Fourteen researchers from York Trials Unit attended and contributed to the success of the 5th International Clinical Trial Methods Conference, ICTMC 2019 held in Brighton in October. Involvement started early with Joy Adamson being a member of the organising committee. She subsequently chaired a number of the panel sessions. YTU researcher contributions from throughout the three day conference are summarised here.
Michelle Watson has been awarded an NIHR Pre Doctoral Fellowship, during which she will look into aspects of delivery of research in the pharmacy sector. Michelle will spend 20 months reviewing the current literature in the field, attending courses and conferences that will further her understanding, and developing a Doctoral Fellowship application.
NIHR Pre Doctoral Fellowships are designed to support people who are looking to start or advance a career in health research methodology. Further information on the Programme is available at https://www.nihr.ac.uk/explore-nihr/academy-programmes/fellowship-programme.htm
If anyone would be interested in hearing more about Michelle’s experience of the process, please do get in touch with her!
An article has recently been published online as part of the KReBS trial - 'Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial'. To access the publication please click here.
The authors on this paper are: Liz Cook, Dr Matthew Northgraves, Caroline Fairhurst, Sarah Ronaldson, Professor David Torgerson, Jonathan Kent and Professor Mike Reed.
The SWHSI-2 trial is now open to recruitment, with the first participant enrolled last week. SWHSI-2 is a two-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of negative pressure wound therapy (NPWT) versus usual care (no NPWT) for surgical wounds healing by secondary intention.
Please see the trials Twitter feed for further updates. @SWHSI_Trial
‘There is insufficient evidence to support guidance on the most effective treatment for patients who fail to mobilise after sustaining a lateral compression type one (LC-1) fragility fracture.’ This was the conclusion of a systematic review undertaken by researchers at York Trials Unit in collaboration with health professionals at Barts Health NHS Trust. Published in BMJ Open, https://bmjopen.bmj.com/content/9/5/e024737 the review examined the evidence of effectiveness of surgical fixation for LC-1 fragility fractures of the pelvis. The review was authored by Alison Booth, Helen Ingoe, Matthew Northgraves, Elizabeth Coleman, Melissa Harden, Jamila Kassam, Iris Kwok, Catherine Hilton, Peter Bates, and Catriona McDaid.
The findings of the review underpinned a successful bid to NIHR HTA programme to undertake L1FE a randomised controlled trial to fill this evidence gap.
A Study Within A Trial (SWAT), that was embedded within the OTIS study, has been published online with F1000Research. The paper is titled 'Using pens as an incentive for trial recruitment of older adults: An embedded randomised controlled trial' and can be accessed online here. F1000Research use open peer review and the paper has recently been approved by two reviewers.
The authors of the paper are: Katie Whiteside, Lydia Flett, Alex Mitchell, Caroline Fairhurst, Sarah Cockayne, Sara Rodgers, and David Torgerson. The paper was published on behalf of the OTIS Study Group.
Members of York Trials Unit (Catherine Arundel, Caroline Fairhurst and Catherine Hewitt) have recently collaborated with the Mental Health Addictions Research Group to deliver the SCIMITAR+ Trial. The results of the trial have been published (https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(19)30047-1/fulltext) and show that a dedicated intervention to help people with severe mental illness stop smoking can double quit rates at six months compared to standard care.
The SCIMITAR+ trial is the largest ever trial to support smoking cessation among people who use mental health services. Smoking rates among people with mental health conditions are among the highest of any group having changed little over the last 20 years, while other smokers have quit. This new study demonstrates that with the right support this inequality could be a thing of the past.
Research Fellow Dr Mike Backhouse has edited and co-written a new book on The Foot and Ankle in Rheumatology. The book is a unique and comprehensive guide to the management of foot and ankle pathologies across the rheumatic diseases.
The book is relevant to a broad range of health professionals, from podiatrists and rheumatologists to orthopaedic surgeons and physiotherapists.
For more information see: https://global.oup.com/academic/product/the-foot-and-ankle-in-rheumatology-9780198734451?
The ACTIVE trial is a study funded by the NIHR Health Technology Assessment Programme (15/130/84) for the treatment of patients with a severe break of the shin bone where it forms the ankle joint. Surgery is needed to fix the broken bone, using a plate and screws under the skin (internal fixation) or fixed from the outside using a ring frame or cage (external fixation).
York Trials Unit hosted an event on 29th March with staff collaborating with us from across the 23 participating hospital sites. This was to discuss strategies to optimize recruitment. The event was very well received, and we are looking forward to working with sites to implement what was discussed.
For more information about the study see http://www.isrctn.com/ISRCTN98152560
'Study reporting guidelines: How valid are they?' There are a number of reporting guidelines available however the methodological strength, or validation of guidelines is unclear. This paper explores what validation of reporting guidelines might involve, and whether this has been conducted for key reporting guidelines. Read the article.
