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Development and Validation of a Patient-Reported Outcome Measure for Female Genital Labia Procedures: The LABIA-Q
Aesthetic Surgery Journal. Open Forum
|April 3, 2026
Summary
The LABIA-Q is a new patient-reported outcome measure (PROM) developed for ciswomen seeking labial appearance or function interventions. This validated tool ensures reliable outcome evaluation in clinical and research settings.
Area of Science:
- Medical Devices and Health Technology
- Patient-Reported Outcome Measures
- Surgical Outcomes Assessment
Background:
- Growing demand for interventions targeting labial appearance, function, and feel.
- Need for a validated patient-reported outcome measure (PROM) to assess these interventions.
- Current lack of standardized tools for evaluating outcomes related to labial procedures.
Purpose of the Study:
- To develop and validate the LABIA-Q, a patient-reported outcome measure (PROM) for ciswomen.
- To create a reliable instrument for assessing outcomes of interventions aimed at improving labial appearance, function, or feel.
- To adhere to international PROM development guidelines throughout the creation process.
Main Methods:
- Concept elicitation interviews with women undergoing labial interventions to inform scale development.
- Content validity established through cognitive debriefing with patients and clinician input.
- Field testing across two cohorts (online and clinical) with item reduction using Rasch measurement theory (RMT).
- Assessment of test-retest reliability and construct validity.
Main Results:
- The LABIA-Q comprises 5 scales: Labia, Inner Labia, Outer Labia (appearance), Symptoms, Life Impact, and Sexual function.
- Rasch measurement theory analyses supported scale performance with good model fit and high reliability (PSI and α > 0.9 for appearance scales; ≥ 0.8 for others).
- High test-retest reliability (ICC > 0.8) and strong construct validity (80-100% hypothesis confirmation) were demonstrated.
Conclusions:
- The LABIA-Q is a validated and reliable patient-reported outcome measure (PROM).
- It is suitable for evaluating outcomes of labial interventions in diverse contexts, including research, clinical practice, quality improvement, and regulatory affairs.
- The LABIA-Q provides a standardized method for assessing patient perspectives on labial procedures.
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