Acceptability of a proposed practice pharmacist-led review for opioid-treated patients with persistent pain: A qualitative study to inform intervention development.

Introduction: Regular review of patients prescribed opioids for persistent non-cancer pain (PCNP) is recommended but not routinely undertaken. The PROMPPT (Proactive clinical Review of patients taking Opioid Medicines long-term for persistent Pain led by clinical Pharmacists in primary care Teams) research programme aims to develop and test a pharmacist-led pain review (PROMPPT) to reduce inappropriate opioid use for persistent pain in primary care. This study explored the acceptability of the proposed PROMPPT review to inform early intervention development. Methods: Interviews (n = 15) and an online discussion forum (n = 31) with patients prescribed opioids for PCNP and interviews with pharmacists (n = 13), explored acceptability of a proposed PROMPPT review. A prototype PROMPPT review was then tested and refined through 3 iterative cycles of in-practice testing (IPT) (n = 3 practices, n = 3 practice pharmacists, n = 13 patients). Drawing on the Theoretical Framework of Acceptability (TFA), a framework was generated (including a priori TFA constructs) allowing for deductive and inductive thematic analysis to identify aspects of prospective and experienced acceptability. Results: Patients felt uncertain about practice pharmacists delivering the proposed PROMPPT review leading to development of content for the invitation letter for IPT (introducing the pharmacist and outlining the aim of the review). After IPT, patients felt that pharmacists were suited to the role as they were knowledgeable and qualified. Pharmacists felt that the proposed reviews would be challenging. Although challenges were experienced during delivery of PROMPPT reviews, pharmacists found that they became easier to deliver with time, practise and experience. Recommendations for optimisations after IPT included development of the training to include examples of challenging consultations. Conclusions: Uptake of new healthcare interventions is influenced by perceptions of acceptability. Exploring prospective and experienced acceptability at multiple time points during early intervention development, led to mini-optimisations of the prototype PROMPPT review ahead of a non-randomised feasibility study.

Designing a primary care pharmacist-led review for people treated with opioids for persistent pain: a multi-method qualitative study.

BACKGROUND: Opioids are frequently prescribed for persistent non-cancer pain despite limited evidence of long-term effectiveness and risk of harm. Evidence-based interventions to address inappropriate opioid prescribing are lacking. AIM: To explore perspectives of people living with persistent pain to understand barriers and facilitators in reducing opioids in the context of a pharmacist-led primary care review, and identify review components and features for optimal delivery. DESIGN & SETTING: Primary care multi-method qualitative study. METHOD: Adults with experience of persistent pain and taking opioids participated in semi-structured interviews (n=15, 73% female) and an online discussion forum (n=31). The Theoretical Domains Framework (TDF) provided a framework for data collection and thematic analysis, involving deductive analysis to TDF domains, inductive analysis within-domains to generate subthemes, and subtheme comparison to form across-domain overarching themes. The behaviour change technique taxonomy v.1 and motivational behaviour change technique classification system were used to systematically map themes to behaviour change techniques to identify potential review components and delivery features. RESULTS: 32 facilitator and barrier subthemes for patients reducing opioids were identified across 13 TDF domains. These combined into six overarching themes: learning to live with pain, opioid reduction expectations, assuming a medical model, pharmacist-delivered reviews, pharmacist-patient relationship and patient engagement. Subthemes mapped to 21 unique behaviour change techniques, yielding 17 components and five delivery features for the proposed PROMPPT review. CONCLUSION: This study generated theoretically-informed evidence for design of a practice pharmacist-led PROMPPT review. Future research will test the feasibility and acceptability of the PROMPPT review and pharmacist training.

Perspectives of community pharmacy staff on commonly encountered skin conditions and the key challenges towards enhancing their role in dermatology.

This research letter discusses the perspectives of community pharmacy staff on commonly encountered skin conditions and the key challenges towards enhancing their role in this area. A mixed methods online survey was created, and a total of 174 community pharmacy staff completed the survey. The results highlight the range of conditions currently encountered in community pharmacy and the breadth of challenges facing community pharmacy staff, in particular challenges surrounding providing a differential diagnosis. Community pharmacies are an integral part of the NHS and have a key role in managing skin conditions; however, in order to optimise this role, the perspectives of staff discussed in this letter need to be further explored and addressed.

