Applying for an NIHR programme grant Professor Denise Kendrick Division of Primary Care, School of Medicine, University of Nottingham

About the ROWTATE PGfAR Multicentre Research Programme to Enhance Return to Work after Trauma (ROWTATE) Competition 24 Starts: 01/03/2019. Duration: 70 months Joint lead applicants Total research costs: £2,405,840 Hosted by Nottingham University NHS Hospitals Trust Aim: To develop, evaluate and assess implementation of a theory- based early intervention to enhance return-to-work and improve QoL and wellbeing in people with at least moderate trauma About the ROWTATE PGfAR

About the ROWTATE PGfAR PPI About the ROWTATE PGfAR Work Package 1 Developing theory, intervention, training and data collection tools Focus groups, interviews, ethnographic research, co- production workshops Outputs: Revised logic model and programme theory Training and mentoring package Outcome and process evaluation data collection tools Feasibility study protocol Work Package 2 Non-randomised feasibility study Intervention delivery Case studies – interviews, observations Baseline and follow up data collection Contamination assessment Focus groups Outputs: Finalised training package, SOPS, fidelity, contamination and outcome data collection tools and processes for RCT Definitive trial protocol  Work Package 3 Randomised controlled trial and economic evaluation RCT with embedded process evaluation, fidelity and contamination assessment, qualitative study and economic evaluation Outputs: Estimates of clinical and cost-effectiveness Economic model    Work Package 4 Implementation and process evaluation Analyses qualitative, ethnographic, fidelity, contamination and process data collected across work packages 1-3 data for implementation relevant data. Develops finalised intervention documents, implementation toolkits and workshops

Time line Oct 2016 May 2017 Jul 2017 Oct 2017 Nov 2017 Jan 2018 Apr 2018 Oct 2018 RDS PGfAR session Pre-submission form Stage 1 application Feedback Stage 2 application Feedback Feedback rebuttal Notification of award Post feedback negotiations completed Don’t underestimate how long it takes!

The real time line 2004- 2008 2008-2013 2009-2013 2013-2016 2015-2017 Return to work after stroke feasibility study Impact of Injuries study FRESH feasibility study (TBI) Return to work after major trauma study Major trauma discussion group UK Burden of Injury study PPI development Don’t underestimate how long it really takes!

What helped our application to be successful? RDS PGfAR session including 1:1 session with PGfAR Director Highlighted need to convince panel return to work is a health outcome and should be primary outcome Pre-submission form Clarify need for new intervention specifically for patient group Insufficient iteration of intervention development ? Use the Person Based Approach for intervention development Justify return to work as primary outcome rather than QoL or mental health outcomes Large number of reviews & responding to reviews 7 from RDS 1 senior academic with PGfAR experience 1 senior academic who sits on PGfAR panel 5 reviews at stage 1 8 reviews at stage 2 Large number of iterations – ≥ 8 between stage 1 and 2 applications Gave ourselves enough time and submitted early What helped our application to be successful?

What helped our application to be successful? Team: Multidisciplinary Joint lead applicants Previous successful PGfAR experience Previous successful collaborations Research & Innovation Lead at host organisation as co-applicant PPI: Long established collaboration Identified new PPI group members PPI lead: designed PPI programme wrote PPI section wrote lay summary Previous work: Developed 2 similar interventions Tested feasibility of delivering interventions Successfully recruited similar populations to similar studies Learning from previous studies used to address risks What helped our application to be successful? Started early – grant writing group started drafting application 1 year before stage 1 submission date

Some positive stage 2 reviewers’ comments: The research is innovative as it recognises return to work as a key determinant of "health" and attempts a cross sector case management approach in a highly complex and geographically disparate patient population. Key strengths include expertise of the team; stepped approach to intervention delivery; mixed methods process and implementation study and patient and stakeholder involvement at key stages. Some positive stage 2 reviewers’ comments: The lead applicants provide good evidence that they will be able to deliver the project. The team are to be commended on the progressive development of this proposal, through a number of relevant prior projects.

Some positive stage 2 reviewers’ comments: The team are to be commended for PPI involvement throughout this application and preceding studies. PPI clearly underpins identification and prioritisation of the research questions. I am very pleased to see a former patient as a co-applicant with a key role in leading the PPI component of this proposal. I also welcome the involvement of former patients on the PPI panel whose experience of rehabilitation/return to work is more recent, ensuring contemporaneity. Delighted to see PPI appropriately costed, and that patient members will be paid for their time. Some positive stage 2 reviewers’ comments: An impressive team with many professions represented and a wide variety of skills relevant to the proposed research. The track record of the researchers is very good in terms of research experience and publication rates.

Important issues that arose from reviews Making the case: Is research needed if similar intervention effective in other injuries? How does this differ from previous work? Is intervention developed enough to go straight for HTA trial? General comments: Linearity of research and dependency of later WPs on earlier WPs Strengthen links with policy makers and employers Incorporate carers views Over ambitious WP comments: More intervention development iterations, longer timescale and co-production How to minimise contamination Conflicting comments re. longer term health economic model and feasibility/cost

How we responded Making the case: Don’t assume the reviewer/panel knows what you know Describe intervention in as much detail as possible and highlight what isn’t known Detailed logic model General comments: Ensured process evaluation and implementation research spanned WPs Widened sample for qualitative work and expanded steering committee Included carers in qualitative work Reduced work and increased time in WP1 WP comments: Increased iterations and timescale Added co-production workshops Provided detailed plan for minimising contamination Protracted negotiation re. health economics How we responded

Responding to reviewers’ comments and panel feedback Take comments and feedback very seriously Read comments, but don’t respond immediately Thank reviewers for helpful comments and highlight positive comments Respond to every point Respond carefully, thoughtfully and clearly and do not sound annoyed Remember if the reviewer hasn’t understood something its because you haven’t made it clear enough Try to incorporate changes in relation to comments wherever possible Stand your ground in a respectful way and make it clear why Highlight conflicts between reviewers to help make your case Provide references to back up statements Good reference for how to respond to reviewers’ comments is: Cummings P, Rivara FP. Responding to reviewers' comments on submitted articles. Arch Pediatr Adolesc Med. 2002; 156:105-7 Responding to reviewers’ comments and panel feedback

Give yourself enough time to develop a good application – block time out in advance Don’t underestimate the number of iterations required Make sure it’s within scope of PGfAR and the type of work they fund Get as much advice as you can from very early on Take advantage of opportunities to talk to PGfAR directors/panel members Remember panel members aren’t experts in your area Develop effective PPI collaboration before you apply Get a lot of reviews, listen to what the reviewers are saying and respond carefully to reviews Highlight strengths of your proposal and don’t be too modest Key tips

Any questions? Contact: denise.kendrick@nottingham.ac.uk Thank you!