. 2021 Nov 27;11(12):1570. doi: 10.3390/brainsci11121570

Table 1.

Observation strategies and choice of decision parameters.

Strategy	Criteria for Detecting Disease Activity	Parameter Choices *
without MRI	at least n^relapse clinical relapses or EDSS disability progression **	n^relapse: {1, 2, 3}
NEDA-3 (visual)	same as “without MRI” or at least n^lesion new lesions, but only a proportion p^lesion of true lesions are caught	n^lesion: {1, 2, 3, 4} p^lesion: 33%, 66%
NEDA-3 (software)	same as “NEDA-3 (visual)”	n^lesion: {1, 2, 3, 4} p^lesion: 90%, 100%
NEDA-4 (software)	same as “NEDA-3 (software)” or annualized whole brain volume loss > α% measurement error between two consecutive scans: ±ε%	α: {0.4, 0.52, 0.72} ε: {0.1, 0.2, 0.3}

* Default values used in the Section 3 are in bold; alternative parameter choices are discussed in Appendix C. ** EDSS disability progression is defined here as one of the following: if baseline EDSS 0, EDSS increase ≥ 1.5 points; if baseline EDSS ≥ 1, EDSS increase ≥ 1 point; if baseline EDSS > 5, EDSS increase ≥ 0.5 points. Abbreviations: EDSS, Expanded Disability Status Scale; NEDA, No Evidence of Disease Activity.