Sexual experience in premenopausal women with type 1 diabetes: development and validation of a patient-reported outcome measure (PROM)

Background: Female sexual dysfunction (FSD) is an under-studied problem in diabetes. Current FSD measures do not address diabetes factors (hypoglycaemia, technology and body image) related to women's sexual experiences. This study developed and validated a measure, Female Sexual Experience in Diabetes Type 1 (FSEDiT_1), to assess sexual experience (SE) in premenopausal women with type 1 diabetes (T1D). Methods: FSEDiT_1 was developed in three phases following the Consensus-based Standards for the selection of health Measurement Instrument (COSMIN) framework. Phase 1. Construct identification - semi-structured interviews with premenopausal women with T1D (n = 18) were conducted between July 2022 and June 2023 to identify constructs associated with SEs, and develop an item bank. Phase 2. Content and structural validity - the items were assessed through focus groups and preliminary testing between August 2023 and May 2024. Phase 3. Psychometric testing (factor analysis, reliability and validity testing) - conducted with participants from a cross-sectional study (n = 429) between June and July 2024. Convergent and discriminant validity were considered using the Diabetes Distress Scale (DDS) and Female Sexual Function Index (FSFI). Test-retest reliability with Intraclass Correlation Coefficients (ICC) was assessed through a sub-sample of participants (n = 44). Findings: FSEDiT_1 is comprised of five subscales, measuring the impact of diabetes on: initiation of sexual activity (4 items), sexual confidence (6 items), sexual enjoyment (7 items), sexual engagement (6 items) and sexual desire (6 items). Confirmatory factor analysis identified that each of the five subscales had good fit indices (comparative fit index ranged from 0·95 to 0·98 across all the subscales). Test-retest reliability was acceptable with ICC scores of: 0·88 (initiation of sexual activity), 0·87 (sexual confidence), 0·94 (sexual enjoyment), 0·94 (sexual engagement), and 0·93 (sexual desire). FSEDiT_1 demonstrated convergent and discriminant validity. Interpretation: FSEDiT_1 is a valid and reliable measure of constructs related to SE in premenopausal women with T1D. Funding: The study is part of a doctoral fellowship funded by the Foundation of European Nurses in Diabetes (FEND). Funding was received from Novo Nordisk Research Foundation to support the transcription of the qualitative interviews in Phase 1.