Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trials.

Background: The Recap of atopic eczema (RECAP) is a patient-reported instrument designed to assess eczema control. There is a lack of evidence on the interpretability of change scores in clinical trials.

Objectives: To calculate the smallest detectable change (SDC) in RECAP and estimate the minimal important change (MIC) for RECAP using various calculation methods in three eczema clinical trial datasets.

Measuring Signs of Atopic Dermatitis in Clinical Practice: A HOME-CP Consensus Statement.

Importance: Outcome measurement is an essential component of value-based health care and can aid patient care, quality improvement, and clinical effectiveness evidence generation. The Harmonising Outcome Measures for Eczema Clinical Practice initiative aims to identify a list of validated, feasible, outcome measurement instruments recommended to measure atopic dermatitis (AD) in the clinical practice setting. The clinical practice set is a list of instruments that clinicians can pick and choose from to suit their needs in the context of clinical care.

Validation of the Recap of Atopic Eczema (RECAP) Measurement Instrument for Eczema Control in Adult Patients in an Asian Clinical Setting.

Recap of atopic eczema (RECAP) is a self-reported 7-item questionnaire recommended by the Harmonising Outcome Measures in Eczema initiative to measure eczema control. As RECAP has not been validated in a real-world clinical population in Asia, RECAP was investigated as a measure of eczema control in Singapore. Patients with atopic eczema at the National Skin Centre from July 2019 to January 2020 were included for analysis.

Online behavioural interventions for children and young people with eczema: a quantitative evaluation.

Background: Two online behavioural interventions (one website for parents/carers of children with eczema; and one for young people with eczema) have been shown in randomised controlled trials to facilitate a sustained improvement in eczema severity.

Aim: To describe intervention use and examine potential mediators of intervention outcomes and contextual factors that may influence intervention delivery and outcomes.

Design And Setting: Quantitative process evaluation in UK primary care.

Cost-effectiveness of two online interventions supporting self-care for eczema for parents/carers and young people.

Objective: To estimate the cost-effectiveness of online behavioral interventions (EczemaCareOnline.org.uk) designed to support eczema self-care management for parents/carers and young people from an NHS perspective.

Treatment of Hidradenitis Suppurativa Evaluation Study: the THESEUS prospective cohort study.

Background: Hidradenitis suppurativa is a chronic inflammatory skin disease characterised by recurrent inflammatory lesions and skin tunnels in flexural sites such as the axilla. Deroofing of skin tunnels and laser treatment are standard hidradenitis suppurativa interventions in some countries but not yet introduced in the United Kingdom.

Objective: To understand current hidradenitis suppurativa management pathways and what influences treatment choices to inform the design of future randomised controlled trials.

How to use the Harmonising Outcome Measures for Eczema Core Outcome Set for atopic dermatitis trials: a users' guide.

Background: The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed upon the Core Outcome Set (COS) for use in atopic dermatitis (AD) clinical trials, but additional guidance is needed to maximize its uptake.

Objectives: To provide answers to some of the commonly asked questions about using the HOME COS; to provide data to help with the interpretation of trial results; and to support sample size calculations for future trials.

Methods And Results: We provide practical guidance on the use of the HOME COS for investigators planning clinical trials in patients with AD.

Treatment of Hidradenitis Suppurativa Evaluation Study (THESEUS): a prospective cohort study.

Background: Hidradenitis suppurativa (HS) is a chronic, painful disease affecting flexures and other skin regions, producing nodules, abscesses and skin tunnels. Laser treatment targeting hair follicles and deroofing of skin tunnels are standard HS interventions in some countries but are rarely offered in the UK.

Objectives: To describe current UK HS management pathways and influencing factors to inform the design of future randomized controlled trials (RCTs).

Developing evidence-based patient-focused learning materials to support health behaviour change for people living with psoriatic arthritis.

