Dementia PSP Protocol

Purpose

The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Dementia Priority Setting Partnership (PSP) and the basic roles and responsibilities of the partners therein.

Steering Group

The Dementia PSP will be led and managed by the following:

People with dementia and carer representatives:

• Alzheimer's Society
  • Nicola Hart
  • Anne Corbett
  • Claire King
• DeNDRoN
  • Denise Wilson
• BUPA
  • Graham Stokes

Clinical and academic representatives:

• University of Cambridge
  • Carol Brayne
  • Louise Lafortune
  • Sarah Kelly
• University of Warwick
  • Angelique Mavrodaris
• King's College London
  • Jill Manthorpe
• Cardiff University
  • Tony Bayer
• Cambridge and Peterborough NHS Foundation Trust
  
  • Claire Lawton

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

• The James Lind Alliance (JLA) and the UK Database of Uncertainties about the Effects of Treatments (UKDUETs)
  • Katherine Cowan (JLA) (Chair)
  • Mark Fenton (UK DUETs)

The Steering Group includes representation of people with dementias, carers, researchers and clinicians.

The Steering Group will agree the resources, including time and experience that they will be able to contribute to each stage of the process. The JLA will be able to advice on this.

Background to the Dementia PSP

The JLA is a project funded by the National Institute of Health Research and supported by the Medical Research Council. Its aim is to provide an infrastructure and process to help people with dementia, carers 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 treatment.

The Dementia PSP arose from an initial approach to the JLA by Professor Carol Brayne on behalf of the Alzheimer’s Society’s Public Health Research Steering Group. This resulted in a funding application to NIHR to incorporate a Dementia PSP in a larger body of work aiming to perform a robust gap analysis of the current state of evidence around interventions for people with dementia. Although the application was unsuccessful the Society feels this is a priority area and has taken the decision to proceed with the initiative through its own funding processes.

The Dementia PSP will feed into the larger gap analysis and enable extensive stakeholder engagement.

Aims, objectives and scope of the PSP

The aim of the Dementia PSP is to work with people with dementia, their carers/former carers, health and care practitioners and members of the community from a broad population perspective to identify uncertainties around the prevention, diagnosis, treatment and care of dementia. With the ageing population, this will help direct future research according to what is important to the whole community.

The objectives of the Dementia PSP are to:

• work with people with dementia, their carers, health and social care professionals and members of the community to identify uncertainties about the prevention, diagnosis, treatment and care of dementia from a broad population perspective
• to agree by consensus a prioritised list of those uncertainties within a Public Health framework, for research and policy considerations
• to raise awareness of the prevention, diagnosis, treatment, and care of dementia among community members, people with dementias and clinicians
• to publicise the results of the PSP and process through appropriate channels and to raise awareness of the priorities for research amongst the research community
• to make the results of research available to commissioning bodies to be considered for funding and to inform policy decisions

This Dementia PSP will inform a larger programme of work to be led by Alzheimer’s Society to develop a robust gap analysis and prioritisation process for dementia research across the entire ‘dementia life course’ within a Public Health framework.

Partners

Organisations and individuals will be invited to take part in the PSP, which represent the following groups:

• people who have dementia
• carers and family members of people who have dementia
• medical doctors, nurses and professionals allied to medicine with clinical experience of dementia
• care professionals including care home and home care staff and social care representatives with experience of dementia
• members of the community, across generations, who are interested in dementia

It is important that all organisations and representatives who can advocate for these groups are invited to become involved in the PSP. The JLA will take responsibility for advising how the various stakeholder groups are able to participate 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 in the prioritising process. 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.

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 and through the JLA’s existing register of affiliates. Potential partners will be contacted and informed of the establishment and aims of the Dementia PSP and invited to attend and participate in an initial stakeholder meeting.

The JLA can draft the invitation, and an agreement should be reached as to the best organisation to distribute it.

Step 2: Initial stakeholder meeting

The initial stakeholder meeting will have several key objectives:

• to welcome and introduce potential members of the Dementia 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
• to discuss methods that partner organisations can use to collect uncertainties

The meeting will be chaired by the JLA in coordination with the administrative process of convening it, which will be managed by the Steering Group in collaboration with the JLA.

Following the meeting, organisations which have decided to participate in the PSP will be asked to complete a declaration of interests, including disclosing relationships with the pharmaceutical industry or others.

Step 3: Identifying uncertainties

Each partner will identify a method for soliciting from its members or representatives uncertainties of practical clinical, care and societal importance relating to the prevention, diagnosis, treatment and care of dementia. A period of 3 – 6 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 prevention, diagnosis, treatment and care uncertainties for people with dementia, clinicians and the society as a whole will be searched. These can include question-answering services for people with dementia and carers, for clinicians and the wider community; 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: www.evidence.nhs.uk.

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, simply to ensure accountability and transparency. The consultation process will produce “raw” unanswered questions about the prevention, diagnosis, treatment and care of dementia. These raw questions will be assembled and categorised and refined by a systematic reviewer at the Cambridge Institute of Public Health (University of Cambridge) 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 a systematic reviewer at the Cambridge Institute of Public Health (University of Cambridge) to see to what extent these refined questions have, or have not, been answered by previous research. The reviewer will also indicate which uncertainties have relevance at a population and policy decision-making level.

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 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 Partnerships keep a record of these readily 'answerable questions' and deal with them separately from the 'true uncertainties' considered during the research priority setting process.

Uncertainties about treatment which are not adequately addressed by previous research will be collated and entered into a Dementia section within the UK Database of Uncertainties about the Effects of Treatments (UK DUETs). Uncertainties about prevention, diagnosis and care will be managed separately.

This is the responsibility of the steering group, which will need to have agreed personnel and resources to carry this accountability. This is a key component of the JLA process, and the next stage of prioritisation can only proceed upon its completion.

These uncertainties will be further included in the larger gap analysis performed by Alzheimer’s Society under the oversight of the Public Health Steering Group to place them across the dementia life course within a population-level framework.

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 prevention, diagnosis, treatment and care of dementia. This will be carried out by members of the steering group and the wider partnership that represents people with dementia, carers, clinicians and the wider community.

The interim stage, to proceed from a long list of uncertainties to a shorter list (e.g. up to 20), may be carried out over email, whereby organisations consult their membership and ask them to consider the long list, then rank their top 10 most important uncertainties. If the long list is deemed too long, and therefore unmanageable, the Steering Group will need to agree a fair and transparent method for reducing it. The JLA can advise on this process.

The final stage, to prioritise the short listed uncertainties and agree a top 10, 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. 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. The Steering Group will need to agree available resources and support for convening a face to face meeting

Findings and research

The outcomes of the Dementia PSP will feed directly into the Alzheimer’s Society Public Health gap analysis work programme. It is anticipated that the findings of the Dementia PSP will also be reported to funding and research agenda setting organisations such as the NIHR HTA Programme and the MRC, as well as the major research funding charities. Steering Group members and partners are encouraged 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, commissioners and policy makers, partners and steering group members are encouraged to publish the findings of the Dementia PSP using both internal and external communication mechanisms, including raising awareness of dementia and the results among scientific audiences and the public to reach the entire community at all levels. 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. The Partnership is asked to keep the JLA informed of activity undertaken to publicise the results of the priority setting exercise.