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"direct outcomes"

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

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | direct outcomes | indirect outcomes | endpoints | adverse effects
Characteristics of Comparative Studies on Off-Label rFVIIa Use With the exception of use in ICH, study sample sizes were small (median of 24 treated patients). The doses used in the studies that are the focus of this effectiveness review varied from 5 to 956 mcg/kg of patient weight, and only for intracranial hemorrhage was there a sufficient range of doses to assess the impact of rFVIIa dosing on outcomes. Most studies used indirect endpoints as their primary outcomes, particularly red blood cell (RBC) transfusion requirements. Direct outcomes, such as mortality, functional status, or thromboembolic events, were frequently reported, but most studies were individually underpowered to evaluate them. Most clinical research on rFVIIa has been directed and sponsored by Novo Nordisk, the product’s manufacturer. The strength of evidence available from existing studies was thereby compromised by small study size, use of indirect outcomes, and heterogeneity in dosage and indication. The applicability was diminished by less acutely ill patients and a mismatch between existing research and real-world patterns of indication and types of use.
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Characteristics of Comparative Studies on Off-Label rFVIIa Use

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | strength of evidence
Conclusions From Available Evidence For the uses examined, current evidence does not show that off-label use of rFVIIa reduces mortality or improves other direct outcomes. Thromboembolic events are increased by using rFVIIa to treat spontaneous intracranial hemorrhage and in adult cardiac surgery.
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Conclusions From Available Evidence

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | conclusions
 
 
 
 
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