Abstract
Background
The challenges of recruitment to randomised controlled trials have been well documented. The additional challenges of recruiting people with intellectual disabilities (ID) and significant health co-morbidities have been the focus of less attention. The aim of this work was to explore issues around the screening and recruitment of adults with ID and Type 2 Diabetes (T2D) into the internal pilot of the ‘My Diabetes and Me’ Randomised Controlled Trial. The findings were used to develop recommendations and implement interventions to address challenges for recruitment to the main study.
Methods
A multiple methods approach using the QuinteT Recruitment Intervention was employed across three National Health Service sites in the United Kingdom. Semi-structured interviews were undertaken with staff, and adults with ID/T2D recruited to the study; analysis of recruitment discussion recordings, and a review of documentation pertaining to screening logs and research meetings was also performed. Thematic analysis identified the complexity of challenges and potential enablers to recruitment in this population.
Results
Recruitment challenges began much earlier than anticipated with significant organisational process challenges to be overcome. The discomfort felt by some staff in putting potential participants forward was evident as they don’t feel the study is appropriate for this population, or they feel out of their depth. Engagement and ‘buy-in’ from people with ID/ T2D were much more positive. The emotional labour involved in ensuring the internal pilot progressed to the main study was noteworthy.
Conclusion
The use of QRI methodology within an ID RCT is a novel approach, unearthing emotional challenges and significant systemic organisational process challenges. The findings of this study clearly illustrate the informed implementation strategies that are needed to improve recruitment processes, minimise the emotional labour relating to NHS organisational ‘buy-in’ and address the preparation and readiness of NHS health and social care staff for research in under-represented populations.
The challenges of recruitment to randomised controlled trials have been well documented. The additional challenges of recruiting people with intellectual disabilities (ID) and significant health co-morbidities have been the focus of less attention. The aim of this work was to explore issues around the screening and recruitment of adults with ID and Type 2 Diabetes (T2D) into the internal pilot of the ‘My Diabetes and Me’ Randomised Controlled Trial. The findings were used to develop recommendations and implement interventions to address challenges for recruitment to the main study.
Methods
A multiple methods approach using the QuinteT Recruitment Intervention was employed across three National Health Service sites in the United Kingdom. Semi-structured interviews were undertaken with staff, and adults with ID/T2D recruited to the study; analysis of recruitment discussion recordings, and a review of documentation pertaining to screening logs and research meetings was also performed. Thematic analysis identified the complexity of challenges and potential enablers to recruitment in this population.
Results
Recruitment challenges began much earlier than anticipated with significant organisational process challenges to be overcome. The discomfort felt by some staff in putting potential participants forward was evident as they don’t feel the study is appropriate for this population, or they feel out of their depth. Engagement and ‘buy-in’ from people with ID/ T2D were much more positive. The emotional labour involved in ensuring the internal pilot progressed to the main study was noteworthy.
Conclusion
The use of QRI methodology within an ID RCT is a novel approach, unearthing emotional challenges and significant systemic organisational process challenges. The findings of this study clearly illustrate the informed implementation strategies that are needed to improve recruitment processes, minimise the emotional labour relating to NHS organisational ‘buy-in’ and address the preparation and readiness of NHS health and social care staff for research in under-represented populations.
| Original language | English |
|---|---|
| Article number | e0332744 |
| Pages (from-to) | 1-19 |
| Number of pages | 19 |
| Journal | PLoS ONE |
| Volume | 20 |
| Issue number | 11 November |
| Early online date | 3 Nov 2025 |
| DOIs | |
| Publication status | Published online - 3 Nov 2025 |
Bibliographical note
Publisher Copyright:© 2025 Kelly et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability Statement
While this was not a requirement of the ethical approval granted for this study, the authors of this paper are of the opinion that it is not appropriate to share the data from this study openly as it is a small sample. While it is de-identified, it is potentially possible that some of the participants could be identified through the quotes and descriptions contained within the data. One of the criteria for participant consent was that they would not be identifiable in any publications so we must adhere to that principle. To that end I can confirm that the following individual has agreed to be the non-author contact for the School of Nursing & Midwifery at Queen’s University, Belfast to which data requests may be sent: Professor Mark Linden School of Nursing and Midwifery Room 05.308 – Medical Biology Centre Queen’s University, Belfast BT7 1NN, United Kingdom Email: [email protected] Phone: +44 (0)28 9097 2820.Funding
Award made to Professor Laurence Taggart (LT), Ulster University Reference No: COM/5637/20 www.research.hscni.net The sponsors did not play any role in the study design, data collection, analysis, decision to publish or preparation of the manuscript. The authors would like to thank all those individuals with ID/T2D who agreed to be interviewed for this research study. We are also grateful to all the NHS health and social care and research professionals who set aside time to be interviewed and to submit documentation as part of the data collection process. We also acknowledge all the work of the co-investigators within each study site and the PPI partners who assisted in the development of the RCT itself. We would also like to thank the local and national funding bodies who supported all aspects of this work.
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
Keywords
- Adult
- Diabetes Mellitus, Type 2/complications
- Female
- Health Personnel/psychology
- Humans
- Intellectual Disability/epidemiology
- Male
- Middle Aged
- Patient Selection
- Randomized Controlled Trials as Topic
- Research Personnel/psychology
- United Kingdom
- Research Personnel
- Health Personnel
- Diabetes Mellitus, Type 2
- Intellectual Disability
- Research Personnel - psychology
- Health Personnel - psychology
- Diabetes Mellitus, Type 2 - complications
- Intellectual Disability - epidemiology
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