Purpose of the PSP and background
The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Concussion 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 – 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 focus of this PSP is concussion. Despite its increasing prevalence there is a lack of research into concussion. There have been several national and international concussion clinical guidelines published which have highlighted the fact that many aspects of concussion lack published evidence to guide prevention, diagnosis, prognosis and management. In order to address this situation, the Canadian Institutes of Health Research (CIHR) has recently called for large multidisciplinary teams to conduct concussion research nationally and in partnership with the NIH in the United States. A standardized process that is led by patients, families, and clinicians is increasingly preferred to establish research priorities that matter most to the patients and families. With the recent interest of funders to support programs of concussion research this is an ideal time to identify research priorities from the perspective of patients, carers and clinicians using the JLA PSP methodology to help drive and focus the research agenda.
Aims, objectives and scope of the PSP
This PSP is concerned with patients who have or have had a concussion. While the term “concussion” is used broadly in society, for this study we use the definition in the fifth Berlin Consensus Statement on Concussion in Sport1. This document defines concussion as a traumatic brain injury induced by biomechanical forces. It may be caused by a direct blow to the head, face, neck or elsewhere on the body, and may or may not have resulted in loss of consciousness.
The aim of the Concussion PSP is to identify the unanswered questions about concussion from patient, carer and clinical perspectives and then prioritise those that patients, carers and clinicians agree are the most important for research to address.
The objectives of the PSP are to:
- Establish and mobilize a partnership of patients, carers, clinicians and community stakeholders who are brought together on an equal footing to identify uncertainties/unanswered questions about the prevention, diagnosis, prognosis and treatment of concussion.
- Work with the partnership to agree by consensus on a prioritized list of these unanswered questions
- Disseminate and publicize the most important unanswered questions to funders and other stakeholders
The scope of the Concussion PSP is focused on:
- Patients either 1) diagnosed with, or 2) suspected as having an acute and/or chronic concussion or mild Traumatic Brain Injury (mTBI).
- This includes patients:
- of any age (ie: children and adult),
- with any type and severity of concussion symptoms and/or signs, and
- resulting from any mechanism of traumatic injury.
- The scope of questions considered will include those relating to prevention, diagnosis, prognosis, and treatment of concussion.
The PSP will exclude from its scope questions about:
- Moderate to severe brain injuries due to intracranial trauma resulting in intracranial haemorrhage or cerebral edema and/or those requiring neurosurgical intervention
- Brain injuries not caused by physical trauma (ie: tumor-related, stroke, infectious (meningitis/encephalitis), neurodevelopmental, neurodegeneration, asphyxia, etc…)
- Spinal cord injuries
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.
The Concussion PSP will be led and managed by a Steering Group involving the following:
Patient and carer representative/s:
- Randene Duncan
- Erin Fox
- Kanika Gupta
- Ash Kolstad
- Rosemary Macklem
- Kinga Olszewska
Research Family Leader Representative
- Michelle Quinlan, Research Family Leader Program Coordinator, Children’s Hospital of Eastern Ontario (CHEO) Research Institute
- Shannon Bauman, Physician, Sports Medicine, Barrie, Ontario
- Mark Bayley, Physician, Physical Medicine and Rehabilitation, Toronto, Ontario
- Phil Fait, Athletic Therapist, Trois-Rivieres, Quebec
- Isabelle Gagnon, Pediatric Physiotherapist, Montreal, Quebec
- Noah Silverberg, Neuropsychologist, Vancouver, British Columbia
- Lyle McKellar, School Teacher, President, School Sport Canada, Regina, Saskatchewan
- Liz Legace, CHEO Research Institute
James Lind Alliance Adviser and Chair of the Steering Group:
- Katherine Cowan, Senior Advisor to the JLA
PSP Lead and Steering Group Co-Chair
- Martin Osmond, Pediatric Emergency Physician, CHEO, Ottawa, Ontario
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.
In addition to the Steering Group, two individuals will assist with both promoting the survey and providing expertise during the evidence-checking stage of the project. They are:
- Lisa Marie Langevin, Research Coordinator, Canadian Concussion Network (CCN), and Program Manager, Brain Injury Research in Children (BIRCh) Laboratory, University of Calgary, Calgary, Alberta
- Stephanie Cowle, Knowledge Translation Coordinator, Canadian Concussion Network (CCN), and Director of Knowledge Translation, Parachute, Ontario
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 one or multiple concussions
- carers of people who have had one or multiple concussions
- health and social care professionals - with experience in concussion
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 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 Concussion 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. 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 Concussion PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of three months will be given to complete this exercise (which may be revised by the Steering Group if required).
The Concussion PSP recognises that there may be groups that require additional consideration. These may be communities that are hard to reach, seldomly heard from or marginalized. These groups include older people, younger children, Indigenous people, and people who live in community shelters. The steering group will devise methods to reach out to these groups, and will monitor survey response demographics, where possible, to check that these groups have made their voice heard through survey completion.
Existing sources of evidence uncertainties may also be searched, including research recommendations in systematic reviews and clinical guidelines. In addition, any previous research prioritization exercises will be reviewed.
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 Liz Legace and Lisa Marie Langevin 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 Liz Legace, Lisa Marie Langevin and Stephanie Cowle. 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 Liz Legace. 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 concussion. 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 (either done in person or online) 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 Martin Osmond.
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 email@example.com.
Agreement of the Steering Group
The Concussion PSP Steering Group agreed the content and direction of this Protocol on [insert date].
1. McCrory P, Meeuwisse W, Dvorak J, et al. Consensus statement on concussion in sport—the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med 2018;51:838-847.