2023/24 publications

Between 1 April 2023 and 31 March 2024, the following articles were published which relate to studies that have been supported by the NIHR Sheffield Clinical Research Facility (CRF).

Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial (STH19901: CRYOSTAT2)

Prehospital early warning scores for adults with suspected sepsis: retrospective diagnostic cohort study (STH20280: PHEWS)

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial (STH20728: UK-REBOA)

Efficacy and safety of hybrid epicardial and endocardial ablation versus endocardial ablation in patients with persistent and longstanding persistent atrial fibrillation: a randomised, controlled trial (STH19031: CEASE AF)

The Impact of Ferric Derisomaltose on Cardiovascular and Noncardiovascular Events in Patients With Anemia, Iron Deficiency, and Heart Failure With Reduced Ejection Fraction (STH19388: IRONMAN)

Pulmonary Hypertension: Intensification and Personalization of Combination Rx (PHoenix): A phase IV randomized trial for the evaluation of dose‐response and clinical efficacy of riociguat and selexipag using implanted technologies (STH21653: PHoenix)

GWAS and meta-analysis identifies 49 genetic variants underlying critical COVID-19 (STH21104: GenOMICC)

Quality of recovery following childbirth: a prospective, multicentre cohort study (STH21138: ObsQoR)

A randomized, double-blind, placebo-controlled phase 2 study of intratympanic OTO-313 in patients with moderate to severe subjective tinnitus (STH21863: OTONOMY OTO)

Can an educational video improve the adequacy of bowel preparation for patients undergoing their first colonoscopy? Results of the EBOPS RCT (STH20459: EBOP)

Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer (STH18293: SHAPE)

Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial (STH20486: TOPSY)

Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): a phase 2 study (STH20540: CITADEL-203)

Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): a phase 2 study (STH20589: CITADEL-205)

Phase 3 Trial of Concizumab in Hemophilia with Inhibitors (STH21015: Explorer 7)

SARS-CoV-2-specific immune responses and clinical outcomes after COVID-19 vaccination in patients with immune-suppressive disease (STH21731: OCTAVE)

Mortality rates among patients successfully treated for hepatitis C in the era of interferon-free antivirals: population based cohort study (STH16263: HCV Research UK V1)

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (STH21355: RECOVERY)

Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (STH21355: RECOVERY)

Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial (STH21355: RECOVERY)

Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial (STH21355: RECOVERY)

Acute blood biomarker profiles predict cognitive deficits 6 and 12 months after COVID-19 hospitalization (STH21439: PHOSP-COVID)

Determinants of recovery from post-COVID-19 dyspnoea: analysis of UK prospective cohorts of hospitalised COVID-19 patients and community-based controls (STH21439: PHOSP-COVID)

Post-acute COVID-19 neuropsychiatric symptoms are not associated with ongoing nervous system injury (STH21439: PHOSP-COVID)

Prevalence of swallow, communication, voice and cognitive compromise following hospitalisation for COVID-19: the PHOSP-COVID analysis (STH21439: PHOSP-COVID)

Persistence of immune response in heterologous COVID vaccination schedules in the Com-COV2 study – A single-blind, randomised trial incorporating mRNA, viral-vector and protein-adjuvant vaccines (STH21800: COM-COV2)

Immunogenicity and safety of AZD2816, a beta (B.1.351) variant COVID-19 vaccine, and AZD1222 (ChAdOx1 nCoV-19) as third-dose boosters for previously vaccinated adults: a multicentre, randomised, partly double-blinded, phase 2/3 non-inferiority immunobridging study in the UK and Poland (STH21874: The AZ Variant Study)

Omicron BA.1-containing mRNA-1273 boosters compared with the original COVID-19 vaccine in the UK: a randomised, observer-blind, active-controlled trial (STH22175: MODERNA BOOSTER)

Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen (STH19197: Baby-OSCAR)

A Double-Blind, Randomized, Placebo-Controlled Trial of Ursodeoxycholic Acid (UDCA) in Parkinson's Disease (STH18493: UP Study)

Decompressive Craniectomy versus Craniotomy for Acute Subdural Hematoma (STH18535: RESCUE-ASDH)

Tau-targeting antisense oligonucleotide MAPTRx in mild Alzheimer’s disease: a phase 1b, randomized, placebo-controlled trial (STH19688: IONIS)

Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis (STH20690: Momenta - MOM-281-004)

Visual dysfunction is a better predictor than retinal thickness for dementia in Parkinson’s disease (STH20705: VIPD)

Variability of Multiple Sclerosis Walking Scale and Multiple Sclerosis Impact Scale Scores in People Without Multiple Sclerosis (STH20727: RIPC)

Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study (STH21068: Raise & STH21113: Raise XT)

Interim phase 1 part A results for ALN-APP, the first investigational RNAi therapeutic in development for Alzheimer’s disease (STH22052: ALN-APP-001)

Catheter event rates in medical compared to surgical peritoneal dialysis catheter insertion (STH18334: UKPDOPPS 2)

Bio-impedance spectroscopy added to a fluid management protocol does not improve preservation of residual kidney function in incident hemodialysis patients in a randomized controlled trial (STH19730: BISTRO)

Unsupervised machine learning to investigate trajectory patterns of COVID-19 symptoms and physical activity measured via the MyHeart Counts App and smart devices (STH15222: CVRU Tissue Bank)

Blood DNA methylation profiling identifies cathepsin Z dysregulation in pulmonary arterial hypertension (STH17049: PAH COHORT)

Comparison of cardiac magnetic resonance imaging, functional and haemodynamic variables in pulmonary arterial hypertension: insights from REPAIR (STH18766: REPAIR)

Early Video-assisted Thoracoscopic Surgery or Intrapleural Enzyme Therapy in Pleural Infection: A Feasibility Randomized Controlled Trial. The Third Multicenter Intrapleural Sepsis Trial—MIST-3 (STH19589: MIST3)

PET-CT-guided versus CT-guided biopsy in suspected malignant pleural thickening: a randomised trial (STH19648: TARGET)

Reflecting real-world patients with mesothelioma in research: an interim report of baseline characteristics from the ASSESS-meso cohort (STH20915: ASSESS-meso)

Early infection risk in patients with systemic lupus erythematosus treated with rituximab or belimumab from the British Isles Lupus Assessment Group Biologics Register (BILAG-BR): a prospective longitudinal study (STH15729: BILAG BR)

Psoriatic arthritis: the role of self-reported non-adherence, non-trough drug levels, immunogenicity and conventional synthetic DMARD co-therapy in adalimumab and etanercept response (STH18928: OUTPASS)

Comparative Effectiveness, Time to Discontinuation, and Patient-Reported Outcomes with Baricitinib in Rheumatoid Arthritis: 2-Year Data from the Multinational, Prospective Observational RA-BE-REAL Study in European Patients (STH20530: RA-BE-REAL)

Patient and health professional views on risk-stratified monitoring of immune-suppressing treatment in adults with inflammatory diseases (STH22308: Monitoring of inflammatory conditions)

A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial (STH18431: BASIL-2)