by Yacoub S, Demidova A, Chan XHS, Ajam A, Baimukhambetova D, Horn A, Kakotkina E, Kosenko M, Mursalova A, Nuil JIV, Phuong CL, Xiao L, Adhikari S, Alvarez JDA, Anderson KB, Avirutnan P, Buchholz S, Chandra R, Chang AY, Chanh HQ, Rodríguez MPC, Daniel V, Diaz JV, Figueiredo-Mello C, Gelvez-Ramírez RM, Huyen TB, Kestelyn E, Lam PK, Leopold SJ, Li R, Luu T, Lye DCB, McBride A, Meyer-Andrieux I, Moorman NJ, Nguyen NM, Omar SFS, Ong HC, Ooi EE, Pazukhina E, Pett SL, Porto DB, Rajahram GS, Rogers M, Rojas E, Rosen J, Rylance J, Schilling WHK, Siqueira AM, Sjö P, Sucerquia-Hernandez A, Tam DTH, Teixeira MM, Tietz A, Trieu HT, Unsworth A, Villar L, Waickman AT, Watson JA, Wills BA, Chia PY, Brasil P, Jaenisch T, Lum L, Malavige GN, McGloughlin S, Vijayaraghavan BKT, Merson L, Munblit D, and the DEN-CORE Study Group. The Lancet Infectious Diseases, 2025. doi: 10.1016/S1473-3099(25)00500-6
Summary: A global, multistakeholder consensus process was conducted to define a core outcome set and core outcome measurement set (COMS) for clinical trials on dengue interventions, addressing long-standing inconsistencies in outcome selection and reporting. Stakeholders from 36 countries prioritised seven core outcomes for hospitalised and 11 outcomes for early-stage dengue trials. These reflect patient-centred priorities and clinically relevant endpoints. Recommendations for measurement instruments, case definitions, and timepoints were developed for each clinical outcome, drawing on existing tools and international consensus to support comparability and implementation. Challenges related to geographical representation, patient-reported outcome measure availability, and feasibility in low-resource settings are acknowledged, and a framework for future updates and regional adaptation was proposed.
