- Email: [email protected]
No SIRS; Quick SOFA Instead
medical expertise in how to use it, he said. “Getting involved would be a really good thing.” Section editor: Truman J. Milling, Jr, MD Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and
other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The author has stated that no such relationships exist. The views expressed in News and Perspective are those of the authors, and do not reflect the views and opinions of the American College of
No SIRS; Quick SOFA Instead SCCM Redefines Sepsis Without Emergency Medicine Input
by JEREMY SAMUEL FAUST Special Contributor to Annals News & Perspective
t’s barely noon and already 5 patients have triggered a sepsis alert in triage. Once that happens, patients are expedited into the emergency department (ED), assessed, and treated urgently. Laboratory tests are ordered; fluids are given. Two systemic inflammatory response criteria and suspect infection is all it takes to sound the alarm, but this may be about to change. Until February, the Society of Critical Care Medicine’s (SCCM’s) definitions for sepsis had remained largely unchanged since 1991, although some revisions were incorporated into a 2003 update. To reflect changes in the understanding of sepsis pathophysiology and to respond to the need for more precise definitions, a task force composed of intensivists and infectious disease, surgical, and pulmonary specialists (emergency medicine was notably absent) was convened from representatives of the SCCM and
I
Volume 67, no. 5 : May 2016
the European Society of Intensive Care Medicine (ESICM) in January 2014. The task force was given the mandate to determine the Third International Consensus Definitions for Sepsis and Septic Shock, which were unveiled at the 45th annual SCCM Critical Care Congress in Orlando, FL, on February 22, 2016, and published as a trio of articles in the Journal of the American Medical Association the same day. According to Clifford S. Deutschman, MS, MD, of the Feinstein Institute for Medical Research, who, along with Mervyn Singer, MBBS, of University College London, cochaired the task force, the new definition states that sepsis is life-threatening organ dysfunction resulting from a dysregulated host response to infection (Figure 1). Septic shock is now defined as a subset of sepsis patients in whom “circulatory and cellular/ metabolic abnormalities are profound enough to substantially increase mortality.”1 In the creation of these definitions, the term “severe sepsis” was determined to be redundant with the new definition of sepsis and
Emergency Physicians or the editorial board of Annals of Emergency Medicine. http://dx.doi.org/10.1016/j.annemergmed. 2016.02.016
REFERENCE 1. Ramirez M, Slovis C. Resident involvement in civilian tactical emergency medicine. J Emerg Med. 2010;39:49-56.
thus was eliminated from official nomenclature. Dr. Deutschman highlighted an important departure from previous official statements on sepsis. “We didn’t just do definitions,” he said by telephone in February. “We did both definitions and clinical criteria.” The purpose was to create the most scientifically valid description of sepsis possible while providing a definition that would be clinically useful. Furthermore, the task force sought to distinguish patients with sepsis—in whom organ damage increased the risk of mortality to greater than 10%—from patients with septic shock, whose mortality exceeded 40%. The criteria, Dr. Deutschman said, are intended to help physicians identify and stratify septic patients by using “proxies for a likely sepsis-related outcome,” which was defined as death from sepsis or a course of 3 or more days in an ICU.2 The problem of quickly identifying patients who may have sepsis was also addressed. Systemic inflammatory response syndrome (SIRS) criteria—in use since 1991—were deemed “unhelpful” by the task force. In work led by Christopher W. Seymour, MD, MSc, of the University of Pittsburgh, SIRS was found to be reasonably sensitive, but extremely nonspecific.2 As an alternative, the use of the Sepsis-related/Sequential Organ Failure Assessment (SOFA) Annals of Emergency Medicine 15A
Previous (1991-2016)
Sepsis
Severe Sepsis
Septic Shock
Syndrome (SIRS) + suspected infection.
