Continuing areas of research interest to the PHR Programme

Please provide the precise aims and research questions your project will address, justifying these by referencing relevant literature. You may like to present these in a PICOST format (Population, Intervention, Comparator, Outcome/s, Setting and Timing).

Summarise your project plan plus any additional points required to support statements made in the previous sections of your application. Include any key references required to justify the points made (for example the use of particular outcome measures or methods of analysis). 

References

Please upload one page of references in the ‘Uploads’ section of the application.

Research design

• for primary research: clearly summarise your study design. Include all of its components (for example primary and secondary outcomes, process and economic evaluations) and relevant time points for baseline and follow-up data collection for each component. You should reference established research techniques, providing details of how exposure to the intervention will be determined or defined. You should fully explain and justify any adaptations of these for the purposes of the research proposed
• for evidence synthesis: if you are proposing a systematic review and/or an evidence synthesis, you should provide details regarding the size of the available literature base, along with details of the search and review strategy

If your application proposes to carry out feasibility and/or pilot studies or is staged (for example, full effectiveness evaluations with a built in pilot phase), you should include clear criteria against which to judge whether progression to the next stage is justified. If you are proposing an evaluation of effectiveness, you should detail any prior scoping, feasibility and/or pilot work and, where appropriate, how the progression criteria of any feasibility and/or pilot study has been met. There are no set progression criteria to use but you should aim to explain whether the uncertainties which need to be addressed have been determined, or how they will be. This will give confidence that a full evaluation is feasible. 

Examples of progression criteria could include (but are not limited to):

• can/did you recruit people/centres within a reasonable timespan and retain them to follow-up?
• is/was the intervention sufficiently acceptable and feasible to implement?
• can the intervention be delivered with reasonable fidelity?
• do you have commitment to fund the intervention for the duration of the study?
• can the outcome measures be measured across your target population?
• is the underlying question still the same/has the context changed?

Please note that the criteria listed above should be used as a guide only. It does not represent a comprehensive list of all the progression criteria that should be included within an application for a feasibility/pilot study. It is also not a comprehensive list for which feasibility will need to be evidenced in an application for an evaluation of effectiveness. 

Evaluation

You should include details of the intervention(s) or policy under evaluation, such as:

• its components and their frequency and intensity
• theoretical basis
• specific techniques used
• modes of delivery
• who will deliver the intervention 

You may like to refer to the TiDIER guidance on reporting interventions (Template for Intervention Description and Replication (TIDieR). Providing a clear description of what is being evaluated or studied is key to justifying the need, value and importance of a study. It is also essential to explain to our Funding Committee how your study design is fit for purpose. We have a broad view on what constitutes an ‘intervention’ or policy under evaluation. 

Logic Model

Please upload a 1 page logic model depicting your theory of change, to help explain the intervention being evaluated.

Control/comparator group

Please state what comparator(s) will be used in your study. Justify its appropriateness for answering the research question, and describe how it will be selected.

Study population

Which population(s) will be the target for the intervention and the participants in the research? How will the population(s) be recruited and retained?

Setting

Where will the research be undertaken and the intervention delivered?

Outcome measures

Please state and justify the primary and secondary outcome measures.

Methods for data collection

For each outcome, process or economic study component proposed, please state the source of the data that will be analysed. Where this is primary data collection, please state the quantitative and/or qualitative method used where appropriate. Where this is secondary data, please describe the characteristics of the dataset and the process by which access will be obtained.

Primary outcomes must be health related. The PHR Programme will accept proxy measures for health as long as they are appropriately defined and the link to health is clearly justified. You are encouraged to consider additional outcome measures including those relating to the broader determinants of health and health inequalities, which should be specified and justified. When describing your approach to health inequalities, please give details of relevant health inequalities related to your study; the nature of the inequality and the definition of the population groups. 

Sample size

Please describe and justify the proposed sample size for each element of the study. Justify the values used in the calculation by giving their source and/or some sensitivity around assumed values.

Data and analysis

Please detail how you will analyse each study data set. Clearly state the purpose of any analysis. You must state the proposed type and frequency of analyses including the selection of participants who will be included in the analyses. Describe any planned interim and sub-group analyses, sensitivity analysis and how missing data will be handled.

Health economics

Understanding the value of public health interventions – whether the outcomes justify their use of resources – is integral to the PHR Programme. The main outcomes for the economic evaluation are expected to include health (including health-related quality of life) and impact on health inequalities, with consideration of broader outcomes welcomed. Your economic evaluation should make clear where resources relate to different economic sectors and budgets. We encourage different approaches to economic evaluation as long as they assess the value and distributive impact of interventions. If your application does not assess distributive impact of interventions or does not include an economic component, you should provide appropriate justification.

Stakeholder engagement

You are strongly encouraged to ensure that a wide range of stakeholders are meaningfully involved in the design and planning of the research and throughout the work. Examples of stakeholders include decision-makers, commissioners, members of the public*, and people with lived experience. You might do this through involving them as costed/rewarded members of the research team. 
*Please note there is a detailed section on public involvement within your study that does not need to be repeated here.

Project timescale and milestones

Please provide a clear indication of the study timescale and dates by which key milestones should be achieved.

Flow Diagram

Please upload a one page flow diagram detailing your study timelines and milestones.

Please state how your study will be managed, and who will manage it. Refer to the roles of specific applicants as appropriate. 

Where applicable, this section should also describe how any conflicts of interest will be managed, such as involving stakeholders with a financial or non-financial interest in the intervention in the study team.

Understanding the value of public health interventions – whether the outcomes justify their use of resources – is integral to the PHR Programme, where resources relating to different economic sectors and budgets are potentially relevant. The main outcomes for economic evaluation are expected to include health (including health-related quality of life) and the impact on health inequalities as a minimum, with consideration of broader outcomes welcomed. Different approaches to economic evaluation are encouraged as long as they assess the value and distributive impact of interventions. Applications that do not include an economic component should provide appropriate justification.

NIHR welcomes partnerships between research active and other less active institutions, and those located in geographical areas of deprivation. Researchers are encouraged to explain how they will share their findings with local and regional governments, social housing providers, special interest, private sector rental and third sector housing organisations, community audiences and other relevant stakeholders. 

Research governance and ethical approval

Please indicate what research governance issues will need to be addressed in your research and state how you will seek and obtain ethical approval. You must either comply with the research ethics framework formulated by the Economic and Social Research Council (ESRC) or obtain approval via the National Research Ethics Service (NRES). 

Please note that we will check all proposals recommended for funding which involve a clinical trial. We check for potential overlaps using WHO trials before we communicate any funding decision. Consequently, a funding recommendation may not be taken forward if a major overlap is identified at this stage. It is therefore important that you highlight any potential overlaps before your application is considered by the Funding Committee. You should then explain how you expect your proposed research will add to the body of knowledge, referring to current policy and practice.