure had higher rates of blood infection from a catheter in a large vein compared to hospitals with an average mortality rate (p<0.001). None of the remaining complications differed.

Readmission Rates and Complications

A correlation was also performed between complications and hospitals with better, average and worse readmission rates for myocardial infarction, heart failure, and pneumonia (Appendix 4). Infections from a urinary catheter and falls and injuries were more frequent in hospitals with better readmission rates for myocardial infarction, heart failure, and pneumonia compared to hospitals with the worse readmission rates (p<0.02, all comparisons). Hospitals with better readmission rates for heart failure also had higher infections from a urinary catheter compared to hospitals with average readmission rates for heart failure (p<0.001). None of the remaining complications significantly differed 

Discussion

The use of “value-based performance” (VBP) has been touted as having the potential for improving care, reducing complications and saving money. However, we identified a negative correlation between deaths and readmissions, i.e., those hospitals with the better mortality rates were receiving larger financial penalties for readmissions and total compensation. Furthermore, correlations of hospitals with better mortality and readmission rates with complications were inconsistent.

Our data compliments and extends the observations of Krumholz et al. (11). These investigators examined the CMS database from 2005-8 for the correlation between mortality and readmissions. They identified an inverse correlation between mortality and readmission rates with heart failure but not heart attacks or pneumonia. However, with the financial penalties now in place for readmissions, it now seems likely hospital practices may have changed.

CMS compensating hospitals for lower readmission rates is disturbing since higher readmission rates correlated with better mortality. This equates to rewarding hospitals for practices leading to lower readmission rates but increase mortality. The lack of correlation for the other half of the payment adjustment, so called “value-based purchasing” is equally disturbing since if apparently has little correlation with patient outcomes.

Although there is an inverse correlation between mortality and readmissions, this does not prove cause and effect. The causes of the inverse association between readmissions and mortality rates are unclear, but the most obvious would be that readmissions may benefit patient survival. The reason for the lack of correlation between mortality and readmission rates with most complication rates is also unclear. VBP appears to rely heavily on complications that are generally infrequent and in some cases may be inconsequential. Furthermore, many of the complications are for all intents and purposes self-reported by the hospitals to CMS since they are based on claims data. However, the accuracy of these data has been called into question (12,13). Meddings et al. (13) studied urinary tract infections. According to Meddings, the data were “inaccurate” and not were “not valid data sets for comparing hospital acquired catheter-associated urinary tract infection rates for the purpose of public reporting or imposing financial incentives or penalties”. The authors proposed that the nonpayment by Medicare for “reasonably preventable” hospital-acquired complications resulted in this discrepancy. Inaccurate data may lead to the lack of correlation a complication and outcomes on the CMS database.

According to the CMS website the complications were chosen by “wide agreement from CMS, the hospital industry and public sector stakeholders such as The Joint Commission (TJC) , the National Quality Forum (NQF), and the Agency for Healthcare Research and Quality (AHRQ) , and hospital industry leaders” (7). However, some complications such as air bubble in the bloodstream or mismatched blood types are quite rare. Others such as signs of uncontrolled blood sugar are not evidence-based (14). Other complications actually correlated with improved mortality or readmission rates. It seems likely that some of the complications might represent more aggressive treatment or could reflect increased clinical care staffing which has previously been associated with better survival (14,15). 

There are several limitations to our data. First and foremost, the data are derived from CMS Hospital Compare where the data has been self-reported by hospitals. The validity and accuracy of the data has been called into question (12,13). Second, data are missing in multiple instances. For example, data from Maryland were not present. There were multiple instances when the data were “unavailable” or the “number of cases are too small”. Third, in some instances CMS did not report actual data but only higher, lower or no different from the National average. Fourth, much of the data are from surrogate markers, a fact which is puzzling when patient-centered outcomes are available. In addition, some of these surrogate markers have not been shown to correlate with outcomes.

It is unclear if CMS Hospital Compare should be used by patients or healthcare providers when choosing a hospital. At present it would appear that the dizzying array of data reported overrelies on surrogate markers which are possibly inaccurate. Lack of adequate outcomes data and even obfuscating the data by reporting the data as average, below or above average does little to help shareholders interpret the data. The failure to apparently incorporate mortality rates as a component of VBP is another major limitation. The accuracy of the data is also unclear. Until these shortcomings can be improved, we cannot recommend the use of Hospital Compare by patients or providers.

References

1. Obama B. Securing the future of American health care. N Engl J Med. 2012; 367:1377-81.
2. Showalter JW, Rafferty CM, Swallow NA, Dasilva KO, Chuang CH. Effect of standardized electronic discharge instructions on post-discharge hospital utilization. J Gen Intern Med. 2011;26(7):718-23.
3. Heidenreich PA, Hernandez AF, Yancy CW, Liang L, Peterson ED, Fonarow GC. Get With The Guidelines program participation, process of care, and outcome for Medicare patients hospitalized with heart failure. Circ Cardiovasc Qual Outcomes. 2012 ;5(1):37-43.
4. Hurley J, Garciaorr R, Luedy H, Jivcu C, Wissa E, Jewell J, Whiting T, Gerkin R, Singarajah CU, Robbins RA. Correlation of compliance with central line associated blood stream infection guidelines and outcomes: a review of the evidence. Southwest J Pulm Crit Care. 2012;4:163-73.
5. Robbins RA, Gerkin R, Singarajah CU. Relationship between the Veterans Healthcare Administration Hospital Performance Measures and Outcomes. Southwest J Pulm Crit Care 2011;3:92-133.
6. Padrnos L, Bui T, Pattee JJ, Whitmore EJ, Iqbal M, Lee S, Singarajah CU, Robbins RA. Analysis of overall level of evidence behind the Institute of Healthcare Improvement ventilator-associated pneumonia guidelines. Southwest J Pulm Crit Care. 2011;3:40-8.
7. http://www.medicare.gov/HospitalCompare/Data/linking-quality-to-payment.aspx (accessed 4/8/13).
8. http://www.medicare.gov/hospitalcompare/ (accessed 4/8/13).
9. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med. 2012;172:405-11.
10. http://capsules.kaiserhealthnews.org/wp-content/uploads/2012/12/Value-Based-Purchasing-And-Readmissions-KHN.csv (accessed 4/8/13).
11. Krumholz HM, Lin Z, Keenan PS, Chen J, Ross JS, Drye EE, Bernheim SM, Wang Y, Bradley EH, Han LF, Normand SL. Relationship between hospital readmission and mortality rates for patients hospitalized with acute myocardial infarction, heart failure, or pneumonia. JAMA. 2013;309(6):587-93. doi: 10.1001/jama.2013.333.
12. Robbins RA. The emperor has no clothes: the accuracy of hospital performance data. Southwest J Pulm Crit Care. 2012;5:203-5.
13. Meddings JA, Reichert H, Rogers MA, Saint S, Stephansky J, McMahon LF. Effect of nonpayment for hospital-acquired, catheter-associated urinary tract infection: a statewide analysis. Ann Intern Med. 2012;157:305-12.
14. NICE-SUGAR Study Investigators. Intensive versus conventional insulin therapy in critically ill patients. N Engl J Med. 2009;360:1283-97.
15. Robbins RA, Gerkin R, Singarajah CU. Correlation between patient outcomes and clinical costs in the va healthcare system. Southwest J Pulm Crit Care. 2012;4:94-100.

Reference as: Robbins RA, Gerkin RD. Comparisons between Medicare mortality, morbidity, readmission and complications. Southwest J Pulm Crit Care. 2013;6(6):278-86. PDF

In Vitro Versus In Vivo Culture Sensitivities: An Unchecked Assumption?

Vinay Prasad, MD*

Nancy Ho, MD^‡

*Medical Oncology Branch

National Cancer Institute

National Institutes of Health

Bethesda, Maryland.

vinayak.prasad@nih.gov

^‡Department of Medicine

University of Maryland 

Case Presentation

A patient presents to urgent care with the symptoms of a urinary tract infection (UTI). The urinalysis is consistent with infection, and the urine culture is sent to lab.  In the interim, a physician prescribes empiric treatment, and sends the patient home. Two days later, the culture is positive for E. coli, resistant to the drug prescribed (Ciprofloxacin, Minimum Inhibitory Concentration (MIC) 64 μg/ml), but attempts to contact the patient (by telephone) are not successful. The patient returns the call two weeks later to say that the infection resolved without sequelae.

Discussion

Many clinicians have the experience of treatment success in the setting of known antibiotic resistance, and, conversely, treatment failure in the setting of known sensitivity. Such anomalies and empiric research described here forces us to revisit assumptions about the relationship between in vivo and in vitro drug responses. 

When it comes to the utility of microbiology cultures, other writers have questioned cost effectiveness and yield (1). Though it is considered a quality measure by some groups in the United States, routine blood cultures seldom change antibiotic choice (3.6%) in patients who present to the emergency room with the clinical and radiographic signs of pneumonia (2)

The objection here is different, but fundamental. Even when culture sensitivities suggest we should change antibiotics, what empirical evidence is there that such changes are warranted? It is by no means a novel doubt. In 1963, at the dawn of in vitro sensitivity techniques, one group questioned their utility to predict clinical outcomes:

“Several objections may be raised…. First, local or host defense mechanisms may act in synergism or antagonism with the antibiotic.  Second, the concentration of antibiotic in tissue fluids, specifically blood, might bear no relation to the concentration at the site of infection…” (3)

And, while substantial pharmacologic progress has been made to ensure proper tissue concentrations, few empirical studies have sought to address the first concern (4). Recent examples suggest the relationship between in vitro and in vivo outcomes may be questionable.

One study of H. pylori tackled this issue (5). Macrolide and metronidazole resistance were determined in lab, and a urea breath test assessed clinical response. Interestingly, treatment with a clarithromycin regiment failed in 77% of persons with clarithromycin-resistant H. pylori compared with 13% of those with clarithromycin-susceptible isolates (relative risk, 6.2 [CI, 1.9 to 37.1]; P < 0.001).  While treatment with metronidazole-based therapy failed in 11% of those with metronidazole-resistant isolates and 38% of those with metronidazole-susceptible isolates (P > 0.25). 

These results suggest that metronidazole susceptibility wholly lacks clinical utility, while clarithromycin sensitivity may be useful. To fully prove the utility of clarithromycin sensitivity testing the authors should show a higher cure rate with a different regiment, and then demonstrate that upfront screening is preferable to empiric treatment and observation.  

Another study suggests that for some organisms and infections— Acanthamoeba keratitis—there exists no relationship at all between in vitro drug sensitivities and the in vivo response (6).

For some conditions, knowing that a causative organism is susceptible in vitro does in fact predict clinical response. For instance, a large study of gram-negative infections treated with cefotaxime found that as the MIC increased, from <4 μg/ml to 64 μg/ml (in vitro), the rate of clinical response fell from 91% to 50% (4). Thus, nearly all patients with susceptible organisms (low MIC) were successfully treated. But, perhaps, what is most interesting about this study is that even resistant organisms were effectively treated in 50% of patients. This finding is supported by work in urinary tract infections, which similarly found a high percentage of clinical response (>80%), even among patients whose causative organisms were resistant to prescribed agents (7).

Basic studies are required for bacteremia, pneumonia, urinary tract infections, endocarditis, and others. To do this work, we should not use our words interchangeably. Treatment failure must refer to an independent clinical outcome and not defined circularly as antibiotic resistance. As of today, faith that in vitro results predict in vivo outcomes remains an unchecked assumption whose treatment implications remain vast and reaching. 

References

1. Glerant JC, Hellmuth D, Schmit JL, Ducroix JP, Jounieaux V. Utility of blood cultures in community-acquired pneumonia requiring hospitalization: influence of antibiotic treatment before admission. Respir Med. 1999;93:208-12.
2. Kennedy M, Bates DW, Wright SB, Ruiz R, Wolfe RE, Shapiro NI. Do emergency department blood cultures change practice in patients with pneumonia? Ann Emerg Med. 2005;46:393-400.
3. Petersdorf RG, Plorde JJ. The usefulness of in vitro sensitivity tests in antibiotic therapy. Annu Rev Med. 1963;14:41-56.
4. Doern GV, Brecher SM. The Clinical Predictive Value (or Lack Thereof) of the Results of In Vitro Antimicrobial Susceptibility Tests. J Clin Microbiol. 2011;49:S11-S4.
5. McMahon BJ, Hennessy TW, Bensler JM, et al. The relationship among previous antimicrobial use, antimicrobial resistance, and treatment outcomes for Helicobacter pylori infections. Ann Intern Med. 2003;139:463-9.
6. Perez-Santonja JJ, Kilvington S, Hughes R, Tufail A, Matheson M, Dart JK. Persistently culture positive acanthamoeba keratitis: in vivo resistance and in vitro sensitivity. Ophthalmology. 2003;110:1593-600.
7. Alizadeh Taheri P, Navabi B, Shariat M. Neonatal urinary tract infection: clinical response to empirical therapy versus in vitro susceptibility at Bahrami Children's Hospital- Neonatal Ward: 2001-2010. Acta Med Iran. 2012;50:348-52.

Reference as: Prasad V, Ho N. In vitro versus in vivo culture sensitivities: an unchecked assumption? Southwest J Pulm Crit Care. 2013;6(3):125-7. PDF

Profiles in Medical Courage: Thomas Kummet and the Courage to Fight Bureaucracy

“You can’t fight city hall”-Unknown.

Abstract

Thomas Kummet was an oncologist wrongly accused in his mind of delivering substandard care. His fight for correcting what he believed to be a mistake illustrates the difficulty physicians face when challenging the current peer review system. In an attempt to defend his reputation he filed suit which was eventually dismissed by a Federal Court. His frustration over the futility of his fight is illustrative of the difficulties many physicians have faced in fighting a large bureaucracy and an unsympathetic justice system.

Introduction

Thomas Kummet (Figure 1) was an oncologist at the Phoenix Veterans Administration (VA) Medical Center.

Figure 1. Dr. Thomas Kummet

 He had been chief of oncology/hematology for nearly 20 years and was well-respected by his colleagues, staff and students. He was regarded as an excellent clinician. During his 20 years at the VA he no law suits or adverse actions. While attending on general medicine, the deaths of two patients launched a series of events leading Dr. Kummet to eventually file suit against the VA.

Case Presentations

Case 1

A 72 year old male patient was admitted to the surgical critical care (SICU) unit after being found comatose on the surgical ward.  He had undergone surgery for peripheral vascular disease 3 days earlier, but the resident physician failed to order monitoring of his warfarin therapy. At the time of the transfer, his prothrombin time was markedly elevated and a cat scan showed a large intracranial hemorrhage.  The surgery resident stated to the family that the diagnosis was disseminated intravascular coagulation as a complication of the surgery. Shortly after transfer to the SICU the patient expired.  The attending intensivist, a medical internist informed the family of the true cause of the bleeding which led to the patient’s death. The family sued, and received a settlement before trial.

In accordance with hospital policy, the chart was sent to the surgery service for review. The surgery service selected the intensivist as being responsible, who learned of that action only much later, when the state of Arizona began an investigation and placed the intensivist’s name on its public website as a physician guilty of malpractice.

Case 2

JV was a 67-year-old man who was admitted from dialysis clinic to the Internal Medicine Service in August 1999 with a history of non-insulin dependent diabetes mellitus, end stage renal disease with dialysis, hypertension, anemia of chronic disease, and chronic ulcerations of the feet.  He had developed progressive ascites for several weeks, and had been feeling weak and tired. JV was admitted with a systolic blood pressure of 87 mm Hg, a WBC count of 20,000 cells/mm³, and fever. A medical workup was begun to find the source of a possible sepsis syndrome. The vascular surgery service was consulted with regard to a wound on the patient's left arm which had been the result of an attempted placement for a dialysis access which had failed to mature.  The patient was evaluated and found to have a seroma which was subsequently drained without any complications.  During follow up, it was noted that the patient had a gangrenous left foot with non-reconstructible peripheral vascular disease. Subsequently a below the knee guillotine amputation was performed.

However, JV continued to have intermittent hypotension and fever. In addition to broad spectrum antibiotics he was receiving enoxaparin 30 mg daily as DVT prophylaxis.  On the first postoperative day the consulting intensivist recommended a thoracentesis of a left pleural effusion followed by a paracentesis to exclude these as a source of infection. The thoracentesis and paracentesis were performed without incident. Approximately 2 liters of clear ascitic fluid was removed from the right upper quadrant. About 2 hours after the procedure, the patient experienced the acute onset of abdominal pain, a sudden decrease in blood pressure, a rigid abdomen, apnea and a Code Arrest was called.  He was successfully resuscitated.  His hemoglobin was noted to have decreased from 11 to 7.9 gm/dl.

JV was taken emergently to the operating room where a damage control laparotomy was initiated and a massive hemoperitoneum was noted.  This was evacuated and a vessel on the right upper abdominal wall was identified and ligated. During the exploration it was noted that while the cirrhotic liver was unmarked, but the stomach had a 1 cm perforated ulcer in the anterior wall which was bleeding briskly. This was oversewn and then patched with omentum. During the resuscitation, he received seven units of red blood cells, seven units of fresh frozen plasma, and multiple infusions of crystalloids and colloid solutions in an attempt to maintain blood pressure. A Swan-Ganz pulmonary artery catheter was inserted and fluid resuscitation was guided by pulmonary artery catheter indices.  After adequate fluid resuscitation, he remained hypotensive with a low cardiac index and was supported with a combination of vasopressor agents and inotropes including super maximal doses of dobutamine, dopamine, phenylephrine and norepinephrine.  However, he remained hypotensive, and with the family at his bedside and after a detailed discussion, the family elected to cease support.  The patient died shortly afterwards.

Pertinent Laboratory

His creatinine was 3.2 mg/dL and his blood urea nitrogen was 37 mg/dL. Both his pleural fluid and ascitic fluid were exudative. Blood cultures and peritoneal cultures were all negative. His prothrombin time at the time of his paracentesis was slightly elevated at 13.8 seconds (upper limits of normal 13.3) but partial thromboplastin time and platelet count were within normal limits.

Hospital Course and Surgical Review

When the surgical team was contacted regarding the sudden drop in blood pressure and rigid abdomen, they accused the medicine team of “puncturing” the patient’s liver by the paracentesis with the family present. The family then confronted the resident and intern who performed the paracentesis for this “screw up”. Relevant is that this surgical team is the same that had recently been responsible for the events in case one.  

Since the patient expired on the surgical service, the chart in case 2 was again sent to the surgical service to assess attending responsibility. The medical attending at the time of the patient’s initial admission was selected as the responsible physician, again without any knowledge or input from that medical attending.

JV’s family had hired an attorney who hired a nephrologist in private practice from Tarzana, CA to review the case. The physician opined that the paracentesis should not have been performed because of an excess bleeding risk and the patient died as a result of the paracentesis. The physician did not mention the perforated gastric ulcer which was bleeding “briskly” at the time of the operation. A local peer review was conducted and concluded that bleeding was almost certainly from the perforated gastric ulcer and had nothing to do with the paracentesis.

The US Attorney’s Office obtained additional expert opinions from outside the VA who concluded there was no merit to the case and all applicable standards of care were met. Despite these reviews, the US Attorney’s Office settled the case for $250,000. The reason for the decision to settle the case remains unclear.

Local VA Actions

The attending physicians discussed of both cases with the Risk Manager at the Phoenix VA, who dismissed concerns by saying that the hospital needed to maintain its hard-to-recruit-and-retain surgery staff, but that the medical physicians who had been with the hospital for 20 years were less likely to leave.  In addition, the hospital risk manager assured the medical service physicians that the hospital would not report them to the National Practitioner Data Bank, as no one felt they were responsible for malpractice.

New VA regulations were in effect when Case 2 was settled.  Thomas Kummet was the internal medicine attending who was informed by the hospital of the matter for the first time when he was told he had ten days to respond to VA headquarters about the “malpractice” case, and according to the regulations he was entitled to supervised review of the chart and the settlement documents.  However, while he was allowed to see the chart, there were no documents to explain the lawsuit or the rationale for settlement. When the Risk Manager was asked for those documents, it was acknowledged that they would not be provided, no matter what VA regulations stated, as the US Attorney’s office refused to provide them to the hospital. Again Dr. Kummet was assured that the VA did not report physicians to the National Practitioner Data Bank in circumstances where there was no malpractice.

Three VA reviewers found no evidence of malpractice in the management of this patient. However, Dr. Kummet was informed he was being reported to the National Practitioner Data Bank and the State of Arizona as being responsible for a malpractice settlement.

Actions by the State of Arizona Board of Medical Examiners (BOMEX)

After being notified of the NPDB placement, the state BOMEX began their own investigation of Dr. Kummet, after first placing notification on their public website that he and the intensivist in Case 1 were responsible for malpractice.  This prompted patients to begin to ask for details of his “multiple” errors, to be referred to other physicians, and of why he was still allowed to practice. BOMEX asked Dr. Kummet for the medical records, which the local VA refused to provide, claiming Federal law precluded release.  When the state responded that Dr. Kummet’s (only) medical license was therefore at risk, Dr. Kummet hired legal representation.  With that assistance, the hospital sent a copy of the patient’s chart to the BOMEX. 

