Dengue Core Outcome Set

The Den-core project is an international consensus study to develop a standardised set of outcomes – a ‘core outcome set’ (COS) – to be used by all future dengue treatment trials.

ISARIC Core Outcome Sets

There are currently no effective treatments for dengue or severe dengue, which cause significant morbidity and mortality worldwide. We are working with partners to plan new clinical trials that address this pressing issue.

To date, dengue research has been based on heterogeneous outcome measures which have prevented the comparison of results across different studies and limited the impact of the evidence generated. By incorporating input from a broad range of stakeholders, including patient groups, health professionals and researchers, a core outcome set will ensure that research is both relevant and patient-centred, resulting in better informed clinical and policy decisions on a global scale. The core outcome set will also anchor the development of target product profiles for new therapeutic agents to treat dengue.

Latest Updates

The Den-core Project has been registered within the Core Outcome Measures in Effectiveness Trials (COMET) Initiative.
The ISARIC-WHO Den-Core Webinar will be held on 22 April 2024 and is open to everyone with experience of dengue or dengue clinical research.

Upcoming opportunities for involvement

You are invited to share your experience of dengue infection, caregiving, or research and development in our upcoming activities to ensure that the outcomes developed to support improved dengue treatment resonate with direct experiences and expert insights.

The following groups of people are invited to share their opinion:

People with lived experience of dengue and their family members or caregivers
Healthcare professionals and researchers involved in dengue studies
Representatives of other dengue stakeholders including funding agencies, governmental and non-governmental bodies, industry, regulatory authorities, etc.

ISARIC-WHO Webinar on the

Dengue Core Outcome Set project

Date: 22 April 2024

Time: 13:00 British Standard Time, UTC+1

This seminar has now taken place. Watch or download the recording below.

Download Agenda

Event Recording

E-Delphi Study to

Improve Dengue Clinical Trials

How to participate: The survey will be available soon

To decide which outcomes are important to measure in all future dengue clinical trials, the den-core team is carrying out a ‘consensus exercise’ in the form of a ‘Delphi’ study. The ‘Delphi process’ is a method in which participants individually respond to a series of questionnaires. Each round is informed by anonymous summaries of the previous round’s responses, with the goal of reaching a consensus. This study will be conducted online and involves participation in two surveys. Detailed information about each survey and subsequent steps will be shared on this page shortly.

About the Project

The Den-core team was formed in 2023 to develop a Core Outcome Set (COS) for use in dengue research with input from patient representatives, health professionals, psychologists, researchers, methodologists, epidemiologists, journal editors, industry, policy makers, and regulators.

Together, this range of stakeholders will develop a consistent framework for outcome selection and reporting. The COS will contribute to improved research quality, data comparability, and evidence synthesis, ultimately facilitating the development of effective interventions and evidence-based clinical practice.

Key Objectives

Defining the scope and applicability of Core Outcome Sets for dengue

Creating Core Outcome Sets and measurement tools to improve dengue research

Achieving consensus on terminology and definitions for measurement instruments related to dengue Core Outcomes

Participants

Types of Den-core project participants:

People with lived experience of dengue

Family members/caregivers of people with dengue

Healthcare professionals delivering care to patients with dengue

Researchers involved in studies of dengue

Other stakeholders who impact dengue treatment (policymakers, regulators, etc.)

Project Stages

The project will follow a step-by-step method recommended by the Core Outcome Measures in Effectiveness Trials Initiative (COMET) to determine what outcomes should be included in the core outcomes set for future dengue studies.

Systematic Literature Review: Our first step involves a thorough analysis of existing literature. We will review clinical trial data and qualitative research on dengue treatments to understand the breadth of outcomes that have been previously reported.
Preliminary Outcome List Development: From the literature review, we will compile a comprehensive list of potential outcomes. This list will serve as a starting point for further refinement.
Consultation with Stakeholders: The preliminary list will be refined through a series of iterative consultations. We will engage with a diverse group of stakeholders, including dengue patients, caregivers, healthcare providers, researchers, policy makers, and regulatory bodies, ensuring the outcomes resonate with direct experiences and expert insights.
Modified E-Delphi Process: To prioritise the outcomes, we will implement a modified Delphi process. This involves multiple rounds of scoring by stakeholders to evaluate the importance of each outcome, allowing us to reach a consensus on which outcomes are critical. Learn more
Consensus Meeting: A final consensus meeting will be held to agree on the key domains of the COS.

How to measure: In the second phase of the project, we will evaluate and select the appropriate measurement instruments for the outcomes we have identified as core. This ensures that future research on dengue treatments can be compared and combined, moving towards more standardized and meaningful results.

What is a Core Outcome Set?

A core outcome set provides a minimal list of outcome measures to be reported in all clinical trials in a specific disease area.

The core outcome set does not preclude trialists from selecting primary, secondary, or safety outcome measures that are not in the core set.

Having a standardised minimal set of measurements for all clinical trials will ensure patient and clinical relevance, and enables comparability across trials thus facilitating Meta-analysis.

This video developed by Core Outcome Measures in Effectiveness Trials (COMET) initiative explains what core outcome sets are, why they are important, and how patients and the public are involved in developing COS: