CVUHB Research and Development Annual Performance Report 2020-2023

Foreword

Foreword

Research & Development Director Foreword

Research & Development Director Foreword

Professor Matt Wise

Professor Matt Wise

This is the sixth edition of Cardiff & Vale University Health Board’s (CV UHB) Research and Development Performance Report and writing this foreword, particularly striking the correct balance between optimism and where we aspire to be, is a challenge. In what feels like an increasingly inhospitable environment the report nevertheless showcases the strength of research activity across our organisation. For the second consecutive year in excess of 7,000 patients have been recruited to a clinical trial or study. Cardiff & Vale UHB continues to be the leading organisation in Wales delivering both commercial and non-commercial clinical trials to patients.

This is the sixth edition of Cardiff & Vale University Health Board's (CV UHB) Research and Development Performance Report and writing this foreword, particularly striking the correct balance between optimism and where we aspire to be, is a challenge. In what feels like an increasingly inhospitable environment the report nevertheless showcases the strength of research activity across our organisation. For the second consecutive year in excess of 7,000 patients have been recruited to a clinical trial or study. Cardiff & Vale UHB continues to be the leading organisation in Wales delivering both commercial and non-commercial clinical trials to patients.

Recruitment is continuously updated for all studies open in Wales and can be accessed here

Recruitment is continuously updated for all studies open in Wales and can be accessed here

The Power BI report can also be used to look at recruitment nationally for any given study in which we are participating.

The Power BI report can also be used to look at recruitment nationally for any given study in which we are participating.

The research delivery team in conjunction with the Health and Care Research Wales (HCRW) performance team have also developed a local version for CAV UHB, access here

The research delivery team in conjunction with the Health and Care Research Wales (HCRW) performance team have also developed a local version for CAV UHB, access here

Figures 1a and 1b - Number of Open & Recruiting Non-Commercial studies (left) and Number of Participants Recruited (right) per NHS organisation (2022-23)

Figures 1a and 1b - Number of Open & Recruiting Non-Commercial studies (left) and Number of Participants Recruited (right) per NHS organisation (2022-23)

Professor Matt Wise Research & Development Director

This year Professor Keith Harding has been appointed as an independent member of the board in the role of research champion and whilst this may increase visibility of research, we are still a long way off from embedding research within the culture of the organisation. Our funding for delivering research is still largely dependent on an allocation from HCRW, which at around £6 million (in real terms accounting for inflation) represents around 25% of the amount the UHB received a decade ago. We seek to have greater autonomy of this budget and I hope that we can move towards this in the near future. Many of you will have heard me say over the years that we cannot rely on HCRW to grow our activity and meet the needs of our investigators. We need to be more adept at developing commercial links and writing grants. I am delighted to say, with respect to the latter, NHS investigators have had an outstanding year with five NIHR grants awarded totalling more than £11 million.

This year Professor Keith Harding has been appointed as an independent member of the board in the role of research champion and whilst this may increase visibility of research, we are still a long way off from embedding research within the culture of the organisation. Our funding for delivering research is still largely dependent on an allocation from HCRW, which at around £6 million (in real terms accounting for inflation) represents around 25% of the amount the UHB received a decade ago. We seek to have greater autonomy of this budget and I hope that we can move towards this in the near future. Many of you will have heard me say over the years that we cannot rely on HCRW to grow our activity and meet the needs of our investigators. We need to be more adept at developing commercial links and writing grants. I am delighted to say, with respect to the latter, NHS investigators have had an outstanding year with five NIHR grants awarded totalling more than £11 million.

• Julie Cornish - POLARiS (Pathway Of Low Anterior Resection Syndrome Relief after Surgery) an international multicentre (30) randomised clinical trial with £1.8 million from UK as well as an additional AUD1.3 million for Australia.

• Julie Cornish - POLARiS (Pathway Of Low Anterior Resection Syndrome Relief after Surgery) an international multicentre (30) randomised clinical trial with £1.8 million from UK as well as an additional AUD1.3 million for Australia

• Jared Torkington and Sadie Jones - The PICCOS Trial (PIPAC in Cancers of the Colon, Ovaries and Stomach) with £2 million funding from NIHR Efficacy and Mechanism Evaluation (EME).

• Peter Collins and Sarah Bell - Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial. A NIHR HS&DR funded study of £3,453,702.95 plus industry collaboration.

• Jared Torkington and Sadie Jones - The PICCOS Trial (PIPAC in Cancers of the Colon, Ovaries and Stomach) with £2 million funding from NIHR Efficacy and Mechanism Evaluation (EME).

• Peter Collins and Sarah Bell - Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth:

• Krishna Narahari - The ELIPSE Study - a randomised controlled trial comparing the clinical and cost-effectiveness of lymph node removal in patients undergoing curative surgery for localised high-risk prostate cancer. A NIHR HTA Researcher-led call Primary Research for funding of £2 million.

• Dave Bosanquet – PLACEMENT trial (Perineural local anaesthetic catheter after major lower limb amputation trial). A NIHR HTA £1,635,918.

Figures 2a and 2b - Number of Open & Recruiting Commercial (left) and Number of Participants Recruited (right) per NHS organisation (2022-23)

Figures 2a and 2b - Number of Open & Recruiting Commercial (left) and Number of Participants Recruited (right) per NHS organisation (2022-23)

It has been clear that a key enabler of this success in several of these grants has been the placement of a clinical trials manager within the surgical clinical board and it is a model that we will be looking to develop further within the Health Board. Obtaining these multicentre grants also poses some new problems around handling large grants as the sponsoring organisation. We shall soon be appointing a finance officer within R&D which will not only facilitate this but give us better day-to-day oversight of R&D income and expenditure.

The recent publication of the Lord O’Shaughnessy review ‘Commercial clinical trials in the UK’ has led to a shift in emphasis in both NIHR and HCRW and is an attempt to address the fall in commercial trial activity in the UK. None of the report should come as a surprise but there is certainly, with the right investigators and R&D infrastructure, the opportunity to provide novel cutting-edge therapies to patients. Both Moderna and BioNTech are looking to invest in the UK, focussing particularly in vaccine trials. Moderna are investing around £2 billion in the manufacture and delivery of vaccines in the UK over the next decade, focussing initially on infectious diseases and later cancer and cardiovascular disease in their trial pipeline. This is a great opportunity not only for patients but also has obvious downstream benefits for preventative healthcare and the burden on the NHS in Wales. Although we wait to hear the final outcome we are hopeful that CV UHB will be able to lead the Moderna program in Wales with a vaccine centre based in the Clinical Research Facility led by Andrew Freedman. It also offers a fantastic opportunity to collaborate with the Systems Immunity Research Institute in Cardiff University.

Another important collaboration which continues to mature is the Cardiff Cancer Research Hub which is a collaborative between CAV, Velindre Cancer Centre (led by Mererid Evans) and Cardiff University (led by Awen Gallimore). This will not only provide a wider access to medium and high-risk early phase trials and advanced cell therapies but also bench to bedside therapies, reverse translation and novel diagnostics.

I hope that if you pick up and read the report that you won’t just focus on your own speciality but look at the breadth of activity within the organisation. Ideally this will stimulate people to seek out and collaborate with other like-minded investigators. As R&D director a key aspect of my job is to provide individual researchers with the appropriate infrastructure so that they can achieve their potential as investigators. This applies equally to the Chief Investigator of an international multicentre randomised control trial to those undertaking observational studies or being an Associate PI (Principle Investigator) as part of the NIHR scheme. Elevating the profile of research across the organisation not only allows patients better access to study participation but also the potential for novel therapeutics that can alter disease trajectory. The downstream benefits of trials include change in practice, education, clinical experience, financial gain, staff recruitment, retention and reputational growth. Unfortunately, many of these trial facets are frequently overlooked but they are key for an organisation to develop and improve patient outcomes. Changing and maintaining a proactive culture that maintains the importance of both research and education cannot be understated as goals for CV UHB. Given the size of the budget compared to the UHB as a whole, R&D punches well above its weight.

I would like to thank all our investigators and research staff for their continued hard work and contribution to improving the care of patients. Thanks also go to Sarah Ballard and Sara Shankland for producing this report. As ever, any other suggestions of how we can improve the report are welcome!

282

Studies Open & Recruiting

7072

Patients recruited this Financial Year

MOVE WALES 1 (NEUROLOGY)

UK’s Highest Recruiter

Top Recruiter in the UK

4514 (Frontier 2): Mim8 in adults and adolescents with haemophilia A

Study’s 1st Top Recruiter

Site to open and recruit in the UK REINFORCE (Surgery)

£3.2m

Awarded to Prof Dayan/Cardiff University by MRC for the LIONNS-D2 study in hypothyroidism (2023-26)

REPEAT phases 1 and 2 (Respiratory disorders)

Top Recruiter in the UK

LISTEN (Long COVID)

Abstract presented at the International Confederation of Midwives (ICM) congress in Bali (June 2023)

Study’s top recruiter

OPTIMAS trial (Stroke)

Shortlisted for the RCM Award for Excellence in Midwifery for Research

Cardiff & Vale Midwifery Research Team

UK’s Top Recruiter

Ver-A-T1D (Type 1 Diabetes)

Study’s

Top Recruiter

First site to recruit nationally/worldwide

LPRI-CF113 in the treatment of endometriosis

Trial Administrators from Research Delivery Team

Abstract presented at HCRW Support & Delivery event (March 2023)

Recruiter in the UK

Urine Biomarkers for Detecting Prostate Cancer

2nd Highest Add-Aspirin (Urology)

3rd Best Recruiter

out of 112 international sites for Prostate Cohort

Clinical Board Recruitment Summary

Clinical Board Recruitment Summary

Clinical Board Recruitment Summary

2022-23

Figure 3 - Non-Commercial Financial Year Recruitment by Clinical Board (2022-23)

Figure 4 - Commercial Financial Year Recruitment by Clinical Board (2022-23)

Figure 5 – Non-Commercial and Commercial Financial Year Recruitment by Clinical Board (2022-23)

Clinical Board Recruitment Summary Clinical Board Recruitment Summary

Clinical Board Recruitment Summary

Figure 6 - Total

and Commercial Financial Year Recruitment by Clinical Board (2019-20)

Figure

Figure 13 - Total Non-Commercial and Commercial Financial Year Recruitment by Clinical Board (2021-22)

Figure

Figure

Figure 8 - Total Non-Commercial and Commercial Financial Year Recruitment by Clinical Board (2022-23)

All Wales Medical Genomics Service Clinical Board

Summary from the AWMGS Clinical Board R&D Lead

The All Wales Medical Genomics Service (AWMGS) continues to support research in the fields of rare disease and precision medicine through its own initiatives and through collaborations with teams around Wales and the UK. Over the last 12 months, we have received grants for the advancement of precision oncology projects and contributed to the Interdisciplinary Precision Oncology Cardiff Hub (IPOCH) collaborative initiative with Cardiff University. Through the SWAN clinic, we have now developed an ethical framework for researchers to access stored genomic data within Wales via the Swansea University biobank, and in the next 12 months this will create a foundation for a significant expansion of our rare disease diagnosis research initiatives. There are also plans to move ahead with novel sequencing research for the undiagnosed patients from the SWAN cohort. We also support rare disease treatment research by facilitating the identification of candidate patients from across Wales in collaboration with other specialities. We have also opened the RECONNECT study for recruitment in collaboration with the Childrens and Young Adults Research Unit (CYARU) in Cardiff. We also continue to contribute towards multiple UK-wide and international research efforts towards understanding and diagnosing rare diseases in patients without a diagnosis from standard NHS testing.

All Wales Medical Genomics Service Clinical Board

All Wales Medical Genomics Service Clinical Board

All Wales Medical Genomics Service Clinical Board

All Wales Medical Genomics Service Clinical Board

3 – All Wales Medical Genomics Service Clinical Board Non-Commercial Recruitment Total Against Target (2022-23)

All Wales Medical Genomics Service Clinical Board

in

22 or 2022-23

Children & Women’s Clinical Board

Summary from the Children & Women’s Clinical Board R&D Lead

This has been another year of new developments in the Children and Women’s Clinical Board.

The obstetric unit had a podium finish at the Royal College of Midwives R&D Team of the Year Award. There have been some significant challenges with staffing levels, but trial recruitment has been maintained which is a credit to the team.

In paediatrics there continues to be a wide portfolio of trials into a number of diseases, most notable being respiratory, endocrine, haematology and infectious diseases. The oncology department became one of the UK’s Experimental Cancer Medicine Centres in partnership with Welsh Government and CRUK. CYARU is opening a number of vaccine trials as part of the Moderna programme and has participated in the HARMONIE RSV trial as well as COMCOV3.

2023-2024 looks to be an exciting year!

Children & Women’s Clinical Board

Children & Women’s Clinical Board

Total Target

PNET 5 PHITT GEM3 Fetal Atrial Flutter &… FaR-RMS

The POOL study nSEP mSEP BLOOD MARKERS FOR INVESTIGATING… ROCkeTS Induced sputum in children with cystic… The 'Big Baby Trial' Cerclage after full dilatation caesarean… CASAP Clinical Characterisation Protocol for… CLOCS FIRST-ABC UK Childhood ITP Registry Azithromycin Therapy for Chronic Lung… RECOVERY trial UMBRELLA. CF START OASI2: PROTECTOR Comparing COVID-19 Vaccine Schedule… The Tommy's National Rainbow Clinic… MyeChild

Quality of life in paediatric sarcoma SMPaeds

Blueprint:Service Design for Children &…

Characterisation of Paediatric… AZTEC2 HOLDS Giant PANDA PRESSURE WILL DECRYPT FaR-RMS ICONIC NCCPG TDM 2018 PHITT REACH study C-STICH2 rEECur SIOP Ependymoma II

Fetal Atrial Flutter & Supraventricular… GEM3 Needle-free, pain medicine for young… PNET 5 Recruitment total

Figure 1 - Children & Women's Clinical Board Non-Commercial Recruitment Total

Figure 2 - Children & Women's Clinical Board Non-Commercial Recruitment Total

Target (2021-22)

Children & Women’s Clinical Board

Children & Women’s Clinical Board

Children & Women’s Clinical Board

Children & Women’s Clinical Board

Figure 4 - Children & Women's Clinical Board Commercial Recruitment Total Against Target (2020-21)

Figure 5 - Children & Women's Clinical Board Commercial Recruitment Total

Target (2021-22)

Children & Women’s Clinical Board

Children & Women’s Clinical Board

Children & Women’s Clinical Board

Children & Women’s Clinical Board

ACUTE CHILD HEALTH Children & Women’s Clinical Board

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

Recruitment Total Target

The POOL study BuRN-Tool Grown in Wales ROCkeTS Induced sputum in children with… mSEP

Pregnancy and Neonatal Outcomes… The 'Big Baby Trial' nSEP

Evaluating Risk in Twin Pregnancies

Clinical Characterisation Protocol for… UK Childhood

ITP Registry FIRST-ABC

BLOOD MARKERS FOR… CHIPS (HIV) Cerclage after full dilatation… PUMA UMBRELLA Calibration and Cross-Validation of… CLARITY CF START CASAP C-STICH CLOCS

Azithromycin Therapy for Chronic… PROTECTOR MyeChild 01

RECOVERY TRIAL HOLDS SMPaeds

Pharmacokinetic variation and… WILL

Characterisation of Paediatric… ECUSTEC NCCPG TDM 2018 SIOP Ependymoma II

rEECur

Investigating the inflammatory… ICONIC Looking at the best needle-free,… DECRYPT PNET

5 PHITT GEM3

Fetal Atrial Flutter &… FaR-RMS Recruitment total

Figure

Figure 1 - Children & Women's Clinical Board Non-Commercial Recruitment Total Against Target (2019-20)

Figure 2 - Children & Women's Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Children & Women’s Clinical Board

Children & Women’s Clinical Board

ACUTE CHILD HEALTH

Children & Women’s Clinical Board

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

The POOL study BuRN-Tool Grown in Wales ROCkeTS Induced sputum in children with… mSEP

Pregnancy and Neonatal Outcomes… The 'Big Baby Trial' nSEP

Evaluating Risk in Twin Pregnancies

Clinical Characterisation Protocol for… UK Childhood

ITP Registry FIRST-ABC BLOOD MARKERS FOR… CHIPS (HIV) Cerclage after full dilatation… PUMA UMBRELLA

Calibration and Cross-Validation of… CLARITY CF START CASAP C-STICH CLOCS

Azithromycin Therapy for Chronic… PROTECTOR

MyeChild 01

RECOVERY TRIAL HOLDS SMPaeds

Pharmacokinetic variation and… WILL

Characterisation of Paediatric… ECUSTEC NCCPG TDM 2018

SIOP Ependymoma II

rEECur

Investigating the inflammatory… ICONIC Looking at the best needle-free,… DECRYPT PNET 5 PHITT GEM3

Fetal Atrial Flutter &… FaR-RMS Recruitment total

Figure 3 – Children & Women’s – Acute Child Health Non-Commercial Recruitment Total Against Target (2022-23)

Figure 1 - Children & Women's Clinical Board Non-Commercial Recruitment Total Against Target (2019-20)

Figure 2 - Children & Women's Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Children & Women’s Clinical Board

Children & Women’s Clinical Board ACUTE CHILD HEALTH

For Acute Child Health Directorate Commercial Recruitment (2020-21 and 2020-22), please see Children & Women’s Commercial Studies’ charts on page 17 (all Commercial data during these years were under Acute Child Health)

For Acute Child Health Directorate Commercial Recruitment (2020-21 and 2020-22), please see Children & Women’s Commercial Studies’ charts on page 17-18 (all Commercial data during these years were under Acute Child Health)

Figure 4 – Children & Women’s – Acute Child Health Commercial Recruitment Total Against Target (2022-23)

Children & Women’s Clinical Board

Children & Women’s Clinical Board

Children & Women’s Clinical Board

OBSTETRICS & GYNAECOLOGY

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

total

The POOL study BuRN-Tool Grown in Wales ROCkeTS Induced sputum in children with… mSEP

Pregnancy and Neonatal Outcomes… The 'Big Baby Trial' nSEP

Evaluating Risk in Twin Pregnancies Clinical Characterisation Protocol for… UK Childhood

ITP Registry FIRST-ABC BLOOD MARKERS FOR… CHIPS (HIV) Cerclage after full dilatation… PUMA UMBRELLA

Calibration and Cross-Validation of… CLARITY CF START CASAP C-STICH CLOCS

Azithromycin Therapy for Chronic… PROTECTOR

MyeChild 01

RECOVERY TRIAL HOLDS SMPaeds

Pharmacokinetic variation and… WILL

Characterisation of Paediatric… ECUSTEC NCCPG TDM 2018 SIOP Ependymoma II

Total Target

needle-free, pain…

rEECur

Investigating the inflammatory… ICONIC Looking at the best needle-free,… DECRYPT PNET

5 PHITT GEM3

Fetal Atrial Flutter &… FaR-RMS

Figure 1 – Children & Women’s – Obstetrics & Gynaecology Directorate Non-Commercial Recruitment Total Against Target (2020-21)

Figure 2 – Children & Women’s – Obstetrics & Gynaecology Directorate Non-Commercial Recruitment Total Against Target (2021-22)

The Tommy's National Rainbow Clinic Study

Figure 1 - Children & Women's Clinical Board Non-Commercial Recruitment Total Against Target (2019-20)

Figure 2 - Children & Women's Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Children & Women’s Clinical Board

Children & Women’s Clinical Board

OBSTETRICS & GYNAECOLOGY

Children & Women’s Clinical Board

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

total

*REINFORCE counted under Other Clinical Board but recruitment split between Children & Women's and Surgical Services

associated… NCCPG TDM 2018

Looking at the best needle-free, pain…

The POOL study BuRN-Tool Grown in Wales ROCkeTS Induced sputum in children with… mSEP

Pregnancy and Neonatal Outcomes… The 'Big Baby Trial' nSEP

Figure 3 – Children & Women’s – Obstetrics & Gynaecology Directorate Non-Commercial Recruitment Total Against Target (2022-23)

Figure 1 - Children & Women's Clinical Board Non-Commercial Recruitment Total Against Target (2019-20)

Figure 2 - Children & Women's Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Children & Women’s Clinical Board

Children & Women’s Clinical Board OBSTETRICS

& GYNAECOLOGY

Clinical Diagnostics & Therapeutics Clinical Board

Summary from the Clinical Diagnostics & Therapeutics Clinical Board R&D Lead

The strategic focus of Research & Development within the Clinical Diagnostics and Therapeutics

Clinical Board for 2022-23 has remained to encourage research led by Clinical Board staff with ensuring, where possible, capacity to support research from other parts of Cardiff & Vale UHB. Pandemic recovery and withdrawal of HCRW funding from R&D leads has created a challenging environment to foster greater R&D activity. However, the Podiatry/CEDAR collaboration to increase research capacity and has yielded an RfPPB application. The CD&T R&D forums have been promising and will hopefully improve research awareness in directorates with smaller numbers of researchactive staff. The strategy for 2022-23 will be to continue to develop such local initiatives and to ensure an appropriate emphasis on research delivery by those who are not medical consultants. The performance data for 2022-23 again highlight the small numbers of trials which are led by the Clinical Board and the recruitment difficulties of trials in recent times. It remains the case that CD&T support a high proportion of studies led from other Clinical Boards. We are currently considering the impact of such potential services changes as TrAMs and Community Diagnostics Centres on our future capacity to support clinical trials.

Publications in peer-reviewed journals from the clinical board include analysis of reports of carbon monoxide exposures and potential cyanide poisoning to the UK National Poisons Information Service. Also from the All Wales Therapeutics & Toxicology Centre was work on the costs of hypoglycaemic agents in primary care, and nirmatrelvir/ritonavir pre-hospital therapy. Therapies staff published work on the consensus statement on physical activity for cystic fibrosis, digital competency for allied health professionals, treatment of foot ulceration and the Nutrition Skills for Life programme.

Radiology have published several papers in 2022-23 on image enhancement and assessment with AI; analysing radiologists’ behaviour when assessing mammograms; management of patients with Hodgkin’s lymphoma, gallbladder polyps and Paget-Schroetter syndrome; electroconvulsive therapy; imaging of aortic dissection; and recruitment into trials of arterio-venous grafts for haemodialysis. Medical Physics & Clinical Engineering’s publications have all come from CEDAR, relating to PREMs in ophthalmology, the Hughes Abdominal Repair Randomised Trial, the All Wales Postpartum Haemorrhage Quality Improvement Initiative and two from NICE work (UroLift for Treating Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia; Parafricta bootees to prevent heel pressure ulcers). A chapter for the recently-published book ‘Patient Reported Outcomes and Quality of Life in Cardiovascular Interventions’ was also written by Kathleen Withers of CEDAR.

Clinical Diagnostics & Therapeutics Clinical Board Clinical Diagnostics & Therapeutics Clinical Board

Clinical Diagnostics & Therapeutics Clinical Board

Medicine Clinical Board

Summary from the Medicine Clinical Board R&D Lead

In 2022-23, research continued to be delivered across the Medicine Clinical Board in areas of existing strength with growth into some new areas, providing more patients groups with access to research. Some highlights are below.

Colonoscopy: CONSCOP-2 is a bowel cancer screening study led by Dr Sunil Dolwani at Cardiff University trialling a new staining method to improve identification and subsequent removal of serrated polyps or cancers in the upper bowel. In 2022-23, 168 patients were recruited (248 in total to date) with gratitude to the Medicine Research Delivery team for sustaining support for the study over the course of a challenging year in terms of staffing capacity. The study is expected to lead to a change in international guidelines with global impact.

Cystic Fibrosis: The CF centre led by Dr Jamie Duckers at UHL has been selected as 1 of 6 early phase CF centres in the UK yielding a Phase I inhaled-mRNA trial currently in set-up. Later phase trials continue, with an open-label study recently being secured which will provide earlier access to very high cost CFTR modulator therapies for CF patients and costs fully covered by the company. Finally, Project Breathe combined remote monitoring via a smart phone app for CF patients with artificial intelligence (AI) to determine exacerbations prior to them becoming clinically apparent. 103 people with CF from across Wales used the remote monitoring service and the project has resulted in a change in clinical practice.

Emergency/Sepsis: The PRONTO study, conducted in the Emergency Unit at UHW by Dr Jonathan Underwood and Dr Nicholas Manville, investigates the use of a rapid bedside Procalcitonin test to aid diagnosis in patients with suspected sepsis. 209 participants were recruited in 2022-23 (372 to date), a great achievement especially considering the challenging environment in which the research is taking place. Special thanks to the ED research nurses Lauren Thomas and Non Smith for their exceptional work on this study. We are delighted that Research Delivery has recently confirmed support for the creation of a new full-time research nurse post in ED/Trauma and look forward to developing a new portfolio of research across this area.

Endocrinology: New therapies continue to be available to patients suffering from a wide range of endocrine conditions via trials at C&V. In the last year, commercial trials led by Professor Aled Rees in Congenital Adrenal Hypoplasia and Adrenal Insufficiency exceeded their recruitment targets, with support from the Early Phase Team. In Type 1 Diabetes, C&V are the UK leading recruiters (8) for the Ver-A-T1D (Verapamil) trial led by Professor Colin Dayan at Cardiff University.

Infectious Disease: On the back of the delivery of very successful and high impact COVID treatment and vaccine trials, the infectious disease portfolio has expanded into new areas. Dr Underwood is leading a new commercial trial in HIV which recently recruited its first patient, in addition to a Phase II Hepatitis B vaccine trial due to open very soon.

Long COVID: LOCOMOTION led by Dr Helen Davies with support from the Research Delivery team at UHL is a study to identify best practice in providing Long COVID services. In 2022-23, 322 patients were recruited making it the Clinical Board’s highest recruiting research study this year. A great achievement in a high priority area.

Stroke: Cardiff & Vale are the UK’s leading recruiters for the OPTIMAS trial, investigating whether an earlier initiation of anticoagulation medication after a stroke (within 4 days) is better than current guidelines (between 7-14 days). Well done to Dr Benjamin Jelley, the Stroke team and the Medicine Research Delivery team for the sustained and exceptional effort in achieving this, with 172 patients recruited to date.

Medicine Clinical Board

Medicine Clinical Board

Medicine Clinical Board

Medicine Clinical Board

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

Figure 1 - Medicine Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Figure 1 - Medicine Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Figure 1 - Medicine Clinical Board Non-Commercial Recruitment Total Against Target (2019-20)

Medicine Clinical Board

Medicine Clinical Board

Medicine Clinical Board

Figure 2 - Medicine Clinical Board Non-Commercial Recruitment Total Against Target (2021-22)

2 - Medicine Clinical Board Non-Commercial Recruitment Total Against Target (2021-22)

Medicine Clinical Board

Medicine Clinical Board

Medicine Clinical Board

Figure 3 - Medicine Clinical Board Non-Commercial Recruitment Total Against Target (2022-23)

Figure 3

Medicine Clinical Board Non-Commercial Recruitment Total Against Target (2022-23)

Medicine Clinical Board

Medicine Clinical Board

Figure 4 - Medicine Clinical Board Commercial Recruitment Total

(2020-21)

-

Medicine Clinical Board

Medicine Clinical Board

(2022-23)

Mental Health Clinical Board

Summary from the Mental Health Clinical Board R&D Lead

The Mental Health Clinical Board had a 50% increase in recruitment numbers in the last financial year compared to 2021-2022. Cardiff and Vale remains by far the most research active health board for mental health in all of Wales. Particular areas of strength on the research portfolio are PTSD, early psychosis and the use of technologies to monitor and treat mental health conditions. We have a number of intervention studies that have allowed patients to access novel therapies including MDMA assisted psychotherapy for PTSD; the use of an antidepressant to prevent depression in people with a recent first episode of psychosis; guided self-help for depressed people with autism; and remotely conducted EMDR (eye movement desensitisation and reprocessing therapy) for military veterans. There has been increased involvement from clinicians in research this year with several new local PIs taking on studies. Work has been completed to allow CRIS (Clinical Record Interactive Search) to extract anonymised data from PARIS – the electronic medical records system used in the Mental Health Clinical Board. In 2023 all agreements should be in place to allow CRIS to assist in conducting research as well as quality improvement projects. We are pleased to include a list of some of the publications coming from the research done within the clinical board, which highlights the range of research taking place into conditions that often come with significant distress and disability, and illustrates the importance of the research activity.

Mental Health Clinical Board

Mental Health Clinical Board Clinical Diagnostics & Therapeutics Clinical Board

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

The influence of autism on restrictive eating disorders in

CD&T also work on PAVE (IRAS: 176799) – Please see 2019-20 recruitment in Specialist Services: Nephrology & Transplant Chart (p.99)

Figure 1 - CD&T Clinical Board Non-Commercial Recruitment Total Against Target (2019-20)

Figure 2 - CD&T Clinical Board Non-Commercial Recruitment Total Against

(2020-21)

Figure 1 - Mental Health Clinical Board Non-Commercial Recruitment

Figure 2 - Mental Health Clinical Board Non-Commercial Recruitment Total

Mental Health Clinical Board

Mental Health Clinical Board

Primary, Community & Intermediate Care (PCIC) Clinical Board

Summary from the PCIC Clinical Board R&D Lead

The Primary, Community, and Intermediate Care (PCIC) Clinical Board includes a wide range of services in the community settings. The Clinical Board delivers health and wellbeing services in patients’ homes, in the community and from a range of other facilities. Research has been identified by the PCIC board as a crucial component of evidence-based care provided within Primary Care, and research development and performance constitute core components of the UHB’s end of life strategy. The Sexual Health department has previously made a successful application for the NHS Research Time Award (NHS RTA) which aimed to build research capacity, and there are strategic plans to expand on research activity.

