This document provides answers to questions relating to the NIHR Programme Grants for Applied Research (PGfAR) and NIHR Programme Development Grants (PDG) highlight notice on for varied research approaches to address National Institute for Clinical Excellence (NICE) and NIHR priorities in multiple long-term conditions (MLTC). A webinar was held on 9 December 2021 to showcase and launch the initiative. This document is intended to supplement the PGfAR guidance for applicants and the highlight notice.
These FAQs will be updated when significant new questions/queries are submitted, so applicants are advised to check the NIHR website frequently for the latest version (as indicated by the date and version number).
Please email any questions to programme.grants@nihr.ac.uk.
Date: 10/02/2022
Version: 1
Scope of call
What is meant by a diverse proposal and methodological innovation?
PGfAR are interested in proposals that include a diverse range of methodologies to address important health and social care questions and to use varied and novel research designs to provide answers that will make a step change in terms of benefits to patients, service users, carers and the public.
The hallmark of the PGfAR scheme is its commitment to supporting the development and testing of complex interventions. This will not change. However, we are keen to see programmes of research that speed up the timescale to yield benefits for patients, service users, carers and the public. We want to encourage applications that, for example, take advantage of ‘natural experiments’, use existing healthcare data or observational cohorts, or involve novel epidemiological or statistical approaches to provide answers of direct relevance to health and care practitioners, policy makers and the public.
A particular priority is research that tackles neglected areas and stretches outside traditional healthcare settings, reaching into public health, social care or the voluntary sector.
The Programme Director, Professor Elaine Hay, has written a blog post that provides further insight. The blog features examples of recently funded awards that are applying diverse methodologies to address real world concerns.
As MLTC are multidimensional, could composite outcomes be used to try to address this?
We are in favour of the use of composite outcomes, particularly where a primary health outcome would not be sufficient to evaluate the changes being investigated. We would be supportive of methodological work that develops the use of composite outcomes within the context of an applied health and care research programme.
How can I balance the need for a methodological proposal against requirements for impact?
The development of novel innovative methodologies should be firmly embedded within the context of the applied health and care research programme, and should be facilitating the production of impactful research.
In contrast to the MRC-NIHR’s Better Research, Better Methods research programme, any methodological development must have a clear practical purpose that adds value to the overall delivery of the programme itself, and should be justified in terms of how the application of the method will lead to benefits for patients, service users, carers, the public and the health and care system.
Generating meaningful research impact requires engaging with the right people from the very beginning of planning your research idea. As outlined in the plan knowledge mobilisation web page, we encourage applicants to embed engagement and involvement of the potential end users of the research, for example policy makers and commissioners, throughout their programme, to increase the likely impact of the research.
We also recommend that applicants liaise with the NIHR Research Design Service and NIHR Infrastructure such as NIHR Applied Research Collaborations and the NIHR Research Schools to draw on their good practice in real world implementation of research findings.
Do PGfAR collaborate with the Medical Research Council (MRC) for co-funded applications?
There is no direct collaboration, but our roles complement each other. The remit of the MRC funded programmes are typically upstream of PGfAR in the translational health and care research pathway. PGfAR is focussed on delivering applied health and care research that can yield a step change in health and care practice and/or outcomes. Read more about how NIHR works with other funders in the Partners and Industry section of our website.
We are keen to support programmes of research that explicitly address the applied health and care research priorities identified by the charitable sector. We also actively engage in specific partnerships with charities. For example, through tailored calls, we have co-funded a number of programmes in partnership with the Diabetes UK and Versus Arthritis.
Will complementary and alternative interventions be considered, now often known as 'Integrative'?
The term ‘integrative’ is intended primarily to relate the aims of the NIHR Strategic Framework for MLTC research. PGfAR aims to fund high quality research to provide an evidence base which:
- identifies and maps common clusters of disease and their trajectories among the population
- identifies the problems and outcomes that matter most to patients and carers and how they would like to see services configured to meet their needs.
- enables the health and social care system to take a patient-centred, whole person approach to the treatment and care for people with MLTC-M, including quality of life and well-being
- Supports the design and delivery of interventions to prevent patients progressing from one long-term condition to MLTC-M.
We are also keen to support research designed to benefit the delivery of Integrated Care Systems that seek to improve access to joined up care and support for people in need from local councils, the NHS and voluntary and community organisations.
