Purpose of the PSP and background
The purpose of this protocol is to clearly set out the aims, objectives and commitments of the type 1 diabetes in adults (defined as any person >18 years old) Priority Setting Partnership (PSP) in line with James Lind Alliance (JLA) principles. The Protocol is a JLA requirement and will be published on the PSP’s page of the JLA website. The Steering Group will review the Protocol regularly and any updated version will be sent to the JLA.
The JLA is a non-profit making initiative, established in 2004. It brings patients, carers and clinicians together in PSPs. These PSPs identify and prioritise the evidence uncertainties, or ‘unanswered questions’, that they agree are the most important for research in their topic area. Traditionally PSPs have focused on uncertainties about the effects of treatments, but some PSPs have chosen to broaden their scope beyond that. The aim of a PSP is to help ensure that those who fund health research are aware of what really matters to patients, carers and clinicians. The National Institute for Health and Care Research (NIHR) coordinates the infrastructure of the JLA to oversee the processes for PSPs, based at the NIHR Coordinating Centre (NIHRCC), University of Southampton.
Type 1 diabetes mellitus is a chronic auto-immune condition which can affect adults and children of any age. The treatment of type 1 diabetes centres around insulin administration and the management of complications or co-morbidities that can also arise.
In 2011 the JLA completed a PSP in the area of type 1 diabetes and identified a number of important unanswered questions in this area. The initial surveys generated >500 replies and >1000 questions. These replies were reviewed and formulated into summary questions and following a further survey and a workshop were then prioritised into a top ten list.
The number of people being diagnosed with type 1 diabetes has increased in recent years and the recent advances in the technologies available for monitoring blood glucose and delivering insulin mean that the treatment landscape has changed significantly since the last PSP was conducted in this area in 2011. We would like to undertake this refresh exercise to re-evaluate the priorities of the diabetes community and those involved in their care, to ensure that priorities are current and a representation of the needs of patients, carers and clinicians.
Aims, objectives and scope of the PSP
The aim of the type 1 diabetes mellitus in adults PSP is to identify the unanswered questions about type 1 diabetes from patient, carer and clinical perspectives and then prioritise those that patients, carers and clinicians agree are the most important for research to address.
The objectives of the PSP are to:
- work with patients, carers and clinicians to identify uncertainties about the treatment and optimisation of management of adults with type 1 diabetes
- to agree by consensus a prioritised list of those uncertainties
- to publicise the results of the PSP and process
- to take the results to research commissioning bodies to be considered for funding.
The scope of the type 1 diabetes mellitus in adults PSP is defined as:
- adults with type 1 diabetes (aged 18 and over), their families, carers, friends and those involved in their care
- the cause, prevention, diagnosis (including misdiagnosis and those who may have had a diagnosis re-classified or altered), screening, prevention, precipitating factors, treatment and management of type 1 diabetes and its complications from patient and clinical perspectives. The type 1 diabetes PSP will focus on type 1 diabetes and its complications, but questions related to other conditions may be submitted where they are relevant in the context of type 1 diabetes.
- physical, social, cultural, economic and psychological aspect
- information, education and service improvement
- within the UK and Republic of Ireland
The PSP will exclude from its scope questions about:
- Paediatric care in type 1 diabetes
- Questions or priorities without a UK or Irish focus or relevance
- Questions or priorities about other forms of diabetes including MODY, type 2 diabetes and gestational diabetes, cystic fibrosis related diabetes etc
The Steering Group is responsible for discussing what implications the scope of the PSP will have for the evidence-checking stage of the process. Resources and expertise will be put in place to do this evidence checking.
The Steering Group
The Steering Group includes membership of patients and carers and clinicians, as individuals or representatives from a relevant group.
