Prehabilitation for Hip and Knee Replacement Surgery 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 Prehabilitation for Hip and Knee Replacement Surgery 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 demand for elective orthopaedic surgery to manage musculoskeletal conditions is continuously increasing. In the UK, hip and knee replacement surgeries account for over 200,000 procedures annually. This demand, coupled with an aging population, has placed unprecedented pressure on orthopaedic services, resulting in long waiting lists, which have been further exacerbated by the backlog from the pandemic. The period of waiting for surgery, therefore, presents a window of opportunity to optimise and influence the mental and physical wellbeing of a patient through prehabilitation. Prehabilitation is defined as structured programmes aimed at improving a patient's functional status before surgery, leading to better postoperative outcomes. 

Although prehabilitation is not an entirely new concept, it is not yet routinely or standardly implemented across all healthcare settings as the evidence base is still developing. We propose to explore the potential for prehabilitation specifically in the context of hip and knee replacement surgeries to identify any uncertainties or gaps in knowledge. Between 2023 and 2024, Joanna Shim expressed an interest in the JLA approach and sought advice from a JLA adviser. Joanna subsequently applied for the proposal of this PSP through a competitive Catalyst Grant funded by Robert Gordon University.

Aims, objectives and scope of the PSP

The aim of the Prehabilitation for Hip and Knee Replacement Surgery PSP is to identify the unanswered questions about prehabilitation 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 prehabilitation in the context of hip and knee replacement surgery:
  • Patients who have been affected by the long waiting times for a hip or knee replacement surgery
  • Patients who have undergone a hip or knee replacement surgery
  • Families and carers of patients who have undergone hip or knee replacement surgery or are on the waiting list for surgery
  • Professionals involved in the treatment, support, and care for patients needing hip or knee replacement surgery
• 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 Prehabilitation for Hip and Knee Replacement Surgery PSP is defined as follows: 

• All aspects of prehabilitation in managing and supporting the emotional and physical well-being of individuals awaiting hip or knee replacement surgery. The focus of the possible impact of this PSP is on research opportunities that will influence future UK-based health and care services. Therefore, the scope also includes questions that relate to prehabilitation strategies aimed at managing symptoms whilst waiting, reducing complications, and improving post-operative outcomes. 
• Patient and carer priorities for support during waiting times.
• Screening, stratification and targeted prehabilitation programmes for different patient groups.
• Impact of prehabilitation on surgical outcomes, health-economic outcomes (including cancellation on day of surgery), functional outcomes, and patient-reported outcomes.
• Strategies for implementing prehabilitation programmes that are accessible and effective for diverse patient populations.
• Integration of digital tools and remote support in prehabilitation programmes.
• Optimal timing and duration of prehabilitation for hip and knee replacement surgery.
• The focus is on adults (individuals over 18), with particular attention to represent patient profiles similar to those published by NHS England Digital, specifically those over 50 years old.

The PSP will exclude from its scope questions about:

• Under 18 years
• Primary care conservative management for osteoarthritis or preventative management to avoid or delay surgery 
• Reasons for any delays to surgery
• Trauma-related hip or knee surgery
• The PSP distinguishes prehabilitation from education alone (e.g., pre-surgical information leaflets or pamphlets), as the latter is not considered prehabilitation. Therefore, we focus on interventions that go above and beyond current standard care practices.

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 Prehabilitation for Hip and Knee Replacement Surgery PSP will be led and managed by a Steering Group involving the following:

Patient and carer representative/s

• Mr Roy Swann, representing patients waiting for knee surgery
• Ms Anushka -, representing carers
• Mr Stuart Clarke, representing patients who has had knee surgery
• Ms Velga Mcdougall, representing patients waiting for knee surgery

Clinical representative/s

• Mr Luke Farrow, Clinical Research Fellow, Aberdeen University; Senior Speciality Registrar in Trauma & Orthopaedics, NHS Grampian
• Mr Jeremy Latham, Consultant Hip Surgeon, Nuffield Health Wessex Hospital
• Mr Andrew Porteous, Lead Knee Surgeon, North Bristol NHS Trust
• Dr Rokhsaneh Tehrany, Therapies Research Lead, Royal National Orthopaedic Hospital
• Dr David McDonald, MBE, clinical specialist orthopaedic physiotherapist, NHS Golden Jubilee National Hospital, Glasgow
• Professor Sandy Jack, Professor of Prehabilitation Medicine and Honorary Consultant Clinician Scientist, Southampton Biomedical Research Centre
• Dr Mary McCallum, Consultant Health Psychologist, NHS Grampian
• Professor Mehool Acharya, Clinical Professor in Orthopaedic Surgery
• Ms Lola Norman, Lead Inpatient Occupational Therapist, Royal National Orthopaedic Hospital
• Mr Benjamin Bolland, Consultant Orthopaedic Surgeon, Somerset NHS Foundation Trust, Beyond Compliance Advisory Board member