Alternative and complementary integrative interventions could be studied within a work package of a broader programme, however the competitiveness of a proposal would ultimately depend on the quality of the application. We recommend that applicants familiarise themselves with the Stage 1 Committee scoring instructions, which outlines the selection criteria used to shortlist applications. The selection committees take into consideration the strength of the case for the proposed research, and the likelihood that the research would produce important findings that could influence or be implemented in the NHS, public health or social care to substantially improve outcomes for patients, service users, carers and the public.
Addressing Inclusivity
What needs to be considered when conducting research on housebound patients with MLTC?
We have a number of research awards on our portfolio where people are participating in research from their homes. Applicants are encouraged to review the literature to determine the most appropriate strategies for the range of living circumstances amongst the participants being investigated.
In addition, by engaging and involving a range of people living with MLTC and their carers in developing the research design, the research team will be able to determine the most acceptable ways to ensure individuals can participate effectively in the study from within their homes.
Award holders should also consider consulting with their local Clinical Research Network (CRN) to understand their offer to support delivering research within homes.
Research Design Service (RDS) support
Can the RDS assist charities with grant applications or is the service limited to health professionals/academics?
The RDS offers high quality, responsive, specialist advice and support on research design and methodology, to researchers making funding applications for submission to NIHR research programmes and national, peer-reviewed funding competitions for applied health or social care research. The RDS is available to advise anyone who is putting together a grant application, including people working with charities.
It should be noted that PGfAR requires that the host organisations for our research awards are NHS bodies or other providers of NHS services in England provided they are capable of fulfilling the role of research sponsor as set out in the UK Policy Framework for Health and Social Care Research. An NHS body means (a) the Board; (b) a Clinical Commissioning Group; (c) a Special Health Authority; (d) an NHS trust; and (e) an NHS foundation trust.
This highlight notice specifically welcomes applications from co-ordinated multidisciplinary teams of investigators spanning relevant health and social care, and public health disciplines, and public and charitable contributors, bringing together all the skills and expertise, experiences and perspectives necessary to deliver the research proposed.
We would encourage charities to work in collaboration with an eligible host organisation, and academic partner organisations, to ensure the correct research governance structure is in place to support their research activities.
Is it imperative for research to occur within the NHS?
The appropriate setting for the delivery of the research should be determined on the basis of the priorities and needs of patients, service users, carers and members of the public involved, engaged and participating in the research. PGfAR offers researchers considerable flexibility to focus on a range of approaches to address relevant topics carried out in any healthcare, social care or public health settings.
The key constraint is that PGfAR research awards must be hosted by an NHS organisation or an organisation that delivers NHS services for the contractual reasons outlined above (question 7).
How do the RDS and funding panels interact in order to provide the most effective advice?
The RDS is a national service funded by the NIHR. The RDS leadership communicates with leaders of the NIHR research programmes to ensure that they are familiar with the nature and expectations associated with funding opportunities. This then informs the advice the RDS are able to provide to applicants.
To ensure impartiality, the competitions are managed by the research programme teams completely independently of the RDS. However, in order to enhance and refine their advice service, members of the RDS are provided with the opportunity to attend committee meetings as observers to the discussion of applications. Care is taken to ensure the RDS observers do not have a conflict of interest with the applications being reviewed.
How does the scheme differ from Health and Social Care Delivery Research (HS&DR) programme?
There is a degree of overlap between the two research programmes. The HS&DR funds evaluative research focused on the organisation and the quality of care, in a nutshell how health and care is delivered. This means in practice that typically HS&DR awards will evaluate process outcomes, whereas PGfAR awards are focused on health related outcomes.
In addition, rather than funding programmes of interrelated research projects as in PGfAR, HS&DR typically funds discrete projects.
We recommend that you contrast the scope of each programme (PGfAR and HS&DR) to determine which is the most appropriate funding scheme for your research proposal. Please consult the RDS if you need further support with your selection.
When thinking of multiple outcomes is there an approved way or guidance for determining what the primary outcome should be?
Part of the rationale for diversifying the types of research designs that PGfAR funds stemmed from the observation that so often the findings of definitive randomised controlled trials are considered ‘negative’ where significant differences are not detected in the primary outcome. However, there may be other important and significant quantitative and qualitative effects identified through the study, such as in the quality of life of the participants, and quality or efficiency enhancements to the service delivered by practitioners. For PGfAR the primary outcome, which usually measures clinical effectiveness, is not the only outcome of interest. Different work streams within the programme can have different outcomes, and the end use of interventions should also be considered and agreed in discussion with stakeholders such as patients, public and commissioners of health care. These concepts are usefully discussed in the recently published ‘A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance’.
