Women’s Cardiovascular Health and Cardiac Rehabilitation PSP protocol

  • Published: 11 May 2023
  • Version: V5
  • 11 min read

Purpose of the PSP and background

The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Women’s Cardiovascular Health and Cardiac Rehabilitation Priority Setting Partnership (PSP) in line with James Lind Alliance (JLA) principles. The Protocol is a JLA requirement and will be published on the PSPs 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 people with lived experience (including family and friends) 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 people with lived experience 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 Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton.

The PSP is co-led by: Dr. Tracey Colella, a clinician and scientist focused on women’s heart health and cardiac rehabilitation. She has an established network of patients, potential partner organisations and experienced in successfully organizing provincial and national meetings. Dr. Jennifer Bethell is an epidemiologist with an interest in patient engagement. She has previously led and conducted two PSPs in Canada (dementia and frailty) using the JLA approach. PSP coordinator, Racquel Brown is a Masters’ trainee in the Rehabilitation Sciences program at the University of Toronto under co-supervision Drs. Colella and Bethell. She will manage all aspects of the project, carried out as her Masters’ thesis including submission to the Research Ethics Board at the University of Toronto.

Aims, objectives and scope of the PSP

The aim of the Women’s Cardiovascular Health and Cardiac Rehabilitation PSP is to identify the unanswered questions about women’s cardiovascular health and cardiac rehabilitation from people with lived experience and clinical perspectives and then prioritise those that people with lived experience and clinicians agree are the most important for research to address.

The objectives of the PSP are to:

  • work with people with lived experience and clinicians to identify uncertainties about cardiac rehabilitation in the context of women’s cardiovascular health in Canada
  • 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 Women’s Cardiovascular Health and Cardiac Rehabilitation PSP is defined as:

  • Adult women (>age 18 yrs) that have experience with
  • Cardiovascular condition(s):
    • Arrhythmia/irregular heartbeat (e.g., atrial fibrillation)
    • Coronary artery disease (CAD) (e.g., angina, myocardial infarction/heart attack)
    • Valvular heart disease (VHD) (e.g., aortic, mitral or tricuspid valve disease)
    • Heart failure
    • Stroke
    • Other
  • Cardiac procedure(s)
    • Percutaneous intervention (e.g., angioplasty or stent)
    • Coronary artery bypass surgery (CABG)
    • Valve replacement or repair
    • Pacemaker or implantable cardioverter defibrillator (ICD)
    • Other

The PSP will exclude from its scope questions about:

  • Aspects of women’s health unrelated to cardiac rehabilitation
  • Primary prevention
  • Biomedical research (i.e., biological mechanisms of heart 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 people with lived experience and clinicians , as individuals or representatives from a relevant group.

The Women’s Cardiovascular Health and Cardiac Rehabilitation PSP will be led and managed by a Steering Group involving the following:

Chair

Tamara Rader, Patient Engagement Officer, JLA Adviser and Chair of the Steering Group

Patient, carer and lived experience representatives:

  • Karen Minden, Toronto, Ontario
  • Elizabeth Pease, Saskatoon, Saskatchewan
  • Louise Walker, Regina, Saskatchewan
  • Bethany Lezama, Nova Scotia, Halifax

Clinician/clinician researcher and knowledge user representatives:

