Faecal Incontinence in Adults PSP protocol

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Published: 11 January 2024

Version: 1

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Purpose of the PSP and background

The purpose of this protocol is to clearly set out the aims, objectives and commitments of the faecal incontinence in adults 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.

Faecal incontinence (FI) is a common, devastating condition with a prevalence of up to 18% of the adult population. It can take ten-years from a patient first presenting to a GP before an accurate diagnosis and treatment is received. Faecal incontinence carries a significant psychosocial burden along with a profound negative impact on a patient’s quality of life. The stigma associated with the condition can lead to a silent affliction and the condition is often under-reported. Despite this, the financial impact of continence care is anticipated to cost 2% of the NHS budget with affected working age individuals also reporting an average of 15 days off work each year due to their condition.

The Pelvic Floor Report 2021, titled ‘Seizing the opportunity to improve patient care’, highlighted six key areas for change in the management of pelvic floor disorders. This included empowering and educating patients, making use of technology, integrating expertise, looking again at surgical procedures, making the most of teams and considering collaborations. This report which was supported by health professionals, patients, industry, charities and government is the catalyst for driving forward research priorities with the JLA. By setting up a faecal incontinence in adults PSP we can ensure that the questions, uncertainties and priorities of patients, carers and clinicians affected by or treating incontinence are taken into account in the commissioning of research.

Aims, objectives and scope of the PSP

The aim of the faecal incontinence in adults PSP is to identify the unanswered questions about faecal incontinence from patient, carer and clinical perspectives and then prioritise those that patients, carers and clinicians agree are the most important for research to address.

In the context of this PSP, the definition of ‘faecal incontinence’ will include:

  • The uncontrolled loss of liquid or solid stool
  • The uncontrolled loss of flatus (flatus incontinence)
  • Faecal urgency
  • The fear or anxiety of incontinence
  • Situations where continence is only maintained due to modifications to a patient’s lifestyle that limit their ability to travel, work or socialise e.g. remaining at home or near toileting facilities.

The objectives of the PSP are to:

  • work with patients, carers and clinicians to identify uncertainties about the epidemiology, aetiology, investigation and management of FI and its associated conditions in the United Kingdom adult population or those under the care of adult healthcare services. This will include identifying uncertainties around the impact of FI on patient’s lives, the challenges of living with FI, the stigma associated with the condition and the barriers experienced by patients and carers in accessing support.
  • 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 faecal incontinence in adults PSP will include questions related to:

  • The epidemiological factors associated with FI
  • The aetiology of FI
  • The investigation of FI
  • The management of FI
  • The effect of FI on patients’ and carers’ lives
  • The barriers experienced by patients and carers in accessing support

The PSP will exclude from its scope questions about:

  • Management of FI under paediatric care
  • FI associated with inflammatory bowel disease or chronic diarrhoea

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 patients and carers and clinicians , as individuals or representatives from a relevant group.

The faecal incontinence in adults PSP will be led and managed by a Steering Group involving the following:

Patient and carer representative/s

Sam Alexandra Rose – Patient & Bowel Research UK patient and public involvement (PPI) Manager
Tara Willson – Patient identified through Bladder and Bowel UK
Anna Clements – Patient & MASIC Events/Education and Support Services Manager
Douglas Hallett - Patient

Clinical representative/s

Thomas Dudding – Consultant Colorectal Surgeon – University Hospital Southampton NHS Trust
Julie Cornish – Consultant Colorectal Surgeon - Cardiff and Vale University Health Board, Cardiff. Vice President of the MASIC Foundation (Mothers with Anal Sphincter Injuries in Childbirth)
Emma Carrington – Consultant Surgeon and Clinical Senior Lecturer Imperial College London – Chair of the Research Committee of The Pelvic Floor Society
Jennie Grainger – Consultant Colorectal Surgeon – Countess of Chester Hospital NHS Foundation Trust
Marcus Drake – Consultant Urologist and Professor of Physiological Urology Imperial College London – Trustee of International Continence Society
Aziza Sesay – General Practitioner, GP educator, Honorary Senior Clinical lecturer
Dipesh Vasant – Consultant Gastroenterologist, Neurogastroenterology Unit, Manchester University NHS Foundation Trust
Polly Weston - Association of Continence Advice (ACA) Chair
Kate Lough - Pelvic Obstetric & Gynaecological Physiotherapy Chair
Tatenda Marunda - Lead Biofeedback Practitioner - St. Mark’s Hospital, London

