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
What is the clinical and cost effectiveness of glucagon-like peptide-1 receptor agonist (GLP-1) therapy for weight loss in patients with severe mental illness?
- Intervention: Glucagon-like peptide-1 (GLP-1) receptor agonist (specific medication within the GLP-1 class and its dose to be defined and justified by the applicants) and usual care (to be defined and justified by applicants). Applicants may consider whether any additional pharmacological or non-pharmacological technology should be included, either alone or synergistically with the GLP-1 therapy. They should justify the inclusion of any additional technologies with reference to current practice and potential patient benefit as balanced against the impact this inclusion would have on the study design, cost effectiveness and delivery, as well as the generalisability of the research findings.
- Patient group: People with severe mental illness who are living with overweight or obesity (to be defined and justified by applicants). Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
- Setting:Any appropriate setting.
- Control:Placebo and usual care (to be defined and justified by applicants).
- Study design: A pragmatic randomised controlled trial and cost-effectiveness analysis 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: Body weight.
- Other outcomes:Glycaemic control (HbA1c); abdominal obesity; lipid profile, blood pressure; diagnosis of diabetes; acceptability to patients; percentage of patients taking their medication (both GLP-1/placebo and any other medication) as prescribed; side effects; relevant mental health outcomes; health-related quality of life; psycho-social outcomes; adverse events; clinician attitudes towards prescribing; cost effectiveness. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant).
- Minimum duration of follow-up: To be defined and justified by applicants.
- Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.
Rationale
People with severe mental illness (SMI), such as schizophrenia or bipolar disorder, are at least twice as likely to live with obesity and be at risk of diabetes as people without SMI. Their lives are – on average – up to twenty years shorter than general life expectancy. They are less likely to receive treatment for chronic physical conditions. Many premature deaths among people with SMI are caused by preventable conditions.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs, sometimes referred to as incretin mimetics) have been used in the management of diabetes. They appear to hold potential for use in other indications, in particular for weight loss in people who do not have diabetes. Two of them, liraglutide and semaglutide, have recently been recommended by NICE for weight loss in some patients.
However, these medications are relatively expensive, most of them have to be injected (although tablets are starting to become available), and they may cause side effects. There is also a lack of reliable evidence of their effectiveness and safety specific to patients with SMI. The HTA Programme wishes to address this lack of evidence by funding a randomised controlled trial, as part of a wider initiative to address the significant needs of patients with physical and mental health co-morbidities.
Applications should be co-produced, demonstrating an equal partnership with service commissioners, providers and service users (or their advocates) in order to provide evidence and actionable findings of immediate utility to decision-makers and service users. Applicants may wish to consult the NIHR Learning for Involvement guidance on co-producing research.
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 online no later than 1pm on the 27 July 2022. Applications will be considered by the HTA Funding Committee at its meeting in September 2022.
Guidance notes and supporting information for HTA Programme applications are available.
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 January 2023.
Applications received electronically after 13:00 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 by email: htacommissioning@nihr.ac.uk