Dataset Information

The views of children and young people on the use of silk garments for the treatment of eczema: a nested qualitative study within the CLOTHing for the relief of Eczema Symptoms (CLOTHES) randomized controlled trial.

ABSTRACT:

Background

Many children suffer with skin diseases but to date most dermatological research has been done 'on' rather than 'with' children; in this study we actively sought the experiences of children and young people. Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects around 20% of children and can impact on the health and wellbeing of children and their families. The role of specialist clothing in the management of AE is poorly understood.

Objectives

The aim of this study, which was nested in a randomized controlled trial, was to qualitatively examine child participants' experiences of using silk garments for the treatment of AE.

Methods

Eighteen children aged 5-15 years, who took part in the CLOTHing for the relief of Eczema Symptoms (CLOTHES) trial, participated in age-appropriate individual interviews or focus groups.

Results

Thematic analysis generated four themes directly related to the silk garments: (i) expectations of the garments; (ii) wearing the garments; (iii) asking if the garments helped; and (iv) thoughts about the garments. The conclusions from this nested qualitative study are that there was some limited improvement in eczema for some children but that the hoped-for 'miracle cure' did not transpire. A mixed picture of knowledge, beliefs and experiences of using the silk garments emerged.

Conclusions

Engaging children in the evaluation of the garments provided first-hand nuanced insights that enhanced understanding of the CLOTHES study as a whole. This nested study demonstrates that children can and indeed want to be engaged in dermatological research in meaningful ways that add to our understanding of treatment options.

SUBMITTER: Wake EV

PROVIDER: S-EPMC6487959 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundThe role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease.Methods and findingsThis was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects.ConclusionsSilk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema.Trial registrationCurrent Controlled Trials ISRCTN77261365.

Project description:BackgroundAtopic eczema (also known as eczema) is a chronic, inflammatory skin condition that often afflicts patients' health and well-being. The Harmonising Outcome Measures for Eczema (HOME) initiative recommends that 'long-term control of eczema' is measured in all clinical trials 3 months or longer in duration. However, little has been published on what eczema control means to those living with or treating atopic eczema.ObjectivesTo (i) develop understanding of what eczema control means to patients, carers and clinicians and (ii) explore the feasibility and acceptability of different ways of measuring eczema control in the long term.MethodsOnline focus groups explored patients/carers experiences in the UK, the United States, the Netherlands, France, Sweden and Japan, and an international online survey gathered views of clinicians. The framework method was used to analyse the focus groups, and thematic analysis was used to analyse survey data. All findings were integrated into a theoretical framework to create overarching themes that cut across these diverse groups.ResultsEight focus groups with patients (16 years+) and eight groups with carers of children took place (N = 97). Sixty-two people took part in the survey. Eczema control was described as a multifaceted construct involving changes in disease activity, the treatment and management of the condition and psychological, social and physical functioning. Patient/carer measurement allows personal accounts and frequent measurement, whilst clinician measurement was deemed less subjective. The burden on patients/carers and issues for analysing and interpreting data should be considered.ConclusionsThis study formed the basis of judging the content validity and feasibility of measurement instruments/methods to assess control of eczema in clinical trials. This online approach to an international qualitative study is an example of how core outcome set developers with limited resources can engage with multiple stakeholder groups on an international basis to inform consensus meeting discussions.

Project description: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.Methods and analysis:Design: pragmatic, multicentre, individually randomised, parallel group superiority trial of four types of emollient (lotions, creams, gel or ointments).Setting:general practitioner surgeries in England.Participants:children aged over 6 months and less than 12 years with mild-to-severe eczema and no known sensitivity to study emollients.Interventions:study-approved lotion, cream, gel or ointment as the only leave-on emollient for 16 weeks, with directions to apply twice daily and as required. Other treatments, such as topical corticosteroids, used as standard care.Follow-up:52 weeks.Primary outcome:validated patient-orientated eczema measure measured weekly for 16 weeks.Secondary outcomes:eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact).Sample size:520 participants (130 per group).Analysis:intention-to-treat using linear mixed models for repeated measures.Nested qualitative study: audio-recording of sample of baseline appointments and up to 60 interviews with participants at 4 and 16 weeks, interviews to be transcribed and analysed thematically.Ethics and dissemination:Ethics approval granted by the NHS REC (South West - Central Bristol Research Ethics Committee 17/SW/0089). Findings will be presented at conferences, published in open-access peer-reviewed journals and the study website; and summaries shared with key stakeholders.Trial registration number:ISRCTN84540529.

