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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. Method: Parents/carers and young people were recruited through primary care. Intervention use was recorded and summarised descriptively. Logistic regression explored sociodemographic and other factors associated with intervention engagement. Mediation analysis investigated whether patient enablement (ability to understand and cope with health issues), treatment use, and barriers to adherence were mediators of intervention effect. Subgroup analysis compared intervention effects among pre-specified participant subsets. Results: A total of 340 parents/carers and 337 young people were recruited. Most parents/carers (87%, n = 148/171) and young people (91%, n = 153/168) in the intervention group viewed the core introduction by 24 weeks. At 24 weeks, users had spent approximately 20 minutes on average on the interventions. Among parents/carers, greater intervention engagement was associated with higher education levels, uncertainty about carrying out treatments, and doubts about treatment efficacy at baseline. Among young people, higher intervention use was associated with higher baseline eczema severity. Patient enablement (the ability to understand and cope with health issues) accounted for approximately 30% of the intervention effect among parents/carers and 50% among young people. Conclusion: This study demonstrated that positive intervention outcomes depended on a modest time commitment from users. This provides further support that the wider implementation of Eczema Care Online is justified. [ABSTRACT FROM AUTHOR]

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. It answers some of the common questions about using the HOME COS, how to access the outcome measurement instruments, what training/resources are needed to use them appropriately and clarifies when the COS is applicable. We also provide exemplar data to inform sample size calculations for eczema trials and encourage standardized data collection and reporting of the COS. Conclusions By encouraging adoption of the COS and facilitating consistent reporting of outcome data, it is hoped that the results of eczema trials will be more comprehensive and readily combined in meta-analyses and that patient care will subsequently be improved. [ABSTRACT FROM AUTHOR]

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). Methods THESEUS was a nonrandomized 12-month prospective cohort study set in 10 UK hospitals offering five interventions: oral doxycycline 200 mg daily; oral clindamycin and rifampicin both 300 mg twice daily for 10 weeks, extended for longer in some cases; laser treatment targeting hair follicles; deroofing; and conventional surgery. The primary outcome was the combination of clinician-assessed eligibility and participant hypothetical willingness to receive each intervention. The secondary outcomes were the proportion of participants selecting each intervention as their final treatment option; the proportion who switch treatments; treatment fidelity; and attrition rates. THESEUS was prospectively registered on the ISRCTN registry: ISRCTN69985145. Results The recruitment target of 150 participants was met after 18 months, in July 2021, with two pauses due to the COVID-19 pandemic. Baseline demographics reflected the HS secondary care population: average age 36 years, 81% female, 20% non-White, 64% current or ex-smokers, 86% body mass index ≥ 25, 68% with moderate disease, 19% with severe disease and 13% with mild disease. Laser was the intervention with the highest proportion (69%) of participants eligible and willing to receive treatment, then deroofing (58%), conventional surgery (54%), clindamycin and rifampicin (44%), and doxycycline (37%). Laser was ranked first choice by the greatest proportion of participants (41%). Attrition rates were 11% and 17% after 3 and 6 months, respectively. Concordance with doxycycline was 52% after 3 months due to lack of efficacy, participant choice and adverse effects. Delays with procedural interventions were common, with only 43% and 26% of participants starting laser and deroofing, respectively, after 3 months. Uptake of conventional surgery was too small to characterize the intervention. Switching treatment was uncommon and there were no serious adverse events. Conclusions THESEUS has established laser treatment and deroofing for HS in the UK and demonstrated their popularity with patients and clinicians for future RCTs. [ABSTRACT FROM AUTHOR]

The article discusses the feasibility of using daily text messages to measure pain in individuals with hidradenitis suppurativa (HS) in clinical trials. The study, called THESEUS, sent daily text messages asking participants to rate their pain on a scale of 0-10. Out of 150 participants, 110 received at least one text message, and 18 participants requested to discontinue the messages. Response rates decreased over time, with 70% responding after 2 weeks and 20% responding after 12 weeks. Some participants found the text messages helpful, while others had concerns or stopped responding for various reasons. The study suggests that daily pain scoring may be feasible for short durations but should be avoided for long-term collection. [Extracted from the article]

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. Both patient- and physician-reported outcome measures were available for correlation analyses. Correlation analysis was also performed to investigate construct validity, and floor or ceiling effects of RECAP. A total of 260 atopic eczema patients aged between 15 and 87 years were recruited. There were minimal floor and ceiling effects for RECAP scores. There were strong, significant correlations of RECAP with POEM (r = 0.84, p < 0.001) and DLQI (r = 0.81, p < 0.001). Correlation with SCORAD was moderate (r = 0.60, p < 0.001). Correlations remained similar after age, gender, and ethnicity adjustments. Discriminative validity was demonstrated by a significant linear trend of increasing RECAP scores with increasing eczema severity. RECAP demonstrates good discriminative and construct validity evidenced by strong correlations with symptoms and quality of life and moderate correlations with eczema signs. RECAP is useful to measure eczema control in Singapore. [ABSTRACT FROM AUTHOR]

