Arabella Scantlebury, Catriona McDaid, Stephen Brealey, Elizabeth Cook, Hemant Sharma, Arun Ranganathan & Joy Adamson on behalf of the ACTIVE and PRESTO study teams have recently had a paper published in BMJ, Trials Journal.
Scantlebury, A., McDaid, C., Brealey, S. et al. Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials. Trials 22, 461 (2021). https://doi.org/10.1186/s13063-021-05420-4
Supervised by Christina Van Der Feltz-Cornelis and Bella Scantlebury, Ailish will be focusing her training and doctoral application on qualitative methodology, patient-public involvement, and designing complex health interventions.
The OTIS trial report has now been published in the NIHR Journals Library, Health Technology Assessment Volume: 25, Issue: 46, Published in July 2021
Arabella Scantlebury presented at the Thinking Qualitatively and International Qualitative Conference on the 6th July 2021.
Presentation Title: Experiences and Challenges of Conducting and Analysing ‘Big Qualitative Data’: Lessons Learned from a National Mixed Methods Evaluation of General Practitioners Working in or Alongside Emergency Departments
Researchers at the York Trials Unit and Hull York Medical School (HYMS) are part of a team set to undertake research aimed at improving the treatment of people with blood cancers.
The team are taking on The Great York Walk, a challenge walking event that will help to transform mental health by raising funds for Mentally Fit York at the University of York. Mental ill-health doesn't discriminate and right now, mental health has never been more important as the social implications of coronavirus begin to unravel.
They will be counting their daily steps for the next three months (10th May - 31st July) to contribute to a 25,000 mile walking goal. That's the equivalent of a walk around the Earth!
Please donate anything you can to help reach their target and improve mental health in York and beyond!
The REDUCE team are delighted to have opened both recruitment sites in June 2021 AND have recruited their first participant to the trial!
The REDUCE Pilot is a randomised controlled trial aiming to recruit and randomise 20 people with healed diabetic foot ulcers. The pilot trial will help inform recruitment strategies for the full effectiveness trial in 2022.
The aim of the REDUCE intervention is to reduce the risk of re-ulcertaion and to promote diabetic foot ulcer healing. The REDUCE intervention combines a complex psychological & behavioural intervention delivered in an eight week programme of one-to-one sessions with a healthcare professional followed by access to a web-based maintenance intervention.
Congratulations to all those involved!
On the 10th, 12th and 13th of May 2021 York Trials Unit (YTU), along with colleagues from the Centre for Health Economics (CHE), Dept for Education (York) and the National Foundation for Educational Research (NFER), hosted the 14th Annual Conference of Randomised Controlled Trials in the Social Sciences. Because of the pandemic this was a virtual event with an array of international speakers.
The Conference was opened by Professor Carole Torgerson (Dept of Education, York) and on the first day the invited speakers were Mette Deding who was introduced by Hannah Ainsworth (YTU). Mette who is the Deputy Director General of VIVE (Denmark) spoke about RCTs in a Danish and historical context. She was followed by Professor Peter Tymms, School of Education (Durham University), who was introduced by Lyn Robinson-Smith (YTU), who talked about how educational RCTs have changed over the last 30 years. Both sessions were facilitated by Dr Ben Styles NFER.
On the 12th of May the two sessions were delivered by two researchers from the USA. Professor Don Green from Columbia University, introduced by Professor David Torgerson, spoke about RCT designs for detecting spillover or contamination effects. Whilst the second speaker Professor Larry Hedges from Northwestern University, introduced by Professor Carole Torgerson, spoke about inferences from randomised trials for policy and practices. Both sessions were facilitated by Professor Catherine Hewitt.
The final two speakers (13th May) were Professor Sarah Miller (Queen's University, Belfast) and Professor Peter John (King's College London). Professor Miller, introduced by Louise Tracey, spoke about the role of RCTs in systematic reviews and building the evidence base in education, whilst Professor John, introduced by Caroline Fairhurst, spoke about voter mobilisation in the UK and the evidence from RCTs. Both sessions were facilitated by Professor Gerry Richardson (CHE) and he also made the concluding remarks.
The conference was well received by delegates and we are planning for the 15th Annual Conference as a face to face event in May 2022. Emma Brooks and Sally Baker (YTU) ensured that all the organisation and technical issues flowed smoothly throughout.
Congratulations to Rachel Carr, her second PhD paper has been accepted for publication in the Health Psychology and Behavioral Medicine Journal, Vol 9, Issue 1.
