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Table 7 Mean change in PROMIS SD-SF-8b total score: PGI-S SD and PGI-C SD categories

From: Psychometric evaluation of the PROMIS SD-SF-8b instrument in individuals experiencing vasomotor symptoms due to menopause

Categories

N

Mean change

Median change

95% CI

PGI-S SD

 Baseline to week 4

  All categories

   Improved 3 points

6

– 19.00

– 20.50

– 29.09, – 8.91

   Improved 2 points

102

– 12.25

– 12.00

– 13.66, – 10.85

   Improved 1 point

341

– 6.07

– 6.00

– 6.65, – 5.49

   No change

377

– 1.02

– 1.00

– 1.58, – 0.46

   Worsened 1 point

97

3.70

4.00

2.53, 4.88

   Worsened 2 points

9

10.56

9.00

6.58, 14.53

   Worsened 3 points

0

   

  Collapsed categories

   Improved ≥ 2 points (collapsed)

108

– 12.63

– 13.00

– 14.04, – 11.22

   Worsened ≥ 2 points (collapsed)

9

10.56

9.00

6.58, 14.53

 Baseline to week 12

  All categories

   Improved 3 points

12

– 18.33

– 22.00

– 23.43, – 13.23

   Improved 2 points

120

– 11.28

– 11.50

– 12.51, – 10.04

   Improved 1 point

313

– 6.30

– 6.00

– 6.92, – 5.68

   No change

311

– 1.17

– 1.00

– 1.78, – 0.57

   Worsened 1 point

98

3.35

3.00

2.16, 4.53

   Worsened 2 points

10

7.30

7.00

2.73, 11.87

   Worsened 3 points

0

   

  Collapsed categories

   Improved ≥ 2 points (collapsed)

132

– 11.92

– 12.00

– 13.16, – 10.67

   Worsened ≥ 2 points (collapsed)

10

7.30

7.00

2.73, 11.87

PGI-C SD

 Baseline to week 4

  All categories

   Much better

160

– 10.98

– 10.00

– 12.12, – 9.84

   Moderately better

152

– 5.93

– 6.00

– 6.86, – 4.99

   A little better

265

– 3.80

– 4.00

– 4.51, – 3.09

   No change

291

0.33

0.00

– 0.32, 0.98

   A little worse

39

2.82

4.00

0.52, 5.12

   Moderately worse

16

3.38

4.00

0.86, 5.89

   Much worse

8

4.63

5.00

0.09, 9.16

  Collapsed categories

   Much or moderately better

312

– 8.52

– 8.00

– 9.31, – 7.73

   Moderately worse or much worse

24

3.79

4.00

1.73, 5.85

   Improvement

577

– 6.35

– 6.00

– 6.92, – 5.78

   No change

291

0.33

0.00

– 0.32, 0.98

   Worsening

63

3.19

4.00

1.60, 4.78

 Baseline to week 12

  All categories

   Much better

189

– 9.69

– 10.00

– 10.71, – 8.67

   Moderately better

170

– 5.87

– 6.00

– 6.77, – 4.97

   A little better

231

– 3.59

– 3.00

– 4.45, – 2.74

   No change

198

– 0.56

0.00

– 1.38, 0.26

   A little worse

37

3.00

2.00

1.20, 4.80

   Moderately worse

29

4.03

4.00

1.72, 6.35

   Much worse

8

6.63

4.50

1.90, 11.35

  Collapsed categories

   Much or moderately better

359

– 7.88

– 8.00

– 8.59, – 7.17

   Moderately worse or much worse

37

4.59

4.00

2.59, 6.60

   Improvement

590

– 6.20

– 6.00

– 6.77, – 5.63

   No change

198

– 0.56

0.00

– 1.38, 0.26

   Worsening

74

3.80

3.00

2.47, 5.13

  1. Bolded categories were used for the triangulation of meaningful change thresholds
  2. CI Confidence interval, PGI-C SD Patient Global Impression of Change Sleep Disturbance, PGI-S SD Patient Global Impression of Severity Sleep Disturbance, PROMIS SD-SF-8b Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b