Delta: The Value That Matters in Fatigue Risk Management.

Noninferiority or equivalence testing are often used when comparing a novel pharmaceutical, operation, or procedure to the current standard designated as safe. Noninferiority and equivalence testing require estimates of a metric called delta: the margin of meaningful difference. Inappropriate delta margins can lead to invalid conclusions, thereby creating uncertainty about a studys scientific credibility. We recommend that a working group be convened with the following goals: 1) to evaluate delta values currently in use in aviation; 2) to determine if it is possible to develop a systematic, evidence-based, and replicable process to derive delta values based on statistical properties from population data, rather than a mixture of evidence- and opinion-based processes; and 3) based on the findings of the second goal, update the current delta values in use in aviation. This working group should include, at a minimum, government agencies and other key stakeholders using these values within operational settings.