Interpersonal counselling for adolescent depression delivered by youth mental health workers without core professional training: the ICALM feasibility RCT.

Background: As milder cases of adolescent depression do not meet treatment thresholds for specialist mental health services, young people often receive support from non-qualified professionals in third-sector/voluntary agencies. Early psychological interventions to meet growing demand with limited resources are crucial.

Objectives: The study aimed to explore the effectiveness and cost effectiveness of interpersonal counselling for adolescents by (1) assessing the feasibility and acceptability of trial procedures; (2) exploring the delivery of, and differences between, interpersonal counselling for adolescents and treatment as usual; (3) evaluating the extent of contamination of the control arm and if it should be mitigated against in a future trial; and (4) investigating whether the interval estimate of benefit of interpersonal counselling for adolescents over treatment as usual in depression post treatment includes a clinically significant effect.

Musculoskeletal shoulder pain: Home exercise frequency and adherence to appointments are not mediators of outcome.

Objective: To investigate whether appointment adherence and frequency of home exercises mediates the association of baseline i) pain self-efficacy (PSE) or ii) patient expectation of recovery, with outcome at 6 months.

Design: Multicentre longitudinal cohort study.

Methods: Six-month outcome data (SPADI, QuickDASH) were provided by 810 of 1030 recruited participants.

Development of a National Ménière's Disease Registry: A Feasibility Study.

Ménière's disease is a disabling condition causing vertigo and hearing loss yet remains incompletely understood. Registry studies have the potential to answer important questions about phenotypes and natural history of clinical conditions. The aim of this study was to explore the feasibility of a patient-centered national Ménière's disease registry.

An online intervention for carers to manage behavioral symptoms in motor neuron disease (MiNDToolkit): a randomized parallel multi-center feasibility trial.

Background: Evidence on management of behavioral symptoms in motor neuron disease (MND) is lacking. The MiNDToolkit, an online psychoeducational platform, supports carers dealing with behavioral symptoms (BehSymp). The study objectives were to ascertain recruitment and retention rates, carer and healthcare professional (HCP) use of the platform, and completion of online assessments, to inform a full-scale trial.

A smoking cessation smartphone app that delivers real-time 'context aware' behavioural support: the Quit Sense feasibility RCT.

Background: During a quit attempt, cues from a smoker's environment are a major cause of brief smoking lapses, which increase the risk of relapse. Quit Sense is a theory-guided Just-In-Time Adaptive Intervention smartphone app, providing smokers with the means to learn about their environmental smoking cues and provides 'in the moment' support to help them manage these during a quit attempt.

Objective: To undertake a feasibility randomised controlled trial to estimate key parameters to inform a definitive randomised controlled trial of Quit Sense.

Effects of an Increased Financial Incentive on Follow-up in an Online, Automated Smoking Cessation Trial: A randomized Controlled Study Within a Trial.

Introduction: Poor retention in clinical trials can impact on statistical power, reliability, validity, and generalizability of findings and is a particular challenge in smoking cessation studies. In online trials with automated follow-up mechanisms, poor response also increases the resource need for manual follow-up. This study compared two financial incentives on response rates at 6 months follow up, in an online, automated smoking cessation feasibility trial of a cessation smartphone app (Quit Sense).

Doing research in non-specialist mental health services for children and young people: lessons learnt from a process evaluation of the ICALM (Interpersonal Counselling for Adolescent Low Mood) feasibility randomised controlled trial.

Background: The rising prevalence of adolescent mild depression in the UK and the paucity of evidence-based interventions in non-specialist sectors where most cases present, creates an urgent need for early psychological interventions. Randomised controlled trials (RCTs) are considered the gold standard for obtaining unbiased estimates of intervention effectiveness. However, the complexity of mental health settings poses great challenges for effectiveness evaluations.

Cluster Analysis to Identify Clinical Subtypes of Ménière's Disease.

Objective: To identify distinct clinical subtypes of Ménière's disease by analyzing data acquired from a UK registry of patients who have been diagnosed with Ménière's disease.

Study Design: Observational study.

Methods: Patients with Ménière's disease were identified at secondary/tertiary care clinics.

A pragmatic, multicentre, double-blind, placebo-controlled randomised trial to assess the safety, clinical and cost-effectiveness of mirtazapine and carbamazepine in people with Alzheimer's disease and agitated behaviours: the HTA-SYMBAD trial.

Background: Agitation is common and impacts negatively on people with dementia and carers. Non-drug patient-centred care is first-line treatment, but we need other treatment when this fails. Current evidence is sparse on safer and effective alternatives to antipsychotics.

Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes.

Background: Hybrid closed-loop insulin therapy has shown promise for management of type 1 diabetes during pregnancy; however, its efficacy is unclear.

Methods: In this multicenter, controlled trial, we randomly assigned pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5% at nine sites in the United Kingdom to receive standard insulin therapy or hybrid closed-loop therapy, with both groups using continuous glucose monitoring.

Risk Factors for the Development of Bilateral Ménière's Disease.

Objective: To identify key risk factors for the development of bilateral Ménière's disease.

