Purpose of the PSP and background
The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Sepsis 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.
Sepsis FEAT is an independent charity founded in 2013 by a sepsis survivor, with a central mission to fund world-leading research designed to improve outcomes for sepsis patients and their families. In response to multiple, small-scale, ad hoc requests for sepsis research funding, Sepsis FEAT Trustees decided to review their approach to funding to ensure the most cost efficient and wide-reaching, impactful, research could be supported.
The vision was to bring together healthcare professionals with patients and their families, and the JLA PSP framework was strongly endorsed by Trustees as the approach that best fit the remit. After consulting with other charities who had undertaken similar PSP processes, Sepsis Research FEAT agreed funding for this sepsis PSP and the project team was put in place. (Some additional funding has been provided by Cambridge University to facilitate the final workshop.)
What is sepsis?
Sepsis is the body’s life-threatening reaction to an infection.
When sepsis occurs in response to an infection, the immune system overreacts and starts attacking not just the infection, but everything else around it including the body’s own tissues and organs. Any type of infection — bacterial, viral or fungal — can lead to sepsis.
Sepsis is the number one cause of preventable death in the world. It is an indiscriminate, potentially deadly condition that can kill a previously healthy adult in a matter of hours (although this is rare), despite all the advances in vaccines, antibiotics and intensive care treatments.
Sepsis is one of the least well-recognised medical conditions and can be hard to diagnose due to the similarity of symptoms in other illnesses.
In the community setting, sepsis often presents as the clinical deterioration of common and preventable infections. Sepsis also frequently results from infections acquired in health care settings, which are one of the most frequent adverse events during care delivery
The World Health Organisation (WHO) sepsis definition
Sepsis is a life-threatening condition that arises when the body’s response to infection causes injury to its own tissues and organs. It is frequently a final common pathway to death for many infectious diseases worldwide. It involves organ dysfunction caused by a dysregulated host response to infection and if not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death.
Estimated number of sepsis cases
Although a precise estimate of the global epidemiological burden of sepsis is difficult to ascertain, a recent scientific publication reported that sepsis affects an estimated 49 million people and causes 11 million deaths globally every year. In the UK it is estimated there are 246,000 cases of sepsis diagnosed every year and 48,000 deaths are annually recorded. Up to half of those who survive sepsis are left with physical and or psychological effects.*
*1990-2007: analysis for Global Burden of Disease Study, The Lancet, Volume 395
Aims, objectives and scope of the PSP
The aim of the Sepsis PSP is to identify the unanswered questions (uncertainties) about sepsis 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:
- identify how to stop people dying from sepsis
- work with patients, carers and clinicians to identify uncertainties about the recognition, diagnosis, treatment and care of patients with sepsis
- identify how to improve care, support and long term outcomes post sepsis
- to agree by consensus a prioritised list of those uncertainties to guide future sepsis research
- to publicise the results of the PSP
- to take, present and champion the PSP priorities for research to relevant commissioning bodies to be considered for future research funding
This will cover all patient groups other than those excluded below (we recognise that some patient groups may raise questions specific to that group. We will ensure that all of the questions related to special interest groups are included in the final workshop)
The scope of this PSP will include all aspects of the management of sepsis in adults.. It will focus on susceptibility, diagnosis, diagnostic engineered tools, treatment (any therapy in hospital and longer-term) and outcomes (physical, psychological, social, and societal) including assessing impact and improving outcomes. We will also explore the impact on family members and caregivers.
The PSP will focus on the UK .
The PSP will exclude from its scope questions about:
- The pre cursor infection that leads to sepsis, whilst recognising that susceptibility to sepsis tends to follow susceptibility to infection
- Paediatric sepsis (will be the subject of a separate PSP)
- Family members who are bereaved due to sepsis
The Steering Group
The Sepsis PSP will be led and managed by a Steering Group that includes membership of patients, carers, and clinicians , as individuals or representatives from a relevant group. The Steering Group is responsible for discussing what implications the scope of the PSP will have for the evidence-checking stage of the process (see later).
