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

Journal of Patient-Reported Outcomes

Table 5 Responsiveness at week 12 based on clinical remission, clinical response, IBDQ remission, and median PGRS score

	Clinical remission^a		Clinical response^b		IBDQ remission^c		PGRS score^d
	No	Yes	No	Yes	No	Yes	> median	≤ median
n	833	246	409	670	474	605	448	638
Mean	− 2.0	− 3.8	− 1.0	− 3.3	− 1.6	− 3.1	− 1.1	− 3.4
Standard deviation	2.47	2.37	2.16	2.36	2.37	2.49	2.10	2.42
Range	− 10 to + 7	− 10 to + 2	− 8 to + 7	− 10 to + 3	− 9 to + 7	− 10 to + 6	− 8 to + 7	− 10 to + 3
Effect size^f	-	0.80	-	1.07	-	0.70	-	1.06
LS mean change from baseline (SE)^e	− 2.0 (0.08)	− 3.8 (0.14)	− 1.0 (0.10)	− 3.3 (0.08)	− 1.3 (0.10)	− 3.3 (0.09)	− 0.9 (0.09)	− 3.5 (0.08)
LS mean difference (SE)^e	–	1.8 (0.16)	–	2.3 (0.13)	–	2.0 (0.13)	–	2.7 (0.12)
p value^e	–	< 0.0001	–	< 0.0001	–	< 0.0001	–	< 0.0001

IBDQ Inflammatory Bowel Disease Questionnaire, LS least-square, NRS Numeric Rating Scale, PGRS Patient Global Rating of Severity, SE standard error
^aClinical 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)
^bDecrease 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
^cIBDQ remission was defined as an IBDQ total score ≥ 170
^dThe median PGRS score at week 12 was 3
^eDerived from one-way analysis of covariance models with change in urgency NRS score as the dependent variable, and baseline Urgency NRS score and meaningful improvement subgroup for the anchor (Yes/No) as independent variables
^fCalculated as the mean difference in change from baseline to week 12 on the Urgency NRS between response groups divided by the pooled standard deviation of the Urgency NRS scores at baseline