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23/44 Effectiveness of oral nutritional supplements in older adults with malnutrition commissioning brief

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Published: 23 March 2023

Version: 1.0 March 2023

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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 effectiveness of oral nutritional supplements in older adults with malnutrition?

  1. Patient group: Community-dwelling adults over the age of 65 and/or residents of care and nursing homes with signs and symptoms of malnutrition, or who are at risk of malnutrition due to factors such as frailty. Applicants should carefully define and justify the patient group taking into consideration the potential heterogeneity of this wide patient group. Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. 
  2. Intervention(s): Oral nutritional supplements (ONS). Choice, dose and duration of supplement to be defined and justified by applicants. 
  3. Comparator: Other interventions with positive signals of efficacy with respect to treating or preventing malnutrition in people over 65, for exanmple energy-dense meals through food enrichment. Applicants may propose to evaluate more than 2 interventions, including multi-component interventions and components aimed at facilitating adherence, through multi-arm trials, factorial trials, platform trials and others. 
  4. Important outcomes: Quality of Life (QoL); Functional outcomes, using both performance and self reported measures. Other outcomes: Patient acceptability; Adherence; Hospitalisation; Morbidity; Mortality; 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, plus other demographic factors where relevant.  
  5. Setting: Community and/or care and nursing homes. Applicants to define and justify the setting taking into consideration any potential heterogeneity. 
  6. Study design: Applicants to propose and justify the trial design which will sufficiently answer the research uncertainty. Applicants are encouraged to propose trial designs that enable a comparative evaluation of 2 or more interventions including multi-component interventions. If feasible, applicants may also consider trial designs that enable differentiation between participants based on relevant characteristics that might further optimise treatment choices through informed prediction of successful interventions. 
  7. Minimum duration of follow-up: Minimum 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.

Rationale

Malnutrition (or undernutrition) defined as the deficiency of energy, protein, vitamins and minerals causes weight loss, muscle loss and functional limitations. It is estimated that more than 1.3 million adults aged 65 or over in the UK are suffering from malnutrition. Malnutrition has serious adverse complications including physical decline; poorer outcomes of disease, increased complications and poor quality of life and well being. People with malnutrition have more GP visits, are more likely to be admitted to hospital, have increased length of hospital stay, increased re-admissions and delayed recovery.

Older people who are frail are at particular risk of malnutrition, and frailty and malnutrition are closely interlinked. Malnutrition is a complex problem and a substantial threat to our health, especially as we age.

Current UK guidance focusses on treating malnutrition to provide oral or artificial nutrition support, where indicated, including dietary advice, food fortification or prescribed oral nutritional supplements (ONS). However, there is little evidence on whether ONS (with or without other nutritional support) are effective in reducing malnutrition specifically for older people with frailty. Well conducted research is crucial to improve outcomes for growing diverse populations of older people with malnutrition and frailty, and to inform guidance for clinicians and practitioners who have a key role in managing these conditions across health and social care settings.

Applicants are expected to ensure research proposals do not duplicate or significantly overlap with other ongoing or published research. Studies should build on and complement these. Applicants are expected to clearly explain how their proposed research fills an important evidence gap.

To support the ambitions of NIHR’s Best Research for Best Health: the next chapter, NIHR strongly encourages the inclusion of nurses, midwives and allied health professionals within well-developed research teams responding to this call, to increase the building of nurse, midwife and allied health professional-related research activity, capacity and capability across the professions. Depending on the level of experience, this could be through the role of lead applicant, as joint co-applicant supported by detailed mentoring plans submitted with the application, or as a co-applicant member of the research team. Through this activity, NIHR aims to support nurses, midwives and allied health professionals to become future research leaders and release the potential to lead, use, deliver and participate in research as a part of their job.

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

Your application must be submitted online no later than 1pm on 20 September 2023. Applications will be considered by the HTA Funding Committee at its meeting in November.

HTA Programme Stage 1 guidance notes are available, alongside supporting information for applicants.

Please note that 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 March 2024.

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, 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. 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 htagb@nihr.ac.uk.