The number of studies with recruitment has significantly increased in 2022-23 and the recruitment has more than doubled compared to the previous years. With the restructuring of Primary Care research delivery and the initiatives taken together with Health & Care Research Wales (HCRW), there has been a sizable increase in research activity. PCIC being one of the largest directorates closely linked to all other departments, there is still a vast potential to enhance research activity within Primary Care and aid recruitment in other directorates within the health board. The restructuring of research delivery and development of academic and secondary care links is still underway, and we can expect further improvements in the future. We aim to continuously improve on the existing processes, making it more efficient and fit for purpose.

Within the Clinical Board, Primary Care, Palliative Care and Sexual Health have been the most research active departments. Development of research and academics in other departments such as nursing, optometry and pharmacy was previously identified as an area of focus that will need further work. The drive to achieve excellence through promotion of research culture within the directorate, underpinned by the principles of the health board research strategy, will be a continuous process.

Primary, Community & Intermediate Care (PCIC) Clinical Board

Primary, Community & Intermediate Care (PCIC) Clinical

Board

Figure 1 - PCIC Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Figure 2 - PCIC Clinical Board Non-Commercial Recruitment Total Against Target (2021-22)

Primary,

Figure 3 - PCIC Clinical Board Non-Commercial Recruitment Total Against Target (2022-23)

Primary, Community & Intermediate Care (PCIC) Clinical Board

Primary, Community & Intermediate Care (PCIC) Clinical

Board

Figure 4 - PCIC Clinical Board Commercial Recruitment Total Against Target (2020-21)

Figure 5 - PCIC Clinical Board Commercial Recruitment Total Against Target (2021-22)

Primary, Community & Intermediate Care (PCIC)

Primary, Community & Intermediate Care (PCIC)

Clinical Board

Figure 6 - PCIC Clinical Board Commercial Recruitment Total Against Target (2022-23)

Specialist Services Clinical Board

Summary from the Specialist Services Clinical Board R&D Lead

Specialist Services as a Clinical Board has recovered well from the COVID pandemic in terms of research performance, with more studies being reactivated and restarted in this financial year. Most of the research nurses who were re-deployed have returned back to their research roles.

In terms of the number of studies that have been recruiting, Specialist Services has maintained over 100 open studies, with 2,173 patients recruited in total for Portfolio Non-Commercial studies - the highest in the health board. 96 of the studies are rated green in terms of ongoing recruitment.

There has been some spectacular recruitment in some studies, such as the Clinical Characteristics Protocol for Severe Emerging Infections in the Critical Care directorate which has recruited 1,233 patients and RADAR in Nephrology which has recruited 847 patients throughout their durations. There are also studies that involve very invasive protocols requiring considerable UHB support which are recruiting well in most of the directorates.

In 2022-23, there has been the highest number of Commercial trials enrolled in the Specialist Services Clinical Board. Highlights include the PNH Registry in Haematology with some of the highest numbers recruited. Important new practice-defining studies are ongoing in the Clinical Board also, including the ongoing pulmonary embolism (PE) treatments being actively researched and recruited into in the cardiothoracic directorate, which will help to inform and shape important future advances in PE treatments.

There have been vast numbers of important publications in high-impact peer-reviewed journals ranging from the New England Journal to the Lancet and the BMJ from the Clinical Board as a whole, with highlights outlined in the appendix.

Some directorates are still finding their overall research and development partially hindered by lack of full alignment with Cardiff University, in terms of staffing and joint supervision of potential research candidates. There is much progress to be made to ensure directorates can maximize their research potential through these avenues.

Despite all of these massive challenges, the directorates that make up Specialist Services had a hugely impressive year in not only delivering high quality clinical care but pushing forward with groundbreaking research embedded in a number of clinical services. Onwards and upwards!

Medicine Clinical Board

Specialist Services Clinical Board Specialist

Specialist Services Clinical Board

Services Clinical Board

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

(2020-21)

Figure 1 - Specialist Services Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Figure 1 - Medicine Clinical Board Non-Commercial Recruitment Total Against Target (2019-20)

Specialist

Services Clinical Board Specialist Services Clinical Board

Specialist Services Clinical Board

Specialist Services Clinical Board Non-Commercial Recruitment Total Against Target (2021-22)

Figure 2 -

Figure 2 - Specialist Services Clinical Board Non-Commercial Recruitment Total Against Target (2021-22)

Specialist Services Clinical Board

Specialist

Specialist Services Clinical Board

Services Clinical Board

Figure 3 - Specialist Services Clinical Board Non-Commercial Recruitment Total Against Target (2022-23)

Figure 3 - Specialist Services Clinical Board Non-Commercial Recruitment Total Against Target (2022-23)

Specialist Services Clinical Board Specialist Services Clinical Board

Specialist Services Clinical Board

Figure 4 - Specialist Services Clinical Board Commercial Recruitment Total Against Target (2020-21)

Recruitment Total Target

Recruitment Total Target

of AZD4573 in Relapsed or Refractory Haematological

observational study to evaluate usage of Hizentra

Emicizumab in Haemophilia A without FVIII Inhibitors GekoTM Pacemaker Interaction Study PDR 001 in Acute myeloid Leukaemia or high risk MDS RENA 4590 (ASCEND-ND)

Vedolizumab in Subjects Undergoing Stem Cell Transplantation aHUS REGISTRY Phase1b study for patients with Relapsed/Refractory AML 021FSG16010DUPLEX, Patients with FSGS

Patients with Acute Myeloid Leukemia. XATOA

Phase 1b/2 Study of KRT-232 in Patients with Acute Myeloid Leukemia. XATOA

BN40955 OLE study to evaluate the safety & tolerability of RO7234292 Phase I/IIa study to evaluate CCS1477 in haem. malignancies v1.0

BN40423 Generation HD 1 ECLIPSE Hookipa H-100-002

BN40955 OLE study to evaluate the safety & tolerability of RO7234292 Phase I/IIa study to evaluate CCS1477 in haem. malignancies v1.0 BN40423 Generation HD 1 ECLIPSE Hookipa H-100-002

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the…

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the…

PROTECT 021IGAN17001

PROTECT 021IGAN17001

A phase 1/2 study with Acalabrutinib and AZD6738 in high risk CLL CALLS IXchange Paradigm 8 HORIZON

A phase 1/2 study with Acalabrutinib and AZD6738 in high risk CLL

Characteristics and outcomes of FCS patients treated with volanesorsen

PCYC-1145-LTLong-term safety rollover for ibrutinib trials CPI-0610 with or without ruxolitinib

Characteristics and outcomes of FCS patients treated with volanesorsen

PCYC-1145-LTLong-term safety rollover for ibrutinib trials

Extended Access of Momelotinib in Myelofibrosis

CPI-0610 with or without ruxolitinib

Safety &Efficacy of Padsevonil in Subjects With DrugResistant Epilepsy

Extended Access of Momelotinib in Myelofibrosis

Uproleselan with chemotherapy vs chemo alone in adults with R/R AML

Safety &Efficacy of Padsevonil in Subjects With DrugResistant Epilepsy

A Phase 2a/b Study of KRT-232 in Polycythemia Vera ARTEMIS-IGAN

Uproleselan with chemotherapy vs chemo alone in adults with R/R AML

A Phase 2a/b Study of KRT-232 in Polycythemia Vera

CQGE031C2303: Ligelizumab in the treatment of CSU

DREAMM-7

ARTEMIS-IGAN

CQGE031C2303: Ligelizumab in the treatment of CSU

Efficacy and safety of LNP023 compared with rituximab in iMN

DREAMM-7

Four oral doses of BI 690517 in patients with Diabetic Nephropathy. Gazyvaro Short Duration Infusion (SDI) study

Efficacy and safety of LNP023 compared with rituximab in iMN

GRAVITAS-309

Four oral doses of BI 690517 in patients with Diabetic Nephropathy.

M19-708 Venetoclax as Maintenance Therapy for AML ORATORIO HAND

Gazyvaro Short Duration Infusion (SDI) study

GRAVITAS-309

Phase 2 study of ACE-536 in MPN-associated myelofibrosis & anaemia

M19-708 Venetoclax as Maintenance Therapy for AML ORATORIO HAND

2 study of ACE-536 in MPN-associated myelofibrosis & anaemia

REGN1979 in patients with relapsed or refractory follicular lymphoma

The Radiance II Pivotal study in Stage II Hypertension.

Rare disease registry Program (Gaucher, Fabry, Pompe, MPS1)

Figure 4 - Specialist Services Clinical Board Commercial Recruitment Total Against Target (2020-21)

Specialist Services Clinical Board

Specialist Services Clinical Board

Specialist Services Clinical Board

Total Against Target (2021-22)

Recruitment Total Target

Recruitment Total Target

total

patients BN40955 OLE study to evaluate the safety & tolerability of RO7234292

DREAMM-7 ECLIPSE Hi-PEITHO Hookipa H-100-002 ARTEMIS-IGAN

CC-92480 with Dexamethasone in Relapsed & Refractory Multiple Myeloma Frontier 2

CC-92480 with Dexamethasone in Relapsed & Refractory Multiple Myeloma Frontier 2

M15-954:Venetoclax and/or Azacitidine in Newly Diagnosed High-Risk MDS

PROTECT 021IGAN17001 The DAPA-MI Study 2-year ext. study to evaluate long-term effectiveness of Mavenclad AGAVE-201-

ELEVATE AHP Registry

GRAVITAS-309

M15-954:Venetoclax and/or Azacitidine in Newly Diagnosed High-Risk MDS PROTECT 021IGAN17001 The DAPA-MI Study 2-year ext. study to evaluate long-term effectiveness of Mavenclad AGAVE-201ELEVATE AHP Registry GRAVITAS-309 IFNg-study M19-708 Venetoclax as Maintenance Therapy for AML Paradigm 8

IFNg-study

M19-708 Venetoclax as Maintenance Therapy for AML Paradigm 8

Phase 3 Study of CPI-0610 in Myelofibrosis (Amendment 1, UK V2.1)

PEG-ADM in ARDS

Recombinant human alkaline phosphatase survival trial REFORM The Rare disease registry Program (Gaucher, Fabry, Pompe, MPS1)

Phase 3 Study of CPI-0610 in Myelofibrosis (Amendment 1, UK V2.1)

Recombinant human alkaline phosphatase survival trial REFORM

Uproleselan with chemotherapy vs chemo alone in adults with R/R AML BE HEARD

The Rare disease registry Program (Gaucher, Fabry, Pompe, MPS1)

Uproleselan with chemotherapy vs chemo alone in adults with R/R AML BE HEARD

Efficacy and safety of LNP023 compared with rituximab in iMN Haven 7 Phase 2 study of ACE-536 in MPN-associated myelofibrosis & anaemia Phase 2 Study of VIS649 for IgA Nephropathy

CARTITUDE-4

Efficacy and safety of LNP023 compared with rituximab in iMN Haven 7

Phase II study of sacubitril/valsartan in patients with nHCM

REGN1979 in patients with relapsed or refractory follicular lymphoma Remix 2

Phase 2 study of ACE-536 in MPN-associated myelofibrosis & anaemia Phase 2 Study of VIS649 for IgA Nephropathy Phase II study of sacubitril/valsartan in patients with nHCM REGN1979 in patients with relapsed or refractory follicular lymphoma Remix 2

SHP655-201: Pharmacokinetics, safety, and efficacy of SHP655 in aTTP SPARKLE Study of WVE-003 in Patients with HD (SNP3) URIROX-2 Recruitment total

Figure 5 - Specialist Services Clinical Board Commercial Recruitment Total Against Target (2021-22)

Figure 5 - Specialist Services Clinical Board Commercial Recruitment

Specialist Services Clinical Board Specialist Services Clinical Board

Specialist Services Clinical Board

Figure 6 - Specialist Services Clinical Board Commercial Recruitment Total Against Target (2022-23)

Figure 6 - Specialist Services Clinical Board Commercial Recruitment Total Against Target (2022-23)

Specialist Services Directorate Recruitment:

Specialist Services Directorate Recruitment: ALAS (incl. Rehabilitation Engineering)

ALAS (inc. Rehabilitation Engineering)

Specialist Services Directorate Recruitment:

CARDIAC SERVICES

Specialist Services Directorate Recruitment: CARDIAC SERVICES

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

Figure 1 - Specialist Services - Cardiac Services Non-Commercial Recruitment Total Against Target (2020-21)

Figure 2 - Specialist Services - Cardiac Services Non-Commercial Recruitment Total Against Target (2021-22)

Specialist Services Directorate Recruitment: CARDIAC SERVICES Specialist Services Directorate Recruitment: CARDIAC

Specialist Services Directorate Recruitment: CRITICAL CARE Specialist Services Directorate Recruitment: CRITICAL CARE

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

Figure

Specialist Services Directorate Recruitment: CRITICAL CARE Specialist Services Directorate Recruitment: CRITICAL CARE

Figure 4 - Specialist Services - Critical Care Commercial Recruitment Total Against Target (2020-21)

Figure 5 - Specialist Services - Critical Care Commercial Recruitment Total Against Target (2021-22)

Specialist Services Directorate Recruitment: CRITICAL CARE Specialist Services Directorate Recruitment: CRITICAL CARE

Figure 6 - Specialist Services - Critical Care Commercial Recruitment Total Against Target (2022-23)

Specialist Services Directorate Recruitment: HAEMATOLOGY & CLINICAL IMMUNOLOGY Specialist Services Directorate Recruitment:

Specialist Services Directorate Recruitment: HAEMATOLOGY & CLINICAL IMMUNOLOGY

Specialist Services Directorate Recruitment: HAEMATOLOGY & CLINICAL IMMUNOLOGY

*ENLIST Vaccination sub-study and COVID-19 ENLIST recruitment (2021-22 and 2022-23) achieved by Nephrology & Transplant team

Figure 3 - Specialist Services - Haematology & Clinical Immunology Non-Commercial Recruitment Total Against Target (2022-23)

Specialist Services Directorate Recruitment: HAEMATOLOGY & CLINICAL IMMUNOLOGY

Specialist Services Directorate Recruitment: HAEMATOLOGY & CLINICAL IMMUNOLOGY

Recruitment total

MUSC 5224

Registry CMV in allogeneic hematopoietic stem cell… AGHOS-UK Study of AZD4573 in Relapsed or Refractory… BO41423 Emicizumab in Haemophilia A… PDR 001 in Acute myeloid Leukaemia or high… RENA 4590 (ASCEND-ND)

Vedolizumab in Subjects Undergoing Stem Cell… An observational study to evaluate usage of… Phase1b study for patients with… A Phase 1b/2 Study of KRT-232 in Patients with… Phase I/IIa study to evaluate CCS1477 in haem.… ECLIPSE A phase 1/2 study with Acalabrutinib and… CALLS Paradigm 8 HORIZON Characteristics and outcomes of FCS patients…

PCYC-1145-LTLong-term safety rollover for…

CPI-0610 with or without ruxolitinib

Extended Access of Momelotinib in…

Uproleselan with chemotherapy vs chemo…

A Phase 2a/b Study of KRT-232 in Polycythemia…

CQGE031C2303: Ligelizumab in the treatment…

DREAMM-7

Short Duration Infusion (SDI) study

Gazyvaro

GRAVITAS-309

M19-708 Venetoclax as Maintenance Therapy… Phase 2 study of ACE-536 in MPN-associated…

REGN1979 in patients with relapsed or…

The Rare disease registry Program (Gaucher,…

Recruitment Total Target

PNH Registry M07-001

Alexion

CMV in allogeneic hematopoietic stem cell…

HORIZON

BO41423 Emicizumab in Haemophilia A… Phase I/IIa study to evaluate CCS1477 in…

Vedolizumab in Subjects Undergoing Stem…

An observational study to evaluate usage of… CPI-0610 with or without ruxolitinib

Study of KRT-232 in Patients…

A Phase 1b/2

DREAMM-7 ECLIPSE

2

CC-92480 with Dexamethasone in Relapsed… Frontier

M15-954:Venetoclax and/or Azacitidine in…

AGAVE-201-

ELEVATE AHP Registry

GRAVITAS-309

IFNg-study

M19-708 Venetoclax as Maintenance…

Paradigm 8

Phase 3 Study of CPI-0610 in Myelofibrosis…

The Rare disease registry Program (Gaucher,…

Uproleselan with chemotherapy vs chemo… BE HEARD

CARTITUDE-4 Haven 7

Phase 2 study of ACE-536 in MPN-associated…

REGN1979 in patients with relapsed or… Remix

2

SHP655-201: Pharmacokinetics, safety, and…

SPARKLE URIROX-2

Figure

Specialist Services Directorate Recruitment: HAEMATOLOGY & CLINICAL IMMUNOLOGY

Specialist Services Directorate Recruitment: HAEMATOLOGY & CLINICAL IMMUNOLOGY

Specialist Services

Directorate Recruitment: NEPHROLOGY & TRANSPLANT Specialist Services Directorate Recruitment: NEPHROLOGY & TRANSPLANT

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

Figure 1 - Specialist Services - Nephrology & Transplant Non-Commercial Recruitment Total Against Target (2020-21) Figure

- Specialist Services -

Specialist Services Directorate Recruitment: NEPHROLOGY & TRANSPLANT Specialist Services Directorate Recruitment: NEPHROLOGY & TRANSPLANT

Figure 6 - Specialist Services - Nephrology & Transplant Commercial Recruitment Total Against Target (2022-23)

Specialist Services Directorate Recruitment: NEUROSCIENCES Specialist Services Directorate Recruitment: NEUROSCIENCES

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

Figure 1 - Specialist Services - Neurosciences Non-Commercial Recruitment Total Against Target (2020-21)

Figure 2 - Specialist Services - Neurosciences Non-Commercial Recruitment Total Against Target (2021-22)

Specialist Services Directorate Recruitment: NEUROSCIENCES Specialist Services Directorate Recruitment: NEUROSCIENCES

Figure 4 - Specialist Services - Neurosciences Commercial Recruitment Total

Figure

Services

Specialist Services Directorate Recruitment: NEUROSCIENCES

Specialist Services Directorate Recruitment: NEUROSCIENCES

6 - Specialist Services - Neurosciences Commercial Recruitment Total Against Target (2022-23)

Surgical Services Clinical Board

Summary from the Surgical Services Clinical Board R&D Lead

We have had another great year in the Surgical Services Clinical Board for research, with more than £11 million of NIHR grants being awarded to 5 Chief Investigators across the board. This unprecedented level of success demonstrates the drive for home-grown research within the clinical board and our commitment to improving patient outcomes through research. The Chief Investigators come from a range of specialties, demonstrating the broadening of the drive for Cardiff-developed research with studies from urology, vascular, anaesthetics and colorectal surgery. The development of the in-house trials manager role has contributed to this and has led to other boards developing a similar role in their departments.

We have increased our commercial research portfolio, however this is something that will continue to be a focus in the coming 3 years as there is still more to do. We have continued to be a leader in delivering high quality research from other centres and have been in the top 5 recruiting sites for ROSSINI 2, POLARiS and PQUiP. We have been expanding the role of allied health professionals and trainees as Principal Investigators through the NIHR Associate PI scheme in several trials, and this is increasing the appetite for research participation in a multidisciplinary manner that adds strength to our holistic approach to research.

Surgical Services Clinical Board

Medicine Clinical Board

Surgical Services Clinical Board

Surgical Services Clinical Board

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

Figure 1 - Surgical Services Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Figure 1 - Surgical Services Clinical Board Non-Commercial Recruitment Total Against Target (2020-21)

Figure 1 - Medicine Clinical Board Non-Commercial Recruitment Total Against Target (2019-20)

Surgical Services Clinical Board

Surgical Services Clinical Board

Surgical Services Clinical Board

burden and quality of life effect of IntAct TRANSLATE PATHOS The HAPI Study Sarcopenia, frailty and nutritional status in… (MOSES) PRIMETIME SOFFT Surgery versus non-surgical splint treatment for… AIR: RRP

or Cast for Injuries of the EpicoNdyle in CPinBOSS UNICORNS Exploring the epigenetic changes in diverticular… FEMuR III HEAR IT HUSH PERCEIVE study WHiTE 11FRUITI NOSTRA-Feasibility Study STAR-TReC BASIS

Surgical Services Clinical Board

Surgical Services Clinical Board

Surgical Services Clinical Board

*REINFORCE counted under Other Clinical Board but recruitment split between Children & Women's and Surgical Services

*REINFORCE counted under Other Clinical Board but recruitment split between Children & Women's and Surgical Services

Surgical Services Clinical Board

Surgical Services Clinical Board

Figure 4 - Surgical Services Clinical Board Commercial Recruitment Total Against Target (2020-21)

Figure 5 - Surgical Services Clinical Board Commercial

Surgical Services Clinical Board

Surgical Services Clinical Board

Figure 6 - Surgical Services Clinical Board Commercial Recruitment Total Against Target (2022-23)

Other (Split) Clinical Board

Other (Split) Clinical Board

: Indicates study opened in Feb/March - towards the end of the financial year. : Indicates study Closed to Recruitment or Withdrawn during the relevant financial year. : Indicates study Suspended. Charts exclude studies in set-up.

Figure 1 - Split Clinical Board/Directorate Non-Commercial Recruitment Total Against Target (2020-21)

Figure 2 - Split Clinical Board/Directorate Non-Commercial Recruitment Total (2021-22)

Other (Split) Clinical Board

Other (Split) Clinical Board

Figure 3 - Split Clinical Board/Directorate Non-Commercial Recruitment Total (2022-23)

*REINFORCE counted under Other Clinical Board but recruitment split between Children & Women's and Surgical Services

No Split Clinical Board/Directorate Commercial Recruitment in 2020-21, 2021-22 or 2022-23

Appendix A

All Wales Medical Genomics Service Clinical Board

Publications

Edgerley, K., Bryson, L., Hanington, L., Irving, R., Joss, S., Lampe, A., Maystadt, I., Osio, D., Richardson, R., Split, M., Sansbury, F.H., Scurr, I., Stewart, H., McNeill, A. and Low, K.J. (2023). SOX5: Lamb–Shaffer syndrome—A case series further expanding the phenotypic spectrum. American Journal of Medical Genetics, 191(5), pp.1447–1458. doi:https://doi.org/10.1002/ajmg.a.63124.

Hamad, A., Sherlaw-Sturrock, C.A., Glover, K.J., Salmon, R., Low, K., Nair, R., Sansbury, F.H., Rawlins, L., Carmichael, J., Horton, R., Wedderburn, S., Edgerley, K., Irving, R.E.A., Callaghan, M., Mercer, C., McGowan, R., Roberts, L., Titheradge, H. and Naik, S. (2023). Expanding the phenotypic spectrum of Chromosome 16p13.11 microduplication: A multicentric analysis of 206 patients. European Journal of Medical Genetics, 66(4), pp.104714–104714. doi:https://doi.org/10.1016/j.ejmg.2023.104714.

Hopes, R., Croxall, J.A. and Morgan, C. (2022). Improved awareness of national genomic initiatives is needed to facilitate genomic education and training in Wales for pharmacists. Pharmacy Education, 22(1), pp.805–813. doi:https://doi.org/10.46542/pe.2022.221.805813.

Jezkova, J., Shaw, S., Taverner, N.V. and Williams, H.J. (2022). Rapid genome sequencing for pediatrics. Human Mutation, 43(11), pp.1507–1518. doi:https://doi.org/10.1002/humu.24466.

Lee, S., Menzies, L., Hay, E., Ochoa, E., Docquier, F., Rodger, F., Deshpande, C., Foulds, N.C., Jacquemont, S., Jizi, K., Kiep, H., Kraus, A., Löhner, K., Morrison, P.J., Popp, B., Richardson, R., Haeringen, A., Martin, E., Toribio, A. and Li, F. (2023). Epigenotype-genotype–phenotype correlations in SETD1A and SETD2 chromatin disorders. Human Molecular Genetics. doi:https://doi.org/10.1093/hmg/ddad079.

Mcvittie, L., Lumb, B., Davies, M., Conti, H., Hildebrandt, T., Hill, J., Davies, M. and Adams, M. (2023). INCIDENTAL FINDINGS IN SURVEILLENCE OF PAEDATRIC LI FRAUMENI PATIENTS - A ONE CENTRE EXPERIENCE. CCLG conference.

Rossi, A., Snijders Blok, L., Neuser, S., Klöckner, C., Platzer, K., Faivre, L.O., Weigand, H., Dentici, M.L., Tartaglia, M., Niceta, M., Alfieri, P., Srivastava, S., Coulter, D., Smith, L., Vinorum, K., Cappuccio, G., Brunetti-Pierri, N., Torun, D., Arslan, M. and Lauridsen, M.F. (2023). POU3F3‐related disorder: Defining the phenotype and expanding the molecular spectrum. Clinical Genetics. doi:https://doi. org/10.1111/cge.14353.

Thomas, R.H., Vinh, A.C., Davies, M., Conti, H., Hildebrandt, T., Morgan, C., Hill, J., Davies, M., Phillips, S. and Adams, M. (2023). 3 Year Experience of the All Wales Paediatric Cancer Predisposition Service. CCLG conference.

Vinh, A.C., Davies, M., Hildebrandt, T., Conti, H., Morgan, C., Hill, J. and Adams, M. (2022). All Wales Paediatric Predisposition Service – Adherence to Referral Guidelines. Welsh Paediatric Society Meeting.

Appendix A

All Wales Medical Genomics Service Clinical Board

Initiatives

Contributed by Dr Ian Tully

SAIL Biobank Collaboration

One of the pressing concerns in genomics is how best to utilise the increasing resource of stored genome data for patient benefit. Re-analysis of exome and genome data has the potential to increase diagnostic yield, even years after the dataset was acquired. As well as presenting a resource issue for the clinical laboratories, there are governance and ethical hurdles to clear.

We have initiated a collaboration with the Swansea SAIL biobank to allow transfer of genomic data for a cohort of well-curated patients via the SWAN clinic. Ethical approval has now been granted and a cohort of 30 patients selected for this investigation. This will provide pilot data for future re-analysis projects.

Musketeers Memorandum Studies

Much rare disease research is carried out on a national basis, with one centre obtaining ethical approval. The Musketeer Memorandum allows recruitment at other UK sites based on the central ethics approval.

We have undertaken a program of promoting these studies in the department to increase recruitment. This has included maintaining an up-to-date database of open studies, contact details and recruitment procedures; and inviting study leads from around the UK to talk about their work at our departmental meetings.

Commercial study promotion

Although Medical Genetics does not traditionally treat patients, commercial research opportunities are emerging in the rare disease sector. Opening to rare disease trials usually involves a small number of recruits (<5) from across Wales. The RECONNECT study is our first collaboration with CYARU to provide day-case care for an EMP in the treatment of Fragile X syndrome. We are also building links with commercial teams in the fields of Tuberous Sclerosis and Neurofibromatosis Type 1.

Syndrome Without a Name (SWAN) clinic – novel investigations

The SWAN pilot is in its second year and we are currently developing further analysis pipelines for patients who still do not receive a diagnosis after the SWAN assessment. These pipelines include data re-analysis (see above), whole transcriptome sequencing and methylation-sensitive sequencing. Research using this cohort will provide an opportunity to develop these novel approaches further for the benefit of patients across the health service.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix A –All Wales Medical Genomics Service Clinical Board

Appendix A All Wales Medical Genomics Service Clinical Board

Non-Commercial

Non-Commercial

Appendix B

Children & Women’s Clinical Board: ACUTE CHILD HEALTH

Publications

Baioumi, A., Burrows, R., Hayward, R. and Pryce, R. (2022). Contrast media-induced hypothyroidism. Endocrine Abstracts, 85. doi: https://doi.org/10.1530/endoabs.85.oc8.5.

Birkebaek, N.H., Kamrath, C., Grimsmann, J.M., Aakesson, K., Cherubini, V., Dovc, K., de Beaufort, C., Alonso, G.T., Gregory, J.W., White, M., Skrivarhaug, T., Sumnik, Z., Jefferies, C., Hörtenhuber, T., Haynes, A., De Bock, M., Svensson, J., Warner, J.T., Gani, O. and Gesuita, R. (2022). Impact of the COVID-19 pandemic on long-term trends in the prevalence of diabetic ketoacidosis at diagnosis of paediatric type 1 diabetes: an international multicentre study based on data from 13 national diabetes registries. The Lancet Diabetes & Endocrinology, 10(11). doi: https://doi.org/10.1016/s22138587(22)00246-7.

