CONCEPTUALISING, OPERATIONALISING AND UTILISING EQUITY, DIVERSITY AND INCLUSION IN CLINICAL TRIALS: A SCOPING REVIEW
Dr Shiva Raj Mishra1, Dr Aidan C. Tan1, Dr Karen Waller1, Prof Clara K. Chow1, Prof Richard Lindley1, Prof Angela Webster1
1University Of Sydney, Australia
Aim: This scoping review sought to understand the conceptualisation, operationalisation, and utilisation of EDI in clinical trials.
Background: Equity, diversity and inclusion (EDI) are social constructs which when used in clinical trials help generate the highest quality evidence for interventions in the populations most likely to benefit. However, the incorporation of these constructs in clinical trials is unclear and inconsistent.
Methods: We systematically reviewed literature from PubMed (via NLM) and Google Scholar from 1990 to 2023. Information on conceptualisation (definition), operationalisation (measuring/coding) and utilisation (analysing) were extracted. Additionally, we searched a sample of websites of health actors across the research lifecycle to identify conceptualisations outside but impacting upon the published literature.
Results: We reviewed 2385 titles/abstracts and 295 ‘related:URL’ searches and included 75 (3%) in analyses. Studies conceptualised EDI as interconnected rather than distinct constructs. These concepts were intertwined and often reinforcing, such as efforts to enhance diversity may also promote equity and foster inclusion. Regarding operationalisation, several frameworks, tools and metrics were identified for EDI assessment across the research lifecycle. A third of publishers (6/20) had EDI considerations; followed by 2/19 trial registries, 12/44 research funders, 7/60 journals, and none of ethics committee and data repositories reported statement on EDI. The proportion of patients excluded varied widely among different exclusion criteria.
Conclusions: This study mapped conceptualisation, operationalisation, and utilisation of EDI in clinical trials and identified metrics for EDI assessment, each with unique strengths and limitations. Future research could explore the impact of different EDI criteria on trial outcomes and the generalisability of trial results.
Keywords: Equity, diversity, inclusion, concepts, metrics, review
Biography:
Dr Shiva Raj Mishra is a research fellow at the NHMRC Clinical Trials Center, University of Sydney. He is involved in designing meta-epidemiological studies looking at health equity, diversity and inclusion in clinical trials and exploring health disparities in cardiovascular outcomes and services.Shiva has several years of training and experience in epidemiology and health data science. He collaborates in studies to improve understanding of health disparities, individual and population-level determinants of risk factors and public health interventions on cardiometabolic diseases with a focus on low-income setting.