A global core outcome measurement set for snakebite clinical trials

Area of Science:

• Global Health
• Clinical Trials
• Snakebite Envenoming

Background:

• Snakebite clinical trials lack standardized outcome measures, hindering research comparability and meta-analysis.
• Heterogeneous outcome reporting complicates the assessment of treatment efficacy and patient recovery.
• There is an urgent global need for standardized core outcome sets in snakebite research.

Purpose of the Study:

• To establish a globally relevant set of core outcome measures for snakebite clinical trials.
• To achieve consensus among diverse stakeholders on essential outcome measurement instruments.
• To provide a standardized framework for future snakebite research and clinical practice.

Main Methods:

• Systematic literature review of snakebite clinical trials to identify outcome domains and measurement instruments.
• Stakeholder engagement, including patient groups, through questionnaires, facilitated discussions, and voting.
• Consensus-building process involving a globally representative group of key stakeholders.

Main Results:

• Five universal core outcome measures were identified: mortality, WHO disability assessment scale, patient-specific functional scale, acute allergic reaction (Brown criteria), and serum sickness (formal criteria).
• Additional syndrome-specific core outcome measures should be selected based on the biting snake species.
• The proposed core outcome set is suitable for diverse settings, including low- and middle-income countries.

Conclusions:

• The developed core outcome measurement set promotes global standardization in snakebite clinical trials.
• This standardization supports patient and clinician priorities, facilitating meta-analyses.
• Implementation of this set will enhance the quality and comparability of snakebite research worldwide.