Validation of a New Patient-Reported Outcome Measure for Facial Acne: The Acne Symptom and Impact Scale (ASIS)
June 2015 | Volume 14 | Issue 6 | Original Article | 552 | Copyright © June 2015
Stacie Hudgens MA,a* Julie C. Harper MD,b Selena R. Daniels MS,c Benjamin Banderas,d Sepideh Varon,c and Andrew F. Alexis MD MPHf
aClinical Outcomes Solutions, Tuscon, AZ
bDermatology and Skin Care Center, Birmingham, AL
cAllergan, Irvine, CA
dAdelphi Values, Boston, MA
eSkin Of Color Center at St. Luke's-Roosevelt, New York, NY; Columbia University College of Physicians and Surgeons, New York, NY
*Author was affiliated with Adelphi Values during the time the research was conducted.
METHODS: Psychometric evaluation was performed using both traditional psychometrics in line with proposed US Food and Drug Administration (FDA) criteria and new psychometric methods, Rasch Measurement Theory (RMT). Assessment of equivalence was also evaluated between Caucasians and Non-Caucasians on individual items.
RESULTS: One-hundred fifty subjects completed baseline and follow-up assessments (89 [59.33%] in the Caucasian group and 61 [40.67%] in the Non-Caucasian group). Psychometric analyses demonstrated that the ASIS Sign and Impact domains both performed well. Each domain fulfilled traditional psychometric criteria (Cronbach’s alpha=0.79-0.92; test-retest reliability=0.75-0.78) and mostly satisfied Rasch psychometric criteria (person-reliability=0.72-0.93; person-separation=1.61-3.69). Select individual ASIS Items also performed well across all measures and were shown to be reliable and valid as stand-alone items. A similar pattern of results were found for both Caucasian and Non-Caucasian racial subgroups.
CONCLUSIONS: These findings provide empirical evidence that the ASIS is a reliable and valid PRO measure that can accurately assess the severity of symptoms and impacts associated with acne vulgaris.
J Drugs Dermatol. 2015;14(6):552-559.