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 © 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.
OBJECTIVE: The objective of this study was to evaluate the psychometric performance of the Acne Symptom and Impact Scale (ASIS) for use in adolescents and adults with acne vulgaris.
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.
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Acne is the most prevalent skin condition amongst 13- to 18-year-olds, presenting in 80% of this population at some point during adolescence.1 While the condition is non-life threatening, acne can have a profound influence on those affected, often levying a heavy emotional toll, impairing functional status, and diminishing health-related quality of life (HRQoL) to a level at times comparable with more grievous diseases (such as chronic disabling asthma, epilepsy and diabetes).2-4
In light of these impacts, the patient’s perspective is increasingly recognized as critical to assessing externally visible skin diseases and their treatment.5 Indeed, a number of patient-reported outcome (PRO) measures have been developed and administered in recent years to evaluate the HRQoL impacts of acne.6-9 However, most pre-date the current U.S. Food and Drug Administration (FDA) Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (hereon referred to as FDA PRO guidance), 10 or are otherwise deficient in adequately capturing the patient experience of acne. In addition to the FDA PRO guidance, the 2013 Prescription Drug User Fee Act (PDFUA) also underscores the importance of capturing the patient’s perspective through-out the drug development and review processes, further indicating the need for a measure specifically tailored to the patient experience in acne.11
To address this gap, the psychometric performance of a newly developed facial acne PRO measure for use in both adolescents and adults-- the Acne Symptom and Impact Scale (ASIS)--was assessed in a prospective, non-interventional study. The ASIS is a 17-item PRO measure, with nine items assessing signs and eight items assessing impacts of acne vulgaris. (The content of the ASIS have been described elsewhere; note the Symptom domain has been renamed to Sign domain). This manuscript describes the comprehensive evaluation of some of the fundamental psychometric measurement properties of the ASIS assessed in accordance with the FDA PRO Guidance.10