Table 3 Mean change ± SD from baseline to final visit (6 months ± 15 days) in the primary and secondary study endpoints (final score—baseline score).

From: Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease

Primary variable

n

Baseline

n

Final

n

Relative change (%)

P value

Effect size (CI 95%)

PDQ-39

58

46.7 ± 13.6

53

33.7 ± 16.9

52

−27.3 ± 30.6

<0.0001

0.87 (0.55,1.19)

Secondary variables (patients)

        

UPDRS-III (ON)

59

30.1 ± 14.2

53

22.9 ± 11.6

53

−22.7 ± 23.6

0.0002

0.55 (0.26,0.84)

NMSS total

59

83.2 ± 32.6

52

48.1 ± 29.8

52

−41.4 ± 34.2

<0.0001

1.15 (0.79,1.50)

VAS Norris/Bond-Lader total

57

42.6 ± 17.6

53

36.6 ± 16.6

51

−12.9 ± 17.1

0.0297

0.31 (0.03,0.59)

PFS-16

57

3.77 ± 0.77

53

3.11 ± 0.90

51

−12.7 ± 17.7

0.0003

0.55 (0.25,0.84)

AS

58

11.4 ± 6.40

53

12.3 ± 6.52

52

0.5 ± 6.9

0.5877

−0.08 (−0.20,0.35)

BDI-II

58

18.1 ± 9.75

53

13.2 ± 10.2

52

−31.3 ± 32.7

0.0002

0.55 (0.25,0.84)

BAI

58

19.8 ± 9.36

53

13.8 ± 10.1

52

−26.9 ± 27.1

<0.0001

0.65 (0.35,0.95)

SATMED-Q

58

52.8 ± 15.7

53

68.9 ± 11.9

52

26.3 ± 16.8

<0.0001

−0.96 (−0.63, −1.29)

Secondary variables (caregivers)

        

SQLC total

54

63.6 ± 26.4

48

66.1 ± 28.7

47

1.7 ± 1.6

0.3126

−0.15 (−0.44,0.14)

ZBI

54

24.9 ± 13.6

48

24.4 ± 14.3

47

−0.4 ± 8.7

0.8321

0.03 (−0.26,0.32)

CSI

54

5.02 ± 3.33

48

4.46 ± 3.25

47

−4.2 ± 9.0

0.1945

0.20 (−0.14,0.38)

Goldberg depression scale

25

5.68 ± 1.95

13

6.00 ± 1.41

10

2.2 ± 2.3

0.7937

–

Goldberg anxiety scale

28

7.18 ± 1.33

15

6.40 ± 1.24

10

−12.9 ± 12.8

0.0234

–

WPAI

        

Outcome score 1 (mean ± SD)

16

12.0 ± 27.5

10

10.6 ± 14.0

9

−1.4 ± 0.7

0.5222

–

Outcome score 2 (mean ± SD)

16

26.4 ± 28.2

10

15.4 ± 18.1

9

−10.8 ± 12.4

1.0000

–

Outcome score 3 (mean ± SD)

16

36.1 ± 33.9

10

25.4 ± 21.8

9

−10.7 ± 12.3

0.6481

–

Outcome score 4 (mean ± SD)

16

25.6 ± 25.3

10

24.0 ± 17.1

9

−1.6 ± 2.9

0.6741

–

  1. UPDRS Unified Parkinson’s Disease Rating Scale (part III, motor examination), ADL Activity of Daily Living, PDQ-39 Parkinson’s Disease Questionnaire 39-item, NMSS Nonmotor Symptom Scale, VAS Visual Analogue Scale, PFS-16 Parkinson’s Fatigue Scale 16-item, AS Apathy Scale, BDI Beck Depression Inventory, BAI Beck Anxiety Inventory, SATMED-Q Satisfaction with the Medication Questionnaire, SQLC Scales of Quality of Life for Caregivers, ZBI Zarit Burden Inventory, CSI Caregiver Strain Index, WPAI Work Productivity And Activity Impairment (Outcome 1: percent work time missed due to APD; Outcome 2: percent impairment while working due to APD; Outcome 3: percent overall work impairment due to APD; and Outcome 4: percent activity impairment due to APD).
  2. Due to the low number of valid data, the effect size of some of the scales/questionnaires haven’t been calculated.
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