Preparing for responsive management versus preparing for renal dialysis in multimorbid older people with advanced chronic kidney disease (Prepare for Kidney Care): Study protocol for a randomised controlled trial.

Background: Chronic kidney disease (CKD) prevalence is steadily increasing, in part due to increased multimorbidity in our aging global population. When progression to kidney failure cannot be avoided, people need unbiased information to inform decisions about whether to start dialysis, if or when indicated, or continue with holistic person-centred care without dialysis (conservative kidney management). Comparisons suggest that while there may be some survival benefit from dialysis over conservative kidney management, in people aged 80 years and over, or with multiple health problems or frailty, this may be at the expense of quality of life, hospitalisations, symptom burden and preferred place of death.

Capturing and reporting topical treatment use in childhood eczema: lessons for data collection in eczema trials.

Background: Emollients and topical corticosteroids (TCS) prevent and treat flares in eczema. However, topical treatment use is poorly recorded and reported in clinical trials. There is no clear consensus of how best to capture and summarise topical treatment use.

Lower urinary tract symptoms in men: the TRIUMPH cluster RCT.

Background: Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery.

Objective: The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care.

Education to improve timeliness of shingles diagnosis in primary care: a cluster randomised study within a trial with nested qualitative study.

Background: Herpes zoster (shingles) is normally diagnosed clinically. Timely diagnosis is important so that antiviral treatment can be started soon after rash onset.

Aim: To assess whether a practice-level educational intervention, aimed at non-clinical patient-facing staff, improves the timely assessment of patients with shingles.

Cost-effectiveness of a primary healthcare intervention to treat male lower urinary tract symptoms: the TRIUMPH cluster randomised controlled trial.

Objectives: To estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care.

Design: Economic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon.

Setting: Thirty NHS general practice sites in England.

Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial.

Background: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed to manage anxiety in adults with an autism diagnosis. However, their effectiveness and adverse effect profile in the autistic population are not well known. This trial aims to determine the effectiveness and cost-effectiveness of the SSRI sertraline in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism compared with placebo and to quantify any adverse effects.

Parent satisfaction with lotion, cream, gel and ointment emollient types: secondary analysis of the Best Emollients for Eczema study.

Background: The main determinant of emollient effectiveness is whether it is used, which in turn is linked with user satisfaction.

Objectives: To compare parental satisfaction with emollient type for the treatment of childhood eczema.

Methods: Secondary analysis of data from the Best Emollients for Eczema (BEE) trial was undertaken.

Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial.

Objective: To determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care.

Design: Cluster randomised controlled trial.

Setting: 30 National Health Service general practice sites in England.

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial.

Background: Cognitive behavioural therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at a lower cost. However, adherence is often poor and, in the absence of therapist support, effects are modest and short-term.

Do temperature changes cause eczema flares? An English cohort study.

Background: It is unclear if ambient temperature changes affect eczema. It is also unclear if people with worse disease are more susceptible to weather-related flares, or specific types of emollient offer protection.

Objectives: To investigate the effect of short-term temperature variations on eczema symptoms in children.

Investigating strategies to improve AccesS to Kidney transplantation (the ASK trial): a protocol for a feasibility randomised controlled trial with parallel process evaluation.

Background: The UK's living-donor kidney transplant (LDKT) activity falls behind that of many other countries internationally, with less than 20% of those eligible receiving a LDKT each year. Certain individuals with kidney disease in the UK appear to be particularly disadvantaged in accessing a LDKT; the most socioeconomically deprived people with kidney disease are 60% less likely to receive a LDKT than the least deprived. Improving equity in living-donor kidney transplantation has been highlighted as an international research priority.

The high-volume haemodiafiltration vs high-flux haemodialysis registry trial (H4RT): a multi-centre, unblinded, randomised, parallel-group, superiority study to compare the effectiveness and cost-effectiveness of high-volume haemodiafiltration and high-flux haemodialysis in people with kidney failure on maintenance dialysis using linkage to routine healthcare databases for outcomes.

Background: More than a third of the 65,000 people living with kidney failure in the UK attend a dialysis unit 2-5 times a week to have their blood cleaned for 3-5 h. In haemodialysis (HD), toxins are removed by diffusion, which can be enhanced using a high-flux dialyser. This can be augmented with convection, as occurs in haemodiafiltration (HDF), and improved outcomes have been reported in people who are able to achieve high volumes of convection.

Effectiveness and safety of lotion, cream, gel, and ointment emollients for childhood eczema: a pragmatic, randomised, phase 4, superiority trial.

Background: To our knowledge, there are no trials comparing emollients commonly used for childhood eczema. We aimed to compare the clinical effectiveness and safety of the four main emollient types: lotions, creams, gels, and ointments.

Methods: We did a pragmatic, individually randomised, parallel group, phase 4 superiority trial in 77 general practice surgeries in England.

Emollient satisfaction questionnaire: validation study in children with eczema.

Background: Emollients are used as maintenance therapy for all severities of eczema but there is a lack of head-to-head comparisons of effectiveness and acceptability.

Aim: To determine the validity of a self-report questionnaire designed to assess user satisfaction with a given emollient and to report the findings.

Methods: Data were analysed from the Choice of Moisturiser for Eczema Treatment trial, which compared four emollient types (Aveeno lotion, Diprobase cream, Doublebase gel and Hydromol ointment) in children aged < 5 years with clinically diagnosed eczema.

Rise in prescribing for anxiety in UK primary care between 2003 and 2018: a population-based cohort study using Clinical Practice Research Datalink.

Background: Little is known about trends in prescribing of anxiolytics (antidepressants, benzodiazepines, beta-blockers, anticonvulsants, and antipsychotics) for treatment of anxiety. Several changes may have affected prescribing in recent years, including changes in clinical guidance.

Aim: To examine trends in prescribing for anxiety in UK primary care between 2003 and 2018.

Frequency of guideline-defined cow's milk allergy symptoms in infants: Secondary analysis of EAT trial data.

Background: Non-IgE-mediated Cow's Milk Allergy (CMA) has a prevalence of less than 1% in children. Guidelines developed to help non-specialists diagnose CMA may lead to misattribution of normal symptoms and contribute to overdiagnosis of CMA. We sought to establish the frequency of symptoms during infancy associated with non-IgE-mediated CMA, using the international Milk Allergy in Primary Care (iMAP) guideline as representative of CMA guidelines more generally.

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.

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.

Using datasets to ascertain the generalizability of clinical cohorts: the example of the European QUALity study on the treatment of advanced chronic kidney disease.

Background: Cohort studies are among the most robust of observational studies but have issues with external validity. This study assesses threats to external validity (generalizability) in the European QUALity (EQUAL) study, a cohort study of people >65 years of age with Stage 4/5 chronic kidney disease.

Methods: Patients meeting the EQUAL inclusion criteria were identified in The Health Improvement Network database and stratified into those attending renal units, a secondary care cohort (SCC) and a not primary care cohort (PCC).

Investigating Ethnic Disparity in Living-Donor Kidney Transplantation in the UK: Patient-Identified Reasons for Non-Donation among Family Members.

There is ethnic inequity in access to living-donor kidney transplants in the UK. This study asked kidney patients from Black, Asian and minority ethnic groups why members of their family were not able to be living kidney donors. Responses were compared with responses from White individuals.

Does anxiety moderate the effectiveness of mirtazapine in patients with treatment-resistant depression? A secondary analysis of the MIR trial.

Background: There is a lack of evidence to guide treatment of comorbid depression and anxiety. Preliminary evidence suggests mirtazapine may be effective in treating patients with both depression and anxiety symptoms.

Methods: We undertook a secondary analysis of mirtazapine (MIR): a placebo-controlled trial of the addition of mirtazapine to a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in treatment-resistant depression (TRD) in primary care.

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).