Bratina, N., Auzanneau, M., Birkebæk, N., de Beaufort, C., Cherubini, V., Craig, M.E., Dabelea, D., Dovc, K., Hofer, S.E., Holl, R.W., Jensen, E.T., Mul, D., Nagl, K., Robinson, H., Schierloh, U., Svensson, J., Tiberi, V., Veeze, H.J., Warner, J.T. and Donaghue, K.C. (2022). Differences in retinopathy prevalence and associated risk factors across 11 countries in three continents: A cross-sectional study of 156,090 children and adolescents with type 1 diabetes. Pediatric Diabetes, 23(8). doi: https://doi.org/10.1111/ pedi.13416.

French, R., Kneale, D., Warner, J.T., Robinson, H., Rafferty, J., Sayers, A., Taylor, P., Gregory, J.W. and Dayan, C.M. (2022). Educational Attainment and Childhood-Onset Type 1 Diabetes. Diabetes Care, 45(12), pp.2852–2861. doi: https://doi.org/10.2337/dc21-0693.

Jones, S. and Pryce, R. (2023). Monitoring the biochemical response in children with X linked hypophosphataemic rickets after starting Burosumab treatment and correlating with biochemical outcomes. RCPCH Spring Meeting.

Prigge, R., McKnight, J.A., Wild, S.H., Haynes, A., Jones, T.W., Davis, E.A., Rami-Merhar, B., Fritsch, M., Prchla, C., Lavens, A., Doggen, K., Chao, S., Aronson, R., Brown, R., Ibfelt, E.H., Svensson, J., Young, R., Warner, J.T., Robinson, H. and Laatikainen, T. (2022). International comparison of glycaemic control in people with type 1 diabetes: an update and extension. Diabetic Medicine, 39(5). doi: https://doi. org/10.1111/dme.14766.

Rees, S., Moss, S. and Pryce, R. (2022). An evaluation of the experiences with services in wales for children and young people and their families with prader willi syndrome (PWS). Endocrine Abstracts, 85. doi: https://doi.org/10.1530/endoabs.85.p69.

Williams, G.M., Leary, S., Leadbetter, S., Toms, S., Mortimer, G., Scorrer, T., Gillespie, K. and Shield, J.P.H. (2022). Establishing breast feeding in infants with Down syndrome: the FADES cohort experience.

BMJ Paediatrics Open, 6(1), p.e001547. doi: https://doi.org/10.1136/bmjpo-2022-001547.

Appendix B

Children & Women’s Clinical Board: ACUTE CHILD HEALTH

Paediatric Emergency Department

Ball, E., Purchase, T. and Morgan, J. (2022). Review of the 2021 Resuscitation Council United Kingdom guideline for the emergency treatment of anaphylaxis. Archives of disease in childhood - Education & Practice Edition, p.edpract-2022-324432. doi: https://doi.org/10.1136/archdischild-2022-324432.

Metezai, H., Wahid, A., Jones, C. and Evans, J. (2022). Fifteen-minute consultation: Rectal bleeding in children. Education and Practice Edition, 23, p.edpract-324626. doi: https://doi.org/10.1136/ archdischild-2022-324626.

Oruganti, S., Evans, J., Cromarty, T., Javaid, A. and Roland, D. (2022). Identification of sepsis in paediatric emergency departments: A scoping review. Acta Paediatrica, 111(12). doi: https://doi. org/10.1111/apa.16536.

Patel, S., Dadnam, C., Hewitson, R., Thakur, I. and Morgan, J. (2022). Fifteen-minute consultation: Recognition of sickle cell crises in the paediatric emergency department. Archives of disease in childhood - - Education & Practice Edition, 107(3), p.edpract-2020-321338. doi: https://doi.org/10.1136/ archdischild-2020-321338.

Smith, A.C., Jones, S.J. and Hanna, D. (2022). Epidemiology and mapping of child road casualties. Archives of Disease in Childhood, 107(6), pp.540–542. doi: https://doi.org/10.1136/ archdischild-2021-323331.

Tolhurst-Cleaver, M.F.J., Evans, J., Waterfield, T., Adamson, J., Marlow, R., Lyttle, M.D. and Roland, D. (2022). Periorbital and orbital cellulitis in children: a survey of emergency physicians and analysis of clinical practice guidelines across the PERUKI network. Emergency Medicine Journal: EMJ, 39(10), pp.766–770. doi: https://doi.org/10.1136/emermed-2021-211713.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix B –

Appendix B

Children & Women’s Clinical Board : ACUTE CHILD HEALTH

Children & Women’s Clinical Board: ACUTE CHILD HEALTH

Non-Commercial

Non-Commercial

Appendix B –

Appendix B

Children & Women’s Clinical Board : ACUTE CHILD HEALTH

Children & Women’s Clinical Board: ACUTE CHILD HEALTH

Appendix B –

Appendix B

–

Children & Women’s Clinical Board : ACUTE CHILD HEALTH

Children & Women’s Clinical Board : ACUTE CHILD HEALTH

*Clinical Characteristics Protocol for Severe Emerging Infection counted under Specialist Services Clinical Board .

*Clinical Characteristics Protocol for Severe Emerging Infection counted under Specialist Services Clinical Board

trial counted under

Clinical Board from 2023-24 onwards.

Appendix B –

Appendix B

Children & Women’s Clinical Board : ACUTE CHILD HEALTH

Children & Women’s Clinical Board: ACUTE CHILD HEALTH

Appendix C

Children & Women’s Clinical Board: OBSTETRICS & GYNAECOLOGY

Publications

Davies, L.C., Sharma, S., Rodrigues, P.R.S., Edkins, S., Strang, A., Shepherd, F., Oram, S., Siddall, K., Keeping, V., Simpson, K., Faggian, F., Bray, M., Bertorelli, C., Bell, S., Collis, R., McLaren, J.E., Zaher, S. and Ghazal, P. (2023). Pregnancy: An immunological stepping-stone to sepsis? Cardiff University

Infection and Immunity Meeting.

Sharma, S., Rodrigues, P.R.S., Zaher, S., Davies, L.C. and Ghazal, P. (2022). Immune-metabolic adaptations in pregnancy: A potential stepping-stone to sepsis. eBioMedicine, 86, p.104337. doi: https://doi.org/10.1016/j.ebiom.2022.104337.

Sharma, S., Rodrigues, P.R.S., Zaher, S., Davies, L.C. and Ghazal, P. (2023). Immune-metabolic adaptations in pregnancy: a potential stepping-stone to sepsis (review article). Cardiff University

Infection and Immunity meeting.

Sharma, S., Zaher, S., Rodrigues, P.R.S., Davies, L.C., Edkins, S., Strang, A., Chakraborty, M., Watkins, W.J., Andrews, R., Parkinson, E., Angelopoulos, N., Moet, L., Shepherd, F., Davies, K.M.M., White, D., Oram, S., Siddall, K., Keeping, V., Simpson, K. and Faggian, F. (2022). mSep: investigating physiological and immune-metabolic biomarkers in septic and healthy pregnant women to predict feto-maternal immune health – a prospective observational cohort study protocol. BMJ Open, [online] 12(9), p.e066382. doi: https://doi.org/10.1136/bmjopen-2022-066382.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix C

Appendix C - Children & Women’s Clinical Board: OBSTETRICS & GYNAECOLOGY

Children & Women’s Clinical Board: OBSTETRICS & GYNAECOLOGY

Appendix C - Children & Women’s Clinical Board: OBSTETRICS & GYNAECOLOGY

Appendix C

Children & Women’s Clinical Board: OBSTETRICS & GYNAECOLOGY

*REINFORCE counted under Other Clinical Board but recruitment split between Children & Women's and Surgical Services

Appendix C

Appendix C - Children & Women’s Clinical Board: OBSTETRICS & GYNAECOLOGY

Children & Women’s Clinical Board: OBSTETRICS & GYNAECOLOGY

Appendix D

Clinical Diagnostics & Therapeutics Clinical Board

All Wales Therapeutics and Toxicology Centre

Publications

Coulson, J.M., Adams, A., Gray, L.A. and Evans, A. (2022). COVID-19 ‘Rebound’ associated with nirmatrelvir/ritonavir pre-hospital therapy. Journal of Infection, 85(4). doi: https://doi.org/10.1016/j. jinf.2022.06.011.

Gentile, D., Adams, R., Klatka, M., Bradberry, S., Gray, L., Thanacoody, R., Jackson, G. and Sandilands, E.A. (2022). Carbon monoxide exposures reported to the UK National Poisons Information Service: a 4-year study. Journal of Public Health, 44(3). doi: https://doi.org/10.1093/pubmed/fdab132.

Haden, M., Wheatley, N., Gray, L.A., Bradberry, S.M., Sandilands, E.A., Thanacoody, R.H. and Coulson, J. (2022). Potential cyanide poisoning reported to the UK national poisons information service: 2008–2019. Clinical Toxicology, 60(9), pp.1–8. doi: https://doi.org/10.1080/15563650.2022.2080074.

Taylor, P.J., Siah, Q.Z., Marei, O., McDade-Kumar, M., Rachedi, N., Bracchi, R., Boldero, R., Haines, K., Ali, M.K., French, R.J. and Dayan, C.M. (2022). Prescribing costs of hypoglycaemic agents and associations with metabolic control in Wales; a national analysis of primary care data. Diabetic Medicine, 39(9). doi: https://doi.org/10.1111/dme.14908.

Medical Physics & Clinical Engineering Publications

Bartlett, R., Absalom, R., Williams, O. and Withers, K.L. (2023). Development and pilot of a community low-vision, service-specific Patient-Reported Experience Measure. Ophthalmic and Physiological Optics. doi: https://doi.org/10.1111/opo.13130.

Dale, M., Bell, S.F., O’Connell, S., Scarr, C., James, K., John, M., Collis, R.E., Collins, P.W. and CarolanRees, G. (2022). What is the Economic Cost of Providing an All Wales Postpartum Haemorrhage Quality Improvement Initiative (OBS Cymru)? A Cost-Consequences Comparison with Standard Care. PharmacoEconomics - Open, 6(6), pp.847–857. doi: https://doi.org/10.1007/s41669-022-00362-2.

HART Collaborative (2022). Incisional hernia following colorectal cancer surgery according to suture technique: Hughes Abdominal Repair Randomized Trial (HART). British Journal of Surgery, 109(10), pp.943–950. doi: https://doi.org/10.1093/bjs/znac198.

Monteagudo-Vela, M., Panoulas, V. and Krasopoulos, G. (2022). ‘QOL and PROMS Following Transcatheter Aortic Valve Implantation’. In: T. Athanasiou, A. Darzi and A.Y. Oo, eds., Patient Reported Outcomes and Quality of Life in Cardiovascular Interventions. Switzerland: Springer Cham, pp.109–122.

O’Connell, S., Islam, S., Sewell, B., Farr, A., Knight, L., Bashir, N., Harries, R.L., Jones, S., Cleves, A., Fegan, G., Watkins, A. and Torkington, J. (2022). Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT. Health Technology Assessment, 26(34), pp.1–100. doi: https://doi.org/10.3310/cmwc8368.

Smith, L., Meggy, A., Watts, T., Knight, L., Torkington, J. and Cornish, J. (2022). Incisional hernia prevention: risk–benefit from a patient perspective (INVITE) – protocol for a single-centre, mixedmethods, cross-sectional study aiming to determine if using prophylactic mesh in incisional hernia prevention is acceptable to patients. BMJ Open, 12(12), p.e069568. doi: https://doi.org/10.1136/ bmjopen-2022-069568.

Appendix D

Clinical Diagnostics & Therapeutics Clinical Board

Pharmacy and Medicines Management Publications

All Wales Medicines Strategy Group (2023). Understanding unlicensed medicines. [online] All Wales Therapeutics and Toxicology Centre. Available at: https://awttc.nhs.wales/files/guidelines-and-pils/ understanding-unlicensed-medicines-pdf/.

Cauchi, M., Willis, M.E., Andrews, A., Backx, M., Brownlee, W.J., Ford, H., Gran, B., Jolles, S., Price, S., Rashid, W., Schmierer, K. and Tallantyre, E.C. (2022). Multiple sclerosis and the risk of infection: Association of British Neurologists consensus guideline. Practical Neurology, 22(5), pp.344–357. doi:https://doi.org/10.1136/practneurol-2022-003370.

Coulson, J.M., Adams, A., Gray, L.A. and Evans, A. (2022). COVID-19 ‘Rebound’ associated with nirmatrelvir/ritonavir pre-hospital therapy. Journal of Infection, 85(4). doi:https://doi.org/10.1016/j. jinf.2022.06.011.

Crawford , P., Jones , E., Smith , H., Miller, K., Barnett , N., Oboh , L., Darcy , C., McKee , H. and Agnew, J. (2022). An outbreak of blisters: exploring the increased promotion of monitored dosage systems for older people. Pharmaceutical Journal, [online] 308(7961). doi:https://doi.org/10.1211/ pj.2022.1.144839.

Cusens, C. and Jones, E. (2022). Charting new territory: medication administration records and transcribing in district nursing services. British Journal of Community Nursing, 27(12), pp.604–610. doi:https://doi.org/10.12968/bjcn.2022.27.12.604.

Dodington, S. and Speakman, A. (2023). Crisis management of HPN (home parenteral nutrition) patients affected by technical services production constraints. Clinical Nutrition ESPEN, 54, pp.721–722. doi:https://doi.org/10.1016/j.clnesp.2022.09.764.

Groves, T., Rees, M. and Alikhan, R. (2022). Apixaban for venous thromboembolism treatment in obese patients with weight >120kg or BMI >40kg m2. In: International Society on Thrombosis and Haemostasis Congress. ISTH 2022 Congress.

Jones, R. and Atkinson, A. (2023). An audit of the post-administration monitoring and documentation of subcutaneous daratumumab at the University Hospital of Wales. Journal of Oncology Pharmacy Practice, 29(1S), pp.S1–S94. doi:https://doi.org/10.1177/10781552231153542.

Jordan, S., Jones, E., Komninou, S., Loane, M. and Damase-Michel, C. (2022). Families need support to reduce the risk of adverse drug reactions from breastfeeding. Pharmaceutical Journal, [online] 309(7968). doi:https://doi.org/10.1211/pj.2022.1.166126.

Smith, S., Duncan, N., Scarfe, H., Davies, E., Shah, R., Maouche, N., Connolly, S. and Gabriel, S. (2022). High dose melphalan conditioning in autologous stem cell transplantation for multiple myeloma—a UK survey of practice. In: Bone Marrow Transplantation. The 48th Annual Meeting of the European Society for Blood and Marrow Transplantation: Pharmacist Committee – Poster Session. pp.451–457.

Wale, A., Ireland, M., Yemm, R., Hiom, S., Jones, A., Spark, J.P., Francis, M., May, K., Allen, L., Ridd, S. and Mantzourani, E. (2020). Unlicensed ‘Special’ Medicines: Understanding the Community Pharmacist Perspective. Integrated Pharmacy Research and Practice, 9, pp.93–104. doi:https://doi. org/10.2147/iprp.s263970.

Appendix D

Clinical Diagnostics & Therapeutics Clinical Board

Wale, A., Young, Z., Zhang, W., Hiom, S., Ahmed, H., Yemm, R. and Mantzourani, E. (2023). Factors affecting the patient journey and patient care when receiving an unlicensed medicine: A systematic review. Research in Social and Administrative Pharmacy, 19(7), pp.1025–1041. doi:https:// doi.org/10.1016/j.sapharm.2023.04.120.

Wyllie, T. and Girvin, J. (2022). P22 Unlicensed medicines use in neonates: do we know what we’re giving? Archives of Disease in Childhood, 107(5), pp.e25.24-e25. doi:https://doi.org/10.1136/ archdischild-2022-nppg.30.

Initiatives

Contributed by Elizabeth Hughes

Consultant Pharmacist Credentialing

The pharmacy department are encouraging experienced clinical pharmacists who have developed and demonstrated a high-level of expertise in their area of practice to complete the consultant pharmacist credentialing process. One of the five assessment domains for the credentialing process is research, including the practice of undertaking research to inform service innovation. This process is therefore a strong initiative to completing, publishing and celebrating pharmacy research. Three pharmacists have successfully credentialed at Consultant level during 2022-2023 and another has submitted their portfolio for review and is awaiting the outcome.

Core Advanced Pharmacist Credentialing

In November 2022 the Royal Pharmaceutical Society launched the credentialing process for clinical pharmacists at ‘Core Advanced’ level. Research is again one of the five assessment domains and so this will drive clinical pharmacists towards completing, publishing and celebrating pharmacy research as they seek to develop and advance their practice. The pharmacy department is actively encouraging pharmacists to undertake their credentialing journey through the establishment of awareness sessions and peer support groups.

Research Impact Case Study

Contributed by Elizabeth Hughes

SMPU is an NHS Pharmacy “Special’s” Manufacturing unit based in Cardiff and Vale UHB. Unlicensed medicines are used across the UK to treat an individual’s clinical needs when there are no appropriate licensed alternatives. Patients, carers and parents have reported facing challenges with unlicensed medicines at the points of transfer of care between settings, a key time when medication errors may occur. There is little known about the patient journey as a whole, or the factors affecting patient care when receiving an unlicensed medicine. To address this knowledge gap a PhD was initiated by SMPU in collaboration with Cardiff School of Pharmacy and Pharmaceutical Sciences, SMPU and Mayberry Pharmacy entitled “Unlicensed “special” medicines: improving the patients’ experience”. Semi-structured interviews were carried out with patients and a variety of Healthcare Professionals to identify themes relating to the use of special’s and the patient journey. Many issues were identified including aspects relating to: clinical decision making; knowledge and understanding; communication with patients; continuity of care during transfer between settings; and quality, ordering, supply and administration issues.

Appendix D

Clinical Diagnostics & Therapeutics Clinical Board

Aspects specifically relating to community pharmacists have been described [Wale, A., et al 2020] and a systematic overview [Wale, A. et al, 2023] as outputs of this research work together with successful completion and publication of the PhD in 2021. Further evidence of the impact and wide reaching effects of this research are demonstrated in the subsequent publication of an All Wales Medicine Strategy Group Guidance Document for improving the management of unlicensed medicines in all sectors of healthcare in NHS Wales, using output from this PhD.

Radiology Publications

Bashir, M., Jubouri, M., White, R.D., Tan, S.ZCP., Bailey, D.M. and Williams, I.M. (2022). Dynamic and Static Vessel Malperfusion as a Consequence of Acute Type B Aortic Dissection. Annals of Vascular Surgery. doi: https://doi.org/10.1016/j.avsg.2022.11.002.

Bashir, M., Tan, S.Z., Jubouri, M., Salahia, G., Whiston, R.J., White, R.D., Bailey, D.M. and Williams, I.M. (2022). A narrative review of the surgical management of Paget-Schroetter syndrome: case series and long-term follow-up. Cardiovascular Diagnosis and Therapy, [online] 12(5), pp.74455–74755. doi: https://doi.org/10.21037/cdt-22-158.

Howells, D., Rees, J., Townsend, R. and Kirov, G. (2022). Electroconvulsive Therapy Reverses Cerebral Hypoperfusion in a Patient With Psychotic Depression and Catatonia. The Journal of ECT, 38(2). doi:https://doi.org/10.1097/yct.0000000000000836.

Kingsmore, D.B., White, R.D., Mestres, G., Stephens, M., Calder, F., Papadakis, G., Aitken, E., Jackson, A., Inston, N., Jones, R.G., Geddes, C., Stevenson, K., Szabo, L., Thomson, P.C., Stove, C., Kasthuri, R., Edgar, B., Tozzi, M., Franchin, M. and Sivaprakasam, R. (2023). Recruitment into randomised trials of arteriovenous grafts: A systematic review. The Journal of Vascular Access, p.112972982311584112972982311584. doi: https://doi.org/10.1177/11297298231158413.

Lou, J., Lin, H., Marshall, D., White, R., Yang, Y., Shelmerdine, S. and Liu, H. (2022). Predicting Radiologist Attention During Mammogram Reading with Deep and Shallow High-Resolution Encoding. IEEE International Conference on Image Processing (ICIP). doi: https://doi.org/10.1109/ icip46576.2022.9897723.

Lou, J., Lin, H., Young, P., White, R., Yang, Z., Shelmerdine, S., Marshall, D., Spezi, E., Palombo, M. and Liu, H. (2023). Predicting Radiologists’ Gaze with Computational Saliency Models in Mammogram Reading. IEEE Transactions on Multimedia, pp.1–14. doi: https://doi.org/10.1109/tmm.2023.3263553.

Mehranian, A., Wollenweber, S.D., Walker, M.D., Bradley, K.M., Fielding, P.A., Huellner, M., Kotasidis, F., Su, K.-H., Johnsen, R., Jansen, F.P. and McGowan, D.R. (2022). Deep learning–based time-offlight (ToF) image enhancement of non-ToF PET scans. European Journal of Nuclear Medicine and Molecular Imaging, 49(11), pp.3740–3749. doi: https://doi.org/10.1007/s00259-022-05824-7.

Shankar, A., Hall, G.W., McKay, P., Gallop-Evans, E., Fielding, P. and Collins, G.P. (2022). Management of children and adults with all stages of nodular lymphocyte predominant Hodgkin lymphoma — All StAGEs: A consensus-based position paper from the Hodgkin lymphoma subgroup of the UK National Cancer Research Institute. British Journal of Haematology, 197(6), pp.679–690. doi: https:// doi.org/10.1111/bjh.18169.

Shelmerdine, S.C., White, R.D., Liu, H., Arthurs, O.J. and Sebire, N.J. (2022). Artificial intelligence for radiological paediatric fracture assessment: a systematic review. Insights into Imaging, 13(1). doi: https://doi.org/10.1186/s13244-022-01234-3.

Appendix D

Clinical Diagnostics & Therapeutics Clinical Board

Therapies

Publications

Beddard, M., Jones, N., Withers, K. and Morris, R. (2022). Towards Zero Deaths from Bowel Cancer in Wales. [online] Moondance Cancer Initiative. Available at: https://moondance-cancer.wales/researchinsights/towards-zero-deaths-from-bowel-cancer.

Frizzati, A., Jones, N., Palmer, R., Dale, M., Withers, K. and Morris, R. (2022). ‘Adferiad’ (Recovery) Long COVID Service National Evaluation (July 2022 update). Available at: https://cedar.nhs.wales/ files/adferiad-recovery-long-covid-service-national-evaluation-july-2022-update/

Jones, N.J. and Barnett, S. (2022). The role of Alprep Pad® in facilitating shared care of diabetic foot ulceration. The Diabetic Foot Journal, 25(2).

Tack, C., Holdsworth, L., Wilson, A., McComiskie, E., McCabe, P., Wilkinson, W. and King, M. (2022). Digital competency: a survey of UK allied health professionals. British Journal of Healthcare Management, 28(8), pp.1–15. doi: https://doi.org/10.12968/bjhc.2021.0123.

Twose, P., Terblanche, E., Jones, U., Firshman, P., Merriweather, J., Rock, C. and Wallace, S. (2023). Protected therapy services for critical care: A subanalysis of the UK-wide workforce survey. Australian Critical Care. doi: https://doi.org/10.1016/j.aucc.2022.11.011.

Williams, C.M., Barker, A.R., Denford, S., van Beurden, S.B., Bianchim, M.S., Caterini, J.E., Cox, N.S., Mackintosh, K.A., McNarry, M.A., Rand, S., Schneiderman, J.E., Wells, G.J., Anderson, P.J., Beever, D., Beverley, Z., Buckley, R., Button, B.M., Causer, A.J., Curran, M. and Dwyer, T. (2022). The Exeter Activity Unlimited statement on physical activity and exercise for cystic fibrosis: methodology and results of an international, multidisciplinary, evidence-driven expert consensus. Chronic Respiratory Disease, 19, p.147997312211216-147997312211216. doi: https://doi.org/10.1177/14799731221121670.

Williams, J.L. and Elliott, M. (2022). Promoting healthy environments, skills and communities in Wales: the Nutrition Skills for Life® programme. Perspectives in Public Health, 142(6), pp.316–318. doi: https://doi.org/10.1177/17579139221106948.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix D

Clinical Diagnostics & Therapeutics Clinical Board Appendix D - Clinical Diagnostics & Therapeutics Clinical Board

Appendix D - Clinical Diagnostics & Therapeutics Clinical Board

Appendix E - Medicine Clinical Board

Clinical Gerontology

Publications

Faheem, W., Nandra, T., Richardson, S., Saliu, D., Wilson, D., Jackson, T.A., Magill, L., McCluskey, L., Perry, R., Welch, C., Wilson, D., Copeland, C., Cunningham, E.L., Davis, D., Treml, J., Pinkney, T., Quinn, T., Nightingale, P., Jelley, B. and Gaunt, V. (2023). Increasing frailty is associated with higher prevalence and reduced recognition of delirium in older hospitalised inpatients: results of a multicentre study. European Geriatric Medicine, 14(2). doi: https://doi.org/10.1007/s41999-022-00737-y.

Jelley, B.J., Hughes, T.A.T. and Jones, P. (2023). The Evolution and Environmental Benefits of the All Wales Stroke Meeting (AWSM), a Video Conference Multidisciplinary Meeting for Stroke Physicians. Journal of Medical Sciences and Health, 9(1), pp.75–78. doi: https://doi.org/10.46347/jmsh.v9i1.22.512.

Lewis-Morton, R., Thomas, C., Mohamed, B., Mahon, S. and Williams, T. (2022). Developing a clinical psychology service for people living with Parkinson’s and their care partners: Reflections from people with Parkinson’s, carers and the multidisciplinary team. Clinical Psychology Forum, 1(359), pp.20–28. doi: https://doi.org/10.53841/bpscpf.2022.1.359.20.

Schroeder, B.E., Robertson, N.P. and Hughes, T.A.T. (2023). Cerebral amyloid angiopathy: an update. Journal of Neurology. doi: https://doi.org/10.1007/s00415-023-11631-3.

Appendix E - Medicine Clinical Board

Dermatology

Publications

Bates, J., Stanton, H., Cannings-John, R., Thomas, K.S., Leighton, P., Howells, L., Rodrigues, F., Howes, R., Collier, F., Harris, C., Gibbons, A., Thomas-Jones, E., Hood, K. and Ingram, J. (2022). Treatment of Hidradenitis Suppurativa Evaluation Study (THESEUS): protocol for a prospective cohort study. British Medical Journal, 12(4), pp.e060815–e060815. doi: https://doi.org/10.1136/bmjopen-2022-060815.

Bosma, A.L., Ouwerkerk, W., Heidema, M.J., Prieto-Merino, D., Ardern-Jones, M.R., Beattie, P., Brown, S.J., Ingram, J.R., Irvine, A.D., Ogg, G., Patel, P., Reynolds, N.J., Hearn, R.M.R., Wan, M., Warren, R.B., Woolf, R.T., Hyseni, A.M., Gerbens, L.A.A., Spuls, P.I. and Flohr, C. (2023). Comparison of real-world treatment outcomes of systemic immunomodulating therapy in atopic dermatitis patients with dark and light skin types. JAAD International, [online] 10, pp.14–24. doi: https://doi.org/10.1016/j. jdin.2022.09.006.

Garg, A., Dirr, M.A., Jemec, G.B.E., Ingram, J.R., Schmitt, J., Spuls, P. and Alam, M. (2022). Shifting focus from ‘what we do’ to the ‘impact of what we do’: Application of outcome measures to routine clinical care in dermatology. Journal of the American Academy of Dermatology, 87(2), pp.e83–e84. doi: https://doi.org/10.1016/j.jaad.2022.04.042.

Garg, A., Rawal, S., Akilov, O., Alavi, A., Ardon, C., Bechara, F.G., Cohen, A.D., Cohen, S.R., Daveluy, S., Del Marmol, V., Delage, M., Esmann, S., Fisher, S., Giamarellos-Bourboulis, E.J., Glowaczewska, A., Goldfarb, N., Gonzalez Brant, E., Grimstad, Ø., Guilbault, S. and Hamzavi, I. (2023). Factors associated with disease-specific life impact in patients with hidradenitis suppurativa: results from the Global VOICE project. British Journal of Dermatology, 188(6), pp.808–810. doi: https://doi.org/10.1093/bjd/ ljad069.

Garg, A., Zema, C., Ciaravino, V., Rolleri, R., Peterson, L., Garcia, L., Massaro, T., Jemec, G.B.E., Kirby, J.S., Thorlacius, L. and Ingram, J.R. (2023). Validation of the Hidradenitis Suppurativa Investigator Global Assessment. JAMA Dermatology. doi: https://doi.org/10.1001/jamadermatol.2023.0797.

Garg, A.X., Zema, C.L., Kim, K.K., Gao, W., Chen, N., Jemec, G.B.E., Kirby, J.S., Thorlacius, L., Villumsen, B. and Ingram, J. (2022). Development and initial validation of the HS-IGA: a novel hidradenitis suppurativa-specific investigator global assessment for use in interventional trials. British Journal of Dermatology, 187(2), pp.203–210. doi: https://doi.org/10.1111/bjd.21236.

Hasan, S.B., Gendra, R., James, J., Morris, D., Orenstein, L.A.V. and Ingram, J.R. (2022). Pain measurement in painful skin conditions and rheumatoid arthritis randomized controlled trials: a scoping review to inform pain measurement in hidradenitis suppurativa. British Journal of Dermatology. doi: https:// doi.org/10.1111/bjd.21821.

