The BAPS / RCSEng Multicentre Collaborative Research Initiative

BAPS, in conjunction with the Royal College of Surgeons of England and the medical research charity SPARKS, launched an initiative to promote and develop multicentre collaborative paediatric surgical research in the UK. The aim is to create a sustainable model for developing and delivering multicentre clinical research across UK centres, involving consultant paediatric surgeons and trainees. Nigel Hall from Southampton has been appointed to lead this initiative and help drive this forwards. We encourage all UK consultants and trainees to consider becoming involved in this initiative and to work together to make it a success. Please contact Nigel directly to register your interest:  [email protected].

 

The Clinical Studies Group

The Clinical Studies Group is the heart of this initiative. It is the forum for sharing and developing research ideas, disseminating information and securing collaboration. The aim is to have at least one consultant surgeon from each of the UK centres along with trainees from the Paediatric Surgery Teaching and Research Network (PSTRN). If there are more interested then there is no limit to numbers in theory but the aim is for one per centre as a start.

The key to the success of this venture is active involvement to establish a real sustainable mechanism for developing not just research projects but also promoting individuals as research leaders. We are looking to members of the Clinical Studies Group to really champion research at their centre. This doesn’t necessarily mean that you have to lead a national project but it does mean that we will look to you to promote and support national research activity at your centre and be a local leader.

The group will meet 2-3 times per year to discuss research ideas and develop them into detailed proposals that can be used to apply for competitive grant funding and subsequently be delivered. Funding has been made available to contribute to travel expenses to facilitate good attendance when these meetings are held face to face. The meeting will also act as a forum to learn from invited experts in the field of clinical research. Topics covered to date include ‘How to design a research study’, ‘The role of the Clinical Trials Unit’, ‘Using Patient and Public Involvement in your research’ and ‘Health economic analysis’. Presentations given by external speakers on these topics can be downloaded using the links below.

Two meeting of the CSG were held in 2018 and 2019. The Spring 2020 meeting had to be cancelled due to COVID but a meeting was held in November 2020.  A further meeting is planned for May 2021.

To join the CSG and be part of this exciting initiative please contact Nigel ([email protected]). By working together we can greatly improve the surgical research landscape in the UK with the ultimate aim of improving the care and outcomes for the babies and children we treat.

Newsletter 1 Spring 2021

Newsletter 2 Autumn 2021

Presentations made to the Clinical Studies Group

• “Developing a Research Question” – Dr Sean Ewings, Research Design Services South Central, Southampton
• “Role of a CTU – what it does and how it help” – Wendy Wood, Senior Trials Manager, Southampton Clinical Trials Unit (pdf)
• “Role of the CRN in helping deliver research” – Miss Harriet Corbett, Paediatric Surgeon, Alder Hey, Liverpool (pdf)
• “Health economic analysis” – Mr Ben O’Sullivan, Paediatric Surgery Trainee (pdf)
• “Designing a study and getting support” – Dr Sean Ewings, Research Design Services South Central, Southampton
• “Associate PI scheme and Involving Trainees in Research” – Mr Dale Vimalachandran (pdf)

 

The Paediatric Surgical Trainees Research Network (PSTRN)

Trainees form a really important part of this initiative. Trainees are often involved in the design and delivery of research projects and it is important they are actively supported in these roles. The PSTRN was established in 2013 to facilitate trainee led research activity on a national basis. A number of trainee-led projects have already been completed and some are ongoing. All trainee projects have active engagement by at least one consultant surgeon amongst the project leadership.

Trainees are welcomed and encouraged to attend the CSG meetings to contribute to discussions on project development, present ideas for trainee-led studies and to benefit from the cumulative research experience of the group as well as the invited presentations.

We actively encourage trainees to take local leadership roles in research studies and clinical trials in particular. We are therefore promoting the NIHR Associate Principal Investigator Scheme  which aims to develop trainees to become principal investigators of the future and provides a mechanism by which trainees can be recognised for their involvement in research studies.

For more information about the PSTRN, their current studies and to get involved please visit their dedicated website, https://www.pstrnuk.org/.

 

Current National Research Activity

The following is a list of national research activity which is currently taking place. Some of this work has come directly from the activity of the clinical studies group. For further information please follow the links provided

• CASCADE

Children with AppendicitiS during the CoronAvirus panDEmic

A national observational cohort study assessing the impact of COVID-19 on treatment and outcomes of appendicitis in children, taking place at specialist children’s hospitals and general hospitals in eth UK and Ireland. Data collection ran from April to July 2020 with follow-up ongoing. For more information please contact: [email protected]

 

• ToSCiN STUDY

Timing of Stoma Closure in Neonates

ToSCiN is a mixed methods study that aims to answer the question: is it feasible to conduct a clinical trial comparing ‘early’ vs. ‘late’ stoma closure in neonates? The study started in late 2019 and will run for 2 years. There are several workstreams including a survey for surgeons to complete and qualitative work with clinicians and parents. It is being led by Nick Lansdale, Paediatric Surgeon in Manchester and supported by the NPEU in Oxford.

For further information:

https://www.npeu.ox.ac.uk/toscin

 

• BLAST study

Blunt Liver and Spleen Trauma

This is a national trainee led study that aims to describe current management of blunt abdominal trauma in the UK. It involves a survey of current UK practice and an observational cohort study of children with these injuries detailing how they are managed and outcomes.

Further information :

https://www.pstrnuk.org/copy-of-current-projects

Past Research Activity

Details are provided below about studies to which the collaborative research group have contributed in the recent past including links to a number of external webpages and publications.

• CONTRACT-F

CONservative TRreatment of Appendicitis in Children randomised controlled Trial (feasibility)

This was a mixed methods study including a feasibility RCT, a surgeon survey and development of a core outcome set for children with uncomplicated acute appendicitis. There was embedded qualitative research and the whole study was underpinned by detailed Patient and Public Involvement. It ran from 2016-2018 and was funded by the NIHR Health Technology Assessment program. The feasibility RCT took place at 3 specialist centres in the UK and BAPS members from all specialists centres as well as many DGH’s in the UK took part in the survey and sore outcome set development work.

Overall, the study concluded that a larger definitive RCT comparing non-operative treatment with surgery for children with uncomplicated acute appendicitis was feasible. An application for funding for this has recently been made with the hope that a full RCT will start in Spring 2021.

The study produced a number of publications . There is further information available about the study at the study website and also the funder’s project webpage.

• Hutchings, N., Wood, W., Reading, I. et al. CONTRACT Study – CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial. Trials 19, 153 (2018). https://doi.org/10.1186/s13063-018-2520-z

Further information

https://www.journalslibrary.nihr.ac.uk/programmes/hta/1419290/

 

• CHINA study

CHildren’s INterval Appendicectomy study

This randomised trial recruited children who presented with an appendix mass and had been successfully treated without surgery. The trial compared routine interval appendicectomy with clinical observation and followed children up for a year. Most specialist paediatric centres in the UK were involved in the study and recruited participants to it. The study generated data that can be used to guide practice and inform discussions with parents. The full report is available using the link below.

https://pubmed.ncbi.nlm.nih.gov/28404154/

CHINA study Hall Lancet GH 2017 (pdf)