Emollient bath additives for the treatment of childhood eczema (BATHE): multi-centre pragmatic parallel group randomised controlled trial of clinical and cost-effectiveness

Objectives: To determine the clinical and cost-effectiveness of including emollient bath additives in the management of childhood eczema. Trial design: Pragmatic randomised open-label superiority trial with two parallel groups. Setting and recruitment: 96 general practices in Wales, West of England and Southern England. Invitation by personal letter or opportunistically by usual clinical team. Participants: Children were eligible to participate if aged over 12 months and less than 12 years, fulfilling UK Diagnostic Criteria for Atopic Dermatitis. Children with inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once a week, or whose carers were not willing to accept randomisation. 483 were randomised and one withdrew, leaving 482 children in the trial: 51% female, 84% white, mean age 5 years. Interventions: The intervention group were prescribed emollient bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management and were given standardised advice on how to wash. Primary outcome: Eczema control measured by Patient Oriented Eczema Measure (POEM, range 0-28) weekly for 16 weeks. Secondary outcomes: Eczema severity over 1 year (4-weekly POEM from baseline to 52 weeks); number of eczema exacerbations resulting in primary healthcare consultation; disease-specific quality of life (QOL) (Dermatitis Family Impact); generic QoL (Child Health Utility-9D); resource utilisation; type and quantity of topical corticosteroid/calcineurin inhibitors prescribed. Randomisation: 483 children were randomised (1:1) using online software, stratified by recruiting centre. Results: 95.6% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 76.8% (370/482) of participants completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean Baseline POEM was 9.5 (s.d. 5.7) in the bath additives group and 10.1 (s.d. 5.8) in the no bath additives group. The mean POEM over the 16-week period was 7.5 (s.d. 6.0) in the bath additives group and 8.4 (6.0) in the no bath additives group. There was no statistically significant difference in weekly POEM scores between groups over 16 weeks. After controlling for baseline severity and confounders (ethnicity, topical corticosteroid use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% CI -0.27 to 1.10), below the published minimal clinically important difference for POEM of 3 points. There was no difference between groups in secondary outcomes, economic outcomes or in adverse effects. Conclusions: This trial found no evidence of clinical benefit from including emollient bath additives in the standard management of childhood eczema. Further research is needed into optimal regimens for leave-on emollient and use of soap substitutes for children with eczema

Feasibility of weekly participant-reported data collection in a pragmatic randomised controlled trial in primary care: Experiences from the BATHE trial (Bath Additives for the Treatment of cHildhood Eczema)

Background Patient-reported outcomes measures in clinical trials ensure that evaluations of effectiveness focus on outcomes that are important to patients. In relapsing-remitting conditions, such as eczema, repeated measurements may allow a more accurate reflection of disease burden and treatment effect than less frequent measurements. We asked parents/carers of children with eczema taking part in a trial of bath emollients to complete weekly questionnaires for 16 weeks. Methods The objective of this study was to determine the acceptability and practicality of collecting weekly measures of eczema severity online for 16 weeks in children aged 1 to 11 years as part of the BATHE study. BATHE randomised patients to bath emollients plus standard eczema care or standard eczema care only. The primary outcome was eczema severity, measured by the seven-item Patient-Oriented Eczema Measure (POEM) repeated weekly for 16 weeks. Acceptability was explored through qualitative interviews with 10 participants. Interviews were audio-recorded, transcribed and analysed thematically. Practicality was assessed by exploring the completeness of the data and keeping a log of any problems. Results Four hundred and eighty-two participants were recruited to the trial and 429 opted to complete measures online (89.0%). Data were collected online for 83% of time points over the 16-week period and there was no association between socio-demographic characteristics and data completeness. Two hundred and six (48%) completed their weekly data every week for 16 weeks and 341 (79%) completed it at least 80% of the time. The mean number of weeks completed was 13.3 out of 16 (SD 4.2). Interviewees said that they understood the rationale behind weekly collection and some welcomed this as it helped them realise how their child’s eczema changed weekly. Whilst some interviewees spoke of weekly questionnaires as onerous, others said that they found them quick and easy. Reminders were welcomed. Parents/carers seemed happy to receive telephone reminders and it was sometimes useful for eliciting problems relating to obtaining trial medication or password problems for online data collection. Conclusions Amongst this population, high levels of data completeness suggests that weekly completion of the online questionnaire appears to be acceptable and feasible over a 16-week period

Feasibility of weekly participant-reported data collection in a pragmatic randomised controlled trial in primary care:experiences from the BATHE trial (Bath Additives for the Treatment of cHildhood Eczema)

