1598-P: Development and Validation of a Novel Screening Measure for Parents/Caregivers of Children Diagnosed with Presymptomatic Type 1 Diabetes

Introduction and Objective: There is no validated and reliable survey to assess the psychosocial impact of paediatric screening for T1D on families. We aimed to develop and validate a novel self-administered measure assessing the psychosocial impact on daily functioning, understanding of the results and broader lived experience. Methods: Individual interviews with parents and healthcare professionals were conducted and analysed for the key themes, using a standardised topic guide. An iterative survey development process included multiple versions of the survey, followed by statistical validation against a number of psychosocial measures assessing emotional state, wellbeing and quality of life. Final survey items were refined via cognitive debriefing interviews for acceptability, ease of completion and comprehension. Results: Thirty adults, aged ≥18 years took part in 1:1 interviews. Interview duration was 60-90 minutes (mean 70 minutes). Sixty-six adults completed the statistical validation survey, age range 21-67 years, 71% female, 57% white, 76% married/co-habiting and 90% college/university degree or higher degree educated. Child’s age, where reported (n=31) was 3-30 years. Participants were located across Europe, India, Pakistan, Saudi Arabia, Rwanda, the USA and UK. Exploratory Factor Analyses (EFA) evaluated the factor structure of the initial 19-item measure. Items were removed due to low item-to-total correlations, low commonalities and >50% endorsed strongly agree. The final 12-item measure demonstrated reliability (Cronbach’s α=0.84). The two subscales reflected Positive Impact of screening (6 items, α=0.86, M=24.0±4.9, range=11-30) and Negative Impact of screening (6 items, α=0.85, M=20.7±4.9, range=6-30). Conclusion: This novel questionnaire is a valid, robust and reliable assessment of psychosocial factors associated with screening for T1D. Disclosure K. Barnard-Kelly: Research Support; Current; Abbott Diabetes, Dexcom, Inc. J. Shapiro: Research Support; Current; American Diabetes Association, Leona M. and Harry B. Helmsley Charitable Trust, Eli Lilly and Company. C. Woombs: None. E. Barnard: None. O. Boiko: None. J. Vercauteren: None. C. Mathieu: Advisory Panel; Current; Abbott Diagnostics, Dexcom, Inc. Board Member; Current; European Association for the Study of Diabetes. Advisory Panel; Current; Novo Nordisk, Eli Lilly and Company, Sanofi, Vertex Pharmaceuticals Incorporated, Medtronic. A. Omar Alsaleh: None. C. Nicholls: Employee; Current; Sanofi. A. Mahieu: Employee; Current; Sanofi. S. Greenfield: None. L.M. Quinn: None. R. Dias: Other - Speaker fee; Ended; Sandoz International GmbH. Advisory Panel; Ended; Sanofi. Other - speaker fee; Ended; Sanofi. P. Narendran: Speaker's Bureau; Current; Lilly. Other - Speaker and advisory board; Current; Sanofi. Funding This work is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101132379 (EDENT1FI). The JU receives support from the European Union’s Horizon Europe research and innovation programme, The Leona M. and Harry B. Helmsley Charitable Trust, Breakthrough T1D, EFPIA, COCIR, Vaccines Europe, EuropaBio and MedTech. Additional funding is provided to associated UK partners through the UK Research and Innovation (UKRI) Guarantee Fund.