Online behavioural interventions for children and young people with eczema: a quantitative evaluation.

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.

Cost-effectiveness of two online interventions supporting self-care for eczema for parents/carers and young people.

OBJECTIVE: To estimate the cost-effectiveness of online behavioral interventions (EczemaCareOnline.org.uk) designed to support eczema self-care management for parents/carers and young people from an NHS perspective. METHODS: Two within-trial economic evaluations, using regression-based approaches, adjusting for baseline and pre-specified confounder variables, were undertaken alongside two independent, pragmatic, parallel group, unmasked randomized controlled trials, recruiting through primary care. Trial 1 recruited 340 parents/carers of children aged 0-12 years and Trial 2 337 young people aged 13-25 years with eczema scored ≥ 5 on Patient-Oriented Eczema Measure (POEM). Participants were randomized (1:1) to online intervention plus usual care or usual care alone. Resource use, collected via medical notes review, was valued using published unit costs in UK £Sterling 2021. Quality-of-life was elicited using proxy CHU-9D in Trial 1 and self-report EQ-5D-5L in Trial 2. RESULTS: The intervention was dominant (cost saving and more effective) with a high probability of cost-effectiveness (> 68%) in most analyses. The exception was the complete case cost-utility analysis for Trial 1 (omitting participants with children aged < 2), with adjusted incremental cost savings of -£34.15 (95% CI - 104.54 to 36.24) and incremental QALYs of - 0.003 (95% CI - 0.021 to 0.015) producing an incremental cost per QALY of £12,466. In the secondary combined (Trials 1 and 2) cost-effectiveness analysis, the adjusted incremental cost was -£20.35 (95% CI - 55.41 to 14.70) with incremental success (≥ 2-point change on POEM) of 10.3% (95% CI 2.3-18.1%). CONCLUSION: The free at point of use online eczema self-management intervention was low cost to run and cost-effective. TRIAL REGISTRATION: This trial was registered prospectively with the ISRCTN registry (ISRCTN79282252). URL www.EczemaCareOnline.org.uk .

'Eczema shouldn't control you; you should control eczema': qualitative process evaluation of online behavioural interventions to support young people and parents/carers of children with eczema.

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.

Associations of Dietary Intake with the Intestinal Microbiota and Short-Chain Fatty Acids Among Young Adults with Type 1 Diabetes and Overweight or Obesity.

BACKGROUND: Diet, a key component of type 1 diabetes (T1D) management, modulates the intestinal microbiota and its metabolically active byproducts-including SCFA-through fermentation of dietary carbohydrates such as fiber. However, the diet-microbiome relationship remains largely unexplored in longstanding T1D. OBJECTIVES: We evaluated whether increased carbohydrate intake, including fiber, is associated with increased SCFA-producing gut microbes, SCFA, and intestinal microbial diversity among young adults with longstanding T1D and overweight or obesity. METHODS: Young adult men and women with T1D for ≥1 y, aged 19-30 y, and BMI of 27.0-39.9 kg/m2 at baseline provided stool samples at baseline and 3, 6, and 9 mo of a randomized dietary weight loss trial. Diet was assessed by 1-2 24-h recalls. The abundance of SCFA-producing microbes was measured using 16S rRNA gene sequencing. GC-MS measured fecal SCFA (acetate, butyrate, propionate, and total) concentrations. Adjusted and Bonferroni-corrected generalized estimating equations modeled associations of dietary fiber (total, soluble, and pectins) and carbohydrate (available carbohydrate, and fructose) with microbiome-related outcomes. Primary analyses were restricted to data collected before COVID-19 interruptions. RESULTS: Fiber (total and soluble) and carbohydrates (available and fructose) were positively associated with total SCFA and acetate concentrations (n = 40 participants, 52 visits). Each 10 g/d of total and soluble fiber intake was associated with an additional 8.8 µmol/g (95% CI: 4.5, 12.8 µmol/g; P = 0.006) and 24.0 µmol/g (95% CI: 12.9, 35.1 µmol/g; P = 0.003) of fecal acetate, respectively. Available carbohydrate intake was positively associated with SCFA producers Roseburia and Ruminococcus gnavus. All diet variables except pectin were inversely associated with normalized abundance of Bacteroides and Alistipes. Fructose was inversely associated with Akkermansia abundance. CONCLUSIONS: In young adults with longstanding T1D, fiber and carbohydrate intake were associated positively with fecal SCFA but had variable associations with SCFA-producing gut microbes. Controlled feeding studies should determine whether gut microbes and SCFA can be directly manipulated in T1D.

