Problematic Menstrual Bleeding 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 Problematic Menstrual Bleeding 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.  

This PSP came together to identify and address the uncertainties regarding the management of the common and debilitating symptom of problematic menstrual bleeding (including irregular, frequent, heavy or prolonged menstrual bleeding). It hopes to amplify the voices of those who experience problematic menstrual bleeding and those who are involved in its management to identify research priorities.

Please note: While a large part of the population who experience periods are women and girls, many transgender, nonbinary, intersex, and gender-nonconforming individuals menstruate, but do not identify as women or girls.  Furthermore, many people who do identify as women or girls do not menstruate, due to age, medical conditions, pregnancy, breastfeeding, or use of contraceptives. As such, we have opted to use the terms women, girls, people/those who menstruate interchangeably throughout this PSP to be as inclusive as possible. 

Aims, objectives and scope of the PSP

The aim of the Problematic Menstrual Bleeding PSP is to identify the unanswered questions about the management (diagnosis, treatment and support) of irregular, frequent, heavy or prolonged menstrual bleeding from the perspective of those with lived experience, their parents and carers, and health and social care professionals, and then prioritise the questions that these groups agree are the most important for research to address. 

The objectives of the PSP are to:

• work with those with lived experience of problematic menstrual bleeding, parents and carers and health and social care professionals to identify uncertainties about the management (diagnosis, treatment and support) of problematic menstrual bleeding in adults.  
• 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 Problematic Menstrual Bleeding PSP is defined as: 

• the diagnosis, treatment and support of the symptom of problematic menstrual bleeding in those with established menstruation, who currently or have previously menstruated and are >1 year from menarche, up to 60 years old.

The PSP will exclude from its scope questions about:

• Specific adolescent gynaecology conditions, e.g., disorders of sex development, menarche related conditions (e.g. immature reproductive axis resulting in irregular menstruation during menarche).
• Chronic pelvic pain
• Absence of periods (amenorrhoea)
• Mood disorders that are not directly related to menstrual bleeding, e.g., PMS, PMDD 
• Symptoms that occur in the absence of problematic menstrual bleeding, e.g., excess hair growth, headaches, fatigue.
• Non-UK respondents
• Access to services

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 those with lived experience of problematic menstrual bleeding, parents and carers and health and social care professionals, as individuals or representatives from a relevant group. 

The Problematic Menstrual Bleeding PSP will be led and managed by a Steering Group involving the following:

Patient and carer representative/s

Jane Plumb - RCOG women's voices
Andie Sterricks - FlowRight representative
Alice Pelton - The Lowdown

Charity representative/s

Rachael Grocott - Bloody Good Period
Jennifer Stewart - Health and Social Care Alliance Scotland
Chrissy Cattle - Irise representative / CEO

Organisation

Kate Shephard Cohen - Menstrual cycle support. 

This organisation's mission is to take a whole system approach to menstrual education providing clinically backed, peer-reviewed and evidence informed digital programmes for teens and adults, available on healthcare referral. They receive referrals from primary, secondary, allied health and social care professionals. Their programmes are currently available in over 500 GP surgeries across the UK, on social prescription, and in several UK-wide schools. 

Menstrual Cycle Support's involvement in the PSP is crucial in disseminating and gathering the experiences of teens and adults relevant to this PSP.

Clinical representative/s

Dharani Hapangama - Professor of Gynaecology, University of Liverpool
Angharad Jones - Consultant Gynaecologist / RCOG Welsh Committee, University Hospital of Wales
Jimi Funlayo Odejinmi - Consultant Gynaecologist / Clinical Research, Barts NHS Trust, London Natalie Cooper - Consultant Obstetrician and Gynaecologist - Queen Mary, Uni of London  
Sarah Gray – General Practitioner, Primary Care Women's Health Forum 
Alison Cooper, Senior Clinical Research Fellow and General Practitioner, University of Cardiff

Cross disciplinary representative/s

Maria Tomlinson - Lecturer in Public Communication and Gender, University of Sheffield

Information Specialist

Hat Porter - The University of Exeter

Project coordinator

Emma Watson – The University of Edinburgh

James Lind Alliance Adviser and Chair of the Steering Group

Sope Wolffs, JLA

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 that are involved with this PSP:

• Cysters 
• Endometriosis UK
• Fair Treatment for the Women of Wales (FTWW)
• PRIME Centre Wales 
• The Guidance Suite

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, girls and people who have / have had problematic menstrual bleeding
• Parents and carers of people who have / have had problematic menstrual bleeding
• Health and social care professionals (HCP/SCP) - with experience of managing problematic menstrual bleeding

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 at 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 problematic menstrual bleeding 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 Problematic Menstrual Bleeding PSP will carry out a consultation to gather uncertainties from those with lived experience, parents and carers and health and social care professionals.  A period of 18 months will be given to complete this exercise (which may be revised by the Steering Group if required).

The Problematic Menstrual Bleeding PSP recognises that the following groups may require additional consideration. Including those from different ethnicities and cultural backgrounds, socio-economically deprived, migrant, and transgender communities. To ensure that these voices are included in this exercise, we have invited members of third sector organisations with connections to these people/communities to sit on the steering group.  

The Steering Group will use the following methods to reach the target groups:

• Ask steering group members to disseminate the survey to their networks
• Provide an Easy Read version of the survey
• Provide both print and online versions of the survey
• Use a survey platform (Qualtrics) that allows surveys to be completed on different electronic devices (e.g. laptops, tablets, mobile phones)   

Existing sources of evidence uncertainties may also be searched. This will include guidelines such as the NICE HMB Guideline, RCOG Audits and others. A review of published literature will also be performed using PubMed and uncertainties collated. These will then be reviewed by the Steering Group, alongside survey responses, to determine a list of uncertainties.

Step 4: Refining questions and uncertainties

The consultation process will produce ‘raw’ questions and comments indicating those with lived experience’s, parents and carers’ and health and social care professionals’ areas of uncertainty.  These raw questions will be categorised and refined by Hat Porter 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 Hat Porter.  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 Hat Porter and the PSP Leads.  This will ensure that appropriate steps and checks have been undertaken 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, 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 problematic menstrual bleeding.  This will involve input from those with lived experience, parents and carers and health and social care professionals.  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 those with lived experience of problematic menstrual bleeding, parents and carers and health and social care professionals 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 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 Lucky Saraswat, Dr Jackie Maybin and Dr Gemma Sharp. 

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 Problematic Menstrual Bleeding PSP Steering Group agreed the content and direction of this Protocol on 28^th November 2024.