Abstract
Abstract
Introduction
All those born with functioning ovaries will eventually experience menopause, and many will be symptomatic. However, significant gaps in the evidence base for menopause care remain. This National Institute for Health and Care Research James Lind Alliance Menopause Priority Setting Partnership (MAPS) will engage with clinicians and those with lived experience globally to determine the leading priorities for future menopause research.
Methods and analysis
MAPS will follow the established James Lind Alliance methodology which has already resulted in over 100 ‘top 10’ research priorities across health domains. It will be led by a steering group comprised of clinicians and lived experience members. Leveraging the networks of steering group members and partner organisations, the priority setting partnership will identify evidence uncertainties using an online survey. Evidence checking will be undertaken to determine which questions have already been answered. Prioritisation will be done in two stages, initially by online survey and then at a face-to-face workshop.
Ethics and dissemination
Ethical approval was not required. The final top 10 priorities for menopause, as ranked by stakeholders at the final consensus workshop, will be disseminated in the relevant peer-reviewed journals. A final report will be available on the MAPS and James Lind Alliance websites. The leading priorities will inform the future global research agenda for menopause.
Keywords: GYNAECOLOGY, Reproductive medicine, General endocrinology
STRENGTHS AND LIMITATIONS OF THIS STUDY.
This will be the first project to set menopause research priorities globally.
The steering group is comprised of leading menopause academics and clinicians and those with lived experience.
Leading international partner organisations have been engaged.
Introduction
Purpose and background
A National Institute for Health and Care Research (NIHR) James Lind Alliance (JLA) priority setting partnership (PSP) is a powerful tool to establish shared priorities for the future research agenda for a defined health area. This established methodology has already advanced translational research in several areas of women’s health, but menopause is a recognised gap.1 There has been no previous consultation with clinicians and those with lived experience of menopause to establish research priorities for menopause. As already demonstrated in other key areas of women’s health research,2 the top 10 menopause research priorities will directly inform future research questions and translate into better health outcomes for women. This information will also be used to deliver responsive and strategic allocation of resources to improve the future health and well-being of women in mid to late life, including those with troublesome menopausal symptoms after cancer treatment. Funding bodies such as NIHR (UK) dedicate specific funds for research addressing leading priorities identified through PSPs.3
The Menopause Priority Setting Partnership (MAPS) will bring together clinicians and those with lived experience on an equal footing to identify gaps in knowledge that are important to both groups. By identifying these gaps in evidence, MAPS will improve the relevance of future global research by addressing the priority unanswered questions for those who are most affected.
The problem
Menopause is a health priority area identified through clinical practice and by those with lived experience. Although menopause eventually affects about half of the world’s population, it is an under-researched area. Basic understanding of why menopause occurs and why experiences differ so much between individuals is lacking.4 There is a lack of consensus about what symptoms menopause causes that are problematic for patients and clinicians.4 Not surprisingly, many report feeling unprepared for menopause and dissatisfied with available information and education.5 There are racial/ethnic variations in menopause timing and symptoms which are poorly understood.6 Growing evidence suggests that severe symptoms may be associated with adverse long-term health consequences such as cardiovascular disease, but the nature of this association remains uncertain.1 This uncertainty and substantial variation between menopause experiences impacts quality of care and limits provision of evidence-based care by healthcare providers.
Gaps in the evidence
Although >70% of those in menopause report symptoms, there remain significant evidence gaps, as symptom severity and duration cannot be reliably predicted,4 and marginalised populations face elevated risks due to stigma, limited access to treatment and financial insecurity.7 Premature ovarian insufficiency and early menopause affect around 1–3% and 10% of women respectively, and more information is needed about causes, symptom differences and the optimum dose and duration of menopausal hormone therapy (MHT) in those undergoing menopause earlier than the age of 45 years.8 Little is known about the impact of menopause in the LGBQTI+population including transgender individuals. Clinical research has primarily focused on medical therapies for vasomotor symptoms (hot flushes/night sweats), overlooking other priority symptoms for patients such as sleep difficulties, fatigue and joint pain.9 MHT is effective for vasomotor and genitourinary symptoms, but systemic doses are associated with certain health risks. For this reason, non-pharmaceutical or ‘natural’ approaches are often preferred for mild symptoms.10 The relative efficacy, risks and benefits of emerging non-hormonal treatments remain poorly defined. Menopausal symptoms often start in the perimenopause, but the relative safety and efficacy of treatments at this stage are uncertain. Similarly, it is uncertain whether MHT has a role in preventing diseases such as cardiovascular disease or dementia.11 Menopause is largely managed in primary care, but the optimal model of care is unknown. In developed countries, nearly half the paid workforce and over 70% of the unpaid/voluntary sector are perimenopausal and postmenopausal. Menopause may impact work participation and performance, disproportionally affecting female-dominated sectors such as health and education.12
MAPS came about through collaborations between clinicians and researchers working in the field of menopause who identified a gap in the evidence around priorities for research for both clinicians and those with lived experience of menopause. A better understanding of menopausal health and preferences of those with lived experience, along with healthcare providers’ perspectives, will inform research and improve care for this growing population.
Aims and objectives
Aim
To understand the questions that people with lived experience and healthcare professionals have about menopause. This includes women and people assigned female at birth who are perimenopausal or menopausal and healthcare professionals who care for menopausal patients.
Objectives
To work with those with lived experience and clinicians to identify uncertainties about menopause and perimenopause.
To include a wide range of perspectives, including LGBQTI+ (particularly trans) communities, those with premature ovarian insufficiency, ethnically, culturally and linguistically diverse groups and those with menopause because of medical treatment
To agree by consensus a prioritised list of those uncertainties for future research.
To publicise the PSP process and results.
To take the PSP results to research commissioning bodies for future funding considerations.
In scope for the PSP are the following
Those with lived experience of menopause, including those in perimenopause and postmenopause. This also includes those with premature ovarian insufficiency or menopause following gonadotoxic treatment (such as chemoradiation) or following oophorectomy (surgical menopause).
Marginalised groups include LGBQTI+ (and particularly transgender community) individuals, ethnic minority, culturally and linguistically diverse groups, those undergoing premature/early menopause, menopause after cancer and those with low literacy. Healthcare providers are those who provide primary, secondary and tertiary menopause care, pharmacists and psychologists. The scope is international, primarily Australia, USA and UK, but all international contributions will be accepted if in English.
The PSP will exclude from its scope questions not asked in English, personal clinical questions and questions about access to services in specific geographical locations which are not generalisable. The impact of menopause or menopausal symptoms on the diagnosis or treatment of other physical conditions is also out of scope.
The steering group (SG) is responsible for discussing what implications the scope of the PSP will have for the evidence-checking stage of the process. They possess the resources and expertise to do this evidence checking.
The methods the PSP will use
Steering group and partner organisations
The SG includes lived experience representatives and healthcare professionals, as individuals or representatives from a relevant group. The SG is a working group, contributing to the running of the PSP, ensuring timely delivery and adherence to the JLA principles of transparency, inclusion, equality and use of existing evidence. The SG ensures that the process is documented, open and transparent and adheres to the survey responses and evidence review.
The JLA adviser supports and guides the PSP, ensuring fair and transparent processes with equal input from all groups. The adviser provides advice and materials for use of the JLA methodology, survey design, documentation, tools, data management and communications and chairs the SG meetings.
Engagement of those with lived experience is fundamental to the process of PSP, and lived experience members will be actively engaged at all stages. Our global SG of approximately 20 people includes at least one quarter lived experience members. The SG also includes healthcare professionals across relevant disciplines (gynaecology, endocrinology, specialist nurses, general practice, psychiatry) and cultural contexts. Some professionals will also have lived experience of menopause.
The SG will agree that they will be able to contribute resources, including time and expertise, to each stage of the process, with input and advice from the JLA adviser.
Partners
Relevant organisations and groups will be invited to be involved with the PSP as partners (online supplemental file 1). Partners will commit to support the PSP, promote the process and encourage their represented groups or members to participate. Partners represent the following groups:
People who have lived experience of menopause (patient organisations).
Health and social care professionals with experience of caring for those experiencing menopause (professional organisations).
Exclusion criteria
Some organisations may be judged by the SG to have conflicts of interest. These may be perceived to potentially cause unacceptable bias. As this is likely to affect the ultimate validity of the 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 SG considers it may be helpful.
