Prof. Ceri Battle, Honorary Professor in Trauma and Emergency Care and Consultant Critical Care Physiotherapist, Swansea University
Applying for a grant during the second wave of a global pandemic, to complete my first multi-centre, randomised controlled trial (RCT) was never going to be my brightest idea. But I wanted to continue with my research work, improving the care of patients with blunt chest trauma. I had completed the ELECT feasibility study successfully in 2018, with a Pathway to Portfolio grant (only available in Wales). The purpose of a feasibility study is to test the methods of the future trial, to work out what processes work best. This can include randomisation procedures, recruitment and follow-up response rates, what outcome measures patients will prefer, whether patients agree to complete the intervention (in this case the exercise programme) and so on. The findings of this study were positive, suggesting a full RCT would be feasible.
The aim of the ELECT work was to investigate whether an early exercise programme was effective in decreasing chronic pain and disability at 3 months following a blunt chest injury. When Health and Care Research Wales released the Research for Patient and Public Benefit (RfPPB) grant call and I duly applied to complete the full RCT. Fast-forward a further wave of the pandemic, I received the email (on the Friday 5pm as with all grant communications) to say that I had been successful in my application. The ELECT2 Trial as it was to be called, was to start on October 2021. Like everybody else who had worked frontline during the pandemic, I wasnt at my fighting best at this point, but time waits for no researcher, so I got cracking.
To be honest, I have led many large, multi-centre research studies over the last 15 years, but never a full RCT. But the principles and processes are very similar, considering the ethics approvals needed, the staff I needed to employ, the mountains of documents I needed to prepare, and the lack of sleep that is involved in those early months. My first aim was to get the trial approved by ethics and the Health Research Authority (HRA), who at the time were prioritising COVID-19 studies. The approvals process was held over TEAMS and I attended with one of my patient representatives, which seemed to be well-received by the ethics committee. It also helped a great deal having completed the feasibility study, as we were able to tell them what had worked well and justify our decisions for our recruitment and consent strategies. We passed that with just minor amendments. That was the first hurdle completed as planned.
I had already lined up the six sites and their principal investigators, so thankfully we were able to hit the ground running in terms of the set up at each hospital. Site initiation visits and training could all be easily conducted on TEAMS, and that worked well and saved a lot of time and travel costs. Finding a trial manager quickly was always going to be the key to my success (and survival) and I was lucky that a critical care research nurse who worked on the same unit as me, was keen to be involved. Her nursing managers were amazing in quickly agreeing a secondment and helping me complete another mountain of paperwork. According to our timelines submitted to the funders, recruitment was due to start in January 2022. We opened our first site on 31st January green light emails, as they are known, are the things of dreams at that stage in set up. That is when you know the Research Departments at sites are finally happy with everything.
Then the first challenge. One of the sites agreed to take part in a COVID-19 vaccine study, so needed to delay opening for three months. When I started out as a chief investigator over 10 years ago, I was reliably informed that finishing a trial on time is one of the key indicators that you have succeeded in the role. I was already on the back foot as recruiting on time was now going to be challenge. The second key indicator I was told about, was finishing on target. Recruitment started well and we were on target, despite the delay in opening a site, but it quickly became apparent that trial participants were not overly motivated to complete our surveys at three months post discharge. So finishing on target quickly became my next reason to wake in a sweat at 2am.
We quickly ran into our next challenge. My wonderful trial manager went off on long term sick due to family illness. I couldnt employ a replacement as she was still employed as part of the team, so I picked up that work with the help of some admin support from my trials unit. We were about six months out of a 12 month recruitment period at this point. Recruitment at sites was still on target and the completion of follow-up surveys by participants had also improved. Then the next disaster struck. One of the trials lead research nurses and top recruiter presented to the ED with a severe blunt chest injury themselves, requiring a long hospital admission and subsequent period of time off work. Although we were able to increase our recruitment numbers that morning (yes, they agreed to be recruited), it wasnt great news for the trial as a whole.
A great source of support for me during that time, was my fellow steering group members of the NIHR Emergency Care Incubator. Hearing that other trauma and emergency care trials were also struggling with follow-up rates and how they were dealing with that, allowed me to draw on their expertise and experience. Dr Edward Baker who is also a steering group member, my friend and another researcher in the field of blunt chest trauma, spent many hours on TEAMS listening while I raged against all things research related.
Eventually the recruitment and final 3 months follow-up period ended. The long job of data cleaning and validation. The REDCap data management system was a great platform and one I would definitely recommend. Im a bit of a technophobe, but I can use it and there were no complaints from the sites research teams. But data cleaning is a pain for everybody. Having been a PI myself many times, I know how time-consuming it can be, trying to find missing data points, or chasing up incomplete Case Report Forms and surveys. But the teams were never complaining, probably as I sent regular chocolates and goodies.
The moment at which my life started to return to normal and my sleep patterns improved (for the first time since October 2021), was the point at which the data was locked and the trials statistician and health economist took over. There was nothing further I could do at that point to change the outcome of the trial. The qualitative part of the trial then started, in which we interviewed clinicians and patients to find out in more depth whether the exercise programme was well received or not. Finding willing patients to participate was a bit challenging, but we got there.
I am happy to report that we finished on time, and to target. Analysis completed, I then had to start work again, getting the final reports written for the funders, ethics committee, research teams and study participants. It is now time to publish and present our findings. Ive been ready to submit for months, but until all authors complete their final checks, I am at their mercy. Just another hurdle in the whole process, but all will soon be revealed (she says confidently), as to whether an early exercise programme is of benefit to patients with blunt chest trauma. Would I run another trial like this? Ask me in a few months when I have forgotten what this was like!