The Core Outcome Measures for Dengue (DEN-CORE)

Currently, there is no specific treatment available for dengue or severe dengue. To address this pressing issue, various dengue trials have been conducted. Previous dengue trials have used highly heterogeneous outcomes and outcomes measures and there is a need for standardisation.

Patients with dengue have distinct disease phases with an initial febrile, viraemic phase (days 1-3) followed by a critical phase (days 4-6) when complications including shock, bleeding and organ impairment can occur, and finally a recovery phase after day 7. Vast majority of patients with dengue are treated in the community with 20-40% being hospitalised and 5-10% of those requiring intensive care support.

Different outcomes measurements are therefore needed for the different stages of disease, reflecting the different goals of interventions. By incorporating input from various stakeholders, including patient groups, health professionals and researchers, DEN-CORE will ensure that research is both relevant and patient-centered, facilitating better informed clinical and policy decisions on a global scale for this major public health concern. This project will also anchor the development of target product profiles for therapeutic agents for the treatment of dengue.

Contributors

Dr Sophie Yacoub, Oxford University Clinical Research Unit (OUCRU) Ho Chi Minh City, Vietnam and Centre for Tropical Medicine and Global Health, University of Oxford, UK.

Dr Daniel Munblit, Division of Care in Long Term Conditions, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, United Kingdom

Dr Laura Merson, ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, United Kingdom

Dr Anastasiia Demidova, Independent researcher, Cyprus

Dr Aigun Mursalova, Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child’s Health, I.M. Sechenov First Moscow State Medical University, Sechenov University, Moscow, Russia

Dr Patricia Brasil, Instituto Nacional de Infectologia Evandro Chagas/ Fiocruz, Rio de Janeiro, Brazil

Dr Lucy Lum, University Malaya, Faculty of Medicine, Department of Paediatrics, 50603 Kuala Lumpur, Malaysia

Dr Thomas Jäenisch, Department of Infectious Diseases, Section Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.

Dr Neelika Malavige, Centre for Dengue Research, University of Sri Jayewardenepura, Gangodawila, Sri Lanka.

Dr Bharath Kumar, The George Institute for Global Health, New Delhi & Chennai Critical Care Consultants Group, India

Dr Angela McBride, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom

Dr James Watson, Oxford University Clinical Research Unit (OUCRU), Ho Chi Minh City, Vietnam and Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom

Dr Huyen Tran Bang, Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam

Dr Xin Hui S Chan, ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, United Kingdom

Further Study Information

Current Stage: Ongoing
Date: October 2023 - March 2025
Funding source(s): To be confirmed


Health Area

Disease Category: Infectious disease

Disease Name: Dengue fever

Target Population

Age Range: 0 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research

Method(s)

- 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

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