Project coordinator

Alex O’Connor – Pelvic Floor Research Fellow – Manchester University NHS Foundation Trust

James Lind Alliance Adviser and Chair of the Steering Group

Louise Dunford, 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 will be invited to be involved with the PSP as partners including:

  • The Pelvic Floor Society (TPFS)
  • Bowel Research UK (BRUK),
  • Bladder and Bowel UK (BBUK),
  • Guts UK,
  • MASIC,
  • Pelvic Obstetric & Gynaecological Physiotherapy (POGP),
  • Cysters,
  • Bladder and Bowel Confidence (BABCON),
  • Association of Continence Advice (ACA).
  • Age UK
  • Prostate Cancer UK
  • The Eve Appeal
  • MS Society UK
  • MND Association
  • Carers UK
  • International Continence Society (ICS)
  • UK Continence Society (UKCS)
  • Scottish Pelvic Floor Network (SPFN)
  • Medical Royal Collages
  • The Royal Society of Medicine

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:

  • adults who have had, or currently suffer with faecal incontinence.
  • carers of adults who have had, or currently suffer with faecal incontinence.
  • health and social care professionals - with experience of faecal incontinence in adults.

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.

JLA PSPs must avoid being influenced by parties with a commercial interest in their topic. This includes avoiding PSPs being directly funded by a commercial organisation that could benefit commercially from the results. In the case of the faecal incontinence in adults PSP, the funding has come from a non-conditional, unrestricted grant from a commercial organisation to The Pelvic Floor Society. The JLA has agreed to support a PSP in this instance under the umbrella of its JLA Lab space (an experimental space where the JLA can test new ideas and methods). The commercial organisation will not take part in the process or have access to data or materials of the priority setting work until it is publicly available. There is no requirement to report back to the commercial source of funding at any stage of the process. The JLA will assess the outcomes and any perceived impact of the commercial funding source on the process and publish a report on its website.

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 faecal incontinence in adults 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 faecal incontinence in adults PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of three months will be given to complete this exercise (which may be revised by the Steering Group if required).

The faecal incontinence in adults PSP recognises that the following groups may require additional consideration:

  • Patients and their carers suffering with faecal incontinence in the community who have not yet accessed support through charitable organisations or through primary care.
  • Patients and their carers in minority ethnic communities
  • Patients and their carers with low socio-economic status
  • Patients and their carers with neurological / cognitive impairment
  • Male patients suffering with FI

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

  • Extensive engagement with community organisations with established links within the affected communities.
  • Communication with community leaders to disseminate the survey details.
  • Engagement with social media platforms to publicise the PSP.
  • The use of paper-based surveys to improve engagement with communities or individuals without access to the internet.

Existing sources of evidence uncertainties may also be searched:

  • Question-answering services for patients and carers and for clinicians.
  • Research recommendations in systematic reviews and clinical guidelines.
  • Protocols for systematic reviews being prepared.
  • Registers of ongoing research.

Step 4: Refining questions and uncertainties

The consultation process will produce ‘raw’ questions and comments indicating patients’, carers’ and clinicians’ areas of uncertainty. These raw questions will be categorised and refined by Toto Gronlund (information specialist) 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 Toto Gronlund (information specialist). 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 Toto Gronlund (information specialist). 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 adult faecal incontinence. This will involve input from patients, carers 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 patients, carers 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 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. It is anticipated that outputs will include 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 The Pelvic Floor Society

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 faecal incontinence in adults PSP Steering Group agreed the content and direction of this Protocol on Wednesday 20th September 2023.