Journal article : Review
Core outcome measurement set for clinical trials in dengue: an international Delphi consensus study (DEN-CORE)
- Abstract:
- 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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
-
-
(Preview, Accepted manuscript, pdf, 1.6MB, Terms of use)
-
- Publisher copy:
- 10.1016/s1473-3099(25)00500-6
Authors
+ Gates Foundation
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- Funder identifier:
- https://ror.org/0456r8d26
- Grant:
- INV-063472
+ Academy of Medical Sciences
More from this funder
- Funder identifier:
- https://ror.org/00c489v88
- Grant:
- NGR1\1953
+ National Institute for Health and Care Research
More from this funder
- Funder identifier:
- https://ror.org/0187kwz08
- Publisher:
- Elsevier
- Journal:
- Lancet Infectious Diseases More from this journal
- Volume:
- 26
- Issue:
- 4
- Pages:
- e231-e244
- Publication date:
- 2025-10-07
- Acceptance date:
- 2025-08-04
- DOI:
- EISSN:
-
1474-4457
- ISSN:
-
1473-3099
- Pmid:
-
41072450
- Language:
-
English
- Keywords:
- Subtype:
-
Review
- Pubs id:
-
2300995
- Local pid:
-
pubs:2300995
- Source identifiers:
-
W4415023037
- Deposit date:
-
2026-06-30
- ARK identifier:
Terms of use
- Copyright holder:
- Elsevier Ltd.
- Copyright date:
- 2025
- Rights statement:
- Copyright: © 2025 Elsevier Ltd. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
- Notes:
- The author accepted manuscript (AAM) of this paper has been made available under the University of Oxford's Open Access Publications Policy, and a CC BY public copyright licence has been applied.
- Licence:
- CC Attribution (CC BY)
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