The type 1 diabetes in adults PSP will be led and managed by a Steering Group involving the following:
Patient and carer representative/s:
- Anna Morris/Kamini Shah (depending on availability) – Diabetes UK
- Rachel Connor/Hilary Nathan (depending on availability) – JDRF
- Kate Gajewska- Diabetes Ireland
- Jinty Moffett ( patient)
- Jake Bromley (patient)
- David Treanor (patient)
- Columb Kavangh (patient)
- Pauline Williams (parent of person with type 1 DM)
Clinical representative/s:
- Sinead Hannan, Consultant Clinical Psychologist, Southern Trust, Health and Social Care, Northern Ireland
- Richard Holt, Professor and Honorary Consultant, Southampton University
- Nick Oliver, Professor and Honorary Consultant,, Imperial College London
- John Petrie, Professor and Honorary Consultant, Glasgow University
- Michael Skarlatos, Diabetes Educator, Leicester Diabetes Centre, England
- Fidlema Dunne, Professor and Honorary Consultant, University of Galway, Ireland
Project coordinator: Peadar Rooney, University of Galway
Information Specialist: Christine Newman, University of Galway
James Lind Alliance Adviser and Chair of the Steering Group: Jonathan Gower
The Steering Group will agree the resources, including time and expertise that they will be able to contribute to each stage of the process, with input and advice from the JLA.
Partners
Organisations and individuals will be invited to be involved with the PSP as partners. Partners are organisations or groups who will commit to supporting the PSP, promoting the process and encouraging their represented groups or members to participate. Organisations which can reach and advocate for these groups will be invited to become involved in the PSP. Partners represent the following groups:
- people who have had type 1 diabetes
- carers of people who have had type 1 diabetes
- health and social care professionals - with experience of type 1 diabetes
Exclusion criteria
Some organisations may be judged by the JLA or the Steering Group to have conflicts of interest. These may be perceived to potentially cause unacceptable bias as a member of the Steering Group. As this is likely to affect the ultimate findings of the PSP, those organisations will not be invited to participate. It is possible, however, that interested parties may participate in a purely observational capacity when the Steering Group considers it may be helpful.
The methods the PSP will use
This section describes a schedule of proposed steps through which the PSP aims to meet its objectives. The process is iterative and dependent on the active participation and contribution of different groups. The methods used in any step will be agreed through consultation between the Steering Group members, guided by the PSP’s aims and objectives. More details of the method are in the Guidebook section of the JLA website where examples of the work of other JLA PSPs can be seen.
Step 1: Identification and invitation of potential partners
Potential partner organisations will be identified through a process of peer knowledge and consultation, through the Steering Group members’ networks. Potential partners will be contacted and informed of the establishment and aims of the type 1 diabetes PSP.
Step 2: Awareness raising
PSPs will need to raise awareness of their proposed activity among their patient, carer and clinician communities, in order to secure support and participation. Depending on budget, this may be done by a face-to-face meeting, or there may be other ways in which the process can be launched, e.g. via social media. It may be carried out as part of steps 1 and/or 3. The Steering Group should advise on when to do this. Awareness raising has several key objectives:
- to present the proposed plan for the PSP
- to generate support for the process
- to encourage participation in the process
- to initiate discussion, answer questions and address concerns.
Step 3: Identifying evidence uncertainties
The type 1 diabetes PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of 12 weeks will be given to complete this exercise (which may be revised by the Steering Group if required).
The type 1 diabetes PSP recognises that the following groups may require additional consideration:
- People with a recent diagnosis of type 1 diabetes due to recent stressors or change in lifestyle, job changes etc. It will be important to gather responses from those with more recent and current experiences of diagnosis and initial contact with diabetes services to ensure gaps which reflect recent and current care and treatments are captured.
- Seldom heard populations e.g. young adults, South Asian populations. There has been much research on engaging with seldom heard groups and different ethnic and cultural groups. The PSP will seek the advice of PPI champions, INVOLVE, the steering group and their contacts. Diabetes UK completed a range of activities to enable representation of these groups for the type 2 PSP. This includes reaching out through their community champions and attending community events
- People with visual impairment (as a result of diabetes or due to other reasons) or people with additional needs
The Steering Group will use the following methods to reach the target groups
- online surveys and social media platforms (including targeted adverts where funding allows) with the option of paper questionnaires
- enabling individuals to respond when convenient for them, via a clear set, easy route that does not require much time and at no cost
- actively seeking advice from experts in the target group or techniques for maximising responses and representativeness as far as reasonably possible and practicable
- where funding allows, the use of paper questionnaires
Existing sources of evidence uncertainties may also be searched and include NICE guidance and NICE Research Recommendations, the Cochrane Database and relevant clinical guidelines published by appropriate professional organisations.