The Steering Group will involve the following:
Clinical representative/s:
Dr Bronwen Connolly, Senior Lecturer in Critical Care, Queen’s University Belfast
Dr Andrew Conway Morris – Clinical Scientist
Professor Paul Dark, Professor of Critical Care Medicine, NIHR Deputy Medical Director, Honorary NHS Consultant University of Manchester
Dr Nazir Lone – Reader in Critical Care and Honorary Consultant in Critical Care at the Royal Infirmary of Edinburgh.
Dr Joanne McPeake- Nurse Consultant in Research and Innovation in NHS Greater Glasgow and Clyde
Professor Susan Moug - Consultant Colorectal and General Surgeon at NHS Greater Glasgow and Clyde
Dr Simon Stockley – GP, RCGP’s clinical champion for sepsis
Patient and carer representative/s :
Kimberley Bradley – Sepsis survivor
Mark Mahoney – Sepsis survivor
Clare Mahoney – Sepsis carer
Mark Oates – Sepsis survivor
Emily Perry – Sepsis survivor
Jane Weaver – Sepsis carer
Yvonne Wiggan – Sepsis survivor and carer for her son (who has had sepsis multiple times)
Project Team:
Joint Project Clinical leads – Dr Nazir Lone, Dr Joanne McPeake, Dr Bronwen Connolly
Project Coordinator - Lynsay Bischoff (Sepsis Research FEAT)
Project Information Specialist – Dr Kristina Staley (Two Can Associates, information specialist for over 20 PSPs)
Project Governance (Sepsis Research FEAT) – Colin Graham (Chief Operating Officer, Sepsis Research FEAT)
PR and Social Media - Abi Dawson (Fundraising & Communications, Sepsis Research FEAT)
Marketing - Rachel Aungsoe (Flourish Marketing)
James Lind Alliance Adviser and Chair of the Steering Group:
Dr. Nahid Ahmad – Preferred Futures (JLA advisor to several PSPs and practising psychologist)
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 sepsis
- carers of people who have had sepsis
- health and social care professionals - with experience of sepsis
- Colleges and organisations that will be engaging as partners (this list will be updated as organisations confirm their engagement and if others are identified by the PSP)
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 Sepsis PSP.
Step 2: Awareness raising
PSPs will need to raise awareness and champion of their proposed activity among their patient, carer, and clinician communities, 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 Sepsis PSP will carry out a consultation process to gather uncertainties from patients, carers, and clinicians. A period of around 3 months will be given to complete this exercise (which may be revised by the Steering Group if required).
The Steering Group will advise and facilitate the PSP so it can reach out to as many diverse, marginalised, and under-served groups as possible to ensure that a broad community of people that have encountered sepsis are included in the PSP.
We will include BAME communities, marginalised groups and isolated communities as they may have worse health outcomes due to socio economic factors, age, language barriers etc.
The PSP will include all four nations of the UK (England, Scotland, Wales & Northern Ireland)
The PSP will use the following methods to reach the target groups
- Online surveys, communicated and supported by social media
- Paper surveys where appropriate
- Face to face interactions (e.g. focus groups or in-person support to complete the survey)
Existing sources of evidence uncertainties may also be searched. Evidence checking will be conducted across national (and where applicable, international) clinical guidelines, recommendations, national surveillance and audit findings, systematic reviews, research publication databases and trials registries. The evidence checking strategy will be informed by the submitted data.
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 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 categorisation 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 the PSP Information Specialist. 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 the PSP Information Specialist. 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.
Questions that are identified but are out of the remit for this process, will be given to Sepsis Research FEAT to identify potential policy, or information provision, that may need to be changed. For example, some patients are unable to access the relevant benefits once home from hospital. Cancer patients are always given full benefits, but this is often not the case for those left with the after effects of sepsis. Education and awareness raising will also be considered by the Charity for known uncertainties identified in the survey.
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 sepsis. 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.
Following the publication of this PSP we plan to work with the NIHR and other funders to understand how the findings from this process can be implemented into UK funding calls in the future.
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 Sepsis Research FEAT.
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 Sepsis PSP Steering Group agreed the content and direction of this Protocol on 02/08/23.
Document History
Version No. 1.0
Date Issued: 07/08/23
Comments: First version, agreed at Steering Group on 02/08/23