Sepsis 3 (2016-) Suspected or documented infection + 2 of qSOFA (systolic blood pressure < 90 mmHG; GCS 13; respiratory rate 22 per minute) or Rise in SOFA score 2 points
Sepsis + any of the following: Systolic blood pressure < 90 mmHG or MAP < 65; lactate > 2.0 mmol/L; INR > 1.5 or PTT > 60s; bilirubin 2.0 mg/dL; creatinine 2.1 > mg/dL urine output < 0.5mL/ kg/hour ( 2 hours); platelets 100 x 10 /L; spO2 < 90% (room air).
Sepsis + hypotension after
nomenclature
Sepsis + vasopressors required to maintain MAP > 65 and lactate > 2.0 mmol/L after
Figure 1.
was discussed (Figure 2).3 However, because a SOFA score cannot be performed in out-of-hospital, triage, and some emergency settings, a new measure relying on 3 easily obtainable clinical features, termed quick SOFA, was derived and validated retrospectively (Figure 3).
EPIDEMIOLOGY AND SURVEILLANCE POSE PROBLEMS he Centers for Disease Control and Prevention (CDC) states that more than 1 million sepsis cases occur annually in the United States and 258,000 die from it. But the CDC faces an unusual problem in surveillance owing to the conspicuous lack of a workable case definition. Until the new SCCM/ESICM consensus definitions were unveiled, sepsis had been defined as the “clinical syndrome defined by the presence of both infection and a systemic inflammatory response.”4 Several problems with this
T
16A Annals of Emergency Medicine
framework have subsequently been identified. One problem is that the previous definition of sepsis inappropriately included normal and appropriate responses to infection, such as fever and tachycardia, whereas the new definition seeks to isolate inappropriate, maladaptive responses. The previous definitions also reflect an antiquated view of sepsis pathophysiology. Today, experts understand sepsis as both a dysregulated pro- and anti-inflammatory response to infection, whereas the previous definitions, many have noted, focused “solely on immune excess.”1 Another major problem with the previous definitions and sepsis definitions in general, noted Anthony Fiore, MD, MPH, Epidemiology Research and Innovations Branch at the CDC, is that diagnosing sepsis relies on the accuracy of a clinician’s suspecting infection. “It’s been a tough nut to crack. Sepsis has always been a broad term,” Dr. Fiore said.
Indeed, the malleability of use for the term sepsis is evident by its apparently increasing incidence during the last decade. This increase is thought to be largely a result not of increased disease but rather enhanced awareness and “capture.” Because sepsis awareness has increased, physicians are more likely to recognize and bill for related care, according to Dr. Fiore. Physicians are now more likely to say, “This is sepsis. I can get reimbursement for this. That isn’t fraud. That’s appropriate reimbursement for patients with complex disease.” The problem, many argue, is that even experts may not ever be able to fully agree precisely on what sepsis even is. What makes sepsis different from other causes of morbidity and mortality that have grabbed our attention over the years is that it is a syndrome, not a disease. No criterion standard for sepsis exists and no single test can diagnose it. Many point out that sepsis is not the cause, but rather Volume 67, no. 5 : May 2016
quick Sequential (Sepsis-Related) Organ Function Assessment (qSOFA) Score.a Feature
Criteria
Blood pressure
Systolic blood pressure
Mental status
100 mmHG
Glasgow Coma Scale
Respiratory rate
13
22 breaths per minute
Figure 2.
is the pathologic result. Sepsis, most experts believe, is merely a final common pathway.
