BACKGROUND:Facial erythema is a primary feature of rosacea. Currently, no validated scales exist that can accurately capture a patient's self-assessment of their own facial erythema. During phase 2 studies for brimonidine tartrate gel, a 5-point numeric rating scale was developed as a tool to allow subjects to provide an independent assessment of visible changes to the facial erythema associated with their rosacea. OBJECTIVE: The objective of this study was to validate the revised patient's self-assessment (PSA) scale and evaluate it for statistical reliability and validity in quantification of facial erythema of rosacea. METHODS: The validity of the PSA scale was evaluated by assessing the test-retest reliability, construct validity, and known-groups validity based on the data collected during a Phase 2b study on brimonidine gel for the treatment of persistent facial erythema of rosacea. RESULTS: Based on the results of this evaluation, this PSA scale demonstrated test-retest reliability, construct validity, and known-groups validity. LIMITATIONS: Study results are most generalizable to those with moderate to severe erythema. CONCLUSION: The PSA is an appropriate scale to assess facial erythema associated with rosacea.
RCT Entities:
BACKGROUND:Facial erythema is a primary feature of rosacea. Currently, no validated scales exist that can accurately capture a patient's self-assessment of their own facial erythema. During phase 2 studies for brimonidine tartrate gel, a 5-point numeric rating scale was developed as a tool to allow subjects to provide an independent assessment of visible changes to the facial erythema associated with their rosacea. OBJECTIVE: The objective of this study was to validate the revised patient's self-assessment (PSA) scale and evaluate it for statistical reliability and validity in quantification of facial erythema of rosacea. METHODS: The validity of the PSA scale was evaluated by assessing the test-retest reliability, construct validity, and known-groups validity based on the data collected during a Phase 2b study on brimonidine gel for the treatment of persistent facial erythema of rosacea. RESULTS: Based on the results of this evaluation, this PSA scale demonstrated test-retest reliability, construct validity, and known-groups validity. LIMITATIONS: Study results are most generalizable to those with moderate to severe erythema. CONCLUSION: The PSA is an appropriate scale to assess facial erythema associated with rosacea.
Authors: Wesley Y Yu; Brian Lu; Daniel Tan; Christine Aroyan; Kanade Shinkai; Kieron S Leslie; Lindy P Fox; Siegrid Yu; Isaac M Neuhaus; Roy C Grekin; Sarah T Arron Journal: JAMA Dermatol Date: 2020-02-01 Impact factor: 10.282