The state investigation was subsequently completed, no action was taken except to remove the notation on the website that a case was under investigation, and a request by the doctor for the documents of the state’s investigation was denied by BOMEX.

VA Headquarters Actions

The Veterans Administration had come under criticism in the early 2000’s because only 37% of physicians involved in a malpractice settlement were reported to the National Practioner Data Bank (NPDB). The VA initiated a peer review process and began reporting all practioners whose care was judged as substandard to the NPDB. This included some instances of previously settled claims such as Dr. Kummet’s. This new policy was designed to report all physicians because, as it was explained to the local Risk Manager, “it is good for the VA to show that we are tough on physicians.”

After the case was settled, it was referred to John Grippi MD from the Buffalo VA who was heading the VA’s peer review. He referred the case to a non-VA panel consisting of Edmond Gicewicz MD, a retired general surgeon; Norbert Kuberka MD, a retired oncologist; and Gregory Czajka PA, a surgical assistant. The panel concluded that “technical errors in the performance of abdominal paracentesis resulted in significant intra-abdominal hemorrhage”.

Dr. Kummet’s name was submitted to the National Practioner Data Bank, 10 days after he was first informed of the claim settlement and 4 years after the patient’s death.

Legal Action

Dr. Kummet obtained legal counsel and suit was filed in Federal court since the VA is a Federal agency. The suit failed, however, as there is no statutory or case law that required the local institution to follow its own procedures, or to allow physicians due process claims in these matters.

The legal proceedings were unsuccessful at obtaining any documents to support the decision to report to the NPDB, only to be told what was done was legal and in the VA’s best interest. The US Attorney’s office responded to a Freedom of Information Act request by supplying one nearly totally redacted document and claimed everything else was protected attorney work product (Figure 2).

Figure 2. Redacted letter from US Attorney’s Office.

Conclusion

Subsequently, Dr. Kummet left the VA system and is in private practice in Washington State. There are multiple instances where hospitals have retaliated against physicians for financial gain or for reporting substandard care (1). However, this does appear to be applicable in this case. If you, the reader, concludes from the case presentation that Dr. Kummet delivered substandard care, then he was justifiably punished.

On the other hand, if you agree the American Association for the Study of Liver Diseases that a abdominal paracentesis should be performed in patients with new-onset ascites (2) and that the patient’s intraperitoneal hemorrhage resulted from the perforated gastric ulcer rather than the paracentesis, then you likely agree with Dr. Kummet that he was falsely accused by the VA’s peer review system.

Dr. Kummel’s experience illustrates that physicians face a hospital peer review and justice system that fails to grant the basic rights to those accused of professional misconduct that it grants to those accused of criminal behavior. These include the right to a speedy and public trial by an impartial jury; to be informed of the nature and cause of the accusation; to be confronted with the witnesses against him; to have compulsory process for obtaining witnesses in his favor; and to have the assistance of counsel for his defense. Furthermore, the decision to settle the lawsuit that negatively impacted Dr. Kummet were made by attorneys without the background or knowledge to know if substandard care was delivered.

Regardless, Dr. Kummet should be admired for his courage in fighting what he views as unfair accusations by those more concerned with political perceptions than improvement in healthcare and a legal system unconcerned with slandering his reputation.

Richard A. Robbins, MD*

References

1. Kinney ED. Hospital peer review of physicians: does statutory immunity increase risk of unwarranted professional injury? MSU Journal of Medicine and Law 2009;57:57-89.
2. Runyon BL. Management of adult patients with ascites due to cirrhosis: An update. Hepatology 2009;49:2087–107.

*Dr. Thomas Kummet assisted in the preparation of this manuscript.

Reference as: Robbins RA. Profiles in medical courage: Thomas Kummet and the courage to fight burearcracy. Southwest J Pulm Crit Care. 2013;6(1):29-35. PDF

Profiles in Medical Courage: The Courage to Serve and Jamie Garcia

“I've seen and met angels wearing the disguise of ordinary people living ordinary lives.”-Tracy Chapman, American singer-songwriter

Abstract

Some of our Profiles in Medical Courage series have dealt with the famous, and several such as Barry Marshall and Archie Cochrane are household names in medical circles. However, some physicians, just as courageous, are not so renowned. Jamie Lynn Garcia was one of those who died earlier this year at the age of 52.  She was a devoted servant of the poor and founder of the Pomona Community Health Center. Her road to becoming a physician was not straight-forward but her life story was an extraordinary one.

Early Life

Jamie was raised in the Westchester section of Los Angeles, just north of the Los Angeles International Airport. She had a rather ordinary middle class upbringing in a Hispanic family where her father was a gardener and her mother a realtor. Her parents were strict Catholics and she attended the Catholic schools. She was a bright student but also had a beautiful singing voice that she was encouraged to develop. "As a child she had severe asthma," but there was a physician who helped her, "a doctor who was inspiring." (1). However, with adolescence her asthma improved but other issues were hard on Jamie. After reading the Bible at age 12, she rejected religion, and after passing a high school proficiency exam, left high school at 16 to become a professional musician.

Rock and Roll Years

Jamie used her voice and her instrumental talent on guitar, bass and keyboards in many of the bands in the Los Angeles during the1980’s while supplementing her income as a realtor (2). These bands followed her eclectic tastes and included country, jazz and pop but the most successful band was the all girl rock band “On the Air”. They had gigs throughout Los Angeles, aired videos on VH1, and garnered the attention of major record labels. However, the band collapsed when the lead singer decided to pursue an education. Several of Jamie’s friends, encouraged Jamie to do the same. Thinking that they might be right, she decided to go to college with no particular goal in mind.

Education

She enrolled at Santa Monica Community College and later transferred to UCLA where she majored in philosophy. During her later years in college she recalled her childhood doctor who treated her asthma. She thought, “I could do that”, and applied to medical school. She attended the University of Washington. There she meant her partner for the next 15 years, Dr. Sue Verrault, a child psychologist. After graduation, Jamie returned to the Los Angeles area for a family practice residency at Pomona Valley Hospital.

As a resident she was moved by what she saw as an enormous need for healthcare of low-income patients, especially those with chronic conditions such as heart disease, diabetes, and asthma. Dr. Jamie, as her patients came to call her, was a compassionate physician, but her faculty noted she spent too much time with patients, especially psychiatric patients. Fearless and confident, she occasionally liberated hospital supplies and took them to the streets to treat the homeless. During her last year in residency, she heard of a homeless man living under a nearby freeway bridge who was in dire need of medical care (2). She crawled under the bridge to find him, and convinced him to come with her back to the hospital. She enrolled him in a treatment program for alcoholics, after which he remained sober.

Pomona Community Health Center

At the time many of the ER’s and clinics were closing in East Los Angeles and she recognized that the inadequacy of the healthcare system to serve the healthcare needs of the poor. While still a resident Jamie partnered with the LA County Department of Public Health to operate the original Pomona Community Health Center, a two-room free clinic serving the homeless, uninsured, and underinsured in east LA County. After completing residency, she continued the clinic with the help of Federal grants (Figure 1).

Figure 1. Dr. Jamie Lynn Garcia (right) with patient at the Pomona Community Health Center.

The next 8 years were difficult. Money was tight but Jamie dreamed of a larger clinic and began the long process of planning the clinic’s expansion. She had no formal training or experience with such a large project, but assembled a board and staff, sketched out each exam room and calculated the cost of materials, planned budgets for doctors, created partnerships to secure a location, and raised over $1.4 million from Federal and other sources.  In 2010 she secured the crucial seed money to build the new clinic and proudly exclaimed on her Facebook page, "We're buildin' a free clinic! We have liftoff!"

Declining Health

Jamie had the fault of many physicians; she often ignored her own health. She had abdominal pain off and on beginning in 2005. When she finally had time to get an abdominal ultrasound in 2008, an ovarian mass was found but it appeared benign and Jamie was too busy to have it investigated. When she got around to a follow-up ultrasound 2 years later, the mass had doubled in size and she was diagnosed with an aggressive form of ovarian cancer. On May 16, 2011, while undergoing chemotherapy she oversaw the groundbreaking ceremony for the new clinic's building on Holt Avenue, in The Village, a "mall" of social services for low income LA residents. She was determined to beat the cancer and complete the new, expanded clinic and live to see it open. "I can't wait to meet the first patient," she told the Inland Valley Daily Bulletin at the groundbreaking (1).

She continued to run the clinic and oversee the construction of the new clinic despite her ongoing chemotherapy. The new clinic opened its doors on July 9, 2012 but three days earlier, Dr. Jamie was admitted to the hospital where she learned she had a large inoperable tumor.  She was advised to prepare for hospice care. On July 27 she died peacefully in her home but had lived to see the clinic open. She was 52.

Legacy

Dr. Garcia received numerous awards (2). She was named Woman of the Year in 2010 by the California State Assembly, a Hospital Hero in 2010 by the National Health Foundation, and her clinic has been recognized by the California State Assembly, National Project Homeless Connect, and the House of Ruth Domestic Violence Shelter. The evening before she died, several doctors from her clinic gathered at Jamie's home and agreed to hang her numerous recognitions on an otherwise-blank wall in the new clinic. "But I don't know, honestly, if there's room for all of them," noted one doctor.

The new 12-room clinic opened its doors on July 9, 2012, and is expected to serve 24,000 uninsured, homeless, and underinsured residents in the Pomona area this year (2). However, her most enduring legacy may be her example in serving the poor. She should be remembered for her enthusiasm, courage and perseverance in making her dream happen. She is representative of the many physicians and other healthcare providers who forgo larger financial awards to serve the poor in relative obscurity. Her life is testimony that "anything is possible" (2).

References

1. Rodriquez M. Garcia helped those who struggled. Inland Valley Daily Bulletin. August 10, 2012. Available at: http://www.dailybulletin.com/news/ci_21288514/garcia-helped-those-who-struggled (accessed 9-10-12).
2. Marks R. RIP Jamie Garcia, a health hero in Pomona, 2010 California Woman of the Year. Off Ramp. August 10, 2012. Available at: http://www.scpr.org/blogs/offramp/2012/08/10/9379/rip-jamie-garcia-health-hero-pomona-2010-californi/ (accessed 9-10-12).

Donations in Dr. Garcia's memory can be made to the Pomona Community Health Center: 1450 E Holt Avenue, Pomona, CA 91767.

Reference as: Robbins RA. Profiles in medical courage: the courage to serve and Jamie Garcia. Southwest J Pulm Crit Care 2012;5:231-4. PDF

Profiles in Medical Courage: Women’s Rights and Sima Samar

“A state that does not educate and train women is like a man who only trains his right arm.”

― Jostein Gaarder, Sophie's World

Richard A Robbins, MD

Phoenix Pulmonary and Critical Care Research and Education Foundation

Abstract

Previous profiles have focused on physicians who placed their careers in jeopardy to follow their beliefs. Sima Samar is different because she has not only risked her career, but her life.  She has shown extraordinary courage in ignoring death threats and defying religious misogynists to ensure that Afghan girls and women had access to health care and education. Following the fall of the Taliban in 2001, Dr. Samar became the first woman appointed to a cabinet position in the interim Afghan government. Ousted by religious conservatives, she serves today as the chair of the Afghan Independent Human Rights Commission.

Early Lessons

Samar was born on February 3, 1957 in Jaghori, a major business center situated in the highlands of central Afghanistan. Her father, Qadam Ali, was a civil servant and her mother, Khurshid, was the first of his two wives. She was one of eleven children and a member of Afghanistan's Hazara ethnic minority. The Hazara are a mountain tribe of Shiite Muslims who have been long oppressed by the Sunni majority.  

During Samar’s childhood, women could receive an education. Samar was sent to school and recalls first noticing ethnic tension in the second grade (1). She was mocked by her Sunni teacher for naming a Muslim holy man in the minority Hazara dialect.

Although Afghan women could vote and often held such prominent positions including judges or governmental ministers, they were still subject to a paternalistic society. Arranged marriages, encumbering restrictions, and husbands with multiple wives were common. "My brothers had more freedom than me in every way," Samar recalled to Alex Spillius of the London Daily Telegraph (2). "They could go where they wanted outside the house." Some of her memories were even more distressing. Her elder sister, Aziza, resisted an arranged marriage to a cousin. “Aziza was only 17 years old," Samar told Sally Armstrong (3). "I remember seeing my mother drag her by her hair to the room where our cousin waited and force her to marry him." Aziza died an unhappy woman at age 21, but before she did, she gave her little sister two words of advice- "Study hard".

Samar took her sister's guidance to heart and threw herself into her studies to avoid a similar fate. She became an avid reader, especially devouring Persian books about improving the lot of women and the poor. Her hard work was eventually recognized. Upon graduation from high school in 1975, she was offered scholarships to attend college in both Australia and Hungary. However, Samar's father forbade her to accept either scholarship to study abroad because unmarried women were not allowed to leave home. Even her acceptance at Kabul University was in jeopardy. To receive her father’s approval, she agreed to an arranged marriage to a man of her father’s choice to continue her education.

Kabul and Political Upheaval

Her father’s selection of a husband proved to be a good one. In 1975, at the age of 18, Samar married physics professor Abdul Chafoor Sultani. Luckily, Sultani was supportive of his wife's academic goals, and she genuinely admired him. The couple set off for Kabul University, and began a quiet existence where Sultani was a physics professor and Samar attended medical school. Together they did the cooking, the housework and raised their newborn son.

However, politics disrupted their quiet life. The late 70’s were a tumultuous time in Afghanistan. The People's Democratic Party of Afghanistan came to power through the Saur Revolution in 1978. Their rule proved highly unpopular not only within Afghanistan, but also the neighboring Soviet Union. The Soviet Union invaded and installed a puppet government in their place. Sultani and Samar joined the resistance movement fighting Afghanistan's Soviet rule, but the couple's political activism came at a high price. Late one night in 1979, Sutani and three of his brothers were kidnapped by 10 men. They were never seen again. "I still don't know the full who, what and when," Samar told Spillius (2). “Every Friday, we were in front of the big jail from early morning to late evening, hoping for news,” Samar said. “There was no news.”

Her husband's tragic disappearance left Samar alone with a young son and an unfinished education. Leaving her son in the care of her parents, Samar persevered and in 1982 became one of the first Hazara women to obtain a medical degree. After a 4 month residency at Wazir Akbar Khan Hospital, she fled Kabul, retrieved her son and settled in the rural area of Jorhi.  There were no hospitals, no medical facilities, no exam rooms, but there she provided medical treatment to patients throughout the remote areas of central Afghanistan. With only a stethoscope and a blood pressure cuff, she often traveled to see patients on foot or horseback, but gained a first hand knowledge of the hardships they faced. "Practicing medicine in a rural district demonstrated brutally that the lives of women were nearly unbearable," Samar told Armstrong (3), "and that the lack of education was a direct cause of the turmoil the country was in."

Pakistan

In 1984, Samar was stricken with whooping cough and her weight dropped dramatically (4). Unable to find medical care for herself, she traveled to Quetta, the Hazara region of Pakistan. “I went to Quetta for treatment,” she said “but then I realized I could get an education for my son there, and I would be able to get funds to help my work”. Once there, she began her life’s work in earnest. Only one hospital there accepted female patients. With initial funding from the NGO, Inter-Church Aid, she opened a hospital for women and children in 1987. Two years later, she founded the Shuhada (Afghan for martyr) organization, dedicated to women and children's needs (Figure 1). Rauf Akbeari, who would become Samar's second husband, helped oversee the organization's operations.

Figure 1. Panel A: Dr. Sima Samar seeing patients. Panel B: A Shuhada clinic at Kart-e-Sulh in central Afghanistan which serves a population of 9,000.

The Taliban

The Soviets withdrew from Afghanistan in 1992 and the United States that had backed the resistance withdrew as well.  Violence and guerilla warfare erupted in the power vacuum. The eventual victors were the Talban, a group of Islamic fundamentalists. Under the Talban’s reign, women lost most of their rights and freedoms. They were denied the right to equality, freedom, the vote, and the abilities to work or inherit. Even highly educated women were forced into slave labor or begging to survive.

Under the auspices of Shuhada, Samar started to open clinics and schools on both sides of the Afghanistan-Pakistan border. Always controversial, her pursuits were now beginning to attract the unwanted attention of the Taliban.  Not surprisingly, Samar's ongoing efforts at educating and uplifting the poor, especially females, were not looked upon favorably. Similarly, her adamant refusals to don the burqa (head to foot dress), observe purdah (seclusion of women from the public), or silence her calls for equality were not appreciated. Indeed, Samar was openly threatened with death if she did not close down her hospitals and schools for women and girls. According to journalist Sally Armstrong, she simply replied, "You know where I am, I won't stop what I'm doing."

True to her word, Samar ignored myriad death threats and fearlessly continued her work. She sometimes relied on trickery, such as operating schools in private homes or posting lower grade levels than were actually taught to circumvent the Taliban’s rules. At other times, she was more openly confrontational. One such instance was when she confronted a Taliban officer who had commandeered a truck loaded with supplies intended for one of her clinics. Coincidentally, the officer's mother had come to Samar for medical treatment around the same time. "It was construction materials . . . and about 6 metric tons of high-protein biscuits from Norway," Samar explained to Steve Lipsher in the Denver Post (5). "They took the whole thing. I told [the officer], "If you don't release my supplies, I'm going to take your mother hostage here in the clinic." The construction materials were returned the next day.

In addition to her social activism, she continued to serve as a physician. She was the first to recognize the increased prevalence of osteomalacia in women wearing burgas, probably due to lack of vitamin D produced by sunlight, .

After the Taliban

The September 11, 2001 terrorist attacks on the United States led to the US invasion of Afghanistan and the ousting of the Taliban. An interim government with Harmid Karzai as the interim president was put into place in December. Much to her surprise, Samar was appointed as one of five deputy prime ministers and the minister of women’s affairs in the new government, becoming the first Afghan woman ever to hold such a high position.

She returned to Afghanistan from Pakistan but her role as women's affairs minister soon presented its own set of challenges. "I knew that it would be difficult," she told journalist Steve Lipsher (5). "I didn't know that it would be this much difficult." She operated out of her own home, had no office, no supplies, no staff and no budget. Women lined up at her door, telling their tales of abuse, forced marriages, and lost jobs but Samar could do nothing.

To make matters worse, she was ignored in cabinet meetings.  Each time a male minister addressed the group, he opened with the phrase, “Brothers, brothers”. Even Karzai used the same phrase. “During the 23 years of war, there were no women in any decision-making, in any policy roles,” she said (6). “The political parties had no women. So they were not used to a woman’s face, a woman’s presence. We had to make a space for ourselves.” So Samar pulled Karzai aside and told him “Brothers, brothers” excluded her and she called for more female ministers in the government, schools for married women, and an end to arranged marriages. "After the meetings," she told Spillius (2), "people say I make too much noise, so I say: why did they appoint me? I am not confrontational . . . that doesn't work . . . but I have to say what I want for women."

She was no more patient with American politicians. She recounts a meeting with Secretary of State Colin Powell in Washington (7). She told Powell, “…please do not repeat the mistakes that you made before… You created these monsters [the Taliban]. Please don’t support them again.” She also chastised him for not being supportive of the Afghan government, spending money on war rather than rebuilding Afghanistan’s infrastructure and having too few US miliary women in Afghanistan. She was no more polite when Powell and Congressional delegations visited Afghanistan (Figure 2).

Figure 2. US Senator Chuck Hagel (left) meeting with President Hamid Karzai (center) and Dr. Sima Samar (right).

In response to her demands, conservatives waged a war of veiled threats and open menace. Matters came to a head in June of 2002 when she was accused of questioning Islam by saying she did not believe in Sharia law in Maujajed’s Message, a Canadian Persian language newspaper (1). Although she vehemently denied the allegation, conservatives ran a front-page headline in a local newspaper calling Samar "Afghanistan's Salman Rushdie," in reference to the Muslim author branded as a heretic by Iran's Ayatollah Ruhollah Khomeini in the 1980s. The damage was done. With little political support at home or the US, Afghan President Hamad Karzai did not appoint her to his permanent government in June, 2003. Certainly disappointed, but unapologetic, she told Kathy Gannon of the Scotsman (8), "I really don't know what my mistake was. I am a woman, I am outspoken, I am a Hazara. That is enough, I guess."

Although Samar's political career was brief, she seems hardly the kind of woman to remain silent. After leaving her cabinet post, she became chair of the Independent Afghanistan Human Rights Commission, and despite ongoing death threats, she continues to operate the Shuhada hospitals and schools and to speak on behalf of women's and human rights. By 2004, the Shuhada Organization operated four hospitals and 12 clinics in Afghanistan and Pakistan, along with 60 Afghan schools. Internationally recognized for her diligent efforts, she also received many accolades, including the 2003 inaugural Perdita Huston Human Rights Award and the 2004 John F. Kennedy Profile in Courage Award. It may be that Samar herself described best why her talents and determination might be best suited to a non-political arena when she told Gannon (8), "I believe we cannot change the country with only words. We have to change it with our minds, our hearts and our attitude."

However, her career in politics may not be over quite yet. In 2011 she was one of the founders of the Truth and Justice Party, a multi-ethnic party opposed to President Hamid Karzai’s regime.

