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Table 6 Change in PRO scores from Week 8 to Month 12 for patients in the maintenance phase sample who sustained or did not sustain remission at Month 12

From: Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study

 

Did not sustain remission

Sustained remission

N

Change in LS Mean (SE)

N

Change in LS Mean (SE)

P a

SF-12v2, mean (SD)

 Physical functioning

110

−4.2 (0.79)‡

225

1.6 (0.56)*

 Role physical

109

−6.0 (0.73)‡

225

1.6 (0.51)*

 Bodily pain

110

−7.2 (0.76)‡

223

0.8 (0.53)

 General health

110

−8.9 (0.88)‡

225

3.0 (0.62)*

 Vitality

110

−5.2 (1.00)‡

221

2.5 (0.71)*

 Social functioning

110

−6.3 (0.82)‡

225

1.0 (0.58)

 Role emotional

110

−4.9 (0.78)‡

223

1.8 (0.55)*

 Mental health

110

−5.1 (0.87)‡

225

2.0 (0.62)*

 PCS

110

−6.3 (0.67)‡

225

1.5 (0.48)*

 MCS

110

−4.9 (0.77)‡

225

1.9 (0.54)*

SIBDQ, mean (SD)

 Bowel symptoms

95

−4.1 (0.33)‡

204

0.4 (0.23)

 Systemic symptoms

96

−1.9 (0.24)‡

206

0.5 (0.17)*

 Emotional function

95

−3.2 (0.32)‡

205

0.6 (0.22)*

 Social function

96

−2.7 (0.24)‡

208

0.5 (0.16)*

 Total score

92

−12.0 (0.96)‡

199

1.8 (0.67)*

WPAI:UC, mean (SD)

 Absenteeism

54

9.3 (2.17)‡

113

−1.6 (1.54)

 Presenteeism

58

19.6 (2.42)‡

117

−2.5 (1.75)

 Overall work impairment

54

25.4 (3.00)‡

111

−3.7 (2.13)

 Activity impairment

92

22.3 (2.04)‡

199

−2.4 (1.42)

  1. LS least squares, MCS mental component summary, PCS physical component summary, PRO patient-reported outcome, SD standard deviation, SE standard error, SF-12v2 SF-12v2 Health Survey, SIBDQ Short Inflammatory Bowel Disease Questionnaire, WPAI:UC Work Productivity and Activity Impairment questionnaire for ulcerative colitis
  2. Findings for each outcome are based on mixed-effects models for repeated measures with subject as a random effect, and sustainer status, visit, and the sustainer status x visit interaction as fixed effects
  3. Week 8 includes early withdrawal visits during the acute phase. “Month 12” includes early withdrawal visits during the maintenance phase
  4. aIndicates statistical significance of the sustainer status x visit interaction effect
  5. *P < 0.05, ‡P < 0.001