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Table 4 PROMIS GH item and domain scores over time (mean ± SD), by participant group

From: Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept

PROMIS GH item/ domaina

Active recurrence (A-RP)

Not symptomatic, Corticosteroid-dependent (CSD-RP)

Baseline (n = 16)

End of TP visit (n = 15)

End of EP visit (n = 15)

ES (95%CI)b

Baseline (n = 7)

End of TP visit (n = 9)

End of EP visit (n = 8)

ES (95%CI)b

GPH

39.94 ± 8.94

51.35 ± 7.96

51.32 ± 6.56

1.44 (0.65 to 2.23)

43.30 ± 5.31

45.09 ± 4.06

46.81 ± 9.27

0.46 (− 0.57 to 1.48)

Item 3: physical health

2.6 ± 0.96

3.2 ± 1.01

3.5 ± 0.83

1.00 (0.25 to 1.75)

2.8 ± 0.46

3.1 ± 0.33

3.0 ± 0.93

0.27 (− 0.75 to 1.29)

Item 7: physical activities

3.3 ± 1.39

4.4 ± 1.06

4.1 ± 1.03

0.65 (− 0.07 to 1.37)

3.4 ± 0.74

3.3 ± 0.87

3.8 ± 1.04

0.44 (− 0.59 to 1.46)

Item 9: fatigue

3.1 ± 0.96

3.7 ± 0.49

3.7 ± 0.82

0.67 (− 0.05 to 1.39)

3.1 ± 0.69

3.2 ± 0.44

3.4 ± 1.06

0.33 (− 0.69 to 1.35)

Item 10: pain

4.8 ± 1.88

0.6 ± 1.18

0.5 ± 1.13

-2.69 (− 3.66 to − 1.72)

1.7 ± 1.60

1.0 ± 1.32

1.4 ± 2.50

-0.14 (− 1.16 to 0.87)

GMH

44.50 ± 10.48

50.13 ± 11.33

50.54 ± 11.00

0.56 (− 0.16 to 1.28)

46.49 ± 7.77

47.91 ± 5.51

50.66 ± 6.30

0.59 (− 0.44 to 1.63)

Item 2: quality of life

3.0 ± 1.03

3.6 ± 1.06

4.0 ± 1.00

0.98 (0.24 to 1.73)

3.3 ± 1.04

3.6 ± 0.73

3.4 ± 0.74

0.11 (− 0.90 to 1.13)

Item 4: mental health

3.3 ± 1.13

3.7 ± 1.23

3.6 ± 1.12

0.27 (− 0.44 to 0.97)

3.4 ± 0.74

3.6 ± 0.73

3.9 ± 0.83

0.63 (− 0.41 to 1.67)

Item 5: social activities and relation-ships

3.1 ± 1.34

3.7 ± 1.18

3.6 ± 1.12

0.40 (− 0.31 to 1.12)

3.1 ± 0.83

3.3 ± 0.50

3.6 ± 0.92

0.57 (− 0.47 to 1.60)

Item 8: emotional problems

3.1 ± 1.41

3.5 ± 1.36

3.4 ± 1.12

0.23 (− 0.47 to 0.94)

3.4 ± 0.98

3.3 ± 0.71

4.0 ± 0.53

0.78 (− 0.27 to 1.83)

Items that are not included in above domains

Item 1: general health

2.9 ± 0.72

3.5 ± 0.83

3.6 ± 0.91

0.82 (0.12 to 1.59)

2.9 ± 0.64

3.1 ± 0.33

3.1 ± 0.64

0.31 (− 0.71 to 1.33)

Item 6: social activities and roles

3.1 ± 1.09

3.5 ± 1.25

3.5 ± 1.13

0.36 (− 0.35 to 1.07)

2.9 ± 0.99

3.1 ± 0.93

3.5 ± 0.93

0.63 (− 0.41 to 1.67)

  1. CI = confidence interval; EP = extension period; ES = effect size; GMH = Global Mental Health; GPH = Global Physical Health; PROMIS GH = Patient Reported Outcome Measurement Information System Global Health; TP = treatment period
  2. aFor Items 1–9, scores range from 1 to 5 with higher scores indicating improvement, and for Item 10, scores range from 0 to 10 with lower scores indicating improvement. Scoring for Item 10 is adjusted when calculating the GPH. To calculate the GMH and GPH domain scores, raw scores are converted to standardized T scores, with a normative mean of 50 and standard deviation of 10
  3. bES is calculated from Baseline and End of EP Visit; Bolded values are large (≥ 0.80)
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BMC Cardiovascular Disorders

ISSN: 1471-2261

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