Purpose of the PSP and background
The purpose of this protocol is to clearly set out the aims, objectives and commitments of the LGBTQIA+ Perinatal Care 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) coordinates the infrastructure of the JLA to oversee the processes for PSPs, based at the NIHR Coordinating Centre (NIHRCC), University of Southampton.
In 2023 a group of health professionals, researchers and LGBTQIA+ people/organisations came together to discuss the potential for a PSP related to the perinatal health, care and experiences of LGBTQIA+ people. A co-produced proposal was successful in securing funding for the project from the University of Oxford (Nuffield Department of Population Health Pump Priming fund and Knowledge Exchange Seed Fund), and from the British Academy’s BA/Leverhulme Small Research Grants Programme.
Aims, objectives and scope of the PSP
The aim of the LGBTQIA+ Perinatal Care PSP is to identify the unanswered questions about attempts by LGBTQIA+ people to conceive, and their experience and outcomes of pregnancy, birth and the postnatal period, from lived/living experience, supporter and health professional perspectives, and then prioritise those that people with lived/living experience, supporters and health professionals agree are the most important for research to address.
The objectives of the PSP are to:
- Work with people with lived and living experience, supporters and health professionals to identify uncertainties about identification of aspects of perinatal health, optimal care pathways and treatments that are specific to LGBTQIA+ people.
- 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 LGBTQIA+ Perinatal Care PSP is defined by the following principles:
- The in-scope health and care areas covered are fertility (attempts to conceive), pregnancy, perinatal loss (including pregnancy loss and baby loss), termination of pregnancy, birth and the twelve months following pregnancy, including lactation. Sexual health conditions that affect these areas are in scope (for example, HIV in pregnancy)
- Health encompasses physical, mental and psychosocial health
- Health systems for the outline areas are in scope, for example the barriers and facilitating factors of the health system for LGBTQIA+ people
- The in-scope LGBTQIA+ population are people who identify as, or have ever in the past identified as, lesbian, gay, bisexual, transgender, intersex, queer or other minority sexual orientation or gender identity. LGBTQIA+ people experiencing the health and care areas outlined above as a partner/co-parent are equally in scope as those who may become pregnant themselves
- In addition to the LGBTQIA+ population, the following people who are not LGBTQIA+ (or not known to be) are in scope where they are impacted by the parent/s’ LGBTQIA+ identity/status: infant/s, partners/co-parents who are not LGBTQIA+, gamete donors and gestational surrogates
The PSP will exclude from its scope questions about:
- Non-UK populations and health systems
- Health conditions in the twelve months following pregnancy that are not related to pregnancy, birth, lactation or early parenting
- Adoption where the child is older than twelve months, and therefore outside the perinatal period
- The impact of in-scope conditions, pathways of care or treatments on out-of-scope individuals
- Health conditions and care considerations specific to intersex infants (also known as infants with differences of sexual development)
- Sexual and reproductive health unrelated to attempts to conceive and pregnancy, birth or lactation (for example, contraception)
- Whether it is appropriate to attempt to change LGBTQIA+ people’s sexual orientation or gender identity (so called ‘conversion therapy’)
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/living experience and health professionals , as individuals or representatives from a relevant group. The LGBTQIA+ Perinatal Care PSP will be led and managed by a Steering Group involving the following (in alphabetical order within each section):
Lived/living experience representative/s (some of whom may also represent their professional experience if required for quoracy, but whose primary focus is their lived experience)
Alex Matheson, Director of Inclusion, LGBT Foundation
Ash Bainbridge (also a student midwife, Worcester University)
Eshe Kiama Zuri, Founder, UK Mutual Aid (also a doula)
Jacob Stokoe, Founder, Transparent Change
Laura-Rose Thorogood, Founder and CEO, LGBT Mummies [lead lived experience organisation]
Matthew Kitson
Clinical representative/s (some of whom may also represent their lived/living experience if required for quoracy, but whose primary focus is their professional experience)
Bunty Lai-Boyd, Academic midwife (Worcester University)
Dean Connolly, Public health doctor and Clinical fellow (Homerton Healthcare NHS Trust; and London School of Hygiene and Tropical Medicine)
Ilana Levene, Neonatal doctor and Visiting fellow (Oxford University Hospitals NHS Trust; and National Perinatal Epidemiology Unit, Oxford University)
Leena Maddock Khan, Obstetric doctor (Sherwood Forest Hospitals NHS Trust)
Natalie Boxall, Infant feeding specialist midwife (Sherwood Forest Hospitals NHS Trust)
Roisin Bailey, Academic midwife (Sandwell and West Birmingham NHS Trust; and Leicester University)
Sophie Lai-Boyd, Obstetric doctor
James Lind Alliance Adviser and Chair of the Steering Group
Caroline Magee
PSP Lead
Ilana Levene, Neonatal doctor and Visiting fellow (Oxford University Hospitals NHS Trust; and National Perinatal Epidemiology Unit, Oxford University)
PSP Coordinator (and lived/living experience representative)
Eshe Kiama Zuri, Founder, UK Mutual Aid
Academic members (who may also represent their lived/living experience4 if required for quoracy, and who have voting rights due to their lived/living experience, but whose primary focus is their professional experience)
Zoe Darwin, Reader in Health Research (University of Huddersfield)
Information Specialists (non-voting)
Catherine Meads [Information Specialist], Professor of Health (Anglia Ruskin University)
Mari Greenfield [Information Specialist], Researcher (The Open University)
Lead from University of Oxford (non-voting)
Jenny McLeish, Health Services Researcher, National Perinatal Epidemiology Unit, University of Oxford
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.
