Is health research undertaken where the burden of disease is greatest? Observational study of geographical inequalities in recruitment to research in England 2013–2018
Abstract:Background: Research is fundamental to high-quality care, but concerns have been raised about whether health research is conducted in the populations most affected by high disease prevalence. Geographical distribution of research activity is important for many reasons. Recruitment is a major barrier to research delivery, and undertaking recruitment in areas of high prevalence could be more efficient. Regional variability exists in risk factors and outcomes, so research done in healthier populations may not gen… Show more
“…These maps show that some parts of the country with high prevalence of specific diseases recruit few research participants to trials relevant to those diseases, suggesting a need to build capacity in areas with low research activity. These data align with a more in-depth analysis that quantifies the extent of geographical mismatch between research recruitment and burden of disease [ 14 ]. Fig.…”
Section: Introductionsupporting
confidence: 63%
“…Bower et al [ 14 ] recently explored geographic variation in research recruitment activity by prevalence of long-term conditions in England. Similar to the heat maps in Fig.…”
Background
Research participation is beneficial to patients, clinicians and healthcare services. There is currently poor alignment between UK clinical research activity and local prevalence of disease. The National Institute of Health Research is keen to encourage chief investigators (CIs) to base their research activity in areas of high patient need, to support equity, efficiency and capacity building. We explored how CIs choose sites for their trials and suggest ways to encourage them to recruit from areas with the heaviest burden of disease.
Methods
Qualitative, semi-structured telephone interviews with a purposive sample of 30 CIs of ongoing or recently completed multi-centre trials, all of which were funded by the UK National Institute of Health Research.
Results
CIs want to deliver world-class trials to time and budget. Approaching newer, less research-active sites appears risky, potentially compromising trial success. CIs fear that funders may close the trial if recruitment (or retention) is low, with potential damage to their research reputation.
We consider what might support a shift in CI behaviour. The availability of ‘heat maps’ showing the disparity between disease prevalence and current research activity will help to inform site selection. Embedded qualitative research during trial set up and early, appropriate patient and public involvement and engagement can provide useful insights for a more nuanced and inclusive approach to recruitment. Public sector funders could request more granularity in recruitment reports and incentivise research activity in areas of greater patient need. Accounts from the few CIs who had ‘broken the mould’ suggest that nurturing new sites can be very successful in terms of efficient recruitment and retention.
Conclusion
While improvements in equity and capacity building certainly matter to CIs, most are primarily motivated by their commitment to delivering successful trials. Highlighting the benefits to trial delivery is therefore likely to be the best way to encourage CIs to focus their research activity in areas of greatest need.
“…These maps show that some parts of the country with high prevalence of specific diseases recruit few research participants to trials relevant to those diseases, suggesting a need to build capacity in areas with low research activity. These data align with a more in-depth analysis that quantifies the extent of geographical mismatch between research recruitment and burden of disease [ 14 ]. Fig.…”
Section: Introductionsupporting
confidence: 63%
“…Bower et al [ 14 ] recently explored geographic variation in research recruitment activity by prevalence of long-term conditions in England. Similar to the heat maps in Fig.…”
Background
Research participation is beneficial to patients, clinicians and healthcare services. There is currently poor alignment between UK clinical research activity and local prevalence of disease. The National Institute of Health Research is keen to encourage chief investigators (CIs) to base their research activity in areas of high patient need, to support equity, efficiency and capacity building. We explored how CIs choose sites for their trials and suggest ways to encourage them to recruit from areas with the heaviest burden of disease.
Methods
Qualitative, semi-structured telephone interviews with a purposive sample of 30 CIs of ongoing or recently completed multi-centre trials, all of which were funded by the UK National Institute of Health Research.
Results
CIs want to deliver world-class trials to time and budget. Approaching newer, less research-active sites appears risky, potentially compromising trial success. CIs fear that funders may close the trial if recruitment (or retention) is low, with potential damage to their research reputation.
