Development and psychometric validation of the Nausea/Vomiting Symptom Assessment patient-reported outcome (PRO) instrument for adults with secondary hyperparathyroidism

Journal of Patient-Reported Outcomes

Table 6 Assessment of known-groups validity for NVSA^© scores

	n	Presence Mean (SE)	Absence Mean (SE)	Difference in Means (Presence-Absence)	Wilcoxon Two-Sample Test	P Value
sPGA^a
Number of Days of Vomiting or Nausea	78	4.16 (0.40)	0.61 (0.21)	3.55	6.57	< 0.0001
Number of Episodes of Vomiting	78	1.88 (0.41)	0.41 (0.15)	1.47	3.58	0.0002
Mean Severity of Nausea	78	1.81 (0.27)	0.13 (0.05)	1.68	6.69	< 0.0001
KDQOL-36™^b
Number of Days of Vomiting or Nausea	83	3.48 (0.39)	0.63 (0.22)	2.85	5.92	< 0.0001
Number of Episodes of Vomiting	83	1.39 (0.30)	0.53 (0.22)	0.86	2.97	0.0015
Mean Severity of Nausea	83	1.39 (0.23)	0.20 (0.08)	1.19	5.93	< 0.0001
FLIE^c
Number of Days of Vomiting or Nausea	83	3.61 (0.44)	0.78 (0.20)	2.83	5.39	< 0.0001
Number of Episodes of Vomiting	83	1.49 (0.33)	0.54 (0.20)	0.95	3.11	0.0009
Mean Severity of Nausea	83	1.50 (0.26)	0.22 (0.08)	1.28	5.69	< 0.0001

N sample size, SE standard error
^aPresence: sPGA nausea ˃ 1; Absence: sPGA nausea = 1
^bPresence: KDQOL-36™ nausea bothersomeness > 1; Absence: KDQOL-36™ nausea bothersomeness =1 nausea. Because NVSA© diary completion started at enrollment (study week 0), week 1 NVSA© data (enrollment to week 1) were used for this analysis while KDQOL-36™ reflects enrollment (week 0)
^cPresence: FLIE Total < 108; Absence: FLIE Total ≥ 108. Because NVSA© diary completion started at enrollment (study week 0), week 1 NVSA^© data (enrollment to week 1) were used for this analysis while FLIE reflects enrollment (week 0)