Case study 1: Developing research ideas
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.
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.
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.
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.
Our portfolio of work includes drugs trials and complex interventions, mechanisms of disease and treatments, cohort studies and informing policy and practice.