Purpose of the PSP and background
The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Mental Health and the Body Clock 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.
The team led by Professor Daniel Smith has been awarded an MRC partnership grant with a number of different aims. As one of the work streams, Professor Alice Gregory and Professor Malcolm von Schantz are leading a PSP with the aim of flagging unanswered questions in the topic of mental health and circadian rhythms.
Aims, objectives and scope of the PSP
The aim of the Mental Health and the Body Clock PSP is to identify the unanswered questions about Mental Health and the Body Clock from lived experience, patient, carer and clinical perspectives and then prioritise those that lived experience-individuals, patients, carers and clinicians agree are the most important for research to address.
The objectives of the PSP are to:
- work with individuals with lived experience, patients, carers, and clinicians to identify uncertainties about Mental Health and the Body Clock – including questions about experiences, difficulties, symptoms, diagnosis, intervention, treatment, and care.
- 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 Mental Health and the Body Clock PSP is defined as:
- Exploring disruption of body clocks in people with mental health difficulties, and mental health difficulties in people with disrupted body clocks.
- General: including experiences, difficulties, symptoms, diagnosis, intervention, treatment and care and will be of relevance to different age groups and different scenarios (e.g., general population as well as shift workers)
The PSP will exclude from its scope questions about:
- Under 11s (This aligns with the age most children transition into secondary/high school, and often when daily routines/sleep schedules become more of a personal responsibility)
- The situation in countries other than the UK (as questions about care and services for example may differ in one country to the other)
- Questions around specifically named local support services (i.e., support services which only supply a particular geographic location)
- Disorder-specific questions based on sleep disorders with other known direct/indirect causes (such as obstructive sleep apnoea). The inclusion/exclusion of disorder-specific questions may need to be dealt with on a case-by-case basis
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 those with lived experience, patients and carers and clinicians, as individuals or representatives from a relevant group.
The Mental Health and the Body Clock PSP will be led and managed by a Steering Group involving the following:
Patient and carer representative/s
Lisa Artis - The Sleep Charity
Maja Mitchell-Grigorjeva - Bipolar Scotland
Rachel Temple - The McPin Foundation
Emma Garavini - The McPin Foundation
Members from The McPin Foundation Lived Experience Advisory Panel working with the Circadian Mental Health Network
Sarah Robertson - Youth Engagement, Generation Scotland, University of Edinburgh
Nina Rzechorzek – Chronobiologist, University of Cambridge
Clinical representative/s
Nicole Needham – Clinical Research Fellow in Psychiatry, University of Edinburgh
Mike Farquhar - Child Sleep Medicine Clinician
Anna Kamusella - Second Year Core Psychiatry Trainee Doctor
Fiona Alexander - Psychiatrist
Nicholas Meyer - Behavioural Sleep Medicine (Psychiatrist), King’s College London
Maria Gardani – Clinical Psychology, University of Edinburgh
Project coordinator
Amy Ferguson – University of Edinburgh
James Lind Alliance Adviser and Chair of the Steering Group
Nahid Ahmad
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 difficulties with mental health or disrupted body clocks
- carers of people who have had difficulties with mental health or disrupted body clocks
- health and social care professionals - with experience of treating, caring for or supporting individuals with difficulties with mental health or disrupted body clocks.
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 Mental Health and the Body Clock PSP.
Step 2: Awareness raising
PSPs will need to raise awareness of their proposed activity among their peer communities and networks, 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 Mental Health and the Body Clock PSP will carry out a consultation to gather uncertainties from individuals with lived experience, patients, carers, and clinicians. A period of 3 months will be given to complete this exercise (which may be revised by the Steering Group if required).
The Mental Health the Body Clock PSP recognises that the following groups may require additional consideration. For example, we plan to obtain data from different groups (e.g., individuals from black and ethnic minority communities, members of the LGBTQIA+ community, individuals without sight, individuals without hearing, individuals with learning difficulties, individuals with different mental health difficulties). We shall seek advice form the steering committee as to possible challenges with practicalities or perceived stigma surrounding our topics of interest.
The Steering Group will use the following methods to reach the target groups. Online questions will form the basis of our approach. However, the Steering Group should advise and agree on the best method of consultation for reaching its groups. It is possible that we will develop paper surveys and face-to-face consultations if necessary.
Existing sources of evidence uncertainties may also be searched. Our primary focus when evidence checking will be reviewing the peer-reviewed literature (and particularly reviews, and meta-analyses) and considering clinical guidelines (e.g., NICE guidelines). The steering committee will be involved in decisions about evidence checking and this task will be led by the information specialist with input from the PSP co-leads as well as the JLA. Members of the Circadian and Mental Health Network (with expertise in this topic) shall also be invited to comment on whether they consider any of the uncertainties to have been adequately answered already.
Step 4: Refining questions and uncertainties
The consultation process will produce ‘raw’ questions and comments indicating individuals with lived experience’s, patients’, carers’, and clinicians’ areas of uncertainty. These raw questions will be categorised and refined by the information specialist (TBC) and project coordinator under the supervision of the PSP co-leads 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 Steering Group will also consider how it will deal with submitted questions that have been answered, and questions that are out of scope.
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 information specialist (TBC) and project coordinator under the supervision of the PSP co-leads. 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 information specialist (TBC) and project coordinator under the supervision of the PSP co-leads. 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.
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 Mental Health and the Body Clock. This will involve input from individuals with lived experience, 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 individuals with lived experience, 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 individuals with lived experience, 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 sharing the results of the priority setting process, such as researchers, funders, peer communities and networks. 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 Professor Malcolm von Schantz and Professor Alice Gregory.
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 Mental Health and the Body Clock PSP Steering Group agreed the content and direction of this Protocol on 07/11/2023.