several describing their chosen response as the severity of their itch compared to their worst-ever itch. These findings align with participants' suggestion that "worst itch" be defined (eg, "rate your itching severity by circling the number that best describes your worst level of itching…"). Quantitative diary data demonstrated acceptable psychometric performance. Participants utilized the majority of the response scale on ≥ 1 days, with an even distribution across response options. Day 7 (test) versus Day 14 (retest) reliability was high, with an observed intraclass correlation coefficient= 0.94 among stable participants. Concurrent validity was acceptable, with strong correlations (0.55-0.76) observed with other diary AD symptom measures. There were no major overall differences between adults and adolescents. ConClusions: Adults and adolescents noted that the Itch NRS was easy to understand and relevant to their AD experiences, with clear alignment between item wording and language used by participants. Psychometrically, the Itch NRS was a valid and reliable measure of itch that applied to both adults and adolescents.

BackgroundInvestigations using classical test theory support the psychometric properties of the original version of the Multiple Sclerosis Impact Scale (MSIS-29v1), a disease-specific measure of multiple sclerosis (MS) impact (physical and psychological subscales). Later, assessments of the MSIS-29v1 in an MS community-based sample using Rasch analysis led to revisions of the instrument’s response options (MSIS-29v2).ObjectiveThe objective of this paper is to evaluate the psychometric properties of the MSIS-29v1 in a clinical trial cohort of relapsing–remitting MS patients (RRMS).MethodsData from 600 patients with RRMS enrolled in the SELECT clinical trial were used. Assessments were performed at baseline and at Weeks 12, 24, and 52. In addition to traditional psychometric analyses, Item Response Theory (IRT) and Rasch analysis were used to evaluate the measurement properties of the MSIS-29v1.ResultsBoth MSIS-29v1 subscales demonstrated strong reliability, construct validity, and responsiveness. The IRT and Rasch analysis showed overall support for response category threshold ordering, person-item fit, and item fit for both subscales.ConclusionsBoth MSIS-29v1 subscales demonstrated robust measurement properties using classical, IRT, and Rasch techniques. Unlike previous research using a community-based sample, the MSIS-29v1 was found to be psychometrically sound to assess physical and psychological impairments in a clinical trial sample of patients with RRMS.

several describing their chosen response as the severity of their itch compared to their worst-ever itch. These findings align with participants' suggestion that "worst itch" be defined (eg, "rate your itching severity by circling the number that best describes your worst level of itching…"). Quantitative diary data demonstrated acceptable psychometric performance. Participants utilized the majority of the response scale on ≥ 1 days, with an even distribution across response options. Day 7 (test) versus Day 14 (retest) reliability was high, with an observed intraclass correlation coefficient= 0.94 among stable participants. Concurrent validity was acceptable, with strong correlations (0.55-0.76) observed with other diary AD symptom measures. There were no major overall differences between adults and adolescents. ConClusions: Adults and adolescents noted that the Itch NRS was easy to understand and relevant to their AD experiences, with clear alignment between item wording and language used by participants. Psychometrically, the Itch NRS was a valid and reliable measure of itch that applied to both adults and adolescents.

A231 based on the same clinical studies and corresponded to improvement in respiratory symptoms (as measured by the CFQ-R). In one case, the improvement in respiratory symptoms was considered as primary endpoint (aztreonam lysine-one study). ConClusions: There are few PRO labeling claims in products approved for CF in Europe and the United States. Discrepancies exist in the CF guidance issued by the FDA and the EMA, where EMA is more favorable to PRO endpoints.

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