24/74 Hysteroscopy and polyp removal for the improvement of premenopausal abnormal uterine bleeding commissioning brief

Introduction

The aim of the Health Technology Assessment (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

Is it feasible to conduct a randomised trial comparing the effectiveness of hysteroscopy and polyp removal (outpatient and inpatient) with conservative management, for the improvement of premenopausal abnormal uterine bleeding?

1. Patient group: Premenopausal women and people with abnormal uterine bleeding diagnosed with endometrial polyp on ultrasound scan. Applications are encouraged to demonstrate that they will be able to recruit from a population that is representative of the wider UK population in a future definitive trial.
2. Intervention: Hysteroscopy and polyp removal (outpatient or inpatient).
3. Comparator: Conservative medical management with hormonal or non-hormonal therapy for abnormal uterine bleeding (to be defined and justified by applicants).
4. Important outcomes and outputs: Determination of equipoise from patient (including ethnic and minority) and key clinician and stakeholder perspectives; numbers of patients potentially eligible for recruitment; acceptability of randomisation to patients and clinicians; determination of important outcomes for use in a future trial to include health-related quality of life, ideally specific to abnormal uterine bleeding, potential benefits and harms; feasibility of trial delivery.
   Applicants are encouraged to report recruitment and findings disaggregated by sex and gender (and other demographic factors where relevant).  
5. Setting: Any appropriate setting.
6. Study design: A feasibility study to assess whether a substantive trial is possible, and to establish key elements of the potential future trial design, including a randomised pilot trial to test key trial processes such as recruitment and adherence. The study should incorporate qualitative work with eligible patients and clinicians to understand the decisions and uncertainties of those involved and the role of hysteroscopy compared to conservative management.

A decision on whether to advertise for a substantive trial will be made at a later date once the results of the feasibility report are known.
It is anticipated that applications to this call will be no more than £500,000; however, there is no formal upper or lower limit. Value for money is a key consideration for all applications and all costs will need to be carefully justified.

Rationale

Endometrial polyps are growths that develop within the lining of the uterus. They are often found in premenopausal women and people who present with abnormal uterine bleeding (AUB) symptoms such as heavy menstrual bleeding, prolonged or frequent bleeding, or bleeding between periods. However, endometrial polyps can also be found during ultrasound scans in premenopausal women and people who have no symptoms, and their role in causing abnormal uterine bleeding is still not completely understood.

Hysteroscopy is a medical procedure that involves using a thin tube with a camera to examine the inside of the uterus, often in gynaecological outpatient and inpatient settings. Simultaneous removal may follow a diagnosis of endometrial polyps if location, size, and clinical conditions allow this (the ‘see & treat’ approach).

There is a shortage of adequate evidence to support the effectiveness of hysteroscopy and polyp removal to improve abnormal uterine bleeding symptoms. Additionally, the proportion of polyps that disappear without treatment is unknown, and research suggests that the likelihood of isolated malignancy in endometrial polyps (in both premenopausal and other women) is rare in the presence of normal endometrial biopsy findings. Alternatively, conservative medical management is a range of non-surgical treatment options (hormonal or non-hormonal) used to control symptoms of premenopausal AUB.

Both outpatient and inpatient hysteroscopy procedures for polyp removal incur significant healthcare costs and resource utilisation. Furthermore, patient groups have reported negative and painful experiences associated with outpatient hysteroscopy and polyp removal. There is a need to evaluate the clinical and cost-effectiveness of hysteroscopy and polyp removal for the improvement of symptoms of abnormal uterine bleeding, however scoping and feasibility work is required prior to full evaluation. Therefore, the HTA Programme wishes to commission research in this area to inform future practice.

Additional 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 would like to apply for this funding opportunity, you can begin your application via the funding opportunity page.

Your application must be submitted online no later than 1pmon 29 January 2025. Applications will be considered by the HTA Funding Committee at its meeting in March 2025.

Guidance notes and supporting information for HTA Programme applications are available

Shortlisted Stage 1 applicants will be given 8 weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in July 2025.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team, other than in unusual circumstances (for example, a lead from a named charity or a unique national expert in a condition).

For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams, and both teams should acknowledge in their application that they are aware of the situation, and that study details have not been shared.

Should you have any queries please contact htagb@nihr.ac.uk