Table 2.
Variable | PD subjects | Healthy controls (HC) | p-Values | |||||||
Baseline (n=423) | Year 1 (n=398) | Year 2 (n=380) | p Value (change over time) | Baseline (n=196) | Year 1 (n=185) | Year 2 (n=174) | p Value (change over time) | Group*Visit Interaction |
PD versus HC | |
MDS-UPDRS Part I score | ||||||||||
Mean (SD) | 5.57 (4.06) | 6.78 (4.60) | 7.68 (5.02) | <0.0001 | 2.94 (2.96) | 3.21 (3.21) | 3.18 (3.03) | 0.3817 | <0.0001 | N/A* |
(Min, Max) | (0.00, 24.00) | (0.00, 29.00) | (0.00, 26.00) | (0.00, 17.00) | (0.00, 16.00) | (0.00, 14.00) | ||||
Missing | 1 | 3 | 4 | 1 | 0 | 1 | ||||
Cognitive impairment | ||||||||||
Normal | 315 (74.64%) | 279 (71.36%) | 242 (64.36%) | 0.0007 | 176 (90.26%) | 170 (91.89%) | 149 (86.13%) | 0.1354 | 0.5412 | <0.0001 |
Slight | 94 (22.27%) | 95 (24.30%) | 102 (27.13%) | 18 (9.23%) | 15 (8.11%) | 24 (13.87%) | ||||
Mild | 13 (3.08%) | 15 (3.84%) | 25 (6.65%) | 1 (0.51%) | 0 (0.00%) | 0 (0.00%) | ||||
Moderate | 0 (0.00%) | 2 (0.51%) | 7 (1.86%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Severe | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Hallucinations and psychosis | ||||||||||
Normal | 409 (96.92%) | 372 (95.14%) | 347 (92.29%) | 0.0057 | 194 (99.49%) | 185 (100.00%) | 171 (98.84%) | N/A† | N/A† | <0.0001 |
Slight | 13 (3.08%) | 19 (4.86%) | 24 (6.38%) | 1 (0.51%) | 0 (0.00%) | 2 (1.16%) | ||||
Mild | 0 (0.00%) | 0 (0.00%) | 4 (1.06%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Moderate | 0 (0.00%) | 0 (0.00%) | 1 (0.27%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Severe | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Depressed mood | ||||||||||
Normal | 322 (76.30%) | 277 (70.84%) | 260 (69.15%) | 0.0111 | 171 (87.69%) | 163 (88.11%) | 153 (88.44%) | 0.9070 | 0.2815 | <0.0001 |
Slight | 85 (20.14%) | 86 (21.99%) | 81 (21.54%) | 21 (10.77%) | 16 (8.65%) | 16 (9.25%) | ||||
Mild | 14 (3.32%) | 23 (5.88%) | 23 (6.12%) | 2 (1.03%) | 4 (2.16%) | 4 (2.31%) | ||||
Moderate | 0 (0.00%) | 5 (1.28%) | 10 (2.66%) | 0 (0.00%) | 2 (1.08%) | 0 (0.00%) | ||||
Severe | 1 (0.24%) | 0 (0.00%) | 2 (0.53%) | 1 (0.51%) | 0 (0.00%) | 0 (0.00%) | ||||
Anxious mood | ||||||||||
Normal | 271 (64.22%) | 257 (65.73%) | 253 (67.29%) | 0.5020 | 157 (80.51%) | 155 (83.78%) | 147 (84.97%) | 0.2748 | 0.6480 | <0.0001 |
Slight | 130 (30.81%) | 101 (25.83%) | 95 (25.27%) | 34 (17.44%) | 24 (12.97%) | 23 (13.29%) | ||||
Mild | 17 (4.03%) | 29 (7.42%) | 18 (4.79%) | 3 (1.54%) | 6 (3.24%) | 3 (1.73%) | ||||
Moderate | 3 (0.71%) | 4 (1.02%) | 9 (2.39%) | 1 (0.51%) | 0 (0.00%) | 0 (0.00%) | ||||
Severe | 1 (0.24%) | 0 (0.00%) | 1 (0.27%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Apathy | ||||||||||
Normal | 351 (83.18%) | 301 (76.98%) | 278 (73.94%) | 0.0002 | 186 (95.38%) | 178 (96.22%) | 165 (95.38%) | 0.8919 | 0.3936 | <0.0001 |
Slight | 60 (14.22%) | 62 (15.86%) | 63 (16.76%) | 8 (4.10%) | 6 (3.24%) | 7 (4.05%) | ||||
Mild | 10 (2.37%) | 25 (6.39%) | 27 (7.18%) | 1 (0.51%) | 1 (0.54%) | 1 (0.58%) | ||||
Moderate | 0 (0.00%) | 3 (0.77%) | 7 (1.86%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Severe | 1 (0.24%) | 0 (0.00%) | 1 (0.27%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Dopamine dysregulation syndrome | ||||||||||
Normal | 413 (97.87%) | 382 (97.70%) | 353 (94.13%) | 0.0188 | 192 (98.46%) | 185 (100.00%) | 171 (98.84%) | N/A† | N/A† | 0.0006 |
Slight | 8 (1.90%) | 7 (1.79%) | 17 (4.53%) | 3 (1.54%) | 0 (0.00%) | 2 (1.16%) | ||||
Mild | 1 (0.24%) | 2 (0.51%) | 5 (1.33%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Moderate | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Severe | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Sleep problems | ||||||||||
Normal | 198 (46.92%) | 163 (41.69%) | 152 (40.43%) | 0.0655 | 110 (56.41%) | 94 (50.81%) | 95 (54.91%) | 0.2950 | 0.3815 | 0.0010 |
Slight | 125 (29.62%) | 106 (27.11%) | 100 (26.60%) | 53 (27.18%) | 55 (29.73%) | 39 (22.54%) | ||||
Mild | 62 (14.69%) | 79 (20.20%) | 80 (21.28%) | 19 (9.74%) | 23 (12.43%) | 24 (13.87%) | ||||
Moderate | 26 (6.16%) | 35 (8.95%) | 31 (8.24%) | 10 (5.13%) | 11 (5.95%) | 13 (7.51%) | ||||
Severe | 11 (2.61%) | 8 (2.05%) | 13 (3.46%) | 3 (1.54%) | 2 (1.08%) | 2 (1.16%) | ||||
Daytime sleepiness | ||||||||||
Normal | 213 (50.47%) | 150 (38.36%) | 118 (31.38%) | <0.0001 | 127 (65.13%) | 117 (63.24%) | 102 (58.96%) | 0.2332 | 0.0228 | N/A* |
Slight | 123 (29.15%) | 133 (34.02%) | 132 (35.11%) | 49 (25.13%) | 42 (22.70%) | 46 (26.59%) | ||||
Mild | 84 (19.91%) | 106 (27.11%) | 119 (31.65%) | 18 (9.23%) | 25 (13.51%) | 25 (14.45%) | ||||
Moderate | 2 (0.47%) | 1 (0.26%) | 4 (1.06%) | 1 (0.51%) | 1 (0.54%) | 0 (0.00%) | ||||
Severe | 0 (0.00%) | 1 (0.26%) | 3 (0.80%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Pain and other sensations | ||||||||||
Normal | 201 (47.63%) | 168 (42.97%) | 142 (37.77%) | 0.0034 | 130 (66.67%) | 114 (61.96%) | 112 (64.74%) | 0.4874 | 0.2124 | <0.0001 |
Slight | 168 (39.81%) | 151 (38.62%) | 171 (45.48%) | 53 (27.18%) | 55 (29.89%) | 46 (26.59%) | ||||