STRENGTHS AND WEAKNESSES he newly released SCCM/ESICM sepsis definitions have been met with mixed reception, leading to aggressive defenses of them. Senior author of the lead article, Derek Angus, MD, MPH, of the Department of Critical Care Medicine at the University of Pittsburgh and leader of the ProCESS sepsis clinical trial, as part of his role as director of clinical
T
research, praised the methods in particular. “It is nice that the task force relied on data,” he said. “In the same way as the Berlin criteria for ARDS [acute respiratory distress syndrome] were also data driven, we are hopefully moving to a new age where definitions are not solely based on expert opinion.” Scott Weingart, MD, of the Division of Emergency Critical Care at Stony Brook Hospital in New York found that the new definitions better represent appropriate clinical contexts, stating that “the new definitions lend a much-desired specificity
to the maelstrom of sepsis definitions. What one can clearly say about patients that meet the new septic shock definition is that they are clearly sick. Concentrating our efforts on these patients makes a great deal of sense.” Others, despite agreeing with the conceptual framework provided by the task force, shared concerns that the definitions have not been adequately validated, whereas others questioned whether physicians would adapt them speedily or at all. Writing to SCCM on behalf of the American College of Emergency Physicians (ACEP), Michael J. Gerardi, MD, stated last year that replacing SIRS with the use of
Sequential (Sepsis-Related) Organ Function Assessment (SOFA) Score.a System / Score
0
1
2
Respiration: PaO2/FiO2, mmHg (kPa)
400 (53.3)
<400 (53.3)
<300 (40)
Coagulation: Platelets x 103/µL
150
<150
<100
Liver: Bilirubin, mg/dL (µmol/L)
<1.2 (20)
Cardiovascular
<1.2-1.9 (20-32) 2.0-5.9 (33-101)
Dopamine <5 or dobutamine MAP 70 mm Hg MAP <70 mm Hg (any dose)b
Central nervous system: Glasgow coma scale scorec
15
13-14
10-12
Renal: Creatinine mg/dL (µmol/L); Urine output, mL/day
<1.2 (110)
1.2-1.9 (110-170)
2.0-3.4 (171-299)
3
4
<200 (26.7) with <100 (13.3) with respiratory respiratory support support
<50
<20
6.0-11.9 (102-204)
>12.0 (204)
Dopamine 5.1-15 or epinephrine 0.1, or norepinephrine 0.1b
Dopamine >15 or epinephrine, >0.1, or norepinephrine >0.1b
6-9
<6
3.5-4.9 >5.0 (440); <200 (300-440); <500
Figure 3. Volume 67, no. 5 : May 2016
Annals of Emergency Medicine 17A
quick SOFA “as a screening tool for sepsis patients and those who might not yet be identified as infected.seems reasonable. However, we are unsure of the sensitivity and the appropriate message regarding those who would be not be identified by this screening system.” Indeed, the task force emphasized that SIRS was an outdated and blunt instrument whose reach often included patients who were not septic while missing up to 1 in 8 severely septic patients.5 Other experts found many such aspects of the new definitions to be improvements but recognized that theory and practice may prove different. “It’s very exciting,” said Donald Yealy, MD, ProCESS first author from the Department of Emergency Medicine at the University of Pittsburgh, “but I can’t compare or predict how it will go.” Administrative issues may prove to be another barrier to definition uptake. “ICD-10 [International Classification of Diseases, 10th Revision] doesn’t recognize this definition, so every piece of software that uses ICD-10 won’t fit the world of the new definition; hence, I suspect limited uptake of the definition,” said Sean Townsend, MD, an intensive care physician in the Division of Pulmonary and Critical Care at California Pacific Medical Center of Sutter Health, who also serves as vice president of quality and safety. Another challenge for implementation is that the new sepsis definitions are not recognized by the Centers for Medicare & Medicaid Services (CMS). CMS’s recently enacted measure to assess the quality of sepsis care on a national level, Early Management Bundle, Severe Sepsis/Septic Shock, known as SEP1, relies on definitions derived from the previous sepsis definitions. At present, the CMS measure developers have no plans to integrate the new definitions. 18A Annals of Emergency Medicine
