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. 2019 Apr 3;90(7):774–782. doi: 10.1136/jnnp-2018-319448

Table 3.

Secondary outcomes at 6 and 12 months

Visit Mean (SD, n) Mean difference (PDSAFE-Control) (95% CI)* P value*
PDSAFE
(n=238)		 Control
(n=236)
Mini-BESTest
(0–28, lower values worse)		 †Baseline
6 months
6 months-baseline		 18.3 (5.7, n=183)
19.4 (5.9, n=183)
1.1 (3.8, n=183)		 17.3 (6.1, n=211)
17.5 (6.4, n=211)
0.2 (3.8, n=211)		 0.95 (0.24 to 1.67) 0.009
†*Baseline
12 months
12 months-baseline		 18.5 (5.8, n=115)
17.9 (6.5, n=115)
−0.7 (4.5, n=115)		 17.5 (6.1, n=126)
17.4 (6.7, n=126)
−0.2 (3.8, n=126)		 −0.41 (−1.48 to 0.66) 0.449
FES-I
(16–64, higher values worse)		 †Baseline
6 months
6 months-baseline		 34.1 (11.0, n=189)
33.4 (10.6, n=189)
−0.7 (7.9, n=189)		 35.1 (11.5, n=211)
36.2 (11.4, n=211)
1.1 (7.2, n=211)		 −1.6 (−3.0 to −0.19) 0.026
†*Baseline
12 months
12 months-baseline		 33.4 (10.7, n=119)
34.8 (11.2, n=119)
1.3 (8.2, n=119)		 33.7 (11.3, n=135)
37.2 (11.6, n=135)
3.5 (9.3, n=135)		 −1.4 (−3.41 to 0.66) 0.184
PASE
(0–400, lower values worse)		 †Baseline
6 months
6 months-baseline		 107.8 (73.5, n=153)
110.2 (70.4, n=153)
2.4 (50.8, n=153)		 100.1 (67.1, n=177)
100.6 (68.0, n=177)
0.5 (49.5, n=177)		 −1.05 (−11.3 to 9.21) 0.841
†*Baseline
12 months
12 months-baseline		 108.1 (71.9, n=98)
99.4 (72.8, n=98)
−8.7 (53.0, n=98)		 98.6 (61.1, n=115)
87.6 (62.3, n=115)
−11.0 (48.5, n=115)		 −0.55 (−13.9 to 12.8) 0.935
PDQ-39
(0–100, higher values worse)		 †Baseline
6 months
6 months-baseline		 27.4 (14.3, n=126)
28.3 (15.0, n=126)
0.8 (8.3, n=126)		 28.7 (15.9, n=153)
29.5 (16.5, n=153)
0.9 (9.0, n=153)		 0.12 (−2.0 to 2.28) 0.911
†*Baseline
12 months
12 months-baseline		 27.2 (13.6, n=77)
29.1 (15.4, n=77)
1.9 (8.6, n=77)		 28.9 (15.9, n=100)
31.7 (15.5, n=100)
2.8 (11.2, n=100)		 0.48 (−2.53 to 3.49) 0.754
GDS
(0–15, higher values worse)		 †Baseline
6 months
6 months-baseline		 7.7 (2.3, n=154)
7.8 (2.5, n=154)
0.3 (1.8, n=154)		 7.7 (2.1, n=183)
8.0 (2.5, n=183)
0.2 (1.9, n=183)		 −0.02 (−0.42 to 0.39) 0.942
†*Baseline
12 months
12 months-baseline		 7.7 (2.1, n=96)
7.8 (2.5, n=96)
0.2 (2.0, n=96)		 8.0 (2.2, n=118)
8.5 (2.4, n=118)
0.4 (1.7, n=118)		 −0.21 (−0.72 to 0.31) 0.421

*Controlled for site, age, gender, repeat falling or not in the year prior to screening, log number of falls in the year prior to falling, log rate of falling in the prerandomisation falls collection period, Hoehn and Yahr and the outcome in question assessed at baseline.

†Baseline results restricted to existing participant assessment at 6 months.

FES-I, Falls Efficacy Scale International; GDS, Geriatric Depression Scale; PASE, Physical Activity Scale for the Elderly; PDQ-39, Parkinson’s Disease Questionnaire.