Pessary use for Prolapse PSP Protocol

Purpose of the Pessary PSP and background

The purpose of this protocol is to set out the aims, objectives and commitments of the Pessary Priority Setting Partnership (PSP) and outline the roles and responsibilities of the partners therein. This protocol will be reviewed by the Steering Group and updated regularly.

The James Lind Alliance (JLA) is a non-profit making initiative, established in 2004. It brings patients, carers and clinicians with an interest in a particular health condition together in Priority Setting Partnerships (PSPs). These partnerships identify and prioritise uncertainties, or ‘unanswered questions’ that they mutually agree are the most important about the effects of treatments for that condition. The aim is to 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.

This PSP is about the use of a vaginal pessary device for the management of symptomatic pelvic organ prolapse. Pelvic organ prolapse, often referred to as ‘prolapse’, is defined by an anatomical change where a pelvic organ which may be the bladder, bowel, rectum or uterus is displaced downwards in the vagina causing the main symptom of ‘something coming down’ or vaginal heaviness but may also produce bladder, bowel or sexual symptoms such as incomplete emptying, leakage or discomfort. Prolapse is a common condition affecting about 1 in 3 women who have had children but it remains a highly stigmatised condition for which many women delay seeking help. Treatment for symptomatic prolapse includes surgery, or conservative interventions including supervised pelvic floor muscle training, lifestyle measures or the use of a vaginal pessary. A pessary aims to provide support to the vaginal walls which in turn reduces the bothersome symptoms from the prolapse.

There are no agreed protocols or guidelines in the UK which can help clinicians and women with prolapse make decisions about the management of the condition and there remains a good deal of uncertainty about the best way to use a pessary for the treatment of pelvic organ prolapse. The existing evidence base for pessary use remains limited.

This PSP will identify the top ten priority questions not yet answered by research about the use of pessaries for prolapse and will be part of a doctoral study to identify the uncertainties and evidence gaps in pessary use for the management of pelvic organ prolapse.

This PSP will not include uncertainties about rectal or urethral prolapse, and will be concerned only with pessary for treatment of a prolapse occurring within the vagina.

Pessary in this PSP refers to devices commonly used in clinical practice to manage the symptoms of prolapse and will not include devices used solely for managing urinary incontinence or for pelvic floor muscle training.

Women with prolapse and clinicians, working together in this PSP, will produce a final top ten priorities which truly reflect where future research should be directed for the mutual benefit of both groups.

Aims and objectives of the Pessary PSP

The aim of this Pessary PSP is to identify the questions not yet answered by research about the management of symptomatic prolapse with pessaries in order to prioritise those that women with prolapse (and their partners and caregivers as appropriate) and clinicians agree are the most important.

The objectives of the Pessary PSP are to:

• work with women with prolapse, their partners, caregivers and clinicians to identify uncertainties about the use of a pessary for the management of symptomatic prolapse
• to agree by consensus a prioritised top ten list of those uncertainties for future research
• to publicise information about the PSP and its outcomes
• take the results to research commissioning bodies to be considered for funding.

The Steering Group

The Pessary PSP will be led and managed by a Steering Group which represents the interests of those affected by this topic:

• Women affected by prolapse and who may also have experience of using a pessary
• Clinicians involved with fitting and advising on pessaries may include urogynaecologists, gynaecologists, urologists, GPs, specialist nurses and physiotherapists
• Pessary manufacturers and providers who run much of the UK training in pessary fitting, and are at the interface between women seeking information about pessaries and clinicians who may not know what pessary options are available
• Researchers in the field of prolapse, pessaries and health who can build on existing research pathways to facilitate the uptake of the top ten priorities into active research

Our Women representatives are:

• Janina Gordon – a PE teacher from Scotland
• Diana Tilston – a specialist physiotherapist in Women’s Health
• A mother of 2 young children from the South East of England

Our Clinician representatives are:

• Dr Rohna Kearney, consultant urogynaecologist, Manchester, who has experience of setting up a self-management pathway for pessary use, is actively involved in research and has published papers on prolapse
• Angie Rantell, specialist urogynaecology nurse with experience of running nurse-led pessary clinics
• Dr Ranee Thakar, consultant urogynaecologist, Croydon, with a background of extensive research publications in prolapse, pessaries and sexual health

Our pessary supplier representative is:

• Francesca McCabe, European product manager for pelvic floor, Mediplus. She has a background in physiology in the NHS and provides training and guidance for pessary use

Additionally the Steering Group will include:

• Suzanne Hagen, Professor at the Nursing, Midwifery and Allied Health Professions Research Unit (NMAHP RU) Glasgow and PhD supervisor. She is actively involved in pelvic floor and prolapse research
• Carol Bugge, Nurse researcher and senior lecturer at University of Stirling, actively involved with research in pessary use and author and reviewer of 2013 Cochrane Review on pessaries
• Catherine White, The James Lind Alliance (JLA) adviser to the Pessary PSP
• Kate Lough, Doctoral student NMAHP RU, and specialist pelvic floor physiotherapist with a particular interest in prolapse

The Steering Group members have agreed the resources, time and expertise that they will be able to contribute to each stage of the process and will operate according to the Terms of Reference for the Pessary PSP.

The wider Partners

Organisations and individuals who represent the parties relevant to this Pessary PSP will be identified and invited to be involved as partners. Partners are groups or individuals who commit to supporting the PSP by disseminating the survey by which the questions and uncertainties of practical clinical importance in relation to pessary use for prolapse will be gathered.

Partners in the Pessary PSP will represent the following groups:

• Woman over 18 who have current or previous experience of pelvic organ prolapse, and their partners
• Doctors, nurses, allied health professionals and care givers with experience of the treatment and management of prolapse
• Organisations who are involved in the training and provision of pessaries

It is important that all organisations that 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 Pessary PSP will use

This section describes a schedule of proposed stages through which the Pessary 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. Refer to appendix 1: Timeline

Step 1: Identification and invitation of potential partners

Potential partners/stakeholders - individuals and organisations -will be identified through a process ofpeer knowledge and consultation, through the Steering Group members’ networks. Potential partners willbe contacted and informed of the launch and aims of the Pessary PSP and invited to participate in the question- gathering phase.

Step 2: Identifying treatment uncertainties

The wider partner network will be invited to distribute and publicise a survey to gather the questions and uncertainties of practical clinical importance relating to the treatment and management of prolapse with a pessary. The survey, agreed by the Steering group will be open for 8 – 10 weeks and may be accessed online or as a paper version.

The methods for gathering the uncertainties and questions may vary according to the organisation and individual requirements but must be as transparent, inclusive and representative as practicable. Methods may include membership meetings, email consultation, postal or web-based questionnaires, social media and focus group work.

All existing sources of published or publically available information including patient information documents, systematic reviews and guidelines about pessaries in the management of symptomatic pelvic organ prolapse will be searched for further known uncertainties.

Step 3: Refining questions and uncertainties

The Steering Group will agree who will be responsible for this stage. The JLA will participate in this process as an observer, to ensure accountability and transparency.

The consultation process will produce “raw” unanswered questions about the use of pessaries in the management of prolapse. These raw questions will be assembled and categorised and refined into “collated indicative questions” which are clear, addressable by research and understandable to all.

Similar or duplicate questions will be combined where appropriate. This work will be done by the members of the Steering Group from the NMAHP RU.

Systematic reviews and guidelines will be identified and checked by Kate Lough and NMAHP RU team members to identify 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 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, a record of these 'answerable questions' will be kept by the PSP and dealt with separately from the 'true uncertainties' considered during the research priority setting process.

True uncertainties (i.e. those which are not adequately addressed by previous research) will be collated and recorded on a database. The Steering Group will be able to verify the process undertaken to make sure that the uncertainties have not already been answered. The Steering Group will agree the personnel and resources required to carry out this accountability. The data will then be submitted to the JLA for publication on its website on completion of the priority setting exercises, taking into account any changes made at the final workshop, in order to ensure that Pessary PSP top ten priorities are publicly available.

Step 4: Prioritisation – interim and final stages

The aim of the final stage of the priority setting process is to prioritise through consensus the identified true uncertainties relating to the use of pessaries in the treatment or management of prolapse. This will be carried out by members of the Steering Group and the wider partnership which represents women with prolapse, their partners, caregivers and clinicians.

• The interim stage, to reduce the long list of uncertainties to a shorter list (up to 30), to go forward to the final priority setting workshop may be carried out over email or online, whereby partner organisations further consult their membership and choose and rank their top 10 most important uncertainties from that shortened list.
• The final stage, to reach the top 10 prioritised uncertainties, will be conducted in a face-to-face meeting, using group discussions/ workshops and facilitated sessions. The consensus method used for this prioritisation process will be determined by consultation with the partner organisations, the Steering group and with the advice of the JLA Adviser. Suitable examples are: adapted Delphi techniques, expert panels, 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 Pessary PSP will be reported to funding and research agenda setting organisations such as the NIHR and the major research funding bodies. Steering Group members and partners are expected to help with the development of the prioritised uncertainties into research questions, which will then be used when approaching potential funders, or when those members and organisations are funding their own research, if applicable.

This Pessary PSP is part of a doctoral study which will include the development of a research proposal addressing one of the top ten priorities.

Publicity

As well as alerting funders, partners and Steering Group members are encouraged to publish the findings of the Pessary PSP widely 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

Read and agreed by the Steering Group and adopted as the Protocol for the Pessary PSP

Names:

1. Ranee Thakar
2. Kate Lough
3. Suzanne Hagen
4. Angie Rantell
5. Francesca McCabe
6. Mother of small children with personal experience of pessary use for prolapse
7. Di Tilston
8. Rohna Kearney
9. Catherine White
10. Nina Gordon
11. Carol Bugge