Major Trauma PSP Protocol

  • Published: 24 May 2021
  • Version: V1.2
  • 12 min read

Purpose of the PSP and background

This protocol sets out the aims, objectives and commitments of the Major Trauma Priority Setting Partnership (PSP) in line with James Lind Alliance (JLA) principles. The Steering Group will review the Protocol regularly and any updated versions 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. The aim of a PSP is to help ensure that funders of 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.

Major trauma is an injury or combination of injuries that are life-threatening and potentially life-changing, carrying with it significant risk of long-term disability. This can be caused by many injuries like blunt and penetrating trauma, including (but not limited to) falls, road traffic collisions, gunshots or stabbing wounds.

It has historically been the leading cause of death and disability in those under the age of 40, but its prevalence in older people has increased as medical care advances result in patients living longer lives. Compounding this are the effects of frailty, which increase the probability of significant injury and prolonged recovery as physiological reserves diminish.

Previous work has often focused on clinician-centred outcomes. Research into injuries represents only 6% of all research funding and the multidisciplinary nature of major trauma necessitates a syncretic approach to identifying research priorities. Previous work looking specifically at older person trauma has identified the need to identify preferred goals of trauma care, and there is a pressing need to identify priorities for patients, families, and their carers. This PSP will be the first to systematically investigate this topic and will be the first to incorporate the priorities of patients and carers. We will keep prompts for questions broad, using patient-centred language to allow patients to express their experiences.

The expansion of the National Institute for Health and Care Research (NIHR) and Trauma Audit and Research Network (TARN), as well as the development of novel methodical approaches, has seen a rise in the number of trials in urgent or emergency care conducted in the NHS over the last 5 years. We now have the infrastructure to deliver high-quality research in the emergency setting and so there is a need to generate the right research questions.

We hope this will give a voice to patients whose lives are altered by their Major Trauma who currently have limited input in shaping future research in this area.

Aims, objectives, and scope of the PSP

The PSP aims to identify the unanswered questions about the assessment and early management and from patient, carer, and clinical perspectives. These are then prioritised by stakeholders to decide which are the highest priority for future research.

PSP priorities:

  • Work with patients, carers, and clinicians to identify uncertainties about the treatment and rehabilitation of patients suffering Major Trauma
  • To agree a prioritised list of these uncertainties for future research
  • To publicise the PSP results
  • To take the PSP results to research commissioning bodies to be considered for funding.

The PSP definition of a Major Trauma will mirror the scope of the NICE guidelines for major trauma: https://www.nice.org.uk/guidance/ng39 and https://www.nice.org.uk/guidance/ng40 in adults.

This will include:

  • Chest injury
  • Abdominal injury
  • Pelvic fractures
  • Major Bleeding
  • Life or Limb-threatening injuries
  • Multiple traumatic injuries

The PSP scope will include the following aspects of care for patients of all ages and geography:

  • Prehospital care (immediately after injury to arrival at hospital)
  • Immediate hospital care after injury (reception and resuscitation)
  • Transfer between acute hospitals (trauma unit to major trauma centre)
  • In-patient care until discharge from an acute hospital

The PSP will exclude from its scope questions about:

  • Isolated spinal cord injury
  • Isolated head injury
  • Injury prevention and public health interventions
  • Post-hospital care and interventions
  • Post-traumatic stress disorder
  • Burns
  • Treatment unique to military or resource-limited settings
  • Hanging, asphyxia and drownings
  • Safeguarding

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 patients, carers, and clinicians - as individuals or representatives from a relevant group.

The Major Trauma PSP will be led and managed by a Steering Group involving the following:

Patient and carer representative/s

  • Shan Martin
  • Scott Johnston
  • Caroline James
  • Russell Neighbour
  • Sarifa Patel
  • Yesmin Begum

