A study published in Advances in Therapy evaluated the psychometric properties of the Psoriasis Symptoms and Impacts Measure (P-SIM), which is a patient-reported outcome (PRO) measure for patient experiences with psoriasis.
The researchers utilized blinded data from the BE RADIANT phase 3b trial. Throughout the trial, patients electronically reported P-SIM scores for three items: itching, skin pain, and scaling. Items were rated from 0 through 10 (0 = no signs/symptoms/impacts; 10 = severe). P-SIM scores were validated against other relevant PRO and clinician-reported outcome measurements.
The P-SIM items were found to yield high test-retest reliability, assessed via intraclass correlation, and demonstrated moderate to strong correlations with other PRO scores. There were statistically significant differences between subgroup scores in all three items for nearly all known-group comparisons.
The P-SIM scores also demonstrated changes from baseline within the acceptable threshold of ≤ 0.30, demonstrating sensitivity to change. According to anchor-based analyses, a ≥4-point reduction in the P-SIM from baseline marks a clinically meaningful improvement.
Source: Advances in Therapy https://link.springer.com/article/10.1007%2Fs12325-021-01836-1