References

1. Gale Encyclopedia of Biography: Sima Samar. Available at: http://www.answers.com/topic/sima-samar (accessed 8-24-12).
2. Spillus A. People say I make too much noise: Dr Sima Samar,Afghanistan's first minister for women's affairs, talks to Alex Spillius. The Daily Telegraph. February 22, 2002.
3. Armstrong S. Rebel unveiled. Chatelaine, April 1, 2002. Available at: http://business.highbeam.com/436992/article-1G1-83994864/rebel-unveiled (accessed 8-24-12).
4. Samar S. Despite the odds - providing reproductive health care to Afghan women. N Engl J Med 2004;351:1047-9.
5. Lipsher S. Women's advocate defies the odds Afghan official battles poverty, male culture. Denver Post, January 27, 2002. Available at: http://www.denverpost.com/archives (accessed 8-24-12).
6. Frey J. A Healing Force For Afghan Women; From Her Cabinet Post, Sima Samar Sees a Long, Hard Road Still Ahead. Washington Post, April 24,2002. Available at: http://www.highbeam.com/doc/1P2-351850.html (accessed 8-24-12).
7. Cott M, Whelan R. Interview with Dr Sima Samar. International Review of the Red Cross 2010;92:847-57. Available at: http://www.icrc.org/eng/assets/files/review/2010/irrc-880-interview.pdf (accessed 8-24-12).
8. Gannon K. She was the minister who fought for Afghan women. Now she is dumped. The Scotsman, June 25, 2002. Available at: http://www.highbeam.com/doc/1P2-12988802.html (accessed 8-24-12).

Reference as: Robbins RA. Profiles in medical courage: women's rights and Sima Samar. Southwest J Pulm Crit Care 2012;5:197-202. PDF

Profiles in Medical Courage: Causation and Austin Bradford Hill

“The secret language of statistics, so appealing in a fact-minded culture, is employed to sensationalize, inflate, confuse, and oversimplify”

-Darrel Huff in How to Lie with Statistics

Abstract

Austin Bradford Hill was a British epidemiologist and statistician who is best remembered for two landmark pulmonary studies. He was the statistician on the Medical Research Council Streptomycin in Tuberculosis Trial. This is regarded as the first randomized clinical trial. The second was the demonstration of the connection between cigarette smoking and lung cancer. However, Hill’s most lasting contribution may be his establishment of a group of conditions necessary to provide adequate evidence of a causal relationship between an incidence and a consequence, widely known as the Bradford Hill Criteria of Causation. In this profile of medical courage we examine his remarkable background that led to the epidemiological equivalent of Koch’s postulates.

Introduction

Recently, two articles have appeared in the Southwest Journal of Pulmonary and Critical Care which involved Sir Austin (Tony) Bradford Hill. The first was Dr. Raschke’s review of Doll and Bradford Hill’s landmark study on the etiology of lung cancer (1). The second was the prior profile in medical courage article on Archie Cochrane, Bradford Hill’s student (2). These prompted me to conduct a study of Bradford Hill and his remarkable career. Although both of his studies are important, his criteria for causation may be his greatest legacy (3). In a time when the unscrupulous utter half-truths to associate an incident with a consequence, Bradford Hill’s criteria for causation are as relevant today as they were when first published in 1965 (3).

Early Life

Austin Bradford Hill was born into an eminent British family in 1897. His great-great uncle, Sir Rowland Hill, invented the rotary press and introduced the first mail stamp 1840.  His father, Sir Leonard Hill, was professor of physiology at the University of London and did seminal work on the cerebral circulation and decompression sickness of divers.

From childhood, Tony, as he came to be called, wanted to be a doctor but the First World War intervened.  He volunteered as an aviator for the Royal Navy and was sent to the Greek islands to support the attack on the Dardanelles.  His plans were cut short when in November 1917 he was diagnosed with severe pulmonary tuberculosis and was sent home to die. The progress of the disease changed after a therapeutic pneumothorax and he slowly improved. While recovering he contemplated his career. Medicine seemed to be out of the question and he opted to study economics by correspondence courses from the University of London as he convalesced.  Three years later he obtained a Bachelor of Science degree– having attended the university only twice to take examinations.

Early Career

Tony had no desire to make a career in economics. His father’s friend, the prominent epidemiologist, Major Greenwood, helped him obtain a grant from the Medical Research Council (MRC) to investigate the reason for the high mortality of young adults in rural Essex. His investigations concluded that the excess was most likely due to selective migration of the fittest to work in urban areas. The success of his research enabled him to obtain further appointments with the MRC and extend his knowledge of statistics by attending courses at the University of London led by Karl Pearson. In 1927 he followed Major Greenwood to the newly-formed London School of Hygiene and Tropical Medicine and taught statistics to at the Postgraduate Medical School at Hammersmith in London (Figure 1).

Figure 1. Austin Bradford Hill lecturing.

His lectures were published as a series of 17 popular articles in the Lancet during 1937 and later in book form, Principles of Medical Statistics (4). The book became very popular and went through multiple editions making him the best known medical statistician in the world, which is remarkable for someone who held no degree in medicine or statistics. In this book he discussed epidemiological methods for investigating the causes of non-infectious diseases, and introduced randomization. He emphasized the need to compare like with like, to avoid potential sources of bias and to allow for the play of chance. However, he avoided the use of mathematical formulas and set out procedures that needed to be adopted in plain English. By so doing he secured the attention of a medical profession that largely had no basic knowledge of mathematics or statistics. The book was important in persuading physicians to present their research results both logically and quantitatively.

He wrote of his lectures, "I deliberately left out the words ‘randomisation’ and ‘random sampling numbers’ at that time, because I was trying to persuade doctors to come into controlled trials in the very simplest form and I might have scared them off. I think the concepts of ‘randomisation’ and ‘random sampling numbers’ are slightly odd to the layman, or for that matter, to the lay doctor, when it comes to statistics. I thought it would be better to get the doctors to walk first, before I tried to get them to run. So I had been thinking about controlled trials for all of those 10 years and hoping for an opportunity that might arise” (5).

Landmark Investigations

After the War, Bradford Hill succeeded Greenwood as Professor of Medical Statistics and directed the Statistical Research Unit of the Medical Research Council (MRC). He was particularly influenced by one of Pearson’s students, Ronald Aylmer Fisher, who had pioneered the use of randomization in agricultural experiments. Up until this time medical investigations were usually a before-and-after design, i.e., patients were treated and the results compared to historical controls. He realized that confounding variables so inherent in before-and-after studies could change results. Although Bradford Hill had advocated randomization in his book, he had not been specific about the methods.

In 1946 Bradford Hill was presented with the opportunity to put his theories into practice. He persuaded the MRC to launch randomized controlled trials, one in preventive medicine to test a pertussis (whooping cough) vaccine, the other in clinical medicine to assess the effect of streptomycin in the treatment of pulmonary tuberculosis (6). The latter is generally regarded as the first randomized medical trial with patients randomized to a treatment group and a control group by a process using random sampling numbers and sealed envelopes.  These trials were followed by a remarkable stream of articles on the principles of clinical trials including practical and ethical problems.

Meanwhile he launched, with Richard Doll, a case-control study comparing lung cancer patients with matched controls. This study showed conclusively that smoking was the predominant risk factor in developing lung cancer (7). This was followed by other case-control studies, and a long-term prospective study of smoking and health which demonstrated that lung cancer was not the only disease to be caused by smoking. This cohort study was conducted on British doctors, an ideal population whose cooperation was testimony to the respect with which Bradford Hill's work was regarded by his medical colleagues. He was by nature a cautious man, and he had been careful initially to claim that a causal effect of smoking on lung cancer was only one of a number of possible explanations for the association. As the evidence mounted he accepted the causal link as being overwhelmingly the most likely explanation. The reception was lukewarm and in particular he was disturbed by skeptical remarks from Ronald Fisher.  Interestingly, it was Fisher who had nominated Hill as a Fellow of the Royal Society in 1954.

In response to criticism, he formulated 9 principles of causation which were published in 1965 and are listed below (3). Although originally presented as a way of determining the causal link between cigarette smoking and lung cancer, Bradford Hill's Criteria forms the basis of modern epidemiological research. Furthermore these principles are equally applicable to other sciences which study causal relationships between phenomena. 

Bradford Hill’s Criteria for Causation

1. Strength. This is defined by the size of the association as measured by appropriate statistical tests. The stronger the association, the more likely it is that the relation of "A" to "B" is causal. For example, lung cancer death rates are 10-30 times higher in smokers than in nonsmokers.
2. Consistency. The association is consistent when results are replicated in studies in different settings using different methods. As an example, Bradford Hill points out that an association between lung cancer and smoking was found in 29 retrospective and 7 prospective studies in 1964.
3. Specificity. This is established when a single putative cause produces a specific effect. This is considered by some to be the weakest of all the criteria. Lung cancer attributed to cigarette smoking does not meet this criterion because the death rate of smokers is higher from other causes in addition to lung cancer. When specificity of an association is found, it provides additional support for a causal relationship. However, absence of specificity in no way negates a causal relationship.
4. Temporality. Exposure always precedes the outcome. If a factor is believed to cause a disease, then the factor must precede the occurrence of the disease. This is the only absolute criterion. In the case of lung cancer, cigarette smoking invariably occurs before the development of the cancer.
5. Biological gradient. By this Bradford Hill means a dose-response relationship. The death rate from lung cancer increases as the number of daily cigarettes smoked increases.
6. Plausibility. The association agrees with currently accepted understanding of pathological processes. In 1965, it was known that tobacco tar induced cancer when painted on the skin of mice (8).
7. Coherence. The association should be compatible with existing knowledge. Both the incidence of lung cancer and cigarette smoking rose beginning after World War I. In 1964 both the incidence of lung cancer and cigarette smoking were lower in women than in men.
8. Experiment. The condition can be prevented or ameliorated by an appropriate experimental regimen. The incidence of lung cancer can be lowered by quitting smoking.
9. Analogy. In judging whether a reported association is causal, it is necessary to determine the extent to which researchers have taken other possible explanations into account and have effectively ruled out such alternate explanations. For example, in their investigations Doll and Bradford Hill were careful to match lung cancer patients with controls to eliminate any potential bias related to exposure to occupational or environmental toxins. A questionnaire was designed to identify potential confounding variables including whether cigarette holders and petrol lighters were used, occupation, residence near a gasworks, exposure to different types of home heating, and previous respiratory illnesses and shown to be independently unrelated to lung cancer.

Bradford Hill pointed out that no formal tests of significance could answer the above questions. During his career, he used the simplest mathematical techniques. It is remarkable that as a statistician he relied so little on statistics and he often pointed out that he had no formal training in medicine or statistics. His success was due to a combination of factors but probably most importantly communication of honest experimental and statistical concepts in a way that nearly all could understand.

Hill died in 1991 a few months short of his 94^th birthday. Up until the time of his death he continued to collect a 100%, war-related, disability pension from the British Government. In hindsight, his development of tuberculosis may have been a fortuitous occurrence for medical investigation. Despite his disability, he did rather well and should be remembered for his courage in standing up for honest, unbiased research.

Richard A. Robbins, MD

References

1. Raschke RA. May 2012 critical care journal club. Southwest J Pulm Crit Care 2012;4:178-9.
2. Robbins RA. Profiles in medical courage: evidence-based medicine and Archie Cochrane. Southwest J Pulm Crit Care 2012;5:?-?.
3. Hill AB. The environment and disease: association or causation? Proc R Soc Med 1965;58:295-300.
4. Hill AB. Principles of Medical Statistics. London: Lancet, 1937.
5. Hill AB. Suspended judgement, memories of the British streptomycin trial, the first randomised clinical trial. Control Clin Trials 1990;1:77-79.
6. Medical Research Council. Streptomycin treatment of pulmonary tuberculosis: a report of the Streptomycin in Tuberculosis Trials Committee. British Medical Journal 1948;2:769-82.
7. Doll R and Hill AB.  A study of the aetiology of carcinoma of the lung.  Br Med J 1952;2:1271-86.
8. Croninger AB, Graham EA, Wynder EL. Experimental production of carcinoma with tobacco products. V. Carcinoma induction in mice with cigar, pipe, and all-tobacco cigarette tar. Cancer Res 1958;18:1263-71.

Reference as: Robbins RA. Profiles in medical courage: causation and Austin Bradford Hill. Southwest J Pulm Crit Care 2012;5:115-20. (Click here for PDF version)

Profiles in Medical Courage: Evidence-Based Medicine and Archie Cochrane

“Medicine is a science of uncertainty and an art of probability.”

-Sir William Osler

Abstract

Archibald (Archie) Cochrane is often credited with being the inspiration for evidence-based medicine. His influential 1971 book, “Effectiveness and Efficiency”, strongly criticized the lack of reliable evidence behind many common healthcare practices. His call for a collection of systematic reviews led to the creation of The Cochrane Collaboration, named in honor of him. Archie Cochrane's life was a tortuous one, which included psychoanalysis, service in two wars, and studies of pneumoconiosis, tuberculosis and healthcare delivery. In this profile of medical courage we explore not only his thoughts on healthcare but his extraordinary background that shaped his ideas.

Early Life

Archie Cochrane was born in 1909 in Galashiels, Scotland, a cloth manufacturing town 30 miles south of Edinburgh. His family was wealthy mill owners that instilled in Archie the principles of self-reliance and accomplishment. This was important since his father died in the First World War when Archie was 8. However, Archie was financially secure since as the first born, he inherited a private income.

By all accounts, he was a bright student. After attending preparatory school at Rhos-on-Sea in Wales, Archie won a scholarship to Uppingham School in Rutland, England, where he became a school prefect and a member of the rugby team. In 1927, he won a scholarship to King’s College Cambridge, where he graduated in 1930 with honors in natural sciences. His inheritance enabled him to continue studying, and during 1931 he worked on tissue culture at the Strangeways Laboratory at Cambridge and later in Toronto. However, he soon tired of what he concluded was trivial research and abandoned basic studies.

Psychoanalysis

At about this time he became anxious about his sexual development. He had developed anejaculation, a condition where he was unable to ejaculate.  This led him to seek medical help but he received little sympathy from the British doctors. However, he found the doctors at the Kaiser Wilhelm Institute in Berlin were willing to take his problem seriously. Between 1931 and 1934 he underwent psychoanalysis with Freud’s leading lay analyst, Theodor Reik. The psychoanalysis began initially in Berlin, but like Freud, Reik was a Jew. Archie followed Reik first to Vienna and later The Hague as Reik fled from Hitler. Archie did some medical studies in Vienna and Leiden during this time, and published his first paper (Elie Metchinikoff and his theory of an ‘instinct de la mort’). Unfortunately, the psychoanalysis did not cure his condition which plagued him for the rest of his life. However, his sojourn in Europe instilled in him a hatred of fascism and a skeptical attitude not only of psychoanalysis, but or all theories which had not been validated by testing. Later in his life, Cochrane condemned the entire field of psychiatry for “using a large number of therapies whose effectiveness has not been proven” and for being “basically inefficient” (1).

Spanish Civil War

Disenchanted, he returned to London in 1934 and continued his studies as a clinical medical student at University College Hospital. His experiences in Europe, his hatred of fascism, and his sense of social justice led him to joint the Socialist Medical Association. In 1936, this group of doctors, medical students and nurses met in London to consider ways of sending medical help to Republicans fighting fascism in the Spanish Civil War. This was viewed by Archie as important since the addition of Spain as a fascist ally to Germany and Italy would likely result in the fall of France and England to fascist aggression. The Socialists decided to send doctors, nurses and medical students to Spain to assist the Republicans and Archie abandoned his studies in order to serve as a volunteer.

Figure 1. Panel A. Archie Cochrane as a medical student. Panel B. As a volunteer in the Spanish Civil War with a “flourishing red beard” (From Cardiff University Library, Cochrane Archive, University Hospital Llandough). 

He served at Grañén near Huesca on the Aragon front and the siege of Madrid. Although not qualified as a physician, he served in an ambulance unit as well as performing duties such as triage in the hospital. During this time Archie had contact with the Communists that made up much of the Republican army. Like many intellectuals of that period, Archie had been attracted by Marx during his undergraduate studies. However, his experience in Spain turned him against communism, but he remained a man of the left throughout his life. After about a year all British medical students were ordered to return home to qualify. Archie had grown sick of the war and was happy to comply.

World War II

He resumed his clinical studies at University College Hospital in 1937, and qualified in 1938. Until the outbreak of the Second World War he worked first as a house physician at the West London Hospital and then as a research assistant University College Hospital. At the beginning of World War II, he enlisted in the Royal Army Medical Corps and served first in Egypt and then as a medical officer in “D” Battalion Layforce, a commando unit. The one military action in which he was involved ended disastrously in Crete when the British troops surrendered and Archie was taken as a prisoner of war (POW).

Figure 2. Archie Cochrane as a POW with his identity card (From Cardiff University Library, Cochrane Archive, University Hospital Llandough).

Shortly after his capture in June 1941, he was sent to a POW camp at Slonica in Greece where he conducted his “first, worst and most successful clinical trial” (2). The camp was a run-down, overcrowded army barracks, infested with bed bugs. The diet was minimal-breakfast: unsweetened "ersatz" coffee; midday: a bowl of vegetable soup; evening: two slices of plain bread- in all, about 400 to 500 calories. Archie was appointed chief medical officer by the Germans, not because of his medical abilities, but because of his time in Germany he spoke fluent German. He also became the senior British officer in charge of 8000 demoralized, hungry British prisoners of war.

In August an epidemic of jaundice accompanied by edema began and rapidly progressed. The German doctors claimed that the edema was due to the sun and not to starvation. Archie was also afflicted with severe jaundice and pitting edema above the knees. He decided that something must be done, and that he was the only one who could do it. He hypothesized, incorrectly as it turns out, that the prisoners were suffering from “wet beriberi" due to a vitamin deficiency. Archie bought some yeast on the black market and recruited 20 young prisoners and divided them between two wards. Each man in one ward received two spoonfuls of yeast daily. Those in the other ward received one tablet of vitamin C. By the fourth day there was a conclusive difference in the edema. Archie asked the members of each ward whether they felt better, the same, or worse. Nine out of ten in the "yeast" ward felt better; none in the other.

Archie showed the results to the Germans and asked for yeast and more food. They said, as usual, that they would see what they could do. However, a young German doctor pointed out that the results were incontrovertible and they could be prosecuted for war crimes unless that did something. This led to the unexpected, the Germans actually produced the yeast and the epidemic was quashed. On reflection, Archie realized the edema was not wet beriberi. Furthermore, his trial numbers were too small, the time too short, and the outcome measurements poor. Yet the treatment worked. Archie later speculated that the small amount of protein in the yeast raised the plasma proteins sufficiently to correct fluid imbalance that led to the edema (2).

Archie’s second experience in POW life at Elsterhorst, Germany was very different. He was assigned to the medical section where there were two other British doctors, who had been captured at Dunkirk. All the POWs with tuberculosis (most of whom were far advanced) of all nationalities, were herded together behind the wire. Archie knew a certain amount about tuberculosis and offered to take over that section of the medical work. Conditions were in many ways not too bad. Through Red Cross parcels there was sufficient food. Archie was able to 'screen' patients and do sputum 'smears' but radiographs were very limited. He could give patients bed rest, pneumothorax, and pneumoperitoneum. There was a French physiologist, an expert in 'adhesion-section', and thoracoplasty was a possibility. This tuberculosis work took up only a small part of Archie’s time. He realized that the rest of efforts must be devoted to "care" as the chance of a cure among these cases was minimal.

He would later state that “I remember at that time reading one of those propaganda pamphlets, considered suitable for POW medical officers about ‘clinical freedom and democracy’. I found it impossible to understand. I had considerable freedom of choice of therapy: my trouble was that I did not know which to use and when. I would gladly have sacrificed my freedom for a little knowledge. I had never heard of ‘randomized controlled trials’, but I knew that there was no real evidence that anything we had to offer had any effect on tuberculosis, and I was afraid that I shortened the lives of some of my friends by unnecessary intervention” (1).

Post-War Studies

After the War, Archie continued his studies. He studied preventive medicine at the London School of Hygiene and Tropical Medicine. There he was greatly influenced by Austin Bradford Hill’s teaching on randomized clinical trials and acknowledged Bradford Hill’s influence for the rest of his life. In 1947, Archie won a Rockefeller Scholarship and went to the Henry Phipps Clinic in Philadelphia, where he became interested in x-ray studies of pulmonary tuberculosis and developed what became a lifelong interest in observer error.

Academic Career

After returning from Philadelphia in 1948, Archie began his academic career at the recently formed Medical Research Council’s Pneumoconiosis Research Unit in Penarth, near Cardiff in South Wales. He initially conducted groundbreaking comparative studies of dust levels in the coal mines of South Wales. Two years later, he launched the Rhondda Fach study to investigate the etiology of progressive massive fibrosis and worked at the Pneumoconiosis Research Unit for over a decade. His main interests were the x-ray classification of coal workers’ pneumoconiosis and the relationship between x-ray categories, dust exposure, and disability. His interest in this field continued for the rest of his life, as reflected in the completion during 1974 to 1986 of twenty year and thirty year follow-up studies of the population of the Rhondda Fach (3-6).

Figure 3. Archie Cochrane in 1949 (From Cardiff University Library, Cochrane Archive, University Hospital Llandough).

Archie’s research achieved very high response rates in surveys and follow-up studies probably due to the team of disabled miners he formed to help maximize survey follow-up rates. This approach was new and revolutionary at the time. The quality of Archie’s research was reflected in the decision by the Medical Research Council to invite him to establish and direct a new epidemiology unit based in Cardiff in 1960. Archie was appointed to the David Davies Chair of Tuberculosis and Diseases of the Chest at the Welsh National School of Medicine. Under Archie’s direction, the Epidemiology Unit quickly established an international reputation for the quality of its surveys and studies of the natural history and etiology of a wide range of common diseases, including anemia, glaucoma, asthma, and gallbladder disease.

Archie is probably best remembered for his advocacy of randomized controlled trials. He always acknowledged influence of Bradford Hill in introducing him to the principles of using these studies to obtain unbiased estimates of the effects of healthcare interventions. He coordinated a wide variety of randomized trials to evaluate pharmaceutical, surgical and health service interventions. The trials with the most enduring and important implications for human health were those done in collaboration with Peter Elwood and included the first studies showing that aspirin could reduce the incidence of cardiovascular diseases (7)

His interest in health care delivery extended to a trial to determine where patients with an uncomplicated myocardial infarction should recover-either at home or in the hospital (8). After several unsuccessful attempts and over the protests of the cardiologists, Archie finally succeeded in receiving approval to start the trial. An interim analysis was planned and Archie gathered the hospital staff to present the results. He passed out a table and began by pointing out that none of the results were statistically significant. Archie went on to say, “Well gentlemen, it turns out that you were right and I was wrong. It is dangerous for patients to be cared for at home and they should be in the hospital.” An immediate cry from the cardiologists went up that “You’re killing people with your clinical trial” and they demanded that Archie stop the study. Archie let the commotion die and replied, “Well that’s very interesting, gentlemen, because when I gave you the table of results, I swapped the columns around. It turns out that your hospitals are killing people and they should be at home. Would you like to close down the trial now; or should we wait until the best results?” Archie referred to the cardiologists’ attitude as the “God complex” (8). By this he meant, no matter how complex the problem, the person has an overwhelming belief that they are infallibly right in their solution.

An invitation from the Nuffield Provincial Hospitals Trusts to prepare the 1971 Rock Carling Lecture provided Archie with an opportunity to speak on controlled clinical trials.  The book that resulted from the lecture, “Effectiveness and efficiency: random reflections on health services” (1), promptly became influential. He emphasized three themes in the book: 1. the importance of using randomized trials to identify which health service interventions are effective; 2. the relevance of assessing the costs or efficiency of the options available; and 3. the importance of equitable access to effective treatments.

Recognition and Later Years

In the year the book was published, 1972, Archie became the first president of the new Faculty of Community Medicine of the Royal College of Physicians (subsequently Faculty of Public Health). He received an honorary doctorate from the University of York the following year; was Dunham Lecturer at Harvard in 1974; became an honorary fellow of the American Epidemiological Association in 1975; and, in 1977, he received an honorary doctorate from Rochester University and became an honorary fellow of the International Epidemiological Association.

Figure 4. Archie Cochrane after retirement (From Cardiff University Library, Cochrane Archive, University Hospital Llandough).

Now with time to reflect, Archie followed up his criticism of the medical profession  in 1979 by stating, “It is surely a great criticism of our profession that we have not organized a critical summary, by specialty or subspecialty, adapted periodically, of all relevant randomized controlled trials” (9). In particular he challenged the obstetric profession for not having used the randomized controlled trial design to ascertain whether interventions related to pregnancy and childbirth were effective. He awarded the “wooden spoon” to obstetrics but the “silver spoon” to phtisiology (the study of tuberculosis) because of his mentor’s, Sir Austin Bradford Hill’s, landmark trials on the use of streptomycin (9). A few years after his death, Archie’s challenge led Iain Chalmers, an obstetrician, and his co-workers to create the Oxford Database of Perinatal Trials (10). Based on this database of controlled clinical trials, it was quickly realized that, to keep up with the rapid developments in the fields of perinatology and neonatology, the published reviews required timely updates. This realization formed the basis for the Cochrane Collaboration, which was established in the early 1990s, and had the aim of helping make well-informed decisions about health care (11). Thousands of volunteers are now involved in preparing and maintaining systematic reviews of randomized trials and other evidence within this international, non-profit organization. Cochrane Reviews are published electronically in The Cochrane Database of Systematic Reviews, the principal element of The Cochrane Library.

Legacy

Archie Cochrane died of cancer in 1988 after a long illness. His life has been described in an autobiography written with the assistance of Max Blythe (12). He did not found the Cochrane Collaboration as commonly believed, although he undoubtedly would be honored to have it named after him. Archie would be delighted with the Collaboration’s 10 principles: 1. collaboration; 2. building on the enthusiasm of individuals; 3. avoiding duplication; 4. minimizing bias; 5. keeping up to date; 6. striving for relevance; 7. promoting access; 8. ensuring quality; 9. continuity; and 10. enabling wide participation. Undoubtedly, if he were alive today, he would have awarded the Collaboration his silver spoon.

Some have questioned whether the Cochrane Collaboration and evidence-based medicine are a threat to physician autonomy. The Lancet has decried evidence-based medicine as an internal threat to the autonomy of the physician (13). Similar fears were expressed by Feinstein and Horwitz (14) in their critique of evidence-based medicine, calling it, “A new form of dogmatic authoritarianism may . . . be revived in modern medicine, but the pronouncements will come from Cochranian Oxford rather than Galenic Rome” (14). However, Hill (15) dismisses these fears and adds the comment that physician autonomy would have been the last of Cochrane’s concerns. I disagree.  Archie would have been very concerned. He would have recognized those with the God complex who cite studies that lack scientific rigor as evidence based medicine. Furthermore, he would have abhorred that this is used by some to advance their own biases or conflicts of interest.  Archie would undoubtedly have viewed these authoritarian and intolerant views of medical practice as disturbing as the lack of evidence and awarded them the wooden spoon.

Richard A. Robbins, MD

Editor, Southwest Journal of Pulmonary and

   Critical Care Medicine

References

1. Cochrane AL. Effectiveness and efficiency: random reflections on health services. London: Nuffield Provincial Hospitals Trust; 1973.
2. Cochrane AL. Sickness in Salonica: my first, worst, and most successful clinical trial. BMJ 1982; 289;1726-7.
3. Cochrane AL, Haley TJ, Moore F, Hole D. The mortality of men in the Rhondda Fach, 1950-1970.Br J Ind Med 1979;36:15-22.
4. Cochrane AL, Moore F, Baker IA, Haley TJ. Mortality in two radom samples of women aged 55-64 followed up for 20 years. Br Med J 1980;280:1131-3.
5. Atuhaire LK, Campbell MJ, Cochrane AL, Jones M, Moore F. Mortality of men in the Rhondda Fach 1950-80. Br J Ind Med 1985;42:741-5.
6. Atuhaire LK, Campbell MJ, Cochrane AL, Jones M, Moore F. Specific causes of death in miners and ex-miners of the Rhondda Fach 1950-80. Br J Ind Med 1986;43:497-9.
7. Elwood PC, Cochrane AL, Burr ML, Sweetnam PM, Williams G, Welsby E, Hughes SJ, Renton R. A randomized controlled trial of acetyl salicylic acid in the secondary prevention of mortality from myocardial infarction. Br Med J 1974;1(5905):436-40.
8. Harford T. Trial, error and the God complex. Available at: http://www.ted.com/talks/tim_harford.html (accessed 7/10/12).
9. Cochrane AL. Medicine For the Year 2000. London: Office of Health and Economics; 1979. 1931–1971: A critical review with particular reference to the medical profession.
10. Chalmers I, Hetherington J, Newdick M, Mutch L, Grant A, Enkin M, Enkin E, Dickersin K. The Oxford database of perinatal trials: developing a register of published reports of controlled trials. Control Clin Trials 1986;7:306–24.
11. Chalmers I, Dickersin K, Chalmers TC. Getting to grips with Archie Cochrane’s agenda. All randomised controlled trials should be registered and reported. BMJ 1992;305:786–8.
12. Cochrane AL, Blythe M. One man’s medicine. An autobiography of Professor Archie Cochrane. London: The British Medical Journal, 1989.
13. Anonymous. Evidence-based medicine, in its place. Lancet 1995;346:785.
14. Feinstein AR, Horwitz RI. Problems in the “evidence” of “evidence-based medicine.” Am J Med 1997;103:529–35.
15. Hill GB. Archie Cochrane and his legacy: an internal challenge to physicians’ autonomy? J Clin Epidemiol 2000;53:1189-92.

Reference as: Robbins RA. Profiles in medical courage: evidence-based medicine and Archie Cochrane. Southwest J Pulm Crit Care 2012;5:65-73. (click here for a PDF version of the manscript)

Profiles of Medical Courage: The Courage to Experiment and Barry Marshall

“The greatest obstacle to knowledge is not ignorance, it is the illusion of knowledge.”-Daniel Boorstein

Previously, four rather obscure physicians and their courageous acts have been described in this series. Barry Marshall is hardly obscure. Along with Robin Warren he won the 2005 Nobel Prize in Medicine for the discovery that H. pylori was the major cause of ulcers.  He has been the subject of numerous articles and interviews. However, his story is so compelling and his courage so remarkable, that it bears repeating.

Figure 1.  Barry Marshall (left) and Robin Warren (right) toasting their 2005 Nobel Prize.

Barry Marshall was an obscure medicine resident (registrar) in Perth, Australia in the early 1980’s. He had an unremarkable career as a medical student and as a resident (1). He was working 14 hour days, was married with 4 children, and his wife was finishing her degree in psychology.

Against this hectic background, he took a 6 month gastroenterology rotation during the later half of 1981. As part of his training, he was encouraged to perform a clinical research project each year and asked his supervisor, Dr Tom Waters, if there was a gastroenterology project he could work on. Waters showed him a letter from Robin Warren, a pathologist, which listed patients with curved bacteria present on their stomach biopsies and asked for someone to clinically follow-up the patients. This was radical stuff in the day. Stomachs were thought to be sterile because the acid killed any bacteria. Marshall was especially interested because one of the patients was a woman he had seen on the ward, who had severe stomach pain but no diagnosis. In desperation Marshall had referred her to a psychiatrist and commenced antidepressant medication for want of a better treatment. The only abnormal finding was some redness in the stomach and bacteria on the stomach biopsy.

He went to visit Warren in the basement of Royal Perth Hospital where the Pathology Department was located. It was to be the first of many afternoon visits during the next year. Warren used to drink strong black coffee and smoke small cigars. Marshall also occasionally indulged. Together they would discuss their research while smoking cigars in the in Warren’s office in the basement.

At the end of 1981, Marshall’s gastroenterology rotation was finished and his rotations for 1982 had been assigned. In the midst of his time in training, Marshall continued his research by fitting it around his other duties. It was a particularly frustrating time. Marshall was attempting to culture the bacteria, and although masses of bacteria were seen on the silver stain of the gastric biopsies, cultures showed no growth. However, fate intervened. A methicillin-resistant Staphylococcus aureus (MRSA) outbreak occurred on one of the wards at Royal Perth. Patients were being quarantined and surveillance cultures were being performed on all staff that had been anywhere near the affected ward. One of Marshall’s research gastric biopsies taken on the Maundy Thursday before Easter of 1982 was sent to the microbiology lab as usual. However, the lab was overwhelmed with MRSA cultures and the Easter holiday.  There was no time to examine Marshall’s cultures on the Saturday before Easter as normally would have been done. The culture plates remained in the incubator, untouched, from Thursday until the following Tuesday. Small transparent colonies were present on the plates and these proved to be a rather pure culture of a Gram negative rod. Why previous cultures showed no growth was explained when Marshall learned the laboratory staff had been processing his research cultures identically to the routine method used for throat-swab cultures. If nothing was seen on the Petri dish after 48 hours, the cultures were discarded. Prior to this, Marshall had no idea that the cultures were only being incubated for 48 hours.

Now that the bacteria had been cultured, Marshall devised a 100 patient observational study of the culture results along with clinical and demographic data. He chose 100 patients simply because in the days before computer spreadsheets this allowed percentages to be easily calculated. He would stay at the hospital each evening to interview inpatients that were due for endoscopy the next morning. In the morning Marshall would arrive early so he could interview the new outpatients as they were being prepared for their endoscopies. Marshall completed his studies in May, 1982 shortly before assuming his next 6 month residency assignment at Port Hedland, a mining town 1,900 km from Perth. In a frenzied weekend while his wife was packing for the trip, Marshall spent Saturday morning at the gastroenterology department photocopying the 100 endoscopy reports.

According to Marshall the time in Port Hedland was an important period. He was able to score the patients’ endoscopies for the presence or absence of ulcers. He had time to do an extensive literature research and discovered that the curved bacteria described by Warren had been described many times before but ignored. Furthermore, he could find no evidence for the existence of stress in causing ulcers. He also had time to digest the results of his study and prepare it for presentation.

In October, 1982, Marshall presented his findings to the local College of Physicians meeting, where it received a mixed response (Figure 2) (1).

Figure 2. Percentage of patients with bacteria identified on gastric biopsy and their endoscopic appearance.

Marshall’s unrestrained enthusiasm, combined with his youthful appearance and informal manner, apparently fed the skepticism of his audience. Marshall's critics contended that the presence of bacteria in the stomachs of patients with gastric diseases was coincidental, and that the bacteria were probably harmless. Furthermore, the bacteria were seen in the stomach and probably could not explain duodenal ulcers. Lastly, it seemed pretty unlikely that a medicine resident was making a significant observation when previously no one thought the bacteria were important.

At about the same time, Marshall found that his contract at Royal Perth would not be renewed for the following year. Previously unfocused, he now wanted to work in gastroenterology or microbiology and continue his research. However, jobs at Royal Perth were not available. Fate intervened for a second time when Marshall was approached by Drs. Norm Marinovich and Ian Hislop at Fremantle Hospital in Perth who offered Marshall a senior registrar position and continued funding of his research. Fremantle was the third and smallest of the teaching hospitals in Perth but had a tradition of openness and experimentation. In the next two years at Fremantle Marshall had an enthusiastic group of collaborators including Ian Hislop, Norm Marinovich, Harvey Turner, David McGechie, Ross Glancy, Neil Noakes, Graeme Francis, Peter Rogers, Neil Stingemore, and importantly, Peter Smith, the chief (superintendent) of medicine.

While at Fremantle, Marshall was able to confirm that the stomach bacteria observed at Royal Perth Hospital also occurred at Fremantle. Furthermore, nearly all peptic ulcer patients had the organism. Freemantle Hospital was supporting Marshall’s work and there Marshall devised the first effective treatment for peptic ulcer disease consisting of antibiotics and bismuth. However, acceptance of the association of the bacteria with peptic ulcer disease was slow. Practitioners of gastroenterology and the pharmaceutical industry were both heavily invested in the theory that peptic ulcers were caused by emotional stress and stomach acids, and could only be treated with repeated courses of antacid medication. While the reduction of stomach acid often alleviated the existing ulcer, inflammation of the stomach lining usually persisted, and most patients found themselves returning in a year or two with another ulcer. Patients were routinely advised to seek psychiatric counseling, find less demanding employment or make other drastic lifestyle changes to address the purported cause of their disease. Volumes were published detailing the alleged psychological causes of gastric ailments, and ulcers remained a frequently cited example of psychosomatic illness.

In 1983 the Gastroenterological Society of Australia meeting was in Perth. This was great news to Marshall because it provided an opportunity to present his research with little cost. He was so poor he could not afford an airfare to any scientific meetings. He submitted an abstract to the meeting, but to his shock, it was rejected (Figure 3).

 

Figure 3. Rejection letter of Marshall’s abstract from the Gastroenterogical Society of Australia meeting held in Perth, 2003.

Sixty-seven abstracts had been submitted and 56 were accepted. The Society suggested that Marshall should seek critical review from his colleagues.

The rejection may have been fortunate because in prompted David McGechie from Fremantle to put Marshall in contact Dr Martin Skirrow in the UK. Skirrow arranged for Marshall to present at the European Campylobacter Meeting in September, 1983. There Marshall’s abstract meant with some acceptance and more publicity. In addition to his presentation, Marshall visited Martin Skirrow in Worcester, England, and attended an endoscopy session at the Worcester Infirmary. Martin's registrar, Cliodna McNulty, was able to successfully isolate the stomach bacteria 3 days later, showing that the spiral organism was not merely an Australian phenomenon but was present in ulcer patients in the UK as well.

After the pilot study was completed, Marshall and Warren submitted their work to the medical journal, The Lancet. Editors were initially reluctant to publish their work because they could find no reviewers who believed their results. Skirrow, contacted The Lancet confirming Warren and Marshal’s findings and, in June 1984, they succeeded in publishing their paper (3).

Despite some success, the time at Fremantle was also frustrating. Marshall’s attempts at making an animal model of peptic ulcer disease were unsuccessful. Furthermore, his research was not receiving the type of attention he had hoped. Criticism had become personal. One prominent gastroenterologist dismissed him as "a crazy guy saying crazy things” (4). His wife overheard comments that were disheartening.

Marshall became convinced that in order to have anyone believe an infectious cause he would have to fulfill Koch’s postulates. However, with the absence of an animal model complicating progress, Marshall decided that he could use himself as a model. Fortunately, he was secretive about the experiment. It is unlikely that any human experimentation committee would have approved. Since he probably would have proceeded anyway, Marshall would likely have been fired. Marshall thought that if he was successful he would develop an ulcer or stomach problems from the bacteria probably in a couple of years. Without explanation he asked Ian Hislop to do a baseline endoscopy and a gastric biopsy. As Hislop put the scope down he said, “Barry, I’m not going to ask why I’m doing this.” (5). From around the gastroscope, Marshall gritted out, “Just take the biopsy.” (5). The endoscopy was normal and the biopsy did not show bacteria.

Then Marshall drank bacteria that were cultured from a patient who did not actually have ulcers, just indigestion and gastritis. Furthermore, Marshall was able to eradicate the patient’s infection with antibiotics, so he already knew that he could, if necessary, take a treatment that worked. Instead of being perfectly well and having a silent infection, he started vomiting after about five days. It was a clear liquid, and there was no acid in it. His wife noticed he was ill and questioned him about it. He told her the truth and she was horrified that he infected himself and took the chance of spreading the infection to her and their kids. She demanded he take an antibiotic. He took the antibiotics and was cured but not before getting another endoscopy and biopsy. He had gastritis and bacteria were everywhere. He had fulfilled Koch’s postulates for gastritis, though not for ulcers. Marshall’s self-experimentation was later immortalized by the comic Ulcer Tales which was distributed to many US physicians (Figure 4) (6).

Figure 4. Ulcer Tales, a comic depicting Marshall’s ingestion of Helicobacter.

Even though he was not officially collaborating with Dr. Warren while he was working at Fremantle Hospital in 1983–84, Marshall and Warren met to discuss the papers they were writing for the Lancet and would meet for dinner with their wives. At one of these dinners Marshall described his self-experimentation. Early the next morning Warren had a call from a journalist in the USA at 5 AM. When asked the usual question about "How do you know it's a pathogen and not a harmless commensal?" Warren blabbed the results of Marshall’s self-experimentation. What Warren did not know was that the journalist was from the "Star" newspaper, the grocery store tabloid. This was right up their alley. In the next issue the story appeared, "Guinea-pig doctor discovers new cure for ulcers ... and the cause” (7).

This became one of those serendipitous, life changing events in Marshall’s life. After the Star article appeared, Marshall was continuously contacted by patients in the USA who read the story and were desperate for treatment. Marshall was able to help. He was treating patients by proxy in the USA as early as 1984. The publicity caught the eye of Mike Manhart, a microbiologist working for Proctor and Gamble in the USA. He tracked down Marshall’s publications and realized the economic potential for P & G who made a bismuth drug. It led to Marshall to leave Perth and spending the next ten years spent at University of Virginia.  

The tide of acceptance began to turn in the early 1990s. By then Marshall could attend a meeting and receive as much praise as criticism. In February 1994 the NIH held a consensus meeting in Washington DC which ended after 2 days with the statement that the key to treatment of duodenal and gastric ulcer was detection and eradication of Helicobacter pylori (8).

However after 10 years in the US, Marshall and his wife decided it was time to go home. Marshall was awarded the McFarlane Burnet Fellowship which funded his lab at the University of Western Australia allowing him to return to Perth. His worked culminated with Robin Warren and him receiving the Nobel prize in 2005. In typical fashion, Marshall acknowledges those who failed to recognize H. pylori in his autobiography (1). Without them Marshall would have had a very different career. He also notes that one of the truly great things about winning the Nobel Prize in 2005 was that he got to share it and celebrate with those who had been involved in the initial work at Royal Perth and Fremantle Hospital. The Australians might refer to this as “partying with your mates”.

