Development and Psychometric Validation of Patient-Reported Outcome Measures for Masseter Muscle Prominence (MMP): The Lower Facial Shape Questionnaire
Author(s)
Catherine Foley, MA, MPH1, Julia Garcia, PhD1, Julie Whyte, MPH2, Martha Gauthier, MA2, Brandon Foster, PhD2, Elisabeth Lee, MBA, MPH1, Vaishali Patel, PharmD1.
1AbbVie, Irvine, CA, USA, 2Lumanity, Boston, MA, USA.
1AbbVie, Irvine, CA, USA, 2Lumanity, Boston, MA, USA.
OBJECTIVES: Masseter muscle prominence (MMP) presents as a widened or square lower face shape that can be of aesthetic concern. Patient-reported outcome (PRO) measures, including the Lower Facial Shape Questionnaire (LFSQ), have been developed to comprehensively understand MMP treatment benefit from the patient perspective. The LFSQ includes 4 modules: the Symptom Assessment, Impact Assessment, Satisfaction Assessment, and Treatment Satisfaction Assessment (LFSQ-SA/-IA/-SAT/-TXSAT). Development evidence for the LFSQ-SA/-IA/-SAT has been presented previously. This abstract presents (1) development of the LFSQ-TXSAT assessing treatment satisfaction, a key outcome of voluntary aesthetic treatment, and (2) psychometric validation of all LFSQ modules.
METHODS: Content validity of the LFSQ-TXSAT was assessed across 2 rounds of cognitive debriefing (CD) interviews (n=15;n=20) using established qualitative research methods and FDA guidance on patient-focused drug development. Psychometric properties, including structural assessments of the multi-item LFSQ modules, were evaluated using data from a Ph2b study (Baseline, n=145;Day 90, n=128). Based on structural results, the LFSQ-SA underwent item reduction; thus, its psychometric properties were confirmed in an observational study (Visit 2/3, n=117;Visit 3/3, n=110).
RESULTS: Across studies, mean participant age range was 39.3-51.4 years; most were female and White. In CD interviews, all participants were at least somewhat bothered by MMP. LFSQ-TXSAT items and response options were interpreted as intended by most participants (≥85.7%). However, to improve clarity the instructions were revised to specify that participants should consider only the appearance of the lower face. This change was also made to the other LFSQ modules and was debriefed. From the Ph2b study, all LFSQ modules met or exceeded acceptable criteria for nearly all psychometric analyses (test-retest reliability, convergent and known-groups validity, inter-item correlations, internal consistency); using observational study data confirmatory psychometric properties of the LFSQ-SA met acceptable criteria.
CONCLUSIONS: These MMP-specific PRO measures exhibited adequate content validity and psychometric properties for use in future studies.
METHODS: Content validity of the LFSQ-TXSAT was assessed across 2 rounds of cognitive debriefing (CD) interviews (n=15;n=20) using established qualitative research methods and FDA guidance on patient-focused drug development. Psychometric properties, including structural assessments of the multi-item LFSQ modules, were evaluated using data from a Ph2b study (Baseline, n=145;Day 90, n=128). Based on structural results, the LFSQ-SA underwent item reduction; thus, its psychometric properties were confirmed in an observational study (Visit 2/3, n=117;Visit 3/3, n=110).
RESULTS: Across studies, mean participant age range was 39.3-51.4 years; most were female and White. In CD interviews, all participants were at least somewhat bothered by MMP. LFSQ-TXSAT items and response options were interpreted as intended by most participants (≥85.7%). However, to improve clarity the instructions were revised to specify that participants should consider only the appearance of the lower face. This change was also made to the other LFSQ modules and was debriefed. From the Ph2b study, all LFSQ modules met or exceeded acceptable criteria for nearly all psychometric analyses (test-retest reliability, convergent and known-groups validity, inter-item correlations, internal consistency); using observational study data confirmatory psychometric properties of the LFSQ-SA met acceptable criteria.
CONCLUSIONS: These MMP-specific PRO measures exhibited adequate content validity and psychometric properties for use in future studies.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR212
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, STA: Multiple/Other Specialized Treatments