ARC GM | Projects

What were we trying to do?

The INCLUDE Ethnicity Framework aims to help trial teams think carefully about which ethnic groups should be included in their research for its results to be widely applicable, and what challenges there may be to making this possible.

In this project, we investigated the feasibility and usability of the INCLUDE Ethnicity Framework and gathered the perspectives of researchers on the likely effectiveness of the Ethnicity Framework.

A sub-focus of the work was the feasibility and usability of the ‘generic’ INCLUDE questions (these are also part of the Ethnicity Framework, but do not focus on ethnic minorities, which enables researchers to consider inclusion of a range of under-served groups).

Why was it important?

Some groups of people are under-represented in health and social care research. Under-representation is characterised by:

Lower levels of inclusion in research compared to population estimates.
High healthcare burden that is not matched by the volume of research.
Important differences in how a group responds to, or engages with interventions, services or research.

Inclusive research involves the under-served groups that the results of the research could apply to, for example, identifying which individuals from under-served groups should be able to access an intervention or treatment that is being evaluated.

Inclusive research also takes proactive steps to involve these under-served individuals and groups. As well as a public service and ethical duty to include under-served groups, there are also clear scientific benefits to inclusive research. For example, ensuring trial results are generalisable to the relevant wider population and that important findings specific to different populations are not missed.

Therefore, trial teams need to do everything possible to make their research relevant to the people the results apply to (often patients) and those expected to apply them (often healthcare professionals).

How did we do it?

We addressed four research questions:

What activities do researchers currently undertake to consider under-served groups in their trials?
How feasible and useable do researchers find application of the INCLUDE Ethnicity Framework to their particular study?
What are researcher views on the potential usefulness and effectiveness of the INCLUDE Ethnicity Framework in terms of meeting the overall aims of engaging with, and improving inclusion of, under-served groups in clinical research?
What additional content or resources do researchers think could enhance the INCLUDE Ethnicity Framework’s comprehensiveness and usability (for example, tips or links to other resources)?

To address the research questions above, we used a short electronic survey of Chief Investigators of relevant research studies, which included randomised controlled trials that were either being prepared, or were funded by NIHR funding streams, such as Research for Patient Benefit (RfPB), Invention for Innovation (I4I), Efficacy and Mechanism Evaluation (EME) and Health Technology Assessment (HTA). We asked questions about how Chief Investigators consider under-served groups in their study planning.

We also asked respondents to indicate whether they were willing to pilot the use of the INCLUDE Ethnicity Framework in their current study. If they agreed, they were invited to take part in a modified ‘think aloud’ assessment of their use of the INCLUDE Ethnicity Framework and a short qualitative interview.

Survey findings

From 823 total NIHR-funded studies, 485 were eligible for inclusion in the project, and 182 of those (36%) responded to the initial survey. 110 studies agreed to use the INCLUDE Ethnicity Framework in their study and to be interviewed - of those, 15 completed a Framework and interview.

The main findings were:

63.2% of respondents reported that under-served groups are relevant to their trial.
85.1% said the design or conduct of the trial had been informed by members of the under-served population that was identified as important.
The most common approach to involving under-served groups was reported as ‘representatives from under-served groups are advisors’, which was the case for 76.5% of respondents.
81.6% of respondents said the approach considered by trial teams to increase the recruitment of under-served groups was PPI.

Overall findings

We found that, while researchers understood the need to increase engagement and recruitment of under-served groups in research trials, their knowledge, ability and drive to work towards this varied.

Although Patient and Community Involvement and Engagement (PCIE) was identified as the most common way to try and improve recruitment of under-served groups, researchers acknowledged that PCIE groups are often still lacking in diversity.

Some researchers said that the INCLUDE Ethnicity Framework raised their awareness of the challenges of inclusive involvement, as well as how inclusion could be improved. But others highlighted the need to share resources and to make wider structural changes before engagement can become easier and more effective.

The study authors recommended that researchers should consider the amount of time that diverse and inclusive recruitment can take, as well as how much it can cost. Funders also need to enable the time and funding required to allow diverse involvement.

In conclusion, we found that it’s important to be pro-active in recruiting under-served groups into PCIE activity, and the we have developed practical guidance for researchers (which is available from the resource section below) to support the involvement of patient, public and community contributors in the INCLUDE Ethnicity Framework.

Who we worked with:

Downloadable resources

More information

Senior Programme Lead

Mike Spence
mike.spence@healthinnovationmanchester.com

Evaluating the feasibility and usability of the INCLUDE framework