Contributions of authors
Melanie J Davies (https://orcid.org/0000-0002-9987-9371) Professor, Diabetes Medicine, was the chief investigator, developed the research questions and the original proposal and grant submission, has had oversight and input into the overall programme of research, and inputted and commented on each of the WS. She worked closely with the project manager to have oversight of the overall programme.
Shona Agarwal (https://orcid.org/0000-0002-1650-4356) Research Associate, Qualitative Research. Conducted the data collection and analysis for the qualitative substudy.
Danielle H Bodicoat (https://orcid.org/0000-0002-2184-4865) Medical Statistician and Writer, Biostatistics. Conducted the analysis of the RCT and observational data.
Alan Brennan (https://orcid.org/0000-0002-1025-312X) Professor, Health Economics and Decision Modelling. Provided oversight of the health economics modelling.
Simon Dixon (https://orcid.org/0000-0001-7394-7009) Professor, Health Economics. Provided oversight of the health economics costing analysis.
Helen Eborall (https://orcid.org/0000-0002-6023-3661) Lecturer, Qualitative Research. Provided oversight of the intervention development and ethnography study.
Agnieszka Glab (https://orcid.org/0000-0003-2738-8829) Trial Manager, Trial Management. Was the programme manager.
Laura J Gray (https://orcid.org/0000-0002-9284-9321) Professor, Medical Statistics. Contributed to the design and analysis of the feasibility study, RCT and observational data.
Michelle Hadjiconstantinou (https://orcid.org/0000-0003-2827-0988) Research Fellow, Behavioural Science. Led and conducted the analysis for the qualitative substudy.
Lisa Huddlestone (https://orcid.org/0000-0002-8054-4475) Research Associate, Qualitative Research. Conducted the ethnography research within the feasibility study and the first part of the RCT.
Nicky Hudson (https://orcid.org/0000-0003-4091-1493) Professor, Medical Sociology. Provided oversight of the intervention development and ethnography study.
Anju Keetharuth (https://orcid.org/0000-0001-8889-6806) Senior Research Fellow, Health Economics. Conducted the health economics costing analysis and the quantitative analysis of the intervention delivery.
Kamlesh Khunti (https://orcid.org/0000-0003-2343-7099) Professor, Primary Care Diabetes and Vascular Medicine. Provided primary care expertise.
Caroline Kristunas (https://orcid.org/0000-0001-8945-4671) Biomedical Statistician, Biostatistics. Conducted the analysis of the feasibility study.
Graham Martin (https://orcid.org/0000-0003-1979-7577) Director of Research, Qualitative Research. Provided oversight of the intervention development and ethnography study.
Alison Northern (https://orcid.org/0000-0001-8193-3934) Implementation Manager, Diabetes SSME. Contributed to the intervention developments and was the lead embedder.
Mike Patterson (https://orcid.org/0000-0003-2888-2407) Public Involvement Representative, Lived Experience of Diabetes. Provided expertise regarding lived experience of diabetes and SSME.
Daniel Pollard (https://orcid.org/0000-0001-5630-0115) Research Fellow, Health Economics. Conducted the health economics modelling.
Rebecca Pritchard (https://orcid.org/0000-0002-2655-7312) Patient and Public Involvement Manager, Public Involvement. Led the public involvement aspects of the research programme.
Sally Schreder (https://orcid.org/0000-0002-4394-9764) Assistant Director of Operations for Research, Diabetes SSME. Contributed to the intervention development and provided expertise around implementation of diabetes SSME programmes.
Jane Speight (https://orcid.org/0000-0002-1204-6896) Foundation Director, Health Psychology. Contributed towards the intervention development and provided expertise in psychological instruments and evaluation.
Bernie Stribling (https://orcid.org/0000-0003-1426-1132) Assistant Director of International and External Business Development, Diabetes SSME. Provided expertise around implementation of diabetes SSME programmes.
Jackie Sturt (https://orcid.org/0000-0003-1281-1401) Professor, Behavioural Medicine in Nursing. Contributed towards the intervention development and provided expertise in diabetes SSME.
Jess Turner (https://orcid.org/0000-0002-4458-5528) Research Assistant, Qualitative Research. Conducted the intervention development research and the ethnography study.
Christina Weis (https://orcid.org/0000-0002-8447-0039) Lecturer, Qualitative Research. Contributed to the ethnography study.
Danielle Bodicoat, Helen Eborall, Michelle Hadjiconstantinou, Nicky Hudson, Anju Keetharuth, Graham Martin, Alison Northern, Daniel Pollard, Rebecca Pritchard and Christina Weis produced initial drafts of sections of the reports. All authors inputted into the design of the overall programme, its WS and its studies (as relevant), and reviewed and revised the report.
Acknowledgements
The authors would like to thank all of the study participants; the investigators and researchers involved in the studies which created the qualitative data sets for secondary analysis in WS1 phase 1; the stakeholders that took part in WS1 phase 2; Liz Shaw for undertaking the secondary analysis and stakeholder interviews in WS1.
Questionnaire acknowledgements
The following licensed questionnaires were included in the patient self-completed questionnaire booklet:
•©2022 Patient Activation Measure® (PAM®) from Insignia Health, a Phreesia company. All rights reserved.
•W-BQ12 © Clare Bradley www.healthpsychologyresearch.com.
Patient data statement
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it is important that there are safeguards to make sure that they are stored and used responsibly. Everyone should be able to find out about how patient data are used #datasaveslives. You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.
