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ܲԱ5, 2024

Failure to Rescue as a Quality Measure in Sepsis

Author Affiliations
  • 1Division of Hospital Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor
  • 2Institute for Health Policy and Innovation, University of Michigan, Ann Arbor
  • 3Section of Hospital Medicine, Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina
  • 4Center for Health System Sciences, Atrium Health, Charlotte, North Carolina
JAMA. Published online June 5, 2024. doi:10.1001/jama.2024.6771

Successful initiatives like the Surviving Sepsis Campaign, with a focus on early diagnosis and treatment, have resulted in significant improvements in mortality for patients with sepsis. However, sepsis remains the leading cause of death and disability, present in 53% of hospitalizations leading to death or discharge to hospice.1 Furthermore, although innovations that support the transition and recovery of sepsis survivors after hospital discharge have produced improvements in postsepsis mortality and rehospitalization, these rates are still intolerably high (eg, 65% readmission or mortality at 12 months).2

Current sepsis quality measures (eg, the Centers for Medicare & Medicaid Services Severe Sepsis/Septic Shock Early Management Bundle) focus entirely on the first few hours of sepsis recognition and treatment. However, sole focus on this early period is inconsistent with extensive evidence that the biological and physiologic effects of sepsis persist for days to weeks after the initial sepsis event. Persistent pathophysiologic changes, invasive treatments, and frequent underlying comorbid illnesses render patients with sepsis vulnerable to high rates of complications during hospitalization (eg, new-onset atrial fibrillation and in-hospital stroke3). Although approaches to mitigate harm from these complications exist, current sepsis treatment guidelines provide no standardized approach to recognizing and responding to these frequent and life-threatening complications.

Conceptualizing sepsis adverse outcomes through the lens of “failure to rescue” (FTR) is an innovative systems-level approach to improving outcomes. FTR is the failure to prevent deterioration and death resulting from a complication of medical care or underlying illness4—in other words, the conditional probability of death given a complication. FTR has been widely incorporated into surgical quality measures and has resulted in numerous interventions that improve postoperative care and outcomes. In the United States, FTR rate was recognized as a patient safety indicator by the US Agency for Healthcare Research and Quality in 2007, and the Department of Veterans Affairs Surgical Quality Improvement Program and the American College of Surgeons National Surgical Quality Improvement Program use the FTR measure to improve quality of care. FTR is now widely accepted as a principal driver of variation in postoperative mortality among hospitals.

Although original and modernized conceptualizations of FTR assume its relevance to medical as well as surgical conditions, the measure has not experienced significant uptake as a quality indicator for medical conditions. In surgical fields, FTR rate is typically defined as the number of postoperative deaths (numerator) among the number of patients with postoperative complications (denominator). The analogous sepsis-FTR rate would be the number of postsepsis deaths (numerator) among the number of patients with postsepsis complications (denominator). As automated data capture improves, the measure could be refined to further emphasize preventability (eg, exclusion of patients with predicted mortality in a range unlikely to be survivable) and patient-centeredness (including nondeath outcomes such as permanent organ dysfunction or loss of independence to avoid “rescue to failure”).

Operationalizing complications to calculate the sepsis-FTR denominator is uniquely challenging for sepsis, a diagnosis defined by the presence of organ dysfunction. To differentiate secondary sepsis complications from the initial organ failure due to the inciting infection, we propose defining complications as new or worsened adverse events at a specified time point (eg, 24 hours after sepsis identification) delineating the end of the initial presentation and resuscitation period. Although debate will inevitably arise over the operationalization of FTR in sepsis, we believe a nascent definition can be refined to yield a clinically meaningful yet objective and reproducible metric. We propose that FTR has multiple features that make it an ideal complement to the current tools for quality measurement and improvement in sepsis.

