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

Abstract

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.

NIHR Race Equality Framework: development of a tool for addressing racial equality in public involvement

“…However, this is similar to the challenges when other equality tools were introduced, such as the Athena Swan Charter to improve gender equality and the INCLUDE Ethnicity Framework to improve inclusion of under-served groups in clinical research. Subsequent research has shown that the implementation of the Athena Swan Charter and the INCLUDE Ethnicity Framework has been associated with positive effects [ 50 – 52 ]. Therefore, we believe that the effects of the Framework are likely to be similar, provided each organisation commits to its implementation with sufficient resources and expertise.…”

Improving the inclusion of an under-served group in trials: development and implementation of the INCLUDE Impaired Capacity to Consent Framework

“…An implementation project was planned to identify and address any barriers to the uptake of the framework, some of which were identified during the pilot stage of the framework development and those identified by Trial Forge [ 22 , 24 ] during the implementation and evaluation if its ‘sister’ framework — the INCLUDE Ethnicity Framework. As a complex intervention that is intended to disrupt current systems for designing trials [ 30 ], we recognised the need for theorising how it would work in practice, which takes account of how it interacts with the context in which it is implemented [ 27 ].…”

“…Working with researchers and people affected by capacity-affecting conditions and their carers, we developed the NIHR INCLUDE Impaired Capacity to Consent Framework to help researchers to design trials that are more inclusive of these groups [ 23 ]. Evidence from the development and evaluation of a previous INCLUDE framework — the Ethnicity Framework — showed that implementation activities are needed to help researchers to use a new framework in practice and are key for it to achieve similarly successful impact [ 24 ]. In this paper, we firstly outline the methods used in the development of the framework and the theoretically-informed implementation project that aims to support researchers to use the framework to design more inclusive trials in the future.…”

Enablers and barriers to engaging under-served groups in research: Survey of the United Kingdom research professional’s views

“…While the issues with the lack of diversity in research populations is well covered in the literature there are limited works on the views of research professionals around improving access to research. Two contemporary works, set in the UK, have been identified that explore researchers' views 30,32 . These works highlight general and specific barriers and facilitators to engagement, including lack of time and funding 32 and issues with approvals and consent processes 30 .…”

“…Two contemporary works, set in the UK, have been identified that explore researchers' views 30,32 . These works highlight general and specific barriers and facilitators to engagement, including lack of time and funding 32 and issues with approvals and consent processes 30 . They explore the complexity of engagement in these groups and the need for researchers to be proactive.…”