Development and Validation of Urological and Appearance Domains of the Post-Affirming Surgery Form and Function Individual Reporting Measure (AFFIRM) for Transwomen following Genital Surgery
Sarah Huber, Cecile Ferrando, Joshua D. Safer, John Henry Y. Pang, Carl G. Streed, Jennifer Priestley, Patrick Culligan
Abstract
PURPOSE: As feminizing gender-affirming surgery becomes increasingly accessible, functional outcomes are increasingly relevant. We aimed to develop and validate the first patient-reported outcome questionnaire focusing on postoperative symptomatology and quality of life. MATERIAL AND METHODS: Questions were developed from interviews with postoperative transwomen followed by face validation from a multispecialty clinician group. The measure was co-administered with established relevant questionnaires for concurrent validity testing. Participants were asked to complete the questionnaire at baseline and at a 2-week retest interval. RESULTS: The AFFIRM questionnaire is a 33-item patient-reported outcome measure comprising Appearance, Urological and Gynecologic domains, each scored to create a composite AFFIRM score. A total of 102 women participated, with 60% completing the test-retest. The overall Cronbach's α for AFFIRM was 0.79, and domain α for AFFIRM-A, AFFIRM-U and AFFIRM-G was 0.85, 0.87 and 0.42, respectively. Test-retest demonstrated score reliability (z values -1.862 to -0.005, p >0.05) with intraclass coefficients demonstrating moderate to good absolute correlation (0.54 to 0.88). The AFFIRM-A and AFFIRM-U correlated well with the Genital Appearance Satisfaction Measure and Urinary Distress Inventory-6, respectively (ρ 0.556 and 0.618, p <0.001); 89% of participants confirmed congruence between their external genitalia and gender identity, 87.8% reported clitoral sensation and 75.6% expressed satisfaction with vaginal caliber. Reported symptoms included a misdirected urinary stream (68.9%), nocturia (51.3%), urinary frequency (29.7%) and vaginal pain (46.7%). CONCLUSIONS: Transwomen have diverse symptoms not captured by unstructured questions or cisgender questionnaires. The AFFIRM questionnaire is the first tool available to reliably evaluate outcomes following feminizing gender-affirming surgery.