Table 2.
Statistical information for all measured variables.
| Category (No. of measures) | Biomarker abbreviation | Biomarker description | IPPOMS1 |
IPPOMS2 |
RIVITALISE |
|||
|---|---|---|---|---|---|---|---|---|
| Mean% Δ | SD | z-scorea | p-value Δ (t-test)b | p-value Δ (t-test)c | p-value Δ (t-test)c | |||
| Clinical (8) | EDSS | Expanded Disability Status Scale | 6.48 | 14.15 | 0.4580 | 0.0116 | 0.0109 | 0.3293d |
| SNRS | Scripps Neurological Rating Scale | −4.54 | 8.71 | 0.5212 | 0.0046 | 0.0052 | 0.0766 | |
| 25FW | 25 Foot Walk (average of two attempts) | 64.52 | 193.12 | 0.3341 | 0.0029 | 0.1537 | 0.3293 | |
| 9HPT | 9 Hole Peg test (average of two attempts per hand) | 18.73 | 86.89 | 0.2156 | 0.1341 | |||
| PASAT | Paces Auditory Serial Addition Test | 5.72 | 23.88 | 0.2395 | 0.3438 | |||
| MSFC | MS functional composite (Composite of 25FW, 9HPT, and PASAT) | −11.24 | 277.32 | 0.0405 | 0.3197 | |||
| SDMT | Symbol Digit Modality Test (# correct) | −2.26 | 12.13 | 0.1863 | 0.2930 | |||
| CombiWISE | Composite of EDSS, SNRS, 25FW, and 9HPT | 9.10 | 13.23 | 0.6878 | 0.0003 | 0.0107 | 0.0445 | |
| Electrophysiological (1) | Σ CMCT | Sum of 6 central motor conduction times, one per each upper and two per each lower extremity | 5.07 | 21.18 | 0.2394 | 0.1852 | ||
| Imaging-volumetric (7) | V-SIENA | Change in brain volume (SIENA method) | −0.70 | 1.70 | 0.4118 | 0.0178 | 0.0980 | 0.6454 |
| V-Brain | Brain volume (LesionTOADS method) | −0.12 | 2.17 | 0.0553 | 0.9803 | |||
| V-Ventricles | Ventricular volume (LesionTOADS method) | 3.45 | 7.01 | 0.4922 | 0.0081 | 0.0032 | 0.0249 | |
| V-CorticalGM | Volume of cortical gray matter (LesionTOADS method) | 1.26 | 15.71 | 0.0802 | 0.4792 | |||
| V-Thalamus | Volume of thalamus (LesionTOADS method) | −3.84 | 8.86 | 0.4334 | 0.0084 | 0.4416 | 0.4314 | |
| V-Caudate + Putamen | Volume of caudate and putamen (LesionTOADS method) | −1.61 | 13.65 | 0.1179 | 0.3879 | |||
| A-CS-Dens | Cross-sectional area of spinal cord (dens level) | −0.31 | 23.04 | 0.0135 | 0.9418 | |||
| Imaging-OCT (1) | OCT | Optical coherence tomography | −1.48 | 4.72 | 0.3136 | 0.0970 | ||
| Imaging-qT1 (9) | qT1-IC | qT1 of anterior limb of internal capsule | 1.71 | 4.84 | 0.3533 | 0.1155 | ||
| qT1-CC | qT1 of corpus callosum | 1.21 | 5.64 | 0.2145 | 0.2507 | |||
| qT1-Caudate | qT1 of the head of the caudate nucleus | 1.71 | 5.84 | 0.2928 | 0.2369 | |||
| qT1-Putamen | qT1 of putamen | 0.99 | 5.47 | 0.1810 | 0.3304 | |||
| qT1-Thalamus | qT1 of thalamus | 2.09 | 5.00 | 0.4180 | 0.0296 | 0.6820 | 0.4314 | |
| qT1-Midbrain | qT1 of midbrain (axial section) | 0.93 | 5.22 | 0.1782 | 0.3394 | |||
| qT1-Pons | qT1 of pons (sagittal section) | 0.00 | 5.06 | 0.0000 | 0.9975 | |||
| qT1-Medulla | qT1 of medulla (axial section) | 0.19 | 5.95 | 0.0319 | 0.8598 | |||
| qT1-SC-Dens | qT1 of spinal cord (dens level; axial section) | 1.46 | 31.53 | 0.0463 | 0.1655 | |||
| Imaging-DTI Tortoise (32) | DTI-T-IC | Radial diffusivity of internal capsule (anterior) | 0.78 | 9.56 | 0.0816 | 0.6584 | ||
| DTI-II-IC | Axial diffusivity of internal capsule (anterior) | 3.69 | 12.19 | 0.3027 | 0.1455 | |||
| DTI-MD-IC | Mean diffusivity of internal capsule (anterior) | 2.23 | 6.85 | 0.3255 | 0.0853 | |||
| DTI-FA-IC | Fractional anisotropy of internal capsule (anterior) | 2.47 | 11.26 | 0.2194 | 0.4937 | |||
| DTI-T-ICPost | Radial diffusivity of internal capsule (posterior) | 1.30 | 11.15 | 0.1166 | 0.5279 | |||
