When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework

Area of Science:

• Public Health Research
• Clinical Trial Methodology
• Health Equity Studies

Background:

• Randomized controlled trials (RCTs) are crucial for evaluating intervention impacts, yet often lack sufficient reporting on health equity considerations.
• Assessing the equity implications of health interventions requires specific methodologies often missing in current trial designs.
• There is a need for standardized approaches to identify and report health equity relevance in RCTs.

Framework:

• A conceptual framework was developed through an interdisciplinary consensus process to define 'health equity-relevant' randomized trials.
• The framework classifies trials based on their assessment of intervention effects on individuals or populations experiencing disadvantage across social determinants of health.
• It distinguishes trials exclusively focused on disadvantaged groups from those collecting data for subgroup analyses.

Implementation:

• The framework was refined through an iterative consensus-building process involving international experts.
• A validation exercise was conducted where independent reviewers applied the emerging framework to classify a sample of RCTs.
• This process ensured the framework's practicality and reliability for classifying trial health equity relevance.

Implications:

• The developed framework can guide the design and reporting of future randomized controlled trials to enhance health equity assessment.
• It provides a tool for researchers to systematically identify studies contributing to the health equity evidence base.
• The framework's principles may be adaptable to other study designs, broadening its utility for advancing health equity research.