TY - JOUR
T1 - Core outcome measurement set for clinical trials in dengue
T2 - an international Delphi consensus study (DEN-CORE)
AU - DEN-CORE Study Group
AU - Yacoub, Sophie
AU - Demidova, Anastasia
AU - Chan, Xin Hui S.
AU - Ajam, Ali
AU - Baimukhambetova, Dina
AU - Horn, Andreij
AU - Kakotkina, Evgeniia
AU - Kosenko, Mark
AU - Mursalova, Aigun
AU - Van Nuil, Jennifer Ilo
AU - Phuong, Chi Le
AU - Xiao, Lin
AU - Adhikari, Sudeep
AU - Alzate Alvarez, Juan David
AU - Anderson, Kathryn B.
AU - Avirutnan, Panisadee
AU - Buchholz, Stephanie
AU - Chandra, Richa
AU - Chang, Aileen Y.
AU - Quang Chanh, Ho
AU - Consuegra Rodríguez, Mónika Patricia
AU - Daniel, Vanessa
AU - Diaz, Janet V.
AU - Figueiredo-Mello, Claudia
AU - Gelvez-Ramírez, Rosa Margarita
AU - Huyen, Tran Bang
AU - Kestelyn, Evelyne
AU - Lam, Phung Khanh
AU - Leopold, Stije J.
AU - Li, Ruobing
AU - Luu, Tran
AU - Lye, David Chien Boon
AU - McBride, Angela
AU - Meyer-Andrieux, Isabelle
AU - Moorman, Nathaniel J.
AU - Nguyen, Nguyet Minh
AU - Omar, Sharifah Faridah Syed
AU - Ong, Hang Cheng
AU - Ooi, Eng Eong
AU - Pazukhina, Ekaterina
AU - Pett, Sarah L.
AU - Porto, Diego Bastos
AU - Rajahram, Giri S.
AU - Rogers, Marc
AU - Rojas, Elsa
AU - Rosen, James
AU - Rylance, Jamie
AU - Schilling, William H.K.
AU - Siqueira, Andre M.
AU - Waickman, Adam Tully
N1 - Publisher Copyright: © 2026 Elsevier Ltd
PY - 2026/4
Y1 - 2026/4
N2 - Dengue, caused by any one of four distinct virus serotypes, is the most rapidly spreading mosquito-borne viral disease worldwide. It is a primary arboviral infection with increasing global incidence, driven by climate change, urbanisation, and the expanding range of Aedes mosquito vectors. Despite growing research interest, outcome and measurement instrument heterogeneity in dengue clinical trials remains high, limiting comparability and evidence synthesis. This project aimed to develop a globally relevant Core Outcome Measurement Set (COMS) for use in dengue clinical trials through international consensus. This consensus study followed core outcome measures in effectiveness trials and Core Outcome Set-Standards for Development (COS-STAD) guidelines and was conducted in two phases. Phase 1 focused on developing a Core Outcome Set (COS) through four steps: (1) a systematic literature review; (2) qualitative interviews with people with lived experience of dengue; (3) review by the management group and steering committee; (4) a two-round modified Delphi survey and structured online consensus meetings to finalise the COS for hospitalised and early stages of dengue disease. Input from critical care experts informed recommendations for the intensive care unit (ICU) and high dependency unit COS. Phase 2 consisted of a further two steps: (1) targeted review of outcome measurement instruments; and (2) a hybrid international consensus workshop to finalise the COMS. The agreed COMS for hospitalised dengue included seven outcomes; the early stage dengue COS included these outcomes plus four more. For critical care trials, use of existing ICU-specific COS was recommended. Unified definitions were developed for nine clinician-reported outcomes. The DEN-CORE COMS provides a consensus-based framework for harmonising outcome selection and measurement in dengue trials, improving comparability and supporting policy and clinical decision making.
AB - Dengue, caused by any one of four distinct virus serotypes, is the most rapidly spreading mosquito-borne viral disease worldwide. It is a primary arboviral infection with increasing global incidence, driven by climate change, urbanisation, and the expanding range of Aedes mosquito vectors. Despite growing research interest, outcome and measurement instrument heterogeneity in dengue clinical trials remains high, limiting comparability and evidence synthesis. This project aimed to develop a globally relevant Core Outcome Measurement Set (COMS) for use in dengue clinical trials through international consensus. This consensus study followed core outcome measures in effectiveness trials and Core Outcome Set-Standards for Development (COS-STAD) guidelines and was conducted in two phases. Phase 1 focused on developing a Core Outcome Set (COS) through four steps: (1) a systematic literature review; (2) qualitative interviews with people with lived experience of dengue; (3) review by the management group and steering committee; (4) a two-round modified Delphi survey and structured online consensus meetings to finalise the COS for hospitalised and early stages of dengue disease. Input from critical care experts informed recommendations for the intensive care unit (ICU) and high dependency unit COS. Phase 2 consisted of a further two steps: (1) targeted review of outcome measurement instruments; and (2) a hybrid international consensus workshop to finalise the COMS. The agreed COMS for hospitalised dengue included seven outcomes; the early stage dengue COS included these outcomes plus four more. For critical care trials, use of existing ICU-specific COS was recommended. Unified definitions were developed for nine clinician-reported outcomes. The DEN-CORE COMS provides a consensus-based framework for harmonising outcome selection and measurement in dengue trials, improving comparability and supporting policy and clinical decision making.
UR - https://www.scopus.com/pages/publications/105020864904
U2 - 10.1016/S1473-3099(25)00500-6
DO - 10.1016/S1473-3099(25)00500-6
M3 - Review article
C2 - 41072450
SN - 1473-3099
VL - 26
SP - e231-e244
JO - The Lancet Infectious Diseases
JF - The Lancet Infectious Diseases
IS - 4
ER -