Background: Patient‐reported outcomes measures in clinical trials ensure that evaluations of effectiveness focus on outcomes that are important to patients. In relapsing‐remitting conditions such as eczema, repeated measurements may allow a more accurate reflection of disease burden and treatment effect than less frequent measurements. We asked parents/carers of children with eczema taking part in a trial of bath emollients to complete weekly questionnaires for 16 weeks.Methods: The objective of this study was to determine the acceptability and practicality of collecting weekly measures of eczema severity online for 16 weeks in children aged 1 to 11 years as part of the BATHE study. BATHE randomised patients to bath emollients plus standard eczema care or standard eczema care only. The primary outcome was eczema severity, measured by the 7‐item Patient‐Oriented Eczema Measure (POEM) repeated weekly for 16 weeks. Acceptability was explored through qualitative interviews with ten participants. Interviews were audio‐recorded, transcribed, and analysed thematically. Practicality was assessed by exploring the completeness of the data and keeping a log of any problems.Results: 482 participants were recruited to the trial and 429 opted to complete measures online(89.0%). Data were collected online for 83% of timepoints over the 16 week period and there was no association between socio‐demographic characteristics and data completeness. 206 (48%) completed their weekly data every week for 16 weeks and 341 (79%) completed it at least 80% of the time. The mean number of weeks completed was 13.3 out of 16 (s.d 4.2). Interviewees said they understood the rationale behind weekly collection and some welcomed this as it helped them realise how their child’s eczema changed weekly. While some interviewees spoke of weekly questionnaires as onerous, others said they found them quick and easy. Reminders were welcomed. Parents/carers seemed happy to receive telephone reminders and it was sometimes useful for eliciting problems relating to obtaining trial medication or password problems for online data collection.Conclusions: Amongst this population, high levels of data completeness suggests that weekly completion of the online questionnaire appears to be acceptable and feasible over a 16 week period.Trial registration number: ISRCTN84102309, Registered on 9/12/201

Adding emollient bath additives to standard eczema management for children with eczema:the BATHE RCT

Background Childhood eczema is very common. Treatment often includes emollient bath additives, despite there being little evidence of their effectiveness. Objectives To determine the clinical effectiveness and cost-effectiveness of emollient bath additives in the management of childhood eczema. Design Pragmatic, randomised, open-label, multicentre superiority trial with two parallel groups. Setting Ninety-six general practices in Wales, the west of England and southern England. Invitation by personal letter or opportunistically. Participants Children aged between 12 months and 12 years fulfilling the UK Diagnostic Criteria for Atopic Eczema. Children with inactive or very mild eczema (a score of ≤ 5 on the Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once per week or whose parents/carers were not prepared to accept randomisation. Interventions The intervention group were prescribed bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued standard eczema management, including regular leave-on emollients and topical corticosteroids (TCSs) when required. Main outcome measures The primary outcome was eczema control measured by Patient Oriented Eczema Measure [POEM, 0 (clear) to 28 (severe)] weekly for 16 weeks. The secondary outcomes were eczema severity over 1 year (4-weekly POEM), number of eczema exacerbations, disease-specific quality of life (QoL) (Dermatitis Family Impact Questionnaire), generic QoL (Child Health Utility-9 Dimensions) and type and quantity of topical steroid/calcineurin inhibitors prescribed. Children were randomised (1 : 1) using online software to either bath additives plus standard eczema care or standard eczema care alone, stratified by recruiting centre, and there was open-label blinding. Results From December 2014 to May 2016, 482 children were randomised: 51% were female, 84% were white and the mean age was 5 years (n = 264 in the intervention group, n = 218 in the control group). Reported adherence to randomised treatment allocation was > 92% in both groups, with 76.7% of participants completing at least 12 (80%) of the first 16 weekly questionnaires for the primary outcome. Baseline POEM score was 9.5 [standard deviation (SD) 5.7] in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. Average POEM score over the first 16 weeks was 7.5 (SD 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group, with no statistically significant difference between the groups. After controlling for baseline severity and confounders (ethnicity, TCS use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% confidence interval –0.27 to 1.10), which is well below the published minimal clinically important difference of 3 points. There was no difference between groups in secondary outcomes or in adverse effects such as redness, stinging or slipping. Limitations Simple randomisation resulted in an imbalance in baseline group size, although baseline characteristics were well balanced between groups. Conclusion This trial found no evidence of clinical benefit of including emollient bath additives in the standard management of childhood eczema