Writing research and grant applications – from idea to submission Dan Hawcutt & Jenny Bellis Alder Hey Children’s NHS Foundation Trust Liverpool

Session Overview Why are you doing this research? What is already known? Setting the scene Developing a research question Selection of methodology Protocol development The research team Patient and public involvement Sources of funding

Example funding application outline Items covered in this session

Public, patients & parents From research idea to research proposal……… Joint Research Office Clinicians Academic Partners Accountants NHS Trust R&D Office Research Funder My Boss! NHS Trust Exec Pharma Methodologists Public, patients & parents

To find ways to improve outcomes for patients Why are you doing this research? For my CV To answer this question, once and for all! Publications To find ways to improve outcomes for patients It’s in my job description! To progress my academic career I’m doing a research degree To gather evidence for how we do things/want to do things

What is already known? Conduct a thorough literature review Ask your librarian for help ?? Undergraduate/pre-reg/diploma/summer student project Identify ongoing work Published protocols Professional networks UK Clinical Network Research Portfolio

Setting the scene Present a clear research question Describe the scale of the problem Ensure the evidence gap is clearly described (use Cochrane Reviews/Systematic Reviews where possible) Construct a health economic case Make sure it fits with the funder Does it fit the guidance or brief? Are there clearly defined outputs? Value for money? Check previous awards from funding body

Developing a research question Foundation for everything else What are the aims and objectives? Population Intervention Comparator Outcome(s) Notes for research question section Ask participants to shout out example research questions - identify PICO for their examples Use the following example, if needed (from NIHR funded project): A randomised controlled trial to determine whether application of emollient from birth for a year, can prevent eczema in high risk children.The primary objective of this study is to determine whether advising parents to apply emollient to their child’s skin daily for the first year of life in addition to best practice infant skin care advice can prevent or delay the onset of eczema in high-risk children, when compared with a control group who are given the best practice infant skin care advice only. Research question: Does the application of emollient from birth prevent eczema in high risk children? P – children at high risk of developing eczema I – emollient + best practice skin care C – best practice skin care only O – development of eczema The details will be developed further when we look at protocol development

Analysis of previous studies Selection of Methodology Study Idea Observational Cohort Case control Cross sectional Interventional Randomised Non-randomised Analysis of previous studies Systematic Review Meta-analysis Notes for selection of methodology section Consult an expert!! Think about Which method answers the question What is feasible Cost implications Ask participants to identify best methodology for their examples (if they have any) Provide examples of when each type of study design may be appropriate: Observational – not practical/ethical/cost-effective to randomise patients, can be pro- or retro-spective e.g. MAGIC, ADRIC Interventional – RCT/NRCT ‘gold standard’ but expensive to conduct e.g. emollient for prevention of eczema Evidence synthesis – may be inconclusive but equally, evidence might already be out there, economical to conduct For our example (eczema study) RCT design selected because………..

Protocol Development RCT http://www.consort-statement.org/ Reporting guidelines are a useful template for protocol writing – bring in collaborators as soon as possible to help you write this RCT http://www.consort-statement.org/ Observational http://www.strobe-statement.org/ Evidence synthesis http://prisma-statement.org/ Notes for protocol development section Consult relevant experts – context, methodology, analysis etc. Ask participants to talk through details under each heading on previous slide for the eczema example. Introduction/Background – prevalence and impact of childhood eczema, current prevention and management, potential impact of research – don’t forget lay summary – Use hospital/university librarians to help with literature search. Undergraduates/pre-regs/diploma students/summer students may be able to help with literature review Design – RCT (single centre / multi-centre / cluster) Participants, Interventions, Outcomes – see earlier Sample size – need statistical input, essential for feasibility assessment (also for elsewhere in the application: Evidence of feasibility from pilot work or feasibility exercises, Describe access to sample and timelines for recruitment, Demonstrate experience of project management) Randomisation – need statistical input, need good level of detail Statistical methods – planned analysis

Protocol Development – e.g. RCT Checklist from; http://www.consort-statement.org/

The Research Team Match the team to the requirements of the study Track record of the team(s) Institutional credibility (clinical/academic) Don’t be parochial Be very clear what each individual or partner brings to the proposal Think about costs Notes for research team section Ask participants to suggest who should be co-applicants for the eczema example / an example brought by them. e.g. Eczema RCT: Clinical lead (dermatologist) Clinical/Research project manager role Expert - RCT methodology and conduct Expert - planned analysis methods Expert in PPI methodology and/or parent

Patient & Public Involvement Not optional! Be creative Ask for help from experts http://www.rds-yh.nihr.ac.uk/ppi/involve-guidance/ Notes for PPI section Ask participants to suggest PPI for a) developing proposal b) inclusion in proposal e.g. Eczema RCT, will be parents rather than children but can involve older children if relevant to the study: Developing proposal – Workshop with parents of newborn babies/parents of babies who have developed eczema to determine focus of research and feasibility of the intervention from their perspective. Within proposal – Plans (and funding for) continuous consultation with parents e.g. planned meetings/email contact/phone calls/invite a willing parent to study management group meetings. Parents can contribute to planned intervention, materials developed to communicate about the study, dissemination of findings.

Sources of Funding Local funds (e.g. hospital charity, personal awards) National Charities NIHR http://www.nihr.ac.uk/funding/research_programmes.htm Pharmacy Research UK / UKCPA http://www.pharmacyresearchuk.org/pharmacy-research-funding/fund-research/ Health Foundation http://www.health.org.uk/funding-and-fellowship-opportunities NPPG Website / email announcement SBRI Healthcare http://www.sbrihealthcare.co.uk/competitions/