“SEP-1 doesn’t recognize the terminology [or] the criteria,” said Dr. Townsend, who helped develop the CMS measure. “With national deployment [of SEP-1] under an old definition, I again see limited uptake.” For his part, Dr. Weingart hoped that CMS would reassess its own definitions, saying that, “CMS should immediately revise their own definition of septic shock to meet this new definition.” This latter point unveils an uneasy philosophical question: should a government entity be the de facto decisionmaker of medical definitions? Noting the conflict between the older definitions (to which the CMS SEP-1 adheres) and the new ones proposed by SCCM/ESICM Task Force, Cameron Berg, MD, of the Department of Emergency Medicine at the North Memorial Medical Center in Minneapolis, MN, found some parts of the now-competing definitions to be “mutually exclusive.” This leaves the lingering question of whom to follow and raises issues of pedagogy. “What should we be teaching people?” Dr. Berg wondered. “When professional clinical society recommendations differ substantially from core measures, then clinicians are placed in a difficult position. Do they listen to the experts or the government?” Dr. Deutschman shared in these concerns but kept an optimistic tone. He hopes that measures such as SEP-1 will eventually integrate new data and definitions: “Ultimately, we all want the same thing: what’s best for patients.” What is clear is that the 2016 sepsis definitions have been sent into a world more complicated than the one its predecessors met, one in which dissemination is on one hand aided by online media publicity (and in which news of major changes such as these “go viral”) but, on the other, may in fact be undermined in practice by
modern fixings, including inelastic quality measures and well-entrenched electronic medical record infrastructure that are difficult to alter.
EMERGENCY PHYSICIANS SNUBBED, A MISTAKE ACKNOWLEDGED lthough the SCCM/ESICM Task Force had the stated goal of providing “simple, data-driven clinical criteria so that practitioners in out-of-hospital, EDs and hospital ward settings,” emergency physicians were not invited to participate in the process. Writing on behalf of ACEP in September 2015 to notify the SCCM that ACEP would not accept its earlier request for ACEP to endorse the new definitions, then-president Dr. Gerardi noted that nearly two thirds of all admitted septic patients present through EDs. He asked that, moving forward, “emergency physicians be included [in] this and future efforts, given the high impact and frequency of sepsis, severe sepsis, and septic shock in the emergency department setting.” Dr. Deutschman recognized the concern, but defended the quality of the task force, saying that “the members were chosen based on prior contributions to sepsis research and our need for input from individuals with expertise in sepsis basic science, clinical trials, and epidemiology, as well as expertise in the function of specific organ systems.” However, he acknowledged that not including emergency physicians in the task force was potentially a political misstep that may have contributed to ACEP’s (and the Society for Academic Emergency Medicine’s) decision not to endorse. “We could have included people from [the] emergency side. With 20/20 hindsight, there were some very deserving people in the [emergency medicine] community
A
Volume 67, no. 5 : May 2016
who could have been included, and this would have allowed us to avoid a political landmine. The only thing we can do is apologize and say we’ll know better.next time.” To that point, Dr. Deutschman hopes that these definitions will be revisited and updated more often. “This is going to be controversial, and I’m glad because this will get people to stand up and argue. I would hope this gets redone more often than every 12 to 14 years, maybe every 3 or 4 years.” For Dr. Yealy’s part, he sees both a mistake and a future opportunity. Although “recognizing the challenge of putting together multidisciplinary groups,” the SCCM/ECISM Task Force “missed a great opportunity to engage a group of physicians who are
Volume 67, no. 5 : May 2016
not only experts but are central to early sepsis care. We stand ready to work with them again.”
http://dx.doi.org/10.1016/j.annemergmed. 2016.03.018
Section editor: Truman J. Milling, Jr, MD Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The author has stated that no such relationships exist. The views expressed in News and Perspective are those of the authors, and do not reflect the views and opinions of the American College of Emergency Physicians or the editorial board of Annals of Emergency Medicine.
1. Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315: 801-810. 2. Seymour CW, Liu VX, Iwashyna TJ, et al. Assessment of clinical criteria for sepsis: for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315:762-774. 3. Vincent JL. Organ dysfunction in patients with severe sepsis. Surg Infect (Larchmt). 2006;7(suppl 2):S69-S72. 4. Levy MM, Fink MP, Marshall JC, et al. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003;31:1250-1256. 5. Kaukonen KM, Bailey M, Bellomo R. Systemic inflammatory response syndrome criteria for severe sepsis. N Engl J Med. 2015;373:881.
REFERENCES
Annals of Emergency Medicine 19A
other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The author has stated that no such relationships exist. The views expressed in News and Perspective are those of the authors, and do not reflect the views and opinions of the American College of
No SIRS; Quick SOFA Instead SCCM Redefines Sepsis Without Emergency Medicine Input
by JEREMY SAMUEL FAUST Special Contributor to Annals News & Perspective
t’s barely noon and already 5 patients have triggered a sepsis alert in triage. Once that happens, patients are expedited into the emergency department (ED), assessed, and treated urgently. Laboratory tests are ordered; fluids are given. Two systemic inflammatory response criteria and suspect infection is all it takes to sound the alarm, but this may be about to change. Until February, the Society of Critical Care Medicine’s (SCCM’s) definitions for sepsis had remained largely unchanged since 1991, although some revisions were incorporated into a 2003 update. To reflect changes in the understanding of sepsis pathophysiology and to respond to the need for more precise definitions, a task force composed of intensivists and infectious disease, surgical, and pulmonary specialists (emergency medicine was notably absent) was convened from representatives of the SCCM and
I
Volume 67, no. 5 : May 2016
the European Society of Intensive Care Medicine (ESICM) in January 2014. The task force was given the mandate to determine the Third International Consensus Definitions for Sepsis and Septic Shock, which were unveiled at the 45th annual SCCM Critical Care Congress in Orlando, FL, on February 22, 2016, and published as a trio of articles in the Journal of the American Medical Association the same day. According to Clifford S. Deutschman, MS, MD, of the Feinstein Institute for Medical Research, who, along with Mervyn Singer, MBBS, of University College London, cochaired the task force, the new definition states that sepsis is life-threatening organ dysfunction resulting from a dysregulated host response to infection (Figure 1). Septic shock is now defined as a subset of sepsis patients in whom “circulatory and cellular/ metabolic abnormalities are profound enough to substantially increase mortality.”1 In the creation of these definitions, the term “severe sepsis” was determined to be redundant with the new definition of sepsis and
Emergency Physicians or the editorial board of Annals of Emergency Medicine. http://dx.doi.org/10.1016/j.annemergmed. 2016.02.016
REFERENCE 1. Ramirez M, Slovis C. Resident involvement in civilian tactical emergency medicine. J Emerg Med. 2010;39:49-56.
thus was eliminated from official nomenclature. Dr. Deutschman highlighted an important departure from previous official statements on sepsis. “We didn’t just do definitions,” he said by telephone in February. “We did both definitions and clinical criteria.” The purpose was to create the most scientifically valid description of sepsis possible while providing a definition that would be clinically useful. Furthermore, the task force sought to distinguish patients with sepsis—in whom organ damage increased the risk of mortality to greater than 10%—from patients with septic shock, whose mortality exceeded 40%. The criteria, Dr. Deutschman said, are intended to help physicians identify and stratify septic patients by using “proxies for a likely sepsis-related outcome,” which was defined as death from sepsis or a course of 3 or more days in an ICU.2 The problem of quickly identifying patients who may have sepsis was also addressed. Systemic inflammatory response syndrome (SIRS) criteria—in use since 1991—were deemed “unhelpful” by the task force. In work led by Christopher W. Seymour, MD, MSc, of the University of Pittsburgh, SIRS was found to be reasonably sensitive, but extremely nonspecific.2 As an alternative, the use of the Sepsis-related/Sequential Organ Failure Assessment (SOFA) Annals of Emergency Medicine 15A
Previous (1991-2016)
Sepsis
Severe Sepsis
Septic Shock
Syndrome (SIRS) + suspected infection.
