Development and Validation of a Patient-Reported Outcome Measure for Female Genital Labia Procedures: The LABIA-Q

Abstract Background Demand for interventions to improve the appearance, function, or feel of labia has grown, highlighting the need for a validated patient-reported outcome measure (PROM). Objectives The aim of this study was to develop the LABIA-Q for use in ciswomen by following international PROM development guidelines. Methods Step 1 involved concept elicitation interviews with women treated at a US outpatient clinic to improve labial appearance, function, or feel, which informed the conceptual framework and preliminary scales. In Step 2, content validity was established and scales refined through cognitive debriefing with patients and clinician input. Step 3 involved field testing with 2 cohorts: an online sample from Prolific and clinical samples from 9 outpatient clinics across the USA and Canada. Item reduction was conducted using the Rasch measurement theory (RMT), along with assessments of test–retest reliability and construct validity. Results Twelve qualitative interviews informed the conceptual framework. Cognitive interviews (n = 7) and clinician feedback (n = 11) yielded 5 scales for field testing. Among 339 participants (mean age 36.2 years, range 18-71 years), RMT analyses supported scale performance. Separate appearance scales were created for Labia, Inner Labia, and Outer Labia, each showing good model fit and high reliability (Person Separation Index [PSI] and α > 0.9). The Symptoms, Life Impact, and Sexual scales demonstrated acceptable fit and reliability (PSI and α ≥ 0.8). Test–retest reliability was high (n = 140; intraclass correlation coefficient > 0.8), and construct validity was supported with 80% to 100% of hypotheses confirmed across scales. Validation of the Treatment Outcome scale was limited by sample size. Conclusions The LABIA-Q is a valid and reliable PROM for evaluating outcomes of labial interventions across research, clinical practice, quality improvement, and regulatory contexts.