Why would anyone cultivate weeds? Alfarabi's The Political Regime prompts this unexpected question. There Alfarabi uses a horticultural metaphor inherited from Plato to describe his ideal regime. His imagined polity is a garden beset by weeds, which threaten to choke the life out of the other plants. Although most of these weeds are to be eradicated for the sake of the garden that is his ideal regime, Alfarabi proposes to cultivate one variety. This kind of weed challenges the official doctrines of the regime. Since the regime is based on false teachings about the universe, such debunking questioning poses a series threat. Yet alfarabi proposes to indulge and encourage the doubts of these weeds. In this paper, we explore the reasons for Alfarabi's strange treatment of these dissidents. We argue that Alfarabi's proposal reflects an important disagreement with his teacher, Plato, about the extent to which an ideal model ought to be tethered to reality. Our argument helps to illuminate one of the more perplexing aspects of Alfarabi's political thought and his relationship with Plato. Most broadly, we show that we will miss important contributions to ideal theory if we fail to appreciate that what constitutes "ideal" may vary widely. [ABSTRACT FROM AUTHOR]

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. Methods Qualitative semistructured interviews were conducted with 17 parents/carers of children with eczema and 17 young people with eczema. Participants were purposively sampled from two randomized controlled trials of the interventions and recruited from GP surgeries in England. Transcripts were analysed using inductive thematic analysis, and intervention modifications were identified using the person-based approach table of changes method. Results Both young people and parents/carers found the interventions easy to use, relatable and trustworthy, and perceived that they helped them to manage their eczema, thus suggesting that Eczema Care Online may be acceptable to its target groups. Our analysis suggested that the interventions may reduce eczema severity by facilitating empowerment among its users, specifically through improved understanding of, and confidence in, eczema management, reduced treatment concerns, and improved treatment adherence and management of irritants/triggers. Reading about the experiences of others with eczema helped people to feel 'normal' and less alone. Some (mainly young people) expressed firmly held negative beliefs about topical corticosteroids, views that were not influenced by the intervention. Minor improvements to the design and navigation of the Eczema Care Online interventions and content changes were identified and made, ready for wider implementation. Conclusions People with eczema and their families can benefit from reliable information, specifically information on the best and safest ways to use their eczema treatments early in their eczema journey. Together, our findings from this study and the corresponding trials suggest wider implementation of Eczema Care Online (EczemaCareOnline.org.uk) is justified. [ABSTRACT FROM AUTHOR]

Https://doi.org/10.1093/bjd/ljad152 Dear Editor, There is a need for high-quality research evidence to support the management of hidradenitis suppurativa (HS).[1],[2] The Treatment of Hidradenitis Suppurativa Evaluation Study (THESEUS) seeks to contribute to this by informing "the design of future HS Randomized Controlled Trials (RCTs)".[3] Its objectives include characterizing potential study interventions, determining current patient pathways, contributing to the validation of a core outcome set,[4] and establishing the feasibility of future trial recruitment.[3] In this article, we provide a report of one aspect of its work - a consensus meeting to prioritize future RCT designs. The participants in the consensus meeting may not be fully representative; only one general practitioner participated, many of those with lived experience had already experienced multiple treatments, and participants were drawn solely from the UK. The priority offered to laser treatment (options C, D, F and M), in parallel with a desire for wide-reaching research, might suggest a comparison of laser plus medical treatment vs. medical alone or laser alone. [Extracted from the article]

