Knowing whether sepsis rates are truly changing has important implications for both policy and practice. Sepsis care mandates are not without risk. The mandate from the Joint Commission and CMS to initiate antibiotic therapy within 4 hours after a patient with community-acquired pneumonia arrives at the hospital is informative in this regard. With hindsight, we now know that this requirement probably led to overdiagnosis of pneumonia and unwarranted antibiotic treatment for patients with undifferentiated respiratory symptoms.5 Sepsis mandates carry similar risks, since the signs and symptoms of sepsis are also subjective and nonspecific; many noninfectious inflammatory disorders can manifest similarly. Protocols that force physician behavior risk promoting inappropriate prescribing of broad-spectrum antibiotics for noninfectious conditions, unnecessary testing, overuse of invasive catheters, diversion of scarce ICU capacity, and delayed identification of nonsepsis diagnoses.
We believe that policy mandates are premature until we can develop better diagnosis and surveillance metrics. Current clinical criteria and claims codes are too subjective and too susceptible to external influences to inform or measure the effects of policy changes. The current policy environment favors more diagnoses and increased coding for sepsis, but if policies evolve to include public reporting, benchmarking, and financial penalties, the pendulum could easily swing toward fewer diagnoses and decreased coding. Sepsis diagnosis, management, and surveillance sciences need to mature before they can become a reliable basis for policies and performance measures.
Fortunately, there are specific steps that stakeholders can take now to improve sepsis care while mitigating the risk of unintended consequences. Clinicians and hospitals can continue to embrace best practices for treating patients with sepsis but be attentive to rates of overtreatment and undertreatment. Policymakers and payers can continue to encourage best practices but avoid mandating rigid protocols or tying reimbursements to protocol-implementation rates or outcomes. We recommend focusing instead on enhancing education for clinicians and the public, providing resources for developing and testing new protocols, and increasing funding for research on sepsis pathophysiology, diagnosis, treatment, and surveillance. There is also a pressing need to evaluate the hospital-level effects of sepsis protocols on total antibiotic dispensing, antimicrobial resistance, Clostridium difficile infections, ICU-bed availability, and complications of central venous catheter placements. Such evaluation is particularly important if policymakers do move ahead with mandates, since forcing behavior increases the risk of unintended harms.
On the surveillance side, there may be lessons to be learned from the CDC's new paradigm for ventilator-associated events. The challenges of sepsis surveillance parallel many of those related to surveillance for ventilator-associated pneumonia; both conditions lack a clear standard definition, and their definitions contain multiple subjective elements. The CDC's paradigm for ventilator-associated events acknowledges the difficulty of accurate clinical identification of ventilator-associated pneumonia and focuses instead on identifying the syndrome of nosocomial respiratory deterioration by monitoring patients' ventilator settings for sustained increases after a period of stability or improvement. This strategy is objective and efficient and permits detection of events strongly associated with increased length of stay and hospital mortality. One analogous strategy for sepsis might be to conduct surveillance for unambiguous, clinically significant, objective events; for example, one could monitor the frequency of positive blood cultures that occur concurrently with lactic acidosis or vasopressor use. This approach would miss some patients, because only about 50% of patients with severe sepsis have bacteremia. Surveillance definitions, however, do not need to be perfectly sensitive to be useful, and they do not need to perfectly match the criteria used to guide the clinical care of patients. It is more important for surveillance definitions to be simple, objective, clinically meaningful, resistant to ascertainment bias, and ideally, suitable for automation using data routinely stored in electronic health records.
Sepsis is a major public health problem. Resources are appropriately being directed toward finding better ways to diagnose, treat, and prevent this important condition. Mandating sepsis bundles and benchmarking hospitals on their adherence rates, however, risk causing unintended harms. Furthermore, current limitations in sepsis diagnosis and surveillance sciences prevent us from being able to reliably measure the impact of sepsis campaigns and policies. Until these issues are resolved, we advise caution before prescribing more mandates.