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

Background: Emollients 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. Objective: To compare the effectiveness and acceptability of four commonly used types of emollients for the treatment of childhood eczema. Design: Four 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. Setting: Primary care (78 general practitioner surgeries) in England. Participants: Children 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. Interventions: Study 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 measures: The 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. Results: A 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. Limitations: Parents 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. Conclusions: The 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 work: Future 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 registration: This trial is registered as ISRCTN84540529 and EudraCT 2017-000688-34. Funding: This 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.

One in five children in the UK have eczema, a long-term, itchy, dry skin condition. It can significantly affect both the child and their family. Most children are diagnosed and looked after by their family doctor (general practitioner) and are prescribed moisturisers (also called emollients) to relieve skin dryness and other creams (topical corticosteroids) to control flare-ups. However, there are many different types of emollients and, to our knowledge, limited research to show which is better. In the Best Emollients for Eczema clinical trial, we compared the four main types of moisturisers ­ lotions, creams, gels and ointments. These types vary in their consistency, from thin to thick. We recruited 550 children (most of whom were white and had moderate eczema) and randomly assigned them to use one of the four different types as their main moisturiser for 16 weeks. We found no difference in effectiveness. Parent-reported eczema symptoms, eczema severity and quality of life were the same for all the four types of moisturisers. However, overall satisfaction was highest for lotions and gels. Ointments may need to be used less and cause less stinging. We interviewed 44 parents and 25 children who took part. Opinions of all four types of moisturisers varied. What one family liked about a moisturiser was not necessarily the same for another and preferences were individual to each user. Sometimes there was a tension between how well a moisturiser worked (effectiveness) and how easy it was to use (acceptability). In these cases, effectiveness tended to decide whether or not parents kept using it. People found moisturisers in pumps and bottles easier to use than those in tubs. A number of participants valued the information they were given about how to use moisturisers. Our results suggest that the type of moisturiser matters less than finding one that suits the child and family.

Determining when a hospital admission of an older person can be avoided in a subacute setting: a systematic review and concept analysis.

OBJECTIVE: To conduct a systematic review of the evidence for when a hospital admission for an older person can be avoided in subacute settings. We examined the definition of admission avoidance and the evidence for the factors that are required to avoid admission to hospital in this setting. METHODS: Using defined PICOD criteria, we conducted searches in three databases (Medline, Embase and Cinahl) from January 2006 to February 2018. References were screened by title and abstract followed by full paper screening by two reviewers. Additional studies were searched from the grey literature, experts in the field and forward and backward referencing. Data were narratively described, and concept analysis was used to investigate the definition of admission avoidance. RESULTS: A total of 17 studies were considered eligible for review; eight provided a definition of admission avoidance and 10 described admission avoidance criteria. We identified three factors which play a key role in admission avoidance in the subacute setting: (1) ambulatory care sensitive conditions and common medical scenarios for the older person, which included respiratory infections or pneumonia, urinary tract infections and catheter care, dehydration and associated symptoms, falls and behavioural management, and managing ongoing chronic conditions; (2) criteria/tools, referring to interventions that have used clinical expertise in conjunction with a range of general and geriatric triage tools; in condition-specific interventions, the decision whether to admit or not was based on level of risk determined by defined clinical tools; and (3) personnel and resources, referring to the need for experts to make the initial decision to avoid an admission. Supervision by nurses or physicians was still needed at subacute level, requiring resources such as short-stay beds, intravenous antibiotic treatment or fluids for rehydration and rapid access to laboratory tests. CONCLUSION: The review identified a set of criteria for ambulatory care sensitive conditions and common medical scenarios for the older person that can be treated in the subacute setting with appropriate tools and resources. This information can help commissioners and care providers to take on these important elements and deliver them in a locally designed way.

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. TRIAL REGISTRATION NUMBER: ISRCTN84540529.

Frailty assessment in primary health care and its association with unplanned secondary care use: a rapid review.

BACKGROUND: The growing frail, older population is increasing pressure on hospital services. This is directing the attention of clinical commissioning groups towards more comprehensive approaches to managing frailty in the primary healthcare environment. AIM: To review the literature on whether assessment of frailty in primary health care leads to a reduction in unplanned secondary care use. DESIGN & SETTING: A rapid review involving a systematic search of Medline and Medline In-Process. METHOD: Relevant data were extracted following the iterative screening of titles, abstracts, and full texts to identify studies in the primary or community healthcare setting which assessed the effect of frailty on unplanned secondary care use between January 2005-June 2016. RESULTS: The review included 11 primary studies: nine observational studies; one randomised controlled trial (RCT); and one non-randomised controlled trial (nRCT). Eight out of nine observational studies reported a positive association between frailty and secondary care utilisation. The RCT and nRCT reported conflicting findings. CONCLUSION: Older people identified as frail in a primary healthcare setting were more likely to be admitted to hospital. Based on the limited and equivocal trial evidence, it is not possible to draw firm conclusions regarding appropriate tools for the identification and management of frail older people at risk of hospital admission.

General practitioners and emergency departments (GPED)-efficient models of care: a mixed-methods study protocol.

INTRODUCTION: Pressure continues to grow on emergency departments in the UK and throughout the world, with declining performance and adverse effects on patient outcome, safety and experience. One proposed solution is to locate general practitioners to work in or alongside the emergency department (GPED). Several GPED models have been introduced, however, evidence of effectiveness is weak. This study aims to evaluate the impact of GPED on patient care, the primary care and acute hospital team and the wider urgent care system. METHODS AND ANALYSIS: The study will be divided into three work packages (WPs). WP-A; Mapping and Taxonomy: mapping, description and classification of current models of GPED in all emergency departments in England and interviews with key informants to examine the hypotheses that underpin GPED. WP-B; Quantitative Analysis of National Data: measurement of the effectiveness, costs and consequences of the GPED models identified in WP-A, compared with a no-GPED model, using retrospective analysis of Hospital Episode Statistics Data. WP-C; Case Studies: detailed case studies of different GPED models using a mixture of qualitative and quantitative methods including: non-participant observation of clinical care, semistructured interviews with staff, patients and carers; workforce surveys with emergency department staff and analysis of available local routinely collected hospital data. Prospective case study sites will be identified by completing telephone interviews with sites awarded capital funding by the UK government to implement GPED initiatives. The study has a strong patient and public involvement group that has contributed to study design and materials, and which will be closely involved in data interpretation and dissemination. ETHICS AND DISSEMINATION: The study has been approved by the National Health Service East Midlands-Leicester South Research Ethics Committee: 17/EM/0312. The results of the study will be disseminated through peer-reviewed journals, conferences and a planned programme of knowledge mobilisation. TRIAL REGISTRATION NUMBER: ISRCTN51780222.

A systematic review of the clinical effectiveness and cost-effectiveness of pharmacological and psychological interventions for the management of obsessive-compulsive disorder in children/adolescents and adults.

BACKGROUND: Obsessive-compulsive disorder (OCD) is a relatively common and disabling condition. OBJECTIVES: To determine the clinical effectiveness, acceptability and cost-effectiveness of pharmacological and psychological interventions for the treatment of OCD in children, adolescents and adults. DATA SOURCES: We searched the Cochrane Collaboration Depression, Anxiety and Neurosis Trials Registers, which includes trials from routine searches of all the major databases. Searches were conducted from inception to 31 December 2014. REVIEW METHODS: We undertook a systematic review and network meta-analysis (NMA) of the clinical effectiveness and acceptability of available treatments. Outcomes for effectiveness included mean differences in the total scores of the Yale-Brown Obsessive-Compulsive Scale or its children's version and total dropouts for acceptability. For the cost-effectiveness analysis, we developed a probabilistic model informed by the results of the NMA. All analyses were performed using OpenBUGS version 3.2.3 (members of OpenBUGS Project Management Group; see www.openbugs.net ). RESULTS: We included 86 randomised controlled trials (RCTs) in our systematic review. In the NMA we included 71 RCTs (54 in adults and 17 in children and adolescents) for effectiveness and 71 for acceptability (53 in adults and 18 in children and adolescents), comprising 7643 and 7942 randomised patients available for analysis, respectively. In general, the studies were of medium quality. The results of the NMA showed that in adults all selective serotonin reuptake inhibitors (SSRIs) and clomipramine had greater effects than drug placebo. There were no differences between SSRIs, and a trend for clomipramine to be more effective did not reach statistical significance. All active psychological therapies had greater effects than drug placebo. Behavioural therapy (BT) and cognitive therapy (CT) had greater effects than psychological placebo, but cognitive-behavioural therapy (CBT) did not. BT and CT, but not CBT, had greater effects than medications, but there are considerable uncertainty and methodological limitations that should be taken into account. In children and adolescents, CBT and BT had greater effects than drug placebo, but differences compared with psychological placebo did not reach statistical significance. SSRIs as a class showed a trend for superiority over drug placebo, but the difference did not reach statistical significance. However, the superiority of some individual drugs (fluoxetine, sertraline) was marginally statistically significant. Regarding acceptability, all interventions except clomipramine had good tolerability. In adults, CT and BT had the highest probability of being most cost-effective at conventional National Institute for Health and Care Excellence thresholds. In children and adolescents, CBT or CBT combined with a SSRI were more likely to be cost-effective. The results are uncertain and sensitive to assumptions about treatment effect and the exclusion of trials at high risk of bias. LIMITATIONS: The majority of psychological trials included patients who were taking medications. There were few studies in children and adolescents. CONCLUSIONS: In adults, psychological interventions, clomipramine, SSRIs or combinations of these are all effective, whereas in children and adolescents, psychological interventions, either as monotherapy or combined with specific SSRIs, were more likely to be effective. Future RCTs should improve their design, in particular for psychotherapy or combined interventions. STUDY REGISTRATION: The study is registered as PROSPERO CRD42012002441. FUNDING DETAILS: The National Institute for Health Research Health Technology Assessment programme.

Using ideas management to identify ways to improve care in the NHS and in organisations.

Nurses and midwives have been asked to implement eight high impact actions, announced by the chief nursing officer for England Dame Christine Beasley in November 2009. Here we describe the process of ideas management that led to the actions being selected for the final list, and suggest ways in which nurses can use this process to implement changes in practice.

Impact of Advanced Access on access, workload, and continuity: controlled before-and-after and simulated-patient study.

BACKGROUND: Case studies from the US suggest that Advanced Access appointment systems lead to shorter delays for appointments, reduced workload, and increased continuity of care. AIM: To determine whether implementation of Advanced Access in general practice is associated with the above benefits in the UK. DESIGN OF STUDY: Controlled before-and-after and simulated-patient study. SETTING: Twenty-four practices that had implemented Advanced Access and 24 that had not. METHOD: Anonymous telephone calls were made monthly to request an appointment. Numbers of appointments and patients consulting were calculated from practice records. Continuity was determined from anonymised patient records. RESULTS: The wait for an appointment with any doctor was slightly shorter at Advanced Access practices than control practices (mean 1.00 day and 1.87 days respectively, adjusted difference -0.75; 95% confidence interval [CI] = -1.51 to 0.004 days). Advanced Access practices met the NHS Plan 48-hour access target on 71% of occasions and control practices on 60% of occasions (adjusted odds ratio 1.61; 95% CI = 0.78 to 3.31; P = 0.200). The number of appointments offered, and patients seen, increased at both Advanced Access and control practices over the period studied, with no evidence of differences between them. There was no difference between Advanced Access and control practices in continuity of care (adjusted difference 0.003; 95% CI = -0.07 to 0.07). CONCLUSION: Advanced Access practices provided slightly shorter waits for an appointment compared with control practices, but performance against NHS access targets was considerably poorer than officially reported for both types of practice. Advanced Access practices did not have reduced workload or increased continuity of care.

Previously unidentified morbidity in patients with intellectual disability.

BACKGROUND: Adults with a learning disability frequently have unmet health needs. The cause for this is complex and may be related to difficulties in accessing usual primary care services. Health checks have been widely recommended as a solution to this need. AIM: To determine the likelihood that a structured health check by the primary care team supported by appropriate education would identify and treat previously unrecognised morbidity in adults with an intellectual disability. DESIGN OF STUDY: Individuals were identified within primary care teams and a structured health check performed by the primary care team. This process was supported by an educational resource. Face-to-face audit with the team was performed 3 months following the check. SETTING: Forty general practices within three health authorities in south and mid-Wales participated. They had a combined registered patient population of 354 000. METHOD: Health checks were conducted for 190 (60%) of 318 identified individuals; 128 people moved, died, withdrew from the study, or refused to participate. RESULTS: Complete data were available on 181 health checks; 51% had new needs recognised, of whom 63% had one health need, 25% two health needs, and 12% more than two. Sixteen patients (9%) had serious new morbidity discovered. Management had been initiated for 93% of the identified health needs by the time of audit. This study is the first to identify new disease findings in a primary care population and the likelihood that such disease will be treated. CONCLUSIONS: The findings reflect a concern that current care delivery leaves adults with an intellectual disability at risk of both severe and milder illness going unrecognised. Health checks present one mechanism for identifying and treating such illness in primary care.