There were many occasions when Marshall was lucky: his meeting with Robin Warren, the MRSA outbreak leading to the first culture of the bacteria, the rejection of his abstract in 1983 and chance meetings with many people who helped and collaborated with him. We should remember Marshall not as much for his good fortune or his brashness in self-experimentation, but in his persistence in challenging the dogma that stomachs are sterile and ulcers result from stress. Marshall continues to lecture and because of his fame some of these lectures are available as videos on the internet. He opened his Nobel prize lecture with the quote from Boorstein that began this article, “The greatest obstacle to knowledge is not ignorance, it is the illusion of knowledge.”(7). It fits Marshall’s story well.

Richard A. Robbins, MD

Editor, Southwest Journal of Pulmonary and

   Critical Care 

References

1. Marshall BJ. Autobiography. Available at Nobelprize.org http://www.nobelprize.org/nobel_prizes/medicine/laureates/2005/marshall-autobio.html (accessed 6/5/2012).
2. Marshall BJ. Lecture by Barry Marshall.  http://www.nobelprize.org/mediaplayer/index.php?id=1721
3. Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Marshall BJ, Warren JR. Lancet 1984;1(8390):1311-5.
4. Barry Marshall Biography. http://www.achievement.org/autodoc/page/mar1bio-1 (accessed 6/5/2012).
5. Barry Marshall gastroenterologist. http://www.science.org.au/scientists/interviews/m/marshall.html#Childhoodleanings (accessed 6/5/2012).
6. http://www.melanievillines.com/samples/HPComic.pdf (accessed 6/5/2012).
7. Marshall BJ. Nobel Prize Lecture. http://www.docstoc.com/docs/77029428/Barry-Marshall-Nobel-Lecture (accessed 6/5/2012).
8. http://consensus.nih.gov/1994/1994HelicobacterPyloriUlcer094html.htm (accessed 6/5/2012).

Reference as: Robbins RA. Profiles of medical courage: the courage to experiment and Barry Marshall. Southwest J Pulm Crit Care 2012;5:12-19. (click here for a PDF version of the manuscript)

Profiles in Medical Courage: Joseph Goldberger, the Sharecropper’s Plague, Science and Prejudice

“You must accept the truth from whatever source it comes”. -Maimonides

The Sharecropper’s Plague

In the early half of the twentieth century a mysterious disease, “the sharecropper’s plague”, reached epidemic proportions in the Southern US (1). Each state decided whether it would recognize and publicly admit the existence of what was then considered an embarrassment. The total number of new annual cases was estimated as about 75,000 in 1915 and about 100,000 throughout the 1920s (2). The disease had a 40% mortality rate, and many survivors with dementia were confined to mental institutions (3). Patients initially presented with symmetrically reddened skin, similar to that produced by a sunburn or poison oak. Later, the dermatitis turned rough and scaly in one or more locations, such as the hands, the tops of the feet, or the ankles, or in a butterfly-shaped distribution across the nose. Disturbances of the digestive tract and the nervous system occurred as late manifestations. This led to the plague being characterized by 4 D’s: dermatitis, diarrhea, dementia and death. In case you have not guessed, the “sharecropper’s plague” was pellagra.

“Pellagraphobia" developed as the disease acquired a social stigma that left victims and their families ostracized (4). Many hospitals refused admittance to patients with pellagra and many staff refused to care for them. Quarantine was common and elementary schools tried to bar children whose family members had pellagra (5). The cause of the disease was unknown. A number of etiologies were proposed including infection; the eating of moldy corn; inherited susceptibility; heavy exposure to sunlight; and exposure to cottonseed oil (2). There were more than 200 proposed "cures" for pellagra included diet, arsenic, castor oil, quinine, strychnine, and the healing waters of mineral springs (5).

In response the US Surgeon General, Walter Wyman, appointed a seven-man commission headed by Dr. Claude H. Lavinder to find the etiologic agent and perhaps identify an insect vector. Lavinder toured affected areas and established a small laboratory at the South Carolina Hospital for the Insane where he injected rabbits, chickens, and guinea pigs with blood, spinal fluid, and spleen pulp from fatal cases of pellagra, without results. In 1911, he set up a larger laboratory at the Marine Hospital in Savannah and unsuccessfully attempted to transmit the causative agent to monkeys. The Commission conducted a survey of pellagra cases in the cotton mill districts in South Carolina where it was especially common. In its 1914 report, the commission concluded that pellagra had no relation to diet, that it spread most rapidly where sanitary disposal of waste was poorest, and that the disease occurred almost exclusively in people who lived in or next to the house of another person with pellagra (6). The general consensus was that pellagra was likely infectious. These conclusions are not surprising since the early twentieth century was an era when infections were being discovered as the causes of many diseases such as yellow fever, dengue fever, typhus, typhoid fever, lobar pneumonia, tuberculosis, cerebrospinal meningitis, syphilis, cholera, malaria, dysentery, scarlet fever, tetanus, and diphtheria. Pellagra was viewed as just another of those diseases with an as yet undiscovered pathogen.

Goldberger’s Investigations

Human Observations and Dietary Interventions

When Lavinder asked to be reassigned in 1914, he was replaced by Joseph Goldberger.

Figure 1. Dr. Joseph Goldberger

Goldberger spent his first 3 weeks in the South, directly observing patients with pellagra and their living environment. He summarized his observations with a report and hypothesis (8).  He stated that pellagra was: 1) present almost exclusively in rural areas; 2) associated with poverty; 3) associated with a relatively cheap and filling diet consisting of the "three M's", meat (fatback), meal (corn meal), and molasses; and 4) not acquired by nurses, attendants, or employees in hospitals or orphanages whose inpatients had the disease. The last finding seemed particularly incompatible with an infectious cause. Goldberger hypothesized that the staff's peculiar exemption from or immunity to the disease could be explained by a difference in diet.

To prove his hypothesis, Goldberger tried to prevent and cure pellagra by dietary interventions. In two orphanages having high rates of endemic pellagra he identified 172 patients with pellagra and 168 children who were initially free of disease (8). He arranged for both groups of to receive a new, more varied diet, subsidized by Federal funds. The results were evident in just a few weeks: No new cases of pellagra occurred and almost all children with pellagra were cured. After a year, the two orphanages had only one case of recurrent pellagra.

Goldberger then repeated the study in a mental asylum, using a randomized, controlled trial (9). Of 72 patients with pellagra, all were cured after the introduction of the new diet. The treatment group had a high drop-out rate, however, because some patients' mental status improved so greatly that they were permitted to leave the asylum. In the group on the old diet, the recurrence rate of pellagra was almost 50%. Interestingly, when the Federal subsidies expired at the end of these studies, the diets returned to the old three M's diet and 40% of the inmates again developed pellagra.

Goldberger then began a new study to induce pellagra by dietary deprivation (10). In a prison where pellagra had never been reported, a dozen volunteers were promised full pardons at the experiment's end for eating an experimental diet. The diet consisted largely of cereal and included biscuits, gravy, cornbread, grits, rice, syrup, collard greens, and yams. By the end of the 9 month study, 7 of the 12 inmates were diagnosed with pellagra. In all instances, resumption of a better diet resulted in cure.

To refute the theory that pellagra was infectious, Goldberger injected blood from patients with pellagra into the deltoids of healthy volunteers, including himself and his wife (11). He also mixed extracts of skin parings, nasal secretions, urine, and feces from patients with pellagra into a wheat dough concoction that was swallowed by all volunteers. These "filth party" experiments were repeated seven times. No signs of pellagra developed in the volunteers.

Demographic Studies

Goldberger next studied the basic demographics, socioeconomic status, and diet of patients with pellagra (12,13). In these surveys, Goldberger found that a poor year in cotton production was usually followed by an increase pellagra mortality (13). He showed an inverse relationship between socioeconomic status and the incidence of pellagra. Goldberger also found a significant correlation between the rise and fall in the price of animal protein foods and the disease's onset and remission (12,13). These data further supported his hypothesis that pellagra was caused by a dietary deficiency.

Laboratory Studies

Goldberger hypothesized that pellagra was caused by an amino acid deficiency, possibly tryptophan, based on his demographic and human studies. Goldberger soon realized that ordinary yeast contained and was the most potent source of the pellagra-preventive factor in rats and in dogs (14). In 1927 he arranged to have the Red Cross ship large quantities of yeast into flood-stricken areas along the Mississippi river (15). The expected outbreak of pellagra did not occur; instead, the disease fell below its usual seasonal incidence. After the emergency, yeast was no longer provided, and the usual level of pellagra returned to the area. Goldberger died in 1929 before he could find a specific pellagra cure.

In 1937 nicotinic acid or niacin was found to cure pellagra in dogs (16). This finding was soon confirmed for human pellagra (17). The final, almost complete elimination of pellagra dates to the 1940s coinciding with improvements in diet and a requirement by many states to enrich food with vitamins including niacin (18). What provoked the epidemic at the beginning of the twentieth century is not entirely clear. However, changes in the methods of milling corn may have led to the outbreak, because the germ or embryo in the corn kernel is removed in the new milling process begun at the turn of the century. The kernel contains a high proportion of lipid, enzymes, and cofactors, including nicotinic acid (19).

Politics and Pellagra

Goldberger investigations are exceptional. He performed community observation, clinical investigation, and laboratory investigations that led to the elimination of a common health problem. Yet, his extraordinary accomplishments are largely unrecognized. Politics and prejudice seem to be largely responsible for Goldberger’s obscurity.

Politics apparently had great influence on pellagra public policy. An association of pellagra with poverty was clear, and offended Southern pride where the disease was concentrated. When the epidemiologic studies of Goldberger, a Northerner, an immigrant, and a Jew pointed to social and economic factors as being responsible for the occurrence of pellagra, Southern sensitivities were further riled. Editorial pages and speeches by congressmen criticized and condemned such insulting inferences concerning the contentment of the people of the South (2).

When a letter from Goldberger to the Surgeon General describing the extent of pellagra and its relationship to poverty and poor diet reached the press; it stimulated the newly inaugurated president, Warren Harding, to write the Surgeon General asking for a complete report. Harding suggested that the Red Cross provide aid, and offered to ask for a congressional appropriation (2). This infuriated a number of influential Southern politicians including Congressman James F. Byrnes (later U.S. Senator, Secretary of State, and Supreme Court Justice). He called the news reports of "famine and plague" in South Carolina an "utter absurdity," calling for rejection of offers of aid from the Red Cross. A Georgia city wired one of their senators, Tom Watson, "When this part of Georgia suffers from famine, the rest of the world will be dead!" (20). The United Daughters of the Confederacy at first voted to thank President Harding for his concern, but a month later it sent him a letter of protest. "Famine does not exist anywhere in the South," their letter stated, "and we fail to find a general increase in pellagra" (20). Since pellagra was common in Italy, Italian immigrants were blamed for the outbreak of the disease (2). No one seemed to notice that the Italians living in the South did not have pellagra, since they did not favor the meat, meal and molasses diet that led to the disease.

Goldberger’s Legacy

Goldberger died in 1929 of renal cell carcinoma not having convinced public health officials of a dietary cause of pellagra. Goldberger should be remembered not only for his superb investigations but for formulating a hypothesis, testing it and not surrendering to insults of his heritage or religion. Although rarely remembered in medical textbooks, he has been immortalized in some unlikely places including “Real Life Comics” in 1941 (Figure 2).

Figure 2. Joseph Goldberger in “Real Life Comics”.

Figure 2. Joseph Goldberger in “Real Life Comics”.

In some aspects Goldberger’s story is echoed in modern day politics where politicians attempt to manipulate or deny scientific discovery to further their own political careers. Even when Goldberger showed that affordable therapy with yeast cured pellagra, many Southern politicians remained reticent to accept diet as a cause of the disease. Their ambitions undoubtedly contributed to the excess mortality and morbidity of thousands of impoverished Southerners in the early twentieth century.

References

1. Elmore JG, Feinstein AR. Joseph Goldberger: An unsung hero of American clinical epidemiology. Ann Intern Med 1994;121:372-37.
2. Bollet AJ. Politics and pellagra: the epidemic of pellagra in the U.S. in the early twentieth century. Yale J Biol Med 1992;65:211-21.
3. Lavinder CH. The prevalence and geographic distribution of pellagra in the United States. Public Health Rep 1912;27:2076-88.
4. Niles GM. Pellagraphobia: A word of caution. JAMA 1912;58:1341.
5. Etheridge EW. The Butterfly Caste: A Social History of Pellagra in the South. Westport, CT: Greenwood Publishing Company; 1972.
6. Siler JF, Garrison PE, MacNeal WJ. Pellagra, a summary of the first progress report of the Thompson-McFadden Pellagra Commission. JAMA 1914;62:8-12.
7. Parsons RP (1943). Trail to light: A biography of Joseph Goldberger. Bobbs-Merrill. ASIN B0007DYTFM.
8. Goldberger J. The etiology of pellagra: The significance of certain epidemiological observations with respect thereto. Public Health Rep1914;29:1683-86.
9. Goldberger J, Waring CH, Tanner WF. Pellagra prevention by diet among institutional inmates. Public Health Rep 1923;38:2361-68.
10. Goldberger J, Wheeler GA. The experimental production of pellagra in human subjects by means of diet. Hygienic Laboratory Bulletin 1920;120:7-116.
11. Goldberger J. The transmissibility of pellagra: Experimental attempts at transmission to human subjects. Public Health Rep. 1916;31:3159-73.
12. Goldberger J, Wheeler GA, Sydenstricker E. A study of the diet of nonpellagrin and of pellagrin households. JAMA 1918;71:944-9.
13. Sydenstricker E, Wheeler GA, Goldberger J. Disabling sickness among the population of seven cotton-mill villages of South Carolina in relation to family income. Public Health Rep. 1918;33:2038-51.
14. Goldberger JG, Wheeler GA, Lillie RD, Rogers LM. A further study of butter, fresh beef and yeast as pellagra preventives, with consideration of the relation of factor P-P of pellagra (and black tongue of dogs) to vitamin B. Public Health Rep 1926;41:297-318.
15. Goldberger JG, Sydenstricker E. Pellagra in the Mississippi flood area. Public Health Rep 1927;42:2706-25.
16. Elvehjem CA, Madden RJ, Strong FM, Wooley DW. Relation of nicotinic acid and nicotinic acid amide to canine black tongue. J Amer Chem Soc 1937;59:1767.
17. Smith DF, Ruffin JM, Smith SG. Pellagra successfully treated with nicotinic acid: a case report. JAMA 1937;109:2054-5.
18. Wilder RM. A brief history of the enrichment of bread and flour. JAMA 1956;162:1539-40.
19. Carpenter KJ. Effects of different methods of processing maize on its pellagragenic activity. Fed Proc 1981;40:1531-5.
20. Etheridge EW: The Butterfly Caste. A Social History of Pellagra in the South. Westport, CT, Greenwood Press, 1972, 278 pp

Reference as: Robbins RA. Profiles in medical courage: Joseph Goldberger, the sharecropper’s plague, science and prejudice. Southwest J Pulm Crit Care 2012;4:189-93. (Click here for a PDF version of the manuscript)

Profiles in Medical Courage: Peter Wilmshurst, the Physician Fugitive

"Nothing defines human beings better than their willingness to do irrational things in the pursuit of phenomenally unlikely payoffs." -Scott Adams, US humorist, in The Dilbert Principle (1996)

Peter Wilmshurst, a cardiologist in the UK, has taken on medical companies over their honesty not once, but twice. His exciting story illustrates how far companies will go to protect their quest for big bucks and the potential financial risk incurred by honest physicians who do clinical research.

A movie entitled “The Fugitive”, based on the popular 1960’s television series, was released in 1993. The movie and television series both tell the story of Dr. Richard Kimble wrongly accused of murdering his wife and Kimble’s search for the real killer, a one-armed man. In the movie version, Harrison Ford plays Kimble and discovers that the one-armed man, Frederick Sykes, is employed by a pharmaceutical company that is working on a new drug. Kimble had investigated the drug and discovered that it caused liver damage. He also discovers that his friend and associate, Dr. Charles Nichols, who is leading the drug's development, arranged a cover-up, and ordered Sykes to kill Kimble, with Kimble’s wife's death being incidental. This is exciting stuff worthy of a movie. Although the plot was plausible, most of us in medical research thought only barely plausible. Little did we realize that the extent some pharmaceutical companies would go to protect their patented products. After all, we are talking about big bucks here.

Peter Wilmshurst

Amrinone

In 1986, seven years before the release of “The Fugitive”, Dr. Peter Wilmshurst, a cardiologist in the United Kingdom, went to the Guardian Newspaper with a fantastic story regarding the development of a new drug.  Wilmshurst’s research was on heart failure. In the 1980’s there were few treatments to improve symptoms of heart failure patients and none to improve survival. Wilmshurst was offered the opportunity to do research on a promising new drug, amrinone, patented by Sterling-Winthrop. Research showed that the drug increased the strength of heart contraction in animals. To assess its effects in man, a group from Peter Bent Brigham Hospital and Harvard Medical School published in the New England Journal of Medicine the results on the hemodynamic responses to amrinone in 8 patients with heart failure immediately after amrinone infusion (1). Amrinone increased cardiac index and left ventricular end-diastolic pressure fell. No toxicity was observed. To those physicians who care for heart failure patients, this new therapy is exciting stuff. The New England Journal is probably the most influential medical journal in the world. The article came from the cardiology department at Harvard and one of the authors was Eugene Braunwald, the most well known cardiologist in the world at the time and head of medicine at Harvard. However, Wilmshurst research disagreed on the effects of amrinone with Braunwald’s findings. In a large series of experiments Wilmshurst group showed that amrinone did not affect contractility in patients with heart failure. Furthermore, life threatening side effects were frequent (2,3).

Wilmshurst reported his findings to Sterling-Winthrop. According to Wilmshurst, Sterling-Winthrop employees asked him to exclude the patients with a downward trend in contractility. When Wilmshurst refused he was threatened with litigation (4). Wilmshurst proceeded with publication of his results in abstracts and meeting presentations but his on-going research studies on amrinone ended when Sterling-Winthrop employees removed the drug stocks from the pharmacy (4).

A number of incidents occurred apparently to prevent presentation or discredit Wilmshurst’s research. One strange incident involved one of Wilmshurst’s colleagues, Alex Crowther, who was due to present Wilmshurst’s and his work on amrinone on the second day of a meeting in Luxembourg (4). When Crowther arrived he discovered that his talk had been rescheduled for the previous day. The organizers had received a forged letter that appeared to be from him asking for his talk to be brought forward a day.

When Wilmshurst presented his findings on side effects at another meeting, a Sterling-Winthrop employee stood up and said that he had made up the findings (4).  At other meetings, three professors of cardiology, each of who was a paid consultant to Sterling-Winthrop, made public statements that they had tried to replicate Wilmshurst’s findings and failed (4). At one point, Wilmshurst was asked to meet with representatives from Sterling-Winthrop and a different professor of cardiology. They assured Wilmshurst he was mistaken about the drug. The cardiologist said that he was aware of findings by other investigators and that these entirely refuted Wilmshurst’s data. He advised that Wilmshurst should not publish any more of his findings. He said that we would be found to be wrong and his reputation would be adversely affected.

The Netherlands Committee for the Evaluation of Medicines reviewed Wilmshurst’s paper on the side effects of amrinone (6). There were major discrepancies when compared with the clinical record cards submitted to the evaluation committee by Sterling-Winthrop compared to the findings published by Wilmshurst.  Wilmshurst showed that Sterling-Winthrop had sent the Netherlands Committee falsified clinical records on his patients with the information on adverse events deleted.

Because of these discrepancies, Wilmshurst contacted the UK Committee on Safety of Medicines (CSM) and discovered that Sterling-Winthrop had also failed to notify CSM of the side effects observed in his patients (4). Furthermore, Sterling-Winthrop had not obtained a Clinical Trials Certificate for oral amrinone, though they had for the amrinone injection (4). When Wilmshurst raised this with the Sterling-Winthrop, he was told that Sterling-Winthrop executives had told the UK Government that if the company was prosecuted it would close its large manufacturing plant in the UK. Wilmshurst also contacted the Association of the British Pharmaceutical Industry, the Faculty of Pharmaceutical Medicine of the Royal College of Physicians and the General Medical Council, none of whom were interested (4). Wilmshurst spoke to editors of medical journals, including BMJ, Lancet and Nature. Although none disputed the facts, all were afraid to take on a multinational pharmaceutical company with comparatively unlimited financial and legal resources.

While this was going on, Sterling-Winthrop told a hearing of the USA’s Food and Drugs Administration that there had been over 1400 serious adverse events in 1200 patients given amrinone in trials and they would cease trials and applications for product licenses worldwide. Yet Sterling-Winthrop continued to market the drug in several third world countries (4). It was at this time Wilmshurst contacted James Erlichman, a Guardian reporter. Erlichman’s paper covered the story on the front, back and the whole of an inside page of one issue and in follow-up stories in other issues (4). Sterling-Winthrop withdrew the oral version of the drug world wide in 1986 (4). This is exciting stuff and could have been the plot for a movie. For his efforts Wilmshurst was awarded the HealthWatch Award in 2003 (7).