Context and scope
Identifying evidence uncertainties (first survey)
The MAPS will gather uncertainties (unanswered questions) from those with lived menopause experience and clinicians.
The SG will design the survey with guidance from the JLA adviser, information specialist and previous successful PSPs. Lived experience members will be engaged at all stages. SG members will contribute to the survey design and development.
The survey will target those with lived experience: people who have experienced menopause and healthcare professionals who care for them. They will be targeted through our extensive SG and partner networks and through social media. For example, the Australian Menopause and Perimenopause Support group has 26 000 members, Red Hot Mamas has 25 000 members and Henpicked works with over 300 workplaces to become ‘menopause friendly’. Based on similar PSPs (eg, contraception13), our global team and our focus (menopause), we anticipate up to 3000 responses. Quality of responses is a priority for MAPS. The survey will be available in online and paper versions (if requested).
The MAPS recognises that the following groups may require additional consideration:
Premature ovarian insufficiency.
LGBQTI+ (and particularly trans) individuals.
Ethnic minority and culturally and linguistically diverse groups.
Menopause because of medical treatment.
We will target marginalised groups using our strong established SG networks including cancer patients, black and Hispanic women, the transgender community, premature/early menopause, menopause after cancer, culturally and linguistically diverse groups and those with low literacy.
Healthcare providers who provide primary, secondary and tertiary menopause care, pharmacists and psychologists.
The survey will cover three areas:
The key unanswered questions for menopause research by asking: ‘Please list up to three questions about menopause that you would like to see answered by research’.
Participants can provide up to three responses. We will specify that personal questions about menopause care cannot be answered.
The survey is anonymous; however, participants can choose to provide their contact details to receive information or be involved in future stages of the PSP. This helps with disseminating and targeting recruitment to the final consensus workshop. Participant names and contact details will not be linked to their survey responses.
Demographic information includes age, race/ethnicity and country of birth, country of current residence, socioeconomic status, sexual orientation and gender, age at menopause and cause of menopause (eg, surgical, chemoradiation, natural).
Respondent group (lived experience, healthcare professionals, researcher), recognises that respondents may identify in more than one group (eg, healthcare professionals and postmenopausal).
The survey will be open for 6 weeks. We will check for saturation after 6 weeks and monitor responses for any new questions/topics. At saturation or after 3000 responses, the survey will close. Otherwise, it will remain open for four more weeks with additional promotion through our partners and social media or targeted promotion.
Existing sources of evidence uncertainties may also be searched.
Summarising the responses gathered into summary questions
We anticipate responses to be a mix of specific questions, personal stories and themes or issues. Survey responses are rarely formed as research questions but will contain a question or issue that is important to the respondent.
The review methodology is a qualitative, interpretative and iterative exercise conducted by an independent information specialist, KS. The responses will be read, categorised and summarised by KS, with the support of the SG. Similar or duplicate responses will be combined where appropriate into summary questions. Out-of-scope and ‘answered’ responses will be compiled separately. The aim is to develop a manageable number of summary questions for the first stage of prioritisation, aiming for 50–60 questions.
The SG provides governance, ensuring that the original responses are interpreted fairly, checking those identified as out-of-scope and checking single questions to determine if they stand alone or should be merged with another question. The summary questions should include a balance of responses from diverse groups. The SG will also ensure that the summary questions are clear, accessible and unambiguous. A focus group may be formed and consulted to support this review of responses. The JLA adviser will observe this to ensure accountability and transparency.
The analysis will result in a list of in-scope summary questions. These are not framed as research questions, as this may make them too technical for a non-research audience. They are framed as researchable questions that capture the themes and topics that people have suggested in their responses.
Evidence checking
These summary questions will be checked against the evidence to determine whether they have already been adequately answered in published research. We will search PubMed for randomised controlled trials, systematic reviews and clinical guidelines to establish whether high-quality evidence already exists to answer the questions identified in the survey. The search will be extensive and include websites of national organisations, professional societies and guidelines databases. Clinicaltrials.gov will be searched for relevant trials in progress. The Cochrane Library and PROSPERO database will be searched for completed or in-progress systematic reviews. The Turning Research Into Practice and PubMed databases will be searched for evidence-based guidelines and systematic reviews.
When the evidence is uncertain (‘borderline questions’) will be discussed among the SG and focus groups to resolve whether these questions are already ‘answered’ or ‘unanswered’. Level of evidence will be graded using the updated Grading of Recommendations, Assessment, Development and Evaluations approach.
The summary questions that are verified as being unanswered form the long list for the first stage of prioritisation. The SG will consider how to deal with the responses that have already been answered and those considered out of scope.
Both the original survey responses and summary questions will be published on the JLA website at the end of the PSP. An audit trail is maintained for transparency showing how the summary questions have been developed, including the original responses, the respondent group and other demographics. The responses should be anonymous but are checked for any inadvertent personal information. Full anonymity will be maintained throughout.
The PSP will complete the JLA Question Verification Form, to document the process used to verify the uncertainty of the questions, before starting prioritisation. This will be published on the JLA website, to enable researchers and other stakeholders to understand how the PSP has decided that its questions are unanswered and any limitations of this.
Prioritisation
There are two stages of prioritisation.
Initial prioritisation (second survey)
Initial 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. Based on similar PSP (contraception),13 we anticipate that the extensive list will contain around 50–60 unanswered summary questions.
We will target the same stakeholder groups as the first survey. We aim to involve as many people as possible, including those who did not contribute to the first consultation. Participants will be asked to select the top 10 questions that are most important to them. The results will be analysed and balanced by group, to avoid skewing the results if there are unequal numbers of participants in each stakeholder group. Where the initial prioritisation does not produce a clear cut-off point, the SG may decide which marginal questions should be taken forward, also considering the balance of themes/topics. The initial prioritisation allows the extensive list of 50+summary questions to be reduced to a concise list of approximately 20. These will be reviewed by the SG and taken to the final priority setting consensus workshop.
Final priority setting (final workshop)
The aim of the final stage of the PSP is to prioritise through consensus the identified unanswered questions about menopause. This will involve input from the priority population and healthcare professionals.
The final priority setting process will be a full day workshop facilitated by the JLA and held in Melbourne in October 2024. Our JLA adviser (TG) will attend in person and chair the workshop. With guidance from the JLA and input from the SG, up to 30 people with lived experience and healthcare professionals will be recruited to participate in the discussion and ranking, to determine the top 10 questions for research.
The final workshop will be face to face in Melbourne, Australia, in late 2024. Participants will equally represent each stakeholder group and include diverse experiences. All participants will declare their interests. The SG will advise on any adaptations to ensure the process is inclusive and accessible. The workshop will follow the standard JLA priority setting approach, drawing on the nominal group technique. This involves participants being provided with the shortlist of questions, which they review and rank for themselves in advance of the workshop. Through a series of small and large group sessions at the workshop, the questions will be ranked through facilitated consensus discussion.
Ethics and dissemination
Ethics
In general, JLA PSPs do not require ethical approval as no personally identifiable data are collected or processed, and people participating in the project are contributing to the design of research and not acting as subjects of research.14 This was also verified against the UK Health Research Authority criteria.15
Data curation and data management
Survey software Qualtrics, Seattle, USA, will be used to facilitate online electronic completion of both the first and second survey. Data will be exported from this for analysis by our information specialist using Microsoft Excel, Washington, USA.
Dissemination – publishing and promoting the top ten priorities
The SG will identify audiences with which it wants to engage when disseminating the results of the priority setting process, such as researchers, funders and lived experience communities. They will need to determine how best to communicate the results to these groups. Previous PSP outputs have included academic papers, lay reports, infographics, conference presentations and videos for social media. Publications will follow the REPRISE reporting guidelines for priority setting of health research.16
It should be noted that the priorities will all be published and made available for research. Those that did not make the top 10 will not be abandoned and will be published in the final report and publication. The priorities are not worded as research questions. The SG should discuss how they will collaborate 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 ZN (PSP coordinator) and MH (PSP lead).
The JLA encourages PSPs to report back about any activities that have come about because of the PSP, including funded research, and the JLA will be kept updated.
The top 10 will be launched in a presentation at the International Menopause Society Conference in October 2024 where healthcare professionals discuss the most recent scientific and research developments in the field.
The SG will identify the key audiences who should be aware of the top 10, including researchers, funders, patient and advocacy groups, conference presentations and social media. The SG and partners will disseminate among networks (#menopausetop10). We anticipate that our findings will be published in high-impact journals.
We will work with global funding bodies and advocacy groups to promote the value of supporting research questions prioritised.
Supplementary material
Footnotes
Funding: Funding was received from the University of Melbourne (Australia), University of Chicago (USA) and The Elizabeth Garret Anderson Charity (UK). The infrastructure of the James Lind Alliance is funded by the National Institute of Health Research, UK. None of the funders have any role or influence on the paper.
Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-096401).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Patient and public involvement: Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.
References
- 1.Hickey M, LaCroix AZ, Doust J, et al. An empowerment model for managing menopause. Lancet. 2024;403:947–57. doi: 10.1016/S0140-6736(23)02799-X. [DOI] [PubMed] [Google Scholar]
- 2.Graham L, Illingworth B, Showell M, et al. Research priority setting in women’s health: a systematic review. BJOG. 2020;127:694–700. doi: 10.1111/1471-0528.16150. [DOI] [PubMed] [Google Scholar]
- 3.NIHR james lind alliance priority setting partnerships rolling call. [28-Jul-2024]. https://www.nihr.ac.uk/documents/nihr-james-lind-alliance-priority-setting-partnerships-rolling-call/28569 Available. Accessed.
- 4.Hickey M, Hunter MS, Santoro N, et al. Normalising menopause. BMJ. 2022;377:e069369. doi: 10.1136/bmj-2021-069369. [DOI] [PubMed] [Google Scholar]
- 5.Stanzel KA, Hammarberg K, Fisher J. Experiences of menopause, self-management strategies for menopausal symptoms and perceptions of health care among immigrant women: a systematic review. Climacteric. 2018;21:101–10. doi: 10.1080/13697137.2017.1421922. [DOI] [PubMed] [Google Scholar]
- 6.Avis NE, Crawford SL, Greendale G, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015;175:531–9. doi: 10.1001/jamainternmed.2014.8063. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Cheung AS, Nolan BJ, Zwickl S. Transgender health and the impact of aging and menopause. Climacteric . 2023;26:256–62. doi: 10.1080/13697137.2023.2176217. [DOI] [PubMed] [Google Scholar]
- 8.Nash Z, Davies M. Premature Ovarian Insufficiency: Clinical Review. BMJ. 2024;384:e077469. doi: 10.1136/bmj-2023-077469. [DOI] [PubMed] [Google Scholar]
- 9.Lan Q, Hickey M, Peate M, et al. Priorities for alleviating menopausal symptoms after cancer. Menopause. 2023;30:136–42. doi: 10.1097/GME.0000000000002108. [DOI] [PubMed] [Google Scholar]
- 10.Christmas M, Janssen I, Joffe H, et al. Menopause hormone therapy and complementary alternative medicine, quality of life, and racial/ethnic differences: the Study of Women’s Health Across the Nation (SWAN) Menopause. 2022;29:1357–64. doi: 10.1097/GME.0000000000002087. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Nash Z, Al-Wattar BH, Davies M. Bone and heart health in menopause. Best Pract Res Clin Obstet Gynaecol. 2022;81:61–8. doi: 10.1016/j.bpobgyn.2022.03.002. [DOI] [PubMed] [Google Scholar]
- 12.Hardy C, Thorne E, Griffiths A, et al. Work outcomes in midlife women: the impact of menopause, work stress and working environment. Womens Midlife Health . 2018;4:3. doi: 10.1186/s40695-018-0036-z. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.James Lind Alliance (JLA) Contraception. [28-Jul-2024]. https://www.jla.nihr.ac.uk/priority-setting-partnerships/contraception/ Available. Accessed.
- 14.James Lind Allicance Consent and ethics. [30-Jul-2024]. https://www.jla.nihr.ac.uk/jla-guidebook/chapter-5/consent-and-ethics.htm Available. Accessed.
- 15.NHS Health Research Authority . Health Research Authority; 2017. [30-Jul-2024]. What approvals and decisions do i need?https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/ Available. Accessed. [Google Scholar]
- 16.Tong A, Synnot A, Crowe S, et al. Reporting guideline for priority setting of health research (REPRISE) BMC Med Res Methodol . 2019;19:243. doi: 10.1186/s12874-019-0889-3. [DOI] [PMC free article] [PubMed] [Google Scholar]