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QuASiL, Subcutaneous Tissue Thickness, and Shear Wave Elastography in Patients with Lipedema: A Cross-Sectional Study of Correlation and Diagnostic Accuracy

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This OSF project contains the protocol for a doctoral study conducted at the Universidade Federal de São Paulo (UNIFESP). This controlled cross-sectional study aims to investigate the relationships among lipedema symptom severity assessed using the QuASiL questionnaire, subcutaneous tissue thickness measured by B-mode ultrasound, and tissue stiffness measured by shear wave elastography (SWE). The study will include a final analytical sample of 50 adult women. Up to 15 additional participants may be recruited exclusively for the independent calibration of masked evaluators and will not be included in the study analyses. Classification into lipedema and control groups will be determined retrospectively by consensus between independent masked evaluators using standardized photographs and QuASiL data, with a third evaluator resolving disagreements. The primary outcomes are the correlation between QuASiL scores and subcutaneous tissue thickness and the diagnostic accuracy of SWE for identifying lipedema. The protocol has been submitted to the Research Ethics Committee of UNIFESP. No participants have been recruited, and no study data have been collected or analyzed.

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