Abstract:Method equivalence assessments should be considered when analytical methods are either modified or substituted. The TOST (two one sided tests) approach provides a sounder data driven method for testing equivalence than a simple comparative intermediate precision study which is typically performed as part of method validation. Prior to designing an equivalency study, an acceptance criterion (an acceptable bias between original and modified/changed method) must be chosen. The choice of acceptance criteria requir… Show more
“…11,12 A difference of δ=0.005 between 2 FFR results was predefined. Such a small difference was considered not to have a clinically relevant impact on interpretation and classification of FFR results.…”
“…11,12 A difference of δ=0.005 between 2 FFR results was predefined. Such a small difference was considered not to have a clinically relevant impact on interpretation and classification of FFR results.…”
“…For this purpose, the 90% confidence interval (CI) was calculated for the differences between the two groups. The acceptable bounds were determined for each parameter separately, based on the differences observed between the first 20 and the second 20 jumps of the NH (Borman et al, 2009). If the differences were statistically insignificant (i.e.…”
The new system allows reactive jumps that are rather comparable to natural jumps. Therefore, the new SJS seems to be an adequate system in order to examine the SSC under controlled and almost natural conditions.
“…Equivalence was tested using the two one-sided tests method (Borman, Chatfield, Damjanov, & Jackson, 2009) (see Table 2). The two one-sided tests method is used for equivalence testing.…”
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