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SURGICAL PERSPECTIVES

Should Zero Harm Be Our Goal?

Aloia, Thomas A. MD, FACS

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doi: 10.1097/SLA.0000000000003316
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ZERO HARM

How many of your hospitals have a program aiming at Zero? Zero Infections, Zero Never Events, Zero Harm?

These terms and initiatives are currently so ubiquitous that their impact on the vast majority of us is certain. Some of you may say, “Why is this even a question? Is it not obvious that we need to aim at Zero?”

Certainly, our patients believe that the answer to the question of our commitment to Zero harm as a goal should universally and emphatically be “Yes!”. But, what if aiming at Zero actually had a downside? And if so, how might we negotiate with our patients the concept that Zero may not be the optimal goal in surgery? The purpose of this Surgical Perspectives is to explore the conflicts associated with “Aiming at Zero,” and to propose an alternative paradigm.

To begin with, I reflect on a traveling fellowship that I was fortunate to be awarded in 2009. I chose to visit the Japanese Red Cross Hospital in Tokyo in order to meet Professor Masatoshi Makuuchi, one of the most famous liver surgeons in the world and a foundational leader in the field.

Immediately upon arriving at his hospital, I was brought to the operating theater. During the next 10 hours of a complex third-time reoperation for neuroendocrine liver metastases, I distinctly recall Professor Makuuchi pounding away at the poor quality of American surgery. Hour after hour after hour he kept saying, “the problem with American surgery is that you build operations for a hundred people, and we build operations for a thousand people.”

In the moment, the implications of this charge did not hit home. What I did not know at the time was that Japan has a national registry of liver surgery outcomes. Professor Makuuchi had the ability to review and regulate the liver surgeons in Japan. He knew exactly what each surgeon's outcomes were and if their mortality went above one percent, he had the ability to modify their practice. What he was contrasting was that our goal in the United States (or the West in general) is 1, 2, 3, or 4 events out of a hundred cases, compared to his country's national surgical goal of 1, 2, 3 (or at least less than 10) events out of a sample of 1000 patients. They were aiming at the equivalent of an order of magnitude lower tolerance for harm.

Shortly after I got back to the States, the impact of his words fully registered. When I went to my next surgical meeting, sure enough, surgeon after surgeon came to the podium proudly boasting of their 15% readmission rate, their 8% wound infection rate, and their 2% mortality rate. In Japan, and many other Eastern surgical units, they are aiming at an order of magnitude lower mortality than the rate that we would accept as standard, or even state of the art, at any Western surgical congress.

And so, this became the focus of my career for the next decade…to build a better operation.

BUILDING A BETTER OPERATION

To determine our starting point, we researched one of the earliest NSQIP participant use (puf) files, and the national outcomes data we found for hepatectomy were startling.1 Bile leak rate: 8%, DVT rate: 4%-twice that of colon surgery. One in 4 patients needing blood transfusion, 1 in 8 coming back to the hospital with a readmission and a national mortality rate for liver surgery of 2.5%. These data clearly showed that we had a lot of work to do.

We took 1 aspect at a time, starting with bile leak. For this we developed an air leak test that quickly and cheaply identified occult open bile ducts in the operating room.2 When we identified these potential leaks and addressed them intraoperatively, the postoperative bile leak rate dropped to 1%. This had multiple corollary benefits as we instantly and substantially reduced the number of patients who required abdominal drains. Likewise, we identified a direct (and likely causal) relationship between postoperative bile leak and VTE events, as we learned that patients with bile leak are 8 times more likely to suffer a VTE.3 By lowering bile leak rates and implementing preoperative and extended pharmacologic prophylaxis beyond discharge, we have nearly eliminated VTE from our practice.4,5

For blood product utilization, with our fellows, we refined our technique for liver transection,6 lowering the transfusion rate to 1.3%.7 Through subsequent implementations of a hepatobiliary fluid protocol,8 resuscitation guided by BNP measurement,8 algorithmic procedure selection,9 Enhanced Recovery in Liver Surgery (ERILS)10 and active discharge management,11 we have lowered our renal and cardiac complication rates, cut postoperative narcotic prescriptions by 70%,12 and our readmission rate has fallen from 14% to 4%. During 2015, in our highest risk patients, we avoided readmission completely.

Of course, all of these gains add up…less complications equate to lower perioperative mortality rates. In the last 2000 hepatectomies, only 3 patients have died within 90 days of surgery. The point of detailing this experience is not self-aggrandizement. The purpose is to ask a serious question. Is this success or is this failure? Most would side with the opinion that this work was successful. If nothing else, at a mortality rate of 0.016%, I could continue to practice liver surgery in Japan!

But if the metric of success is Zero, then this experience could objectively be viewed as a failure.

As well, what is most important about this experience is not the final destination, but what we learned along the way.

