Snowball in a Blizzard

by Steven Hatch

  Patients should also ask about the difference between relative and absolute risks and benefits. When possible, try to have your doctor put numbers to these ideas. How many people like me need to take this drug before one life is saved? is but one question that can be asked of a physician. At present, many physicians do not automatically incorporate relative versus absolute benefits into their medical decision making, so this process may take some time and so “the” conversation may require several discussions at more than one office visit. Furthermore, patients are better served in the conversation by knowing more about statistics and probability, so that if their doctors are able to rattle off data from the latest large, randomized trial, they will have a working idea about what’s impressive and what isn’t. Needless to say, familiarizing oneself with all of these concepts takes some time. The more you read about these matters, the more adept you will become at grasping what’s really at stake in a medical recommendation. In that way you will become a more equal partner with your physician, able to formulate a plan based on your goals, rather than follow a plan handed to you by fiat.

  Let’s look at two specific examples of how I think this type of conversation can play out. The first case is hypothetical, and I will talk about it from my perch as a doctor. The second case, however, really did happen, and it happened to me, but as someone on the receiving end of the medical system, as a family member of a patient.

  Earlier in the book I wrote about the complicated issue concerning blood pressure management in a select, but large, group of seniors: those age sixty to eighty with blood pressures above 140 but below 150 without diabetes or kidney disease. What would I do if I were evaluating a new patient who fit this demographic and presented a pressure of 146, which was then confirmed after repeated checks at several early visits? How would I go about discussing the controversy with such a patient?

  I am not a specialist in blood pressure management, and I have only a nodding familiarity with the studies that have formed the basis of the guidelines published by the JNC8 group and the dissenting minority. In this respect, I’m not much different from typical primary care physicians who must grapple with such matters for their patients, although as an infectious disease physician, I do much less blood pressure management than a primary care doctor. What this means is that I do not have a definitive, expert opinion about whether I should follow the older JNC7 guideline and recommend that the patient start treatment to take him below 140. That said, I think I could have a reasonable conversation with the patient about how uncertainty is crucial to understanding why there is disagreement, and in doing so help him make a fairly informed decision about his goals with respect to his blood pressure.

  The first point I would make in such a conversation is that, despite much heated rhetoric surrounding this process, there is actually a significant overlap between the JNC8 and minority groups about most blood pressure targets in most people. “Although there was almost unanimous agreement on nearly all recommendations, a minority of the panel disagreed with the recommendations to increase the target blood pressure . . . in persons 60 years or older without diabetes or chronic kidney disease,” stated the authors of the minority report (my emphasis). In other words, the current dispute about the applicability of JNC8 applies to just one type of patient. Granted, there are about 30 million of these patients, but anyone who has diabetes or chronic kidney disease, or is over the age of eighty, need not worry about ambiguous messages. For these patients, all of the experts weighed the evidence and arrived at precisely the same conclusions. This is important because it emphasizes to the patient that the experts are hardly in overall disarray, so one just shouldn’t throw up one’s hands and say “nobody knows anything,” and walk out of the office.

  If the patient in front of me was among those 30 million who might be affected by the new guidelines, our conversation would be aimed at exploring how uncertainty led to the dispute. I would explain that the difference of opinion boiled down not so much to a quarrel about the numbers, but the attitudes we have toward evidence and the goals of guidelines in the first place. For although it may be true that it is easy to memorize a target pressure of 140 or 150, nobody really believes that, all of a sudden, the totality of lifesaving benefits of blood pressure control kick in if someone drops from 141 to 139. Consequently, some of the disagreement can be explained by the intellectual and emotional response to data as much as the data itself.

  I would also explain what we observed in various instances in this book: that there are big benefits to treatment if your problem is severe, but as you approach “normal” the risk-to-benefit ratio changes, such that the risks become greater and the benefits correspondingly smaller. So if my patient was skittish about taking medications, as many patients are for perfectly justifiable reasons, I would explain that one option is to hold off. But I’d also emphasize that it’s critically important to continue to receive evaluation, because if that patient’s pressure gradually moves up to the 170s or 180s, those bigger benefits kick in, and my recommendation to start treatment would become much stronger. In other words, the severity of this patient’s hypertension influences where my advice to take medication can be found on the spectrum of certainty: the higher it is, the more leftward it moves.

  Some patients, however, can’t stand the idea that they are at risk for some complication of their disease, and will want to do everything they can to minimize those risks. For such patients I would explain the controversy in a slightly different way by emphasizing the potential downsides of treatment, and emphasizing what I noted in that chapter, that lowering one’s pressure too far can lead to its own set of problems. Still, if this were the kind of patient I was facing, I wouldn’t actively discourage him from trying to aim for a goal below 140, for the JNC8 guidelines merely noted that there wasn’t evidence to indicate that such a goal was unambiguously beneficial—but neither did they indicate that it put one in danger of complications.