Mild | 32 (7.58%) | 39 (9.97%) | 38 (10.11%) | 5 (2.56%) | 7 (3.80%) | 9 (5.20%) | ||||
Moderate | 17 (4.03%) | 30 (7.67%) | 19 (5.05%) | 6 (3.08%) | 7 (3.80%) | 6 (3.47%) | ||||
Severe | 4 (0.95%) | 3 (0.77%) | 6 (1.60%) | 1 (0.51%) | 1 (0.54%) | 0 (0.00%) | ||||
Urinary problems | ||||||||||
Normal | 207 (49.05%) | 170 (43.48%) | 160 (42.55%) | 0.0228 | 148 (75.90%) | 139 (75.54%) | 133 (76.88%) | 0.9005 | 0.3128 | <0.0001 |
Slight | 165 (39.10%) | 160 (40.92%) | 142 (37.77%) | 39 (20.00%) | 33 (17.93%) | 31 (17.92%) | ||||
Mild | 35 (8.29%) | 45 (11.51%) | 52 (13.83%) | 6 (3.08%) | 11 (5.98%) | 8 (4.62%) | ||||
Moderate | 11 (2.61%) | 14 (3.58%) | 19 (5.05%) | 2 (1.03%) | 1 (0.54%) | 1 (0.58%) | ||||
Severe | 4 (0.95%) | 2 (0.51%) | 3 (0.80%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Constipation | ||||||||||
Normal | 282 (66.82%) | 206 (52.69%) | 187 (49.73%) | <0.0001 | 171 (87.69%) | 161 (87.03%) | 153 (88.44%) | 0.7779 | 0.0272 | N/A* |
Slight | 109 (25.83%) | 139 (35.55%) | 135 (35.90%) | 21 (10.77%) | 22 (11.89%) | 18 (10.40%) | ||||
Mild | 26 (6.16%) | 36 (9.21%) | 40 (10.64%) | 2 (1.03%) | 2 (1.08%) | 2 (1.16%) | ||||
Moderate | 5 (1.18%) | 10 (2.56%) | 14 (3.72%) | 1 (0.51%) | 0 (0.00%) | 0 (0.00%) | ||||
Severe | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Lightheadedness | ||||||||||
Normal | 311 (73.70%) | 274 (70.08%) | 244 (64.89%) | 0.0061 | 175 (89.74%) | 163 (88.11%) | 157 (90.75%) | 0.6703 | 0.2232 | <0.0001 |
Slight | 96 (22.75%) | 97 (24.81%) | 99 (26.33%) | 20 (10.26%) | 19 (10.27%) | 16 (9.25%) | ||||
Mild | 12 (2.84%) | 18 (4.60%) | 23 (6.12%) | 0 (0.00%) | 3 (1.62%) | 0 (0.00%) | ||||
Moderate | 3 (0.71%) | 2 (0.51%) | 9 (2.39%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Severe | 0 (0.00%) | 0 (0.00%) | 1 (0.27%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Fatigue | ||||||||||
Normal | 210 (49.76%) | 181 (46.29%) | 161 (42.82%) | 0.0524 | 146 (74.87%) | 131 (70.81%) | 119 (68.79%) | 0.2992 | 0.9097 | <0.0001 |
Slight | 165 (39.10%) | 144 (36.83%) | 138 (36.70%) | 44 (22.56%) | 46 (24.86%) | 48 (27.75%) | ||||
Mild | 34 (8.06%) | 51 (13.04%) | 62 (16.49%) | 2 (1.03%) | 5 (2.70%) | 6 (3.47%) | ||||
Moderate | 10 (2.37%) | 13 (3.32%) | 12 (3.19%) | 3 (1.54%) | 3 (1.62%) | 0 (0.00%) | ||||
Severe | 3 (0.71%) | 2 (0.51%) | 3 (0.80%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | ||||
Cognitive/psychiatric subdomain | ||||||||||
Mean (SD) | 1.23 (1.57) | 1.53 (1.85) | 1.87 (2.27) | <0.0001 | 0.54 (1.08) | 0.48 (1.13) | 0.52 (1.01) | 0.6261 | <0.0001 | N/A* |