Ingram, J. (2022). A watershed moment for the BJD: Authors retain their article copyright. British Journal of Dermatology, 188(1), pp.1–2. doi: https://doi.org/10.1093/bjd/ljac006.

Ingram, J.R., Bettoli, V., Espy, J.I., Kokolakis, G., Martorell, A., Villani, A.P., Wallinger, H., Coak, E., Kasparek, T., Muscianisi, E., Richardson, C. and Kimball, A.B. (2022). Unmet clinical needs and burden of disease in hidradenitis suppurativa: real-world experience from EU5 and US. Journal of the European Academy of Dermatology and Venereology, 36(9), pp.1597–1605. doi: https://doi. org/10.1111/jdv.18163.

James, J.F., Madray, V.M., Salame, N., Hasan, S.B., White, M.S., Barron, J.R., Kirby, J., Ingram, J.R. and Orenstein, L.A.V. (2022). Demographic Gaps and Requirements for Participation: A Systematic Review of Clinical Trial Designs in Hidradenitis Suppurativa. Dermatology, 239(1), pp.45–51. doi: https://doi.org/10.1159/000526069.

Appendix E - Medicine Clinical Board

McCluskey, D., Benzian-Olsson, N., Mahil, S.K., Hassi, N.K., Wohnhaas, C.T., Burden, A.D., Griffiths, C.E.M., Ingram, J., Levell, N.J., Parslew, R., Pink, A., Reynolds, N.J., Warren, R.B., Visvanathan, S., Baum, P., Barker, J., Smith, C.H. and Capon, F. (2022). Single-cell analysis implicates TH17-to-TH2 cell plasticity in the pathogenesis of palmoplantar pustulosis. Journal of Allergy and Clinical Immunology, 150(4), pp.882–893. doi: https://doi.org/10.1016/j.jaci.2022.04.027.

Midgette, B., Strunk, A., Akilov, O.E., Alavi, A., Ardon, C.B., Bechara, F.G., Cohen, A.D., Cohen, S.P., Daveluy, S., Del Marmol, V., Delage, M., Esmann, S., Fisher, S., Giamarellos-Bourboulis, E.J., Głowaczewska, A., Goldfarb, N., Gonzalez Brant, E., Grimstad, Ø., Guilbault, S. and Hamzavi, I.H. (2022). Factors associated with treatment satisfaction in patients with hidradenitis suppurativa: results from the Global VOICE project. British Journal of Dermatology, 187(6), pp.927–935. doi: https://doi.org/10.1111/bjd.21798.

Ring, H.C., Yao, Y., Maul, J., Ingram, J.R., Frew, J.W., Thorsen, J., Nielsen, M., Wu, J.J., Thyssen, J.P., Thomsen, S.F. and Egeberg, A. (2022). The road to biologics in patients with hidradenitis suppurativa: a nationwide drug utilization study. British Journal of Dermatology. doi: https://doi.org/10.1111/ bjd.21673.

Shah, R., Finlay, A.Y., Salek, S., Nixon, S.J., Otwombe, K., Ali, F.M. and Ingram, J.R. (2023). Meaning of Family Reported Outcome Measure (FROM-16) severity score bands: a cross-sectional online study in the UK. British Medical Journal, 13(3), pp.e066168–e066168. doi: https://doi.org/10.1136/ bmjopen-2022-066168.

Tatovic, D., McAteer, M.A., Barry, J., Barrientos, A., Rodríguez Terradillos, K., Perera, I., Kochba, E., Levin, Y., Dul, M., Coulman, S.A., Birchall, J.C., von Ruhland, C., Howell, A., Stenson, R., Alhadj Ali, M., Luzio, S.D., Dunseath, G., Cheung, W.Y., Holland, G. and May, K. (2022). Safety of the use of gold nanoparticles conjugated with proinsulin peptide and administered by hollow microneedles as an immunotherapy in type 1 diabetes. Immunotherapy Advances, 2(1). doi: https://doi.org/10.1093/ immadv/ltac002.

van Straalen, K.R., Ingram, J.R., Augustin, M. and Zouboulis, C.C. (2022). New treatments and new assessment instruments for Hidradenitis suppurativa. Experimental Dermatology, 31(S1), pp.33–39. doi: https://doi.org/10.1111/exd.14609.

Vyas, J., Johns, J.R., Ali, F.M., Singh, R.K., Ingram, J.R., Salek, S. and Finlay, A.Y. (2023). A systematic review of 457 randomised controlled trials using the Dermatology Life Quality Index: experience in 68 diseases and 42 countries. British Journal of Dermatology. doi: https://doi.org/10.1093/bjd/ljad079.

Wainman, H.E., Lane, P.C. and Ingram, J.R. (2022). Hidradenitis suppurativa diagnosis and management in primary care: not just recurrent boils. British Journal of General Practice, 73(726), pp.43–45. doi: https://doi.org/10.3399/bjgp23x731733.

Willems, D., Hinzpeter, E.-L., Van der Zee, H.H., Sayed, C.J., Ingram, J., Beaudart, C., Evers, S.M.A.A. and Hiligsmann, M. (2023). Patient Preferences in the Management of Hidradenitis Suppurativa: Results of a Multinational Discrete Choice Experiment in Europe. Patient, 16(2), pp.153–164. doi: https://doi.org/10.1007/s40271-022-00614-7.

Willems, D., Sayed, C.J., Van der Zee, H.H., Ingram, J.R., Hinzpeter, E.L., Beaudart, C., Evers, S.M.A.A. and Hiligsmann, M. (2023). A discrete-choice experiment to elicit the treatment preferences of patients with hidradenitis suppurativa in the United States. Journal of Medical Economics, 26(1), pp.503–508. doi: https://doi.org/10.1080/13696998.2023.2194804.

Appendix E - Medicine Clinical Board

Williams, J.C., Alhusayen, R., Guilbault, S., Hills, N.K., Ingram, J.R., Kudlinski, M.V., Lowes, M.A., Marzano, A.V., Paul, M., Villumsen, B., Yannuzzi, C.A. and Naik, H.B. (2022). Biologic Therapy Is Not Associated with Increased COVID-19 Severity in Patients with Hidradenitis Suppurativa: Updated Findings from the Global Hidradenitis Suppurativa COVID-19 Registry. Dermatology, 239(2), pp.283–286. doi: https://doi.org/10.1159/000527401.

Yiu, Z.Z.N., Chi, C. -C., Ingram, J.R. and Flohr, C. (2022). Checking for update…living systematic reviews and clinical practice guidelines in the BJD. British Journal of Dermatology, 186(5), pp.761–762. doi: https://doi.org/10.1111/bjd.20896.

Integrated Medicine

Publications

Allen, L.A., Shrikrishnapalasuriyar, N. and Rees, D.A. (2022). Long-term health outcomes in young women with polycystic ovary syndrome: A narrative review. Clinical Endocrinology, 97(2), pp.187–198. doi: https://doi.org/10.1111/cen.14609.

Cauldwell, M., Steer, P., Adamson, D., Alexander, C., Allen, L., Bhagra, C., Bolger, A., Bonner, S., Calanchini, M., Carroll, A., Casey, R., Curtis, S., Head, C., English, K., Hudsmith, L., James, R., Joy, E., Keating, N., MacKiliop, L. and McAuliffe, F. (2022). Pregnancies in women with Turner syndrome: a retrospective multicentre UK study. BJOG: An International Journal of Obstetrics & Gynaecology, [online] 129(5), pp.796–803. doi: https://doi.org/10.1111/1471-0528.17025.

Daughters, K., Rees, D.A., Hunnikin, L., Wells, A., Hall, J. and van Goozen, S. (2022). Oxytocin administration versus emotion training in healthy males: considerations for future research. Philosophical Transactions of the Royal Society B: Biological Sciences, 377(1858). doi: https://doi. org/10.1098/rstb.2021.0056.

Elhassan, Y.S., Iqbal, F., Arlt, W., Baldeweg, S.E., Levy, M., Stewart, P.M., John A.H. Wass, Pavord, S., D. Aled Rees and Ronchi, C.L. (2023). COVID-19-related adrenal haemorrhage: Multicentre UK experience and systematic review of the literature. Clinical Endocrinology. doi: https://doi.org/10.1111/ cen.14881.

McCarthy, O., Pitt, J.P., Keay, N., Vestergaard, E.T., Tan, A.S.Y., Churm, R., Rees, D.A. and Bracken, R.M. (2022). Passing on the exercise baton: What can endocrine patients learn from elite athletes? Clinical Endocrinology, 96(6), pp.781–792. doi: https://doi.org/10.1111/cen.14683.

Panagiotou, G., Taylor, P.N., Rees, D.A. and Okosieme, O.E. (2022). Late offspring effects of antenatal thyroid screening. British Medical Bulletin, 143(1), pp.16–29. doi: https://doi.org/10.1093/bmb/ ldac018.

Perros, P., Basu, A., Boelaert, K., Dayan, C., Vaidya, B., Williams, G.R., Lazarus, J.H., Hickey, J., Drake, W.M., Crown, A., Orme, S.M., Johnson, A., Ray, D.W., Leese, G.P., Jones, T.H., Abraham, P., Grossman, A., Rees, A., Razvi, S. and Gibb, F.W. (2022). Postradioiodine Graves’ management: The PRAGMA study. Clinical Endocrinology, 97(5). doi: https://doi.org/10.1111/cen.14719.

Tschaidse, L., Reisch, N., Arlt, W., de la Perriere, A.B., Linden Hirschberg, A., Juul, A., Mallappa, A., Merke, D.P., Newell-Price, J.D.C., Perry, C.G., Prete, A., Rees, D.A., Stikkelbroeck, N., Touraine, P., Coope, H., Porter, J.B., Ross, R.J. and Quinkler, M. (2023). Modified-release hydrocortisone is associated with lower plasma renin activity in patients with salt-wasting congenital adrenal hyperplasia. European Journal of Endocrinology, 188(1). doi: https://doi.org/10.1093/ejendo/lvac006.

Whelan, C., Burnley-Hall, N., Morris, K., Rees, D.A. and James, P.E. (2022). The procoagulant effects of extracellular vesicles derived from hypoxic endothelial cells can be selectively inhibited by inorganic nitrite. Nitric Oxide, 122-123, pp.6–18. doi: https://doi.org/10.1016/j.niox.2022.02.002.

Appendix E - Medicine Clinical Board

Grants

Project Official Short/ Full Title

ICF:LIothyrONiNe Sulphate (T3S) use in hypothyroid subjects on T4 homozygous for the Thr92Ala Deiodinase 2 (D2) polymorphism - the LIONNS-D2 study

A clinical trial platform for combined beta cell preservation therapy

Preparing for the Future – extension of the UK T1D Immunotherapy Consortium. 2022-2023. $150k/£100k

Improving outcomes for patients with pituitary disease: advancing therapeutics and diagnostics using electronic health records and molecular imaging

Making up your mind: Obesity and Female Adolescent Brain development (O-FAB Trial)

Lead Investigator/s

Professor Colin Dayan

Professor Colin Dayan

Professor Colin Dayan

Professor Aled Rees

Dr Rachel Lord (Cardiff University)

Professor Aled Rees (co-applicant)

Appendix E - Medicine Clinical Board

Rheumatology Publications

Aletaha, D., Kerschbaumer, A., Kastrati, K., Dejaco, C., Dougados, M., McInnes, I.B., Sattar, N., Stamm, T., Takeuchi, T., Trauner, M., van der Heijde, D., Scholte-Voshaar, M., Winthrop, K.L., Ravelli, A., Betteridge, N., Burmester, G.R., Bijlsma, J.W.J., Bykerk, V.P., Caporali, R. and Choy, E. (2022). Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update. Annals of the Rheumatic Diseases, 82(6), p.annrheumdis-222784. doi: https://doi.org/10.1136/ ard-2022-222784.

Galloway, J., Raine, T., Rivett, L., Roberts, J., Dews, S.-A. and Choy, E.H. (2022). Herpes zoster and Janus kinase inhibition in rheumatology and gastroenterology patients: managing risk and vaccination. Clinical and Experimental Rheumatology, 40(7). doi: https://doi.org/10.55563/ clinexprheumatol/0jdyse.

Guillo, L., Rabaud, C., Choy, E.H., D’Amico, F., Danese, S., Ng, S.C. and Peyrin-Biroulet, L. (2022). Herpes Zoster and Vaccination Strategies in Inflammatory Bowel Diseases: A Practical Guide. Clinical Gastroenterology and Hepatology, 20(3), pp.481–490. doi: https://doi.org/10.1016/j.cgh.2020.10.027.

Nagy, G., Roodenrijs, N.M.T., Welsing, P.M.J., Kedves, M., Hamar, A., Goes, M.C. van der, Kent, A., Bakkers, M., Pchelnikova, P., Blaas, E., Senolt, L., Szekanecz, Z., Choy, E.H., Dougados, M., Jacobs, J.W., Geenen, R., Bijlsma, J.W., Zink, A., Aletaha, D. and Schoneveld, L. (2022). EULAR points to consider for the management of difficult-to-treat rheumatoid arthritis. Annals of the Rheumatic Diseases. doi: https://doi.org/10.1136/annrheumdis-2021-220973.

Cystic Fibrosis Publications

Acaster, S., Mukuria, C., Rowen, D., Brazier, J.E., Wainwright, C.E., Quon, B.S., Duckers, J., Quittner, A.L., Lou, Y., Sosnay, P.R. and McGarry, L.J. (2022). Development of the Cystic Fibrosis QuestionnaireRevised-8 Dimensions: Estimating Utilities From the Cystic Fibrosis Questionnaire-Revised. Value in Health, 26(4), pp.567–578. doi: https://doi.org/10.1016/j.jval.2022.12.002.

Ayling-Smith, J., Speight, L., Dhillon, R., Backx, M., White, P.L., Hood, K. and Duckers, J. (2022). The Presence of Exophiala dermatitidis in the Respiratory Tract of Cystic Fibrosis Patients Accelerates Lung Function Decline: A Retrospective Review of Lung Function. Journal of Fungi, 8(4), p.376. doi: https://doi.org/10.3390/jof8040376.

Duckers, J., Fitzgerald, R., Proud, D., Addy, C. and Datta, D. (2022). Forewarned is forearmed: The cardiovascular time bomb in Cystic Fibrosis. Journal of Cystic Fibrosis, 21(3). doi: https://doi. org/10.1016/j.jcf.2021.11.008.

McNarry, M.A., Berg, R.M.G., Shelley, J., Hudson, J., Saynor, Z.L., Duckers, J., Lewis, K., Davies, G.A. and Mackintosh, K.A. (2022). Inspiratory Muscle Training Enhances Recovery Post COVID-19: A Randomised Controlled Trial. European Respiratory Journal, 60(4). doi: https://doi.org/10.1183/13993003.031012021.

Metcalfe, R.S., Swinton, P.A., Mackintosh, K.A., Berg, R., Shelley, J., Saynor, Z.L., Hudson, J., Duckers, J., Lewis, K., Davies, G.A. and McNarry, M.A. (2023). Heterogenous Treatment Effects Following Inspiratory Muscle Training during Recovery from Post-Acute COVID-19 Syndrome. Medicine & Science in Sports & Exercise, [online] Publish Ahead of Print. doi: https://doi.org/10.1249/mss.0000000000003207.

Appendix E - Medicine Clinical Board

Nye, C., Duckers, J. and Dhillon, R. (2022). Cefiderocol to manage chronic, multi-drug-resistant Burkholderia cepacia complex infection in a patient with cystic fibrosis: a case report. Access Microbiology, 4(10). doi: https://doi.org/10.1099/acmi.0.000413.

O’Leary, C., Edwards, V., Hardcastle, K.A., McCulloch, A. and Duckers, J.M. (2022). Adverse Childhood Experiences (ACEs) in Adults with Cystic Fibrosis. Psychology Research and Behavior Management, 15, pp.1601–1605. doi: https://doi.org/10.2147/prbm.s322425.

Riezk, A., Vasikasin, V., Wilson, R.K., Rawson, T.M., Mcleod, J.G., Dhillon, R., Duckers, J., Cass, A. and Holmes, A. (2023). Triple quadrupole LC/MS method for the simultaneous quantitative measurement of cefiderocol and meropenem in serum. Royal Society of Chemistry Journal (Analytical Methods), 15(6), pp.746–751. doi: https://doi.org/10.1039/d2ay01459a.

Roberts, A.E.L., Xanthe, C., Hopkins, A.L., Bodger, O., Lewis, P., Mahenthiralingam, E., Duckers, J. and Jenkins, R.E. (2022). A pilot study investigating the effects of a manuka honey sinus rinse compared to a standard sinus rinse on sino-nasal outcome test scores in cystic fibrosis patients. Pilot and Feasibility Studies, 8(1). doi: https://doi.org/10.1186/s40814-022-01175-0.

Shelley, J., Hudson, J., Mackintosh, K.A., Saynor, Z.L., Duckers, J., Lewis, K., Davies, G.A., Berg, R.M.G. and McNarry, M.A. (2022). Perceptions of inspiratory muscle training in adults recovering from COVID-19. PLOS ONE, 17(11), p.e0270620. doi: https://doi.org/10.1371/journal.pone.0270620.

Sutharsan, S., McKone, E.F., Downey, D.G., Duckers, J., MacGregor, G., Tullis, E., Van Braeckel, E., Wainwright, C.E., Watson, D., Ahluwalia, N., Bruinsma, B.G., Harris, C., Lam, A.P., Lou, Y., Moskowitz, S.M., Tian, S., Yuan, J., Waltz, D., Mall, M.A. and Aurora, P. (2022). Efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor in people with cystic fibrosis homozygous for F508del-CFTR: a 24-week, multicentre, randomised, double-blind, active-controlled, phase 3b trial. The Lancet Respiratory Medicine, 10(3), pp.267–277. doi: https://doi.org/10.1016/ s2213-2600(21)00454-9.

Williams, D., Esan, O.B., Schlüter, D.K., Taylor-Robinson, D., Shantini Paranjothy, Duckers, J., Goodchild, N. and Phillips, R. (2023). Sharing decisions on reproductive goals: A mixed-methods study of the views of women who have cystic fibrosis. Journal of Cystic Fibrosis, 22(2), pp.207–216. doi: https:// doi.org/10.1016/j.jcf.2023.02.007.

Appendix E - Medicine Clinical Board

Grants

Project Official Short/Full Title

Eureka HRaas (Healthcare Robotics as a Service)

Lead Investigator/s

Dr Esyin Chew

Use of machine learning to predict acute pulmonary exacerbations in Cystic Fibrosis

CF Trust Fellow

Translation of Concept Scheme (Institutional Translational Partnership Award (ITPA) Ref: A rapid assay towards detection of Mycobacterium abscessus in clinical sputum samples from patients with cystic fibrosis

Dr Jamie Duckers (co-applicant)

Dr Jamie Duckers (co-applicant)

Dr Jamie Duckers (co-applicant)

Research Impact Case Study

Contributed by Dr Jamie Duckers

Project Breathe

Remote monitoring for people with cystic fibrosis (CF) and newly funded AI to determine exacerbations prior to them becoming clinically apparent. 103 people with CF from all across Wales on remote monitoring and has changed clinical practice.

Vertex VX21-522-001 first in human study of inhaled mrna therapy for cystic fibrosis

We have been selected as an Early Phase Centre and will be opening this early phase study for people with CF who cannot access the novel CF therapies available to date. We have been working to set up an early phase trial on the CF ward in Llandough and this is the first time this has happened. We now have a pipeline of early pahse studies for CF and bronchiectasis - all to be delivered in the ward setting.

Vertex VX20-12-104-OLS

We have secured an open label study for people with CF thus allowing earlier access to this CFTR modulator and provided by the company. These are very high cost therapies.

Appendix E - Medicine Clinical Board

Endocrinology

Publications

Agrawal, M., Lewis, S., Premawardhana, L., Dayan, C.M., Taylor, P.N. and Okosieme, O.E. (2022). Antithyroid drug therapy in pregnancy and risk of congenital anomalies: Systematic review and meta-analysis. Clinical Endocrinology, 96(6), pp.857–868. doi: https://doi.org/10.1111/cen.14646.

Dayan, C.M., Lecumberri, B., Muller, I., Ganesananthan, S., Hunter, S.F., Selmaj, K.W., Hartung, H.P., Havrdova, E., LaGanke, C., Ziemssen, T., Van Wijmeersch, B., Meuth, S.G., Margolin, D., Poole, E.M., Baker, D.P. and Senior, P.A. (2023). Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies. Multiple Sclerosis Journal –Experimental, Translational and Clinical, 9(1), p.205521732211427-205521732211427. doi: https:// doi.org/10.1177/20552173221142741.

Eason, R.J., Thomas, N.J., Hill, A.V., Knight, B.A., Carr, A., Hattersley, A.T., McDonald, T.J., Shields, B.M., Jones, A.G., Simon, G., Ramos, A., Norris, A., Tan, K., Narendran, P., Ramtoola, S., Ali, A., Banerjee, M., Brooks, A., Chakera, A. and Johnson, A. (2022). Routine Islet Autoantibody Testing in Clinically Diagnosed Adult-Onset Type 1 Diabetes Can Help Identify Misclassification and the Possibility of Successful Insulin Cessation. Diabetes Care, 45(12), pp.2844–2851. doi: https://doi.org/10.2337/dc220623.

French, R., Kneale, D., Warner, J.T., Robinson, H., Rafferty, J., Sayers, A., Taylor, P., Gregory, J.W. and Dayan, C.M. (2022). Educational Attainment and Childhood-Onset Type 1 Diabetes. Diabetes Care, 45(12), pp.2852–2861. doi: https://doi.org/10.2337/dc21-0693.

Thomas, N.J., Hill, A.V., Dayan, C.M., Oram, R.A., Shields, B.M. and Jones, A.G. (2023). Age of Diagnosis Does Not Alter the Presentation or Progression of Robustly Defined Adult-Onset Type 1 Diabetes. Diabetes Care, 46(6), pp.1156–1163. doi: https://doi.org/10.2337/dc22-2159.

Research Impact Case Study

Contributed by Professor Aled Rees

A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.

This phase III clinical trial compared the effectiveness of a new modified release formulation of hydrocortisone (Efmody/ Chronocort®) with conventional glucocorticoid replacement in controlling disease activity in patients with Congenital Adrenal Hyperplasia (CAH) due to 21-hydroxylase deficiency. Patients with CAH have a significant unmet health need. Whilst good disease control (with respect to biochemical normalisation of androgen levels and clinical symptoms) can be achieved in some patients with existing glucocorticoids, many others have suboptimal control whether assessed clinically (e.g. menstrual irregularity, sub-fertility, hirsutism, weight gain, adrenal rest tumours) or biochemically. This suboptimal control reflects the difficulty in regulating androgens on the one hand, whilst avoiding glucocorticoid over-replacement on the other. In some patients, good control of androgens (17-hydroxyprogesterone, androstenedione) can only be achieved at the expense of higher than ideal doses of glucocorticoid (resulting in weight gain and the longer-term sequelae [e.g. cardiometabolic risk, osteopenia] associated with excess glucocorticoid exposure).

Appendix E - Medicine Clinical Board

We recruited 4 patients with this rare disorder to the initial randomised trial and subsequent extension study. Efmody was shown to improve biochemical disease control in adults, with reduction in steroid dose over time and patient-reported benefit, leading to marketing authorisation being granted by the MHRA in 2021.

The trial also led to a high impact primary publication (Merke, D. P. et al, (2021). Modified-release hydrocortisone in congenital adrenal hyperplasia. J Clin Endocrinol Metab, 106(5), e2063-e2077) which was among the top 10% of articles (based on citation rate) published in this internationallyleading journal that year. A secondary publication has shown an additional benefit on lowered fludrocortisone replacement dose requirements consequent upon improved mineralocorticoid activity with lowering of 17-hydroxyprogesterone levels (Tschaidse, L., et al. (2023). Modified-release hydrocortisone is associated with lower plasma renin activity in patients with salt-wasting congenital adrenal hyperplasia. Eur J Endocrinol, 188(1), Ivac006).

The clinical and cost-effectiveness of Efmody for adults and children with CAH was reviewed by the All-Wales Medicines Strategy Group in 2022. They approved Efmody for use as a second-line treatment option in adults not adequately controlled on maximum guideline doses of immediaterelease hydrocortisone and/or prednisolone. This represents the first new drug therapy for patients with CAH for over 50 years. Our success as a centre has led to the capture of new studies with Efmody in primary adrenal insufficiency and of a novel corticotrophin releasing hormone receptor antagonist in patients with CAH.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix E - Medicine Clinical Board

Appendix E - Medicine Clinical Board

Non-Commercial

Non-Commercial

Appendix E - Medicine Clinical Board

Appendix E - Medicine Clinical Board

Appendix E - Medicine Clinical Board

Appendix E - Medicine Clinical Board

Appendix E - Medicine Clinical Board

Appendix E - Medicine Clinical Board

*Clinical Characteristics Protocol for Severe Emerging Infection counted under Specialist Services Clinical Board.

**RECOVERY trial counted under Medicine Clinical Board from 2023-24 onwards.

Appendix E - Medicine Clinical Board

Appendix E - Medicine Clinical Board

Appendix E - Medicine Clinical Board

Appendix E - Medicine Clinical Board

Appendix F - Mental Health Clinical Board

Publications

Haddad, M. and Young, N. (2022). Self-harm and suicide: occurrence, risk assessment and management for general nurses. Nursing Standard, 37(6). doi: https://doi.org/10.7748/ns.2022.e11911.

Hayes, D., Hunter-Brown, H., Camacho, E., McPhilbin, M., Elliot, R., Ronaldson, A., Bakolis, I., Repper, J., Meddings, S., Stergiopoulos, V., Brophy, L., De Ruysscher, C., Okoliyski, M., Kubinová, P., Falgaard Eplov, L., Toernes, C., Narusson, D., Tinland, A., Puschner, B. and Hiltensperger, R. (2023). Recovery College characteristics, fidelity, commissioning models and unit costs: a cross-sectional global survey of 28 countries. doi: https://doi.org/10.31234/osf.io/kxtmb.

Howells, D., Rees, J., Townsend, R. and Kirov, G. (2022). Electroconvulsive Therapy Reverses Cerebral Hypoperfusion in a Patient With Psychotic Depression and Catatonia. The Journal of ECT, 38(2), pp.141–143. doi: https://doi.org/10.1097/yct.0000000000000836.

Psychology & Counselling

Adkins, K., Overton, P.G., Moses, J. and Thompson, A. (2022). Investigating the Role of Upward Comparisons and Self-compassion on Stigma in People With Acne: Cross-sectional Study. JMIR Dermatology, 6. doi: https://doi.org/10.2196/45368.

Adkins, K.V., Overton, P.G. and Thompson, A.R. (2022). A brief online writing intervention improves positive body image in adults living with dermatological conditions. Frontiers in Medicine, 9. doi: https://doi.org/10.3389/fmed.2022.1064012.

Anning, K.L., Langley, K., Hobson, C., De Sonneville, L. and Van Goozen, S.H.M. (2023). Inattention symptom severity and cognitive processes in children at risk of ADHD: the moderating role of separation anxiety. Child Neuropsychology, pp.1–25. doi: https://doi.org/10.1080/09297049.2023.21 90964.

Astill Wright, L., McElroy, E., Barawi, K., Roberts, N.P., Simon, N., Zammit, S. and Bisson, J.I. (2023). Associations among psychosis, mood, anxiety, and posttraumatic stress symptoms: A network analysis. Journal of Traumatic Stress, 36(2), pp.385–396. doi: https://doi.org/10.1002/jts.22916.

Bisson, J.I., Ariti, C., Cullen, K., Kitchiner, N., Lewis, C., Roberts, N.P., Simon, N., Smallman, K., Addison, K., Bell, V., Brookes-Howell, L., Cosgrove, S., Ehlers, A., Fitzsimmons, D., Foscarini-Craggs, P., Harris, S.R.S., Kelson, M., Lovell, K., McKenna, M. and McNamara, R. (2022). Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID). BMJ (Clinical research ed.), 377, p.e069405. doi: https://doi. org/10.1136/bmj-2021-069405.

Clarke, E.N., Norman, P. and Thompson, A.R. (2022). How does self-compassion help people adjust to chronic skin conditions? A template analysis study. Frontiers in Medicine, 9. doi: https://doi. org/10.3389/fmed.2022.974816.

Dighton, G., Wood, K., Armour, C., Fossey, M., Hogan, L., Kitchiner, N., Larcombe, J., Rogers, R.D. and Dymond, S. (2022). Gambling problems among United Kingdom armed forces veterans: Associations with gambling motivation and posttraumatic stress disorder. International Gambling Studies, 23(1), pp.1–22. doi: https://doi.org/10.1080/14459795.2022.2063923.

Appendix F - Mental Health Clinical Board

Ferguson, C., Hobson, C., Hedge, C., Waters, C., Anning, K. and van Goozen, S. (2023). Disentangling the relationships between motor control and cognitive control in young children with symptoms of ADHD. Child Neuropsychology, pp.1–26. doi: https://doi.org/10.1080/09297049.2023.2190965.

Field, S.L., Fox, J.R.E., Jones, C.R.G. and Williams, M.O. (2023). ‘Work WITH us’: a Delphi study about improving eating disorder treatment for autistic women with anorexia nervosa. Journal of Eating Disorders, 11(1). doi: https://doi.org/10.1186/s40337-023-00740-z.

Green, C. and Cappleman, R. (2023). Staff views on reflective practice groups in an inpatient assessment and treatment unit for people with intellectual disabilities. Advances in Mental Health and Intellectual Disabilities, 17(2). doi: https://doi.org/10.1108/amhid-11-2022-0045.

Heapy, C., Norman, P., Emerson, L.-M., Murphy, R., Bögels, S. and Thompson, A.R. (2022). Mindful parenting intervention for parents of children with skin conditions: A single group experimental cases series. Behavioural and Cognitive Psychotherapy, 50(5), pp.462–480. doi: https://doi.org/10.1017/ S1352465822000170.

Hewitt, R.M., Ploszajski, M., Purcell, C., Pattinson, R., Jones, B., Wren, G.H., Hughes, O., Ridd, M.J., Thompson, A.R. and Bundy, C. (2022). A mixed methods systematic review of digital interventions to support the psychological health and well-being of people living with dermatological conditions. Frontiers in Medicine, 9. doi: https://doi.org/10.3389/fmed.2022.1024879.

Hill, C., Sims, S., ap Robert, M. and Collier, S. (2022). A thematic analysis of staff perspectives on the impact of a mental health nurse (RMN) in a critical care unit. Journal of the Intensive Care Society, p.175114372211164. doi: https://doi.org/10.1177/17511437221116474.

Howard, T.L.M., Williams, M.O., Woodward, D. and Fox, J.R.E. (2022). The relationship between shame, perfectionism and Anorexia Nervosa: A grounded theory study. Psychology and Psychotherapy: Theory, Research and Practice, 96(1). doi: https://doi.org/10.1111/papt.12425.

Howe-Davies, H., Hobson, C., Waters, C. and van Goozen, S.H.M. (2022). Emotional and socio-cognitive processing in young children with symptoms of anxiety. European Child & Adolescent Psychiatry. doi: https://doi.org/10.1007/s00787-022-02050-2.

Johns, G., Samuel, V. and Waddington, L. (2022). Prevalence and predictors of mental health outcomes in UK doctors and final year medical students during the COVID-19 pandemic. Journal of Affective Disorders, 311, pp.267–275. doi: https://doi.org/10.1016/j.jad.2022.05.024.

Knight, L. and Samuel, V. (2022). Acceptance and commitment therapy interventions in secondary schools and their impact on students’ mental health and well-being: A systematic review. Journal of Contextual Behavioral Science, 25, pp.90–105. doi: https://doi.org/10.1016/j.jcbs.2022.06.006.

Lavender, S.R., Waters, C.S. and Hobson, C.W. (2022). The efficacy of group delivered mentalizationbased parenting interventions: A systematic review of the literature. Clinical Child Psychology and Psychiatry, 28(2), pp.761–784. doi: https://doi.org/10.1177/13591045221113392.

Lynham, A., Knott, S., Underwood, J., Hubbard, L., Agha, S.S., Bisson, J.I., van der Bree, M.B.M., Chawner, S.J.R.A., Craddock, N., O’Donovan, M., Jones, I., Kirov, G., Langley, K., Martin, J., Rice, F., Roberts, N.P., Thapar, A., Anney, R., Owen, M.J. and Hall, J. (2023). DRAGON-Data: a platform and protocol for integrating genomic and phenotypic data across large psychiatric cohorts. British Journal of Psychology Open, 9(2). doi: https://doi.org/10.1192/bjo.2022.636.

Appendix F - Mental Health Clinical Board

Macbeth, A.E., Holmes, S., Harries, M., Chiu, W.S., Tziotzios, C., de Lusignan, S., Messenger, A.G. and Thompson, A.R. (2022). The associated burden of mental health conditions in alopecia areata: a population-based study in UK primary care. British Journal of Dermatology, 187(1), pp.73–81. doi: https://doi.org/10.1111/bjd.21055.

Moledina, Z., McPhee, M., Ravenscroft, J., Healy, E., Radley, K., Thomas, K.S. and Burden-Teh, E. (2023). How is oral isotretinoin prescribed for the treatment of acne vulgaris? Results from a UK Dermatology Clinical Trials Network (UKDCTN) and British Dermatological Nursing Group (BDNG) survey of health professionals. Clinical and Experimental Dermatology, 48(1), pp.20–23. doi: https:// doi.org/10.1093/ced/llac015.

Morrison, J., Williams, M.O. and Fox, J.R.E. (2022). Negative childhood events and the development of the anorexic voice: A grounded theory. Psychology and Psychotherapy: Theory, Research and Practice, 95(4). doi: https://doi.org/10.1111/papt.12416.

Muftin, Z., Gilbert, P. and Thompson, A.R. (2022). A Randomised Controlled Feasibility Trial of Online Compassion-focused Self-Help for Psoriasis. British Journal of Dermatology, 186(6), pp.955–962. doi: https://doi.org/10.1111/bjd.21020.

Musa, N., Pang, N.T.P., Kamu, A., Ho, C.M., Waters, C., Berrett, J., Moghaddam, N. and Wider, W. (2022). The Development and Validation of the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)—Malay Version. International Journal of Environmental Research and Public Health, 19(15), p.9624. doi: https://doi.org/10.3390/ijerph19159624.

Parker, H., Carlton, E., Harris, S. and Daniels, J. (2022). Psychological predictors of health anxiety and pain in ambulatory presentations in a hospital emergency department. Behavioural and Cognitive Psychotherapy, 51(1), pp.11–20. doi: https://doi.org/10.1017/s1352465822000352.

Rawlings, G.H., Novakova, B., Armstrong, I. and Thompson, A.R. (2023). Can self-compassion help us better understand the impact of pulmonary hypertension on those with the condition and their carers? A cross-sectional analysis. Pulmonary Circulation, 13(1). doi: https://doi.org/10.1002/ pul2.12208.

Rawlings, G.H., Thompson, A.R., Armstrong, I. and Beail, N. (2022). What is the psychosocial burden of COVID-19 on people with pulmonary hypertension? Clinical Respiratory Journal, 17(2), pp.124–126. doi: https://doi.org/10.1111/crj.13570.

Rawlings, G.H., Thompson, A.R., Armstrong, I., Novakova, B. and Beail, N. (2022). Cognitive and behavioral processes predict anxiety and depression in patients with pulmonary hypertension. Pulmonary Circulation, 12(4). doi: https://doi.org/10.1002/pul2.12174.

Rawlings, G.H., Thompson, A.R., Armstrong, I., Novakova, B. and Beail, N. (2022). Coping styles associated with depression, health anxiety and health-related quality of life in pulmonary hypertension: cross-sectional analysis. BMJ Open, 12(8), pp.e062564–e062564. doi: https://doi. org/10.1136/bmjopen-2022-062564.

Roberts, G., Halstead, S., Pepper, R. and McDonnell, L. (2023). Social care professionals’ perceived barriers to implementing attachment and trauma-informed care training in their practice. Developmental Child Welfare, 5(1), pp.3–20. doi: https://doi.org/10.1177/25161032231153643.

Roberts, N.P., Lotzin, A. and Schäfer, I. (2022). A systematic review and meta-analysis of psychological interventions for comorbid post-traumatic stress disorder and substance use disorder. European Journal of Psychotraumatology, 13(1). doi: https://doi.org/10.1080/20008198.2022.2041831.

Appendix F - Mental Health Clinical Board

Rowe, R., Stride, C.B., Day, M.R., Thompson, A.R., McKenna, F.P. and Poulter, D.R. (2022). Why are newly qualified motorists at high crash risk? Modelling driving behaviours across the first six months of driving. Accident Analysis & Prevention, 177, p.106832. doi: https://doi.org/10.1016/j. aap.2022.106832.

Schut, C., Dalgard, F.J., Bewley, A., Evers, A.W.M., Gieler, U., Lien, L., Sampogna, F., Ständer, S., TomásAragonés, L., Vulink, N., Finlay, A.Y., Legat, F.J., Titeca, G., Jemec, G.B., Misery, L., Szabó, C., GrivchevaPanovska, V., Spillekom-van Koulil, S., Balieva, F. and Szepietowski, J.C. (2022). Body dysmorphia in common skin diseases: results of an observational, cross-sectional multicentre study among dermatological outpatients in 17 European countries. British Journal of Dermatology, 187(1). doi: https://doi.org/10.1111/bjd.21021.

Silver, J.H., Lewton, M. and Lewis, H.W. (2022). Mediators of negative content and voice-related distress in a diverse sample of clinical and non-clinical voice-hearers. British Journal of Clinical Psychology, 62(1). doi: https://doi.org/10.1111/bjc.12396.

Simon, N., Cunningham, E., Samuel, V. and Waters, C. (2023). Videoconference-delivered group acceptance commitment therapy for perinatal mood and anxiety disorders: facilitators views and recommendations. Journal of Reproductive and Infant Psychology, pp.1–15. doi: https://doi.org/10.1 080/02646838.2023.2180143.

Souch, A.J., Jones, I.R., Shelton, K.H.M. and Waters, C.S. (2022). Maternal childhood maltreatment and perinatal outcomes: A systematic review. Journal of Affective Disorders, 302, pp.139–159. doi: https://doi.org/10.1016/j.jad.2022.01.062.

Thompson, A.R., Eleftheriadou, V. and Nesnas, J. (2022). The mental health associations of vitiligo: UK population-based cohort study. BJPsych Open, 8(6). doi: https://doi.org/10.1192/bjo.2022.591.

Tinlin, R.M., Beckwith, H., Gregory, J.D. and Lomax, C.L. (2022). What is underneath all that stuff? A Q-methodological exploration of profiles of beliefs and vulnerabilities in hoarding disorder. Behavioural and Cognitive Psychotherapy, 50(5), pp.538–555. doi: https://doi.org/10.1017/ s1352465822000261.

Tour, S.K., Thompson, A., Howard, R.A. and Larkin, M. (2022). The Experience of Blogging About Visible and Long-Term Skin Conditions: An Interpretative Phenomenologicak Analysis. JMIR Dermatology, 5(2). doi: https://doi.org/10.2196/29980.

Waters, C.S., Cannings-John, R., Channon, S., Lugg-Widger, F., Robling, M. and Paine, A.L. (2022). The impact of a specialist home-visiting intervention on the language outcomes of young mothers and their children: a pragmatic randomised controlled trial. BMC Psychology, 10(1). doi: https://doi. org/10.1186/s40359-022-00926-1.

Whitmarsh, L., Player, L., Jiongco, A., James, M., Williams, M., Marks, E. and Kennedy-Williams, P. (2022). Climate anxiety: What predicts it and how is it related to climate action? Journal of Environmental Psychology, 83, p.101866. doi: https://doi.org/10.1016/j.jenvp.2022.101866.

Wilson, R.B., Thompson, A.R., Rowse, G. and Freeth, M. (2023). The experience of seeking, receiving, and reflecting upon a diagnosis of autism in the UK: A meta-synthesis of qualitative studies conducted with autistic individuals. Research in Autism Spectrum Disorders, 103, p.102135. doi: https://doi. org/10.1016/j.rasd.2023.102135.

Wilson, R.B., Thompson, A.R., Rowse, G., Smith, R., Dugdale, A.-S. and Freeth, M. (2022). Autistic women’s experiences of self-compassion after receiving their diagnosis in adulthood. Autism, p.136236132211367. doi: https://doi.org/10.1177/13623613221136752.

Appendix F - Mental Health Clinical Board

Wren, G., Baker, E.R., Underwood, J., Humby, T., Thompson, A.R., Kirov, G., Escott-Price, V. and Davies, W. (2022). Characterising heart rhythm abnormalities associated with Xp22.31 deletion. Journal of Medical Genetics, p.jmg-108862. doi: https://doi.org/10.1136/jmg-2022-108862.

Wren, G., Humby, T., Thompson, A.R. and Davies, W. (2022). Mood symptoms, neurodevelopmental traits, and their contributory factors in X-linked ichthyosis, ichthyosis vulgaris and psoriasis. Clinical Experimental Dermatology, 47(6), pp.1097–1108. doi: https://doi.org/10.1111/ced.15116.

Grants

Project/Grant Title

Investigating the benefits and harms of reduced daily dose oral isotretinoin in the treatment of acne: A parallel group, assessor blind, non-inferiority, multicentre randomised controlled trial, with an internal pilot (Acne-ID)

Developing and testing an online intervention to support self-management, improve outcomes and reduce antibiotic use in acne

The Autism Depression Trial-2 (ADEPT-2)

Lead Local Investigator Professor Andrew Thompson (Cardiff University; co-applicant) Professor Andrew Thompson (Cardiff University; co-applicant)

Dr Rona Aldridge

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix F - Mental Health Clinical Board

Appendix F - Mental Health Clinical Board

Non-Commercial

Non-Commercial

Appendix F - Mental Health Clinical Board

Appendix F - Mental Health Clinical Board

Appendix G - Primary, Community & Intermediate Care (PCIC) Clinical Board

Palliative Care Publications

Byrne, A., Torrens-Burton, A., Sivell, S., Moraes, F.Y., Bulbeck, H., Bernstein, M., Nelson, A. and Fielding, H. (2022). Early palliative interventions for improving outcomes in people with a primary malignant brain tumour and their carers. Cochrane Database of Systematic Reviews, 2022(1). doi: https://doi.org/10.1002/14651858.cd013440.pub2.

Gale, N., Hopkinson, J., Wasley, D. and Byrne, A. (2023). The promotion of homebased physical activity for people with lung cancer and cachexia, a qualitative study of healthcare professionals, patients and carers. Journal of Cancer Survivorship, 17, pp.677–685. doi: https://doi.org/10.1007/s11764-02301376-3.

Graham-Wisener, L., Nelson, A., Byrne, A., Islam, I., Harrison, C., Geddis, J. and Berry, E. (2022). Understanding public attitudes to death talk and advance care planning in Northern Ireland using health behaviour change theory: a qualitative study. BMC Public Health, 22(1). doi: https://doi. org/10.1186/s12889-022-13319-1.

Hussain, J.A., White, I.R., Johnson, M.J., Byrne, A., Preston, N.J., Haines, A., Seddon, K. and Peters, T.J. (2022). Development of guidelines to reduce, handle and report missing data in palliative care trials: A multi-stakeholder modified nominal group technique. Palliative Medicine, 36(1), pp.59–70. doi: https://doi.org/10.1177/02692163211065597.

Millward, C.P., Armstrong, T.S., Barrington, H., Brodbelt, A., Bulbeck, H., Byrne, A., Dirven, L., Gamble, C., Grundy, P.E., Islim, A.I., Javadpour, M., Keshwara, S.M., Krishna, S., Mallucci, C., Marson, A.G., McDermott, M.W., Meling, T.R., Oliver, K., Pizer, B. and Plaha, P. (2022). Opportunities and challenges for the development of ‘core outcome sets’ in neuro-oncology. Neuro-Oncology, 24(7), pp.1048–1055. doi: https://doi.org/10.1093/neuonc/noac062.

Retzer, A., Sivell, S., Scott, H., Nelson, A., Bulbeck, H., Seddon, K., Grant, R., Adams, R., Watts, C., Aiyegbusi, O.L., Kearns, P., Cruz Rivera, S., Dirven, L., Baddeley, E., Calvert, M. and Byrne, A. (2022). Development of a core outcome set and identification of patient-reportable outcomes for primary brain tumour trials: protocol for the COBra study. British Medical Journal Open, 12(9), pp.e057712–e057712. doi: https://doi.org/10.1136/bmjopen-2021-057712.

Selman, L.E., Sutton, E., Medeiros Mirra, R., Stone, T., Gilbert, E., Rolston, Y., Murray, K., Longo, M., Seddon, K., Penny, A., Mayland, C.R., Wakefield, D., Byrne, A. and Harrop, E. (2022). ‘Sadly I think we are sort of still quite white, middle-class really’ – Inequities in access to bereavement support: Findings from a mixed methods study. Palliative Medicine, 37(4), pp.586–601. doi: https://doi. org/10.1177/02692163221133665.

Appendix G - Primary, Community & Intermediate Care (PCIC) Clinical Board

Grants

Project Official Short/Full Title

Marie Curie Research Centre Cardiff Core Grant

Marie Curie Palliative Care Research Centre Transitional Core grant Patient Reported Core Outcomes in Brain Tumour Trials: the COBra study

Supporting people bereaved during COVID-19: a mixed methods study of bereaved people’s experiences and the bereavement services supporting them

Lead Investigator

Dr Anthony Byrne (co-applicant)

Dr Anthony Byrne

of Grant (Date from/to) 2023-2028 Grant Awarded (Total) £3,169,980 £468,815 £152,949 £355,328

Duration Funder Name/ Source of Funding Marie Curie Marie Curie The Brain Tumour Charity UKRI/ Economic and Social Research Council

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

123

Appendix G - Primary, Community & Intermediate Care (PCIC) Clinical Board Appendix G - Primary, Community & Intermediate Care (PCIC) Clinical Board

Non-Commercial

Non-Commercial

Appendix G - Primary, Community & Intermediate Care (PCIC) Clinical Board

Appendix G - Primary, Community & Intermediate Care (PCIC) Clinical Board

Appendix H - Specialist Services Directorate: ALAS (inc. Rehabilitation Engineering)

Publications

Green, A.J. (2022). Establishing and Improving compliance with the Pressure Management Pathway within a South Wales Posture and Mobility Service; a clinical audit. MSc Dissertation.

James, A.J. (2022). The application of tilt-in-space and backrest recline for tissue viability in wheelchair users: An evidence-based review. MSc Dissertation.

McGinty, G. (2022). The prevalence of musculoskeletal disorders amongst carers who push wheelchair users in South Wales. MSc Dissertation.

Wentworth, S.D. (2023). An investigation into an objective measure of muscle health: can electrical impedance myography measurements inform clinical decision making. DClinSci Thesis.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix H - Specialist Services Directorate:

CARDIAC SERVICES

Publications

Adlam, D., Zarebinski, M., Uren, N.G., Ptaszynski, P., Oldroyd, K.G., Munir, S., Zaman, A., Contractor, H., Kiss, R.G., Édes, I., Szachniewicz, J., Nagy, G.G., Garcia, M.J., Tomcsanyi, J., Irving, J., Sharp, A.S.P., Musialek, P., Lupkovics, G., Shirodaria, C. and Selvanayagam, J.B. (2022). A Randomized, double-blind, dose ranging clinical trial of intravenous FDY-5301 in acute STEMI patients undergoing primary PCI. International Journal of Cardiology, 347, pp.1–7. doi: https://doi.org/10.1016/j.ijcard.2021.11.016.

Ali, Z.A. and Sharp, A.S.P. (2022). The Bigger the Highway, the Less Likely the Traffic Jam. Circulation: Cardiovascular Interventions, 15(9). doi: https://doi.org/10.1161/circinterventions.122.012368.

Artico, J., Shiwani, H., Moon, J.C., Gorecka, M., McCann, G.P., Roditi, G., Morrow, A., Mangion, K., Lukaschuk, E., Shanmuganathan, M., Miller, C.A., Chiribiri, A., Prasad, S.K., Adam, R.D., Singh, T., Bucciarelli-Ducci, C., Dawson, D., Knight, D., Fontana, M. and Manisty, C. (2023). Myocardial Involvement After Hospitalization for COVID-19 Complicated by Troponin Elevation: A Prospective, Multicenter, Observational Study. Circulation, 147(5), pp.364–374. doi: https://doi.org/10.1161/ CIRCULATIONAHA.122.060632.

Atkinson, C., Hughes, S., Richards, L., Sim, V.M., Phillips, J., John, I.J. and Yousef, Z. (2022). Palliation of heart failure: value-based supportive care. BMJ Supportive & Palliative Care. doi: https://doi. org/10.1136/bmjspcare-2021-003378.

Azizi, M., Mahfoud, F., Weber, M.A., Sharp, A., Schmieder, R.E., Lurz, P., Lobo, M.D., Fisher, N.D.L., Daemen, J., Bloch, M.J., Basile, J., Sanghvi, K., Saxena, M., Gosse, P., Jenkins, J.S., Levy, T., Persu, A., Kably, B., Claude, L. and Reeve-Stoffer, H. (2022). Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation. JAMA Cardiology, 7(12), pp.1244–1244. doi: https://doi. org/10.1001/jamacardio.2022.3904.

Azizi, M., Saxena, M., Wang, Y., Jenkins, J.S., Devireddy, C., Rader, F., Fisher, N.D.L., Schmieder, R.E., Mahfoud, F., Lindsey, J., Sanghvi, K., Todoran, T.M., Pacella, J., Flack, J., Daemen, J., Sharp, A.S.P., Lurz, P., Bloch, M.J., Weber, M.A. and Lobo, M.D. (2023). Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA, 329(8), pp.651–661. doi: https://doi.org/10.1001/jama.2023.0713.

Azizi, M., Saxena, M., Wang, Y., Jenkins, J.S., Devireddy, C., Rader, F., Fisher, N.D.L., Schmieder, R.E., Mahfoud, F., Lindsey, J., Sanghvi, K., Todoran, T.M., Pacella, J., Flack, J., Daemen, J., Sharp, A.S.P., Lurz, P., Bloch, M.J., Weber, M.A. and Lobo, M.D. (2023). Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA, 329(8), pp.651–661. doi: https://doi.org/10.1001/jama.2023.0713.

Banning, A.P., Serruys, P., De Maria, G.L., Ryan, N., Walsh, S., Gonzalo, N., Jan van Geuns, R., Onuma, Y., Sabate, M., Davies, J., Lesiak, M., Moreno, R., Cruz-Gonzalez, I., Hoole, S.P., Piek, J.J., Appleby, C., Fath-Ordoubadi, F., Zaman, A., Van Mieghem, N.M. and Uren, N. (2022). Five-year outcomes after state-of-the-art percutaneous coronary revascularization in patients with de novo three-vessel disease: final results of the SYNTAX II study. European Heart Journal, 43(13), pp.1307–1316. doi: https://doi.org/10.1093/eurheartj/ehab703.

Barbato, E., Azizi, M., Schmieder, R.E., Lauder, L., Böhm, M., Brouwers, S., Maria Bruno, R., Dudek, D., Kahan, T., Kandzari, D.E., Lüscher, T.F., Parati, G., Pathak, A., Ribichini, F.L., Schlaich, M.P., Sharp, A.S.P., Sudano, I., Volpe, M., Tsioufis, C. and Wijns, W. (2023). Renal denervation in the management of hypertension in adults. A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). European Heart Journal, 44(15), pp.1313–1330. doi: https://doi.org/10.1093/eurheartj/ehad054.

Appendix H - Specialist Services Directorate: CARDIAC SERVICES

Bourke, J.P., Turner, C., Bradlow, W., Chikermane, A., Coats, C., Fenton, M., Ilina, M., Johnson, A., Kapetanakis, S., Kuhwald, L., Morley-Davies, A., Quinlivan, R., Savvatis, K., Schiava, M., Yousef, Z. and Guglieri, M. (2022). Cardiac care of children with dystrophinopathy and females carrying DMD-gene variations. Open Heart, 9(2), pp.e001977–e001977. doi: https://doi.org/10.1136/openhrt-2022-001977. Das, A., Kelly, C., Teh, I., Nguyen, C., Brown, L.A.E., Chowdhary, A., Jex, N., Thirunavukarasu, S., Sharrack, N., Gorecka, M., Swoboda, P.P., Greenwood, J.P., Kellman, P., Moon, J.C., Davies, R.H., Lopes, L.R., Joy, G., Plein, S., Schneider, J.E. and Dall’Armellina, E. (2022). Phenotyping hypertrophic cardiomyopathy using cardiac diffusion magnetic resonance imaging: the relationship between microvascular dysfunction and microstructural changes. European Heart Journal - Cardiovascular Imaging, 23(3), pp.352–362. doi: https://doi.org/10.1093/ehjci/jeab210.

Davies, R.H., Augusto, J.B., Bhuva, A., Xue, H., Treibel, T.A., Ye, Y., Hughes, R.K., Bai, W., Lau, C., Shiwani, H., Fontana, M., Kozor, R., Herrey, A., Lopes, L.R., Maestrini, V., Rosmini, S., Petersen, S.E., Kellman, P., Rueckert, D. and Greenwood, J.P. (2022). Precision measurement of cardiac structure and function in cardiovascular magnetic resonance using machine learning. Journal of Cardiovascular Magnetic Resonance, 24(1). doi: https://doi.org/10.1186/s12968-022-00846-4.

De Filippo, O., Cortese, M., ascenzoF.D., Raposeiras-Roubín, S., Abu-Assi, E., Kinnaird, T., ArizaSolé, A., Manzano-Fernández, S., Templin, C., Velicki, L., Xanthopoulou, I., Cerrato, E., Rognoni, A., Boccuzzi, G., Montefusco, A., Montabone, A., Taha, S., Durante, A., Gili, S. and Magnani, G. (2019). Real-World Data of Prasugrel vs. Ticagrelor in Acute Myocardial Infarction: Results from the RENAMI Registry. American Journal of Cardiovascular Drugs, 19(4), pp.381–391. doi: https://doi.org/10.1007/ s40256-019-00339-3.

Domínguez-Rodríguez, L.M., Raposeiras-Roubín, S., Abu-Assi, E., Cespón-Fernández, M., MelendoViu, M., D’Ascenzo, F., Kinnaird, T., Ariza-Solé, A., Manzano-Fernández, S., Templin, C., Velicki, L., Xanthopoulou, I., Cerrato, E., Quadri, G., Rognoni, A., Boccuzzi, G., Montabone, A., Taha, S., Durante, A. and Gili, S. (2022). Ischemic-hemorrhagic balance in diabetic and non-diabetic patients after acute coronary syndrome. REC: CardioClinics, 57(3), pp.203–211. doi: https://doi.org/10.1016/j. rccl.2022.02.006.

Evans, M., Lewis, R.D., Morgan, A.R., Whyte, M.B., Hanif, W., Bain, S.C., Davies, S., Dashora, U., Yousef, Z., Patel, D.C. and Strain, W.D. (2022). A Narrative Review of Chronic Kidney Disease in Clinical Practice: Current Challenges and Future Perspectives. Advances in Therapy, 39(1), pp.33–43. doi: https://doi.org/10.1007/s12325-021-01927-z.

Evans, M., Morgan, A.R., Bain, S.C., Davies, S., Hicks, D., Brown, P., Yousef, Z., Dashora, U., Viljoen, A., Beba, H. and Strain, W.D. (2022). Meeting the Challenge of Virtual Diabetes Care: A Consensus Viewpoint on the Positioning and Value of Oral Semaglutide in Routine Clinical Practice. Diabetes Therapy, 13(2), pp.225–240. doi: https://doi.org/10.1007/s13300-021-01201-z.

Evans, M., Morgan, A.R., Patel, D., Dhatariya, K., Greenwood, S., Newland-Jones, P., Hicks, D., Yousef, Z., Moore, J., Kelly, B., Davies, S. and Dashora, U. (2020). Risk Prediction of the Diabetes Missing Million: Identifying Individuals at High Risk of Diabetes and Related Complications. Diabetes Therapy, 12(1), pp.87–105. doi: https://doi.org/10.1007/s13300-020-00963-2.

Appendix H - Specialist Services Directorate: CARDIAC SERVICES

Evans, M., Morgan, A.R., Whyte, M.B., Hanif, W., Bain, S.C., Kalra, P.A., Davies, S., Dashora, U., Yousef, Z., Patel, D.C. and Strain, W.D. (2022). New Therapeutic Horizons in Chronic Kidney Disease: The Role of SGLT2 Inhibitors in Clinical Practice. Drugs, 82(2), pp.97–108. doi: https://doi.org/10.1007/s40265021-01655-2.

Fisher, N.D.L., Kirtane, A.J., Daemen, J., Rader, F., Lobo, M.D., Saxena, M., Abraham, J., Schmieder, R.E., Sharp, A.S.P., Gosse, P., Claude, L., Song, Y. and Azizi, M. (2022). Plasma renin and aldosterone concentrations related to endovascular ultrasound renal denervation in the RADIANCE-HTN SOLO trial. Journal of Hypertension, 40(2), pp.221–228. doi: https://doi.org/10.1097/hjh.0000000000002994.

Fraser, A.G., Biasin, E., Bijnens, B., Bruining, N., Caiani, E.G., Cobbaert, K., Davies, R.H., Gilbert, S.H., Hovestadt, L., Kamenjasevic, E., Kwade, Z., McGauran, G., O’Connor, G., Vasey, B. and Rademakers, F.E. (2023). Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives. Expert Review of Medical Devices, 20(6), pp.467–491. doi: https://doi.org/10.1080/17434440.2023.2184685.

Ganesananthan, S., Zahid, A., Choudhry, A., Vadiveloo, T.V., Khan, N., Yang, T., Urrehman, H., Mahesh, S. and Yousef, Z. (2022). The Utility and Educational Impact of a Virtual Webinar to Deliver an International Undergraduate Cardiovascular Conference. Advances in Medical Education and Practice, 13, pp.993–1002. doi: https://doi.org/10.2147/amep.s376114.

Goss, M., Morgan, H. and Kinnaird, T. (2022). Personalisation of DAPT: from ‘bench’ to bedside. Journal of Prescribing Practice, 4(1), pp.20–22. doi: https://doi.org/10.12968/jprp.2022.4.1.20.

Götzinger, F., Lauder, L., Sharp, A.S.P., Lang, I.M., Rosenkranz, S., Konstantinides, S., Edelman, E.R., Böhm, M., Jaber, W. and Mahfoud, F. (2023). Interventional therapies for pulmonary embolism. Nature Reviews Cardiology, pp.1–15. doi: https://doi.org/10.1038/s41569-023-00876-0.

Hooper, S.M., Wu, S., Davies, R.H., Bhuva, A., Schelbert, E.B., Moon, J., Kellman, P., Xue, H., Langlotz, C.P. and Ré, C. (2023). Evaluating semi-supervision methods for medical image segmentation: applications in cardiac magnetic resonance imaging. Journal of Medical Imaging, 10(02). doi: https:// doi.org/10.1117/1.jmi.10.2.024007.

Hughes, R., Augusto, J., Knott, K., Davies, R.H., Shiwani, H., Seraphim, A., Malcolmson, J., Khoury, S., Joy, G., Mohiddin, S.A., Rocha Lopes, L., McKenna, W.J., Kellman, P., Xue, H., Tome, M., Sharma, S., Captur, G. and Moon, J. (2023). Apical Ischemia Is a Universal Feature of Apical Hypertrophic Cardiomyopathy. Circulation: Cardiovascular Imaging, 16(3), pp.e014907. doi: https://doi.org/10.1161/ circimaging.122.014907.

Jordan, A.N., Anning, C., Wilkes, L., Ball, C., Pamphilon, N., Clark, C.E., Bellenger, N.G., Shore, A.C., Sharp, A.S.P. and Valderas, J.M. (2022). Cross-cultural adaptation of the Spanish MINICHAL instrument into English for use in the United Kingdom. Health and Quality of Life Outcomes, 20(1), pp.1–12. doi: https://doi.org/10.1186/s12955-022-01943-9.

Jubouri, M., Al-Tawil, M.M., Yip, H.Y., Bashir, A.K., Tan, P., Bashir, M., Anderson, R.A., Bailey, D.M., Nienaber, C.A., Coselli, J.S. and Williams, I.D. (2022). Mid- and long-term outcomes of thoracic endovascular aortic repair in acute and subacute uncomplicated type B aortic dissection. Journal of Cardiac Surgery, 37(5), pp.1328–1339. doi: https://doi.org/10.1111/jocs.16349.

Appendix H - Specialist Services Directorate: CARDIAC SERVICES

Kandzari, D.E., Mahfoud, F., Weber, M.A., Townsend, R.R., Parati, G., Fisher, N.D.L., Lobo, M.D., Bloch, M.H., Böhm, M., Sharp, A.J., Schmieder, R.E., Azizi, M., Schlaich, M.P., Papademetriou, V., Kirtane, A.J., Daemen, J., Pathak, A., Ukena, C., Lurz, P. and Grassi, G. (2022). Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium. Circulation, 145(11), pp.847–863. doi: https://doi. org/10.1161/circulationaha.121.057687.

Kinnaird, T., Gallagher, S., Farooq, V., Protty, M., Back, L., Devlin, P., Anderson, R., Sharp, A., Ludman, P., Copt, S., Mamas, M.A. and Curzen, N. (2023). Temporal Trends in In-Hospital Outcomes Following Unprotected Left-Main Percutaneous Coronary Intervention: An Analysis of 14 522 Cases From British Cardiovascular Intervention Society Database 2009 to 2017. Circulation: Cardiovascular Interventions, 16(1). doi: https://doi.org/10.1161/circinterventions.122.012350.

Kirtane, A.J., Sharp, A., Mahfoud, F., Fisher, N.D.L., Schmieder, R.E., Daemen, J., Lobo, M.D., Lurz, P., Basile, J., Bloch, M.J., Weber, M.A., Saxena, M., Wang, Y., Sanghvi, K., Jenkins, J.S., Devireddy, C., Rader, F., Gosse, P., Sapoval, M. and Barman, N.C. (2023). Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiology, 8(5), pp.464–473. doi: https://doi.org/10.1001/jamacardio.2023.0338.

Klok, F.A., Piazza, G., Sharp, A.J., Áinle, F.N., Jaff, M.R., Chauhan, N., Patel, B., Barco, S., Goldhaber, S.Z., Kucher, N., Lang, I.M., Schmidtmann, I., Sterling, K.M., Becker, D., Martin, N., Rosenfield, K. and Konstantinides, S. (2022). Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. American Heart Journal, 251, pp.43–53. doi: https://doi.org/10.1016/j.ahj.2022.05.011.

Mahfoud, F., Kandzari, D.E., Kario, K., Townsend, R.R., Weber, M.A., Schmieder, R.E., Tsioufis, K., Pocock, S., Dimitriadis, K., Choi, J.W., East, C., D’Souza, R., Sharp, A.S.P., Ewen, S., Walton, A., Hopper, I., Brar, S., McKenna, P., Fahy, M. and Böhm, M. (2022). Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet, 399(10333), pp.1401–1410. doi: https://doi.org/10.1016/S01406736(22)00455-X.

Millesimo, M., Elia, E., Marengo, G., De Filippo, O., Raposeiras-Roubín, S., Wańha, W., Abu-Assi, E., Kinnaird, T., Ariza-Solé, A., Liebetrau, C., Manzano-Fernández, S., Iannaccone, M., Henriques, J.P.S., Templin, C., Wilton, S.B., Velicki, L., Xanthopoulou, I., Correia, L., Cerrato, E. and Rognoni, A. (2022). Antithrombotic Strategy in Secondary Prevention for High-Risk Patients with Previous Acute Coronary Syndrome: Overlap between the PEGASUS Eligibility and the COMPASS Eligibility in a Large Multicenter Registry. American Journal of Cardiovascular Drugs, 23(1). doi: https://doi. org/10.1007/s40256-022-00554-5.

Mohamed, M., Kinnaird, T., Wijeysundera, H.C., Johnson, T., Zaman, S., Rashid, M., Moledina, S. and Ludman, P. (2022). Impact of Intracoronary Imaging-Guided Percutaneous Coronary Intervention on Procedural Outcomes Among Complex Patient Groups. Journal of the American Heart Association, 11(19). doi: https://doi.org/10.1161/jaha.122.026500.

Mohamed, M., Sirker, A., Chieffo, A., Avanzas, P., Nolan, J., Rashid, M., Dafaalla, M., Moledina, S., Ludman, P., Kinnaird, T. and Mamas, M.A. (2022). Temporal patterns, characteristics, and predictors of clinical outcomes in patients undergoing percutaneous coronary intervention for stent thrombosis. EuroIntervention, 18(9), pp.729–739. doi: https://doi.org/10.4244/eij-d-22-00049.

Appendix H - Specialist Services Directorate: CARDIAC SERVICES

Mullens, W., Auricchio, A., Martens, P., Witte, K., Cowie, M.R., Delgado, V., Dickstein, K., Linde, C., Vernooy, K., Leyva, F., Bauersachs, J., Israel, C.W., Lund, L.H., Donal, E., Boriani, G., Jaarsma, T., Berruezo, A., Traykov, V., Yousef, Z. and Kalarus, Z. (2020). Optimized implementation of cardiac resynchronization therapy: a call for action for referral and optimization of care: A joint position statement from the Heart Failure Association (HFA), European Heart Rhythm Association (EHRA), and European Association of Cardiovascular Imaging (EACVI) of the European Society of Cardiology. European Journal of Heart Failure, 22(12), pp.2349–2369. doi: https://doi.org/10.1002/ejhf.2046.

Papetti, D.M., Van Abeelen, K., Davies, R.H., Menè, R., Heilbron, F., Perelli, F., Artico, J., Seraphim, A., Moon, J., Parati, G., Xue, H., Kellman, P., Badano, L.P., Besozzi, D., Nobile, M.S. and Torlasco, C. (2023). An accurate and time-efficient deep learning-based system for automated segmentation and reporting of cardiac magnetic resonance-detected ischemic scar. Computer Methods and Programs in Biomedicine, 229, pp.107321–107321. doi: https://doi.org/10.1016/j.cmpb.2022.107321.

Patel, M.R., Jeremias, A., Maehara, A., Matsumura, M., Zhang, Z., Schneider, J.E., Tang, K., Talwar, S., Marques, K., Shammas, N.W., Gruberg, L., Seto, A.H., Samady, H., Sharp, A., Ali, Z., Mintz, G.S., Davies, J.E. and Stone, G.W. (2022). 1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial. JACC Cardiovascular Interventions, 15(1), pp.52–61. doi: https://doi.org/10.1016/j.jcin.2021.09.042.

Patti, G., D’Ascenzo, F., De Filippo, O., Bruno, F., Leonardi, S., Chieffo, A., Iannaccone, M., Liebetrau, C., Manzano-Fernández, S., Gallone, G., Omedè, P., Cerrato, E., Kinnaird, T., Conrotto, F., Piroli, F., Henriques, J.P.S., Wańha, W., Elia, E., Dominguez-Rodriguez, A. and Raposeiras-Roubin, S. (2022). Safety and efficacy of different P2Y12 inhibitors in patients with acute coronary syndromes stratified by the PRAISE risk score: a multicentre study. European Heart Journal - Quality of Care and Clinical Outcomes, 8(1), pp.881–891. doi: https://doi.org/10.1093/ehjqcco/qcac002.

Protty, M., Gallagher, S., Sharp, A., Farooq, V., Egred, M., O’Kane, P., Ludman, P., Mamas, M.A. and Kinnaird, T. (2022). The Impact of Intracoronary Imaging on PCI Outcomes in Cases Utilising Rotational Atherectomy: An Analysis of 8,417 Rotational Atherectomy Cases from the British Cardiovascular Intervention Society Database. Journal of Interventional Cardiology, 2022, pp.1–9. doi: https://doi. org/10.1155/2022/5879187.

Protty, M., Gallagher, S., Sharp, A.S., Anderson, R., Ludman, P., Curzen, N., Nolan, J., Rashid, M., Mamas, M. and Kinnaird, T. (2022). Brachial arterial access for PCI: an analysis of the British Cardiovascular Intervention Society database. EuroIntervention, 17(13), pp.1100–1103. doi: https://doi.org/10.4244/ eij-d-21-00294.

Protty, M., Hussain, H.I., Gallagher, S., Al-Raisi, S., Aldalati, O., Farooq, V., Sharp, A., Egred, M., O’Kane, P., Ludman, P., Anderson, R., Mamas, M.A. and Kinnaird, T. (2020). Excimer laser coronary atherectomy during complex PCI: An analysis of 1,471 laser cases from the British Cardiovascular Intervention Society database. Catheterization and Cardiovascular Interventions, 97(5), pp.E653–E660. doi: https://doi.org/10.1002/ccd.29251.

Protty, M., Sharp, A.S.P., Gallagher, S., Farooq, V., Spratt, J.C., Ludman, P., Anderson, R., McEntegart, M.M., Hanratty, C., Walsh, S., Curzen, N., Smith, E., Mamas, M. and Kinnaird, T. (2022). Defining Percutaneous Coronary Intervention Complexity and Risk. JACC: Cardiovascular Interventions, 15(1), pp.39–49. doi: https://doi.org/10.1016/j.jcin.2021.09.039.

Appendix H - Specialist Services Directorate: CARDIAC

SERVICES

Protty, M., Sharp, A.S.P., Gallagher, S., Farooq, V., Spratt, J.C., Ludman, P., Anderson, R., McEntegart, M.M., Hanratty, C., Walsh, S., Curzen, N., Smith, E., Mamas, M. and Kinnaird, T. (2022). Defining Percutaneous Coronary Intervention Complexity and Risk: An Analysis of the United Kingdom BCIS Database 2006-2016. JACC: Cardiovascular Interventions, 15(1), pp.39–49. doi: https://doi. org/10.1016/j.jcin.2021.09.039.

Pruszczyk, P., Klok, F.A., Kucher, N., Roik, M., Meneveau, N., Sharp, A.J., Nielsen-Kudsk, J.E., Obradović, S., Barco, S., Giannini, F., Stefanini, G.G., Tarantini, G., Konstantinides, S. and Dudek, D. (2022). Percutaneous treatment options for acute pulmonary embolism: a clinical consensus statement by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function and the European Association of Percutaneous Cardiovascular Interventions. EuroIntervention, 18(8), pp.e623–e638. doi: https://doi.org/10.4244/eij-d-22-00246.

Rashid, M., Kinnaird, T., Ludman, P., Keeble, T.R., Mamas, M.A. and Curzen, N. (2022). Variation in practice for out-of-hospital cardiac arrest treated with percutaneous coronary intervention in England and Wales. Catheterization and Cardiovascular Interventions, 100(3), pp.306–316. doi: https://doi.org/10.1002/ccd.30316.

Rashid, M., Stevens, C.V., Zaman, S., Pinilla-Echeverri, N., Velagapudi, P., Chieffo, A., Shoaib, A., Ludman, P., Mills, N.L., Nolan, J., Kinnaird, T. and Mamas, M.A. (2022). Sex Differences in Use of Intracoronary Imaging in Patients Undergoing Percutaneous Coronary Intervention. Cardiovascular Interventions, 15(12), pp.1290–1292. doi: https://doi.org/10.1016/j.jcin.2022.03.034.

Rashid, M., Zaman, M., Ludman, P., Wijeysundera, H.C., Curzen, N., Kinnaird, T., Moledina, S., Abbott, J.D., Grines, C.L. and Mamas, M.A. (2022). Left Main Stem Percutaneous Coronary Intervention: Does On-Site Surgical Cover Make a Difference? Circulation: Cardiovascular Interventions, 15(10). doi: https://doi.org/10.1161/circinterventions.122.012037.

Rehman, A., Kellman, P., Xue, H., Pierce, I., Davies, R.H., Fontana, M. and Moon, J. (2022). Convolutional neural network transformer (CNNT) for free-breathing real-time cine imaging. European Heart Journal-Cardiovascular Imaging, 23(Supplement_2). doi: https://doi.org/10.1093/ehjci/jeac141.001.

Reynolds, C.J., Pade, C., Gibbons, J.M., Otter, A.D., Lin, K.-M., Muñoz Sandoval, D., Pieper, F.P., Butler, D.K., Liu, S., Joy, G., Forooghi, N., Treibel, T.A., Manisty, C., Moon, J.C., Semper, A., Brooks, T., McKnight, Á., Altmann, D.M., Boyton, R.J. and Abbass, H. (2022). Immune boosting by B.1.1.529 (Omicron) depends on previous SARS-CoV-2 exposure. Science, 377(6603). doi: https://doi.org/10.1126/science. abq1841.

Routledge, H., Sharp, A.S., Kovac, J., Westwood, M., Keeble, T.R., Bathula, R., Eteiba, H., Grunwald, I.Q. and Curzen, N. (2022). Can Interventional Cardiologists Help Deliver the UK Mechanical Thrombectomy Interventional Programme for Patients with Acute Ischaemic Stroke? A Discussion Paper from the British Cardiovascular Interventional Society Stroke Thrombectomy Focus Group. Interventional Cardiology: Reviews, Research, Resources, 17. doi: https://doi.org/10.15420/icr.2021.35.

Sato, Y., Sharp, A., Mahfoud, F., Tunev, S., Forster, A., Ellis, M., Gómez, A.M., Dhingra, R., Ullman, J., Schlaich, M., Lee, D., Trudel, J., Hettrick, D.A., Kandzari, D.E., Virmani, R. and Finn, A.V. (2023). Translational value of preclinical models for renal denervation: a histological comparison of human versus porcine renal nerve anatomy. EuroIntervention, 18(13), pp.e1120–e1128. doi: https://doi. org/10.4244/eij-d-22-00369.

Appendix H - Specialist Services Directorate: CARDIAC SERVICES

Saxena, M., Schmieder, R.E., Kirtane, A.J., Mahfoud, F., Daemen, J., Basile, J., Lurz, P., Gosse, P., Sanghvi, K., Fisher, N.D.L., Rump, L.C., Pathak, A., Blankestijn, P.J., Mathur, A., Wang, Y., Weber, M.A., Sharp, A.S.P., Bloch, M.J., Barman, N.C. and Claude, L. (2022). Predictors of blood pressure response to ultrasound renal denervation in the RADIANCE-HTN SOLO study. Journal of Human Hypertension, 36(7), pp.629–639. doi: https://doi.org/10.1038/s41371-021-00547-y.

Seraphim, A., Dowsing, B., Rathod, K.S., Shiwani, H., Patel, K., Knott, K., Zaman, S., Johns, I., Razvi, Y., Patel, R., Xue, H., Jones, D.A., Fontana, M., Cole, G., Uppal, R., Davies, R.H., Moon, J., Kellman, P. and Manisty, C. (2022). Quantitative Myocardial Perfusion Predicts Outcomes in Patients With Prior Surgical Revascularization. Journal of the American College of Cardiology, 79(12), pp.1141–1151.

doi: https://doi.org/10.1016/j.jacc.2021.12.037.

Shamkhani, W., Kinnaird, T., Ludman, P., Rashid, M. and Mamas, M.A. (2022). Sex differences in high-risk but indicated coronary interventions (CHiP): National report from British Cardiovascular Intervention Society Registry. Catheterization and Cardiovascular Interventions, 99(2), pp.447–456.

doi: https://doi.org/10.1002/ccd.30081.

Shamkhani, W., Kinnaird, T., Wijeysundera, H.C., Ludman, P., Rashid, M. and Mamas, M.A. (2022). Ethnicity in Complex High-Risk but Indicated Percutaneous Coronary Intervention Types and Outcomes. The American Journal of Cardiology, 175, pp.26–37. doi: https://doi.org/10.1016/j. amjcard.2022.03.056.

Sharp, A.S.P., Tunev, S., Schlaich, M., Lee, D.P., Finn, A.V., Trudel, J., Hettrick, D.A., Mahfoud, F. and Kandzari, D.E. (2022). Histological evidence supporting the durability of successful radiofrequency renal denervation in a normotensive porcine model. Journal of Hypertension, 40(10), pp.2068–2075.

doi: https://doi.org/10.1097/HJH.0000000000003236.

Shoaib, A., Sharma, V., Spratt, J.C., Wilson, S., Hussain, S., Velagapudi, P., Siller-Matula, J., Rashid, M., Ludman, P., Cockburn, J., Kinnaird, T. and Mamas, M.A. (2023). Sex Differences in Clinical Profile and Outcome After Percutaneous Coronary Intervention for Chronic Total Occlusion. Cardiovascular Revascularization Medicine, 49, pp.34–41. doi: https://doi.org/10.1016/j.carrev.2022.12.005.

Shoaib, A., Spratt, J.C., Curzen, N., Wilson, S., Rashid, M., Ahmad, F., Ludman, P., Kinnaird, T. and Mamas, M.A. (2022). Clinical outcomes of percutaneous coronary intervention for chronic total occlusion by treated segment length. Catheterization and Cardiovascular Interventions, 99(2), pp.234–244. doi: https://doi.org/10.1002/ccd.30015.

Thornton, G., Musa, T.A., Rigolli, M., Loudon, M., Chin, C., Pica, S., Malley, T., Foley, J.R., Vassiliou, V.S., Davies, R.H., Captur, G., Dobson, L.E., Moon, J., Dweck, M.R., Myerson, S.G., Prasad, S., Greenwood, J.P., McCann, G.P. and Treibel, T.A. (2022). Association of Myocardial Fibrosis and Stroke Volume by Cardiovascular Magnetic Resonance in Patients With Severe Aortic Stenosis With Outcome After Valve Replacement: The British Society of Cardiovascular Magnetic Resonance AS700 Study. JAMA Cardiology, 7(5), pp.513–520. doi: https://doi.org/10.1001/jamacardio.2022.0340.

van Geuns, R.-J., Chang, C.-C., McEntegart, M., Меркулов, Е.В., Kretov, E., Lesiak, M., O’Kane, P., Hanratty, C.G., Bressollette, E., Silvestri, M., Wlodarczak, A., Barragan, P., Anderson, R., Protopopov, A., Peace, A., Menown, I., Rocchiccioli, P., Onuma, Y. and Oldroyd, K.G. (2022). Bioabsorbable polymer drug-eluting stents with 4-month dual antiplatelet therapy versus durable polymer drug-eluting stents with 12-month dual antiplatelet therapy in patients with left main coronary artery disease: the IDEAL-LM randomised trial. EuroIntervention, 17(18), pp.1467–1476. doi: https://doi.org/10.4244/ eij-d-21-00514.

Appendix H - Specialist Services Directorate: CARDIAC SERVICES

Von Oppell, U., Szafranek, A. and Anderson, R. (2022). Cardiac surgery and percutaneous interventions in the elderly. Pathy’s Principles and Practice of Geriatric Medicine, 1, pp.455–481. doi: https://doi. org/10.1002/9781119484288.ch35.

Webber, M., Falconer, D., Alfarih, M., Joy, G., Chan, F., Davie, C., Howes, L., Wong, A., Rapala, A., Bhuva, A., Davies, R.H., Morton, C.L., Aguado-Sierra, J., Vázquez, M., Tao, X., Krausz, G., Tanackovic, S., Guger, C., Xue, H. and Kellman, P. (2022). Study protocol: MyoFit46—the cardiac sub-study of the MRC National Survey of Health and Development. BMC Cardiovascular Disorders, 22(1). doi: https:// doi.org/10.1186/s12872-022-02582-0.

Xue, H., Artico, J., Davies, R.H., Adam, R., Shetye, A., Augusto, J., Bhuva, A., Fröjdh, F., Wong, T.C., Fukui, M., Cavalcante, J.L., Treibel, T.A., Manisty, C., Fontana, M., Ugander, M., Moon, J., Schelbert, E.B. and Kellman, P. (2022). Automated In-Line Artificial Intelligence Measured Global Longitudinal Shortening and Mitral Annular Plane Systolic Excursion: Reproducibility and Prognostic Significance. Journal of the American Heart Association, 11(4). doi: https://doi.org/10.1161/jaha.121.023849.

Xue, H., Rehman, A., Davies, R.H., Moon, J., Fontana, M. and Kellman, P. (2022). CNNT DB-LGE: freebreathing dark blood late enhancement imaging using the convolutional neural network transformer speeds acquisition by 50%. European Heart Journal-Cardiovascular Imaging, 23(Supplement_2). doi: https://doi.org/10.1093/ehjci/jeac141.006.

Zaman, A., Prendergast, B., Hildick-Smith, D., Blackman, D.J., Anderson, R., Spence, M.S., Mylotte, D., Smith, D., Wilding, B., Chapman, C., Atkins, K., Pollock, K.G., Qureshi, A.C. and Banning, A.P. (2023a). An Update on Anti-thrombotic Therapy Following Transcatheter Aortic Valve Implantation: Expert Cardiologist Opinion from a UK and Ireland Delphi Group. Interventional Cardiology, 18(e13). doi: https://doi.org/10.15420/icr.2022.11.

Zaman, M., Stevens, C., Ludman, P., Wijeysundera, H.C., Siudak, Z., Sharp, A.S.P., Kinnaird, T., Mohamed, M.O., Ahmed, J.M., Rashid, M. and Mamas, M.A. (2023b). Intracoronary imaging in PCI for acute coronary syndrome: Insights from British Cardiovascular Intervention Society registry. Cardiovascular Revascularization Medicine. doi: https://doi.org/10.1016/j.carrev.2023.05.020.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix H - Specialist Services Directorate: CRITICAL

CARE

Publications

Andersen-Ranberg, N., Poulsen, L.M., Perner, A., Hästbacka, J., Morgan, M.Z., Citerio, G., Collet, M.O., Weber, S.-O., Andreasen, A.S., Bestle, M.H., Uslu, B., Pedersen, H.B.S., Nielsen, L.G., Damgaard, K., Jensen, T.B., Sommer, T., Dey, N., Mathiesen, O. and Granholm, A. (2022a). Agents intervening against delirium in the intensive care unit trial—Protocol for a secondary Bayesian analysis. Acta Anaesthesiologica Scandinavica, 66(7), pp.898–903. doi: https://doi.org/10.1111/aas.14091.

Andersen-Ranberg, N., Poulsen, L.M., Perner, A., Hästbacka, J., Morgan, M.Z., Citerio, G., Collet, M.O., Weber, S.-O., Andreasen, A.S., Bestle, M.H., Uslu, B., Pedersen, H.S., Nielsen, L.G., Damgaard, K., Jensen, T.B., Sommer, T., Dey, N., Mathiesen, O. and Granholm, A. (2023). Haloperidol vs. placebo for the treatment of delirium in ICU patients: a pre-planned, secondary Bayesian analysis of the AID–ICU trial. Intensive Care Medicine, 49(4), pp.411–420. doi: https://doi.org/10.1007/s00134-023-07024-9.

Andersen-Ranberg, N.C., Poulsen, L.M., Perner, A., Wetterslev, J., Estrup, S., Hästbacka, J., Morgan, M., Citerio, G., Caballero, J., Lange, T., Kjær, M.-B.N., Ebdrup, B.H., Engstrøm, J., Olsen, M.H., Oxenbøll Collet, M., Mortensen, C.B., Weber, S.-O., Andreasen, A.S., Bestle, M.H. and Uslu, B. (2022b). Haloperidol for the Treatment of Delirium in ICU Patients. New England Journal of Medicine, (26), pp.2425–2435. doi: https://doi.org/10.1056/nejmoa2211868.

Ashton, N.J., Moseby-Knappe, M., Benedet, A.L., Grötschel, L., Lantero-Rodriguez, J., Karikari, T.K., Hassager, C., Wise, M.P., Stammet, P., Kjaergaard, J., Friberg, H., Nielsen, N., Cronberg, T., Zetterberg, H. and Blennow, K. (2023). Alzheimer Disease Blood Biomarkers in Patients With Out-of-Hospital Cardiac Arrest. JAMA Neurology, 80(4), pp.388–396. doi: https://doi.org/10.1001/jamaneurol.2023.0050.

Borthwick, M., Granholm, A., Marker, S., Krag, M., Lange, T., Wise, M.P., Bendel, S., Keus, F., Guttormsen, A.B., Schefold, J.C., Wetterslev, J., Perner, A. and Møller, M.H. (2023). Associations between enteral nutrition and outcomes in the SUP-ICU trial: Protocol for exploratory post hoc analyses. Acta Anaesthesiologica Scandinavica, 67(4), pp.481–486. doi: https://doi.org/10.1111/aas.14194.

Burton, R.J., Cuff, S.M., Morgan, M.P., Artemiou, A. and Eberl, M. (2022). GeoWaVe: geometric median clustering with weighted voting for ensemble clustering of cytometry data. Bioinformatics, 39(1). doi: https://doi.org/10.1093/bioinformatics/btac751.

Crescioli, E., Klitgaard, T., Lone Musaeus Poulsen, Brand, B., Siegemund, M., Grøfte, T., Keus, F., Pedersen, U.G., Bäcklund, M., Karttunen, J., Morgan, M., Ciubotariu, A., Bunzel, A.-M.G., Vestergaard, S.R., Jensen, N.M., Jensen, T.S., Kjær, M.N., Georg, K., Lange, T. and Wetterslev, J. (2022). Long-term mortality and health-related quality of life of lower versus higher oxygenation targets in ICU patients with severe hypoxaemia. Intensive Care Medicine, 48(6), pp.714–722. doi: https://doi.org/10.1007/ s00134-022-06695-0.

Düring, J., Annborn, M., Cariou, A., Chew, M.S., Dankiewicz, J., Friberg, H., Haenggi, M., Haxhija, Z., Jakobsen, J.C., Langeland, H., Taccone, F.S., Thomas, M., Ullén, S., Wise, M.P. and Nielsen, N. (2022). Influence of temperature management at 33 °C versus normothermia on survival in patients with vasopressor support after out-of-hospital cardiac arrest: a post hoc analysis of the TTM-2 trial. Critical Care, [online] 26(1), p.231. doi: https://doi.org/10.1186/s13054-022-04107-9.

Eastwood, G., Nichol, A.D., Hodgson, C.L., Parke, R.L., McGuinness, S., Nielsen, N., Bernard, S., Skrifvars, M.B., Stub, D., Taccone, F.S., Archer, J., Kutsogiannis, D., Dankiewicz, J., Lilja, G., Cronberg, T., Kirkegaard, H., Capellier, G., Landoni, G., Horn, J. and Olasveengen, T. (2023). Mild Hypercapnia or Normocapnia after Out-of-Hospital Cardiac Arrest. New England Journal of Medicine, 389(1), pp.45–57. doi: https://doi.org/10.1056/nejmoa2214552.