We consider what might support a shift in CI behaviour. The availability of ‘heat maps’ showing the disparity between disease prevalence and current research activity will help to inform site selection. Embedded qualitative research during trial set up and early, appropriate patient and public involvement and engagement can provide useful insights for a more nuanced and inclusive approach to recruitment. Public sector funders could request more granularity in recruitment reports and incentivise research activity in areas of greater patient need. Accounts from the few CIs who had ‘broken the mould’ suggest that nurturing new sites can be very successful in terms of efficient recruitment and retention.
Conclusion
While improvements in equity and capacity building certainly matter to CIs, most are primarily motivated by their commitment to delivering successful trials. Highlighting the benefits to trial delivery is therefore likely to be the best way to encourage CIs to focus their research activity in areas of greatest need.
“…There is little point to the Framework if we do not know whether it has any impact. The UK’s research infrastructure contains some strengths in this regard [ 15 ] but there remain challenges, not least the need to more routinely record data on ethnicity. How to go about recording ethnicity is not trivial.…”
Background
Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process, facilitated by Trial Forge, that was used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies.
Methods
Development of the Framework was done in seven phases: (1) outline, (2) initial draft, (3) stakeholder meeting, (4) modify draft, (5) Stakeholder feedback, (6) applying the Framework and (7) packaging. Phases 2 and 3 were face-to-face meetings. Consultation with stakeholders was iterative, especially phases 4 to 6. Movement to the next phase was done once all or most stakeholders were comfortable with the results of the current phase. When there was a version of the Framework that could be considered final, the Framework was applied to six trials to create a set of examples (phase 6). Finally, the Framework, guidance and examples were packaged ready for dissemination (phase 7).
Results
A total of 40 people from stakeholder groups including patient and public partners, clinicians, funders, academics working with various ethnic groups, trial managers and methodologists contributed to the seven phases of development. The Framework comprises two parts. The first part is a list of four key questions:
Who should my trial apply to?
Are the groups identified likely to respond in different ways?
Will my study intervention make it harder for some groups to engage?
Will the way I have designed the study make it harder for some groups to engage?
The second part is a set of worksheets to help trial teams address these questions. The Framework can be used for any stage of trial, for a healthcare intervention in any disease area. The Framework was launched on 1st October 2020 and is available open access at the Trial Forge website: https://www.trialforge.org/trial-forge-centre/include/.
Conclusion
Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are.
“…There is little point to the Framework if we do not know whether it has any impact. The UK's research infrastructure contains some strengths in this regard 15 but there remain challenges, not least the need to more routinely record data on ethnicity.…”
Background Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies. Methods Development of the Framework was done in seven phases: 1) Outline; 2) Initial draft; 3) Stakeholder meeting; 4) Modify draft; 5) Stakeholder feedback; 6) Applying the Framework; 7) Packaging. Phases 2 and 3 were face-to-face meetings. Consultation with stakeholders was iterative, especially phases 4 to 6. Movement to the next phase was done once all or most stakeholders were comfortable with the results of the current phase. When there was a version of the Framework that could be considered final, the Framework was applied to six trials to create a set of examples (Phase 6). Finally, the Framework, guidance and examples were packaged ready for dissemination (Phase 7). Results A total of 40 people from stakeholder groups including patient and public partners, clinicians, funders, academics working with various ethnic groups, trial managers and methodologists contributed to the seven phases of development. The Framework comprises two parts. The first part is a list of four key questions:Who should my trial apply to? Are the groups identified likely to respond in different ways? Will my study intervention make it harder for some groups to engage? Will the way I have designed the study make it harder for some groups to engage? The second part is a set of worksheets to help trial teams address these questions. The Framework can be used for any stage of trial, for a healthcare intervention in any disease area. The Framework was launched on 1 st October 2020 and is available open access at https://www.trialforge.org/trial-forge-centre/include/ Conclusion Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are.
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