Sepsis: A Mandate In Search of a Meaning

NQF and CMS are attempting to regulate treatment for a disease we can’t really define, which could force emergency physicians to adhere to non-evidenced based guidelines

The National Quality Forum (NQF) recently adopted a metric for adherence to sepsis protocols which included recommendations for initial screening and resuscitation, hemodynamic support, and other supportive therapy for sepsis patients. Subsequently, the Centers for Medicare and Medicaid Services (CMS) adopted this NQF metric for public reporting and payment programs [1]. CMS monitoring of adherence to sepsis protocols was scheduled to take effect January 1, 2015, but implementation was fortunately delayed in response to concerns by ACEP that the sepsis protocol was not supported by good scientific evidence [2].

Emergency physicians should be alarmed that CMS nearly created a national treatment standard on a diagnosis as subjective as “sepsis.” Advocates for making “sepsis” a quality measure argue that following quality initiatives can improve outcome measures and that their recommendations were based on the “Surviving Sepsis Guidelines [3].” However, imposing quality initiatives on hospitals may not have the intended effect.

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First, if financial penalties are imposed upon hospitals that do not meet treatment guidelines concerning any disease, there will be a temporary improvement in the metrics regardless of the scientific quality of the protocol. Why? Once a disease is being monitored, the hospitals dedicate more personnel and resources to managing the disease. We saw this initially with stroke teams in which persons with less comorbidity were placed on the neurology ward with more professionals overseeing the care of the stroke patient [4]. However, long term quality measures for diseases such as STEMI and stroke have failed to demonstrate improvements in patient outcomes [5,6]. Initially, small observational trials looking at quality metrics may seem encouraging – until larger randomized controlled trails show no benefit in patient outcome. We would likely see this same pattern if quality metrics for sepsis were implemented.

Second, following guidelines should not be confused with practicing evidence-based medicine [7]. Guidelines are often the weakest type of scientific evidence and are often created by consensus panel arguments [8]. In addition, guidelines may not be updated on a regular basis, leaving them several years behind current scientific studies.

The proposed adoption of sepsis guidelines as a measure of quality is just another example of bad judgment – especially since the recommendations behind the “Surviving Sepsis Campaign” have almost completely been dismantled. This Campaign, sponsored by Eli Lilly, promoted early goal directed therapy, central lines, steroids, tight glucose control, aggressive transfusion parameters, and Xigris (an Eli Lilly product). The benefit of each of these therapies has since been disproven [9,10,11] leaving only fluids and antibiotics as Level C recommendations (meaning there are no studies to prove or disprove their benefit). The only new recommendation is norepinephrine as the preferred ionotrope and even this recommendation is debatable. High quality randomized control trials show no difference in outcomes between norepinephrine’s and dopamine, and any potential differences may be moot in light of recent studies advocating “permissive hypotension” (eg. allowing MAP of 50 – 65 without ionotropes) as an alternative to aggressive ionotropic support [12]. The current “best evidence” we have in treating sepsis is to administer intravenous fluids and to order antibiotics as soon as we think it is “sepsis.” This is hardly a novel concept.

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Therein lies the irony: Federal mandates are attempting to regulate treatment of a disease that we cannot accurately define1. Sepsis is a nebulous diagnosis based upon “suspected infection” with “acute organ dysfunction due to the infection” using an extensive list of criteria without hierarchy. There is no clear guidance on whether a patient with a white blood cell count of 15,000 and a creatinine of 1.7 or a nursing home transfer with “mental status change” and a heart rate of 110 is truly “septic.” This is exactly why we pull from a trash bucket of terms ranging from “septicemia,” “SIRS,” “sepsis syndrome,” “uro-sepsis,” and “sepsis” as well as diagnoses that sidestep the sepsis pathway.

“Septic shock” may appear to be more obvious and therefore more accurate, however we also have no clear working definition of “shock”. The academic definition appears to be a MAP < 65; but most healthcare workers still speak and work in terms of systolic limits. Furthermore, the determination whether a patient is suffering from “septic shock” is currently made after a fluid challenge, making the data difficult to collect and pragmatically disregarded. A variance in baseline blood pressures makes even the determination of “hypotension” difficult. Ultimately, we must better measure tissue hypoperfusion as the definition of “shock” rather than some arbitrary blood pressure value.

Most troubling is that these “quality” measurements are often not based on clinical data but rather on insurance codes used by hospital billing offices.

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Insurance codes are unreliable because they are not based upon a strict set of data and because coding patterns change over time. How can we ethically recommend clinical treatment decisions based upon insurance claim codes?

If we were serious about gathering quality sepsis data to benefit patients we would begin with very simple and practical definitions for all health personnel to use at the bedside. For example, use only “septic shock” (documented fever with a MAP < 65) and “severe sepsis” (documented fever with lactate > 4). We would use such very limited but easy definitions to begin a foundation of data that is more consistent and accurate to compare across hospitals and regions.
But even then, I remain skeptical. The sepsis mandate – if it is ultimately adopted – will be another scientific mistake by CMS with a financial windfall for the government. Hospitals will then be forced to spend ever-increasing amounts of time, money and resources in order to report better data so they can win in the documentation-for-dollars facade we call “quality measures”.

REFERENCES
1. Rhee,C. et al. “Regulatory Mandates for Sepsis Care—Reasons for Caution.” NewEnglJ Med., May 1, 2014: 370: 1673-1676.
2. “CMS Sepsis Quality Measure Implementation Delayed” ACEP Now, Sept. 25, 2014.
3. Cooke, C. et al. “Sepsis Mandates: Improving Care While Advancing Quality improvement.’ JAMA 2014: 312 (14): 1397 – 1398.
4. Denaro C. “Evidence-based Care and Outcomes of Acute Stroke Managed in Hospital Specialty Units” MIA October 6, 2003: 179 :386.
5. Menees, DS. et al., “Door-to-Balloon Time And Mortality Among Patients Undergoing Primary PCI.”New Engl J Med Sept. 5, 2013 ; 369: 901-909.
6. Lakshminarayab K., et al. “A Cluster Randomized Trial to Improve Stroke Care in Hospitals” Neurology 74 (20): 1634-42.
7. Djulbegovic, B. “Evidence-Based Practice Is Not Synonymous With Delivery of Uniform Health Care.” JAMA Oct. 1, 2014; 312(13): 1293 – 1294.
8. Eijkenaar, F. et al. “Effects of Pay For Performance in Health Care.” Health Policy 2013 ; 110(2-3): 115-130.
9. The ARISE Investigaters. “Goal-Directed Resuscitation for Patients with Early Septic Shock.” New Engl J Med Oct. 16, 2014; 371(16): 1496-1506.
10. The ProCESS Investigators. “A Randomized Trial of Protocol-Based Care for Early Septic Shock.” New Engl J Med 2014; 370: 1583-1593.
11. Green JP, et al., “The 2012 Surviving Sepsis Campaign: Management of Severe Sepsis and Septic Shock—an update on the guidelines for initial therapy.” Curr Emerg Hosp Med Rep ,2013; 1 : 154-171.
12. Asfar, P. et al. “High Versus Low Blood Pressure Target in Patients with Septic Shock” New Engl J Med 2014 ; 370 : 1583-1593.