Effectiveness and cost-effectiveness of guided self-help for depression for autistic adults: the Autism Depression Trial (ADEPT-2) - protocol for a multicentre, randomised controlled trial of a remotely delivered low-intensity intervention.

Introduction: Depression is three to four times more prevalent in autistic people and is related to reduced quality of life. There is a need for empirically supported psychological interventions for depression specifically adapted to meet the needs of autistic adults. ADEPT-2 aims to establish the clinical and cost-effectiveness of an adapted low-intensity psychological intervention (guided self-help) for depression in autistic adults.

Paramedic or GP consultations in primary care: prospective study comparing costs and outcomes.

Background: General Practice faces pressures due to increased demand and a shortage of GPs. Paramedics in General Practice (PGPs), increasingly contribute to managing minor illnesses, conducting home visits, and providing urgent consultations.

Aim: Explore the impact of paramedic-consultations on patient-reported experience, safe management and NHS costs.

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.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients' musculoskeletal pain and enablement.

Introduction: Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.

Identification and prioritisation of items for a draft participant-reported questionnaire to measure use of social care, informal care, aids and adaptations.

Background: Resource-use measurement is integral for assessing cost-effectiveness within trial-based economic evaluations. Methods for gathering resource-use data from participants are not well developed, with questionnaires typically produced for each trial and rarely validated. The healthcare module of a generic, modular resource-use measure, designed for collecting self-report resource-utilisation data, has recently been developed in the UK.

Development of a brief, generic, modular resource-use measure (ModRUM): piloting with patients.

Background: Bespoke self-report resource-use measures (RUMs) are commonly developed or adapted for each new randomised controlled trial. Consequently, RUMs lack standardisation and validation is rarely conducted. A new generic RUM, ModRUM, has been developed using a rigorous process, including consultation with health economists and patients.

Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial.

Objectives: To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures.

Design: Pragmatic, parallel group, open label, randomised controlled trial.

Setting: High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018.

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.

The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial.

Background: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement.

Methods: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals.

Aspects and Challenges of Resource Use Measurement in Health Economics: Towards a Comprehensive Measurement Framework.

Background: While the methods for conducting health economics research in general are improving, current guidelines provide limited guidance regarding resource use measurement (RUM). Consequently, a variety of methods exists, yet there is no overview of aspects to consider when deciding on the most appropriate RUM methodology. Therefore, this study aims to (1) identify and categorize existing knowledge regarding aspects of RUM, and (2) develop a framework that provides a comprehensive overview of methodological aspects regarding RUM.

Development of a brief, generic, modular resource-use measure (ModRUM): cognitive interviews with patients.

Background: Self-report resource-use measures (RUMs) are often used to collect healthcare use data from participants in healthcare studies. However, RUMs are typically adapted from existing measures on a study-by-study basis, resulting in a lack of standardisation which limits comparability across studies. Psychometric testing of RUMs is rarely conducted.

Test-guided dietary management of eczema in children: A randomized controlled feasibility trial (TEST).

Background: Parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain.

Objective: To determine whether a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible.

Methods: Children (>3 months and <5 years) with mild-to-severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care.

What are the inpatient and day case costs following primary total hip replacement of patients treated for prosthetic joint infection: a matched cohort study using linked data from the National Joint Registry and Hospital Episode Statistics.

Background: Prosthetic joint infection (PJI) following total hip replacement (THR) surgery is a serious complication that negatively impacts patients' lives and is financially burdensome for healthcare providers. As the number of THRs increases, so does this financial burden. This research estimates the economic burden with respect to inpatient and day case hospital admissions for patients receiving revision surgery for PJI following primary THR.

Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT.

Background: Prostate cancer is the most common cancer among men in the UK. Prostate-specific antigen testing followed by biopsy leads to overdetection, overtreatment as well as undertreatment of the disease. Evidence of treatment effectiveness has lacked because of the paucity of randomised controlled trials comparing conventional treatments.

The ProtecT randomised trial cost-effectiveness analysis comparing active monitoring, surgery, or radiotherapy for prostate cancer.

Background: There is limited evidence relating to the cost-effectiveness of treatments for localised prostate cancer.

Methods: The cost-effectiveness of active monitoring, surgery, and radiotherapy was evaluated within the Prostate Testing for Cancer and Treatment (ProtecT) randomised controlled trial from a UK NHS perspective at 10 years' median follow-up. Prostate cancer resource-use collected from hospital records and trial participants was valued using UK reference-costs.

Results of the feasibility phase of the managed activity graded exercise in teenagers and pre-adolescents (MAGENTA) randomised controlled trial of treatments for chronic fatigue syndrome/myalgic encephalomyelitis.

Background: Chronic fatigue syndrome (CFS) also known as myalgic encephalomyelitis (ME) is relatively common in young people and causes significant disability. Graded exercise therapy (GET) and activity management are recommended by the National Institute for Health and Care Excellence (NICE) despite a limited evidence-base for either treatment in paediatric CFS/ME. This paper reports on feasibility and acceptability measures from the feasibility phase of the ongoing MAGENTA randomised controlled trial (RCT) investigating GET versus activity management for young people with CFS/ME.

Best emollients for eczema (BEE) - comparing four types of emollients in children with eczema: protocol for randomised trial and nested qualitative study.

Introduction: Atopic dermatitis/eczema affects around 20% of children and is characterised by inflamed, dry, itchy skin. Guidelines recommend 'leave-on' emollients that are applied directly to the skin to add or trap moisture and used regularly, they can soothe, enhance the skin barrier and may prevent disease 'flares'. However, the suitability of the many different emollients varies between people and there is little evidence to help prescribers and parents and carers decide which type to try first.

A process evaluation of the PLAN-A intervention (Peer-Led physical Activity iNtervention for Adolescent girls).

Background: Few adolescent girls engage in enough physical activity (PA) to meet recommendations and there is a need for new interventions to increase girls PA. We have previously published the results of the PLAN-A cluster randomised feasibility trial which was a peer-led school-based PA intervention, showing that the intervention was feasible and held promise to increase the PA of girls aged 12-13 years. In PLAN-A, pupils nominated by their peers as influential attend training to teach them how to influence, promote and normalise physical activity amongst their peer-group.

TEST (Trial of Eczema allergy Screening Tests): protocol for feasibility randomised controlled trial of allergy tests in children with eczema, including economic scoping and nested qualitative study.

Background: Early onset eczema is associated with food allergy, and allergic reactions to foods can cause acute exacerbations of eczema. Parents often pursue dietary restrictions as a way of managing eczema and seek allergy testing for their children to guide dietary management. However, it is unclear whether test-guided dietary management improves eczema symptoms, and whether the practice causes harm through reduced use of conventional eczema treatment or unnecessary dietary restrictions.

Evaluation of an intervention to promote walking during the commute to work: a cluster randomised controlled trial.

Background: Opportunities for working adults to accumulate recommended physical activity levels (at least 150 min of moderate intensity physical activity in bouts of at least 10 min throughout the week) may include the commute to work. Systematic reviews of interventions to increase active transport suggest studies have tended to be of poor quality, relying on self-report and lacking robust statistical analyses.

Methods: We conducted a multi-centre parallel-arm cluster randomised controlled trial, in workplaces in south-west England and south Wales, to assess the effectiveness of a behavioural intervention to increase walking during the commute.