Diabetes (Type 2) PSP Protocol


Published: 15 January 2020

Version: V1.0

Print this document

Purpose of the PSP and background

The purpose of this protocol is to set out the aims, objectives and commitments of the Type 2 Diabetes Priority Setting Partnership (PSP) and the basic roles and responsibilities of the partners therein.  It is recommended that the Protocol is reviewed by the Steering Group and updated on at least a quarterly basis.

The James Lind Alliance (JLA) is a non-profit making initiative, established in 2004. It brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs). These partnerships identify and prioritise uncertainties, or ‘unanswered questions’, about the effects of treatments that they agree are the most important.  The aim of this is to help ensure that those who fund health research are aware of what really matters to both patients and clinicians.  The National Institute for Health and Care Research (NIHR – www.nihr.ac.uk) funds the infrastructure of the JLA to oversee the processes for priority setting partnerships, based at the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton. 

The Type 2 Diabetes PSP is funded by Diabetes UK and supported by the James Lind Alliance.  Diabetes UK is keen to identify the research priorities of people living with Type 2 diabetes and people caring for those who live with Type 2 diabetes, to help inform the research priorities of the charity, feed into diabetes Clinical Studies Groups, help diabetes researchers identify questions of importance to users and to inform the priorities of other research funders. 

Aims, objectives and scope of the PSP

The aim of the Type 2 diabetes PSP is to identify the unanswered questions about the cause, prevention, diagnosis, treatment and management of Type 2 diabetes and its complications from patient and clinical perspecitives and then prioritise those that patients and clinicians agree are the most important.  The Type 2 diabetes PSP will focus on Type 2 diabetes and its complications, but questions related to other conditions may be submitted where they are relevant in the context of Type 2 diabetes.

The objectives of the PSP are to:

  • work with patients, carers and clinicians to identify uncertainties about the cause, prevention, diagnosis, treatment and management of Type 2 diabetes and its complications
  • to agree by consensus a prioritised list of those uncertainties, for research
  • to publicise the results of the PSP and process
  • to take the results to research commissioning bodies to be considered for funding.

The Steering Group

The Type 2 diabetes PSP will be led and managed by the following:

Patient representative/s

  • Diabetes UK - members (people with Type 2 diabetes)
    • Mick Browne, Martin Jenner, Paul Robb, Jenny Stevens and Angelina Whitmarsh

Clinical representative/s

  • Dr Ali Chakera, Consultant at the Royal Sussex County Hospital in Brighton, Chair of the Young Diabetologists and Endocrinologists Forum
  • Professor Andrew Farmer, Professor of General Practice at the University of Oxford and associate general practitioner at South Oxford Health Centre
  • Dr Sarah Finer, Consultant in Diabetes and Endocrinology, Newham University Hospital and Honorary Senior Lecturer in Diabetes
    Paul McArdle, NIHR Clinical Doctoral Research Fellow & Lead Clinical Dietitian, Birmingham Community Healthcare NHS Trust

The Partnership and the priority setting process will be supported and guided by:

  • Diabetes UK - Staff
    • Emily Burns, Davina Krakovic-Patel, Anna Morris, Simon O'Neill, Krishna Sarda and Kamini Shah
  • The James Lind Alliance (JLA)
    • Leanne Metcalf
  • Ann Daly, Independent Information Specialist

The Steering Group includes representation of patient/carer groups and clinicians.  In some cases, it has been suggested that researchers are represented at this level, to advise on the shaping of research questions.  However, researchers cannot participate in the priorities exercise.  This is to ensure that the final prioritised research questions are those agreed by patients, carers and clinicians only, in line with the JLA's mission.


Organisations and individuals will be invited to be involved with the PSP as partners. Partners are groups or individuals who will commit to supporting the PSP by disseminating the PSP survey and helping the PSP to gather questions and uncertainties of practical clinical importance relating to the treatment and management of the health problem in question.  Partners represent the following groups:

  • people who have Type 2 diabetes
  • carers and family members of people who have Type 2 diabetes
  • medical doctors, nurses and Allied Health Professionals with clinical experience of Type 2 diabetes
  • individuals, and groups, who support people living with Type 2 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 adversely affect those organisations' views, causing unacceptable bias.  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 stages 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 adopted in any stage will be agreed through consultation between the Steering Group members, guided by the PSP’s aims and objectives. More details can be found 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 2 diabetes PSP.