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. However, it is unclear whether the self‐reported version shows adequate content validity when completed by young people (8–16 years) in these languages. Objectives: To assess the content validity (comprehensibility, relevance and comprehensiveness) of the English, German and Dutch versions of the self‐reported RECAP in young people with atopic eczema and to identify the most appropriate age cutoff for self‐completion. Methods: We conducted 23 semistructured cognitive interviews with young people aged 8–16 years, using the 'think‐aloud' method. In Germany and the Netherlands, participants were recruited in dermatology clinics and in the UK through social media and existing mailing lists. Interviews were audio recorded, transcribed verbatim and analysed in the three languages, using a problem‐focused coding manual. Transcripts were coded by two independent reviewers in each country. Themes were translated into English and compared across the three countries. Results: Significant age‐related comprehensibility issues with the last three items of the questionnaire occurred with young people aged 8–11 years, causing difficulties completing RECAP without help. However, older children had only minor problems and were able to complete the questionnaire by themselves. The self‐reported version of RECAP has sufficient content validity for self‐completion in young people aged 12 years and above. However, the German version with some translational adaptations may be appropriate for children from the age of 8 years. There may be some situations where the proxy version is needed for older children too. Conclusions: The self‐reported version of RECAP is appropriate for use from the age of 12 years. The proxy version can be used in children younger than 12 years. Other measurement properties should be further investigated. What is already known about this topic?Recap of atopic eczema (RECAP) is an instrument recommended by the Harmonising Outcome Measures for Eczema initiative for the core outcome domain of long‐term control of atopic eczema.Content validity of RECAP for self‐completion by adults and of the proxy version has been assessed. What does this study add?In this study, content validity (comprehensibility, relevance and comprehensiveness) of the self‐reported version of RECAP among young people (aged 8–16 years) with atopic eczema across the UK, Germany and the Netherlands is assessed.Based on these findings, key recommendations on how to measure eczema control in young people with atopic eczema are formulated. What are the clinical implications of this work?The Dutch, English and German self‐completion versions of RECAP are recommended for use in adolescents from the age of 12 years.The proxy version could be used in children younger than 12 years or where children are cognitively or physically incapable of reporting their experience of eczema control.Caregivers should be encouraged to complete RECAP together with their child where possible. [ABSTRACT FROM AUTHOR]

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. We compared outcome assessments made by trial participants with assessments of images by clinicians and people with vitiligo who were not trial participants [Patient and Public Involvement (PPI) panel]. Hypothesis testing assessed psychometric properties of the VNS, with κ statistics to assess agreement between outcomes. Three focus groups and two online discussion groups provided insight into the use of VNS by people with vitiligo. Results: Our hypothesis of a positive association between VNS and participant‐reported global treatment success was supported for trial participants (κ = 0·41 if VNS success was defined as ≥ 4; κ = 0·71 if VNS success was defined as ≥ 3), but not for the blinded PPI panel (κ = 0·28). As hypothesized, the association with participant‐reported global success was higher for VNS (κ = 0·41) than for clinician‐reported percentage repigmentation (κ = 0·17). Seventy‐five per cent of trial participants valued a VNS of 3 (partial response) as a treatment success. Test–retest reliability was good: κ = 0·69 (95% confidence interval 0·63–0·74). Age and skin phototype did not influence interpretation of the VNS scores. To people with vitiligo, the VNS is an acceptable and meaningful patient‐reported outcome measure. Conclusions: Trial participants may assess their vitiligo differently compared with blinded assessors. A VNS score of 3 may be more highly valued by people undergoing vitiligo treatment than was previously thought. What is already known about this topic?Vitiligo is a common condition, and can have a considerable psychological impact.A Vitiligo Core Outcome Set is being developed, to enable the results of vitiligo trials to be compared and combined more easily.The Vitiligo Noticeability Scale (VNS) is a patient‐reported outcome measure (PROM) developed in partnership with people with vitiligo; initial validation studies have been promising. What does this study add?The VNS shows good construct validity, reliability and acceptability; it can be used in all ages and skin phototypes.All five levels of the VNS scale should be reported for transparency, to aid interpretation of trial findings, and to facilitate meta‐analysis in systematic reviews.VNS assessments made by trial participants and independent observers are likely to be qualitatively different, making blinded assessment of VNS by independent observers difficult to interpret.Blinding of participants to trial interventions is recommended whenever possible. What are the clinical implications of the work?The VNS can be used as a PROM to assess the cosmetic acceptability of repigmentation at individual patches of vitiligo.A VNS score of 3 or more is likely to be valued by patients as a treatment success. [ABSTRACT FROM AUTHOR]

The article discusses the importance of patient-reported outcome measures (PROMs) in dermatology. It highlights the need for PROMs that capture the patient's experience and self-report of health, rather than solely relying on biomedically defined outcome measures. The article introduces the Patient-Reported Impact of Dermatological Diseases (PRIDD) as a new PROM that has been developed using high-standard methodology and follows the approach outlined by the COSMIN group. The PRIDD questionnaire consists of 16 questions that assess different domains of impact, and it has the potential to be a valuable tool for measuring the impact of dermatological conditions on patients in both research and practice. [Extracted from the article]

This paper is the fourth in a series devoted to dermatology nursing research methods. We have already given a brief introduction to both qualitative and quantitative research methods in our second article. 1 This short article is designed to explore the value of qualitative research for dermatology nursing, introduce different qualitative methods and approaches, and look at how to assess the rigour or trustworthiness of qualitative research. [ABSTRACT FROM AUTHOR]

The authors need to justify their replication in relation to author influence or conflicts of interest in previously published NMAs2-4. For example, if the NMA authors cite this being high-priority research, but do not cite this in comparison with a previously published NMA, they are not assessing priority in relation to the need for replication2. The assessment of this being a high-priority NMA should be made explicitly in relation to the need for replication of previously published NMAs. [Extracted from the article]

