Latest news
12th May 2022
New publication in the Journal of Contemporary Clinical Trials
Congratulations to Katherine Jones, Rachel Carr, Caroline Fairhurst and Joy Adamson for their new publication in the Journal of Contemporary Clinical Trials.
10th May 2022
News from the OSTRICH trial
The egg has finally hatched. The OSTRICH trial (Orthotics for Treatment of Symptomatic Flat Feet in Children) has recruited its first patient. Well done to everyone involved.
10th May 2022
Co-Director of York Trials Unit
Professor Catherine Hewitt has taken up the role of Co-Director of York Trials Unit alongside Professor David Torgerson.
3rd May 2022
New publication in SSM - Qualitative Research in Health
Congratulations to Bella Scantlebury, Catriona McDaid, Liz Cook and Joy Adamson for their new publication in SSM - Qualitative Research in Health.
27th April 2022
New systematic review publication
Congratulations to Dan March on his recent systematic review and meta-analysis publication. This review investigates the effect of non-pharmacological and pharmacological interventions on measures associated with sarcopenia in end-stage kidney disease.
Published as part of a Special Issue titled Protein-Energy Wasting, Sarcopenia, Cachexia and Muscle Wasting in Patients Living with Chronic Kidney Disease.
19th April 2022
FIREFLI has started recruitment!
We are pleased to announce that the FIREFLI trial has started recruitment!
FIREFLI is a randomised controlled trial to investigate if Safe and Well home Visits delivered by the Fire and Rescue Service reduce falls and improve the quality of life in older people. We will be working with Humberside Fire and Rescue Service and Kent Fire and Rescue Service to recruit 1156 people aged 70 or over for the study. Recruitment has now begun in Humberside!
12th April 2022
New publication for the SSHeW Trial Team in Injury Prevention
Congratulations to the SSHeW Trial Team for their publication in the BMJ Injury Prevention Journal.
11th April 2022
New publication for the OSTRICH Trial in BMC Trials
Congratulations to the OSTRICH Trial Team for their publication in the BMC Trials Journal.
28th March 2022
E-PLAYS-2 opens school recruitment!
We are excited to announce that the E-PLAYS-2 trial is open!
E-PLAYS-2 is a cluster randomised controlled trial planning to recruit 84 schools (and 1100 children aged 5-7) to investigate the effectiveness of a computer game that aims to improve children's language development.
We are looking to recruit mainstream primary and special needs schools with Y1-3 pupils located in Hertfordshire, Bedfordshire or North London. If your school is interested in taking part and would like more information please email EPlays2@beds.ac.uk
22nd March 2022
Presentation at UKTMN Conference
Rachel Carr presented at the UKTMN Conference on the 22nd of March, on behalf of the OSTRICH team.
The presentation was titled: "A SWAT to determine whether video and online multimedia resources improve recruitment of children to clinical trials".
15th March 2022
'Ask the Researcher', Pharmacy Technicians International
Michelle Watson was invited to speak at an 'Ask the researcher' session organised by Pharmacy Technicians International. At the event, Michelle discussed her roles as a pharmacy technician and researcher, her research interests, and answered questions raised by those who attended.
12th March 2022
New publication for the QIST Team
Congratulations to the QIST Trial Team for their publication in the BMC Implementation Science Journal.
28th February 2022
New publication for the BRIGHT Trial Team
Congratulations to the BRIGHT Trial Team for their publication in the BMC Oral Health Journal.
22nd February 2022
Open access publication in BMC Nephrology
Congratulations to Daniel March for his publication in BMC Nephrology. They are the first guidelines of their kind.
Titled: Clinical practice guideline exercise and lifestyle in chronic kidney disease
15th February 2022
BioDriveAFS Trial Logo Competition
Congratulations to Poppy Nordberg, a student at Beverley High School, for designing the winning BioDriveAFS trial logo.
Students at Beverley High School in Beverley, East Riding of Yorkshire were invited to take part in the logo competition, as part of the trial’s outreach activities. The winner received a £50 gift card, which was presented by their headteacher, Miss Japp.
15th February 2022
The University of York, Internal Funding
Congratulations to Bella Scantlebury, who has received funding from the University of York Internally Distributed funding autumn call 2021 for the following project: Understanding what influences orthopedic surgical decision making: a mixed methods systematic review
24th January 2022
New publication in Contemporary Clinical Trials Journal
Congratulations to Catherine Knowlson, Alexandra
It can be accessed for free until 9th March 2022.
11th January 2022
Gateway Trial: Published protocol paper in BMC Trials
Congratulations to the Gateway trial team for their publication in the BMC Trials Journal.
11th January 2022
Congratulations to Helen Anderson
Helen Anderson has recently been appointed to the International Council of Nurses (ICN) Advanced Practice Education Group.
The ICN is a federation of more than 130 national nurses associations representing more than 27 million nurses worldwide. The current focus of the group is to develop educational competencies for advanced nursing practice on behalf of the International Council of Nurses.
10th January 2022
YTU Education trials team successfully complete over 3000 baseline pupil assessments and randomise 228 education settings for two large trials!
Within YTU we have had two large cluster randomised education trials running in tandem; Maths Champs 2 which is evaluating the impact of a maths CPD intervention in 134 nurseries on children (aged 3-4) maths skills, and TEEM UP which is evaluating a maths CPD intervention in 94 schools on children’s (aged 5-7) maths skills. Between September 2021 and December 2021, in both trials simultaneously, working relationships with educational establishments had to be established and maintained, over 3000 children were recruited, and baseline assessments completed. For TEEMUP, the trial team developed an innovative method for collecting TEEMUP baseline data using a complex Qualtrics data collection form, with built-in decision making, making the assessment substantially easier for assessment administrators to conduct on-site in schools and collect data live using an iPad.
Working with this number of schools/nurseries and children simultaneously at any time would be a huge undertaking but conducting this research with schools during the pandemic was a momentous challenge. The work on these two trials is predominantly managed by small teams of experienced, dedicated researchers within YTU who have shown huge determination and resilience to ensure the success of the research!
Huge congratulations to the trial teams!
10th January 2022
A briefing paper published for Convalescence Long-COVID-Study
17th December 2021
New publication in BMJ - Christmas Edition
Congratulations to Izzy Coleman and the PROMETHEUS and Trial Forge Teams along with colleagues from the University of Aberdeen for their publication in BMJ (Christmas Issue).
7th December 2021
Attendance at Vascular Society Annual Scientific Meeting
Catherine Arundel attended to present an update on SWHSI-2 and VenUS 6 study design and site status at the Vascular Society Annual Scientific Meeting in Manchester on 1st to 3rd December. It was great to reconnect with participating sites for both studies, and to meet some potential new sites too!
30th November 2021
New Funding from General Nursing Council of England and Wales Trust
Congratulations to Helen Anderson and Joy Adamson for receiving funding from the General Nursing Council of England and Wales Trust to carry out a qualitative study of General Practice Nurses' experiences during Covid-19 (GenCo).
23rd November 2021
The Gentle Years Yoga (GYY) Trial Recruitment Complete
22nd November 2021
PRESTO - Trial results published
The full report of the PRESTO Trial has now been published in the NIHR Journals Library, Health Technology Assessment Volume: 25, Issue: 62; Surgery versus conservative management of stable thoracolumbar fracture: the PRESTO feasibility RCT.
This study concluded that a full trial is unlikely to be feasible mainly owing to the low proportion of eligible patients identified.
15th November 2021
SWHSI-2 Trial: Published protocol paper in BMC Trials
Congratulations to the SWHSI-2 trial team for their publication in the BMC Trials Journal.
8th November 2021
Congratulations to the STEPFORWARD team
The STEPFORWARD trial paper entitled “A Randomised Feasibility Study of a Self-Aligning Prosthetic Ankle-Foot for Older Patients with Vascular-Related Amputations: The STEPFORWARD Study” has won the World Congress Best Paper Prize for Advancing Technology.
Congratulations team!
1st November 2021
DISC Trial: Published protocol paper in BMC Trials
Congratulations to the DISC trial team for their publication in the BMC Trials Journal.
27th October 2021
New publication for the BASIL-C19 (Behavioural Activation in Social Isolation) Trial
A simple form of talking therapy reduced loneliness in older people left isolated during the pandemic, initial results of BASIL-C19 have revealed.
People were contacted weekly over the telephone by trained support workers and encouraged to maintain their social contacts and to stick to a daily schedule, which included both routine and enjoyable activities.
The intervention developed in the BASIL-C19 study lasted for eight weeks and was designed in partnership with older people who had direct experience of social isolation, loneliness and depression during the pandemic.
The study was led from by Professor Simon Gilbody, Director of the Mental Health & Addictions Research Group (MHARG), and Professor David Ekers, Clinical Director for research and development at TEWV NHS Foundation Trust and Honorary Professor at the University of York.
Lauren Burke, Caroline Fairhurst, Samantha Gascoyne, Catherine Hewitt, Kalpita Joshi and colleagues in MHARG were involved in the work, which was published in PLOS Medicine.
Results of the study were also released in a University of York press release and are covered over on the BASIL twitter (@BASIL_Research).
26th October 2021
Paper published in Journal of Clinical Epidemiology
Congratulations to Rachel Carr, Laura Clark, Lauren Burke, Izzy Coleman, Gareth Roberts and David Torgerson for their publication in the Journal of Clinical Epidemiology.
26th October 2021
The BATH-OUT-2 team are happy to announce the randomisation of their first two participants to the trial!
BATH-OUT-2 is a randomised controlled trial aiming to recruit and randomise 360 people set within local authority housing adaptations services. The trial aims to determine the clinical and cost effectiveness of bathing adaptations compared to no adaptations.
Congratulations team!
25th October 2021
New Publication in BMC Medicine
Congratulations to Sarah Cockayne, Adwoa Parker, and David Torgerson for their new publication in BMC Medicine.
5th October 2021
Society for Social Medicine and Public Health Annual Conference in September
1st October 2021
Association of Pharmacy Technicians UK (APTUK) 10 year registration anniversary celebration event
Michelle Watson was invited to speak at the Association of Pharmacy Technicians UK (APTUK) 10 year registration anniversary celebration event, where she spoke about her Pre Doctoral Fellowship, career to date, and future plans. A brief summary of this information was included in The Pharmacy Technician Journal.
29th September 2021
QIST goes to the British Orthopaedic Association Annual Conference in Aberdeen on 23rd September.
Izzy Coleman and Ashley Scrimshire along with other members of the QIST team presented the results of the Scaling up Quality Improvement for Surgical Teams (QIST) trial at the British Orthopaedic Association Annual Conference in Aberdeen on 23rd September.
29th September 2021
Wounds REsearch Network meeting (WREN) at the Tissue Viability Society Conference
Catherine Arundel presented an update on SWHSI-2 and VenUS 6 study design and site status on 21st September 2021 at the Wounds Research Network (WREN) Scientific Meeting) as part of the recent Tissue Viability Society Virtual Conference.
New paper published in the International Journal of Nursing Studies
Congratulations to Helen Anderson, Arabella Scantlebury, Heather Leggett, and Joy Adamson who have recently had a paper published in the Internation Journal of Nursing Studies.
Upcoming conference presentations
Helen Anderson has a busy September ahead with three conference presentations planned.
Paper published in the Critical Reviews in Food Science and Nutrition journal
Congratulations to Katherine Jones who has recently had a paper published in the Critical Reviews in Food Science and Nutrition journal titled “The effect of dietary anthocyanins on biochemical, physiological, and subjective exercise recovery: a systematic review and meta-analysis”.
Studies Within A Trial (SWATs): Submissions for a Special Issue
We are inviting submissions for a special issue of the journal Research Methods in Medicine & Health Sciences addressing the issue of Studies Within A Trial (SWATs) (guest editors Professor Mike Clarke and Dr Adwoa Parker). SWATs are an underused approach to evaluate ways to increase the efficiency and rigour of randomised trials. The aim of this special issue is to promote their use and report key methodological advances. Therefore, we are inviting submissions from researchers for completed SWATs and SWAT methodology (both quantitative and qualitative). There will be no article processing fees for authors, and articles will be free to access. Please submit manuscripts by October 30, using the following link: https://journals.
A SWAT Reporting Guidelines Template is currently being piloted, and authors are welcome to use it to report their SWATs. This is available at: https://www.york.ac.uk/
Any correspondence, queries or additional requests for information on the manuscript submission process should be sent to the Research Methods in Medicine & Health Sciences editorial office as follows:
Joel Gagnier, Editor-in-Chief: jgagnier@umich.edu
Adwoa Parker, Editorial Board Member (SWATs): adwoa.parker@york.ac.uk
New paper published for the ACTIVE and PRESTO trial teams
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.
NIHR Pre-Doctoral Fellowships Awarded.
Congratulations go to both Andrew Mott and Ailish Byrne who have been awarded Pre-Doctoral Fellowships by the National Institute of Health Research.
Supervised by Catherine Hewitt, Catriona McDaid, and Jamie Kirkham, Andrew will be focusing his training and doctoral application on interventions to improve the design and conduct of trials.
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.
OTIS Trial results published
The OTIS trial report has now been published in the NIHR Journals Library, Health Technology Assessment Volume: 25, Issue: 46, Published in July 2021
Thinking Qualitatively and International Qualitative Conference
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
Results of SSHeW trial published as NIHR Alert
Research to explore improved treatment for blood cancers
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 York Trails Users take on The Great York Walk 2021!
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.
Introducing the team: Ada Keding, Rachel Cunningham-Burley, Maddy Elliott, Laura Wiley, Rachel Carr, Caroline Fairhurst, Tom Pool, Belen Corbacho, Camila Maturana and Kate Flemming.
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!
For more information and to donate.
REDUCE - Pilot trial opens and first participant recruited!
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!
Trial Forge SWAT network group
14th Annual Conference of RCTs in the Social Sciences
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.
Two new qualitative publications for YTU
Bella Scantlebury and Laura Sheard have a new publication in the Digital Health journal.
Bella Scantlebury, Helen Anderson, Heather Leggett and Joy Adamson have a new publication in BMJ Open
The Gentle Years Yoga Trial Protocol Publication
New publication for Rachel Carr
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 presents at UKTMN Annual Conference
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".
SSHeW - Trial results published
VenUS 6 - Trial opens and first participant recruited!
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.
Congratulations team!
Third International Conference on Stepped Wedge Trial Design
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 (emma.brooks@york.ac.uk)
Keynote Speaker: Professor Andrew Forbes, Monash University (Australia).
Admission: FREE
To book your place please visit the event page.
Fellowship of the Higher Education Academy for Dr Catriona McDaid
PhD by Publication success
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.
New publication for the SSHeW trial
Sarah Cockayne, Caroline Fairhurst, Rachel Cunningham-Burley and David Torgerson have a new publication about the main results of the SSHeW trial.
Results of the study were also released in a University of York press release which was picked up by the local York Press.
UK FROST trial about treatment for a frozen shoulder is published in the HTA journal
"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
Congratulations to Katherine Jones who has just passed her PhD viva with minor corrections.
PROMETHEUS Webinar – The Implementation and Management of Studies Within A Trial (SWATs).
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 Prometheus-group@york.ac.uk
Or you can visit our webpage at https://www.york.ac.uk/healthsciences/research/trials/research/swats/prometheus/
SWIFFT trial about the treatment of scaphoid fractures in the wrist is published in the HTA journal
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.
Does your Emergency Department need a GP?
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!
SOFFT - Trial opens and first participant recruited!
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.
