Psychometric Validation and Meaningful Change Thresholds of the New Nasal Polyposis Symptom Diary.

ABSTRACT:

Objectives

The Nasal Polyposis Symptom Diary (NPSD) is a novel and short patient-reported outcome (PRO) tool specifically developed to assess important and relevant symptoms reported by patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). We evaluated the psychometric properties of 4 predefined NPSD-derived scores intended to support symptom-improvement assessments of investigational therapies for inclusion in product labeling.

Methods

Five hundred eighteen patients with severe CRSwNP from a Phase III clinical trial (NCT03401229) completed the NPSD, comprising 11 items: 8 symptom-specific, 2 symptom-impact, and 1 optional medication-compliance. The psychometric characteristics of 3 single-item symptom scores (Nasal Blockage Score [NBS], Nasal Congestion Score

SUBMITTER: Shih VH 

PROVIDER: S-EPMC10571433 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature