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How to include older people in health and social care research


These recommendations have been designed to aid researchers designing clinical trials to consider barriers to including older patients in their trial. The recommendations can also help researchers to develop strategies to attempt to address such barriers in order to improve the design and conduct of health and social care research. Although the recommendations were 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 the recommendations focus on the inclusion of older patients, 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.


Older people constitute a broad heterogenous group, ranging from healthy individuals to those with severe health issues and dependency. Along with people who have multiple long-term conditions, older people are the highest users of health and care resources but are often excluded in some areas of health and social care research through restrictions in upper age limits, the presence of comorbidities, and cognitive impairment.

The recommendations for including older people in health and social care research and based on the NIHR INCLUDE framework and aim to provide researchers with practical advice to improve the inclusion of older people in research.

The following four questions may guide those developing, reviewing and funding research relevant to older people:

  1. Engagement: Are representative older people, their family members, advocates, and those with experience of working with older people involved in designing the research?
  2. Inclusive study design: Has consideration been given to where the research takes place, how researchers interact with older people and family members and what happens during interactions to maximise the accessibility of research to older people and family members? This may involve piloting study procedures to ensure they are feasible and acceptable.
  3. Resources: Have adequate infrastructure and financial resources been costed into funding applications to maximise participation, minimise withdrawals and ensure recruitment targets are met? There is a need to recognise that studies involving older people and family members may require additional resources, such as staff time and travel to conduct face-to-face recruitment and data collection at the person’s home.
  4. Communication: Have a range of approaches to communicating with older people and family members about research been considered in terms of promoting the study, recruitment, data collection and dissemination.

The full paper describing the development of the recommendations can be found here.

The work was led by Professor Vicki Goodwin at Exeter University.


To come in the future.
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coming in the future…


The recommendations for older people are new and we thought some insights from people who have used it might be useful.
coming in the future…


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 Belgian Health Care Knowledge Centre, KCE, signposts applicants to INCLUDE and the INCLUDE Ethnicity Framework in its Useful links & resources for investigators.

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.

The Wellcome Trust signposts applicants to INCLUDE (and therefore to the Ethnicity Framework) in its Clinical Trials Policy guidance.

The NHS Research and Development Forum includes the INCLUDE Ethnicity Framework in its resources to support health care research in the UK.


Below we list some resources which we hope you might find useful:
Describes challenges in recruitment and retention of older people in clinical trials as well as possible solutions. Additionally, pitfalls that can result in intervention effect under- or overestimation are examined.
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.

Download general INCLUDE guidance
Download COVID-19 specific INCLUDE guidance

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).

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 or Dr Chris Newby
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.
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