Development of a New Patient-Reported Outcome Measure for Facial Acne: The Acne Symptom and Impact Scale (ASIS)
March 2014 | Volume 13 | Issue 3 | Original Article | 333 | Copyright © March 2014
Andrew Alexis MD MPH,a Selena R. Daniels PharmD MS,b Nathan Johnson MPH,c*
Farrah Pompilus MA,d Somali Misra Burgess PhD,e* and Julie C. Harper MDf
aSkin Of Color Center at St. Luke's-Roosevelt, New York, NY
bAllergan, Irvine, CA
cEndpoint and Outcomes Research, Boston, MA
dAdelphi Values, Boston, MA eIndependent Consultant, Mission Viejo, CA
fDermatology and Skin Care Center, Birmingham, AL
* Nathan Johnson and Somali Misra Burgess were affiliated with Adelphi Values at the time of research
METHODS: A literature and PRO review, patient interviews (concept elicitation), and input from clinical experts were used to develop a conceptual framework for the outcomes deemed important to facial acne patients, and to construct items for a preliminary PRO measure: the Acne Symptom and Impact Scale (ASIS). Cognitive interviews were conducted to pilot test the ASIS.
RESULTS: A review of the literature and PROs revealed that, of the 34 measures identified, no suitable PRO measure for the population of interest was available. The conceptual framework comprised two main themes: symptoms and psychosocial impacts. Concept elicitation interviews included a diverse set of patients (n=48) with facial acne, of various ages: 12-17 years (n=15), 18-25 years (n=20), and 26-50 years (n=13). The most frequently reported symptoms were: pimples, oily skin, scabs/scars/marks, blackheads, acne, and whiteheads. The most frequently reported impacts were impacts on appearance, self-consciousness, annoyance, bothersomeness, mood, social criticism, embarrassment, confidence, and social withdrawal. These reported symptoms and impacts constituted the 15-item draft ASIS. The draft ASIS was modified following the analysis of 20 cognitive interviews, resulting in the current 17-item ASIS.
CONCLUSIONS: Results from both the concept elicitation and cognitive interviews demonstrated that the ASIS is content valid in both adolescents and adults with facial acne. The ASIS will undergo psychometric evaluation to further support its validity in both adolescents and adults with facial acne.
J Drugs Dermatol. 2014;13(3):333-340.