Timetable and Budget
| Description | Deadline/Limit |
|---|---|
| Deadline for Stage 1 Applications | 24 October 2023, 1PM |
| Notification of outcome of Stage 1 Application | 09 January 2024 |
| Deadline for Stage 2 application | 20 February 2024, 1PM |
| Notification of outcome of Stage 2 Application | June-July 2024 |
| Project Start | Within two months of award notification |
| Project Duration | 24-30 Months |
| Budget | £400,000 to £500,000 per project |
Introduction
The National Institute for Health and Care Research (NIHR) Policy Research Programme (PRP) invites applications for a single research project to evaluate the effectiveness of the current Thalidomide Health Grant in supporting Thalidomide Survivors health needs.
Background
The Thalidomide Community
Between 1958 and 1961, the drug Thalidomide was taken by expectant mothers to control symptoms of morning sickness. The drug led to many babies being born with physical disabilities, and we refer to this group of people as people affected by Thalidomide, and/or beneficiaries of the Thalidomide health grant.
There are currently 302 beneficiaries living in England, all aged between 59 and 64. They are living with a wide range of disabilities which include damage to the upper and lower limbs, musculoskeletal problems, facial damage, sensory impairment and damage to internal organs. A small number of beneficiaries also have cognitive impairments.
The Thalidomide Trust is a registered charity established in 1973 to provide support to individuals living with disabilities as a result of their mothers taking Thalidomide whilst pregnant in the UK. As well as administering grants to individual beneficiaries, The Thalidomide Trust provides a wide range of non-financial support, including information, advice and advocacy on health, independent living, housing and benefits, emotional support and assistance with financial management.
Please see Annex A for further detail from the Thalidomide Trust on the background and context.
The Thalidomide Health Grant
In 2012, the Government agreed a 10-year Thalidomide Health Grant of £80 million to support people affected by Thalidomide. The Grant was made in recognition of their additional health and wellbeing support needs especially as they get older. It enables them to personalise the way their health and care needs are met, maintain independence, and minimise any further deterioration in their health.
In 2021, the Chancellor committed to life-time support for people affected by Thalidomide, including around £40 million in the first instance. In 2023, the Department for Health and Social Care (DHSC) issued a four-year grant agreement with The Thalidomide Trust. At the end of this four-year period, there is an agreement that beneficiary numbers and needs will be reviewed as part of implementing the lifetime commitment.
The Grant is paid on an annual basis to the charity The Thalidomide Trust, who then allocate a sum each year to beneficiaries who have been affected by Thalidomide, based on their level of thalidomide damage. This grant can only be used to meet health and wellbeing related needs of beneficiaries who are resident in England.
Research priorities
The aim of this research, which we anticipate will involve both impact and process evaluation, is to provide evidence to help understand:
- The additional health and care needs of people affected by Thalidomide particularly as they age (which will include drawing on existing evidence available as provided by the
- Thalidomide Trust),
- What funded resources or activities produce the most tangible benefits to this group,
- How best to distribute financial support to this group,
- The extent to which their needs are met by the Thalidomide health grant.
Input from people affected by Thalidomide is key to this research, as will information available from the Thalidomide Trust. Applicants are expected to engage with and involve people affected by Thalidomide throughout this evaluation work. Applications without active involvement from this community will not be successful. Successful applicants will be able to make contact with beneficiaries who agree to participate in the research, via the Thalidomide Trust.
We anticipate that the evaluation will consist of three strands. Below we have outlined priority research questions. We are open to suggestions for additional topics and questions for inclusion in the research.
The first strand aims to understand the changing needs of people affected by Thalidomide. We need to understand how the needs of people affected by Thalidomide are changing with age and how to assess these needs.
Key research questions we would like to answer within this strand include:
What are the unique health and wellbeing support needs of people affected by Thalidomide? How are these needs evolving with age, and can they be generalised or are they person specific?
What are the different ways the unique health and wellbeing needs of beneficiaries can be assessed, and how often, to plan what financial support beneficiaries require to live independent lives?
We propose researchers take the following two-stage approach to this strand:
- A review of the existing evidence on beneficiaries’ health and care needs, including evidence already gathered by the Thalidomide Trust. The Trust has gathered data over several years on beneficiaries’ current needs, working with external experts to define the projected future needs of beneficiaries with different patterns of damage. The Trust have also used external data and their own records of beneficiaries’ expenditure to identify the cost of meeting current and future needs and worked with an independent forensic accountant to model the likely future costs at different age-points. This information can be shared with the successful applicant.
- Additional Primary research on beneficiaries’ needs will be informed by findings from the review of existing evidence in part a.
The second strand aims to understand the impact of the Grant on the lives of people affected by Thalidomide. The successful applicant will be able to make contact with beneficiaries who agree to participate in the research, via the Thalidomide Trust.