Research on Russian civil society focuses largely on the repressive legislative side of state policies, to the virtual exclusion of the rise of domestic funding, be it individual, corporate, or public. This article instead contributes to the discussion of state funding for the third sector by looking at the Russian Presidential Grant Fund, a state institution that has disbursed RUB18 billion (approx. $275 million at the August 11, 2019, exchange rate) to the third sector since 2016, making it one of the most influential sources of financial support to Russian civil society. A data-driven analysis of the Fund reveals that, although it prioritizes certain types of non-governmental organizations (NGOs) over others, there is a discernible attempt to address some of the most pressing social ills in Russia today. Whereas some grant directions, such as the "preservation of historical memory" and "development of public diplomacy and support of compatriots," further long-held, Kremlin-sponsored ideological projects, the biggest categories supported by the Fund focus on more classical philanthropic issues, confirming the state's growing delegation of the provision of public services to the third sector. [ABSTRACT FROM AUTHOR]

Objective: Little is known about how people with psoriatic arthritis (PsA) cope with and manage their condition, but data show that psychological problems are underrecognized and undertreated. The Common Sense Self-Regulatory Model (CS-SRM) suggests illness beliefs, mediated by coping, may influence health outcomes. The study aimed to investigate the roles of disease severity, illness beliefs, and coping strategies in predicting depression, anxiety, and quality of life (QoL) in people with PsA. Additionally, we aimed to assess the role of depression and anxiety in predicting QoL.Methods: We conducted a cross-sectional observational study, where adults with PsA (n = 179) completed validated measures of predictor (illness beliefs, coping strategies, disease severity) and outcome variables (depression, anxiety, QoL) using an online survey distributed via social media.Results: The participants were a community sample of 179 adults with PsA, ages 20 to 72 years (77.1% female). After controlling for disease severity, hierarchical multiple regression models indicated that more negative beliefs about consequences and behavioral disengagement as a coping method predicted levels of depression, and self-blame predicted anxiety. Beliefs about consequences and the presence of depression predicted quality of life scores after controlling for disease severity.Conclusion: This study offers support for the use of the CS-SRM in explaining variation on psychological outcomes in individuals with PsA. The illness beliefs and coping strategies identified as predictors in this article are potential targets for interventions addressing PsA-related distress and QoL. [ABSTRACT FROM AUTHOR]

Objective To inform the development of a core outcome set for eczema by engaging with people with eczema and parents of children with eczema to understand their experiences and understanding of the concept 'eczema control'. Design 37 participants took part in a total of six semistructured online focus groups held in a typed chatroom with 5-7 participants per group. Three groups involved adults with eczema and three groups involved parents of children with eczema. Framework analysis was used for data analysis. Setting A community-based sample was recruited from across the UK via social media and email. Participants 19 adults aged 17-61 years (15/19 female, 16/19 white) and 18 parents of children with eczema aged 9 months-17 years (9/18 female, 18/19 white). Results Four main themes were identified: (1) 'Commonalities and differences in the experiences of control': a reduction in symptoms such as itch and sleep loss characterised eczema control, but what level was acceptable differed across participants;(2) 'Eczema control goes beyond the skin': psychological factors, social factors, the constant scratching and the impact on everyday activities are a variety of ways an individual can be impacted;(3) 'Stepping up and down of treatment': participants' stepped-up treatment in response to loss of control, but several factors complicated this behaviour. Control needed to be maintained after stepped-up treatment ended to be acceptable; and (4) 'How to measure control': self-report was generally preferred to allow frequent measurements and to capture unobservable features. Although most thought their eczema needed to be measured frequently, many also felt that this was not always realistic or desirable. Conclusions 'Eczema control' is a complex experience for people with eczema and parents of children with the condition. These experiences could have important implications on how long-term control should be measured in eczema clinical trials and clinical practice. [ABSTRACT FROM AUTHOR]

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. Guidance to improve COS uptake in dermatology is lacking., Objectives: To develop a structured practical guide to COS implementation., Methods: Members of the Harmonising Outcome Measurement for Eczema (HOME) executive committee developed an expert opinion-based roadmap founded on a combination of a review of the COS implementation literature, the Core Outcome Measures in Effectiveness Trials (COMET) initiative resources, input from HOME members and experience in COS development and clinical trials., Results: The data review and input from HOME members was synthesized into themes, which guided roadmap development: (a) barriers and facilitators to COS uptake based on stakeholder awareness/engagement and COS features; and (b) key implementation science principles (assessment-driven, data-centred, priority-based and context-sensitive). The HOME implementation roadmap follows three stages. Firstly, the COS uptake scope and goals need to be defined. Secondly, during COS development, preparation for future implementation is supported by establishing the COS as a credible evidence-informed consensus by applying robust COS development methodology, engaging multiple stakeholders, fostering sustained and global engagement, emphasizing COS ease of use and universal applicability, and providing recommendations on COS use. Thirdly, incorporating completed COS into primary (trials) and secondary (reviews) research is an iterative process starting with mapping COS uptake and stakeholders' attitudes, followed by designing and carrying out targeted implementation projects. Main themes for implementation projects identified at HOME are stakeholder awareness/engagement; universal applicability for different populations; and improving ease-of-use by reducing administrative and study burden. Formal implementation frameworks can be used to identify implementation barriers/facilitators and to design implementation strategies. The effect of these strategies on uptake should be evaluated and implementation plans adjusted accordingly., Conclusions: COS can improve the quality and applicability of research and, so, clinical practice but can only succeed if used and reported consistently. The HOME implementation roadmap is an extension of the original HOME roadmap for COS development and provides a pragmatic framework to develop COS implementation strategies., Competing Interests: Conflicts of interest Y.A.L. has received honoraria or fees from AbbVie, Sanofi, Genentech, Regeneron, Pfizer and Dexcel Pharma, an independent research grant from AbbVie and has – without personal compensation – provided investigator services for Eli Lilly, Pfizer and AbbVie, all unrelated to this study. E.L.S. reports personal fees from Advances in Cosmetic Medical Derm Hawaii, AbbVie, Amgen, AOBiome, Arcutis Biotherapeutics, Arena Pharmaceuticals, Aslan Pharma, Boehringer Ingelheim USA, Boston Consulting Group, Bristol Myers Squibb, Collective Acumen (CA), CorEvitas, Dermira, Eli Lilly, Evelo Biosciences, Evidera, ExcerptaMedica, FIDE, Forte Bio RX, Galderma, GlaxoSmithKline, Incyte, Janssen, Johnson & Johnson, Kyowa Kirin Pharmaceutical Development, LEO Pharma, Medscape, Merck, MauiDerm, MLG Operating, MJH Holding, Pfizer, Physicians World, PRImE, Regeneron, Revolutionizing Atopic Dermatitis, Roivant, Sanofi-Genzyme, Trevi Therapeutics, Valeant, Vindico Medical Education and WebMD. He also reports grants (or serves in a Principal Investigator role for) from AbbVie, Acrotech Biopharma, Amgen, Arcutis, Aslan, Castle Biosciences, CorEvitas, Dermavant, Dermira, Eli Lilly, Incyte, Kymab, Kyowa Kirin, National Jewish Health, LEO, Pfizer, Regeneron, Sanofi and Target RWE. These potential conflicts of interest have been reviewed and managed by Oregon Health & Science University. C.A. has received institutional funding from the Dr Wolff Group and Bionorica, and consultancy fees or honoraria from the Dr Wolff Group, Bionorica, Sanofi, LEO Pharma and RHEACELL. He was also involved in the development and testing of one of the HOME core outcome instruments [Recap of atopic eczema (RECAP)]. P.I.S. has received departmental independent research grants for the TREAT NL registry from pharma since December 2019; is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of, for example, psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital; is Chief Investigator of the systemic and phototherapy atopic eczema registry (TREAT NL) for adults and children; and was involved in the development of one of the HOME core outcome instruments (RECAP). K.S.T. was involved in the development and testing of one of the HOME core outcome instruments (RECAP). J.S. reports institutional grants for investigator-initiated research from the German Federal Joint Committee (G-BA), the Federal Ministry of Health (BMG), Federal Ministry of Research and Education (BMBF), European Union, Federal State of Saxony, Novartis, Sanofi, ALK and Pfizer. He has also participated in advisory board meetings as a paid consultant for Sanofi, Eli Lilly and ALK. L.H. has received consultation fees from the University of Oxford on an educational grant funded by Pfizer, unrelated to the submitted work, and was involved in the development of the RECAP instrument. N.K. has received honoraria as a speaker/consultant for Sanofi, Maruho, AbbVie, Eli Lilly Japan, Mitsubishi Tanabe Pharma, Janssen Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, Kyowa Kirin, Celgene Japan and LEO Pharma; and has received grants as an investigator from Maruho, Eli Lilly Japan, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, Boehringer Ingelheim Japan, Kyowa Kirin, Jansen Pharma, Boehringer Ingelheim Japan, A2 Healthcare, AbbVie and LEO Pharma. H.C.W. chaired the HOME core outcome set initiative from 2008 to 2021 and was involved in the development of the Patient Oriented Eczema Measure (POEM). H.C.W., K.S.T. and L.H. are employed at the research centre where the POEM was developed. The University of Nottingham owns copyright to license POEM – chargeable for commercial users. L.A.A.G. and M.E.J. declare no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.)