The current role and perceived benefits and barriers of secondary care pharmacists facilitating patient participation in Clinical Trials of Investigational Medicinal Products (CTIMPs) conducted within the NHS: A cross‐sectional survey. Read the article.
York Trials Unit were delighted that a study being undertaken jointly with Northumbria Healthcare Foundation Trust was Highly Commended in the Acute Sector Innovation category of the HSJ Awards 2018. Quality Improvement in Surgical Trials (QIST) involves training teams from 30 Trusts in England in a Breakthrough Series Collaborative to introduce best practice at scale in the NHS. Focussing on hip and knee replacement surgery, half the Trusts are being trained to introduce a service improvement protocol to reduce post operative infection and the other half a protocol to reduce post operative blood transfusions. The trial is evaluating the effectiveness of the Breakthrough Series Collaborative at introducing these changes in practice at scale. The Trusts have been randomly allocated to the protocols and are acting as each others control. On completion of the study the Trusts will be given the opportunity to be trained and supported in the alternate protocol. Mike Reed, the Chief Investigator for the QIST study said, "I am delighted the HSJ judges recognised the value of this project and a huge thanks to all of the teams making this ambitious collaborative project such a success."
Dr Rhian Gabe (Reader in Clinical Trials, YTU) recently represented the UK, presenting on research on Low Dose CT screening for Lung Cancer in Toronto, where the IASLC World Conference on Lung Cancer was held.
In addition, exciting news about the European NELSON screening trial was shared. Read Rhian's blog here for more information!
Dr Adwoa Parker has led on a Study Within A Trial (SWAT) article published in the Trials journal, which found that optimised patient information materials did not improve participant recruitment in a lung cancer screening trial.
The paper is titled The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial. Read more.
Mona Kanaan recently organised a session on Stepped Wedge design at the Royal Statistical Society Conference in Cardiff on behalf of the Medical Section and presented a talk entitled 'Brief Introduction to the Stepped Wedge Design'.
Mona Kanaan is a co-author of a recently published paper in Addiction entitled "Varenicline versus placebo for waterpipe smoking cessation: A double‐blind randomised‐controlled trial".
Ada Keding and Mona Kanaan took part in the Race for Life event at the Knavesmire race course on 16th Septempber 2018. You can see them at the finish line here at around 34 min of the video. Team Jasmine has raised £390 + £80 gift aid so far and would like to thank everyone for their support!
The Trials Unit hosted the 13th Annual Conference of Randomised Controlled Trials in the Social Sciences at King's Manor last week, from the 5th to the 7th of September.
Key speakers included Professor Don Green from Columbia University, USA speaking about the advantages and disadvantages of adaptive designs. Delegates also heard from Michael Sanders, Chief Scientific Officer of the Behavioural Insights Team about the compromises that are often required to undertake Trials with Government Departments.
The workshop, led by Professor James Carpenter from the MRC clinical trials unit, was about dealing with missing data. In addition, there were presentations from delegates across Europe reporting the design and results of trials in Scandinavia, Holland and Italy as well as the UK. The next conference will be in mid-May 2020.
Where available, presentations will be available as PDFs on the conference webpage shortly.
An article has recently been published online as part of the OTIS study - 'Can occupational therapist-led home environmental assessment prevent falls in older people? A modified cohort randomised controlled trial protocol'.
The authors on this paper are: Sarah Cockayne, Dr Alison Pighills, Professor Joy Adamson, Caroline Fairhurst, Professor Avril Drummond, Professor Catherine Hewitt, Sara Rodgers, Sarah Ronaldson, Professor Sarah Lamb, Shelley Crossland, Sophie Boyes, Professor Simon Gilbody, Dr Clare Relton, and Professor David Torgerson.
The NIHR's latest message is delivered by Professor Hywel Williams, Director of the Health Technology Assessment Programme, and encourages trial teams to do SWATs. Professor Williams specifically mentions YTU's PROMETHEUS programme, led by Professor David Torgerson, which is funding trial teams up to £5000 to undertake a SWAT. Professor Williams encourages trialists to contact the PROMETHEUS team. You can watch the message here.
The OTIS trial team are delighted to have finished recruitment to the study. Participants are now being followed up until the end of June 2019. The results of the study will be available at the end of the year. We would like to thank all of our participants and collaborators for their help with the study.
Trial Support Officer - apply by 3rd of September
Research Fellow (Trial Coordinator) - apply by 16th of September
The new Musculoskeletal Core Capabilities Framework was published on the 30th of July. This important framework has been developed through several professional bodies and national groups - including NHS England and Health Education England.
Dr Mike Backhouse was on the Project Management Group for its development, and also led the Delphi exercise which played a key role in developing the framework content.
The PROFHER-2 team are delighted to have recruited their first participant to the trial! PROFHER-2 is a three-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of Reverse Shoulder Arthroplasty versus Hemiarthroplasty versus Non-surgical care for acute three and four-part fractures of the proximal humerus in older adults.
Research Fellow (Grade 7) or Senior Research Fellow (Grade 8) to join our team to undertake research within the unit and to oversee the day-to-day operational management of RDS, further details.
This review highlights the importance of organisation, openness and positivity in the delivery of trials, and focused processes and resources as important in the monitoring and controlling of trial progress.
Dr Mona Kanaan is leading on the statistical elements of ASTRA a new, international research programme aimed at reducing the harm caused by smokeless tobacco (ST) use in South Asia - for more details see here.
Dr Mona Kanaan is a co-author on, 'Do people favour policies that protect future generations? Evidence from a British survey of adults'. Graham, HM, Bland, JM, Cookson, RA, Kanaan, M & White, PCL 2017. Journal of Social Policy, pp. 1-23. DOI: 10.1017/S0047279416000945" which was shortlisted for Cambridge University Press Awards for Excellence in Social Policy Scholarship
Paul Baker, along with collaborators, has recently had a paper published in the journal BMC Health Services Research. Entitled 'Protocol paper: Development of an occupational advice intervention for patients undergoing lower limb arthroplasty (The OPAL study)', this paper is part of the OPAL study - Occupational advice for Patients undergoing Arthroplasty of the Lower limb.
Other authors on this paper are: Carol Coole, Avril Drummond, Dr Catriona McDaid, Sayeed Khan, Louise Thomson, Professor Catherine Hewitt, Iain McNamara, David McDonald, Judith Fitch and Professor Amar Rangan.
An article has recently been published online as part of the REFORM study - 'Cost-Effectiveness of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People: The REducing Falls with Orthoses and a Multifaceted Podiatry Intervention Trial Findings'.
The authors are Belen Corbacho, Sarah Cockayne, Caroline Fairhurst, Professor Catherine Hewitt, Dr Kate Hicks, Sara Rodgers, Dr Arabella Scantlebury, Dr Jude Watson, Professor David Torgerson, and collaborators from the NIHR Leeds Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, National University of Ireland and the School of Allied Health at La Trobe University.
The York Trials Unit is proud to be participating in round 7 of the NIHR Fellowships Programme 2018, recently launched by The National Institute for Health Research (NIHR).
Applications are invited from existing NIHR Trainees with an interest in, and experience of, working with clinical trials as part of their current training award who would benefit from further training within the setting of a Clinical Trials Unit (CTU) that is in receipt of NIHR CTU Support Funding. Applications are submitted jointly by the CTU and the trainee.
All applicants must have contacted the relevant CTU by Wednesday 11th July 2018 and applications must be submitted by 13:00 on Thursday 23rd August 2018.
Further information, including guidance notes, is available on the NIHR website.
For enquiries to the York Trials Unit please contact Professor David Torgerson (firstname.lastname@example.org)
A review of qualitative evidence on the views and experiences of non-mental health professionals receiving mental health training and the barriers and facilitators to training delivery and implementation has been published.
The KReBS trial has recruited their 2000th participant to the study! KReBS is a randomised controlled trial investigating the effect of a two-layer compression bandage system on knee function following total knee replacement.
Thank you to all our site staff and to the participants for their continued support of and commitment to the study.
The SSHeW trial team are delighted to have recruited over 2500 participants to the study. Thank you to our collaborators and to the participants for their help and commitment to the study.
The SSHeW study is a multicentred randomised controlled trial evaluating the effectiveness of slip resistant footwear in NHS staff. The study is due to end in June 2019.
PRESTO is a randomised, controlled, parallel group, multi-centre feasibility study. This study aims to establish whether it is feasible to deliver a trial comparing surgical fixation to initial non-operative management for patients with a stable thoracolumbar fracture without spinal cord injury.
The results of the SWHSI Pilot, Feasibility Trial, conducted as part of a NIHR Programme Grant for Applied Research have now been published. The trial has identified that it would be feasible to complete a larger trial to investigate the clinical and cost effectiveness of negative pressure wound therapy for patients with surgical wounds healing by secondary intention, and has identified key considerations required when designing a larger trial of this nature.
The publication is available online.
The SWIFFT trial team has published in the Journal of Clinical Epidemiology a study-within-a-trial (SWAT) which provides evidence that it was feasible to use remote or on-site visits for the the initial contact when setting up hospitals in a multicenter surgical trial. This study and the wider literature questions what is the most effective and efficient contact that Trial Co-ordinators should have with a site during set up and ongoing monitoring.