Distinguishing emotional distress from mental disorder: A qualitative exploration of the Four-Dimensional Symptom Questionnaire (4DSQ).

BACKGROUND: Primary care clinicians see people experiencing the full range of mental health problems. Determining when symptoms reflect disorder is complex. The Four-Dimensional Symptom Questionnaire (4DSQ) uniquely distinguishes general distress from depressive and anxiety disorders. It may support diagnostic conversations and targeting of treatment. AIM: We aimed to explore peoples' experiences of completing the 4DSQ and their perceptions of their resulting score profile across distress, depression, anxiety and physical symptoms. DESIGN AND SETTING: A qualitative study conducted in the UK with people recruited from primary care and community settings. METHOD: Participants completed the 4DSQ then took part in semi-structured telephone interviews. They were interviewed about their experience of completing the 4DSQ, their perceptions of their scores across four dimensions, and the perceived utility if used with a clinician. Interviews were transcribed verbatim and data were analysed thematically. RESULTS: Twenty-four interviews were conducted. Most participants found the 4DSQ easy to complete and reported that scores across the four dimensions aligned well with their symptom experience. Distinct scores for distress, depression and anxiety appeared to support improved self-understanding. Some valued the opportunity to discuss their scores and provide relevant context. Many felt the use of the 4DSQ with clinicians would be helpful and likely to support treatment decisions, although some were concerned about time-limited consultations. CONCLUSION: Distinguishing general distress from depressive and anxiety disorders aligned well with people's experience of symptoms. Use of the 4DSQ as part of mental health consultations may support targeting of treatment and personalisation of care.

Perceptions and experiences of living with and providing care for multimorbidity: A qualitative interview study.

Background: Experiences of living with and seeking care for multimorbidity is a relatively under-researched field. By analysing experiences of people with multimorbidity, caregivers and care professionals, we can better understand the complex care needs of those with multimorbidity and identify improvements to care management. This paper reports findings from research that elicited the views of key stakeholders to inform future care practice and policy. Aim: To elicit care recipient and care provider views to understand the care needs of those living with and seeking care for multimorbidity. Method: A qualitative interview study using purposive sampling of those living with and providing care in multimorbidity. Results: Increased support to those with multimorbidity and caregivers to navigate care systems was advocated. Establishing trusting care relationships featured prominently in participants accounts. Fragmented care, inadequate coordination and poor communication between care providers, were identified as system-wide challenges. There was agreement that integrated care models were needed, which delivered personalised care, such as shared decision-making, choice in care options and accessing services, and individualised care plans. Conclusion: We found significant agreement among stakeholders on care need and management in multimorbidity. Understanding the experiences of those with multimorbidity, caregivers and care professionals, can inform future improvements in care management.

'Either something's wrong, or I'm a terrible parent': A systematic review of parent experiences of illness-related interpretations for unsettled babies.

AIMS: To explore parents' experiences of unsettled babies and medical labels. DESIGN: Qualitative systematic review, thematic synthesis and development of a conceptual model. REVIEW METHODS: Systematic review and thematic synthesis of primary, qualitative research into parents' experiences of unsettled babies <12 months of age. 'Unsettled' was defined as perception of excessive crying with additional feature(s) such as vomiting, skin or stool problems. The Critical Appraisal Skills Programme (CASP) checklist was used to assess trustworthiness. DATA SOURCES: Structured searches completed in CINAHL, Medline, Embase, PsychINFO and CochraneCT on 23 March 2022 and rerun on 14 April 2023. RESULTS: Ten eligible studies were included across eight countries contributing data from 103 mothers and 24 fathers. Two analytical themes and eight descriptive themes were developed. Firstly, parents expressed fearing judgement, feeling guilty and out of control as a result of babies' unsettled symptoms and seeking strategies to construct an 'Identity as a "Good Parent"'. This desire for positive parenting identity underpinned the second analytical theme 'Searching for an explanation' which included seeking external (medical) causes for babies' unsettled behaviours. CONCLUSION: Parents can become trapped in a cycle of 'searching for an explanation' for their baby's unsettled behaviours, experiencing considerable distress which is exacerbated by feelings of guilt and failure. IMPACT AND IMPLICATIONS FOR PATIENT CARE: Insight gained from this review could inform interventions to support parents, reducing inaccurate medicalization. Health visiting teams supporting parents with unsettled baby behaviour could focus on supporting a positive parenting identity by managing expectations, normalizing the continuum of infant behaviours, reducing feelings of guilt or uncertainty and helping parents regain a feeling of control. REPORTING METHOD: ENTREQ guidelines were adhered to in the reporting of this review. PATIENT OR PUBLIC CONTRIBUTION: Parent input was crucial in the design phase; shaping the language used (e.g., 'unsettled babies') and in the analysis sense-checking findings.

Living with unsettled baby behaviours: Qualitative interview study exploring parental perceptions and experiences of help-seeking.

AIM: To explore parents' perceptions/experiences of help-seeking for unsettled baby behaviours, including views and experiences of obtaining advice from primary healthcare professionals. DESIGN: Semi-structured qualitative interviews. METHODS: Recruitment occurred via social media, general practice and health visiting teams. Remote semi-structured interviews were conducted with parents of babies. Babies were under 12 months old at time of interview, and parents had perceived unsettled baby behaviours in their first 4 months of life. Interviews were transcribed and data analysed using reflexive thematic analysis. RESULTS: Based on interviews with 25 mothers, four main themes were developed. 'The need for answers' highlighted parental uncertainty about what constitutes normal baby behaviour, leading to help-seeking from multiple sources. 'The importance of health professionals' and 'Experiencing health professional support' identified perceptions about limited access, communication, mixed advice and how these influenced parental perception/management of behaviours. 'Foundations to help-seeking' highlighted important roles of social support and online help for valued shared experiences, emotional and practical support. CONCLUSION: Health professional access and advice are important to parents, despite the increasing role of online help and importance of social support. More support and improved access to reliable sources of information is needed for parents. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Findings will inform future research and clinical practice to address parental uncertainties. Qualitative research with front-line health professionals is necessary. IMPACT: Findings can inform the development of resources to support professionals/families managing unsettled babies. REPORTING METHOD: Standards for Reporting Qualitative Research. PUBLIC INVOLVEMENT: A public contributor was involved throughout all stages of the research. Emerging findings were discussed at a parent group. WHAT DOES THIS PAPER CONTRIBUTE TO THE WIDER GLOBAL CLINICAL COMMUNITY?: Addressing parental uncertainties is important; about what is normal, non-pharmacological approaches and when pharmacological intervention is required. A digital information/self-management intervention may be useful for parents/clinicians.

Multiple long-term conditions, loneliness and social isolation: A scoping review of recent quantitative studies.

BACKGROUND: Multiple long-term conditions (MLTC), loneliness and social isolation are common in older adults. Recent studies have explored the association of MLTC with loneliness and social isolation. This scoping review aimed to map this current evidence and identify gaps in the literature. METHODS: A scoping review was conducted following the PRISMA guidelines for scoping reviews. Ovid Medline, Embase, CINAHL, The Cochrane Library, PsycInfo, and Bielefeld Academic Search Engine were searched for studies published between January 2020-April 2023. Quantitative studies, published in any language, that assessed the association of MLTC with loneliness and/or social isolation were included. RESULTS: 1827 records were identified and screened. Of these, 17 met inclusion criteria. Most studies were cross-sectional and based on older adults. Studies were conducted in Europe, the US, Canada, and low- and middle-income countries. Ten studies focused on the association between MLTC and loneliness, six assessed the association between MLTC and social isolation and one examined associations with both loneliness and social isolation. Most studies reported a significant cross-sectional association of MLTC with loneliness, but there was weaker evidence for a longitudinal association between MLTC and loneliness and an association between MLTC and social isolation. Studies were heterogenous in terms of measures and definitions of loneliness/social isolation and MLTC, confounders adjusted for, and analytical models used, making comparisons difficult. CONCLUSIONS: Further population-based longitudinal studies using consistent measures and methodological approaches are needed to improve understanding of the association of MLTC with both loneliness and social isolation.