  From my vantage as a physician, this conversation depends upon a patient’s aims, concerns, willingness to live with the risks of medications, and attitudes about the disease. The conversation also depends on an honest assessment of what constitutes a small amount of risk versus a big amount of risk. These form all the essential ingredients of the process we call informed consent.

  Now let me pivot to relate a different story where I was on the flip side of the equation.

  Several years ago a much-loved family member went out one winter’s day to collect the mail and collapsed. A neighbor happened to see him fall to the ground and called 911. If it had not been for that chance event, he would have died in all likelihood, but because of the call and the rapid response of the emergency medical technicians, who were on the scene in a matter of minutes, he was revived, intubated, and taken to the nearest hospital. The family was summoned from various corners of the country to support one another and review the doctors’ recommendations.

  One vital problem was that, unbeknownst to the EMTs, our relative had a “do not resuscitate” order in place. He was seventy-six and had various medical problems, including diabetes, heart disease, and high blood pressure. He directly expressed to his primary care doctor that he had no interest in lingering in a hospital bed for months on end if he should have some terrible medical calamity befall him. Once he was brought to the hospital, where this could be sorted out, it should have been a simple matter of “reversing” his status, taking him off the ventilator and letting him pass away (or live, if that should be the case). His primary care physician was well aware of his DNR status, and there is no ethical dilemma in extubating a patient who never wanted to be intubated in the first place. A few phone calls could have taken care of the issue, and although tragic, it would have been consistent with my relative’s clearly stated wishes.

  As I made my way across the country I thought it would end there, but the team of doctors, which included an intensive care physician, a neurologist, a cardiologist, and the primary care physician, never
even hinted they were considering withdrawing care. When we as a family pointed out the advanced directive, they responded that he was on a new treatment known as a “hypothermia protocol,” and that this required time to see how he would fare. The family turned to me, as the lone physician in the bunch, waiting for an explanation.

  Only I hadn’t heard of a hypothermia protocol. It had been more than five years since I had last worked in an intensive care unit, and I wasn’t familiar with this new practice, which had very rapidly been adopted by the neurology community. This meant that, although I had a more sophisticated grasp of the technical matters in play, I was not much different from any nonmedical family member speaking with the doctors about the plan. I learned that the hypothermia protocol was designed to preserve the brain function of patients who were “found down” and that it involved lowering the patient’s central body temperature from the high nineties to the low eighties Fahrenheit through the use of cooling blankets and other means. The protocol lasted for seventy-two hours. By the time I had arrived, the first twenty-four hours of the protocol had already passed, and before I could even formulate questions about the process, another twenty-four had flown by. We were given status updates, but never at any point was there a conversation about whether it made sense to take this course of action given our relative’s wishes.

  Eventually, I decided to call some of my own colleagues back in Massachusetts—first a few neurologists to learn more about prolonged hypothermia, and then a palliative care doctor familiar with the ethics of situations such as these. What I learned from the neurologists was a case study in uncertainty. For, far from bringing all or even most patients back to resuming anything close to their previous lives, patients who survived events like these through hypothermia protocols were assessed in terms of their ability, for example, to hold a toothbrush six months after the event. It sounded like this kind of life was exactly the fate our relative was trying to avoid. Moreover, while the trials performed on patients with these hypothermia protocols showed a reasonable relative benefit, the absolute benefit was (as we have seen many times in this book) much smaller.

  Not one physician with whom our family spoke during this time ever made this clear; all of them assumed that this was something that we should simply want by dint of the fact that, well, it just worked. There was no individual or collective recognition that “worked” was a term that might need some further explanation, and that, because our relative had made explicit that he didn’t want the kind of things done to him that currently were being done to him, there absolutely should have been someone making some attempt to do so. They were behaving as if this protocol belonged at the far left of the spectrum of certainty, so clearly beneficial it hardly merited a second thought. Once I got my head around the concept and took a cursory glance at the studies on this new technology, I thought it just a hair to the left of dead center. It’s entirely reasonable that some patients and families should want such treatment without question, but it also seemed clear to me that this isn’t what our relative would want.

  Eventually, after many long and painful family discussions, we became more assertive with the physicians about these matters, finally convincing them to extubate our relative, which they grudgingly did a few days after he completed the hypothermia protocol. He survived that event but passed away several days later, never having awakened after the initial event, his brain simply having taken too much of a hit during those minutes after he collapsed.

  That relative was my father.

  Looking back, what astonished me most about my own role in the saga of my father’s final days is how much I was intimidated by the process. After all, I know medicine; I know how to talk to doctors, I know how they think. I also knew without any doubt what my father wanted out of the medical system, and it was plain to see as I watched him lie in a bed with a tube stuck down his throat, with a machine doing his breathing for him, that this wasn’t what he wanted. But faced with a new set of variables (he had inadvertently been intubated by people who weren’t aware of his wishes, here’s this fancy new technology that we use leading to better outcomes) I hesitated. The consequences of that hesitation included a great deal of tension within our family about how to proceed. We were fortunate to resume, after a time, our loving and caring relationships with one another. Other families who find themselves in a similar bind may not be so lucky.

