Scepticaemia: The impact on the health system and patients of delaying new treatments with uncertain evidence; a case study of the sepsis bundle.

BACKGROUND: A sepsis care bundle of intravenous vitamin C, thiamine, and hydrocortisone was reported to improve treatment outcomes. The data to support it are uncertain and decision makers are likely to be cautious about adopting it. The objective of this study was to model the opportunity costs in dollars and lives of waiting for better information before adopting the bundle.

METHODS: A decision tree was built using information from the literature. We modelled the impact of bundle adoption under three scenarios using a simulation in which the bundle was effective as reported in the primary trial, less effective based on other information, and ineffective. The measurements were health services costs, quality-adjusted life years, and transition probabilities.

RESULTS: If the bundle proves to be effective under either scenario, it will save billions of dollars and millions of life-years in the United States. This is the opportunity cost of delaying an adoption decision and waiting for better quality evidence. We suggest that hospital decision-makers consider implementing the bundle on a trial basis while monitoring costs and outcomes data even while the evidence base is uncertain.

CONCLUSIONS: If the decision maker is unwilling to use the best available evidence now, but rather wishes to wait for definitive evidence they are risking incurring large costs for health care systems and for the patients they serve. An explicit analysis of uncertain clinical outcomes is a useful adjunct to guide decision making where there is clinical ambiguity. This approach offers a valid alternative to the default of clinical inactivity when faced with uncertainty.