Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2026
Psychometric evaluation of the Mastocytosis Symptom Severity Daily Diary (MS2D2) in adults with nonadvanced systemic mastocytosis (NonAdvSM).
Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05186753 (A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 in Subjects With Nonadvanced Systemic Mastocytosis), which is not on this map. Not yet cited in PubMed.
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A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 in Subjects With Nonadvanced Systemic Mastocytosis
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8 authors.
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Abstract
purposeThis study evaluated the measurement properties and ability to detect clinically meaningful change of the Mastocytosis Symptom Severity Daily Diary (MS2D2), a patient-reported outcome instrument designed to measure symptom severity in adults with nonadvanced systemic mastocytosis (NonAdvSM).
methodsPsychometric evaluation of the MS2D2 used blinded data from 230 adults with NonAdvSM enrolled in the Summit Phase 2 study (NCT05186753). The study comprised two parts: Part 1 (n = 54) for dose-finding and initial domain structure development, and Part 2 (n = 179) for efficacy evaluation, validation and longitudinal assessment. Analyses included item-level statistics, confirmatory factor analysis (CFA), internal consistency (Cronbach's α), test-retest reliability (ICC), convergent and known-groups validity, responsiveness, and anchor-based estimation of meaningful change thresholds.
resultsStructural validity supported a four-domain, 11-item Total Symptom Score (TSS) framework. Internal consistency and test-retest reliability were excellent (α = 0.79-0.95; ICC = 0.95-0.98). Convergent validity was supported through strong correlations with disease-specific symptom and health-related quality of life (HRQoL) measures (r = 0.85 and r = 0.59). Known-groups validation revealed domain scores differing by 2-5 points between anchor severity strata and TSS by 2.8 points (all p < 0.05). Scores were sensitive to change, correlating (r = 0.39-0.74) with changes in patient status. TSS within-patient meaningful improvement thresholds were 1.6-2.2 points (0-10 scale) and 17.2-24.7 points (0-110 sum), with domains showing similar ranges. Percent change thresholds indicated meaningful improvement at approximately 30-40% reduction for both TSS and domain scores.
conclusionsMS2D2 is a reliable, valid, and responsive instrument for assessing symptom severity in NonAdvSM, with evidence supporting its use in clinical trials to evaluate treatment benefit.
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