Purpose of the PSP and background
The purpose of this protocol is to set out the aims, objectives and commitments of the Postmastectomy Breast Reconstruction (PMBR) Priority Setting Partnership (PSP) and the basic roles and responsibilities of the partners therein. It is recommended that the Protocol is reviewed by the Steering Group and updated on at least a quarterly basis.
The James Lind Alliance (JLA) is a non-profit making initiative, established in 2004. It brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs). These partnerships identify and prioritise uncertainties, or ‘unanswered questions’, about the effects of treatments that they agree are the most important. The aim of this is to help ensure that those who fund health research are aware of what really matters to both patients and clinicians. The National Institute for Health and Care Research (NIHR – www.nihr.ac.uk)
funds the infrastructure of the JLA to oversee the processes for priority setting partnerships, based at the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton.
Background to the Postmastectomy Breast Reconstruction 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 the effects of treatment.
The Postmastectomy Breast Reconstruction Priority Setting Partnership is part of larger initiative to develop a National research consortium on postmastectomy breast reconstruction. The funding for the start-up of the consortium has been provided through the Canadian Institutes of Health Research (CIHR) foundation scheme grant. Dr Toni Zhong is the recipient of this award and will lead the consortium and the PMBR PSP. The Consortium will act as an expert multi-disciplinary working group which includes general and reconstructive surgeons, patients and cancer support agencies. The primary goal of the consortium is to promote an integrated research effort across the country to improve knowledge of and access to breast reconstruction postmastectomy. The JLA priority setting process plays an integral role in identifying areas of patient-centred research which have not been fully explored.
Aims and objectives of the PMBR PSP
The aim of the Postmastectomy Breast Reconstruction (PMBR) PSP is to identify the unanswered questions about PMBR treatment from patient and clinical perspectives and then prioritise those that patients and clinicians agree are the most important. The PMBR PSP is part of a National Quality Improvement program in postmastectomy breast reconstruction that will optimize the patient-centred experience and address key quality of life and survivorship issues for breast cancer patients.
The objectives of the PMBR PSP are to:
- work with patients and clinicians to identify uncertainties about the effects of postmastectomy breast reconstruction surgeries
- 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 includes:
Postmastectomy Breast Reconstruction- immediate and delayed
Including: Prophylactic & therapeutic mastectomy
Excluding:
- Plastics procedures for lumpectomy
- Male mastectomy
- Other malignancies for mastectomy (i.e. sarcoma)
- Chest wall reconstruction
- Patients with metastatic breast cancer
All stages of the postmastectomy breast reconstruction process including:
1. Mastectomy Surgery Consultation (includes prophylactic mastectomy)
a. Information or resources on BR
i. Access to information or resources
- educators, system navigators, peer to peer counselling, videos, print or website material
ii. Content of information
- Video, vs. print material, importance of Canadian content vs. decision aid, information sessions like BRA day
b. Access to consultation on BR
i. Includes communication between physicians (family physician, oncologist, radiation oncologist, general surgeons and plastic surgeons) and patient
ii. Accurate information on what plastic surgeons who perform breast reconstruction (i.e. Who the patients should be referred to)
2. Breast reconstruction surgery consultation
a. Personal decision making process
i. Access to information on BR
- What type of information (content, quantity, format)
- Method of information delivery (who should deliver it, how to deliver)
ii. Type of reconstruction
iii. Timing of reconstruction
iv. Psychosocial considerations
- Emotional, social, spiritual
- Lifestyle/personal issues (family, work, sexuality)
- Family concerns and fears
- Financial impact
- Long term outcomes (cancer recurrence, future treatments, other illnesses)
3. Waiting period for surgery
a. Wait times (delayed reconstruction)
b. Wait times (prophylactic)
c. support services while waiting for delayed breast reconstruction (e.g. workshops, physical(referrals to PT, OT), emotional services (counselling, peer support), financial services/counselling )
4. Surgery
a. Surgical techniques that can consistently yield high satisfaction (if not in every patient, in certain patient subgroups)
b. Surgical techniques that results in least complications or reoperations
5. Post-Surgical Recovery
a) Use of Ancillary therapies (e.g. PT, massage, acupuncture)
b) Short term Recovery
- Coordination of care and resources (home)
- Pain Management
- Wound management
- Mobility management
- Complications
- Length of hospital stay
c) Long-term Recovery
- Pain management
- Mobility management
- Long-term complications
- Reoperations
d) Long term results
- Breast cancer recurrence
- Surveillance
- Patient reported outcomes and psychosocial outcomes
The Steering Group
The PMBR PSP will be led and managed by the following:
Patient/care giver representatives:
- Dawn Eagleson, Patient
- Jamie Mezzapelli, Patient
- Catherine Painvin, Patient
- David Pawlik, Patient caregiver
- Susan Schendel, Patient
- Maggie Easton, Patient
- Natalie Witkin, Canadian Breast Cancer Foundation
- Cathy Ammendolea, Canadian Breast Cancer Network
Clinical representatives:
- Dr Toni Zhong (Lead), University Health Network (Toronto, ON)
- Dr Martin LeBlanc, QEII Health Sciences Centre (Halifax, NS)
- Dr Geoff Porter, QEII Health Sciences Centre (Halifax, NS) & Canadian Partnership Against Cancer
- Dr Amanda Roberts, University of Ottawa (Ottawa, ON)
- Dr Claire Temple-Oberle, Tom Baker Cancer Centre (Calgary, AB)
- Agnes Wisniewski, Clinical Nurse Coordinator University Health Network (Toronto, ON)
- Dr Perry Gdalevitch, Hospital Saint- Eustache (Montreal, QC)
The Partnership and the priority setting process will be supported and guided by:
- The James Lind Alliance (JLA)
Katherine Cowan
The Steering Group includes representation of patient/carer groups and clinicians.
