A randomised controlled clinical and cost effectiveness trial of an online integrated bipolar parenting intervention (IBPI) compared to treatment as usual in improving child emotional and behavioural outcomes: a study protocol.

Background: Bipolar disorder (BD) is a severe mental health problem linked to substantial personal and social costs. Many individuals living with bipolar disorder are parents. Due to the nature of the condition, parents with BD often experience challenges in delivering consistent parenting.

A feasibility study of a physical activity intervention for people with severe mental illness in medium secure psychiatric services in the United Kingdom.

Background: In the UK, there are approximately 3500 individuals detained in medium secure service. Service users in such settings have complex and severe mental illness (SMI), often with co-morbid physical health problems, shorter life expectancy and low levels of physical activity (PA). However, there are few studies about PA interventions for medium secure service users in the United Kingdom.

Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change: Bipolar At Risk Trial II (BART II).

Background: Research has demonstrated the ability to identify and treat individuals at high risk of developing psychosis. It is possible to use a similar strategy to identify people who have an emergent risk of bipolar disorder (BD). Interventions during the early phase may improve outcomes and reduce risk of transition.

Promoting smoking cessation and preventing relapse to tobacco use following a smoke-free mental health inpatient stay (SCEPTRE feasibility study): a multicentre randomised controlled feasibility study protocol.

Introduction: Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond.

DIAMONDS-a diabetes self-management intervention for people with severe mental illness: protocol for an individually randomised controlled multicentre trial.

Introduction: Type 2 diabetes mellitus (T2DM) is two to three times more common in people with severe mental illness (SMI) than in the general population. Supporting self-management in diabetes is fundamental to improving clinical outcomes. The DIAMONDS trial aims to evaluate the clinical and cost effectiveness of a novel, codesigned, supported diabetes self-management programme for people with T2DM and SMI.

Sessions of acupuncture and nutritional therapy evaluation for atrial fibrillation (Santé-AF): a randomised feasibility study.

Background: Atrial fibrillation is a common cardiac arrhythmia, associated with debilitating symptoms and a decrease in health-related quality of life. Current treatments for atrial fibrillation may not provide symptomatic relief and are associated with risks and adverse responses. Large-scale trials are justified to investigate whether complementary therapies may improve symptoms and/or health-related quality of life in atrial fibrillation.

Autism Spectrum Social Stories in Schools Trial 2 (ASSSIST-2): a pragmatic randomised controlled trial of the Social Stories™ intervention to address the social and emotional health of autistic children in UK primary schools.

Background: Autistic children can experience mental health, social and emotional difficulties. Carol Gray's Social Stories™ are a highly personalised intervention that provide social information in a short individually tailored story.

Methods: A multi-site pragmatic cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of Social Stories™ alongside care as usual in autistic children aged 4-11 years.

A cross-over, randomised feasibility study of digitally-printed versus hand-painted artificial eyes in adults: PERSONAL-EYE-S.

Background/objectives: Over 60,000 patients in the United Kingdom are estimated to have artificial eyes. Manufacturing and hand-painting of artificial eyes have not changed significantly since 1948. Delays and colour-matching issues may severely impact a patient's rehabilitation pathway.

Cost-utility analysis of Social Stories™ for children with autism spectrum disorder in mainstream primary schools: results from a randomised controlled trial.

Background: One in 57 children are diagnosed with autism in the UK, and the estimated cost for supporting these children in education is substantial. Social Stories™ is a promising and widely used intervention for supporting children with autism in schools and families. It is believed that Social Stories™ can provide meaningful social information to children that can improve social understanding and may reduce anxiety.

Living with an artificial eye: qualitative insights into patient and family member experiences.

Purpose: Artificial eye users (AEUs) can experience a negative impact on psychological and emotional wellbeing, including reduced social functioning, which may be a consequence of living with one eye removed, and/or of having a prosthetic eye. This may have wider consequences for their families. We aimed to explore what it means to live with a prosthetic eye, for both AEUs and their families-and how any quality of life (QoL) issues impact on their day-to-day functioning.

From Pandemic to Epidemic: Lessons Learned From COVID-19 Applied to Mpox Outbreak Response, Westchester County, Metropolitan New York.

The COVID-19 pandemic vaccination infrastructure was redeployed to address the Mpox epidemic. The Westchester County Department of Health coordinated an effective vaccine distribution, tracking, and data collection process with community partners with real-time feedback of operational challenges and updated public health directives. Westchester County, which comprises 9% of the New York State population, administered 24% (6770 doses) of JYNNEOS (smallpox and monkeypox vaccine) across the state.

A systematic review and meta-analysis of randomised controlled trials of surgical treatments for ingrown toenails part II: healing time, post-operative complications, pain, and participant satisfaction.

