Perinatal emotional skills groups for women and birthing people with borderline personality disorder: outcomes from a feasibility randomised controlled trial.

Background: There is no clear evidence about how to support people with borderline personality disorder (BPD) during the perinatal period. Perinatal emotional skills groups (ESGs) may be helpful, but their efficacy has not been tested.

Aims: To test the feasibility of conducting a randomised controlled trial (RCT) of perinatal ESGs for women and birthing people with BPD.

The feasibility and acceptability of delivering a group trauma-focused intervention to children in care.

Objective: Young people in care (i.e., in the child welfare system) are a group who have often experienced very high rates of potentially traumatic events, including maltreatment.

Protocol update for a multi-centre randomised controlled trial of exercise rehabilitation for people with pulmonary hypertension: the SPHERe trial.

Background: The SPHERe (Supervised Pulmonary Hypertension Exercise Rehabilitation) trial is a multi-centre, pragmatic, randomised controlled trial assessing the clinical and cost-effectiveness of supervised exercise rehabilitation with psychosocial and motivational support compared to best-practice usual care for people with pulmonary hypertension (PH). The original protocol was published in BMC Pulmonary Medicine (accessible online). We randomised our first participant in January 2020.

Conservative management versus invasive management of significant traumatic pneumothoraces in the emergency department (the CoMiTED trial): a study protocol for a randomised non-inferiority trial.

Introduction: Traumatic pneumothoraces are present in one of five victims of severe trauma. Current guidelines advise chest drain insertion for most traumatic pneumothoraces, although very small pneumothoraces can be managed with observation at the treating clinician's discretion. There remains a large proportion of patients in whom there is clinical uncertainty as to whether an immediate chest drain is required, with no robust evidence to inform practice.

The RELIEF feasibility trial: topical lidocaine patches in older adults with rib fractures.

Background: Lidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible.

Randomised pilot and feasibility trial of a group intervention for men who perpetrate intimate partner violence against women.

Background: There is a need for robust evidence on the effectiveness and cost-effectiveness of domestic abuse perpetrator programmes in reducing abusive behaviour and improving wellbeing for victim/survivors. While any randomised controlled trial can present difficulties in terms of recruitment and retention, conducting such a trial with domestic abuse perpetrators is particularly challenging. This paper reports the pilot and feasibility trial of a voluntary domestic abuse perpetrator group programme in the United Kingdom.

The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol.

Background: Topical lidocaine patches, applied over rib fractures, have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. Older patients may gain most benefit from improved analgesic regimens yet lidocaine patches are untested as an early intervention in the Emergency Department (ED). The aim of this trial is to investigate uncertainties around trial design and conduct, to establish whether a definitive randomised trial of topical lidocaine patches in older patients with rib fractures is feasible.

The effectiveness and cost-effectiveness of a group domestic abuse perpetrator programme: protocol for a randomised controlled trial.

Background: In contrast to evidence for interventions supporting victim/survivors of domestic violence and abuse (DVA), the effectiveness of perpetrator programmes for reduction of abuse is uncertain. This study aims to estimate the effectiveness and cost-effectiveness of a perpetrator programme for men.

Methods: Pragmatic two-group individually randomised controlled trial (RCT) with embedded process and economic evaluation.

Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study.

Background: Incidence of gestational diabetes mellitus (GDM) is increasing and is associated with adverse perinatal outcomes including macrosomia, pre-eclampsia, and pre-term delivery. Optimum glycaemic control can reduce these adverse perinatal outcomes. Continuous glucose monitoring (CGM) informs users about interstitial glucose levels allowing early detection of glycaemic excursions and pharmacological or behavioural intervention.

Flash glucose monitoring in young people with type 1 diabetes-a qualitative study of young people, parents and health professionals: '.

Objectives: Flash glucose monitoring for patients with T1 diabetes avoids frequent painful finger-prick testing, thus potentially improving frequency of glucose self-monitoring. Our study aimed to explore experiences of young people using Freestyle Libre sensors and their parents, and to identify benefits and challenges to National Health Service (NHS) staff of its adoption in their care provision.

