[ed note: Michael Jorrin is longtime medical writer who has been sharing his thoughts with our readers as “Doc Gumshoe” for several years (he’s not a doctor, I gave him the name). He generally covers medical and health news and sometimes health promotions and hype, but he rarely opines about investments or specific stocks. All of his past commentaries can be seen here]
To kick things off, here are four little case studies, or perhaps I should call them anecdotes.
Anecdote One: A few years ago, when I was finishing up the paperwork after my annual physical examination, I was astonished to find in my record that I was obese. I, obese? No way! I questioned the finding, and the nurse who had initially weighed and measured me told me that I was 5’ 11” inches in stature and weighed 216 pounds, which gave me a BMI of 30.1, just over the line into obese territory. But I was not to worry; I could easily shed those extra pounds.
With some heat I pointed out that my height measurement was plainly wrong. I am 6’ 2’’ tall, and that would give me a BMI right in the middle of the overweight category – overweight, perhaps, but certainly not obese! (And, incidentally, there are abundant data showing that persons with a BMI in that range have better overall survival rates than those in the “normal” BMI range.) I could easily see why the nurse had gotten my height measurement wrong – she was just too short to see over my head to the top of the measuring device. However, the front office was not eager to correct the record. It had already entered the sacred precincts of the office computer system.
I was not willing to put up with this feeble excuse and made a major fuss. The front office people looked as though they were ready to call the cops. Finally, a sensible woman took it upon herself to do whatever was necessary to remeasure me and correct the records. Was this a medical error, or did I over-react?
Anecdote Two: A woman we know went to her doctor with symptoms suggesting Lyme disease, which is common in our part of the country – fever, aches, bulls-eye rashes (erythema migrans). Blood tests confirmed Lyme, and she was treated with the usual 28 day course of doxycycline. But she got no better, despite having completed her doxy regimen. Instead, she got progressively worse. Her doctor ratcheted up her therapy to intravenous antibiotics, given in hospital. And she got worse and worse – weakness, loss of appetite – no sign that the treatment was doing any good at all.
Finally, a repeat blood test came back with a surprising result: her red blood count was exceedingly low. She had developed hemolytic anemia, which is not a normal Lyme disease symptom. But it is a symptom of babesiosis, another increasingly common tick-borne disease in these parts. She was treated for the babesiosis, and for the hemolytic anemia, and is now entirely recovered.
But the question remains, why was the babesiosis not diagnosed earlier? Was this a significant medical error? Perhaps so and perhaps not: the initial blood test, in which ELISA confirmed Lyme, was done before the babesiosis had progressed to the point of affecting her red blood count. And, having confirmed that she really did have Lyme, and that Lyme at that point appeared to account for her symptoms, there was no pressing reason to repeat the blood test, particularly since the Lyme antibodies would continue to be present in her blood for an extended period, so the blood test would yield no new information. Then, when she did not respond to the IV antibiotics, it finally occurred to somebody on the medical team that something else might be wrong, and the repeat blood test was performed, disclosing the tell-tale hemolytic anemia.
Anecdote Three: An eminent surgeon recounted that during his first year as a resident, he was carrying out an appendectomy under the supervision of the chief resident. The appendix had already been cut free, and he now had to remove it from the body cavity. But he lost his grip on the slimy object, and it disappeared from view! He had to open the incision to some degree so that he could perhaps see the missing appendix. He did some fishing around in the abdominal cavity of this patient, who was a boy of about ten. He was terrified that the contents of the appendix might have leaked out into the cavity, which might result in severe sepsis.
Needless to say, this young patient was given all possible treatment and attention to prevent the onset of this potentially fatal condition. The future eminent surgeon spent a good deal of time at the bedside of this patient and in conversation with the boy’s family members, who were never informed of the episode of the truant appendix. The boy, fortunately for all involved, did not develop sepsis, the resident went on to a distinguished career, and the boy’s family thought of his young resident as a supremely caring doctor.