Primary care COPD study published in Collaboration with Oxford University, Kings College, Norway University, Maastricht University, University of Southampton, Cardiff University and University of York (Ann Cochrane); published online 9th March 2021 in The Journal of General Practice.
YTU had several researchers present at the UK Trial Manager Network (UKTMN) Annual Conference on 2nd March 2021. Liz Cook and Bella Scantlebury spoke about "Working together to optimize recruitment to RCTs: Lessons learned from the PRESTO Feasibility study". Rachel Carr gave a presentation on "Impact on Recruitment of Using an Invitation Letter Informed by Self-Determination Theory". Ann Cochrane presented her topic "Adapting a public health study co-produced by the police (Gateway), to enable recruitment and data collection under COVID-19 restrictions".
The VenUS 6 team are delighted to have opened to recruitment at it's first site in January 2021 AND February 2021 have recruited the first participant to the trial!
VenUS 6 is a randomised controlled trial aiming to recruit and randomise 675 people with venous leg ulcers to investigate the clinical and cost effectiveness of different compression treatments.
22nd and 23rd March 2021, Online Conference
Following the success of previous years and keeping pace with this ever more popular design, we are delighted to invite you to our online conference.
The conference will take place on 22nd and 23rd of March 2021 with a variety of presentations and discussions grouped into topical sessions throughout the two days. You are welcome to join as many sessions as you wish. Full timings will be released nearer the time
For further information please contact Emma Brooks (firstname.lastname@example.org)
Keynote Speaker: Professor Andrew Forbes, Monash University (Australia).
Congratulations go to Alison Booth, Senior Research Fellow at YTU, who has passed her PhD by Publication viva with minor amendments to her thesis on "Systemaƚic review protocol registration and reporting guidelines: development, implementation and utility.
Cockayne, S, Fairhurst, CM, Frost, G, Liddle, M, Cunningham-Burley, RA, Zand, M, Hewitt, CE, Illes-Smith, H, Green, L & Torgerson, DJ 2021, 'Slip-resistant footwear reduces slips among National Health Service workers in England: A randomised controlled trial', Occupational and Environmental Medicine. https://doi.org/10.1136/oemed-
Results of the study were also released in a University of York press release which was picked up by the local York Press.
"Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST 3-arm RCT" has now been published in the HTA journal on the NIHR Journals Library website and can be downloaded here.
In the largest clinical trial of its kind, researchers led by a team at South Tees Hospitals NHS Foundation Trust and University of York Trials Unit, have found that keyhole surgery was no more effective than two other less costly and invasive treatments using a patient-reported questionnaire about shoulder pain and function. One was Manipulation Under Anaesthesia - a minimally invasive procedure where surgeons move the shoulder joint to a full range of motion. The other was early structured physiotherapy with a steroid injection - a treatment specially designed for the trial that doesn’t require a general anaesthetic.
The authors concluded that at a time when NHS resources are stretched, encouraging surgeons to use keyhole surgery more selectively when less costly and less invasive interventions fail, could save valuable theatre time and limit the need for people to undergo unnecessary lengthy procedures.
Congratulations to Katherine Jones who has just passed her PhD viva with minor corrections.
The second webinar of the PROMETHEUS webinar series was successfully held on November 10th, 2020. The webinar consisted of experienced SWAT teams providing their first-hand practical knowledge and helpful tips of how to implement SWATs within host trials to prospective teams. Presenters included researchers from a variety of clinical trials units from across the UK, covering a wide range of both retention and recruitment interventions. Dr Sandra Galvin also presented on behalf of the Health Research Board, Trials Methodology Research Network, discussing the use of SWATs in Ireland.
The PROMETHEUS team would like to say a huge thank you to both the presenters and all of the attendees, for making it such a successful morning. If you would like the opportunity to view this webinar or catch up on anything you may have missed, please use the following link to access the webinar recording: https://eu-lti.bbcollab.com/
If you would like any further knowledge in relation to SWATs or the support that the PROMETHEUS team can provide, please contact us on Prometheusemail@example.com
Or you can visit our webpage at https://www.york.ac.uk/healthsciences/research/trials/research/swats/prometheus/
The research suggests that by opting for a plaster cast, patients can avoid the risk of surgery, while hospitals can keep service delivery simple and cost effective, without compromising patient outcomes. The team, therefore, concluded that a plaster cast should be used in the first instance, with surgery only being considered if the bone doesn’t heal.