Participants: Young people with T1 diabetes, their parents and healthcare professionals were interviewed between February and December 2021.

Study protocol for First Dental Steps Intervention: feasibility study of a health visitor led infant oral health improvement programme.

Background: Dental caries in childhood is a burden on the daily lives of children and their families, and associated with poor oral health in adulthood. In England, dental caries is the most common reason for young children to be admitted to hospital. It is believed that most tooth extractions (due to decay) for children aged 10 years and under, could be avoided with improved prevention and early management.

Protocol for the RELATE trial: a feasibility and pilot randomised controlled trial of a low-intensity group intervention for young people in care with elevated posttraumatic stress symptoms.

Introduction: Young people in out-of-home care have often experienced trauma, such as direct maltreatment or witnessing violence. There is good evidence that rates of mental health difficulties are high in this group, including posttraumatic stress disorder (PTSD), a trauma-specific mental health outcome. There remains less evidence to guide how to effectively address elevated PTSD symptoms (PTSS) in these young people, particularly in ways that are feasible and scalable for stretched social-care and mental health services.

Mycophenolate Mofetil for First-Line Treatment of Immune Thrombocytopenia.

Background: Immune thrombocytopenia is a rare autoimmune disorder with associated bleeding risk and fatigue. Recommended first-line treatment for immune thrombocytopenia is high-dose glucocorticoids, but side effects, variable responses, and high relapse rates are serious drawbacks.

Methods: In this multicenter, open-label, randomized, controlled trial conducted in the United Kingdom, we assigned adult patients with immune thrombocytopenia, in a 1:1 ratio, to first-line treatment with a glucocorticoid only (standard care) or combined glucocorticoid and mycophenolate mofetil.

Costs and Cost-Effectiveness of User-Testing of Health Professionals' Guidelines to Reduce the Frequency of Intravenous Medicines Administration Errors by Nurses in the United Kingdom: A Probabilistic Model Based on Voriconazole Administration.

Aim: In the UK, injectable medicines are often prepared and administered by nurses following the Injectable Medicines Guide (IMG). Our earlier study confirmed a higher frequency of correct administration with user-tested versus standard IMG guidelines. This current study aimed to model the cost-effectiveness of user-testing.

Considerations for Individual-Level Versus Whole-School Physical Activity Interventions: Stakeholder Perspectives.

Strategies to address declining physical activity levels among children and adolescents have focused on 'individual-level' approaches which often fail to demonstrate impact. Recent attention has been on an alternative 'whole-school' approach to increasing physical activity that involves promoting physical activity throughout all aspects of the school environment. There is, however, a lack of evidence on how whole-school physical activity approaches could be implemented in the UK.

Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial.

Background: Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls.

Physical Activity and Psychosocial Characteristics of the Peer Supporters in the PLAN-A Study-A Latent Class Analysis.

PLAN-A is a cluster randomised controlled trial of a peer-led physical activity intervention which uses peer supporters to increase the physical activity of 13-14-year-old girls in the UK. This paper uses latent class analysis to identify classes in the whole study population and investigate how those selected as peer supporters in PLAN-A were drawn from different social groups. We identified five classes of girls, based on psychosocial variables (self-esteem, physical activity self-efficacy, motivation, physical activity values among friends and peer support for physical activity (PA) and physical activity behaviour variables (average minutes of weekday MVPA, sedentary time and screen viewing).

Involving Patients in Health Economics Research: "The PACTS Principles".

Discussion of public and patient involvement (PPI) in health economics (HE) research is growing. There is much literature on PPI principles and standards, but little specifically regarding involving patients in HE research. Here, we outline "PACTS", a set of principles, developed with a PPI group, for considering patient involvement in HE research.

Limit of detection of troponin discharge strategy versus usual care: randomised controlled trial.

Introduction: The clinical effectiveness of a 'rule-out' acute coronary syndrome (ACS) strategy for emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown.

Methods: A randomised controlled trial, across eight hospitals in the UK, aimed to establish the clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy. Eligible adult patients presented with chest pain; the treating clinician intended to perform investigations to rule out an ACS; the initial ECG was non-ischaemic; and peak symptoms occurred <6 hours previously.