When reviewing applications proposing a clinical trial, the Committee members see the primary outcome as having two different purposes: one is to ensure the study is large enough to give a robust answer; and the other is to ensure that the research answers the question of most importance to stakeholders including patients and the public. These two parts should be looked at in their own right, and clearly justified.
The RDS can provide expert advice on helping to determine the most appropriate primary outcomes for trials and the suitable outcomes for other evaluation methods.
Further questions
Is studying the prevention of a likely comorbidity appropriate for this call?
As outlined in the NIHR Strategic Framework for Multiple Long-Term Conditions (Multimorbidity) MLTC-M Research, MLTC-M and comorbidity provide two different perspectives through which to consider a patient with more than one concurrent condition.
Whilst the term MLTC-M includes ‘discordant multimorbidity’, research commissioned within the NIHR MLTC-M strategic framework will also be inclusive of single conditions which result in multisystem impacts or functional loss. The NIHR will fund high quality research to provide an evidence base which supports design and delivery of interventions to prevent patients progressing from one long-term condition to MLTC-M.
Prevention of a likely co-morbidity is within scope for this PGfAR funding call.
Would extensions to existing data sources be funded?
This is very much dependent on what will be investigated and determined by extending the data source. PGfAR will not fund data collection in itself, but will fund the collection of data where it is directly related to finding the answer to relevant research questions.
As stated above, we want to encourage applications that, for example, take advantage of ‘natural experiments’, use existing healthcare data or observational cohorts, or involve novel epidemiological or statistical approaches to provide answers of direct relevance to health and care practitioners, policy makers and the public.
Where there is poor IT infrastructure, could some of the PGfAR monies be used to unblock that big data opportunity?
Across England there are a number of NHS, local authority and university partnerships, funded by the NIHR Infrastructure awards such as the NIHR Biomedical Research Centres (NIHR BRCs) and the NIHR Applied Research Collaborations (NIHR ARCs), which are working strategically to resolve data management and governance issues so that the potential of the patient and service user data can be realised. For example, the NIHR Health Informatics Collaborative (HIC) is a partnership of 30 NHS trusts and health boards, including the 20 hosting NIHR BRCs, working together to facilitate the equitable re-use of NHS data for translational research. Another example is the Population Evidence and Data Science (PEDS) theme hosted by the NIHR ARC East of England.
PGfAR has a track record of funding research programmes that foster partnerships in the use of big data. Most notably the study ‘Improving the quality of care of patients with angina and heart attack’ which aimed to link and use electronic health records (EHRs) from primary care, hospitalisations and national registries in cardiovascular disease to identify opportunities to improve outcomes for patients with stable coronary artery disease and acute coronary syndrome. The research team created a novel research platform called CALIBER, involving linkage of four EHR data sources and over 600 phenotyping algorithms for diseases and risk factors.The investigators from this award went on to successfully established the Farr Institute London (led by MRC), which has subsequently informed national and international public health policy and become part of Health Data Research UK.
We encourage applicants to form partnerships with existing initiatives running in the NIHR Infrastructure, and other public sector data specialist organisations, to pool experience. Consideration could also be given to exploring a partnership with NHS Digital as appropriate.
What Clinical Research Network (CRN) support is available?
The NIHR Clinical Research Network (CRN) provides researchers with the practical support they need to make clinical studies happen in both the NHS and the wider health and social care environment. More information can be found on the CRN webpage.
As outlined in our webinar, in developing the PGfAR call we have been working with the senior leaders within the CRN and RDS. There are dedicated experts in local CRNs across the country who can support pre-applications to the PGfAR highlight notice call alongside the RDS.
The CRN will be able to specifically support you with the development of your application by using a new tool that draws together data from the NIHR, NHSE, PHE, ONS and devolved administrations. In line with NIHR’s strategic priority to bring clinical and applied research to under-served regions and communities with major health needs, the prevalence of different conditions in regions and communities can be geographically mapped using this CRN tool. The CRN can also use the tool to identify potential sites for your studies that will enable you to extend your research beyond local ‘tried and trusted' research sites to reflect the prevalence data. For more information please email inforequest@nihr.ac.uk.
When applying for PGfAR research funding, applicants are expected to consult their local CRN representatives who will support the completion of a Schedule of Events Cost Attribution Template (SoECAT) to determine the excess treatment cost, the NHS Support costs and the site level research costs. In Stage 1, applicants are expected to provide a strong estimate of the treatment and support costs associated with the proposal. A completed and signed SoECAT form is a mandatory part of a Stage 2 application, and informs the funding committee of the total cost of delivering the proposed research.
For more information please email inforequest@nihr.ac.uk.