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View article: O04 Mission EB -mesenchymal intravenous stromal cell infusions in children with recessive dystrophic epidermolysis bullosa: a randomised, double-blinded, placebo controlled, crossover trial
O04 Mission EB -mesenchymal intravenous stromal cell infusions in children with recessive dystrophic epidermolysis bullosa: a randomised, double-blinded, placebo controlled, crossover trial Open
Recessive Dystrophic Epidermolysis Bullosa (RDEB) is a severe type of epidermolysis bullosa resulting from mutations in COL7A1 gene. Patients experience various degrees of blistering following minor trauma which can over time lead to fibro…
View article: Increasing activity and reducing sedentary behaviour for people with severe mental illness: what are the active ingredients for behaviour change? A systematic review
Increasing activity and reducing sedentary behaviour for people with severe mental illness: what are the active ingredients for behaviour change? A systematic review Open
Increasing physical activity (PA) and reducing sedentary behaviour (SB) can improve health outcomes and reduce rates of premature mortality for people with severe mental illness (SMI). In this systematic review we aimed to explore the acti…
View article: Mesenchymal intravenous stromal cell infusions in children with recessive dystrophic epidermolysis bullosa: MissionEB protocol for a randomised, double-blinded, placebo-controlled, two-centre, crossover trial with an internal phase I dose de-escalation phase and open-label extension
Mesenchymal intravenous stromal cell infusions in children with recessive dystrophic epidermolysis bullosa: MissionEB protocol for a randomised, double-blinded, placebo-controlled, two-centre, crossover trial with an internal phase I dose de-escalation phase and open-label extension Open
Introduction Recessive dystrophic epidermolysis bullosa (RDEB) is a severe genetic mucocutaneous fragility disorder characterised by chronic blistering, slow wound healing and increased risk of squamous cell carcinoma. Current management o…
View article: Randomised controlled trial with parallel process evaluation and health economic analysis to evaluate a nutritional management intervention, OptiCALS, for patients with amyotrophic lateral sclerosis: study protocol
Randomised controlled trial with parallel process evaluation and health economic analysis to evaluate a nutritional management intervention, OptiCALS, for patients with amyotrophic lateral sclerosis: study protocol Open
Introduction Amyotrophic lateral sclerosis (ALS) is a devastating illness that leads to muscle weakness and death usually within around 3 years of diagnosis. People with ALS (pwALS) often lose weight due to raised energy requirements and s…
View article: Multiple Symptoms Study 3 – An extended-role general practitioner clinic for patients with persistent physical symptoms: a Randomised Controlled Trial
Multiple Symptoms Study 3 – An extended-role general practitioner clinic for patients with persistent physical symptoms: a Randomised Controlled Trial Open
Background People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based Symptoms Clinic intervention in people with mul…
View article: TRanscutaneous lImb reCovEry Post-Stroke (TRICEPS): study protocol for a randomised, controlled, multiarm, multistage adaptive design trial
TRanscutaneous lImb reCovEry Post-Stroke (TRICEPS): study protocol for a randomised, controlled, multiarm, multistage adaptive design trial Open
Introduction Arm weakness after stroke is one of the leading causes of adult-onset disability. Invasive vagus nerve stimulation (VNS) paired with rehabilitation has been shown to improve arm recovery in chronic stroke. Small studies of non…
View article: Acceptance and Commitment Therapy for people living with motor neuron disease: the COMMEND feasibility study and randomised controlled trial
Acceptance and Commitment Therapy for people living with motor neuron disease: the COMMEND feasibility study and randomised controlled trial Open
Background Motor neuron disease is a progressive, fatal neurodegenerative disease for which there is no cure. Formal psychological therapies are not routinely part of United Kingdom standard motor neuron disease care due to a lack of evide…
View article: Recommendations on recording harms in randomised controlled trials of behaviour change interventions
Recommendations on recording harms in randomised controlled trials of behaviour change interventions Open
Harms are possible from behaviour change interventions, such as the worsening of a health behaviour intended for change (rebound effect), improving a health behaviour but with subsequent worsening of another behaviour (risk compensation), …
View article: Development of the STEP UP guidance to help researchers design inclusive clinical trials.
