First Time Soft Tissue Knee Injuries PSP Protocol

Purpose of the PSP and background

The purpose of this protocol is to clearly set out the aims, objectives and commitments of the First Time Soft Tissue Knee Injuries 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 Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton.

The knee is the most commonly injured joint in sporting accidents (1), but sports injuries account for only half of the knee injuries that are seen in practice (2). The largest population study, which comes from the Swedish registry, has demonstrated an annual incidence for soft tissue knee injuries to be 766 and 676 per 100,000 of the population for males and females, respectively. The peak rate of soft tissue knee injuries occurred in 15 to 19 year olds, with 1698/100,000 in males and 1464/100,000 in females (3).

Soft tissue injuries comprise a wide range of injuries, with meniscal (cartilage) tears accounting for about 11% of knee injuries, ligament injuries occurring in about 40% of all knee injuries (1) and ACL in approximately 50% of knee injuries (4). The annual incidence of ACL injuries has been shown to be 71/100,000 (3) while the incidence of meniscal injuries is estimated to be 60-70/100,00 per annum (5).

The burden of disease of ACL injuries continues to increase particularly in the paediatric population, with an estimated rise of 143% in ACL injuries in girls aged between 13 and 15, over an 18 year period (6). An estimated 15,000 ACL reconstructions take place in the UK per annum (7); the real figure is believed to be closer to 50,000 based on the incidence per 100,000 reported abroad (3). In the UK, there has been an estimated 12-fold rise in ACL reconstruction over a 20 year period (8).

Knee injuries frequently affect young people and can cause substantial disability, time off work, and may lead to long-term problems (9). Critically, injured knees have a 3 to 6 times increased risk of osteoarthritis, adding to the burden of osteoarthritis nationally (10,11). The risk of developing knee osteoarthritis by 65 years has been estimated to be about 14% in those who have had a knee injury in adolescence versus 6% in those who have not had a knee injury (12). With the cost of ACL surgery alone estimated (conservatively) at more than £60 million (13), the added cost of non-operative management and subsequent surgery related to sequelae from the initial soft tissue knee injury, is considerably higher.

Despite the significant burden of these injuries, their presentation and clinical treatment is very variable around the UK. Only around 20% of injuries present through A&E (14) and, often due to delays in diagnosis, it is not uncommon for treatment to occur following a period of delay, potentially affecting future outcomes (15). Even when treated, management is very variable around the country.

Furthermore, there remains a limited number of high-quality randomised controlled trials assessing soft tissue knee injuries, with no consensus found in a large-scale Cochrane studies (16,17). With the clinical and financial burden rapidly increasing, key focus areas requiring answers include the prevention of injuries; provision of ‘acute knee’ care (ie early diagnosis/treatment pathways); patient support availability and the optimum management for acute and delayed soft tissue knee injuries. These remain key surgical priorities that need to be defined but also require the perspectives of patients in order to better understand deficits in care and improve planning of future management strategies.

Aims, objectives and scope of the PSP

The aim of the First Time Soft Tissue Knee Injuries PSP is to identify the unanswered questions about First Time Soft Tissue Knee Injuries 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:

• work with patients, carers and clinicians to identify uncertainties about the prevention, diagnosis, management and delivery of services relating to first time soft tissue knee injuries
• 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 First Time Soft Tissue Knee Injuries PSP is defined as:

• The prevention, diagnosis, management and delivery of services relating to first time soft tissue knee injuries
• The first injury causing disability, which may lead to repeated injuries. These can be sports related or secondary to work and accidents e.g. twisting your knee whilst walking. They can cause swelling, pain, instability, difficulty walking and reduced movement of the affected knee.
• Include patella (kneecap) dislocations, ligament injuries, cartilage injuries (meniscus/joint surface)
• Include patients who are 12 years and older

The PSP will exclude from its scope questions about:

• Chronic injuries (i.e. not first injury)
• Patients younger than 12 years old
• Fractures

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 First Time Soft Tissue Knee Injuries problem PSP will be led and managed by a Steering Group involving the following:

Patient/carer/charity representatives:

Sarah Iqbal, Sheffield
Dr Sushilla Gerleman, Warwick
Liz Hay, Cambridge
Chloe Thompson, Leeds
Jonathon McRobb, Warwick
Chris Farrell, Day One Trauma Charity

Clinical representatives:

Mr Stephen McDonnell, Consultant T&O Surgeon / Associate Professor Cambridge University, Lead
Mr Sanjeev Anand, Consultant T&O Surgeon, BOSTAA
Mr Nicolas Nicolaou, Consultant T&O Surgeon, BOSTAA
Mr Andrew Metcalfe, Consultant T&O Surgeon / Associate Professor Warwick University, BASK
Mr Humza T Osmani, T&O Registrar (EoE Deanery) / Cambridge University, Co-ordinator and Information Specialist
Dr Faraz Siddiqui, General Practitioner, East Berkshire NHS Trust
Jonathan Room, Physiotherapist, ATOCP
Hayley Carter, Physiotherapist, ATOCP
Dr Deepak Krishnaa, ED Doctor, Bedford Hospital
Helen Kirbyshire, ED Physio, Cambridge
Nick Pettitt, Extended Nurse Practitioner, Cambridge
Dr OR, Consultant Radiologist, Bedfordshire Hospitals NHS Trust

Project coordinator: Mr Humza T Osmani, T&O Registrar (EoE Deanery) / Cambridge University

James Lind Alliance Adviser and Chair of the Steering Group: Dr Jonathan Gower, 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 who have had first time soft tissue knee injuries
• carers of people who have had first time soft tissue knee injuries
• health and social care professionals - with experience of first time soft tissue knee injuries

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 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 first time soft tissue knee injuries 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 first time soft tissue knee injuries PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of 12 to 15 months will be given to complete this exercise (which may be revised by the Steering Group if required).

The first time soft tissue knee injuries PSP recognises that the following groups may require additional consideration: paediatric groups. [If applicable, the Steering Group should consider the nature of the groups that it is targeting, their needs and how to reach potentially seldom heard or marginalised communities].

The Steering Group will use the following methods to reach the target groups:

• Online surveys - available on social media, via email and specialty websites
• Paper surveys - clinics / scientific meetings
• Target audiences via BASK and BOSTAA national meetings to include adult and paediatric surgeons
• Target audiences via social media e.g. twitter
• Target audiences via charity websites

Existing sources of evidence uncertainties may also be searched.
Question-answering services for patients and carers and for clinicians
Research recommendations in systematic reviews and clinical guidelines
Protocols for systematic reviews being prepared and registers of ongoing research

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 Humza Osmani / Cambridge research nurse/ BASK Research Fellow 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 Humza Osmani / Cambridge research nurse/ BASK Research fellow. 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 Humza Osmani / Cambridge research nurse/ BASK Research fellow. 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 First time Soft Tissue Knee Injuries. 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 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 Humza Osmani.

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 First Time Soft Tissue Knee Injuries PSP Steering Group agreed the content and direction of this Protocol on 28/02/22.