Key research questions we would like to answer within this strand include:
To what extent is the main aim of the Thalidomide Health Grant (which is to support people affected by Thalidomide with their additional health and wellbeing support needs) met, and how does this differ by groups of beneficiaries (i.e. level of capacity, impairment scores, pattern of damage)?
What works particularly well, and what works less well, in terms of supporting people affected by Thalidomide with the Grant? Are there any unintended impacts, and could anything be improved?
The third strand aims to explore how support could be improved based on the findings from the first strand (around how needs are changing) and second strand (around the impact of the current grant). This will also allow us to understand how their financial support is planned and whether there are ways to make the distribution mechanism better suited to meet the evolving needs.
DHSC and the Thalidomide Trust can provide researchers with the necessary background context and financials on the current grant funding mechanism to support work on this strand.
Key research questions we would like to answer within this strand include:
How does the current health grant rate work and is it set at an optimal value to distribute the grant equitably in line with identified needs?
Is funding distributed in a way that best takes account of individual needs? How would we best assess relative needs, and what would the costs and anticipated effects of assessing in this way be?
How equitable is the current distribution system for allocating money to different groups of beneficiaries (i.e., level of capacity, impairment scores, pattern of damage)?
How are “exceptional needs” classified? Could these needs be anticipated and considered within holistic needs assessments carried out by the Trust with beneficiaries every 3 years, rather than allow additional applications on a case-by-case basis?
Are there ways in which the level of beneficial impact on people affected by Thalidomide can be improved within the same Grant budget? Are there any additional cost burdens of changing the way that funding is utilised?
Eligibility
Eligibility for the NIHR PRP is laid out in our Standard Information for Applicants and applies to all calls unless otherwise stated in the individual research specification.
Expertise required
Stakeholder engagement: Stakeholder engagement skills are essential as the successful applicant will be directly working with The Thalidomide Trust and people affected by Thalidomide.
Expertise and experience of working with people with lived experience of disability: All people affected by Thalidomide have physical disabilities, and in addition a number have hearing or vision impairment, learning disabilities, cognitive impairments and/or be neurodivergent. A significant number also have limited literacy, so materials for engagement with beneficiaries will need to be produced in different formats, such as video, easy read and British Sign Language (BSL). It will be critical to establish a relationship of trust with participants and engagement will need to be managed sensitively to ensure they feel supported and protected throughout. Please see Annex B for further context provided by the Thalidomide Trust, on working with beneficiaries.
Outputs
Applicants are asked to consider the timing and nature of deliverables in their proposals. Policymakers will need research evidence to meet key policy decisions and timescales, so resource needs to be flexible to meet these needs. A meeting to discuss policy needs with DHSC officials will be convened as a matter of priority following contracting. The research outputs could comprise messages for the DHSC and the Thalidomide Trust about the operation of the Health Grant for consideration and discussion, ahead of the review following the current four-year grant agreement.
Outputs should include:
- Interim reports and updates as agreed at project scoping, as required, and to meet timings as set by the Health Grant funding periods.
- A final publishable report, with an executive and lay summary for the first and second strand of work.
- Reports should be available in accessible formats to suit a range of audiences, including easy read versions. This includes all reports, including interim reports.
- Other summative outputs (such as policy briefings), if required.
- Presentations of findings to DHSC colleagues and key stakeholders from other government departments and arms-length bodies, The Thalidomide Trust and people affected by Thalidomide, where required, including for interim reports.
- Access to the raw data from the research at the end of the research period for DHSC colleagues to use in further policy decision making (this is desirable, but not essential).
Budget and duration
Applications will be assessed on value for money, we would expect them to cost between £400,000 - £500,000.
At this stage, we would expect the research project to be completed by late 2026 to provide detailed and useful insight for the future grant agreement. Interim reports are expected throughout this period in a form suitable for busy policymakers and include easy read formats.
Costings can include up to 100% full economic costing (FEC) but should exclude output VAT. Applicants are advised that value for money is one of the key criteria that peer reviewers and commissioning panel members will assess applications against.
Management arrangements
A research advisory group including, but not limited to, representatives of DHSC, The Thalidomide Trust, people with lived experience, and the successful applicants for the research should be established by the successful applicant. The advisory group will provide guidance, meeting regularly over the lifetime of the research. The successful applicants should be prepared to review research objectives with the advisory group, and to share emerging findings on an ongoing basis. The successful applicant will therefore be expected to:
- Provide regular feedback on progress
- Produce timely reports to the advisory group
- Produce a final report for sign off
Research contractors will be expected to work with nominated officials in DHSC, its partners and the NIHR. Nominated contacts should be provided to DHSC for day-to-day enquiries.
Applicants will be required to engage with The Thalidomide Trust throughout the research. Applicants should consider how they propose minimising the burden on the Trust when designing their research proposal.
Key documents including, for example, research protocols, research instruments, reports and publications must be provided to DHSC in draft form allowing sufficient time for review. This time to review should be factored into project timelines at the beginning of the research process. Review timelines are estimated to take a month.