Relationship Between Moderate-to-Vigorous Physical Activity and Glycemia Among Young Adults with Type 1 Diabetes and Overweight or Obesity: Results from the Advancing Care for Type 1 Diabetes and Obesity Network (ACT1ON) Study.

Aims: Using data from the ACT1ON study, we conducted secondary analyses to assess the relationship between minutes of moderate-to-vigorous physical activity (MVPA) and glycemia in adults with type 1 diabetes (T1D) and overweight or obesity. Materials and Methods: Participants (n = 66) with T1D provided measures of glycemia (hemoglobin A1c [HbA1c], percent of time below range <70 mg/dL, time-in-range [TIR 70-180 mg/dL], and time above range [TAR >180 mg/dL]) and self-reported physical activity (Global Physical Activity Questionnaire [GPAQ] and Previous Day Physical Activity Recalls [PDPAR]) at baseline, 3, 6, and 9 months postintervention. Wearable activity data were available for a subset of participants (n = 27). Associations were estimated using mixed effects regression models adjusted for design, demographic, clinical, and dietary covariates. Results: Among young adults 19-30 years of age with a baseline HbA1c of 7.9% ± 1.4% and body mass index of 30.3 (interquartile range 27.9, 33.8), greater habitual weekly MVPA minutes were associated with higher HbA1c through the GPAQ (P < 0.01) and wearable activity data (P = 0.01). We did not observe a significant association between habitual MVPA and any continuous glucose monitoring metrics. Using PDPAR data, however, we observed that greater daily MVPA minutes were associated with more TAR (P < 0.01) and reduced TIR (P < 0.01) on the day following reported physical activity. Conclusions: Among young adults with T1D and overweight or obesity, increased MVPA was associated with worsened glycemia. As physical activity is vital to cardiovascular health and weight management, additional research is needed to determine how to best support young adults with T1D and overweight or obesity in their efforts to increase physical activity. Clinical Trial Registration number: NCT03651622.

'Much more convenient, just as effective': Experiences of starting continuous glucose monitoring remotely following Type 1 diabetes diagnosis.

AIM: Initiating continuous glucose monitoring (CGM) shortly after Type 1 diabetes diagnosis has glycaemic and quality of life benefits for youth with Type 1 diabetes and their families. The SARS-CoV-2 pandemic led to a rapid shift to virtual delivery of CGM initiation visits. We aimed to understand parents' experiences receiving virtual care to initiate CGM within 30 days of diagnosis. METHODS: We held focus groups and interviews using a semi-structured interview guide with parents of youth who initiated CGM over telehealth within 30 days of diagnosis during the SARS-CoV-2 pandemic. Questions aimed to explore experiences of starting CGM virtually. Groups and interviews were audio-recorded, transcribed and analysed using thematic analysis. RESULTS: Participants were 16 English-speaking parents (age 43 ± 6 years; 63% female) of 15 youth (age 9 ± 4 years; 47% female; 47% non-Hispanic White, 20% Hispanic, 13% Asian, 7% Black, 13% other). They described multiple benefits of the virtual visit including convenient access to high-quality care; integrating Type 1 diabetes care into daily life; and being in the comfort of home. A minority experienced challenges with virtual care delivery; most preferred the virtual format. Participants expressed that clinics should offer a choice of virtual or in-person to families initiating CGM in the future. CONCLUSION: Most parents appreciated receiving CGM initiation education via telehealth and felt it should be an option offered to all families. Further efforts can continue to enhance CGM initiation teaching virtually to address identified barriers.

Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials.

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.

Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers.

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.

Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care.

OBJECTIVES: To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care. METHODS: This was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0-10 Numeric Rating Scale) from baseline measured daily over the first 7 days: mean change from baseline was compared between groups over days 1-7 by intention to treat. RESULTS: Between 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1-7 (colchicine vs naproxen: mean difference -0.18; 95% CI -0.53 to 0.17; p=0.32). During days 1-7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54). CONCLUSION: We found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications. TRIAL REGISTRATION NUMBER: ISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

Perceptions and Experiences of Women Participating in a Digital Technology-Based Physical Activity Intervention (the mPED Trial): Qualitative Study.

BACKGROUND: Despite the benefits of regular physical activity, women in every age group have lower activity levels than men, and few women meet the recommended levels of physical activity. Digital technologies have been useful in increasing physical activity during the course of an interventional study. However, sustaining that activity once the clinical trial was complete was a major challenge. OBJECTIVE: This study aimed to describe the experiences and perspectives of physically inactive women who completed the mobile phone-based physical activity education (mPED), a randomized controlled trial, at 12 months. METHODS: Of 210 women who were enrolled in the mPED trial, 203 completed a 12-month open-ended exit interview and survey through phone. The participants were asked about their physical activity levels; their digital technology use; what they learned from, liked, and would change about the trial; their motivations to keep active post-trial; and their advice for other women. Interviews were transcribed verbatim and thematically analyzed using the brief survey qualitative description. Descriptive statistics were used to describe the survey data with the significance level set at P<.05. RESULTS: In the 12-month survey, a greater proportion of the participants in the intervention group, compared with the control group, reported that they regularly wore a pedometer or physical activity tracker (49.3%, 66/143 vs 26.1%, 18/69; P=.002) and engaged in brisk walking (54.5%, 73/134 vs 30.4%, 21/69; P=.001). The experiences and perceptions of physical activity of physically inactive women over time were embedded in a complex interplay of internal and external factors. A total of 6 interactive themes emerged as critical in supporting continued engagement in physical activity postintervention: tracking, technology versus personal touch, accountability, resources and environment, motivation, and habit formation. Technology allowed for self-tracking, which supported internal accountability. However, tracking by another person (personal touch) was needed for external accountability. Resources and environment underpinned the relationship among the themes of tracking, technology versus personal touch, accountability, motivation, and habit formation. CONCLUSIONS: Future research is needed to identify the best ways to harness this dynamic process in promoting and sustaining physical activity among inactive women. Digital technology is evolving at an exponential rate and provides new opportunities to transform research into new approaches to promote physical activity. TRIAL REGISTRATION: ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1471-2485-11-933.

The Life-Space Assessment Measure of Functional Mobility Has Utility in Community-Based Physical Therapist Practice in the United Kingdom.

BACKGROUND: The Life-Space Assessment (LSA) has demonstrable validity and reliability among people sampled from nonclinical settings. Its properties in clinical settings, especially physical therapy services, are less well established. OBJECTIVE: The aim of this study was to test the construct/convergent validity, responsiveness, and floor/ceiling effects of the LSA among patients who had musculoskeletal, orthopedic, neurological, or general surgical presentations and were receiving individually tailored, community-based physical therapist interventions to address gait/balance impairments in an urban location in the United Kingdom. DESIGN: A prospective, repeated-measures, comparative cohort design was used. METHODS: Two hundred seventy-six community-dwelling, newly referred patients were recruited from three cohorts (outpatients; domiciliary, nonhospitalized; and domiciliary, recent hospital discharge). Data were collected from the LSA and the Performance-Oriented Mobility Assessment (POMA1) at initial assessment and discharge. Two hundred twenty-eight participants were retained at follow-up. RESULTS: The median age was 80.5 years, 73.6% were women, and the median number of physical therapist contacts over 53 days was five. LSA scores at assessment and changes over treatment distinguished between cohorts, even after adjustment for covariates. Weak correlations (0.14-0.41) were found between LSA and POMA1 scores. No LSA floor/ceiling effects were found. Significant improvements in the LSA score after the intervention were found for each cohort and for the sample overall. For the whole sample, the mean change in the LSA score was 10.5 points (95% CI = 8.3-12.8). LIMITATIONS: The environmental demands participants faced were not measured. Caregivers answered the LSA questions on behalf of participants when necessary. Assessors were not always masked with regard to the measurement point. CONCLUSIONS: The LSA has utility as an outcome measure in routine community-based physical therapist practice. It has satisfactory construct validity and is sensitive to change over a short time frame. The LSA is not a substitute for the POMA1; these measures complement each other, with the LSA bringing the added value of measuring real-life functional mobility.

Patients' understanding of cellulitis and their information needs: a mixed-methods study in primary and secondary care.