Anecdote Four: This one concerns my mother. In her late 80s, she developed a persistent urinary tract infection (UTI). She went to her regular physician, a geriatrician who was himself approaching retirement and perhaps becoming a bit inattentive. This chap, who was entertaining dreams of retiring to a life of trout fishing on the Pecos River in New Mexico, prescribed Pyridium (phenazopyridine), which does nothing more than temporarily ease the UTI symptoms. At the same time, my mother complained of backache, for which he prescribed a tricyclic antidepressant, on the theory that in elderly folks, depression was often the root cause of otherwise unexplained aches and pains.
My mother, being a very well-brought-up lass, did not communicate this to me at the time, no doubt because it would be unseemly to discuss such an intimate matter with her son. But some months later, when the regimen had failed to bring about any improvement, she brought herself to tell me about her disorder. I was more than a bit shocked. The Pyridium regimen was meant to be used for just a few days purely for relief of the irritating symptoms of the UTI, not continued as chronic therapy. The particular antidepressant had, among its side effects, urinary incontinence. Not an advisable combo. I told her to stop both drugs at once and find another doctor.
Her new doctor confirmed my views and put her on an up-to-date antibiotic for her UTI, which by then had become chronic and perhaps more difficult to treat. But about six days after my mother started on the new drug, she developed a ferocious itch all over her body. When she telephoned me with this piece of news, I advised her to quit taking that other drug immediately. Her response, typical of a woman who had prided herself on toughness and frugality, was that it was a seven-day course, and she could just tough it out one more day.
But that same night, the itching became unbearable. She telephoned 911, and was taken to the hospital, where she was immediately given a drug to quell the itching, likely a steroid. Her new doctor was called, tut-tutted, and gave her a different antibiotic. After about a day in the hospital, she was released to a skilled nursing facility, where it was expected that she would be observed for a couple of days and then permitted to go home.
However, during her first night at the nursing facility, she felt the need to go to the toilet, slipped on the polished floor (not like her carpeted bedroom floor), fell, and broke her hip. The break did not require surgical treatment, but her movement was severely limited, and, of course, she could not go home.
She spent the last year and a half of her life in that nursing home, mostly in bed. She could take a few careful steps, but could only get to the communal spaces in a wheelchair. I visited her as often as I could; in one year I took six cross-country trips to see her. She was in tolerably good spirits, but she understood that her life was over. She died just shy of her 92nd birthday, glad to be shuffling off her mortal coil. The cause of death was heart failure.
What do those four anecdotes tell us?
Clearly, these were all medical errors of one or another type, and the range of possible medical errors is enormous. Here’s a simple attempt at grouping these errors:
One: errors in screening assessments, such as the error that led to the entry in my medical record that I was obese – in my case a trivial error, easily corrected. At worst, that error could have led to higher health or life insurance premiums. But all kinds of screening errors can, and obviously do take place. Blood samples sent to different labs can produce significantly different results. The automated monitors that are routinely used to measure heart rate, blood oxygen level, and blood pressure, may be inaccurate. A responsible physician would confirm these before taking action. But screening errors may well lead to missing medical conditions that need some kind of intervention.
Two: incorrect diagnoses and failures or delays in making a correct diagnosis. In the case of our friend whose babesiosis was not detected until it had progressed far enough to make her seriously ill, we could say at least that her physician was not on top of the case. Lyme disease almost always responds to treatment within a few weeks; if symptoms persist beyond a month, it would be reasonable to look for another cause. However, diagnosis is not an exact science; intuition guided by experience plays a major part in diagnosis, despite the immense numbers of tests that can now be performed. In this particular case, the treating physician was not familiar with babesiosis symptoms and didn’t have it on his radar screen.
An incorrect diagnosis can have worse consequences for a patient than a simple admission on the part of the health-care providers that the cause of the symptoms is as yet undetermined. In the latter case, the search for the correct diagnosis continues, but in the first case, the physician is content that the right answer has been determined, and further investigation ceases.
It has to be admitted that doctors are loath to send a patient away without some kind of diagnosis. For example, many patients with pain in their joints, but with none of the specific signs that point to either osteo- or rheumatoid arthritis, are diagnosed as having fibromyalgia, even though it is estimated that as many as three-quarters of patients diagnosed with fibromyalgia do not meet the guidelines for diagnosis with that condition. But the problem with pasting a diagnostic label on a patient is that it may tend to squelch any further investigation, with the potential of missing the real origin on the patient’s problems.