Objectives: In psoriatic arthritis (PsA), self-management is important for patient function and quality of life. Behaviour change can be difficult, patients could benefit from high-quality support to initiate change. Our aim was to codesign the project as theory-informed, evidence-based, patient-focused, materials supporting healthy lifestyle changes for patients diagnosed with PsA.

The Harmonising Outcome Measures for Eczema (HOME) implementation roadmap.

Background: Core outcome sets (COS) are consensus-driven sets of minimum outcomes that should be measured and reported in all clinical trials. COS aim to reduce heterogeneity in outcome measurement and reporting, and selective outcome reporting. Implementing COS into clinical trials is challenging.

'Eczema shouldn't control you; you should control eczema': qualitative process evaluation of online behavioural interventions to support young people and parents/carers of children with eczema.

Background: There is a lack of well-conducted randomized controlled trials evaluating the effectiveness of theory-based online interventions for eczema. To address these deficiencies, we previously developed and demonstrated the effectiveness of two online behavioural interventions: Eczema Care Online for parents/carers of children with eczema, and Eczema Care Online for young people with eczema.

Objectives: To explore the views and experiences of people who have used the Eczema Care Online interventions to provide insights into how the interventions worked and identify contextual factors that may impede users' engagement with the interventions.

Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials.

Objective: To determine the effectiveness of two online behavioural interventions, one for parents and carers and one for young people, to support eczema self-management.

Design: Two independent, pragmatic, parallel group, unmasked, randomised controlled trials.

Setting: 98 general practices in England.

Measuring Atopic Eczema Control and Itch Intensity in Clinical Practice: A Consensus Statement From the Harmonising Outcome Measures for Eczema in Clinical Practice (HOME-CP) Initiative.

Importance: Measuring outcomes in clinical practice can aid patient care, quality improvement, and real-world evidence generation. The Harmonising Outcome Measures for Eczema (HOME) Clinical Practice initiative is developing a list of validated, feasible instruments to measure atopic eczema in clinical care. Prior work identified symptoms and long-term control as the most important domains to measure in clinical practice.

Content validity of the Recap of atopic eczema (RECAP) instrument in Dutch, English and German to measure eczema control in young people with atopic eczema: a cognitive interview study.

Background: Recap of atopic eczema (RECAP) is a patient-reported outcome measure assessing eczema control. This instrument has been developed and validated in the UK. There are self-reported and proxy-reported versions in English, Dutch and German.

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.

Using the Vitiligo Noticeability Scale in clinical trials: construct validity, interpretability, reliability and acceptability.

Background: Validated outcome measures are needed for vitiligo trials.

Objectives: To assess construct validity, interpretability, reliability and acceptability of the Vitiligo Noticeability Scale (VNS).

Methods: We used images of vitiligo before and after treatment, plus outcome data, from the HI-Light Vitiligo trial.

Treatment of Hidradenitis Suppurativa Evaluation Study (THESEUS): protocol for a prospective cohort study.

Background: Hidradenitis suppurativa (HS) is a chronic, painful, inflammatory skin disease with estimates of prevalence in the European population of 1%-2%. Despite being a relatively common condition, the evidence base for management of HS is limited. European and North American management guidelines rely on consensus for many aspects of treatment and within the UK variations in management of HS have been identified.

The HOME Core outcome set for clinical trials of atopic dermatitis.

Core outcome sets are critically important outcomes that should be measured in clinical trials. Their absence in atopic dermatitis is a form of research waste and impedes combining evidence to inform patient care. Here, we articulate the rationale for core outcome sets in atopic dermatitis and review the work of the international Harmonising Outcome Measures for Eczema group from its inception in Munich, 2010.

Strategies for using topical corticosteroids in children and adults with eczema.

Background: Eczema is a common skin condition. Although topical corticosteroids have been a first-line treatment for eczema for decades, there are uncertainties over their optimal use.

Objectives: To establish the effectiveness and safety of different ways of using topical corticosteroids for treating eczema.