MIST Trial

Wilmshurst’s experience may have served him well in knowing the lengths commercial companies will go to protect their patented products. In 2000 he published an interesting observation suggesting a relationship between the repair of patent foramen ovale (PFO) and the cure or reduction of migraines (8). PFO is a flap-like opening in the atrial septum of the heart, is the most common cause of a right to left shunt, and associated with an increased risk of migraine. As many as one person in four has a PFO (9). The research interested NMT Medical, a small, start-up medical device company based in Boston which manufactured a percutaneously inserted PFO closure device called STARFlex. NMT was planning a trial to see if their device would relief migraine in those with a PFO. The trial, eventually named the Migraine Intervention with STARFlex Technology (MIST) and Wilmshurst seemed the perfect partner for NMT. He had published in the area and was known as an ethical physician who had won the HealthWatch award (10). NMT estimated that a target population of 3.8 million migraine sufferers and the financial opportunity to be in excess of $15 billion (11). NMT was riding high with a stock price approaching $25/share. We are talking big bucks here and this must have been exciting stuff to NMT executives.

The trial ran from during 2005. However, who should conduct the final, post-procedure transthoracic echocardiograms, the implanting cardiologists or echocardiography specialists, was unclear. The echocardiograms would ensure that the STARFlex device had closed the shunts. Wilmshurst, who was not one of the trial’s implanting cardiologists, says he had argued from the outset for a central echocardiography core laboratory, however, NMT proceeded with having the implanting cardiologists read the echocardiograms. A compromise was reached. Wilmshurst would review the final echocardiograms. In contrast to the implanting cardiologists who interpreted the echos to indicate that only four of 65 patients had moderate or large residual shunts, Wilmshurst reported that more than a third had a significant residual shunt.

Wilmshurst’s results were potentially devastating to NMT with the efficacy of their device being called into question. NMT organized a second review which also identified over a third of the patients with residual shunt although most were classified as pulmonary rather than atrial shunts (10). When the paper was published in 2008, an accompanying editorial in Circulation stated “The lack of an established independent core laboratory for echocardiographic data analysis must haunt the trial investigators.” (13).

The results of the MIST trial were announced at the American College of Cardiology meeting in March, 2006. Although the study found “an approximate 37% reduction in migraine burden in those patients who received a STARFlex implant and a 17% reduction in those who received the sham procedure,” it had failed to reach a significant difference in its primary end point, eliminating migraines (12). Based on previous observational studies, including Wilmshurst’s, researchers had expected migraine to have stopped in 40% of the treatment group at six months compared with 15% in the control group (13).

Publication Dispute

Matters came to a head when Wilmshurst attended the Transcatheter Cardiovascular Therapeutics Conference in Washington, October 25-27, 2007. According to Wilmshurst, it had been agreed that he would make presentations about the trial at cardiac meetings and Andrew Dowson, the other PI on the MIST trial, would present the data at neurology meetings. However, Wilmshurst was surprised when he discovered Dowson was scheduled to present the MIST trial data at the cardiology meeting. In the course of giving a separate talk on patent foramen ovale and migraine at the same meeting, Wilmshurst mentioned the MIST trial. At the session was Shelley Wood, a writer for TheHeart.org, who realized there was disagreement about the rate of residual shunts and interviewed Wilmshurst. Her article published October 26 during the meeting quotes Wilmshurst as alleging that NMT lied about whether echocardiograms from the MIST patients have been independently reviewed, and massaged the data to portray its STARFlex device in the best possible light (15). The article also quotes an NMT spokesperson, who says Wilmshurst was "on a warpath" and was never really the co-principal investigator for MIST. Furthermore, the NMT spokesman claimed Wilmshurst had been dropped from the trial for committing protocol violations. Wilmshurst claims he committed no protocol violations. This must have been exciting stuff to those who relish a controversy in medicine.

 Libel Suit

Less than two weeks after returning from Washington, Wilmshurst received a letter from UK solicitors acting for NMT, accusing him of having made “seriously defamatory allegations” in the interview he had given to TheHeart.org (10). According to the solicitors, NMT “has a reputation in this jurisdiction which it cannot permit to be tarnished by [Wilmhurst’s] serious and unjustified libels upon it.” NMT sued Dr. Wilmshurst for libel in the UK during December 2007. Subsequently, three more suits were filed over the next few years.

NMT did not sue TheHeart.org or Shelley Wood who reported Wilmhurst’s comments. This may be because the suit would need to be filed in the US and American courts are highly protective of free speech rights under the US Constitution. However, the UK libel laws differ in several aspects from the US and have several provisions that favor the plaintiff (16):

1. The onus of proof is on the defendant.
2. Legal fees are usually considerably greater than the damages that might be awarded. In other words, even if the defendant wins he may have a considerable financial loss. 
3. Lawyers fees are often not contingent on winning in the UK. 
4. Trials are long often placing considerable financial hardship on the defendant.
5.  There is no compensation for personal cost, such as time wasted and earnings lost by spending time dealing with the case.
6. “Libel tourism” is permitted, so that wealthy foreign individuals or corporations are allowed to sue in the UK but are themselves immune to actions brought against them in the UK.

Wilmshurst’s libel case created some attention in the UK. Wilmshurst was asked to appear on BBC 4’s morning radio program (for which he was sued again by NMT) and even called to the office of the UK Minister of Justice to discuss his case. Several medical journals picked up on the case, most notably the British Medical Journal which published a 4 page review in January, 2010 (10). The perception was that an American corporation was using the UK courts to suppress a UK physician from telling the truth resulted in a call for libel reform in the UK (17). This is exciting stuff.

Circulation Correction

Over a year after publication of the MIST trial in August, 2009 Circulation published a 700 word correction (18). The correction notes that Dr. Peter Wilmshurst did not sign the Copyright Transfer Agreement because of an internal disagreement about the conduct of study. According to Wilmshurst the correction contains information regarding device embolization which had not been disclosed in the original paper, but there is no mention of several of Wilmshurst’s other concerns, including the alleged conflicts of interest of some authors of the paper and the two echocardiogram reviews (16).

CLOSURE I Trial

In January 2008, NMT announced it was closing its follow-up MIST trial in the US. Although the company denied that failure of the first trial was the reason for cancellation, they did note that the trial had become “an expensive endeavor with little likelihood of being completed in a reasonable timeframe.” (10). Costs of the trial were estimated at $14 million and instead NMT decided to focus its resources on a trial designed to evaluate the effectiveness of PFO closure by STARFlex as a treatment for stroke compared with existing medical therapy, the CLOSURE I trial.  However, like the MIST trial the results of the CLOSURE trial were disappointing (19). The rates of stroke or TIA were no different between those who had the STARFlex device inserted and anticoagulant therapy.  

Financial Fallout

The results of the CLOSURE I were obviously distressing financial news for NMT. NMT’s stock which had been as high as $25/share had decreased to $0.25/share after announcement of the CLOSURE I trial.

Apparently legal trials move as slowly in the UK as in the US. In the three years that had elapsed since filing of the initial the suit and the announcement of the CLOSURE I results, no legal action was taken, although legal expenses continued to accumulate (16). Wilmshurst had accrued over $150,000 in out of pocket expenses and was in danger of losing his house. The anticipated trial costs were estimated at over $5 million for each side and would have required Wilmshurst to be in court for about 6 months. Obviously this would be both financially and professionally ruinous to Wilmshurst. Predictably, NMT filed for bankruptcy in April, 2011 but not before filing the fourth libel action against Wilmshurst in March. The bankruptcy filing ended the legal actions against Wilmshurst. 

Wilmshurst’s Account

After the bankruptcy filing, Wilmshurst published a summary of his experience in Radical Statistics (16). In this article Wilmshurst points out that while the data supporting the STARFlex device was unfavorable, NMT’s website and annual report did not reflect the data. On a rotating banner on the website and in the annual report were the names and photographs of the three patients who had a STARFlex implant and who were free of migraine. Wilmshurst points out that an important question is how NMT came to make contact with the three patients.

Wilmshurst said “My experience suggests that corporations can use the English defamation laws to misrepresent the results of clinical research. A corporation can propagate a misleading version and can use the defamation laws to bully those who object into remaining silent.” (16). He goes on to say “The law courts are not the best way to determine scientific truth. Few judges and even fewer juries have the training to weigh scientific evidence. An adversarial system is not the appropriate way, particularly when it pits an ordinary individual with limited financial resources against expensive barristers employed by corporations with more money. Truth should not be decided by those with greatest wealth using bullying and threats to make a scientist retract what he or she knows is true.”

We should remember Peter Wilmshurst for his courage in standing up for the truth, not once but twice. However, given our system and the comparatively large financial resources of corporations, physicians do so at their own professional and financial peril. Some such as the UK not for profit group, Libel Reform, seek to change the UK libel laws to prevent incidents such as Wilmshurst’s.  Many physicians both in the UK and US likely agree that the exciting stuff experienced by Wilmshurst do not need to happen when a physician stands up for the truth. However, this is doubtful in the absence of real legal reform. After all, we are talking about big bucks here.  

References

1. Benotti JR, Grossman W, Braunwald E, Davolos DD, Alousi AA. Hemodynamic assessment of amrinone. N Engl J Med 1978;299:1373-7.
2. Wilmshurst PT, Walker JM, Fry CH, et al. Inotropic and vasodilator effects of amrinone on isolated human tissue. Cardiovasc Res 1984,18:302-9.
3. Wilmshurst PT, Thompson DS, Juul SM, Dittrich HC, Dawson JR, Walker JM, Jenkins BS, Coltart DJ, Webb-Peploe MM. Effects of intracoronary and intravenous amrinone infusion in patients with cardiac failure and patients with near normal cardiac function. Br Heart J 1985;53:493-506.
4. Erlichman J. Drug firm "made threats". Company tested heart drug with DHSS clearance. The Guardian 3rd November 1986; 1 and 6.
5. B Massie, M Bourassa, R DiBianco, M Hess, M Konstam, M Likoff, M Packer. Long-term oral administration of amrinone for congestive heart failure: lack of efficacy in a multicenter controlled trial. Circulation 1985,71:963-971.
6. Wilmshurst PT, Webb-Peploe MM. Side-effects of amrinone therapy. Br Heart J 1983;49:447-51.
7. http://www.healthwatch-uk.org/awardwinners/peterwilmshurst.html
8. Wilmshurst P, Nightingale S, Walsh K, Morrison W. Effect on migraine of closure of cardiac right-to-left shunts to prevent recurrence of decompression illness or stroke or for haemodynamic reasons. Lancet 2000;356:1648-51.
9. Hagen PT, Scholz DG, Edwards WD. Incidence and size of patent foramen ovale during the first 10 decades of life: an autopsy study of 965 normal hearts. Mayo Clin Proc 1984;59:17-20.
10. Gornall J. A very public break-up. BMJ 2010;34:180-3.
11. PR Newswire. NMT Medical initiates patient enrollment in migraine headache study, expects earlier completion. Press release, January 7, 2005. http://www.advfn.com/news_NMT-Medical-Initiates-Patient-Enrollment-in-Migraine-Headache-Study-Expects-Ear_9896513.html
12. Dowson A, Mullen MJ, Peatfield R, Muir K, Khan AA, Wells C, et al. Migraine intervention with STARFlex Technology (MIST) trial. Circulation 2008;117:1397-404.
13. Carroll J. A controversial trial of migraine and patent foramen ovale closure. Circulation 2008;117:1358-60.
14. Nugent AW, Britt A, Gauvreau K, Piercey GE, Lock JE, Jenkins KJ. Device closure rates of simple atrial septal defects optimized by the STARFlex device. J Am Coll Cardiol 2006;48:538-44.
15. Wood S. Co-PI of MIST trial alleges data mismanagement, misinformation. TheHeart.org. October 26, 2007. http://www.theheart.org/article/821779.do
16. Wilmshurst P. The effects of the libel laws on science-a personal experience. Rad Stats 2011;104:1-10. 
17.  http://www.libelreform.org/
18. Correction for Dowson et al. Circulation 2009; DOI: DOI: 10.1161/CIRCULATIONAHA.109.192626. Available at: http://circ.ahajournals.org
19. Wood S. CLOSURE I: No overall benefit, no reduction in stroke or TIA with PFO closure. TheHeart.org. November 15, 2010. Available at: http://www.theheart.org/article/1149945.do
20. Sample I. Setback for US company suing cardiologist Peter Wilmshurst for libel. The Guardian. December 1, 2010. Available at: http://www.guardian.co.uk/science/2010/dec/01/company-suing-peter-wilmshurst-libel
21. http://www.libelreform.org/news/492-a-british-cardiologist-sued-by-an-american-medical-company-for-a-canadian-article

Acknowledgements

The author is indebted to Michael Garrett MD who suggested Dr. Wilmshurst as a subject for Profiles in Medical Courage and Peter Wilmshurst who reviewed the manuscript.

Referece as: Robbins RA. Profiles in medical courage: Peter Wilmshurst, the physician fugitive. Southwest J Pulm Crit Care 2012;4:134-41. (Click here for a PDF version of the posting)

Correlation between Patient Outcomes and Clinical Costs in the VA Healthcare System

Richard A. Robbins, M.D.¹

Richard Gerkin, M.D.²

Clement U. Singarajah, M.D.¹

¹Phoenix Pulmonary and Critical Care Medicine Research and Education Foundation and ²Banner Good Samaritan Medical Center, Phoenix, AZ

Abstract

Introduction: Increased nursing staffing levels have previously been associated with improved patient outcomes.  However, the effects of physician staffing and other clinical care costs on clinical outcomes are unknown.

Methods: Databases from the Department of Veterans Affairs were searched for clinical outcome data including 30-day standardized mortality rate (SMR), observed minus expected length of stay (OMELOS) and readmission rate. These were correlated with costs including total, drug, lab, radiology, physician (MD), and registered nurse (RN), other clinical personnel costs and non-direct care costs.

Results: Relevant data were obtained from 105 medical centers. Higher total costs correlated with lower intensive care unit (ICU) SMR (r=-0.2779, p<0.05) but not acute care (hospital) SMR. Higher costs for lab, radiology, MD and other direct care staff costs and total direct care costs correlated with lower ICU and acute care SMR (p<0.05, all comparisons). Higher RN costs correlated only with ICU SMR. None of the clinical care costs correlated with ICU or acute care OMELOS with the exception of higher MD costs correlating with longer OMELOS. Higher clinical costs correlated with higher readmission rates (p<0.05, all comparisons). Nonclinical care costs (total costs minus direct clinical care costs) did not correlate with any outcome.

Conclusions: Monies spent on clinical care generally improve SMR. Monies spent on nonclinical care generally do not correlate with outcomes.

Introduction

Previous studies have demonstrated that decreased nurse staffing adversely affects patient outcomes including mortality in some studies (1-5). However, these studies have been criticized because studies are typically cross-sectional in design and do not account for differences in patients’ requirements for nursing care. Other observers have asked whether differences in mortality are linked not to nursing but to unmeasured variables correlated with nurse staffing (6-9). In this context, we correlate mortality with costs associated with other clinical expenditures including drug, lab, radiology, physician (MD), and other clinical personnel costs.

The observed minus the expected length of stay (OMELOS) and readmission rates are two outcome measures that are thought to measure quality of care. It is often assumed that increased OMELOS or readmission rates are associated with increased expenditures (10,11). However, data demonstrating this association are scant. Therefore, we also examined clinical care costs with OMELOS and readmission rates.

Methods

The study was approved by the Western IRB.  

Hospital level of care. For descriptive purposes, hospitals were grouped into levels of care. These are classified into 4 levels: highly complex (level 1); complex (level 2); moderate (level 3), and basic (level 4). In general, level 1 facilities and some level 2 facilities represent large urban, academic teaching medical centers.

Clinical outcomes. SMR and OMELOS were obtained from the Inpatient Evaluation Center (IPEC) for fiscal year 2009 (12). Because this is a restricted website, the data for publication were obtained by a Freedom of Information Act (FOIA) request. SMR was calculated as the observed number of patients admitted to an acute care ward or ICU who died within 30 days divided by the number of predicted deaths for the acute care ward or ICU. Admissions to a VA nursing home, rehabilitation or psychiatry ward were excluded. Observed minus expected length of stay (OMELOS) was determined by subtracting the observed length of stay minus the predicted length of stay for the acute care ward or ICU from the risk adjusted length of stay model (12). Readmission rate was expressed as a percentage of patients readmitted within 30 days.

Financial data. Financial data were obtained from the VSSC menu formerly known as the klf menu.  Because this is also a restricted website, the data for publication were also obtained by a Freedom of Information Act (FOIA) request. In each case, data were expressed as costs per unique in order to compare expenditures between groups. MD and RN costs reported on the VSSC menu were not expressed per unique but only per full time equivalent employee (FTE). To convert to MD or RN cost per unique, the costs per FTE were converted to MD or RN cost per unique as below (MD illustrated):

Similarly, all other direct care personnel costs/unique was calculated as below:

Direct care costs were calculated as the sum of drug, lab, x-ray, MD, RN, and other direct care personnel costs. Non-direct care costs were calculated as total costs minus direct care costs.

Correlation of Outcomes with Costs. Pearson correlation coefficient was used to determine the relationship between outcomes and costs. Significance was defined as p<0.05.

Results

Costs: The average cost per unique was $6058. Direct care costs accounted for 53% of the costs while non-direct costs accounted for 47% of the costs (Table 1 and Appendix 1).

Table 1. Average and percent of total costs/unique.

Hospital level. Data were available from 105 VA medical centers with acute care wards and 98 with ICUs. Consistent with previous data showing improved outcomes with larger medical centers, hospitals with higher levels of care (i.e. hospitals with lower level numbers) had decreased ICU SMR (Table 2). Higher levels of care also correlated with decreased ICU OMELOS and readmission rates (Table 2). For full data and other correlations see Appendix 1.

Table 2. Hospital level of care compared to outcomes. Lower hospital level numbers represent hospitals with higher levels of care.

 

*p<0.05

SMR. Increased total costs correlated with decreased intensive care unit (ICU) SMR (Table 3, r=-0.2779, p<0.05) but not acute care (hospital) SMR. Increased costs for lab, radiology, MD and other direct care staff costs and total direct care costs also correlated with decreased SMR for both ICU and acute care SMR (p<0.05, all comparisons). However, drug costs did not correlate with either acute care or ICU SMR. Increased RN costs correlated with improved ICU SMR but not acute care SMR. For full data and other correlations see Appendix 1.

Table 3. Correlation of SMR and costs.

*p<0.05

OMELOS. There was no correlation between SMR and OMELOS for either acute care (r= -0.0670) or ICU (r= -0.1553). There was no correlation between acute care or ICU OMELOS and clinical expenditures other than higher MD costs positively correlated with increased OMELOS (Table 4, p<0.05, both comparisons).

Table 4. Correlation of OMELOS and costs

*p<0.05

Readmission rate. There was no correlation between readmission rates and acute care SMR (r= -0.0074) or ICU SMR (r= 0.0463).Total and all clinical care costs directly correlated with readmission rates while non-direct clinical care costs did not (Table 5).

Table 5.Correlation of readmission rates and costs.

*p<0.05

Discussion

The data in this manuscript demonstrate that most clinical costs are correlated with a decreased or improved SMR Only MD costs correlate with OMELOS but all clinical costs directly correlate with increased readmission rates. However, non-direct care costs do not correlate with any clinical outcome.

A number of studies have examined nurse staffing.  Increased nurse staffing levels are associated with improved outcomes, including mortality in some studies (1-5). The data in the present manuscript confirm those observations in the ICU but not for acute care (hospital). However, these data also demonstrate that higher lab, X-ray and MD costs also correlate with improved SMR. Interestingly, the strongest correlation with both acute care and ICU mortality was MD costs. We speculate that these observations are potentially explained that with rare exception, nearly all physicians see patients in the VA system. The same is not true for nurses. A number of nurses are employed in non-patient care roles such as administration, billing, quality assurance, etc. It is unclear to what extent nurses without patient care responsibilities were included in the RN costs.

These data support that readmission rates are associated with higher costs but do not support that increased OMELOS is associated with higher costs implying that efforts to decrease OMELOS may be largely wasted since they do not correlate with costs or mortality. It is unclear whether the increased costs with readmissions are because readmissions lead to higher costs or the higher clinical care costs cause the higher readmissions, although the former seem more likely.

These data are derived from the VA, the Nation’s largest healthcare system. The VA system has unique features and actual amounts spent on direct and non-direct clinical care may differ from other healthcare systems. There may be aspects of administrative costs that are unique to the VA system, although it is very likely there is applicability of these findings to other healthcare systems. 

A major weakness of these data is that it is self reported. Data reported to central reporting agencies may be confusing with overlapping cost centers. Furthermore, personnel or other costs might be assigned to inappropriate cost centers in order to meet certain administrative goals. For example, 5 nurses and 1 PhD scientist were assigned to the pulmonary clinic at the Phoenix VA Medical Center while none performed any services in that clinic (Robbins RA, unpublished observations). These types of errors could lead to inaccurate or inappropriate conclusions after data analysis.

A second weakness is that the observational data reported in this manuscript are analyzed by correlation.  Correlation of decreased clinical care spending with increased mortality does not necessarily imply causation (13). For example, clinical costs are increased with readmission rates. However, readmission rates may also be higher with sicker patients who require readmission more frequently. The increased costs could simply represent the higher costs of caring for sicker patients.

A third weakness is that non-direct care costs are poorly defined by these databases. These costs likely include such essential services as support service personnel, building maintenance, food preparation, utilities, etc. but also include administrative costs. Which of these services account for variation in non-direct clinical costs is unknown. However, administrative efficiency is known to be poor and declining in the US, with increasing numbers of administrators leading to increasing administrative costs (14).