Three: errors during surgery. The appendix that went astray in the boy’s body cavity could certainly have led to his death. It’s difficult to point to any basic fault in the surgical procedure that leads to mishaps of this type. Surgery inevitably depends on a degree of manual dexterity on the part of the surgeon, whether in making the incisions necessary to carry out the procedure, or manipulating the parts of the anatomy in the surgical field, or suturing the several incisions. Even when sophisticated instruments are involved, and the surgery is quasi-robotic, the manual skill of the surgeon is an essential part of the procedure.
Another brief anecdote further illustrates this point, this time concerning my first cousin. He developed an acoustic neuroma in his early 40s. Acoustic neuromas are small usually non-malignant tumors that press on the acoustic nerve and affect the hearing. In some cases the symptoms don’t go much beyond irritating tinnitus, but in my cousin’s case, the effects on his hearing were beyond what he could tolerate. He agreed to a surgical procedure to remove the tumor. During the surgery, the surgeon’s scalpel nicked my cousin’s spinal cord, and he died on the operating table.
That surgeon had made a bad move. But this was not a fundamental flaw in the procedure; surgery to correct acoustic neuromas is performed frequently and almost always with complete success. However, as in most surgeries, the life of the patient is literally in the surgeon’s hands. A tiny wrong move can have enormous consequences.
In considering errors during surgery, it’s necessary to distinguish wrong moves from erroneous decisions. Wrong moves, we hope, can be minimized through the medical education process. The person with clumsy fingers might be an excellent diagnostician, but his hands should stay off the scalpel.
Erroneous decisions are entirely another matter. Surgery entails an enormous and sometimes bewildering number of decisions, by no means all of which are made by the surgeon. Any of those decisions can, if made erroneously, lead to dire outcomes. We’ll go into what can be done to minimize these a bit later.
Four: other treatment errors. My mother’s story illustrates a chain of errors. Her physician prescribed a totally ineffective drug for her UTI, and then cavalierly followed it up with the assumption that her backache was due to depression and not to some anatomical cause. (I should note here that antidepressants are often prescribed for fibromyalgia, which from my perspective is a failure to get to the bottom of this common set of symptoms.)
How egregious was this blunder? My mother and this doctor were on pretty good terms. They travelled in the same social circle, and, knowing my mother, she may well have understated her symptoms. And she would not have been prone to question her doctor’s judgment. Her physician likely thought her ailments were no big deal, reverted to the “tried and true” nostrums of yesteryear (even though Pyridium does nothing more than mask symptoms) and forgot about it.
The downstream consequences were not trivial. If my mother had initially been treated for her UTI with any of the common, effective, and benign agents that were then available, the episode would probably have resolved quickly. She would not have needed the agent that led to the allergic reaction; she would not have needed to go to the hospital on an emergency basis; she would not have been released to the nursing facility; she would probably not have fallen and broken her hip.
But did this chain of events lead to an untimely death? She was almost 92. She had been a smoker most of her life. She didn’t pay much attention to the edicts of “healthy living.” How much longer would she have lived? That’s impossible to say. What seems clear is that the casual treatment she initially received had a severe impact on her quality of life in her last couple of years on Planet Earth. And it’s entirely possible that if the initial treatment for her UTI had been correct, she might have had several more years of life.
Medical error as a cause of death
In the past few months, there has been a great deal of buzz in the media about this scary topic, which gets reduced to a simplistic reduction: “Doctors are Killing an Awful Lot of Patients.” This is based on a piece in the British Medical Journal by Martin A. Makary and Michael Daniel titled “Medical Error – the Third Leading Cause of Death in the U. S.” (BMJ. 2016;353:i2139). The BMJ article – not a study directly based on data, but an opinion piece referring to several previously published analyses – described some initiatives that might reduce preventable medical errors resulting or contributing to mortality. This was beyond doubt a worthy and commendable effort. The authors’ assertion that medical error is the third leading cause of death in the US, however, is based on aggregations of previous estimates, and is, in the opinion of several commentators, grossly overstated.