Project coordinator

• Ms Emma Stage, Research Assistant, Robert Gordon University

James Lind Alliance Adviser and Chair of the Steering Group

• Dr Jonathan Gower, Adviser, James Lind Alliance

Charity representative

• Mr Evert Smith, Consultant Orthopaedic Surgeon, Director, Arthroplasty for Arthritis Charity

The study team

• Dr Joanna Shim, Chancellor’s Fellow, Robert Gordon University
• Dr Luke Farrow, Clinical Research Fellow, Aberdeen University; Senior Speciality Registrar in Trauma & Orthopaedics, NHS Grampian
• Dr Lyndsay Alexander, Associate Professor in Applied Health Research, Robert Gordon University
• Dr Paul Swinton, Associate Professor in Applied Statistics, Robert Gordon University
• Professor Sandy Jack, Professor of Prehabilitation Medicine and Honorary Consultant Clinician Scientist, Southampton Biomedical Research Centre

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 undergone hip or knee replacement surgery or are waiting for a hip or knee surgery and the groups/organisations that represent them
• carers of people who have had a family member who had undergone hip or knee replacement surgery or are waiting for a hip or knee replacement surgery
• health and social care professionals with clinical experience of managing osteoarthritis or are involved in the care and delivery of hip and knee replacement surgery.

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.

JLA Lab

The aim is to complete the PSP in a shorter time frame than is usual for PSPs, which may add some limitations to the levels of engagement with stakeholders and add some risk to overall delivery and completion of the PSP.  For this reason, the JLA has agreed to support this PSP under the umbrella of its JLA Lab space (an experimental space where the JLA can test new ideas and methods). As part of the JLA’s learning, it will assess the outcomes and any perceived impact of the planned short time frame on the process and publish feedback on this on the JLA Lab section of its website.

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 Prehabilitation for Hip and Knee Replacement Surgery PSP. 

Step 2: Awareness raising 

PSPs will need to raise awareness of their proposed activity among their patient, carer and clinician communities, 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 Prehabilitation for Hip and Knee Replacement Surgery PSP will carry out a consultation to gather uncertainties from 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).  Figure 1 details the project activity timeline for this PSP.

This consultation process would involve survey development, distribution, and data collection. The Steering Group would first develop a survey to gather uncertainties. This survey would include open-ended questions to allow respondents to submit their own uncertainties about prehabilitation for hip and knee replacement surgery and be designed to be accessible and easy to understand for patients, carers, and clinicians. The survey would be distributed widely through various channels including patient support groups and charities related to arthritis and joint replacement, professional networks of clinicians involved in hip and knee replacement surgery, social media platforms, and PSP partner organisations' websites.

The Prehabilitation for Hip and Knee Replacement Surgery PSP recognises that the following groups may require additional consideration:

• Adults and carers from marginalised communities e.g., those from low socioeconomic backgrounds
• Older adults who might be digitally excluded
• Adults from ethnic minority backgrounds
• Adults living in rural or remote areas of the UK.

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

• Method 1: Develop online and paper surveys to ensure accessibility for those who may not have internet access or prefer to engage through non-digital technology.
• Method 2: Conduct face-to-face workshops or community meetings to engage with groups unlikely to access digital platforms.
• Method 3: Collaborate with local healthcare providers, community and third sector organisations (e.g., Versus Arthritis, Alliance) to distribute information and gather input.

Existing sources of evidence uncertainties may also be searched as appropriate. A systematic search of the databases, including MEDLINE, CINAHL, EMBase, the Cochrane Database of Systematic Reviews, and JBI Evidence Synthesis, may be conducted to identify additional uncertainties relating to services for patients undergoing hip and knee replacement surgery and carers, and for clinicians. Clinical guidelines such as NICE, SIGN, and relevant Royal Colleges’ guidance and protocols for systematic reviews being prepared, and registers of ongoing research (ClinicalTrials.gov, ISRCTN Registry, EU-CTR European Union Clinical Trials Registry) may also be searched. To supplement the survey, the PSP might also conduct focus groups or interviews with patients and carers and analyse patient helpline inquiries related to the topic, if appropriate.

Step 4: Refining questions and uncertainties

Over the 3-month period, respondents would submit their ‘raw’ questions and comments indicating patients’, carers’ and clinicians’ areas of uncertainty. The Steering Group will monitor responses and may extend the survey period if needed to ensure adequate participation. These raw questions will be categorised and refined by Joanna Shim supported by the study team 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 Joanna Shim and agreed by the Steering Group. 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 Joanna Shim and the coordinator (to be appointed) with agreement from the Steering Group. 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 Prehabilitation for Hip and Knee Replacement Surgery. 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 the Steering Group. 

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 Prehabilitation for Hip and Knee Replacement Surgery PSP Steering Group agreed the content and direction of this Protocol on the 15^th of October 2024.