Healthcare professionals' experiences and views of providing continence support and advice to people living at home with dementia: "That's a carer's job".

BACKGROUND: People living with dementia at home and their family carers often feel unsupported by healthcare professionals in managing continence problems. In turn, primary and community-based healthcare professionals have reported lacking specific knowledge on dementia-continence. This study aimed to understand more about healthcare professionals' experiences and views of supporting people living with dementia experiencing continence problems, as part of developing acceptable resources. Having a nuanced understanding of unmet need would facilitate the design of engaging resources that enable healthcare professionals to provide more effective continence support to people living with dementia at home. METHODS: Semi-structured interviews were conducted with a range of healthcare professionals (n = 31) working in primary and community care in the South of England in 2023. Transcribed interviews were uploaded to NVivo 12, then analysed inductively and deductively using a thematic framework. RESULTS: Continence-related conversations were avoided by many healthcare professionals due to lack of dementia-continence specific knowledge. Many considered that continence problems of people living with dementia were largely outside their remit once a physical cause had been ruled out. This contributed to a lack of priority and proactivity in raising the subject of continence in their consultations. Challenges to providing support included limited consultation time and lack of access to specialist services with availability to support individuals. CONCLUSION: There is substantial scope to support primary and community-based healthcare professionals in their provision of continence-related support and advice to people living at home with dementia. This includes addressing knowledge deficits, enhancing confidence and instilling a sense of accomplishment.

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 .

How can community pharmacists be supported to manage skin conditions? A multistage stakeholder research prioritisation exercise.

OBJECTIVE: To establish research priorities which will support the development and delivery of community pharmacy initiatives for the management of skin conditions. DESIGN: An iterative, multistage stakeholder consultation consisting of online survey, participant workshops and prioritisation meeting. SETTING: All data collection took place online with participants completing a survey (delivered via the JISC Online Survey platform, between July 2021 and January 2022) and participating in online workshops and meetings (hosted on Microsoft Teams between April and July 2022). PARTICIPANTS: 174 community pharmacists and pharmacy staff completed the online survey.53 participants participated in the exploratory workshops (19 community pharmacists, 4 non-pharmacist members of pharmacy staff and 30 members of the public). 4 healthcare professionals who were unable to attend a workshop participated in a one-to-one interview.29 participants from the workshops took part in the prioritisation meeting (5 pharmacists/pharmacy staff, 1 other healthcare professional and 23 members of the public). RESULTS: Five broad areas of potential research need were identified in the online survey: (1) identifying and diagnosing skin conditions; (2) skin conditions in skin of colour; (3) when to refer skin conditions; (4) disease-specific concerns and (5) product-specific concerns.These were explored and refined in the workshops to establish 10 potential areas for research, which will support pharmacists in managing skin conditions. These were ranked in the prioritisation meeting. Among those prioritised were topics which consider how pharmacists work with other healthcare professionals to identify and manage skin conditions. CONCLUSIONS: Survey responses and stakeholder workshops all recognised the potential for community pharmacists to play an active role in the management of common skin conditions. Future research may support this in the generation of resources for pharmacists, in encouraging public take-up of pharmacy services, and in evaluating the most effective provision for dealing with skin conditions.

Selective serotonin reuptake inhibitors (SSRIs) in women of reproductive age: a systematic review of local formularies.

