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.

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.

Home parenteral nutrition for people with inoperable malignant bowel obstruction.

BACKGROUND: People with advanced ovarian or gastrointestinal cancer may develop malignant bowel obstruction (MBO). They are able to tolerate limited, if any, oral or enteral (via a tube directly into the gut) nutrition. Parenteral nutrition (PN) is the provision of macronutrients, micronutrients, electrolytes and fluid infused as an intravenous solution and provides a method for these people to receive nutrients. There are clinical and ethical arguments for and against the administration of PN to people receiving palliative care. OBJECTIVES: To assess the effectiveness of home parenteral nutrition (HPN) in improving survival and quality of life in people with inoperable MBO. SEARCH METHODS: We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), MEDLINE (Ovid), Embase (Ovid), BNI, CINAHL, Web of Science and NHS Economic Evaluation and Health Technology Assessment up to January 2018, ClinicalTrials.gov (http://clinicaltrials.gov/) and in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal (http://apps.who.int/trialsearch/). In addition, we handsearched included studies and used the 'Similar articles' feature on PubMed for included articles. SELECTION CRITERIA: We included any studies with more than five participants investigating HPN in people over 16 years of age with inoperable MBO. DATA COLLECTION AND ANALYSIS: We extracted the data and assessed risk of bias for each study. We entered data into Review Manager 5 and used GRADEpro to assess the quality of the evidence. MAIN RESULTS: We included 13 studies with a total of 721 participants in the review. The studies were observational, 12 studies had only one relevant treatment arm and no control and for the one study with a control arm, very few details were given. The risk of bias was high and the certainty of evidence was graded as very low for all outcomes. Due to heterogeneity of data, meta-analysis was not performed and therefore the data were synthesised via a narrative summary.The evidence for benefit derived from PN was very low for survival and quality of life. All the studies measured overall survival and 636 (88%) of participants were deceased at the end of the study. However there were varying definitions of overall survival that yielded median survival intervals between 15 to 155 days (range three to 1278 days). Three studies used validated measures of quality of life. The results from assessment of quality of life were equivocal; one study reported improvements up until three months and two studies reported approximately similar numbers of participants with improvements and deterioration. Different quality of life scales were used in each of the studies and quality of life was measured at different time points. Due to the very low certainty of the evidence, we are very uncertain about the adverse events related to PN use. Adverse events were measured by nine studies and data for individual participants could be extracted from eight studies. This revealed that 32 of 260 (12%) patients developed a central venous catheter infection or were hospitalised because of complications related to PN. AUTHORS' CONCLUSIONS: We are very uncertain whether HPN improves survival or quality of life in people with MBO as the certainty of evidence was very low for both outcomes. As the evidence base is limited and at high risk of bias, further higher-quality prospective studies are required.

Development of a supportive care measure for economic evaluation of end-of-life care using qualitative methods.

BACKGROUND: An imperative to assess the economic impact of care at the end of life is emerging in response to national policy developments in a number of settings. Current focus on health benefits in economic evaluation may not appropriately capture benefits of interventions at the end of life. No instruments are available for measuring such benefits for economic evaluation of end-of-life care. AIM: To develop a descriptive system for a measure for use in economic evaluation of end-of-life care. DESIGN: An initial phase of in-depth interviews was conducted to develop conceptual attributes for inclusion in a measure; a second phase of semi-structured repeat interviews with a subsample of informants was carried out to clarify and confirm the final set of attributes and to develop meaningful wording for a measure. SETTING/PARTICIPANTS: In total, 23 older people from three groups across the dying trajectory: older people (1) within the general population, (2) living in residential care and (3) receiving palliative care. RESULTS: Interviews suggested that the important domains to include within this framework from the perspective of those approaching the end-of-life are choice/having a say in decision-making, love and affection/being with people who care, freedom from physical suffering, freedom from emotional suffering, dignity and self-respect, support, and preparation. A full descriptive system comprising seven questions, each representing one attribute, was developed. CONCLUSION: Economic evaluation should reflect the broader benefits of end-of-life care. Although the supportive care measure developed here requires validation and valuation, it provides a substantial step forward in appropriate economic evaluation of end-of-life care.

Coordinate My Care: a clinical service that coordinates care, giving patients choice and improving quality of life.

INTRODUCTION: If palliative care is to lead the way towards a new model for integrated care, the ability to share information across the whole of health and social care is essential. Coordinate My Care (CMC) is a service dedicated to preserving dignity and autonomy at the end of life. Its care pathways enable health professionals from primary and secondary care to put the patient at the centre of health care delivery. This service is underpinned by an electronic solution. The CMC record can be accessed 24/7 by all health and social care professionals who have a legitimate relationship with the patient. PATIENTS AND METHODS: The record displays diagnosis, prognosis, advanced care plan, resuscitation status and patients wishes for end of life care patients across London. This article is a review of CMC use and outcomes from August 2010- March 2012. RESULTS: 1087 CMC patient records were analysed. The primary diagnosis was non-cancer in 52.3%, cancer in 46.3% and unknown in 1.4%, 42% of all patients were cared for by generalist only and had no specialist palliative care involvement. At the time of analysis 207 had died. Actual place of death was home 38.6%, care/nursing home 16.4%, hospice 12.1% and 30% in hospital. This equates to 55% of patients dying in their usual place of residence and reflects that 70% died outside of hospital. CONCLUSION: The CMC service has a well defined pathway underpinned by an electronic solution. It has been shown to change culture and deliver fully integrated, personalised end of life care. A pan-London CMC roll out will take place over the next 12 months.

Investigating Choice Experiments for Preferences of Older People (ICEPOP): evaluative spaces in health economics.

This paper deals with three concerns about the evaluative framework that is currently dominant within health economics. These concerns are: that the evaluative framework is concerned entirely with health; that the evaluative framework has an individualistic focus on patients alone; and that the methods used to estimate 'health' within the current evaluative framework could be improved both in terms of the generation of descriptive systems and in using valuation methods that rely less on people's ability to express their preferences on a cardinal scale. In exploring these issues the Investigating Choice Experiments for Preferences of Older People (ICEPOP) programme has explicitly focused on both the topic of older people and the methods of discrete choice experiments. A capability index has been developed and attributes for an economic measure of end-of-life care are currently being generated, providing the possibility of extending the evaluative framework beyond health alone. A measure of carer's experience and a framework for extending measurement in end-of-life care to loved ones are both also in development, thus extending the evaluative framework beyond the patient alone. Rigorous qualitative methods employing an iterative approach have been developed for use in constructing attributes, and best-worst scaling has been utilized to reduce task complexity and provide insights into heterogeneity. There are a number of avenues for further research in all these areas, but in particular there is need for greater attention to be paid to the theory underlying the evaluative framework within health economics.