NIHR Leeds MIC advocates the importance of engaging underserved groups in research

13 January 2022

NIHR Leeds MIC advocates the importance of engaging underserved groups in research

Sajid Javid announces international review into bias in medical devices

The UK Health Secretary commissioned an international review, in partnership with his US counterpart, to ensure medical devices have been tested on people of all ethnicities before they are allowed to be sold. The importance of this inclusive approach is a theme already embedded in our research projects.

In this case study, we highlight the importance, benefits and challenges of targeted research to better guide care pathways and safeguard against the dangers of generalising research results to underserved groups.

Patient and wider public focus

At the NIHR Leeds In Vitro Diagnostics Co-operative (NIHR Leeds MIC) working with patients and the wider public is vital. It enables us to assess the feasibility and effectiveness of In-Vitro Diagnostic (IVD) tests and thereby deliver better care pathways.

Patients and the wider public bring a wealth of experience and provide valuable perspectives and insight into the way IVD tests should be developed and prioritised. Our dedicated Patient and Public Involvement and Engagement (PPIE) groups are forums for sharing insights to ensure our testing and development programmes support patient-led approaches.

Dr Sunil Daga, Deputy Renal Theme Lead, NIHR Leeds MIC

Sunil is delivering a number of important leading research initiatives to ensure Patient and Public Involvement work is truly representative of the patient groups he sees and treats on a daily basis.

A Consultant Nephrologist and Renal Transplant Physician, Sunil’s role at the NIHR Leeds MIC is to address the urgent need to improve diagnostics and therapeutic interventions for patients with kidney disease. His research is designed to help us better understand our patient audience and make more informed decisions around the validation of IVD tests, especially for underserved groups in our region.

This is particularly timely, as the NIHR Leeds MIC is currently involved in the validation of remote blood and urine tests for renal patients: engaging all patient groups effectively is key to successful roll-out.

What we mean by ‘underserved groups’

Our funding organisation, the National Institute for Health and Care Research (NIHR), launched the INCLUDE* project in 2017 to improve inclusion of underserved groups in clinical research. In this context, the term ‘underserved communities’ reflects groups of patients who do not engage in research and highlights the need for the research community to provide a more inclusive service.

Each region and medical specialities will have different characteristics of underserved groups and need to review their data to define these in the context of their work. Underserved populations generally include those from lower social economic backgrounds, non-English speaker, ethnic minority groups and those with lower educational levels. These groups are not well represented in research, particularly in renal medicine (Health inequalities in Kidney Health).

In Leeds, kidney disease is disproportionately high in members of the South Asian community. However, representation of this group in clinical research activities is disproportionately low.

Sunil explainsThis gap in representation in research creates a number of problems: at its most basic, it creates a disconnect when you don’t understand the decision-making considerations or ‘speak the language’ of the audience you are trying to reach. Decisions are made based upon ‘assumptions’ and a one model approach is adopted; one that is traditionally based on research conducted with a limited and non-representative cohort. The ‘privileged white male view’ can be presented as a current one size fits all approach”.

Kidney disease and donation – the challenge

Patients from a South Asian background typically have to wait significantly longer for a successful kidney match than other patients, due to a shortage of suitably matched donors. This has worsened post-COVID-19, as donation figures across the board have dropped significantly. If more people from certain ethnic groups donated their organs after death, or became a living donor, transplant waiting times would reduce.

The latest statistics taken from NHS Blood and Transplant’s annual report into organ donation and transplantation in Black, Asian and Minority ethnic (BAME) groups  show  there were just 146 organ donors from these groups in 2020/21 (84 deceased, and 62 living); a 25% reduction in deceased donor and a 61% reduction in living donors compared to 2019/20.

Over the same period, there were 1,180 total deceased organ donors in the UK with only 7% from  ethnic minority backgrounds, yet there are 1,237 people on the waiting list from these communities, accounting for 29.5% of all patients waiting for a transplant. When approached about organ donation over the course of the past year, 39.5% of BAME families agreed to support donation, compared to 69% of white families.

