COSSMaT

Developing a Core Outcome Set for trials in the treatment of severe malaria

Which outcomes should every trial in severe malaria measure?

What is this study about?

Malaria remains a global health challenge with a significant impact on morbidity and mortality. While progress has been made, challenges persist in treating severe cases due to a lack of consensus on outcomes for clinical trials.

A systematic review revealed considerable variation in outcome measures, emphasising the need for a core outcome set (COS) for severe malaria treatment. Addressing this gap is crucial for standardising definitions, improving research quality, and facilitating transparent and credible comparisons. Establishing a COS not only refines individual studies but also contributes to evidence-based treatment protocols, ultimately reducing the global health burden of severe malaria.  

The study will adhere to the COMET Initiative guidelines to create a reliable, valid, and responsive COS for clinical trials addressing severe malaria treatment. This will involve gathering outcomes reported by patients, parents, and guardians/caregivers through qualitative research methods and systematically reviewing reported outcome sets and measurement instruments in severe malaria treatment trials, followed by collaboration with key stakeholders and experts to prioritise outcomes through a Delphi survey, and finally achieving consensus on the core set through a consensus meeting. 

Contact details

gideon.asamoah.23@ucl.ac.uk
elizabeth.george@ucl.ac.uk

Who is funding the study?

COSSMaT is funded by the UK Medical Research Council (via the MRC Clinical Trials Unit at UCL) and International Scholar Awards for Doctoral Training (ISAD) from the UCL Doctoral School.

When is it taking place?

The study opened in September 2023 and is expected to run until September 2026.

Where is it taking place?

The study is taking place in the UK.

Who is included?

Key stakeholders, encompassing clinical experts, patient/support group representatives, health care workers, pharmaceutical industry representatives, policymakers, and researchers, will be involved in the COS development process.