INCLUDED: Promoting INCLUsivity through improving the practice anD utility of Ethnicity Data collection in trials

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INCLUDED: Promoting INCLUsivity through improving the practice anD utility of Ethnicity Data collection in trials

Ethnicity data are essential if we are to understand how different groups are impacted by different medical conditions and/or how they respond to different treatments. Many of these differences are likely to focus on issues of accessibility and acceptability rather than biological differences and ensuring that people of all ethnicities can access and accept potential health interventions is crucial to health equity. Routinely collected NHS data, though improved over the past decade, still shows incompleteness and inconsistencies within ethnicity coding, particularly for ethnic minority groups. Further, questions about ethnicity need to be asked appropriately (including about language spoken or language preference) to identify differences among ethnic sub-groups, and sufficient information needs to be provided to participants so they can understand why they are being asked and how their data will be used. A recent study amongst UK-based South Asian volunteers from community centres and places of worship indicated that they thought the collection of patients’ ethnicity data was important but were concerned about its use. It is not known whether this view extends to other groups in the UK. More research has been done in the USA, but little is known about if/how ethnicity data collection contributes to underrepresentation in UK research. 

The current UK census definitions of ethnicity do not necessarily fit with the way individuals wish to self-describe, though work is being done to improve this. Of the 10 most recent National Institute for Health Research’s Journals Library trial reports published on or before 20/01/2021, three did not report ethnicity data; one reported ‘White ethnicity, n (%)’ only; and each of the remaining six reports presented ethnicity data differently. None detailed how or who was involved with data that were collected. A recent paper calls for a more coordinated and comprehensive approach to the collection, quality, and utilisation of ethnicity data to promote health equity. Additionally, addressing health equity is a key theme in RAND Europe’s recent report to NIHR on Future of Health.

This project aims to provide initial guidance to improve the collection of ethnicity data in UK clinical trials by: 

1. understanding how potential trial participants feel about the collection of ethnicity data, the possible effects on inclusion in trials and what might be done to improve this. 

The above is part of work package two (WP2) of a bigger study and will be the focus of this protocol only. 

The bigger study comprises following two more work packages that aim to: 

2. Understand how ethnicity data are currently collected and handled in UK clinical trials and the effect of this on interpretability of results (WP1). 

3. Develop guidance through consensus for trialists and others on collecting and recording ethnicity information and making suggestions regarding reporting (WP3).

This is a highly collaborative project, involving the Pragmatic Clinical Trials Unit at Queen Mary University of London, Keele Clinical Trials Unit, Oxford Clinical Trials Research Unit, Social Action for Health, Egality Health, Caribbean and African Health Network, Race Equality First, the Astha UK Centre for Applied Research PPI Group at the University of Edinburgh, Trial Forge, and the University of Aberdeen’s Health Services Research Unit and Centre for Healthcare Randomised Trials (CHaRT). COUCH Health's Dr Heidi Green co-leads this project with QMUL’s Dr Ratna Sohanpal. Funding was secured from the NIHR Clinical Trials Unit Support Fund. 

Contacts

Status

Ongoing