Table 4 Observational study known-groups validity hypotheses for HPES-Symptom

Total

PGIS-Overall

Patients with higher levels of severity on PGIS-Overall will have a higher mean score than patients with less severity

1 = No noticeable symptoms/Very mild

18

14.7 (3.54)

Overall < 0.0001

1 vs. 2 0.0035

1 vs. 3 < 0.0001

1 vs. 4 < 0.0001

2 vs. 3 < 0.0001

2 vs. 4 < 0.0001

3 vs. 4 < 0.0001

Yes

2 = Mild

92

28.1 (1.57)

3 = Moderate

160

38.8 (1.19)

4 = Severe/Very severe

30

57.1 (2.74)

Total

SF-36 general health

Patients who report better scores on the SF-36 general health item will have a lower mean score than patients who report worse SF-36 general health scores

1 = Excellent/Very good

62

23.2 (1.96)

Overall < 0.0001

1 vs. 2 < 0.0001

1 vs. 3 < 0.0001

1 vs. 4 < 0.0001

2 vs. 3 < 0.0001

2 vs. 4 < 0.0001

3 vs. 4 0.1606

Yes

2 = Good

156

34.2 (1.24)

3 = Fair

72

47.2 (1.82)

4 = Poor

10

58.6 (4.88)

Total

SDS Days Lost (for RU employment = Yes)

Employed patients with fewer days lost from work (SDS) will have a lower mean score than patients with a greater number of days lost

1 = 25th percentiles or less

84

34.0 (1.70)

0.2534

No

2 = 75th percentiles or more

72

31.1 (1.84)

Total

SDS Unproductive Days (for RU employment = Yes)

Employed patients with fewer unproductive days (SDS) will have a lower mean score than patients with a greater number of unproductive days

1 = 25th percentiles or less

120

27.7 (1.43)

 < 0.0001

Yes (Not planned within the psychometric analysis plan)

2 = 75th percentiles or more

77

42.8 (1.79)

Total

SII Overall

Patients who report greater QOL interference due to their HP overall symptoms will have a higher mean score than patients who report less QOL interference

1 = Not at all/A little

71

21.8 (1.54)

Overall < 0.0001

1 vs. 2 < 0.0001

1 vs. 3 < 0.0001

1 vs. 4 < 0.0001

2 vs. 3 < 0.0001

2 vs. 4 < 0.0001

3 vs. 4 0.1130

Yes

2 = Some

160

33.3 (1.03)

3 = A lot

42

53.4 (2.01)

4 = Extremely

27

60.9 (2.51)

Total

Calcium levels (Question 14)

Patients with lower than normal calcium levels will have higher mean score than patients with normal calcium levels

1 = Much lower than normal

8

58.0 (6.20)

Overall 0.0037

1 vs. 2 0.0016

1 vs. 3 0.0055

1 vs. 4 0.1925

2 vs. 3 0.9655

2 vs. 4 0.9999

3 vs. 4 1.0000

Yes

2 = Slightly lower than normal

193

34.7 (1.26)

3 = Normal

94

36.4 (1.81)

4 = Higher than normal

5

36.9 (7.84)

Physical

PGIS-Physical

Patients with higher levels of severity on PGIS-Physical will have a higher mean score than patients with less severity

1 = No noticeable symptoms/Very mild

20

20.0 (3.63)

Overall < 0.0001

1 vs. 2 0.4848

1 vs. 3 < 0.0001

1 vs. 4 < 0.0001

2 vs. 3 < 0.0001

2 vs. 4 < 0.0001

3 vs. 4 < 0.0001

Yes

2 = Mild

99

26.5 (1.63)

3 = Moderate

140

38.6 (1.37)

4 = Severe/Very severe

41

52.9 (2.53)

Physical

SII Physical

Patients who have greater QOL interference due to their HP physical symptoms will have a higher mean score than patients with less QOL interference

1 = Not at all/A little

144

25.5 (1.12)

Overall < 0.0001

1 vs. 2 0.0002

1 vs. 3 < 0.0001

1 vs. 4 < 0.0001

2 vs. 3 < 0.0001

2 vs. 4 < 0.0001

3 vs. 4 0.0135

Yes

2 = Some

85

33.2 (1.45)

3 = A lot

42

53.6 (2.07)

4 = Extremely

29

63.6 (2.49)

Physical

Calcium levels (Question 14)

Patients with lower than normal calcium levels will have a higher mean score than patients with normal calcium levels (based on Question 14)

1 = Much lower than normal

8

58.6 (6.48)

Overall 0.0026

1 vs. 2 0.0013

1 vs. 3 0.0061

1 vs. 4 0.3043

2 vs. 3 0.8846

2 vs. 4 0.9920

3 vs. 4 0.9998

Yes

2 = Slightly lower than normal

193

33.8 (1.32)

3 = Normal

94

36.2 (1.89)

4 = Higher than normal

5

38.7 (8.20)

Cognitive

PGIS Cognitive

Patients with higher levels of severity on PGIS Cognitive will have a higher mean score than patients with less severity

1 = No noticeable symptoms/Very mild

33

19.1 (3.35)

Overall < 0.0001

1 vs. 2 0.0277

1 vs. 3 < 0.0001

1 vs. 4 < 0.0001

2 vs. 3 < 0.0001

2 vs. 4 < 0.0001

3 vs. 4 0.0823

Yes

2 = Mild

113

30.0 (1.81)

3 = Moderate

107

42.4 (1.86)

4 = Severe/Very severe

47

50.7 (2.81)

Cognitive

SII Cognitive

Patients who report greater impact on QOL interference due to their HP cognitive symptoms will have a higher mean score than patients with less QOL interference

1 = Not at all/A little

117

27.1 (1.61)

Overall < 0.0001

1 vs. 2 0.0108

1 vs. 3 < 0.0001

1 vs. 4 < 0.0001

2 vs. 3 < 0.0001

2 vs. 4 < 0.0001

3 vs. 4 0.3188

Yes

2 = Some

128

34.1 (1.54)

3 = A lot

43

59.8 (2.65)

4 = Extremely

12

70.4 (5.03)