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
Are pain management programmes a clinically and cost-effective intervention for patients with endometriosis-related chronic pain not adequately controlled by surgical and/ or pharmacological treatment?
- Intervention: Pain management programme
The NICE definition of a pain management programme: any intervention that has two or more components including a physical and a psychological component, with some interaction/coordination between the two.
Applicants to define and justify content, duration and delivery of pain management programme. Including adaptations/tailoring of current pain management programmes for this patient group. - Patient group: Women with endometriosis-related chronic pain not adequately controlled by surgical and/ or pharmacological treatment. Applicants to define and justify criteria for chronic pain.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. - Comparator: Standard care
- Setting: Patients should be recruited from all relevant settings, noting there may be more than one. Applicants should ensure that all relevant healthcare professionals are represented in the applicant team. Intervention to be delivered in any appropriate setting - applicants to define and justify.
- Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
- Important outcomes: Health related quality of life; Pain intensity and pain frequency
Other outcomes- Physical activity, Emotional wellbeing, Medication and healthcare utilisation, Satisfaction with social roles and activity, Productivity (social and work-related activities) Discontinuation, Cost effectiveness.
Applicants should consider the recent core outcome set for Endometriosis (BJOG 2020)
Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. - Minimum duration of follow-up: 12 months
Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.
The NIHR recognises that people have diverse gender identities, and in this research brief, the word ‘women’ is used to describe patients or individuals whose sex was assigned at birth as female, whether they identify as female, male, or non-binary.
Rationale
In the UK, around 1.5 million women and those assigned female at birth are currently living with endometriosis. Endometriosis is a gynaecological condition where cells similar to the ones in the lining of the womb are found elsewhere in the body (definition by Endometriosis UK). Each month these cells react in the same way as those in the womb, building up and breaking down and bleeding. Unlike the cells in the womb that leave the body as a period, this blood has no way to escape.
Endometriosis can have a significant impact on a person’s life in a number of ways including chronic pain, fatigue/lack of energy, depression/isolation, problems with a couple’s sex life/relationship, an inability to conceive, and difficulty in fulfilling work and social conditions.
Currently there is no cure for endometriosis. The different treatments available for endometriosis aim to reduce the severity of symptoms and improve the quality of life for someone living with the condition. Treatment options include pharmacological, non-pharmacological and surgical treatments. Often the choice of treatment depends on the person's preferences and priorities in terms of pain management and/or fertility.
When pain caused by endometriosis is not adequately controlled by the options above, or they are not the preference of the patient, a referral to a pain clinic may occur to help manage the chronic pelvic pain often seen with endometriosis. Pain management programmes (PMPs) are designed to help people better manage their chronic pain and everyday activities. They do not aim to cure pain. PMPs are usually delivered as a group intervention by a multidisciplinary team of healthcare professionals who have specialist training in pain management. The British Pain Society Guideline for pain management programmes for adults state: “The general aim of PMPs is to improve participation in daily activities and enhance “quality of life” for those with persistent pain and disability. This includes a focus on increasing mobility, self-care, work, leisure and social activities, emotional well-being and reducing reliance on medication or healthcare use.”
The clinical and cost effectiveness of PMP as an intervention for women with endometriosis was a research recommendation from the NICE guideline- Endometriosis: diagnosis and management [NG73]. NICE are currently updating their guidance on endometriosis and through surveillance and scoping they could not identify any significant new evidence for pain management programmes since NG73 was published in 2017: “Despite there being a recommendation for research for pain management programmes, there remains insufficient new evidence to trigger an update in this topic area. NICE will explore further research opportunities for this with the National Institute for Health and Care Research (NIHR).’” The HTA programme therefore wishes to commission the trial outlined above.
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 would like to apply for this funding opportunity, you can begin your application via the Funding opportunities page.
Your application must be submitted online no later than 1pm, 24 July 2024. Applications will be considered by the HTA Funding Committee at its meeting in September 2024.
Guidance notes and supporting information for HTA Programme applications are available by clicking the links.
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 January 2025.
Applications received electronically after 1pm 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, 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 us via email: htacommissioning@nihr.ac.uk.