Purpose
The purpose of this protocol is to set out the aims, objectives and commitments of the Alcohol related Liver Disease Priority Setting Partnership (PSP) and the basic roles and responsibilities of the partners therein.
Steering Group
The Alcohol Related Liver Disease PSP will be led and managed by the following:
Patient representative/s:
- Diane Goslar, patient representative
- Andrew Langford, British Liver Trust
- Lynda Waters, carer representative
Clinical representative/s:
- Dr Michael Allison, Consultant Hepatologist – Addenbrooke’s Hosptal
- Simran Arora, Clinical Specialist Hepatology / Liver Transplant Dietitian
- Dr Jane Collier, Consultant Hepatologist – Oxford
- Aisling Considine, Acting Liver Pharmacy Team Leader – Kings College
- Dr Ranjita Dhital, Community Pharmacist/ Research Pharmacist – King’s College London
- Dr Zul Mirza, Consultant in Emergency Medicine
- Lynn Owens, Nurse Consultant- Alcohol Services
- Dr Steve Ryder, Consultant Hepatologist BSG representative
- Dr Nick Sheron, Consultant Hepatologist – British Association for the Study of Liver Disease
- Dr Julia Sinclair, Associate Professor in Psychiatry
- Dr Stephen Willott, GP – Nottingham
The Partnership and the priority setting process will be supported and guided by:
The James Lind Alliance (JLA)
- Sheela Upadhyaya (JLA Adviser)
- Beccy Maeso (JLA, National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre - NETSCC)
- Amy Street (JLA, National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre - NETSCC)
The Steering Group will provide support as detailed in the agreed Terms of Reference.
Background to the Alcohol Related Liver Disease PSP
The JLA is a project which is overseen by the National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre (NETSCC). Its aim is to provide an infrastructure and process to help patients and clinicians work together to agree which are the most important treatment uncertainties affecting their particular interest, in order to influence the prioritisation of future research in that area. The JLA defines an uncertainty as a “known unknown” – in this case relating to the effects of an intervention or treatment.
Alcohol related liver disease has been identified by the NIHR as an important area for research. One of the key findings in the Chief Medical Officer Professor Dame Sally Davies’s first annual report published in November 2012 was that comprehensive action is needed to stop the rising tide of liver disease. In 2010 to 2011 there were 1.2 million alcohol-related hospital admissions and around 15,000 deaths caused by alcohol. Liver disease is the only major cause of mortality and morbidity that is on the increase in England while it is decreasing among our European peers. Between 2000 and 2009, deaths from chronic liver disease and cirrhosis in the under 65s increased by around 20% while they fell by the same amount in most EU countries. Liver disease is the fifth most common cause of death in the UK and disproportionally affects young people and disadvantaged groups. In England and Wales 2012 the years of life lost (to age 75) due to mortality from diseases of the liver in men was 74,000 (rate of 27 per 10,000 of the population) and 43,000 (15 per 10,000) in women.
Aims and objectives of the Alcohol Related Liver Disease PSP
The aim of the Alcohol Related Liver Disease PSP is to identify the unanswered questions about Alcohol Related Liver Disease prevention and treatment from patient and clinical perspectives and then prioritise those that patients and clinicians agree are the most important.
The objectives of the Alcohol Related Liver Disease PSP are to:
- work with patients and clinicians to identify uncertainties about the effects of Alcohol Related Liver Disease prevention and treatments
- to agree by consensus a prioritised list of those uncertainties, for research
- to publicise the results of the PSP and process to the research community
- to take the results to research commissioning bodies to be considered for funding
PSP Scope
The scope will cover primary, secondary and tertiary care, gathering uncertainties relating to interventions in the treatment of alcohol related liver diseases i.e. actions taken to improve the health and wellbeing of people. Healthcare interventions will cover treatment, prevention, diagnosis, and service considerations.