Joy Adamson, Helen Anderson, Heather Leggett and Arabella Scantlebury presented findings from the NIHR Health Services and Delivery Research (HS&DR) funded GPED (General Practitioners and Emergency Departments: Efficient models of care) study at a virtual all-day dissemination event on 21st October 2020. The main study findings and key results papers along with the main HS&DR report are being prepared for publication – watch this space!
The SOFFT team are delighted to have opened to recruitment at two sites in October AND to have recruited the first participant to the trial!
SOFFT is a randomised controlled trial comparing two methods of repairing fractures of the olecranon (the bony point of the elbow). The target is to recruit 280 patients in at least 35 NHS hospitals around the country.
The difficulties in accessing Nicotine Replacement Therapy, as observed in the SCIMITAR+ trial, and potential solutions has been published in the British Journal of Psychiatry Open, access the paper here.
Activity and experiences in the conduct of the SCIMITAR+ Trial identified that nicotine replacement therapy (NRT) is routinely difficult for patients to access, and where accessible that appropriate provision was not always provided. As a result, the SCIMITAR+ team suggests that the availability of smoking cessation support and NRT provision would benefit from being made clearer, simpler and more easily accessible so as to enhance smoking cessation rates.
Frozen shoulder is a common and painful condition in which movements in the shoulder become restricted. It affects 10 per cent of women and eight per cent of men of working age and can last years.
A common surgical treatment is Arthroscopic Capsular Release (ACR), a keyhole procedure under general anaesthetic where a probe is inserted into the shoulder, along with a camera and the joint capsule is released, stretched and manipulated to regain a range of movement. This is a costly and invasive treatment.
However, in the largest clinical trial of its kind, researchers led by a team at South Tees Hospitals NHS Foundation Trust and University of York Trials Unit, have found that ACR was no more effective than two other less costly and invasive treatments using a patient-reported questionnaire about shoulder pain and function. One was Manipulation Under Anaesthesia (MUA) - a minimally invasive procedure where surgeons move the shoulder joint to a full range of motion. The other was early structured physiotherapy (ESP) with a steroid injection - a treatment specially designed for the trial that doesn’t require a general anaesthetic.
Chief Investigator Professor Amar Rangan at the University of York and Consultant Orthopaedic Surgeon at South Tees NHSFT, said “Our trial has shown that an expensive keyhole surgery is no better than two alternative therapies. This could provide more choice for patients - especially those with conditions like diabetes who have to manage a chronic disease and who may not want the additional inconvenience and risk of surgery under anaesthetic.”
The randomised controlled trial was carried out in 35 UK hospitals and recruited over 500 patients. All three treatments led to substantial improvements in patient reported shoulder pain and function over one year, but none of the treatments were superior.
Although ACR resulted in the least number of further treatments: 4%, compared to 7% for MUA and 15% for ESP, it carried relatively higher risks, mostly general risks from having a surgical procedure, and had longer waiting times to access.
ESP with a steroid injection could be accessed quickly, had relatively fewer risks than ACR and was cheaper, but more patients required further treatment.
Overall MUA was found to be the most cost-effective option to the NHS.
Dr Stephen Brealey, Trial Manager at University of York, added that “At a time when NHS resources are stretched, encouraging surgeons to use keyhole surgery more selectively when less costly and less invasive interventions fail, could save valuable theatre time and limit the need for people to undergo unnecessary lengthy procedures.”
Booth A, Mitchell A, Mott A, James S, Cockayne S, Gascoyne S, McDaid C. An assessment of the extent to which the contents of PROSPERO records meet the systematic review protocol reporting items in PRISMA-P [version 2; peer review: 2 approved]. F1000Research 2020; 9. DOI: 10.12688/f1000research.25181.
'Effects of rapid recruitment and dissemination on Covid-19 mortality: the RECOVERY trial' it can be accessed here.
The findings from the SWHSI Programme Grant for Applied Research have recently been published in the NIHR Journals Library: Programme Grants for Applied Research volume 8, number 7
This programme sought to investigate the epidemiology, management and impact of surgical wounds healing by secondary intention and included the SWHSI feasibility RCT.
