COSSMaT Study: Protocol for Developing a Core Outcome Set for Severe Malaria Treatment Trials.

ObjectivesSevere malaria remains a significant global health issue, especially in endemic regions, due to its high rates of morbidity and mortality. Despite progress, the variability in outcome measures across clinical trials hampers the synthesis of evidence and the development of standardised treatment guidelines. Developing a Core Outcome Set (COS) for severe malaria trials is crucial to address these inconsistencies, enhance research quality, and support evidence-based clinical practices. This study aims to develop a core outcome set for trials in the treatment of severe malaria. MethodThe study will follow the COMET Initiative guidelines to develop a reliable, valid, and responsive COS for clinical trials focused on severe malaria treatment. This will involve updating a systematic review of outcomes reported in severe malaria trials and collecting outcomes reported by patients, parents, and guardians/caregivers through qualitative research. Subsequently, collaboration with key stakeholders with expertise in severe malaria (including patient/support group representatives, healthcare workers, pharmaceutical industry representatives, policymakers, and researchers) will prioritise outcomes through a multi-stage Delphi survey. A Consensus meeting will be held virtually with stakeholder representatives to discuss and vote on the outcomes to include in the final COS. ConclusionThe global burden of malaria, particularly among children and vulnerable populations such as pregnant women, underscores the necessity of a COS to standardise outcomes in severe malaria trials. Addressing this gap is essential for standardising definitions, enhancing research quality, and facilitating transparent and credible comparisons. Establishing a COS not only improves individual studies and the combination of studies but also contributes to evidence-based treatment protocols to ensure effective treatment is identified, ultimately reducing the global health burden of severe malaria. Study registrationCore Outcome Measures in Effectiveness Trials (COMET) initiative 2908. https://www.comet-initiative.org/Studies/Details/2908