BDRF project helps overcome the challenges of recruiting to clinical trials

GeneRAtiNg sUrgicaL rEcruiters for randomised trials

Give a surgeon a fish and feed them for a day, teach a surgeon how to fish and feed them for a lifetime.

We believe that equipping medical students with the practical skills for recruitment of patients into clinical trials would be a major step forward for evidence-based clinical practice in the UK.

The BDRF funded GRANULE courses do just that.

We sent BDRF employee Glen Saffery to Bristol for the day to find out what goes on at one of the GRANULE courses and here is how he got on:

‘From 1982 to 2005 I never saw a surgeon recruit someone into a Randomised Controlled Trial’    

These were the words of Professor Jane Blazeby opening the latest GRANULE workshop for medical students, which aims to make surgical research an everyday part of hospital life, rather than a rarity. After the courses are complete, many students are ready to begin bringing patients into research from day one of their medical career.

This readiness is vital to improving care and treatment. Randomised Controlled Trials (RCTs) are the best way of creating the high-quality evidence needed to make big steps forward. Without reliable evidence it is difficult to set standards in the NHS that can be applied to all patients, guaranteeing them the best possible treatment. Simply not enough comparative work has been done to establish evidence-based best practice in a lot of areas.

Big changes are underway, and in recent years it has been widely acknowledged that increasing the number of RCTs in surgery is paramount to improving NHS care.

However, RCTs remain extremely complicated and difficult to deliver in a surgical setting. The single biggest stumbling block is actually recruiting patients into trials – and is the top reason trials fail. Specialised communication skills are vital in explaining why the study is needed, what randomisation is and why it is so crucial, and establishing genuine equipoise among both professionals and patients.

GRANULE workshops have been designed to help surgeons develop the skills they need to successfully deliver research studies. Skills which are not simply technical but focussed on communicating extremely complex information in a simple way.

At the course in Bristol, a room full of students were able to practise these under the guidance of experienced researchers. The morning session comprised lectures on the challenges researchers face, and how these challenges had been overcome in successful studies. Health service researchers had used tape recordings of a large number of consultations to coach surgeons on their recruitment technique. By analysing the communication, they had been able to both drive up recruitment in these studies and draw out common themes on what works and what doesn’t.

It turns out gambling metaphors are a big no-no! But it was also clear that navigating the emotional responses of patients and understanding personal preferences without pushing people in a particular direction was extremely hard. In many ways, these challenges are nothing to do with medicine, but everything to do with communication.

The afternoon session saw our budding surgeons get the chance to put this into practice, with actors playing the role of patients to be recruited. Armed with the knowledge from the morning session, the students made great strides forward and the improvement in their confidence from first practice consultation to last was absolutely massive.

As the day concluded, it was abundantly clear that the future of surgical research is in good hands. For now, we were extremely proud to see cameras from the National Institute for Health Research capturing the lectures, with a view to disseminating this knowledge far and wide.

GRANULE is already making enormous strides in improving the training of a whole generation of surgical researchers – the challenge now is to make this content accessible for as many people as possible, potentially across the globe. In a medical world being transformed by the internet and social media, creating an online bank of educational materials has the power to achieve great things, and ensure Prof Blazeby’s experience of a total lack of surgical trials is not repeated. We are extremely proud to have seed-funded what could be a revolutionary piece of work, and excited to see what the future brings!

James Glasbey NIHR Academic Clinical Fellow in General Surgery at University of Birmingham sums up the GRANULE course:

“In order to drive improvement in the quality of care we deliver to NHS patients it is essential that we continue to develop an evidence base for novel interventions and treatment pathways through high quality randomised controlled trials.

The GRANULE course fosters a culture of early trial engagement and quality assured informed consent to research that will support future recruitment to research across surgery and clinical medicine”

BDRF CEO Peter Rowbottom comments

“BDRF is really proud of being involved in GRANULE. If there is one element of our work that can be truly held up as the foundation for helping us achieve our vision as a charity then I believe it is this.

GRANULE will help pave the way for enabling us all to work together to one day eradicate bowel disease.

My utmost respect and thanks go to all those who have been involved in this project – keep up the excellent work”












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