Case studies

Background

I currently am a Consultant Vascular Surgeon and Honorary Senior Lecturer working in Aneurin Bevan University Health Board. You have to go back to 2015 for my first interaction with RDCS. Prior to this I had completed an MD in the basic sciences of wound healing, and had some experience with grant applications, but had no prior experience of running up an idea from scratch and applying for competitive funding.

I was a registrar at the time, and a research-active consultant and I had discussed the possibility of looking at evaluating a technique for reducing pain after major lower limb amputation – a tiny tube (catheter) placed next to the cut end of the major nerve at the time of surgery, with a continuous infusion of local anaesthetic via it for 5 days postoperatively.

Difference in practice

The impetus was in part driven by the difference in practice seen in different hospitals in Wales. We looked into the current data available and found only poor quality data on which to derive practice – so it was unsurprising to see this different approaches in different units. However pain, relief around the time of amputation is crucial, it is an important point determining how well people recover from surgery and it may influence how much people suffer with long standing phantom limb pain.

Initial contact

I initially contacted the Centre for Trials Research at Cardiff University, who pointed me in the direction of their RDCS team: a team of statisticians, qualitative researchers and experienced trial managers embedded with the registered clinical trials unit: they have access to over 160 professionals within the trials unit.

Appointment

I arranged an appointment and went, data in hand, unsure as to what to expect. My first meeting presented the rationale, our background systematic review, and a broad proposal for an evaluation. The consultant was excellent in every respect, and immediately was able to provide broad strokes suggestions.

Research meetings

We rapidly started convening research meetings, with RDCS members, the surgical team, patient representatives and other experts. An amputation charity (Douglas Bader Foundation) supported us with seedcorn funding, which was helpful in demonstrating to people that this was viewed as important in the amputation community.

Developing research idea

RDCS were able to put flesh on the bones of the research idea, and to bring it to a stage where we were able to submit to CTU for adoption to their portfolio. This was a key step as it unlocks their support for the work up to a competitive funding bid. I was delighted when they adopted us.

We applied to the Research for Patient and Public Benefit grant, awarded by Health and Care Research Wales. RDCS and CTU worked in tandem and together we put in an application. We were successful in funding, and launched the feasibility trial (called PLACEMENT) in 2018. We recruited our target of patients slightly ahead of time, and published our results in 2019.

Full effectiveness RCT

The next step is applying for funding for a full effectiveness randomised controlled trial (RCT). Our timetable was delayed due to the COVID-19 pandemic, but we are planning for a bid in early 2021. The same team which was formed back in 2015 is still largely the same, and hopefully we can continue to bigger and better things.

Benefit of consultant support

Research is hugely rewarding, and given the relative lack of high quality research in the area of amputation, I believe that answering the kind of questions posed by PLACEMENT has the potential to dramatically improve outcomes for patients undergoing amputation. However it comes with challenges. Possibly the greatest is the binary outcome of funding applications. So much can hinge on the outcomes of these bids, and the difference in workload between a positive and negative outcome can be very large. Such uncertainty makes planning ahead challenging, which is why having a dedicated and experienced team to consult with - based in a registered clinical trials unit - is invaluable.

Efi Mantzourani is Research Lead for Choose Pharmacy and Senior Lecturer in Pharmacy Practice in the NHS Wales Informatics Service and Cardiff University. She describes her experience of working with the Research Design and Conduct Service (RDCS) South East Wales.

Background

Although I have experience as a researcher, I have none as a Principal Investigator. A colleague told me about the RDCS and my initial experience of contacting the team was excellent - I got a prompt response from my support request and they asked key questions to help structure the support they gave me.

I had a combination of RDCS support in a group setting and one on one. Both of these ways were extremely helpful: the group setting utilised the different viewpoints of the members present - the one on one provided targeted support for areas that needed working on.

Areas of support

We got comprehensive help in these areas:

• Health economics – agreed on our methodology
• Statistics – confirmed our approach was valid
• Flowchart – we got feedback on our initial version; as a result, we completely re-drafted it
• Research question – we amended this to fit with our proposed methodology
• Patient involvement – we learnt about the new National Standards for Patient and Public Involvement
• Different sections of the bid – we reflected on feedback from previous (anonymised) applications
• Budget – we discussed areas we needed to include, and some we would not have thought about
• Roles of people on the team – we had queries on how to present the dual role of one of our team, and the RDCS consultant directed us to the right people to ask.

Improved application

With support of the RDCS consultant, we realised that our initial proposed approach needed changes to be more aligned with funder expectations. They explained the concepts and directed us to a named person to support us with the bid.

After we received feedback on our initial flowchart, we spent time reflecting and redrafting it. We discussed the amended version with one of the consultants available - he gave us very constructive feedback on the amended version, which allowed us to complete the project.

We had support to amend wording of certain areas of the application. The RDCS consultant supported us to understand where we needed to be more focused in our application, and where we needed to expand more, including referencing the most recent literature.

Impact of working with the RDCS

As a result of experience with the RDCS, I understand the process of applying for a research grant a lot better. I feel more confident to take the initiative in leading a future application. I was also able to make a submission of my grant proposal.

I would highly recommend the Research Design and Conduct Service to anyone else who works in the NHS or social care who is considering creating a high quality research proposal suitable for a funding application, even if you are just starting out.