Appendix H - Specialist Services Directorate: CRITICAL CARE

Fisher, B.A., Veenith, T., Slade, D.J., Gaskell, C., Rowland, M.J., Whitehouse, T., Scriven, J., Parekh, D., Balasubramaniam, M., Cooke, G.S., Morley, N., Gabriel, Z., Wise, M.E., Porter, J.C., McShane, H., Ho, L.-P., Newsome, P.N., Rowe, A., Sharpe, R. and Thickett, D.R. (2021). Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multiarm, multistage, open-label, adaptive, phase 2, proof-of-concept trial. The Lancet Respiratory Medicine, 10(3), pp.255–266. doi: https://doi.org/10.1016/s2213-2600(21)00460-4.

Heimburg, K., Cronberg, T., Tornberg, Å., Ullén, S., Friberg, H., Nielsen, N., Hassager, C., Horn, J., Kjaergaard, J., Kuiper, M., Rylander, C., Wise, M.P. and Lilja, G. (2022). Self-reported limitations in physical function are common 6 months after out-of-hospital cardiac arrest. Resuscitation Plus, 11. doi: https://doi. org/10.1016/j.resplu.2022.100275.

Hookham, L., Fisher, C., Manson, J.J., Morgan, M., O’Hara, G., Riley, P., Tattersall, R.S. and Goodman, A.L. (2022). Understanding the diagnosis and management of multisystem inflammatory syndrome in adults (MIS-A) in the UK: results of a national Delphi process. Clinical Medicine, [online] 22(3), pp.266–270. doi: https://doi.org/10.7861/clinmed.2021-0700.

Lagebrant, A., Lang, M., Nielsen, N., Blennow, K., Dankiewicz, J., Friberg, H., Hassager, C., Horn, J., Kjaergaard, J., Kuiper, M.A., Mattsson-Carlgren, N., Pellis, T., Rylander, C., Sigmund, R., Stammet, P., Zetterberg, H., Wise, M.P., Cronberg, T. and Knappe, M.M. (2023). Brain injury markers in blood predict signs of hypoxic ischaemic encephalopathy on head computed tomography after cardiac arrest. Resuscitation, 184, pp.109668–109668. doi: https://doi.org/10.1016/j.resuscitation.2022.12.006.

Lang, M., Leithner, C., Scheel, M., Kenda, M., Cronberg, T., Düring, J., Rylander, C., Annborn, M., Dankiewicz, J., Deye, N., Halliday, T., Lascarrou, J.-B., Thomas, M., McGuigan, P., Morgan, M., Thomas, M., Ullén, S., Undén, J., Nielsen, N. and Moseby-Knappe, M. (2022). Prognostic accuracy of head computed tomography for prediction of functional outcome after out-of-hospital cardiac arrest: Rationale and design of the prospective TTM2-CT-substudy. Resuscitation Plus, 12. doi: https://doi.org/10.1016/j.resplu.2022.100316.

Law, D. and Morgan, M. (2021). Listening to patients in intensive care. Practical Neurology, 22(2), pp.96–97. doi: https://doi.org/10.1136/practneurol-2021-003255.

Moseby-Knappe, M., Levin, H., Blennow, K., Ullén, S., Zetterberg, H., Lilja, G., Dankiewicz, J., Jakobsen, J.C., Lagebrant, A., Friberg, H., Nichol, A., Ainschough, K., Eastwood, G.M., Wise, M.P., Thomas, M., Keeble, T., Cariou, A., Leithner, C., Rylander, C. and Düring, J. (2022). Biomarkers of brain injury after cardiac arrest; a statistical analysis plan from the TTM2 trial biobank investigators. Resuscitation Plus, 10. doi: https://doi. org/10.1016/j.resplu.2022.100258.

Ooi, S.Z.Y., Spencer, R.J., Hodgson, M., Mehta, S., Phillips, N.L., Preest, G., Manivannan, S., Wise, M.P., Galea, J. and Zaben, M. (2022). Interleukin-6 as a prognostic biomarker of clinical outcomes after traumatic brain injury: a systematic review. Neurosurgical Review, 45(5), pp.3035–3054. doi: https://doi.org/10.1007/ s10143-022-01827-y.

Pandey, M., May, A., Tan, L., Hughes, H., Jones, J.P., Harrison, W., Bradburn, S., Tyrrel, S., Muthuswamy, B., Berry, N., Pugh, R., Sutton, D., Campbell, A. and Morgan, M. (2022). Comparative incidence of early and late bloodstream and respiratory tract co-infection in patients admitted to ICU with COVID-19 pneumonia versus Influenza A or B pneumonia versus no viral pneumonia: wales multicentre ICU cohort study. Critical Care, 26(1). doi: https://doi.org/10.1186/s13054-022-04026-9.

Papathanasiou, A., Hibbert, A., Tallantyre, E., Harding, K., Selvam, A.P., Morgan, M., Quainton, C., Talaei, M., Arun, T., Ingram, G., Law, G.R. and Evangelou, N. (2023). Real-world annualized relapse rates from contemporary multiple sclerosis clinics in the UK: a retrospective multicentre cohort study. Neurological Sciences, pp.1–7. doi: https://doi.org/10.1007/s10072-023-06838-1.

Appendix H - Specialist Services Directorate: CRITICAL CARE

Ponsford, M.J., Burton, R.J., Smith, L., Khan, P.Y., Andrews, R., Cuff, S., Tan, L., Eberl, M., Humphreys, I.R., Babolhavaeji, F., Artemiou, A., Pandey, M., Jolles, S.R.A. and Underwood, J. (2021). Examining the utility of extended laboratory panel testing in the emergency department for risk stratification of patients with COVID-19: a single-centre retrospective service evaluation. Journal of Clinical Pathology, 75(4), pp.255–262. doi: https://doi.org/10.1136/jclinpath-2020-207157.

Rasmussen, B.S., Klitgaard, T., Perner, A., Brand, B., Hildebrandt, T., Siegemund, M., Hollinger, A., Aagaard, S., Bestle, M.H., Marcussen, K.V., Brøchner, A.C., Sølling, C., Poulsen, L.M., Laake, J.H., Aslam, T.N., Bäcklund, M., Okkonen, M., Morgan, M., Sharman, M. and Lange, T. (2021). Oxygenation targets in ICU patients with COVID-19: A post hoc subgroup analysis of the HOT-ICU trial. Acta Anaesthesiologica Scandinavica, 66(1), pp.76–84. doi: https://doi.org/10.1111/aas.13977.

Riddell, J.R., Jones, B.J., Fernandes, B.M., Law, D.J., Cooper, J.A. and Wise, M.P. (2022). Mechanical ventilation variables associated with high pulmonary artery pressures in ARDS patients: a post hoc analysis. Critical Care, [online] 26(1). doi: https://doi.org/10.1186/s13054-022-04282-9.

Saud, Z., Ponsford, M., Bentley, K., Cole, J., Pandey, M., Jolles, S., Fegan, C., Humphreys, I.R., Wise, M.P. and Stanton, R.J. (2022). Mechanically Ventilated Patients Shed High-Titer Live Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) for Extended Periods From Both the Upper and Lower Respiratory Tract. Clinical Infectious Diseases, 75(1), pp.e82–e88. doi: https://doi.org/10.1093/cid/ ciac170.

Shehabi, Y., Neto, A.S., Bellomo, R., Howe, B., Arabi, Y.M., Bailey, M., Bass, F., Kadiman, S., McArthur, C., Reade, M.C., Seppelt, I., Takala, J., Wise, M.P., Webb, S., Mashonganyika, C., McKee, H., Tonks, A., Donnelly, A.M., Hemmings, N. and O’Kane, S. (2023). Dexmedetomidine and Propofol Sedation in Critically Ill Patients and Dose-associated 90-Day Mortality: A Secondary Cohort Analysis of a Randomized Controlled Trial (SPICE III). American Journal of Respiratory and Critical Care Medicine, 207(7), pp.876–886. doi: https://doi.org/10.1164/rccm.202206-1208oc.

Simpson, R., Dankiewicz, J., Karamasis, G.V., Pelosi, P., Haenggi, M., Young, P., Jakobsen, J.C., BannardSmith, J., Wendel-Garcia, P.D., Silvio Taccone, F., Nordberg, P., Wise, M.P., Grejs, A.M., Lilja, G., Olsen, R.B., Cariou, A., Lascarrou, J.B., Saxena, M., Hovdenes, J. and Thomas, M. (2022). Speed of cooling after cardiac arrest in relation to the intervention effect: a sub-study from the TTM2-trial. Critical Care, 26(1). doi: https://doi.org/10.1186/s13054-022-04231-6.

Stefanizzi, F., Zhang, L., Salgado-Somoza, A., Dankiewicz, J., Stammet, P., Hassager, C., Wise, M.P., Friberg, H., Cronberg, T., Hundt, A., Kjaergaard, J., Nielsen, N. and Devaux, Y. (2022). Circular RNAs to predict clinical outcome after cardiac arrest. Intensive Care Medicine Experimental, 10(1). doi: https:// doi.org/10.1186/s40635-022-00470-7.

White, P.L., Springer, J., Wise, M.P., Einsele, H., Löffler, C., Seif, M., Prommersberger, S., Backx, M. and Löffler, J. (2022). A Clinical Case of COVID-19-Associated Pulmonary Aspergillosis (CAPA), Illustrating the Challenges in Diagnosis (Despite Overwhelming Mycological Evidence). Journal of Fungi, 8(1), p.81. doi: https://doi.org/10.3390/jof8010081.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix H - Specialist Services Directorate: HAEMATOLOGY & CLINICAL IMMUNOLOGY

Publications

Dillon, R., Maycock, S., Jackson, A.L., Fox, S., Freeman, S., Craddock, C., Thomas, C., Homer, E., Leahy, J., Mamwell, A., Potter, N., Russell, N., Wei, A., Beier Ommen, H., Hemmaway, C., Knapper, S. and Billingham, L. (2022). Venetoclax combined with low dose cytarabine compared to standard of care intensive chemotherapy for the treatment of favourable risk adult acute myeloid leukaemia (VICTOR): Study protocol for an international, open-label, multicentre, molecularly-guided randomised, phase II trial. BMC Cancer, 22(1). doi: https://doi.org/10.1186/s12885-022-10221-2.

Freeman, S.D., Thomas, A., Thomas, I., Vyas, P., Gilkes, A.F., Metzner, M., Jakobsen, B., Kennedy, A., Moore, A., Marquez Almuina, N., Burns, S., King, S., Andrew, G.M., Gallagher, K.M.E., Sellar, R., Cahalin, P., Weber, D., Dennis, M.M., Mehta, P. and Knapper, S. (2022). A Randomized Comparison of the Fractionated Versus Single Dose Schedule of Gemtuzumab Ozogamicin at Induction with Determinants of Benefit for Older AML Patients: UK NCRI AML18 Trial Results. Blood, 140(Supplement 1), pp.532–533. doi: https://doi.org/10.1182/blood-2022-162245.

Iland, H.J., Russell, N.H., Dillon, R., Schuh, A.C., Tedjaseputra, A., Wei, A.H., Khwaja, A.I., Knapper, S., Lane, S.W., Reynolds, J.V., McMullin, M.F., Martin, A.M., Tan, P., Taussig, D., Wong, A., Taper, J., Fraga, C.G.S., Kelly, R., Tawana, K. and Mehta, P. (2022). Characteristics and outcomes of patients with acute promyelocytic leukemia and extreme hyperleukocytosis at presentation. Blood Advances, 7(11), pp.2580–2585. doi: https://doi.org/10.1182/bloodadvances.2022007126.

Munir, T., Cherrill, L.-R., Webster, N., Dalal, S., Boucher, R.H., Sankhalpara, C., Yates, F., Fox, S., Macdonald, D., Fegan, C., McCaig, A., Schuh, A., Pettitt, A., Gribben, J.G., Patten, P.E.M., Devereux, S., Bloor, A., Fox, C.P., Forconi, F. and Rawstron, A.C. (2022). MRD4 Eradication at 6 Months and Early Clearance of MRD with Combination of Ibrutinib Plus Venetoclax Results in Sustained Clinical and MRD Responses: Exploratory Analysis of the Blood Cancer UK TAP Clarity Study. Blood, 140(Supplement 1), pp.222–223. doi: https://doi.org/10.1182/blood-2022-166700.

Mussai, F., De Santo, C., Cheng, P., Thomas, I.F., Ariti, C., Upton, L., Scarpa, U., Stavrou, V., Sydenham, M., Burnett, A.K., Knapper, S.K., Mehta, P., McMullin, M.F., Copland, M., Russell, N.H. and Dennis, M. (2022). A randomised evaluation of low-dose Ara-C plus pegylated recombinant arginase BCT-100 versus low dose Ara-C in older unfit patients with acute myeloid leukaemia: Results from the LI-1 trial. British Journal of Haematology, 200(5), pp.573–578. doi: https://doi.org/10.1111/bjh.18560.

Othman, J., Dillon, R., Wilhelm-Benartzi, C., Knapper, S., Batten, L.M., Canham, J., Hinson, E.L., Villiers, W., Kleeman, M., Gilkes, A.F., Potter, N., Overgaard, U.M., Mehta, P., Kottaridis, P., Cavenagh, J., Hemmaway, C., Arnold, C., Dennis, M.M. and Russell, N.H. (2022). Genomic Correlates of Outcome in a Randomised Comparison of CPX-351 and FLAG-Ida in High-Risk Acute Myeloid Leukaemia and Myelodysplastic Syndrome: Results from the UK NCRI AML19 Trial. Blood, 140(Supplement 1), pp.1036–1038. doi: https://doi.org/10.1182/blood-2022-159433.

Russell, N.H., Wilhelm-Benartzi, C., Knapper, S., Batten, L.M., Canham, J., Hinson, E.L., Overgaard, U.M., Gilkes, A.F., Othman, J., Potter, N., Dillon, R., Mehta, P., Kottaridis, P., Cavenagh, J., Hemmaway, C., Arnold, C., Freeman, S.D. and Dennis, M.M. (2022). FLAG-Ida Combined with Gemtuzumab Ozogamicin (GO) Improves Event Free Survival in Younger Patients with Newly Diagnosed Acute Myeloid Leukaemia (AML) and Shows an Overall Survival Benefit in NPM1 and FLT3 mutated Subgroups. Results from the UK NCRI AML19 Trial. Blood, 140(Supplement 1), pp.526–528. doi: https://doi.org/10.1182/blood-2022-162377.

Appendix H - Specialist Services Directorate: HAEMATOLOGY & CLINICAL IMMUNOLOGY

Wolf, J., Thomas, I., Stanworth, S., Knapper, S. and Griffin, J. (2022). Leukocytapheresis in the management of adults with acute myeloid leukaemia: A survey of AML treating centres highlighting variability in practice. Transfusion Medicine, 33(2). doi: https://doi.org/10.1111/tme.12929.

Wood, H., Bourlon, C., Kulasekararaj, A.G., Borg, A., Pavlu, J., Elder, P., Taussig, D., Veitch, S., Knapper, S., Othman, J., Dillon, R., Aries, J., Mitchell, E., Basheer, F., Leak, S., Murthy, V., Cross, J.W., Mehta, P., Jain, M. and Khan, A. (2022). Venetoclax-Based Non-Intensive Combinations Successfully Salvage Molecular Relapse of Acute Myeloid Leukemia and Are an Important Bridge to Cellular Therapy in Relapsed/Refractory Disease - Real-World Data from a UK-Wide Programme. Blood, 140(Supplement 1), pp.9016–9018. doi: https://doi.org/10.1182/blood-2022-167097.

Myeloma

Popat, R., Wilson, W.J., Camilleri, M., Ramasamy, K., Streetly, M., Sive, J., Bygrave, C., Benjamin, R., Chapman, M.A., Chavda, S.J., Phillips, B.M., del Mar Cuadrado, M., Pang, G., Jenner, R., Dadaga, T., Kamora, S., de Tute, R., Cavenagh, J.D., Clifton-Hadley, L. and Owen, R.G. (2022). Impact of Autologous Stem Cell Transplant (ASCT) Versus Consolidation on Health-Related Quality of Life (HRQoL) for Patients with Multiple Myeloma Receiving Carfilzomib Maintenance: Results from the Cardamon Trial. Blood, 140(Supplement 1), pp.10191–10192. doi: https://doi.org/10.1182/blood-2022-166344.

Rampotas, A., Vallance, G., Panitsas, F., Basker, N., Sangha, G., Salhan, B., Karim, F., Al-kaisi, F., Gudger, A., Ngu, L., Poynton, M., Lam, H.T., Morgan, L., Yang, L., Young, J., Walker, M.C., Tsagkaraki, I., Anderson, L., Chauhan, S.R. and Maddams, R. (2022). Isatuximab with Pomalidomide and Dexamethasone Provides Comparable Efficacy Outcomes in Frail Routine Care Myeloma Patients in a UK-Wide Cohort. Blood, 140(Supplement 1), pp.5206–5207. doi: https://doi.org/10.1182/ blood-2022-163025.

Royle, K.-L., Coulson, A.L., Ramasamy, K., Cairns, D.A., Hockaday, A., Quezada, S., Drayson, M., Kaiser, M., Owen, R.G., Auner, H.W., Cook, G., Meads, D., Olivier, C., Barnard, L., Lambkin, R., Paterson, A., Dawkins, B., Chapman, M., Pratt, G. and Popat, R. (2022). Risk and response adapted therapy following autologous stem cell transplant in patients with newly diagnosed multiple myeloma (RADAR (UKMRA Myeloma XV Trial): study protocol for a phase II/III randomised controlled trial. British Medical Journal Open, 12(11), pp.e063037. doi: https://doi.org/10.1136/bmjopen-2022-063037.

Walker, I., D’arcy, V., Rodriguez Romera, A., Anderson, G., Aubareda, A., Roy, J.P., Khandelwal, G., Wilson, W.J., Fitzsimons, E., Galas-Filipowicz, D., Foster, K., Popat, R., Ramasamy, K., Streetly, M., Bygrave, C., Benjamin, R., de Tute, R., Camilleri, M., Chavda, S.J. and Pang, G. (2022). Developing a Flow Cytometric Signature of Carfilzomib Responsiveness in Myeloma. Blood, 140(Supplement 1), pp.10106–10107. doi: https://doi.org/10.1182/blood-2022-169882.

Yong, K., Wilson, W., de Tute, R., Camilleri, M., Ramasamy, K., Streetly, M., Sive, J., Bygrave, C., Benjamin, R., Chapman, M., Chavda, S., Philips, E., del Mar Cuadrado, M., Pang, G., Jenner, R., Dadaga, T., Kamora, S., Cavenagh, J., Clifton-Hadley, L. and Owen, R. (2022). ASCT does not benefit patients who are MRD negative following induction therapy: updated results from the Phase 2 Cardamon study. In: International Myeloma Society. International Myeloma Society ASM.

Appendix H - Specialist Services Directorate: HAEMATOLOGY

& CLINICAL IMMUNOLOGY

Yong, K., Wilson, W., Tute, R.M. de, Camilleri, M., Ramasamy, K., Streetly, M., Sive, J., Bygrave, C.A., Benjamin, R., Chapman, M., Chavda, S.J., Phillips, E.H., Cuadrado, M. del M., Pang, G., Jenner, R., Dadaga, T., Kamora, S., Cavenagh, J., Clifton-Hadley, L. and Owen, R.G. (2023). Upfront autologous haematopoietic stem-cell transplantation versus carfilzomib–cyclophosphamide–dexamethasone consolidation with carfilzomib maintenance in patients with newly diagnosed multiple myeloma in England and Wales (CARDAMON): a randomised, phase 2, non-inferiority trial. The Lancet Haematology, 10(2), pp.e93–e106. doi: https://doi.org/10.1016/S2352-3026(22)00350-7.

Lymphoma

Kirkwood, A.A., Goulden, N., Moppett, J., Samarasinghe, S., Mee, J., Hough, R., Kearns, P.R., Lawson, S., Rowntree, C.J. and Vora, A. (2022). High Dose Methotrexate Does Not Reduce the Risk of CNS Relapse in Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoblastic Lymphoma. Results of the Randomised Phase III Study UKALL 2011. Blood, 140(Supplement 1), pp.516–518. doi: https://doi.org/10.1182/blood-2022-160129.

Patel Wrench, B., Kirkwood, A.A., Zuborne Alapi, K., Clifton-Hadley, L., Lee, S., Marks, D.I., Moorman, A.V., Morley, N.J., Patrick, P., Rana, Z., Rowntree, C.J., Snowden, J.A. and Fielding, A.K. (2022). Final Results from UKALL60+ (NCT01616238), a UK National Cancer Research Institute Trial for Older People with De Novo Acute Lymphoblastic Leukaemia. In: American Society of Hematology. American Society of Hematology Annual Meeting.

Nurse-Led Research

Williams, E. (2022). How my CAR-T therapy research seeks to improve cancer care and empower nurses. Nurse Researcher, 30(2), pp.6–7. doi: https://doi.org/10.7748/nr.30.2.6.s2.

Williams, E. and Jones, C.H. (2022). The need for researchers and how their research can embed a positive research culture into practice. In: National PROMS Annual Research Conference.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix H - Specialist Services Directorate: NEPHROLOGY & TRANSPLANT

Publications

Clinical Nephrology

Sridhar, V.S. and Fraser, D.J. (2023). SGLT2 inhibition, glucose transport and peritoneal dialysis: Finding the sweet spot. Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis, 43(2), pp.115–118. doi: https://doi.org/10.1177/08968608231161178.

Heerspink, H.J.L., Radhakrishnan, J., Alpers, C.E., Barratt, J., Bieler, S., Diva, U., Inrig, J., Komers, R., Mercer, A., Noronha, I.L., Rheault, M.N., Rote, W., Rovin, B., Trachtman, H., Trimarchi, H., Wong, M.G., Perkovic, V., Alarmartine, E., Barratt, J. and Chae, D.W. (2023). Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. The Lancet, 401(10388). doi: https://doi.org/10.1016/S0140-6736(23)00569-X.

Herrington, W.G., Staplin, N., Wanner , C., Green , J.B., Hauske , S.J., Emberson , J.R., Preiss , D., Judge , P., Mayne , K.J., Ng , S.Y.A., Sammons , E., Zhu, D., Hill , M., Stevens , W., Wallendszus , K., Brenner , S., Cheung , A.K., Liu, Z.H., Li, J. and Hooi , L.S. (2022). Empagliflozin in Patients with Chronic Kidney Disease. New England Journal of Medicine, 388(2). doi: https://doi.org/10.1056/nejmoa2204233.

COVID-19

Asderakis, A., Khalid, U., Koimtzis, G., Ponsford, M.J., Szabo, L., Chalklin, C., Bramhall, K., Grant, L., Moat, S.J., Humphreys, I.R. and Jolles, S.R. (2022). An Analysis of Serological Response and Infection Outcomes Following Oxford-AstraZeneca (AZD1222) and Pfizer-BioNTech (mRNA BNT162b2) SARSCoV-2 Vaccines in Kidney and Kidney Pancreas Transplants. Transplantation, 106(7). doi: https://doi. org/10.1097/tp.0000000000004105.

Ponsford, M.J., Burton, R.J., Smith, L., Khan, P.Y., Andrews, R., Cuff, S., Tan, L., Eberl, M., Humphreys, I.R., Babolhavaeji, F., Artemiou, A., Pandey, M., Jolles, S.R.A. and Underwood, J. (2022). Examining the utility of extended laboratory panel testing in the emergency department for risk stratification of patients with COVID-19: a single-centre retrospective service evaluation. Journal of Clinical Pathology, 75(4), pp.255–262. doi: https://doi.org/10.1136/jclinpath-2020-207157.

Qualitative Research

Boadu, P., Mclaughlin, L., Al-Haboubi, M., Bostock, J., Noyes, J., O’Neill, S. and Mays, N. (2023). A machine-learning approach to estimating public intentions to become a living kidney donor in England: Evidence from repeated cross-sectional survey data. Frontiers in Public Health, 10. doi: https://doi.org/10.3389/fpubh.2022.1052338.

Faherty, G., Williams, L., Noyes, J., McLaughlin, L., Bostock, J. and Mays, N. (2022). Analysis of content and online public responses to media articles that raise awareness of the opt-out system of consent to organ donation in England. Frontiers in Public Health, 10. doi: https://doi.org/10.3389/ fpubh.2022.1067635.

McKeaveney, C., Noble, H., Courtney, A., Griffin, S., Gill, P., Johnston, W., Maxwell, A., Teasdale, F. and Reid, J. (2022). Dialysis, Distress, and Difficult Conversations: Living with a Kidney Transplant. Healthcare, 10(7), p.1177. doi: https://doi.org/10.3390/healthcare10071177.

Appendix H - Specialist Services Directorate:

NEPHROLOGY & TRANSPLANT

Transplantation

Bailey, P., Selman, L., Exley, C., Griffin, S., Hancock, A., Maxted, P. and Noyes, J. (2023). The IN-FAKT Study Protocol: Investigating the Experiences and Management of Individuals With Failing Kidney Transplants. International Journal of Qualitative Methods, 22, p.160940692311684. doi: https://doi. org/10.1177/16094069231168485.

Gittus, M., Bailey, P.K. and Griffin, S. (2023). Management of Patients with a Failing Kidney Transplant: a Survey of Uk-Based Renal Units. Nephrology Dialysis Transplantation. doi: https://doi.org/10.1093/ ndt/gfad084.

Mamode, N., Bestard, O., Claas, F., Furian, L., Griffin, S., Legendre, C., Pengel, L. and Naesens, M. (2022). European Guideline for the Management of Kidney Transplant Patients With HLA Antibodies: By the European Society for Organ Transplantation Working Group. Transplant International, 35. doi: https://doi.org/10.3389/ti.2022.10511.

Nimmo, A., Graham-Brown, M., Griffin, S., Sharif, A., Ravanan, R. and Taylor, D. (2022). Pre-Kidney Transplant Screening for Coronary Artery Disease: Current Practice in the United Kingdom. Transplant International, 35. doi: https://doi.org/10.3389/ti.2021.10039.

Dialysis

Damgov, I., Bartosova, M., Marinovic, I., Istanbuly, O., Kieser, M., Lambie, M., Davies, S.J., Schmitt, C.P., Vychytil, A., Raby, A.-C., Colmont, C., Aufricht, C., Johnson, D.W., Fraser, D., Eringa, E., Morelle, J., Valdivielso, J.M., Kratochwill, K., Jakulj, L. and Vervloet, M. (2023). IMPROVE-PD Finder: A WebBased Platform to Search and Share Peritoneal Dialysis Biobank, Registry, and Clinical Trial Metadata. Kidney International Reports, 8(4), pp.912–915. doi: https://doi.org/10.1016/j.ekir.2023.01.003.

Reproductive Health

Mc Laughlin, L., Jones, C., Neukirchinger, B., Noyes, J., Stone, J., Williams, H., Williams, D., Rapado, R., Phillips, R. and Griffin, S. (2023). Feminizing care pathways: Mixed-methods study of reproductive options, decision making, pregnancy, post-natal care and parenting amongst women with kidney disease. Journal of Advanced Nursing. doi: https://doi.org/10.1111/jan.15659.

Mclaughlin, L., Neukirchinger, B. and Noyes, J. (2022). Interventions for and experiences of shared decision-making underpinning reproductive health, family planning options and pregnancy for women with or at high risk of kidney disease: a systematic review and qualitative framework synthesis. BMJ, 12(8), pp.e062392. doi: https://doi.org/10.1136/bmjopen-2022-062392.

Appendix H - Specialist Services Directorate:

NEPHROLOGY & TRANSPLANT

Basic Science

Hamilton, K., Czajkowski, D., Kong, N.J., Tran, T.D., Gustafson, K.R., Pauly, G.T., Boyle, G.M., Simmons, J.L., Steadman, R., Moseley, R., Brooks, P., Ogbourne, S.M. and Russell, F.D. (2022). Anti-Fibrotic Potential of Tomentosenol A, a Constituent of Cerumen from the Australian Native Stingless Bee, Tetragonula carbonaria. Antioxidants, 11(8), pp.1604. doi: https://doi.org/10.3390/antiox11081604.

Sharma, S., Zaher, S., Rodrigues, P.R.S., Davies, L.C., Edkins, S., Strang, A., Chakraborty, M., Watkins, W.J., Andrews, R., Parkinson, E., Angelopoulos, N., Moet, L., Shepherd, F., Davies, K.M.M., White, D., Oram, S., Siddall, K., Keeping, V., Simpson, K. and Faggian, F. (2022). mSep: investigating physiological and immune-metabolic biomarkers in septic and healthy pregnant women to predict feto-maternal immune health – a prospective observational cohort study protocol. BMJ Open, 12(9), p.e066382. doi: https://doi.org/10.1136/bmjopen-2022-066382.