| DTI-II-ICPost | Axial diffusivity of internal capsule (posterior) | 2.66 | 8.68 | 0.3065 | 0.1064 | |||
| DTI-MD-ICPost | Mean diffusivity of internal capsule (posterior) | 1.89 | 6.25 | 0.3024 | 0.1080 | |||
| DTI-FA-ICPost | Fractional anisotropy of internal capsule (posterior) | 1.24 | 7.12 | 0.1742 | 0.7887 | |||
| DTI-T-CC | Radial diffusivity of corpus callosum | −1.77 | 14.81 | 0.1195 | 0.5172 | |||
| DTI-II-CC | Axial diffusivity of corpus callosum | 1.69 | 7.51 | 0.2250 | 0.4837 | |||
| DTI-MD-CC | Mean diffusivity of corpus callosum | 0.59 | 7.12 | 0.0829 | 0.6513 | |||
| DTI-FA-CC | Fractional anisotropy of corpus callosum | 1.40 | 4.15 | 0.3373 | 0.1439 | |||
| DTI-T-Caudate | Radial diffusivity of the head of the caudate | 4.78 | 8.89 | 0.5377 | 0.0063 | 0.0032 | 0.0783 | |
| DTI-II-Caudate | Axial diffusivity of the head of the caudate | 3.14 | 7.52 | 0.4176 | 0.0294 | 0.0035 | 0.0342 | |
| DTI-MD-Caudate | Mean diffusivity of the head of the caudate | 4.06 | 7.72 | 0.5259 | 0.0074 | 0.0032 | 0.0457 | |
| DTI-FA-Caudate | Fractional anisotropy of the head of the caudate | −2.48 | 14.25 | 0.1740 | 0.3480 | |||
| DTI-T-Putamen | Radial diffusivity of the putamen | 0.92 | 7.16 | 0.1285 | 0.9322 | |||
| DTI-II-Putamen | Axial diffusivity of the putamen | 2.18 | 6.59 | 0.3308 | 0.0810 | |||
| DTI-MD-Putamen | Mean diffusivity of the putamen | 1.40 | 6.62 | 0.2115 | 0.5137 | |||
| DTI-FA-Putamen | Fractional anisotropy of the putamen | 7.27 | 18.92 | 0.3842 | 0.0443 | 0.0052 | 0.6454 | |
| DTI-T-Thalamus | Radial diffusivity of the thalamus | 1.16 | 5.64 | 0.2057 | 0.2674 | |||
| DTI-II-Thalamus | Axial diffusivity of the thalamus | 1.63 | 6.22 | 0.2621 | 0.1608 | |||
| DTI-MD-Thalamus | Mean diffusivity of the thalamus | 1.35 | 5.40 | 0.2500 | 0.1817 | |||
| DTI-FA-Thalamus | Fractional anisotropy of the thalamus | 2.21 | 11.16 | 0.1980 | 0.2874 | |||
| DTI-T-Midbrain | Radial diffusivity of the midbrain (axial section) | 3.17 | 10.42 | 0.3042 | 0.1063 | |||
| DTI-II-Midbrain | Axial diffusivity of the midbrain (axial section) | 3.40 | 10.91 | 0.3116 | 0.1558 | |||
| DTI-MD-Midbrain | Mean diffusivity of the midbrain (axial section) | 3.01 | 7.99 | 0.3767 | 0.0484 | 0.0433 | 0.0018 | |
| DTI-FA-Midbrain | Fractional anisotropy of the midbrain (axial section) | 1.60 | 11.73 | 0.1364 | 0.8951 | |||
| DTI-T-Medulla | Radial diffusivity of the medulla (axial section) | 6.58 | 10.61 | 0.6202 | 0.0020 | 0.0034 | 0.0157 | |
| DTI-II-Medulla | Axial diffusivity of the medulla (axial section) | 2.13 | 7.16 | 0.2975 | 0.1132 | |||
| DTI-MD-Medulla | Mean diffusivity of the medulla (axial section) | 4.46 | 8.17 | 0.5459 | 0.0057 | 0.0032 | 0.0138 | |
| DTI-FA-Medulla | Fractional anisotropy of the medulla (axial section) | −5.19 | 14.96 | 0.3469 | 0.0673 | |||
One-sample t-test was used to calculate p-values for the tests for the yearly change for each variable. P-values in bold highlight variables that showed significant at the 5% level.
az-score was calculated by dividing the mean group change over 1 year by the group SD.
bRaw p-values are displayed.
cOnly variables that showed statistical significance in IPPOMS1 cohort were subjected to statistical testing in IPPOMS2 and RIVITALISE cohorts. p-values are adjusted for tests performed on 15 variables using step-down Sidak method.
dt-test performed on the whole dataset – outlier removal would eliminate 32% of subjects from the cohort.