The Makary-Daniel piece in the BMJ estimated that the number of deaths in the US due to medical errors was 251,454 annually, ranking deaths with that cause as the third most common, behind cancer deaths at 585,000 and heart disease at 611,000 annually. They arrived at that figure based on a series of assumptions.
First, it is important to know that medical error is not listed as a cause of death on death certificates in the US. The cause of death must be an International Classification of Disease (ICD) code. Thus, even if the boy in my first example had perished of sepsis due to the lost appendix, the cause of death would have been sepsis, and not the surgeon’s mishap.
The assertion that medical error is the cause of 251,454 annual deaths would lead to some conclusions that are more than a bit unlikely. Of the total annual deaths in the US, approximately 2.6 million, about 715,000 take place in hospitals. If Makary’s estimate is correct, those 251,454 deaths due to medical error would account for fully 35% of all hospital deaths.
Makary et al arrived at his estimate partly based on a 1999 report by the Institute of Medicine (IOM) entitled “To Err Is Human.” This report estimated that between 44,000 and 98,000 deaths annually could be attributed to medical error. In turn, this report was based on two separate studies – actual studies, not recalculations of earlier reports. The studies the IOM based its report on were, one, in Colorado and Utah, and, two, in New York. The Colorado-Utah study concluded that adverse events occurred in 2.9% of hospitalizations, and 6.6% of those adverse events resulted in death. The New York study concluded that adverse events occurred in 3.6% of hospitalizations, and 13.6% of them resulted in death. That’s 6.6% of the 2.9%, and 13.6% of the 3.6%. They then applied those percentages to the total number of hospitalizations in the US – 33.6 million, and came up with the range of 44,000 to 98,000 deaths.
The IOM conclusion is quite a long way from the 251,454 number that Makary came up with. But the BMJ piece employed another estimate, this one by David Classen, working with a different measurement instrument, the Global Trigger Tool developed by the Institute for Healthcare Improvement in 2004. This methodology attempts to unearth medical errors by means of a rigorous examination of patient charts, discharge codes, physician progress notes, and any other record possibly pointing to error. The Institute for Health Improvement’s method arrived at an estimate that medical error occurred at something between four and ten times greater frequency than the conclusions of the IOM report. This could mean a range between about 160,000 and nearly one million deaths per year based on medical error.
Did I need to go through this to substantiate my belief that the Makary assertion about medical error is malarkey? Makary examined all the available estimates, which were themselves based on estimates, and then zeroed in on a specific number, which the media seized upon as a piece of hot news. The Makary assertion that medical error is the cause of 251,454 annual US deaths is an estimate based on estimates based on estimates. The margin of error is wider than the Pacific Ocean.
What determines whether an action or decision is a medical error?
The surgery that resulted in the death of my cousin could certainly be called a medical error. But is there any way that errors of that type could reliably be prevented? The tumor that caused my cousin’s acoustic neuroma was pressing on the bundle of nerves adjacent to his spinal cord. My cousin had reached the point where he felt he could not live with the disorder, and knowingly accepted the risk associated with the surgery. It is impossible to make sure that such surgery is risk free; the only certain way to prevent that particular medical error is simply to forgo surgery as a way of treating acoustic neuromas. Most of those surgeries are successful (even though in many or most cases, the patient loses the hearing in the affected ear), and to guarantee that there should be no fatalities would entail ruling out a treatment that has been successful in most cases.
A similar situation occurred with a good friend, the conductor of our chorus, who was diagnosed with advanced pancreatic cancer and told that his life expectancy was quite short. The only hope was an exceedingly complex and risky surgery called the Whipple procedure, or pancreaticoduodenectomy. The “full Whipple,” as it is known, entails removing not only the pancreas, but part of the stomach and the duodenum. It is a risky procedure, and the survival rate is not encouraging. At that point our friend was living in Houston, Texas, and one of the major teaching hospitals there refused to do the procedure on the ground that it was too dangerous, because it would involve incisions in the immediate proximity of the aorta.
He then went to M. D. Anderson, where a surgeon agreed to perform the surgery. On the night of the surgery, we and several other members of our chorus held a sort of informal vigil for this man and asked whatever powers there be to preserve him. The Whipple procedure was a success; our friend survived for 10 years in good health and died at the age of 70 of other causes.
