Purpose of the PSP and background
The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Quality Use of Medicines in People Living with Dementia 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 people with lived experience of the condition (also referred to as consumers), 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 people with lived experience of the condition, carers and clinicians. The National Institute for Health and Care Research (NIHR – www.nihr.ac.uk) coordinates the infrastructure of the JLA to oversee the processes for PSPs, based at the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton.
The Quality Use of Medicines in People Living with Dementia Priority Setting Partnership (PSP) was initiated by the Medicines and Dementia Special Interest Group (MEDDEM SIG) of the NHMRC National Institute for Dementia Research (NNIDR). The MEDDEM SIG is composed of clinicians and researchers with interest in optimising medication use in people living with dementia. The idea of determining the consumer and clinician priorities for research in this field was born at the 2019 MEDDEM SIG meeting. A team of researchers was then assembled to apply for funding to conduct this work.
Aims, objectives and scope of the PSP
The aim of the Quality Use of Medicines in People Living with Dementia PSP is to identify the unanswered questions about Quality Use of Medicines in People Living with Dementia from people with lived experience of the condition, carer and clinical perspectives and then prioritise those that people with lived experience of the condition, carers and clinicians agree are the most important for research to address.
The objectives of the PSP are to:
• work with people living with dementia, carers and clinicians to identify uncertainties about how to achieve quality use of medicines in people living with dementia.
Quality use of medicines means using medicines safely and effectively to get the best possible health outcomes. It also means only using medicines when they are needed. People living with dementia represent the diverse adult health population, having multiple other medical conditions and from all socio-cultural backgrounds. Therefore, we are interested in all the different types of medications taken by people living with dementia.
• to agree by consensus a prioritised list of those uncertainties, 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 scope of the Quality Use of Medicines in People Living with Dementia PSP includes questions about:
- The benefits and harms of medications (including combinations of medications) in people living with dementia.
- Appropriate medication use across the different stages of dementia and in different settings.
- How to collaboratively achieve the goal of quality use of medicines in people living with dementia.
- All medications that people living with dementia could take (for any condition), including prescription, over-the-counter and complementary/herbal medications.
The PSP will exclude from its scope questions about:
- The development or discovery of new medicines to treat or prevent dementia.
- Non-drug care of people living with dementia (unless it is related to quality use of medicines, for example, how we can reduce use of harmful or unnecessary medicines)
(These types of questions are also important, but they are not the focus of this study)
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 people with lived experience of the condition and carers and clinicians , as individuals or representatives from a relevant group.
The Quality Use of Medicines in People Living with Dementia PSP will be led and managed by a Steering Group involving the following:
Person with lived experience of the health condition and carer representative/s:
- Ann Pietsch
- Timothy Pietsch
- Ron Sinclair
Clinical representative/s:
- Craig Whitehead, Geriatrician
- Stephanie Daly, GP
- Josephine To, Pharmacist
- Marie Wittwer, Director of Care and Manager Residential Facilities (Nurse)
- Judy Deimel, Nurse Practitioner
- Lenore de la Perrelle, Social Worker
- Psychiatrist or psychogeriatrician to be recruited if possible
PSP Lead and SG Chair
- Emily Reeve, University of South Australia
PSP Support Officer:
- TBD
James Lind Alliance Adviser:
- Katherine Cowan, JLA
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 living with dementia
• carers of people living with dementia
• health and social care professionals - with experience of caring for people living with dementia
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.
Partner organisations
- NHMRC National Institute for Dementia Research (NNIDR)
- James Lind Alliance (JLA)
A list of potential partner organisations will be drafted by the PSP Lead and reviewed by the Steering Group. Then these organisations will be invited to become partner organisations and will be added to the list if they agree. Potential partner organisations include consumer advocacy organisations (e.g. Dementia Australia, Carers Australia), professional bodies (e.g. Royal Australian College of General Practitioners) and other organisations involved in the research and care of people with dementia (e.g. Cochrane Review Groups).
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 at www.jla.nihr.ac.uk 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 Quality Use of Medicines in People Living with Dementia PSP.
