Table 3.
UPDRS and DRS-II scores
|
Baseline |
1 year |
Change between baseline and 1 year |
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Surgery |
Medical therapy |
Surgery |
Medical therapy |
Difference in means at 1 year (95% CI) | p |
Surgery |
Medical therapy |
Difference in the mean change (95% CI) | p | |||||||
| n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | |||||
| UPDRS* | ||||||||||||||||
| Part I: mental | 176 | 2·3 (1·7) | 181 | 2·2 (1·6) | 154 | 2·3 (1·8) | 151 | 2·5 (1·7) | −0·2 (−0·6 to 0·2) | 0·29 | 148 | −0·01 (1·8) | 149 | 0·3 (1·6) | −0·3 (−0·7 to 0·1) | 0·15 |
| Part II: activities of daily living (on) | 170 | 9·9 (6·5) | 172 | 10·3 (6·0) | 150 | 9·9 (5·9) | 146 | 10·9 (6·5) | −1·0 (−2·4 to 0·4) | 0·16 | 142 | 0·3 (6·4) | 138 | 1·0 (5·1) | −0·6 (−2·0 to 0·7) | 0·36 |
| Part II: activities of daily living (off) | 162 | 23·8 (7·2) | 167 | 24·7 (7·3) | 130 | 17·6 (8·1) | 139 | 23·9 (7·6) | −6·3 (−8·2 to −4·4) | <0·0001 | 123 | −6·9 (7·2) | 129 | −0·5 (5·9) | −6·4 (−8·0 to −4·7) | <0·0001 |
| Part III: motor (on) | 165 | 18·9 (11·4) | 164 | 20·1 (11·4) | 146 | 16·0 (8·8) | 136 | 20·4 (10·8) | −4·5 (−6·8 to −2·2) | 0·0001 | 135 | −3·3 (9·4) | 124 | 0·8 (9·1) | −4·0 (−6·3 to −1·8) | 0·0006 |
| Part III: motor (off) | 161 | 47·6 (14·0) | 162 | 48·6 (14·3) | 126 | 30·6 (15·2) | 135 | 47·3 (15·4) | −16·6 (−20·4 to −12·9) | <0·0001 | 119 | −17·2 (13·1) | 123 | −0·4 (13·3) | −16·8 (−20·1 to −13·4) | <0·0001 |
| Part IV: complications of therapy | 145 | 9·0 (3·4) | 145 | 9·1 (3·4) | 119 | 4·5 (3·1) | 118 | 9·0 (3·7) | −4·6 (−5·4 to −3·7) | <0·0001 | 106 | −4·4 (3·8) | 112 | −0·2 (2·8) | −4·2 (−5·1 to −3·3) | <0·0001 |
| Total (I–III) score (on) | 161 | 30·9 (16·6) | 159 | 32·6 (16·3) | 141 | 28·1 (13·8) | 132 | 34·0 (15·6) | −5·9 (−9·5 to −2·4) | 0·001 | 128 | −2·8 (14·2) | 116 | 2·5 (11·5) | −5·4 (−8·6 to −2·1) | 0·002 |
| Total (I–III) score (off) | 155 | 73·1 (19·7) | 158 | 75·7 (20·0) | 121 | 50·9 (21·3) | 127 | 73·3 (21·7) | −22·4 (−27·8 to −17·1) | <0·0001 | 114 | −23·7 (17·5) | 113 | −0·5 (18·0) | −23·2 (−27·9 to −18·6) | <0·0001 |
| Total (I–IV) score (on) | 136 | 39·6 (17·8) | 129 | 39·5 (15·4) | 111 | 32·7 (14·6) | 107 | 41·6 (16·3) | −8·9 (−13·0 to −4·7) | <0·0001 | 95 | −6·6 (15·3) | 91 | 1·6 (12·2) | −8·3 (−12·3 to −4·3) | <0·0001 |
| Total (I–IV) score (off) | 137 | 81·5 (21·4) | 132 | 83·6 (21·0) | 100 | 55·6 (22·4) | 105 | 81·9 (24·3) | −26·3 (−32·8 to −19·9) | <0·0001 | 89 | −27·4 (18·9) | 91 | −0·9 (20·1) | −26·6 (−32·3 to −20·9) | <0·0001 |
| Cognition† | ||||||||||||||||
| DRS-II | 159 | 10·7 (2·8) | 156 | 10·4 (2·9) | 126 | 10·6 (3·2) | 144 | 10·1 (3·0) | 0·5 (−0·3 to 1·2) | 0·20 | 121 | −0·4 (3·5) | 133 | −0·4 (2·9) | 0·05 (−0·7 to 0·8) | 0·90 |
UPDRS=unified Parkinson's disease rating scale. DRS-II=dementia rating scale II.
177 patients in the surgery group and 181 in the medical therapy group were assessed at baseline, and 155 in the surgery group and 152 in the medical therapy group were assessed at 1 year. Data on 150 patients in each group were included in assessments of mean changes between baseline and 1 year. The numbers analysed for each part of the UPDRS are different because of missing data. There are no imputation methods for the UPDRS. UPDRS score ranges: mental 0–16; activities of daily living 0–52; motor 0–108; complications 0–23; total (parts I–III) 0–176; total (parts I–IV) 0–199 (high scores=worse clinical assessment of the patient's Parkinson's disease). UPDRS negative change=improvement.
When the trial started patients were allowed to complete either the mini-mental state examination or DRS-II; therefore data on the DRS-II were not available for all patients. DRS-II range: 0–18 (high score=better cognitive function). DRS-II negative change=deterioration.