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., Participants: Parents and carers of children (0-12 years) with eczema (trial 1) and young people (13-25 years) with eczema (trial 2), excluding people with inactive or very mild eczema (≤5 on POEM, the Patient-Oriented Eczema Measure)., Interventions: Participants were randomised (1:1) using online software to receive usual eczema care or an online (www.EczemaCareOnline.org.uk) behavioural intervention for eczema plus usual care., Main Outcome Measures: Primary outcome was eczema symptoms rated using POEM (range 0-28, with 28 being very severe) every four weeks over 24 weeks. Outcomes were reported by parents or carers for children and by self-report for young people. Secondary outcomes included POEM score every four weeks over 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, treatment use, perceived barriers to treatment use, and intervention use. Analyses were carried out separately for the two trials and according to intention-to-treat principles., Results: 340 parents or carers of children (169 usual care; 171 intervention) and 337 young people (169 usual care; 168 intervention) were randomised. The mean baseline POEM score was 12.8 (standard deviation 5.3) for parents and carers and 15.2 (5.4) for young people. Three young people withdrew from follow-up but did not withdraw their data. All randomised participants were included in the analyses. At 24 weeks, follow-up rates were 91.5% (311/340) for parents or carers and 90.2% (304/337) for young people. After controlling for baseline eczema severity and confounders, compared with usual care groups over 24 weeks, eczema severity improved in the intervention groups: mean difference in POEM score -1.5 (95% confidence interval -2.5 to -0.6; P=0.002) for parents or carers and -1.9 (-3.0 to -0.8; P<0.001) for young people. The number needed to treat to achieve a 2.5 difference in POEM score at 24 weeks was 6 in both trials. Improvements were sustained to 52 weeks in both trials. Enablement showed a statistically significant difference favouring the intervention group in both trials: adjusted mean difference at 24 weeks -0.7 (95% confidence interval -1.0 to -0.4) for parents or carers and -0.9 (-1.3 to -0.6) for young people. No harms were identified in either group., Conclusions: Two online interventions for self-management of eczema aimed at parents or carers of children with eczema and at young people with eczema provide a useful, sustained benefit in managing eczema severity in children and young people when offered in addition to usual eczema care., Trial Registration: ISRCTN registry ISRCTN79282252., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: no support from any organisation other than the National Institute for Health and Care Research for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work, other than LH has received consultancy fees from the University of Oxford on an educational grant funded by Pfizer, unrelated to the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.)

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. Children aged between 6 months and 12 years with eczema (Patient Orientated Eczema Measure [POEM] score >2) were randomly assigned (1:1:1:1; stratified by centre and minimised by baseline POEM score and age, using a web-based system) to lotions, creams, gels, or ointments. Clinicians and parents were unmasked. The initial emollient prescription was for 500 g or 500 mL, to be applied twice daily and as required. Subsequent prescriptions were determined by the family. The primary outcome was parent-reported eczema severity over 16 weeks (weekly POEM), with analysis as randomly assigned regardless of adherence, adjusting for baseline and stratification variables. Safety was assessed in all randomly assigned participants. This trial was registered with the ISRCTN registry, ISRCTN84540529., Findings: Between Jan 19, 2018, and Oct 31, 2019, 12 417 children were assessed for eligibility, 550 of whom were randomly assigned to a treatment group (137 to lotion, 140 to cream, 135 to gel, and 138 to ointment). The numbers of participants who contributed at least two POEM scores and were included in the primary analysis were 131 in the lotion group, 137 in the cream group, 130 in the gel group, and 126 in the ointment group. Baseline median age was 4 years (IQR 2-8); 255 (46%) participants were girls, 295 (54%) were boys; 473 (86%) participants were White; and the mean POEM score was 9·3 (SD 5·5). There was no difference in eczema severity between emollient types over 16 weeks (global p value=0·77), with adjusted POEM pairwise differences of: cream versus lotion 0·42 (95% CI -0·48 to 1·32), gel versus lotion 0·17 (-0·75 to 1·09), ointment versus lotion -0·01 (-0·93 to 0·91), gel versus cream -0·25 (-1·15 to 0·65), ointment versus cream -0·43 (-1·34 to 0·48), and ointment versus gel -0·18 (-1·11 to 0·75). This result remained unchanged following multiple imputation, sensitivity, and subgroup analyses. The total number of adverse events did not significantly differ between the treatment groups (lotions 49 [36%], creams 54 [39%], gels 54 [40%], and ointments 48 [35%]; p=0·79), although stinging was less common with ointments (12 [9%] of 138 participants) than lotions (28 [20%] of 137), creams (24 [17%] of 140), or gels (25 [19%] of 135)., Interpretation: We found no difference in effectiveness between the four main types of emollients for childhood eczema. Users need to be able to choose from a range of emollients to find one that they are more likely to use effectively., Funding: National Institute for Health and Care Research., Competing Interests: Declaration of interests LH currently acts as a consultant for the University of Oxford on an educational grant funded by Pfizer, unrelated to the submitted work. All other authors declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

