Skin Cancer 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 Skin 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 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.
Skin surgery is essential as the primary form of skin cancer treatment in most cases. To date, no previous PSP has been undertaken on the topic of skin cancer surgery. Many previously reported trials in skin cancer surgery are of poor quality, under powered or have high risk of bias which has left many gaps in the literature regarding best practice.
The plan for this PSP was put forward by Dr Aaron Wernham and Dr David Veitch as an idea for the UK Dermatology Clinical Trials Network (UKDCTN) themed call 2019 funding award. This work will help to focus and prioritise future research efforts related to this topic in order to improve patient outcomes for those being treated for skin cancer.
Following presentation of the PSP strategy, the initiative was supported and funded by the UKDCTN steering committee and British Society of Dermatological Surgery.
Aims, objectives and scope of the PSP
The aim of the Skin Cancer Surgery PSP is to identify the unanswered questions about surgery for skin cancer 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 skin cancer surgery (including consent, local and general anaesthesia, steps of the surgery to remove the cancer, wound care, aftercare instructions, repeat surgery for incomplete skin cancer removal and different types of skin surgery procedures).
- 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 Skin Cancer Surgery PSP is defined as:
- Uncertainties relevant to skin cancer surgery for all types of suspected primary skin cancer.
- Uncertainties relevant to surgery for local and regional skin cancer recurrence.
- Uncertainties related to service delivery or the patient pathway / multi-disciplinary teams (MDTs) which result in delivering skin cancer surgery.
- Examples include anything related to the consent, anaesthesia, antibiotics, variations in the procedure, scar outcomes, wound care, follow-up related to scar outcome or surgical outcome.
The PSP will exclude from its scope questions about:
- All other types of surgery not relevant to skin cancer surgery.
- Uncertainties relevant to removal of benign lesions only or cosmetic skin procedures.
- Uncertainties solely related to other treatment modalities for skin cancer e.g. Radiotherapy or Laser unless as a comparison to surgery.
- Uncertainties related to prevention of skin cancer, monitoring for recurrence not relevant to the surgical technique, service delivery and service management questions not relevant to surgery for skin cancer.
- Uncertainties related specifically to skin cancer in the paediatric population <18 years old.
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 Skin Cancer Surgery PSP will be led and managed by a Steering Group involving the following:
Patient and carer representative/s:
Dr Matthew Helbert
Dr Aaron Wernham, Consultant Dermatologist, Walsall Healthcare NHS Trust / Worcestershire Acute Hospitals NHS Trust.
Dr David Veitch, Post-CCT Mohs Fellow, Nottingham University Hospitals NHS Trust
Dr Rachel Abbott, Consultant Dermatologist, Cardiff and the Vale Health Board.
Dr Jonathan Batchelor, Consultant Dermatologist, Beckenham / University of Nottingham
Dr Claudia Degiovanni, Consultant Dermatologist Brighton and Sussex University Hospitals NHS Trust
Mr Jonathan Pollock, Consultant Plastic Surgeon, Nottingham University Hospitals
Mr Jeremy Rodrigues Consultant Plastic Surgeon, Stoke Mandeville Hospital
Ms Carrie Newlands – Maxillofacial surgeon, Royal Surrey County hospital
Carrie Wingfield – Nurse Consultant in Dermatology, Norfolk & Norwich University foundation Hospital
Dr Angelika Razzaque – Executive chair of the Primary Care Dermatology Society and GP in South East London.
Mr David Snow, Consultant ENT Surgeon, Wrexham Maelor Hospital
Diane Thompson, Skin Cancer Nurse Specialist, North West Anglia NHS Foundation Trust
Non-steering Committee members / Data analysis team:
Dr Stela Ziaj - Post CCT Mohs fellow, Oxford University Hospitals NHS Trust
Dr Alistair Brown - Senior Registrar in Dermatology, South West.
Eleanor Earp – Registrar in Edinbugh and current UKDCTN fellow
Project coordinator: Maggie Mcphee
Information Specialist advisor: Douglas Grindlay
James Lind Alliance Adviser and Chair of the Steering Group: Suzannah Kinsella
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.
Organisations and individuals will be invited to be involved with the PSP. 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 surgery for skin cancer
carers of people who have had surgery for skin cancer
health and social care professionals - with experience of managing skin cancer
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 Skin Cancer 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 Skin Cancer Surgery PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of 5 months will be given to complete this exercise (which may be revised by the Steering Group if required).
The Steering Group will use the following methods to reach the target groups:
- Paper surveys
- Online surveys
- Promotion in the clinic setting / dermatology outpatient units
- Promotion on social media
- Promotion via skin cancer charities
- Qualitative interviews with patients who have undergone skin cancer surgery.
Existing sources of evidence uncertainties may also be searched.
- BAD, NICE and SIGN guideline recommendations
- Research recommendations in systematic reviews relevant to skin surgery
- 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 Dr Stela Ziaj, Dr Alistair Brown, Dr Eleanor Earp, Dr Aaron Wernham, Dr David Veitch and Dr Claudia Degiovanni 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 Dr Aaron Wernham, Dr David Veitch, Dr Alistair Brown, Dr Eleanor Earp and Dr Stela Ziaj. 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 Dr Aaron Wernham, Dr David Veitch, Dr Alistair Brown and Dr Stela Ziaj. 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 skin cancer 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.
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.
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 Dr Aaron Wernham and Dr David Veitch.
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 email@example.com.
Agreement of the Steering Group
The Skin Cancer Surgery PSP Steering Group agreed the content and direction of this Protocol 20th October 2020.