Development of the STEP UP guidance to help researchers design inclusive clinical trials. Open
Background It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular un…
View article: The accuracy of prehospital triage decisions in English trauma networks – a case-cohort study
The accuracy of prehospital triage decisions in English trauma networks – a case-cohort study Open
Background Care for injured patients in England is provided by inclusive regional trauma networks. Ambulance services use triage tools to identify patients with major trauma who would benefit from expedited Major Trauma Centre (MTC) care. …
View article: Cost‐effectiveness of acceptance and commitment therapy for people living with motor neuron disease, and their health‐related quality of life
Cost‐effectiveness of acceptance and commitment therapy for people living with motor neuron disease, and their health‐related quality of life Open
Background Given the degenerative nature of the condition, people living with motor neuron disease (MND) experience high levels of psychological distress. The purpose of this research was to investigate the cost‐effectiveness of acceptance…
View article: Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review
Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review Open
Background Participants in clinical trials often do not reflect the populations that could benefit from the treatments being investigated. There are known barriers to trial participation for under-served groups, but limited evidence on str…
View article: Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)
Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs) Open
Background Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on repl…
View article: Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives
Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives Open
Objectives To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials. Design Qualitative interviews analysed using thematic analysis. Setting and participants Five professionals (clinical researchers…
View article: Supporting physical activity through co-production in people with severe mental ill health (SPACES): protocol for a randomised controlled feasibility trial
Supporting physical activity through co-production in people with severe mental ill health (SPACES): protocol for a randomised controlled feasibility trial Open
Background Severe mental ill health (SMI) includes schizophrenia, bipolar disorder and schizoaffective disorder and is associated with premature deaths when compared to people without SMI. Over 70% of those deaths are attributed to prevent…
View article: Implementation successes and lessons learnt from a randomised controlled trial of a complex school-based intervention
Implementation successes and lessons learnt from a randomised controlled trial of a complex school-based intervention Open
Background The UK has seen a recent shift towards children’s mental health being supported and treated in school settings. Several current school-based interventions focus on autism and social skills, with education professional involvemen…
View article: Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial
Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial Open
Introduction Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III …
View article: Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme
Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme Open
Background Randomised controlled trials (‘trials’) are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and reten…
View article: Identifying the Active Ingredients of a Computerized Speech and Language Therapy Intervention for Poststroke Aphasia: Multiple Methods Investigation Alongside a Randomized Controlled Trial
Identifying the Active Ingredients of a Computerized Speech and Language Therapy Intervention for Poststroke Aphasia: Multiple Methods Investigation Alongside a Randomized Controlled Trial Open
Background Aphasia is a communication disorder affecting more than one-third of stroke survivors. Computerized Speech and Language Therapy (CSLT) is a complex intervention requiring computer software, speech and language therapists, volunt…
View article: Play brick therapy to aid the social skills of children and young people with autism spectrum disorder: the I-SOCIALISE cluster RCT
Play brick therapy to aid the social skills of children and young people with autism spectrum disorder: the I-SOCIALISE cluster RCT Open
Background Social skills interventions are commonly recommended to help children and young people with autism spectrum disorder develop social skills, but some struggle to engage in these interventions. LEGO ® (LEGO System A/S, Billund, De…
View article: Interventions to increase physical activity and reduce sedentary behaviour in severe mental ill health: How effective are they?’- A systematic review
Interventions to increase physical activity and reduce sedentary behaviour in severe mental ill health: How effective are they?’- A systematic review Open
Background People with severe mental ill health experience a mortality gap of 15–20 years and one of the main reasons for this is due to preventable physical health conditions. Physical activity can reduce the risk of developing physical h…
View article: Acceptance and Commitment Therapy for people living with motor neuron disease: an uncontrolled feasibility study
Acceptance and Commitment Therapy for people living with motor neuron disease: an uncontrolled feasibility study Open
Background Motor neuron disease (MND) is a fatal, progressive neurodegenerative disease that causes progressive weakening and wasting of limb, bulbar, thoracic and abdominal muscles. Clear evidence-based guidance on how psychological distr…
View article: (325) The Role of Advanced Practice Providers Who Treat Men’s Health Urologic Conditions: An Analysis of Medicare and Commercial Claims in the United States
(325) The Role of Advanced Practice Providers Who Treat Men’s Health Urologic Conditions: An Analysis of Medicare and Commercial Claims in the United States Open
Introduction The role of advanced practice providers (APPs) had expanded in the recent years according to the AUA. This increase of APPs had been endorsed by AUA to offset the increasing burden on the urologist workforce. Moreover, contemp…
View article: I-SOCIALISE: Results from a cluster randomised controlled trial investigating the social competence and isolation of children with autism taking part in LEGO<sup>®</sup> based therapy (‘Play Brick Therapy’) clubs in school environments
I-SOCIALISE: Results from a cluster randomised controlled trial investigating the social competence and isolation of children with autism taking part in LEGO<sup>®</sup> based therapy (‘Play Brick Therapy’) clubs in school environments Open
Social learning through friendships is important in child development. Autistic children often initiate and engage in social interactions differently than neurotypical peers. LEGO ® based therapy is a group intervention which facilitates s…
View article: Identifying the Active Ingredients of a Computerized Speech and Language Therapy Intervention for Poststroke Aphasia: Multiple Methods Investigation Alongside a Randomized Controlled Trial (Preprint)
Identifying the Active Ingredients of a Computerized Speech and Language Therapy Intervention for Poststroke Aphasia: Multiple Methods Investigation Alongside a Randomized Controlled Trial (Preprint) Open
BACKGROUND Aphasia is a communication disorder affecting more than one-third of stroke survivors. Computerized Speech and Language Therapy (CSLT) is a complex intervention requiring computer software, speech and language therapists, volun…
View article: Physical Activity in Adults with Schizophrenia and Bipolar Disorder: A Large Cross-Sectional Survey Exploring Patterns, Preferences, Barriers, and Motivating Factors
Physical Activity in Adults with Schizophrenia and Bipolar Disorder: A Large Cross-Sectional Survey Exploring Patterns, Preferences, Barriers, and Motivating Factors Open
Adults with severe mental ill health may have specific attitudes toward physical activity. To inform intervention development, we conducted a survey to assess the physical activity patterns, preferences, barriers, and motivations of adults…