Evaluating a tool to improve engagement and recruitment of under-served groups in trials

Lydia Morris* (Corresponding Author), Jo Dumville, Shaun Treweek, Nasima Miah, Ffion Curtis, Peter Bower

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)


BACKGROUND: Despite substantial awareness that certain groups (e.g. ethnic minorities) are under-represented and under-served in trials, limited progress has been made in addressing this. As well as a public service and ethical duty to recruit and engage under-served groups in relevant research, importantly, there are clear scientific benefits, for example, increased generalisability. The key aims of the current study were to explore the following: general barriers and facilitators to enhancing the recruitment of under-served groups into trials, the usability and value of a specific tool (INCLUDE Ethnicity Framework) to support engagement and recruitment of under-served groups, and ways of engaging diverse patient, public and community involvement and engagement (PCIE) groups.

METHODS: Firstly, researchers completed a brief survey in relation to a specific trial in which they were involved (N = 182, 38% response rate). A second stage involved sampling survey respondents and asking them to complete the INCLUDE Ethnicity Framework and then a remote semi-structured interview (N = 15). Qualitative data were analysed using thematic analysis. Finally, we conducted a consultation process with PCIE contributors primarily to develop guidelines for discussing the INCLUDE Ethnicity Framework with PCIE representatives.

RESULTS: Researchers recognised the importance of increasing engagement and recruitment of under-served groups within trials, but varied in their knowledge, ability and commitment to implementation in practice. The INCLUDE Ethnicity Framework was described by some as raising their awareness of how inclusion could be improved. Respondents highlighted a need for shared resources and wider structural change to facilitate such engagement. PCIE was identified, in the survey and interviews, as the most common method of trying to improve recruitment of under-served groups. However, researchers also commonly highlighted that PCIE groups were sometimes not very diverse.

CONCLUSIONS: There is a need for researchers to consider the funding and time resources required for diverse and inclusive recruitment to trials and for funders to enable this. The INCLUDE Ethnicity Framework can help to raise awareness of inclusion challenges. This study indicates that it is important to take proactive steps to involve relevant under-served groups in PCIE and practical suggestions are made to facilitate this.

Original languageEnglish
Article number867
Number of pages13
Publication statusPublished - 9 Oct 2022

Bibliographical note

Many thanks to all those who participated in the study and particularly the public and community involvement and engagement contributors from Greater Manchester and East Midlands. Thanks to the National Institute for Health Research Applied Research Collaboration Greater Manchester’s Public and Community Involvement and Engagement (PCIE) Forum and Panel and to The Centre for Ethnic Health Research for their support of this work. Thanks also to Francisco Beduschi Neto for creating the participant flow diagram. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates.

This research was supported by the National Institute for Health Research Applied Research Collaboration Greater Manchester.

Data Availability Statement

The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.


  • Clinical Trials as Topic
  • Humans
  • Research Design
  • Research Personnel
  • Surveys and Questionnaires
  • Inclusion under-served groups
  • public involvement (PPI)
  • Minoritised groups
  • Patient
  • Trial methodology
  • Ethnic minority groups
  • public and community involvement and engagement (PCIE)


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