Complex Fractures PSP Protocol

Contents

Purpose of the PSP and background

This protocol sets out the aims, objectives and commitments of the complex fractures 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 those who fund health research are aware of what really matters to patients, carers and clinicians. The National Institute for Health 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.

This PSP came together in collaboration with AOUK and the Orthopaedic Trauma Society.

Complex fractures are fractures of the pelvis, or of an extremity with associated features. Complex fractures make up the minority of the 1.8 million fractures that occur in England each year but are associated with significant morbidity and are a large burden on healthcare resources. They often involve high-energy mechanisms, such as road traffic accidents. Multiple injuries or fractures can be sustained at the same time. In elderly patients, the same spectrum of severe injuries can occur with lower-energy accidents such as a fall down the stairs. The treatment of complex fractures is often complicated and usually involves multiple healthcare professionals and specialists.

A complex fracture may represent a life-changing injury, though when treatment goes to plan patients often experience a full return of function and can return to their job role. When patients experience more severe injuries or complications (e.g. infection) their treatment can be prolonged, resulting in permanent disability and mental health problems. These factors represent high direct and indirect economic costs to the health service and wider society. There is a pressing need to determine the recovery priorities for these patients and their families. This PSP will be the first to systematically investigate this.

The expansion of the National Institute for Health 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 complex fractures who currently have limited input in shaping future research in this area.

Aims, objectives and scope of the PSP 

The PSP aim is to identify the unanswered questions about complex fractures 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 complex fractures
  • 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 complex fracture will mirror the scope of the NICE guidelines for complex fractures: https://www.nice.org.uk/guidance/ng37. This will include:

  • Pelvis and acetabular fractures
  • Extremity fractures associated with:
    • More than one fracture
    • Open fractures
    • Comminuted (broken into multiple pieces) intra-articular fractures of the lower limb
  • The PSP scope will include the following aspects of care in the first 12 months following injury:
    • Both operative and non-operative care of bony and soft tissue injuries, wounds, and incisions
    • Rehabilitation both physical and mental, including occupational therapy and return to work
    • Service design and delivery 

The PSP will exclude from its scope questions about:

  • Fractures in children and younger people (less than 18 years old)
  • Emergency department and pre-hospital care
  • Isolated Hand 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 patients and carers and clinicians, as individuals or representatives from a relevant group. 

The complex fractures PSP will be led and managed by a Steering Group involving the following:

Patient and carer representative/s:

  • Angela Thornhill
  • Philip Bell
  • Maize McKenzie
  • Shan Martin
  • Steven Jolly

Clinical representative/s:

  • William Eardley, Trauma and Orthopaedics, South Tees Hospitals NHS Trust, PSP Lead
  • Chris Bretherton, Trauma and Orthopaedics, Oxford University Hospitals Trust, PSP Information Specialist
  • Harry Claireaux, Trauma and Orthopaedics, Oxford University Hospitals Trust, PSP Information Specialist
  • Louise Johnson, Clinical Psychology, Leeds Teaching Hospitals NHS Trust
  • Lucy Silvester, Physiotherapy, University Hospitals Coventry and Warwickshire NHS Trust
  • Mark Baxter, Orthogeriatrics, University Hospitals Southampton
  • Paul Dixon, Trauma and Orthopaedics, Sunderland Royal Hospital
  • Rebecca Kearney, Physiotherapy, University Hospitals Coventry and Warwickshire NHS Trust
  • Stuart White, Anaesthetics, Brighton and Sussex University Hospitals
  • Victoria Giblin, Plastic Surgery, Sheffield Teaching Hospitals
  • Xavier Griffin, Trauma and Orthopaedics, Oxford University Hospitals Trust

Project coordinator: 

  • Lisa Robertson, South Tees Hospital NHS Trust 

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 complex fractures
  • carers of people who have sustained complex fractures
  • health and social care professionals - with experience of complex fractures.

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 complex fractures PSP.

We have identified the following partner organisations with links to the Steering Group participants:

  • After Trauma
  • AOUK & Ireland
  • 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)
  • Cochrane
  • Day One
  • Fragility Fracture Network (FFN)
  • National Major Trauma ODN (GroupPAN)
  • National Trauma Research & Innovation Collaborative
  • NIHR CRN Trauma and Emergencies Specialty Group
  • Orthopaedic Trauma Society (OTS)
  • People in Research
  • 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
  • Versus Arthritis
  • Wessex Trauma Network

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 will need to raise awareness of their activity among stakeholder 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 (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 complex fractures. This exercise has been assigned five months. (which 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 complex fractures.  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 complex fractures PSP Steering Group agreed the content and direction of this Protocol on 13th December 2019.