Study Designs: Observational study.

Setting: Four NHS Trusts and four independent hospitals or clinics, within three distinct urban and rural regions within the United Kingdom (Norfolk, Leicestershire, and London).

Proprioception Analysis following Anterior Cruciate Ligament Reconstruction using Stabilometry: A Prospective, Longitudinal Study.

 Commonly used methods for measuring proprioception have resulted in conflicting reports regarding knee proprioception with anterior cruciate ligament (ACL) rupture and the influence of ACL reconstruction.  One hundred subjects (50 patients with radiologically and arthroscopically confirmed unilateral ACL rupture and 50 normal controls) were assessed with regards to proprioception using dynamic single-leg stance postural stabilometry. Instrumented knee ligament laxity and knee outcome scores were also measured.

Alcohol Consumption and Measures of Sarcopenic Muscle Risk: Cross-Sectional and Prospective Associations Within the UK Biobank Study.

Alcohol intake is a major modifiable risk factor for many diseases. Alcohol can also damage skeletal muscle health during ageing which in turn increases risk of sarcopenia, frailty and falls but this relationship is understudied. The aim of this study was to model the relationship between a full range of alcohol consumption and components of sarcopenic risk, skeletal muscle mass and function, in middle-aged and younger older-aged men and women.

An Automated, Online Feasibility Randomized Controlled Trial of a Just-In-Time Adaptive Intervention for Smoking Cessation (Quit Sense).

Introduction: Learned smoking cues from a smoker's environment are a major cause of lapse and relapse. Quit Sense, a theory-guided Just-In-Time Adaptive Intervention smartphone app, aims to help smokers learn about their situational smoking cues and provide in-the-moment support to help manage these when quitting.

Methods: A two-arm feasibility randomized controlled trial (N = 209) to estimate parameters to inform a definitive evaluation.

Multimorbidity pattern and risk of dementia in later life: an 11-year follow-up study using a large community cohort and linked electronic health records.

Background: Several long-term chronic illnesses are known to be associated with an increased risk of dementia independently, but little is known how combinations or clusters of potentially interacting chronic conditions may influence the risk of developing dementia.

Methods: 447 888 dementia-free participants of the UK Biobank cohort at baseline (2006-2010) were followed-up until 31 May 2020 with a median follow-up duration of 11.3 years to identify incident cases of dementia.

Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial.

Objective: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes.

Design: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes.

Setting: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads.

A randomised feasibility study of serial magnetic resonance imaging to reduce treatment times in Charcot neuroarthropathy in people with diabetes (CADOM).

Aim: This study aims to explore the feasibility of using serial MRI without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot, in order to decide whether a large-scale trial is warranted.

Methods: A multicentre, randomised, prospective, two arm, open, feasibility study (CADOM) of people with diabetes with a suspected or confirmed diagnosis of Charcot neuroarthropathy. Participants were randomised (1:1) to 'standard care plus', including repeated foot temperature measurements and X-rays, or the intervention arm, with additional three-monthly MRI, until remission of Charcot neuroarthropathy or a maximum 12 months (active phase).

Clinical Outcome Measures in Arthroscopic Meniscectomy: Clinician Patient Completed Knee Scores.

 The aim of the present study was to investigate the difference between clinician-completed and patient-completed outcome scores in detecting improvement following arthroscopic meniscectomy in patients with meniscal tears of the knee.  Thirty-four patients with meniscal tears were prospectively assessed using 9 clinical outcome measures. The five clinician-completed knee scores included the Tegner Activity Score, the Lysholm Knee Score, the Cincinnati Knee Score, the International Knee Documentation Committee (IKDC) Examination Knee Score, and the Tapper and Hoover Meniscal Grading Score.

Psychiatric inpatient admissions and discharges of people with intellectual disabilities: A time series analysis of English national data.

Background: We examined whether a series of variables were related to the number of psychiatric inpatients using publicly available data about English psychiatric bed utilisation and NHS workforce.

Method: Using linear regression, with auto-regressive errors, we examined relationships between variables over time using data from December 2013 to March 2021.

Results: Over time, the number of inpatients reduced by either 6.

Patient reported outcome measures in anterior cruciate ligament rupture and reconstruction: The significance of outcome score prediction.

Background: Numerous anterior cruciate ligament (ACL) clinical outcome measures exist. However, the result of one score does not equate to the findings of another even when evaluating the same patient group.

Aim: To investigate if statistically derived formulae can be used to predict the outcome of one knee scoring system when the result of another is known in patients with ACL rupture before and after reconstruction.

A systematic review of in-patient psychiatric care for people with intellectual disabilities and/or autism: effectiveness, patient safety and experience.

Background: An increasing number of children, adolescents and adults with intellectual disabilities and/or autism are being admitted to general psychiatric wards and cared for by general psychiatrists.

Aims: The aim of this systematic review was to consider the likely effectiveness of in-patient treatment for this population, and compare and contrast differing models of in-patient care.

Method: A systematic search was completed to identify papers where authors had reported data about the effectiveness of in-patient admissions with reference to one of three domains: treatment effect (e.