A number of strategies to control medical expenditures have been initiated, although these have almost invariably been directed at clinical costs. Programs designed to limit clinical expenditures such as utilization reviews of lab or X-ray expenditures or decreasing clinical MD or RN personnel have become frequent.  Even if costs are reduced, the present data imply that these programs may adversely affect patient mortality, suggesting that caution in limiting clinical expenses are needed. In addition, programs have been initiated to reduce both OMELOS and readmission rates. Since neither costs nor mortality correlate with OMELOS, these data imply that programs focusing on reducing OMELOS are unlikely to be successful in improving mortality or in reducing costs.

Non-direct patient care costs accounted for nearly half of the total healthcare costs in this study. It is unknown which cost centers account for variability in non-clinical areas. Since non-direct care costs do not correlate with outcomes, focus on administrative efficiency could be a reasonable performance measure to reduce costs. Such a performance measure has been developed by the Inpatient and Evaluation Center at the VA (15). This or similar measures should be available to policymakers to provide better care at lower costs and to incentivize administrators to adopt practices that lead to increased efficiency.

References

1. Needleman J, Buerhaus P, Mattke S, Stewart M, Zelevinsky K. Nurse-staffing levels and the quality of care in hospitals. N Engl J Med 2002;346:1715-22.
2. Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA 2002;288:1987-93.
3. Aiken LH, Cimiotti JP, Sloane DM, Smith HL, Flynn L, Neff DF. Effects of nurse staffing and nurse education on patient deaths in hospitals with different nurse work environments. Med Care 2011;49:1047-53.
4. Diya L, Van den Heede K, Sermeus W, Lesaffre E. The relationship between in-hospital mortality, readmission into the intensive care nursing unit and/or operating theatre and nurse staffing levels. J Adv Nurs 2011 Aug 25. doi: 10.1111/j.1365-2648.2011.05812.x. [Epub ahead of print]
5. Cho SH, Hwang JH, Kim J. Nurse staffing and patient mortality in intensive care units. Nurs Res 2008;57:322-30.
6. Volpp KG, Rosen AK, Rosenbaum PR, Romano PS, Even-Shoshan O, Canamucio A, Bellini L, Behringer T, Silber JH. Mortality among patients in VA hospitals in the first 2 years following ACGME resident duty hour reform. JAMA 2007;298:984-92.
7. Lagu T, Rothberg MB, Nathanson BH, Pekow PS, Steingrub JS, Lindenauer PK. The relationship between hospital spending and mortality in patients with sepsis. Arch Intern Med 2011;171:292-9.
8. Cleverley WO, Cleverley JO. Is there a cost associated with higher quality? Healthc Financ Manage 2011;65:96-102.
9. Chen LM, Jha AK, Guterman S, Ridgway AB, Orav EJ, Epstein AM. Hospital cost of care, quality of care, and readmission rates: penny wise and pound foolish? Arch Intern Med 2010;170:340-6.
10. Render ML, Almenoff P. The veterans health affairs experience in measuring and reporting inpatient mortality. In Mortality Measurement. February 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/qual/mortality/VAMort.htm
11. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med;360:1418-28.
12. Render ML, Kim HM, Deddens J, Sivaganesin S, Welsh DE, Bickel K, Freyberg R, Timmons S, Johnston J, Connors AF Jr, Wagner D, Hofer TP. Variation in outcomes in Veterans Affairs intensive care units with a computerized severity measure. Crit Care Med 2005;33:930-9.
13. Aldrich J. Correlations genuine and spurious in Pearson and Yule. Statistical Science 1995;10:364-76.
14. Woolhandler S, Campbell T, Himmelstein DU. Health care administration in the United States and Canada: micromanagement, macro costs. Int J Health Serv. 2004;34:65-78.
15. Gao J, Moran E, Almenoff PL, Render ML, Campbell J, Jha AK. Variations in efficiency and the relationship to quality of care in the Veterans health system. Health Aff (Millwood) 2011;30:655-63.

Click here for Appendix 1.

Reference as: Robbins RA, Gerkin R, Singarajah CU. Correlation between patient outcomes and clinical costs in the va healthcare system. Southwest J Pulm Crit Care 2012;4:94-100. (Click here for a PDF version)

Profiles in Medical Courage: Of Mice, Maggots and Steve Klotz

“I never did give them hell. I just told the truth, and they thought it was hell.”-Harry S. Truman 

Mice and maggots bring to mind visions of filth and decay with an accompanying sense of sickening revulsion-hardly the impression you want associated with a hospital. However, an infestation of mice and maggots did occur in a hospital- not in medieval Europe as you might expect, but in 1998 at the Kansas City Veterans Administration (VA) Hospital. Although the mice and maggots are the attention grabbers, the story is worth repeating because it illustrates how dysfunctional modern hospitals can become and how Steve Klotz tried to affect change by speaking against the management that allowed the situation to occur.

To understand the story, we need to go back to 1995, ancient history to our fellows, residents and medical students but not so ancient to lots of us. Many Veterans Affairs (VA) hospitals were called Dean’s hospitals and had a special relationship with a local medical school (1). Each of these hospitals had a Dean’s committee, made up of officials from the VA and the local medical school. This committee approved physician hires and had a voice in most major decisions affecting the medical school faculty at the VA. The rationale for such an arrangement was the VA would not be able to hire high-quality faculty unless associated with a medical school where the faculty had an appointment. Overall this arrangement had served the VA well since shortly after World War II. The VA did get first rate faculty resulting in a level of care that could not be provided to Veterans by less qualified practioners.

However, not everyone was happy with the arrangement, particularly the hospital administrators. At that time, the administrators were in charge of the Medical Administration Service (MAS). This service supervised the business functions of the hospital (fiscal, human resources, purchasing, etc.) and several of the non-medical services (food preparation, janitorial services, security, etc.). The medical functions were headed by the chief of staff. The hospital director and the chief of staff had a shared and equal partnership between the hospital director and the chief of staff.

The administrators argued that the arrangement was disadvantageous to the VA in several ways. First, it gave the medical school, and therefore, the physicians too much voice in hospital operations. Second, physicians were often hired to fill medical school needs rather than VA needs. Third, the physician hires were often subspecialist and there was a move at the VA to emphasize primary care. Fourth, split responsibilities sometimes resulted in conflicts that were not easily resolved. Dr. Ken Kizer, then Under Secretary for Veterans Health Affairs in charge of all VA hospitals, was persuaded to dissolve the partnership and make the hospital director the ultimate authority at the hospitals in his Prescription for Change (2).

Against this background, Dr. Steve Klotz, an infectious disease specialist was consulted on two patients in the Kansas City VA ICU with nasal myasis (3). The first case occurred in July, 1998. The myasis was thought to be due to flies having direct access to the hospital through open windows during construction. However, after the second case in September, 1998, Klotz called his brother, John Klotz, an entomologist at the University of California, Riverside. He advised sending some of the flies and maggots to Nancy Hinkle, an entomologist with expertise on flies. She identified the flies and maggots as the green blowfly and explained to Klotz that these flies prefer to lay their eggs in mice carcasses. She suggested that the presence of green blowfly maggots suggested that the hospital had a mouse infestation.

In agreement with Dr. Hinkle’s speculation, the Kansas City VA was known to have a mouse problem preceding and coincident with the two cases of myasis (3). In response to this problem, warfarin-based mouse bait had been scattered throughout the hospital by a pest control contractor. However, this approach was largely unsuccessful. Numerous mice were observed during the daylight hours on all hospital floors. In some patient wards mice were being cared for as pets by the nursing personnel. Mice were so common in the building that they scampered over the feet of the associate hospital director during administrative morning report in the hospital director’s suite.

On learning of the egg-laying preferences of the blowfly, the warfarin baits and traps were replaced with live traps. The results of mouse captures showed the mice to be centered on the fourth floor of the hospital where the canteen was located (3). During an infection control inspection of the canteen and hospital canteen, inspectors discovered mouse carcasses in food storage rooms adjacent to the canteen on glue boards, mouse nests behind boxes on food shelves in the canteen, live mice trapped in a large wastebasket, and mouse droppings covering the floor of the canteen work room.

However, the above did not explain why there was a mouse problem.  All VA hospitals have canteens, many are in older buildings, and most do not have a mouse problem. It was apparent from the results of the live trappings and the canteen inspection that the mice seemed centered around the canteen (3). However, the real clue to the cause came when Klotz asked the janitors (S. Klotz, personal communication). They pointed out that a computer program had been purchased to indicate when rooms would be cleaned. The head of housekeeping was removed during downsizing along with the night time janitor who cleaned the canteen. However, the canteen and its storage rooms were not on the cleaning schedule. The janitors pointed out that these rooms had not been cleaned by housekeeping personnel for at least a year and every canteen employee was aware of the magnitude of the mouse problem (3).

Given that this was an interesting chain of epidemiological events, Klotz published the results of his investigations on March 25, 2002 (3). Action by VA Central Office was swift. Anthony Principi, Secretary of Veterans Affairs removed the regional network director, Patricia Crosetti, and ordered a full investigation. Principi would likely have removed the acting hospital director, Kent Hill, except that he was just hired. Hill had replaced the previous hospital director, Hugh Doran, who resigned after being filmed soliciting prostitution on “John TV”.  

Even prior to publication of the article, Klotz had phone calls from Hill and was told “not to talk to anyone” (4). The VISN headquarters in Kansas City closed a research lab with six employees that Klotz had formerly supervised. The employees were keyed out of the lab. Crosetti, the VISN director who had been removed, was heard to say ‘‘Klotz ain’t gonna work for the VA anymore” (4).

The publicity caused Congress to be involved and a field hearing was held at the Kansas City VA in June, 2002 (4). Klotz appeared as a witness and went first. Although he discussed the mice and maggot problem, he focused on five major root causes which he thought led to the incident:

1. “The addition of an entire cadre of middle managers who embrace a business model of management. These managers have fiscal oversight in the clinical side of the organization and are neither sufficiently knowledgeable nor trained in the areas they supervise.
2. The hospital director has more real power than the chief of staff. There is no equal partnership.
3. A sundering of any meaningful relationship with local medical schools.
4. Individuals in the organization with direct patient care, for example, physicians and nurses, have no meaningful influence in the organization of patient care.
5. Supervisory positions are all too frequently held until retirement.”

To support his claims he showed that the number of doctors and nurses caring for the patients decreased in the VA while the number of support personnel increased (Table 1).

 

Yet the number of patients and expenditures had increased (Table 2).

When all of this was occurring, it appeared as if the possession of real credentials for a job position was grounds for immediate disqualification at the Kansas City VA according to Klotz (4). For example, “an engineer was given authority over pharmacy and housekeeping, disciplines for which he was untrained and had only superficial knowledge. Internists were placed in direct charge of subspecialty surgeons whose specific requirements often went unmet. A nonphysician was placed in charge of pathology and radiology”. The chief of pulmonary was asked to set a broken arm. When he refused, he was asked “You’re a doctor, aren’t you?” The position of Chief of Staff was eliminated because it was “obsolete”.  

Testimony was given by a representative from the office of inspector general (IG). He stated that most of the environmental problems identified during the April, 2002 inspection ordered by Principi fell into one of several categories: 1. An overall lack of cleanliness; 2 Failure to maintain equipment, furniture, utilities, hospital services; and 3. Inadequate pest control (4). Not mentioned is that 10 months prior to this report the IG had visited the Kansas City VA on a routine visit (5). Although rodent problems were identified by the employees, the IG’s recommended action was to remove the rodent traps from patient areas and the canteen.

Officials from the VA management testified next. Although there were multiple administrators that testified, particularly revealing were the testimonies of Doran, the former director of the Kansas City VA, and Robert Roswell, then Under Secretary of Veterans Health Affairs.

Doran went first. He stated that, “The unfortunate incident involving the maggots was handled expeditiously and appropriately by our staff.” This was the last time he mentioned any of his staff in a positive light. He went on to say that his first priority had been patient care and that he had initiated a number of construction projects towards this end. According to Doran, the problems arose from the Kansas City VA being an older building with an inadequate budget. Attacking Klotz he said, “There is absolutely no evidence to establish a relationship between the two nasal myasis cases and the alleged mouse problem. You have an obviously disgruntled former employee’s opinion who managed to get the article published.” Doran went on to tout his accomplishments at the Kansas City VA, particularly noting his Joint Commission on Healthcare Organization (JCAHO) scores. He noted that the JCAHO had recently inspected the hospital and found no problems. However, he failed to acknowledge the nurses, doctors and support personnel who were responsible for the success.

The ranking minority member, Dr. Bob Filner (D, CA) was unconvinced. By background, Dr. Filner is a former academic from the University of San Diego whose PhD is in the history of science. After some intense questioning, Filner chastised Doran saying, “The vocabulary used and the tone you use to defend yourself makes your testimony suspect in my eyes and it is contradictory to everything that we have heard over the years about problems here [Kansas City VA]. So I will tell you if you had to have me vote on who I was going to believe here, I would vote for the employees on the first line and I would have to say, you, sir, are the weakest link.”

Doran responded by attacking Dr. Filner. Saying that Filner’s personal attack was “unprofessional and totally uncalled for” and only done to embarrass him. He further accused Filner of “grandstanding for the cameras”.

Roswell, who had been confirmed as the Under Secretary for Veterans Healthcare Affairs only a few months earlier, went next. Like Doran, he also attacked Klotz noting that, “Despite the author’s assertions of a relationship between the rodents and the flies, there was (and is) no conclusive evidence that such a relationship existed”.  Again like Doran, Roswell went on to blame the age of the facility but did acknowledge the “lack of effective supervision and leadership in the housekeeping department…Due to the lack of knowledgeable leadership and supervision, the infrastructure within the housekeeping department eroded”.

Representative Dr. Filner was again skeptical. He asked Roswell, “What is it about a system that requires a publication of a significant problem to direct the resources where they need to go?” Roswell responded, “I think what we are dealing with is a situation where there were competing priorities, limited resources, ineffectual communication between various levels of management, and less than ideal monitoring.” Filner asked Roswell to assure him that the VA would not be retaliate against Klotz and was assured that the VA would not.

With that, the hearing and the controversy surrounding the cleanliness at the Kansas City VA ended. The Kansas City VA did receive a multi-million dollar facelift, but no changes occurred affecting the management problems that according to Klotz led to the incident.  Central office management became more concerned about employees publically speaking even through scientific publications.  A mandate was issued that all scientific manuscripts needed to be submitted to the local Research and Development Committee for review prior to publication (6).  

In the aftermath of the controversy Patricia Crosetti was proven right-Klotz does not work for the VA anymore. After receiving poor reviews on his Merit Review grant which he held for nearly 20 years, he left the VA to become a full time university professor. He is currently Chief of Infectious Disease at the University of Arizona. Ken Kizer left the VA when it became apparent his appointment would not be renewed by Congress. Roswell resigned from the VA a couple of years after these events in a controversy about a failed computer system. Patricia Crossetti, the VA regional director, was subsequently dismissed. Kent Hill became the permanent director of the Kansas City VA where he is today. Dr. Filner remains on the Veterans Affairs Committee and Hugh Doran remains retired.

Although Klotz’s 5 root causes of the mice and maggots incident have yet to result in substantial change, we should remember Klotz for his courage in speaking up and identifying the managerial problems that led to the infestation of mice and maggots.

Richard A. Robbins, M.D.*

References

1. http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=979 (accessed 3/18/2012).
2. www.va.gov/HEALTHPOLICYPLANNING/rxweb.pdf (accessed 3/18/2012).
3. Beckendorf R, Klotz SA, Hinkle N, Bartholomew W. Nasal myiasis in an intensive care unit linked to hospital-wide mouse infestation. Arch Intern Med 2002;162:638-40.
4. http://veterans.house.gov/107th-congress-hearing-archives (accessed 3/18/2012).
5. www.va.gov/oig/CAP/01-01515-40.pdf (accessed 3/18/2012).
6. http://www.research.va.gov/resources/policies/pub_notice.cfm (accessed 3/26/2012).

*Dr. Robbins is a former employee of the Department of Veterans Affairs and was the Associate Chief of Staff for Research at the Southern Arizona VA when these events occurred in 2002.

Reference as: Robbins RA. Profiles in medical courage: of mice, maggots and Steve Klotz. Southwest J Pulm Crit Care 2012;4:71-7. (Click here for a PDF version of the manuscript)

Profiles in Medical Courage: Michael Wilkins and the Willowbrook School

“Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has. "- Margaret Mead

With this article we begin an intermittent series on physicians who displayed courage in trying to help their patients. Although there are many examples, hopefully what will be illustrated are examples of the lesser known doctors who identified problems and stood up to address them. Few remember the controversy surrounding the now closed Willowbrook School and Dr. Michael Wilkins’ involvement. However, Wilkins’ courage in advocating for change not only resulted in substantial improvement in conditions at the school but also led to the Civil Rights of Institutionalized Persons Act (CRIPA) of 1980.

Wilkins was originally from Kansas City and graduated from the University of Missouri School of Medicine in 1967 (1). He left Missouri to do his pediatric internship and complete his military obligation in the United States Public Health Service on Staten Island. There he became familiar with the Willowbrook State School, which at the time was the largest institution for the mentally retarded in the world. After completing his time in the Public Health Service, Wilkins was persuaded by his friend, Dr. Bill Bronston, to join him at Willowbrook as a full time physician.

The Willowbrook School already had a bad reputation when Wilkins arrived (2). Built in the late 1930’s, the campus was large with 38 buildings on 375 acres in the Willowbrook section of Staten Island. Designed to hold 4000 patients, it held 6000 when Wilkins arrived. As a result of the overcrowding and unsanitary conditions, virtually all children developed hepatitis, primarily hepatitis A. This led to a highly controversial medical study carried out from the mid-1950s through the 1970s by researchers Saul Krugman and Robert W. McCollum. Healthy children were intentionally inoculated, orally and by injection, with hepatitis virus, then monitored to gauge the effects of gamma globulin in combating the infection (2,3). Senator Robert Kennedy of New York, the younger brother of the slain President John Kennedy, had toured the institution in 1965 and proclaimed that individuals in the overcrowded facility were "living in filth and dirt, their clothing in rags, in rooms less comfortable and cheerful than the cages in which we put animals in a zoo" and offered a series of recommendations for improving conditions (4). However, the result was a public relations effort with the creation of a few “model” buildings (5). Visitors were escorted through these “model” buildings and the controversy subsided.

Wilkins was not assigned to one of the model buildings but to building 6. There he cared for about 70 severely mentally retarded clients along with 2 or 3 attendants. In a 2008 interview Wilkins said, “The first thing that assaults you when you walk in the building is the smell and that sets the tone for the whole experience. The smell is the smell of decay and a mixture of sweat and feces and lack of being cleansed …it permeated the building” (1). The clients spent their days in the day room. Few went to school. For the incontinent the attendants would get 6-8 clients together in the shower room and hose them to keep them clean and clean up after them between showers. The severely retarded would be on the floor in straightjackets so as not to scratch themselves or assault other patients. Some would rock on the floor, while others sat motionless. Each building had a supervisor, sometimes with a nursing degree, but in Wilkins’ building the supervisor had no nursing background. He was the person that would answer to the administration and carry out their orders.

Wilkins and Bronston began advocating for change especially in the wake of Governor Nelson Rockefeller’s budget cuts which decreased the number of employees from 3000 to 2000. Parents and friends were not allowed in the buildings so they held Sunday weenie roasts for the clients and their parents. There they would advocate for improvement in the conditions. This eventually led to a conference for the parents. The keynote speaker, an expert on mental retardation, described conditions at Willowbrook as “primitive” and “outdated” (1). After trying to organize the parents to advocate change, Wilkins was fired by the School’s administrator, Dr. Jack Hammond.

Now unemployed, and not having completed his residency, Wilkins fought back. He contacted his friend, a local WABC-TV New York newsman, Geraldo Rivera. Fortunately, when Wilkins was fired, Willowbrook had not asked for his key and he used it to let Rivera come to Willowbrook and document the conditions. The State of New York attempted to prevent the release of the resultant film citing patients’ privacy, but Rivera, an attorney by education, persuaded his producer to make the film public. The exposé, entitled “Willowbrook: The Last Disgrace”, garnered national attention and won a Peabody Award for Rivera. Rivera and Wilkins later appeared on the nationally televised Dick Cavett Show with the film.

As a result of the conditions, a class-action lawsuit was filed against the State of New York and a settlement in the case was reached mandating reforms. The publicity generated by the case was a major contributing factor to the passage of the Federal Civil Rights of Institutionalized Persons Act of 1980. This law enabled the US Department of Justice to protect the rights of those individuals who were in the care of state institutions, including jails and prisons, juvenile correctional facilities, public nursing homes, mental health facilities and institutions for individuals with intellectual disabilities. The law allows for the US Attorney General to intervene on behalf of institutionalized people whose rights may have been oppressed and ensure the safety of those individuals who may feel uncomfortable reporting issues of abuse in these government run institutions.

After leaving Willowbrook, Wilkins returned to Kansas City and completed his residency. For many years he ran a clinic in the inner city serving Kansas City’s poor. We should remember Dr. Michael Wilkins and how his act of courage led to improvement at Willowbrook and a law protecting all institutionalized individuals.

