Purpose of the PSP and background
The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Breast Cancer 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 – 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.
Background to the Breast Cancer Surgery PSP
The JLA is a project which is overseen by the National Institute for Health and Care Research Evaluation, Trials and Studies Coordinating Centre (NETSCC). Its aim is to provide an infrastructure and process to help patients and clinicians work together to agree which are the most important treatment uncertainties affecting their particular interest, in order to influence the prioritisation of future research in that area. The JLA defines an uncertainty as a “known unknown” – in this case relating to all areas of diagnosis, treatment and survivorship where surgeons are involved.
The Academic and Research Committee (ARC) of the Association of Breast Surgery (ABS) aims to facilitate the Association’s objective of enhancing care and outcomes for patients with breast disease through the promotion and support of research and innovation. The ARC recently completed a breast cancer surgical gap analysis which evaluated some of the evidence uncertainties specific to breast surgery; this was largely through expert opinion from clinicians and researchers and has been published in Lancet Oncology (Cutress et al, Lancet Oncology 2018). However, to further develop the research portfolio and to identify, address and prioritise key areas of patient-centred research (which have not to date been fully explored), the ABS is supporting the Breast Surgery PSP.
Aims, objectives and scope of the PSP
The aim of the Breast Surgery PSP is to identify the unanswered questions in breast cancer, in the key areas for which breast surgeons have responsibility, from patient, carer and clinical perspectives and then to 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 within the surgical management pathways for men and women with breast disease
- 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 Breast Surgery PSP is defined as encompassing those aspects of breast cancer where breast surgeons have primary responsibility for clinical management, or where surgical input is critical to multi-disciplinary treatment. This includes:
- identification and management of people at increased risk of breast cancer
- assessment, diagnosis and primary treatment selection for men and women with breast cancer (both invasive and non-invasive)
- surgical techniques, technologies and devices, including oncoplastic and reconstructive breast cancer surgery, and their implementation and evaluation
- interactions between surgical treatments and neoadjuvant/adjuvant systemic and loco-regional therapies
- quality of life issues related to the surgical treatment of breast cancer
The PSP will exclude from its scope questions about:
- breast surgery that is purely aesthetic (but not symmetrising or revisional surgery after breast reconstruction)
- adjuvant therapies for breast cancer, both systemic (chemotherapy/hormonal therapy/targeted therapies) and loco-regional (radiotherapy)
preclinical or basic science research relating to breast disease - 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 Breast Cancer Surgery PSP will be led and managed by a Steering Group involving the following:
Patient and carer representative/s:
Sophia Turner, ICPV
Silvia Panico, Breast Cancer Now
Pat Fairbrother, ICPV
Ian Lewis, NCRI
Hilary Stobart, ICPV
Clinical representative/s:
Stuart McIntosh (Lead), Queen’s University Belfast
Ramsey Cutress, University of Southampton
Ranjeet Jeevan, Manchester University NHS Foundation Trust
Shelley Potter, University of Bristol
Tim Rattay, University of Leicester
Rachel O’Connell, Royal Marsden Hospitals NHS Trust
Chris Holcombe, University of Liverpool
Nigel Bundred, University of Manchester
Project coordinator:
Association of Breast Surgery Office
James Lind Alliance Adviser and Chair of the Steering Group:
Katherine Cowan
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 breast cancer requiring treatment
- those at high risk of breast cancer requiring surveillance or active risk management
- carers of people who have had breast cancer
- health and social care professionals (including surgeons and specialist breast care nurses) - with experience of clinical experience of the diagnosis and management of breast disease.
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 Breast Surgery 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 Breast Surgery PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of 6 months will be given to complete this exercise (which may be revised by the Steering Group if required).
The Breast Surgery PSP recognises that the following groups may require additional consideration.
- Male breast cancer patients
- Older patients with breast cancer
- Ethnic minorities
The Steering Group may use the following methods, as considered appropriate, to reach the target groups
- Web-based questionnaire
- Postal questionnaire
- Membership meetings
- Email consultation
- Focus group work
In the current climate resulting from COVID-19, the Steering Group recognise that some groups, particularly those with limited internet access, may be more challenging to reach; nevertheless, the methods above will be used to try and ensure broad representation from target groups wherever possible.
Existing sources of evidence uncertainties may also be searched. These may include the existing Association of Breast Surgery Gap Analysis (Cutress et al, Lancet Oncology 2018), Knowledge Gaps in Oncolplastic Breast Surgery (Weber et al, Lancet Oncology 2020), NICE guidance and NICE Research Recommendations, the Cochrane Database and relevant clinical guidelines published by appropriate professional organisations.
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 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, by the appointed information specialist. 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 appointed information specialist. 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 breast 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 Stuart McIntosh in conjunction with the Association of Breast Surgery Academic and Research Committee.
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 Breast Surgery PSP Steering Group agreed the content and direction of this Protocol on 14th December 2020.