Sunil expands: “At any one time we have a number of patients in kidney clinic who have received a donated kidney from a close relative. Most of these patients tend to be of white ethnicity, are well educated, and come from more affluent backgrounds. One issue we have is that many women from South Asian groups do not receive donated kidneys from a relative and less so from a male relative for cultural reasons. It’s not even something they consider an option and it is not talked about within those families and communities. We refer to this as ‘cultural silence’.

 This is not a new challenge and it is not an easy fix but ensuring that underserved groups are better represented in research and are communicated with in a personalised way is where our focus needs to be.”

Representative research is key

Sunil is currently involved in a number of research initiatives that all focus on addressing this representation gap. These include qualitative studies to understanding decision making in underserved groups and working directly with leading kidney charities and organisations to widen participation and deliver service improvement in our region.

The qualitative study involved interviews with over 40 patients and analysis of patient literature about living donation from renal units across the UK.  The results suggest the information about kidney donation provided in current health care, is hard to read and compounds the effect of health literacy and is not focusing on the underserved audiences: this has a tangible impact on patient outcomes. As a result of this review, recommendations were made to UK Kidney organisations on content that must be included in future health publications and communication platforms which would resonate better with underserved audiences.

Sunil comments:Leaflets are an issue in themselves. In some communities, a leaflet is regarded as something accessed only by the privileged. I regularly engage with the patient groups with whom I treat and find that written ‘leaflet style’ content is not the right vehicle for disseminating information to these marginalised audiences. WhatsApp, for example, is more widely used amongst those from a South Asian background in Leeds and content needs to be bitesize, multimedia, and audio-visual. This goes back to the idea of understanding how to reach these groups first and more diverse and representative research is the silver bullet to understanding this.”

Sunil is involved in a quality improvement proposal for medical students to allow them to study how to improve research participation from underserved groups, particularly those from a South Asian background in Yorkshire. He is a working in partnership with Kidney Care UK, the largest patient association in widening participation for service improvements in the region. This specifically involves addressing the need for more role models/ambassadors to get out into the community and support clinical decision making. In relation to living kidney donation, this work is the first of its kind in Yorkshire. Sunil is gathering a pool of patients to be involved in this project and expects to recruit more through a series of workshops across the Yorkshire Region.

How does this work impact the NIHR Leeds MIC?

Sunil’s awareness of the cultural and behavioural characteristics of our underserved groups and the research work he is involved in will help shape the way in which IVD tests are assessed going forward, driving better outcomes for all patients. In the past, IVDs have not been tested on a truly representative of the demographics we serve and we will address this in future innovations.

A significant project for the NIHR Leeds MIC team, which will benefit from Sunil’s work, involves home monitoring of drug levels and kidney health. This will have a beneficial impact on the lives of renal patients who have to attend regular hospital appointments for the rest of their lives pre- and post-transplant for monitoring. Effective communication with representative patients will be key to the success of this project.

Stephanie Roberts, Patient and Public Involvement Lead at NIHR Leeds MIC concludes: “The need to include underserved groups  in co-development of research is vital and engaging with a higher percentage of patients from underserved backgrounds is a key target. Dr Daga’s work and involvement in research in this area means that we will have first-hand access to the resultant learnings, which will guide our approach to improving engagement with these groups.”

BE-SURE Campaign – Broadening Engagement and Serving the Underserved in Research

An upcoming example of this work includes an NIHR Leeds MIC funded roadshow – BE-SURE Broadening Engagement and Serving the Underserved in Research, that will target Leeds groups where research participation is currently low. Dr Daga and his team will deliver events to community groups that showcase the opportunities and benefits of being involved in clinical research. This will include talks from patients who are already participating in research.

* NIHR INCLUDE Project – INCLUDE is a collaborative effort involving researchers, health professionals, funders, charities, participants, families and carers, regulatory bodies, the life sciences industry, and colleagues from across the NIHR and Clinical Research Network. The project has benefitted from having the strategic input of an expert steering group comprising members from across our stakeholder groups. Further information can be found HERE.

Related Themes

Related Team Members

Dr Sunil Daga

Renal Medicine Deputy Lead

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