Sepsis 3 (2016-) Suspected or documented infection + 2 of qSOFA (systolic blood pressure < 90 mmHG; GCS 13; respiratory rate 22 per minute) or Rise in SOFA score 2 points
Sepsis + any of the following: Systolic blood pressure < 90 mmHG or MAP < 65; lactate > 2.0 mmol/L; INR > 1.5 or PTT > 60s; bilirubin 2.0 mg/dL; creatinine 2.1 > mg/dL urine output < 0.5mL/ kg/hour ( 2 hours); platelets 100 x 10 /L; spO2 < 90% (room air).
Sepsis + hypotension after
nomenclature
Sepsis + vasopressors required to maintain MAP > 65 and lactate > 2.0 mmol/L after
Figure 1.
was discussed (Figure 2).3 However, because a SOFA score cannot be performed in out-of-hospital, triage, and some emergency settings, a new measure relying on 3 easily obtainable clinical features, termed quick SOFA, was derived and validated retrospectively (Figure 3).
EPIDEMIOLOGY AND SURVEILLANCE POSE PROBLEMS he Centers for Disease Control and Prevention (CDC) states that more than 1 million sepsis cases occur annually in the United States and 258,000 die from it. But the CDC faces an unusual problem in surveillance owing to the conspicuous lack of a workable case definition. Until the new SCCM/ESICM consensus definitions were unveiled, sepsis had been defined as the “clinical syndrome defined by the presence of both infection and a systemic inflammatory response.”4 Several problems with this
T
16A Annals of Emergency Medicine
framework have subsequently been identified. One problem is that the previous definition of sepsis inappropriately included normal and appropriate responses to infection, such as fever and tachycardia, whereas the new definition seeks to isolate inappropriate, maladaptive responses. The previous definitions also reflect an antiquated view of sepsis pathophysiology. Today, experts understand sepsis as both a dysregulated pro- and anti-inflammatory response to infection, whereas the previous definitions, many have noted, focused “solely on immune excess.”1 Another major problem with the previous definitions and sepsis definitions in general, noted Anthony Fiore, MD, MPH, Epidemiology Research and Innovations Branch at the CDC, is that diagnosing sepsis relies on the accuracy of a clinician’s suspecting infection. “It’s been a tough nut to crack. Sepsis has always been a broad term,” Dr. Fiore said.
Indeed, the malleability of use for the term sepsis is evident by its apparently increasing incidence during the last decade. This increase is thought to be largely a result not of increased disease but rather enhanced awareness and “capture.” Because sepsis awareness has increased, physicians are more likely to recognize and bill for related care, according to Dr. Fiore. Physicians are now more likely to say, “This is sepsis. I can get reimbursement for this. That isn’t fraud. That’s appropriate reimbursement for patients with complex disease.” The problem, many argue, is that even experts may not ever be able to fully agree precisely on what sepsis even is. What makes sepsis different from other causes of morbidity and mortality that have grabbed our attention over the years is that it is a syndrome, not a disease. No criterion standard for sepsis exists and no single test can diagnose it. Many point out that sepsis is not the cause, but rather Volume 67, no. 5 : May 2016
quick Sequential (Sepsis-Related) Organ Function Assessment (qSOFA) Score.a Feature
Criteria
Blood pressure
Systolic blood pressure
Mental status
100 mmHG
Glasgow Coma Scale
Respiratory rate
13
22 breaths per minute
Figure 2.
is the pathologic result. Sepsis, most experts believe, is merely a final common pathway.
STRENGTHS AND WEAKNESSES he newly released SCCM/ESICM sepsis definitions have been met with mixed reception, leading to aggressive defenses of them. Senior author of the lead article, Derek Angus, MD, MPH, of the Department of Critical Care Medicine at the University of Pittsburgh and leader of the ProCESS sepsis clinical trial, as part of his role as director of clinical
T
research, praised the methods in particular. “It is nice that the task force relied on data,” he said. “In the same way as the Berlin criteria for ARDS [acute respiratory distress syndrome] were also data driven, we are hopefully moving to a new age where definitions are not solely based on expert opinion.” Scott Weingart, MD, of the Division of Emergency Critical Care at Stony Brook Hospital in New York found that the new definitions better represent appropriate clinical contexts, stating that “the new definitions lend a much-desired specificity
to the maelstrom of sepsis definitions. What one can clearly say about patients that meet the new septic shock definition is that they are clearly sick. Concentrating our efforts on these patients makes a great deal of sense.” Others, despite agreeing with the conceptual framework provided by the task force, shared concerns that the definitions have not been adequately validated, whereas others questioned whether physicians would adapt them speedily or at all. Writing to SCCM on behalf of the American College of Emergency Physicians (ACEP), Michael J. Gerardi, MD, stated last year that replacing SIRS with the use of
Sequential (Sepsis-Related) Organ Function Assessment (SOFA) Score.a System / Score
0
1
2
Respiration: PaO2/FiO2, mmHg (kPa)
400 (53.3)
<400 (53.3)
<300 (40)
Coagulation: Platelets x 103/µL
150
<150
<100
Liver: Bilirubin, mg/dL (µmol/L)
<1.2 (20)
Cardiovascular
<1.2-1.9 (20-32) 2.0-5.9 (33-101)
Dopamine <5 or dobutamine MAP 70 mm Hg MAP <70 mm Hg (any dose)b
Central nervous system: Glasgow coma scale scorec
15
13-14
10-12
Renal: Creatinine mg/dL (µmol/L); Urine output, mL/day
<1.2 (110)
1.2-1.9 (110-170)
2.0-3.4 (171-299)
3
4
<200 (26.7) with <100 (13.3) with respiratory respiratory support support
<50
<20
6.0-11.9 (102-204)
>12.0 (204)
Dopamine 5.1-15 or epinephrine 0.1, or norepinephrine 0.1b
Dopamine >15 or epinephrine, >0.1, or norepinephrine >0.1b
6-9
<6
3.5-4.9 >5.0 (440); <200 (300-440); <500
Figure 3. Volume 67, no. 5 : May 2016
Annals of Emergency Medicine 17A
quick SOFA “as a screening tool for sepsis patients and those who might not yet be identified as infected.seems reasonable. However, we are unsure of the sensitivity and the appropriate message regarding those who would be not be identified by this screening system.” Indeed, the task force emphasized that SIRS was an outdated and blunt instrument whose reach often included patients who were not septic while missing up to 1 in 8 severely septic patients.5 Other experts found many such aspects of the new definitions to be improvements but recognized that theory and practice may prove different. “It’s very exciting,” said Donald Yealy, MD, ProCESS first author from the Department of Emergency Medicine at the University of Pittsburgh, “but I can’t compare or predict how it will go.” Administrative issues may prove to be another barrier to definition uptake. “ICD-10 [International Classification of Diseases, 10th Revision] doesn’t recognize this definition, so every piece of software that uses ICD-10 won’t fit the world of the new definition; hence, I suspect limited uptake of the definition,” said Sean Townsend, MD, an intensive care physician in the Division of Pulmonary and Critical Care at California Pacific Medical Center of Sutter Health, who also serves as vice president of quality and safety. Another challenge for implementation is that the new sepsis definitions are not recognized by the Centers for Medicare & Medicaid Services (CMS). CMS’s recently enacted measure to assess the quality of sepsis care on a national level, Early Management Bundle, Severe Sepsis/Septic Shock, known as SEP1, relies on definitions derived from the previous sepsis definitions. At present, the CMS measure developers have no plans to integrate the new definitions. 18A Annals of Emergency Medicine
“SEP-1 doesn’t recognize the terminology [or] the criteria,” said Dr. Townsend, who helped develop the CMS measure. “With national deployment [of SEP-1] under an old definition, I again see limited uptake.” For his part, Dr. Weingart hoped that CMS would reassess its own definitions, saying that, “CMS should immediately revise their own definition of septic shock to meet this new definition.” This latter point unveils an uneasy philosophical question: should a government entity be the de facto decisionmaker of medical definitions? Noting the conflict between the older definitions (to which the CMS SEP-1 adheres) and the new ones proposed by SCCM/ESICM Task Force, Cameron Berg, MD, of the Department of Emergency Medicine at the North Memorial Medical Center in Minneapolis, MN, found some parts of the now-competing definitions to be “mutually exclusive.” This leaves the lingering question of whom to follow and raises issues of pedagogy. “What should we be teaching people?” Dr. Berg wondered. “When professional clinical society recommendations differ substantially from core measures, then clinicians are placed in a difficult position. Do they listen to the experts or the government?” Dr. Deutschman shared in these concerns but kept an optimistic tone. He hopes that measures such as SEP-1 will eventually integrate new data and definitions: “Ultimately, we all want the same thing: what’s best for patients.” What is clear is that the 2016 sepsis definitions have been sent into a world more complicated than the one its predecessors met, one in which dissemination is on one hand aided by online media publicity (and in which news of major changes such as these “go viral”) but, on the other, may in fact be undermined in practice by
modern fixings, including inelastic quality measures and well-entrenched electronic medical record infrastructure that are difficult to alter.
EMERGENCY PHYSICIANS SNUBBED, A MISTAKE ACKNOWLEDGED lthough the SCCM/ESICM Task Force had the stated goal of providing “simple, data-driven clinical criteria so that practitioners in out-of-hospital, EDs and hospital ward settings,” emergency physicians were not invited to participate in the process. Writing on behalf of ACEP in September 2015 to notify the SCCM that ACEP would not accept its earlier request for ACEP to endorse the new definitions, then-president Dr. Gerardi noted that nearly two thirds of all admitted septic patients present through EDs. He asked that, moving forward, “emergency physicians be included [in] this and future efforts, given the high impact and frequency of sepsis, severe sepsis, and septic shock in the emergency department setting.” Dr. Deutschman recognized the concern, but defended the quality of the task force, saying that “the members were chosen based on prior contributions to sepsis research and our need for input from individuals with expertise in sepsis basic science, clinical trials, and epidemiology, as well as expertise in the function of specific organ systems.” However, he acknowledged that not including emergency physicians in the task force was potentially a political misstep that may have contributed to ACEP’s (and the Society for Academic Emergency Medicine’s) decision not to endorse. “We could have included people from [the] emergency side. With 20/20 hindsight, there were some very deserving people in the [emergency medicine] community
A
Volume 67, no. 5 : May 2016
who could have been included, and this would have allowed us to avoid a political landmine. The only thing we can do is apologize and say we’ll know better.next time.” To that point, Dr. Deutschman hopes that these definitions will be revisited and updated more often. “This is going to be controversial, and I’m glad because this will get people to stand up and argue. I would hope this gets redone more often than every 12 to 14 years, maybe every 3 or 4 years.” For Dr. Yealy’s part, he sees both a mistake and a future opportunity. Although “recognizing the challenge of putting together multidisciplinary groups,” the SCCM/ECISM Task Force “missed a great opportunity to engage a group of physicians who are
Volume 67, no. 5 : May 2016
not only experts but are central to early sepsis care. We stand ready to work with them again.”
http://dx.doi.org/10.1016/j.annemergmed. 2016.03.018
Section editor: Truman J. Milling, Jr, MD Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The author has stated that no such relationships exist. The views expressed in News and Perspective are those of the authors, and do not reflect the views and opinions of the American College of Emergency Physicians or the editorial board of Annals of Emergency Medicine.
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REFERENCES
Annals of Emergency Medicine 19A