Scope
This framework has been designed to aid researchers, who are designing clinical trials, to consider barriers to including patients from socioeconomically disadvantaged backgrounds in their trial. The framework can also help researchers to develop strategies to attempt to address such barriers in order to improve the design and conduct of clinical research. Although this framework was developed with UK-based clinical trials in mind, aspects may also be relevant to different types of research and research conducted in populations outside of the UK. Whilst this framework focuses on socioeconomic disadvantage, the list of underserved groups in clinical research is extensive and researchers need to be aware of this when identifying barriers to research and developing to strategies to address barriers.
Launch webinar – 24th January 2023
The recording from the webinar that launched the INCLUDE Socioeconomic Disadvantage Framework is available below. You can downloads the slides that were used for the webinar here.
What is socioeconomic disadvantage?
There is no consensus on a definition of socioeconomic status, nor does a widely accepted measure of socioeconomic status exist. There are many different domains of socioeconomic status, but it is typically measured as a combination of income, employment and education. In general terms, being socioeconomically disadvantaged includes living in less favourable social and economic circumstances than the majority of others in the same society.
Socioeconomic disadvantage is complex, multidimensional and can be dynamic; one’s socioeconomic status is not necessarily the same throughout the life course, and events can change socioeconomic status over time. We are aware that the language and terminology used to describe socioeconomic disadvantage can be sensitive. We would welcome any feedback and suggestions for improvement that you may have at: info@trialforge.org
This work is linked to the INCLUDE initiative from the UK’s National Institute for Health and Care Research (NIHR), which aims to improve trial delivery for under-served groups.
Four Key Questions and worksheets
The INCLUDE Socioeconomic Disadvantage Framework has four Key Questions, each of which is intended to prompt trial teams to think about who should be involved as participants, and how to facilitate their involvement as much as possible. These questions should be considered by trial teams in partnership with patient and public partners.
Answering the Key Questions can be tricky. To help with this we have developed some worksheets that give pointers to the sort of things to think about when answering the Questions.
The Key Questions and worksheets can be downloaded from the links below.
The INCLUDE Socioeconomic Disadvantage Framework
The four Key Questions, the worksheets and appendices as a single download.
How to cite: Gardner H, Biggs K, Sherratt FC. The INCLUDE Socioeconomic Disadvantage Framework, 2022. Available: https://www.trialforge.org/trial-forge-centre/socioeconomic-disadvantage-framework[Accessed [insert date]].
This appendix gives the background and next steps for the Framework.
This document lists the development phases of the INCLUDE Socioeconomic Disadvantage Framework and all the people involved.
Examples
Coming in 2023.
Insights
The INCLUDE Socioeconomic Disadvantage Framework is new and we thought some insights from people who have used it might be useful.
Heidi Gardner, University of Aberdeen, and one of the lead developers of the INCLUDE Socioeconomic Disadvantage Framework talks about developing the Framework (audio coming in 2023).
Funders and others signposting researchers to INCLUDE
NIHR signposts grant applicants to INCLUDE and the Ethnicity Framework in its Stage 2 Standard Guidance for Applicants when applying for Health Technology Assessment funding.
The Wellcome Trust signposts applicants to INCLUDE (and therefore to the Ethnicity Framework) in its Clinical Trials Policy guidance.
The Belgian Health Care Knowledge Centre, KCE, signposts applicants to INCLUDE and the INCLUDE Ethnicity Framework in its Useful links & resources for investigators.
The NHS Research and Development Forum includes the INCLUDE Ethnicity Framework in its resources to support health care research in the UK.
The Chief Scientist Office, Scotland, points grant applicants to the INCLUDE Ethnicity Framework for both its Health Improvement, Protection and Services Research Committee and its Translational Clinical Studies Research Committee.
Additional resources
Below we list some resources which we hope you might find useful:
Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process
Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. This article describes a multicomponent project – called INCLUDE –to improve representation of under-served groups in clinical trials.
Improving inclusion of under-served groups in clinical research: Guidance from the INCLUDE project
This guidance summarises what an under-served group is, a roadmap suggesting intervention points to improve inclusion, examples of under-served groups and example barriers to inclusion. It also has examples of good practice and other resources to guide teams seeking to engage with, and improve inclusion of, under-served groups in clinical research.
Guidance for researchers to involve patient, public and community contributors in the INCLUDE Ethnicity Framework
Development of this guidance involved Patient and Public Involvement Groups based at the University of Manchester and the University of Leicester.
It was supported by the National Institute for Health and Care Research (NIHR) Applied Research Collaborations (ARCs) for Greater Manchester, and East Midlands. Groups were primarily coordinated and facilitated by Lydia Morris (University of Manchester, NIHR ARC Greater Manchester) and Nasima Miah (The Centre for Ethnic Health Research, NIHR ARC East Midlands).
The Research Design Services (RDS) Equality, Diversity and Inclusion Toolkit
This has been developed as part of the RDS’s national priority work on EDI, led by RDS East Midlands. This toolkit can be used as a resource to support your clients to respond to the National Institute for Health Research’s requirements to address EDI considerations in funding applications.
If you have any questions or would like to offer any feedback about the toolkit or experiences of using it in your advising, please email Dr Rebecca Barnes rb358@le.ac.uk or Dr Chris Newby Christopher.newby@nottingham.ac.uk
How to make sure your recruitment materials and strategy don’t discriminate
This white paper from Couch Health– recruiting diverse populations for clinical studies – guides you through important considerations you need to make to help make the process more accommodating for everyone.
Patient reported outcome assessment must be inclusive and equitable
Mel Calvert and colleagues describe why those using patient-reported outcomes need to think about strategies to include underserved groups in the design, selection, use and completion of patient-reported outcomes to avoid increasing health disparities.
Funding
This work has received funding from:
Collaborators
This work been a collaboration between Trial Forge, INCLUDE and the following networks and groups.