ARLD Scope summary
In scope:
- InterventionsofARLD
- Physical interventions
- Drugs
- Surgery
- Psychological
- Psychosocial
- Individual / community re-enforcement / education / workplace
- Diet and nutrition
- Addiction interventions
- Co-morbidities associated with ARLD
- Diagnosis
- Prevention of ARLD
- Person centred care
- Patient pathway
- Commissioning
- Palliative care
- Service Delivery
- Primary care
- Secondary care
Out of Scope
- Non alcohol fatty liver disease
- Other drug related Liver disease
- Aetiology causes of ARLD
- Prognosis testing
- Any issues relating to changing policy
- Social research issues
Partners
Organisations and individuals will be invited to take part in the PSP, which represent the following groups:
- people who have had Alcohol Related Liver Disease
- carers, relatives and friends of people who have or had Alcohol Related Liver Disease
- health and social care professionals, medical doctors, nurses and professionals allied to medicine with clinical experience of Alcohol Related Liver Disease
- Public Health
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 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.
Methods
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 partners, guided by the PSP’s aims and objectives. More details and examples can be found in the JLA Guidebook.
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 by the steering group members of the establishment and aims of the Alcohol Related Liver Disease PSP and how they can be involved.
Initial stakeholder meeting / awareness raising
The initial stakeholder meeting / awareness meeting was held in April 2014 and had several key objectives:
- to welcome and introduce potential members of the Alcohol Related Liver Disease 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 PSP’s 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
Identifying treatment uncertainties
In consultation with the PSP Steering Group, the JLA will develop an online survey (with alternative formats available) to identify patients’ carers’ and clinicians’ unanswered questions about alcohol related liver disease treatment. Steering Group members and partner organisations will be asked to promote the survey and ensure it reaches their members and respective constituent groups. A period of three months will be given to complete this exercise.
Existing sources of information about alcohol related liver disease treatment uncertainties will be searched. These may include 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.
Sources of uncertainties for research recommendations may include:
- Cochrane database
- NHS Evidence – UK DUETs
- NICE Guidance and NICE Research recommendations database
- MJ clinical evidence
- Relevant College guidance
- Pub Med
In consultation with the Steering Group, the JLA will commission an information specialist with appropriate skills and knowledge to carry out this piece of work, and to manage the process of refining the survey data, as described in the next section.
Refining questions and uncertainties
The Steering Group will to have agree 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 the appointed 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.
The existing literature will be researched by the information specialist to see to what extent these refined questions have, or have not, been answered by previous research. The JLA definition of an uncertainty is that:
- no up-to-date, reliable systematic reviews of research evidence addressing the uncertainty about the effects of treatment exist
- up-to-date systematic reviews of research evidence show that uncertainty exists
The Steering Group will agree the scope of the literature and evidence against which each uncertainty will be checked. The limitations of this will be made clear in future reporting on the PSP.
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 prepared for entry into a Alcohol Related Liver Disease section within the UK Database of Uncertainties about the Effects of Treatments (UK DUETs) by the appointed information specialist. This will ensure that the uncertainties have been actually checked to be uncertainties. 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 entered into UK DUETs on completion of the priority setting exercise, in order to ensure any updates or changes to the data have been incorporated beforehand. (Please note the UK DUETs database was discontinued in 2015. All PSP uncertainties now appear on the JLA website).
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 Alcohol Related Liver Disease. 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 (e.g. up to 30), may be carried out over email, whereby organisations consult their membership and choose and rank their top 10 most important uncertainties. Or, it may involve individuals. The Steering Group will make a transparent decision about how to proceed once the process is under way.
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.
Findings and research
The steering group will be responsible for reporting the Alcohol Related Liver Disease PSP. It will be reported to research funding organisations such as the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC). Steering Group members will help 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
The steering group will work with the JLA to develop a dissemination strategy to disseminate the findings as widely as possible. As well as alerting funders, partners and Steering Group members are encouraged to publish the findings of the Alcohol Related Liver Disease PSP using both internal and external communication mechanisms. The JLA may also capture and publicise the results, through descriptive reports of the process itself. 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.
Signed by the Steering Group
The PSP agree to follow the Alcohol Related Liver Disease Priority Setting Protocol.