Step 2: Identifying uncertainties relating to the cause, prevention, diagnosis, treatment and management of Type 2 diabetes

Each partner will identify a method for soliciting from its members questions and uncertainties of practical clinical importance relating to the cause, prevention, diagnosis,treatment and management of Type 2 diabetes. A period of 3 months will be given to complete this exercise.

The methods may be designed according to the nature and membership of each organisation, but must be as transparent, inclusive and representative as practicable. Methods may include membership meetings, email consultation, postal or web-based questionnaires, internet message boards and focus group work.

Existing sources of information about uncertainties for patients and clinicians will be searched. These can include question-answering services for patients and carers and for clinicians; research recommendations in systematic reviews and clinical guidelines; protocols for systematic reviews being prepared; priority areas raised via the Diabetes UK Careline and registers of ongoing research.

The starting point for identifying sources of uncertainties and research recommendations is NHS Evidence website.

Step 3: Refining questions and uncertainties

The Steering Group will need to have agreed exactly who will be responsible for this stage – the JLA can advise on the amount of time likely to be required for its execution. The JLA will participate in this process as an observer, to ensure accountability and transparency.

The consultation process will produce “raw” unanswered questions about cause, prevention, diagnosis, management and the effects of treatments. These raw questions will be assembled and categorised and refined by Ann Daly (Information specialist) into “collated indicative questions” which are clear, addressable by research and understandable to all. Similar or duplicate questions will be combined where appropriate.

Systematic reviews and guidelines will be identified and checked by Ann Daly (Information Specialist) to see to what extent these refined questions have, or have not, been answered by previous research. Sometimes, uncertainties are expressed that can in fact be resolved with reference to existing research evidence – i.e. they are "unrecognised knowns" and not uncertainties. If a question about treatment effects can be answered with existing information but this is not known, it suggests that information is not being communicated effectively to those who need it. A record of these questions will be maintained by the steering group and, resource permitting, Diabetes UK will investigate methods to inform its membership and other relevant parties.

Uncertainties which are not adequately addressed by previous research will be collated and recorded on a template supplied by the JLA) by Ann Daly (Information specialist). This will demonstrate the checking undertaken to make sure that the uncertainties have not already been answered. This is the responsibility of the Steering Group, which will need to have agreed personnel and resources to carry this accountability. 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.

Step 4: Prioritisation – interim and final stages

The aim of the final stage of the priority setting process is to prioritise through consensus the identified uncertainties relating to the treatment or management of Type 2 diabetes. This will be carried out by members of the Steering Group and the wider partnership that represents patients and clinicians.

  • The interim stage, to proceed from a long list of uncertainties to a shorter list to be discussed at the final priority setting workshop (e.g. up to 30), may be carried out over email or online, whereby organisations consult their membership and choose and rank their top 10 most important uncertainties. There are examples of how other PSPs have achieved this at www.jla.nihr.ac.uk in the Key Documents of the Anaesthesia and Perioperative Care PSP section and the Childhood Disability PSP section.
  • The final stage, to reach, for example, 10 prioritised uncertainties, will be conducted in a face-to-face meeting, using group discussions and plenary sessions.
  • The methods used for this prioritisation process will be determined by consultation with the partner organisations and with the advice of the JLA Adviser. Methods which have been identified as potentially useful in this process include: adapted Delphi techniques; expert panels or nominal group techniques; consensus development conference; electronic nominal group and online voting; interactive research agenda setting and focus groups.

    The JLA will facilitate this process and ensure transparency, accountability and fairness. Participants must declare their interests in advance of this meeting.

Dissemination of findings and research

Findings and research

It is anticipated that the findings of the Type 2 diabetes PSP will be reported to funding and research agenda setting organisations such as the NIHR and the MRC and the major research funding charities. Steering Group members and partners are expected to develop the prioritised uncertainties into research questions, and to work to establish the research needs of those unanswered questions to use when approaching potential funders, or when allocating funding for research themselves, if applicable.


As well as alerting funders, partners and Steering Group members are encouraged to publish the findings of the Type 2 diabetes PSP using both internal and external communication mechanisms. The Steering Group may capture and publicise the results through descriptive reports of the process itself in Plain English. This exercise will be distinct from the production of an academic paper, which the partners are also encouraged to do. However, production of an academic paper should not take precedence over publicising of the final results.

Agreement of the Steering Group

The undersigned agree to follow the Type 2 diabetes Priority Setting Protocol: