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Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children. We did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment. 1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 [95% CI 0·78 to 1·16], p=0·61; adjusted risk difference –1·2% [–5·9 to 3·6]). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (0·46) in the control group; adjusted incidence rate ratio 1·55 (95% CI 1·15 to 2·09). We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn. National Institute for Health Research Health Technology Assessment.

AbstractObjectiveTo assess the effectiveness of oral spironolactone for acne vulgaris in adult women.DesignPragmatic, multicentre, phase 3, double blind, randomised controlled trial.SettingPrimary and secondary healthcare, and advertising in the community and on social media in England and Wales.ParticipantsWomen (≥18 years) with facial acne for at least six months, judged to warrant oral antibiotics.InterventionsParticipants were randomly assigned (1:1) to either 50 mg/day spironolactone or matched placebo until week six, increasing to 100 mg/day spironolactone or placebo until week 24. Participants could continue using topical treatment.Main outcome measuresPrimary outcome was Acne-Specific Quality of Life (Acne-QoL) symptom subscale score at week 12 (range 0-30, where higher scores reflect improved QoL). Secondary outcomes were Acne-QoL at week 24, participant self-assessed improvement; investigator’s global assessment (IGA) for treatment success; and adverse reactions.ResultsFrom 5 June 2019 to 31 August 2021, 1267 women were assessed for eligibility, 410 were randomly assigned to the intervention (n=201) or control group (n=209) and 342 were included in the primary analysis (n=176 in the intervention group and n=166 in the control group). Baseline mean age was 29.2 years (standard deviation 7.2), 28 (7%) of 389 were from ethnicities other than white, with 46% mild, 40% moderate, and 13% severe acne. Mean Acne-QoL symptom scores at baseline were 13.2 (standard deviation 4.9) and at week 12 were 19.2 (6.1) for spironolactone and 12.9 (4.5) and 17.8 (5.6) for placebo (difference favouring spironolactone 1.27 (95% confidence interval 0.07 to 2.46), adjusted for baseline variables). Scores at week 24 were 21.2 (5.9) for spironolactone and 17.4 (5.8) for placebo (difference 3.45 (95% confidence interval 2.16 to 4.75), adjusted). More participants in the spironolactone group reported acne improvement than in the placebo group: no significant difference was reported at week 12 (72% v 68%, odds ratio 1.16 (95% confidence interval 0.70 to 1.91)) but significant difference was noted at week 24 (82% v 63%, 2.72 (1.50 to 4.93)). Treatment success (IGA classified) at week 12 was 31 (19%) of 168 given spironolactone and nine (6%) of 160 given placebo (5.18 (2.18 to 12.28)). Adverse reactions were slightly more common in the spironolactone group with more headaches reported (20% v 12%; p=0.02). No serious adverse reactions were reported.ConclusionsSpironolactone improved outcomes compared with placebo, with greater differences at week 24 than week 12. Spironolactone is a useful alternative to oral antibiotics for women with acne.Trial registrationISRCTN12892056

AbstractObjectiveTo determine the effectiveness of two online behavioural interventions, one for parents and carers and one for young people, to support eczema self-management.DesignTwo independent, pragmatic, parallel group, unmasked, randomised controlled trials.Setting98 general practices in England.ParticipantsParents 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).InterventionsParticipants 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 measuresPrimary 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.Results340 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.ConclusionsTwo 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 registrationISRCTN registry ISRCTN79282252.

Epidemiological studies and anecdotal reports suggest a possible link between household use of hard water and atopic eczema. We sought to test whether installation of an ion-exchange water softener in the home can improve eczema in children. This was an observer-blind randomised trial involving 336 children (aged 6 months to 16 years) with moderate/severe atopic eczema. All lived in hard water areas (≥200 mg/l calcium carbonate). Participants were randomised to either installation of an ion-exchange water softener plus usual eczema care, or usual eczema care alone. The primary outcome was change in eczema severity (Six Area Six Sign Atopic Dermatitis Score, SASSAD) at 12 weeks, measured by research nurses who were blinded to treatment allocation. Analysis was based on the intent-to-treat population. Eczema severity improved for both groups during the trial. The mean change in SASSAD at 12 weeks was -5.0 (20% improvement) for the water softener group and -5.7 (22% improvement) for the usual care group (mean difference 0.66, 95% confidence interval -1.37 to 2.69, p = 0.53). No between-group differences were noted in the use of topical corticosteroids or calcineurin inhibitors. Water softeners provided no additional benefit to usual care in this study population. Small but statistically significant differences were found in some secondary outcomes as reported by parents, but it is likely that such improvements were the result of response bias, since participants were aware of their treatment allocation. A detailed report for this trial is also available at http://www.hta.ac.uk. Current Controlled Trials ISRCTN71423189 Please see later in the article for the Editors' Summary.

Background Globally, most countries have policies and guidelines requiring maternal and perinatal death surveillance and response (MPDSR), a system that can reduce avoidable maternal and perinatal deaths. Economic studies of MPDSR help inform resources to implement and sustain MPDSR at subnational and national levels. This review aims to scope the range of economic studies available and examine types of costs incurred by LMICs to implement and maintain MPDSR. Methods We searched 11 electronic databases for key terms related to economics, maternal and/or perinatal death, health systems, surveillance, or audits/reviews. We included quantitative, qualitative, or mixed methods articles reporting costs of MPDSR, published in English, Spanish, or French during 2012–2023. Two independent authors screened titles and abstracts and extracted data. Costs were converted to the United States dollar price year 2024. Results A total of 14,078 articles were systematically screened. Only 5 were included, as they reported costs of maternal and/or perinatal death surveillance and/or review. Of these only 3 reported itemized costs. None reported on costs of implementing recommendations. From the articles reporting itemized costs, in year 1 (start-up), the cost per death reviewed ranged from $113 to $5,758 and the cost per capita ranged from $0.40 to $1.11. In year 3, these declined to $86 to $577, and $0.26 to $0.66, respectively. The lowest cost per death was for conducting only maternal death reviews in health facilities. For community MPDSR, the lowest cost per capita was achieved by using a pre-existing functional household surveillance system to identify and investigate maternal and neonatal deaths. The highest cost was for establishing a new comprehensive death surveillance and review system, which investigated all deaths in women of reproductive age to identify maternal deaths only. Conclusion Comparability was challenging because available literature was sparse and economic methods and study designs were heterogeneous. The cost–benefit of community death surveillance and review, compared to facility-based death notification and review, has not been clearly established. Better understanding of MPDSR costs is needed to prioritize and integrate MPDSR in health planning across system levels.

Purpose Measuring quality of life in acute asthmatics is challenging, especially when asthma attacks can occur sporadically. Several questionnaires can be used to measure quality of life in this patient group; however, psychometric testing is limited on questionnaires that can be used to estimate Quality Adjusted Life years. The objective of this study is to assess the construct validity (convergent and discriminative validity) and responsiveness of the EuroQol-5-Dimensions 5-Level (EQ-5D-5L), Asthma Quality of Life Utility Index-5 Dimensions (AQL-5D) and Time Trade-Off (TTO) in acute asthma patients. Methods Data from a prospective cohort study were used to test the validity and responsiveness of the EQ-5D-5L, AQL-5D and TTO in asthma patients who were recruited from UK accident & emergency departments or hospital wards. The spearman’s rank correlation coefficient, the Kruskal–Wallis test statistic and the standardized response mean were used to test for convergent validity, discriminative validity and responsiveness, respectively. Results One hundred and twenty-one participants were included in the available case analysis. The EQ-5D-5L and AQL-5D showed moderate to strong correlations for convergent validity at baseline, week 4 and week 8. The AQL-5D and TTO showed moderate correlations at week 4 and week 8. No statistical significance was observed for discriminative validity at baseline. Both the EQ-5D-5L and the AQL-5D also showed that they were sensitive to change for the recovery responses. Conclusions The EQ-5D-5L and AQL-5D showed stronger construct validity and responsiveness compared to the TTO. Therefore, both the EQ-5D-5L and AQL-5D should be considered for use in future economic evaluations.

Background Eczema Care Online ( www.EczemaCareOnline.org.uk/ ) is an online self-management toolkit which includes tailored content for young people (13–25 years) and for parents of children that have eczema (0–12 years). Testing in two randomised controlled trials has shown that it is easy to use, cost effective and offers a sustained improvement in eczema symptoms. Implementing Eczema Care Online outside of a funded research study and ensuring that it reaches those that will most benefit from is now a key challenge. This paper describes the lessons learnt from developing and delivering an implementation strategy. Methods Data from systematic reviews, stakeholder consultation meetings, interviews with trial participants, intervention usage data during the trial, and existing eczema information websites informed our implementation plan. Using Normalisation Process Theory, an implementation plan combined these findings with practical, context-specific actions to encourage wider adoption of the intervention. Results Data was successfully mapped to the four constructs of Normalisation Process Theory, and factors and processes that encourage implementation identified. These include: promoting how Eczema Care Online is different to other sources of information; aligning to and embedding in existing eczema resources (from charities and healthcare providers); simplifying aspects to aid ease of use; and, highlighting evidence that shows that Eczema Care Online works. Key lessons in developing an implementation strategy include 1) start implementation work early 2) maintain flexibility to explore multiple routes to implementation 3) use secondary data sources 4) balance theory with practicalities 5) consider longer-term maintenance beyond the life of the research project. Conclusion Implementation planning is a key stage of the research process that is often not adequately resourced. Implementation planning ensures effective interventions developed and evaluated in research studies are utilised in everyday practice.

A key goal for working age stroke survivors is to return to work, yet only around 50% achieve this at 12 months. Currently, there is limited evidence of effectiveness of early stroke-specialist vocational rehabilitation (ESSVR) interventions from randomised controlled trials. This study examined fidelity to ESSVR and explored social and structural factors which may have influenced implementation in the RETurn to work After stroKE (RETAKE) randomised controlled trial. Mixed-methods process evaluation assessing intervention fidelity and incorporating longitudinal case-studies exploring stroke survivors' experiences of support to return to work. Normalisation Process Theory, and the Conceptual Model for Implementation Fidelity, informed data collection and analysis. Sixteen sites across England and Wales participated in RETAKE. Forty-eight occupational therapists (OTs), supported by 6 mentors experienced in vocational rehabilitation (VR), delivered the intervention (duration 12 months) between February 2018 and April 2022. Twenty-six participants (15 ESSVR, 11 usual care (UC)) were included in longitudinal case-studies. An additional 18 participants (8 ESSVR and 10 UC) were interviewed once. Nineteen OTs, 6 mentors and 19 service managers were interviewed. Fidelity was measured for 39 ESSVR participants; mean fidelity score was 78.8% (SD:19.2%, range 31-100%). Comparison of the experiences of ESSVR and UC participants indicated duration and type of support to return to work were perceived to be better for ESSVR participants. They received early, co-ordinated support including employer liaison and workplace adjustments where appropriate. In contrast, UC participants reported limited or no VR or return to work support from health professionals. Typically, UC support lasted 2-8 weeks, with poor communication and co-ordination between rehabilitation providers. Mentor support for OTs appeared to increase fidelity. Service managers indicated ESSVR would enhance post-stroke services. ESSVR was valued by participants and was delivered with fidelity; implementation appeared to be facilitated by mentor support for OTs.

The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects. Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. Current Controlled Trials ISRCTN77261365.

Recruitment and retention of participants remain critical challenges in clinical trials, often requiring innovative approaches to ensure sufficient enrolment and sustained engagement. Social media advertising offers the potential to reach target populations quickly by leveraging demographic, geographic and interest-based targeting. This mixed-methods observational study evaluates participant experiences and the effectiveness of various recruitment routes within a trial of a treatment for acne. Demographic variables, including age, ethnicity, acne severity and acne duration, were stratified primary care, secondary care, community and social media recruitment routes and 12 participant interviews were analysed using reflexive thematic analysis. Social media recruitment accounted for over half of participants (53.9%). It was particularly effective in recruiting individuals with higher acne severity (IGA ≥ 3; 57.5% of its recruits, n  = 127), longer duration of disease (> 5 years history of acne; 60.2% of its recruits, n  = 133) and from ethnic minority groups (9.0% of its recruits, n  = 20), the latter being notably higher than the proportion recruited via primary care (1.5% of its recruits, n  = 1). Slight variations in retention by recruitment route were observed, with social media (85%) and primary care (84%) achieving the highest retention rate at the 12-week follow-up. All routes lost between 25 and 32% of participants by the 24-week follow-up, signifying the importance of implementing effective retention strategies to keep participants engaged. Overall, participants found targeted social media advertisements to be an acceptable and convenient recruitment approach; initial signals of trust were provided by high-quality graphics and recognisable NHS and university logos, which coupled with responsive trial staff, were suggested to provide a seamless enrolment experience. This study demonstrates that social media recruitment can be an effective and acceptable component of a multi-route strategy for clinical trial enrolment.