  • Paul Oh, Medical Director, Cardiac Rehabilitation and Secondary Prevention Program, Toronto Rehabilitation Institute – University Health Network
  • Sharon Mulvagh, Cardiologist and Professor of Medicine, Dalhousie University; Professor Emeritus of Cardiovascular Medicine, Mayo Clinic
  • Monica Parry, Nurse Practitioner and Associate Professor, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto
  • Marilyn MacKay-Lyons, Physiotherapist and Professor, School of Physiotherapy, Dalhousie University
  • Kerri-Anne Mullen, Director of Canadian Women’s Heart Health Centre & Prevention and Wellness Centre, and Scientist, University of Ottawa
  • Heather Foulds, Heart & Stroke/CIHR Indigenous Early Career Women’s Heart and Brain Health Chair and Co-Scientific Director of aen mamawii kiiayaahk (Healing Together) Metis Health and Wellness Research Network, and Associate Professor, University of Saskatchewan
  • Mireille Landry, Physiotherapist and Exercise Coordinator, Women’s Cardiovascular Health Initiative Cardiac Rehabilitation, Women’s College Hospital; Lecturer, University of Toronto
  • Jennifer Harris, Physiotherapist and Regional Manager of CVD Prevention and Rehabilitation Outreach, University of Ottawa Heart Institute
  • Lisa Cotie, Kinesiologist, High Performance Specialist and Scientific Associate, University Health Network/ Toronto Rehabilitation Cardiovascular Prevention & Rehabilitation Program
  • Patrice Lindsay, Director of Health Systems Change, Heart and Stroke Foundation of Canada

PSP

  • Tracey Colella – PSP Lead, Research Scientist and Clinician, KITE Research Institute, Toronto Rehabilitation Institute – University Health Network
  • Jennifer Bethell – PSP Lead, Affiliate Scientist, KITE Research Institute, Toronto Rehabilitation Institute –University of Health Network
  • Racquel Brown – PSP coordinator, MSc Trainee, Rehabilitation Sciences Institute, KITE Research Institute, Toronto Rehabilitation Institute – University Health Network

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:

  • Women with lived experience of cardiovascular condition(s) and/or procedure(s)
  • Family, friends, and caregivers of women with lived experience of cardiovascular condition(s) and/or procedure(s)
  • Clinicians involved in the care of women who have experienced cardiovascular condition(s) and/or procedure(s)

The following groups have already committed to partnership with Women’s Cardiovascular Health and Cardiac Rehabilitation PSP:

  • Heart and Stroke Foundation of Canada
  • Canadian Association of Cardiovascular Prevention and Rehabilitation
  • Canadian Women’s Heart Health Alliance

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 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 Women’s Heart Health and Cardiac Rehabilitation PSP.

Step 2: Awareness raising

PSPs will need to raise awareness of their proposed activity among their people with lived experience 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 Women’s Cardiovascular Health and Cardiac Rehabilitation PSP will carry out a consultation to gather uncertainties from people with lived experience and clinicians. A period of 3-4 months will be given to complete this exercise (which may be revised by the Steering Group if required).

The Women’s Heart Health and Cardiac Rehabilitation PSP recognises that certain groups may be limited by factors such as internet access, language (ability to respond in English) or opportunities to respond to surveys.

The Steering Group will use the following methods to reach out to potential participants:

  • Partnering with organizations with diversity mandates
  • Leveraging partnerships to access populations (e.g., rural and remote)
  • Tracking and monitoring response data demographics to describe the responses and target outreach
  • Offering postage-paid paper surveys if technology is not readily available to some groups
  • Translating surveys to French
  • Stratifying long and short list priorities to ensure priorities of different groups are considered

Existing sources of evidence uncertainties may also be searched. These can include question-answering services for people with lived experience and for clinicians; research recommendations in systematic reviews and clinical guidelines; protocols for systematic reviews being prepared and registers of ongoing research.

Step 4: Refining questions and uncertainties

The consultation process will produce ‘raw’ questions and comments indicating people with lived experience and clinicians’ areas of uncertainty. These raw questions will be categorised and refined by Racquel Brown and Dr. Jennifer Bethell 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 Racquel Brown and Dr. Jennifer Bethell. 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 Racquel Brown and Dr. Jennifer Bethell. 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 Women’s Cardiovascular Health and Cardiac Rehabilitation PSP. This will involve input from people with lived experience 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 people with lived experience 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 people with lived experience 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 people with lived experience 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. Colella, Dr. Bethell and Racquel Brown.

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 Women’s Cardiovascular Health and Cardiac Rehabilitation PSP Steering Group agreed the content and direction of this Protocol on April 18, 2023.