Table 2

Sensitivity and specificity, with the corresponding 95% CI, of the ALSFRS-R decline and the ALS-MITOS worsening from baseline to 6 months compared to the primary composite outcome (ie, survival, tracheotomy or >23 h non-invasive ventilation) at 12 and 18 months

ScaleCompared to primary outcome at 12 monthsCompared to primary outcome at 18 months
Sensitivity
(95% CI)
Specificity
(95% CI)
Sensitivity
(95% CI)
Specificity
(95% CI)
6-month ALSFRS-R decline
 6 points93%
(86% to 100%)
58%
(50% to 66%)
83%
(74% to 92%)
63%
(54% to 72%)
 7 points87%
(77% to 97%)
64%
(56% to 72%)
76%
(66% to 86%)
69%
(61% to 78%)
 8 points82%
(71% to 93%)
69%
(62% to 77%)
71%
(61% to 82%)
75%
(67% to 83%)
 9 points80%
(68% to 92%)
75%
(68% to 82%)
69%
(58% to 79%)
80%
(73% to 88%)
6-month ALS-MITOS system worsening
 1 function82%
(71% to 93%)
63%
(55% to 71%)
71%
(61% to 82%)
68%
(60% to 77%)
  • ALS, amyotrophic lateral sclerosis; ALSFRS-R, Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised; ALS-MITOS, ALS Milano-Torino staging.