Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) in a phase 2 clinical study

Table 3 Pearson correlations of ISM-SAF total and domain scores with other measures administered at C4D1 (N = 34^a)

Concurrent scores	Pearson correlation^b
Concurrent scores	Total symptom score	Gastrointestinal symptom score	Skin symptom score
SF-12v2®
Physical functioning	− 0.390	− 0.329	− 0.212
Role-physical	− 0.566	− 0.357	− 0.348
Bodily pain	− 0.459	− 0.421	− 0.056
General health	− 0.558	− 0.363	− 0.306
Vitality	− 0.518	− 0.354	− 0.170
Social functioning	− 0.358	− 0.365	− 0.275
Role-emotional	− 0.255	− 0.329	− 0.166
Mental health	− 0.215	− 0.216	− 0.178
MCS	− 0.226	− 0.275	− 0.179
PCS	− 0.536	− 0.368	− 0.218
MC-QoL
Symptoms	0.695	0.541	0.382
Social life/functioning	0.624	0.498	0.498
Emotions	0.456	0.399	0.329
Skin	0.530	0.265	0.881
Total score	0.695	0.538	0.550
EQ-5D-5L
EQ-5D-5L VAS	− 0.612	− 0.432	− 0.328
PGIS
PGIS	0.656[a]	0.401[a]	0.618[a]

ISM-SAF biweekly item scores range from 0 to 10 with higher scores associated with worse signs and symptoms, with the exception of Item 11, which asks about frequency of events. ISM-SAF biweekly domain scores range from 0 to 30 and total score ranges from 0 to 110 with higher scores associated with more severe signs and symptoms. The SF-12v2® scores are norm-based normalized to United States general population with mean 50 and standard deviation of 10, with higher score indicating better functioning or well-being. The MC-QoL scores range from 0 to 100 where higher scores represent more health-related quality of life impairment. The EQ-5D-5L VAS ranges from 0 to 100 where higher scores represent better health states
C#D# cycle number, day number, EQ-5D-5L five-level EQ-5D, ISM-SAF Indolent Systemic Mastocytosis Symptom Assessment Form, MC-QoL Mastocytosis Quality of Life Questionnaire, MCS Mental Component Summary, PCS Physical Component Summary, PGIS Patient Global Impression of Severity, VAS visual analogue scale
^aN value is based on number of subjects with both ISM-SAF domain scores and concurrent scores available at Baseline
^bCorrelations and p-values were calculated as Pearson's correlations and Fisher's z-transformation except [a]ordinal variables where correlations and p-values were calculated using polyserial correlations and likelihood ratio tests

ISSN: 1750-1172