LESSONS LEARNED: QUALITY AND SAFETY

During this journey, the first concept we learned is that there is a very important difference between Quality and Safety. These 2 words are frequently thought to be synonyms, but there are important distinctions between them and the vocabulary does matter (Fig. 1).

FIGURE 1
FIGURE 1:
The relationship of safety and quality after a surgical intervention. By limiting exposure to harm, quality is experienced sooner and to a greater extent.

Quality is the achievement of a positive outcome. It is the reason we suggest that an operation may improve the patient's condition. For example, quality is removing a patient's tumor so completely that it does not come back. Further, it is the patient recovering from surgery so well that they rapidly return to home, family, work, life, and themselves.

In contrast, safety is the avoidance of a negative outcome. In fact, harm is the inverse of safety. Wound infection, DVT, and mortality are all harm events. Ninety-five percent of the objective metrics being used to judge physicians, and surgeons in particular, are harm metrics. But no surgeon takes a patient to the operating room for the primary purpose of not having them have a postoperative myocardial infarction. Safety is what we do as surgeons, but quality is why we became surgeons.13

The second concept we learned is that aiming at Zero has costs and that these costs can be substantial. The costs fall into 4 main areas. First, perfection limits patient access. There are countless macro examples of this that are well documented from cardiac surgery to transplantation to almost every field of surgery. More personally, in the micro, every surgeon knows that in recent years the prospect of reporting a complication (or being reported on) has made them at least think twice before offering a frail, highly comorbid, and/or elderly patient a potentially beneficial procedure. Stated more bluntly, despite massive improvements in perioperative care and surgical technique, less high-risk patients are being offered surgery. If you take the average 80-year-old woman with a liver tumor, most of us would pause with just that information. But statistically, as she has lived into her eighties, her expected lifespan is now 92; a full 12 more years! Why wouldn’t we leap to offer her a procedure that could double her 5-year survival? Let's say that procedure has a 5% mortality rate, this means that 95% of the time she will survive and benefit. Mathematically, every statistician would advise that we should perform the procedure, but the decision now depends not on the mathematical odds, but on the system's willingness to accept a 5% mortality rate on the books of that surgeon's practice; very far from 5 out of 1000, much less Zero.

The second cost of aiming at Zero is that perfection and radical innovation are not compatible. There are many operations performed around the world that we do not participate in the United States because they are deemed “too dangerous.” Within liver surgery, over the last 5 years, we have been immersed in a geopolitical battle over the innovative ALPPS operation, that was thrust into practice with a mortality rate of at least 12%.14,15 I would lose my medical license if I routinely performed an operation that 1 in 8 patients died from. But with experience and practice, the mortality rate will go down. The learning curve will bend. And like liver transplantation, that had to weather a moratorium before regaining traction to become a miraculously routine procedure today, the ALPPS operation will also become routine.16 But this will largely happen outside of the United States. Because we have lost the tolerance for risk, we will not gain the requisite experience to bend the learning curve, and the innovation will never become part of our practice-ultimately to the detriment of future patients.

Third, perfection and training are not compatible. If I, as a teacher, am being held to a crucible of Zero harm, how can I let the amateurs do the critical portions of the operation? It is abundantly clear that the current product that general surgical education is producing is not as experienced nor technically as sound as previous generations. Much of this decline in graduating trainee proficiency has been blamed on the 80-hour work week, but I would suggest that hyper-focus on harm has taken more repetitions away from trainees than the 80-hour work week. As evidence, few trainees are complaining about doing too few cases, but all are complaining about a loss of autonomy and a failure of teachers to progress them to independence during the cases they do participate in.

Lastly, the ultimate cost of aiming at Zero when Zero cannot be obtained is surgeon burnout. It can be argued that a primary cause of the current burnout epidemic in young surgeons is a disproportionate emphasis on surgical safety. The evidence for this is compelling. First, the temporal overlap between the imbalanced focus on safety and the burnout epidemic cannot be denied. Second, there is a generational difference in burnout causation. Senior surgeons, who have accrued protective equity and can more easily defend a mortality based on a long track record, routinely site the electronic health record as the primary source for their burnout. However, younger surgeons frequently dismiss the EHR as a contributor, instead citing terror and dread over reporting out a single explainable poor outcome in Morbidity and Mortality conference.

In the 10 years since Shanafelt et al17 published their landmark article on surgeon burnout in Annals of Surgery, we have learned a great deal about surgeon and healthcare provider resilience. The negative results of burnout are undeniable. Burnout adversely impacts relationships, and mires victims in addiction, disruptive behavior, and even worse. Currently, physician suicide annually takes the same number of lives as populate one medical school graduating class. And while I am not suggesting that the entire blame for 300 physician deaths per year rests solely on the surgical safety movement, we also cannot deny the impact of unrealistically aiming at Zero on the daily stresses faced by surgeons.

