Editor's Note July 16, 2019

Government Regulation of Sepsis Care

Demetrios N. Kyriacou

JAMA. 2019;322(3):250-251. doi:10.1001/jama.2019.9230

Sepsis is estimated to affect more than 30 million people and cause an estimated 6 million deaths worldwide every year. Although new medical treatments are continually being proposed and tested, the greatest reduction in sepsis-related deaths over the past few decades has come from the early recognition of this syndrome and rapid treatment with intravenous antibiotics and crystalloid fluid resuscitation. These important components of sepsis management have been bundled with other critical care interventions and laboratory tests as recommended in the Surviving Sepsis Campaign guidelines.¹ However, aggressive sepsis management according to these guidelines often is not implemented in hospital settings, resulting in higher than necessary mortality and morbidity rates.²

As a result, instituting effective treatment guidelines for sepsis care has become an important public health objective. In this issue of JAMA, Kahn and colleagues³ found that the implementation of regulations in New York State (beginning in 2013) mandating protocolized recognition and treatment of sepsis, as well as clinician training and reporting, was associated with a greater than expected reduction in sepsis-related mortality over a 2-year study period compared with 4 other states that did not implement similar sepsis care regulations. This finding is important because it illustrates a rarely used but potentially effective public health intervention for reducing mortality and morbidity from sepsis.

The New York State sepsis care regulations combined several administrative and clinical management procedures into 1 bundled hospital-based intervention. However, this approach does not allow the assessment of the individual components of the intervention. Based on prior experience, it is possible that some of the bundled components are clinically effective while others are not important. An example of this phenomenon is the first clinical trial of early goal-directed therapy for sepsis care in the emergency department setting that demonstrated significant reduction in mortality with a bundled treatment package.⁴Subsequent studies found that only parts of the intervention (eg, early recognition of sepsis and prompt delivery of intravenous fluids and antimicrobial agents) were likely effective.⁵ Including administrative and clinical elements that may be ineffective in mandated protocolized sepsis care might divert efforts and resources from effective elements.

Mandated guidelines and protocols may also have unintended negative consequences. A well-known clinical example is a previous standard implemented by the Joint Commission to administer antibiotics within 4 hours to patients with pneumonia presenting at the emergency department. Multiple studies identified earlier antibiotic treatment as being associated with better outcomes, especially in older patients, prompting the use of the 4-hour rule as a quality indicator linked to financial compensation.⁶ However, subsequent research found more patients being misdiagnosed with pneumonia and given antibiotics they did not need.⁷ The Joint Commission subsequently revised the 4-hour rule. In addition, mandated care regulations usually require increased administrative and clinical resources. Unless additional resources are specifically dedicated to compliance with new regulations, resources could be diverted from other critical care interventions.

The approach of the New York State government to improve overall sepsis care and outcomes is an experiment. Because major public health interventions cannot be based on a single observational study, such as that by Kahn and colleagues,³ further assessments of the association, potential effects (both intended and unintended), and costs are warranted before implementation of similar sepsis care regulations in other states. In addition, future research should focus on the identification of specific elements of sepsis care that provide rigorous scientific evidence of clinical effectiveness. Because demands on nurses and physicians to provide rapid intensive care to patients in critical settings can affect patient treatment, any strategy aimed toward reducing sepsis-related morbidity and mortality must be based on convincing evidence before being mandated by governmental regulations.