The Steering Group will agree to 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:
- Women who have had breast cancer requiring mastectomy
- Women who have had prophylactic mastectomy
- Women who are genetically pre-disposed to an increased risk of breast cancer (BRCA 1 or 2)
- Carers of women who have had breast cancer requiring mastectomy or are hereditarily predisposed to an increased risk of breast cancer (BRCA 1 or 2)
- Medical doctors, nurses and allied health professionals with clinical experience of breast cancer requiring mastectomy
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 Adviser will take responsibility for ensuring the various stakeholder groups are able to contribute equally to the process.
Exclusion criteria
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 methods the PSP will use
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. Potential partners will be contacted and informed of the establishment and aims of the Postmastectomy Breast Reconstruction PSP.
Step 2: Initial stakeholder awareness meeting
This CIHR funded National Breast Reconstruction research consortium met on April 15, 2016.
During the meeting the consortium achieved four core objectives:
- Formalize the CIHR funded PMBR consortium
- Provide an overview of the current national landscape of breast reconstruction in Canada
- Initiate discussions towards developing a National knowledge translation and exchange plan for PMBR which incorporates patient perspectives and input.
- Introduce the James Lind Alliance Priority Setting Process and agree to:
(a) Proceed with the process of identifying the top 10 research priorities for PMBR
(b) Form a Steering Group
The steering group will continue to build on the last objective by:
- Identifying 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
- Establishing 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.
Step 3: Identifying treatment uncertainties
Each partner will identify a method for soliciting from its member’s questions and uncertainties of practical clinical importance relating to the treatment and management of postmastectomy breast reconstruction. A period of approximately 3 months will be given to complete this exercise.
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 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. 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 Steering Group will hire an external, temporary data manager for this portion of the process. The JLA will participate in this process as an observer, to ensure accountability and transparency.
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 an information specialist hired specifically for this process 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 the information specialist to see to what extent these refined questions have, or have not, been answered by previous research. Sometimes, uncertainties are expressed that can in fact be resolved with reference to existing research evidence - i.e. they are unrecognised knowns" and not uncertainties. If a question about treatment effects can be answered with existing information but this is not known, it suggests that information is not being communicated effectively to those who need it. Accordingly, the JLA recommends strongly that PSPs keep a record of these 'answerable questions' and deal with them separately from the 'true uncertainties' considered during the research priority
setting process.
Uncertainties which are not adequately addressed by previous research will be collated and recorded on a template supplied by the JLA by the information specialist. 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 postmastectomy breast reconstruction. 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, whereby organisations consult their membership and choose and rank their top 10 most important uncertainties. There are examples of how other PSPs have achieved this at www.jla.nihr.ac.uk in the Key Documents of the Anaesthesia and Perioperative Care PSP section and the Childhood Disability PSP section.
- The final stage, to reach, for example, 10 prioritised uncertainties, is likely to be conducted in a face-toface meeting, using group discussions and plenary sessions.
- The methods used for this prioritisation process will be determined by consultation with the partner organisations and with the advice of the JLA Adviser. Methods which have been identified as potentially useful in this process include: adapted Delphi techniques; expert panels or nominal group techniques;consensus development conference; electronic nominal group and online voting; interactive research agenda setting and focus groups.
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.
Dissemination of findings and research
Findings and research
It is anticipated that the findings of the PMBR 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 the PMBR 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
Signed by the Steering Group
The steering group members have agreed to follow the PMBR Priority Setting Protocol as outlined above.
Toni Zhong
Lead, Postmastectomy Breast Reconstruction PSP
October 11, 2018