Supplemental Material, Gimeno_#2_Appendix_A_FINAL - Protocol for <i>N</i>-of-1 trials with replications across therapists for childhood-onset dystonia rehabilitation: Study 2

<p>Supplemental Material, Gimeno_#2_Appendix_A_FINAL for Protocol for <i>N</i>-of-1 trials with replications across therapists for childhood-onset dystonia rehabilitation: Study 2 by Hortensia Gimeno, Helene J. Polatajko, Victoria Cornelius, Jean-Pierre Lin, and Richard G. Brown in Canadian Journal of Occupational Therapy</p

Supplemental Material, Gimeno_#1_Appendix_A_Supplementary_FINAL - Protocol for <i>N</i>-of-1 trials proof of concept for rehabilitation of childhood-onset dystonia: Study 1

<p>Supplemental Material, Gimeno_#1_Appendix_A_Supplementary_FINAL for Protocol for <i>N</i>-of-1 trials proof of concept for rehabilitation of childhood-onset dystonia: Study 1 by Hortensia Gimeno, Helene J. Polatajko, Victoria Cornelius, Jean-Pierre Lin, and Richard G. Brown in Canadian Journal of Occupational Therapy</p

Supplemental Material, Gimeno_#1_Appendix_C_Supplementary_FINAL_FINAL - Protocol for <i>N</i>-of-1 trials proof of concept for rehabilitation of childhood-onset dystonia: Study 1

<p>Supplemental Material, Gimeno_#1_Appendix_C_Supplementary_FINAL_FINAL for Protocol for <i>N</i>-of-1 trials proof of concept for rehabilitation of childhood-onset dystonia: Study 1 by Hortensia Gimeno, Helene J. Polatajko, Victoria Cornelius, Jean-Pierre Lin, and Richard G. Brown in Canadian Journal of Occupational Therapy</p

Supplemental Material, Gimeno_#1_Appendix_B_FINAL_FINAL - Protocol for <i>N</i>-of-1 trials proof of concept for rehabilitation of childhood-onset dystonia: Study 1

<p>Supplemental Material, Gimeno_#1_Appendix_B_FINAL_FINAL for Protocol for <i>N</i>-of-1 trials proof of concept for rehabilitation of childhood-onset dystonia: Study 1 by Hortensia Gimeno, Helene J. Polatajko, Victoria Cornelius, Jean-Pierre Lin, and Richard G. Brown in Canadian Journal of Occupational Therapy</p

Additional file 3: Figure S3. of Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial

Gantt chart (timeline of the study, DOC). (DOCX 16 kb

Additional file 1: Figure S1. of Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial

SPIRIT 2013 Checklist. (DOC 272 kb

Study booklet for control group.

BackgroundBathing babies less frequently and intensively in the first six months of life may prevent eczema, but this has not yet been definitively tested in a randomised controlled trial. Such a trial would require evidence-based support to help parents engage with a minimal bathing routine. The present study reports the development of this support.MethodsWe adopted a four-stage design process: (i) Pregnant women and their families (n = 31) were interviewed to ascertain key barriers and facilitators towards following the minimal bathing intervention. (ii) These barriers and facilitators were mapped to behaviour change techniques, focussing on the intervention types of education, persuasion and environmental restructuring, alongside appropriate modes of delivery, and prototype intervention materials were developed. (iii) We iteratively refined these materials in a workshop with multidisciplinary experts and Patient and Public Involvement and Engagement (PPIE) representatives (n = 13) and an (iv) intervention walkthrough with families (n = 5). The design process was informed by the Behaviour Change Wheel, Theoretical framework of acceptability and the Template for intervention description and replication.ResultsSocial influences and motivational factors are likely to influence both uptake and adherence to the intervention. Anticipated emotional reward from participating in research for the benefit of others was indicated to be a strong facilitator for intervention uptake. Alternatives to bathing, having fun with the baby and the night-time routine, alongside family support, were notable facilitators suggested to aid adherence to the intervention. Barriers included hygiene concerns and anticipated negative social appraisal. Barriers and facilitators were mapped to thirty-six behaviour change techniques, focussing on the intervention types of education, persuasion and environmental restructuring, all of which were embedded into the package of support. The prototype intervention materials received positive feedback from the expert workshop and study walkthrough with families. The final package of support comprises printed and digital prompts and cues, a study booklet, video, and digital tool for self-monitoring.ConclusionsThe intervention design process incorporated the ‘real world’ views and experiences of families, experts and PPIE representatives, alongside criteria for designing behavioural interventions. The effectiveness of the package of support will be tested in a feasibility trial and embedded process evaluation.</div

Image of control group pack.

BackgroundBathing babies less frequently and intensively in the first six months of life may prevent eczema, but this has not yet been definitively tested in a randomised controlled trial. Such a trial would require evidence-based support to help parents engage with a minimal bathing routine. The present study reports the development of this support.MethodsWe adopted a four-stage design process: (i) Pregnant women and their families (n = 31) were interviewed to ascertain key barriers and facilitators towards following the minimal bathing intervention. (ii) These barriers and facilitators were mapped to behaviour change techniques, focussing on the intervention types of education, persuasion and environmental restructuring, alongside appropriate modes of delivery, and prototype intervention materials were developed. (iii) We iteratively refined these materials in a workshop with multidisciplinary experts and Patient and Public Involvement and Engagement (PPIE) representatives (n = 13) and an (iv) intervention walkthrough with families (n = 5). The design process was informed by the Behaviour Change Wheel, Theoretical framework of acceptability and the Template for intervention description and replication.ResultsSocial influences and motivational factors are likely to influence both uptake and adherence to the intervention. Anticipated emotional reward from participating in research for the benefit of others was indicated to be a strong facilitator for intervention uptake. Alternatives to bathing, having fun with the baby and the night-time routine, alongside family support, were notable facilitators suggested to aid adherence to the intervention. Barriers included hygiene concerns and anticipated negative social appraisal. Barriers and facilitators were mapped to thirty-six behaviour change techniques, focussing on the intervention types of education, persuasion and environmental restructuring, all of which were embedded into the package of support. The prototype intervention materials received positive feedback from the expert workshop and study walkthrough with families. The final package of support comprises printed and digital prompts and cues, a study booklet, video, and digital tool for self-monitoring.ConclusionsThe intervention design process incorporated the ‘real world’ views and experiences of families, experts and PPIE representatives, alongside criteria for designing behavioural interventions. The effectiveness of the package of support will be tested in a feasibility trial and embedded process evaluation.</div

Consolidated criteria for reporting qualitative research (COREQ) items.

Consolidated criteria for reporting qualitative research (COREQ) items.</p

Effects of EGF on primary bronchial epithelial cell (PBEC) proliferation and mediating neutrophil chemotaxis.

<p>(A) PBECs were exposed to EGF and proliferation was assessed using a colorimetric assay based on methylene blue uptake and release (<i>see Results section; pilot experiments</i>). The stimulation index derived by dividing the methylene blue uptake of cells exposed to EGF (10 ng/ml, 24 h) by the uptake of unexposed cells were <1 in all subject groups, suggesting that, EGF did not increase the numbers of epithelial cells (<i>n</i> = 3–5 donors from each group). (B) Dose-dependency of chemotactic responses to PBEC conditioned media. PBECs were stimulated with EGF (10 ng/ml) to generate EGF-CM or left untreated (Basal-CM). Neutrophil chemotaxis induced by the CM was compared to SFM as described in <i>Methods</i>. The chemotactic activity was concentration-dependent with a maximal effect observed when using neat CM (<i>n</i> = 3 donors).</p