Ethics statement
This research was conducted in accordance with the Declaration of Helsinki. Ethical approval was sought and received from West Midlands – Edgbaston Research Ethics Committee (reference number: 18/WM/0036; approval date: 25 January 2018) and the Health Research Authority (reference number: 238291; approval date: 5 February 2018). The University of Leicester Research Ethics Committee granted approval for the secondary analysis of qualitative data and the stakeholder workshop elements of WS1.
Information governance statement
The University of Leicester is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, University of Leicester is the Data Controller, and you can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for our Data Protection Officer here https://le.ac.uk/ias/data-protection.
Disclosure of interests
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/KWYF5914.
Primary conflicts of interest: All authors received funding from the National Institute for Health Research for the current manuscript and the work underpinning it. University Hospitals of Leicester NHS Trust (Melanie Davies, Shona Agarwal, Agnieszka Glab, Michelle Hadjiconstantinou, Kamlesh Khunti, Alison Northern, Rebecca Pritchard, Sally Schreder, Bernie Stribling) received not-for-profit income through licensing fees to support implementation of a diabetes structured education programme (DESMOND and its online counterpart MyDESMOND) in CCGs in the UK, Ireland and Australia; all payments were made to the trust. Jackie Sturt manages the licensing, via University of Warwick, for a diabetes structured education programme (Diabetes Manual) that is commercially available; royalties have been paid to University of Warwick but not to Jackie Sturt personally. Danielle Bodicoat has undertaken paid consultancy work for the University of Leicester for this programme and other projects. Alan Brennan and Daniel Pollard have received funding for projects from the European Union and National Institute for Health Research. Kamlesh Khunti was a member of the HS&DR Funding Committee 2019–22. Graham Martin has received consulting fees from the Health Foundation and has participated in or chaired advisory groups and steering groups for work funded by the Health Foundation, City University, National Institute for Health Research and Leicester Centre for Ethnic Health Research. Martin has also been a trustee for the Foundation for the Sociology of Health and Illness and a member of the National Institute for Health Research NETSCC National Stakeholder Advisory Group. Daniel Pollard has received personal payment from Novo Nordisk for a market research interview and is receiving in-kind support for other projects from Abbott Diabetes Care, Eli Lilly and Company, Medtronic International Trading, Novo Nordisk, and Sanofi. Sally Schreder has received funding for projects from the National Institute of Health Research. The other authors have no other potential conflicts of interest to disclose.
Publications
Peer-reviewed journal articles
Davies MJ, Kristunas CA, Alshreef A, Dixon S, Eborall H, Glab A, et al. The impact of an intervention to increase uptake to structured self-management education for people with type 2 diabetes mellitus in primary care (the embedding package), compared to usual care, on glycaemic control: study protocol for a mixed methods study incorporating a wait-list cluster randomised controlled trial. BMC Fam Pract 2019;20:152. https://doi.org/10.1186/s12875-019-1038-0
Davies M, Kristunas CA, Huddlestone L, Alshreef A, Bodicoat D, Dixon S, et al. Increasing uptake of structured self-management education programmes for type 2 diabetes in a primary care setting: a feasibility study. Pilot Feasibility Stud 2020;6:71. https://doi.org/10.1186/s40814-020-00606-0
Huddlestone L, Turner J, Eborall H, Hudson N, Davies M, Martin G. Application of normalisation process theory in understanding implementation processes in primary care settings in the UK: a systematic review. BMC Fam Pract 2020;21:52. https://doi.org/10.1186/s12875-020-01107-y
Turner J, Martin G, Hudson N, Shaw L, Huddlestone L, Weis C, et al. Using normalisation process theory (NPT) to develop an intervention to improve referral and uptake rates for self-management education for patients with type 2 diabetes in UK primary care. BMC Health Serv Res 2022;22:1206. https://doi.org/10.1186/s12913-022-08553-7
Davies MJ, Bodicoat DH, Brennan A, Dixon S, Eborall H, Glab A, et al. Uptake of self-management education programmes for people with type 2 diabetes in primary care through the embedding package: a cluster randomised control trial and ethnographic study. BMC Prim Care 2024;25:136. https://doi.org/10.1186/s12875-024-02372-x
Pollard DJ, Keetharuth A, Brennan A, Bodicoat DH, Glab A, Hadjiconstantinou M, et al. A model based cost-utility analysis of Embedding referral to structured self-management education into standard practice (Embedding) compared to usual care for people with type 2 diabetes diagnosis in the last 12 months in England. BMJ Open 2025;15:e093327. https://doi.org/10.1136/bmjopen-2024-093327
Other publications
Embedding structured education for self-management of type 2 diabetes in primary care: an NPT informed analysis. Presented at the British Sociological Association Medical Sociology Group Annual Conference, York, 13 September 2017.
Factors influencing the implementation of an intervention to increase uptake of type-2 diabetes structured management education in NHS primary care: an ethnographic study using normalisation process theory. Poster presentation, College of Life Sciences (University of Leicester) Early Career Researcher Symposium, 12 September 2019.
The feasibility of using routinely collected primary care data in a trial testing approaches to increase uptake to education programmes for type 2 diabetes. Poster presentation, 5th International Clinical Trials Methodology Conference, 7 October 2019.
Seeing the wood and the trees. University of Leicester Doctoral College ‘Images of Research’ exhibition, 27 November 2019.
Disclaimers
This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, CCF, PGfAR or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the PGfAR programme or the Department of Health and Social Care.