Background: When performing nail surgery, clinicians must choose from a multitude of procedures and variations within each procedure. Much has been published to guide this decision making, but there are a lack of up to date robust systematic reviews to assess the totality of this evidence.

Methods: Five databases (MEDLINE, Embase, CINAHL, Web of Science and CENTRAL) and two registers (Clinicaltrials.

A systematic review and meta-analysis of randomised controlled trials on surgical treatments for ingrown toenails part I: recurrence and relief of symptoms.

Background: Ingrown toenails are a common nail pathology. When conservative treatments are ineffective, a surgical approach is often utilised. Despite recent narrative reviews, there is a need for an up-to-date and rigorous systematic review of surgical methods for treating ingrown toenails.

A randomised controlled, feasibility study to establish the acceptability of early outpatient review and early cardiac rehabilitation compared to standard practice after cardiac surgery and viability of a future large-scale trial (FARSTER).

Objective: To determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable.

Methods: A randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18-80 years from two UK cardiac centres who had undergone elective or urgent cardiac surgery via a median sternotomy. Eligible, consenting participants were randomised 1:1 by a remote, centralised randomisation service to postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control), or postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention).

'A whole different ball game': the qualitative experience of older adults with a transtibial amputation and the use of a self-aligning prosthetic ankle-foot on the STEPFORWARD trial.

Background: Older patients with lower limb amputation, categorised as having "limited community mobility", are under-researched. Understanding their experience with a new prosthetic ankle-foot is important when designing clinical trials. The aim of this qualitative study was to explore the adjustments they made after amputation and the acceptability of a self-aligning ankle-foot (SA-AF) to older adults.

A cross-over, randomised feasibility study of digitally printed versus hand-painted artificial eyes in adults: PERSONAL-EYE-S - a study protocol.

Background/objective: Around 11,500 artificial eyes are required yearly for new and existing patients. Artificial eyes have been manufactured and hand-painted at the National Artificial Eye Service (NAES) since 1948, in conjunction with approximately 30 local artificial eye services throughout the country. With the current scale of demand, services are under significant pressure.

Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial.

Objective: To examine effectiveness, cost effectiveness, generalisability, and acceptability of financial incentives for smoking cessation during pregnancy in addition to variously organised UK stop smoking services.

Design: Pragmatic, multicentre, single blinded, phase 3, randomised controlled trial (Cessation in Pregnancy Incentives Trial phase 3 (CPIT III)).

Setting: Seven UK stop smoking services provided in primary and secondary care facilities in Scotland, Northern Ireland, and England.

Effectiveness of offering tailored text message, self-help smoking cessation support to pregnant women who want information on stopping smoking: MiQuit3 randomised controlled trial and meta-analysis.

Aims: To test the efficacy of 'MiQuit', a tailored, self-help, text message stop smoking programme for pregnancy, as an adjunct to usual care (UC) for smoking cessation in pregnancy.

Design: Multicentre, open, two-arm, parallel-group, superiority randomised controlled trial (RCT) and a trial sequential analysis (TSA) meta-analysis combining trial findings with two previous ones.

Setting: Twenty-four English hospital antenatal clinics.

Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR).

Objective: To establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service.

Design: Randomised controlled, open feasibility trial with embedded economic and process evaluations.

Setting: Audiology departments in two hospitals in two UK cities.

STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations.

Objectives: To determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot.

Design: Multicentre parallel group feasibility RCT.

Setting: Five prosthetics centres in England recruiting from July 2018 to August 2019.

Optimising retention success: a research team's experience of following-up participants recruited to a pilot trial through community pharmacies in England.

: The CHAMP-1 ( Community pharmacy: Highlighting Alcohol use in Medication a Ppointments) pilot trial aimed to explore an intervention discussing alcohol during medication consultations with community pharmacists. It presented various challenges regarding patient retention, as participants were recruited by their pharmacist and followed-up remotely by a trained researcher, who they had not met, two months later.  We discuss our actions and experiences of completing follow-up activities.

The RESPECT study: a feasibility randomised controlled trial of a sexual health promotion intervention for people with serious mental illness in community mental health services in the UK.

Background: People with serious mental illness (SMI) have sexual health needs but there is little evidence to inform effective interventions to address them. In fact, there are few studies that have addressed this topic for people with SMI outside USA and Brazil. Therefore, the aim of the study was to establish the acceptability and feasibility of a trial of a sexual health promotion intervention for people with SMI in the UK.

A pilot cluster randomised trial of the medicines and alcohol consultation (MAC): an intervention to discuss alcohol use in community pharmacy medicine review services.

Background: Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial.

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial.

Background: Eighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit.