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.
ContributorsSophie Yacoub, Anastasia Demidova, Xin Hui S Chan, Ali Ajam, Dina Baimukhambetova, Andreij Horn, Evgeniia Kakotkina, Mark Kosenko, Aigun Mursalova, Jennifer Ilo Van Nuil, Chi Le Phuong, Lin Xiao, Sudeep Adhikari, Juan David Alzate Alvarez, Kathryn B Anderson, Panisadee Avirutnan, Stephanie Buchholz, Richa Chandra, Aileen Y Chang, Ho Quang Chanh, Mónika Patricia Consuegra Rodríguez, Vanessa Daniel, Janet V Diaz, Rosa Margarita Gelvez-Ramírez, Tran Bang Huyen, Claudia Figueiredo-Mello, Evelyne Kestelyn, Phung Khanh Lam, Stije J Leopold, Ruobing Li, Tran Luu, David Chien Boon Lye, Angela McBride, Isabelle Meyer-Andrieux, Nathaniel J Moorman, Nguyet Minh Nguyen, Sharifah Faridah Syed Omar, Hang Cheng Ong, Eng Eong Ooi, Ekaterina Pazukhina, Sarah L Pett, Diego Bastos Porto, Giri S Rajahram, Marc Rogers, Elsa Rojas, James Rosen, Jamie Rylance, William HK Schilling, Andre M Siqueira, Peter Sjö, Alfonso Sucerquia-Hernandez, Dong Thi Hoai Tam, Mauro Martins Teixeira, Andreas Tietz, Huynh Trung Trieu, Annalise Unsworth, Luis Villar, Adam Tully Waickman, James A Watson, Bridget A Wills, Chia Po Ying, Patricia Brasil, Thomas Jaenisch, Lucy Lum, Neelika Malavige, Steven Mcgloughlin, Bharath Kumar Tirupakuzhi Vijayaraghavan, Laura Merson, Daniel Munblit *
Disease Category: Infectious disease
Disease Name: Dengue fever
Age Range: 0 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- Service providers
- Service users
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Interview
- Semi structured discussion
- Systematic review
The project will incorporate the following steps:
- Development of a long list of outcomes based on the data from ongoing scoping systematic review. It will be further complemented with the qualitative data collected from people with lived experience of Dengue fever with regards to their expectations from potential interventions.
- Existing COS initiatives will be reviewed for potential applicability for use in Dengue fever.
- A modified Delhi process will be undertaken in multiple languages to select the most critical outcomes to be measured in Dengue fever trials. Delphi processes will be conducted independently for different disease stages (e.g. Tier 1 – early disease stage and Tier 2 hospitalised patients ( general wards (moderate dengue) and ICU (severe dengue))
- Consensus meeting will be held to discuss the outcomes of the Delphi process and finalise the COS