The SWHSI team are now building on this work, undertaking a full scale randomised trial of treatments (negative pressure wound therapy versus wound dressings) for surgical wounds healing by secondary intention. Further details are available at the SWHSI-2 webage
'Improving patient experience and safety at transitions of care through the Your Care Needs You (YCNY) intervention: a study protocol for a cluster randomised controlled feasibility trial', it can be accessed here
Katherine Jones recently had a paper published with Alimentary Pharmacology and Therapeutics.
'Randomised clinical trial: Combined impact and resistance training in adults with stable Crohn’s disease', it can be accessed here
Plaster casts are just as effective as surgery at healing scaphoid waist fractures in the wrist, according to a study involving researchers at the University of York.
The SWIFFT trial, conducted in collaboration with the University-based York Trials Unit, concluded that for a scaphoid waist fracture in the wrist, a plaster cast should be used in the first instance, with surgery only being considered if the bone doesn’t heal.
The findings are published in The Lancet today (6 August 2020).
Fracture of the scaphoid bone (one of eight small bones in the wrist) is common in young, active people, caused by a fall on the hand or the hand being suddenly forced backward. The research suggests that by opting for a plaster cast, patients can avoid the risk of surgery, while hospitals can keep service delivery simple and cost effective, without compromising patient outcomes.
The trial compared outcomes for patients who either had surgery to hold the broken scaphoid with a special screw, or had their wrist immobilised in a plaster cast.
After one year from the initial injury, patients were measured on a number of factors, including wrist pain and function.
The study showed no significant difference between the two groups in pain, function, days off work and the number of fractures that did not heal properly. But 12 per cent of patients who had surgery were assessed by the hospitals to have more complications following treatment compared to 2 per cent for the plaster cast group.
The researchers also considered the health economics of surgery versus plaster cast. Over the year, the cost of surgery to the NHS was significantly higher at £2,350, compared with the cost of plaster cast treatment, which was £727 for each patient.
Dr Stephen Brealey, Trial Manager at York, said: “We are incredibly grateful to the patients who took part in this important study, which shows with their support what can be achieved through research to ensure patients get the best care by informing doctors’ decision-making, which also benefits the NHS.”
The study was led by University Hospitals of Leicester NHS Trust and funded by the National Institute for Health Research Health Technology Assessment (HTA) programme (project number 11/36/37).
Please use the following 50 day free access link to download the paper until September 25th.
Catherine Arundel has recently had a publication accepted in the Journal of Tissue Viability.
'Exploring experiences of research nurse participation in conducting a randomised controlled trial of wound care treatments', it can be accessed here.
'Reporting of placebo medication descriptors in randomised controlled trials: A review of three medical journals', it can be accessed here.
Congratulations to Jonny Kent who has just passed his MD viva with minor corrections.
New publication from Phil Williamson in The Journal of Pain.
"Inter-individual differences in the responses to pain neuroscience education in adults with chronic musculoskeletal pain: A systematic review and meta-analysis of randomised controlled trials", it can be accessed here.
New publication from Mona Kanaan in BMJ Open.
"Compliance of smokeless tobacco supply chain actors and products with tobacco control laws in Bangladesh, India and Pakistan: protcol for a multicentre sequential mixed-methods study", it can be accessed here.
Congratulations to PhD student Zainab Kidwai who won 1st place & Peoples' Choice winner at last night's 3MT three minute thesis competition. You can see her presentation 'Can you catch it before it's Cancer?' here
"Children and young people’s concerns and needs relating to their use of health technology to self-manage long-term conditions: a scoping review", it can be accessed here.
New publication from Heather Leggett in the JDR Clinical and Translational Research journal.
"Whose Responsibility Is It Anyway? Exploring Barriers to Prevention of Oral Diseases across Europe", it can be accessed here.
This paper is a qualitative study which aimed to explore barriers and facilitators to prevention from the perspectives of dental teams, dental insurers, dental policy makers and patients across six European countries. The results from this study provide an initial first step for those interested in exploring and working toward the paradigm shift to preventive focused dentistry. Hopefully these findings will encourage more research exploring the complex relationship among dental stakeholders, with a view to overcoming the barriers.
The PROMETHEUS team at York Trials Unit will be hosting a 2 hour webinar on Monday 29th June, 10.00am - 12.00pm.
This webinar will cover an overview of the PROMETHEUS project and their work with Trial Forge, including details of work carried out in response to the COVID-19 pandemic. It will outline the current evidence around strategies to increase recruitment and retention in trials and will offer practical advice to enable researchers to quickly set up SWATs within their own trials, as activity restarts in due course.
To book your place now please use this link https://www.eventbrite.co.uk/
Please note: This replaces the previously advertised dissemination event that was due to take place in York.
Simon Gilbody, David Torgerson, Catherine Hewitt and Belen Corbacho were invited to attend the XL AES conference as keynote speakers presenting work from Health Sciences' ongoing research studies. Unfortunately, the conference will be postponed until June 2021 due to the COVID-19 pandemic. AES Scientific Committee announced it will be a pleasure to meet the researchers from York in Zaragoza next year.
"Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention", it can be accessed here.
The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project-specific fidelity can be assessed using a truly mixed-methods approach when informed by qualitative insights.
Rachel Carr has recently passed her PhD in "Dyadic interventions to promote physical activity". Congratulations Rachel.
On the 27th February Belen Corbacho presented a seminar at the Centre of Health Economics (CHE) on “Does the use of health technology assessment have an impact on the utilisation of health care resources? Evidence from two European countries.
Different jurisdictions organize their health technology assessment (HTA) capacity in different ways. Some establish capacity at the central level and undertake assessments that result in recommendations for the whole country; other establish capacity at the regional level resulting in several HA bodies within the same country and the possibility of several sets of recommendations. We conducted a comparative analysis of anticancer drugs in England (centralised HTA approach) and Spain (regional HTA approach) and used a regression approach to explore the association between HTA guidance and drug usage. This seminar will present the results of this study and outline the potential opportunities of different HTA models in supporting decision-making and their impact in a uniform development of services across the whole country.
New publication from Belen Corbacho in The European Journal of Health Economics "Does the use of health technology assessment have an impact on the utilisation of health care resources? Evidence from two European countries". It can be accessed here.
York Trials Unit, in conjunction with Professor Jo Dumville at the University of Manchester, are pleased to announce confirmation of funding from the National Institute for Research Health Technology Assessment Programme for the VenUS-6 Trial (Reference: NIHR128625).
This trial follows on from a number of previous successful trials, conducted by the Department of Health Sciences, into treatments for venous leg ulcers (VenUS I, VenUS II, VenUS III, and VenUS-IV).
The VENUS-6 trial will compare evidence based compression (choice of four-layer bandage or two-layer compression hosiery), two-layer bandage or adjustable hook-and-loop fastened compression systems (“compression wraps” ), to see if these make any difference to how quickly venous leg ulcers heal. The study aims to randomise 675 participants, 225 to evidence based compression, 225 to two layer bandage, and 225 to compression wraps. The primary outcome is time to ulcer healing. The associated costs of these treatment to the NHS will also be evaluated.
New publication in the Journal of Pain and Symptom Management; Johnson, M, Nabb, S, English, A, Booth, S & Kanaan, M 2020, '“Openness” personality trait associated with benefit from a non-pharmacological breathlessness intervention in people with intra-thoracic cancer: an exploratory analysis'. It can be accessed here.
This annual event provides plenty of enlightening (and entertaining!) presentations of the latest trials research in musculoskeletal trauma. This includes publicising up-and-coming trials looking for new sites and promoting recruitment, invited speakers, and even results of much anticipated research! There was representation from York for several trials (ACTIVE, L1FE, PROFHER2 & SOFFT) and we publicised findings about a SWAT of staff training to improve participant recruitment into surgical trials. We were really pleased to meet up with team members and collaborators at our network of sites, and received some excellent interest in and support of our portfolio of musculoskeletal trials. A great start to 2020, and looking forward to the year ahead!
16th and 17th MARCH 2020, UNIVERSITY OF YORK (UK)
On the back of the success of the first two conferences and the ever increasing interest in the topic, we are pleased to announce that the University of York will host the third International Conference on Stepped Wedge Trial Design 16th – 17th March 2020
The conference will run over two days on Monday 16th March and Tuesday 17th March at the University of York (UK), including workshop, evening meal at Barley Hall and invited presentations
Confirmed Keynote Speaker: Professor Andrew Forbes, Monash University (Australia)
Abstracts are invited for oral and poster contributions
Early acceptance deadline: Noon (GMT) 16th December 2019 and final deadline: Noon (GMT) 27th January 2020
Registration is now open with early bird rates available until 14th February 2020
Further information, including how to submit an abstract and how to register can be found at the following link
Please forward to any colleagues who may be interested in this event
Please contact Emma Brooks (firstname.lastname@example.org) for further information
We hope to welcome you to York in 2020!
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 (email@example.com)
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