Foot Health PSP Protocol
- Published: 2 January 2024
- Version: V1
- 8 min read
Purpose of the PSP and background
The purpose of this protocol is to set out the aims, objectives and commitments of the Foot Health 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 Research (NIHR) 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 DR William M Scholl Endowment Fund has agreed to fund a Priority Setting partnership (PSP) using the JLA methodology to identify the top ten foot health research priorities. The Dr William M Scholl fund has been a major supporter of foot health research over the last 19 years supporting a wide range of scholarships, fellowships and collaboratively funded projects. The PSP will be led by Professor Chris Nester from the School of Health Sciences at the University of Salford.
Aims and objectives of the (health problem) PSP
The aim of the Foot Health PSP is to identify the unanswered questions about Foot Health from patient and clinical perspectives and then prioritise those that patients and clinicians agree are the most important.
The objectives of the Foot Health PSP are to:
- work with patients and clinicians to identify questions Foot Health treatments
- to agree by consensus a prioritised list of those questions, 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 Foot Health PSP will be led and managed by the following:
Patient representative/s:
- Ralphy Bell – Representative for people with Arthritis (National Rheumatoid Arthritis Society Local Rep)
- Phil Hayward – Representative for people with Diabetes (Diabetes Uk & link to Warrington Wolves Rugby)
- Beccy Jones – Representative for people with Diabetes (Local Diabetes UK rep)
- Sharron Hardman – Representative for people with lower limb neurological disability (link with Salford Disability Forum, The Polio Association and children with special educational needs)
- Duncan Mason – Representative for Sports/ Running coaches and community (children and adult) (link with UK Athletics and local running groups)
Clinical representative/s:
- Professor Mark Gabbay – Representative for General Practitioners
- Dr Leanne Atkin (Specialist nurse)– Representative for Lower Limb vascular and tissue viability pathology
- Deborah Ruff (Specialist nurse) – Representative for Lower limb vascular pathology
- Dr Declan Sweeney (Orthotist) – Representative for Orthotists with clinical managerial experience
- Matthew Fitzpatrick (Podiatrist) – Podiatry manager and clinical representative with MSK interest
- Sylvia Moss (Specialist Physiotherapist) – Representative for Physiotherapy and specialist area of neuro-rehab.
The Partnership and the priority setting process will be supported and guided by:
- The James Lind Alliance (JLA) - Dr Patricia Ellis
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 prioritisation 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.
The Steering Group will agree the resources, including time and expertise that they will be able to contribute to each stage of the process. The JLA will advise on this.
The wider Partners
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 had foot health problems
- National patient associations/voices -
- Carers of people who have had foot health problems
- Medical doctors, nurses and professionals allied to medicine with clinical experience of foot health problems
- Society of Chiropodists and Podiatrists
- Chartered Society of Physiotherapists
- Occupational Therapists
- Health Visitors
- Ortho surgery, Rheumatology, geriatrics, GPs
- Public Health (CHAMP)
It is important that all organisations which can reach and advocate for these groups should be invited to become involved in the PSP. The JLA Adviser will take responsibility for ensuring the various stakeholder groups are able to contribute equally to the process.
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 fulfil 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 also 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 Foot Health PSP and may be invited to attend and participate in an initial stakeholder meeting if this is being arranged.
Step 2: Initial stakeholder meeting / awareness raising
PSPs will need to raise awareness of their proposed activity among their patient and clinician communities, in order to secure support and participation. Depending on budget this may be done by way of a face-to-face meeting, or there may be other mechanisms by which the process can be launched.
The initial stakeholder meeting / awareness raising will have several key objectives:
- to welcome and introduce potential members of the Foot Health PSP
- to present the proposed plan for the PSP
- to initiate discussion, answer questions and address concerns
- to identify those potential partner organisations which will commit to the PSP and identify individuals who will be those organisations’ representatives and the PSPs principal contacts
- to establish principles upon which an open, inclusive and transparent mechanism can be based for contributing to, reporting and recording the work and progress of the PSP.
Step 3: Identifying treatment uncertainties
Each partner will identify a method for soliciting from its member’s questions and uncertainties of practical clinical importance relating to the treatment and management of Foot Health problems. 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 treatment 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 and registers of ongoing research.
The starting point for identifying sources of uncertainties and research recommendations is NHS Evidence.
Step 4: 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 diagnosis and the effects of treatments. These raw questions will be assembled and categorised and refined by Andrea Graham 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 Andrea Graham 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 - ie 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. Accordingly, the JLA recommends strongly that PSPs keep a record of these 'answerable questions' and deal with them separately from the 'true uncertainties' considered during the research priority setting process.
Uncertainties which are not adequately addressed by previous research will be collated and recorded on a template supplied by the JLA) by Andrea Graham. 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 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 relating to the treatment or management of Foot Health problems. 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.
- The final stage, to reach, for example, 10 prioritised uncertainties, is likely to 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 will be expected to declare their interests in advance of this meeting.
Dissemination of findings and research
Findings and research
It is anticipated that the findings of the Foot Health PSP will be reported to funding and research agenda setting organisations such as the NIHR 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.
Publicity
As well as alerting funders, partners and Steering Group members are encouraged to publish the findings of the Foot Health 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
Signed by the Steering Group