2019 has been an exciting year here at the Surgical Intervention Trials Unit.
Key Events that happened in SITU 2019
- 3 new studies awarded – NEON, PROCURE and PASHION (our first device trial). NEON has started with PROCURE and PASHION set to start in Jan 2020. We have continued our drive to support new investigators with these trials.
- We have been able to set up a study for Cerebral Palsy patients undergoing Single Event Multi Level Surgery called CPinBOSS.
- FUTURE-GB will be looking at using new technologies to surgically treat patients with glioblastoma. We are looking to start recruitment in the spring.
- Hot off the press, we were awarded a £2million grant from the NIHR to look at the response to surgical emergencies. The RESPOND study will be developed over the next year to recruit sites in the 2021.
- Members of the SITU team attended and presented at ICTMC in Brighton – Heidi drew lots of diagrams!
- SITU members helped to organise and run the Bristol Oxford Surgical Trials Course (BOSTiC)
- We attended several conferences promoting the unit. Association of Breast Surgeons; British Association of Urological Surgeons; The Association of Cancer Surgery. There was significant engagement and we are optimistic to encourage further collaboration.
There have been a number of successes
- Loretta Davies successfully completed her DPhil.
- Teya Agnese completed her Level 2 Business Admin course. She is set to start Level 3 in Jan 2020.
- Steffi Le Conte and Emma Harper successfully completed their qualifications: Postgraduate certificate/diploma/MSc in Clinical Trials, distance learning. Please click here to find out more about the course. Emma says: "Steffi and I both completed modules in this course, this year. For me, it was my 8th and final module of the diploma course, after 5 years of part-time study. It was hard work but I enjoyed it and found it useful. If anyone is interested in doing the course and would like to know more (from a student’s point of view!), please feel free to contact me!"
- We have survived 3 audits! More to come in 2020.
- The SITU team ran 10k in May for the Oxford Town and Gown to help raise money for Muscular Dystrophy.
- We've had many new and lovely faces join the SITU team (James Van Santen, Lucy Paterson, Charlotte Drodge & Emma Harper) and the return of some familiar faces to come in early in 2020.
- Michael Douek started as Co-Director.
- We are sad to see Steffi Le Conte leaving us after a number of years. Steffi has been instrumental in running the PART feasibility trial and setting up and the MACRO trial. Her contribution has been outstanding. Stephen Jones will be taking over the MACRO trial manager position in the New Year.
- After over 13 years with SITU, we are very sad to see Cushla Cooper leave for new adventures (but we are glad she is not too far away!). As summarised by David Beard at the SITU Christmas meal – Cushla has been heavily influential in the development of SITU over the years and we all would not be working within the unit today without her.
How have our Trials progressed this year?
UK TAVI: "It’s been a rollercoaster ride in 2019 for UK TAVI as we head towards publishing the primary endpoint in early 2020. There have been challenges along the way, but we’re all very excited to be bringing everything together after years of hard work by the trial team, sites, and stakeholders."
PENTAGONS: ‘’It’s been a busy year for PENTAGONS with sites being set up, amendments, the engagement of Primary care to further aid our recruitment and a link on the Diabetes UK website. As you can imagine, the team are looking forward to a well-earned Xmas break (and rest!) ready for the annual joint TSC/DSMC committee meeting when they return in January. We're hoping to have lots of randomisations in the New Year and to hit our target of 56 patients by October 2020!’’
PART: “The PART trial is currently still in set-up, with an anticipated recruitment start date of March 2020. We had an Investigators’ Meeting in London in December, for the 6 ‘Hub’ sites who will be delivering the intervention arm treatment (Vascular Targeted Photodynamic Therapy).”
SPAARK: "The SPAARK trial has very nearly reached its recruitment target, with 495 of 500 patients recruited! Challenges next year will be patient follow-up and retention, data cleaning and analysis.
My favourite memory of 2019 is 'Barbara' ".
My favourite memory was finishing the 10k Oxford Town & Gown with our SITU team (sorry Heidi)."
NINJA: "2019 saw NINJA continue to recruit quickly, so much that we were able to close in July, 6 months ahead of our predicted date. In fact, we closed with a 108% recruitment rate! After that, we needed to extend our follow up period to enable us to capture the maximum amount of data as effectively as possible. Trying to get fingernail photographs from 450 participants across the UK is no mean feat, and thanks to the help of each of our sites and the generosity of our participants and their parents, we have over half of our valuable photos submitted now! Also this year we published our trial protocol in BMJ Open, which was great to have it accepted in such a well renowned journal!
