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21/583 Patient reported outcome measures (PROMs) for pelvic floor disorders commissioning brief

Published

21 December 2021

Version

1.0

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research Question:

The development and validation of a patient reported outcome measure (PROM) for patients being treated for pelvic floor disorders, to inform clinical effectiveness trials.
      
1. Aim of study: To develop a patient reported outcome measure (PROM) which may or may not include elements of existing patient reported experience measures (PREMs) following surgery for stress urinary incontinence (SUI) or pelvic organ prolapse (POP).  The PROM should be validated as a tool for use in future clinical effectiveness trials.
2. Patient group: Women who have undergone surgical procedures (including mesh and alternatives) for the treatment of SUI or POP.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
3. Study design:  The PROM should be designed, taking into account existing measures, and validated through an appropriate study design (applicants to define and justify).  Applicants should consider using a preference-based approach. The study design must include a strong qualitative component to assess acceptability to patients and clinicians, and barriers to implementation.  There should be clear progression criteria between each stage.
4. Outputs:  A validated PROM following surgery for SUI or POP, with associated qualitative research findings regarding acceptability and barriers to implementation.
5. Timescale and cost: Proposals should represent good value for money and should aim to complete within a reasonable timescale to inform timely effectiveness research.

Rationale:
The organs within a woman’s pelvis (the uterus, bladder, and rectum) are normally held in position by the ligaments and muscles of the pelvic floor.  If these ligaments and muscles become weakened, they can no longer hold the pelvic organs in place, and so they bulge into the vagina.  This is pelvic organ prolapse (POP).  Symptoms include urinary and bowel dysfunction, pelvic and back pain, and painful sex.  Weakened pelvic floor muscles can also cause stress urinary incontinence (SUI): if the abdominal pressure is raised, for example when a person laughs or coughs, urine may leak out.  Pregnancy and vaginal birth, obesity, and ageing can increase the chance of developing POP and SUI, which can have a significant negative effect on women’s quality of life.  If non-surgical treatment options are unsuccessful, women will need to have an operation to improve their POP or SUI.  Several of these procedures involve the use of surgical mesh, which is used to provide artificial support to weakened ligaments.  Whilst these were often successful in treating the POP or SUI, an increasing number of women reported significant complications such as pain, bleeding, and urinary and faecal incontinence, which were significantly impacting on their quality of life.  As such, in 2018 the government and NHS announced that surgical mesh was not to be used as a treatment option for POP and SUI unless there was no alternative, and only after thorough consultation between patient and clinician.
The Cumberlege report (First Do No Harm) published in 2020 investigated how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices and included pelvic mesh implants.  The report recommended that there should be a registry to research and audit the outcomes of surgery both in terms of device safety and patient reported outcome measures (PROMs).  There are a significant number of PROMs available, but there are limitations which mean they are not entirely suitable for addressing this research need, key amongst these being that they are not procedure-specific. Currently, to explore complications from POP and/or SUI using existing validated PROMs means using multiple PROMs in a process which patients may find longwinded and cumbersome. The lack of specific guidance by NICE also reflects an evidence gap in this area. 
As such, a PROM which is manageable and specific to POP/SUI needs to be developed and validated in order to support further research into the best treatment decisions, with cross-cultural applicability. It is intended that this work should enable studies to evaluate the benefits and risks of procedures for pelvic floor disorders and ultimately inform guidance.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 30th March 2022. Applications will be considered by the HTA Funding Committee at its meeting in May 2022.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in September 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.

Should you have any queries please contact us:

Email:   

htacommissioning@nihr.ac.uk