Developing trials with surgeons: Hughes Abdominal Repair Trial (HART) Trial

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Published: 12 Nov 2013
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Dr Julie Cornish - University of Cardiff, UK and Dr Andrew Torrace - University of Birmingham, UK

Julie Cornish and Andy Torrance discuss the collaborative experience of recent trainee-led surgical trials and first-hand experience of the surgical research collaborative infrastructure.

The HART trial s a randomised controlled trial that is currently being developed by the Welsh Barbers Research Group.

The aim of the trial is to compare the incidence of incisional hernias for two methods of wound closure for patients undergoing surgery for colorectal cancer.

http://www.welshbarbers.org/
http://wmresearch.org.uk/
http://www.asit.org/

Dr Julie Cornish

In about 2009 I attended a conference and there were a number of West Midlands trainees there. I got talking to them, thought it was a fantastic idea and essentially thought that we could do that in Wales. So went back, tried to persuade people and no-one was really particularly interested for a while and eventually we came up with a project which is the HART trial, which is the Hughes Abdominal Repair Trial. On the back of that we’ve now got 160 members in the Welsh Barbers Research Group, we’ve received HTF funding for this trial and we’ve started the feasibility stage for this.

So the West Midlands have been fairly inspiring, actually, and as a result of this there have now been 26 collaborative groups that have started and I’m sure there are probably more that just haven’t made themselves known. It’s a brilliant idea; the thing that I particularly like about it is the idea that you are developing and training not only junior trainees but actually medical students we’re taking on board as well. You’re involving them in the research idea, you’re getting them trained with good clinical practice and essentially you’re developing tomorrow’s researchers and you’re taking them from not only senior registrars but they’re going to become the next consultants. So what we’re hoping from this collaborative model is that you’re going to create a group of surgical consultants who are willing to network, who have got the skills behind them and then we’ll be able to improve the quality of surgical research in this country.

Do you have any issues persuading people to join?

We all have to enhance our CV, essentially the carrot is that we need lines on our CV. We use a collaborative authorship model which has proved successful for a CV and actually a couple of the national audits that have gone through. Now that that’s happened people can see that they will actually become acknowledged then they’re willing to become involved. There is work involved in it, people have to be motivated but most people are motivated if they can actually see they’re going to get something at the end of it. We will quite often be given projects by consultants or other people that don’t go anywhere so the idea that you can be involved in something that will be successful is really great.

On the back of the National Appendicectomy Audit that was run last year which was really successful, a lot of the collaboratives have now sprung up in different regions and we have formed a national group which meets once a year. The next meeting is in London in December, the one after that, next year, is Cardiff in 2014. It’s open for everyone to come along and essentially there we’re promoting the idea of involving all regions, different specialities, we’re not just done for colorectal or general surgery, we’re trying to encourage others. I think the orthopaedic trainees are hoping to set up their own national network soon.

Dr Andrew Torrance

I chair the West Midlands Research Collaborative and this is a trainee-led research collaborative. It’s a novel idea first started by our group in 2007; really it’s encouraging trainees to not have to take time out of research and to collaborate together and produce large-scale meaningful studies which influence patient care.

How does this collaboration take place?

In the West Midlands we have a committee who chair the meetings that we hold. We have a Champion who is Professor Dion Morton who guides us and gives advice and a lot of encouragement to us. Then we have various trial leads who are all trainees who co-ordinate the trials that we deliver and then we have a team associated with those leads which includes junior doctors from first qualification right up to senior registrars and they work at different trusts around the region and, in fact, around the country now to deliver these trials.

How does it help people to deliver trials?

Really the collaborative is there as a focal point for people’s trials. We have meetings on a monthly basis, as I said, at these meetings we discuss trial ideas, we discuss on-going trials, really give advice about the direction of trials. We have speakers in and, of course, we have our Champion, Professor Morton, who guides us and gives advice and problem solves any problems that come up with these trials.

We’ve just completed a trial which was the ROSSINI trial, this was first started in 2010; it’s a trial led by trainees, designed by trainees and delivered by trainees. The basic premise of it was to randomise patients to either receive a wound edge protection device or not and in fact we recruited 760 patients over two years, finishing early in our recruitment stats. We’re currently running two other randomised controlled trials, these have built on the work performed by ROSSINI and have exceeded expectation. In fact, the DREAMS trial, which was looking at single dose dexamethasone to reduce post-operative nausea and vomiting, it’s a double-blinded randomised controlled trial, is now open at forty centres around the country. It has really been following on the back of the success of ROSSINI and also the development of other regional collaboratives have taken this project on board and it’s really doing excellently. It has already hit its recruitment targets, it has done so 18 months early and in fact the trials are now being expanded by another 400 patients to increase the power of this study. So really doing very well.