Richard A. Robbins, M.D.

Editor, Southwest Journal of Pulmonary and Critical Care

References

1. library.albany.edu/speccoll/findaids/apap015/WILKINS.pdf CSEA interview with Dr. Michael Wilkins. Accessed February 21, 2012.
2. http://en.wikipedia.org/wiki/Willowbrook_State_School Accessed February 21, 2012.
3. Giles JP, McCollum RW, Berndtson LW Jr, Drugman S. Viral hepatitis — relation of Australia/sh antigen to the Willowbrook ms-2 strain. N Engl J Med 1969; 281:119-122.
4. "Excerpts From Statement by Kennedy", The New York Times, September 10, 1965. Accessed February 21, 2012.
5. library.albany.edu/speccoll/findaids/apap015/BRONSTON.pdf CSEA interview with Dr. William Bronston. Accessed February 21, 2012.

Reference as: Robbins RA. Profiles in medical courage: Michael Wilkins and the Willowbrook School. Southwest J Pulm Crit Care 2012;4:54-6. (Click here for a PDF version)

Relationship between the Veterans Healthcare Administration Hospital Performance Measures and Outcomes

Richard A. Robbins, M.D.¹

Richard Gerkin, M.D.²

Clement U. Singarajah, M.D.¹

¹Phoenix Pulmonary and Critical Care Medicine Research and Education Foundation and ²Banner Good Samaritan Medical Center, Phoenix, AZ

Abstract

Health care organizations have been using performance measures to compare hospitals. However, it is unclear if compliance with these performance measures results in better healthcare outcomes. We examined compliance with acute myocardial infarction, congestive heart failure, pneumonia and surgical process of care measures with traditional outcome measures including mortality rates, morbidity rates, length of stay and readmission rates using the Veterans Healthcare Administration Quality and Safety report. Disappointingly, increased compliance with the performance measures was not correlated with better outcomes with the single exception of improved mortality with higher rates of compliance with echocardiography. We also evaluated the hospital level of care and found that higher levels of complexity of care correlated with the acute myocardial infarction performance measure, but not with the congestive heart failure, pneumonia, or surgical process of care performance measures. However, level of complexity of care strongly correlated with all cause mortality (p<0.001), surgical mortality (p=0.037) and surgical morbidity (p=0.01). These data demonstrate that compliance with the performance measures are not correlated with improved healthcare outcomes, and suggest that if measures are used to compare hospitals, different measures need to be developed.

Introduction

The Joint Commission recently released “Improving America’s Hospitals: The Joint Commission’s Annual Report on Quality and Safety 2011 (1). In this report the results of hospital compliance with the Joint Commission’s performance measures are listed. The Joint Commission announced not only is compliance improving but identified 405 hospitals as their “Top Performers on Key Quality Measures Program”. In a letter at the beginning of the report Mark Chassin, President of the Joint Commission, said “This program is designed to be an incentive for better performance on accountability measures and to support organizations in their quest to do better”.

However, there have been several criticisms of the report. First, many hospitals which were recognized as top hospitals by US News & World Report, HealthGrades Top 50 Hospitals, or Thomson Reuters Top Cardiovascular Hospitals were not included (2). Small community hospitals were overrepresented and large academic medical centers were underrepresented in the report. Chassin commented that this should be "a wake-up call to larger hospitals to put more resources into these programs…”. This is surprising since teaching hospitals, which are usually large, urban hospitals, have previously been reported to have lower risk-adjusted mortality rates and lengths of stay (3). Second, it has been pointed out that many of the performance measures are not or only weakly associated with traditional outcomes such as mortality (4-7). Therefore, we compared the compliance with the Joint Commission performance measures compared to mortality rates, morbidity rates, length of stay and readmissions using the Nation’s largest healthcare system, the Department of Veterans Affairs. The results demonstrate that compliance with performance measures are not correlated with improved outcomes.

Methods

The study was approved by the Western IRB.

Process Performance Measures. We evaluated hospital performance based on publicly available data from the 2010 VHA Facility Quality and Safety Report (9). These measures evaluate quality of care for acute myocardial infarction, congestive heart failure, pneumonia and surgical care improvement program (SCIP) during fiscal year 2009. For each of the measures, a hospital’s performance is calculated as the proportion of patients who received the indicated care out of all the patients who were eligible for the indicated care. The quality indicators are based on, and in most cases identical to those used for the Joint Commission’s Hospital Compare (acute myocardial infarction-Appendix 1; congestive heart failure-Appendix 2; pneumonia-Appendix 3, surgical quality-Appendix 4). Data were also available for each component of the congestive heart failure quality measure (see Appendix 2) which was evaluated independently.

Disease specific mortality. Hospital-specific, risk-standardized rates of mortality within 30 days of discharge are reported for patients hospitalized with a principal diagnosis of heart attack, heart failure, and pneumonia. For each condition, the risk-standardized (also known as "adjusted" or "risk-adjusted") hospital mortality rate are calculated using mathematical models that use administrative data to adjust for differences in patient characteristics that affect expected mortality rates (10).

Surgical morbidity and mortality. VA’s Surgical Quality Improvement Program (VASQIP) monitors major surgical procedures performed at VHA facilities and tracks risk adjusted surgical complications (morbidity) and mortality rates. Patient data are collected at each facility by a specially trained nurse and entered into the VA’s electronic health record: detailed preoperative patient characteristics including chart-abstracted medical conditions, functional status, recent laboratory tests, information about the surgical procedure performed, and 30-day outcomes data.

The VASQIP program analyzes these patient data using mathematical models to predict an individual patient’s expected outcome based on the patient’s preoperative characteristics and the type and nature of the surgical procedure. Overall patient outcomes for major surgical procedures are expressed by comparing observed rates of mortality and morbidity to the expected rates for those patients undergoing the procedure as observed-to-expected (O/E) ratios. For example, if, based on patient characteristics, a facility expected 5 deaths following major surgery, but only 4 patients died, the O/E ratio would be reported as 0.8.

Medical Surgical Length of Stay (LOS). These data are the VA hospital average length of stay for patients who were discharged from acute medicine or surgery bed sections. It does not include patients discharged from observation beds or discharged from other areas of the hospital such as mental health.

Readmission rates. A readmission was defined as a patient who has had a recent hospital stay and needs to re-enter the hospital again within 30 days. These rates are not adjusted for patient characteristics that affected expected admission rates, so comparisons among hospitals should be interpreted with caution.

CHF readmissions were reported separately. CHF readmission is defined by patients who had an initial hospitalization for CHF and were readmitted at least once to acute care in the hospital within 30 days following discharge for CHF.

Hospital level of care. For descriptive purposes, hospitals were grouped into levels of care. These are classified into 4 levels: highly complex (level 1); complex (level 2); moderate (level 3), and basic (level 4). In general, level 1 facilities and some level 2 facilities represent large urban, academic teaching medical centers.

Correlation with Outcomes. Pearson’s correlation coefficient was used to assess the correlation of compliance with the performance measures and outcomes. Significance was defined as p<0.05. For comparisons among hospital levels, ANOVA or Kruskall-Wallis testing was done, as appropriate.

Results

Disease specific and all cause mortality rates compared to performance measures. Hospital-specific, risk-standardized rates of mortality within 30 days of discharge for patients hospitalized with a principal diagnosis of heart attack, heart failure, and pneumonia were compared to performance measure compliance. There was no correlation (Table 1, p>0.05 all conditions) but with an increased incidence of pneumonia actually weakly correlating with higher compliance with the pneumonia performance measures (Table 1, p=0.0411). Furthermore, there was no correlation between all cause mortality and the average of the three compliance measures (Table 1, p>0.05). Because each table is large, only the correlation coefficients are presented in the text. The table data on which the correlations are based are given at the end of the manuscript. (N=the number of hospitals. NA=not available).

Table 1. Disease Specific Mortality Correlated with Performance Measure Compliance

Correlation Coefficients	r value	N	p value
Acute Myocardial Infarction Mortality and AMI Performance Measure	0.0266	103	0.7897
Congestive Heart Failure Mortality and CHF Performance Measure	0.0992	123	0.2752
Pneumonia Mortality and Pneumonia Performance Measure	0.1844	123	0.0411
All Cause Mortality vs. Average of Performance Measures	0.1118	122	0.2202

Each component of the congestive heart failure performance measure was evaluated individually. Performance of echocardiography correlated with improved mortality (Table 2, p=0.0496) but there was no correlation with use of a angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at discharge, discharge instructions, nor smoking cessation advice (Table 2, p>0.05 all comparisons).

Table 2. Heart Failure Mortality Correlated with Compliance to Individual Heart Failure Performance Measures

Correlation Coefficients	r value	N	p
ACEI or ARB	-0.1007	112	0.2908
Smoking Cessation	0.0651	112	0.4953
Discharge Instructions	0.1411	111	0.1396
Echocardiography	-0.1860	112	0.0496

Surgical mortality and morbidity rates compared to surgical performance measures. There was no correlation between compliance with the surgical care improvement program (SCIP) and surgical mortality or morbidity (Table 3, p>0.05 both comparisons).

Table 3. Surgical Care Improvement Program (SCIP) Compliance Correlated with Observed/Expected (O/E) Morbidity/Mortality

Correlation Coefficients	r value	N	p value
O/E Mortality	0.0943	99	0.3530
O/E Morbidity	0.0031	99	0.9757

Length of Stay. None of the performance measures correlated with medical-surgical length of stay (Table 4, p>0.05 all comparisons).

Table 4. Length of Stay (LOS) Correlated with Performance Measure Compliance

Correlation Coefficients	r value	N	p value
LOS compared to AMI	0.1047	103	0.2926
LOS compared to CHF	-0.0178	123	0.8451
LOS compared to Pneumonia	-0.1679	123	0.0634
LOS compared to SCIP	-0.0404	106	0.6809
LOS compared to Average	0.0028	123	0.9755

Readmission rates. There was no correlation between all cause readmission rates and the acute myocardial infarction, congestive heart failure, pneumonia or surgical performance measures (Table 5, p>0.05 all comparisons). There was no correlation between heart failure readmission rate and the heart failure performance measure (data not shown, r=0.1525, p=0.0921).

Table 5. Readmission Rate Correlated with Performance Measure Compliance

Correlation Coefficients
	r value	N	p
AMI	0.1688	103	0.0883
CHF	0.1505	123	0.0966
Pneumonia	0.0581	123	0.5233
Average	0.1281	122	0.1597

Hospital level of care. Acute myocardial infarction performance measures inversely correlated with the hospital level of care, i.e., the higher the hospital complexity level, the better the compliance (Table 6, p=0.004). However, there was no correlation between congestive heart failure, pneumonia, surgical care improvement program or the average of the measures and the hospital level of care (Table 6).

Table 6. Hospital Level Correlated with Performance Measure Compliance

ANOVA	N	p
Acute Myocardial Infarction (AMI)	103	0.004
Congestive Heart Failure (CHF)	120	0.782
Community Acquired Pneumonia	120	0.296
Surgical Care Improvement Program (SCIP)	106	0.801
Average of Process of Care Measures	120	0.285

There was no correlation between the level of hospital care and the acute myocardial infarction, congestive heart failure, nor pneumonia mortality (Table 7, p>0.05 all comparisons). However, there was a strong correlation between all cause morality (p<0.001) and a correlation between surgical Observed/Expected mortality (Table 7, p=0.037) and surgical Observed/Expected morbidity (p=0.010).

Table 7. Hospital Level Correlated with Mortality and Surgical Morbidity

ANOVA	N	p
Acute Myocardial Infarction (AMI) Mortality	103	0.835
Congestive Heart Failure (CHF) Mortality	120	0.493
Pneumonia Mortality	120	0.547
All Cause Mortality	106	<0.001
Surgical O/E Mortality	99	0.037
Surgical O/E Morbidity	99	0.010

Discussion

These data from the Nation’s largest healthcare system demonstrate that increasing compliance of the performance measures prescribed by the Joint Commission does not affect disease specific mortality, all cause mortality, surgical mortality, surgical morbidity, length of stay or readmissions with the single exception of improved mortality correlating with increased compliance with performance of echocardiography. In contrast to the Joint Commission’s list of top hospitals which found smaller and rural hospitals to be overrepresented, we found that only the acute myocardial infarction performance measure correlated with a higher level of hospital care which represents mostly large, urban hospitals. We did find that all cause mortality and surgical morbidity highly correlated with the level of care. This would appear to differ from the Joint Commission’s list of top hospitals which tended to be small and rural, since VA hospitals with higher levels of care largely represent large urban, academic teaching medical centers.

There are multiple possible reasons for the lack of correlation between the performance measures and outcomes. Many of the outcomes are evidence based but several are not. For example, there are no randomized, multi-center studies evaluating the efficacy of discharge instructions, smoking cessation advice and pneumococcal vaccination. Studies with discharge instructions are retrospective, observational studies and have largely not shown improved outcomes (11,12). Several meta-analyses have failed to demonstrate the efficacy of pneumococcal vaccine in adults (13-15). Advice to quit smoking without follow up support or pharmacologic intervention has not been shown to lower smoking cessation rates (16). Mandating ineffective interventions such as these would not be expected to have a positive effect on outcomes. However, this is where most of the improvement in performance measure outcome has occurred (2).

Most of the interventions are grouped or bundled. Lack of compliance with any one of the bundle is taken as noncompliance with the whole. However, if the only difference between hospitals is noncompliance with an ineffective performance measure, there would not be any expected improvement in outcomes.

Many of the strongly evidence-based outcomes have very high compliance, usually exceeding 95% (9). It is possible that small improvements of 1 or 2% in effective performance measures might have too small an impact on outcomes to be detected even in large databases such as the Veterans Administration which examined 485,774 acute medical/surgical discharges in 2009.

The performance measures appear to avoid highly technical or costly interventions and often avoid interventions which have been shown positively affect outcomes. For example, beta blockers and spironolactone have been shown to be effective in heart failure but are not included in the congestive heart failure performance measures (17,18). Furthermore, carvedilol has been shown to be superior to metoprolol in improving survival (19). Why the performance measures include use of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker but not carvedilol and spironolactone is unclear.

Some of the performance measures may have caused inadvertent harm. For example, administration of antibiotics within 4 hours to patients with pneumonia was a previous performance measure. However, studies showed that this performance measurement led to administration of antibiotics in many patients who proved not to have pneumonia or another infectious disease, and a systematic review concluded that “evidence from observational studies fails to confirm decreased mortality with early administration of antibiotics in stable patients with [community acquired pneumonia]” (20-22). The time has since been changed to 6 hours, but it is unclear if that it is any better than the initial 4 hour timing used (7).

We did not confirm the Joint Commission’s findings that the top hospitals are overrepresented by small, rural hospitals. We found no correlation between hospital level of complexity of care and performance measure compliance with the exception of acute myocardial infarction which was higher in hospitals with higher complexities of care. Although we found no correlation of the performance measures with any outcome measures, we did find a strong correlation between the hospital level of complexity of care and overall survival and surgical morbidity with the hospitals having the higher level of complexity having improved survival and decreased surgical morbidity. This would seem consistent with concept that volume of care correlates with outcomes.

It seems surprising that initiation of performance measures seem to go through such little scrutiny. In a 2005 editorial Angus and Abraham (23) addressed the issue of when there is sufficient evidence for a concept to be widely applied as a guideline or performance measure. Comparing guidelines to evaluation of novel pharmacologic therapies, they point out that promising phase II studies are insufficient for regulatory approval. Instead, one, and usually two, large multicenter phase III trials are necessary to confirm reliability. The same principle is echoed in evidence-based medicine, where grade A recommendations are based on two or more large, positive, randomized, and multicenter trials. This seems a reasonable suggestion. Perhaps what is needed is an independent Federal or private agency to review and approve performance measures, and as Angus and Abraham suggest, require at least two randomized, multicenter trials before implementation

The data presented in this manuscript do not support the usefulness of increasing compliance with the Veterans Administration’s (or the Joint Commission’s) performance measures in improving outcomes such as mortality, morbidity, length of stay or readmission rates. Until compliance with the performance measures results in improved outcomes, investment to improve these performance measures seems to be a poor utilization of resources. It suggests that oversight of regulatory agencies is needed in developing and implementing performance measures. If performance measures are to be used, new, clinically meaningful measures that correlate with outcomes need to be developed.

References

1. Available at: http://www.jointcommission.org/accreditation/hospitals.aspx (accessed 9-25-11).
2. Available at: http://www.forbes.com/sites/davidwhelan/2011/09/20/is-the-joint-commission-list-of-top-hospitals-worth-heeding/ (accessed 9-25-11).
3. Rosenthal GE, Harper DL, Quinn LM. Severity-adjusted mortality and length of stay in teaching and nonteaching hospitals. JAMA 1997;278:485-90.
4. Werner RM, Bradlow ET. Relationship between Medicare's hospital compare performance measures and mortality rates. JAMA 2006;296:2694-702.
5. Peterson ED, Roe MT, Mulgund J, DeLong ER, Lytle BL, Brindis RG, Smith SC Jr, Pollack CV Jr, Newby LK, Harrington RA, Gibler WB, Ohman EM. Association between hospital process performance and outcomes among patients with acute coronary syndromes. JAMA 2006;295:1912-20.
6. Fonarow GC, Yancy CW, Heywood JT; ADHERE Scientific Advisory Committee, Study Group, and Investigators. Adherence to heart failure quality-of-care indicators in US hosptials: analysis of the ADHERE Registry. Arch Int Med 2005;165: 1469-77.
7. Wachter RM, Flanders SA, Fee C, Pronovost PJ. Public reporting of antibiotic timing in patients with pneumonia: lessons from a flawed performance measure. Ann Intern Med 2008;149:29-32.
8. Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010;303:2479-85.
9. Available at: http://www.va.gov/health/docs/HospitalReportCard2010.pdf (accessed 9-28-11).
10. Ross JS, Maynard C, Krumholz HM, Sun H, Rumsfeld JS, Normand SL, Wang Y, Fihn SD. Use of administrative claims models to assess 30 day mortality among Veterans Health Administration hospitals. Medical Care 2010; 48: 652-658.
11. VanSuch M, Naessens JM, Stroebel RJ, Huddleston JM, Williams AR. Effect of discharge instructions on readmission of hospitalised patients with heart failure: do all of the Joint Commission on Accreditation of Healthcare Organizations heart failure core measures reflect better care? Qual Saf Health Care 2006;15:414-7.
12. Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Pieper K, Sun JL, Yancy C, Young JB; OPTIMIZE-HF Investigators and Hospitals. Association between performance measures and clinical outcomes for patients hospitalized with heart failure. JAMA 2007;297:61-70.
13. Fine MJ, Smith MA, Carson CA, Meffe F, Sankey SS, Weissfeld LA, Detsky AS, Kapoor WN. Efficacy of pneumococcal vaccination in adults. A meta-analysis of randomized controlled trials. Arch Int Med 1994;154:2666-77.
14. Dear K, Holden J, Andrews R, Tatham D. Vaccines for preventing pneumococcal infection in adults. Cochrane Database Sys Rev 2003:CD000422.
15. Huss A, Scott P, Stuck AE, Trotter C, Egger M. Efficacy of pneumococcal vaccination in adults: a meta-analysis. CMAJ 2009;180:48-58.
16. Rigotti NA, Munafo MR, Stead LF. Smoking cessation interventions for hospitalized smokers: A systematic review. Arch Intern Med 2008;168:1950-1960.
17. Gottlieb SS, McCarter RJ, Vogel RA. Effect of beta-blockade on mortality among high-risk and low-risk patients after myocardial infarction. N Engl J Med 1998;339:489-97.
18. Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J for the Randomized Aldactone Evaluation Study Investigators. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med 1999;341:709-17.
19. Poole-Wilson PA, Swedberg K, Cleland JG, Di Lenarda A, Hanrath P, Komajda M, Lubsen J, Lutiger B, Metra M, Remme WJ, Torp-Pedersen C, Scherhag A, Skene A. Carvedilol Or Metoprolol European Trial Investigators. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol or Metoprolol European Trial (COMET): randomised controlled trial. Lancet. 2003;362:7-13.
20. Kanwar M, Brar N, Khatib R, Fakih MG. Misdiagnosis of community acquired pneumonia and inappropriate utilization of antibiotics: side effects of the 4-h antibiotic administration rule. Chest 2007;131:1865-9.
21. Welker JA, Huston M, McCue JD. Antibiotic timing and errors in diagnosing pneumonia. Arch Intern Med 2008;168:351-6.
22. Yu KT, Wyer PC. Evidence-based emergency medicine/critically appraised topic. Evidence behind the 4-hour rule for initiation of antibiotic therapy in community-acquired pneumonia. Ann Emerg Med 2008;51:651-62.
23. Angus DC, Abraham E. Intensive insulin therapy in critical illness: when is the evidence enough? Am J Resp Crit Care 2005;172:1358-9

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Reference as: Robbins RA, Gerkin R, Singarajah CU. Relationship between the Veterans Healthcare Administration Hospital Performance Measures and Outcomes. Southwest J Pulm Crit Care 2011;3:92-133. (Click here for PDF version of manuscript)