Project description:BackgroundEarly 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. The aim of the Trial of Eczema allergy Screening Tests Study is to determine the feasibility of conducting a trial comparing food allergy testing and dietary advice versus usual care, for the management of eczema in children.Methods and analysisDesign: A single centre, two-group, individually randomised, feasibility randomised controlled trial (RCT) with economic scoping and a nested qualitative study.SettingGeneral Practioner (GP) surgeries in the west of England.Participantschildren aged over 3 months and less than 5 years with mild to severe eczema.Interventionsallergy testing (structured allergy history and skin prick tests) or usual care. Sample size and outcome measures: we aim to recruit 80 participants and follow them up using 4-weekly questionnaires for 24 weeks. Nested qualitative study: We will conduct ~20 interviews with parents of participating children, 5-8 interviews with parents who decline or withdraw from the trial and ~10 interviews with participating GPs. Economic scoping: We will gather data on key costs and outcomes to assess the feasibility of carrying out a cost-effectiveness analysis in a future definitive trial.Ethics and disseminationThe study has been reviewed by the Health Research Authority and given a favourable opinion by the NHS REC (West Midlands - South Birmingham Research Ethics Committee, Reference Number 18/WM/0124). Findings will be submitted for presentation at conferences and written up for publication in peer-reviewed journals, which may include mixed-method triangulation and integration of the quantitative and qualitative findings.Trial registrationISRCTN15397185; Pre-results.

Project description:BackgroundWomen commonly seek medical advice about menopausal symptoms. Although menopausal hormone therapy is the most effective treatment, many women prefer non-pharmacological treatments, such as physical activity. The effectiveness of physical activity has been inconclusive when assessed by randomised controlled trials, and it remains unclear how women feel about it as a possible treatment approach. The aim of the study was to explore symptomatic menopausal women's views and experiences of physical activity as a treatment for vasomotor and other menopausal symptoms.MethodsAn in-depth qualitative study was embedded within a randomised controlled trial that assessed the effectiveness of physical activity as a treatment for vasomotor menopausal symptoms in previously inactive vasomotor symptomatic women. Participants were randomised to one of two physical activity interventions or a usual care group. Both physical activity interventions involved two one-to-one consultations, plus either supporting materials or access to physical activity support groups, over 6 months. Semi-structured interviews were conducted with 17 purposively selected participants from all three trial groups after they had completed trial follow-up. Interviews were audio recorded, transcribed verbatim, and analysed by constant comparison.ResultsAll participants talked positively about physical activity as a treatment for their menopausal symptoms, with most reporting participation had improved their hot flushes and night sweats. They reported that they had experienced improved sleep, physical health and psychological well-being. Those who received the physical activity plus social-support intervention reported their ability to cope with their menopausal symptoms had improved. Many participants commented that they would prefer doctors to discuss physical activity as a possible treatment for their hot flushes and night sweats, before offering medication.ConclusionsBased on the views and experiences of the women who participated in this study, healthcare professionals should continue discussing physical activity as a potential first treatment option with menopausal women. Furthermore, healthcare professionals should ensure they prepare, support, and encourage these women both physically and emotionally.Trial registrationISRCTN ISRCTN06495625 Registered 10/11/2010.

Project description:ObjectiveTo explore views of service providers caring for injured people on: the extent to which services meet patients' needs and their perspectives on factors contributing to any identified gaps in service provision.DesignQualitative study nested within a quantitative multicentre longitudinal study assessing longer term impact of unintentional injuries in working age adults. Sampling frame for service providers was based on patient-reported service use in the quantitative study, patient interviews and advice of previously injured lay research advisers. Service providers' views were elicited through semistructured interviews. Data were analysed using thematic analysis.SettingParticipants were recruited from a range of settings and services in acute hospital trusts in four study centres (Bristol, Leicester, Nottingham and Surrey) and surrounding areas.Participants40 service providers from a range of disciplines.ResultsService providers described two distinct models of trauma care: an 'ideal' model, informed by professional knowledge of the impact of injury and awareness of best models of care, and a 'real' model based on the realities of National Health Service (NHS) practice. Participants' 'ideal' model was consistent with standards of high-quality effective trauma care and while there were examples of services meeting the ideal model, 'real' care could also be fragmented and inequitable with major gaps in provision. Service provider accounts provide evidence of comprehensive understanding of patients' needs, awareness of best practice, compassion and research but reveal significant organisational and resource barriers limiting implementation of knowledge in practice.ConclusionsService providers envisage an 'ideal' model of trauma care which is timely, equitable, effective and holistic, but this can differ from the care currently provided. Their experiences provide many suggestions for service improvements to bridge the gap between 'real' and 'ideal' care. Using service provider views to inform service design and delivery could enhance the quality, patient experience and outcomes of care.