Guidance on Health and Care Inequalities and associate data collection within NIHR PRP Research
Health and care Inequalities is a high priority area within the Department of Health and Social Care and the NIHR and is often present in a majority of funded projects.We are now assessing all NIHR research proposals in relation to health inequalities. We ask that you please clearly identify in the research plan section of the application whether your application has an inequalities component or theme as well as how this research hopes to impact inequalities or not. Please also detail the core set of inequality breakdown data that will be collected, if applicable. More information on this request can be found in the Standard information for applicants.
Annex A: Background/context
Text below provided by the Thalidomide Trust.
The Thalidomide Community
There are currently 302 beneficiaries living in England, all aged between 59 and 64.
They are living with a wide range of disabilities which include damage to the upper and lower limbs, musculoskeletal problems, facial damage, sensory impairment and damage to internal organs. A small number of beneficiaries also have cognitive impairments.
More than 85% of beneficiaries have some form of damage to their upper limbs – with over 40% of these having arms significantly shorter than elbow length and many with no arms at all – and over a quarter of all beneficiaries have both upper and lower limb damage.
Although the impact of lower limb damage is well understood, the impact of upper limb damage – which is less common in the general population - is considerable and the majority of beneficiaries with these disabilities have difficulty undertaking at least some normal day-to-day tasks that most people would take for granted, without support or adaptations.
Beneficiaries live with significantly worse physical and mental health than the general population of the same age. Not only are they living with the impact of their original thalidomide damage but normal health issues associated with ageing are frequently exacerbated by their disabilities. A comparison between beneficiary data collected at Holistic Needs Assessments (HNAs) and representative and comparable sample of the general population from the Health Survey for England (HSE) shows they have a significantly higher prevalence of physical health conditions across all 11 measured health categories – nervous system, digestion, ear, cardiovascular, eye, sleep, urinary, chest, musculoskeletal, diabetes and cancer.
Pain is not recorded as a specific health category in the routine HSE data, however, over 90% of beneficiaries report experiencing pain in comparison to 43% of the general population aged 55-64 referenced in ‘Chronic pain in adults 2017: Health Survey for England’.
Many beneficiaries’ academic achievements were limited by the fact that they were sent to schools for the disabled that did not prioritise academic achievements and/or because their education was interrupted by multiple hospital admissions at a time when there was no additional support provided to children with disabilities. A number are either unable to read or write or have very low levels of literacy.
A small number of beneficiaries (circa 20) have been assessed as lacking capacity to make decisions about their health and finances and require a significant level of support.
The Thalidomide Trust
The Thalidomide Trust – a registered charity - was established in 1973 to provide support to individuals living with disabilities as a result of their mothers taking thalidomide whilst pregnant in the UK.
As well as administering grants to individual beneficiaries, the Trust provides a wide range of non-financial support, including information, advice and advocacy on health, independent living, housing and benefits, emotional support and assistance with financial management.
As part of the package of support offered, trained staff visit each beneficiary every three years to undertake a holistic needs assessment (HNA) and identify areas where needs are changing and additional support is required.
These assessments not only result in tailored support for the individual beneficiary but enable the collection of comprehensive data on the needs of the community which informs future service planning. A key principle underpinning the HNAs undertaken is that the information shared will not in any way influence the level of funding received by the individual beneficiary and this has helped foster openness and honesty.
The Trust has also commissioned a number of research projects – often drawing on HNA data as the evidence base. This includes a detailed study of the forecast future costs faced by beneficiaries, depending on their pattern of thalidomide.
Because of the complex communication needs of beneficiaries, the Trust routinely produces information in a recorded as well as written format, with BSL subtitles and in an Easy Read format. We also offer professional interpreters for scheduled one-to-one communications with hearing impaired beneficiaries who use BSL.
Background to the Health Grant
Following a pilot, the 10-year Health Grant agreement was put in place in 2012 in recognition of the increased health and wellbeing needs - and associated costs – resulting from their thalidomide damage. A key principle underpinning the Health Grant is that it can be used to meet both physical and mental health & wellbeing needs and that each beneficiary is able to personalise the way they spent their Health Grant to meet their specific, individual needs. However, there are a number of defined categories of expenditure that the Health Grant can be spent on, and beneficiaries must sign a declaration each year to confirm that they will only utilise their Health Grant for these. They are:
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Independent Living
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Home Adaptions
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Personal Assistance
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Medical Treatment
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Technology
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Respite
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Social Activities
Every three years, when they have an HNA, each beneficiary provides a detailed breakdown of their Health Grant expenditure over the preceding 12 months under each of the agreed expenditure categories.
Annex B: Working with beneficiaries
Text below provided by the Thalidomide Trust
Working with beneficiaries
Researchers working with beneficiaries will need to show sensitivity and empathy. A significant proportion of beneficiaries have an inherent fear and mistrust of authority and of the medical profession. It will, therefore, be critical to establish a relationship of trust with participants and engagement will need to be managed sensitively to ensure they feel supported and protected throughout.