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Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Slide: 11 of 36

Outcomes of Interest for Off-Label rFVIIa Use in the Hospital Setting

This slide lists examples of potential outcomes of rFVIIa use. These encompass a range, from indirect outcomes—of process/resource use or intermediate/surrogate outcomes (which are perhaps the easiest to measure but are not always closely connected to patient status)—to direct clinical endpoints such as death, adverse events, or functional status (which are the most relevant to patient well-being but are often more difficult to measure or occur less frequently than the other outcomes). Ideally, the CER would focus primarily on direct clinical outcomes for each of the clinical research questions, but this is not always possible given that the studies and other data sources may only report indirect outcome measures or have few events of this type.