Abstract
Objectives
The Psoriasis Symptom Inventory (PSI) is a patient-reported outcome instrument that measures the severity of psoriasis signs and symptoms. This study evaluated measurement properties of the PSI in patients with moderate to severe plaque psoriasis.
Methods
This secondary analysis used pooled data from a phase 3 brodalumab clinical trial (AMAGINE-1). Outcome measures included the PSI, Psoriasis Area and Severity Index (PASI), static Physician’s Global Assessment (sPGA), psoriasis-affected body surface area, 36-item Short-Form Health Survey version 2, and the Dermatology Life Quality Index (DLQI). The PSI was evaluated for dimensionality, item performance, reliability (internal consistency and test-retest), construct validity, ability to detect change, and agreement between PSI response and response measures based on the PASI, sPGA, and DLQI.
Results
Results supported unidimensionality, good item fit, ordered responses, and PSI scoring. The PSI demonstrated reliability: baseline Cronbach’s alpha ≥ 0.92 and intraclass correlation coefficients ≥ 0.95. Correlations between PSI total score and DLQI item 1 (r = 0.86), DLQI symptoms and feelings (r = 0.87), and 36-item Short-Form Health Survey version 2 bodily pain (r = –0.61) supported convergent validity. PSI scores differed significantly (P 75/≥ 75) and sPGA (0–1/≥ 2), and showed good agreement (k ≥ 0.66) between PSI response and PASI, sPGA, and DLQI responses.
Conclusion
The PSI demonstrated excellent validity, reliability, and ability to detect change in the severity of psoriasis signs and symptoms.
Authors
Hema N. Viswanathan Alex Mutebi Cassandra E. Milmont Kenneth Gordon Hilary Wilson Hao Zhang Paul A. Klekotka Dennis A. Revicki Matthias Augustin Gregory Kricorian Ajay Nirula Bruce Strober