It is certainly true that the surgery could have resulted in his death; instead it gave him about 10 more years of life, during which he attained high honors and continued to enjoy music, and to enjoy life in general. If, based on the uncertainty and risk of the outcome, Whipple procedures were simply ruled out, many patients like our friend would be deprived of a chance at more years of life.
What about the adventure of the stray appendix? It has been known for more than two centuries that appendectomies, carefully carried out, successfully prevented deadly peritonitis. The decision to perform surgery on that boy was almost certainly correct. When the surgeon lost his grip on the appendix, that was an unpredictable accident, and not the result of a medical error. If the toxic content of the resected appendix had leaked into the boy’s body cavity, and he had died, would that have been the result of medical error, or of a simple mishap?
The central question: can harm due to medical errors be prevented?
And, if so, exactly how? Shortly after the Institute of Medicine report was published, the Harvard School of Public Health conducted a large survey in 831 practicing physicians and 1207 members of the public to try to find out more about perceptions of medical error in these two populations, and to inquire about ideas about how to address the problem. In preliminary investigations, the researchers found that neither physicians nor the public were clear as to what constituted a medical error, so, for the purposes of the survey, they formulated this simple definition: “Sometimes when people are ill and receive medical care, mistakes are made that result in serious harm, such as death, disability, or additional or prolonged treatment. These are called medical errors. Some of these errors are preventable, whereas others may not be.”
The respondents, including both physicians and the general public, thought that the number of deaths resulting from medical errors was much, much lower than the Institute of Medicine’s estimate, which, as you remember, was from 44,000 to 98,000 deaths per year. The average number in the estimates of the survey responders was 5,000 deaths per year.
As might be expected, the views of the general public as to what might be effective in reducing the numbers of medical errors included several distinctly punitive measures, including loss of licensure for physicians found responsible for such errors, and much higher medical malpractice damages. Needless to say, the physician responders did not go along with this.
A clear majority of physicians, more than 70%, thought that medical errors related to a specific procedure were more likely to occur at hospitals that performed a low volume of that procedure. Physicians thought that the most important causes of medical error were the understaffing of nurses in hospitals, and overwork, illness, or fatigue on the part of health professionals.
According to the general public, the most important causes of medical error were physicians not having enough time with patients; overwork, stress, or fatigue on the part of physicians; failure of health professionals to work together or communicate as a team; and understaffing of nurses in hospitals.
When it comes down to the crucial matter of what can be done to prevent medical error, the responses followed directly from the perceptions of the respondents regarding causes: more staff support for the physicians and allowing physicians to spend more time with patients.
One proposed solution that was seen by both physicians and the general public as an effective means of reducing medical error was (and I quote) “requiring hospitals to develop systems for preventing medical errors.” That response, in my opinion, is a result of an inherent flaw in the survey itself: how could anyone simply reject “systems for preventing medical errors” as a way to reduce medical errors. Every respondent would answer “yes” when offered that choice as a proposed solution.
But what might such a system be? A New Yorker article back in 2007 had a pretty good idea. It was called “The Checklist,” by Atul Gawande. Here’s a quote:
“A decade ago, Israeli scientists published a study in which engineers observed patient care in I.C.U.s for twenty-four-hour stretches. They found that the average patient required a hundred and seventy-eight individual actions per day, ranging from administering a drug to suctioning the lungs, and every one of them posed risks. Remarkably, the nurses and doctors were observed to make an error in just one per cent of these actions—but that still amounted to an average of two errors a day with every patient. Intensive care succeeds only when we hold the odds of doing harm low enough for the odds of doing good to prevail. This is hard. There are dangers simply in lying unconscious in bed for a few days. Muscles atrophy. Bones lose mass. Pressure ulcers form. Veins begin to clot off. You have to stretch and exercise patients’ flaccid limbs daily to avoid contractures, give subcutaneous injections of blood thinners at least twice a day, turn patients in bed every few hours, bathe them and change their sheets without knocking out a tube or a line, brush their teeth twice a day to avoid pneumonia from bacterial buildup in their mouths. Add a ventilator, dialysis, and open wounds to care for, and the difficulties only accumulate.”
Gawande goes on to describe a really scary case, a patient who developed a line infection after a fairly routine surgery. A line infection is an infection transmitted to a patient by means of an intravenous line; this should certainly be a preventable medical error. The question addressed by Gawande is how to prevent this preventable error. He then relates an approach initiated by Peter Provonost at John’s Hopkins to address the issue of line infections. Provonost developed a very simple five-point checklist that should be followed every time an IV line is placed. The list itself is truly elementary. What is radical in Provonost’s approach is that the nurse monitors the checklist, and if the doctor skipped a step or did it incorrectly, the nurse would have the authority to intervene. Here’s Gawande’s description of the results:
“Pronovost and his colleagues monitored what happened for a year afterward. The results were so dramatic that they weren’t sure whether to believe them: the ten-day line-infection rate went from eleven per cent to zero. So they followed patients for fifteen more months. Only two line infections occurred during the entire period. They calculated that, in this one hospital, the checklist had prevented forty-three infections and eight deaths, and saved two million dollars in costs.”
The notion that checklists can reduce the rate of medical errors runs counter to the view that what really makes a difference in medical care is the genius of the individual physician. Good doctors are not comfortable with having their decisions questioned by staff members lower down on the totem pole. In a previous Doc Gumshoe piece, I cited counter-intuitive evidence that patients admitted to hospitals when the top doctors were away attending medical meetings actually had better outcomes, perhaps because the doctors and support staff were more closely hewing to established treatment guidelines. The checklist initiative isn’t meant to usurp the authority or the skill of the brilliant doctors, only to make sure that, in the grip of their genius and passion, they don’t overlook obvious steps or make dumb mistakes.
The checklist initiative has progressed slowly, partly because of resistance from above, but also because many hospitals are understaffed, and immediate attention to the patient takes precedence over checking boxes on some stupid form. But it has been adopted here and there, with remarkable results. In Michigan, Blue Cross – Blue Shield supports hospitals in what is known as the Keystone Initiative, deploying checklists to prevent hospital infections. One result of the Keystone Initiative is that the infection rate in Michigan ICUs dropped by 66%.
I doubt whether checklists would have prevented any of the medical errors that I described in this piece. I chose them to illustrate how difficult it would be to institute systems that would effectively eliminate or even just minimize medical errors. The dumb errors can perhaps be eliminated. For instance, one of the checklist steps on the list to prevent line infection is that surgeons are supposed to wash their hands with chlorhexidine soap. But when the Keystone Initiative was launched, it was learned that only about one third of Michigan hospitals had chlorhexidine soap. Getting chlorhexidine soap, and making sure hand-washing is done, is an easy fix, and, along with the other easy fixes, had a highly significant result. At the other end of the scale, how about a measure to prevent the surgeon’s hand from going a bit too far with the scalpel? Maybe a body of experts could come up with a checklist, but I have no idea what might be on it.
If I have any conclusions on this subject, they are modest. For a start, it seems pretty clear that the statement about medical errors being the third most common cause of death in the US is hugely overstated. All the same, even if Makary’s quarter of a million plus is incorrect, even one percent of that number – 2500 – is too many and whatever can be done to fix it should be done.
As to what might work, it seems to me that the helpful initiatives point to getting more eyes and minds focused on the job. The essential feature of Provonost’s line infection checklist plan that made it work was not the items on the checklist itself, but the fact that nurses and physician assistants were empowered to make sure that all members of the team went through those elementary but necessary steps to prevent those life-threatening events. By and large, the medical errors to target are the dumb mistakes – the ones everyone recognizes as being dumb. It’s hard to see what measures could be taken that would guarantee that the surgeon’s hand wouldn’t stray. But if the patient with Lyme disease is getting steadily worse after six weeks of treatment, it’s time to do another blood test. My mother’s doctor was flying solo when he prescribed Pyridium for her UTI. A second pair of eyes might have granted her a few more years of life.
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Many thanks for the numerous comments on the drugs vs. supplements piece. I answered some and will scan the thread again for more open questions. Best to all, Michael Jorrin (aka Doc Gumshoe)