BACKGROUND: Cellulitis is a painful infection of the skin and underlying tissues, commonly affecting the lower leg. Approximately one-third of people experience recurrence. Patients' ability to recover from cellulitis or prevent recurrence is likely to be influenced by their understanding of the condition. AIM: To explore patients' perceptions of cellulitis, and their information needs. DESIGN AND SETTING: Mixed-methods study comprising semi-structured, face-to-face interviews and a cross-sectional survey, recruiting through primary and secondary care, and advertising. METHOD: Adults aged ≥18 years with a history of cellulitis were invited to take part in a survey, qualitative interview, or both. RESULTS: In all, 30 interviews were conducted between August 2016 and July 2017. Qualitative data highlighted a low awareness of cellulitis before the first episode, uncertainty about when it had been diagnosed, concern/surprise at the severity of cellulitis, and a perceived insufficient information provision. People were surprised that they had never heard of cellulitis and that they had not received advice or leaflets giving self-care information. Some sought information from the internet and found this confusing.A total of 240 surveys were completed (response rate 17%). These showed that, although many participants had received information on the treatment of cellulitis (60.0%, n = 144), they often reported receiving no information about causes (60.8%, n = 146) or prevention of recurrence (73.3%, n = 176). CONCLUSION: There is a need to provide information for people with cellulitis, particularly in regard to naming their condition, the management of acute episodes, and how to reduce the risk of recurrences.

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. FUTURE WORK: Further research is required on optimal regimens of leave-on emollients and the use of emollients as soap substitutes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84102309. FUNDING: This project was funded by the NIHR Health Technology Assessment Programme and will be published in full in Health Technology Assessment; Vol. 22, No. 57. See the NIHR Journals Library website for further project information.

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. TRIAL REGISTRATION: ISRCTN84102309 . Registered on 9 December 2013.

The appeal of the Functional Fitness MOT to older adults and health professionals in an outpatient setting: a mixed-method feasibility study.

PURPOSE: To understand the views and perceptions regarding the Functional Fitness MOT (FFMOT), a battery of functional tests followed by a brief motivational interview, of both the older people undergoing it and the health professionals delivering it. PATIENTS AND METHODS: Physically inactive older adults (n=29) underwent the FFMOT and subsequently attended focus groups to share their perceptions of it and to discuss the barriers, motivators, health behavior change, and scope to improve physical activity (PA) levels. PA levels were recorded at baseline and again at 12 weeks together with a post-intervention questionnaire concerning behavior change. Participating physiotherapists and technical instructors were interviewed. RESULTS: Most participants felt they had learned about their abilities and comparisons with their peers, had a change in perception about the importance of good balance and strength, and felt the FFMOT helped raise their awareness of local and self-directed physical activity opportunities. Most felt their awareness of the need for PA had not changed, but 25% of participants started a new organized PA opportunity. The health professionals perceived the FFMOT as being easy to administer, educating, and motivating for participants to increase their PA. Space, time, finances, and insecurity about having the necessary skills to conduct the FFMOTs were seen as barriers in implementing the FFMOT in daily practice. CONCLUSION: Over half of those offered the FFMOT accepted it, suggesting it is appealing. However, most participants felt they were already active enough and that their awareness of the need for PA had not changed. There were positive perceptions of the FFMOT from both professionals and older people, but both felt the FFMOT could be held in a community venue. The overall findings suggest that the FFMOT is feasible in the clinical setting, but its effectiveness has yet to be determined.

Ankle Kinematics and Temporal Gait Characteristics over the Duration of a 6-Minute Walk Test in People with Multiple Sclerosis Who Experience Foot Drop.

Foot drop is a common gait impairment in people with MS (pwMS) but in some foot drop may only occur after a period of prolonged walking and may be a sign of motor fatigability. The purpose of the study was to explore whether, for pwMS, an adapted six-minute walk test (6minWT) would result in an increase in foot drop as measured using electrogoniometry. Sagittal ankle kinematics were recorded for fifteen participants (10 females and 5 males, aged 37-64) with MS (EDSS 4-6) throughout the 6minWT. Ankle kinematics and temporal stride parameters were compared between the first and last 10 gait cycles of the 6minWT. Peak dorsiflexion in swing was significantly reduced at the end of the 6minWT compared to the start, with six of the fifteen participants having a decrease of two degrees or more. Statistically significant changes in temporal stride parameters suggested a decrease in walking speed. Our results suggest that with the protocol used in this study it is feasible to identify patients who experience increased foot drop as a result of a prolonged exercise task.

Applying Natural Language Processing to Understand Motivational Profiles for Maintaining Physical Activity After a Mobile App and Accelerometer-Based Intervention: The mPED Randomized Controlled Trial.