BACKGROUND: Depression is the second most common chronic condition affecting women of reproductive age; 23.4% of women enter pregnancy with depression and use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy is often necessary for maternal wellbeing. However, SSRI use during pregnancy can cause congenital malformations, postpartum haemorrhage (PPH), and persistent pulmonary hypertension of the newborn (PPHN). In UK primary care, prescribing formularies are one medium by which prescribers are provided with local medicines advice. AIM: To review all local prescribing formularies with respect to prescribing SSRIs in women of reproductive age, during pregnancy, and during breastfeeding. DESIGN & SETTING: A systematic review of prescribing formularies in England and Wales. METHOD: A systematic keyword search of all clinical commissioning group and Integrated Care Board websites in England and Local Health Board websites in Wales was undertaken between December 2021-22 to identify prescribing formularies. Data were extracted on prescribing guidance for SSRIs. RESULTS: Seventy-four prescribing formularies were reviewed. Of these, 14.9% (n = 11/74) provided links to the Medicines and Healthcare products Regulatory Agency guidance on congenital abnormalities associated with SSRIs, 28.4% (n = 21/74) provided links to guidance on PPH risk, and 1.4% (n = 1/74) provided links to guidance on PPHN. Specific local guidance was given on SSRI prescribing for women of reproductive age, during pregnancy, and during breastfeeding in 12.2% (n = 9/74), 23.0% (n = 17/74), and 21.6% (n = 16/74) of formularies, respectively. CONCLUSION: Our results suggest that prescribers may be poorly informed by local formularies about the risks of SSRI use around pregnancy. This could place babies at increased risk of unintentional SSRI exposure.

Pharmacists' perspectives on recommending herbal medicines for acute infections: a qualitative study.

BACKGROUND: Community pharmacists have an essential role in antimicrobial stewardship by providing self-care advice for self-limiting infections. AIM: To explore community pharmacists' perceptions and experiences of advising patients on management of acute respiratory tract infections (RTIs) and urinary tract infections (UTIs), and to explore issues regarding use of over-the-counter (OTC) medicines, including herbal medicines. DESIGN & SETTING: A qualitative study using semi-structured interviews with community pharmacists in England. METHOD: Qualitative interviews with community pharmacists were carried out face to face and by telephone between November 2019 and March 2020. Data were collected through in-depth, semi-structured interviews, recorded and transcribed. A reflexive thematic analysis was undertaken. RESULTS: In total, 18 community pharmacists were interviewed. Three main themes were identified. Theme 1 was self-management recommendations. Community pharmacists considered patients' preferences when recommending self-management strategies. Some believed that conventional OTC medications had quicker and stronger effects, while others preferred herbal OTCs as a more natural approach, particularly for less severe symptoms. Theme 2 was factors influencing pharmacists' recommendations for acute infections. This included pharmacists' perceptions of patient preferences, nature or severity of illness, research evidence, training, commercial pressures, and patient concerns about medication cost. Theme 3 was pharmacist-patient communication. Pharmacists sometimes experienced challenges with language barriers and patients' expectations of receiving antibiotics. Pharmacists emphasised the importance of being trusted by their patients. There was widespread acceptance of their role in self-management advice for acute illness and interest in the role of herbal medicines, but pharmacists did not feel confident in recommending these. CONCLUSION: Pharmacists are central to the management of self-limiting infections. There is a need to educate the public about appropriate use of antibiotics and provide training and support for pharmacists on self-management strategies including herbal medicine.

The association between stress and multiple long-term conditions: A cohort study.

BACKGROUND: Stress is an important predictor of long-term conditions. We examine whether hair cortisol (a biomarker of stress) is associated with incidence and accumulation of multiple long-term conditions (MLTC). METHODS: We included data from 4295 individuals aged ≥50 years within the English Longitudinal Study of Ageing dataset with data on hair cortisol, sociodemographic and health behaviour variables. Cox proportional hazards models were used to quantify the association between hair cortisol at baseline and accumulation of MLTC between 2012/2013 and 2018/2019, both for individuals with and without MLTC at baseline. RESULTS: Our cohort included 1458 (34.0%) individuals who accumulated MLTC between 2012/2013 and 2018/2019. The proportion of individuals with zero, 1, and ≥ 2 conditions at baseline who accumulated MLTC were 12.0% (n = 127), 40.4% (n = 520), and 41.7% (n = 811), respectively. Higher cortisol levels were associated with higher risk of accumulation of MLTC in both unadjusted [HR:1.15(1.05-1.25)] and models adjusted for sociodemographic and health behaviours [HR:1.12(1.02-1.22)]. For individuals without MLTC at baseline, higher cortisol levels were significantly associated with higher risk of developing MLTC in unadjusted [HR: 1.20(1.05-1.36)] and adjusted models [HR: 1.16(1.02-1.32)]. CONCLUSION: The study provides the first evidence of the role of stress in the development and accumulation of MLTC. This modifiable risk factor could be targeted to reduce the risk of MLTC. However, further work is needed to better understand the mechanisms and pathways that link stress and accumulation of MLTC.

Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial.

OBJECTIVE: This study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks. DESIGN: Economic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial. SETTING: Primary and secondary healthcare, community and social media advertising. PARTICIPANTS: Women ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment. INTERVENTIONS: Participants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment. MAIN OUTCOME MEASURES: Cost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator's global assessment, IGA <3 vs ≥3)) and baseline variables (Acne-QoL symptom subscale score, resource use costs, EQ-5D score and use of topical treatments). RESULTS: Spironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence's threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis). CONCLUSIONS: The results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis. TRIAL REGISTRATION NUMBER: ISRCTN registry (ISRCTN12892056).

Managing acne vulgaris: an update.

Acne vulgaris is very common and can have significant negative impact on people. While sometimes a transient problem, acne may persist for many years and often leads to permanent scars or pigment changes. Guidelines unanimously advise topical treatments as first-line, although differ in recommending either topical benzoyl peroxide or topical retinoid (mainly adapalene) alone or in combination. Guidance published by the National Institute for Health and Care Excellence advises counselling patients regarding avoidance of skin irritation when starting topical treatments and promoting adherence (treatments take 6-8 weeks to work). Oral antibiotics are currently overprescribed for acne but have a role when coprescribed with a non-antibiotic topical treatment. Hormonal treatments, such as the combined contraceptive pill, are also effective and there is growing evidence for the use of spironolactone for women with persistent acne. Recent guidance from the Medicines and Healthcare products Regulatory Agency regarding isotretinoin has implications for specialist prescribing and monitoring, and increasing public awareness of potential risks of mental health problems and sexual dysfunction. Although acne is associated with psychiatric disorder, the mental health effects of isotretinoin remain controversial.

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.

Factors that influence women's enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial.

BACKGROUND: The use of decentralised clinical trials (which bring trials to patients through remote processes and technology versus central on-site visits) has been thought to be a potential solution to common recruitment and retention barriers. However, there is a lack of evidence to understand the experiences, needs and preferences of the public to inform trial methodologies that appeal to different populations. We report participant experiences of SAFA, a partially decentralised randomised clinical trial, to inform the methodology used in future dermatology trials that aim to appeal to women aged 18 and over. METHODS: Participants of the SAFA (Spironolactone for Adult Female Acne) trial were invited to take part in a qualitative semi-structured interview to explore their experience and perspectives of taking part in the trial. Questions focused on their experience of using decentralised methods to access and enrol in the trial (e.g. social media advertising), in addition to the decentralised trial visit and data collection methods used throughout. Interviews were conducted remotely, recorded, and transcribed. Data were analysed using reflexive thematic analysis. RESULTS: Twelve SAFA participants (all women, age range 22-36 years) were interviewed. Initially, participants were influenced to enrol by trusted online information, the feeling of validation the trial provided, and the convenience and flexibility offered by the decentralised methods and research staff made participants feel valued and enabled them to engage in the trial with minimal interference to existing commitments. SAFA participants were generally accepting of trial demands, such as the text-heavy paperwork and on-site visits for blood collection and highlighted several areas relevant for trial conduct going forwards including where decentralised methods may (and may not) be accepted and how trial accessibility and understanding could be improved. CONCLUSIONS: The study has shown that decentralised methods used by responsive and approachable staff were widely accepted in the SAFA trial. Interviewees found the methods adopted in the SAFA trial helped the trial to fit with their needs and promoted a sense of feeling valued that encouraged ongoing trial engagement. Decentralised methods should be considered favourably when designing a dermatology trial as they can potentially enhance both recruitment and retention. TRIAL REGISTRATION NUMBER: ISRCTN 12892056. Registered on October 15, 2018.