Peninsula Clinical Trials Unit: publications

2025

Alimentary Pharmacology and Therapeutics – March 2025
Balancing Cost and Consequence of Colon Capsule Endoscopy in Colorectal Cancer Pathways—Finding the Sweet Spot. Authors' Reply

Spectrom PDP – Research in Developmental Disabilities – March 2025
Pattern of psychotropic prescribing in adults with intellectual disabilities in the community settings in the UK: A cross-sectional view

Spectrom PDP – Journal of Mental Health Research in Intellectual Disabilities – March 2025
Short-Term PsychoEducation for Carers to Help Reduce the Over Medication of People with Intellectual Disabilities Programme Development Project: A Feasibility Randomized Controlled Trial Protocol

Alimentary Pharmacology & Therapeutics – February 2025 – Multicentre Study of 10,369 Symptomatic Patients Comparing the Diagnostic Accuracy of Colon Capsule Endoscopy, Colonoscopy and CT Colonography

2024

The ARMS-Hub Study – NIHR Open Research – October 2024
An alcohol-related liver disease multi-stakeholder hub to enhance research activity in underserved communities in the UK

THE ALD Study – Nature Reviews Gastroenterology & Hepatology – October 2024
An expert panel Consensus Statement on ALD without experts by experience

The MYRIAD Study – Cognition and Emotion – October 2024
Investigation of the mental health and cognitive correlates of psychological decentering in adolescence

The RESOLVE Study – Pilot and Feasibility Studies – September 2024
Protocol for a feasibility multi-centre randomised controlled trial of a pre-operative two-week very low-calorie diet to reduce steatosis prior to liver resection

The MIRAGE Study – BMJ Open Gastroenterology – January 2024
Mental Imagery to Reduce Alcohol-related harm in patients with alcohol use disorder and alcohol-related liver damaGE: the MIRAGE randomised pilot trial results

The personal impact is considerable for family caregivers at the end-of-life – BMJ Supportive & Palliative Care
25 Family caregiver socio-economic status, access to palliative care and patients’ place of death: a health survey for England study

2023

The potential for medicinal cannabis to help manage challenging behaviour in people with intellectual disability: A perspective review – Sage Journals – November 2023
Around 2% of the population have intellectual disabilities. Over one-third people with intellectual disabilities (PwID) present with ‘challenging behaviour’, which nosologically and diagnostically is an abstract concept.

The Myriad Study – Journal of the American Academy of Child & Adolescent Psychiatry – October 2023
Student- and School-Level Factors Associated With Mental Health and Well-Being in Early Adolescence

Treatment of age-related macular degeneration with aflibercept using a treat, extend and fixed protocol; A 4-year study of treatment outcomes, durability, safety and quality of life – Acta Ophthalmologica Journal – September 2023
The aim of this study was to provide outcomes, safety, durability and quality-of-life data with aflibercept using a modified treat, extend and fixed regime over 4 years.

Effectiveness of out-patient based acute heart failure care: a pilot randomised controlled trial – Acta Ophthalmologica Journal – September 2023
Acute heart failure (AHF) hospitalisation is associated with 10% mortality. Outpatient based management (OPM) of AHF appeared effective in observational studies. We conducted a pilot randomised controlled trial (RCT) comparing OPM with standard inpatient care (IPM).

A pilot examination of the validity of stylus and finger drawing on visuomotor-mediated tests on ACEmobile – Journal of Clinical and Experimental Neuropsychology – August 2023
The current study sought to test whether administering visuospatial and writing tests using a tablet (finger or stylus drawing), would demonstrate equivalence to traditional pencil and paper administration on ACEmobile.

Epilepsy in people with and without intellectual disabilities – Journal of Neurology – August 2023
Rapid switching from levetiracetam to brivaracetam in pharmaco-resistant epilepsy in people with and without intellectual disabilities: a naturalistic case control study

The COVID-19 PD Study – Plus One – July 2023
Clinical features and outcomes of hospitalised patients with COVID-19 and Parkinsonian disorders: A multi-centre UK-based study

The SSEP Study – Clinical Neurophysiology – July 2023
Enhanced analysis of somatosensory evoked potentials at 20–30 milliseconds can predict neurological outcome after cardiac arrest

The e-coachER Study – Mental Health and Physical Activity – June 2023
Adding web-based support to exercise referral schemes improves symptoms of depression in people with elevated depressive symptoms: A secondary analysis of the e-coachER randomised controlled trial

The MATE study – Pilot and Feasibility Studies – April 2023
A multicentre, mixed-methodology, pilot, randomised controlled trial in neovascular age-related macular degeneration

The TARS study – Addiction – March 2023
Effectiveness and cost-effectiveness of behavioural support for prolonged abstinence for smokers wishing to reduce but not quit: Randomised controlled trial of physical activity assisted reduction of smoking

The Attachment Study – NIHR Journal – February 2023
Routinely used interventions to improve attachment in infants and young children: a national survey and two systematic reviews

The DIADS Study – International Journal of Environmental Research and Public Health – January 2023
Comparison of Diagnostic Profiles of Deaf and Hearing Children with a Diagnosis of Autism

