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Table 3 Known-groups validity of the Urgency NRS at baseline and Week 12

From: Psychometric evaluation of the Urgency NRS as a new patient-reported outcome measure for patients with ulcerative colitis

 

Urgency NRS score

n

Mean (SD)

Median (range)

LS mean (SE)a

LS mean difference (95% CI)a

p valuea

Cohen’s db

Baseline

Median PGRS score at baseline

  ≤ median (4)c

713

5.4 (2.05)

5 (0–10)

5.4 (0.07)

–

–

–

  > median (4)c

435

7.5 (1.71)

8 (0–10)

7.5 (0.09)

2.1 (1.8, 2.3)

 < 0.0001

1.07

Week 12

PGRS score at week 12

  ≤ 3

638

2.5 (1.98)

2 (0–10)

2.6 (0.08)

–

–

–

  > 3

448

5.4 (2.32)

4 (0–10)

5.3 (0.09)

2.7 (2.4, 2.9)

 < 0.0001

1.39

Clinical remission at week 12d

 Yes

246

2.2 (1.92)

2 (0–9)

2.3 (0.14)

–

–

–

 No

833

4.1 (2.59)

4 (0–10)

4.1 (0.08)

1.8 (1.5, 2.2)

 < 0.0001

0.79

Clinical response at week 12

 Yes

670

2.8 (2.24)

2 (0–10)

2.8 (0.08)

–

–

–

 No

409

5.1 (2.46)

5 (0–10)

5.2 (0.10)

2.3 (2.1, 2.6)

 < 0.0001

1.00

  1. CI confidence interval, LS least-square, NRS Numeric Rating Scale, PGRS Patient Global Rating of Severity, SD standard deviation, SE standard error
  2. aDerived from analysis of variance models that included Urgency NRS score as the dependent variable and PGRS subgroup as the independent variable
  3. bDerived as the mean difference in Urgency NRS between known groups divided by the pooled standard deviation of the Urgency NRS scores at the given time point
  4. cThe median PGRS score at baseline was 4. The median PGRS score at week 12 was 3
  5. dClinical remission of UC was defined as a Mayo stool frequency subscore of 0, or 1 with a ≥ 1-point decrease from baseline; a Mayo rectal bleeding subscore of 0; and a Mayo endoscopic subscore of 0 or 1 (excluding friability)
  6. eDecrease in MMS total score from baseline of ≥ 2 points and ≥ 30%; and Mayo rectal bleeding subscore 0 or 1 or decreased by ≥ 1 point from baseline