  You might conclude from all of this that I’ve just given you another example of doctors lacking in humility about the value of their medical plan—which it most certainly is—but I am providing this as an example about what can be done when speaking to doctors because eventually I did assert myself, and, along with my family, we did ask the right questions, explained our goals, and repeatedly drew their attention to what my father wanted. I wish that they had listened better and understood us sooner, or even had been proactive in seeking our thoughts once they realized that his advanced directive was in conflict with what was taking place in his care.* Yet, with polite but firm insistence, we got them to understand (if perhaps only dimly) that this was not about their plan but his. From a patient standpoint, that is the essential point to grasp when you begin a conversation with a doctor. Your medical plan is yours: you own it, and your doctor should be your guide, not your director.

  One doctor “got it” right from the start: the palliative care physician. For me in particular, he was critically important because early on I thought I was losing my mind for even bringing up the issue of whether he should be extubated, given the subtle but unpleasant response from the other physicians, as if I was a cruel and heartless son for wishing such a thing.

  The Spectrum of Certainty, Redux

  As we think about how to have a conversation with physicians and deal with uncertainty, it’s important to emphasize the altered perception of certainty among people both inside and outside medicine. I hope to have shown that our treatments and technologies are sometimes given far too much credit for their effectiveness once one carefully considers the data. This is one of the reasons why about-faces like that seen in the changing evidence on the benefits of hormone replacement therapy seem so embarrassing, and why physicians a century hence might view the rhetoric from today’s leading doctors as ridiculously and sometimes lethally smug, as we sometimes view what passed for common knowledge among physicians who came one hundred years before us.

  As I’ve tried to persuade you to see, the level of certainty in many of the topics I have covered in this book resemble those of the JNC8 guidelines mentioned above, falling somewhere toward the middle part of the spectrum. The evidence supporting the proposition that screening mammograms save lives in women over fifty is mixed, but on the whole many or perhaps even most experts still favor some form of screening—although as discussed previously, the popular perception about the scientific certainty of mammography’s benefits is profoundly different from this mild statement.

  In women younger than fifty, there is much, much less certainty. Does the evidence from scientific trials suggest that screening mammograms in women under fifty belong on the other side of the certainty spectrum, and move toward some level of evidence of harm? It’s hard to say at the moment, in part because it’s extremely difficult to quantify and measure harms of mammography in such a trial, and the expense in conducting such a trial is enormous at the very time when the US government (and a good many other governments) is cutting back on its support of scientific and medical research. After spending time doing the research to write this book, I now believe in general that screening mammograms for women under fifty does indeed provide net harms without a clear corresponding net benefit. It’s not far to the right, but I’m fairly confident that, barring some additional technology that will help separate false positives from true positives, it doesn’t belong to the left of the center on certainty’s spectrum.

  Of course, nothing magic occurs in the biology of a woman when she turns fifty, so the precise moment when the risks of the false-positive mammogram
are outweighed by the benefits of early detection may range from anywhere in the late forties to the early fifties (if they exist at all) and could be influenced by any number of factors that can really only be measured in theory. That is, one could, for instance, perform a screening mammogram trial on women aged forty-seven to fifty-three who are positive for the BRCA1 gene mutation, which predisposes women to a higher risk of breast cancer, but the logistical hurdles required to address such a narrow question make such a study impossible in reality.

  (As an aside, as this book is finishing its final revisions in mid-2015, the US Preventive Services Task Force is seeking public comment on a draft form of its newest iteration of screening mammography guidelines. It does not appear to be a dramatic departure from the 2009 document for the three major items. Screening for women under fifty has retained a C grade, while every-other-year mammograms for women fifty to seventy-four continues to be given a B grade, and mammograms for women seventy-five and over are still given an I grade.*

  I’ll explain the I grade a little later in the chapter.

  It is hard to predict what the reception will be like, but an early indicator might be found in a press release by the American College of Radiology. Recall that the ACR had taken the USPSTF to task in 2009, and that stance has not changed. “They ignored more modern studies that have shown much greater benefit,” said Dr. Barbara Monsees, the chair of the ACR Breast Imaging Commission. “These limitations result in the misrepresentation of the real trade-offs that women and health care providers need to know about in order to make good decisions about screening. They also ignored the demonstrated views of American women on screening. Unfortunately, these recommendations will only add to confusion that is placing women at risk,” she noted. Why the ACR’s opposition doesn’t also appear to add to the confusion is not made clear by Dr. Monsees. And again the USPSTF continues to be charged with having been tone deaf to the “views of American women,” as if somehow that were one unified, monolithic view, and as if the view should forever be fixed without ever reconsidering the strength of the data.