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      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

      research-article
      1 , 2 , 3 , 2 , 4 , 5 , , the U.K. Dermatology Clinical Trials Network's CLOTHES Trial Team
      The British Journal of Dermatology
      John Wiley and Sons Inc.

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          Summary

          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.

          Abstract

          What's already known about this topic?

          • Eczema affects around 20% of children and can have a detrimental effect on the child and their family.

          • Adherence with topical treatments is often poor and can lead to treatment failure.

          • Although children are often end‐users of eczema treatments, they are rarely engaged in research involving these products beyond completing questionnaires.

          What does this study add?

          • Children and young people can be meaningfully engaged in dermatology research and add new dimensions of understanding that would not be gained by proxy data.

          • Children told us about their expectations of the garments and their views once they had worn them.

          • The added value of child data lies in enhancing understanding of reasons for adherence and nonadherence, in facilitating interpretation of the trial results, and in ensuring selected objective outcome measures include factors important to children.

          What are the clinical implications of the work?

          • This study illustrates the need to communicate effectively with children and young people to ascertain their thoughts and beliefs about treatment regimens and assess the likelihood of adherence.

          Linked Comment:  Teasdale. Br J Dermatol 2018; 178:25–26 .

          Plain language summary available online

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          Most cited references22

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          The Children's Dermatology Life Quality Index (CDLQI): initial validation and practical use.

          Skin disease can cause severe disability and handicap in children. Measurement of the impact of skin disease on the quality of life is required to aid clinical decision-making, for clinical research, for audit of paediatric dermatology services, and for political reasons, to aid arguments for more resources for the care of children with skin disease. Adult measures are inappropriate, as the lives of children differ markedly from those of adults. The purpose of this study was to create and initially validate a simple practical questionnaire for use in children. One hundred and sixty-nine children, aged 3-16 years, attending a paediatric dermatology clinic, wrote down, with the help of their parents, all the ways in which their skin disease affected their lives. One hundred and eleven different aspects were identified; 10 questions were composed to cover these aspects, using a structure similar to the Adult Dermatology Life Quality Index. This draft questionnaire was piloted on two series, totalling 40 children, and minor alterations were made to improve clarity. The Children's Dermatology Life Quality Index (CDLQI) questionnaire (maximum score 30) was then given to a further 233 dermatology paediatric out-patients (CDLQI mean = 5.1, SD = 4.9), 47 normal controls (mean 0.4, 0.7) and 55 control patients attending a general paediatric clinic (mean 0.7, 2.5). The CDLQI scores for eczema (mean = 7.7, 5.6, n = 47), psoriasis (5.4, 5.0, n = 25) and acne (5.7, 4.4, n = 40), were all highly significantly greater than for moles and naevi (2.3, 2.9, n = 29). The highest mean score was that for scabies (mean = 9.5, 10.5, n = 6).(ABSTRACT TRUNCATED AT 250 WORDS)
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            Establishing rigour in qualitative research: the decision trail. 1993.

            Karel Koch (2005)
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              Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study

              Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research. Conclusions Health researchers combining qualitative research and trials viewed this practice as strengthening evaluative research. Teams viewing the qualitative research as essential to the trial, and resourcing it in practice, may have a better chance of delivering its added value to the trial.
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                Author and article information

                Contributors
                fiona.cowdell@bcu.ac.uk
                Journal
                Br J Dermatol
                Br. J. Dermatol
                10.1111/(ISSN)1365-2133
                BJD
                The British Journal of Dermatology
                John Wiley and Sons Inc. (Hoboken )
                0007-0963
                1365-2133
                07 January 2018
                January 2018
                : 178
                : 1 ( doiID: 10.1111/bjd.2018.178.issue-1 )
                : 183-190
                Affiliations
                [ 1 ] Faculty of Health and Social Care University of Hull Hull U.K.
                [ 2 ] Centre of Evidence Based Dermatology The University of Nottingham Nottingham U.K.
                [ 3 ] Dermatology Department The Rotherham NHS Foundation Trust Rotherham U.K.
                [ 4 ] Nottingham Clinical Trials Unit The University of Nottingham Nottingham U.K.
                [ 5 ] Faculty of Health Education and Life Sciences Birmingham City University Birmingham U.K.
                Author notes
                [*] [* ] Correspondence

                Fiona Cowdell.

                E‐mail: fiona.cowdell@ 123456bcu.ac.uk

                Author information
                http://orcid.org/0000-0001-7785-7465
                http://orcid.org/0000-0002-9355-8059
                Article
                BJD15909
                10.1111/bjd.15909
                6487959
                28856661
                927aad40-84cb-4916-8ebc-89057d91fd6d
                © 2018 The Authors British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 15 August 2017
                Page count
                Figures: 2, Tables: 7, Pages: 8, Words: 6235
                Funding
                Funded by: National Institute for Health Research (NIHR) Health Technology Assessment programme
                Award ID: 11/65/01
                Funded by: U.K. Dermatology Clinical Trials Network
                Funded by: British Association of Dermatologists
                Funded by: University of Nottingham
                Funded by: Nottingham Clinical Trials Unit
                Funded by: NIHR Clinical Research Network
                Categories
                Qualitative and Outcomes Research
                Original Articles
                Qualitative and Outcomes Research
                Custom metadata
                2.0
                bjd15909
                January 2018
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.2.1 mode:remove_FC converted:29.04.2019

                Dermatology
                Dermatology

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