Evidence map›Paper›PMID 33971916›Full record

ArticleTrials2021

Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve.

Shaun Treweek, Katie Banister, Peter Bower, Seonaidh Cotton, Declan Devane, Heidi R Gardner, Talia Isaacs, Gary Nestor, Adepeju Oshisanya, Adwoa Parker and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
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  3. The experiences of minority language users in health and social care research: A systematic review.The International journal of health planning and management · 2025
    Pooled it
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  6. Guideline
  7. Pooled it
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  10. Trial
  11. Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT.Health technology assessment (Winchester, England) · 2024
    Trial
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  13. Article
  14. Article
  15. Article
  16. Review
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11 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Shaun TreweekHealth Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Aberdeen, AB25 2ZD, UK. streweek@mac.com.ORCID http://orcid.org/0000-0002-7239-7241
Katie BanisterHealth Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Aberdeen, AB25 2ZD, UK.
Peter BowerNIHR Clinical Research Network, Manchester Academic Health Science Centre, Centre for Primary Care and Health Services Research, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
Seonaidh CottonHealth Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Aberdeen, AB25 2ZD, UK.
Declan DevaneNational University of Ireland Galway, School of Nursing and Midwifery, University Road, Galway, Ireland.
Heidi R GardnerHealth Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Aberdeen, AB25 2ZD, UK.
Talia IsaacsUCL Centre for Applied Linguistics, UCL Institute of Education, University College London, London, UK.
Gary NestorNIHR Clinical Research Network Cluster E, Campus for Ageing and Vitality, Newcastle University, Newcastle, NE4 5PL, UK.
Adepeju OshisanyaPublic and Patient Representative, London, UK.
Adwoa ParkerYork Clinical Trials Unit, University of York, York, UK.
Lynn RochesterTranslational and Clinical Research Institute; NIHR Clinical Research Network Cluster E, Campus for Ageing and Vitality, Newcastle University, Newcastle, NE4 5PL, UK.
Irene SoulsbyPublic and Patient Representative, Newcastle, UK.
Hywel WilliamsCentre of Evidence-Based Dermatology, Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, NG7 2UH, UK.
Miles D WithamNIHR Newcastle Biomedical Research Centre, Campus for Ageing and Vitality, Newcastle University and Newcastle upon Tyne NHS Trust, Newcastle, NE4 5PL, UK.

Funding

Chief Scientist Office HSRU1Medical Research Council MR/K025643/1Medical Research Council MR/V020544/1
6 · The paper itself

Abstract

backgroundEnsuring 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.

methodsDevelopment 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).

resultsA 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: 1. Who should my trial apply to? 2. Are the groups identified likely to respond in different ways? 3. Will my study intervention make it harder for some groups to engage? 4. 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/ .

conclusionThinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are.

Indexed as

EthnicityHumansEthnicityExternal validityInclusionMethodologyRandomised controlled trials

Identifiers

PMID33971916
PMCPMC8108025

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.