2022

The PD-Stat Study – Jama Neurology – October 2022
Evaluation of Simvastatin as a Disease-Modifying Treatment for Patients With Parkinson Disease

The e-coachER Study – International Journal of Behavioral Nutrition and Physical Activity – September 2022
A process evaluation, with mediation analysis, of a web-based intervention to augment primary care exercise referral schemes: the e-coachER randomised controlled trial

The ProGroup Study – National Library of Medicine – September 2022
A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol

The BREATHE Study – ERJ Open – August 2022
Mixed-methods feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness

The EMaPP Study – BMJ Open – August 2022
Evaluating the Management of chronic Pelvic girdle Pain following pregnancy (EMaPP): study protocol for a randomised controlled feasibility trial to compare a customised pelvic orthosis with standard care

The PD Stat Study – Journal of Parkinson's Disease – July 2022
Challenges of Incorporating Digital Health Technology Outcomes in a Clinical Trial: Experiences from PD STAT

The PD Stat Study – Journal of Parkinson's Disease – July 2022
Enhancing Trial Delivery in Parkinson’s Disease: Qualitative Insights from PD STAT

The MIRAGE Study – BMJ Open – May 2022
Mental Imagery to Reduce Alcohol-related harm in patients with alcohol dependence and alcohol-related liver damaGE: the MIRAGE pilot trial protocol

The COVID-19 Study – JMIR Aging – April 2022
Implementing Affordable Socially Assistive Pet Robots in Care Homes Before and During the COVID-19 Pandemic: Stratified Cluster Randomized Controlled Trial and Mixed Methods Study

The SPIRES Study – Pilot and Feasibility Studies – March 2022
Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial

2021

The MaKKRO trial – Bone & Joint Open – November 2021
A randomized controlled trial comparing functional outcomes for navigated kinematically aligned total knee arthroplasty versus navigated mechanically aligned total knee arthroplasty

Mental Health Provision in UK Secondary Schools – MDPI – November 2021
Research reports high levels of mental health problems faced by young people in the UK. Schools provide a range of mental health support services, although these are often not robustly evaluated

Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic – PLOS One – October 2021
Analysis of linked cohort data

The ADIR-Deaf Adaptation and the ADOS-2 Deaf Adaptation – Journal of Clinical Medicine – September 2021
Diagnosing Autism Spectrum Disorders in Deaf Children Using Two Standardised Assessment Instruments: The ADIR-Deaf Adaptation and the ADOS-2 Deaf Adaptation

The FLYBITE Study – Wellcome Open Research – June 2021
A clinical study to optimise a sand fly biting protocol for use in a controlled human infection model of cutaneous leishmaniasis

A mixed-method feasibility study of a novel transitional regime of incremental haemodialysis – Clinical and Experimental Nephrology – June 2021
Study design and protocol

The ENDURE Study – Clinical and Experimental Nephrology – June 2021
A mixed‑method feasibility study of a novel transitional regime of incremental haemodialysis: study design and protocol

The Partners 2 Study – BJGP Open – May 2021
Evaluation of a primary care-based collaborative care model (PARTNERS2) for people with diagnoses of schizophrenia, bipolar, or other psychoses: study protocol for a cluster randomised controlled trial

Ferric Derisomaltose (FDI) – BMC Nephrology – March 2021
A multi-centre prospective double blinded randomised controlled trial of intravenous iron (ferric Derisomaltose (FDI)) in Iron deficient but not anaemic patients with chronic kidney disease on functional status

The ADOS-2 Study – Journal of Autism and Developmental Disorders – March 2021
Adapting and validating the Autism Diagnostic Observation Schedule Version 2 for use with deaf children and young people

The CANDO Study – Brain, Behaviour, & Immunity - Health – February 2021
Assessment of Cytokines, microRNA and patient related outcome measures in Conversion Disorder/Functional Neurological Disorder (CD/FND): the CANDO clinical feasibility study

The MP Rapid 2019-NCOV Study – Sage Journals – February 2021
Evaluation of the MP Rapid 2019-NCOV IgM/IgG combo POCT test vs. an established platform-based method

The NoPAC Study – Annals of Emergency Medicine – February 2021
The Use of Tranexamic Acid to Reduce the Need for Nasal Packing in Epistaxis (NoPAC): Randomized Controlled Trial

The REACH-HF Study – NIHR Journals – February 2021
A facilitated home-based cardiac rehabilitation intervention for people with heart failure and their caregivers: a research programme including the REACH-HF RCT

The EXPRESS Study – Annals of Clinical Biochemistry – February 2021
Evaluation of the MP Rapid 2019-NCOV IgM/IgG Combo POCT test vs an established platform-based method

The PINS Study – The Bone & Joint Journal – February 2021
A prospective randomised clinical trial comparing a traditional versus an emollient skincare regimen for the care of pin-sites in patients with circular frames

The NAT-C Study – January 2021
A cluster randomised trial of a Needs Assessment Tool for adult Cancer patients and their carers (NAT-C) in primary care: A feasibility study

The SARS-CoV-2 Study – Clinical Medicine Journal – January 2021
Review of hygiene adaptations among UK doctors in controlling the spread of SARS-CoV-2 infection