The publication is available here.
Congratulations to Dr Rhian Gabe, who has recently been appointed as Screening Subgroup Chair for the NCRI Primary Care Clinical Studies Group.
The NIHR Research Design Service Yorkshire and the Humber (RDS YH) has been awarded a further five-year contract funded by the National Institute for Health Research (NIHR), to continue delivering the service until September 2023. Click here for more information.
The National Institute for Health Research Health Research Programme has recently funded York Trials Unit to undertake a study to examine the effectiveness of an out-of-court community-based Gateway intervention programme aimed at improving health and well-being for young adult offenders. For more information about the trial see the Gateway webpage.
The OTIS trial team are delighted to have recruited their 1000th participant to the study. Thank you to our collaborators and to the participants for their help and commitment to the study. The OTIS study is a multi-centre randomised control trial evaluating the effectiveness of an occupational therapist intervention for the prevention of falls. The study is due to end in summer 2019.
Dr Mike Backhouse will present an invited talk at the British Society of Rheumatology's Annual Conference later this week. His talk is titled 'Variation in access to foot care in people with rheumatoid arthritis' and is part of a session on enhancing multidisciplinary teams working in the care of patients with inflammatory arthritis.
For more information about the conference please see the British Society of Rheumatology website.
Three members of staff working on the Yorkshire Lung Screening Trial have been awarded visiting titles from the Leeds Institute of Health Sciences, within the Faculty of Medicine and Health at the Univeristy of Leeds - congratulations!
A team led by Professor David Torgerson, Dr Adwoa Parker, Professor Catherine Hewitt, Catherine Arundel, Helen Tilbrook and Izzy Coleman at York Trials Unit will be testing ways to improve clinical trials in the NHS, using a 'Studies Within A Trial' (SWAT) approach. The project, funded by the Medical Research council and involving 10 universities including York and Oxford, aims to undertake 25 SWATs in order to develop an evidence base for how to do trials.
To find out more on this project please see the press release.
Dr Adwoa Parker and Professor David Torgerson have co-authored a blog with collaborators for the NIHR website titled ‘Why the NIHR's new funding stream for ‘Studies Within A Trial (SWATs) is potentially game-changing’. This blog is to support the NIHR’s new funding stream for ‘Studies Within A Trial (SWATs)’ in the Health Technology Assessment (HTA) Programme.
The York Trials Unit recently hosted the Second International Conference on Stepped Wedge Trial Design, on Monday the 19th and Tuesday the 20th of March, 2018. The conference featured an array of distinguished speakers, including: Dr Karla Hemming, Professor Jim Hughes, Mr Alan Girling and Professor Sandra Eldridge. For more information about this event, and a full list of presentations (some of which are available to download), please click here.
Dr Mona Kanaan is part of a recently funded project "Addressing Smokeless Tobacco Use and Building Research Capacity in South Asia (ASTRA)", lead by Kamran Siddiqi in collaboration with other UK and South Asian institutes.
Mona has also recently presented and chaired an E-poster session at the World Conference on Tobacco or Health.
Dr Adwoa Parker and Professor David Torgerson, along with collaborators, have recently published the following paper in the journal Trials on Studies Within A Trial (SWATs): Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?
Dr Adwoa Parker, together with collaborators, has published the following article in Nature Reviews Rheumatology: The RA-MAP Consortium: a working model for academia–industry collaboration
The HERO Trial (Hydroxychloroquine Effectiveness in Reducing Symptoms of Hand Osteoarthritis Trial) has recently published its results. The study shows there was no benefit in taking hydroxychloroquine (an off-label drug prescribed to treat osteoarthritis of the hand) to control debilitating pain when compared to a placebo.
The study was hosted at the York Trials Unit (YTU), University of York, working in conjunction with the Chief Investigator, Professor Philip Conaghan, and his team at the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds.
The study is published in the journal Annals of Internal Medicine.
Congratulations to Lydia Flett and Andrew Mott who both graduated from the University of York on 19th January 2018. Lydia graduated with a Masters in Public Health (Distinction) and Andrew with an MSc in Applied Health Research. Andrew was also awarded the Outstanding Academic Achievement Award. Well done to you both.
A new publication which reflects on the successful recruitment to SCIMITAR+ Trial https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2460-7
The SWIFFT trial team published a paper that explores stakeholder perspectives upon participant retention in clinical trials. The study concludes that a participatory approach to trial retention might engage all relevant stakeholders in the delivery of a clinical trial, it might also support the generation of speciﬁc and contextually relevant solutions to the challenge of participant retention. The article is available on-line at http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1756-5391/earlyview