Step 2: Awareness raising
PSPs will need to raise awareness of their proposed activity among their consumer, carer and clinician communities, in order 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 Quality Use of Medicines in People Living with Dementia PSP will carry out a consultation to gather uncertainties from people with lived experience of the condition, carers and clinicians. A period of up to 3 months will be given to complete this exercise (which may be revised by the Steering Group if required).
The Quality Use of Medicines in People Living with Dementia PSP recognises that the following groups may require additional consideration.
Some people living with dementia and their carers may have difficulty completing an online or paper survey. We will allow for alternative methods of feedback, such as having a research or other person complete the survey for them based on an interview. We will also use our partner organisations and Steering Group members to engage with these individuals
The Steering Group will use the following methods to reach the target groups.
Evidence uncertainties will be gathered using a self-administered questionnaire in either online or paper version. The questionnaire will ask the respondent (using language appropriate for the group) to list up to 3 evidence uncertainties. For example, clinicians will be asked to share questions that they encountered in patient interactions and that they were unable to find evidence-based guidance on. Where appropriate, the questionnaire may be administered by a member of the research team, in person or over the phone (at the request of the participant). That is, the researcher will read the questions out loud to the participants and record their responses, providing additional clarification where necessary. Participants can also get a family member, friend or advocate to help them complete it. The questionnaire and all materials have been reviewed by researchers and clinicians with expertise in dementia and consumer representatives and are in accordance with the principles for communicating with people living with dementia as per Dementia Australia guidelines.
Potential participants will be recruited through a multifaceted approach:
1. Dissemination of materials to relevant organisations – materials in electronic or paper form will be sent to relevant organisations such as professional societies and consumer advocacy groups. These organisations will be asked to distribute the materials (advertisements, links to the online questionnaires, paper copies of questionnaire etc) as they see fit, such as through regular newsletters.
2. Dissemination of materials at events – investigators will advertise and distribute paper materials at relevant events, such as professional conferences.
3. Dissemination of materials through personal contacts – members of the research team will distribute advertising materials to relevant professional and personal contacts.
4. Dissemination of advertisements through social media – members of the research team will create ‘Tweets’ or other social media posts to advertise the research project via their own or organisations accounts. We will also establish a Twitter account for this project to aid in awareness and dissemination of materials
5. Posting of advertisements on relevant organisations research opportunities boards, e.g. Dementia Australia, Universities, StepUp for Dementia Research
6. Participants will be encouraged to and will have the ability to share/advertise the study with their personal contacts (i.e. a snowballing approach).
Existing sources of evidence uncertainties may also be searched. For example:
- Request information from the Aged Care Quality and Safety Commission about complaints made about medicines over the past 5 years.
- Recent Australian guidelines related to the treatment of dementia to identify gaps in the literature.
- Pharmaceutical Society of Australia, Medicine Safety in Aged Care Report (2020)
Step 4: Refining questions and uncertainties
The consultation process will produce ‘raw’ questions and comments indicating people with lived experience of the condition, carers’ and clinicians’ areas of uncertainty. These raw questions will be categorised and refined by members of the research team (Emily Reeve, Mouna Sawan, Tuan Nguyen) 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 members of the research team (Emily Reeve, Mouna Sawan, Tuan Nguyen, Lisa Kalisch Ellett, Julia Gilmartin Thomas, Edwin Tan, Lynn Chenoweth, Sarah Hilmer and Janet Sluggett). 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 members of the research team (Emily Reeve, Mouna Sawan, Tuan Nguyen, Lisa Kalisch Ellett, Julia Gilmartin Thomas, Edwin Tan, Lynn Chenoweth, Sarah Hilmer and Janet Sluggett). 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.
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 Quality Use of Medicines in People Living with Dementia. This will involve input from people living with dementia, 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 people with lived experience of the condition, 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 people with lived experience of the condition, 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 people with lived experience 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 Emily Reeve.
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 Quality Use of Medicines in People Living with Dementia PSP Steering Group agreed the content and direction of this Protocol on 23rd of April 2020.