Problematic Hip Replacement PSP Protocol

Purpose of the PSP and background

This purpose of this protocol is to set out the aims, objectives and commitments of the Problematic Hip Replacement Priority Setting Partnership (PSP) in line with the James Lind Alliance (JLA) principles. We include the basic roles and responsibilities of the partners therein. The Steering Group will review the protocol regularly and updated versions will be sent to the JLA.

The JLA is a non-profit making initiative and is funded by the National Institute of Health Research (NIHR). It was established in 2004 and is part of the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC). It aims to help patients, carers and clinicians work together and form Priority Setting Partnerships (PSPs) in order to reach a consensus on the most important treatment uncertainties in their particular area of interest. These “known unknowns” about the effects of treatments are identified and ranked such that future research and its funding can be prioritised to answer these uncertainties.

The National Joint Registry (NJR) shows a trend of increasing numbers of total hip replacements being performed in the UK annually. In the majority of cases, a hip replacement is a successful procedure that improves a patient’s joint pain, quality of life and functional activity. Over time such replacements may become problematic for a variety of reasons causing patients to experience further pain, swelling, stiffness or instability. This can, in turn, limit patients by reducing their ability to perform desired activities. In many cases it can lead to the need for revision surgery.

This PSP focusses on patients with problematic hip replacements. Patients experiencing problems after hip replacement may present to primary or secondary care for assessment. Further management may involve non-operative treatments such as pain relief medications, physiotherapy and rehabilitation or operative treatments such as debridement, removal of part of or all of the original implants and replacement with new ones. These re-replacement procedures are termed revision hip replacements and approximately 62,300 such surgeries have been performed in the UK between 2013 and 2019 (17th NJR Annual Report). There is a paucity of high level evidence (such as well-designed trials) regarding the assessment, management and rehabilitation of this group of patients. This lack of information leaves patients, carers and clinicians faced with uncertainties regarding the best way to move forward. We will identify key research questions to help address these uncertainties.

Aims and objectives

The aim of the Problematic Hip Replacement PSP is to identify the unanswered questions about the assessment, management or rehabilitation of patients with problematic hip replacements, from patient and clinical perspectives and then prioritise those that patients and clinicians agree are the most important.

The objectives of the Problematic Hip Replacement PSP are:

• To work with patients and clinicians to identify uncertainties about the assessment, management and rehabilitation of patients with problematic hip replacements
• 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.

Scope

The scope of this PSP will cover patients who have problems after hip replacement from the point they experience problems with that joint, through the assessment and management stages (encompassing investigation, decision making and both operative and non-operative treatments) and the rehabilitation stage. We will exclude uncertainties relating to prevention of problems with primary hip replacements.

Exclusion criteria

After extensive discussion within the Steering Group in a formal meeting, it was decided that we would exclude uncertainties related to revision hip surgery outside the UK, although evidence from around the world will be reviewed and considered where it adequately addresses unanswered questions. Uncertainties regarding prevention of problems with primary hip replacements would also be excluded.

Some organisations may be judged by the JLA or the Steering Group to have conflicts of interest. These may be perceived to adversely affect those organisations’ views, causing unacceptable bias. 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 Steering Group

The Problematic Hip Replacement PSP will be led and managed by the following:

Project Lead:

Professor Tim Board, Consultant Orthopaedic Surgeon, Wrightington Hospital

Project Co-ordinator:

Asim Khan, Consultant Orthopaedic Surgeon at the Golden Jubilee Hospital, Clydebank, Glasgow

Administrative support:

Liz Newton, Wrightington

Patient representative/s:

Dr Cat Ball, Head of Policy, Association of Medical Research Charities, ORUK Trustee
Professor Jerri Daboo, Patient
Frank O’Brien, Patient
Allan Harle, Patient

Clinical representative/s:

Surgeons:

Hiren Divecha, Surgeon, Wrightington
Mike Reed, Surgeon, Northumbria
Vikas Khanduja, Surgeon, Cambridge
Jason Webb, Surgeon, Bristol
Mike Whitehouse, Surgeon, Bristol
Henry Wynn Jones, Surgeon Wrightington

Allied Health Professionals:

Sarah Briggs, Physiotherapist, Wrightington
Jo Clarke, Arthroplasty Practitioner, Wrightington
Professor Becky Kearney, Associate Director of Warwick Clinical Trials Unit, Warwick
Justine Theaker, Research Physiotherapist, Manchester

The Steering Group will be assisted by the following:

Trainees:

Jonathan Lamb, Research Fellow, Leeds
Tony Sorial, Research Fellow, Newcastle

Allied Health Professional:

Justine Theaker, Research Physiotherapist, Manchester

The Partnership and the priority setting process will be supported and guided by:

Tricia Ellis, Adviser, The James Lind Alliance (JLA)
Kristina Staley, Independent Information Specialist, TwoCan Associates

The Steering Group will agree the resources, including time and expertise that they will be able to contribute to each stage of the process. The JLA will advise on this.

The Wider Partners

Organisations and individuals will be invited to be involved with the PSP as partners. Partners are groups or individuals who will commit to supporting the PSP by disseminating the PSP survey and helping the PSP to gather questions and uncertainties of practical clinical importance relating to the treatment and management of the health problem in question.

Partners represent the following groups:

• People who have had problematic hip replacements
• Carers of people who have had problematic hip replacements
• Medical doctors, nurses and professionals allied to medicine with clinical experience of problematic hip replacements

It is important that all organisations which can reach and advocate for these groups should be invited to become involved in the PSP. The JLA will take responsibility for ensuring the various stakeholder groups are able to participate equally in the process.

Methods

This section describes a schedule of proposed stages through which the PSP aims to fulfil its objectives. The process is iterative and dependent on the active participation and contribution of different groups. The methods adopted in any stage will be agreed through consultation between the Steering Group members, guided by the PSP’s aims and objectives. More details can be found in the Guidebook section of the JLA website at www.jla.nihr.ac.uk where examples of the work of other JLA PSPs can also 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 and through the JLA's existing register of affiliates. Potential partners will be contacted and informed of the establishment and aims of the Problematic Hip Replacement PSP and may be invited to attend and participate in an initial stakeholder meeting if this is being arranged.

Step 2: Initial Meeting

The initial meeting will have several key objectives:

• to welcome and introduce potential members of the Problematic Hip PSP
• to present the proposed plan for the PSP
• to initiate discussion, answer questions and address concerns
• to identify those potential partner organisations which will commit to the PSP and identify individuals who will be those organisations' representatives and the PSP's principal contacts
• to establish principles upon which an open, inclusive and transparent mechanism can be based for contributing to, reporting and recording the work and progress of the PSP

The administrative process for convening this meeting will be managed by the Steering Group, supported by Asim Khan and Liz Newton in coordination with the JLA.

Step 3: Identifying treatment uncertainties

Each partner will identify a method for soliciting from its members’ questions and uncertainties of practical clinical importance relating to the treatment and management of problematic hip replacements.

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 face to face or virtual membership meetings, email consultation, postal or web-based questionnaires, internet message boards and focus group work.

Existing sources of information about treatment uncertainties for patients and clinicians will be searched. In due course, these existing sources of information will be named in later versions of the protocol. These can include 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. The starting point for identifying sources of uncertainties and research recommendations is NHS Evidence: www.evidence.nhs.uk.

Step 4: Refining questions and uncertainties

The consultation process will produce “raw” unanswered questions about diagnosis and the effects of treatments. These raw questions will be assembled and categorised and refined by the independent information specialist into “collated indicative questions” which are clear, addressable by research and understandable to all. Similar or duplicate questions will be combined where appropriate.

