As we strive to improve the quality and safety of the surgical care we deliver, a large body of research has focused on identifying characteristics of both hospitals and individual surgeons that function as a proxy for high-quality care. Many studies, notably the work of John Birkmeyer,1,2 have validated a volume-outcome relationship in which numerous patient outcome measures improve when surgical procedures are performed at high-volume centers and by surgeons who perform a larger number of the procedure. Last year, these findings were translated into policy as 3 major academic hospital systems announced a “Take the Volume Pledge,”3,4 which sets a minimum volume threshold for hospitals and surgeons performing 10 different complex surgical procedures.
There is no doubt that the motivation behind this pledge, to improve patient outcomes, is sound. However, volume, although undeniably correlated with improved care, is an imperfect stand-alone measure of quality. Notably, a surgeon's years of past experience or advanced training are discounted in a simplified threshold of number of cases performed per year. Proponents of the policy argue that waiting for further research before effecting these changes would represent an unnecessary delay. However, in this article, we would argue that implementing policy based on incomplete analysis will lead to more harm than good for the patients.
CONSEQUENCES OF RUSHED POLICY-MAKING
Setting large-scale policy, even with good intentions, based on an imperfect metric can lead to long-term negative effects that are often not considered until it is too late. A recent example is “No Child Left Behind”, the act passed by Congress in 2001 aimed at improving public education by setting measurable standards to evaluate school quality.5 The act intensely focused on standardized testing as an outcome measure, with schools that failed to meet yearly improvement standards either being supplemented with additional tutoring services, penalized by offering students the opportunity to transfer to higher performing schools, or in the most severe cases, permanently closed. Initially, education advocates applauded the law as a concrete step to address failing schools.
However, the consequences of using an incomplete quality metric soon became clear. Because standardized testing was used as a singular marker of excellence and a benchmark for resource distribution, even the most creative teachers were forced to bend their teaching to fit test content. Students did not take advantage of tutoring services, and failure rates remained unchanged. Most interestingly, only a tiny percentage of eligible students agreed to transfer from their local school to a higher performing one, even with the offer of free transportation.6 Students and parents preferred their local school even once it had been defined as in need of improvement. As these issues became clear, the education community and policymakers turned against the law. On December 2, 2015, Congress passed sweeping revisions amending national testing standards, and allowing states and local school districts to set their own measures of quality with remediation plans for underperformers.7 Passed with strong bipartisan support, these revisions were a recognition that the attempt to define quality with a single outcome measure failed to account for a number of serious adverse downstream effects.
POTENTIAL UNINTENDED EFFECTS OF MANDATORY VOLUME THRESHOLDS
Before making the same mistakes in writing national healthcare policy, we should carefully consider the negative implications of setting a volume threshold for performance of surgical procedures. Significant impact of this change will be felt at the patient, family, hospital, and societal levels.
At the patient level, an obvious impact is the increased travel burden they will face as care becomes regionalized. Patients will be forced to spend more time in traveling, not only for the index procedure, but also for every preoperative and postoperative appointment. More time in transit means more missed days of work, increased need for childcare coverage, and higher cost. Although some of this access issue could be ameliorated through a military-like system of transport to regional centers, an outside entity would need to pay for the service to avoid saddling patients with this financial hardship. Taxpayers currently fund emergency medical services and transport for transplantable organs, but paying for similar transportation for elective surgical patients would represent a huge additional cost. High-volume centers, which would benefit from this policy, could contribute, but would be unlikely to do so voluntarily.
An obligatory policy centralizing complex surgery has social and economic consequences for patients’ families as well. When an elderly or pediatric patient is hospitalized, a family member often wants, or needs, to visit daily to provide social support and advocate for patient needs. Health insurance companies do not cover the cost of travel or accommodations for family members. Furthermore, a family member's spending multiple nights, or even weeks, away from home to be with a hospitalized loved one carries a high social cost. Not only must family members miss work, but this situation also leaves a single spouse home to take care of siblings and other domestic responsibilities.
Hospitals will also be significantly affected by this national policy. One important issue is that using procedure volume as a solitary outcome metric fails to capture the relevant support systems within a hospital that not only bolster surgical quality, but also contribute to ability to rescue when complications arise. These components include intensive care capability, presence of experienced nurses, as well as 24-hour access to subspecialty surgeons, interventional radiology, and advanced gastroenterology. A policy that focuses narrowly on procedural volume may disincentivize these other system-level investments that can ultimately prove crucial in patient care. These components could likely be improved upon at community centers, limiting the need for regionalization.
There is also the practical concern that many regional centers are already operating at, or above, capacity the majority of the time. With emergency rooms overflowing, inpatient and intensive care beds full, and operating room schedules booked out for months, there is limited capability to absorb additional patients. Forcing more volume into overloaded academic centers will inevitably increase wait times for procedures. This capacity problem will be exacerbated by the fact that surgeons tend to have a higher threshold for discharging patients who have traveled a long distance for care. Patients must be not only medically ready for discharge, but also sufficiently recovered to tolerate increased travel time home and confident that they will remain well until their scheduled follow-up. Escalating lengths of stay will only further contribute to hospital census overload.
Furthermore, the societal impact of compulsory regionalization must be recognized. Although the initial “Volume Pledge” only applies to 10 different complex surgical procedures, a trend of defining a minimum number of cases per surgeon for all major procedures cannot be far behind. Community surgeons will find it difficult to meet these numbers, and slowly the scope of their practice will become limited, no matter how technically talented or well trained they are.3 These restrictions will not only make community surgery less satisfying intellectually and more financially tenuous, but will also starve small hospitals into economic disaster or even closure.8 Patients residing in more rural areas will then have limited access to care, even for smaller procedures. In this way, an initiative intended to improve patient outcomes actually negatively affects the quality of care delivered outside of major academic centers.
A final issue with imposing volume standards as a proxy for quality is that it will essentially create a quota system. Surgeons nearing the end of the year without having performed a sufficient number of a given procedure may be tempted to offer an operation to a patient who does not truly need one, simply to meet their volume requirement. Although nonoperative management is often the superior therapeutic option for patients, surgical appropriateness would potentially be compromised under the new system. A policy that introduces any incentive other than medical necessity into patient care decisions is dangerous. Fundamentally, volume metrics ignore the importance of surgical judgment in cases where patients are best served by not offering them an operation.
There is no argument about the fact that the outcomes of elective complex surgery are improved when performed by surgeons and at centers with higher volume. However, before rushing to make national policy using this singular imperfect measure as a threshold, we need to have a real debate about potential unintended consequences. The urge to act now instead of waiting for more in-depth research is strong, especially when the motivation is to improve patient outcomes. However, we should keep in mind the old adage that “for every complex problem, there is an answer that is clear, simple, and wrong.”9 Our experience with “No Child Left Behind” taught us that flawed policy created with the best of intentions has unforeseen costs and ultimately needs substantial revision. The goal of engaging in further discussion is not to inhibit progress, but rather to avoid creating our own “No Patient Left Behind” act. We must take the time to develop a more comprehensive policy that defines quality using multiple metrics and, most importantly, includes solutions to address the negative consequences of the changes proposed.