Grants

Project/Grant Title

Interaction between early CKD-associated endogenous ligands of TLRs and adaptive immune cells and its impact on atherosclerosis

Investigating novel mechanisms that drive cardiovascular disease in kidney patients, the relationship between systemic inflammation, alteration in hyaluronan matrix and arterial vascular calcification

What’s so special about the female kidney? Using single cell nuclear RNA sequencing to understand proximal tubular cell heterogeneity

Lead Investigator

Dr Siân Griffin

Dr Soma Meran, Professor Donald Fraser, Dr AnneCatherine Raby, Professor Dipak Ramji (Cardiff University; coapplicants)

Dr Tanya Smith

Appendix H - Specialist Services Directorate: NEPHROLOGY & TRANSPLANT

Project/Grant Title

Improving organ and tissue donation awareness within ethnic minority communities in Wales

Investigating nutritional amino acid regulation of antiviral immunity in kidney transplant recipients

National Unified Renal Translational Research Enterprise (NURTuRE) –

Acute Kidney Injury (two projects)

Investigating the experiences and management of individuals with failing kidney transplants: preparation for a randomised controlled trial (IN-FAKT)

Lead Investigator

Dr Farah Latif (Cardiff University

Professor Ian Humphreys (Cardiff University)

Professor Donald Fraser (Cardiff University)

Dr Siân Griffin (co-applicant)

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix H - Specialist Services Directorate: NEUROSCIENCES

Publications

Altmann, A., Ryten, M., Di Nunzio, M., Ravizza, T., Tolomeo, D., Reynolds, R.H., Somani, A., Bacigaluppi, M., Iori, V., Micotti, E., Di Sapia, R., Cerovic, M., Palma, E., Ruffolo, G., Botía, J.A., Absil, J., Alhusaini, S., Alvim, M.K.M., Auvinen, P. and Bargallo, N. (2022). A systems-level analysis highlights microglial activation as a modifying factor in common epilepsies. Neuropathology and Applied Neurobiology, 48(1). doi: https://doi.org/10.1111/nan.12758.

Ambati, S., Wilson, C. and Hamandi, K. (2023). A case of Frontal Lobe Brain sagging syndrome. In: JNNP.

Attard Navarro, G. and Hamandi, K. (2022). Lessons from the video-EEG telemetry unit. Practical Neurology, 22(4), p.practneurol-2021-003313. doi: https://doi.org/10.1136/practneurol-2021-003313.

Beesley, R., Cauchi, M., Davies, L., Upcott, M., Norton, E., Loveless, S., Anderson, V., WynfordThomas, R., Pickersgill, T.P., Uzochukwu, E., Wardle, M., Robertson, N.P., Tallantyre, E. and Willis, M.D. (2022). Multiple sclerosis and COVID-19: Assessing risk perception, patient behaviors and access to disease-modifying therapies. Multiple Sclerosis and Related Disorders, 68, p.104121. doi: https:// doi.org/10.1016/j.msard.2022.104121.

Berkovic, S.F., Cavalleri, G.L., Koeleman, B.P.C. and International League Against Epilepsy Consortium on Complex Epilepsies (2022). Genome-wide meta-analysis of over 29,000 people with epilepsy reveals 26 loci and subtype-specific genetic architecture. medRxiv. doi: https://doi.org/10.1101/2022. 06.08.22276120.

Cauchi, M., Willis, M.E., Andrews, A., Backx, M., Brownlee, W.J., Ford, H., Gran, B., Jolles, S., Price, S., Rashid, W., Schmierer, K. and Tallantyre, E.C. (2022). Multiple sclerosis and the risk of infection: Association of British Neurologists consensus guideline. Practical Neurology, 22(5), pp.344–357. doi: https://doi.org/10.1136/practneurol-2022-003370.

Cohen, N.T., You, X., Krishnamurthy, M., Sepeta, L.N., Zhang, A., Oluigbo, C.O., Whitehead, M.T., Gholipour, T., Baldeweg, T., Wagstyl, K., Adler, S. and Gaillard, W.D. (2022). Networks Underlie Temporal Onset of Dysplasia-Related Epilepsy: A MELD Study. Annals of Neurology, 92(3), pp.503–511. doi: https://doi.org/10.1002/ana.26442.

Ferreira-Atuesta, C., de Tisi, J., McEvoy, A.W., Miserocchi, A., Khoury, J., Yardi, R., Vegh, D., Butler, J., Lee, H.J., Deli-Peri, V., Yao, Y., Wang, F.-P., Zhang, X.-B., Shakhatreh, L., Siriratnam, P., Neal, A., Sen, A., Tristram, M., Varghese, E. and Biney, W. (2022). Predictive models for starting antiseizure medication withdrawal following epilepsy surgery in adults. Brain, 146(6). doi: https://doi.org/10.1093/brain/ awac437.

Garjani, A., Liu, B.J.-Y., Allen, C.M., Gunzler, D.D., Gerry, S.W., Planchon, S.M., das Nair, R., Chataway, J., Tallantyre, E.C., Ontaneda, D. and Evangelou, N. (2022). Decentralised clinical trials in multiple sclerosis research. Multiple Sclerosis Journal, 29(3), p.135245852211004. doi: https://doi. org/10.1177/13524585221100401.

Harding, K.E., Ingram, G., Tallantyre, E.C., Joseph, F., Wardle, M., Pickersgill, T.P., Willis, M.D., Tomassini, V., Pearson, O.R. and Robertson, N.P. (2022). Contemporary study of multiple sclerosis disability in South East Wales. Journal of Neurology, Neurosurgery & Psychiatry, 94(4). doi: https:// doi.org/10.1136/jnnp-2022-330013.

Appendix H - Specialist Services Directorate: NEUROSCIENCES

Jacobs, B.M., Schalk, L., Dunne, A., Scalfari, A., Nandoskar, A., Gran, B., Mein, C.A., Sellers, C., Spilker, C., Rog, D., Visentin, E., Bezzina, E.L., Uzochukwu, E., Tallantyre, E., Wozniak, E., Sacre, E., HassanSmith, G., Ford, H.L., Harris, J. and Bradley, J. (2023). ADAMS project: a genetic Association study in individuals from Diverse Ancestral backgrounds with Multiple Sclerosis based in the UK. BMJ Open, 13(5), pp.e071656–e071656. doi: https://doi.org/10.1136/bmjopen-2023-071656.

Kinney, M.O., Smith, P.E.M. and Craig, J.J. (2022). Preventing Teratogenicity in Women with Epilepsy. Seminars in Neurology, 42(05), pp.679–692. doi: https://doi.org/10.1055/s-0042-1759579.

Kreft, K.L. and Robertson, N. (2022). Innovative biomarkers to predict unfavourable outcomes after initiating multiple sclerosis treatment. Journal of Neurology, 269(9), pp.5192–5193. doi: https://doi. org/10.1007/s00415-022-11300-x.

Larivière, S., Royer, J., Rodríguez-Cruces, R., Paquola, C., Caligiuri, M.E., Gambardella, A., Concha, L., Keller, S.S., Cendes, F., Yasuda, C.L., Bonilha, L., Gleichgerrcht, E., Focke, N.K., Domin, M., von Podewills, F., Langner, S., Rummel, C., Wiest, R., Martin, P. and Kotikalapudi, R. (2022). Structural network alterations in focal and generalized epilepsy assessed in a worldwide ENIGMA study follow axes of epilepsy risk gene expression. Nature Communications, 13(1). doi: https://doi.org/10.1038/ s41467-022-31730-5.

Lopes, M.A., Bhatia, S., Brimble, G., Zhang, J. and Hamandi, K. (2022). A Computational Biomarker of Photosensitive Epilepsy from Interictal EEG. eNeuro, 9(3), pp.ENEURO.0486-21.2022. doi: https://doi. org/10.1523/eneuro.0486-21.2022.

Lopes, M.A., Hamandi, K., Zhang, J. and Creaser, J.L. (2023). The role of additive and diffusive coupling on the dynamics of neural populations. Scientific Reports, 13(1). doi: https://doi.org/10.1038/s41598023-30172-3.

Lopez, S.M., Aksman, L.M., Oxtoby, N.P., Vos, S.B., Rao, J., Kaestner, E., Alhusaini, S., Alvim, M., Bender, B., Bernasconi, A., Bernasconi, N., Bernhardt, B.C., Caciagli, L., Caldairou, B., Caligiuri, M.E., Calvet, A., Cendes, F., Concha, L., Conde-Blanco, E. and Davoodi-Bojd, E. (2022). Event-based modeling in temporal lobe epilepsy demonstrates progressive atrophy from cross-sectional data. Epilepsia, 63(8), pp.2081–2095. doi: https://doi.org/10.1111/epi.17316.

MacIver, C.L., Tax, C.M.W., Jones, D.K. and Peall, K.J. (2022). Structural magnetic resonance imaging in dystonia: A systematic review of methodological approaches and findings. European Journal of Neurology, 29(11), pp.3418–3448. doi: https://doi.org/10.1111/ene.15483.

Park, B., Larivière, S., Rodríguez-Cruces, R., Royer, J., Tavakol, S., Wang, Y., Caciagli, L., Caligiuri, M.E., Gambardella, A., Concha, L., Keller, S.S., Cendes, F., Alvim, M.K.M., Yasuda, C., Bonilha, L., Gleichgerrcht, E., Focke, N.K., Kreilkamp, B.A.K., Domin, M. and von Podewils, F. (2022). Topographic divergence of atypical cortical asymmetry and atrophy patterns in temporal lobe epilepsy. Brain, 145(4). doi: https://doi.org/10.1093/brain/awab417.

Roebber, J.K., Lewis, P.A., Crunelli, V., Navarrete, M. and Hamandi, K. (2022). Effects of Anti-Seizure Medication on Sleep Spindles and Slow Waves in Drug-Resistant Epilepsy. Brain Sciences, 12(10), p.1288. doi: https://doi.org/10.3390/brainsci12101288.

Shakeshaft, A., Laiou, P., Abela, E., Stavropoulos, I., Richardson, M.P., Pal, D.K., Orsini, A., Howell, A., Hyde, A., McQueen, A., Duran, A., Gaurav, A., Collingwood, A., Kitching, A., Shakeshaft, A., Papathanasiou, A., Clough, A., Gribbin, A., Swain, A. and Needle, A. (2022). Heterogeneity of resting-state EEG features in juvenile myoclonic epilepsy and controls. Brain Communications, 4(4). doi:https://doi.org/10.1093/braincomms/fcac180.

Appendix H - Specialist Services Directorate: NEUROSCIENCES

Shakeshaft, A., Panjwani, N., Collingwood, A., Crudgington, H., Hall, A., Andrade, D.M., Beier, C.P., Fong, C.Y., Gardella, E., Gesche, J., Greenberg, D.A., Hamandi, K., Koht, J., Lim, K.S., Møller, R.S., Ng, C.C., Orsini, A., Rees, M.I., Rubboli, G. and Selmer, K.K. (2022). Sex-specific disease modifiers in juvenile myoclonic epilepsy. Scientific Reports, 12(1). doi: https://doi.org/10.1038/s41598-022-06324-2.

Shastin, D., Genc, S., Parker, G.D., Koller, K., Tax, C.M.W., Evans, J., Hamandi, K., Gray, W.A., Jones, D.K. and Chamberland, M. (2022). Surface-based tracking for short association fibre tractography. Neuroimage, 260, pp.119423–119423. doi: https://doi.org/10.1016/j.neuroimage.2022.119423.

Smith, P.E.M. and Pierri, M. (2022). Neurology teambuilding event. Practical Neurology, 22(6), pp.472–477. doi: https://doi.org/10.1136/practneurol-2022-003358.

Spitzer, H., Ripart, M., Whitaker, K., D’Arco, F., Mankad, K., Chen, A.A., Napolitano, A., De Palma, L., De Benedictis, A., Foldes, S.T., Humphreys, Z., Zhang, K., Hu, W., Zhang, K., Likeman, M., Davies, S., Güttler, C., Lenge, M., Cohen, N.T. and Tang, Y. (2022). Interpretable surface-based detection of focal cortical dysplasias: a Multi-centre Epilepsy Lesion Detection study. Brain, 145(11), pp.3859–3871. doi: https:// doi.org/10.1093/brain/awac224.

Tallantyre, E.C. (2022). Long-term treatment with anti-CD20 monoclonal antibodies is untenable because of risk: No. Multiple Sclerosis Journal, 28(8), pp.1175–1177. doi: https://doi. org/10.1177/13524585221091404.

Tallantyre, E.C., Scurr, M.J., Vickaryous, N., Richards, A., Anderson, V., Baker, D., Chance, R., Evangelou, N., George, K., Giovannoni, G., Harding, K.E., Hibbert, A., Ingram, G., Jolles, S., Jones, M., Kang, A.S., Loveless, S., Moat, S.J., Robertson, N.P. and Rios, F. (2022). Response to COVID-19 booster vaccinations in seronegative people with multiple sclerosis. Multiple Sclerosis and Related Disorders, [online] 64. doi: https://doi.org/10.1016/j.msard.2022.103937.

Tax, C.M.W., Genc, S., MacIver, C.L., Nilsson, M., Wardle, M., Szczepankiewicz, F., Jones, D.K. and Peall, K.J. (2023). Ultra-strong diffusion-weighted MRI reveals cerebellar grey matter abnormalities in movement disorders. Neuroimage Clinical, 38, p.103419. doi: https://doi.org/10.1016/j.nicl.2023.103419.

Topcu, G., Smith, L., Mhizha-Murira, J.R., Goulden, N., Hoare, Z., Drummond, A., Fitzsimmons, D., Evangelou, N., Schmierer, K., Tallantyre, E.C., Leighton, P., Allen-Philbey, K., Stennett, A., Bradley, P., Bale, C., Turton, J., das Nair, R. and NEuRoMS Collective (2022). Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial. Pilot and Feasibility Studies, 8(1), p.123. doi: https://doi.org/10.1186/ s40814-022-01073-5.

Wagstyl, K., Whitaker, K., Raznahan, A., Seidlitz, J., Vértes, P.E., Foldes, S., Humphreys, Z., Hu, W., Mo, J., Likeman, M., Davies, S., Lenge, M., Cohen, N.T., Tang, Y., Wang, S., Ripart, M., Chari, A., Tisdall, M., Bargallo, N. and Conde-Blanco, E. (2022). Atlas of lesion locations and postsurgical seizure freedom in focal cortical dysplasia: A MELD study. Epilepsia, 63(1), pp.61–74. doi: https://doi.org/10.1111/epi.17130.

Zaben, M., Ved, R. and Manivannan, S. (2022). The Roles of HMGB1 Post-Brain Injury: Implications for Injury and Repair. In: HMGB1: Functions, Inhibitors and Clinical Significance. New York: Nova Science Publishers, pp.188–218.

Zaben, M., Ved, R., Manivannan, S. and Tasker, I. (2022). High mobility group box protein 1 and white matter injury following traumatic brain injury: perspectives on mechanisms and therapeutic strategies. Neural Regeneration Research, 17(8), p.1739. doi: https://doi.org/10.4103/1673-5374.332135.

Appendix H - Specialist Services Directorate: NEUROSCIENCES

Grants

Project/Grant Title

Exploring cell-type specific microstructural alterations in dystonia using diffusion-weighted MR spectroscopy 68200, AC68200UII

Making the Invisible Visible: a Multi-Scale Imaging Approach to Detect and Characterise Cortical Pathology

CRTF Fellowship (PhD Studentship)

Lead Investigator

Dr Kathryn Peall

Clinical Heterogeneity and Gene Environment

Stratification in Multiple Sclerosis (CHANGES in MS)

Professor Derek Jones

Dr Khalid Hamandi (coapplicant)

Professor William Gray, Ronak Ved

Dr Karim Kreft

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix H - Specialist Services Clinical Board

Appendix H - Specialist Services Clinical Board

Non-Commercial

Appendix H - Specialist Services Clinical Board

Appendix H - Specialist Services Clinical Board

Appendix H - Specialist Services Clinical Board

Appendix H - Specialist Services Clinical Board

Appendix H - Specialist Services Clinical Board

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Appendix H - Specialist Services Clinical Board

*COVID-19 ENLIST & ENLIST Vaccination sub-study recruitment achieved by Nephrology & Transplant team.

Appendix H - Specialist Services Clinical Board

Appendix H - Specialist Services Clinical Board

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Appendix H - Specialist Services Clinical Board

Appendix H - Specialist Services Clinical Board

Appendix I - Surgical Services Clinical Board

Perioperative Care Publications

Bailey, D.M., Halligan, C.L., Davies, R.G., Funnell, A., Appadurai, I.R., Rose, G.A., Rimmer, L., Jubouri, M., Coselli, J.S., Williams, I.M. and Bashir, M. (2022). Subjective assessment underestimates surgical risk: On the potential benefits of cardiopulmonary exercise testing for open thoracoabdominal repair. Journal of Cardiac Surgery, 37(8), pp.2258–2265. doi: https://doi.org/10.1111/jocs.16574.

Bailey, D.M., Rose, G.A., O’Donovan, D., Locker, D., Appadurai, I.R., Davies, R.G., Whiston, R.J., Bashir, M., Lewis, M.H. and Williams, I.M. (2022). Retroperitoneal Compared to Transperitoneal Approach for Open Abdominal Aortic Aneurysm Repair Is Associated with Reduced Systemic Inflammation and Postoperative Morbidity. Aorta, 10(5), pp.225–234. doi: https://doi.org/10.1055/s-0042-1749173.

Bell, S.F., Collis, R.E. and Collins, P.W. (2022). Comparison of haematological indices and transfusion management in severe and massive postpartum haemorrhage: analysis of a two-year national prospective observational study. International Journal of Obstetric Anesthesia, 50, p.103547. doi: https://doi.org/10.1016/j.ijoa.2022.103547.

Bell, S.F., de Lloyd, L., Preston, N. and Collins, P.W. (2023). Managing the coagulopathy of postpartum haemorrhage: an evolving role for viscoelastic haemostatic assays. Journal of Thrombosis and Haemostasis. doi: https://doi.org/10.1016/j.jtha.2023.03.029.

Brogly, N., Varvinskiy, A., Varosyan, A., Ateleanu, B., Engelhardt, W., Geldner, G., Madách, K., Ringvold, E.-M. . and Zerafa, M. (2022). On-Line Assessment (OLA) as a preparation for the European Diploma in Anaesthesiology and Intensive Care (EDAIC), a retrospective observational study on the results and the potential impact on the Part-I examination. Revista Española de Anestesiología y Reanimación (English Edition), 69(8), pp.454–462. doi: https://doi.org/10.1016/j.redare.2022.08.006.

Chandler, H.L., Stickland, R.C., Patitucci, E., Germuska, M., Chiarelli, A.M., Foster, C.E., BhomeDhaliwal, S., Lancaster, T.M., Saxena, N.K., Khot, S., Tomassini, V. and Wise, R.G. (2022). Reduced brain oxygen metabolism in patients with multiple sclerosis: Evidence from dual-calibrated functional MRI. Journal of Cerebral Blood Flow and Metabolism, 43(1), pp.115–128. doi: https://doi. org/10.1177/0271678x221121849.

Chiarelli, A.M., Germuska, M., Chandler, H.L., Stickland, R.C., Patitucci, E., Biondetti, E., Mascali, D., Saxena, N.K., Khot, S., Steventon, J.J., Foster, C.E., Rodríguez-Soto, A.E., Englund, E.K., Murphy, K., Tomassini, V., Wehrli, F.W. and Wise, R.G. (2022). A flow-diffusion model of oxygen transport for quantitative mapping of cerebral metabolic rate of oxygen (CMRO2) with single gas calibrated fMRI. Journal of Cerebral Blood Flow & Metabolism, 42(7), pp.0271678X2210773. doi: https://doi. org/10.1177/0271678x221077332.

Clayton-Smith, M., Narayanan, H., Shelton, C., Bates, L., Brennan, F., Deido, B., Donnellon, M., Dorey, J., Evans, B., Gower, J., Hamdaoui, Y., Hitchman, J., Kinsella, S.M., Knagg, R., Lawson, C., Morris, D., Pegna, V., Radcliffe, T., Schaff, O. and Sheppard, T. (2023). Greener Operations: a James Lind Alliance Priority Setting Partnership to define research priorities in environmentally sustainable perioperative practice through a structured consensus approach. BMJ Open, 13(3), pp.e066622. doi: https://doi. org/10.1136/bmjopen-2022-066622.

Collis, R. and Bell, S. (2022). The Role of Thromboelastography during the Management of Postpartum Hemorrhage: Background, Evidence, and Practical Application. Seminars in Thrombosis and Hemostasis, 49(2), pp.145–161. doi: https://doi.org/10.1055/s-0042-1757895.

Corner, H., Barley, M. and Metodiev, Y. (2023). The use of processed electroencephalography (pEEG) in obstetric anaesthesia: a narrative review. International Journal of Obstetric Anesthesia, 54, pp.103650. doi: https://doi.org/10.1016/j.ijoa.2023.103650.

Appendix I - Surgical Services Clinical Board

Dale, M., Bell, S.F., O’Connell, S., Scarr, C., James, K., John, M., Collis, R.E., Collins, P.W. and CarolanRees, G. (2022). What is the Economic Cost of Providing an All Wales Postpartum Haemorrhage Quality Improvement Initiative (OBS Cymru)? A Cost-Consequences Comparison with Standard Care. PharmacoEconomics - Open, 6(6), pp.847–857. doi: https://doi.org/10.1007/s41669-022-00362-2.

de Lloyd, L., Jenkins, P.P., Bell, S.F., Mutch, N.J., Freyer, J., Badenes, P.M., James, D., Ridgeway, A., Cohen, L., Roberts, T., Field, V., Collis, R.E. and Collins, P.L. (2022). Acute obstetric coagulopathy during postpartum hemorrhage is caused by hyperfibrinolysis and dysfibrinogenemia: an observational cohort study. Journal of Thrombosis and Haemostasis, 21(4), pp.862–879. doi: https://doi.org/10.1016/j. jtha.2022.11.036.

Hawkins, T., Agarwal, S. and Evans, C.R. (2023). Centre for Perioperative Care anaemia guideline: implications for anaesthesia. British Journal of Anaesthesia, 130(2), pp.115–119. doi: https://doi. org/10.1016/j.bja.2022.11.009.

Kelly, F.E., Frerk, C., Bailey, C.R., Cook, T.M., Ferguson, K., Flin, R., Fong, K., Groom, P., John, C., Lang, A.R., Meek, T., Miller, K.L., Richmond, L., Sevdalis, N. and Stacey, M.R. (2023). Human factors in anaesthesia: a narrative review. Anaesthesia, 78(4), pp.479–490. doi: https://doi.org/10.1111/ anae.15920.

Kelly, F.E., Frerk, C., Bailey, C.R., Cook, T.M., Ferguson, K., Flin, R., Fong, K., Groom, P., John, C., Lang, A.R., Meek, T., Miller, K.L., Richmond, L., Sevdalis, N. and Stacey, M.R. (2023). Implementing human factors in anaesthesia: guidance for clinicians, departments and hospitals. Anaesthesia, 78(4). doi: https://doi.org/10.1111/anae.15941.

Metodiev, Y. and Lucas, D.N. (2022). The role of total intravenous anaesthesia for caesarean delivery. International Journal of Obstetric Anesthesia, 51, p.103548. doi: https://doi.org/10.1016/j. ijoa.2022.103548.

Metodiev, Y. and Mushambi, M. (2023). The role of supraglottic airway devices in obstetric anaesthesia. Current Opinion in Anaesthesiology, 36(3), pp.276–280. doi: https://doi.org/10.1097/ aco.0000000000001241.

Minto, T., Abdelrahman, T., Jones, L.E., Wheat, J., Key, T., Shivakumar, N., Ansell, J., Seddon, O., Cronin, A., Tomkinson, A., Theron, A., Trickett, R., Sagua, N., Sultana, S., Clark, A., McKay, E., Johnson, A., Behera, K., Towler, J. and Kynaston, H. (2022). Safety of maintaining elective and emergency surgery during the COVID-19 pandemic with the introduction of a Protected Elective Surgical Unit (PESU): A cross-specialty evaluation of 30-day outcomes in 9,925 patients undergoing surgery in a University Health Board. Surgery Open Science, 10, pp.168–173. doi: https://doi.org/10.1016/j. sopen.2022.09.005.

Perry, H., Reeves, N., Ansell, J., Cornish, J., Torkington, J., Morris, D.S., Brennan, F. and Horwood, J. (2022). Innovations towards achieving environmentally sustainable operating theatres: A systematic review. The Surgeon, 21(3). doi: https://doi.org/10.1016/j.surge.2022.04.012.

Potter, T.L., Cronin, J.W., Kua, J., Nurmi, E., Wong, D.J.N., Ahmad, I., Cook, T., El-Boghdadly, K. and AeroComp Trainee Research Networks (2022). Aerosol precautions and airway complications: a national prospective multicentre cohort study. Anaesthesia, 78(1), pp.23–35. doi: https://doi. org/10.1111/anae.15851.

Rose, G.A., Davies, R.G., Appadurai, I.R., Williams, I.M., Bashir, M., Berg, R.M.G., Poole, D.C. and Bailey, D.M. (2022). ‘Fit for surgery’: the relationship between cardiorespiratory fitness and postoperative outcomes. Experimental Physiology, 107(8), pp.787–799. doi: https://doi.org/10.1113/EP090156.

Appendix I - Surgical Services Clinical Board

Rose, G.A., Davies, R.G., Torkington, J., Berg, R.M.G., Appadurai, I.R., Poole, D.C. and Bailey, D.M. (2023). Assessing cardiorespiratory fitness relative to sex improves surgical risk stratification. European Journal of Clinical Investigation. doi: https://doi.org/10.1111/eci.13981.

Sharma, S., Zaher, S., Rodrigues, P.R.S., Davies, L.C., Edkins, S., Strang, A., Chakraborty, M., Watkins, W.J., Andrews, R., Parkinson, E., Angelopoulos, N., Moet, L., Shepherd, F., Davies, K.M.M., White, D., Oram, S., Siddall, K., Keeping, V., Simpson, K. and Faggian, F. (2022). mSep: investigating physiological and immune-metabolic biomarkers in septic and healthy pregnant women to predict feto-maternal immune health – a prospective observational cohort study protocol. BMJ Open, 12(9), p.e066382. doi: https://doi.org/10.1136/bmjopen-2022-066382.

Vora, J., Leslie, D. and Stacey, M. (2022). Awake tracheal intubation. BJA Education, 22(8), pp.298–305. doi: https://doi.org/10.1016/j.bjae.2022.03.006.

Warde, D., Huckle, D. and Hatch, D. (2023). The first fifty years of The Association of Paediatric Anaesthetists of Great Britain and Ireland. Paediatric Anaesthesia, 33(7). doi: https://doi.org/10.1111/ pan.14676.

Appendix I - Surgical Services Clinical Board

Initiatives

Contributed by Dr Danielle Huckle

Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial

Excess bleeding is the most common complication of childbirth. Every year about 50,000 women in the UK lose 1 litre (almost 2 pints) of blood or more. Many women need a blood transfusion, are admitted to intensive care and find the experience of bleeding traumatic, developing mental health issues after having their baby. Women from ethnic backgrounds are disproportionately affected. We developed a care bundle for treating bleeding after childbirth called the ‘Obstetric Bleeding Strategy’ (OBS) and in a pilot study we rolled this out to maternity units, using quality improvement methods eg education and training. We saw a fall in the number of women having excess bleeding and fewer needed blood transfusion. Staff described improvements in teamwork. These results are encouraging, but since this was only a small study with limited data, we do not know whether these improvements were due to the change in care or whether the care bundle is value for money. To find this out, the OBS UK study will compare clinical outcomes, psychological wellbeing and cost of care for women in maternity units that use the care bundle with women receiving standard care.

We will use routine NHS data on about 189,000 women from 36 NHS maternity units over 30 months, including data about ethnicity. Women’s data will be included, whether they have excess bleeding or not. All maternity units will start with a period of standard care, they will then adopt the OBS care bundle using quality improvement methods over 9 months, followed by a period of OBS care. To measure how effective the OBS care bundle is, we will compare rates of blood transfusion before and after it is introduced. We will also study intensive care admission, hysterectomy and breastfeeding rates. Women with experience of excess bleeding have advised us on the study’s importance, its design and outcomes. Add-on studies will look at the effect of the OBS care bundle on the psychological wellbeing of women and birthing partners and how units adopt the care bundle, with special attention to ethnicity and organisational factors. This will include interviewing women, their birth partners and staff to understand their experiences of excess bleeding and whether the OBS care bundle changes how teams deliver care. The cost will also be studied.

Our research will establish whether (and how) the OBS care bundle improves outcomes and experiences of women giving birth. We will share our findings widely with the support of UK maternity providers and patient representatives.

Please note: all grants, publications, research impact case studies or initiatives have been provided by Clinical Board and Directorate R&D leads. Therefore, there may be further grants, publications, case studies or initiatives not mentioned in this report.

Appendix I - Surgical Services Clinical Board

Appendix I - Surgical Services Clinical Board

Non-Commercial

Appendix I - Surgical Services Clinical Board

Appendix I - Surgical Services Clinical Board

Appendix I - Surgical Services Clinical Board

Appendix I - Surgical Services Clinical Board

Appendix I - Surgical Services Clinical Board

Appendix I - Surgical Services Clinical Board

*REINFORCE counted under Other Clinical Board but recruitment split between Children & Women's and Surgical Services

Appendix I - Surgical Services Clinical Board

Appendix I - Surgical Services Clinical Board

Other (Split) Clinical Board

Other (Split) Clinical Board

Non-Commercial

*REINFORCE counted under Other Clinical Board but recruitment split between Children & Women's and Surgical Services