Step 4: Refining questions and uncertainties
The consultation process will produce ‘raw’ questions and comments indicating patients’, carers’ and clinicians’ areas of uncertainty. These raw questions will be categorised and refined by Christine Newman and Peadar Rooney into summary questions which are clear, addressable by research, and understandable to all. Similar or duplicate questions will be combined where appropriate. Out-of-scope and ‘answered’ submissions will be compiled separately. The Steering Group will have oversight of this process to ensure that the raw data is being interpreted appropriately and that the summary questions are being worded in a way that is understandable to all audiences. The JLA Adviser will observe to ensure accountability and transparency.
This will result in a long list of in-scope summary questions. These are not research questions and to try and word them as such may make them too technical for a non-research audience. They will be framed as researchable questions that capture the themes and topics that people have suggested.
The summary questions will then be checked against evidence to determine whether they have already been answered by research. This will be done by Christine Newman. The PSP will complete the JLA Question Verification Form, which clearly describes the process used to verify the uncertainty of the questions, before starting prioritisation. The Question Verification Form includes details of the types and sources of evidence used to check uncertainty. The Question Verification Form should be published on the JLA website as soon as it has been agreed to enable researchers and other stakeholders to understand how the PSP has decided that its questions are unanswered, and any limitations of this.
Questions that are not adequately addressed by previous research will be collated and recorded on a standard JLA template by Christine Newman. This will show the checking undertaken to make sure that the uncertainties have not already been answered. The data should be submitted to the JLA for publication on its website on completion of the priority setting exercise, taking into account any changes made at the final workshop, in order to ensure that PSP results are publicly available.
The Steering Group will also consider how it will deal with submitted questions that have been answered, and questions that are out of scope.
Step 5: Prioritisation – interim and final stages
The aim of the final stage of the priority setting process is to prioritise through consensus the identified uncertainties about type 1 diabetes. This will involve input from patients, carers and clinicians. The JLA encourages PSPs to involve as wide a range of people as possible, including those who did and did not contribute to the first consultation. There are usually two stages of prioritisation.
Interim prioritisation is the stage where the long list of questions is reduced to a shorter list that can be taken to the final priority setting workshop. This is aimed at a wide audience, and is done using similar methods to the first consultation. With the JLA’s guidance, the Steering Group will agree the method and consider how best to reach and engage patients, carers and clinicians in the process. The most highly ranked questions (around 25) will be taken to a final priority setting workshop. Where the interim prioritisation does not produce a clear ranking or cut off point, the Steering Group will decide which questions are taken forwards to the final prioritisation.
The final priority setting stage is generally a one-day workshop facilitated by the JLA. With guidance from the JLA and input from the Steering Group, up to 30 patients, carers and clinicians will be recruited to participate in a day of discussion and ranking, to determine the top 10 questions for research. All participants will declare their interests. The Steering Group will advise on any adaptations needed to ensure that the process is inclusive and accessible.
Dissemination of results
The Steering Group will identify audiences with which it wants to engage when disseminating the results of the priority setting process, such as researchers, funders and the patient and clinical communities. They will need to determine how best to communicate the results and who will take responsibility for this. Previous PSPs’ outputs have included academic papers, lay reports, infographics, conference presentations and videos for social media.
It should be noted that the priorities are not worded as research questions. The Steering Group should discuss how they will work with researchers and funders to establish how to address the priorities and to work out what the research questions are that will address the issues that people have prioritised. The dissemination of the results of the PSP will be led by Fidelma Dunne in conjunction with the steering group.
The JLA encourages PSPs to report back about any activities that have come about because of the PSP, including funded research. Please send any details to jla@soton.ac.uk.
Agreement of the Steering Group
The type 1 diabetes PSP Steering Group agreed the content and direction of this Protocol on 28th April 2023.