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 HS James Lind Alliance Priority Setting Partnership (PSP) published a top 10 list of future HS research priorities including both medical and surgical interventions. The aims of the THESEUS study are to inform the design of future HS randomised controlled trials (RCTs) and to understand how HS treatments are currently used. THESEUS incorporates several HS PSP research priorities, including investigation of oral and surgical treatments. Core outcome domains have been established by the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) and THESEUS is designed to validate instruments to measure the domains., Methods and Analysis: The THESEUS study is a prospective observational cohort study. Participants, adults with active HS of any severity, will be asked to select one of five HS treatment options that is appropriate for their HS care. Participants will be allocated to their chosen treatment intervention and followed for a period of up to 12 months. Outcomes will be assessed at 3-monthly intervals using HISTORIC core outcome instruments. Video recordings of the surgical and laser operations will provide informational and training videos for future trials. Nested mixed-methods studies will characterise the interventions in clinical practice, understand facilitators and barriers to recruitment into future HS RCTs and examine patients' and clinicians' perspectives on HS treatment choices., Trial Registration Number: ISRCTN69985145., Competing Interests: Competing interests: JRI: Consultant for UCB Pharma, Novartis, Boehringer Ingelheim and ChemoCentryx; Advisory Boards for Kymera Therapeutics,Viela Bio and Insmed; Honoraria for BJD Editor-in-Chief, UpToDate HS chapter author; Copyright holder for HiSQOL, HS Patient Global Assessment, HS Investigator Global Assessment, and HS Guideline lead for British Association of Dermatologists. JR is funded by a National Institute of Health Research (NIHR) Postdoctoral Fellowship (PDF-2017-10-075). This represents independent research funded by the NIHR., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