First, the FTR concept aligns with current understanding of the trajectory of pathophysiologic events in sepsis. Sepsis is characterized by a “dysregulated host response to infection,” which manifests as both hyperinflammatory and hypoinflammatory responses, and macrocirculatory and microcirculatory dysfunction, leading to organ injury. Initial injury potentiates further organ system deterioration. Applying the concept of FTR captures the “spiral” of deterioration from an initial complication to subsequent complications and death, emphasizes the important role of these complications in sepsis morbidity and mortality, and provides a target for developing interventions to improve prevention, detection, and mitigation of complications rather than accepting them as the natural course of the disease.

Second, FTR recognizes that complications of serious illnesses may be inevitable, but the capacity to respond and manage complications is largely the difference-maker for improving mortality. Silber et al4 proposed the FTR metric in 1992 to explain differences in mortality among hospitals with similar complication rates. Indeed, whereas postoperative complication rates do not explain hospital-level variability in mortality, rates of FTR after complications are markedly higher in high-mortality hospitals compared with low-mortality hospitals.5 Variation in complication rates can be driven by patient characteristics present on admission or the high-risk nature of the index event (eg, cardiovascular surgery or sepsis), whereas the ability to rescue patients (prevent morbidity or mortality from complications) reflects the resources, preparedness, and quality of the hospital.

Third, FTR is intended to better capture inpatient morbidity and mortality that is avoidable vs due to natural progression of a severe or preexisting disease. This is especially important in sepsis, which commonly occurs in patients with preexisting failing health. For example, a multicenter cohort study found that hospice-qualifying conditions were present on admission in 40% of sepsis-associated deaths.2 Applying FTR as a quality indicator for sepsis would address existing controversy that current metrics do not adequately account for unmodifiable factors such as delayed presentation or the fact that sepsis is often a “common final pathway” for death due to multiple underlying conditions.

Fourth, because of its inherent causal linkage to hospital system culture and processes, FTR is a measure of organizational quality that can guide effective, sustained improvement strategies. FTR has come to indicate a safety failure and thus invokes multilevel institutional response strategies. Macrosystem factors like hospital volume and nurse and physician staffing explain a small proportion of FTR rates, suggesting that microsystem factors such as safety culture, communication, and teamwork may largely drive effective response to complications.6 Applying the FTR framework to sepsis primes the use of these well-tested safety-culture tenets in quality improvement.

Last, FTR may provide an important approach to reduction of quality-of-care disparities in sepsis. Variations in FTR are known to contribute to disparities in postoperative mortality for people from marginalized racial and ethnic groups and for socioeconomically disadvantaged patients and thus can be an effective lever for health equity improvements.7 Understanding and improving FTR rates after sepsis may be a critical factor in mitigating the hospital and neighborhood disadvantage–level disparities seen in sepsis.

Implementation of a FTR quality metric for sepsis requires overcoming some foreseeable challenges to ensure the metric is clinically meaningful, yet objective, reproducible, and amenable to automation. Measurement reliability will be unambiguously tied to the accuracy of data. Nonetheless, sepsis morbidity and mortality remain intolerably poor, in part because patients with sepsis are medically complex with many underlying conditions that influence these outcomes. Traditional sepsis metrics lack a framework to distill preventable from unpreventable events and ignore the importance of responding to the inevitable complications that occur after the initial early sepsis treatment period is over. FTR after sepsis represents such a framework emphasizing not just the first few hours of sepsis treatment but sustained vigilance and response to complications throughout the hospitalization.

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Article Information

Corresponding Author: Stephanie Parks Taylor, MD, MS, University of Michigan, 1500 E Medical Center Blvd, Ann Arbor, MI 48109 (stptay@med.umich.edu).

Published Online: June 5, 2024. doi:10.1001/jama.2024.6771

Conflict of Interest Disclosures: Dr Taylor reported receiving grants from the National Institute of Nursing Research (NINR), National Heart, Lung, and Blood Institute (NHLBI), and Agency for Healthcare Research and Quality (AHRQ), and the Duke Foundation and receiving consulting fees from Abionyx. Dr Kowalkowski reported receiving grants from NINR, AHRQ, and the Duke Foundation.

References
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