BACKGROUND: Regular physical activity is associated with reduced risk of chronic illnesses. Despite various types of successful physical activity interventions, maintenance of activity over the long term is extremely challenging. OBJECTIVE: The aims of this original paper are to 1) describe physical activity engagement post intervention, 2) identify motivational profiles using natural language processing (NLP) and clustering techniques in a sample of women who completed the physical activity intervention, and 3) compare sociodemographic and clinical data among these identified cluster groups. METHODS: In this cross-sectional analysis of 203 women completing a 12-month study exit (telephone) interview in the mobile phone-based physical activity education study were examined. The mobile phone-based physical activity education study was a randomized, controlled trial to test the efficacy of the app and accelerometer intervention and its sustainability over a 9-month period. All subjects returned the accelerometer and stopped accessing the app at the last 9-month research office visit. Physical engagement and motivational profiles were assessed by both closed and open-ended questions, such as "Since your 9-month study visit, has your physical activity been more, less, or about the same (compared to the first 9 months of the study)?" and, "What motivates you the most to be physically active?" NLP and cluster analysis were used to classify motivational profiles. Descriptive statistics were used to compare participants' baseline characteristics among identified groups. RESULTS: Approximately half of the 2 intervention groups (Regular and Plus) reported that they were still wearing an accelerometer and engaging in brisk walking as they were directed during the intervention phases. These numbers in the 2 intervention groups were much higher than the control group (overall P=.01 and P=.003, respectively). Three clusters were identified through NLP and named as the Weight Loss group (n=19), the Illness Prevention group (n=138), and the Health Promotion group (n=46). The Weight Loss group was significantly younger than the Illness Prevention and Health Promotion groups (overall P<.001). The Illness Prevention group had a larger number of Caucasians as compared to the Weight Loss group (P=.001), which was composed mostly of those who identified as African American, Hispanic, or mixed race. Additionally, the Health Promotion group tended to have lower BMI scores compared to the Illness Prevention group (overall P=.02). However, no difference was noted in the baseline moderate-to-vigorous intensity activity level among the 3 groups (overall P>.05). CONCLUSIONS: The findings could be relevant to tailoring a physical activity maintenance intervention. Furthermore, the findings from NLP and cluster analysis are useful methods to analyze short free text to differentiate motivational profiles. As more sophisticated NL tools are developed in the future, the potential of NLP application in behavioral research will broaden. TRIAL REGISTRATION: ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812 (Archived by WebCite at http://www.webcitation.org/70IkGagAJ).

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

OBJECTIVES: To determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children. DESIGN: Pragmatic randomised open label superiority trial with two parallel groups. SETTING: 96 general practices in Wales and western and southern England. PARTICIPANTS: 483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded. INTERVENTIONS: Participants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants. MAIN OUTCOME MEASURES: The primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed. RESULTS: 483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) 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 score was 9.5 (SD 5.7) in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. The mean POEM score over the 16 week period was 7.5 (SD. 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group. No statistically significant difference was found 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 additives group were 0.41 points higher than in the bath additives group (95% confidence interval -0.27 to 1.10), below the published minimal clinically important difference for POEM of 3 points. The groups did not differ in secondary outcomes, economic outcomes, or adverse effects. CONCLUSIONS: This trial found no evidence of clinical benefit from including emollient bath additives in the standard management of eczema in children. Further research is needed into optimal regimens for leave-on emollient and soap substitutes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84102309.

A weight loss intervention using a commercial mobile application in Latino Americans-Adelgaza Trial.

More than half of Latino adults living in the USA are expected to develop type 2 diabetes in their lifetime. Despite the growing interest in smartphone use for weight loss and diabetes prevention, relatively few clinical trials have evaluated the efficacy of mobile app-based interventions in Latino populations. The aim of this study was to evaluate the potential efficacy of an in-person weight loss intervention in conjunction with a commercially available Fitbit app in a Latino sample at risk for type 2 diabetes and explore significant predictors associated with weight loss. After the run-in period, 54 self-identified Latinos with body mass index (BMI) > 24.9 kg/m2 were enrolled in an 8-week uncontrolled pilot study, and received a Fitbit Zip, its app, and two in-person weight loss sessions adapted from the Diabetes Prevention Program. Mean age was 45.3 (SD ± 10.8) years, 61.1% were born in the USA, and mean BMI was 31.4 (SD ± 4.1) kg/m2. Participants lost an average of 3.3 (SD ± 3.4) % of their body weight (p < .0005). We also observed statistically significant reductions in hip and waist circumferences, and systolic and diastolic blood pressure (p < .001). After controlling for demographic factors, use of the mobile app weight diary at least twice a week (p = .01) and change in the International Physical Activity Questionnaire score (p = .03) were associated with change in percent body weight. The intervention showed the potential efficacy of this intervention, which should be formally evaluated in a randomized controlled trial.