Liver Cirrhosis PSP protocol


Published: 31 January 2024

Version: 2.2

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Purpose of the PSP and background

The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Liver Cirrhosis 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.

Liver cirrhosis represents the advanced stage of chronic liver disease, which is now the second leading cause of preventable death in the United Kingdom. Mortality rates from liver disease have increased fourfold in the past three decades and liver disease now accounts for more working years of life lost than cancer. The majority of symptoms and healthcare costs associated with liver disease occur during this advanced stage, termed ‘decompensated cirrhosis’. Most treatments are directed towards symptom control at this stage, which remains sub-optimal. Despite considerable investment in large clinical trials for cirrhosis in the UK in recent years, we have not developed a novel treatment for liver cirrhosis for two decades. Research is important for us to be able to improve the lives of people living with liver cirrhosis.

This is a unique opportunity to conduct this PSP, as it coincides with the award of an NIHR ‘research partnership’ grant award to create a network of stakeholders involved in the research and clinical care of patients with decompensated cirrhosis. The combined work will enable us to involve stakeholders from across the communities involved; patients, families, caregivers, primary care practitioners, hospital specialists and liver disease researchers. The UK-CLIF network has already brought together patients, cares, clinical specialists and researchers who are interested in improving delivery and impact of liver disease research. The Network is growing its membership through engagement on Twitter, online meetings and in-person events. UK CLIF will be partnering with the British Liver Trust, the UK’s leading liver health charity, working to improve liver health for all and supporting those affected by liver disease. As such, the charity is in touch with thousands of patients and carers across the UK through its regular newsletters and online forum. British Liver Trust and UK CLIF Network will be involved in awareness raising and publicising the PSP.

Aims, objectives and scope of the PSP

The aim of the Liver Cirrhosis PSP is to identify the unanswered questions about symptom management, active treatment and clinical care for decompensated cirrhosis from patient, carer and clinical perspectives and then prioritise those questions 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 symptom management, active treatment and care for decompensated cirrhosis;
  • agree by consensus a prioritised list of those uncertainties, for research;
  • publicise the results of the PSP and process;
  • take the results to research commissioning bodies to be considered for funding.

The scope of the Liver Cirrhosis PSP is defined as:

  • disease-modifying treatments for prevention and treatment of decompensation in cirrhosis;
  • clinical management of decompensated cirrhosis in primary care, acute hospital and tertiary specialist care settings; including non-pharmacological therapies (mental health, physiotherapy and nutrition);
  • understanding and control of symptoms of decompensated cirrhosis;
  • clinical factors affecting variation in delivery of care of decompensated cirrhosis.

The scope of the PSP may be refined through early discussion in the Steering Group.

While the following issues are important in the broad context of liver disease, the PSP will maintain a tight focus on the areas outlined above, and will exclude from its scope questions about:

  • treatment of decompensated cirrhosis outside of the UK;
  • liver disease in children as the disease profile and treatment pathways for children differ to those for adults;
  • aetiology specific management of liver disease;
  • end of life care for people with liver disease;
  • the role of alcohol or addiction in society as a contributor to liver disease;
  • public health and preventative care to reduce liver disease;
  • clinical research into liver transplantation.

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. Researchers will also be represented on the Steering Group, 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 Liver Cirrhosis PSP will be led and managed by a Steering Group involving the following:

Patient and carer representatives

  • Julie Adams, British Liver Trust
  • Richard Allen, Patient
  • Adam Ashborn, Carer
  • Karen Rockell, Patient Co-Director/PPIE Lead, UK Organ Donation and Transplantation Research Network

Clinical representative/s

  • Gautam Mehta, Hepatology Consultant
  • Michael Allison, Hepatology Consultant
  • Laura Kent, Hepatology Clinical Nurse Specialist
  • Dina Mansour, Hepatology Consultant and British Society of Gastroenterology representative
  • Lynsey Spillman, Hepatology and Liver Transplant Dietitian
  • Oliver Tavabie, Hepatology Consultant
  • Felicity Williams, Assistant Professor in Physiotherapy for Chronic Conditions

Additional members are being sought to represent the views of relatives and carers and also to extend representation across the UK, particularly for areas with high prevalence of liver disease.

Project coordinator

Helen Crisp, UK CLIF Network

James Lind Alliance Adviser and Chair of the Steering Group

Nahid Ahmad, James Lind Alliance

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.


Organisations and individuals will be invited to be involved with the PSP as partners with UK CLIF Network and the British Liver Trust. 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 currently experiencing, or having previously experienced, decompensated cirrhosis of the liver;
  • carers and family members of people who have, or had, decompensated cirrhosis ;
  • health care professionals - with experience of decompensated cirrhosis.

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 Liver Cirrhosis 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. This will be achieved through the use of social media, professional, patient and carer networks, including UK CLIF Network and using existing meetings, such as those of BASL. Awareness raising will in part be carried out through step 1 above. The Steering Group will advise on the communication channels and timing of 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 Liver Cirrhosis PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of 8 – 12 weeks will be given to complete this exercise (which may be revised by the Steering Group if required).

The Liver Cirrhosis PSP recognises the need to involve people affected by liver cirrhosis who may be seldom heard and the following groups may require additional consideration.

  • Black, Asian and minority ethnic (BAME) communities
  • Those who do not have easy access to the internet (digital exclusion)

The Steering Group will use the following methods to reach the target groups:

  • Online surveys
  • Paper version of survey available in clinic settings (where possible) with a reply-paid response
  • Paper version to be requested, sent out by mail with a reply-paid response
  • Promotion through existing regular meetings including patient carer support groups and professional seminars and conferences (virtual and in-person)
  • Clinical colleagues to gather questions through face to face meetings, such as local liver patient support groups and in clinic settings, when appropriate.

Existing sources of evidence uncertainties will also be searched. These will include a recently completed systematic review into interventions for decompensated cirrhosis, research recommendations in clinical guidelines and health policy literature and online information and question answering services for patients.

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 Helen Crisp 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 Gautam Mehta, Helen Crisp and a research fellow (to be appointed). 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 Helen Crisp. This will show the checking undertaken to make sure that the uncertainties have not already been answered. The data will 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 liver cirrhosis. 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.

  1. 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.

  2. 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 Gautam Mehta.

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 the JLA.

Agreement of the Steering Group

The JLA Liver Cirrhosis PSP Steering Group agreed the content and direction of this Protocol on Monday 29 January 2024.