Comparison of lotions, creams, gels and ointments for the treatment of childhood eczema: The BEE RCT

BackgroundEmollients are recommended for children with eczema (atopic eczema/dermatitis). A lack of head-to-head comparisons of the effectiveness and acceptability of the different types of emollients has resulted in a ‘trial and error’ approach to prescribing.ObjectiveTo compare the effectiveness and acceptability of four commonly used types of emollients for the treatment of childhood eczema.DesignFour group, parallel, individually randomised, superiority randomised clinical trials with a nested qualitative study, completed in 2021. A purposeful sample of parents/children was interviewed at ≈ 4 and ≈ 16 weeks.SettingPrimary care (78 general practitioner surgeries) in England.ParticipantsChildren aged between 6 months and 12 years with eczema, of at least mild severity, and with no known sensitivity to the study emollients or their constituents.InterventionsStudy emollients sharing the same characteristics in the four types of lotion, cream, gel or ointment, alongside usual care, and allocated using a web-based randomisation system. Participants were unmasked and the researcher assessing the Eczema Area Severity Index scores was masked.Main outcome measuresThe primary outcome was Patient-Oriented Eczema Measure scores over 16 weeks. The secondary outcomes were Patient-Oriented Eczema Measure scores over 52 weeks, Eczema Area Severity Index score at 16 weeks, quality of life (Atopic Dermatitis Quality of Life, Child Health Utility-9 Dimensions and EuroQol-5 Dimensions, five-level version, scores), Dermatitis Family Impact and satisfaction levels at 16 weeks.ResultsA total of 550 children were randomised to receive lotion (analysed for primary outcome 131/allocated 137), cream (137/140), gel (130/135) or ointment (126/138). At baseline, 86.0% of participants were white and 46.4% were female. The median (interquartile range) age was 4 (2–8) years and the median Patient-Oriented Eczema Measure score was 9.3 (SD 5.5). There was no evidence of a difference in mean Patient-Oriented Eczema Measure scores over the first 16 weeks between emollient types (global p = 0.765): adjusted Patient-Oriented Eczema Measure pairwise differences – cream–lotion 0.42 (95% confidence interval –0.48 to 1.32), gel–lotion 0.17 (95% confidence interval –0.75 to 1.09), ointment–lotion –0.01 (95% confidence interval –0.93 to 0.91), gel–cream –0.25 (95% confidence interval –1.15 to 0.65), ointment–cream –0.43 (95% confidence interval –1.34 to 0.48) and ointment–gel –0.18 (95% confidence interval –1.11 to 0.75). There was no effect modification by parent expectation, age, disease severity or the application of UK diagnostic criteria, and no differences between groups in any of the secondary outcomes. Median weekly use of allocated emollient, non-allocated emollient and topical corticosteroids was similar across groups. Overall satisfaction was highest for lotions and gels. There was no difference in the number of adverse reactions and there were no significant adverse events. In the nested qualitative study (n = 44 parents, n = 25 children), opinions about the acceptability of creams and ointments varied most, yet problems with all types were reported. Effectiveness may be favoured over acceptability. Parents preferred pumps and bottles over tubs and reported improved knowledge about, and use of, emollients as a result of taking part in the trial.LimitationsParents and clinicians were unmasked to allocation. The findings may not apply to non-study emollients of the same type or to children from more ethnically diverse backgrounds.ConclusionsThe four emollient types were equally effective. Satisfaction with the same emollient types varies, with different parents/children favouring different ones. Users need to be able to choose from a range of emollient types to find one that suits them.Future workFuture work could focus on how best to support shared decision-making of different emollient types and evaluations of other paraffin-based, non-paraffin and ‘novel’ emollients.Trial registrationThis trial is registered as ISRCTN84540529 and EudraCT 2017-000688-34.FundingThis project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (HTA 15/130/07) and will be published in full in Health Technology Assessment; Vol. 27, No. 19. See the NIHR Journals Library website for further project information

Physical activity and psychosocial characteristics of the peer supporters in the PLAN-A study – a latent class analysis

PLAN-A is a cluster randomised controlled trial of a peer-led physical activity intervention which uses peer supporters to increase the physical activity of 13–14-year-old girls in the UK. This paper uses latent class analysis to identify classes in the whole study population and investigate how those selected as peer supporters in PLAN-A were drawn from different social groups. We identified five classes of girls, based on psychosocial variables (self-esteem, physical activity self-efficacy, motivation, physical activity values among friends and peer support for physical activity (PA) and physical activity behaviour variables (average minutes of weekday MVPA, sedentary time and screen viewing). Peer supporters were similar to the whole study population in terms of overall demographics, but were drawn unequally from the five classes. In addition, there was considerable variation in the distribution of peer supporters between schools. The selection of peer supporters is an integral component of peer-led interventions and should be explored and linked to underlying theory to understand the characteristics of those recruited. However, demographic representativeness is not necessarily the aim, and simple reporting of overall demographic comparisons may mask important differences within subgroups

Action 3:30R: Results of a cluster randomised feasibility study of a revised teaching assistant-led extracurricular physical activity intervention for 8 to 10 year olds

Many children are not sufficiently physically active. We conducted a cluster-randomised feasibility trial of a revised after-school physical activity (PA) programme delivered by trained teaching assistants (TAs) to assess the potential evidence of promise for increasing moderate-to-vigorous physical activity (MVPA). Participants (n = 335) aged 8–10 years were recruited from 12 primary schools in South West England. Six schools were randomised to receive the intervention and six acted as non-intervention controls. In intervention schools, TAs were trained to deliver an after-school programme for 15 weeks. The difference in mean accelerometer-assessed MVPA between intervention and control schools was assessed at follow-up (T1). The cost of programme delivery was estimated. Two schools did not deliver the intervention, meaning four intervention and six control schools were analysed at T1. There was no evidence for a difference in MVPA at T1 between intervention and control groups. Programme delivery cost was estimated at £2.06 per pupil per session. Existing provision in the 12 schools cost £5.91 per pupil per session. Action 3:30 was feasible to deliver and considerably cheaper than existing after-school provision. No difference in weekday MVPA was observed at T1 between the two groups, thus progression to a full trial is not warranted

What about the Rest of Them? Fatal Injuries Related to Production Agriculture Not Captured by the Bureau of Labor Statistics (BLS) Census of Fatal Occupational Injuries (CFOI)

Surveillance of injuries in production agriculture is necessary to inform stakeholders about workplace hazards and risks in order to improve and advance injury prevention policies and practices for this dangerous industry. The most comprehensive fatal injury surveillance effort currently in the United States is the Bureau of Labor Statistics (BLS) Census of Fatal Occupational Injuries (CFOI), which covers occupational fatalities in all U.S. industries, including production agriculture. However, this surveillance does not include many categories of fatalities that occur during agricultural work or on production agriculture worksites. To better capture the human cost of production agriculture, the authors of this paper call for the collection of additional data with a broader scope that supplements, not replaces, the current CFOI. This paper describes challenges in surveillance, highlights key procedural gaps, and offers recommendations for advancing national surveillance of fatal traumatic injuries associated with production agriculture

Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls:Results of a cluster randomised controlled trial

Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy

Best emollients for eczema (BEE) – comparing four types of emollients in children with eczema: protocol for randomised trial and nested qualitative study

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

The STAR care pathway for patients with pain at 3 months after total knee replacement:a multicentre, pragmatic randomised controlled trial

BACKGROUND: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. METHODS: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0–10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361. FINDINGS: Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was −0·65 (95% CI −1·17 to −0·13; p=0·014) and the mean between-group difference in the BPI interference score was −0·68 (−1·29 to −0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group. INTERPRETATION: STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. FUNDING: National Institute for Health Research

Peer-led physical activity intervention for girls aged 13 to 14 years : PLAN-A cluster RCT

Background: Increasing physical activity among girls is a public health priority. Peers play a central role in influencing adolescent behaviour. Peer-led interventions may increase physical activity in adolescent girls, and a feasibility trial had shown that PLAN-A (Peer-led physical Activity iNtervention for Adolescent girls) had evidence of promise to increase physical activity in adolescent girls. Objective: The objective was to test whether or not PLAN-A can increase adolescent girls’ physical activity, relative to usual practice, and be cost-effective. Design: This was a two-arm, cluster-randomised controlled trial, including an economic evaluation and a process evaluation. Participants: State-funded secondary schools in the UK with girls in Year 9 (aged 13–14 years) participated in the trial. All Year 9 girls in participating schools were eligible. Randomisation: Schools were the unit of allocation. They were randomised by an independent statistician, who was blinded to school identities, to the control or intervention arm, stratified by region and the England Index of Multiple Deprivation score. Intervention: The intervention comprised peer nomination (i.e. identification of influential girls), train the trainers (i.e. training the instructors who delivered the intervention), peer supporter training (i.e. training the peer-nominated girls in techniques and strategies underpinned by motivational theory to support peer physical activity increases) and a 10-week diffusion period. Outcomes: The primary outcome was accelerometer-assessed mean weekday minutes of moderate to vigorous physical activity among Year 9 girls. The follow-up measures were conducted 5–6 months after the 10-week intervention, when the girls were in Year 10 (which was also 12 months after the baseline measures). Analysis used a multivariable, mixed-effects, linear regression model on an intention-to-treat basis. Secondary outcomes included weekend moderate to vigorous physical activity, and weekday and weekend sedentary time. Intervention delivery costs were calculated for the economic evaluation. Results: A total of 33 schools were approached; 20 schools and 1558 pupils consented. Pupils in the intervention arm had higher Index of Multiple Deprivation scores than pupils in the control arm. The numbers randomised were as follows: 10 schools (n = 758 pupils) were randomised to the intervention arm and 10 schools (n = 800 pupils) were randomised to the control arm. For analysis, a total of 1219 pupils provided valid weekday accelerometer data at both time points (intervention, n = 602; control, n = 617). The mean weekday moderate to vigorous physical activity was similar between groups at follow-up. The central estimate of time spent engaging in moderate to vigorous physical activity was 2.84 minutes lower in the intervention arm than in the control arm, after adjustment for baseline mean weekday moderate to vigorous physical activity, the number of valid days of data and the stratification variables; however, this difference was not statistically significant (95% confidence interval –5.94 to 0.25; p = 0.071). There were no between-arm differences in the secondary outcomes. The intervention costs ranged from £20.85 to £48.86 per pupil, with an average cost of £31.16. Harms: None. Limitations: The trial was limited to south-west England. Conclusions: There was no evidence that PLAN-A increased physical activity in Year 9 girls compared with usual practice and, consequently, it was not cost-effective. Future work: Future work should evaluate the utility of whole-school approaches to promote physical activity in schools. Trial registration: This trial is registered as ISRCTN14539759. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 6. See the NIHR Journals Library website for further project information. This trial was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a United Kingdom Clinical Research Commission (UKCRC)-registered Clinical Trials Unit that, as part of the Bristol Trials Centre, is in receipt of NIHR Clinical Trials Unit support funding. The sponsor of this trial was University of Bristol, Research and Enterprise Development www.bristol.ac.uk/red/. The costs of delivering the intervention were funded by Sport England