Clinical representative/s

  • Akshay Patel, Cardiothoracic Surgery, University Hospitals Birmingham, UK
  • Caroline Leech, University Hospitals Coventry & Warwickshire NHS Trust, UK
  • Ceri Battle, Physiotherapy, Swansea Hospital, UK
  • Chris Bretherton, Trauma and Orthopaedics, Oxford University Hospitals Trust, PSP Trainee-lead
  • Chris Farrell, Dayone Trauma Charity, UK
  • Claire Jackson, Trauma Nurse Coordinator Hampshire Hospitals NHS Foundation Trust, UK
  • Daniel Axelrod, Trauma and Orthopaedics, McMaster, Ontario, Canada
  • Daphne Van Embden, Trauma Surgery, Amsterdam University Medical Centre, the Netherlands
  • David Stockton, Trauma and Orthopaedics, Shock Trauma, Baltimore, USA
  • Edd Carlton, Emergency Medicine University of Bristol/ Royal College of Emergency Medicine, UK
  • Edward Caruana, Thoracic Surgery, University Hospitals of Leicester, UK
  • Elaine Cole, Nursing, Barts and the London NHS Trust, UK
  • Fiona Lecky, Emergency Medicine, Salford Royal Hospitals NHS Trust, UK
  • Gordon Fuller, Emergency Medicine, Sheffield, UK
  • Hamez Gacaferi, Oxford University Hospitals Trust, UK, PSP Information Specialist
  • Heather Vallier, Trauma and Orthopaedics, Case Western Reserve University, USA
  • Ian Greaves, Emergency Medicine, South Tees Hospitals NHS Trust, UK
  • Jacqueline Robson, Occupational Therapist in the Major Trauma Rehabilitation Service, Newcastle Upon Tyne Hospitals, UK
  • Justine Theaker, Consultant AHP, Trauma and Major Trauma, Manchester University, UK
  • Karim Brohi, Vascular Surgeon, Barts and the London NHS Trust, UK
  • Louise Johnson, Clinical Psychology, Leeds Teaching Hospitals NHS Trust
  • Lucy Nickson, Dayone Trauma Charity, UK
  • Maritz Laubscher, Trauma and Orthopaedics, Capetown, South Africa
  • Mary Breslin, Trauma and Orthopaedics, Case Western Reserve University, USA
  • Melissa Webb, Physiotherapy, Melbourne, Australia
  • Michael Wilson, Consultant Upper GI and General Surgeon at NHS Forth Valley, UK
  • Naomi Davis, Children’s Orthopaedic Surgeon, Royal Manchester Children’s Hospital, UK
  • Philip Braude, Consultant in Geriatric Medicine, North Bristol NHS Trust, Southmead Hospital, UK
  • Rachel Jenner, Consultant in Paediatric Emergency Medicine, Royal Manchester Children’s Hospital, UK
  • Rayner Maayen, Trauma Surgery, Medical Spectrum Twente, Enschede, The Netherlands
  • Robert Hirst, Emergency Medicine, UK, PSP Information Specialist
  • Ross Davenport, Vascular Surgeon, Barts and the London NHS Trust, UK
  • Sarah Hendrickson, Trauma and Orthopaedics, Case Western Reserve University, USA
  • Sarah Norris, Specialist Occupational Therapist in the Major Trauma Rehabilitation Service, Newcastle Upon Tyne Hospitals, UK
  • Sithombo Maqungo, Trauma and Orthopaedics, Capetown, South Africa
  • Spencer Wade, Clinical Psychology, British Colombia, Canada
  • Xavier Griffin, Trauma and Orthopaedics, Barts and the London NHS Trust, UK, PSP Lead

Project coordinator

  • Lauren Exell, Barts and The London School of Medicine and Dentistry, Queen Mary University of London

James Lind Alliance Adviser and Chair of the Steering Group

  • Jonathan Gower

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 those that 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 sustained Major Trauma
  • Carers of people who have sustained Major Trauma
  • Health and social care professionals with experience of Major Trauma

It is important that all organisations that can reach and advocate for these groups should be invited to become involved in the PSP. The JLA Adviser will take responsibility for ensuring the various stakeholder groups can 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 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 the steps the PSP will take to achieve the aims and 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 Major Trauma PSP.
We have identified the following partner organisations with links to the Steering Group participants:

Organisation

  • After Trauma
  • Association of Surgeons of Great Britain and Ireland (ASGBI)
  • American Trauma Survivor’s Network
  • AOUK & Ireland
  • AO Alliance
  • Association of Anaesthetists of Great Britain and Ireland (AAGBI)
  • Association of Carers
  • Association of Trauma and Orthopaedic Chartered Physiotherapists (ATOCP)
  • British Association of Occupational Therapists (BAOT)
  • British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS)
  • British Geriatric Society (BGS)
  • British Limb Reconstruction Society (BLRS)
  • British Orthopaedic Association (BOA)
  • British Trauma Society (BTS)
  • Canadian Orthopaedic Association
  • Cochrane
  • College of Paramedics
  • Day One Trauma
  • European Society of Thoracic Surgeons
  • European Association for Cardio-Thoracic Surgery
  • Faculty of Prehospital Care (RCSEd)
  • Fragility Fracture Network (FFN)
  • Limbless Association
  • NARSG
  • National Major Trauma ODN GroupPAN
  • National Major Trauma Rehabilitation Group
  • National major trauma psychology network
  • National Major Trauma Nursing Group
  • National Trauma Research & Innovation Collaborative
  • Nederlandse Orthopedie Vereniging (Dutch orthop Association)
  • Nederlandse Trauma Vereniging (Dutch trauma Association)
  • NIHR CRN Trauma and Emergencies Specialty Group
  • NIHR Emergency Care Incubator
  • Ongevalsstichting
  • Orthopaedic Research Collaboration in Africa (ORCA)
  • Orthopaedic Trauma Association
  • Orthopaedic Trauma Society (OTS)
  • People in Research
  • Paediatric Emergency Research Network UK and Ireland (PERUKI)
  • Royal Centre of Defence Medicine
  • Royal College Emergency Medicine
  • Royal College of Occupational Therapists
  • Slachtofferhulp Nederland/ Victim Support Nederland
  • Society of Cardiothoracic Surgeons
  • South African Orthopaedic Trauma Society (SAOTS)
  • The Association of Surgeons in Training (ASiT)
  • The British Orthopaedic Trainees Association (BOTA)
  • The Chartered Society of Physiotherapy (CSP)
  • Trauma Audit and Research Network (TARN)
  • TraumaCareUK
  • Vascular Society
  • Versus Arthritis

The Steering Group will identify other partner organisations to become involved with this PSP. This list will be available on the PSP website.

Step 2: Awareness-raising

The PSP group will raise awareness of their activity among stakeholder communities to secure support and participation. Depending on the 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 (identification and invitation of potential partners) and/or 3 (identifying evidence uncertainties). 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

Each partner will identify how best seek important questions and uncertainties relating to Major Trauma. This exercise has been assigned five months. (This may be revised by the Steering Group if required).

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 on treatment uncertainties for patients and clinicians will be searched. These can include question-answering services for patients, carers, and clinicians; 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.

Existing sources of evidence uncertainties may also be searched.

  • Question-answering services for patients and carers and clinicians
  • NICE guideline [NG37] Fractures (complex) assessment and management
  • Systematic reviews
  • Registers of ongoing research (trials register, PROSPERO, observational)

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 the information specialist into summary questions, which are clear, can be addressed by research, and understandable to all. Similar 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 lay audience. The summary questions 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 the information specialists. 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 specialists. This will show the process to ensure that the uncertainties have not already been answered. The data will be submitted to the JLA for publication on its website on completion of the priority setting exercise 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 PSP process is to prioritise the uncertainties around Major Trauma. This will involve input from patients, carers, and clinicians. There will be two stages:

  1. Interim prioritisation involves the long list of questions being refined to a shorter list that can be taken to the final priority setting workshop. The most highly ranked questions (circa 25) will be taken to a final PSP workshop. Where the interim prioritisation does not produce a clear ranking or cut off point, the Steering Group will decide which questions are taken forward to the final prioritisation.
  2. The final priority setting stage is typically a one-day workshop facilitated by the JLA. 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 key audiences to engage when disseminating the results of PSP, such as researchers, funders, patients, and clinicians. The group will determine how best to communicate 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 will discuss how they will work with funders and researchers to address which research questions could address the chosen priorities. The dissemination of results will be led by the PSP lead.

Agreement of the Steering Group

The Major Trauma PSP Steering Group agreed the content and direction of this Protocol on 7th February 2022