(Min, Max) | (0.00, 13.00) | (0.00, 10.00) | (0.00, 14.00) | (0.00, 8.00) | (0.00, 8.00) | (0.00, 5.00) | ||||
Missing | 1 | 7 | 4 | 1 | 0 | 1 | ||||
Score=0 | 177 (41.94%) | 150 (38.36%) | 129 (34.31%) | 137 (70.26%) | 140 (75.68%) | 122 (70.52%) | ||||
One or above | 245 (58.06%) | 241 (61.64%) | 247 (65.69%) | 0.0290 | 58 (29.74%) | 45 (24.32%) | 51 (29.48%) | 0.2169 | 0.1156 | <0.0001 |
Two or above | 134 (31.75%) | 148 (37.85%) | 164 (43.62%) | 0.0001 | 27 (13.85%) | 18 (9.73%) | 20 (11.56%) | 0.2925 | 0.0204 | N/A* |
Sleep subdomain | ||||||||||
Mean (SD) | 1.58 (1.49) | 1.93 (1.55) | 2.13 (1.60) | <0.0001 | 1.13 (1.30) | 1.28 (1.30) | 1.33 (1.39) | 0.0737 | 0.0089 | N/A* |
(Min, Max) | (0.00, 7.00) | (0.00, 8.00) | (0.00, 8.00) | (0.00, 6.00) | (0.00, 5.00) | (0.00, 6.00) | ||||
Missing | 1 | 7 | 4 | 1 | 0 | 1 | ||||
Score=0 | 123 (29.15%) | 87 (22.25%) | 70 (18.62%) | 83 (42.56%) | 63 (34.05%) | 64 (36.99%) | ||||
One or above | 299 (70.85%) | 304 (77.75%) | 306 (81.38%) | 0.0003 | 112 (57.44%) | 122 (65.95%) | 109 (63.01%) | 0.1001 | 0.2159 | <0.0001 |
Two or above | 187 (44.31%) | 221 (56.52%) | 235 (62.50%) | <0.0001 | 63 (32.31%) | 63 (34.05%) | 67 (38.73%) | 0.2330 | 0.0259 | N/A* |
Autonomic subdomain | ||||||||||
Mean (SD) | 1.40 (1.37) | 1.74 (1.48) | 1.99 (1.70) | <0.0001 | 0.54 (0.81) | 0.59 (0.86) | 0.51 (0.85) | 0.4648 | <0.0001 | N/A* |
(Min, Max) | (0.00, 7.00) | (0.00, 10.00) | (0.00, 8.00) | (0.00, 4.00) | (0.00, 4.00) | (0.00, 5.00) | ||||
Missing | 1 | 7 | 4 | 1 | 0 | 1 | ||||
Score=0 | 127 (30.09%) | 88 (22.51%) | 75 (19.95%) | 120 (61.54%) | 111 (60.00%) | 113 (65.32%) | ||||
One or above | 295 (69.91%) | 303 (77.49%) | 301 (80.05%) | 0.0002 | 75 (38.46%) | 74 (40.00%) | 60 (34.68%) | 0.3327 | 0.0060 | N/A* |
Two or above | 162 (38.39%) | 198 (50.64%) | 209 (55.59%) | <0.0001 | 21 (10.77%) | 26 (14.05%) | 19 (10.98%) | 0.4175 | 0.0432 | N/A* |
Report generated on data submitted as of 04 January 2016.
p Values for individual Part I items are from logistic models considering response=0 versus any other response.
*PD versus HC comparison is not applicable if test of interaction was significant. A significant test of interaction means the rates of change over time are different between the two groups.
†Test could not be performed because all subjects from one group are in only one category for at least one time point.
MDS-UPDRS, Movement Disorder Society Unified Parkinson’s Disease Rating Scale; N/A, not applicable;PD, Parkinson’s disease.