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 discontinuing thickened fluids compared to continuing thickened fluids in adults with slowly progressing oropharyngeal dysphagia?
- Patient group: Adults with slowly progressing oropharyngeal dysphagia who have been using thickened fluids regularly with a current expectation that they will continue using them.
The HTA Programme is particularly interested in applications focused on patient groups where evidence is especially lacking and the long-term use of thickened fluids for dysphagia is common, for example, adults in care homes, adults with learning disabilities. Applicants are encouraged to keep the patient group as broad as possible and use subgroup analysis if appropriate.
Applicants to define and justify the patient group, including health condition(s), length of time using thickened fluids, etc. Depending on the patient group, applicants need to be aware of the underlying principles and provisions of the Mental Capacity Act when working with research participants who lack, or may lack, capacity.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. - Intervention: Discontinuation of thickened fluids. Applicants will need to define and justify a protocol for the discontinuation of thickened fluids. Other aspects of an individual’s treatment for dysphagia should continue as usual.
- Comparator: Continuation of thickened fluids. Other aspects of an individual’s treatment for dysphagia should continue as usual.
- Important outcomes: Quality of life; Clinically relevant respiratory health outcomes (e.g., aspiration pneumonia).
- Other outcomes:
- General physical health; hydration; nutritional status; weight loss; hospital admissions; number of antibiotic prescriptions; mental health; mealtime performance; adherence; patient/carer acceptability; carer outcomes; adverse events; side effects; mortality, fidelity to discontinuation protocol; 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). - Setting: Thickened fluids are used across health and social care settings. Applicants to define and justify the most appropriate setting(s) for their specified patient group.
- Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment, adherence and the protocol for discontinuing thickened fluids.
Clear stop/go criteria should be provided to inform progression from pilot to full trial. - Minimum duration of follow-up: 1 year.
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.
Rationale
Oropharyngeal dysphagia (hereon referred to as dysphagia) is a problem with swallowing. Signs of the condition include coughing or choking when eating or drinking and bringing food back up. Dysphagia is usually caused by another health condition. It is present in people across many health conditions and, therefore, treated and managed across many different health and social care settings. Difficulties with swallowing, eating and drinking can lead to other problems such as weight loss, dehydration and aspiration. Aspiration, where food and fluids enter the airways beyond the vocal cords, may increase the risk of respiratory complications.
Thickened fluids are one of the most common interventions for dysphagia. Thickened fluid moves more slowly in the mouth with the intention to help reduce aspiration and any potential complications of aspiration. However, despite the widespread use, there is a lack of evidence demonstrating its effectiveness. A recent review concluded that there is no convincing evidence that thickened fluids prevent pneumonia or improve quality of life, nutritional status or oral intake. When asked, patients prefer not to use thickened fluids, and their use has been associated with worsening emotional well-being and social-related quality of life.
At the beginning of 2024, the Royal College of Speech and Language Therapists (RCSLT) published a position paper on the use of thickened fluids in the management of dysphagia in response to requests from their members for guidance. The position paper included the best available evidence and expert opinion. It concluded that although thickened fluids remain one of several interventions for dysphagia, there is uncertainty about its effectiveness and a clear need for further research. One of the research recommendations highlighted in the position paper is how discontinuing using thickened fluids would affect health and quality of life. This refers to a significant cohort of patients who remain on thickened fluids for protracted periods of time often without an attempt to stop them. There is a lack of evidence to inform healthcare practitioners’ and patients’ decision-making about whether thickened fluids should be continued or discontinued.
Therefore, the HTA Programme is considering funding research to address this uncertainty and is particularly interested in applications focused on patient groups where evidence is especially lacking, and the long-term use of thickened fluids is common.
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 call, you can begin your application via the funding call page.
Your application must be submitted online no later than 1pm on 27 November 2024. Applications will be considered by the HTA Funding Committee at its meeting in January 2025.
Guidance notes and supporting information for HTA Programme applications are available.
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 May 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, 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 email htacommissioning@nihr.ac.uk.