Delphi (DEN-CORE)

To decide which outcomes are important to measure in all future clinical trials of dengue we need to get everyone’s opinion and try to reach agreement, or “consensus”, on the most important outcomes.

In order to do this, we carry 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 can be found below.

Details

This study has 4 parts: outcomes for hospitalised patients, outcomes for mild disease, outcomes for severe disease and outcome measurement tools. this survey covers outcomes for hospitalised patients.

Delphi Round 1: Closes 26 July 2024

Delphi Round 2: TBA

Who can participate in this study?

  • Adults (18 years of age or older) with lived experience of dengue
  • Adult family members or/caregivers who have cared for adults or children with dengue.
  • Healthcare professionals delivering care to patients with dengue
  • Researchers involved in studies of dengue
  • Representatives of other dengue stakeholders including funding agencies, governmental and non-governmental bodies, industry, regulatory authorities, etc.

Want to know more about the research?

Download a participant information sheet here:

Participate

Take part in the survey here. Contact dencore@isaric.org if you have any questions.

Main Steps of the Study

 1. Survey 1 (15-20 minutes to complete)

In the first survey, you will view a list of outcomes related to dengue. Link to survey.

For each outcome, you will rate how important you think it is to measure that outcome for all future clinical trials of dengue.

At the end of the survey, you can also suggest any other important outcomes that are missing from the list.

You can add comments to explain your decisions.

2. Survey 2 (10-15 minutes to complete)

Once the second survey is ready, you will see the same list of outcomes from survey 1 with a reminder of your own rating.

This time, you will also see a chart that shows how groups of people who took the first survey rated each outcome. This is a chance for you to consider the opinions of others and to reflect on your own previous ratings. You may think the same as you did before or if you would like to change your view. There is no right or wrong and it is fine to keep your answer the same and it is also fine to change your answer. It is totally up to you!

3. After these two surveys

After these two surveys there is the possibility of the need for an ‘Online Consensus Meeting’ to which a smaller subgroup of people with lived experience, health professionals, researchers and other groups representatives will be invited to discuss the results and agree the final core outcomes. If you would like to be considered for a place at this meeting you can tell us at the end of the second survey.

4. Results of the Study

The results will be analysed and published in a medical journal at the end of the study. We will also share a summary with relevant patient and health organisations.

You will not be identified in the publication unless you tell us (at the end of the second survey) that you want to be acknowledged for your contribution. If this is the case, your name will be included in a specific acknowledgements section of the publication. We will not present your individual thoughts on outcomes in the publication; rather all results will be presented according to the different groups that took part (i.e. people with lived experience, health professionals, researchers, etc.).

Frequently Asked Questions

Why are we doing this study?

Despite the widespread impact of dengue, currently no specific treatment exists for either the disease or its severe manifestations. This problem is due, in part, to there being no universally-agreed outcomes to measure in dengue clinical trials.

Different researchers and health professionals around the world are measuring different outcomes. Hence, their results cannot be easily compared, potentially slowing the improvements in clinical care.

This study aims to find the outcomes that are essential to measure in clinical trials. These outcomes are called core outcomes and will be included in a core outcome set. In the future, new studies can ensure they measure these core outcomes, promoting more efficient collaboration and potentially accelerating improvements in clinical care. This approach can help doctors and policymakers make better decisions about this important health issue. It can also lay the groundwork for developing specific treatments for dengue.

What is an outcome?

An ‘outcome’ is a term we use to talk about the effects of a disease that really matter to someone’s life. These could be measurements of how an individual feels, of biological markers of illness like blood tests, of an individual’s ability to go about their lives, or other aspects relevant to health. To put it simply, we seek to answer this question: “If a new medication for dengue fever were developed, what health effects or improvements would you hope to see from it?”

In this project, we want to find which outcomes are the most important in dengue. The list of these important outcomes is called a Core Outcome Set.

Watch this short video explaining what core outcomes are, why they are important and how patients and health professionals are involved in developing them:

Does it matter how an outcome is measured?

In the first part of our study, we are interested in “what” outcomes should be measured. That means deciding which outcomes are the most meaningful for dengue clinical trials. Deciding how each outcome should be measured is important and will be decided in the next stage of the study.

Are there any risks involved with taking part in this study?

We do not expect there to be any major risks, although occasionally some people can find it upsetting thinking about outcomes related to their experience. If you do feel uncomfortable or distressed, you can stop taking part at any time and/or you can provide feedback on any areas of concern. If you decide to include your name on the study reports or participate openly in a consensus meeting, your participation will no longer be private.

Will I get paid for taking part in this study?

There is no payment for taking part in the online survey or online consensus meeting.

Will my participation be confidential?

Your email address is the only information collected that may identify you. Your email will be kept confidential. It will only be used to send you information about participating in the study surveys and knowing the results. When you submit your survey, your email will be stored separately from your data and the research team who analyse the data cannot identify you. No person outside the research team will have access to any of your data. Your email will be deleted after the study is complete in approximately 1 year. Your IP address will not be stored. We will take all reasonable measures to ensure that data remain confidential.

The responses you provide on the survey will be anonymised and stored in a password-protected electronic file at the University of Oxford for 25 years. The survey results will be analysed across all respondents and shared in presentations and publications for the academic, public health and patient communities. 

How can I find support during the study?

If you have a concern about any aspect of this research, please contact the study team at dencore@isaric.org and we will do our best to answer your query. We will acknowledge your concern within 10 working days and give you an indication of how it will be dealt with. If you remain unhappy or wish to make a formal complaint, please contact the University of Oxford Research Governance, Ethics & Assurance (RGEA) team at rgea.complaints@admin.ox.ac.uk or on +44 (0)1865 616480

About the team

We are an international team of health professionals, researchers and people with lived experience of dengue. Our goal is to identify the most important outcomes for dengue clinical trials through collecting the views of different people from around the world.