New publication in the British Journal of Psychiatry from the SCIMITAR+ Trial
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.
Keyhole surgery no more effective at treating ‘frozen shoulder’ than less invasive therapies
Keyhole surgery is no better at treating frozen shoulder than two alternative therapies, an NIHR funded trial published in the Lancet today has found and as shown in an animation.
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.”
A team from YTU have published their study on the content of systematic review protocol information in PROSPERO registrations
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.
https://f1000research.com/
New paper published with F1000Research
David Torgerson and Catherine Knowlson recently had a paper published with F1000Research.
'Effects of rapid recruitment and dissemination on Covid-19 mortality: the RECOVERY trial' it can be accessed here.
SWHSI Programme Grant publish findings
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
New publication from the PACT team
Catherine Hewitt, Sarah Cockayne, Laura Sheard and the PACT team recently had a paper published with Pilot and Feasibility Studies.
'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
Paper published with Alimentary Pharmacology and Therapeutics
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 can avoid the need for surgery for common wrist fractures, study concludes
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).
Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial is published in The Lancet.
Please use the following 50 day free access link to download the paper until September 25th.
New publication for SWHSI in the Journal of Tissue Viability
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.
New publication in Research Methods in Medicine & Health Sciences
Michelle Watson, Catherine Arundel, Laura Clark, and Liz Cook have a new publication in the Research Methods in Medicine & Health Sciences journal.
'Reporting of placebo medication descriptors in randomised controlled trials: A review of three medical journals', it can be accessed here.
Congratulations to Jonny Kent
Congratulations to Jonny Kent who has just passed his MD viva with minor corrections.
New publication in The Journal of Pain
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 in BMJ Open
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 Zainab Kidwai
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
New publication in Archives of Disease in Childhood journal
Camila Maturana and Alex Dean have a new publication in the Archives of Disease in Childhood journal.
"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 in JDR Clinical & Translational Research journal
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.
PROMETHEUS team to host a 2 hour Webinar - 29th June, 10.00am - 12.00pm
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.
York at the 2020 XL Spanish Health Economics Association (AES) Conference (24th to 26th June, Zaragoza, Spain)
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.
New publication in the Trials Journal
New publication in the Trials Journal from Arabella Scantlebury, Sarah Cockayne, Caroline Fairhurst, Sara Rodgers, David Torgerson, Catherine Hewitt and Joy Adamson.
"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.
Congratulations to Rachel Carr
Rachel Carr has recently passed her PhD in "Dyadic interventions to promote physical activity". Congratulations Rachel.
Seminar Presentation at Centre of Health Economics (CHE)
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 in European Journal of Health Economics
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.
Venous Leg Ulcer Research Returns to York
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
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.
New publication in the Journal of Clinical Nursing
8th NIHR OTS Musculoskeletal Trauma Trials Annual Meeting
15 January 2020 Hilton Newcastle Gateshead
Attended: Stephen Brealey, Liz Cook, Lydia Flett, Sophie James, Joanne Laycock, Grace O'Carroll and Catherine Arundel.
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!
POSTPONED: THIRD INTERNATIONAL CONFERENCE ON STEPPED WEDGE TRIAL DESIGN
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
https://www.york.ac.uk/healthsciences/research/trials/ytu-events/sw2020/
Please forward to any colleagues who may be interested in this event
Please contact Emma Brooks (emma.brooks@york.ac.uk) for further information
We hope to welcome you to York in 2020!
Fab 14 from YTU take International Clinical Trial Methods conference by storm!
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.
NIHR Pre Doctoral Fellowship Award
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!
KReBS Trial Protocol Publication
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.
SWHSI-2 now open to recruitment
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
Best treatment for fragility fracture of spine unclear: YTU trial now underway
‘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.
Paper published with F1000Research
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.
Recent collaboration with Mental Health Addictions Research 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.
Researcher co-authors new book on The Foot and Ankle in Rheumatology
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?
York Trials Unit hosts a feedback event about the ACTIVE trial
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