Systematic reviews and guidelines will be identified and checked by Jonathan Lamb (Leeds) and Tony Sorial (Newcastle) to see to what extent these refined questions have, or have not, been answered by previous research. This process will involve double screening/reviewing by other members of the group (including Asim Khan, Becky Kearney, Justine Theaker and Hiren Divecha) depending on number of results. A search specialist from the University of Leeds will aid the development of a search strategy to identify:

• Relevant systematic reviews, randomised controlled trials (RCTs) and guidelines from databases including Medline, Embase, Cochrane and CINAHL.

Expert advice will also be taken to check if any of the long list summary questions have been answered by any published research that is lower level than systematic review or randomised controlled trial.

Uncertainties which are not adequately addressed by previous research will be collated and recorded on a template (supplied by the JLA) by Asim Khan and brought to the pre-interim prioritisation meeting. This will demonstrate the checking undertaken to make sure that the uncertainties have not already been answered. This is the responsibility of the Steering Group, which will need to have agreed personnel and resources to carry this accountability. 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.

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 relating to the treatment or management of Problematic Hip Replacement. This will be carried out by members of the Steering Group and the wider partnership that represents patients and clinicians.

The interim stage, to proceed from a long list of uncertainties to a shorter list to be discussed at the final priority setting workshop (e.g. up to 30), may be carried out over email or online video communication, whereby organisations consult their membership and choose and rank their top 10 most important uncertainties. Each ranked uncertainty will be given a score (1st rank to be given 10 points, 2nd rank to be given 9 points and so on) – cumulative points for each submission will be calculated, thus giving an overall interim ranking.

The final stage, to reach, for example, 10 prioritised uncertainties, is to be conducted in a virtual online workshop, using group discussions and plenary sessions. At the final workshop, it will be the individuals involved who will reach a consensus (with or without a vote) on the top 10 priorities.

The JLA will facilitate this process and ensure transparency, accountability and fairness. Participants will be expected to declare their interests in advance of this meeting.

To recruit for these stages, all steering groups will approach their contacts locally and nationally. In addition, Asim Khan will email out to all respondents from the initial survey who expressed an interest in being involved in latter stages of the project. The steering group members will contact the wider partners including:

AFPP (The Association for Perioperative Practice), ACPA (Arthroplasty Care Practitioner's Association), MACP (Musculoskeletal Association of Chartered Physiotherapists), ATOCP (Association of Trauma and Orthopaedic Chartered Physiotherapists), BHS (British Hip Society), BOA (British Orthopaedic Association), BOTA (British Orthopaedic Trainee Association), Royal College of Anaesthetists, Royal College of General Practitioners, Royal College of Nursing Society of T&O, Royal College of Occupational Therapists, Royal College of Surgeons, Patient and Public Involvement groups, INVOLVE (UK’s leading public participation charity), National Voices, Pain Concern, ARMA (Arthritis and Musculoskeletal Alliance), Association of Medical Research Charities, BAPO (British Association of Prosthetists and Orthotists), Versus Arthritis, and ORUK (Orthopaedic Research UK).

Dissemination of findings and research

It is anticipated that the findings of the Problematic Hip Replacement PSP will be reported to funding and research agenda setting organisations such as the NIHR and the major research funding charities. Steering Group members and partners are expected to develop the prioritised uncertainties into research questions, and to work to establish the research needs of those unanswered questions to use when approaching potential funders, or when allocating funding for research themselves, if applicable.

Publicity

As well as alerting funders, partners and Steering Group members are encouraged to publish the findings of Problematic Hip Replacement PSP using both internal and external communication mechanisms. The Steering Group may capture and publicise the results through descriptive reports of the process itself in Plain English. This exercise will be distinct from the production of an academic paper, which the partners are also encouraged to do. However, production of an academic paper should not take precedence over publicising of the final results.

Agreement of the Steering Group

Agreed by the Problematic Hip Replacement PSP Steering group members on 30/09/2021.