If I polled many groups of surgeons, I don’t think I could find one of them who would point to that moment that they decided to become a surgeon and say, “Yes, I distinctly recall that my motivation to go into surgery was because I wanted to do 100 consecutive operations without a wound infection.” The reason we went into surgery is to provide a positive outcome, and yet we are almost solely judged on metrics of harm.

One of the most common questions I’ve been asked in my time as a quality improvement specialist regards stalled surgical quality projects. The conversation typically proceeds as follows: “We have a problem with wound infections in our OR, but I can’t get my surgeons to engage. How do you get surgeons to engage? I mean I don’t understand it. We keep pounding them with the wound infection data but they just won’t participate. What do you think is going on?”

MORALE

What we have also learned is that if we keep monotonously beating the safety drum, the surgeons will continue to regress because a solitary focus on safety drains provider morale.

Encouragingly, a focus on Quality builds provider morale. The next time that you have an issue with surgeon buy-in and you have to communicate data I suggest trying this approach: It's called the SQC score (safety+quality+compassion). Instead of just focusing on the wound infection (a.k.a. harm) data, the SQC approach calls for feedback delivered on 3 domains: one-third safety, one-third quality, and one-third compassion. This is how it might look. Instead of “Doctor, your wound infection rates aren’t that great. Again, you are a high outlier, what's going on?” a better approach might look like “Doctor, your wound infection rates remain elevated and you are a high outlier, but we see that your patient satisfaction is good and we note that your survivals at five years for cancer surgery are excellent. We realize this is super hard. You’ve done something one way your entire career and now we’re asking you to change that.” Likewise, periodically swapping out a Morbidity and Mortality conference for a Saves and Salutes conference could be a powerful antidote to burnout.

The balance between safety and quality is one of the many reasons why Enhanced Recovery has been embraced by so many surgeons. The reduction in complications is a small part of the surgical enthusiasm for these programs. Far more of the positive energy comes from the frequent and visible quality outcomes that are associated with ERAS. The patients are not in pain, they are discharged and go back to work and/or adjuvant therapies quickly. And they are happier. ERAS is a model for value generation in medicine precisely because it recognizes and promotes quality as it simultaneously lowers harm.

If we understand that access, innovation, training, and provider experience are all dependent on rebalancing our emphasis to include equal parts safety and quality, how do we manage the zealots for Zero in each of our institutions? Regardless of compelling essays in prominent surgical journals, these advocates and their posters are not going away anytime soon.

In our unit, we struggled with this for a long time. The improvements that we’ve made in our program are pretty phenomenal and we are proud to have NSQIP, Vizient, USNWR and other ratings commend us, but none of our outcomes are Zero. And I am fairly convinced that it's impossible to get to Zero, particularly if we are going to continue to lead in innovation and education. So, if Zero is the goal, is our work, in fact, a failure? And if these outcomes represent failure, what motivation do we have to continue to improve?

CATCHING EXCELLENCE

At 1 point, I had given up on finding an answer to these questions, but then in an odd place (the Green Bay Packers locker room) I stumbled on what I think is the solution. When Vince Lombardi was named head coach of the Packers, he was actually not very well known. When he came to the first team meeting, with Bart Starr and many other great athletes in the locker room, he said two amazing things. The first statement he made was, “I want to thank you all for allowing me be your coach.” [As a side note, imagine the impact of walking into an operating room and thanking everybody on the team that day for allowing you to operate with them.] The second remarkable thing that he said was this: “We are going to chase perfection, and we will chase it relentlessly, knowing all the time that we can never attain it, because along the way we shall catch excellence.

By acknowledging that perfection was impossible, but committing to the goal of pursuit of perfection, excellence became attainable. Vision statements are meant to be aspirational, and may purposely be unattainable, but we know that successful goals need to be SMART (Specific, Measurable, ATTAINABLE, Relevant, and Time-bound). For the Packers, it worked out pretty well. Lombardi coached for 11 seasons. His record was 105–35–6, with a playoff record of 9–1 and his teams won 6 world championships.

Assimilating this, I urge all of the entities that are charged with setting our goals, including the regulatory bodies, the government, our societies, our colleagues, the public, the media, and the patients, to not demand perfection. Instead each of them does have the right to demand that we chase perfection, provided that all involved remember that the patient and the surgeon are equally human.

Further, if we conclude that surgery should focus on the pursuit of perfection, we should commit that it is a human pursuit of perfection. Here, again the subtle vocabulary may seem trivial but it is actually critical, because if we do not rapidly balance our safety and quality goals, we will burn through an entire generation of surgeons.

For a full-length recorded version of this piece please access the link: https://youtu.be/5ypZKGo9VtU.

Acknowledgment

Special thank you to Ms. Brigitte Taylor for transcribing the oral presentation of this lecture for subsequent editing.

REFERENCES

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Keywords:

burnout; complications; quality; resiliency; safety; surgical education

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