The year ahead will see NINJA close to follow ups, and the data analysed in February 2020, with the final report submitted in June. We will be publishing the Oxford Finger Nail Appearance Score paper for the method we’ve developed here, and the final study paper – so lots more of NINJA in print in 2020.
I think for me the highlight of 2019 was about seeing all the finger photos submitted from our participants, and the stories that must underlie them. For example a photo of a toddler with their fingers in one place, and in focus, must require a lot of behind-the-scenes shenanigans from their parents to get it to happen! It’s also nice to see that the injuries have healed so well, which must be a reassurance to all involved and a credit to the careful work our teams do on such small fingers!"
CPinBOSS: "CPinBOSS opened for recruitment in July 2019. After steady progress we have opened 15 sites and recruited 19 patients thus far. We are looking at potentially extending recruitment until the end of 2020 to give the sites a long recruitment period. The challenge for 2020 is to get the remaining 15 sites up and running as soon as we can and continue recruitment over the year.
My highlight of the year was the Christmas party day, with lots of food and drinks!"
TOPKAT: “It has been an exciting year for the TOPKAT study. After finishing the 5 year follow-up and analysis at the end of last year the team (collaboration between Oxford & Aberdeen University [CHaRT] and 27 participating hospital teams) successfully submitted the final monograph report to the funding body and had the study published in the Lancet. Things are not going to stop there…follow-up continues and the extended 10 year follow-up will start in Jan 2020…
My favourite memory of the year was seeing everything come together for TOPKAT after years of hard work by the team, and also lying down in a dark room after finishing my DPhil!”
ACL SNNAP: “With the continued efforts and enthusiasm of recruiting teams throughout the UK, ACL SNNAP has almost reached recruitment target with 297 of the 320 patients recruited. A great achievement by all involved. Early next year should see us hit target and we will continue to work on the challenge of retention…"
PROMOTE: "This first in man trial looking at how to better visualise cancer in the prostate during operations, has recruited its first patients in the dose finding stage. We are looking forward to taking this forward into a randomised controlled trial in 2020."
TWO: "The TWO study is up and running randomising patients who require kidney transplants onto standard care or immunosuppression using the patients own cells. The initial difficulties of this complex trial have been overcome and now we are aiming to ramp up recruitment in the New Year."
NEON: "In October we started setting up a new study looking at surgery for injured digital nerves. We have written the study documents and will meet with an ethics committee in the new year to organise our approvals. Watch this space as we aim to open to recruitment in April 2020."
STIFF-F and SPINOUT-F: "Our feasibility studies, studying segmental tibia fractures and spinal stenosis respectively, are now half way through their study timeline. Our recruitment is slower than expected but we are still going strong! We expect to have the results of these studies by summer 2020."
PARCS: "PARCS is a feasibility study aiming to design a trial for patch use in rotator cuff repair. Way back in January we completed the final consensus stage of this study, and have spent the year finalising the results and our monograph. We expect this to be published early next year. In the meantime you can read the protocols for this study: https://rdcu.be/bZkhV and https://rdcu.be/bZkhX ."
How has the Data Management team progressed this year?
Heidi Fletcher has been doing an excellent job at managing the data management team and setting trial and data related goals throughout the year to help support the trials team. Goals achieved include:
- Helping to set up and use REDCap for trials (which Akiko Greshon has helped massively with).
- Moving more trials towards remote data entry.
- Introducing Trello to the team as a project management tool.
- Heidi Fletcher and Aimi Hewitt attended ICTMC and came back with lots of ideas for data management. Inspired by the conference, Heidi created a presentation titled 'Data Bloat' which explains how much data is collected by trials and how to best to manage it.
Data management team 2020 goals:
- Begin to move more trials towards remote data entry including the inputting of screening, training, delegation and staff contact logs, as well as other key trial information.
- Unleash the opportunities of REDCap, taking advantage of what the system has to offer.
- Create auto-reporting for TMG meetings.
- Ensure processes are more uniform across the trials.
The Data Management Christmas Angels
SITU also had a bit of Christmas Fun! We kick-started the celebrations with lunch whilst we exchanged our Secret Santa gifts. Afterwards, Lisa Poulton and Gemma Greenall did an excellent job at hosting this year's Christmas Quiz. Then finally, in the evening, everyone went out for a lovely Christmas meal - huge thanks to Ivy Raymundo for organising the meal for our department.
Thank you everyone for your help and support throughout the year.
Have a Merry Christmas and a Happy New Year.