For transparency, we note that members in the lived/living experience section above are offered payment for their time. Where these members are individuals, they are offered the NIHR recommended rate, and childcare expenses. Where these members represent organisations, they are offered an individual payment rate mutually agreed according to their own organisational needs; thus one larger organisation has chosen to receive a lower rate than the other organisations. All of the lived/living experience organisations were involved equally and transparently in these arrangements. In addition the Information Specialists and Coordinator roles are offered payment according to JLA recommendations. No value judgement is associated with the specific payment offered to any steering group member.
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 are (or have in the past identified as) LGBTQIA+ and have experience of attempts to conceive, pregnancy, birth and/or the postnatal period
- Partners/co-parents, gamete donors, surrogates or children of LGBTQIA+ people who have had experience of attempts to conceive, pregnancy, birth and/or the postnatal period
- Health and social care professionals - with professional experience of LGBTQIA+ attempts to conceive, pregnancy, birth and/or the postnatal period
In addition to general partners (who we term “Supporters”), a smaller number of individuals/organisations will have the larger role of “Advocates”. Advocates are offered resources to assist and empower LGBTQIA+ people to be involved in the PSP process. Examples include an organisation working individually with LGBTQIA+ people to explain the questionnaire in simpler or culturally specific terminology, to help record individual responses if literacy is low, or providing interpreting services for LGBTQIA+ people with limited English.
Partners will sign up to the following code of conduct:
In any communication or activity that relates to this PSP, Supporters and Advocates will:
- Ensure that it is clear that they are independent of the PSP and do not speak on behalf of the PSP
- Pay careful attention to language, using the PSP language explanation document to choose the appropriate form of inclusive language for their population
- Actively support inclusion for all LGBTQIA+ people and not discriminate against any section of the LGBTQIA+ population
- Respect and uphold the human rights of all LGBTQIA+ people, including the right to explore and define one’s own sexual orientation and/or gender identity and the right to be free from attempts to change one’s sexual orientation and/or gender identity (conversion ‘therapy’)
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. This includes more detail on why REC/HRA ethical approval is not usually required for research priority setting activities, which are seen as service evaluation and development rather than research.
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 LGBTQIA+ Perinatal Care PSP.
Step 2: Awareness raising
PSPs will need to raise awareness of their proposed activity among the communities of people with lived/living experience, carers and health professionals, 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 LGBTQIA+ Perinatal Care PSP will carry out a consultation to gather uncertainties from people with lived/living experience, supporters and health professionals. A period of three months will be given to complete this exercise (which may be revised by the Steering Group if required).
The LGBTQIA+ Perinatal Care PSP recognises that the following groups may require additional consideration. LGBTQIA+ people with intersectional marginalisation, specifically people of colour, people from areas of social deprivation and people with disabilities and neurodivergences. In addition, people living in Scotland, Wales and Northern Ireland will require additional focus.
The Steering Group will use the following methods to reach and engage the target groups:
- Online and paper surveys disseminated via partner organisations and networks
- Seeking partners with particular connections to the specific communities listed, including those who may be able to offer language interpretation (including sign language)
- Promoting emotional safety for participants engaging with the PSP
- Partner-facilitated face to face or online events, at partner venues and pop-up locations
- Partner-facilitated individual support, using interpreting services if appropriate
- Creating multiple forms of public facing materials with a variety of terminology to increase cultural congruence
- Providing very basic descriptions to explain who is in scope, without any assumptions about what potential participants might know already
- Consideration of providing payment for involvement in questionnaires
- Consideration of Welsh translation (due to the legal status of Welsh specifically)
- Consideration of ability to respond to questionnaires with oral recordings in addition to written responses
The Steering Group recognises that LGBTQIA+ people may need support with emotions exacerbated by engaging with the PSP. Partners and lived/living experience organisations on the Steering Group will recommend resources and avenues for support that can be signposted, which will be provided on the questionnaire itself and to all partners. The PSP itself will not provide direct emotional support.
Existing sources of evidence uncertainties may also be searched.
Step 4: Refining questions and uncertainties
The consultation process will produce ‘raw’ questions and comments indicating people with lived/living experience, supporters’ and clinicians’ areas of uncertainty. These raw questions will be categorised and refined by Catherine Meads and/or Mari Greenfield 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 Catherine Meads and/or Mari Greenfield. 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 Catherine Meads and/or Mari Greenfield. 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 LGBTQIA+ Perinatal Care. This will involve input from people with lived experience, supporters 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 people with lived experience, supporters 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 people with lived experience, supporters 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 Ilana Levene and the lead lived experience organisation.
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 LGBTQIA+ Perinatal Care PSP Steering Group agreed the content and direction of this Protocol on 1st July 2024.
This project is supported financially by the University of Oxford Nuffield Department of Population Health, the University of Oxford Knowledge Exchange Seed Fund and the British Academy’s BA/Leverhulme Small Research Grants Programme