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
Abstract
OBJECTIVE: Facial acne has been associated with impaired health-related quality of life, which is an essential patient outcome for evaluating the success of acne treatment. In consideration of the US Food and Drug Administration’s (FDA) new recommendations on patient reported outcome (PRO) measures, the objectives of this study were to (1) establish the need for a new PRO measure that assesses facial acne outcomes and satisfies the criteria set forth by the FDA and (2) develop the content of a new facial acne PRO measure appropriate for use in both adolescents and adults as well as adherent to the FDA PRO Guidance.
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.
INTRODUCTION
Outcomes in dermatology have traditionally been measured via clinician assessment. However, the patient’s perspective is increasingly recognized as valuable in externally visible skin diseases, as these conditions substantially impact health-related quality of life (HRQoL).1 HRQoL refers to physical, psychological, and social well-being as reported by patients.2 In the United States, facial acne vulgaris (hereafter referred to as acne) is one of the most prevalent externally visible skin diseases among individuals aged 15 to 40 years and has been associated with impaired HRQoL of comparable severity to that of life-threatening diseases.3;4 As such, HRQoL is an essential patient outcome for evaluating the success of acne treatment.
Numerous acne-specific patient-reported outcome (PRO) measures – questionnaires that assess HRQoL and/or significant outcome variables (eg, satisfaction) from the patient’s perspective – have been developed to measure HRQoL-encompassing symptoms and psychosocial impacts of acne.2;5-7 These existing measures were developed using a range of methods, and most pre-date current US Food and Drug Administration (FDA) recommendations, outlined in the FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the FDA PRO Guidance) released in 2009.8 The FDA recommends that a measure should be (1) valid in terms of content, (2) reliable, (3) valid in terms