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., Search Methods: We searched databases to January 2021 (Cochrane Skin Specialised Register; CENTRAL; MEDLINE; Embase; GREAT) and five clinical trials registers. We checked bibliographies from included trials to identify further trials., Selection Criteria: Randomised controlled trials in adults and children with eczema that compared at least two strategies of topical corticosteroid use. We excluded placebo comparisons, other than for trials that evaluated proactive versus reactive treatment., Data Collection and Analysis: We used standard Cochrane methods, with GRADE certainty of evidence for key findings. Primary outcomes were changes in clinician-reported signs and relevant local adverse events. Secondary outcomes were patient-reported symptoms and relevant systemic adverse events. For local adverse events, we prioritised abnormal skin thinning as a key area of concern for healthcare professionals and patients., Main Results: We included 104 trials (8443 participants). Most trials were conducted in high-income countries (81/104), most likely in outpatient or other hospital settings. We judged only one trial to be low risk of bias across all domains. Fifty-five trials had high risk of bias in at least one domain, mostly due to lack of blinding or missing outcome data. Stronger-potency versus weaker-potency topical corticosteroids Sixty-three trials compared different potencies of topical corticosteroids: 12 moderate versus mild, 22 potent versus mild, 25 potent versus moderate, and 6 very potent versus potent. Trials were usually in children with moderate or severe eczema, where specified, lasting one to five weeks. The most reported outcome was Investigator Global Assessment (IGA) of clinician-reported signs of eczema. We pooled four trials that compared moderate- versus mild-potency topical corticosteroids (420 participants). Moderate-potency topical corticosteroids probably result in more participants achieving treatment success, defined as cleared or marked improvement on IGA (52% versus 34%; odds ratio (OR) 2.07, 95% confidence interval (CI) 1.41 to 3.04; moderate-certainty evidence). We pooled nine trials that compared potent versus mild-potency topical corticosteroids (392 participants). Potent topical corticosteroids probably result in a large increase in number achieving treatment success (70% versus 39%; OR 3.71, 95% CI 2.04 to 6.72; moderate-certainty evidence). We pooled 15 trials that compared potent versus moderate-potency topical corticosteroids (1053 participants). There was insufficient evidence of a benefit of potent topical corticosteroids compared to moderate topical corticosteroids (OR 1.33, 95% CI 0.93 to 1.89; moderate-certainty evidence). We pooled three trials that compared very potent versus potent topical corticosteroids (216 participants). The evidence is uncertain with a wide confidence interval (OR 0.53, 95% CI 0.13 to 2.09; low-certainty evidence). Twice daily or more versus once daily application We pooled 15 of 25 trials in this comparison (1821 participants, all reported IGA). The trials usually assessed adults and children with moderate or severe eczema, where specified, using potent topical corticosteroids, lasting two to six weeks. Applying potent topical corticosteroids only once a day probably does not decrease the number achieving treatment success compared to twice daily application (OR 0.97, 95% CI 0.68 to 1.38; 15 trials, 1821 participants; moderate-certainty evidence). Local adverse events Within the trials that tested 'treating eczema flare-up' strategies, we identified only 26 cases of abnormal skin thinning from 2266 participants (1% across 22 trials). Most cases were from the use of higher-potency topical corticosteroids (16 with very potent, 6 with potent, 2 with moderate and 2 with mild). We assessed this evidence as low certainty, except for very potent versus potent topical corticosteroids, which was very low-certainty evidence.  Longer versus shorter-term duration of application for induction of remission No trials were identified. Twice weekly application (weekend, or 'proactive therapy') to prevent relapse (flare-ups) versus no topical corticosteroids/reactive application Nine trials assessed this comparison, generally lasting 16 to 20 weeks. We pooled seven trials that compared weekend (proactive) topical corticosteroids therapy versus no topical corticosteroids (1179 participants, children and adults with a range of eczema severities, though mainly moderate or severe). Weekend (proactive) therapy probably results in a large decrease in likelihood of a relapse from 58% to 25% (risk ratio (RR) 0.43, 95% CI 0.32 to 0.57; 7 trials, 1149 participants; moderate-certainty evidence). Local adverse events We did not identify any cases of abnormal skin thinning in seven trials that assessed skin thinning (1050 participants) at the end of treatment. We assessed this evidence as low certainty. Other comparisons  Other comparisons included newer versus older preparations of topical corticosteroids (15 trials), cream versus ointment (7 trials), topical corticosteroids with wet wrap versus no wet wrap (6 trials), number of days per week applied (4 trials), different concentrations of the same topical corticosteroids (2 trials), time of day applied (2 trials), topical corticosteroids alternating with topical calcineurin inhibitors versus topical corticosteroids alone (1 trial), application to wet versus dry skin (1 trial) and application before versus after emollient (1 trial). No trials compared branded versus generic topical corticosteroids and time between application of emollient and topical corticosteroids., Authors' Conclusions: Potent and moderate topical corticosteroids are probably more effective than mild topical corticosteroids, primarily in moderate or severe eczema; however, there is uncertain evidence to support any advantage of very potent over potent topical corticosteroids. Effectiveness is similar between once daily and twice daily (or more) frequent use of potent topical corticosteroids to treat eczema flare-ups, and topical corticosteroids weekend (proactive) therapy is probably better than no topical corticosteroids/reactive use to prevent eczema relapse (flare-ups). Adverse events were not well reported and came largely from low- or very low-certainty, short-term trials. In trials that reported abnormal skin thinning, frequency was low overall and increased with increasing potency. We found no trials on the optimum duration of treatment of a flare, branded versus generic topical corticosteroids, and time to leave between application of topical corticosteroids and emollient. There is a need for longer-term trials, in people with mild eczema., (Copyright © 2022 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.)

Introduction: Eczema care requires management of triggers and various treatments. We developed two online behavioural interventions to support eczema care called ECO (Eczema Care Online) for young people and ECO for families. This protocol describes two randomised controlled trials (RCTs) aimed to evaluate clinical and cost-effectiveness of the two interventions. METHODS AND ANALYSIS: Design : Two independent, pragmatic, unmasked, parallel group RCTs with internal pilots and nested health economic and process evaluation studies. Setting : Participants will be recruited from general practitioner practices in England. Participants : Young people aged 13-25 years with eczema and parents and carers of children aged 0-12 years with eczema, excluding inactive or very mild eczema (five or less on Patient-Oriented Eczema Measure (POEM)). Interventions : Participants will be randomised to online intervention plus usual care or to usual eczema care alone. Outcome measures : Primary outcome is eczema severity over 24 weeks measured by POEM. Secondary outcomes include POEM 4-weekly for 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, health service and treatment use. Process measures include treatment adherence, barriers to adherence and intervention usage. Our sample sizes of 303 participants per trial are powered to detect a group difference of 2.5 (SD 6.5) in monthly POEM scores over 24 weeks (significance 0.05, power 0.9), allowing for 20% loss to follow-up. Cost-effectiveness analysis will be from a National Health Service and personal social service perspective. Qualitative and quantitative process evaluation will help understand the mechanisms of action and participant experiences and inform implementation., Ethics and Dissemination: The study has been approved by South Central Oxford A Research Ethics Committee (19/SC/0351). Recruitment is ongoing, and follow-up will be completed by mid-2022. Findings will be disseminated to participants, the public, dermatology and primary care journals, and policy makers., Trial Registration Number: ISRCTN79282252., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)